END-BALLUSER MANUAL

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TABLE OF CONTENTS

Page 3. Insertion

Page 6. Checking / Removal

Page 8. User Manual

Insertion

Characteristics of the endoscopy Characteristics of the endoscope to be used for installation and removal of our intragastric balloon is stated above.

Step 1. Opening the package

Step 2. Control the EndoscopyBefore the installation, check the status of stomach is necessary.

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Open the bag Take out the system Remove the clip

Ready for use

Remove the protective tube

Important! Note the distance between the mouth and the cardia from the

markings on the endoscope.

Cardia Duodenum Fundus Lesser curvature Pylorus

Step 3. PreparationMoisten the tip of the endoscope.

⦁ Place the balloon on the endoscope

⦁ And put surgical gel on the balloon

Step 4. Insertion

⦁ Passage through the oesophagus (Finger technique)

⦁ Descent of the balloon into the stomach (Peripheral view)

⦁ Connect the syringe Inject a syringe of air

Use of the syringes

⦁ Inflation with air: Use the 50/60 ml syringe for the inflation

⦁ Inflation with liquid:

Use the liquid filling kit (Connection between the bag of physiological saline and the anti-return valve)

Use the 30 ml syringe for the inflation

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1 2

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⦁ 2 syringes of air to release the balloon from its holder

Step 5. Inflate the balloon

⦁ Let go of the balloon near the cardia

⦁ Disconnect and withdraw the needle of the system introduction

⦁ And pull up the “Endoscope and introduction system” assembly

⦁ Check the position of the balloon in the stomach

Filling the balloon

Use of other syringe capacities : 30 ml syringe -> Multiply the figures by 2, 20 ml syringe -> Multiply the figures by 3

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4

Air 100% Air 2/3, Liquid 1/3 Air 1/3, Liquid 2/3 Liquid 100%

13 syringes of air7 syringes of air +

4 syringes full of liquid3 syringes of air +

7 syringes full of liquid2 syringes of air +

9 syringes full of liquid

4g 240g 370g 540g

Diameter 100mm, Volume 600ccEND T70

5 6

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Checking / RemovalCheck the condition of stomachEndalis suggests to check the condition of End-ball regularly after the installation. Condition checking procedure can be performed by X-ray / Echography. If the condition of End-ball is fair enough, you may see the images suggested below.

Check out the extraction kitTo remove the End-ball successfully, please check the accessories are correctly included in the extraction kit package.

Step 1. Connect the needle/catheter to the aspiration (Use the biconical connector)

⦁ Insert the endoscope into the stomach And visualise the balloon

⦁ Push the drainage needle down through the operator channel of the endoscope

⦁ And pierce the balloon

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6

Biconial connector Extraction hooks Hollow drainage needles

1 2

⦁ Connect the needle/catheter to the aspiration (Use the biconical connector)

⦁ Wait until the balloon has completely deflated

⦁ Then remove the needle/catheter

Step 2. Extract the balloon

⦁ Push the extraction forceps through the operator channel

⦁ Capture the balloon with the hooks

⦁ Hold the balloon firmly against the end of the endoscope

⦁ And pull the assembly back up

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3 4

5

4

6

Warning! Perform a control endoscopy to check there is no connection after

the balloon has been removed.

User Manual

END BALL® - Intra-Gastric Balloon System

END BALL® is a non-surgical, temporary intra-gastric balloon system for the treatment of obesity.

Our device provides an appropriate solution for experienced gastroenterologists, anxious to offer a solution to patients suffering from obesity. The technical innovations for this new implant are aimed at improving patient quality of life, whilst reducing the risks linked to the device.

The operation involves filling a balloon in the stomach with air and physiological liquid. The volume occupied encourages a sensation of satiety and thus weight loss. After inflation, this balloon acts as an artificial bezoar and rests freely in the stomach.

The intra-gastric balloon system is a temporary device, the use of which must not exceed a period of 6 months. It is designed to enable excess weight to be lost, when a monitored slimming programme has not produced the expected results.

Introduction

Our device does not have an independent introduction kit; it is fixed to the end of the endoscope. This particular characteristic makes it possible to use the endoscope as a guide for the passage of the balloon into the stomach and also to enable the practitioner to have a direct view of the inflation and release of the balloon.

Technical Description

This non-sterile, single use device is made up of:

1. An intra-gastric balloon system

⦁ An intra-gastric balloon (radio-opaque), a single pouch (air and liquid) in polyurethane pre-connected to the introduction system

⦁ An introduction system

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2.Accessories (separate packaging)

⦁ 1 x 50/60 ml sterile, single use syringe

⦁ 1 single use extraction kit composed of:

⦁ 1 hollow drainage needle (sclerosis type)

⦁ 1 universal biconical connector for the connection between the drainage needle and the aspiration

⦁ 1 pair of extraction forceps (with hooks).

