The Insides Neo Instructions for Use

(8-minute read)

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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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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.

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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.

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Contact Information

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The Insides Neo Instructions for Use

(8-minute read)

Click here to download

Définitions

Soignant

Personne qui aide au changement d'un appareil de stomie

Chymé

Contenu qui sort de la stomie

Sonde d'alimentation

Un tube inséré dans la stomie qui fournit de la nutrition

Professionnel de santé

Chirurgiens/Médecins/Infirmières

Intestins

Un organe du corps par lequel circule la nourriture

Appareil pour stomie

Un sac qui repose sur le ventre et récupère le contenu de la stomie

Stomate

Une ouverture créée chirurgicalement sur l’abdomen

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TLES INSIDES® Néo

THE INSIDES® Neo est un dispositif médical destiné aux patients pédiatriques. THE INSIDES® Neo se compose d'un boîtier, d'un adaptateur et d'un clip. Le dispositif permet de réinjecter le chyme d'un appareil de stomie dans le membre distal du tractus intestinal à travers la stomie.

Le boîtier et l'adaptateur sont assemblés ensemble via l'orifice de vidange d'un appareil de stomie. Une sonde d'alimentation ENFit est connectée au boîtier et est insérée dans le membre distal de la stomie ; le clip maintient le tube en place. Lorsque l'appareil de stomie se remplit de chyme, une seringue est connectée à l'adaptateur et le piston de la seringue peut être tiré pour aspirer le fluide de l'appareil de stomie dans la seringue. Le piston est enfoncé pour pousser le liquide à travers la sonde d'alimentation, dans le tractus intestinal.

THE INSIDES® Neo est remplacé avec le changement de sac, jusqu'à quatre jours maximum après l'installation.

THE INSIDES® Neo est destiné à un usage unique sur un seul patient.

Indication d'utilisation

THE INSIDES® Neo est destiné à être utilisé chez les patients pédiatriques ayant subi une entérostomie en anse, une entérostomie abcarienne ou une entérostomie terminale avec fistule muqueuse permettant l'accès à l'intestin distal. Le dispositif est destiné à agir comme un conduit pour faciliter le transfert du chyme d'un appareil de stomie vers une stomie.L'appareil peut être utilisé dans une gamme d'environnements, notamment les hôpitaux, les urgences, les cliniques et à domicile.

Utilisation prévue

THE INSIDES® Neo est destiné à canaliser le chyme d’un appareil de stomie vers le membre distal du tractus intestinal d’un patient pour l’aider à maintenir sa nutrition et sa santé intestinale.

Contre-indications

THE INSIDES® Neo ne convient pas aux patients qui :

Ne disposez pas de deux ouvertures de stomie disponibles avec des membres intestinaux proximaux et distaux.
Ne peut pas recevoir de chyme dans son membre distal
J'ai commencé à manger des aliments solides
Avoir Clostridium difficile actif
Ne pas avoir de personnel soignant qui puisse vous aider à utiliser le produit
Ne peut pas couvrir sa stomie avec l'appareil de stomie spécifié

Avertissements

Contactez votre professionnel de la santé si l’un des événements suivants se produit :

Diminution de la réalimentation, pour quelque raison que ce soit, pendant 24 heures ou plus
Diarrhée abondante ou aqueuse
Fièvres, frissons
Vomissement
THE INSIDES® Neo cesse de fonctionner

Pour un fonctionnement sûr et efficace de THE INSIDES® Neo, veuillez vous familiariser avec les informations suivantes. Veuillez lire et conserver toutes les instructions de sécurité et d'utilisation.

Avertissements concernant l'adéquation du patient :

THE INSIDES® Neo ne doit pas être utilisé chez les patients suivant un régime alimentaire solide. – Les particules provoqueront des blocages dans l'appareil, ce qui entraînera des dommages pour le patient.

Ne réalimentez pas le chyme si les patients présentent des anomalies potentielles ou suspectées de la paroi intestinale. - La réalimentation en chyme chez les patients présentant des défauts dans l'intégrité du tractus intestinal peut entraîner une perforation et une septicémie entraînant de graves préjudices pour le patient.

Les patients prenant des médicaments devront peut-être faire réviser leurs posologies par leur professionnel de la santé lorsqu'ils utilisent THE INSIDES® Neo. La réinfusion de chyme peut augmenter la posologie des médicaments reçus par le patient. – Cela pourrait provoquer une toxicité pour le patient.

Avertissements concernant la réalimentation :

Ne réalimentez pas le chyme qui est resté hors du corps pendant 12 heures ou plus. – Une accumulation de bactéries peut nuire au patient.

L'activation d'une infection colique latente à Clostridium difficile peut survenir lors de la première utilisation de THE INSIDES® Neo. Cela ne se produira que chez les patients présentant cette bactérie présente dans leur intestin. Cette infection peut s’accompagner de symptômes tels qu’une diarrhée aqueuse, de la fièvre, des douleurs abdominales et des malaises. Si vous avez des inquiétudes, contactez votre professionnel de la santé. – L’infection pourrait entraîner une hospitalisation.

THE INSIDES® Neo ne doit être utilisé que selon les instructions de votre professionnel de la santé pour réinjecter du chyme dans l'intestin distal. – La réalimentation d'autres liquides ou médicaments pourrait nuire au patient.

Ne réalimentez pas le chyme à un rythme rapide. – Cela pourrait nuire au patient, comme une perforation ou des lésions intestinales.

Le chyme doit être réinfusé à un rythme lent. – Un taux élevé peut provoquer des ballonnements, des nausées ou des inconforts.

Appuyez lentement sur le piston de la seringue tout en réinjectant du chyme. – Une pression élevée peut nuire au patient.

Si aucun chyme ne pénètre dans la seringue lorsqu'elle est aspirée, assurez-vous que le boîtier est immergé dans le liquide et que les valves sont exemptes de tout débris. – Le blocage de l'appareil pourrait causer des dommages et nuire au patient.

Ne réalimentez pas à partir de récipients incorrects. – Une contamination pourrait entraîner une infection du patient.

Ne réinjectez pas d'air dans le tractus intestinal. – La réalimentation en air peut provoquer une gêne chez le patient.

Avertissements concernant une mauvaise utilisation de l'appareil :

Le non-respect de toutes les instructions applicables peut entraîner des blessures au patient ou au personnel soignant et peut avoir un effet néfaste sur les résultats.

Aucune modification de cet équipement n'est autorisée. – Les altérations pourraient provoquer des surfaces rugueuses qui endommagent l’intestin ou la peau ; toute modification pourrait entraîner une défaillance du produit.

L’utilisation de THE INSIDES® Neo au-delà de sa durée de vie recommandée pourrait exposer les patients à des toxines. - Réaction allergique; une toxicité pour le patient pourrait survenir.

THE INSIDES® Neo doit être éliminé conformément aux conseils d’élimination des appareils. – Les déchets biologiques présents dans les produits usagés peuvent provoquer une contamination.

Les produits INSIDES® Neo sont à usage unique UNIQUEMENT et ne doivent pas être réutilisés chez un patient ou partagés – La contamination pourrait entraîner une infection du patient.

Si l'emballage de THE INSIDES® Neo est endommagé avant utilisation, jetez le produit. – Une contamination pourrait entraîner une infection du patient.

THE INSIDES® Neo doit être éliminé conformément aux pratiques médicales acceptées et aux lois et réglementations locales, étatiques et fédérales applicables. – Une élimination incorrecte peut entraîner une infection chez les personnes entrant en contact avec l'appareil.

Avertissements concernant les accessoires :

THE INSIDES® Neo ne doit être utilisé qu’avec un appareil de stomie approuvé. – Une contamination pourrait entraîner une toxicité pour le patient.

Si, après l'insertion de la sonde d'alimentation par le professionnel de la santé, la stomie cesse de libérer du contenu, contactez votre professionnel de la santé. – Des blocages pourraient entraîner une hospitalisation.

Seul un professionnel de la santé peut insérer la sonde d'alimentation. Si le tube tombe, contactez votre professionnel de la santé pour un remplacement. – Une insertion incorrecte du tube peut nuire au patient.

THE INSIDES® Neo peut être utilisé avec des rallonges de tube qui pourraient présenter un risque d'étranglement pour les jeunes enfants. – Les cordes peuvent s’emmêler autour du cou des petits enfants.

Mode d'emploi

Lisez les avertissements avant d’installer THE INSIDES® Neo.

1. Avant utilisation

Tout utilisateur entrant en contact avec THE INSIDES® Neo ou ses accessoires associés doit se laver les mains avant utilisation.

2. Assemblage des INSIDES® Neo

Lavez-vous les mains, préparez un espace de travail propre et enfilez les EPI appropriés.

Préparez l'appareil de stomie, la sonde d'alimentation et THEINSIDES® Reportez-vous à la section « Accessoires » pour connaître les appareils de stomie et les sondes d'alimentation compatibles.

Connectez la sonde d'alimentation au boîtier.

Retirez l’orifice de vidange de l’appareil de stomie si nécessaire.

Trempez le nez du corps de THE INSIDES® Neo dans un lubrifiant à base d'eau.

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Insérez le boîtier de THE INSIDES® Neo dans le sac de stomie par la grande ouverture, jusqu'à ce que le boîtier se trouve au bas de l'appareil de stomie. Appuyez doucement et tournez dans le sens des aiguilles d'une montre pour permettre à l'appareil de passer à travers l'orifice de vidange. Si le joint torique noir se déplace lorsque le dispositif est poussé à travers l'appareil de stomie, remettez le joint torique dans la bonne position.

Connectez l'adaptateur au boîtier en appuyant dessus. Vous devriez entendre un clic.
Vérifiez que le boîtier et l'adaptateur sont correctement connectés. Le nez du boîtier doit être visible à travers l'adaptateur.
Enroulez le tube et placez-le dans le sac de manière à ce que presque tout le tube se trouve à l'intérieur du sac. La longueur du tube à l’extérieur du sac sera insérée dans la branche distale du tractus intestinal du patient.

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Insérez le bouchon fourni dans la base de l'appareil pour vous assurer qu'aucun chyme ne puisse s'échapper.

3. Mise en place du patient avec THE INSIDES® Neo

Assurez-vous que THE INSIDES® Neo a été assemblé avec l’appareil de stomie et le tube comme décrit ci-dessus.
Appliquez un colloïde autour de la stomie.
Retirez l'autocollant pour exposer l'adhésif de l'appareil de stomie.
Tout en tenant le sac, insérez le tube dans la branche distale de la stomie.
Une fois le tube inséré au niveau souhaité, appliquez la plaque de base sur l'abdomen, autour de la stomie.
Utilisez le clip pour fixer le tube sur le côté de l'appareil de stomie, près de la stomie. Il faudra peut-être reculer le tube avant de placer le clip.
Assurez-vous que le bouchon à la base de l’appareil de stomie est en place. Cela empêchera les fuites de l’appareil de stomie.

4. Réalimentation avec THE INSIDES® Neo

AVERTISSEMENT : Ne réalimentez pas le chyme qui est resté à l'extérieur du corps pendant 12 heures ou plus. – Une accumulation de bactéries peut nuire au patient.

Retirez la fiche de l'adaptateur.
Connectez une extension de sonde d'alimentation à l'adaptateur de THE INSIDES® Neo et une seringue à l'extension. Si vous réalimentez manuellement, connectez la seringue directement à THEINSIDES®
Remarque : La réalimentation manuelle peut provoquer un débit ou une pression excessive susceptible d'endommager l'intestin. Reportez-vous aux AVERTISSEMENTS.
Remplissez la seringue de chyme en retirant le piston de la seringue. La seringue peut être purgée de son air à ce moment si nécessaire.

Remarque : Seul le chyme qui est resté à l'extérieur du corps pendant moins de 12 heures peut être réinjecté dans le membre distal, voir AVERTISSEMENTS.
Pour réintroduire du chyme dans le membre distal, soit :
1. Appuyez manuellement sur le piston de la seringue. Cela doit être effectué très lentement pour réduire le reflux ou les modifications des dommages à l'intestin. Ou;
2. Insérez la seringue dans un pousse-seringue à alimentation entérale pour réalimenter le chyme à un débit adapté au patient.
Une fois le piston complètement enfoncé :
La seringue et le tube d'extension doivent être déconnectés de l'adaptateur et le bouchon doit être réinséré. Ou;
Le piston de la seringue peut être retiré pour remplir de chyme pour une réalimentation ultérieure.

5. Remplacement de THE INSIDES® Neo

THE INSIDES® Neo est remplacé par le changement de sac habituel ou dans un délai maximum de 4 jours.
Retirez le bouchon, puis utilisez une seringue pour extraire autant de chyme que possible. Débranchez la seringue.
Si la sonde d'alimentation doit rester en place, dévissez soigneusement la sonde d'alimentation du boîtier de THE INSIDES® Neo et retirez le clip.
Retirez l'appareil de stomie avec THE INSIDES®

6. Élimination de THE INSIDES® Neoo

Après utilisation, manipulez et jetez THE INSIDES® Neo conformément aux pratiques médicales acceptées et aux lois et réglementations locales, étatiques et fédérales applicables. Ces informations peuvent provenir de votre autorité locale ou du fournisseur du dispositif médical dans votre région.

Nettoyage et désinfection

Le bouchon doit être essuyé avec une lingette désinfectante recommandée par l'EPA, ou similaire, chaque fois qu'il est détaché du corps principal de l'appareil pour éliminer tout chyme visible.

Aucune autre partie de THE INSIDES® Neo ne doit être nettoyée car cela pourrait entraîner une contamination du produit et nuire au patient.

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Guide de dépannage

Le joint torique se déplace pendant l'assemblage

Si le joint torique sort de sa rainure désignée pendant l'assemblage, il peut être replacé dans la rainure d'origine.

Insérez le boîtier à travers l'orifice de vidange à une vitesse plus lente avec plus de lubrifiant.

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EChyme s'échappe de l'appareil

Assurez-vous que les composants de l’appareil sont correctement assemblés. Si l'appareil fuit toujours, retirez et remplacez l'appareil.

LES INSIDES® Neo blocs

Retirez et remplacez l'appareil.

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Reflux

Ilpeut toujours y avoir une petite quantité de reflux lors de la réinjection.Pour réduire la quantité de reflux, diminuez la vitesse à laquelle le chyme estdirigé dans le membre distal.

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Accessories

Tous les accessoires doivent être utilisésselon les instructions du fabricant. L’utilisation d’accessoires en dehors desindications peut nuire au patient.

Dispositif d’ostomie

· Poche vidangeable HollisterPouchkins™ Newborn, 1 pièce pour prématurés - Support plan en SoftFlex™ (3778)

· Flex Poche ColoplastSenSura® Mio Baby, 2 pièces (18700)

Sonde d'alimentation gastrique

· Toutes les sondesd’alimentation entérale ENFIT adaptées

Pousse-seringue

· Toutes les pompes àseringues adaptées à l’alimentation entérale

Propriété intellectuelle

Tous les droits d’auteur, de conception, de brevet et depropriété intellectuelle existant dans nos conceptions et nos produits ainsique dans les images, le texte et la conception de notre site internet / matérielde marketing sont la propriété de The Insides Company. Consultez www.insidescompany.com pour plusd’informations.

