WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Prior to commencing chyme reinfusion therapy the patient’s distal intestine must be
checked to ensure patency. A method of doing this is contrast imaging.
The Insides System contains two sizes of The Insides Tube, 28 Fr and 22 Fr. As a general
guide:
If the Clinician determines that neither the 28 Fr or 22 Fr tube sizes are appropriate, a
minimum 20 Fr balloon retained tube is recommended. Please note, a balloon retained tube with an ENFit™ connection does not couple with The Insides Pump.
The Insides Tube 28Fr tube is recommended when applicable. If the 28Fr does not fit, smaller tubes can be used to reinfuse small boluses to rehabilitate the intestine. After a short period EN 10 of intestinal rehabilitation, the patient may be able to transition to a version of The Insides Tube or transition from the 22 Fr to the 28 Fr Tube.
If a patient has a parastomal hernia, caution is needed when inserting the tube. Possible bowel kinking can prevent the tube from being inserted and can create a risk of perforation. The increased external length of bowel can prevent the tube from being positioned and anchored correctly. Digitally palpating the distal tract will indicate the direction of distal limb, any narrowing or kinking, and the distance to fascia.
If the patient has a prolapsed distal limb of their enterostomy or enterocutaneous fistula (ECF), caution is needed when inserting the tube due to the extended, unsupported length of intestine that is external to the body. The Insides Tube is not suitable for this type of patient.
If a patient has an ECF, caution and careful clinical decision making are required when selecting the correct tube to use for the patient. Patients may have little or no fascia around the location of tube insertion. Consequently, a retention sleeve or cuff may not prevent the migration of the tube into the distal intestine as it matures. An appropriate tube should be selected and monitored to ensure the migration does not occur.
The Insides Tube can be used with any ostomy appliance. Initially, it is recommended the patient use a clear ostomy appliance, so it is easy to watch chyme move up the tube and see the volume in the ostomy appliance decreasing. If a tube, other than The Insides Tube, is required initially, then this tube and pump must fit comfortably within the ostomy appliance without any pressure exerted on the tube and The Insides Pump.
The installation of a feeding tube into the patient’s distal limb may increase the size of the stoma on the abdomen. Consequently, it is recommended that the patient’s template on the base plate of the ostomy appliance, is re-measured. This is to ensure there is a clearance of 2 – 3 mm between the enterostomy and the edge of the base plate. This allows for peristalsis and the natural movement of the enterostomy and tube complex to prevent the risk of mucosal erosion due to rubbing on the side of the base plate. It is best to re-measure the patient’s template periodically. The base plate should also be re-measured if there have been any changes as a result of weight gain, weight loss, herniation, or prolapse.
When starting therapy with The Insides System, the patient will spend a short period of time increasing their tolerance to chyme reinfusion therapy, rehabilitating their distal bowel, and slowly introducing oral food. During this period, it is recommended to keep the patient’s parenteral nutrition prescription and anti-motility medication at the same dose. This will allow the patient to become independent with The Insides System and not become overwhelmed with the increase in their output from weaning the anti-motility medication. This will also maintain their nutrition while they are transitioning to reinfuse all of their output and ensure their nutrition is optimised.
THE INSIDES® Driver (driver) should be fully charged before the first use. The charging light will turn ON while the driver is charging and will turn OFF when it is fully charged. The full charge cycle could take up to four hours. After each use of the driver, all accessible surfaces should be wiped down using a damp cloth followed by an EPA recommended disinfectant wipe.
Before commencing prepare a clean work station and don gloves.
The patient must have visibility into the ostomy appliance to ensure that THE INSIDES® System is successfully reinfusing chyme. Use a clear ostomy appliance or remove outer lining of the patient's usual ostomy appliance to ensure adequate visibility.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
THE INSIDES® Tube must be inserted by a healthcare professional. The Insides® Tube must be replaced every 28 days.
1. Select the appropriately size feeding tube based on the diameter of the patient’s
stoma.
2. The patient should be resting in a comfortable supine position. Remove the patient's ostomy appliance and wipe away any excess chyme from the area. Only reinfuse chyme that is less than eight-hours old. Store the patient's chyme if this is the first use of THE INSIDES® System.
3. Unpackage the tube. A retention sleeve and guidewire are also provided to aid user comfort and insertion, respectively.
4. Lubricate the tube using 10-20 mL of water-based lubricant as described below:
a. Unfold the arms of the retention
sleeve from the tube.
b. Spread lubricant in front of and
behind the retention sleeve. With adequate force, pull the retention sleeve backward, towards the handle of the guidewire, over the lubricant, then return it to its original position. Continue this until the retention sleeve moves freely. Add more lubricant if it is required. Then, move the retention sleeve towards the bulbous section of the tube. Ensure the retention sleeve is not pulled off.
c. Lubricate the bulbous section of the tube.
d. Set the tube aside on the clean workstation.
5. With additional lubricant, digitally examine the direction of the
distal tract. Palpate the fascia to gauge the approximate length required for the insertion of the tube. If the distal tract is tight or kinked, insert 3-10 mL of additional lubricant.
6. During the examination, the patient may feel some abdominal discomfort. Discomfort is due to the stretching of the intestinal lumen and should be expected. After digitally palpating the distal tract, replace gloves.
7. Collapse the tube's bulbous feature by inserting the guidewire until the base of the tube touches the 'stop' on the guidewire. Pinch the guidewire between the tube and maintain pressure so it stays in place. Ensure that the guidewire's tip is sitting within the nose of the tube and not sticking out through the bulbous section.
8. While the bulbous section is collapsed, use the free hand to guide the tube and insert it into the distal limb. Apply gentle pressure until the bulbous feature of the tube is 10-20 mm past the abdominal fascia. The intestine may not allow the tube to be immediately inserted; it may take up to 60 seconds for peristalsis to help move the tube into place.
9. Firmly hold the tube in place with one hand and remove the guidewire with the other.
10. Allow the tube to settle into its natural position. The tube may move outwards up to 10mm due to peristalsis.
11. Move the retention sleeve up the tube until it sits 1-2 mm away from the stoma. Fold the arms of the retention sleeve over the tube to secure it in place.
Due to differing patient anatomy, the retention sleeve may block the proximal outlet. If this occurs, chyme may leak under the baseplate of the ostomy appliance. If this happens, the retention sleeve can be moved down the tube, away from the stoma.
12. Gently tug on the tube to confirm it is anchored in place.
13. If the tube becomes dislodged, remove it entirely from the patient before reinserting the guidewire into the tube:
a. Move the retention sleeve toward the bulbous feature.
b. Insert lubricant into the Tube.
c. Insert the guidewire into the Tube, beyond the retention sleeve in a single fluid
motion.
d. If the guidewire does not slide beyond the retention sleeve, move the guidewire's tip back into the lubricant, then repeat Step c.
e. Hold the guidewire in place and move the retention sleeve to the centre of the Tube.
f. Return to Step 3.
14. Once the tube is successfully inserted, dispose of the guidewire appropriately.
WARNING: Do not insert the guidewire into the Tube while it is positioned inside a patient - this could result in perforation of the bowel.
NOTE: Peristalsis may move the tube in and out of the stoma slightly. When placed correctly, the tube should not fall out on its own and the retention sleeve will prevent it from being pulled too far into the distal intestine.
1. Connect the pump to the tube. The base of the tube should touch the third ring of the pump outlet to ensure it cannot be accidentally dislodged.
2. Allow the patient or their carer to practise connecting and disconnecting the pump while ensuring that the tube position is not disturbed.
3. Measure the ostomy appliance against the tube and pump. Trim the end of the tube so
that the pump sits 10-20 mm above the bottom of the ostomy appliance when attached.
4. The pump can rotate around the tube until oriented such that the position allows the connecting of the pump to the driver.
A clip is provided to hold the tube in place. Once the Ostomy appliance has been applied, a clip can be attached to the tube from the outside of the bag to help prevent the tube falling out and
reduce pulling on the stoma. Choose the clip that will fit around the section of the tube immediately below the retention sleeve.
This will depend on the size of the tube and how short the tube is trimmed. Ensure the patient is aware of which clip should be used.
1. Assess the suitability of the patient's chyme from the patient's previous ostomy
appliance.
a. Pinch the ostomy appliance between the thumb and forefinger. Release it quickly to observe the time it takes for the chyme to refill the space. If it is instantaneous, the chyme can be pumped; otherwise, it may be too thick and should be discarded.
b. Chyme sitting for less than eight hours is suitable for pumping; otherwise, it must be discarded.
c. There must be enough volume for the Pump to be fully submerged in the chyme, approximately 70-100 mL.
2. If the patient's chyme is suitable for reinfusing, transfer the chyme into the new ostomy appliance. If not, fill a new ostomy appliance with enough water to submerge the Pump. Water can be used to demonstrate chyme reinfusion to the patient. Ensure the patient understands that they should not add water to the ostomy appliance in any other setting. Secure the ostomy appliance as described above.
1. Ensure the pump is fully submerged in the chyme.
2. Magnetically connect the pump to the driver.
a. Hold the driver and pump in an orientation allowing the user to see the tube. The user should be able to be to see whether chyme is progressing up the tube.
3. Reinfusing chyme stretches the luminal walls of the bowel, which may cause abdominal discomfort. To reduce this discomfort, begin chyme reinfusion slowly. For more information, refer to the ETD-14 Patient Management listed on The Insides Company Training Portal.
a. While holding the pump against the driver, press the 'MODE' button to start at 'MODE 1', the slowest speed setting. If chyme moves quickly up the tube, stay on 'MODE 1' and reinfuse a small volume of chyme.
b. After 30 seconds, if chyme is not progressing up the
tube, increase to the next ‘MODE’. Continue this process until chyme is progressing up the tube. If chyme is not progressing up the tube after 60 seconds on 'MODE 5', refer to the Troubleshooting section below.
c. If chyme starts to reflux out of the stoma, or if the patient feels nauseous or bloated, reduce the 'MODE' on the driver or cease reinfusing for several minutes. Reducing the ‘MODE’ can be accomplished by pressing the ‘MODE’ button, which transitions through all five speeds and off. For further information about reflux, refer to the Troubleshooting section.
4. After reinfusing a small amount of chyme, decouple the driver from the pump and turn it off by cycling through each ‘MODE’.
Ensure the patient receives routine ostomy appliance changes. Make sure the patient takes care when removing the appliance so that the tube is not pulled out. The pump may get caught in the ostomy appliance upon removal. Ensure the patient holds onto the tube with one hand and removes the ostomy appliance with the other hand. If this is too difficult, detach the pump from the tube within the ostomy appliance to be removed together.
The time required to reinfuse chyme varies depending on the chyme's thickness, which may differ across the day and the patient's oral intake. THE INSIDES® System is not suitable for thick or fibrous chyme, therefore some chyme may be discarded. Any amount of chyme that is refed is beneficial.
The patients using THE INSIDES® System should adhere to the following steps for optimal results:
If reinfusion takes longer than expected or if the patient is unable to reinfuse, attempt the following remedial steps:
If none of these solutions work, THE INSIDES® System may not be suitable for the patient.
When using THE INSIDES® System, patients may experience reflux of chyme from the distal intestine, around the tube, back into the ostomy appliance. Reflux occurs when the distal intestine receives more chyme than it can accommodate. While reflux is not harmful to the patient, it can increase its time to reinfuse successfully.
Reflux may be reduced by:
NOTE: Loperamide and similar anti-motility therapies can cause constipation, blocking the intestine and preventing chyme reinfusing. Adjust the dose of motility therapies as required and refer to ETD-14 Patient Management with The Insides System if further action is needed.
Please contact the manufacturer or the local representative for assistance with setting up, using, or maintaining THE INSIDES™ System or to report unexpected operations or events.
Local Representative Contact Information:
Online Assistance
Company
The Insides Company LTD
Website
clinical@theinsides.co
New Zealand
Company
The Insides Company LTD
Phone
+64 9 887 9309
Address
487 Parnell Rd, Parnell
Auckland 1052
New Zealand
Australian Sponsor
Company
GSE Pty. Ltd.
Phone
+61 (412) 159 732
Address
323 Toohey Road,
Tarragindi, QLD 4121
Australia
EC Representative
Company
Advena LTD
Phone
+44 20 3389 6331
Address
Tower Business Centre, 2nd Fl.
Tower Street, Swatar, BKR 4013
Malta
UK Representative
Company
Advena LTD
Phone
+44 (0) 1926 800153
Address
Pure Offices
Plato Close, Tachbrook Park
Warwick CV34 6WE UK
CH Representative
Company
Swiss AR Services GmbH
Phone
+41 41 480 40 00
Address
Industriestrasse 47
CH-6300 Zug,
Switzerland
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Avant de commencer le traitement par réinstillation du chyme, l’intestin distal du patient doit être examiné pour s’assurer de sa perméabilité. Cela peut être effectué avec l’imagerie par contraste.
The Insides System offre deux tailles de The Insides Tube : 28 Fr et 22 Fr. De manière
générale :
Si le médecin détermine que ni la sonde de 28 Fr ni la sonde 22 Fr ne sont appropriées, il est recommandé d’utiliser une sonde à ballonnet de retenue d’au moins 20 Fr. Veuillez noter qu’une sonde à ballonnet de retenue avec une connexion ENFitTM n’est pas compatible avec The Insides Pump.
The Insides Tube de 28 Fr est recommandée le cas échéant. Si la sonde de 28 Fr ne convient pas, de plus petites sondes peuvent être utilisées pour réinstiller des petits bolus afin de rééduquer l’intestin. Après une courte période de rééducation intestinale, le patient peut être en mesure de passer à une version de The Insides Tube ou de passer de la sonde de 22 Fr à celle de 28 Fr.
Si un patient a une hernie parastomale, il faut faire preuve de prudence lors de l’insertion de la sonde. Un éventuel pli de l’intestin peut empêcher l’insertion de la sonde et peut créer un risque de perforation. L’augmentation de la longueur externe de l’intestin peut empêcher la sonde d’être positionnée et ancrée correctement. La palpation digitale du tractus distal indiquera la direction du membre distal, tout rétrécissement ou pliure et la distance par rapport au fascia.
Si le patient présente un prolapsus du membre distal de son entérostomie ou une fistule entéro-cutanée (FEC), il faut faire preuve de prudence lors de l’insertion de la sonde en raison de la longueur étendue et non soutenue de l’intestin qui est externe au corps. The Insides Tube ne convient pas à ce type de patient.
Si le patient a une FEC, il faut faire preuve de prudence et prendre des décisions cliniques avisées lors du choix de la sonde adéquate pour le patient. Les patients peuvent avoir peu ou pas de fascia autour de l’emplacement où la sonde est insérée. Par conséquent, une manche ou un manchon de rétention peut ne pas empêcher la migration de la sonde dans l’intestin distal à mesure qu’il mûrit. Il est important de sélectionner une sonde appropriée et de la surveiller pour s’assurer qu’elle ne migre pas.
The Insides Tube peut être utilisée avec n’importe quel appareillage de stomie. Dans un premier temps, il est recommandé au patient d’utiliser un appareillage de stomie
transparent, de manière à voir facilement le chyme remonter la sonde et voir le volume diminuer dans l’appareillage de stomie. S’il est nécessaire d’utiliser une sonde autre que The Insides Tube au départ, cette sonde et cette pompe devront s’adapter commodément à l’appareillage de stomie sans aucune pression exercée sur la sonde et sur The Insides Pump.
L’installation d’une sonde d’alimentation dans le membre distal du patient peut augmenter la taille de la stomie sur l’abdomen. Par conséquent, il est recommandé de mesurer à nouveau le gabarit du patient sur la plaque de base de l’appareillage de stomie. Il s’agit de s’assurer qu’il y ait un espace de 2 à 3 mm entre l’entérostomie et le bord de la plaque de base. Cela permet le péristaltisme et le mouvement naturel de l’entérostomie et du complexe tubulaire pour prévenir le risque d’érosion des muqueuses due au frottement sur le côté de la plaque de base. Il est indiqué de mesurer le gabarit du patient périodiquement. La plaque de base doit également être mesurée à nouveau s’il y a eu des changements à la suite d’une prise de poids, d’une perte de poids, d’une hernie ou d’un prolapsus.
Lors du démarrage du traitement avec The Insides System, le patient passera une courte période à augmenter sa tolérance au traitement par réinstillation du chyme, à rééduquer son intestin distal et à introduire lentement des aliments par voie orale. Pendant cette période, il est recommandé de maintenir la prescription de nutrition parentérale et les médicaments antimotilité du patient à la même dose. Cela permettra au patient de devenir indépendant avec The Insides System et de ne pas être submergé par l’augmentation de sa production due au sevrage du médicament antimotilité. Cela maintiendra également sa nutrition pendant la période de transition de réinstillation de la production afin d’assurer une nutrition optimale.
Le dispositif de commande THE INSIDES® Driver doit être complètement chargé avant la première utilisation. Le voyant de charge s’allumera pendant le chargement du dispositif de commande et s’éteindra lorsque le dispositif de commande sera complètement chargé Le cycle de charge complète peut prendre jusqu'à quatre heures. Après chaque utilisation du dispositif de commande, toutes les surfaces accessibles du dispositif de commande doivent être essuyées à l'aide d'un chiffon humide afin d'éliminer tout débordement.
Avant de commencer, nettoyez votre poste de travail et mettez des gants.
Le patient doit avoir une bonne visibilité dans l'appareillage de stomie pour s'assurer que le système THE INSIDES® System réinstille le chyme avec succès. Utilisez un appareillage de stomie transparent ou retirez la doublure extérieure de l'appareillage de stomie habituel du patient pour une bonne visibilité.
La pompe THE INSIDES® Pump a un diamètre de 35 mm et sera insérée dans le gabarit de l'appareillage de stomie. Par conséquent, il peut être nécessaire de découper un gabarit plus grand et d'utiliser un joint hydrocolloïde pour protéger la peau exposée. Si cela ne convient pas, on peut utiliser un appareillage de stomie avec une fermeture de type "lock and roll" au fond de la poche. Dans ce cas de figure, la pompe sera connectée à la sonde THE INSIDES® Tube par cette ouverture.
AVERTISSEMENT: N'insérez pas le fil-guide dans la sonde lorsqu'elle est placée à l'intérieur d'un patient - cela pourrait entraîner une perforation de l'intestin.
NOTE : Le péristaltisme peut entraîner un léger déplacement de la sonde de la stomie à l’intérieur ou à l’extérieur. Lorsqu'elle est correctement placée, la sonde ne doit pas
basculer et le manchon de maintien l'empêchera d'être trop tirée dans l'intestin distal.
Un clip est fourni pour maintenir le tuyau en place. Une fois que l'appareil de stomie a été placé, un clip peut être attaché au tuyau depuis l'extérieur du sac pour empêcher le tuyau de tomber et réduire la traction sur la stomie. Choisissez le clip qui s'adaptera autour de la section du tuyau immédiatement sous le manchon de rétention. Cela dépendra de la section du tuyau et de la longueur du tuyau. Assurez-vous d'informer le patient du clip qu'il convient d'utiliser.
Veillez à ce que le patient reçoive les changements d'appareillage de stomie de routine. Veillez à ce que le patient soit prudent lorsqu'il retire l'appareil afin que la sonde ne soit pas arrachée. La pompe peut se coincer dans l'appareillage de stomie lors de son retrait. Veillez à ce que le patient tienne la sonde d'une main et retire l'appareillage de stomie de l'autre main. Si cela est trop difficile, détachez la pompe de la sonde à l'intérieur de l'appareillage de stomie avant le retrait.
Le temps nécessaire pour réinstiller le chyme varie en fonction de l'épaisseur du chyme, qui peut varier au cours de la journée et de la prise orale du patient. Le système THE INSIDES® System n'est pas adapté au chyme épais ou fibreux donc une certaine quantité de chyme peuvent être jetée. Toute quantité de chyme qui est refoulée est bénéfique.
Les patients qui utilisent le système THE INSIDES® System doivent suivre les étapes suivantes pour obtenir des résultats optimaux :
Si la réinstillation prend plus de temps que prévu ou si le patient ne peut pas l’effectuer essayez les mesures correctives suivantes :
Si aucune de ces solutions ne fonctionne, LE SYSTÈME THE INSIDES® System peut ne pas
être adapté au patient.