Single use device

The balloon is single use because it is destroyed when it is removed.

The introduction kit is single use in order to

⦁ Reduce the risks of cross-contamination, infection, etc.

⦁ Achieve its performance safely and effectively (insertion of the balloon)

⦁ Simplify its use for practitioners (no cleaning, disinfection and sterilisation procedures to be implemented by users)

Furthermore, ENDALIS® has not demonstrated that its device is compliant with the basic requirements of Directive 93/42/CEE, if it is re-used.

Consequently, the practitioner exposes himself to serious risks (see below) if he reuses this single use device.

References & Characteristics

END T70:

⦁ Single pouch polyurethane balloon

⦁ Size of the balloon empty: Flat 70mm disc

⦁ Balloon can take a maximum of 500cc of liquid and air (0 to 500g)

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Accompanying documents:

⦁ Instructions for use of the medical device

⦁ User manual

⦁ Individual identification card

⦁ Identification labels for the files

Packaging

The device is for SINGLE USE. The device is delivered NON-STERILE. The device is packaged in a peel-back sachet, heat sealed and packed in a case.

Shipping

When dispatched to the practitioner or the health establishment, the device is placed in a shipping box with its accessories (60cc syringes and extraction kit). Devices are delivered STERILE and are for SINGLE USE (they have CE marking from a different manufacturer to Laboratoire ENDALIS®).

Storage

To be kept in a cool, dry place at ambient temperature.

Biocompatibility

Device compatible with the human body (NF EN ISO 10993).

Gastroscope/ Endoscope

The END BALL intra-gastric balloon system must be used on a gastroscope/endoscope with the following characteristics as a minimum:

⦁ Tube length: 1 m

⦁ Distal end diameter from 8.8 mm to 9.4mm

⦁ Operator channel diameter of 2.8mm minimum

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Disposal of waste

After use all our products must be considered as medical waste carrying a risk of infection and related risks (D.A.S.R.I. in France).

It is ESSENTIAL that the procedure for sorting and disposal established in the user health establishment is followed.

Indications

The intra-gastric balloon is a temporary, non-surgical device, the use of which is for 6 months or less. It is designed to enable weight loss when a monitored slimming programme has not been sufficient.

The current data is not sufficient to specify the indications and their place in the treatment strategy for obese adult patients.

Nevertheless, the indications are:

In patients with a BMI ≥ 40 kg/m² or ≥ 35 kg/m² + comorbidity factors

⦁ Before bariatric surgery

⦁ In subjects presenting a contraindication to bariatric surgery

⦁ In the context of orthopaedic surgery

Expected weight loss

At 6 months in the order of 32% of the excess weight corresponding to a weight loss of about 14 to 18 kg.

There is currently no significant study on maintenance of the weight loss over time.

Important

⦁ The insertion and extraction of an intra-gastric balloon requires specific training in these techniques.

⦁ The practitioner must be experienced in endoscopy techniques.

⦁ The anesthesia and the endoscopy must be compliant with the procedures applied by the health establishment. ⦁ The preparation of the patient for the endoscopy must be compliant with the procedure applied by the health establishment.

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⦁ The intra-gastric balloon must be filled to a minimum of 500 cc (air and liquid) to make complete deployment possible.

⦁ The balloon must be removed after 6 months.

⦁ Any balloon damaged (deterioration, leakage or contamination) before insertion must be returned to G’nox® with a covering letter explaining the problem.

Contraindications

The presence of one of the following conditions is a contraindication to the insertion of the balloon:

⦁ Previous history of gastric surgery;

⦁ Digestive pathology: large hiatus hernia (> 5 cm), active peptic ulcers, severe oesophagitis either Grade III or IV (Savary-Miller classification ) or Grade C or D (Los Angeles classification), Crohn’s disease or any other digestive tract lesion that could bleed, pyloric stenosis and anomalies in the structure of the digestive tract

⦁ Diseases which could affect the vital prognosis in the short to medium term

⦁ Severe cognitive or mental disorders

⦁ Severe eating disorders that are not stabilized

⦁ Alcoholism, drug addiction

⦁ Treatment with platelet aggregation inhibiting drugs or non-steroidal anti-inflammatory without adjuvant treatment with acid-blockers

⦁ Anticoagulants

⦁ Foreseeable inability of the patient to take part in a prolonged medical follow-up

⦁ Absence of previously identified medical treatment

⦁ Pregnancy, desire for a pregnancy during treatment with the balloon, breastfeeding

⦁ Severe liver disease

⦁ Haemostatic disorder.

Some of these contraindications may be temporary.