« Coloplast », « SenSura®Mio » sont des marques déposées deColoplast Corporation. Les marques déposées « Coloplast » et « SenSura®Mio » dans ces instructions sontutilisées strictement à des fins d’information afin de fournir des informationsprécises sur les produits à nos clients. The Insides Company Limited n’impliquedonc aucun soutien, affiliation, parrainage ou approbation de la part deColoplast Corporation. Nous affirmons par la présente que nous reconnaissonsles droits de propriété intellectuelle exclusifs de Coloplast Corporation surles marques déposées « Coloplast », « SenSura®Mio », et toute référence à laditemarque déposée est faite de bonne foi pour décrire fidèlement la compatibilitéou l’utilisation de leur produit.

« Hollister », « Pouchkins™ » sont des marques déposées de Hollister Incorporated. Lesmarques déposées « Hollister » et « Pouchkins » dans ces instructions sont utilisées strictement à desfins d’information afin de fournir des informations précises sur les produits ànos clients. The Insides Company Limited n’implique donc aucun soutien,affiliation, parrainage ou approbation de la part de Hollister Incorporated.Nous affirmons par la présente que nous reconnaissons les droits de propriété intellectuelle exclusifs de Hollister Incorporated surles marques déposées « Hollister », « Pouchkins™ », et toute référence àladite marque déposée est faite de bonne foi pourdécrire fidèlement la compatibilité ou l’utilisation de leur produit.

Déclaration de garantie

The Insides Company garantit que l’appareil, lorsqu’exploité conformément au manuelde l’utilisateur, ne présente aucun défaut de fabrication ou de matériau et fonctionne dans le respect des spécifications officielles publiées par The Insides Company pendant une période de deux ans à compter de la date d’achat par le client. Cette garantie estsoumise aux limitations et exceptions énoncées en détail sur le site : www.theinsides.co/warranty-statement.

Travaux de maintenance

L’appareil n’est pas réparable et ne contient aucune pièceréparable. Veuillez adresser les questions relatives à l’appareil au fabricantou à votre représentant local.

L’appareil ne nécessite pas d’entretien préventif.

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The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

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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

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Contact Information

‍

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

Definities

Verzorger

Persoon die assisteert bij hetveranderen van stomazakje

Chymus

Inhouddie uit de stoma komt

Voedingssonde

Een buisje ingebracht in de stomadie voeding levert

Zorgprofessional

Chirurgen/Artsen/Verpleegkundigen

Ingewanden

Een orgaan in het lichaam waarvoedsel doorheen stroomt

Stomazakje

Een zak die op de maag zit eninhoud van de stoma verzamelt

Stoma

Een chirurgisch gecreëerdeopening op de buik

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THE INSIDES® Neo

THE INSIDES® Neo is een medisch hulpmiddelaccessoire voorpediatrische patiënten. Het wordt geleverd als accessoire bij het ColoplastSensura® Mio 2-delige flexzak voor baby of het Hollister Pouchkins™ Eendeligstomazakje voor zuigeling – Flat Barrier.

THE INSIDES^® Neo is een medisch hulpmiddel voorpediatrische patiënten. THE INSIDES^® Neo bestaat uit een behuizing,adapter en clip. Het apparaat werkt om chymus van eenstomazakje terug te leiden in de distale zone van het darmkanaal door de stoma.

De behuizing en adapter worden samen gemonteerd via deafvoerpoort van een stomazakje. Een EnFIT-voedingssonde is verbonden met debehuizing en wordt in de distale zone van de stoma ingebracht; de clipbevestigt de buis op zijn plaats. Wanneer het stomazakje met chymus wordtgevuld, wordt een spuit op de adapter aangesloten en kan de zuiger van de spuitworden getrokken om vloeistof uit het stomazakje in de spuit te trekken. Dezuiger wordt ingedrukt om de vloeistof door de voedingssonde in het darmkanaalte duwen.

THE INSIDES^® Neo wordtvervangen met de zakwissel, tot maximaal vier dagen na installatie.

THE INSIDES^® Neo is alleen voorgebruik door één patiënt.

Indicatie voor Gebruik

THE INSIDES^® Neo is bedoeld voorgebruik bij pediatrische patiënten met een enterostomielus, abcarianenterostomie of enterostomie met slijmfistel die toegang geeft tot de distaledarm. Het apparaat is bedoeld om te fungeren als een leiding om de overdrachtvan chymus van een stomazakje naar een stoma te vergemakkelijken. Het apparaat kanworden gebruikt in verschillende omgevingen, waaronder ziekenhuizen, SEH,klinieken en thuisgebruik.

Beoogd gebruik

THE INSIDES^® NEO is bedoeld om chymusvan een stomazakje in de distale zone van het darmkanaal van een patiënt te kanaliserenom voeding en darmgezondheid te ondersteunen.

Contra-indicaties

THE INSIDES^® Neo is niet geschiktvoor patiënten die:

Geen twee beschikbarestomale openingen met proximale en distale intestinale zones hebben.
Chymus niet in hun distalezone kunnen leiden
Zijn begonnen met vastvoedsel
Actieve Clostridiumdifficile hebben
Geen verzorger hebben diekan helpen bij het gebruik van het product
Hun stoma niet kunnenbedekken met het gespecificeerde stomazakje

Waarschuwingen

Neem contact op met uw zorgverlener als een vande volgende situaties zich voordoet:

Verminderde refeeding, omwelke reden dan ook, gedurende 24 uur of langer
Overvloedige of waterigediarree
Koorts, koude rillingen
Braken
THE INSIDES^® Neostopt met werken

Gelieve u vertrouwd te maken met de volgendeinformatie voor een veilige en effectieve werking van THE INSIDES^®Neo. Lees en bewaar alle veiligheids- en gebruiksinstructies.

Waarschuwingen over de geschiktheid van depatiënt:

THE INSIDES^® Neo mag niet wordengebruikt bij patiënten met een dieet van vast voedsel. – Deeltjes zullenverstoppingen in het apparaat veroorzaken, wat resulteert in schade voor depatiënt.

Refeed chymus niet als patiënten potentiële of vermoededarmwanddefecten hebben. - Refeed van chymus bij patiënten met defecten in deintegriteit van het darmkanaal kan leiden tot perforatie en sepsis die leidentot ernstige schade aan de patiënt

Patiënten die medicatie gebruiken, moeten mogelijk hun doseringen latencontroleren door hun zorgverlener tijdens gebruik van THE INSIDES^®Neo. Herinfusie van chymus kan de dosering van benodigde medicijnen door depatiënt te verhogen. – Dit kan toxiciteit bij de patiënt veroorzaken.

Waarschuwingen over refeeding:

Refeed chymus niet wanneer deze 12 uur of langer buiten het lichaamwas. – Een opeenhoping van bacteriën kan de patiënt schade toebrengen.

Activering van latente colonische infectie met Clostridium difficilekan optreden wanneer THE INSIDES^® Neo voor het eerst wordt gebruikt.Dit komt alleen voor bij patiënten met deze bacterie in hun darmen. Dezeinfectie kan gepaard gaan met symptomen zoals waterige diarree, koorts,buikpijn en gevoel van onwel. Als u zich zorgen maakt, neem dan contact op metuw zorgverlener. – Infectie kan ziekenhuisopname veroorzaken.

THE INSIDES^® Neo mag alleen worden gebruikt volgens deinstructies van uw zorgverlener om chymus in de distale darm te voeren. – Hetopnieuw geven van andere vloeistoffen of medicatie kan de patiënt schadetoebrengen.

Refeed chyme niet in een snel tempo. – Dit kan schade aan de patiëntveroorzaken, zoals perforatie of schade aan de darm.

Chymus moet langzaam opnieuw worden geïnfuseerd. – Een hoge snelheidkan een opgeblazen gevoel, misselijkheid of ongemak veroorzaken.

Druk de zuiger van de spuit langzaam in bij de refeeding van chymus.– Hoge druk kan de patiënt schade toebrengen.

Als er geen chymus in de spuit komt wanneer deze wordt getrokken,zorg er dan voor dat de behuizing ondergedompeld is in vloeistof en dat dekleppen vrij zijn van vuil. – Blokkering van het apparaat kan schadeveroorzaken en leiden tot schade voor de patiënt.

Voer geen refeeding uit verkeerde vaten uit. – Besmetting kan leidentot infectie van de patiënt.

Zuig geen lucht in het darmkanaal. – Het opnieuw toedienen van luchtkan ongemak voor de patiënt veroorzaken.

Waarschuwingen over de geschiktheid van depatiënt:

The Insides Neo mag niet worden gebruikt bij patiënten met een dieetvan vast voedsel. – Deeltjes zullen verstoppingen in het apparaat veroorzaken,wat resulteert in schade voor de patiënt.

Waarschuwingen over misbruik van het apparaat:

Het niet zorgvuldig opvolgen van alle toepasselijke instructies kanleiden tot letsel bij de patiënt of verzorgers en kan een nadelig effect hebbenop de uitkomst.

Wijziging van deze apparatuur is niet toegestaan. – Veranderingenkunnen ruwe oppervlakken veroorzaken die de darm of huid beschadigen;modificatie kan leiden tot productfalen.

Het gebruik van THE INSIDES^® NEO na de aanbevolenlevensduur kan patiënten blootstellen aan toxines. – Allergische reactie;toxiciteit voor de patiënt kan optreden.

THE INSIDES^® Neo moet worden weggegooid in overeenstemmingmet het verwijderingsadvies van het apparaat. – Biologisch afval in gebruikteproducten kan verontreiniging veroorzaken.

THE INSIDES^® NEO-producten zijn ALLEEN voor eenmaliggebruik en mogen niet worden hergebruikt bij een patiënt of worden gedeeld –Besmetting kan leiden tot infectie bij de patiënt.

Als de verpakking van THE INSIDES^® NEO voor gebruikbeschadigd is, gooi het product dan weg. – Besmetting kan leiden tot infectievan de patiënt.

THE INSIDES^® NEO moet worden verwijderd in overeenstemmingmet de geaccepteerde medische praktijk en de toepasselijke lokale, provincialeen federale wet- en regelgeving. – Onjuiste verwijdering kan leiden totinfectie bij mensen die in contact komen met het apparaat.

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Waarschuwingenover accessoires:

THE INSIDES^® Neo mag alleen worden gebruikt met eengoedgekeurd stomazakje. – Besmetting kan leiden tot toxiciteit voor de patiënt.

Als de stoma na het inbrengen van de voedingssonde door dezorgverlener stopt met het vrijgeven van inhoud, neem dan contact op met uwzorgverlener. – Blokkades kunnen ziekenhuisopname veroorzaken.

Alleen een beroepsbeoefenaar in de gezondheidszorg kan devoedingssonde inbrengen. Als de buis uitvalt, neem dan contact op met uwzorgverlener voor een vervanging. – Het verkeerd inbrengen van het buisje kande patiënt schade toebrengen.

De Insides Neo kan worden gebruikt met buisverlengingen die eenwurgingsrisico voor jonge kinderen kunnen veroorzaken. – Koorden kunnenverstrikt raken rond de nek van kleine kinderen.

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Gebruikershandleiding

Lees de waarschuwingen voordat u THEINSIDES^® Neo instelt.

1. Voor ingebruikname

Gebruikers die in contact komen met THE INSIDES^®NEO of de bijbehorende accessoires moeten hun handen wassen voor gebruik.

2. THE INSIDES^® Neo monteren

Was uw handen, bereideen schone werkplek voor en doe geschikte PBM's aan.
Bereidhet stomazakje, de voedingssonde en THE INSIDES^® Neo voor. Raadpleeg het gedeelte 'Accessoires' voor compatibele stomatoestellen envoedingssondes.

Hollister™ accessoire

Sluit de voedingssondeaan op de behuizing.
Verwijder indien nodigde afvoerpoort van het stoma-aparaat.
Dompel de neus van hetlichaam van THE INSIDES^® Neo in een glijmiddel op waterbasis.
Steek de behuizing van THE INSIDES^® NEO door de groteopening in het stomazakje, totdat de behuizing zich aan de onderkant van hetstomazakje bevindt. Druk en draai voorzichtig met de klok mee om het apparaatdoor de afvoerpoort te laten bewegen. Als de zwarte o-ring verschuift wanneerhet apparaat door het stomazakje wordt geduwd, breng dan de o-ring in de juistepositie terug.
Sluit de adapter aan opde behuizing door deze op zijn plaats te drukken. Een klik zou hoorbaar moetenzijn.
Controleer of debehuizing en adapter correct zijn aangesloten. De neus van de behuizing moetdoor de adapter worden gezien.
Rol het buisje op enplaats dit in de zak, zodat bijna alle buisjes in de zak zitten. De lengte vanhet buisje buiten de zak wordt ingebracht in de distale zone van het darmkanaalvan de patiënt.
Steekde meegeleverde plug in de basis van het apparaat om ervoor te zorgen dat ergeen chymus uit kan lekken.

Coloplast® accessoire

Sluit de voedingssondeaan op de behuizing.
Verwijder indien nodigde afvoerpoort van het stoma-aparaat.
Dompel de neus van deadapter in een glijmiddel op waterbasis.
Steek de adapter doorde afvoerpoort, van buitenaf in de zak.
Steek de behuizing inhet stomazakje door de opening, totdat deze de bodem bereikt.
Sluit de behuizing aanop de adapter door deze op zijn plaats te klikken, u zou een klik moeten horen.
Rol het buisje op enplaats dit in de zak, zodat bijna alle buisjes in de zak zitten. De lengte vanhet buisje buiten de zak wordt ingebracht in de distale zone van het darmkanaalvan de patiënt.
Steekde meegeleverde plug in de basis van het apparaat om ervoor te zorgen dat ergeen chymus uit kan lekken.

3. THE INSIDES^® Neo instellen op de patiënt

Zorg ervoor dat THEINSIDES^® NEO is gemonteerd met het stomazakje en het buisje zoalshierboven beschreven.
Breng een hydrocolloïdeaan rond de stoma.
Verwijder de sticker omde lijm van het stomazakje bloot te leggen.
Terwijl u de zak vasthoudt, plaatst u het buisje in de distale zonevan de stoma.
Zodra het buisje op hetgewenste niveau is ingebracht, brengt u de basisplaat aan op de buik, rond destoma.
Gebruik de clip om debuis vast te zetten aan de zijkant van het stomazakje, in de buurt van destoma. Het kan nodig zijn om het buisje terug op te rollen voordat u de clipplaatst.
Zorgervoor dat de stekker aan de basis van het stomazakje op zijn plaats zit. Ditvoorkomt lekken uit het stomazakje.

4. Refeeding met THE INSIDES^® Neo

WAARSCHUWING:Refeed chymus niet wanneer deze 12 uur of langer buiten het lichaam was.– Een opeenhoping van bacteriën kan de patiënt schade toebrengen.

‍Verwijder de stekkervan de adapter.
Sluit een verlengstukvan de voedingssonde aan op de adapter van THE INSIDES^® Neo en eenspuit op de extensie. Als het refeedinghandmatig gebeurt, sluit dan de spuit rechtstreeks aan op THE INSIDES^®Neo.
Opmerking: Handmatigrefeeding kan overmatige stroming of druk veroorzaken die de darm kanbeschadigen, raadpleeg WAARSCHUWINGEN.
Vul de spuit met chymusdoor de zuiger van de spuit terug te trekken. De spuit kan op dit moment indiennodig worden ontlucht.

