Base Plate
Component of a two-piece ostomy appliance which sticks to the skin and sits around the stoma
Chyme
Content which exits from the stoma
Chyme Refeeding/Chyme Reinfusion
The act of delivering chyme into a patient’s lower intestine
Carer
Person who assists with an ostomy appliance change
Distal Ostomy Appliance
Ostomy appliance that chyme is transferred to, from he Proximal Ostomy Appliance.
Healthcare Professional
Surgeons/Doctors/Nurses
Ostomy Appliance
A bag which sits on the stomach and collects content from the Stoma
Proximal Ostomy Appliance
Ostomy appliance that collects chyme prior to transferring it to the Distal Ostomy appliance via The Insides Channel
Stoma
A surgically created opening on the abdomen
THE INSIDES® Channel is an accessory intended to be used with THE INSIDES® System.
When a patient has a separated stoma THEINSIDES® System cannot be utilized. This accessory is specifically designed to allow patients with a separated stoma the ability to transfer chyme from one ostomy appliance to another. THE INSIDES® Channel consists of THE INSIDES® Channel Tubing (tubing),THE INSIDES® Pump (pump), THE INSIDES® Channel Connectors (connectors)
* THE INSIDES® Channel is for single patient use only.
* THE INSIDES® Channel must be replaced every three days.
THEINSIDES® Channel is an accessory intended to be used with THEINSIDES® System for patients with a separated stoma. It facilitatesthe transfer of fluids and nutrients lost from enterocutaneous fistulas and/orenterostomies from one ostomy appliance to another.
Following this transfer, THEINSIDES® System is used to actively refeed the chyme into the distal limb in order to return fluids and nutrients, to reverse or prevent debilitating complications, and restore gut health.
THE INSIDES® Channel is an accessory intended to be used with THE INSIDES® System in order to return chyme to the lower intestine to prevent complications, and restore gut health.
THEINSIDES® Channel is NOT suitable for patients who:
· Do not have a seperated stoma
· Are not using THE INSIDES® System
Caution: For THE INSIDES® System Contraindications, please refer to THE INSIDES® System Instructions and Technical Description
Thoroughly read this document before using THE INSIDES® Channel.
Use this document in conjunction with THE INSIDES® System Instructions and Technical Description and THE INSIDES® System Set-Up Guide.
Thoroughly read THE INSIDES® System Instructions and Technical Description and THE INSIDES® System Set-Up Guide before using THE INSIDES® Channel.
· Do not use if packaging is damaged or opened. If the packaging of THE INSIDES® Channel is damaged prior to use, discard the product. – Contamination could lead to patient infection.
· THE INSIDES® Channel is for single patient use ONLY, and is not to be shared between patients. – Contamination could lead to patient infection.
· 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.
· 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.
· Contains strong magnetic material. Do not use if you have a Pacemaker. – Magnetic fields could interfere with the function of the Pacemaker.
· Contains strong magnetic material. Keep a safe distance (20cm/8in) 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.
· Patients undergoing an MRI should have the pump removed from their person prior to entering the MRI suite. – Continued use could cause patient harm.
· 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.
· 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.
· The pump is to be used for no longer than three days MAXIMUM, before replacing this component. – Material leaching can cause patient toxicity, including Nickel. – Allergic reaction; patient toxicity could occur.
· The pump should be disposed of in accordance with local refuse regulations. – Heavy metals in products can cause environmental damage.
· The pump is single use ONLY, and is not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
· Care should be taken when removing the pump from packaging and installing it onto the ostomy appliance, to ensure that it is not contaminated before being used by the patient. – Contamination could cause patient toxicity.
· Ensure that fingers are kept away from the inlet of the pump during use. – This could result in cutting or crushing of fingers.
· The tubing is single use ONLY, and is not to be reused in a patient or shared between patients. – Contamination could lead to patient infection.
· The tubing should be disposed of in accordance with local refuse regulations. – Contamination could lead to patient infection.
The Insides Channel must be set up as follows:
Prepare The Ostomy Appliances
The Insides Channel can be set up with any of the following ostomy appliances in any combination:
· Eakin Dot 1-Piece Convex High Output
· Coloplast SenSura Mio High Output ostomy appliance
· Eakin dot Bung Closure Wound Pouches
Eakin dot 1-piece Convex High Output and/or Coloplast Sensura Mio High Output
1. Prepare the Ostomy Appliances: Cut the base plates of both ostomy appliances to fit securely around their respective ostomies.
2. Attach The Insides Pump: Take the ostomy appliance that will be placed on the ostomy that collects the chyme (proximal). Thread The Inside Pump through the base plate hole.