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Extraction of the intra-gastric balloon

The extraction of the balloon is generally indicated due to:

⦁ Reaching the end of the recommended insertion period (6 months)

⦁ The occurrence of a complication: gastric perforation, gastric ulcer or erosion, intestinal obstruction, deflation and migration of the balloon

⦁ Intolerance to the balloon particularly due to vomiting or persistent abdominal pain

⦁ Incorrect positioning of the balloon in the stomach (balloon blocked, not free in the gastric antrum)

⦁ Unusual appearance of the balloon (bag slack, balloon shrunk, etc.).

Complications

1. Complications linked to the insertion or extraction of the balloon. Apart from complications inherent in upper digestive endoscopy (perforation or digestive haemorrhage, bronchial inhalation by gastric reflux, cardiac rhythm disorders) or the anaesthetic, a certain number of complications specific to the insertion of the balloon are possible. These are pharyngo-oesophageal damage when the balloon is introduced, inflation of an incorrectly positioned balloon in the oesophagus or duodenum with the risk of perforation.

2. Mechanical complications due to the balloon. Ulceration of the gastric wall which could result in perforation has been described (heaviness of the balloon filled with 100% liquid) necessitating an urgent surgical operation with risk to life. Digestive tract obstructions are possible where there is migration, which is seen if the balloon is not sufficiently filled or is partially deflated. It can be a gastric obstruction if the balloon becomes impacted in the gastric antrum or an intestinal obstruction which sometimes requires a surgical operation. The risk of these complications is greatly increased if the maximum duration of six months for the implantation of the intra-gastric balloon is not respected.

3. Functional complications (side effects). Insertion of an intra-gastric balloon is sometimes accompanied in the early days by gastric heaviness, and nausea and vomiting which normally recede in 2 to 7 days. Symptoms of gastro-oesophageal reflux are also possible. These problems can be corrected by appropriate treatment with drugs (anti-secretory medication, anti-nausea drugs). Sometimes vomiting persists necessitating premature removal of the balloon.

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4. Metabolic complications. These result from uncontrolled or neglected vomiting which can be the cause of dehydration, metabolic alkalosis, hypokalaemia, and functional renal failure. Hypokalaemia can be responsible for serious cardiac rhythm disorders with a risk to life.

5. Failures. Absence or a refusal of dietary treatment concomitant with the insertion of an intra-gastric balloon compromises the results as far as weight loss is concerned. Similarly, the risk of regaining weight after the removal of the intra-gastric balloon is even more likely if the obesity is longstanding and serious.

Restriction of activity

It is strictly forbidden for the patient to dive or to fly in an unpressurised aircraft (if the balloon is filled with air). Combat and extreme sports are definitely not recommended.

Recommendations – Before the procedure

⦁ Treatment of patients with a view to inserting a balloon must be global. It must take place within multidisciplinary teams, liaising with the attending physician. These teams will include as a minimum a gastroenterologist, a doctor specialising in obesity (nutritionist, endocrinologist or specialist in internal medicine), a dietician, a psychiatrist or psychologist and an intensive care anaesthetist. These teams can take the advice of other health professionals as required (surgeon, endocrinologist specialising in diabetes, radiologist, cardiologist, doctor specialising in lung disease, rheumatologist, rehabilitation doctor, dentist, physiotherapist, etc.)

⦁ The patient must be informed of the advantages and disadvantages of the balloon (including failure rates, and complications), the obligation to remove the balloon after 6 months, the necessity of multidisciplinary treatment and long-term follow-up.

⦁ Patients must be advised on contraception

⦁ The decision to insert the balloon must be taken after discussion and consultation with the multidisciplinary team

⦁ Before the procedure routine pregnancy testing using a plasma b-HCG assay should be performed for women of childbearing age

⦁ Testing for and treatment of a Helicobacter pylori infection is not routine but left to the discretion of the operator.

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Recommendations – Performance of the procedure

The balloon must be inserted under general anaesthetic with or without tracheal intubation, under endoscopic control in the endoscopy room with equipment for monitoring vital functions and a respirator, by professionals who have received specific training in a referral centre already practising these procedures.

A control endoscopy is recommended to check:

The integrity of the oesophagus (cardia), stomach (fundus, lesser curvature and pylorus) and the duodenum.

Photographs of all these anatomical parts should be taken and placed in the patient’s file.

Recommendations – After the procedure

⦁ A control endoscopy is recommended to check:

o The correct inflation of the balloon (bag under tension, smooth appearance, etc.)

o The correct positioning and freedom of movement of the balloon in the gastric antrum

⦁ Advice on progressive, appropriate return to eating should be given to the patient

⦁ The prescription of acid-blockers for 6 months is recommended with anti-emetics, anti-spasmodics and/or analgesics on demand

⦁ A blood ionogram and a creatinaemia are advised at about the 3rd day

⦁ A consultation with a member of the multidisciplinary team is recommended every 4 to 6 weeks

⦁ It is recommended that a programme of therapeutic education is established with the patient and implemented with the multidisciplinary team before the procedure and continued after the procedure

⦁ Important: Do not prescribe food supplements or their equivalent containing enzymes of biological origin.

