Disposable Biopsy Valves
Contents
1. Page 9 Storage conditions Page 9 Chapter 4 Disposal of waste Page 10 Waste control rrr reer ree eee Page 10 The Disposal of the waste Page 10 Chapter 5 Service Information Page 10 Chapter 0 Notice upon Use of Product 0 1 Intend Use This valve has been designed to be attached to the endoscopes listed in the 4 ENDOSCOPE COMPATIBILITY and to prevent reflux of body fluids This device should not be used for any purpose other than its intended use 0 2 Instruction manual This instruction manual contains essential information on using this instrument safely and effectively Before use thoroughly review this manual and the manuals of all equipment which will be used during the procedure and use the instruments as instructed Keep this and all related instruction manuals in a safe accessible location If you have any questions or comments about any information in this manual please contact Wilson or it s distributor 0 3 User qualification The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique This manual therefore does not explain or discuss clinical endoscopic proce2. Heyinovo Disposable Biopsy Valves User Manual Technical Publications Document No WI RD 13 M07 Rev B 0137 Copyright By Wilson Instruments SHA Co Ltd Regulatory Requirement This product complies with regulatory requirements of the following European Directive 93 42 EEC concerning medical devices C q 0197 Revision History Jun 06 2010 Mr Yaodong Wang Mr Xin Huang Sep 06 2013 Ms xiaoping Qian Mr Xin Huang Certifications e General Medical Systems is ISO 9001 and ISO 13485 certified Original Documentation e The original document was written in English Attention This manual contains necessary and sufficient information to operate the system safely Advanced equipment training may be provided by a factory trained Applications Specialist for the agreed upon time period Read and understand all instructions in this manual before attempting to use the Disposable Biopsy Valves Keep this manual with the equipment at all times for ready use Periodically review the procedures for operation and safety precautions If any queries about the content of this manual feel free to contact us Table of Contents Regulatory Requirement rrr rere ee Page 2 Revision History rrr cc crc cr rrr ere eee etree Page 2 C nilicalOn ss soe stSeas era See eee ine Deere a eee ae Page 3 Original Documentation lt s lt s seseeseosce Ses ee eee ee cies Ss Page 3 AUCHIO
3. N Meese Stee ate e ae eee eee See eee ee eee eestor Page 3 Chapter 0 Notice upon Use of Product ILE GUS 6 esas erg a ieesa te Sarre ie eae se ane rece Se eee aaa ee A ate Page 5 instruction ManUal S23 sesame se erie re a ee eee eee a ee Page 5 User qualification Page 5 Instrument Compatibility Page 5 Check the Package Contents Page 5 symbols and Signal Words Page 6 Sterilization method Page 6 Operating environment Page 6 Attention 2 2 eee ee eee ee eee eee Page 6 Chapter 1 Instrument Nomenclature and Specifications Page 7 Nomenclature Page 7 Specification Page 7 Chapter 2 Preparation Inspection and Operation Page 8 Prepara eomp gi a E A ea a Page 8 INSDECION E Aei sie Serer E eer eee E S S EES A ae ee eee a Sar Page 8 Operation 7 7 7 Page 9 Chapter 3 Storage Page 9 Inspection before Storage seats Sse esses ere i e cote ee eee sree Page 9 Storage requirement
4. ce with a new valve immediately and contact Wilson or it s distributor CAUTION e This valve is single use performing sterilization by ETO gas with E e Before use if any irregularities are detected replace with a new valve immediately e Do not crush the product otherwise it will damage the product a Prepare all equipment and personal protection equipment which will be used with the instrument in accordance with their respective Instruction manuals Appropriate protection equipment may include Protective eye wear a face mask moisture resistant protective clothing and gloves etc b Always have spare instrument available 2 2 Inspect 2 2 1 Inspection of the sterile package WARNING Do not attempt to sterilize the instrument This could pose an infection control risk cause tissue irritation equipment damage or malfunction Inspect the sterile package for tears inadequate sealing or water damage If the sterile package shows any irregularities the sterile condition of the instrument has been compromised Use a spare instead 2 2 2 Inspect of the appearance Inspect that there are no cracks tears or deformation of the Biopsy Valve 2 3 Operation WARNING e When using the instrument Always wear appropriate personal protective equipment Otherwise blood mucous and other potentially infections material from the patient could pose an infection control risk Appropriate personal protective equipment may include Eye wear a face mas
5. dures 0 4 Instrument Compatibility Refer to the Tables in Section 1 2 Specifications to confirm that this instrument is compatible with the ancillary equipment being used Using incompatible equipment can result in patient injury or equipment damage 0 5 Check the Package Contents Match all items in the package with the components shown below Inspect each item for damage If the instrument is damaged a component is missing or you have any questions do not use the instrument immediately contact Wilson or it s distributor 0 6 Symbols and Signal Words a The following signal words are used throughout this manual WARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury It may also be used to alert against unsafe practices or potential equipment damage NOTE Indicates additional helpful information b The meaning of the symbol shown on the package of this instrument is as follows C CE Mark Indicates that the device conforms to Council ini Directive 93 42 EEC concerning medical devices gt Keep away from sunlight a es e ee ee 0 7 Sterilization method Sterilization of the product is sterilized with ethylene oxide 0 8 Operating environment Ambient Temperature 10 to 40 C 50 to 104F Relative Humidity 30 to 85 Air Press