Opmerking:Alleen chymus die minder dan 12 uur buiten het lichaam heeft gezeten, kan inhet distale gebied worden teruggeplaatst, raadpleeg WAARSCHUWINGEN.
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Refeeding van de chymusin het distale gebied uitvoeren, ofwel:
1. Druk de zuiger van despuit handmatig in. Dit moet zeer langzaam worden uitgevoerd om reflux ofverandering van schade aan de darm te verminderen. Of;
2. Steek de spuit in eenenterale voedingsspuitpomp voor refeeding van de chymus met een snelheid diegeschikt is voor de patiënt.
Zodra de zuigervolledig is ingedrukt:
De spuit en deverlengbuis moeten worden losgekoppeld van de adapter en de plug moet opnieuwworden geplaatst. Of;
Dezuiger van de injectiespuit kan worden teruggetrokken om opnieuw te wordengevuld met chymus voor verdere refeeding.

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5. THE INSIDES^® Neo vervangen

THE INSIDES® Neo wordt vervangen met de gebruikelijke zakwissel of na maximaal 4 dagen.
Verwijder het stomazakje samen met The INSIDES® Neo en de voedingssonde
Raadpleeg STAP 2 en STAP 3 voor het vervangen van THE INSIDES® Neo

6. Hetverwijderen van THE INSIDES^® Neo

THE INSIDES^® Neo na gebruik hanterenen weggooien in overeenstemming met de geaccepteerde medische praktijk en detoepasselijke lokale, provinciale en federale wet- en regelgeving. Dezeinformatie kan afkomstig zijn van uw lokale autoriteit of van de leveranciervan het medische hulpmiddel in uw regio.

Reiniging en ontsmetting

De plug moet worden afgeveegd met een door EPA aanbevolendesinfecterend doekje of iets dergelijks, elke keer dat het wordt losgemaaktvan de hoofdbehuizing van het apparaat om zichtbare chymus te verwijderen.

Geenenkel ander deel van THE INSIDES^® NEO mag worden gereinigd, omdatdit kan leiden tot verontreiniging van het product en kan leiden tot schadevoor de patiënt.

Gids voor probleemoplossing

O-ring beweegt tijdensmontage

Als de O-ring tijdens de montageuit de daarvoor bestemde groef beweegt, kan deze weer in de oorspronkelijkegroef worden verplaatst.

Steek de behuizing door deafvoerpoort op een langzamere snelheid met meer smeermiddel.

Chymus lekt uit apparaat

Zorg ervoor dat de onderdelen van hetapparaat correct zijn gemonteerd. Als het apparaat nog steeds lekt, verwijderten vervangt u het apparaat.

THE INSIDES^®Neo blokkeert

Verwijder en vervang het apparaat.

Reflux

Erkan altijd een kleine hoeveelheid reflux optreden bij refeeding. Om dehoeveelheid reflux te verminderen, verlaagt u de snelheid waarmee chymus in dedistale zone wordt geleid.

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Accessoires

Alle accessoires moeten worden gebruikt zoals gespecificeerddoor de fabrikant. Off-label gebruik van accessoires kan leiden tot schade aande patiënt.

Stomazakje

Hollister Pouchkins™Eendelig stomazakje voor zuigeling – Flat Barrier (3778)
Coloplast SenSura® Mio2-delige flexzak voor baby (18700)

Voedingssonde

Alle geschikte ENFITenterale voedingssondes

Stuurprogramma Spuit

Allegeschikte enterale voedingsspuitpompen

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Intellectueel eigendom

Alle auteursrechten, ontwerpen, octrooien en intellectuele eigendomsrechten die bestaan in onze ontwerpen en producten en in de afbeeldingen, tekst en het ontwerp van onze website / marketingmateriaal zijn eigendom van The Insides Company. Zie www.theinsides.co voor meer informatie.

‘Coloplast’, ‘SenSura® Mio’ zijn geregistreerde handelsmerken van Coloplast Corporation. Het gebruik van de handelsmerken ‘Coloplast’, ‘SenSura® Mio‘ in deze instructies is strikt voor informatieve doeleinden om nauwkeurige productinformatie aan onze klanten te verstrekken. The Insides Company Limited impliceert geen goedkeuring, affiliatie, sponsoring of goedkeuring door Coloplast Corporation. We bevestigen hierbij onze erkenning van de exclusieve intellectuele eigendomsrechten van Coloplast Corporation op het handelsmerk ‘Coloplast‘, ’SenSura® Mio', en alle verwijzingen naar genoemd handelsmerk worden te goeder trouw gemaakt om de compatibiliteit of het gebruik van hun product naar waarheid te beschrijven.

‘Hollister’, ‘Pouchkins™’ zijn geregistreerde handelsmerken van Hollister Incorporated. Het gebruik van de handelsmerken ‘Hollister’, ‘Pouchkins‘ in deze instructies is strikt voor informatieve doeleinden om nauwkeurige productinformatie aan onze klanten te verstrekken. The Insides Company Limited impliceert geen goedkeuring, affiliatie, sponsoring of goedkeuring door Hollister Incorporated. We bevestigen hierbij onze erkenning van de exclusieve intellectuele eigendomsrechten van Hollister Incorporated op het handelsmerk ‘Hollister‘, ’Pouchkins™', en alle verwijzingen naar genoemd handelsmerk worden te goeder trouw gemaakt om de compatibiliteit of het gebruik van hun product naar waarheid te beschrijven.

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The Insides Neo Instructions for Use

(8-minute read)

Click here to download

Begriffsbestimmungen

Betreuer*in

Person, die bei einem Wechsel des Ostomiegeräts hilft

Chymus

Inhalt, der aus dem Stoma austritt

Ernährungssonde

Ein Schlauch, der in das Stoma eingeführt wird und die Ernährung bereitstellt

Medizinische Fachkraft

Chirurg*innen/Ärzte/Arztinnen/Krankenpfleger*innen

Darm

Ein Organ im Körper, durch das Nahrung fließt

Ostomiegerät

Eine Tasche, die auf dem Bauch sitzt und Inhalte aus dem Stoma auffängt

Stoma

Eine chirurgisch geschaffene Öffnung auf dem Bauch

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THE INSIDES® Neo

THE INSIDES® Neo ist ein Medizinprodukt-Zubehör für pädiatrische Patient*innen. Es wird als Zubehör für den zweiteiligen Flex-Beutel „Coloplast Sensura® Mio Baby“ oder den einteiligen Beutel (Flache Barriere) „Hollister Pouchkins™ Newborn“ geliefert.

THE INSIDES® Neo ist ein Medizinprodukt für pädiatrische Patient*innen. THE INSIDES® Neo besteht aus einem Gehäuse, einem Adapter und einem Clip. Das Gerät dient dazu, den Chymus aus einem Ostomiegerät durch das Stoma in die distale Extremität des Darmtraktes nachzufüttern.

Gehäuse und Adapter werden durch die Ablauföffnung eines Ostomiegerätes zusammengefügt. Eine EnFIT-Ernährungssonde ist mit dem Gehäuse verbunden und wird in die distale Extremität des Stomas eingeführt; der Clip sichert den Schlauch an Ort und Stelle. Wenn sich das Stoma mit Chymus füllt, wird eine Spritze an den Adapter angeschlossen, und der Kolben der Spritze kann gezogen werden, um Flüssigkeit aus dem Ostomiegerät in die Spritze zu ziehen. Der Kolben wird niedergedrückt, um die Flüssigkeit durch die Ernährungssonde in den Darmtrakt zu drücken.

THE INSIDES® Neo wird bis maximal vier Tage nach dem Einsatz mit dem Beutelwechsel ersetzt.

THE INSIDES ® Neo ist nur für den einmaligen Gebrauch bestimmt.

Anwendungshinweis

THE INSIDES® Neo ist für den Einsatz bei pädiatrischen Patient*innen vorgesehen, die eine Schlaufenenterostomie, eine abkarianische Enterostomie oder eine Endenterostomie mit Schleimfisteln haben, die den Zugang zum distalen Darm ermöglichen. Die Vorrichtung soll als Leitung zur Unterstützung des Transfers von Chymus von einem Ostomiegerät in ein Stoma dienen. Das Gerät kann in einer Reihe von Umgebungen verwendet werden, einschließlich in Krankenhäusern, Notaufnahmen, Kliniken und zu Hause.

Bestimmungsgemäße Verwendung

THE INSIDES® Neo soll den Chymus aus einem Ostomiegerät in die distalen Extremitäten des Darmtraktes von Patient*innen leiten, um deren Ernährung und Darmgesundheit zu unterstützen.

Gegenanzeigen

THE INSIDES® Neo ist nicht geeignet für Patient*innen, bei denen:

keine zwei Magenöffnungen mit proximalen und distalen Darmextremitäten verfügbar sind,
der Chymus nicht in die distale Extremität zurückgeführt werden kann,
mit der Einnahme fester Nahrung begonnen wurde,
ein aktives Clostridium difficile besteht,
keine(n) Betreuer*in verfügbar ist, die/der bei der Verwendung des Produkts behilflich sein kann
nicht die Möglichkeit besteht, ihr Stoma mit der angegebenen Stoma-Vorrichtung abzudecken.

Warnhinweise

Wenden Sie sich an Ihren Arzt, wenn einer der folgenden Fälle eintritt:

Verminderte Rückfütterung, aus welchem Grund auch immer, über 24 Stunden oder länger
Übermäßiger oder wässriger Durchfall
Fieber, Schüttelfrost
Erbrechen
THE INSIDES® Neo funktioniert nicht mehr

Für einen sicheren und effektiven Betrieb von THE INSIDES® Neo machen Sie sich bitte mit den folgenden Informationen vertraut. Bitte lesen Sie sich alle Sicherheits- und Gebrauchsanweisungen sorgfältig durch und bewahren Sie sie auf.

Warnhinweise zur Eignung für Patient*innen:

THE INSIDES® Neo sollte nicht bei Patient*innen angewendet werden, die sich mit fester Nahrung ernähren. – Partikel führen zu Verstopfungen im Gerät, die zu Verletzungen von Patient*innen führen.

Füttern Sie keinen Chymus nach, wenn Patient*innen potenzielle oder vermutete Darmwanddefekte haben. - Die Nachfütterung von Chymus bei Patient*innen mit Defekten in der Integrität des Darmtraktes kann zu Perforationen und Sepsis führen, was zu schweren Verletzungen der Patient*innen führen kann

Patient*innen, die Medikamente einnehmen, müssen ihre Dosierungen möglicherweise von ihrem Arzt überprüfen lassen, während sie THE INSIDES® Neo verwenden. Die Reinfusion von Chymus kann die Dosierung der Medikamente, die Patient*innen erhalten, erhöhen. – was zu einer Toxizität führen könnte.

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Warnhinweise zur Nachfütterung:

Füttern Sie keinen Chymus, der 12 Stunden oder länger außerhalb des Körpers verbracht hat. – Eine Ansammlung von Bakterien kann Patient*innen Schaden zufügen.

Bei der ersten Verwendung von THE INSIDES® Neo kann die Aktivierung einer latenten Dickdarminfektion mit Clostridium difficile auftreten. Diese tritt nur bei Patient*innen auf, bei denen dieses Bakterium im Darm vorhanden ist. Diese Infektion kann mit Symptomen wie wässrigem Durchfall, Fieber, Bauchschmerzen und Unwohlsein einhergehen. Wenn Sie Bedenken haben, wenden Sie sich an Ihren Arzt. – Eine Infektion könnte einen Krankenhausaufenthalt notwendig machen.

THE INSIDES ® Neo darf nur nach Anweisung Ihres medizinischen Fachpersonals verwendet werden, um Chymus in den distalen Darm nachzufüttern. – Das Nachfüttern anderer Flüssigkeiten oder Medikamente kann Patient*innen Schaden zufügen.

Füttern Sie den Chymus nicht zu schnell nach. – Dies kann zu Verletzungen von Patient*innen wie Perforationen oder Schäden am Darm führen.

Chymus sollte langsam reinfundiert werden. – Eine hohe Rate kann zu Blähungen, Übelkeit oder anderen Beschwerden führen.

Drücken Sie den Kolben der Spritze langsam herunter, während Sie den Chymus nachfüttern. – Hoher Druck kann zu Verletzungen von Patient*innen führen.

Wenn kein Chymus in die Spritze gelangt, wenn sie gezogen wird, stellen Sie sicher, dass das Gehäuse in Flüssigkeit eingetaucht ist und die Ventile frei von Ablagerungen sind. – Blockierungen des Geräts können zu Schäden an diesem und Verletzungen von Patient*innen führen.

Nicht aus falschen Behältern nachfüllen. – Eine Kontamination könnte zu einer Patienteninfektion führen.

Führen Sie keine Luft in den Darmtrakt ein. – Das Nachfüttern von Luft kann zu Beschwerden bei Patient*innen führen.

Warnhinweise zur Eignung für Patient*innen:

The Insides Neo sollte nicht bei Patient*innen angewendet werden, die sich mit fester Nahrung ernähren. – Partikel führen zu Verstopfungen im Gerät, die zu Verletzungen von Patient*innen führen.

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Warnhinweise zum Missbrauch des Geräts:

Die Nichtbeachtung aller geltenden Anweisungen kann zu Verletzungen bei Patient*innen oder der Betreuer*innen führen und sich nachteilig auf das Ergebnis auswirken.

Änderungen an diesem Gerät sind unzulässig. – Veränderungen können raue Oberflächen verursachen, die den Darm oder die Haut schädigen; Änderungen können zu Produktversagen führen.

Die Verwendung von THE INSIDES® Neo über seine empfohlene Lebensdauer hinaus könnte Patien*innen Giftstoffen aussetzen. – Allergische Reaktion; Patiententoxizität kann auftreten.

THE INSIDES® Neo muss entsprechend den Entsorgungshinweisen entsorgt werden. – Biologische Abfälle in gebrauchten Produkten können zu Kontaminationen führen.

Die Produkte von THE INSIDES® Neo sind NUR für den einmaligen Gebrauch bestimmt und dürfen nicht von Patient*innen wiederverwendet oder gemeinsam genutzt werden – eine Kontamination könnte zu einer Infektion der Patient*innen führen.

Wenn die Verpackung von THE INSIDES® Neo vor Gebrauch beschädigt ist, entsorgen Sie das Produkt. – Eine Kontamination könnte zu einer Patienteninfektion führen.

THE INSIDES® Neo müssen in Übereinstimmung mit der anerkannten medizinischen Praxis und den geltenden lokalen, staatlichen und bundesstaatlichen Gesetzen und Vorschriften entsorgt werden. – Eine falsche Entsorgung kann zu Infektionen bei Personen führen, die mit dem Gerät in Berührung kommen.

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Warnhinweise zum Zubehör:

THE INSIDES® Neo sollte nur mit zugelassenem Ostomiegerät verwendet werden. – Eine Kontamination könnte zu Toxizität führen.

Wenn das Stoma nach dem Einführen der Ernährungssonde durch den Arzt keinen Inhalt mehr freigibt, wenden Sie sich an Ihren Arzt. – Verstopfungen können zu Krankenhausaufenthalten führen.