En utilisant le système THE INSIDES® System, les patients peuvent ressentir un reflux du
chyme de l'intestin distal, autour de la sonde, vers l'appareil de stomie. Le reflux se produit lorsque l'intestin distal reçoit plus de chyme qu'il ne peut en contenir. Bien que le reflux ne soit pas nocif pour le patient, il peut augmenter le temps nécessaire à une bonne réinstillation.
Le reflux peut être réduit :
NOTE: Le lopéramide et les thérapies anti-motilité similaires peuvent provoquer la
constipation, en bloquant l'intestin et en empêchant la réinstillation du chyme. Ajustez la dose des thérapies de la motilité selon les besoins et reportez-vous à la voie de soins des patients ETD-14 Prise en charge des patients si une action supplémentaire est nécessaire.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Inden påbegyndelse af chyme-reinfusionsterapi skal patientens distale tarm kontrolleres for at sikre åbenhed. En metode til at gøre dette er kontrastbilleddannelse.
Insides System indeholder to størrelser af The Insides Tube, 28 Fr og 22 Fr. Som en general vejledning:
Hvis klinikeren fastslår, at hverken 28 Fr eller 22 Fr rørstørrelserne er passende, anbefales et minimum 20 Fr ballonfastholdt rør. Bemærk venligst, at et ballonfastholdt rør med en ENFit™ -forbindelse ikke forbindes med The Insides Pump.
Insides Tube 28Fr-røret anbefales, når det er relevant. Hvis 28Fr ikke passer, kan mindre rør bruges til at reinfundere små boluser for at rehabilitere tarmen. Efter en kort periode med tarmrehabilitering kan patienten muligvis overgå til en version af The Insides Tube eller overgangen fra 22 Fr til 28 Fr Tube.
Hvis en patient har en parastomal brok, skal der udvises forsigtighed, når røret indsættes. Mulig tarmbøjning kan forhindre, at røret indsættes, og kan skabe risiko for perforering. Den øgede ydre længde af tarmen kan forhindre røret i at blive placeret og forankret korrekt. Digital palpering af den distale kanal vil indikere retningen af distale lemmer, enhver indsnævring eller eventuelle knæk og afstanden til fascia.
Hvis patienten har en prolapset distal ekstremitet af deres enterostomi eller enterokutan fistel (ECF), skal der udvises forsigtighed, når røret indsættes på grund af den udvidede, ikke-understøttede tarmlængde, der er uden for kroppen. Insides Tube er ikke egnet til denne type patient.
Hvis en patient har en ECF, skal der udvises forsigtighed og foretages omhyggelig klinisk beslutningstagning, når der vælges det korrekte rør, der skal bruges til patienten. Patienter kan have ringe eller ingen fascia omkring området, hvor røret indsættes. Derfor er det muligt, at en fastholdelsesmuffe eller en manchet ikke forhindrer migrationen af røret ind i den distale tarm, efterhånden som det modnes. Et passende rør skal vælges og overvåges for at sikre, at migrationen ikke forekommer.
Insides Tube kan bruges med ethvert stomiapparat. I første omgang anbefales det, at
patienten bruger et klart stomiapparat, så det er nemt at se chyme bevæge sig op ad røret og se volumenet i stomiapparatet falde. Hvis et andet rør end The Insides Tube er påkrævet i starten, skal dette rør og denne pumpe passe komfortabelt ind i stomiapparatet uden noget tryk på røret og The Insides Pump.
Installationen af et fodringsrør i patientens distale lem kan øge størrelsen af stomien på maven. Derfor anbefales det, at patientens skabelon på stomiapparatets bundplade måles igen. Dette er for at sikre, at der er en afstand på 2 – 3 mm mellem enterostomien og kanten af bundpladen. Dette giver mulighed for peristaltik og den naturlige bevægelse af enterostomi- og rørkomplekset for at forhindre risikoen for slimhindeerosion på grund af gnidning på siden af bundpladen. Det er bedst at måle patientens skabelon med jævne mellemrum. Bundpladen skal også måles igen, hvis der er sket ændringer som følge af vægtøgning, vægttab, brok eller prolaps.
Når behandlingen med The Insides System påbegyndes, vil patienten bruge en kort periode på at øge sin tolerance over for chyme-reinfusionsbehandling, rehabilitere sin distale tarm og langsomt introducere oral mad. I denne periode anbefales det at holde patientens parenterale ernæringsrecept og anti-motilitetsmedicin på samme dosis. Dette vil gøre det muligt for patienten at blive uafhængig med The Insides System og ikke blive overvældet af stigningen i deres output fra fravænning af anti-motilitetsmedicin. Dette vil også opretholde deres ernæring, mens de overgår til at genbruge al deres produktion og sikre, at deres ernæring er optimeret.
THE INSIDES® Driver (driver) should be fully charged before the first use. The charging light will turn ON while the driver is charging and will turn OFF when it is fully charged. The full charge cycle could take up to four hours. After each use of the driver, all accessible surfaces should be wiped down using a damp cloth followed by an EPA recommended disinfectant wipe. Before commencing prepare a clean work station and don gloves.
The patient must have visibility into the ostomy appliance to ensure that THE INSIDES® System is successfully reinfusing chyme. Use a clear ostomy appliance or remove outer lining of the patient's usual ostomy appliance to ensure adequate visibility.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
ADVARSEL: Du må ikke indføre ledetråden ind i røret, imens den befindes inde i patienten – dette kan føre til perforering af tarmene.
NOTE: Peristalik kan let flytte røret ind og ud af stomien. Når det er placeret rigtigt, vil røret ikke falde af selv, og fastgørelsesbøsningen vil forhindre det fra at trækkes for langt inde i den distale tarm.
Der er en clips til at holde røret på plads. Når stomihjælpemidlet er blevet anbragt, kan der sættes en clips på slangen fra posens yderside
for at forhindre, at slangen falder ud, og for at mindske træk på stomien. Vælg den clips, der passer rundt om den del af røret, der ligger umiddelbart under holde-muffen. Dette afhænger af rørets størrelse og af, hvor kort røret er klippet. Sørg for, at patienten er klar over, hvilken clips der skal bruges.
Sikr dig, at patienten modtager rutineudskiftning af stomianordningen. Sikr dig, at
patienten passer på, når han fjerner anordningen, således at røret ikke trækkes ud.
Pumpen kan fanges I stomianordningen ved fjernelse. Sikr dig, at patienten holder røret med den ene hånd og fjerner stomianordningen med den anden. Hvis dette er for besværligt, frakobl pumpen fra røret indenfor stomianordningen, så at de begge kan fjernes samtidigt.
Den tid, der skal til for at genforsyne mavesyre, varierer afhængigt af mavesyrens
viskositet, som kan ændre sig i løbet af dagen og patientens orale indtagelse.
THE INSIDES® System egner sig ikke til tyk og fibrøs mavesyre, derfor kan nogen mavesyre afskaffes. Al mavesyre, der genforsynes, er gavnlig.
Patienter, der anvender THE INSIDES® System skal overholde følgende skridt for at opnå bedste resultater:
Hvis genforsyning tager mere end forventet, eller patienten ikke er i stand til at genforsyne, prøv følgende afhjælpende foranstaltninger:
Hvis der ikke er nogle af ovenstående foranstaltninger, der virker, kan det være at
THE INSIDES® System ikke egnes til patienten.
Ved anvendelse af THE INSIDES® System kan patienten opleve mavestyrerefluks fra den distale tarm omkring røret tilbage i stomianordningen. Refluks foregår, når den distale tarm modtager mere mavesyre, end den kan indeholde. Imens refluks ikke er farlig for patienten, kan den øge, den tid, der er nødvendig for at genforsynes.
Refluks kan mindskes ved at:
NOTE: Loperamide og lignende anti-mobilitet terapier kan forårsage forstoppelse og
blokere tarmen samt genforsyning af mavesyre. Juster dosering af mobilitetsterapier, som krævet, og se ETD-14 Håndtering af patienter hvis der kræves yderligere handling
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Vor Beginn der Chymus-Reinfusionstherapie muss der distale Darm des Patienten
überprüft werden, um die Durchgängigkeit sicherzustellen. Eine Methode hierfür ist die
Kontrastmittelaufnahme.
The Insides System enthält zwei Größen von The Insides Tube, 28 Fr und 22 Fr. Als
allgemeiner Richtwert gilt:
Stellt der Arzt fest, dass weder die Schlauchgrößen 28 Fr noch 22 Fr geeignet sind,
wird ein ballongestützter Schlauch von mindestens 20 Fr empfohlen. Bitte beachten
Sie, dass ein ballongestützter Schlauch mit einem ENFit™-Anschluss nicht mit The
Insides Pump gekoppelt werden kann.
„The Insides Tube 28Fr“-Schlauch wird empfohlen, sofern anwendbar. Wenn der 28Fr nicht passt, können kleinere Schläuche verwendet werden, um kleine Boli zu reinfundieren, um den Darm zu rehabilitieren. Nach einer kurzen Zeit der Darmsanierung kann der Patient möglicherweise auf eine Version von The Insides Tube umsteigen oder vom Schlauch 22 Fr auf den Schlauch 28 Fr wechseln.
Wenn ein Patient eine parastomale Hernie hat, ist beim Einführen des Schlauchs Vorsicht geboten . Mögliche Darmknicke können das Einführen des Schlauchs verhindern und das Risiko einer Perforation bergen. Die größere äußere Länge des Darms kann verhindern, dass der Schlauch richtig positioniert und verankert werden kann. Durch digitales Abtasten des distalen Trakts lassen sich die Richtung des distalen Glieds, etwaige Verengungen oder Knicke sowie der Abstand zur Faszie feststellen.
Wenn der Patient ein prolabiertes distales Glied seiner Enterostomie oder eine
enterokutane Fistel (ECF) hat, ist beim Einführen der Sonde aufgrund der verlängerten,
nicht gestützten Länge des Darms, der außerhalb des Körpers liegt, Vorsicht geboten. The Insides Tube ist für diese Art von Patienten nicht geeignet.
Wenn ein Patient eine ECF hat, sind bei der Auswahl des richtigen Schlauchs für den
Patienten Vorsicht und eine sorgfältige klinische Entscheidungsfindung erforderlich. Die Patienten haben möglicherweise wenig oder gar keine Faszien um die Stelle, an der der Schlauch eingeführt wird. Folglich kann eine Retentionshülse oder -manschette die Wanderung des Schlauchs in den distalen Darm während der Reifung nicht verhindern. Es sollte ein geeigneter Schlauch ausgewählt und überwacht werden, um sicherzustellen, dass die Migration nicht stattfindet
The Insides Tube kann mit jedem Ostomiegerät verwendet werden. Zu Beginn wird dem Patienten empfohlen, eine durchsichtige Stomaversorgung zu verwenden, so dass es einfach ist, die Bewegung des Speisebreis im Schlauch zu beobachten und zu sehen, wie das Volumen in der Stomaversorgung abnimmt. Wenn anfangs ein anderer Schlauch als The Insides Tube erforderlich ist, müssen dieser Schlauch und die Pumpe bequem in die Stomavorrichtung passen, ohne dass Druck auf den Schlauch und The Insides Pump ausgeübt wird.
Die Installation eines Ernährungsschlauchs in die distale Extremität des Patienten kann die Größe des Stomas auf dem Bauch erhöhen. Daher wird empfohlen, die Schablone des Patienten auf der Grundplatte des Ostomiegeräts erneut zu messen. Dadurch soll sichergestellt werden, dass zwischen der Enterostomie und dem Rand der Grundplatte ein Abstand von 2–3 mm besteht. Dies ermöglicht die Peristaltik und die natürliche Bewegung des Enterostomie- und Schlauchkomplexes, um das Risiko von Schleimhauterosionen aufgrund von Reibung an der Seite der Grundplatte zu vermeiden. Es ist am besten, die Vorlage des Patienten regelmäßig neu zu messen. Auch bei Veränderungen durch Gewichtszunahme, Gewichtsabnahme, Hernie oder Prolaps sollte die Grundplatte neu vermessen warden.
Zu Beginn der Therapie mit The Insides System wird der Patient eine kurze Zeit damit
verbringen, seine Toleranz gegenüber der Chymus-Reinfusionstherapie zu erhöhen, seinen distalen Darm zu rehabilitieren und langsam orale Nahrung einzuführen. Während dieser Zeit wird empfohlen, die parenterale Ernährung des Patienten und die
Antimotilitätsmedikation in der gleichen Dosis zu halten. Dies wird es dem Patienten
ermöglichen, mit The Insides System unabhängig zu werden und nicht mit der Erhöhung seiner Leistung durch die Entwöhnung der Anti-Motilität-Medikamente überfordert zu werden. Dies wird auch ihre Ernährung während des Übergangs aufrechterhalten, um ihre gesamte Leistung wiederherzustellen und sicherzustellen, dass ihre Ernährung optimiert wird.
THE INSIDES® Driver sollte vor Erstinbetriebnahme vollständig aufgeladen sein. Die
Ladelampe leuchtet während des Ladevorgangs und schaltet sich aus, wenn der Driver vollständig aufgeladen ist. Der vollständige Ladezyklus kann bis zu vier Stunden dauern. Nach jeder Verwendung des Drivers sollten alle zugänglichen Oberflächen mit einem feuchten Tuch und anschließend mit einem von der EPA empfohlenen Desinfektionsmittel abgewischt werden.
Halten Sie Ihren Arbeitsplatz sauber, bevor Sie beginnen und ziehen Sie Handschuhe an.
Der Patient muss die Stomaversorgung sehen können, um sicherzustellen, dass
THE INSIDES® System Nahrungsbrei erfolgreich zurückpumpt. Verwenden Sie eine
durchsichtige Stomaversorgung oder entfernen Sie die äußere Verkleidung der üblichen Stomaversorgung, um eine ausreichende Sicht zu gewährleisten.
THE INSIDES® Pump (Pumpe) hat einen Durchmesser von 35 mm und wird durch die Schablone der Stomaversorgung geschraubt. Daher muss möglicherweise eine größere Schablone zugeschnitten und eine Hydrokolloidversiegelung zum Schutz der freiliegenden Haut verwendet werden. Wenn dies nicht funktioniert, kann eine Stoma Vorrichtung mit einem "Lock and Roll"-Verschluss am Beutelboden verwendet werden. In diesem Fall wird die Pumpe durch diese Öffnung an THE INSIDES® Tube (Schlauch) angeschlossen.
WARNHINWEIS: Den Führungsdraht nicht in den Schlauch einführen, wenn letzterer in
den Patienten eingeführt ist - Dies kann Darmperforation verursachen.
ANMERKUNG: Die Peristaltik kann den Schlauch geringfügig in das Stoma hineinziehen und herausbewegen. Bei korrekter Platzierung sollte der Schlauch nicht von selbst herausfallen. Die Rückhaltemuffe verhindert, dass er zu weit in den distalen Darm gezogen wird.
Ein Clip wird mitgeliefert, um die Tube an Ort und Stelle zu halten. Nach dem Anlegen der Ostomievorrichtung kann an der Außenseite des Beutels ein Clip an der Tube angebracht werden,
um zu verhindern, dass die Tube herausfällt, und um das Ziehen am Stoma zu verringern. Wählen Sie die Größe des Clips aus, die um den Abschnitt der Tube unmittelbar unter der Retentionshülse passt. Dies hängt von der Größe der Tube ab und davon, wie kurz die Tube geschnitten wird. Stellen Sie sicher, dass der Patient weiß, welcher Clip verwendet werden
soll.
Stellen Sie sicher, dass die Stomaversorgung des Patienten regelmässig gewechselt wird. Achten Sie darauf, dass der Patient beim Entfernen des Geräts vorsichtig ist, damit der Schlauch nicht herausgezogen wird. Die Pumpe kann sich beim Entfernen in der Stoma Vorrichtung verfangen. Achten Sie darauf, dass der Patient den Schlauch mit einer Hand festhält und die Stoma Vorrichtung mit der anderen Hand entfernt. Wenn dies zu schwierig ist, trennen Sie in der Stomaversorgung die Pumpe vom Schlauch, statt sie gemeinsam zu entfernen.
Die Zeit, die für die Zufuhr von Nahrungsbrei benötigt wird, variiert mit dessen Viskosität, die je nach Tageszeit unterschiedlich sein kann. Auch die orale Nahrungsaufnahme des Patienten spielt eine Rolle. THE INSIDES® System ist nicht für dicken oder faserigen Speisebrei geeignet, daher kann ein solcher verweigert werden. Jede Menge Speisebrei, die zugeführt wird, ist nützlich.
Die Patienten, die THE INSIDES® System anwenden, sollten sich an die folgenden Abläufe halten, um optimale Ergebnisse zu erzielen:
Wenn die Aufnahme des Nahrungsbreis länger als erwartet dauert oder wenn der Patient den Nahrungsbrei nicht aufnehmen kann, versuchen Sie die folgenden
Abhilfemaßnahmen:
Wenn keine dieser Lösungen funktioniert, ist THE INSIDES® System möglicherweise nicht für den Patienten geeignet.
Bei der Verwendung von THE INSIDES® System kann es bei Patienten um den Schlauch
herum zu einem Rückfluss von Speisebrei aus dem Enddarm zurück in die Stomaversorgung kommen. Reflux tritt auf, wenn der distale Darm mehr Speisebrei erhält, als er aufnehmen kann. Reflux ist zwar nicht schädlich für den Patienten, kann aber die Zeit bis zur erfolgreichen Nahrungsaufnahme verlängern.
Reflux kann reduziert werden durch:
ANMERKUNG: Loperamid und ähnliche Antimotilitätstherapien können Verstopfung
verursachen, indem sie den Darm blockieren und die Rückführung von Speisebrei
verhindern. Passen Sie die Dosis der Motilitätstherapien wie erforderlich an und beziehen Sie sich auf ETD-14 Patientenmanagement, wenn weitere Massnahmen notwendig sind.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Voorafgaand aan het starten van chyme-herfusietherapie moet de distale darm van de patiënt worden gecontroleerd om de doorgankelijkheid te garanderen. Een methode om dit te doen is contrastbeeldvorming.
The Insides System bevat twee maten The Insides Tube, 28 Fr en 22 Fr. Als algemene leidraad:
Als de clinicus vaststelt dat de buisgroottes 28 Fr of 22 Fr niet geschikt zijn, wordt een minimaal bewaard buisje van 20 Fr met ballon aanbevolen. Houd er rekening mee dat een ballon met een ENFitTM-verbinding niet kan worden gekoppeld aan The Insides Pump.
The Insides Tube 28Fr-buis wordt aanbevolen indien van toepassing. Als de 28Fr niet past, kunnen kleinere buisjes worden gebruikt om kleine bolussen opnieuw te fuseren om de darm te rehabiliteren. Na een korte periode van darmrevalidatie kan de patiënt mogelijk overschakelen naar een versie van The Insides Tube of van de 22 Fr naar de 28 Fr Tube.
Als een patiënt een parastomale hernia heeft, is voorzichtigheid geboden bij het inbrengen van het buisje. Mogelijke darmknikken kan voorkomen dat het buisje wordt ingebracht en kan een risico op perforatie veroorzaken. De verhoogde externe lengte van de darm kan voorkomen dat de buis correct wordt gepositioneerd en verankerd. Digitaal palperen van het distale kanaal geeft de richting van het distale ledemaat, eventuele vernauwing of knikken en de afstand tot de fascia aan.
Als de patiënt een verzakt distaal ledemaat van zijn enterostoma of enterocutane fistel (ECF) heeft, is voorzichtigheid geboden bij het inbrengen van het buisje vanwege de verlengde, niet-ondersteunde darmlengte die buiten het lichaam ligt. The Insides Tube is niet geschikt voor dit type patiënt.
Als een patiënt een ECF heeft, zijn voorzichtigheid en zorgvuldige klinische besluitvorming vereist bij het selecteren van het juiste buisje voor gebruik voor de patiënt. Patiënten kunnen weinig of geen fascia hebben rond de locatie van het inbrengen van de buis. Bijgevolg kan een retentiehuls of manchet de migratie van de buis naar de distale darm tijdens het rijpen niet voorkomen. Er moet een geschikte buis worden geselecteerd en gecontroleerd om ervoor te zorgen dat de migratie niet plaatsvindt.