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Recommendations – extraction of the balloon

The extraction is a technically difficult procedure which must be performed:

⦁ Under general anaesthetic with tracheal intubation

⦁ Under endoscopic control using the kits supplied by the manufacturers as first intention

⦁ In the endoscopy room with equipment for monitoring vital functions and a respirator

⦁ By professionals having received specific training in a referral centre already practising these procedures.

After the extraction procedure:

⦁ An endoscopic examination to check there is no gastric or oesophageal lesion is necessary.

⦁ The patient is seen about the 15th day by a member of the multidisciplinary team. After that the follow-up must be multidisciplinary according to the methods defined in the recommendations for the treatment of the obese adult.

Cleaning

⦁ No cleaning is necessary.

⦁ In no circumstances must the product be sterilised as no procedures have been validated for the product.

⦁ Do not soak the product in disinfectant. The material may absorb some of the solution and cause a tissue reaction.

Preparation & Insertion & Release of the balloon & Extraction of the intra-gastric balloon Correspondence table

Refer to the Manual attached to this leaflet

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Recommendations - Anaesthetic

An anaesthetist must administer the anaesthetic for which he will be solely responsible.

Insertion:

⦁ General anaesthetic using Propofol, a short-term anaesthetic drug (e.g. Diprivan or a generic)

⦁ Spontaneous ventilation

⦁ Duration: ~15 minutes

Extraction:

⦁ General anaesthetic using Propofol, a short-term anaesthetic drug (e.g. Diprivan or a generic)

⦁ Patient intubated and ventilated

⦁ Duration: ~20 minutes

Recommendations - Prescription of medicines

This is the responsibility of the practitioner.

Short term (the first 8 days)

⦁ Anti-nausea drugs such as metoclopramide, either long-acting or to be taken twice daily

⦁ As required, digestive anti-spasmodic such as tiemonium methyl sulphate 50mg.

Long term (during the 6 months)

⦁ Proton pump inhibitor (PPI) gastric anti-secretory agent, full dose taken daily (e.g. Lansoprazole 30mg/d) Important

⦁ Do not prescribe food supplements or their equivalent containing enzymes of biological origin.

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Warning

The Company, ENDALIS®, does not exercise any control over the conditions of use, the choice of patient, the implantation and extraction procedures used, the pressures placed upon the device and the handling of the device after sale. The Company, ENDALIS®, cannot be held responsible for any damage, accidental or indirect, or for losses or costs resulting directly or indirectly from the use of this product. There will be no reimbursement for any product explanted due to patient intolerance. The procedure for the explantation of the balloon requires specialist equipment. The gastroenterologist must use the equipment recommended by the Company, ENDALIS®. No responsibility will be accepted by the Company, ENDALIS®, if different equipment is used. The intra-gastric balloon is implanted for a maximum duration of 6 months. Any use for duration longer than that recommended will relieve the Company, ENDALIS®, of any responsibility.

End-ball 설치 후 추천식단

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음식명 분량 음식명 분량

아침

흰죽미역국갈치구이계란찜숙주나물시금치 나물물김치국물

1공기1그릇1토막1개1접시1접시1/2접시

아침

흰죽쇠고기무국두부구이어포무침고구마순나물물김치국물

1공기1그릇1/6모1접시1접시1/2공기

점심

흰죽아욱된장국불고기

느타리버섯무침무나물물김치국물

1공기1그릇1접시1접시1접시1/2공기

점심

흰죽마른새우다시마국돼지고기피망볶음배추된장나물가지나물물김치국물

1공기1그릇1접시1접시1접시1/2접시

간식 크림스프과일쥬스

1공기1병

간식 잣죽토마토

1공기1개

저녁

흰죽순두부새우젓국닭살볶음잡채오이나물물김치국물

1공기1그릇1/6모1접시1접시1/2공기

저녁

흰죽감자국임연수구이두부조림표고버섯볶음호박나물물김치국물

1공기1그릇1토막1접시1접시1접시1/2공기

주의점: 시술 직후에는 위의 용적이 작아지고 소화능력이 저하되므로 죽이나, 스프 등의 부드러운 음식을 소량씩 섭취하는 것이 좋으며 이때, 소량의 열량을 섭취하되, 고단백의 음식을 적당량 섭취하도록 권장됩니다.

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(주) 지녹스

서울시 강남구 논현동 192-5 정빌딩 5층 / 02-511-0865 / ginox.info@gmail.com

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