The Insides Neo Instructions for Use

Definitions

Carer                                                    

Person who assists with an Ostomy Appliance change

Chyme

Content which exits from the stoma                                                                                              

Feeding Tube                       

A tube inserted into the Stoma which supplies nutrition

Healthcare Professional  

Surgeons/Doctors/Nurses

Intestines                                             

An organ in the body which food flows through

Ostomy Appliance                              

A bag which sits on the stomach and collects content from the Stoma

Stoma                                                   

A surgically created opening on the abdomen

THE INSIDES® Neo

THE INSIDES^® Neo is a medical device accessory for paediatric patients. It is supplied as an accessory to either the Coloplast Sensura^® Mio Baby 2-piece Flex Bag, or the Hollister Pouchkins™ Newborn One-Piece Ostomy Pouch-Flat barrier.

THE INSIDES^® Neo consists a of a housing, adapter and clip. The device works to refeed chyme from an ostomy appliance, into the distal limb of the intestinal tract through the stoma.

The housing and adapter are assembled together through the drain port of an ostomy appliance. An ENFit feeding tube is connected to the housing and is inserted into the distal limb of the stoma; the clip secures the tube inplace. When the ostomy appliance fills with chyme, a syringe is connected to the adapter and the plunger of the syringe can be drawn to pull fluid from the ostomy appliance into the syringe. The plunger is depressed to push the fluidthrough the feeding tube, into the intestinal tract.

THE INSIDES^® Neo is replaced with the bag change, up to a maximum of four days after installation.

THE INSIDES® Neo is for single patient use only.

Indication for Use

THE INSIDES^® Neo is intended to be used in paediatric patients who have aloop enterostomy, abcarian enterostomy or end enterostomy with mucous fistula allowing access to the distal intestine. The device is intended to act as aconduit to aid the transfer of chyme from an ostomy appliance into a stoma. The device can be used in a range of environments including hospitals, A&E and clinics.

Intended Use

THE INSIDES® Neo is intended to channel chyme from an ostomy appliance into the distal limb of a patient’s intestinal tract to help sustain their nutrition and gut health.

Contraindications

THE INSIDES® Neo is not suitable for patients who:

• Do not have two available stomal openings with proximal and distal intestinal limbs.
• Cannot have chyme refed into their distal limb
• Have started solid foods
• Have active Clostridium difficile
• Do not have a carer that can assist in the use of the product
• Cannot cover their stoma with the specified stoma appliance

Warnings

Contact your healthcare professional if any of the following occurs:

• Decreased refeeding, due to any reason, for 24 hours or longer
• Profuse or watery diarrhoea
• Fevers, chills
• Vomiting
• THE INSIDES® Neo stops working

For safe and effective operation of THE INSIDES® Neo, please familiarize yourself with the following information. Please read and keep all safety and use instructions.

Warnings about patient suitability:

THE INSIDES® Neo should not be used on patients on a solid food diet. – Particles will cause blockages in the device resulting in patient harm.

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

Patients on medication may need to have their dosages reviewed by their healthcare professional while using THE INSIDES® Neo. Reinfusion of chyme can increase the dosage of medications received by the patient. – This could cause patient toxicity.

Warnings about refeeding:

Do not refeed chyme which has been sitting outside the body 12 hours or longer. – An accumulation of bacteria may cause patient harm.

Activation of latent colonic Clostridium difficile infection could occur when THE INSIDES® Neo 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 diarrhoea, fevers, abdominal pain and malaise. If you have any concerns, contact your healthcare provider. – Infection could cause hospitalization.

THE INSIDES® Neo is only to be used as instructed by your healthcare professional to refeed chyme into the distal bowel. – Refeeding other fluids or medication could cause patient harm.

Do not refeed chyme at a fast rate. – This may cause patient harm such as perforation or damage to the intestine.

Chyme should be reinfused at a slow rate. – A high rate may cause bloating, nausea or discomfort.

Depress plunger of syringe slowly while refeeding chyme. – High pressure may cause patient harm.