The Insides Tube kan worden gebruikt met elk stomazakje. In eerste instantie wordt aanbevolen dat de patiënt een doorzichtig stomazakje gebruikt, zodat het gemakkelijk is om te zien hoe de chymus door de buis beweegt en het volume in het stomazakje afneemt. Als er in eerste instantie een buis, anders dan The Insides Tube, nodig is, dan moeten deze buis en pomp comfortabel in het stomazakje passen zonder enige druk op de buis en The Insides Pump.
De installatie van een voedingssonde in de distale extremiteit van de patiënt kan de grootte van de stoma op de buik vergroten. Daarom wordt aanbevolen om het sjabloon van de patiënt op de basisplaat van het stomazakje opnieuw te meten. Dit om ervoor te zorgen dat er een ruimte van 2 – 3 mm is tussen de enterostoma en de rand van de basisplaat. Dit zorgt voor peristaltiek en de natuurlijke beweging van het enterostomie- en buiscomplex om het risico op slijmvlieserosie als gevolg van wrijving aan de zijkant van de basisplaat te voorkomen. Het is het beste om het sjabloon van de patiënt periodiek opnieuw te meten. De basisplaat moet ook opnieuw worden gemeten als er veranderingen zijn opgetreden als gevolg van gewichtstoename, gewichtsverlies, hernia of verzakking.
Bij het starten van de therapie met The Insides System, zal de patiënt een korte periode besteden aan het verhogen van hun tolerantie voor chyme-herfusietherapie, het rehabiliteren van hun distale darm en het langzaam introduceren van orale voeding. Tijdens deze periode wordt aanbevolen om het recept voor parenterale voeding en de antimotiliteitsmedicatie van de patiënt in dezelfde dosis te houden. Dit zal de patiënt in staat stellen om onafhankelijk te worden met The Insides System en niet overweldigd worden door de toename van hun output van het spenen van de antimotiliteitsmedicatie. Dit zal ook hun voeding behouden terwijl ze overgaan om al hun output opnieuw te verrijken en ervoor te zorgen dat hun voeding wordt geoptimaliseerd.
THE INSIDES® Driver (stuurprogramma) moet vóór het eerste gebruik volledig worden opgeladen. Het plaadlampje gaat branden terwijl het stuurprogramma aan het opladen is en gaat uit wanneer het volledig opgeladen is. De volledige laadcyclus kan tot vier uur duren. Na elk gebruik van het stuurprogramma moeten alle bereikbare oppervlakken worden afgeveegd met een vochtige doek en vervolgens door een door het EPA aanbevolen desinfectiedoekje.
Maak alvorens te beginnen een schone werkplek klaar en trek handschoenen aan.
De patiënt moet zicht hebben in het stoma-apparaat om er zeker van te zijn dat THE INSIDES® System met succes chyme afgeeft. Gebruik een doorzichtig stoma-apparaat of verwijder de buitenbekleding ervan om voor de patiënt om voldoende zicht te garanderen.
THE INSIDES® Pump (pomp) heeft een diameter van 35 mm en wordt door het sjabloon van het stoma-apparaat geschoven. Daarom kan het nodig zijn een groter sjabloon uit te snijden en een hydrocolloïde afdichting te gebruiken om de blootgestelde huid te beschermen. Als dit niet geschikt is, kan een stoma-apparaat met een "lock and roll"-sluiting aan de onderkant van de zak worden gebruikt. In dit scenario wordt de pomp via deze opening aangesloten op THE INSIDES® Tube (slang).
WAARSCHUWING: Steek de voerdraad niet in de slang terwijl deze in een patiënt is geplaatst - dit kan leiden tot doorboring van de darm.
OPMERKING: Peristaltiek kan de slang lichtjes in en uit de stoma bewegen. Indien correct geplaatst, zou de slang er niet uit zichzelf uit moeten vallen en de borgarm zal voorkomen dat de slang te ver in de distale darm wordt getrokken.
Er wordt een clip meegeleverd om de slang op zijn plaats te houden. Nadat het stoma-apparaat is aangebracht, kan er vanaf de buitenkant van de zak een clip aan de slang worden bevestigd om te voorkomen dat de slang eruit valt en om trekken aan de stoma te verminderen. Kies de maat van de clip die om het gedeelte van de slang direct onder de retentiehuls past. Dit hangt af van de maat van de slang en hoe kort de slang is bijgesneden. Zorg ervoor dat de patiënt weet welke clip moet worden gebruikt.
Zorg ervoor dat de patiënt zijn stoma-apparaat regelmatig verwisselt. Zorg ervoor dat de patiënt voorzichtig is bij het verwijderen van het apparaat, zodat de slang er niet uitgetrokken wordt. De pomp kan bij het verwijderen vast komen te zitten in het stoma-apparaat. Zorg ervoor dat de patiënt de slang met één hand vasthoudt en verwijder het stoma-apparaat met de andere hand. Als dit te moeilijk is, maakt u de pomp los van de slang in het stoma-apparaat dat u samen wilt verwijderen.
De tijd die nodig is om chyme terug te voeren varieert afhankelijk van de dikte van het chyme, die in de loop van de dag kan verschillen, en de orale inname van de patiënt. THE INSIDES® System is niet geschikt voor dik of vezelig chyme, daarom kan wat chyme worden weggegooid. Elke hoeveelheid chyme die toegediend wordt is gunstig.
Patiënten die THE INSIDES® System gebruiken, moeten voor optimale resultaten de volgende stappen in acht nemen:
Als het terugvoeren langer duurt dan verwacht of als de patiënt niet in staat is om terug te voeren, probeer dan de volgende corrigerende stappen:
Als geen van deze oplossingen werkt, THE INSIDES® System mogelijk niet geschikt voor de patiënt.
Bij het gebruik van THE INSIDES® System, kunnen patiënten reflux van chyme uit de distale darm, rond de slang, terug in de stoma-apparaat ervaren. Reflux treedt op wanneer de distale darm meer chyme ontvangt dan het kan verwerken. Hoewel reflux niet schadelijk is voor de patiënt, kan het de tijd verlengen voordat het terugvoeren succesvol is.
Reflux kan verminderd worden door:
OPMERKING: Loperamide en soortgelijke anti-motiliteitstherapieën kunnen constipatie veroorzaken, waardoor de darm wordt geblokkeerd en chyme niet kan worden teruggevoerd. Pas de dosering zo nodig aan en raadpleeg ETD-14 Patiëntenzorgpad voor de The Insides System (ETD-14 Patient Care Pathway for The Insides System ) als verdere actie nodig is.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Antes de comenzar la terapia de reinfusión de quimo, se debe revisar el intestino distal del paciente para comprobar la permeabilidad. Una forma de hacerlo son las imágenes de contraste.
The Insides System incluye The Insides Tube de dos tamaños: 28 Fr y 22 Fr. Por regla
general:
Si el médico determina que los tamaños de tubo de 28 Fr o 22 Fr no son apropiados, se recomienda un tubo con balón retenido de 20 Fr como mínimo. Tenga en cuenta que un tubo con balón retenido con una conexión ENFitTM no se puede acoplar a The Insides Pump.
Se recomienda utilizar The Insides Tube 28 Fr en los casos correspondientes. Si el 28 Fr no encaja, se pueden usar tubos más pequeños para reinfundir bolos pequeños a fin de rehabilitar el intestino. Después de un corto período de rehabilitación intestinal, el paciente puede pasar a una versión de The Insides Tube o bien pasar del tubo de 22 Fr al de 28 Fr.
Si un paciente tiene una hernia paraestomal, es necesario proceder con precaución al insertar la sonda. El posible retorcimiento intestinal puede impedir la inserción del tubo y dar lugar a un riesgo de perforación. El aumento de la longitud externa del intestino puede impedir colocar y fijar correctamente el tubo. La palpación digital del tracto distal indicará el sentido del miembro distal, cualquier estrechamiento o retorcimiento, y la distancia hasta la fascia.
Si el paciente tiene una extremidad distal de su enterostomía prolapsada o una fístula enterocutánea (FEC), debe proceder con precaución al insertar la sonda debido a la longitud prolongada y sin soporte del intestino externo al cuerpo. The Insides Tube no es adecuado para este tipo de pacientes.
Si un paciente tiene una FEC, se requiere precaución y una toma de decisiones clínicas cuidadosa a la hora de seleccionar el tubo correcto para usar para el paciente. Los pacientes pueden presentar poca o una ausencia total de fascia alrededor de la ubicación de la inserción del tubo. Por tanto, es posible que un manguito o manguito de retención no evite la migración del tubo al intestino distal a medida que madura. Se debe seleccionar un tubo apropiado y supervisarlo para garantizar que no se produzca la migración.
The Insides Tube se puede utilizar con cualquier aparato de ostomía. Se recomienda que el paciente use al principio un aparato de ostomía transparente, que permite ver con facilidad cómo sube el quimo por el tubo y cómo disminuye el volumen en el aparato de ostomía. Si se requiriera al comienzo un tubo que no sea The Insides Tube, dicho tubo y la bomba deben encajar cómodamente dentro del aparato de ostomía sin ejercer presión sobre el tubo ni The Insides Pump.
La instalación de una sonda de alimentación en el miembro distal del paciente puede aumentar el tamaño del estoma en el abdomen. Así pues, se recomienda volver a medir la plantilla del paciente en la placa base del aparato de ostomía para garantizar que quede una holgura de 2 a 3 mm entre la enterostomía y el borde de la placa base. Esto permite la peristalsis y el movimiento natural del conjunto de la enterostomía y la sonda para evitar el riesgo de erosión de la mucosa por el roce en el lado de la placa base. Lo mejor es repetir la medición de la plantilla del paciente periódicamente. La placa base también debe volver a medirse si ha habido algún cambio como resultado de un aumento de peso, pérdida de peso, hernia o prolapso.
La instalación de una sonda de alimentación en el miembro distal del paciente puede aumentar el tamaño del estoma en el abdomen. Así pues, se recomienda volver a medir la plantilla del paciente en la placa base del aparato de ostomía para garantizar que quede una holgura de 2 a 3 mm entre la enterostomía y el borde de la placa base. Esto permite la peristalsis y el movimiento natural del conjunto de la enterostomía y la sonda para evitar el riesgo de erosión de la mucosa por el roce en el lado de la placa base. Lo mejor es repetir la medición de la plantilla del paciente periódicamente. La placa base también debe volver a medirse si ha habido algún cambio como resultado de un aumento de peso, pérdida de peso, hernia o prolapso.
THE INSIDES® Driver (aparato) debe estar completamente cargado antes de usarlo por primera vez. La luz de carga se ENCENDERÁ mientras el aparato está cargando, y se APAGARÁ cuando esté totalmente cargado. El ciclo completo de carga podría tardar hasta unas cuatro horas. Después de cada uso del aparato, todas las superficies accesibles deben limpiarse con un paño mojado, además de con una toallita desinfectante recomendada por la EPA.
Antes de empezar, prepare la zona de trabajo y póngase unos guantes.
El paciente debe tener visibilidad del dispositivo de ostomía para asegurarse de que
THE INSIDES® System está reinfundiendo correctamente el quimo. Utilice un dispositivo de ostomía transparente o retire el revestimiento exterior del dispositivo de ostomía habitual del paciente para garantizar una visibilidad adecuada.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
ADVERTENCIA: No inserte el cable guía en la sonda mientra está colocado dentro de un paciente - esto puede provocar una perforación del intestino.
NOTA: La peristalsis puede mover la sonda dentro y fuera del estoma un poco. Si se coloca correctamente, la sonda no debería caerse sola y el manguito de sujeción evitará que tire demasiado del intestino distal.
El producto viene con un clip para sujetar el tubo. Después de colocar el dispositivo de ostomía, podrá fijarse un clip al tubo desde
el exterior de la bolsa para evitar que se caiga y reducir la tensión en el estoma. Elija un clip que tenga el tamaño adecuado para colocarlo alrededor de la sección del tubo situada inmediatamente debajo del manguito de fijación. Esto dependerá del tamaño del
tubo y de cuánto se haya recortado este. Asegúrese de que el paciente sepa qué clip debe usar.
Asegúrese de que el paciente recibe los cambios rutinarios de los dispositivos de ostomía. Asegúrese de que el paciente tenga cuidado al retirar el dispositivo para que el tubo no se salga. La bomba puede quedar atrapada en el dispositivo de ostomía al retirarla. Asegúrese de que el paciente agarra la sonda con una mano y se quita el dispositivo de ostomía con la otra. Si esto es demasiado difícil, separe la bomba de la sonda dentro del dispositivo de ostomía para retirarlos juntos.
El tiempo necesario para reinfundir el quimo varía en función del espesor del mismo, que puede variar a lo largo del día, y de lo que ingiera el paciente. THE INSIDES® System no es adecuado para el quimo espeso o fibroso, por lo que se puede descartar parte del quimo. Cualquier cantidad de quimo que se reinfunda es beneficiosa.
Los pacientes que utilicen THE INSIDES® System deben seguir los siguientes pasos para obtener los mejores resultados:
Si la reinfusión tarda más de lo esperado o si el paciente es incapaz de llevarla a cabo, intente los siguiente:
Si nada de esto funciona, es posible que THE INSIDES® System no sea adecuado para el paciente.
Cuando se utiliza el sistema THE INSIDES® System, los pacientes pueden experimentar
reflujo de quimo desde el intestino distal, alrededor de la sonda, de vuelta al dispositivo de ostomía. El reflujo se produce cuando el intestino distal recibe más quimo del que puede albergar. Aunque el reflujo no es perjudicial para el paciente, puede aumentar el tiempo de la reinfusión.
El reflujo puede ser reducirse:
NOTA: La loperamida y otras terapias similares contra la motilidad gastrointestinal pueden causar estreñimiento, bloqueando el intestino e impidiendo la reinfusión del quimo. Ajustar la dosis de las terapias de motilidad según sea necesario y remitirse a la ETD-14 Manejo del paciente si es necesario tomar otras medidas.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Före påbörjad återinfusionsbehandling med chymus måste patientens distala tarmkanal kontrolleras för att säkerställa öppenhet. En metod för att göra detta är med kontrastavbildning.
The Insides System innehåller två storlekar av The Insides Tube, 28 Fr och 22 Fr. Som en allmän vägledning:
Om klinikern fastställer att varken 28 Fr- eller 22 Fr-storlekarna är lämpliga rekommenderas en ballonghållen slang på minst 20 Fr. Observera att en ballonghållen slang med en ENFitTM-anslutning inte kopplas ihop med The Insides Pump.
The Insides Tube-slangen på 28 Fr rekommenderas när den är möjlig att använda. Om 28 Fr inte passar kan mindre slangar användas för att återinföra små bolusar för att rehabilitera tarmen. Efter en kort period av tarmrehabilitering kan patienten eventuellt byta till en version av The Insides Tube eller byta från 22 Fr till en 28 Fr-slang.
Om en patient har ett parastomalt bråck måste försiktighet iakttas när slangen förs in. Eventuella tarmveck kan förhindra att slangen förs in och kan skapa risk för perforering. Den ökade yttre längden på tarmen kan förhindra att slangen placeras och förankras korrekt. Digital palpering av det distala området kan indikera riktningen för distala extremiteter, eventuell förträngning eller veckning och avståndet till fascia.
Om patienten har en framfallen distal extremitet i sin enterostomi, eller en enterokutan fistel (ECF), krävs försiktighet vid införande av slangen på grund av den förlängda, ej stödda del av tarmarna som befinner sig utanför kroppen. The Insides Tube är inte lämplig för denna typ av patient.
Om en patient har en ECF krävs försiktighet och noggrant kliniskt beslutsfattande vid val av rätt slang för patienten. Patienter kan ha liten eller ingen fascia runt platsen för slanginsättningen. Följaktligen kan det hända att en kvarhållningshylsa eller manschett inte förhindrar att slangen migrerar in i den distala tarmen när den mognar. En lämplig slang bör väljas och övervakas för att säkerställa att migrering inte sker.
The Insides Tube kan användas med alla stomianordning. Inledningsvis rekommenderas att patienten använder en klar stomianordning, så det är lätt att se chymus flyta genom slangen och se att volymen i stomianordningen minskar. Om en annan slang än The Insides Tube krävs initialt, måste denna slang och pump passa väl inuti stomianordningen utan att något tryck utövas på slangen och The Insides Pump.
Anläggandet av en matningsslang i patientens distala extremitet kan öka storleken på stomin på buken. Följaktligen rekommenderas att patientens mall på stomianordningens bottenplatta mäts om. Detta för att säkerställa att det finns ett avstånd på 2–3 mm mellan enterostomin och kanten på bottenplattan. Detta möjliggör peristaltik och en naturlig rörelse hos enterostomin och slangkomplexet, för att förhindra risken för slemhinneerosion på grund av nötning på sidan av bottenplattan. Det är bäst att mäta om patientens mall med jämna mellanrum. Basplattan bör också mätas om det har skett några förändringar till följd av viktökning, viktminskning, bråck eller prolaps
När behandlingen med The Insides System påbörjas kommer patienten att ägna en kort tidsperiod åt att öka sin tolerans för återinfusionsbehandling med chymus, rehabilitera sin distala tarm och långsamt introducera oral mat. Under denna period rekommenderas att patientens recept för parenteral näring och anti-motilitetsläkemedel bibehålls i samma dos. Detta gör det möjligt för patienten att bli självständig med The Insides System och inte bli överväldigad av ökningen sin produktion i samband med avvänjning från anti-motilitetsläkemedlet. Detta kommer också att bibehålla deras näringsnivå medan de övergår till att återinföra all sin produktion och se till att deras näring är optimerad.
THE INSIDES® Driver (drivare) bör vara helt laddad innan den används för första gången. Laddningslampan tänds när drivaren laddas och slocknar när den är fulladdad. Det kan ta upp till fyra timmar att ladda enheten. Efter varje användning av drivaren ska alla tillgängliga ytor först torkas av med en fuktig trasa och därefter med en EPA-godkänd desinfektionsduk.
Förbered en ren arbetsstation och ta på dig handskar innan du börjar.
Patienten måste kunna se in i ostomiapparaten för att säkerställa att THE INSIDES® System matar in kymus. Använd en transparent ostomiapparat eller ta bort den yttre täckningen från patientens vanliga stomiapparat för att säkerställa god synlighet.
THE INSIDES® Pump (pump) är 35 mm i diameter och träs igenom mallen på ostomiapparaten. Därför kan en större mall behöva skäras ut och en hydrokolloid försegling användas för att skydda den exponerade huden. Om detta är olämpligt kan en ostomiapparat med ”lock and roll”-tillslutning i botten av påsen användas. I detta fall ansluts pumpen till THE INSIDES® Tube (slang) genom denna öppning.
Välj matningsslang av lämplig storlek baserat på diametern på patientens stomi.
VARNING: Inför inte styrtråden i slangen medan den är införd i en patient – detta kan leda till perforering av tarmen.
Anmärkning: Peristaltiken kan röra slangen in och ut av stomin något. När slangen sitter rätt ska den inte falla ut av sig själv och retentionshylsan ska hindra den från att dras för långt in i krumtarmen.
En klämma tillhandahålls för att hålla slangen på plats. När stomianordningen har applicerats, kan en klämma fästas på slangen från utsidan av påsen för att förhindra att slangen faller ut och
minska draget i stomin. Välj den klämma som passar runt slangen omedelbart under fästhylsan. Detta beror på slangens storlek, och
hur kort slangen är skuren. Se till att patienten är medveten om vilken klämma som ska användas.
Patientens ostomiapparat ska bytas ut regelbundet. Se till att patienten är försiktig när hen tar bort apparaten så att slangen inte dras ut. Pumpen kan fastna i ostomiapparaten vid borttagning. Säkerställ att patienten håller i slangen med den ena handen och tar bort ostomiapparaten med den andra. Om detta är för svårt kan pumpen kopplas bort från slangen inuti ostomiapparaten varefter de tas bort tillsammans.
Hur lång tid det tar att mata in kymus varierar beroende på dess tjocklek, som kan skilja sig åt under dagen och beroende på patientens förtäring. THE INSIDES® System är olämpligt för tjock eller fibröst kymus och en del kymus kan därför kasseras. Eventuellt återinmatad kymus är fördelaktigt.
Patienterna som använder THE INSIDES® System bör följa följande steg för optimala
resultat:
Om inmatningen tar längre tid än förväntat eller om patienten inte klarar av att göra det själv, prova följande avhjälpande steg:
Om ingen av dessa lösningar fungerar kanske THE INSIDES® System är olämpligt för
patienten.
