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USER MANUAL
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TABLE OF CONTENTS
Page 3. Insertion
Insertion
Remove the protective tube Open the bag Take out the system Remove the clip
Cardia
Duodenum
Fundus
Lesser curvature
Pylorus
Step 3. Preparation
Moisten the tip of the endoscope.
Place the balloon on the endoscope And put surgical gel on the balloon
Step 4. Insertion
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Air 1/3, Liquid 2/3 3 syringes of air + 7 syringes full of liquid 370g
Use of other syringe capacities : 30 ml syringe -> Multiply the gures by 2, 20 ml syringe -> Multiply the gures by 3
Checking / Removal
Check the condition of stomach
Endalis 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.
Biconial connector
Extraction hooks
Step 1. Connect the needle/catheter to the aspiration (Use the biconical connector)
Insert the endoscope into the
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stomach And visualise the balloon Push the drainage needle down through the operator channel of the endoscope
Connect the needle/catheter to the aspiration (Use the biconical connector) Wait until the balloon has completely deated
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 lling a balloon in the stomach with air and physiological liquid. The volume occupied encourages a sensation of satiety and thus weight loss. After ination, this balloon acts as an articial 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 xed 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 ination 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
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).
Accompanying documents:
Instructions for use of the medical device User manual Individual identication card Identication labels for the les
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 sufcient. The current data is not sufcient 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/m or 35 kg/m + comorbidity factors
Before bariatric surgery In subjects presenting a contraindication to bariatric surgery In the context of orthopaedic surgery
Important
The insertion and extraction of an intra-gastric balloon requires specic 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 lled 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 Gnox 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), Crohns 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 identied medical treatment Pregnancy, desire for a pregnancy during treatment with the balloon, breastfeeding Severe liver disease Haemostatic disorder.
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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 reux, cardiac rhythm disorders) or the anaesthetic, a certain number of complications specic to the insertion of the balloon are possible. These are pharyngo-oesophageal damage when the balloon is introduced, ination 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 lled 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 sufciently lled or is partially deated. 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 reux 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 y in an unpressurised aircraft (if the balloon is lled with air). Combat and extreme sports are denitely not recommended.
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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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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
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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
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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
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