Nur medizinisches Fachpersonal darf die Ernährungssonde einführen. Wenn der Schlauch herausfällt, wenden Sie sich an Ihren Arzt, um einen Ersatz zu erhalten. – Falsches Einführen des Schlauchs kann zu Verletzungen von Patient*innen führen.

Insides Neo kann mit Schlauchverlängerungen verwendet werden, die ein Strangulationsrisiko für Kleinkinder darstellen könnten. – Stränge können sich um den Hals kleiner Kinder wickeln.

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Bedienungsanleitung

Lesen Sie vor der Einrichtung von THE INSIDES ® Neo die Warnhinweise durch.

1. Vor der Verwendung

Alle Benutzer, die mit THE INSIDES® Neo oder dem dazugehörigen Zubehör in Berührung kommen, müssen sich vor dem Gebrauch die Hände waschen.

2. Montage von THE INSIDES ® Neo

Waschen Sie sich die Hände, bereiten Sie einen sauberen Arbeitsbereich vor und tragen Sie eine geeignete PSA.
Bereiten Sie das Ostomiegerät, die Ernährungssonde und THE INSIDES® Neo vor. Weitere Informationen zu kompatiblen Ostomiegeräten und Ernährungssonden finden Sie im Abschnitt „Zubehör“.

Hollister™ Zubehör

Verbinden Sie den Ernährungsschlauch mit dem Gehäuse.
Entfernen Sie bei Bedarf den Ablassanschluss vom Ostomiegerät.
Tauchen Sie die Nase des Gehäuses vom THE INSIDES ® Neo in ein Gleitmittel auf Wasserbasis.
Stecken Sie das Gehäuse des THE INSIDES® Neo durch die große Öffnung in den Ostomiebeutel, bis sich das Gehäuse am Boden des Ostomiegeräts befindet. Drücken und drehen Sie das Gerät vorsichtig im Uhrzeigersinn, damit es sich durch die Ablassöffnung bewegen kann. Wenn sich der schwarze O-Ring verschiebt, wenn das Gerät durch das Ostomiegerät geschoben wird, bringen Sie den O-Ring wieder in die richtige Position.
Verbinden Sie den Adapter mit dem Gehäuse, indem Sie ihn in die richtige Position drücken. Hierbei sollte ein Klicken zu hören sein.
Überprüfen Sie, ob das Gehäuse und der Adapter richtig angeschlossen sind. Die Nase des Gehäuses sollte durch den Adapter sichtbar sein.
Wickeln Sie den Schlauch auf und legen Sie ihn so in den Beutel, dass fast der gesamte Schlauch im Inneren des Beutels sitzt. Das Schlauchstück außerhalb des Beutels wird in die distale Extremität des Darmtrakts des/der Patient*in eingeführt.
Stecken Sie den mitgelieferten Stopfen in den Sockel des Geräts, um sicherzustellen, dass kein Chymus auslaufen kann.

Hollister™ Zubehör

Verbinden Sie den Ernährungsschlauch mit dem Gehäuse.
Entfernen Sie bei Bedarf die Ablassöffnung vom Ostomiegerät.
Tauchen Sie die Nase des Adapters in ein Gleitmittel auf Wasserbasis.
Führen Sie den Adapter durch die Ablassöffnung von außen in den Beutel.
Führen Sie das Gehäuse durch die Öffnung in das Ostomiegerät ein, bis es den Boden erreicht.
Verbinden Sie das Gehäuse mit dem Adapter, indem Sie es einrasten lassen. Es sollte ein Klicken zu hören sein.
Wickeln Sie den Schlauch auf und legen Sie ihn so in den Beutel, dass fast der gesamte Schlauch im Inneren des Beutels sitzt. Das Schlauchstück außerhalb des Beutels wird in die distale Extremität des Darmtrakts des/der Patient*in eingeführt.
Stecken Sie den mitgelieferten Stopfen in denSockel des Geräts, um sicherzustellen, dass kein Chymus auslaufen kann

3. **Vorbereiten des/der Patient*in auf THE INSIDES® Neo**

Stellen Sie sicher, dass THE INSIDES® Neo mit dem Ostomiegerät und dem Schlauch wie oben beschrieben zusammengebaut wurde.
Tragen Sie ein Hydrokolloid um das Stoma auf.
Entfernen Sie den Aufkleber, um den Klebstoff des Ostomiegeräts freizulegen.
Führen Sie den Schlauch in die distale Extremität des Stomas ein, während Sie den Beutel halten.
Sobald der Schlauch bis zum gewünschten Niveau eingeführt ist, legen Sie die Grundplatte um das Stoma herum auf den Bauch.
Befestigen Sie den Schlauch mit dem Clip an der Seite des Ostomiegeräts in der Nähe des Stomas. Möglicherweise muss der Schlauch vor der Befestigung mit dem Clip zurückgewickelt werden.
Stellen Sie sicher, dass der Stopfen am Sockel des Ostomiegeräts angebracht ist. Dadurch wird ein Auslaufen aus dem Ostomiegerät verhindert.

4. Nachfüttern mit THE INSIDES® Neo

WARNHINWEIS: Füttern Sie keinen Chymus, der 12 Stunden oder länger außerhalb des Körpers verbracht hat. – Eine Ansammlung von Bakterien kann Patient*innen Schaden zufügen.

Entfernen Sie den Stopfen vom Adapter.
Verbinden Sie eine Verlängerung des Ernährungsschlauchs mit dem Adapter von THE INSIDES® Neo und eine Spritze mit der Verlängerung. Wenn Sie manuell nachfüttern, verbinden Sie die Spritze direkt mit THE INSIDES® Neo.
Hinweis: Das manuelle Nachfüttern kann zu übermäßigem Durchfluss oder Druck führen, der den Darm schädigen könnte, siehe WARNHINWEISE.
Füllen Sie die Spritze mit Chymus, indem Sie den Kolben der Spritze zurückziehen. Die Spritze kann zu diesem Zeitpunkt bei Bedarf entlüftet werden.
Hinweis: Nur Chymus, der weniger als 12 Stunden außerhalb des Körpers verbracht hat, darf in die distale Extremität zurückgeführt werden, siehe WARNHINWEISE.
Zur Rückfütterung von Chymus in die distale Extremität, gehen Sie wie folgt vor:
1. Drücken Sie den Kolben der Spritze manuell. Dies sollte sehr langsam durchgeführt werden, um den Rückfluss oder Veränderungen und damit eine Schädigung des Darms zu reduzieren. oder
  1. Setzen Sie die Spritze in eine enterale Ernährungsspritzenpumpe ein, um den Chymus mit einer für den/die Patient*in geeigneten Rate nachzufüllen.
Nach vollständigem Niederdrücken des Kolbens:
Sollten die Spritze und der Verlängerungsschlauch vom Adapter getrennt und der Stopfen wieder eingesetzt werden. oder
Der Spritzenkolben kann zurückgezogen werden, um Chymus zur weiteren Nachfütterung nachzufüllen.

5. Ersatz der THE INSIDES® Neo

THE INSIDES® Neo wird beim üblichen Beutelwechsel oder maximal nach 4 Tagen ersetzt.
Entfernen Sie das Ostomiegerät zusammen mit THE INSIDES® Neo und dem Ernährungsschlauch.
Siehe SCHRITT 2 und SCHRITT 3 für den Austausch von THE INSIDES® Neo

6. Entsorgungvon THE INSIDES^® Neo

Nach Gebrauch behandelnund entsorgen Sie THE INSIDES^® Neo in Übereinstimmung mit deranerkannten medizinischen Praxis und den geltenden lokalen, staatlichen undbundesstaatlichen Gesetzen und Vorschriften. Diese Informationen können vonIhrer örtlichen Behörde oder vom Lieferanten des Medizinprodukts in IhrerRegion bezogen werden.

Reinigung und Desinfektion

Der Stopfen muss jedes Mal mit einem von der EPA empfohlenen Desinfektionstuch oder ähnlichem abgewischt werden, wenn er vom Hauptteil des Geräts abgenommen wird, um sichtbaren Chymus zu entfernen.

Kein anderer Teil von THE INSIDES® Neo sollte gereinigt werden, da dies zu einer Kontamination des Produkts und Verletzungen des/der Patient*in führen kann.

Anleitung zur Fehlerbehebung

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Der O-Ring bewegt sichwährend der Montage

Bewegt sich der O-Ring bei derMontage aus seiner vorgesehenen Nut heraus, kann er in die ursprüngliche Nutzurückbewegt werden.

Führen Sie das Gehäuse langsamerund mit mehr Schmiermittel durch die Ablassöffnung.

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Chymus tritt aus dem Gerätaus

Stellen Sie sicher, dass dieKomponenten des Geräts richtig zusammengebaut sind. Wenn das Gerät immer nochundicht ist, entfernen und ersetzen Sie das Gerät.

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THE INSIDES^®Neo blockiert

Entfernen und ersetzen Sie das Gerät.

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Rückfluss

Bei der Rückfütterung kann es immerzu einem geringen Rückfluss kommen. Um die Menge des Rückflusses zu verringern,verringern Sie die Geschwindigkeit, mit der der Chymus in die distaleExtremität geleitet wird.

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Zubehör

Alle Zubehörteile sollten wie vom Hersteller angegeben verwendet werden. Die nicht bestimmungsgemäße Verwendung von Zubehör kann zu Schäden an Patient*innen führen.

Ostomiegerät

Hollister Pouchkins Neugeborene Einteiliger Ostomiebeutel – Flache Barriere(3778)
Coloplast SenSura® Mio Baby, zweiteiliger Flex-Beutel (18700)

Ernährungssonde

Alle geeigneten ENFIT-Ernährungssonden

Spritzenkolben

‍Alle geeigneten enteralen Ernährungsspritzenpumpen

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Geistiges Eigentum

Alle Urheber-, Design-,Patent- und geistigen Eigentumsrechte an unseren Designs und Produkten sowie anden Bildern, dem Text und dem Design unserer Website/unseres Marketingmaterialssind Eigentum des Unternehmens The Insides Company. Weitere Informationen finden Sie unter www.theinsides.co.

„Coloplast“ und „SenSura® Mio“ sind eingetragene Marken derColoplast Corporation. Die Verwendung der Marken „Coloplast“ und „SenSura® Mio“in diesem Handbuch dient ausschließlich Informationszwecken und dazu, unserenKund*innen genaue Produktinformationen zur Verfügung zu stellen. The InsidesCompany Limited impliziert keine Billigung, Zugehörigkeit, Unterstützung oderGenehmigung durch die Coloplast Corporation. Wir bestätigen hiermit, dass wirdie exklusiven geistigen Eigentumsrechte der Coloplast Corporation an denMarken „Coloplast“ und „SenSura® Mio“ anerkennen und dass alle Verweise aufdiese Marken in gutem Glauben erfolgen, um die Kompatibilität oder Verwendungvon deren Produkt wahrheitsgemäß zu beschreiben.

„Hollister“ und „Pouchkins™“ sind eingetragene Marken vonHollister Incorporated. Die Verwendung der Marken „Hollister“ und „Pouchkins“in diesem Handbuch dient ausschließlich Informationszwecken und dazu, unserenKund*innen genaue Produktinformationen zur Verfügung zu stellen. The InsidesCompany Limited impliziert keine Billigung, Zugehörigkeit, Unterstützung oderGenehmigung durch Hollister Incorporated. Wir bestätigen hiermit, dass wir dieexklusiven geistigen Eigentumsrechte von Hollister Incorporated an den Marken„Hollister“ und „Pouchkins™“ anerkennen und dass alle Verweise auf diese Markenin gutem Glauben erfolgen, um die Kompatibilität oder Verwendung von derenProdukt wahrheitsgemäß zu beschreiben.

Garantieerklärung

Das UnternehmenThe Insides Company garantiert, dass das Gerät bei bestimmungsgemäßer Verwendungfrei von Verarbeitungs- und Materialfehlern ist und für einen Zeitraum von 2 Jahren nach demKaufdatum durch den Kunden gemäß den offiziellvon The Insides Company veröffentlichtenProduktspezifikationen funktioniert. Diese Garantie unterliegt den hier im Einzelnenaufgeführten Einschränkungen und Ausnahmen: www.theinsides.co/warranty-statement.

Wartung

Das Gerät kann nicht repariert werden und enthält keinereparierbaren Teile. Bitte wenden Sie sich bei Fragen zum Gerät an denHersteller oder Ihren örtlichen Vertreter.

DasGerät erfordert keine vorbeugende Wartung.

‍

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

Definiciones

Cuidador

Persona que ayuda a cambiar undispositivo de ostomía

Quimo

Contenidoque sale del estoma

Sonda de alimentación

Una sonda insertada en el estomaque suministra nutrición

Profesionalde la salud

Cirujanos/Médicos/Enfermeros

Intestino

Un órgano del cuerpo a través delcual fluye el alimento

Dispositivode ostomía

Una bolsa que se asienta sobre elestómago y recoge el contenido del estoma

Estoma

Una abertura creada quirúrgicamenteen el abdomen

THE INSIDES® Neo

THE INSIDES® Neo es un accesorio de productos sanitariospara pacientes pediátricos. Se suministra como accesorio de la bolsa flexiblede 2 piezas Coloplast SenSura® Mio Baby o de la bolsa-barrera plana de ostomía deuna pieza Pouchkins™ Newborn.

THE INSIDES^® Neo es un dispositivo médico parapacientes pediátricos. THE INSIDES^® Neo consiste en una cánula,un adaptador y un clip. El dispositivo funciona para realimentarel quimo de un dispositivo de ostomía en el asa distal del tracto intestinal, através del estoma.

La cánula y el adaptador se ensamblan juntos a través delpuerto de drenaje del dispositivo de ostomía. Una sonda de alimentación EnFITse conecta a la cánula y se inserta en la extremidad distal del estoma; el clipfija la sonda en su sitio. Cuando el dispositivo de ostomía se llena con quimo,se conecta una jeringa al adaptador y se puede tirar del émbolo de la jeringapara extraer fluido del dispositivo de ostomía con la jeringa. Si se presionael émbolo se empuja el líquido por la sonda de alimentación hasta el tractointestinal.

THE INSIDES^® Neo sesustituye con el cambio de bolsa, hasta un máximo de cuatro días después de lainstalación.

THE INSIDES^® Neo es de uso exclusivo para cadapaciente.

Indicaciones de uso

THE INSIDES^® Neo está pensado parasu uso en pacientes pediátricos quetienen una enterostomía de asa, unaenterostomía de tipoAbcarian o una enterostomía terminal confístula mucosa que permita el acceso al intestino distal. El dispositivoestá pensado para actuar como un conducto que ayude a la transferencia dequimo desde un aparato de ostomía a un estoma. El dispositivo se puede utilizar en unavariedad de entornos, incluidos hospitales, urgencias, clínicas y en lapropia casa.

Uso previsto

THE INSIDES^® Neo está pensado para canalizar elquimo de un aparato de ostomía en la extremidad distal del tracto intestinal deun paciente. Ayuda a proporcionar nutrición y protege la salud intestinal.

Contraindicaciones

THE INSIDES^® Neo no es adecuado para pacientesque:

no tienen dos aberturasestomales disponibles con asas intestinales proximales y distales;
no pueden recibir quimo ensu asa distal;
han comenzado a ingeriralimentos sólidos;
tienen activa una infecciónpor Clostridioides difficile;
no tienen un cuidador quepueda ayudar en el uso del producto;
no pueden cubrir su estomacon el dispositivo de estoma especificado.