Vid användning av THE INSIDES® System kan patienter uppleva att kymus flödar ut från krumtarmen, runt slangen och tillbaka in i ostomiapparaten. Detta inträffar när
krumtarmen tar emot mer kymus än den rymmer. Visserligen är utflöde inte skadligt för patienten, men det kan öka tiden för en lyckad inmatning.
Utflöde kan minskas genom att:
Anmärkning: Loperamid och liknande antimotilitetsmedel kan orsaka förstoppning,
blockera tarmen och förhindra inmatning av kymus. Justera dosen vid behov och se i ETD-14 Patienthantering om ytterligare åtgärd krävs.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Prior to commencing chyme reinfusion therapy the patient’s distal intestine must be
checked to ensure patency. A method of doing this is contrast imaging.
The Insides System contains two sizes of The Insides Tube, 28 Fr and 22 Fr. As a general
guide:
If the Clinician determines that neither the 28 Fr or 22 Fr tube sizes are appropriate, a
minimum 20 Fr balloon retained tube is recommended. Please note, a balloon retained tube with an ENFit™ connection does not couple with The Insides Pump.
The Insides Tube 28Fr tube is recommended when applicable. If the 28Fr does not fit, smaller tubes can be used to reinfuse small boluses to rehabilitate the intestine. After a short period EN 10 of intestinal rehabilitation, the patient may be able to transition to a version of The Insides Tube or transition from the 22 Fr to the 28 Fr Tube.
If a patient has a parastomal hernia, caution is needed when inserting the tube. Possible bowel kinking can prevent the tube from being inserted and can create a risk of perforation. The increased external length of bowel can prevent the tube from being positioned and anchored correctly. Digitally palpating the distal tract will indicate the direction of distal limb, any narrowing or kinking, and the distance to fascia.
If the patient has a prolapsed distal limb of their enterostomy or enterocutaneous fistula (ECF), caution is needed when inserting the tube due to the extended, unsupported length of intestine that is external to the body. The Insides Tube is not suitable for this type of patient.
If a patient has an ECF, caution and careful clinical decision making are required when selecting the correct tube to use for the patient. Patients may have little or no fascia around the location of tube insertion. Consequently, a retention sleeve or cuff may not prevent the migration of the tube into the distal intestine as it matures. An appropriate tube should be selected and monitored to ensure the migration does not occur.
The Insides Tube can be used with any ostomy appliance. Initially, it is recommended the patient use a clear ostomy appliance, so it is easy to watch chyme move up the tube and see the volume in the ostomy appliance decreasing. If a tube, other than The Insides Tube, is required initially, then this tube and pump must fit comfortably within the ostomy appliance without any pressure exerted on the tube and The Insides Pump.
The installation of a feeding tube into the patient’s distal limb may increase the size of the stoma on the abdomen. Consequently, it is recommended that the patient’s template on the base plate of the ostomy appliance, is re-measured. This is to ensure there is a clearance of 2 – 3 mm between the enterostomy and the edge of the base plate. This allows for peristalsis and the natural movement of the enterostomy and tube complex to prevent the risk of mucosal erosion due to rubbing on the side of the base plate. It is best to re-measure the patient’s template periodically. The base plate should also be re-measured if there have been any changes as a result of weight gain, weight loss, herniation, or prolapse.
When starting therapy with The Insides System, the patient will spend a short period of time increasing their tolerance to chyme reinfusion therapy, rehabilitating their distal bowel, and slowly introducing oral food. During this period, it is recommended to keep the patient’s parenteral nutrition prescription and anti-motility medication at the same dose. This will allow the patient to become independent with The Insides System and not become overwhelmed with the increase in their output from weaning the anti-motility medication. This will also maintain their nutrition while they are transitioning to reinfuse all of their output and ensure their nutrition is optimised.
THE INSIDES® Driver (driver) should be fully charged before the first use. The charging light will turn ON while the driver is charging and will turn OFF when it is fully charged. The full charge cycle could take up to four hours. After each use of the driver, all accessible surfaces should be wiped down using a damp cloth followed by an EPA recommended disinfectant wipe.
Before commencing prepare a clean work station and don gloves.
The patient must have visibility into the ostomy appliance to ensure that THE INSIDES® System is successfully reinfusing chyme. Use a clear ostomy appliance or remove outer lining of the patient's usual ostomy appliance to ensure adequate visibility.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
THE INSIDES® Tube must be inserted by a healthcare professional. The Insides® Tube must be replaced every 28 days.
1. Select the appropriately size feeding tube based on the diameter of the patient’s
stoma.
2. The patient should be resting in a comfortable supine position. Remove the patient's ostomy appliance and wipe away any excess chyme from the area. Only reinfuse chyme that is less than eight-hours old. Store the patient's chyme if this is the first use of THE INSIDES® System.
3. Unpackage the tube. A retention sleeve and guidewire are also provided to aid user comfort and insertion, respectively.
4. Lubricate the tube using 10-20 mL of water-based lubricant as described below:
a. Unfold the arms of the retention
sleeve from the tube.
b. Spread lubricant in front of and
behind the retention sleeve. With adequate force, pull the retention sleeve backward, towards the handle of the guidewire, over the lubricant, then return it to its original position. Continue this until the retention sleeve moves freely. Add more lubricant if it is required. Then, move the retention sleeve towards the bulbous section of the tube. Ensure the retention sleeve is not pulled off.
c. Lubricate the bulbous section of the tube.
d. Set the tube aside on the clean workstation.
5. With additional lubricant, digitally examine the direction of the
distal tract. Palpate the fascia to gauge the approximate length required for the insertion of the tube. If the distal tract is tight or kinked, insert 3-10 mL of additional lubricant.
6. During the examination, the patient may feel some abdominal discomfort. Discomfort is due to the stretching of the intestinal lumen and should be expected. After digitally palpating the distal tract, replace gloves.
7. Collapse the tube's bulbous feature by inserting the guidewire until the base of the tube touches the 'stop' on the guidewire. Pinch the guidewire between the tube and maintain pressure so it stays in place. Ensure that the guidewire's tip is sitting within the nose of the tube and not sticking out through the bulbous section.
8. While the bulbous section is collapsed, use the free hand to guide the tube and insert it into the distal limb. Apply gentle pressure until the bulbous feature of the tube is 10-20 mm past the abdominal fascia. The intestine may not allow the tube to be immediately inserted; it may take up to 60 seconds for peristalsis to help move the tube into place.
9. Firmly hold the tube in place with one hand and remove the guidewire with the other.
10. Allow the tube to settle into its natural position. The tube may move outwards up to 10mm due to peristalsis.
11. Move the retention sleeve up the tube until it sits 1-2 mm away from the stoma. Fold the arms of the retention sleeve over the tube to secure it in place.
Due to differing patient anatomy, the retention sleeve may block the proximal outlet. If this occurs, chyme may leak under the baseplate of the ostomy appliance. If this happens, the retention sleeve can be moved down the tube, away from the stoma.
12. Gently tug on the tube to confirm it is anchored in place.
13. If the tube becomes dislodged, remove it entirely from the patient before reinserting the guidewire into the tube:
a. Move the retention sleeve toward the bulbous feature.
b. Insert lubricant into the Tube.
c. Insert the guidewire into the Tube, beyond the retention sleeve in a single fluid
motion.
d. If the guidewire does not slide beyond the retention sleeve, move the guidewire's tip back into the lubricant, then repeat Step c.
e. Hold the guidewire in place and move the retention sleeve to the centre of the Tube.
f. Return to Step 3.
14. Once the tube is successfully inserted, dispose of the guidewire appropriately.
WARNING: Do not insert the guidewire into the Tube while it is positioned inside a patient - this could result in perforation of the bowel.
NOTE: Peristalsis may move the tube in and out of the stoma slightly. When placed correctly, the tube should not fall out on its own and the retention sleeve will prevent it from being pulled too far into the distal intestine.
1. Connect the pump to the tube. The base of the tube should touch the third ring of the pump outlet to ensure it cannot be accidentally dislodged.
2. Allow the patient or their carer to practise connecting and disconnecting the pump while ensuring that the tube position is not disturbed.
3. Measure the ostomy appliance against the tube and pump. Trim the end of the tube so
that the pump sits 10-20 mm above the bottom of the ostomy appliance when attached.
4. The pump can rotate around the tube until oriented such that the position allows the connecting of the pump to the driver.
A clip is provided to hold the tube in place. Once the Ostomy appliance has been applied, a clip can be attached to the tube from the outside of the bag to help prevent the tube falling out and
reduce pulling on the stoma. Choose the clip that will fit around the section of the tube immediately below the retention sleeve.
This will depend on the size of the tube and how short the tube is trimmed. Ensure the patient is aware of which clip should be used.
1. Assess the suitability of the patient's chyme from the patient's previous ostomy
appliance.
a. Pinch the ostomy appliance between the thumb and forefinger. Release it quickly to observe the time it takes for the chyme to refill the space. If it is instantaneous, the chyme can be pumped; otherwise, it may be too thick and should be discarded.
b. Chyme sitting for less than eight hours is suitable for pumping; otherwise, it must be discarded.
c. There must be enough volume for the Pump to be fully submerged in the chyme, approximately 70-100 mL.
2. If the patient's chyme is suitable for reinfusing, transfer the chyme into the new ostomy appliance. If not, fill a new ostomy appliance with enough water to submerge the Pump. Water can be used to demonstrate chyme reinfusion to the patient. Ensure the patient understands that they should not add water to the ostomy appliance in any other setting. Secure the ostomy appliance as described above.
1. Ensure the pump is fully submerged in the chyme.
2. Magnetically connect the pump to the driver.
a. Hold the driver and pump in an orientation allowing the user to see the tube. The user should be able to be to see whether chyme is progressing up the tube.
3. Reinfusing chyme stretches the luminal walls of the bowel, which may cause abdominal discomfort. To reduce this discomfort, begin chyme reinfusion slowly. For more information, refer to the ETD-14 Patient Management listed on The Insides Company Training Portal.
a. While holding the pump against the driver, press the 'MODE' button to start at 'MODE 1', the slowest speed setting. If chyme moves quickly up the tube, stay on 'MODE 1' and reinfuse a small volume of chyme.
b. After 30 seconds, if chyme is not progressing up the
tube, increase to the next ‘MODE’. Continue this process until chyme is progressing up the tube. If chyme is not progressing up the tube after 60 seconds on 'MODE 5', refer to the Troubleshooting section below.
c. If chyme starts to reflux out of the stoma, or if the patient feels nauseous or bloated, reduce the 'MODE' on the driver or cease reinfusing for several minutes. Reducing the ‘MODE’ can be accomplished by pressing the ‘MODE’ button, which transitions through all five speeds and off. For further information about reflux, refer to the Troubleshooting section.
4. After reinfusing a small amount of chyme, decouple the driver from the pump and turn it off by cycling through each ‘MODE’.
Ensure the patient receives routine ostomy appliance changes. Make sure the patient takes care when removing the appliance so that the tube is not pulled out. The pump may get caught in the ostomy appliance upon removal. Ensure the patient holds onto the tube with one hand and removes the ostomy appliance with the other hand. If this is too difficult, detach the pump from the tube within the ostomy appliance to be removed together.
The time required to reinfuse chyme varies depending on the chyme's thickness, which may differ across the day and the patient's oral intake. THE INSIDES® System is not suitable for thick or fibrous chyme, therefore some chyme may be discarded. Any amount of chyme that is refed is beneficial.
The patients using THE INSIDES® System should adhere to the following steps for optimal results:
If reinfusion takes longer than expected or if the patient is unable to reinfuse, attempt the following remedial steps:
If none of these solutions work, THE INSIDES® System may not be suitable for the patient.
When using THE INSIDES® System, patients may experience reflux of chyme from the distal intestine, around the tube, back into the ostomy appliance. Reflux occurs when the distal intestine receives more chyme than it can accommodate. While reflux is not harmful to the patient, it can increase its time to reinfuse successfully.
Reflux may be reduced by:
NOTE: Loperamide and similar anti-motility therapies can cause constipation, blocking the intestine and preventing chyme reinfusing. Adjust the dose of motility therapies as required and refer to ETD-14 Patient Management with The Insides System if further action is needed.
Please contact the manufacturer or the local representative for assistance with setting up, using, or maintaining THE INSIDES™ System or to report unexpected operations or events.
Local Representative Contact Information:
Online Assistance
Company
The Insides Company LTD
Website
clinical@theinsides.co
New Zealand
Company
The Insides Company LTD
Phone
+64 9 887 9309
Address
487 Parnell Rd, Parnell
Auckland 1052
New Zealand
Australian Sponsor
Company
GSE Pty. Ltd.
Phone
+61 (412) 159 732
Address
323 Toohey Road,
Tarragindi, QLD 4121
Australia
EC Representative
Company
Advena LTD
Phone
+44 20 3389 6331
Address
Tower Business Centre, 2nd Fl.
Tower Street, Swatar, BKR 4013
Malta
UK Representative
Company
Advena LTD
Phone
+44 (0) 1926 800153
Address
Pure Offices
Plato Close, Tachbrook Park
Warwick CV34 6WE UK
CH Representative
Company
Swiss AR Services GmbH
Phone
+41 41 480 40 00
Address
Industriestrasse 47
CH-6300 Zug,
Switzerland
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Prior to commencing chyme reinfusion therapy the patient’s distal intestine must be
checked to ensure patency. A method of doing this is contrast imaging.
The Insides System contains two sizes of The Insides Tube, 28 Fr and 22 Fr. As a general
guide:
If the Clinician determines that neither the 28 Fr or 22 Fr tube sizes are appropriate, a
minimum 20 Fr balloon retained tube is recommended. Please note, a balloon retained tube with an ENFit™ connection does not couple with The Insides Pump.
The Insides Tube 28Fr tube is recommended when applicable. If the 28Fr does not fit, smaller tubes can be used to reinfuse small boluses to rehabilitate the intestine. After a short period EN 10 of intestinal rehabilitation, the patient may be able to transition to a version of The Insides Tube or transition from the 22 Fr to the 28 Fr Tube.
If a patient has a parastomal hernia, caution is needed when inserting the tube. Possible bowel kinking can prevent the tube from being inserted and can create a risk of perforation. The increased external length of bowel can prevent the tube from being positioned and anchored correctly. Digitally palpating the distal tract will indicate the direction of distal limb, any narrowing or kinking, and the distance to fascia.
If the patient has a prolapsed distal limb of their enterostomy or enterocutaneous fistula (ECF), caution is needed when inserting the tube due to the extended, unsupported length of intestine that is external to the body. The Insides Tube is not suitable for this type of patient.
If a patient has an ECF, caution and careful clinical decision making are required when selecting the correct tube to use for the patient. Patients may have little or no fascia around the location of tube insertion. Consequently, a retention sleeve or cuff may not prevent the migration of the tube into the distal intestine as it matures. An appropriate tube should be selected and monitored to ensure the migration does not occur.
The Insides Tube can be used with any ostomy appliance. Initially, it is recommended the patient use a clear ostomy appliance, so it is easy to watch chyme move up the tube and see the volume in the ostomy appliance decreasing. If a tube, other than The Insides Tube, is required initially, then this tube and pump must fit comfortably within the ostomy appliance without any pressure exerted on the tube and The Insides Pump.
The installation of a feeding tube into the patient’s distal limb may increase the size of the stoma on the abdomen. Consequently, it is recommended that the patient’s template on the base plate of the ostomy appliance, is re-measured. This is to ensure there is a clearance of 2 – 3 mm between the enterostomy and the edge of the base plate. This allows for peristalsis and the natural movement of the enterostomy and tube complex to prevent the risk of mucosal erosion due to rubbing on the side of the base plate. It is best to re-measure the patient’s template periodically. The base plate should also be re-measured if there have been any changes as a result of weight gain, weight loss, herniation, or prolapse.
When starting therapy with The Insides System, the patient will spend a short period of time increasing their tolerance to chyme reinfusion therapy, rehabilitating their distal bowel, and slowly introducing oral food. During this period, it is recommended to keep the patient’s parenteral nutrition prescription and anti-motility medication at the same dose. This will allow the patient to become independent with The Insides System and not become overwhelmed with the increase in their output from weaning the anti-motility medication. This will also maintain their nutrition while they are transitioning to reinfuse all of their output and ensure their nutrition is optimised.
THE INSIDES® Driver (driver) should be fully charged before the first use. The charging light will turn ON while the driver is charging and will turn OFF when it is fully charged. The full charge cycle could take up to four hours. After each use of the driver, all accessible surfaces should be wiped down using a damp cloth followed by an EPA recommended disinfectant wipe.
Before commencing prepare a clean work station and don gloves.
The patient must have visibility into the ostomy appliance to ensure that THE INSIDES® System is successfully reinfusing chyme. Use a clear ostomy appliance or remove outer lining of the patient's usual ostomy appliance to ensure adequate visibility.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
THE INSIDES® Tube must be inserted by a healthcare professional. The Insides® Tube must be replaced every 28 days.
1. Select the appropriately size feeding tube based on the diameter of the patient’s
stoma.
2. The patient should be resting in a comfortable supine position. Remove the patient's ostomy appliance and wipe away any excess chyme from the area. Only reinfuse chyme that is less than eight-hours old. Store the patient's chyme if this is the first use of THE INSIDES® System.
3. Unpackage the tube. A retention sleeve and guidewire are also provided to aid user comfort and insertion, respectively.
4. Lubricate the tube using 10-20 mL of water-based lubricant as described below:
a. Unfold the arms of the retention
sleeve from the tube.
b. Spread lubricant in front of and
behind the retention sleeve. With adequate force, pull the retention sleeve backward, towards the handle of the guidewire, over the lubricant, then return it to its original position. Continue this until the retention sleeve moves freely. Add more lubricant if it is required. Then, move the retention sleeve towards the bulbous section of the tube. Ensure the retention sleeve is not pulled off.
c. Lubricate the bulbous section of the tube.
d. Set the tube aside on the clean workstation.
5. With additional lubricant, digitally examine the direction of the
distal tract. Palpate the fascia to gauge the approximate length required for the insertion of the tube. If the distal tract is tight or kinked, insert 3-10 mL of additional lubricant.
6. During the examination, the patient may feel some abdominal discomfort. Discomfort is due to the stretching of the intestinal lumen and should be expected. After digitally palpating the distal tract, replace gloves.
7. Collapse the tube's bulbous feature by inserting the guidewire until the base of the tube touches the 'stop' on the guidewire. Pinch the guidewire between the tube and maintain pressure so it stays in place. Ensure that the guidewire's tip is sitting within the nose of the tube and not sticking out through the bulbous section.
8. While the bulbous section is collapsed, use the free hand to guide the tube and insert it into the distal limb. Apply gentle pressure until the bulbous feature of the tube is 10-20 mm past the abdominal fascia. The intestine may not allow the tube to be immediately inserted; it may take up to 60 seconds for peristalsis to help move the tube into place.
9. Firmly hold the tube in place with one hand and remove the guidewire with the other.
10. Allow the tube to settle into its natural position. The tube may move outwards up to 10mm due to peristalsis.
11. Move the retention sleeve up the tube until it sits 1-2 mm away from the stoma. Fold the arms of the retention sleeve over the tube to secure it in place.
Due to differing patient anatomy, the retention sleeve may block the proximal outlet. If this occurs, chyme may leak under the baseplate of the ostomy appliance. If this happens, the retention sleeve can be moved down the tube, away from the stoma.
12. Gently tug on the tube to confirm it is anchored in place.
13. If the tube becomes dislodged, remove it entirely from the patient before reinserting the guidewire into the tube:
a. Move the retention sleeve toward the bulbous feature.
b. Insert lubricant into the Tube.
c. Insert the guidewire into the Tube, beyond the retention sleeve in a single fluid
motion.
d. If the guidewire does not slide beyond the retention sleeve, move the guidewire's tip back into the lubricant, then repeat Step c.
e. Hold the guidewire in place and move the retention sleeve to the centre of the Tube.
f. Return to Step 3.
14. Once the tube is successfully inserted, dispose of the guidewire appropriately.
WARNING: Do not insert the guidewire into the Tube while it is positioned inside a patient - this could result in perforation of the bowel.
NOTE: Peristalsis may move the tube in and out of the stoma slightly. When placed correctly, the tube should not fall out on its own and the retention sleeve will prevent it from being pulled too far into the distal intestine.
