The Insides System Instructions For Use

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Thoroughly read this document before using THE INSIDES® System.

Use this document in conjunction with THE INSIDES® System Instructions and Technical Description.

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 Reinfusing with The Insides System

Contrast Imaging of Distal Intestinal Tract

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.

  • Chyme reinfusion therapy may not be appropriate for patients with a distal stenosis from inflammatory bowel disease.
  • Patients with a distal stenosis from other aetiology can be dilated before starting chyme reinfusion therapy if safe to do so.
  • During installation of a tube, do not advance the tube if there is significant resistance, or if advancement causes the patient to experience pain.

Selecting the Correct Tube Size

The Insides System contains two sizes of The Insides Tube, 28 Fr and 22 Fr. As a general
guide:

  • The 28 Fr is suitable for most enterostomy patients within six months of enterostomy
    formation.
  • The 22 Fr is suitable if the patient has:
    • been defunctioned for over six months, or
    • an enteroatmospheric fistula (EAF)

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.

Parastomal Hernia

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. 

  • The tube should not be advanced against any resistance or if advancing the tube
    causes the patient to experience pain. Chyme reinfusion therapy with The Insides
    System is not indicated if tube intubation is unsuccessful or tube placement causes pain.
  • If the distance to the fascia is greater than 70 mm, consider using a straight balloon retained tube that has no retention sleeve/cuff that can reach the fascia safely. The longer tube should not be advanced against resistance or if advancement causes the patient to experience pain.
  • Ensure that there is suitable facial opening so that the tube does not migrate into the distal intestine.

Prolapsed Distal Limb

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.

  • Carefully consider whether the clinical benefit of chyme reinfusion therapy balances the increased risk of a potentially difficult tube insertion.
  • Consider using a straight balloon retained tube that has no retention sleeve/cuff.
    The full length of the balloon retained tube may need to be inserted into the limb which means when The Insides Pump is attached, it may sit close to the outlet of the distal limb.
  • The longer tube should not be advanced against significant resistance or if
    advancement of the tube causes the patient pain.
  • Modifying an enteral feeding tube may cause the tube to migrate into the distal
    intestine.

Enterocutaneous Fistulas

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.

Ostomy Appliance Selection

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.

Basic Stomal Therapy Principles

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.

Commencing Treatment with The Insides System

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® System Setup 

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.

Preparing the Ostomy Appliance

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.

Inserting THE INSIDES® Tube

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. 

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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.

Connecting The Insides® Pump

The Insides® Pump must be replaced every three days.

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.


Connecting the Clip

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.

 

 

Initial Demonstration of THE INSIDES® System

Use the patient's chyme when reinfusing for the first time, if possible. This method provides a more realistic understanding of the time requirement for reinfusing chyme, which is longer than reinfusing water.

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.

Reinfusing Chyme with THE INSIDES® System

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.

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4. After reinfusing a small amount of chyme, decouple the driver from the pump and turn it off by cycling through each ‘MODE’.

Changing the Ostomy Appliance

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.

Troubleshooting

Chyme Reinfusion Tips 

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:

  • Maintain adequate fluid intake and hydration.
  • Avoid fibrous foods (refer to the ETD-3 Dietary Guidelines for further information).
  • Reinfuse before the ostomy appliance is full.
  • The pump must be changed at least once every three days.
  • If the tube falls out ensure the patient does not replace the tube themselves. Insertion of the tube must only be carried out by a healthcare professional.
  • Do not reinfuse anything (including water) other than chyme.
  • Chyme which has been sitting in the ostomy appliance for eight or more hours must be discarded.

If reinfusion takes longer than expected or if the patient is unable to reinfuse, attempt the following remedial steps: 

  • Increase the ‘MODE’ (speed) on the driver.
  • Ensure that the tube is not kinked within the ostomy appliance.
  • Raise the ostomy appliance so that it is horizontal, ensuring that the pump is not working against gravity.
  • Turn the driver off and on again.
  • Uncouple the driver and manipulate solid food particles which have gathered around the pump.
  • Change the pump in case it has become blocked.

If none of these solutions work, THE INSIDES® System may not be suitable for the patient.

Reflux

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:

  • Using a lower speed setting on the driver.
  • Pumping smaller volumes of chyme for the first few days until the patient has their first bowel movement.
  • More reflux is expected in the beginning, while the intestine is adjusting to the
    reintroduction of chyme. Once established and the patient has regular bowel
    movements, the amount and frequency of reflux will be reduced.

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.

Contact Information

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

www.theinsides.co

Email

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 

 

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