Advertencias

Contacte con su profesional sanitario si se da alguna de lassiguientes situaciones:

disminución de larealimentación, por cualquier motivo, durante 24 horas o más;
diarrea profusa o acuosa;
fiebre, escalofríos;
vómitos;
THE INSIDES^® Neodeja de funcionar.

Para un funcionamiento seguro y eficaz de THEINSIDES^® Neo, familiarícese con la siguiente información. Por favor,lea y guarde todas las instrucciones de seguridad y de uso.

Advertencias sobre la idoneidad del paciente:

THE INSIDES^® Neo no debe usarseen pacientes con una dieta de alimentos sólidos: las partículas provocarán queel dispositivo se tapone y eso ocasionará daños al paciente.

No reintroducir el quimo si los pacientes tienen defectos potencialesen la pared intestinal: la realimentación de quimo en pacientes con defectos enla integridad del tracto intestinal puede conducir a perforación y sepsis, queprovocarán daños graves al paciente.

Los pacientes que toman medicamentos pueden necesitar que unprofesional sanitario revise sus dosis mientras usan THE INSIDES^®Neo. La reintroducción de quimo puede aumentar la dosis de medicamentos querecibe el paciente: esto podría causar toxicidad al paciente.

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Advertencias sobre la realimentación:

No realimente el quimo que ha estado fuera del cuerpo durante 12horas o más: una acumulación de bacterias puede causar daño al paciente.

Cuando se usa THE INSIDES^® Neo por primera vez podríadarse una activación de la infección colónica latente por Clostriroidesdifficile. Esto solo ocurrirá en pacientes con dicha bacteria en su intestino.Esta infección podría ir acompañada de síntomas como diarrea acuosa, fiebre,dolor abdominal y malestar. Si tiene alguna duda, comuníquese con su proveedorde atención médica: la infección podría requerir hospitalización.

THE INSIDES^® Neo solo se debe usar según las instruccionesde su profesional sanitario y para realimentar el quimo en el intestino distal.Realimentar otros líquidos o medicamentos podría causar daños al paciente.

No realimente el quimo a un ritmo rápido. Esto puede causar daños alpaciente como perforación o lesiones en el intestino.

El quimo debe ser reintroducido a un ritmo lento: hacerlo demasiadorápido puede causar hinchazón, náuseas o molestias.

Presione el émbolo de la jeringa lentamente mientras realimenta elquimo: demasiada presión puede causar daños al paciente.

Si no entra ningún quimo en la jeringa al tirar del émbolo, asegúresede que la cánula esté sumergida en líquido y de que las válvulas estén limpiasde residuos. Si el dispositivo se tapona, se podrían causar daños y provocarlesiones al paciente.

No realimente con recipientes incorrectos: la contaminación podríaprovocar una infección en el paciente.

No realimente aire en el tracto intestinal: la realimentación de airepuede causar molestias al paciente.

Advertencias sobre la idoneidad del paciente:

THE INSIDES® Neo no debe usarse en pacientes con una dieta dealimentos sólidos: las partículas provocarán que el dispositivo se tapone y esoocasionará daños al paciente.

Los pacientes que toman medicamentos pueden necesitar que un profesionalsanitario revise sus dosis mientras usan THE INSIDES^® Neo. Lareintroducción de quimo puede aumentar la dosis de medicamentos que recibe elpaciente: esto podría causar toxicidad al paciente.

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Advertenciassobre un mal uso del dispositivo:

No seguir cuidadosamente todas las instrucciones aplicables puedeprovocar lesiones al paciente o a los cuidadores y puede tener un efectoadverso en el resultado.

No se permite ninguna modificación de este equipo: las alteracionespodrían dar lugar a superficies ásperas que dañen el intestino o la piel; lamodificación podría provocar fallos en el producto.

El uso THE INSIDES^® Neo más allá de su vida útilrecomendada podría exponer a los pacientes a toxinas: reacción alérgica; podríaprovocar toxicidad en el paciente.

THE INSIDES^® Neo debe desecharse siguiendo los consejos deeliminación del dispositivo: los residuos biológicos de los productos usadospueden causar contaminación.

Los productos THE INSIDES^® Neo son de un SOLO uso y no deben reutilizarseen el mismo paciente ni compartirse: la contaminación podría provocar unainfección en el paciente.

Si el embalaje de THE INSIDES^® Neo está dañado antes de suuso, deseche el producto: la contaminación podría provocar una infección en elpaciente.

THE INSIDES^® Neo debe desecharse siguiendo las prácticasmédicas aceptadas y las leyes y regulaciones locales, estatales y federalesaplicables. Si se desecha de forma incorrecta se puede provocar una infecciónen las personas que entren en contacto con el dispositivo.
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Advertenciassobre accesorios:

THE INSIDES^® Neo solo debe usarse con un aparato deostomía aprobado: la contaminación podría causar toxicidad en el paciente.

Si después de la inserción de la sonda de alimentación por parte delprofesional sanitario, el estoma deja de liberar contenido, contacte con suprofesional sanitario: las obstrucciones pueden requerir hospitalización.

Solo un profesional sanitario puede insertar la sonda dealimentación. Si la sonda se suelta, contacte con su profesional sanitario parasustituir el tubo: una inserción incorrecta del tubo puede causar daños alpaciente.

THE INSIDES® Neo se puede usar con extensiones de sonda que podríansuponer un riesgo de estrangulación en niños pequeños: los cables puedenenredarse en el cuello de los niños pequeños.

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Manual de usuario

Lea las advertencias antes de colocar THEINSIDES^® Neo.

1. Antes de suuso

Cualquier usuario que entre en contacto con THE INSIDES^®Neo o con sus accesorios debe lavarse las manos antes de su uso.

2. Montaje de THE INSIDES^® Neo

Lávese las manos,prepare un espacio de trabajo limpio y póngase el EPI adecuado.
Prepareel aparato de ostomía, la sonda de alimentación y THE INSIDES^® Neo. Consulte la sección «Accesorios» para consultar los dispositivos de ostomía ylas sondas de alimentación compatibles.

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Accesorio Hollister™

Conecte la sonda dealimentación a la cánula.
Retire el puerto dedrenaje del aparato de ostomía si es necesario.
Sumerja la punta de laestructura de THE INSIDES^® Neo en un lubricante a base de agua.
Inserte la cánula de THE INSIDES^® Neo en la bolsa deostomía a través de la abertura grande hasta que la cánula esté en la parteinferior del aparato de ostomía. Presione y gire suavemente en el sentido delas agujas del reloj para permitir que el dispositivo se mueva a través delpuerto de drenaje. Si la junta tórica negra se desplaza cuando se empuja eldispositivo a través del aparato de ostomía, devuelva la junta tórica a laposición correcta.
Conecte el adaptador ala carcasa fijándolo en su lugar. Debería oir un clic.
Compruebe que la cánulay el adaptador se hayan conectado correctamente. La punta de la cánula debeverse a través del adaptador.
Enrollela sonda y colóquela en la bolsa de forma que casi toda la sonda quede dentrode la bolsa. Toda la sonda que quede fuera de la bolsa se insertará en el asadistal del tracto intestinal del paciente.
Inserte el conectorsuministrado en la base del dispositivo para asegurarse de que no haya fugas dequimo.

Accesorio Coloplast®

Conecte la sonda dealimentación a la cánula.
Retire el puerto dedrenaje del aparato de ostomía si es necesario.
Sumerja la punta deladaptador en un lubricante a base de agua .
Inserte el adaptador en la bolsa a través delpuerto de drenaje, desde el exterior.
Inserte la cánula en elaparato de ostomía a través de la abertura, hasta que llegue a la parteinferior.
Conecte la cánula aladaptador acoplándolo en su sitio. Debería oírse un clic.
Enrolle la sonda ycolóquela en la bolsa de forma que casi toda la sonda quede dentro de la bolsa.Toda la sonda que quede fuera de la bolsa se insertará en el asa distal deltracto intestinal del paciente.
Inserte el conector suministrado en la base del dispositivo paraasegurarse de que no haya fugas de quimo.

3. Colocaciónde THE INSIDES^® Neo en el paciente

Asegúrese de que THEINSIDES^® Neo se haya ensamblado con el aparato de ostomía y la sondacomo se describe más atrás.
Aplique un hidrocoloidealrededor del estoma.
Retire la pegatina paraexponer el adhesivo del aparato de ostomía.
Mientras sostiene labolsa, inserte la sonda en el asa distal del estoma.
Una vez que la sonda seha introducido al nivel deseado, aplique la base en el abdomen, alrededor delestoma.
Utilice el clip parafijar la sonda al lado del aparato de ostomía, cerca del estoma. Puede que seanecesario recoger la sonda antes de colocar el clip.
Asegúrese de que eltapón de la base del aparato de ostomía esté bien colocado. Esto evitará fugasdesde aparato de ostomía.

4. Realimentacióncon THE INSIDES^® Neo

ADVERTENCIA: No realimente el quimo que ha estado fuera del cuerpo durante 12 horas omás: una acumulación de bacterias puede causar daños al paciente.

Retire el conector deladaptador.
Conecte una extensiónde sonda de alimentación al adaptador THE INSIDES^® Neo y una jeringaa la extensión. Si está realimentando manualmente, conecte la jeringadirectamente a THE INSIDES^® Neo.
Nota: La realimentaciónmanual podría causar un flujo o una presión excesivos que podrían dañar elintestino, consulte las ADVERTENCIAS.
Llene la jeringa conquimo tirando del émbolo de la jeringa. La jeringa se puede purgar de aire eneste momento, si es necesario.
Nota:Solo se puede volver a introducir en el asa distal el quimo que ha estado fueradel cuerpo menos de 12 horas, consultelas ADVERTENCIAS.
Para realimentar elquimo en el asa distal:
1. presione manualmente elémbolo de la jeringa (esto debe hacerse muy lentamente para reducir el reflujoo la posibilidad de dañar el intestino); o
  1. inserte la jeringa en unabomba de jeringa de alimentación enteral para realimentar el quimo a unavelocidad adecuada para el paciente.
Una vez que el émbolose haya presionado completamente:
la jeringa y laextensión de sonda deben desconectarse del adaptador y el tapón debe volver ainsertarse; o
el émbolo de la jeringa puede retirarse para rellenarse con quimo, si es necesariorealimentar de nuevo.

5. Sustituciónde THE INSIDES^® Neo

THE INSIDES^®Neo se sustituye con el cambio de bolsa habitual o en un máximo de 4 días.
Retire el aparato deostomía junto con THE INSIDES® Neo y la sonda de alimentación.
Consulte el PASO 2 y elPASO 3 para cambiar THE INSIDES® Neo.

6. Cómodesechar THE INSIDES^® Neo

Después de su uso, manipule y deseche THEINSIDES^® Neo siguiendo las prácticas médicas aceptadas y las leyes yregulaciones locales, estatales y federales aplicables. Esta información puedeprovenir de la autoridad local o del proveedor del dispositivo médico de supaís.

Limpieza y desinfección

El tapón debe limpiarse con una toallita desinfectanterecomendada por la EPA, o similar, cada vez que se separe de la estructuraprincipal del dispositivo para eliminar cualquier quimo visible.

Nodebe limpiarse ninguna otra parte de THE INSIDES^® Neo, ya que sepodría provocar la contaminación del producto y ocasionar daños al paciente.

Guía de resolución de problemas

La junta tórica se mueve durante el montaje

Si la junta tórica se sale de suranura durante el montaje, se puede poner de nuevo en la ranura original.

Insertela cánula a través del puerto de drenaje a una velocidad más lenta, con máslubricante.

Fuga de quimo del dispositivo

Asegúrese de que los componentes del dispositivoestén montados correctamente. Si el dispositivo todavía tiene fugas, retire eldispositivo y sustitúyalo.

THE INSIDES^®Neo se tapona

Retire el dispositivo y sustitúyalo.

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Reflujo

Siempre puede haber una pequeñacantidad de reflujo cuando se está realizando la realimentación. Para disminuirla cantidad de reflujo, disminuya la velocidad a la que el quimo se dirigehacia el asa distal.

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Accesorios

Todos los accesorios se deben usar de acuerdo con las especificacionesdel fabricante. Todo uso de los accesorios fuera de lo indicado puede resultaren daños al paciente.

Dispositivo para ostomía

Bolsa-barrera plana deostomía de una pieza Hollister Pouchkins™ Newborn (3778)
Bolsa flexible de 2 piezasColoplast SenSura® Mio Baby (18700)

Sonda de alimentación

Todas las sondas dealimentación enteral ENFIT son compatibles

Controlador de jeringa

Todas las bombas de jeringade alimentación enteral son compatibles

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Propiedad intelectual

Todos los derechos de autor, diseño, patentes y derechos depropiedad intelectual existentes en nuestros diseños y productos, y en lasimágenes, los textos y el diseño de nuestro sitio web/material de marketing sonpropiedad de The Insides Company. Consulte www.theinsides.co para obtener más información.

Coloplast y SenSura® Mio son marcas registradas de ColoplastCorporation. Las marcas registradas Coloplast y SenSura® Mio se usan en estasinstrucciones estrictamente con fines informativos para proporcionarinformación precisa sobre el producto a nuestros clientes. The Insides CompanyLimited no sugiere ningún respaldo, afiliación, patrocinio o aprobación porparte de Coloplast Corporation. Por el presente afirmamos nuestroreconocimiento de los derechos de propiedad intelectual exclusivos de ColoplastCorporation para las marcas registradas Coloplast y SenSura® Mio, y cualquierreferencia a dichas marcas registradas se hace de buena fe para describirhonradamente la compatibilidad o el uso de su producto.

Hollister y Pouchkins™ son marcas registradas de HollisterIncorporated. Las marcas registradas Hollister y Pouchkins se usan en estasinstrucciones estrictamente con fines informativos para proporcionarinformación precisa sobre el producto a nuestros clientes. The Insides CompanyLimited no sugiere ningún respaldo, afiliación, patrocinio o aprobación porparte de Hollister Incorporated. Por el presente afirmamos nuestroreconocimiento de los derechos de propiedad intelectual exclusivos de HollisterIncorporated para las marcas registradas Hollister y Pouchkins™, y cualquierreferencia a dichas marcas registradas se hace de buena fe para describirhonradamente la compatibilidad o el uso de su producto.

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Declaración de garantía

The InsidesCompany garantiza que el dispositivo, cuando se utilice siguiendo lasinstrucciones de uso, no tendrá defectos defabricación ni materiales defectuosos y funcionará de acuerdo con las especificacionesoficiales del producto publicadas por The Insides Company durante un período de 2 años a partir de la fecha de compra por parte del cliente. Esta garantía está sujeta a las limitaciones y excepciones establecidas en detalle aquí: www.theinsides.co/warranty-statement.

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Mantenimiento

El dispositivo no se puede reparar y no contiene piezas quese puedan reparar. Si tiene dudas relacionadas con el dispositivo consulte conel fabricante o con su representante local.

El dispositivo no requiere mantenimiento preventivo.