1. Connect the pump to the tube. The base of the tube should touch the third ring of the pump outlet to ensure it cannot be accidentally dislodged.
2. Allow the patient or their carer to practise connecting and disconnecting the pump while ensuring that the tube position is not disturbed.
3. Measure the ostomy appliance against the tube and pump. Trim the end of the tube so
that the pump sits 10-20 mm above the bottom of the ostomy appliance when attached.
4. The pump can rotate around the tube until oriented such that the position allows the connecting of the pump to the driver.
A clip is provided to hold the tube in place. Once the Ostomy appliance has been applied, a clip can be attached to the tube from the outside of the bag to help prevent the tube falling out and
reduce pulling on the stoma. Choose the clip that will fit around the section of the tube immediately below the retention sleeve.
This will depend on the size of the tube and how short the tube is trimmed. Ensure the patient is aware of which clip should be used.
1. Assess the suitability of the patient's chyme from the patient's previous ostomy
appliance.
a. Pinch the ostomy appliance between the thumb and forefinger. Release it quickly to observe the time it takes for the chyme to refill the space. If it is instantaneous, the chyme can be pumped; otherwise, it may be too thick and should be discarded.
b. Chyme sitting for less than eight hours is suitable for pumping; otherwise, it must be discarded.
c. There must be enough volume for the Pump to be fully submerged in the chyme, approximately 70-100 mL.
2. If the patient's chyme is suitable for reinfusing, transfer the chyme into the new ostomy appliance. If not, fill a new ostomy appliance with enough water to submerge the Pump. Water can be used to demonstrate chyme reinfusion to the patient. Ensure the patient understands that they should not add water to the ostomy appliance in any other setting. Secure the ostomy appliance as described above.
1. Ensure the pump is fully submerged in the chyme.
2. Magnetically connect the pump to the driver.
a. Hold the driver and pump in an orientation allowing the user to see the tube. The user should be able to be to see whether chyme is progressing up the tube.
3. Reinfusing chyme stretches the luminal walls of the bowel, which may cause abdominal discomfort. To reduce this discomfort, begin chyme reinfusion slowly. For more information, refer to the ETD-14 Patient Management listed on The Insides Company Training Portal.
a. While holding the pump against the driver, press the 'MODE' button to start at 'MODE 1', the slowest speed setting. If chyme moves quickly up the tube, stay on 'MODE 1' and reinfuse a small volume of chyme.
b. After 30 seconds, if chyme is not progressing up the
tube, increase to the next ‘MODE’. Continue this process until chyme is progressing up the tube. If chyme is not progressing up the tube after 60 seconds on 'MODE 5', refer to the Troubleshooting section below.
c. If chyme starts to reflux out of the stoma, or if the patient feels nauseous or bloated, reduce the 'MODE' on the driver or cease reinfusing for several minutes. Reducing the ‘MODE’ can be accomplished by pressing the ‘MODE’ button, which transitions through all five speeds and off. For further information about reflux, refer to the Troubleshooting section.
4. After reinfusing a small amount of chyme, decouple the driver from the pump and turn it off by cycling through each ‘MODE’.
Ensure the patient receives routine ostomy appliance changes. Make sure the patient takes care when removing the appliance so that the tube is not pulled out. The pump may get caught in the ostomy appliance upon removal. Ensure the patient holds onto the tube with one hand and removes the ostomy appliance with the other hand. If this is too difficult, detach the pump from the tube within the ostomy appliance to be removed together.
The time required to reinfuse chyme varies depending on the chyme's thickness, which may differ across the day and the patient's oral intake. THE INSIDES® System is not suitable for thick or fibrous chyme, therefore some chyme may be discarded. Any amount of chyme that is refed is beneficial.
The patients using THE INSIDES® System should adhere to the following steps for optimal results:
If reinfusion takes longer than expected or if the patient is unable to reinfuse, attempt the following remedial steps:
If none of these solutions work, THE INSIDES® System may not be suitable for the patient.
When using THE INSIDES® System, patients may experience reflux of chyme from the distal intestine, around the tube, back into the ostomy appliance. Reflux occurs when the distal intestine receives more chyme than it can accommodate. While reflux is not harmful to the patient, it can increase its time to reinfuse successfully.
Reflux may be reduced by:
NOTE: Loperamide and similar anti-motility therapies can cause constipation, blocking the intestine and preventing chyme reinfusing. Adjust the dose of motility therapies as required and refer to ETD-14 Patient Management with The Insides System if further action is needed.
Please contact the manufacturer or the local representative for assistance with setting up, using, or maintaining THE INSIDES™ System or to report unexpected operations or events.
Local Representative Contact Information:
Online Assistance
Company
The Insides Company LTD
Website
clinical@theinsides.co
New Zealand
Company
The Insides Company LTD
Phone
+64 9 887 9309
Address
487 Parnell Rd, Parnell
Auckland 1052
New Zealand
Australian Sponsor
Company
GSE Pty. Ltd.
Phone
+61 (412) 159 732
Address
323 Toohey Road,
Tarragindi, QLD 4121
Australia
EC Representative
Company
Advena LTD
Phone
+44 20 3389 6331
Address
Tower Business Centre, 2nd Fl.
Tower Street, Swatar, BKR 4013
Malta
UK Representative
Company
Advena LTD
Phone
+44 (0) 1926 800153
Address
Pure Offices
Plato Close, Tachbrook Park
Warwick CV34 6WE UK
CH Representative
Company
Swiss AR Services GmbH
Phone
+41 41 480 40 00
Address
Industriestrasse 47
CH-6300 Zug,
Switzerland
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Antes de iniciar a terapêutica de reinfusão de quimo, é necessário verificar a permeabilidade do segmento distal do intestino do doente. Um método para a realizar é através da imagiologia com contraste.
O sistema The Insides System é composto por dois tamanhos de sonda The Insides Tube, 28 Fr e 22 Fr. A título de orientação geral:
Se o médico determinar que os tamanhos de sonda 28 Fr ou 22 Fr não são adequados, recomenda-se a utilização de uma sonda com balão de retenção, no mínimo, de tamanho 20 Fr. Tenha em atenção que uma sonda com balão de retenção com uma conexão ENFitTM não pode ser acoplada à bomba The Insides Pump.
A sonda The Insides Tube 28Fr é recomendada quando for aplicável. Se o tamanho 28Fr não se ajustar, podem ser utilizadas sondas menores para a reinfusão de bólus de pequeno volume para a reabilitação do intestino. Após um curto período de reabilitação intestinal, o doente poderá ser capaz de fazer a transição para uma versão da sonda The Insides Tube ou a transição da sonda de 22 Fr para a sonda de 28 Fr.
Se um doente apresentar uma hérnia paraestomal, é necessário ter precaução ao inserir a sonda. Uma possível torção intestinal pode impedir a inserção da sonda e criar um risco de perfuração. O aumento da porção exteriorizada do intestino pode impedir que a sonda seja posicionada e ancorada corretamente. A palpação digital do trato distal irá detetar a direção do segmento distal, algum estreitamento ou torção e a distância até à fáscia.
Se o doente apresentar um segmento distal prolapsado da sua enterostomia ou fístula enterocutânea (FEC), é necessário ter precaução ao inserir a sonda, devido ao comprimento expandido e desprotegido do intestino que estiver exteriorizado. A sonda The Insides Tube não é adequada para este tipo de doentes.
Se um doente apresentar uma FEC, é necessário ter precaução e efetuar uma cuidadosa tomada de decisão clínica ao selecionar a sonda correta a utilizar para o doente. Os doentes poderão ter pouca ou nenhuma fáscia à volta da região de inserção da sonda. Consequentemente, uma manga ou um cuff de retenção poderão não evitar a migração da sonda para o segmento distal do intestino, à medida que este se adapta. Deve ser selecionada uma sonda adequada e monitorizada para assegurar que não ocorre a sua migração.
A sonda The Insides Tube pode ser utilizada com qualquer dispositivo de ostomia. Inicialmente, recomenda-se que o doente utilize um dispositivo de ostomia transparente, para que seja fácil observar a subida do quimo através da sonda e visualizar o volume no dispositivo de ostomia a diminuir. Se for necessário utilizar inicialmente uma sonda que não seja a The Insides Tube, então essa mesma sonda e a bomba devem se ajustar confortavelmente no dispositivo de ostomia, sem que seja exercida qualquer pressão na sonda e na bomba The Insides Pump.
A colocação de uma sonda de alimentação no segmento distal do doente pode aumentar o tamanho do estoma no abdómen. Consequentemente, recomenda-se que seja novamente medido o molde da placa de base no dispositivo de ostomia do doente. Desta forma, é possível assegurar que haja uma margem de 2 a 3 mm entre a enterostomia e o bordo da placa de base. Isto permite que ocorra o peristaltismo e o movimento natural do complexo de enterostomia e sonda, para evitar o risco de erosão da mucosa devido à fricção no rebordo lateral da placa de base. É preferível voltar a medir periodicamente o molde do doente. A placa de base também deve ser medida novamente, se houver quaisquer alterações resultantes do aumento ou perda de peso, herniação ou prolapso.
Ao iniciar a terapêutica com o sistema The Insides System, o doente passará um curto período de tempo a aumentar a sua tolerância à terapêutica de reinfusão de quimo, a reabilitar o segmento distal do intestino e a introduzir lentamente alimentos por via oral. Durante este período, recomenda-se que a prescrição de nutrição parentérica e dos medicamentos modificadores da motilidade gastrointestinal do doente sejam mantidos na mesma dose. Isto permitirá que o doente se torne independente com o sistema The Insides System e não fique sobrecarregado com o aumento do seu débito resultante do desmame dos medicamentos modificadores da motilidade gastrointestinal. Desta forma, a sua nutrição também será mantida durante a transição para que seja reinfundido todo o próprio débito e assegurar a otimização da sua nutrição.
THE INSIDES® Driver (driver) should be fully charged before the first use. The charging light will turn ON while the driver is charging and will turn OFF when it is fully charged. The full charge cycle could take up to four hours. After each use of the driver, all accessible surfaces should be wiped down using a damp cloth followed by an EPA recommended disinfectant wipe. Before commencing prepare a clean work station and don gloves.
The patient must have visibility into the ostomy appliance to ensure that THE INSIDES® System is successfully reinfusing chyme. Use a clear ostomy appliance or remove outer lining of the patient's usual ostomy appliance to ensure adequate visibility.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
AVISO: não insira o fio guia no tubo enquanto este estiver inserido num paciente: isso
pode resultar na perfuração do intestino.
NOTA: os movimentos peristálticos podem movimentar ligeiramente o tubo para dentro epara fora do estoma. Quando colocado corretamente, o tubo não deverá cair sozinho e a manga de retenção evitará que o mesmo entre demasiado no intestino distal.
É fornecido um clipe para manter a sonda no lugar. Depois de o aparelho de ostomia ser aplicado, pode ser encaixado um clipe
no tubo do lado de fora da bolsa para ajudar a evitar que o tubo caia e reduzir a tração no estoma. Escolha o tamanho do clipe que caberá em torno da secção do tubo imediatamente abaixo da manga de retenção. Isso dependerá do tamanho do tubo e de quão curto o tubo é cortado. Certifique-se de que o doente
está ciente de que clipe deve ser utilizado.
Certifique-se de que o paciente efetua substituições regulares do dispositivo de ostomia. Certifique-se de que o paciente tem cuidado ao retirar o dispositivo para que o tubo não seja retirado. A bomba pode ficar presa no dispositivo de ostomia durante a remoção. Certifique-se de que o paciente segura o tubo com uma mão e retira o dispositivo de ostomia com a outra. Se isto for demasiado difícil, desencaixe a bomba do tubo dentro do dispositivo de ostomia para os retirar conjuntamente.
O tempo necessário para realizar a reinfusão do quimo varia dependendo da espessura do mesmo, que pode variar ao longo do dia e de acordo com a ingestão oral do paciente. THE INSIDES® System não é adequado para quimo espesso ou fibroso; portanto, poderá ser necessário descartar algum quimo. Qualquer quantidade de quimo realimentado é benéfica.
Os pacientes que utilizem THE INSIDES® System devem respeitar os passos seguintes para obterem resultados ótimos:
Se a realimentação demorar mais do que o esperado ou se o paciente não conseguir realizar a realimentação, tente os seguintes passos corretivos:
Se nenhuma destas soluções funcionar, THE INSIDES® System poderá não ser adequado para o paciente.
Ao usar THE INSIDES® System, os pacientes podem deparar-se com refluxo do quimo a partir do intestino distal, ao redor do tubo, de volta ao dispositivo de ostomia. O refluxo ocorre quando o intestino distal recebe mais quimo do que o espaço disponível. Embora o refluxo não seja prejudicial para o paciente, pode aumentar o tempo necessário para uma realimentação bem-sucedida.
O refluxo pode ser reduzido das seguintes formas:
NOTA: a Loperamida e terapêuticas antimotilidade similares podem provocar prisão de ventre, obstruindo o intestino e impedindo a reinfusão do quimo. Ajuste a dose das terapêuticas de motilidade conforme necessário, e consulte o ETD-14 Gerenciamento de pacientes se houver necessidade de ações adicionais
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Prior to commencing chyme reinfusion therapy the patient’s distal intestine must be
checked to ensure patency. A method of doing this is contrast imaging.
The Insides System contains two sizes of The Insides Tube, 28 Fr and 22 Fr. As a general
guide:
If the Clinician determines that neither the 28 Fr or 22 Fr tube sizes are appropriate, a
minimum 20 Fr balloon retained tube is recommended. Please note, a balloon retained tube with an ENFit™ connection does not couple with The Insides Pump.
The Insides Tube 28Fr tube is recommended when applicable. If the 28Fr does not fit, smaller tubes can be used to reinfuse small boluses to rehabilitate the intestine. After a short period EN 10 of intestinal rehabilitation, the patient may be able to transition to a version of The Insides Tube or transition from the 22 Fr to the 28 Fr Tube.
If a patient has a parastomal hernia, caution is needed when inserting the tube. Possible bowel kinking can prevent the tube from being inserted and can create a risk of perforation. The increased external length of bowel can prevent the tube from being positioned and anchored correctly. Digitally palpating the distal tract will indicate the direction of distal limb, any narrowing or kinking, and the distance to fascia.
If the patient has a prolapsed distal limb of their enterostomy or enterocutaneous fistula (ECF), caution is needed when inserting the tube due to the extended, unsupported length of intestine that is external to the body. The Insides Tube is not suitable for this type of patient.
If a patient has an ECF, caution and careful clinical decision making are required when selecting the correct tube to use for the patient. Patients may have little or no fascia around the location of tube insertion. Consequently, a retention sleeve or cuff may not prevent the migration of the tube into the distal intestine as it matures. An appropriate tube should be selected and monitored to ensure the migration does not occur.
The Insides Tube can be used with any ostomy appliance. Initially, it is recommended the patient use a clear ostomy appliance, so it is easy to watch chyme move up the tube and see the volume in the ostomy appliance decreasing. If a tube, other than The Insides Tube, is required initially, then this tube and pump must fit comfortably within the ostomy appliance without any pressure exerted on the tube and The Insides Pump.
The installation of a feeding tube into the patient’s distal limb may increase the size of the stoma on the abdomen. Consequently, it is recommended that the patient’s template on the base plate of the ostomy appliance, is re-measured. This is to ensure there is a clearance of 2 – 3 mm between the enterostomy and the edge of the base plate. This allows for peristalsis and the natural movement of the enterostomy and tube complex to prevent the risk of mucosal erosion due to rubbing on the side of the base plate. It is best to re-measure the patient’s template periodically. The base plate should also be re-measured if there have been any changes as a result of weight gain, weight loss, herniation, or prolapse.
When starting therapy with The Insides System, the patient will spend a short period of time increasing their tolerance to chyme reinfusion therapy, rehabilitating their distal bowel, and slowly introducing oral food. During this period, it is recommended to keep the patient’s parenteral nutrition prescription and anti-motility medication at the same dose. This will allow the patient to become independent with The Insides System and not become overwhelmed with the increase in their output from weaning the anti-motility medication. This will also maintain their nutrition while they are transitioning to reinfuse all of their output and ensure their nutrition is optimised.
THE INSIDES® Driver (driver) should be fully charged before the first use. The charging light will turn ON while the driver is charging and will turn OFF when it is fully charged. The full charge cycle could take up to four hours. After each use of the driver, all accessible surfaces should be wiped down using a damp cloth followed by an EPA recommended disinfectant wipe.
Before commencing prepare a clean work station and don gloves.
The patient must have visibility into the ostomy appliance to ensure that THE INSIDES® System is successfully reinfusing chyme. Use a clear ostomy appliance or remove outer lining of the patient's usual ostomy appliance to ensure adequate visibility.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
THE INSIDES® Tube must be inserted by a healthcare professional. The Insides® Tube must be replaced every 28 days.
1. Select the appropriately size feeding tube based on the diameter of the patient’s
stoma.
2. The patient should be resting in a comfortable supine position. Remove the patient's ostomy appliance and wipe away any excess chyme from the area. Only reinfuse chyme that is less than eight-hours old. Store the patient's chyme if this is the first use of THE INSIDES® System.
3. Unpackage the tube. A retention sleeve and guidewire are also provided to aid user comfort and insertion, respectively.
4. Lubricate the tube using 10-20 mL of water-based lubricant as described below:
a. Unfold the arms of the retention
sleeve from the tube.
b. Spread lubricant in front of and
behind the retention sleeve. With adequate force, pull the retention sleeve backward, towards the handle of the guidewire, over the lubricant, then return it to its original position. Continue this until the retention sleeve moves freely. Add more lubricant if it is required. Then, move the retention sleeve towards the bulbous section of the tube. Ensure the retention sleeve is not pulled off.
c. Lubricate the bulbous section of the tube.
d. Set the tube aside on the clean workstation.
5. With additional lubricant, digitally examine the direction of the
distal tract. Palpate the fascia to gauge the approximate length required for the insertion of the tube. If the distal tract is tight or kinked, insert 3-10 mL of additional lubricant.
6. During the examination, the patient may feel some abdominal discomfort. Discomfort is due to the stretching of the intestinal lumen and should be expected. After digitally palpating the distal tract, replace gloves.
7. Collapse the tube's bulbous feature by inserting the guidewire until the base of the tube touches the 'stop' on the guidewire. Pinch the guidewire between the tube and maintain pressure so it stays in place. Ensure that the guidewire's tip is sitting within the nose of the tube and not sticking out through the bulbous section.
8. While the bulbous section is collapsed, use the free hand to guide the tube and insert it into the distal limb. Apply gentle pressure until the bulbous feature of the tube is 10-20 mm past the abdominal fascia. The intestine may not allow the tube to be immediately inserted; it may take up to 60 seconds for peristalsis to help move the tube into place.
9. Firmly hold the tube in place with one hand and remove the guidewire with the other.
10. Allow the tube to settle into its natural position. The tube may move outwards up to 10mm due to peristalsis.
11. Move the retention sleeve up the tube until it sits 1-2 mm away from the stoma. Fold the arms of the retention sleeve over the tube to secure it in place.
Due to differing patient anatomy, the retention sleeve may block the proximal outlet. If this occurs, chyme may leak under the baseplate of the ostomy appliance. If this happens, the retention sleeve can be moved down the tube, away from the stoma.
12. Gently tug on the tube to confirm it is anchored in place.
13. If the tube becomes dislodged, remove it entirely from the patient before reinserting the guidewire into the tube:
a. Move the retention sleeve toward the bulbous feature.
b. Insert lubricant into the Tube.
c. Insert the guidewire into the Tube, beyond the retention sleeve in a single fluid
motion.
d. If the guidewire does not slide beyond the retention sleeve, move the guidewire's tip back into the lubricant, then repeat Step c.
e. Hold the guidewire in place and move the retention sleeve to the centre of the Tube.
f. Return to Step 3.
14. Once the tube is successfully inserted, dispose of the guidewire appropriately.
WARNING: Do not insert the guidewire into the Tube while it is positioned inside a patient - this could result in perforation of the bowel.
NOTE: Peristalsis may move the tube in and out of the stoma slightly. When placed correctly, the tube should not fall out on its own and the retention sleeve will prevent it from being pulled too far into the distal intestine.
1. Connect the pump to the tube. The base of the tube should touch the third ring of the pump outlet to ensure it cannot be accidentally dislodged.
2. Allow the patient or their carer to practise connecting and disconnecting the pump while ensuring that the tube position is not disturbed.
