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 is a medical device for paediatric patients. 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 in place. 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 fluid through 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.
THE INSIDES® Neo is intended to be used in paediatric patients who have a loop enterostomy, abcarian enterostomy or end enterostomy with mucous fistula allowing access to the distal intestine. The device is intended to act as a conduit 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, clinics and home 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.
THE INSIDES® Neo is not suitable for patients who:
Contact your healthcare professional if any of the following occurs:
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 diarrhea, 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.
Read the warnings prior to setting up THE INSIDES® Neo.
Any users who come into contact with THE INSIDES® Neo or its associated accessories must wash their hands prior to use.
WARNING: Do not refeed chyme which has been sitting outside the body 12 hours or longer. – An accumulation of bacteria may cause patient harm.
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.
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.
THE INSIDES® NeoMass (g)
5.5
Dimensions (mm)
55 x 55 x 15
Colour
Purple; Orange; Yellow
External Material
Polypropylene; Acrylonitrile butadiene styrene; Nitrile
Internal Materials
Polypropylene; Silicone
Maximum Storage Period
3 years
Maximum Use Period
4 days after installation
Conditions for Transport and Storage and use
Temperature
3 years
0°C – 40°C
32°F - 104°F
Humidity
90%RH Max
Ostomy Appliance
Feeding Tube
Syringe Driver
Caution
Consult instructions for use
Single use only
Do not resterilize
Batch Code
Indoor Use Only
Manufacturer
Serial Number
Authorised representative in the European Community
If marked, conforms with applicable EC directives
Use-by date
Do Not Use if Package is Damaged
MRI Safe
Catalogue Number
Temperature Limit
Humidity Limitation
Swiss Authorised Representative
Australian Sponsor
Medical Device
Label includes the UDI (Unique Device Identification) in both human
Sterilized using ethylene oxide
(01)09421905447034
(17)220504
(10)0000001
(21)05000099
readable format and machine-readable format
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.theinsides.co for more information.
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.
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.
Please contact the manufacturer or the local representative for assistance with setting up, using, or maintaining THE INSIDESNeo or to report unexpected operations or events.
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