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The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

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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

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Contact Information

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The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

‍

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

‍

Contact Information

‍

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

‍

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

‍

Contact Information

‍

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

‍

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

‍

Contact Information

‍

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

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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

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Contact Information

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The Insides Neo Instructions for Use

(8-minute read)

Click here to download

Ngā Whakamāramatanga

Kaitautiaki

Ko te tangata e āwhina ana ki tehuri Pūrere Poka-poare (ostomy)

Chyme

Ko ngāmatū e puta atu i te poare

Ngongo whangai

He ngongo e kuhuna ana ki tePoare me te tuku taiora

MātangaHauora

Nga Rata Hāparapara/Rata/Nēhi

NgāKōpiro

He whēkau kei roto i te tinana erere ana te kai

PūrerePoka-poare (ostomy)

He pēke e noho ana i runga i tepuku ka kohikohi i ngā matū mai i te Poare

Poare

Hepuare nā te hāparapara i hanga i

THE INSIDES® Neo

Ko THE INSIDES^® Neo he taonga tāpiri taputapu hauora mā ngātūroro tamariki. Ka tukuna hei taonga tāpiri mō te Peke Waewae Mio Baby2-wāhanga a Coloplast Sensura®, te Peke Kotahi-Waahanga Ostomy a te Pēpē aHollister Pouchkins™ me te Arai-Papa.

Ko THE INSIDES^® Neo he mīhini hauora mō ngātūroro tamariki. I roto i THE INSIDES^®Neo he whare, he whāurutaume te rawhi. He mahi tā te mīhini te whāngai anōi te chyme mai i te pūrere poka-poare (ostomy) ki te peka tawhiti o te arakōpiro mā roto poare.

Ko te whare me te urutau ka whakaemitia tahitia mā roto i tetauranga whakamimiti o te pūrere poka-poare (ostomy). E honoa ana he ngongowhāngai EnFIT ki te whare, ka kuhuna ki te peka tawhiti o te poare; mā te rawhie whītiki ai te ngonogo i tōna wāhi. Ka kapi te chyme i te pūrere poka-poare(ostomy), ka honoa te pūwero ki te urutau, ā, ka taea te pūurupou o te pūwerote hautō kia kumea ai te wai mai i te pūrere poka-poare ki te pūwero. Ka hekeiho te pūurupou hei pana i te wai mā roto i te ngongo whāngai, ki te arakōpiro.

Kawhakakapia THE INSIDES^®Neo ki te huringa pēke, kia whā rā te mōrahiā muri i te tāutanga.

Mā te tūroro kotahi anake THE INSIDES^®Neo.

Tohu Whakamahi

Ko THE INSIDES^® Neo mā ngā tūroro tamariki i pā mai ēnei hāparapara ki a rātou: loopenterostomy, abcarian enterostomy, tērā rānei end enterostomy with mucous fistula e āhei ana ki te kōpiro tāwhiti. Ko te tikangao te pūrere ki te arataki ite whakawhiti o te chyme mai i te pūrere poka-poare ki te poare. E taea ana te mīhini te whakamahi i ngā tūmomo wāhi tae atu ki ngā hōhipera, ngā taiwhanga ohorere,ngā whare haumanu me tekāinga.

Whakamahi Takune

Ko te tikanga o THE INSIDES^®Neo ki tewhakawhiti i te chyme mai i te pūrere poka-poare ki roto i te peka tawhiti o teara kōpiro o te tūroro kia mau tonu tana kai taiora me tōna hauora kōpiro.

Ngā mea whakahē

Kāre THE INSIDES^®Neo i te tika māēnei tūroro:

Kāre e rua ōna poare me ngāpeka tata me te tawhiti.
Kāre e taea te chyme tewhāngai anō ki tōna peka tawhiti
Kua tīmata ki te kai totoka
He hohe nei te pokenga kiClostridium difficile
Kāre he kaitautiaki e āheiana te āwhina ki te whakamahi i te hua
Kāree taea tōna poare te uhi ki te pūrere poare whakapūtā.

Ngā Whakatūpato

Whakapā atu ki tō mātanga hauora mēnā ka pā maihe mea whai ake nei:

Kua iti iho te whāngai anō,ahakoa te pūtake, mō te 24 haora he roa ake rānei
He mate tikotiko waiwai
He kirikā, he haukōeoeo
He ruaki
Ka mutu te mahi a THEINSIDES^® Neo

Kia haumaru ai, kia whai hua hoki te mahi a THEINSIDES^® , tēnā koa kia wāia koe ki ngā kōrero e whai ake nei. Mepānui me te pupuri i te katoa o ngā tohu whakamaru me te whakamahi instructions.

Ngā whakatūpato mō ngā tūroro hāngai:

Me kaua THE INSIDES^® Neo e whakamahia ki ngā tūroro e kaitotoka ana. – Mā ngā korakora e aukati ai te pūrere, ka tūkinotia te tūroro.

Kaua te chyme e whāngaitia anōtia me he mate pātū kōpiro pea ā ngātūroro. - Ki te whāngai anō ki te chyme i ngā tūroro e mate whakauruuruā-kōpiro ana, ka whaona, ka paihanatia te toto, ā, ka tino tūkinotia te tūroro.

Mō ngā tūroro e kai rongoā ana, me arotake e ō rātou mātanga hauora auapota ina whakamahi ana i THE INSIDES^®Neo. Ka rere anō i te chyme, kawhakapikia pea te pota o ngā rongoā kua whiwhi te tūroro. - Mā tēnei e paihanapea te tūroro

Ngā whakatūpato mō te whāngai anō:

Kaua e whāngaitia anōtia te chyme i noho rā i waho atu o te tinana mōte 12 haora he roa ake rānei - Mā te whakaemi huakita e tūkino ai te tūroro.

Ka hohe te pokenga torohū ki Clostridium difficile ina matuawhakamahi ana i THE INSIDES ^®Neo. Ka aituā ake tēnei ki ngā tūroro epokea ana e tēnei huakita i roto i ā rātou kōpiro. Mā tēnei pokenga e puta maihe tohumate pēnei i te tikotiko waiwai, kirikā, te mamae o te puku me tetahumaero. Me he āwangawanga ōu, whakapāatu ki tō kaimahi hauora. - Mā te pokenga e kuhu pea koe ki te hōhipera.

Me whakamahi anake i THE INSIDES^®Neo e ai ki ngā tohutohua tō mātanga hauora kia whāngai anō i te chyme ki te puku tawhiti. - Ki tewhāngai anō i ērā atu wai, rongoā rānei, ka tūkinotia pea te tūroro.

Kaua e tere te whāngai anō i te chyme. - Mā tēnei e tūkino pea tetūroro pērā i te whaonga, i te tūkinotanga o te kōpiro.

Me āta rere anō i te chyme. - Mā te terenga teitei e pā pea te pukungārara, te paipairuaki, te manawarau rānei.

Āta panaia ihotia te pūurupou o te pūwero ina whāngai ana anō i techyme. - Mā te tino pēhanga e tūkino pea te tūroro.

Mēnā kore he chyme e kuhuna ki te pūwero ina hautōia ana, whakaritenei kia toremi ai te whare i rō wai, ā, kia kore ai he para ki ngā takirere. -Ki te aukatia te pūrere, ka pakaru pea, ā, ka tūkinotia ai te tūroro.

Kaua e whāngai anō mai i ngā ipu hē. - Ka tāhawahawatia, ka pokea peate tūroro.

Kaua te hau e whāngaitia anōtia. - Ka whāngaitia anō ki te hau, kamanawarau pea te tūroro.

Ngā whakatūpato mō ngā tūroro hāngai:

Me kaua The Insides Neo e whakamahia ki ngā tūroro e kai totoka ana.– Mā ngā korakora e aukati ai te pūrere, ka tūkinotia te tūroro.

Ngā Whakatūpato e pā ana ki te whakamahi kino ite pūrere:

Ki te kore e āta whai i ngā tohutohu hāngai katoa, ka whara pea tetūroro, ngā kaimahi rānei, ā, ka aituā pea te hua.

Kaua rawa tēnei taputapu e whakakētia. - Mā ngā whakakē, ka puta maingā mata mātoretore e whakapakarutia ana te puku, te kiri rānei; ki te whakakē,ka rahua pea te hua.

Ki te whakamahi i THE INSIDES^® ā muri i tōna ora tūtohu, kapaihanatia ai ngā tūroro. - Tauhohe pāwera; ka pā pea te tāoke ki te tūroro.

Me ākiri i THE INSIDES^® Neo e ai ki te tohu mō te ākiri pūrere. - Kataea e ngā para koiora o ngā hua whakapau te tāhawahawa.

Kia kotahi ANAKE te whakamahi i ngā hua a THE INSIDES^®Neo, ā, kaua aua mea e whakamahia anōtia, etiria rānei ki te tūroro. – Ka tāhawahawatia, ka pokea ai te tūroro.

Ki te pakaru te pākete o THE INSIDES^® Neo i mua i tewhakamahi, ākiria atu te hua. - Ka tāhawahawatia, ka pokea ai te tūroro.

Meākiri i THE INSIDES^® Neo e ai ki ngā tikanga noa o te mahi rongoāme ngā ture me ngā waeture hāngai ā-takiwā, ā-rohe, ā-motu hoki. - Ki te ākirihē, ka pokea ai ngā tāngata e whakaraeraetia ana ki te pūrere

Ngā whakatūpato mō ngā apatoko:

Me whakamahi anake i THE INSIDES® Neo me ngā mīhini poka-poare whaimana. - Ka tāhawahawatia, ka paihanatia ai te tūroro.

Mēnā, whai muri i te kōkuhu a te Mātanga Hauora i te Ngongo Whāngai, ka mutu te tuku matū a te poare, whakapā atu ki tō Mātanga Hauora. - Mā te aukatinga e kuhu pea koe ki te hōhipera

Me kōkuhu e te mātanga hauora anake te ngongo whāngai. Ki te taka atu te ngongo, whakapā atu ki tō mātanga hauora hei whakakapi. – Ki te kōkuhu hē i te ngongo, ka tūkinotia ai te tūroro.

Me whakamahi pea The Insides Neo me ngā toronga ngongo e mōrea ana te tārona o ngā tamariki paku. - Ka porowhīwhiwhia pea e ngā aho ngā kakī o ngā tamariki paku.

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Aratohu Kaiwhakamahi

Pānuitia te whakatūpato i mua i te tatū iTHEINSIDES^® Neo.

1. I mua i te Whakamahi

Ko ngā kaiwhakamahi e whāwhā ana i THE INSIDES^®Neo, i ana apatoko pātahi, me horoi ōna ringaringa i mua i te whakamahi

2. Te Whakaemi i THE INSIDES^® Neo

Horoia ō ringaringa,whakaritea he wāhi mahi mā, ā, me mau PPE tika
Whakariteate taputapu poka-poare, te ngongo whāngai, me THE INSIDES^® Neo. Tirohia ki te wāhanga "Apatoko" mō ngā mīhini poka-poare hototahi mengā ngongo whāngai.

Taonga a Hollister™

Honoa te ngongo whāngai ki te whare.
Tangohia te tauranga whakamimiti mai i te mīhini poka-poare ina hiahiatia ana.
Koutua te ihu o te tinana o THE INSIDES® Neo ki te hekewaku ā-wai.
Kōkuhuna te whare o THE INSIDES® Neo ki te pēke poka-poare mā te puare nui kia whakararo rā anō te whare i te mīhini poka-poare. Āta pēhia ka takawiri whakatekaraka kia neke ai te pūrere ki roto i te tauranga whakamimiti. Ki te neke te rīngi-o ina panaia ana te pūrere mā roto i te mīhini poka-poare, whakahokia te rīngi-o ki te tūnga tika.
Honoa te whāurutau ki te whare mā te pēhi i tēnā ki tōna wāhi. Me whakarongo koe ki te ngotongoto.
Hihiri nei kei te tika te hononga o te whare me te whāurutau. Ka kitea ai te ihu o te whare mā te whāurutau.
Pōkaitia te ngongo ka raua ki roto i te pēke kia noho ai te katoa āwhiwhi o te ngongo i roto i te pēke. Ka kōkuhuna te roa o te ngongo i waho i te pēke ki te peka tawhiti o te ara kōpiro o te tūroro.
Kōkuhuna te puru i tukuna ki raro o te pūrere kia kore ai he chyme e komama atu

Taonga a Coloplast®

Honoa te ngongo whāngaiki te whare.
Tangohia te taurangawhakamimiti mai i te mīhini poka-poare ina hiahiatia ana.
Tōmenea te ihu o teurutau ki roto i te whakahinuhinu e hāngai ana ki te wai.
Whakauruhia te urutau mā rotoi te tauranga tuku, mai i waho ki roto i te pēke.
Whakauruhia te whare kiroto i te taputapu ostomy mā roto i te whakatuwheratanga, kia tae ra ano ki teraro.
Hihiri nei kei te tikate hononga o te whare me te whāurutau. Ka kitea ai te ihu o te whare mā te whāurutau.
Pōkaitia te ngongo ka raua ki roto i te pēkekia noho ai te katoa āwhiwhi o te ngongo i roto i te pēke. Ka kōkuhuna te roa ote ngongo i waho i te pēke ki te peka tawhiti o te ara kōpiro o te tūroro.
Kōkuhunate puru i tukuna ki raro o te pūrere kia kore ai he chyme e komama atu.

3. Te Whakarite i te tūroro ki THE INSIDES^® Neo

Me whakarite nei kuawhakaemia THE INSIDES^® Neo me te mīhini poka-poare me te ngongo e aiki te kōrero i runga ake nei.
Pania he hydrocolloidhuri noa i te poare.
Tangohia te tapanga heiwhakakite i te kāpia o te mīhini poka-poare.
Ina puritia ana te pēke, kōkuhuna te ngongo ki te peka tawhiti o tepoare.
Kōkuhuna rawa atu tengongo ki te taumata e hiahiatia ana, tukuna te pereti-taketake (baseplate) kite puku e karapoti ana i te poare.
Whakamahia te rawhi kiapūmau ai te ngongo ki te taha o te mīhini poka-poare e tata ana ki te poare. Mepōkai anō pea i te ngongo i mua i te rau i te rawhi.
Mewhakarite nei kei te wāhi tika ko te puru i te pūtake o te mīhini poka-poare.Mā tēnei e ārai ai te papītanga mai i te mīhini poka-poare.

4. Te Whāngai anō mā THE INSIDES® Neo

KIA TŪPATO: Kaua e whāngai anō ki te chyme i noho rā i waho atu o te tinana mō te 12 haora he roa ake rānei - Mā te whakaemi huakita e tūkino ai te tūroro.

Tangohia atu te puru i te whāuruatu.
Honoa he toronga ngongo whāngai ki te whāurutau o THE INSIDES® Neo, me te Pūwero ki te toronga. Mēnā ka whāngai anō ā-ringa koe, honoa torotikatia te pūwero ki THE INSIDES® Neo.
Kia mōhio nei: Mā te whāngai anō ā-ringa e hārukiruki ai te rerenga, te pēhanga, ka pakaru pea te kōpiro, tirohia ki ngā WHAKATŪPATO.
Whakakīia te pūwero ki te chyme mā te hautō whakamuri i te pūurupou o te pūwero. Ka āhei te whakawātea hau i te pūwero i taua wā ina hiahiatia ana.