3. Measure the ostomy appliance against the tube and pump. Trim the end of the tube so
that the pump sits 10-20 mm above the bottom of the ostomy appliance when attached.
4. The pump can rotate around the tube until oriented such that the position allows the connecting of the pump to the driver.
A clip is provided to hold the tube in place. Once the Ostomy appliance has been applied, a clip can be attached to the tube from the outside of the bag to help prevent the tube falling out and
reduce pulling on the stoma. Choose the clip that will fit around the section of the tube immediately below the retention sleeve.
This will depend on the size of the tube and how short the tube is trimmed. Ensure the patient is aware of which clip should be used.
1. Assess the suitability of the patient's chyme from the patient's previous ostomy
appliance.
a. Pinch the ostomy appliance between the thumb and forefinger. Release it quickly to observe the time it takes for the chyme to refill the space. If it is instantaneous, the chyme can be pumped; otherwise, it may be too thick and should be discarded.
b. Chyme sitting for less than eight hours is suitable for pumping; otherwise, it must be discarded.
c. There must be enough volume for the Pump to be fully submerged in the chyme, approximately 70-100 mL.
2. If the patient's chyme is suitable for reinfusing, transfer the chyme into the new ostomy appliance. If not, fill a new ostomy appliance with enough water to submerge the Pump. Water can be used to demonstrate chyme reinfusion to the patient. Ensure the patient understands that they should not add water to the ostomy appliance in any other setting. Secure the ostomy appliance as described above.
1. Ensure the pump is fully submerged in the chyme.
2. Magnetically connect the pump to the driver.
a. Hold the driver and pump in an orientation allowing the user to see the tube. The user should be able to be to see whether chyme is progressing up the tube.
3. Reinfusing chyme stretches the luminal walls of the bowel, which may cause abdominal discomfort. To reduce this discomfort, begin chyme reinfusion slowly. For more information, refer to the ETD-14 Patient Management listed on The Insides Company Training Portal.
a. While holding the pump against the driver, press the 'MODE' button to start at 'MODE 1', the slowest speed setting. If chyme moves quickly up the tube, stay on 'MODE 1' and reinfuse a small volume of chyme.
b. After 30 seconds, if chyme is not progressing up the
tube, increase to the next ‘MODE’. Continue this process until chyme is progressing up the tube. If chyme is not progressing up the tube after 60 seconds on 'MODE 5', refer to the Troubleshooting section below.
c. If chyme starts to reflux out of the stoma, or if the patient feels nauseous or bloated, reduce the 'MODE' on the driver or cease reinfusing for several minutes. Reducing the ‘MODE’ can be accomplished by pressing the ‘MODE’ button, which transitions through all five speeds and off. For further information about reflux, refer to the Troubleshooting section.
4. After reinfusing a small amount of chyme, decouple the driver from the pump and turn it off by cycling through each ‘MODE’.
Ensure the patient receives routine ostomy appliance changes. Make sure the patient takes care when removing the appliance so that the tube is not pulled out. The pump may get caught in the ostomy appliance upon removal. Ensure the patient holds onto the tube with one hand and removes the ostomy appliance with the other hand. If this is too difficult, detach the pump from the tube within the ostomy appliance to be removed together.
The time required to reinfuse chyme varies depending on the chyme's thickness, which may differ across the day and the patient's oral intake. THE INSIDES® System is not suitable for thick or fibrous chyme, therefore some chyme may be discarded. Any amount of chyme that is refed is beneficial.
The patients using THE INSIDES® System should adhere to the following steps for optimal results:
If reinfusion takes longer than expected or if the patient is unable to reinfuse, attempt the following remedial steps:
If none of these solutions work, THE INSIDES® System may not be suitable for the patient.
When using THE INSIDES® System, patients may experience reflux of chyme from the distal intestine, around the tube, back into the ostomy appliance. Reflux occurs when the distal intestine receives more chyme than it can accommodate. While reflux is not harmful to the patient, it can increase its time to reinfuse successfully.
Reflux may be reduced by:
NOTE: Loperamide and similar anti-motility therapies can cause constipation, blocking the intestine and preventing chyme reinfusing. Adjust the dose of motility therapies as required and refer to ETD-14 Patient Management with The Insides System if further action is needed.
Please contact the manufacturer or the local representative for assistance with setting up, using, or maintaining THE INSIDES™ System or to report unexpected operations or events.
Local Representative Contact Information:
Online Assistance
Company
The Insides Company LTD
Website
clinical@theinsides.co
New Zealand
Company
The Insides Company LTD
Phone
+64 9 887 9309
Address
487 Parnell Rd, Parnell
Auckland 1052
New Zealand
Australian Sponsor
Company
GSE Pty. Ltd.
Phone
+61 (412) 159 732
Address
323 Toohey Road,
Tarragindi, QLD 4121
Australia
EC Representative
Company
Advena LTD
Phone
+44 20 3389 6331
Address
Tower Business Centre, 2nd Fl.
Tower Street, Swatar, BKR 4013
Malta
UK Representative
Company
Advena LTD
Phone
+44 (0) 1926 800153
Address
Pure Offices
Plato Close, Tachbrook Park
Warwick CV34 6WE UK
CH Representative
Company
Swiss AR Services GmbH
Phone
+41 41 480 40 00
Address
Industriestrasse 47
CH-6300 Zug,
Switzerland
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Pred začetkom ponovne infuzije himusa preglejte bolnikovo distalno črevo, da zagotovite prehodnost. Za to uporabite metodo kontrastnega slikanja.
Sistem The Insides System vsebuje dve velikosti cevk The Insides Tube, 28 Fr in 22 Fr. Splošno vodilo:
Če zdravnik ugotovi, da velikosti cevk 28 Fr ali 22 Fr nista primerni, se priporoča vstavitev cevk z balonom velikosti najmanj 20 Fr. Upoštevajte, da cevka z balonom s priključkom ENFitTM ni združljiva s črpalko The Insides Pump.
Če je primerno, se priporoča cevka The Insides Tube 28Fr. Če se velikost 28Fr ne prilega, lahko uporabite manjše cevke za ponovno infuzijo majhnih bolusov za rehabilitacijo črevesja. Po kratkem obdobju črevesne rehabilitacije bo bolnik morda lahko prešel na različico cevk The Insides Tube ali z velikosti cevk 22 Fr na velikost 28 Fr.
Če ima bolnik parastomalno kilo, bodite pri vstavljanju cevke previdni. Morebitno upogibanje črevesja lahko prepreči vstavljanje cevke in povzroči tveganje za perforacijo. Povečana zunanja dolžina črevesja lahko prepreči pravilno namestitev in pritrditev cevke. Digitalno otipanje distalnega trakta bo pokazalo smer distalnega uda, morebitno zoženje ali upogibanje in razdaljo do fascije.
Če ima bolnik prolaps distalnega uda enterostome ali enterokutane fistule (ECF), previdno vstavite cevko zaradi podaljšane, nepodprte dolžine črevesja, ki je zunaj telesa. Cevka The Insides Tube ni primerna za to vrsto bolnika.
Če ima bolnik ECF, previdno in skrbno premislite o izbiri ustrezne cevke za bolnika. Bolniki imajo lahko malo ali nič fascije okoli mesta vstavitve cevke. Posledično zadrževalni tulec ali manšeta med zorenjem morda ne bosta preprečila prehajanje cevke v distalno črevo. Izberite in spremljajte ustrezno cevko, da preprečite prehajanje.
Cevko The Insides Tube lahko uporabljate s katerim koli pripomočkom za stomo. Na začetku je priporočljivo, da bolnik uporablja prozoren pripomoček za stomo, da lahko lažje opazuje, kako se himus premika po cevki navzgor in se volumen v pripomočku zmanjšuje. Če na začetku potrebujete cevko, ki ni cevka The Insides Tube, se morata cevka in črpalka ustrezno prilegati v pripomoček za stomo, ne da bi pritiskala na cevko in črpalko The Insides Pump.
Namestitev cevke za hranjenje v bolnikov distalni ud lahko poveča velikost stome na trebuhu. Zato je priporočljivo, da ponovno izmerite bolnikovo predlogo na osnovni plošči pripomočka za stomo. S tem zagotovite 2–3 mm razmika med enterostomo in robom osnovne plošče. To omogoča peristaltiko in naravno gibanje enterostome in cevnega kompleksa, da se prepreči tveganje za erozijo sluznice zaradi drgnjenja na strani osnovne plošče. Najbolje je, da občasno ponovno izmerite bolnikovo predlogo. Osnovno ploščo ponovno izmerite tudi, če je prišlo do sprememb zaradi povečanja telesne mase, izgube telesne mase, hernije ali prolapsa.
Ob začetku zdravljenja s sistemom The Insides System bo bolnik kratek čas povečeval svojo toleranco na zdravljenje s ponovno infuzijo himusa, saniral distalno črevesje in počasi uvajal peroralno hrano. V tem obdobju je priporočljivo, da sta bolnikov recept za parenteralno prehrano in zdravilo proti gibljivosti v enakem odmerku. To bo bolniku omogočilo, da s sistemom The Insides System postane neodvisen in se ne obremenjuje preveč zaradi povečanega izločanja zaradi odvajanja od zdravil proti gibljivosti. Hkrati bo zadržalo hranila med prehodom na ponovno infuzijo izločkov in jih optimiziralo.
Pred prvo uporabo je treba gonilo THE INSIDES® Driver popolnoma napolniti. Lučka za polnjenje se bo prižgala, medtem ko se gonilo polni. Ko je gonilo popolnoma napolnjeno, bo lučka ugasnila. Celoten cikel polnjenja lahko traja do štiri ure. Po vsaki uporabi gonila je treba vse dostopne površine obrisati z vlažno krpo, nato pa z razkužilnim robčkom, ki ga priporoča organizacija EPA.
Pred začetkom pripravite čisto delovno mesto in si nadenite rokavice.
Bolnik mora videti v vrečko za stomo, da lahko preveri, ali sistem THE INSIDES® System uspešno ponovno dovaja himus. Uporabite prozorno vrečko za stomo ali pa odstranite zunanjo oblogo bolnikove običajne vrečke za stomo, da zagotovite ustrezno vidljivost.
Črpalka THE INSIDES® Pump ima premer 35 mm in bo vstavljena skozi šablono vrečke za stomo. Zato boste morda morali izrezati večjo šablono in uporabiti hidrokoloidno oblogo za zaščito izpostavljene kože. Če to ni primerno, lahko uporabite vrečko za stomo z izpustom in zapiranjem na dnu vrečke. V tem primeru bo črpalka priključena na cev THE INSIDES® Tube skozi to odprtino.
Cev mora vstaviti zdravstveni delavec. Cevko THE INSIDES® Tubefi mora vsakih 28 dni zamenjati zdravstveni delavec.
OPOZORILO: vodilne žice ne vstavljajte v cev, medtem ko je ta vstavljena v bolnika. To lahko povzroči perforacijo črevesja.
OPOMBA: peristaltika lahko cev rahlo premakne v stomo in iz nje. Če je cev pravilno nameščena, ne sme sama izpasti, zadrževalni tulec pa preprečuje, da bi jo potegnilo predaleč v distalno črevo.
Črpalko THE INSIDES® Pumpfi je treba zamenjati vsake tri dni.
Priložena je sponka za pritrditev cevke. Po namestitvi pripomočka za stomo lahko na cevko z zunanje strani vrečke pritrdite sponko, ki preprečuje, da bi cevka izpadla, in zmanjšuje poteg stome. Izberite velikost sponke, ki se bo prilegala delu cevke neposredno pod zadrževalnim tulcem. To bo odvisno od velikosti cevke in tega, kako kratko je cevka odrezana. Prepričajte se, da bolnik ve, katero sponko je treba uporabiti.
Pri prvem ponovnem dovajanju uporabite bolnikov himus, če je to mogoče. Na ta način lahko bolniku bolj realno predstavite, kako dolgo traja ponovno dovajanje himusa, ki je daljše od ponovnega dovajanja vode.
Zagotovite, da bolnik redno menjuje vrečko za stomo. Prepričajte se, da je bolnik pri odstranjevanju vrečke previden, da ne izvleče cevi. Črpalka se lahko ob odstranitvi zatakne v vrečko za stomo. Prepričajte se, da bolnik z eno roko drži cev, z drugo roko pa odstrani vrečko za stomo. Če je to pretežko, snemite črpalko s cevi v vrečki za stomo in ju odstranite skupaj.
Trajanje ponovnega dovajanja himusa je odvisno od gostote himusa, ki se lahko razlikuje čez dan in bolnikov peroralni vnos. Sistem THE INSIDES® Systemfi ni primeren za gost ali vlaknast himus, zato lahko nekaj himusa zavržete. Vsaka ponovno dovedena količina himusa je koristna.
Bolniki, ki uporabljajo sistem THE INSIDES® Systemfi, morajo za doseganje optimalnih rezultatov upoštevati naslednje korake:
Če ponovno dovajanje traja dlje kot pričakovano ali če bolnik ponovnega dovajanja ne more izvesti, poskusite z naslednjimi popravnimi koraki:
Če nobena od teh rešitev ne deluje, sistem THE INSIDES® Systemfi morda ni primeren za bolnika.
Pri uporabi sistema THE INSIDES® Systemfi lahko pri bolnikih pride do refluksa himusa iz distalnega črevesa: okoli cevi in nazaj v vrečko za stomo. Do refluksa pride, ko distalno črevo prejme več himusa, kot ga lahko sprejme. Čeprav refluks za bolnika ni škodljiv, lahko podaljša čas za uspešno ponovno dovajanje.
Refluks je mogoče zmanjšati na naslednje načine:
OPOMBA: loperamid in podobna zdravila za zmanjševanje motilitete prebavil lahko povzročijo zaprtje, blokirajo črevesje in preprečijo ponovno dovajanje himusa. Po potrebi prilagodite odmerek zdravil za zmanjševanje motilitete in glejte dokument ETD-14 Pot oskrbe bolnikov za sistem The Insides Systemfi, če je potrebno nadaljnje ukrepanje.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Prior to commencing chyme reinfusion therapy the patient’s distal intestine must be
checked to ensure patency. A method of doing this is contrast imaging.
The Insides System contains two sizes of The Insides Tube, 28 Fr and 22 Fr. As a general
guide:
If the Clinician determines that neither the 28 Fr or 22 Fr tube sizes are appropriate, a
minimum 20 Fr balloon retained tube is recommended. Please note, a balloon retained tube with an ENFit™ connection does not couple with The Insides Pump.
The Insides Tube 28Fr tube is recommended when applicable. If the 28Fr does not fit, smaller tubes can be used to reinfuse small boluses to rehabilitate the intestine. After a short period EN 10 of intestinal rehabilitation, the patient may be able to transition to a version of The Insides Tube or transition from the 22 Fr to the 28 Fr Tube.
If a patient has a parastomal hernia, caution is needed when inserting the tube. Possible bowel kinking can prevent the tube from being inserted and can create a risk of perforation. The increased external length of bowel can prevent the tube from being positioned and anchored correctly. Digitally palpating the distal tract will indicate the direction of distal limb, any narrowing or kinking, and the distance to fascia.
If the patient has a prolapsed distal limb of their enterostomy or enterocutaneous fistula (ECF), caution is needed when inserting the tube due to the extended, unsupported length of intestine that is external to the body. The Insides Tube is not suitable for this type of patient.
If a patient has an ECF, caution and careful clinical decision making are required when selecting the correct tube to use for the patient. Patients may have little or no fascia around the location of tube insertion. Consequently, a retention sleeve or cuff may not prevent the migration of the tube into the distal intestine as it matures. An appropriate tube should be selected and monitored to ensure the migration does not occur.
The Insides Tube can be used with any ostomy appliance. Initially, it is recommended the patient use a clear ostomy appliance, so it is easy to watch chyme move up the tube and see the volume in the ostomy appliance decreasing. If a tube, other than The Insides Tube, is required initially, then this tube and pump must fit comfortably within the ostomy appliance without any pressure exerted on the tube and The Insides Pump.
The installation of a feeding tube into the patient’s distal limb may increase the size of the stoma on the abdomen. Consequently, it is recommended that the patient’s template on the base plate of the ostomy appliance, is re-measured. This is to ensure there is a clearance of 2 – 3 mm between the enterostomy and the edge of the base plate. This allows for peristalsis and the natural movement of the enterostomy and tube complex to prevent the risk of mucosal erosion due to rubbing on the side of the base plate. It is best to re-measure the patient’s template periodically. The base plate should also be re-measured if there have been any changes as a result of weight gain, weight loss, herniation, or prolapse.
When starting therapy with The Insides System, the patient will spend a short period of time increasing their tolerance to chyme reinfusion therapy, rehabilitating their distal bowel, and slowly introducing oral food. During this period, it is recommended to keep the patient’s parenteral nutrition prescription and anti-motility medication at the same dose. This will allow the patient to become independent with The Insides System and not become overwhelmed with the increase in their output from weaning the anti-motility medication. This will also maintain their nutrition while they are transitioning to reinfuse all of their output and ensure their nutrition is optimised.
THE INSIDES® Driver (driver) should be fully charged before the first use. The charging light will turn ON while the driver is charging and will turn OFF when it is fully charged. The full charge cycle could take up to four hours. After each use of the driver, all accessible surfaces should be wiped down using a damp cloth followed by an EPA recommended disinfectant wipe.
Before commencing prepare a clean work station and don gloves.
The patient must have visibility into the ostomy appliance to ensure that THE INSIDES® System is successfully reinfusing chyme. Use a clear ostomy appliance or remove outer lining of the patient's usual ostomy appliance to ensure adequate visibility.
THE INSIDES® Pump (pump) is 35 mm in diameter and will be threaded through template of the ostomy appliance. Therefore, a larger template may need to be cut and a hydrocolloid seal used to protect the exposed skin. If this is not suitable an ostomy appliance with a “lock and roll” closure at the bottom of the bag can be used. In this scenario, the pump will be connected to THE INSIDES® Tube (tube) through this opening.
THE INSIDES® Tube must be inserted by a healthcare professional. The Insides® Tube must be replaced every 28 days.
1. Select the appropriately size feeding tube based on the diameter of the patient’s
stoma.
2. The patient should be resting in a comfortable supine position. Remove the patient's ostomy appliance and wipe away any excess chyme from the area. Only reinfuse chyme that is less than eight-hours old. Store the patient's chyme if this is the first use of THE INSIDES® System.
3. Unpackage the tube. A retention sleeve and guidewire are also provided to aid user comfort and insertion, respectively.
4. Lubricate the tube using 10-20 mL of water-based lubricant as described below:
a. Unfold the arms of the retention
sleeve from the tube.
b. Spread lubricant in front of and
behind the retention sleeve. With adequate force, pull the retention sleeve backward, towards the handle of the guidewire, over the lubricant, then return it to its original position. Continue this until the retention sleeve moves freely. Add more lubricant if it is required. Then, move the retention sleeve towards the bulbous section of the tube. Ensure the retention sleeve is not pulled off.
c. Lubricate the bulbous section of the tube.
d. Set the tube aside on the clean workstation.
5. With additional lubricant, digitally examine the direction of the
distal tract. Palpate the fascia to gauge the approximate length required for the insertion of the tube. If the distal tract is tight or kinked, insert 3-10 mL of additional lubricant.
6. During the examination, the patient may feel some abdominal discomfort. Discomfort is due to the stretching of the intestinal lumen and should be expected. After digitally palpating the distal tract, replace gloves.
7. Collapse the tube's bulbous feature by inserting the guidewire until the base of the tube touches the 'stop' on the guidewire. Pinch the guidewire between the tube and maintain pressure so it stays in place. Ensure that the guidewire's tip is sitting within the nose of the tube and not sticking out through the bulbous section.
8. While the bulbous section is collapsed, use the free hand to guide the tube and insert it into the distal limb. Apply gentle pressure until the bulbous feature of the tube is 10-20 mm past the abdominal fascia. The intestine may not allow the tube to be immediately inserted; it may take up to 60 seconds for peristalsis to help move the tube into place.
9. Firmly hold the tube in place with one hand and remove the guidewire with the other.
10. Allow the tube to settle into its natural position. The tube may move outwards up to 10mm due to peristalsis.
11. Move the retention sleeve up the tube until it sits 1-2 mm away from the stoma. Fold the arms of the retention sleeve over the tube to secure it in place.