If no chyme enters the syringe when it is drawn, ensure the housing is submerged in fluid and the valves are clear of any debris. – Blocking the device could cause damage and result in patient harm.

Do not refeed from incorrect vessels. – Contamination could lead to patient infection.

Do not refeed air into the intestinal tract. – Refeeding air may cause patient discomfort.

Warnings about device misuse:

Failure to carefully follow all applicable instructions may result in injury to the patient, or attendants and may have an adverse effect on outcome.

No modification of this equipment is allowed. – Alterations could cause rough surfaces that damage the bowel or skin; modification could result in product failure.

Use of THE INSIDES® Neo past its recommended life could expose patients to toxins. – Allergic reaction; patient toxicity could occur.

THE INSIDES® Neo should be disposed of in accordance with device disposal advice. – Biological waste in used products can cause contamination.

THE INSIDES® Neo products are single use ONLY and are not to be reused in a patient or shared – Contamination could lead to patient infection.

If the packaging of THE INSIDES® Neo is damaged prior to use, discard product.  – Contamination could lead to patient infection.

THE INSIDES® Neo must be disposed of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. – Incorrect disposal may lead to infection in people coming into contact with the device.

Warnings about accessories:

THE INSIDES® Neo should only be used with approved ostomy appliance. – Contamination could cause patient toxicity.

If, after the insertion of the Feeding Tube by the Healthcare Professional, the stoma stops releasing content, contact your Healthcare Professional. – Blockages could cause hospitalization.

Only a healthcare professional can insert the feeding tube. If the tube falls out, contact your healthcare professional for a replacement. – Incorrect insertion of the tube may cause patient harm.  

THE INSIDES® Neo may be used with tube extensions that could cause a strangulation risk to young children. – Chords may become entangled around small children’s necks.

User Guide

Read the warnings prior to setting up THE INSIDES® Neo.  

1. Prior To Use

Any users who come into contact with THE INSIDES® Neo or its associated accessories must wash their hands prior to use.

2. Assembling THE INSIDES® Neo

1. Wash your hands, prepare a clean workspace and don appropriate PPE.
2. Prepare the ostomy appliance, feeding tube, and THE INSIDES® Neo. Refer to the “Accessories” section for compatible ostomy appliances and feeding tubes.

Hollister™ Accessory

1. Connect the feeding tube to the housing.
2. Remove the drain port from the ostomy appliance if required.
3. Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
4. Insert the housing of THE INSIDES® Neo into the ostomy bag through the large opening, until the housing is at the bottom of the ostomy appliance. Gently press and twist in a clockwise direction to allow the device to move through the drain port. If the black O-ring shifts when the device is pushed through the ostomy appliance, return the O-ring the correct position.
5. Connect the adaptor to the housing by pressing it into place. You should hear a click.
6. Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
7. Coil the tube and place it in the bag so that nearly all of the tube sits inside of the bag. The length of tube outside the bag will be inserted into the distal limb of the patient’s intestinal tract.
8. Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

1. Connect the feeding tube to the housing.
2. Remove the drain port from the ostomy appliance if required.
3. Dip the nose of the adapter into a water-based lubricant.
4. Insert the adapter through the drain port, from the outside into the bag.
5. Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
6. Connect the housing to the adapter by clicking it into place, you should hear a click.
7. Coil the tube and place it in the bag so that nearly all of the tube sits inside of the bag. The length of tube outside the bag will be inserted into the distal limb of the patient’s intestinal tract.
8. Insert the supplied plug into the base of the device to ensure that no chyme can leak out.
   

3. Setting up the patient with THE INSIDES® Neo

1. Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
2. Apply a hydrocolloid around the stoma.
3. Remove the sticker to expose the adhesive of the ostomy appliance.
4. While holding the bag, insert the tube into the distal limb of the stoma.
5. Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
6. Use the clip to secure the tube to the side of the ostomy appliance, near to the stoma. The tube may need to be recoiled before placing the clip.
7. Ensure the plug at the base of the ostomy appliance is in place. This will prevent leaks from the ostomy appliance.