Kia mōhio nei: Me whāngai anō i te chyme anake e noho ana i waho atu i te tinana kia iti iho i te 12 haora, ki te peka tawhiti, tirohia ngā WHAKATŪPATO
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Hei whāngai anō i te chyme ki te peka tawhiti, meinga tētahi e whai ake nei:
1. Whakahekea ā-ringatia te pūurupou o te pūwero. Me tino āta mahi kia iti iho te hokimuri, te huringa rānei o te tūkino ki te kōpiro. Tērā rānei;
2. Kōkuhuna te pūwero ki tētahi papu pūwero whāngai kōpiro hei whāngai anō i te chyme i te terenga e tika ana mō te tūroro.
Whakahekea katoatia rawa atu te pūurupou:
Me wete te pūwero me te ngongo toronga i te whāurutau, ka kōkuhuna anōtia te puru. Tērā rānei;
Me hautō pea te pūurupou pūwero kia whakakī anō ki te chyme hei whāngai atu anō.

5. Te Whakakapi i THE INSIDES® Neo

Ka whakakapia THE INSIDES® Neo me te huringa pēke noa iho, ki te roanga rānei o ngā rā e 4 te mōrahi.
Tangohia te taputapu ostomy me THE INSIDES® Neo, me te ngongo whāngai.
Tirohia te HIPANGA 2 me te HIPANGA 3 mō te whakakapinga o THE INSIDES® Neo.

6. Te Ākiri i THE INSIDES® Neo

Whai muri i te whakamahi, raweketia ka āriki i THE INSIDES® Neo e ai ki ngā tikanga noa o te mahi rongoā me ngā ture me ngā waeture ā-takiwā, ā-rohe, ā-motu hoki. Ka taea aua mōhiohio te riro mai i tō mana paetata, i te kaiwhakarato o te pūrere hauora kei tō rohe.

Te Horoi me te Patuero

Me muru te puru mā te pepa patuero tūtohu-ā-EPA, he mea rite rānei, i ia wā ko ia ka wehe atu i te tinana matua o te pūere kia tangohia he chyme e kitea ana.

Kaua ētahi atu wāhanga o THE INSIDES® Neo e horoia, kei tūpono tēnei ka tāhawahawatia ai te hua, ka tūkinotia pea te tūroro.

Aratohu Raparongoā

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Ka Neke te Rīngi-O i te wāWhakaemi

Mēnā ka neke atu te rīngi-o i wahoi tōna awa ūnga ina whakaemi ana, ka taea tēnā te neke hoki mai rā ki te awataketake.

Kia pōturi ake te kōkuhu i tewhare ki te tauranga whakamimiti, ā, kia nui ake te hekewaku.

E komama ana te chyme maii te pūrere.

Me whakarite nei kei te tika tewhakaemi i ngā wae o te pūrere. Ki te komama tonu te pūrere, tango me tewhakakapi i te pūrere.

Ngā paraka THE INSIDES ^®Neo

Tango me te whakakapi i te pūrere.

Hokimuri

Ākenepea he hokimuri tonu ina whāngai ana anō. Kia iti iho te nuinga o te hokimuri,kia pōturi ake te anga whakamua i te chyme ki te peka tawhiti.

Tauākī Taurangi

He kī taurangi tā te Kamupene a The Insides, ina whakamahia ana e ai ki ngā tohutohu whakamahi, ka kore he hapa i te pūrere e pā ana ki te ringarehe me ngā matū, ā, ka mahi e pēnei ana ki ngā whakaritenga hua whaimana kua tāia e te Kamupene a The Insides mō te 2 tau mai i te rā i hokona mai e te kiritaki. Ko tēnei taurangi kei raro i ngā whakatepenga me ngā aweretanga e kīia amikitia ana i konei: www.theinsides.co/warranty-statement.

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Ratonga

Tē taea te pūrere te tapitapi, ā, kāre he wāhanga e taea ana te tapitapi. Tēnā koa, tukuna atu ngā uiui e pā ana ki te pūrere ki te kaihanga, ki tō māngai paetata rānei.

Kāre te pūrere e hiahiatia ana te tautiaki karo.

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Ngā Apatoko

Mīhini Poka-poare (Ostomy)‍

Hollister Pouchkins™ NewbornOne-Piece Ostomy Pouch – Flat Barrier (3778)
Coloplast SenSura® Mio Baby2-piece Flex bag (18700)

Ngongo Whāngai

Ngā ngongo whāngai ā-kōpiroENFIT tōtika katoa

Haukuru Pūwero

Ngāpapu pūwero whāngai ā-kōpiro tōtika katoaps

Rawa Hinengaro

Ko ngā mana tārua, hoahoa, mana pupuri, me ngā mana rawa hinengaro kei roto i ā mātou hoahoa me ngā hua, tae atu ki ngā whakaahua, kuputuhi, me te hoahoa o tā mātou paetukutuku / rauemi hokohoko he rawa nō The Insides Company. Tirohia www.theinsides.co mō ētahi atu mōhiohio.

Ko ‘Coloplast’, ‘SenSura® Mio’ he tohu rēhita nō Coloplast Corporation. Ko te whakamahi i ngā tohu ‘Coloplast’, ‘SenSura® Mio’ i ēnei tohutohu he mea tino whāiti mō ngā kaupapa whakamārama kia whakaratohia he mōhiohio hua tika ki ō mātou kaihoko. Kāore te Kamupene Limited o The Insides e tohu i tētahi tautoko, hononga, tautoko, whakaaetanga rānei nā Coloplast Corporation. Ka whakapūmau mātou i tō mātou whakaū i ngā mana rawa hinengaro motuhake a Coloplast Corporation i roto i te tohu ‘Coloplast’, ‘SenSura® Mio’, ā, ko ētahi tohutoro ki taua tohu he mea mahi pono ki te whakaahua tika i te hototahitanga, te whakamahinga rānei o tā rātou hua.

Ko ‘Hollister’, ‘Pouchkins™’ he tohu rēhita nō Hollister Incorporated. Ko te whakamahi i ngā tohu ‘Hollister’, ‘Pouchkins’ i ēnei tohutohu he mea tino whāiti mō ngā kaupapa whakamārama kia whakaratohia he mōhiohio hua tika ki ō mātou kaihoko. Kāore te Kamupene Limited o The Insides e tohu i tētahi tautoko, hononga, tautoko, whakaaetanga rānei nā Hollister Incorporated. Ka whakapūmau mātou i tō mātou whakaū i ngā mana rawa hinengaro motuhake a Hollister Incorporated i roto i te tohu ‘Hollister’, ‘Pouchkins™’, ā, ko ētahi tohutoro ki taua tohu he mea mahi pono ki te whakaahua tika i te hototahitanga, te whakamahinga rānei o tā rātou hua.

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The Insides Neo Instructions for Use

(8-minute read)

Click here to download

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

التعريفات

مقدم الرعاية

الشخص الذي يساعد في تغيير جهاز الفغر

كيموس

المحتوى الذي يخرج من الفغر

أنبوب التغذية

أنبوب يُدخل في الفغر التي توفر التغذية

أخصائي الرعاية الصحية

الجراحون/الأطباء/الممرضات

الأمعاء

عضو في الجسم يتدفق الغذاء من خلاله

جهاز الفغر

كيس يستقر في المعدة ويجمع المحتوى من الفغر

فغر

فتحة على البطن تُفتح جراحيًا

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THE INSIDES® Neo

يُعدّ INSIDES® Neo ملحق جهاز طبيللأطفال المرضى. ويتم توفيره كملحق إما لحقيبة Coloplast Sensura® Mio Baby المرنة المكوّنة من قطعتين، أو لحقيبة الفغر HollisterPouchkins™ Newborn المكونة منقطعة واحدة لحديثي الولادة.

يُجمع المبيت والمحول معًا من خلال منفذ تصريف جهاز الفغر. يتصل أنبوبتغذية ENFIT بالمبيت، ويُدخل في الطرف البعيدللفوهة؛ ويثبت المشبك الأنبوب في مكانه. عندما يمتلئ جهاز الفغر بالكيموس، تتصلحقنة بالمحول ويمكن سحب مكبس الحقنة لسحب السائل من جهاز الفغر إلى الحقنة. يُضغطعلى المكبس لدفع السائل من خلال أنبوب التغذية، في الأمعاء.

يُستبدل The INSIDES^®Neo مع تغيير الكيس، بحد أقصىأربعة أيام بعد التثبيت.

جهاز The INSIDES^®Neo مخصص للاستخدام الفردي فقط.

إشارة إلى الاستخدام

صُمّم The INSIDES^®Neoللاستخدام لدى الأطفال المرضى الذين لديهم فغر معوي حلقي أو فغر معوي أبكري أو فغرمعوي نهائي مع ناسور مخاطي يسمح بالوصول إلى الأمعاء البعيدة. صُمم الجهاز للعملكقناة للمساعدة في نقل الكيموس من جهاز الفغر إلى الفغرة. يمكن استخدام الجهاز فيمجموعة من البيئات بما في ذلك المستشفيات، وأقسام استقبال الطوارئ، والعيادات،والاستخدام المنزلي.

الغرض من الاستخدام

يهدف The INSIDES^®Neo إلى توجيه الكيموس من جهاز فغر إلى الطرف البعيد من القناةالمعوية للمريض للمساعدة في الحفاظ على تغذيته وصحة الأمعاء.

موانع الاستعمال

The INSIDES^®Neo غير مناسب للمرضى الذين:

لا يوجد فتحتان فغر متاحتان مع أطراف معوية قريبة وبعيدة.
لا يمكن إعادة تغذية الكيموس إلىأطرافهم البعيدة
بدأ تناول الأطعمة الصلبة
التعرّض لعدوى المطثية العضال
ليس لديك مقدم رعاية يمكنه المساعدةفي استخدام المنتج
لا يمكن تغطية الفغر بجهاز الفغر المحدد

التحذيرات

اتصل بأخصائي رعايتك الصحية في حالة حدوث أي مما يلي:

انخفاض إعادة التغذية، لأي سبب من الأسباب، لمدة 24 ساعة أو أكثر
الإسهال الغزير أو المائي
الحمى، القشعريرة
التقيؤ
توقف The INSIDES® Neo عن العمل

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للتشغيل الآمن والفعال لجهاز The INSIDES® Neo ، يرجى الاطلاع على المعلومات التالية. يرجى قراءة جميع تعليمات السلامة والاستخدام والاحتفاظ بها.

تحذيرات بشأن ملاءمة المريض:

يجب ألا يُستخدم The INSIDES® Neo مع المرضى الذين يتناولون نظامًا غذائيًا صلبًا. – تسبب الجسيمات انسدادًا في الجهاز مما يؤدي إلى ضرر للمريض.

لا تقم بإعادة تغذية الكيموس إذا كان المرضى يعاني من عيوب محتملة أو مشتبه بها في جدار الأمعاء. - إعادة تغذية الكيموس لدى المرضى الذين يعانون من عيوب في سلامة الأمعاء قد تؤدي إلى ثقب وتعفن الدم ما يؤدي إلى ضرر شديد للمريض

قد يحتاج المرضى الذين يتناولون الدواء إلى قيام أخصائي الرعاية الصحية بمراجعة جرعاتهم أثناء استخدام The INSIDES® Neo. قد تؤدي إعادة تغذية الكيموس إلى زيادة جرعة الأدوية التي يتلقاها المريض. – قد يسبب هذا سمية للمريض.

تحذيرات بشأن إعادة التغذية:

لا تقم بإعادة تغذية الكيموس الذي كان موجودًا خارج الجسم لمدة 12 ساعة أو أكثر - قد يسبب تراكم البكتيريا ضررًا للمريض.

تحذير: قد يحدث تنشيط عدوى المطثية العسيرة القولونية الكامنة عند استخدام The INSIDES® Neo لأول مرة. يحدث هذا لدى المرضى الذين يعانون من هذه البكتيريا الموجودة في الأمعاء. قد تكون هذه العدوى مصحوبة بأعراض مثل الإسهال المائي والحمى وآلام البطن والتعب. إذا انتابتك أي مخاوف، فاتصل بمقدم رعايتك الصحية. - قد تسبب العدوى دخول المستشفى.

يُستخدم The INSIDES® Neo فقط وفقًا لتعليمات أخصائي رعايتك الصحية لإعادة تغذية الكيموس في الأمعاء البعيدة. – قد تسبب إعادة تغذية السوائل أو الأدوية الأخرى ضررًا للمريض.

لا تقم بإعادة تغذية الكيموس بمعدل سريع. – قد يسبب ذلك ضررًا للمريض مثل ثقب الأمعاء أو ضررًا لها.

يجب إعادة تسريب الكيموس بمعدل بطيء. – قد يسبب المعدل المرتفع الانتفاخ والغثيان أو عدم الراحة.

اضغط على مكبس الحقنة ببطء أثناء إعادة تغذية الكيموس. – قد يسبب الضغط العالي ضررًا للمريض.

إذا لم يدخل أي كيموس إلى الحقنة عند سحبها، فتأكد من غمر المبيت في السائل وأن الصمامات خالية من أي ترسبات. – قد يسبب انسداد الجهاز الضرر ويؤدي إلى ضرر المريض.

لا تقم بإعادة التغذية من الأوعية غير الصحيحة. – قد يؤدي التلوث إلى عدوى المريض.

لا تقم بإعادة تغذية الهواء إلى القناة المعوية. – قد يسبب هواء التغذية عدم راحة المريض.

تحذيرات بشأن ملاءمة المريض:

يجب ألا يُستخدم The INSIDES® Neo مع المرضى الذين يتناولون نظامًا غذائيًا صلبًا. – تسبب الجسيمات انسدادًا في الجهاز مما يؤدي إلى ضرر المريض.

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تحذيرات عن الاستخدام الخاطئ للجهاز:

قد يؤدي عدم اتباع جميع التعليمات المعمول بها بعناية إلى إصابة المريض أو الطبيب أو المرافقين وقد يكون له تأثير سلبي على النتيجة.

لا يُسمح بتعديل هذا الجهاز. – قد تنتج عن التعديلات أسطح خشنة التي تلحق الضرر بالأمعاء أو الجلد؛ وقد يؤدي التعديل إلى فشل المنتج.

قد يعرّض استخدام The INSIDES® Neo أكثر من مدة صلاحيته الموصى بها المرضى إلى السموم. – رد فعل تحسسي؛ وقد تحدث سمية للمريض.

يجب التخلص من The INSIDES® Neo وفقًا لنصيحة التخلص من الجهاز. – النفايات البيولوجية في المنتجات المستعملة قد تسبب التلوث.

منتجات The INSIDES® Neo مخصصة للاستخدام مرة واحدة فقط ولا يمكن إعادة استخدامها لدى المريض أو مشاركتها – قد يؤدي التلوث إلى إصابة المريض.

في حالة تلف عبوة The INSIDES® Neo قبل الاستخدام، تخلص من المنتج. – قد يؤدي التلوث إلى عدوى للمريض.

يجب التخلص من The INSIDES® Neo وفقًا للممارسة الطبية المقبولة والقوانين واللوائح المحلية والولائية والاتحادية المعمول بها. – قد يؤدي التخلص غير الصحيح إلى إصابة الأشخاص الذين يكونون على تماس مع الجهاز.