Due to differing patient anatomy, the retention sleeve may block the proximal outlet. If this occurs, chyme may leak under the baseplate of the ostomy appliance. If this happens, the retention sleeve can be moved down the tube, away from the stoma.
12. Gently tug on the tube to confirm it is anchored in place.
13. If the tube becomes dislodged, remove it entirely from the patient before reinserting the guidewire into the tube:
a. Move the retention sleeve toward the bulbous feature.
b. Insert lubricant into the Tube.
c. Insert the guidewire into the Tube, beyond the retention sleeve in a single fluid
motion.
d. If the guidewire does not slide beyond the retention sleeve, move the guidewire's tip back into the lubricant, then repeat Step c.
e. Hold the guidewire in place and move the retention sleeve to the centre of the Tube.
f. Return to Step 3.
14. Once the tube is successfully inserted, dispose of the guidewire appropriately.
WARNING: Do not insert the guidewire into the Tube while it is positioned inside a patient - this could result in perforation of the bowel.
NOTE: Peristalsis may move the tube in and out of the stoma slightly. When placed correctly, the tube should not fall out on its own and the retention sleeve will prevent it from being pulled too far into the distal intestine.
1. Connect the pump to the tube. The base of the tube should touch the third ring of the pump outlet to ensure it cannot be accidentally dislodged.
2. Allow the patient or their carer to practise connecting and disconnecting the pump while ensuring that the tube position is not disturbed.
3. Measure the ostomy appliance against the tube and pump. Trim the end of the tube so
that the pump sits 10-20 mm above the bottom of the ostomy appliance when attached.
4. The pump can rotate around the tube until oriented such that the position allows the connecting of the pump to the driver.
A clip is provided to hold the tube in place. Once the Ostomy appliance has been applied, a clip can be attached to the tube from the outside of the bag to help prevent the tube falling out and
reduce pulling on the stoma. Choose the clip that will fit around the section of the tube immediately below the retention sleeve.
This will depend on the size of the tube and how short the tube is trimmed. Ensure the patient is aware of which clip should be used.
1. Assess the suitability of the patient's chyme from the patient's previous ostomy
appliance.
a. Pinch the ostomy appliance between the thumb and forefinger. Release it quickly to observe the time it takes for the chyme to refill the space. If it is instantaneous, the chyme can be pumped; otherwise, it may be too thick and should be discarded.
b. Chyme sitting for less than eight hours is suitable for pumping; otherwise, it must be discarded.
c. There must be enough volume for the Pump to be fully submerged in the chyme, approximately 70-100 mL.
2. If the patient's chyme is suitable for reinfusing, transfer the chyme into the new ostomy appliance. If not, fill a new ostomy appliance with enough water to submerge the Pump. Water can be used to demonstrate chyme reinfusion to the patient. Ensure the patient understands that they should not add water to the ostomy appliance in any other setting. Secure the ostomy appliance as described above.
1. Ensure the pump is fully submerged in the chyme.
2. Magnetically connect the pump to the driver.
a. Hold the driver and pump in an orientation allowing the user to see the tube. The user should be able to be to see whether chyme is progressing up the tube.
3. Reinfusing chyme stretches the luminal walls of the bowel, which may cause abdominal discomfort. To reduce this discomfort, begin chyme reinfusion slowly. For more information, refer to the ETD-14 Patient Management listed on The Insides Company Training Portal.
a. While holding the pump against the driver, press the 'MODE' button to start at 'MODE 1', the slowest speed setting. If chyme moves quickly up the tube, stay on 'MODE 1' and reinfuse a small volume of chyme.
b. After 30 seconds, if chyme is not progressing up the
tube, increase to the next ‘MODE’. Continue this process until chyme is progressing up the tube. If chyme is not progressing up the tube after 60 seconds on 'MODE 5', refer to the Troubleshooting section below.
c. If chyme starts to reflux out of the stoma, or if the patient feels nauseous or bloated, reduce the 'MODE' on the driver or cease reinfusing for several minutes. Reducing the ‘MODE’ can be accomplished by pressing the ‘MODE’ button, which transitions through all five speeds and off. For further information about reflux, refer to the Troubleshooting section.
4. After reinfusing a small amount of chyme, decouple the driver from the pump and turn it off by cycling through each ‘MODE’.
Ensure the patient receives routine ostomy appliance changes. Make sure the patient takes care when removing the appliance so that the tube is not pulled out. The pump may get caught in the ostomy appliance upon removal. Ensure the patient holds onto the tube with one hand and removes the ostomy appliance with the other hand. If this is too difficult, detach the pump from the tube within the ostomy appliance to be removed together.
The time required to reinfuse chyme varies depending on the chyme's thickness, which may differ across the day and the patient's oral intake. THE INSIDES® System is not suitable for thick or fibrous chyme, therefore some chyme may be discarded. Any amount of chyme that is refed is beneficial.
The patients using THE INSIDES® System should adhere to the following steps for optimal results:
If reinfusion takes longer than expected or if the patient is unable to reinfuse, attempt the following remedial steps:
If none of these solutions work, THE INSIDES® System may not be suitable for the patient.
When using THE INSIDES® System, patients may experience reflux of chyme from the distal intestine, around the tube, back into the ostomy appliance. Reflux occurs when the distal intestine receives more chyme than it can accommodate. While reflux is not harmful to the patient, it can increase its time to reinfuse successfully.
Reflux may be reduced by:
NOTE: Loperamide and similar anti-motility therapies can cause constipation, blocking the intestine and preventing chyme reinfusing. Adjust the dose of motility therapies as required and refer to ETD-14 Patient Management with The Insides System if further action is needed.
Please contact the manufacturer or the local representative for assistance with setting up, using, or maintaining THE INSIDES™ System or to report unexpected operations or events.
Local Representative Contact Information:
Online Assistance
Company
The Insides Company LTD
Website
clinical@theinsides.co
New Zealand
Company
The Insides Company LTD
Phone
+64 9 887 9309
Address
487 Parnell Rd, Parnell
Auckland 1052
New Zealand
Australian Sponsor
Company
GSE Pty. Ltd.
Phone
+61 (412) 159 732
Address
323 Toohey Road,
Tarragindi, QLD 4121
Australia
EC Representative
Company
Advena LTD
Phone
+44 20 3389 6331
Address
Tower Business Centre, 2nd Fl.
Tower Street, Swatar, BKR 4013
Malta
UK Representative
Company
Advena LTD
Phone
+44 (0) 1926 800153
Address
Pure Offices
Plato Close, Tachbrook Park
Warwick CV34 6WE UK
CH Representative
Company
Swiss AR Services GmbH
Phone
+41 41 480 40 00
Address
Industriestrasse 47
CH-6300 Zug,
Switzerland
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
قبل البدء في علاج إعادة تسریب الكیموس، یجب فحص الثلث الاخیر من أمعاء المریض لضمان أنھ سالك. وإحدى الطرق للقیام بذلك ھي
التصویر المتباین.
:عامة وكقاعدة .Fr 22و Fr 28 وھما ،The Insides Tube من مقاسین The Insides System ی
إذا قرر الطبيب أن مقاسي الأنبوب FR 28 أو FR 22 غير مناسبين، فيوصى باستخدام بالون FR 20 على الأقل. يُرجى ملاحظة أن الأنبوب المثبت بالبالون مع وصلة TMENFit لا يقترن بـ The Insides Pump.
يوصى باستخدام The Insides Tube مقاس 28Fr عند الاقتضاء. إذا لم يكن 28Fr مناسبًا، فيمكن استخدام أنابيب أصغر لإعادة تسريب جرعات صغيرة لإعادة تأهيل الأمعاء. قد يصبح المريض قادرًا، بعد فترة قصيرة من إعادة التأهيل المعوي، على الانتقال إلى نسخة من The Insides Tube أو الانتقال من أنبوب FR 22 إلى FR 28.
إذا كان المريض يعاني من فتق مجاور للفغرة، فيجب توخي الحذر عند إدخال الأنبوب. قد يمنع الالتواء المحتمل للأمعاء إدخال الأنبوب وقد يشكّل خطر حدوث ثقب. قد تمنع زيادة الطول الخارجي للأمعاء وضع الأنبوب وتثبيته بشكل صحيح. سيشير جس الجهاز الهضمي القاصي رقميًا إلى اتجاه الطرف القاصي، وأي تضييق أو التواء، والمسافة إلى اللفافة.
إذا كان المريض يعاني من تدلي الطرف القاصي لفغر الأمعاء أو الناسور المعوي الجلدي (ECF)، فيجب توخي الحذر عند إدخال الأنبوب بسبب طول الأمعاء الممتد وغير المدعوم الخارجي للجسم. ولا يُعدّ The Insides Tube مناسبًا لهذا النوع من المرضى.
إذا كان المريض يعاني من ناسور معوي جلدي، فيجب توخي الحذر واتخاذ قرار سريري دقيق عند اختيار الأنبوب الصحيح لاستخدامه للمريض. قد تكون لدى المرضى لفافة صغيرة أو معدومة بجوار مكان إدخال الأنبوب. وبالتالي، قد لا يمنع غلاف التثبيت أو الكفة انتقال الأنبوب إلى الأمعاء البعيدة أثناء اقترابه. يجب اختيار أنبوب مناسب ومراقبته لضمان عدم حدوث الانتقال.
يمكن استخدام The Insides Tube مع أي جهاز فغر. في البداية، يوصى المريض باستخدام جهاز فغر شفاف، بحيث تسهل مشاهدة الكيموس يتحرك لأعلى الأنبوب ومشاهدة انخفاض الحجم في جهاز الفغر. إذا كان الأنبوب، بخلاف The Insides Tube، مطلوبًا في البداية، فيجب أن يتناسب هذا الأنبوب والمضخة بشكل مريح مع جهاز الفغر من دون أي ضغط على الأنبوب وThe Insides Pump.
قد يؤدي تركيب أنبوب تغذية في الطرف القاصي للمريض إلى زيادة حجم الفغر على البطن. وبالتالي، يوصى بإعادة قياس قالب المريض على اللوحة الأساسية لجهاز الفغر. سيضمن هذا وجود خلوص بحدود 2 – 3 مم بين فغر الأمعاء وحافة لوحة القاعدة. وسيسمح هذا بالتمعج والحركة الطبيعية لمجموعة فغر الأمعاء والأنبوب لمنع خطر تآكل الغشاء المخاطي بسبب الفرك على جانب الصفيحة القاعدية. ومن الأفضل إعادة قياس قالب المريض بشكل دوري. يجب أيضًا إعادة قياس صفيحة القاعدة إذا حصلت أي تغييرات نتيجة لزيادة الوزن أو فقدان الوزن أو الفتق أو الهبوط.
عند بدء العلاج باستخدام The Insides System، سيقضي المريض فترة قصيرة من الوقت في زيادة قدرته على تحمل العلاج بإعادة تسريب الكيموس، وإعادة تأهيل الأمعاء البعيدة، وإدخال الطعام الفموي ببطء. خلال هذه الفترة، يوصى بالحفاظ على وصفة التغذية الوريدية للمريض والأدوية المضادة للحركية بالجرعة نفسها. وسيتيح هذا للمريض إمكانية تمتعه بالاستقلالية مع The Insides System وألا يتعب من الزيادة في إنتاجه من إيقاف الدواء المضاد للحركية. سيحافظ هذا أيضًا على تغذيتهم أثناء انتقالهم لإعادة ضخ كل الإنتاج وضمان تحسين تغذيتهم.
يجب شحن محرك THE INSIDES® Driver بالكامل قبل الاستخدام الأول. سيضيء ضوء الشحن أثناء شحن المحرك وسينطفئ عندما يتم شحنه بالكامل. قد تستغرق دورة الشحن الكاملة ما يصل إلى أربع ساعات. بعد كل استخدام للمحرك، يجب مسح جميع الأسطح التي يمكن الوصول إليها باستخدام قطعة قماش مبللة ويتبع ذلك مسح بمطهر موصى به من وكالة حماية البيئة. قبل البدء قم بإعداد محطة عمل نظيفة وارتد قفازات.
يجب أن تكون لدى المريض رؤية في جهاز الفغر للتأكد من أن THE INSIDES® System يعيد تسريب الكيموس بنجاح. استخدم جهاز فغر شفاف أو قم بإزالة البطانة الخارجية لجهاز الفغر المعتاد للمريض لضمان الرؤية الكافية.
يبلغ قطر مضخة THE INSIDES® Pump 35 مم وسيتم ربطها من خلال قالب جهاز الفغر. لذلك، قد تحتاج إلى قطع قالب أكبر واستخدام مانع تسرب هيدروكولويد لحماية الجلد المكشوف. وإذا لم يكن ذلك مناسبًا، يمكن استخدام جهاز فغر مع قفل "قفل وتدوير" في الجزء السفلي من الكيس. في هذا السيناريو، سيتم توصيل المضخة بأنبوب THE INSIDES® Tube من خلال هذه الفتحة.
تحذير: لا تدخل سلك التوجيه في الأنبوب أثناء وضعه داخل المريض
- قد يؤدي هذا إلى ثقب الأمعاء.
ملاحظة: قد يحرك التمعج الأنبوب داخل وخارج الفغرة قليلاً. عند وضع الأنبوب بشكل صحيح، لا ينبغي أن يسقط من تلقاء نفسه وسيمنعه غلاف التثبيت من الانجراف بعيدًا جدًا في الأمعاء البعيدة.
مرفق مقطع لتثبيت الأنبوب في مكانه. بمجرد وضع جهاز الفغر، يمكن توصيل مشبك بالأنبوب من خارج الكيس للمساعدة في منع خروج الأنبوب من مكانه وتقليل شد الفغرة. اختر المقطع الذي يتناسب مع مقطع الأنبوب الموجود أسفل غطاء التثبيت مباشرةً. ويعتمد هذا على حجم الأنبوب ومدى قصر الأنبوب. تأكد من أن المريض على علم بأي مقطع يجب
أن تستخدمه.
تأكد من أن المريض يتلقى تغييرات روتينية في جهاز الفغر. تأكد من رعاية المريض عند إزالة الجهاز حتى لا يتم سحب الأنبوب من مكانه. قد تتعطل المضخة في جهاز الفغر عند إزالتها. تأكد من أن المريض يمسك الأنبوب بيد واحدة ويزيل جهاز الفغر باليد الأخرى. إذا كان هذا صعبًا للغاية، فافصل المضخة عن الأنبوب الموجود داخل جهاز الفغر لإزالته معًا.
يختلف الوقت اللازم لإعادة تسريب الكيموس اعتمادًا على سمك الكيموس، والذي قد يختلف على مدار اليوم وتناول المريض عن طريق الفم. إن THE INSIDES® System غير مناسب للكيموس السميك أو الليفي، وبالتالي يمكن التخلص من بعض الكيموس. أي كمية من الكيموس يتم تجديدها مفيدة.
يجب على المرضى الذين يستخدمون THE INSIDES® System الالتزام بالخطوات التالية للحصول على أفضل النتائج:
إذا استغرقت إعادة التسريب وقتًا أطول من المتوقع أو إذا كان المريض غير قادر على إعادة التسريب، فجرّب الخطوات العلاجية التالية:
إذا لم ينجح أي من هذه الحلول، فقد لا يكون THE INSIDES® System مناسبًا للمريض.
عند استخدام THE INSIDES® System ، قد يعاني المرضى من ارتجاع الكيموس من الأمعاء البعيدة، حول الأنبوب، مرة أخرى إلى جهاز الفغر. يحدث الارتجاع عندما تتلقى الأمعاء البعيدة كمية من الكيموس أكثر مما يمكنها استيعابها. ومع أن الارتجاع ليس ضارًا للمريض، فإنه قد يزيد من وقت إعادة امتصاصه بنجاح.
يمكن تقليل الارتجاع عن طريق:
ملاحظة: قد يسبب اللوبراميد والعلاجات المماثلة المضادة للحركة يسبب الإمساك، ومنع الأمعاء ومنع إعادة تسريب الكيموس. اضبط جرعة علاجات الحركة كما هو مطلوب وارجع إلى مسار رعاية المرضى ETD-14 لـ THE INSIDES® System إذا كانت هناك حاجة إلى مزيد من الإجراءات.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Prije početka terapije ponovnog unosa himusa mora se provjeriti distalno crijevo bolesnika kako bi se utvrdila prohodnost. Metoda koja se upotrebljava za to jest kontrastno snimanje.
Proizvod The Insides System sadrži dvije veličine cijevi The Insides Tube: jednu promjera 9,3 mm, a drugu promjera 7,3 mm. U pravilu:
Ako liječnik utvrdi da nijedna od te dvije veličine cijevi (9,3 mm ili 7,3 mm) nije prikladna, preporučuje se cijev promjera najmanje 6,7 mm s balonom. Imajte na umu da cijev s balonom s priključkom ENFitTM nije kompatibilna s proizvodom The Insides Pump.
Ako je primjenjivo, preporučuje se cijev The Insides Tube promjera 9,3 mm. Ako je cijev promjera 9,3 mm prevelika, manje cijevi mogu se koristiti za ponovni unos malih bolusa za vraćanje funkcije crijeva. Nakon kratkog razdoblja vraćanja funkcije crijeva navedenom terapijom, pacijent će možda moći prijeći na neku verziju proizvoda The Insides Tube ili s cijevi od 7,3 mm na cijev od 9,3 mm.
Ako pacijent ima parastomalnu kilu, potreban je oprez pri uvođenju cijevi. Pregibi crijeva mogli bi spriječiti uvođenje cijevi i prouzročiti rizik od perforacije. Povećana vanjska duljina crijeva može spriječiti pravilno postavljanje i pričvršćivanje cijevi. Palpacijom distalnog trakta pokazat će se smjer distalnog segmenta, moguća suženja ili pregibi te udaljenost do fascije.
Ako pacijent ima prolaps distalnog segmenta enterostome ili enterokutane fistule (ECF), potreban je oprez pri uvođenju cijevi zbog proširenog dijela crijeva koji je izvan tijela i nije poduprt. Proizvod The Insides Tube nije prikladan za tu vrstu pacijenata.
Ako pacijent ima enterokutalne fistule, potreban je oprez i pažljivo donošenje kliničke odluke pri odabiru odgovarajuće cijevi koja će se upotrijebiti za pacijenta. Pacijenti mogu imati malo ili nimalo fascije oko mjesta uvođenja cijevi. Slijedom toga, pričvrsni naglavak možda neće spriječiti migraciju cijevi u distalno crijevo tijekom sazrijevanja. Potrebno je odabrati i nadzirati odgovarajuću cijev kako bi se osiguralo da ne dođe do migracije.
Proizvod The Insides Tube može se upotrebljavati s bilo kojim uređajem za stomu. U početku se preporučuje da pacijent upotrebljava prozirni uređaj za stomu kako bi se lakše pratilo pomicanje himusa uz cijev i postigao bolji pregled smanjenja volumena u uređaju za stomu. Ako je u početku osim proizvoda The Insides Tube potrebna još jedna cijev, ta cijev i pumpa moraju biti priključeni na uređaj za stomu bez ikakvog pritiska na cijev i proizvod The Insides Pump.
Postavljanje cijevi za hranjenje u distalni segment pacijenta može povećati veličinu stome na trbuhu. Stoga se preporučuje ponovno mjerenje predloška pacijenta na osnovnoj ploči uređaja za stomu. Time se osigurava razmak od 2 – 3 mm između enterostome i ruba osnovne ploče. To omogućuje peristaltiku i prirodno kretanje enterostome i kompleksa cijevi kako bi se spriječio rizik od erozije sluznice zbog trljanja sa strane osnovne ploče. Najbolje je povremeno ponovno izmjeriti pacijentov predložak. Osnovnu ploču također treba ponovno izmjeriti ako je došlo do bilo kakvih promjena kao posljedice dobivanja na težini, gubitka težine, hernije ili prolapsa.
Prilikom započinjanja terapije proizvodom The Insides System pacijent će provesti kratko vrijeme povećavajući toleranciju na terapiju ponovnog unosa himusa, vraćajući funkciju distalnom segmentu crijeva i polagano uvodeći unos hrane oralnim putem. Tijekom tog razdoblja preporučuje se održavati istu dozu pacijentove parenteralne prehrane i lijekova s antiperistaltičkim djelovanjem. To će pacijentu omogućiti da postane neovisan o proizvodu The Insides System i da mu organizam ne počne preopterećivati povećana količina himusa koju izbacuje iz tijela zbog odvikavanja od terapije lijekovima s antiperistaltičkim djelovanjem. To će također održati prehranu pacijenata dok se prebacuju na ponovni unos himusa koji su izbacili iz tijela i osigurati optimizaciju prehrane.