4.  Refeeding with THE INSIDES® Neo

WARNING: Do not refeed chyme which has been sitting outside the body 12 hours or longer. – An accumulation of bacteria may cause patient harm.

1. Remove the plug off the adaptor.
2. Connect a feeding tube extension to adaptor of THE INSIDES® Neo, and a Syringe to the extension. If you are refeeding manually, connect the syringe directly to THEINSIDES®
3. Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
4. Fill the syringe with chyme by drawing back the plunger of the syringe. The syringe can be purged of air at this time if required.
   
   Note: Only chyme which has been sitting outside the body for less than 12 hours can be refed into the distal limb, refer to WARNINGS. 
   
   
5. To refeed chyme into the distal limb, either:
   
   1. Manually depress the plunger of the syringe. This should be performed very slowly to reduce reflux or change of damage to the intestine. Or;
   2. Insert the syringe into an enteral feeding syringe pump to refeed the chyme at a rate suitable for the patient.
6. Once the plunger has been fully depressed:
7. The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
8. The syringe plunger can be drawn back to refill with chyme for further refeeding.

5.  Replacing THE INSIDES® Neo 

1. THE INSIDES® Neo is replaced with the usual bag change or at a maximum of 4 days.
2. Remove the ostomy appliance along with THE INSIDES® Neo, and feeding tube
3. Refer to STEP 2 and STEP 3 for replacement of THE INSIDES® Neo

6.  Disposing of THE INSIDES® Neo 

1. After use, handle and dispose of THE INSIDES® Neo 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.

Cleaning and Disinfection 

The plug should be wiped down with an EPA recommended disinfectant wipe, or similar, each time it is detached from the main body of the device to remove any visible chyme.

No other part of THE INSIDES® Neo should be cleaned as it can result in contamination of the product and may result in patient harm.

Troubleshooting Guide

O-Ring Moves during Assembly

If the o-ring moves out of its designated groove during assembly, it can be moved back into the original groove.

Insert the housing through the drain port at a slower speed with more lubricant.

Chyme leaking from device

Ensure the components of the device are assembled correctly. If the device is still leaking, remove and replace the device.

THE INSIDES® Neo blocks

Remove and replace the device.

Reflux

There may always be a small amount of reflux when refeeding is occurring. To decrease the amount of reflux, decrease the speed at which chyme is directed into the distal limb. 

Product Specifications 

Servicing

The device is not repairable and does not contain any repairable parts. Please refer queries relating to the device to the manufacturer or your local representative.

The device does not require preventative maintenance.

Warranty Statement

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 2 years 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.

‍

Accessories

All accessories should be used as specified by the manufacturer. Off-label use of accessories may result in harmto the patient.

Ostomy Appliance

• Hollister Pouchkins™ Newborn One-Piece Ostomy Pouch – Flat Barrier (3778)
• Coloplast SenSura® Mio Baby 2-piece Flex bag (18700)

Feeding Tube

• All suitable ENFit enteral feeding tubes

Syringe Driver

• All suitable enteral feeding syringe pumps

Safety Signs and Symbol Glossary

Intellectual Property

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. See www.insidescompany.com for more information.

‘Coloplast’, ‘SenSura® Mio ’ are registered trademarks of Coloplast Corporation. The use of the trademarks ‘Coloplast’, ‘SenSura® Mio ‘in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Coloplast Corporation. We hereby affirm our recognition of Coloplast Corporation 's exclusive intellectual property rights in the trademark ‘Coloplast’, ‘SenSura® Mio,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.

‘Hollister’, ‘Pouchkins™’ are registered trademarks of Hollister Incorporated. The use of the trademarks ‘Hollister’, ‘Pouchkins‘ in these instructions is strictly for informational purposes to provide accurate product information to our customers. The Insides Company Limited does not connote any endorsement, affiliation, sponsorship, or approval by Hollister Incorporated. We hereby affirm our recognition of Hollister Incorporated 's exclusive intellectual property rights in the trademark ‘Hollister’, ‘Pouchkins™,' and any references to said trademark are made in good faith to truthfully describe the compatibility or usage of their product.

‍

Contact Information

‍