3. Position The Insides Pump: Move the Pump to the bottom of the ostomy appliance, aligning the connector so it faces the bung.
4. Secure The Insides Pump: Firmly press The Insides Pump into the back of the bung to create a tight seal and fit. Ensure the flat side of The Insides Pump faces outwards.
Eakin dot Bung Closure Wound Pouches
1. Remove the End Flange: Before using this ostomy appliance, the end flange and the bung must be removed to allow The Insides Channel tubing to connect. Cut behind the flange with scissors or a knife to remove it, including the connection to the bung.
2. Attach The Insides Pump: Take the ostomy appliance that will be placed on the ostomy that collects the chyme(proximal). Thread The Inside Pump through the base plate hole.
3. Position The Insides Pump: Move the Pump to the bottom of the ostomy appliance, aligning the connector so it faces the bung.
Secure The Insides Pump: Firmly press The Insides Pump into the back of the bung to create a tight seal and fit. Ensure the flat side of The Insides Pump faces outwards.
Connect the ostomy appliances
1. Position the Ostomy Appliances: Lay the ostomy appliances on a flat surface, aligning them in the same orientation as they will be placed on the patient.
2. Attach the Right-Angle Connectors: Connect the tubing on the right-angle connectors to the ostomy appliance ports.
3. Complete the Connection: Attach the final piece of tubing to both right angle connectors to complete the setup. If required cut it to ensure both ports on the ostomy appliances can be connected and the assembly sits flat.
Setting Up the Patient
1. Apply the Ostomy Appliances: After assembling The Insides Channel and The Insides System, carefully place the ostomy appliances on the patient.
2. Check Tubing Alignment: Ensure that the tubing lies flat without any kinks or obstructions to maintain smooth flow.
Using The Insides Channel
1. Prepare for Transfer: Once chyme has collected in the proximal ostomy appliance, it can be transferred to the distal ostomy appliance. Ensure that The Insides Pump is fully submerged in the chyme.
2. Position The Insides Pump: Locate The Insides Pump within the ostomy appliance and orientate the pump so the flat surface faces towards The Insides Driver.
3. Attach The Insides Pump to The Insides Driver: Place The Insides Pump between the four feet of The Insides Driver, ensuring the flat surface of The Insides Pump sits flush against The Insides Driver. Note: For easier alignment, avoid completely filling the ostomy appliance before positioning The Insides Pump.
4. Select the Appropriate Mode:
· The Insides Driver has five different MODES to accommodate chyme of varying thickness.
· MODE 1 is the slowest setting for thin chyme, while MODE 5 is the fastest setting for thicker chyme.
· THE INSIDES® System is unable to pump extremely thick chyme which is comparable to porridge (oatmeal); this chyme will need to be discarded.
5. Adjusting the Mode:
· The five different MODES are accessed using the ‘MODE’ button.
· Press the ‘MODE‘ button once will start at the lowest speed.
· Continue pressing the button will continue to increase the speed of the Driver, up to MODE 5
· Pressing MODE again after reaching MODE 5 will turn the Driver off.
6. Operating the Driver Safely: It is important to hold the Driver against the Pump at all times while it is operating. Ensure that fingers are kept away from the inlet of the pump to avoid harm.
7. Using The Insides System: Refer to The Insides System Instructions and Technical Description for Chyme Reinfusion.
If chyme starts flowing back into the proximal ostomy appliance before or while refeeding, place a clip on The Insides Channel tubing. Ensure this is removed after refeeding.
* Any serious incident that has occurred in relation to THE INSIDES® System should be reported to the manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.
THE INSIDES® Channel (Pump, Tubing and Connectors)
After use, handle and dispose of these products in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
This information can be sourced from your local authority or from the supplier of the medical device in your region.
The pump, tubing and connectors should not be cleaned as it can result in contamination of the product and may result in patient harm.
The Insides Company warrants that the device, when used in accordance with the instructions for use, shall be free from defects in workmanship and materials and will perform in accordance with The Insides Company official published product specifications for a period of 2years from the date of purchase by the customer. This warranty is subject to the limitations and exceptions set out in detail here: www.theinsides.co/warranty-statement
For Safety Signs and Symbol Glossary, please refer to THE INSIDES® System Instructions and Technical Description
Please contact the manufacturer or the local representative for assistance with setting up, using, or maintaining THE INSIDES® Channel or to report unexpected operations or events.
https://www.theinsides.co/contact-us
.png){kind=small}
© 2024 The Insides Company. All copyright, design, patent and intellectual property rights existing in our designs and products and in the images, text and design of our website / marketing material are the property of The Insides Company.