THE INSIDES® Driver (upravljačka jedinica) treba u potpunosti napuniti prije prve uporabe. Svjetlo punjenja će se UKLJUČITI dok se upravljačka jedinica puni i isključit će se kada je u potpunosti napunjen. Puni ciklus punjenja može potrajati do četiri sata. Nakon svake uporabe upravljačke jedinice, sve dostupne površine treba obrisati vlažnom krpom nakon koje slijedi brisanje dezinfekcijskom maramicom koju preporučuje agencija za zaštitu okoliša (EPA). Prije početka pripremite čisto radno mjesto i navucite rukavice.
Pacijent mora moći vidjeti u aparat za stomu kako bi osigurao da THE INSIDES® System uspješno reinfuzira himus. Koristite prozirni aparat za stomu ili uklonite vanjsku oblogu pacijentovog uobičajenog aparata za stomu kako biste osigurali odgovarajuću vidljivost.
THE INSIDES® Pump (pumpa) je promjera 35 mm i bit će provučena kroz predložak aparata za stomu. Stoga će možda trebati izrezati veći predložak i koristiti hidrokoloidnu brtvu za zaštitu izložene kože. Ako to nije prikladno, može se upotrijebiti aparat za stomu s "lock and roll" zatvaračem na dnu vrećice. U ovom scenariju, pumpa će biti spojena na THE INSIDES® Tube (cijev) kroz ovaj otvor.
Cijev mora biti umetnuta od strane zdravstvenog radnika. THE INSIDES® Tube mora se zamijeniti svakih 28 dana.
UPOZORENJE: Nemojte umetati žicu vodilicu u cijev dok je umetnuta u pacijenta - To može dovesti do perforacije crijeva.
NAPOMENA: Peristaltika može malo pomaknuti cijev unutra i izvan stome. Kada se pravilno postavi, cijev ne bi trebala ispasti sama od sebe, a pričvrsna čahura spriječit će njeno povlačenje predaleko u distalno crijevo.
Priložena je spojnica koja drži cijev na mjestu. Nakon postavljanja aparata za stomu, spojnica se može pričvrstiti na cijev s vanjske strane vrećice kako bi se spriječilo ispadanje cijevčice. Odaberite kopču koja će stati oko dijela cijevi neposredno ispod pričvrsne čahure. To će ovisiti o veličini cijevi i o tome koliko je cijev kratko obrezana. Osigurajte da je pacijent upoznat s time koju spojnicu treba koristiti.
Pobrinite se da pacijentu budu omogućene rutinske promjene aparata za stomu. Pazite da pacijent pri uklanjanju aparata pazi da se cijev ne izvuče. Pumpa može zapeti za stomu nakon uklanjanja. Uvjerite se da pacijent jednom rukom drži cijev, a drugom rukom skida uređaj za stomu. Ako je to preteško, odvojite pumpu od cijevi unutar aparata za stomu koju želite zajedno ukloniti.
Vrijeme potrebno za reinfuziju himusom varira ovisno o viskoznosti himusa, koja se može razlikovati tijekom dana i pacijentovom oralnom unosu. THE INSIDES® System nije pogodan za gusti ili vlaknasti himus, stoga se dio himusa može odbaciti. Bilo koja količina himusa koja se ponovno hrani je korisna.
Pacijenti koji koriste THE INSIDES® Sytem trebali bi se pridržavati sljedećih koraka za optimalne rezultate:
Ako reinfuzija traje dulje od očekivanog ili ako pacijent nije sposoban za ponovnu reinfuziju, pokušajte poduzeti sljedeće korake:
Ako niti jedno od ovih rješenja ne uspije, THE INSIDES® System možda neće odgovarati pacijentu.
Kada koristite THE INSIDES® System, pacijenti mogu doživjeti refluks himusa iz distalnog crijeva, oko cijevi, natrag u aparat za stomu. Refluks nastaje kada distalno crijevo primi više himusa nego što ga može primiti. Iako refluks nije štetan za pacijenta, može povećati vrijeme potrebno za uspješnu reinfuziju.
Refluks se može smanjiti:
BILJEŠKA: Loperamid i slične terapije protiv motiliteta mogu izazvati zatvor, blokirajući crijeva i sprječavajući reinfuziju himusa. Prilagodite dozu terapije pokretljivosti prema potrebi i pogledajte ETD-14 redoslijed njege pacijenta za THE INSIDES® System ako su potrebne daljnje radnje.
WARNING: Do not use if packaging is damaged or opened.
WARNING: If the packaging of THE INSIDES® System is damaged prior to use, discard the product. – Contamination could lead to patient infection.
WARNING: THE INSIDES® System is for single patient use ONLY, and are not to be shared
between patients. – Contamination could lead to patient infection.
WARNING: Failure to carefully follow all applicable instructions may result in injury to the patient, physician, or attendants and may have an adverse effect on outcome.
WARNING: If you stop using THE INSIDES® System contact your healthcare professional. – Changing the amount of chyme pumped into the intestine will affect medicine
concentration.
WARNING: Contains strong magnetic material. Caution should be exercised when in use around metal objects or other magnets. – Skin may be pinched; Small metal objects may be strongly attracted causing skin damage
WARNING: Contains strong magnetic material. Do not use if you have a Pacemaker. –
Magnetic fields could interfere with the function of the Pacemaker.
WARNING: Contains strong magnetic material. Keep a safe distance (20cm) between the magnets and all objects that can be damaged or affected by magnetism. Items include, other health equipment including MRI, CRT monitors and televisions, credit cards, mechanical watches, and other magnetically stored media. – Interference with medical devices could create a hazardous situation.
WARNING: Patients undergoing an MRI should have the pump and the driver removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
WARNING: THE INSIDES® System should not be used at altitudes of 3000 m or higher. – May result in patient harm.
WARNING: THE INSIDES® System includes cables that may cause a strangulation risk to
young children. – Cable may become entangled around small children’s necks.
WARNING: Ensure that the driver and pump are not connected and activated outside of the ostomy appliance. – This could result in cutting or crushing of fingers that could fit into the pump.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this
equipment and other equipment should be observed to verify that they are operating
normally. – Dehydration could require medical treatment.
WARNING: THE INSIDES® System should only be used in a commercially available Ostomy Appliance. – Contamination could cause patient toxicity.
WARNING: Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in the increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. – Using this device with aftermarket equipment could affect other electrical devices, resulting in injury.
WARNING: No modification of this equipment is allowed. Access to electronic parts could cause electric shock. Access to rotating parts could cause minor skin damage or bruising.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12”) to any part of THE INSIDES® System, including cables specified by the manufacturer. - This could cause degradation of the performance of the medical device resulting in injury.
WARNING: THE INSIDES® System is only to be used as instructed by your healthcare
professional to refeed content into the distal intestine. – Refeeding other fluids or
medication could cause patient harm.
WARNING: Use of the device may be associated with minor symptoms of abdominal
fullness, bloating, cramping, pain or nausea. If these symptoms are severe or intolerable see your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: Do not refeed chyme which has been sitting in the ostomy appliance for eight hours or longer. – An accumulation of bacteria may cause patient harm.
WARNING: If you experience severe bloating, severe abdominal cramps / pain, fevers, or any bleeding, immediately inform your Healthcare Professional. – Ignoring symptoms may result in hospitalization.
WARNING: If the ostomy appliance does not seem to reduce in volume after 15 minutes of pumping, contact your Healthcare Professional. – Dehydration could require medical treatment.
WARNING: The pump is to be used for no longer than three days MAXIMUM, before
replacing this component. – Material leaching can cause patient toxicity, including Nickle. – Allergic reaction; patient toxicity could occur.
WARNING: The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: The pump is single use ONLY, and are not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
WARNING: If the pump fails to pump chyme, inform your Healthcare Professional to ensure that your hydration levels are properly cared for. – Dehydration could require medical treatment.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. –Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Care should be taken when removing the pump from packaging and installing it onto the feeding tube, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
WARNING: When connecting the pump to the tube, do not use any lubricants or fixings. – Contamination could lead to patient infection; Injection of small parts could damage the intestine.
WARNING: If the pump becomes disconnected from the tube within the ostomy appliance, discontinue use of THE INSIDES® System until the pump is changed or reconnected. – Dehydration could occur if THE INSIDES® System is not used for periods longer than 24 hours.
WARNING: Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
WARNING: The pump is only to be used with an approved feeding tube, placed by a
healthcare professional. – Feeding tube compatibility may affect patient’s wellbeing.
WARNING: Only a healthcare professional can insert the tube. If the tube falls out contact your healthcare professional for a replacement – Incorrect insertion of the tube may cause patient harm.
WARNING: If, after the insertion of the tube by the Healthcare Professional, your stoma
stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.
WARNING: The tube is to be used for no longer than 28 days MAXIMUM, before replacing this component. – Extended product harm may irritate the bowel – Intestinal granulation, ulcers or other defects may result.
WARNING: The tube is single use ONLY, and is not to be reused in a patient or shared
between patients. – Contamination could lead to patient infection.
WARNING: The tube should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
WARNING: THE INSIDES® Tube includes small parts that may cause a choking risk to young children. – The clip may be swallowed and cause harm.
WARNING: As this medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series, there is a possibility that a misconnection can occur between this medical device and a medical device using a different alternative smallbore connector, which can result in a hazardous situation causing harm to the patient. Special measures need to be taken by the user to mitigate these reasonable foreseeable risks.
WARNING: If the driver fails, discontinue use and contact your Healthcare Professional. – Dehydration could require medical treatment
WARNING: The driver should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
WARNING: Activation of latent colonic Clostridium difficile infection could occur when
THE INSIDES® System is first used. This will only occur in patients with this bacterium
existing in their intestine. This infection could be accompanied by symptoms such as
watery diarrhea, fevers, abdominal pain and tiredness. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.
WARNING: Patients’ fascial openings should be clinically evaluated prior to intubation as to select the correct feeding tube. - Large fascial openings, such as peristomal hernia or enteroatmospheric fistula, may allow the feeding tube and retention sleeve or cuff to migrate into the distal limb causing patient harm.
WARNING: Patients on medication may need to have their dosages reviewed by their
healthcare professional while using THE INSIDES® System. Refeeding of chyme can
increase the dosage of medications received by the patient. – This could cause patient toxicity.
WARNING: Incorrect placement of the tube or a tube that is too long externally or internally can cause excess pressure on the intestine resulting in a pain response. - If not resolved immediately this can cause inflammation, ulcers or perforation resulting in hospitalization.
WARNING: Do not refeed chyme if patients have potential or suspected intestinal wall
defects. - Refeeding chyme in patients with defects in the integrity of the intestinal tract may lead to perforation and sepsis leading to severe patient harm.
WARNING: THE INSIDES® System can be used in conjunction with, or as a replacement to, other medical interventions that maintain patient nutrition and hydration. - Patients should be closely monitored as required to ensure minimum hydration, nutrition and electrolyte levels are maintained. Failure to do so could cause patient harm.
WARNING: Do not insert the guidewire into the tube while inserted in a patient - This could result in perforation of the intestine.
WARNING: Use of the retention sleeve on some patients may result in chyme remaining in contact with the skin. – This could result in skin irritation.
WARNING: The performance and safety of the device has not been established in the
following patients: Insufficient distal access channel; Bowel obstruction in efferent limb; Current infection small intestinal bacterial overgrowth (SIBO); Signs or symptoms of systemic infection; Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, fecal incontinence, and gastroparesis; Metabolic, neurogenic, or endocrine disorders known to cause colonic dysmotility, e.g., multiple sclerosis, Parkinson’s disease, hypothyroidism; Known peritoneal metastatic disease prior to DES/ECF closure; Liver cirrhosis; Hereditary coagulopathy; Severe chronic renal insufficiency prior to DES/ECF formation (eGFR<30mL/min/1.73m2); Metal stents implanted within 20cm of expected use of the controller; Women who are pregnant or breastfeeding.
Prima di iniziare la terapia di reinfusione del chimo, occorre controllare la pervietà
dell'intestino distale del paziente. Un metodo per farlo è l'imaging a contrasto.
The Insides System contiene due formati di sondini The Insides Tube, 28 Fr e 22 Fr. In
generale:
Se il medico determina che né le dimensioni del sondino da 28 Fr né quelle da 22 Fr sono appropriate, si consiglia un sondino con palloncino da almeno 20 Fr. Tenere presente che un sondino con palloncino con raccordo ENFit™ non si accoppia con The Insides Pump. Il sondino The Insides Tube da 28 Fr è consigliato quando applicabile. Se il sondino da 28 Fr non è adatto, è possibile utilizzare sondini più piccoli per reinfondere piccoli boli per riabilitare l'intestino. Dopo un breve periodo di riabilitazione intestinale, il paziente può essere in grado di passare a una versione di The Insides Tube o dal sondino da 22 Fr al sondino da 28 Fr.
Se un paziente ha un'ernia parastomale, è necessario procedere con cautela durante
l'inserimento del sondino. Una possibile torsione intestinale può impedire l'inserimento del sondino e può creare un rischio di perforazione. L'aumento della lunghezza esterna dell'intestino può impedire il corretto posizionamento e ancoraggio del sondino. La palpazione digitale del tratto distale indicherà la direzione dell'arto distale, qualsiasi restringimento o torsione e la distanza dalla fascia.
Se il paziente ha un arto distale con prolasso dell'enterostomia o della fistola
enterocutanea (ECF), è necessario procedere con cautela durante l'inserimento del
sondino a causa della lunghezza estesa e non supportata dell'intestino esterno al corpo. Il sondino The Insides Tube non è adatto a questo tipo di pazienti.
Se un paziente ha una ECF, è necessario procedere con cautela e seguendo un attento processo decisionale clinico quando si seleziona il sondino corretto da utilizzare per il paziente. I pazienti possono presentare una fascia limitata o del tutto assente intorno alla posizione di inserimento del sondino. Di conseguenza, un manicotto di ritenzione può non impedire la migrazione del sondino nell'intestino distale durante la maturazione. Deve essere selezionato un sondino appropriato, che dovrà essere monitorato per garantire che non si verifichi la migrazione.
The Insides Tube può essere utilizzato con qualsiasi apparecchio per stomia. Inizialmente, si consiglia al paziente di utilizzare un apparecchio per stomia trasparente, attraverso il quale sia quindi facile osservare il chimo muoversi lungo il sondino e vedere diminuire il volume nell'apparecchio per stomia. Se all'inizio è necessario un sondino diverso da The Insides Tube, tale sondino e la pompa devono adattarsi comodamente all'interno dell'apparecchio per stomia senza esercitare alcuna pressione sul sondino e su The Insides Pump.
L'installazione di un sondino di alimentazione nell'arto distale del paziente può aumentare le dimensioni dello stoma sull'addome. Di conseguenza, si consiglia di misurare nuovamente il modello del paziente sulla piastra di base dell'apparecchio per stomia. Questo per garantire una distanza di 2-3 mm tra l'enterostomia e il bordo della piastra di base. Ciò consente la peristalsi e il movimento naturale del gruppo enterostomia/sondino per prevenire il rischio di erosione della mucosa, dovuta allo sfregamento sul lato della piastra di base. È meglio misurare nuovamente il modello del paziente periodicamente. La piastra di base deve essere nuovamente misurata anche in caso di cambiamenti a seguito di aumento o perdita ponderale, ernia o prolasso.
Quando si inizia la terapia con The Insides System, il paziente trascorrerà un breve
periodo aumentando la tolleranza alla terapia di reinfusione del chimo, riabilitando
l'intestino distale e introducendo lentamente il cibo per via orale. Durante questo periodo, si consiglia di mantenere la prescrizione nutrizionale parenterale del paziente e i farmaci anti-motilità alla stessa dose. Ciò consentirà al paziente di diventare indipendente con The Insides System e di non essere sopraffatto dall'aumento di produzione intestinale derivante dall'eliminazione del farmaco anti-motilità. Ciò manterrà inoltre la nutrizione durante la transizione per reinfondere interamente la produzione e garantire che la nutrizione sia ottimizzata.
THE INSIDES® Driver (driver) deve essere completamente caricato prima del primo utilizzo. La luce di ricarica si accende mentre il driver è in carica e si spegne quando è
completamente carico. Il ciclo completo di carica potrebbe richiedere fino a quattro ore. Dopo ogni uso del driver, tutte le superfici accessibili devono essere pulite con un panno umido seguito da una salvietta disinfettante raccomandata dall'EPA.
Prima di iniziare, preparate una stazione di lavoro pulita e indossate i guanti
Il paziente deve avere visibilità nel dispositivo per stomia per assicurarsi che THE INSIDES® System stia reinfondendo con successo il chimo. Utilizzare un apparecchio per stomia pulito o rimuovere il rivestimento esterno dell'apparecchio per la stomia abituale del paziente per garantire un'adeguata visibilità.
La pompa INSIDES® Pump (pompa) ha un diametro di 35 mm e sarà infilata attraverso la sagoma del dispositivo per stomia. Pertanto, potrebbe essere necessario tagliare una mascherina più grande e utilizzare un sigillo idrocolloidale per proteggere la pelle esposta. Se questo non è adatto, si può usare un apparecchio per stomia con una chiusura "lock and roll" sul fondo della sacca. In questo scenario, la pompa sarà collegata a THE INSIDES® Tube (catetere) attraverso questa apertura.
AVVERTENZA: Non inserire il filo guida nel catetere mentre è posizionato all'interno di un paziente - questo potrebbe provocare la perforazione dell'intestino.
NOTA: La peristalsi può spostare leggermente il catetere dentro e fuori lo stoma. Se
posizionato correttamente, il catetere non dovrebbe uscire e cadere da solo e il manicotto di ritenzione impedirà che venga tirato troppo lontano nell'intestino distale.
Viene fornita una clip per mantenere il catetere in posizione. Una volta applicato il dispositivo Ostomy, è possibile fissare la clip al catetere dall'esterno della sacca per evitare che il catetere cada e riduca la trazione sullo stoma. Scegliere una clip che si adatti alla sezione del catetere immediatamente al di sotto del manicotto di ritenzione. Ciò dipenderà dalle dimensioni e dalla lunghezza del catetere. Assicurarsi che il paziente sia a conoscenza della clip da utilizzare.
Assicurarsi che il paziente riceva i cambi di routine dei dispositivi per stomia. Assicurarsi che il paziente faccia attenzione quando rimuove l'apparecchio in modo che il catetere non venga estratto. La pompa può rimanere impigliata nel dispositivo per stomia al momento della rimozione. Assicurarsi che il paziente tenga il catetere con una mano e rimuova il dispositivo per stomia con l'altra. Se questo è troppo difficile, staccare la pompa dal catetere all'interno del dispositivo per stomia da rimuovere insieme.
Il tempo necessario per reinfondere il chimo varia a seconda dello spessore del chimo, che può variare nel corso della giornata e dell'assunzione orale del paziente.
THE INSIDES® System non è adatto per il chimo spesso o fibroso, quindi un po' di chimo può essere scartato. Qualsiasi quantità di chimo che viene reinfuso è benefica.
I pazienti che utilizzano THE INSIDES® System devono attenersi ai seguenti passi per
ottenere risultati ottimali:
Se la reinfusione richiede più tempo del previsto o se il paziente non è in grado di
reinfondere, tentare i seguenti passi correttivi:
Se nessuna di queste soluzioni funziona, THE INSIDES® System potrebbe non essere adatto al paziente.
Quando si usa THE INSIDES® System, i pazienti possono sperimentare il reflusso di chimo dall'intestino distale, intorno al catetere, di nuovo nel dispositivo per stomia. Il reflusso si verifica quando l'intestino distale riceve più chimo di quello che può ospitare. Mentre il reflusso non è dannoso per il paziente, può aumentare il tempo per effettuare con successo la reinfusione.
Il reflusso può essere ridotto da:
NOTA: Il loperamide e terapie similari anti-motilità possono causare stitichezza, bloccando l'intestino e impedendo la reinfusione del chimo. Regolare la dose delle terapie per la motilità come richiesto e fare riferimento al documento ETD-14 Gestione del paziente se sono necessarie ulteriori azioni
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