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تحذيرات عن الملحقات:

يجب استخدام The INSIDES® Neo فقط مع جهاز فغر معتمد. – قد يسبب التلوث سمية المريض.

إذا توقف الفغر عن إخراج المحتوى بعد قيام أخصائي الرعاية الصحية بإدخال الأنبوب، فاتصل بأخصائي الرعاية الصحية. – قد يؤدي الانسداد إلى دخول المستشفى.

لا يجوز لأي شخص إدخال الأنبوب سوى أخصائي الرعاية الصحية. إذا خرج الأنبوب من مكانه، فاتصل بأخصائي الرعاية الصحية المشرف عليك لتبديله. – قد يتسبب الإدخال غير الصحيح للأنبوب في ضرر للمريض.

يمكن استخدام The INSIDES® Neo مع تمديدات الأنابيب التي قد تسبب خطر الاختناق للأطفال الصغار. – قد تصبح الأسلاك متشابكة حول أعناق الأطفال الصغار.

دليل المستخدم

اقرأ التحذيرات قبل إعداد The INSIDES® Neo.

1. قبل الاستخدام

يجب على أي مستخدم يكون على تماس مع The INSIDES® Neo أو الملحقات المرتبطة به غسل يديه قبل الاستخدام.

2. تجميع The INSIDES^®Neo

اغسل يديك، وجهّز مساحة عمل نظيفة وارتد معدات الوقاية الشخصية المناسبة.
قم بتحضير جهاز الفغر وأنبوب التغذية The INSIDES® Neo. راجع قسم "الملحقات" للحصول على أجهزة فغر متوافقة وأنابيب التغذية.

Hollister™ ملحقات

وّصل أنبوب التغذية بالمبيت.
أزل منفذ التصريف من جهاز الفغر إذا لزم الأمر.
اغمر طرف جسم The INSIDES® Neo في مادة تزليق مائية.
أدخل مبيت The INSIDES® Neo في كيس الفغر من خلال الفتحة الكبيرة، حتى يصبح المبيت في الجزء السفلي من جهاز الفغر. اضغط برفق ولف في اتجاه عقارب الساعة للسماح للجهاز بالتحرك عبر منفذ التصريف. إذا تحركت الحلقة السفلية السوداء عند دفع الجهاز عبر جهاز الفغر، فأعد الحلقة السفلية إلى الموضع الصحيح.
وّصل المحول بالمبيت عن طريق الضغط عليه في مكانه. يجب أن تسمع صوت نقرة.
تأكد من توصيل المبيت والمحول بشكل صحيح. يجب رؤية طرف المبيت من خلال المحول.
لف الأنبوب وضعه في الكيس بحيث يستقر الأنبوب بكامله تقريبًا داخل الكيس. يُدخل طول الأنبوب خارج الكيس في الطرف البعيد من القناة المعوية للمريض.
أدخل القابس المرفق في قاعدة الجهاز للتأكد من عدم تسرب الكيموس.

Coloplast® ملحقات

قم بوصل أنبوب التغذية بالمبيت.
أزل منفذ التصريف من جهاز الفغر إذا لزم الأمر.
اغمر طرف المحول في مادة تزليق مائية.
أدخِل المحول من خلال منفذ التصريف، من الخارج إلى الكيس.
أدخل المبيت في جهاز الفغر من خلال الفتحة، حتى يصل إلى القاع.
قم بتوصيل المبيت بالمحول عن طريق النقر عليه لتثبيته في مكانه، يجب أن تسمع صوت نقرة.
لف الأنبوب وضعه في الكيس بحيث يستقر الأنبوب بكامله تقريبًا داخل الكيس. يُدخل طول الأنبوب خارج الكيس في الطرف البعيد من القناة المعوية للمريض.
أدخل القابس المرفق في قاعدة الجهاز للتأكد من عدم تسرب الكيموس.

3. إعداد المريض مع The INSIDES® Neo

تأكد من تجميع The INSIDES® Neo مع جهاز الفغر والأنبوب كما هو موضح أعلاه.
ضع مادة غروانية مائية حول الفغرة.
أزل الملصق لتعريض المادة اللاصقة لجهاز الفغر.
أثناء الإمساك بالكيس، أدخل الأنبوب في الطرف البعيد من الفغر.
بمجرد إدخال الأنبوب إلى المستوى المطلوب، ضع الصفيحة القاعدية على البطن، حول الفغر.
استخدم المشبك لتثبيت الأنبوب على جانب جهاز الفغر، بالقرب من الفغر. قد تكون هناك حاجة لإعادة لف الأنبوب قبل وضع المشبك.
تأكد من أن القابس الموجود في قاعدة جهاز الفغر في مكانه. يؤدي ذلك إلى منع التسرب من جهاز الفغر.

4. إعادة التغذية مع The INSIDES® Neo

تحذير: لا تعد الكيموس الذي كان مستقرًا خارج الجسم لمدة 12 ساعة أو أكثر - تراكم البكتيريا قد يسبب ضررًا للمريض.

أزل القابس من المحول.
وصّل وصلة أنبوب تغذية بمحول The INSIDES® Neo ، وحقنة بالوصلة. إذا كنت تعيد التغذية يدويًا، فقم بوصل الحقنة مباشرة بـ The INSIDES® Neo.
ملاحظة: قد تسبب إعادة التغذية اليدوية تدفقًا مفرطًا أو ضغطًا قد يؤدي إلى تلف الأمعاء، راجع التحذيرات.
املأ الحقنة بالكيموس عن طريق سحب مكبس الحقنة. يمكن إفراغ الحقنة من الهواء في هذا الوقت إذا لزم الأمر.

ملاحظة: لا يمكن إعادة سوى الكيموس الذي كان مستقرًا خارج الجسم لمدة تقل عن 12 ساعة إلى الطرف البعيد، راجع التحذيرات.
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لإعادة تغذية الكيموس إلى الطرف البعيد، إما:
1. اضغط مكبس الحقنة يدويًا. يجب أن يتم ذلك ببطء شديد لتقليل الارتجاع أو تغيير تلف الأمعاء. أو
2. أدخل الحقنة في مضخة حقنة التغذية المعوية لإعادة تغذية الكيموس بمعدل مناسب للمريض.
بمجرد تحقيق ضغط كامل للمكبس:
يجب فصل الحقنة وأنبوب التمديد عن المحول، ويجب إعادة إدخال القابس. أو
8.يمكن سحب مكبس الحقنة مرة أخرى لإعادة ملئه بالكيموس لمزيد من إعادة التغذية.

5. استبدال The INSIDES® Neo

يتم استبدال THE INSIDES® Neo مع التغيير المعتاد للكيس أو بحد أقصى 4 أيام.
أزل جهاز الفغر مع THE INSIDES® Neo وأنبوب التغذية.
راجع الخطوة 2 والخطوة 3 لاستبدال THE INSIDES® Neo

6. التخلص من The INSIDES® Neo

بعد استخدام The INSIDES® Neo والتعامل معه والتخلص منه وفقًا للممارسة الطبية المقبولة والقوانين واللوائح المحلية والفيدرالية المعمول بها. يمكن الحصول على هذه المعلومات من السلطة المحلية أو من مورد الجهاز الطبي في منطقتك.

التنظيف والتطهير

يجب مسح القابس بمسح مطهر أوصت به وكالة حماية البيئة، أو ما شابه ذلك، في كل مرة يتم فصله عن الجسم الرئيسي للجهاز لإزالة أي كيموس مرئي.

يجب عدم تنظيف The INSIDES® Neo لاحتمال أن يؤدي ذلك إلى تلوث المنتج وقد يؤدي إلى ضرر للمريض.

‍

دليل تحديد الخلل

تتحرك الحلقة الدائرية في أثناء التجميع

إذا تحركت الحلقة الدائرية خارج الأخدود المخصص لها في أثناء التجميع، يمكن نقلها مرة أخرى إلى المسار الأصلي.

أدخل المبيت من خلال منفذ التصريف بسرعة أبطأ مع المزيد من مواد التشحيم.

الكيموس يتسرب من الجهاز

تأكد من تجميع مكونات الجهاز بشكل صحيح. إذا كان الجهاز لا يزال يتسرب، فأزل الجهاز وبدله.

كتل The INSIDES® Neo

أزل الجهاز وبدله.

الارتجاع

قد تكون هناك دائمًا كمية صغيرة من الارتجاع عند حدوث إعادة التغذية. لتقليل كمية الارتجاع، قلل سرعة توجيه الكيموس إلى الطرف البعيد.

‍

الإكسسوارات

يجب استخدام جميع الملحقات كما هو محدد من الشركة المصنعة. قد يؤدي استخدامالملحقات خارج الاستخدام الوارد في الملصق إلى إلحاق الضرر بالمريض.

جهاز الفغر

· كيس فغر Hollister Pouchkins™ Newborn من قطعة واحدة لحديثي الولادة – حاجز مسطح (3778(

· حقيبة Coloplast SenSura® Mio Baby المرنة المكونة من قطعتين(18700)

أنبوب التغذية

· جميع أنابيب التغذية المعوية ENFIT المناسبة

موجه الحقنة

· جميع مضخات حقنة التغذية المعويةالمناسبة

‍

الملكية الفكرية

جميع حقوق الطبع والنشر والتصميم وبراءات الاختراع وحقوق الملكية الفكرية الموجودة في تصاميمنا ومنتجاتنا وفي الصور والنصوص وتصميم موقعنا على الإنترنت /المواد التسويقية هي ملك لـ The Insides Company. راجع www.insidescompany.com لمزيد من المعلومات.

إن "Coloplast"، و"SenSura® Mio " هما علامتان تجاريتان مسجلتان لشركة Coloplast Corporation. إن استخدام العلامتين التجاريتين "Coloplast" و"SenSura® Mio" في هذه التعليمات هو لأغراض إعلامية فقط لتوفير معلومات دقيقة عن المنتج لعملائنا. لا تشير The Insides Company Limited إلى أي تأييد أو انتماء أو رعاية أو موافقة من Coloplast Corporation. نؤكد بموجب هذا اعترافنا بحقوق الملكية الفكرية الحصرية لشركة Coloplast Corporation في العلامتين التجاريتين "Coloplast"، و"SenSura ® Mio"، وأي إشارات إلى العلامة التجارية المذكورة تتم بحسن نية لوصف توافق أو استخدام منتجاتها بصدق.

إن "Hollister"، و"™Pouchkins" هما علامتين تجاريتين مسجلتين لشركة Hollister Incorporated. إن استخدام العلامتين التجاريتين "Hollister" و"Pouchkins" في هذه التعليمات هو لأغراض إعلامية فقط لتوفير معلومات دقيقة عن المنتج لعملائنا. لا تشير The Insides Company Limited إلى أي تأييد أو انتماء أو رعاية أو موافقة من Hollister Incorporated. نؤكد بموجب هذا اعترافنا بحقوق الملكية الفكرية الحصرية لشركة Hollister Incorporated في العلامتين التجاريتين "Hollister"، و"™Pouchkins"، وأي إشارات إلى العلامة التجارية المذكورة تتم بحسن نية لوصف توافق أو استخدام منتجاتها بصدق

‍

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

‍

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

‍

Contact Information

‍

The Insides Neo Instructions for Use

(8-minute read)

Click here to download

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 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 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

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.

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.

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.

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.

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

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

Hollister™ Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the housing of THE INSIDES® Neo into a water-based lubricant.
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.
Connect the adaptor to the housing by pressing it into place. You should hear a click.
Check that the housing and adaptor have been properly connected. The nose of the housing should be seen through the adapter.
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.
Insert the supplied plug into the base of the device to ensure that no chyme can leak out.

Coloplast® Accessory

Connect the feeding tube to the housing.
Remove the drain port from the ostomy appliance if required.
Dip the nose of the adapter into a water-based lubricant.
Insert the adapter through the drain port, from the outside into the bag.
Insert the housing into the ostomy appliance through the opening, until it reaches the bottom.
Connect the housing to the adapter by clicking it into place, you should hear a click.
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.
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

Ensure THE INSIDES® Neo has been assembled with the ostomy appliance and tube as described above.
Apply a hydrocolloid around the stoma.
Remove the sticker to expose the adhesive of the ostomy appliance.
While holding the bag, insert the tube into the distal limb of the stoma.
Once the tube is inserted to the desired level, apply the baseplate to the abdomen, around the stoma.
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.
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.

Remove the plug off the adaptor.
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®
Note: Manual refeeding could cause excessive flow or pressure which could damage the intestine, refer to WARNINGS.
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.
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.
Once the plunger has been fully depressed:
The syringe and extension tube should be disconnected from the adaptor, and the plug should be reinserted. Or;
The syringe plunger can be drawn back to refill with chyme for further refeeding.

5. Replacing THE INSIDES® Neo

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

6. Disposing of THE INSIDES® Neo

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

‍

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

‍

Contact Information

‍

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The Insides Neo Instructions for Use

Definitions

THE INSIDES® Neo

Indication for Use

Intended Use

Contraindications

Warnings

User Guide

1. Prior To Use

2. Assembling THE INSIDES® Neo

3. Setting up the patient with THE INSIDES® Neo

4. Refeeding with THE INSIDES® Neo

5. Replacing THE INSIDES® Neo

6. Disposing of THE INSIDES® Neo

Cleaning and Disinfection

Troubleshooting Guide

Product Specifications

Servicing

Warranty Statement

Accessories

Safety Signs and Symbol Glossary

Intellectual Property

Contact Information

The Insides Neo Instructions for Use

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1. Avant utilisation

2. Assemblage des INSIDES® Neo

3. Mise en place du patient avec THE INSIDES® Neo

4. Réalimentation avec THE INSIDES® Neo

5. Remplacement de THE INSIDES® Neo

6. Élimination de THE INSIDES® Neoo

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The Insides Neo Instructions for Use

Definitions

THE INSIDES® Neo

Indication for Use

Intended Use

Contraindications

Warnings

User Guide

1. Prior To Use

2. Assembling THE INSIDES® Neo

3. Setting up the patient with THE INSIDES® Neo

4. Refeeding with THE INSIDES® Neo

5. Replacing THE INSIDES® Neo

6. Disposing of THE INSIDES® Neo

Cleaning and Disinfection

Troubleshooting Guide

Product Specifications

Servicing

Warranty Statement

Accessories

Safety Signs and Symbol Glossary

Intellectual Property

Contact Information

‍

The Insides Neo Instructions for Use

Definities

THE INSIDES® Neo

Indicatie voor Gebruik

Beoogd gebruik

Contra-indicaties

Waarschuwingen

Gebruikershandleiding

1. Voor ingebruikname

2. THE INSIDES® Neo monteren

3. THE INSIDES® Neo instellen op de patiënt

2. THE INSIDES^® Neo monteren

3. THE INSIDES^® Neo instellen op de patiënt

4. Refeeding met THE INSIDES^® Neo

5. THE INSIDES^® Neo vervangen

6. Hetverwijderen van THE INSIDES^® Neo

3. **Vorbereiten des/der Patient*in auf THE INSIDES® Neo**

6. Entsorgungvon THE INSIDES^® Neo

2. Montaje de THE INSIDES^® Neo

3. Colocaciónde THE INSIDES^® Neo en el paciente

4. Realimentacióncon THE INSIDES^® Neo

5. Sustituciónde THE INSIDES^® Neo

6. Cómodesechar THE INSIDES^® Neo