6. issue irritation e Store the instrument in the sterile package at room temperature in a clean and dry environment Do not store the instrument in direct sunlight Ensure that the package is not crushed by surrounding objects during storage 3 1 Inspection Before Storage Prior to storage inspect the sterile package as follows a Confirm that the sterile package is free of tears and inadequate sealing b Confirm that the sterile package is free from water damage 3 2 Storage requirement Store the instrument in the sterile package at room temperature in a clean and dry environment Do not store it in direct sunlight Ensure that the packaged instrument is not crushed by surrounding objects during storage Follow any additional storage instructions provided by the manufacturer of the sterile package 3 3 Storage conditions Ambient temperature from 20 C to 60 C Humidity 10 to 90 Atmospheric pressure 500hPa 1060hPa Chapter 4 Disposal of waste WARNING e The equipment is disposable products Do not reuse or attempt to sterilization again e The used disposable products should be controlled and disposed together or they may cause pollution to the environment and the public and cause bad consequences 4 1 Waste control The used disposable products should be collected together and closed off They should never be stored at will 4 2 The Disposal of the waste The waste of the products should be destroyed and disposed acco
7. k moisture resistant clothing and chemical resistant gloves that fit properly and are long enough so that your skin is not exposed NOTE e At low temperature the Biopsy Valve may become stiff and difficult to be attached 2 3 1 Attaching the Biopsy Valve to the Endoscope Push the Biopsy Valve down on to the Suction Valve Holder or the Instrument Channel Port until the valve snaps into place 2 3 2 Feeding solution with a syringe CAUTION Angled or incomplete insertion may result in leakage of solution from the valve Insert a syringe firmly and hold it perpendicular to the valve Press the plunger to feed solution 2 3 3 Aspirating solution with a syringe Remove the valve from the Suction Valve holder or Instrument channel Port Insert a syringe and withdraw the plunger to aspirate solution 2 3 4 Inserting and withdrawing the Endo Therapy Accessories CAUTION Inserting the Endo Therapy Accessory straight into the valve 1 Insert the Endo Therapy Accessory through the slit 2 After use slowly withdraw the Endo Therapy accessory 2 3 5 Removing the Biopsy Valve from the Endoscope Remove the Biopsy Valve from the Suction Valve Holder or Instrument Channel Port Chapter 3 Storage WARNING e Do not store the sterile packages containing the instrument in places where they will become damaged wet or improperly sealed Otherwise the sterility of the instrument may be compromised and pose an infection control risk or cause t
8. rding to related local law and regulatory requirements of the state or area Randomly cast off is strictly forbidden Chapter 5 Service information If you have any questions about any information in these instructions please contact our by the following information ual WILSON INSTRUMENTS SHA CO LTD 25D He Yi Business Plaza No 420 Jiang Ning Rd Shanghai China 200041 Tel 0086 21 66311471 Fax 0086 21 66311472 EC EC REP EC Representative Company Lotus Global Co Ltd Address 15 Alexandra Road London NW80DP United Kingdom Contact Person Peter Tel 0044 20 75868010 Fax 0044 20 79006187
9. ure 700 to 1060hPa 0 9 Attention WARNING The product is special accessories of endoscopy can not be used alone shall not be altered without authorization or used for other purposes Chapter 1 Instrument Nomenclature and Specifications 1 1 Nomenclature M CIC T Loran for sterile Code of the product Biopsy valve W wilsion S sign for sign use product 1 2 Specifications Oval Fenestrated a Application erile Cups Endoscope Compatibility f FIT FOR OLYMPUS amp WS M 01 NO FUJINON GI WS M 01E YES ENDOSCOPES Oval Fenestrated Application Sterile eae Cups Endoscope Compatibility WS M 02 NO FIT FOR PENTAX GI WS M 02E YES ENDOSCOPES Oval Fenestrated Application sterile cae Cups Endoscope Compatibility WS M 03 NO FIT FOR OLYMPUS GI WS M 03E YES ENDOSCOPES This device complies with the requirements of Directive Medical Device 93 42 EEC concerning medical devices 0197 Classification Class I Directive Chapter 2 Preparation Inspection and Operation 2 1 Preparation WARNING e Do not use an instrument after the expiration date displayed on the sterile package Doing so may pose an infection control risk or cause tissue Irritation e Before each case prepare and inspect the instrument as_ instructed below Inspect other equipment to be used with the instrument as instructed in their respective instruction manuals Should the slightest irregularity be suspected do not use the instrument repla
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