Disposable Bite Blocks
Contents
1. Page 9 Storage conditions Page 9 Chapter 4 Disposal of waste Page 9 Waste control 7777 Page 9 The Disposal of the waste Page 9 Chapter 5 Service Information Page 10 Chapter 0 Notice upon Use of Product 0 4 Intend Use Sturdy yet forgiving material protects delicate instruments and provides comfort for patients 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 procedures 0 4 Instrument Compatibility Refer to the Tables in Se2. information udi 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 10
3. Heyinovo Disposable Bite Block User Manual Technical Publications Document No WI RD 13 Y007 Rev B C C 0187 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 C 0197 Revision History Feb 24 201 1 Mr Yaodong Wang Mr Xin Huang Sep 13 2013 Ms xiaoping Qian Mr Xin Huang Certifications 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 Head and understand all instructions in this manual before attempting to use the Disposable bite block 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 c00 0co e Page 2 Revision History IIIIIIIIIIIIIee Page 2 Certieallorjeses eere deep sce ue pointe Sis ey ee ee Se eee Page 3 Original Documentation eee emm RERBA EHE TEES Page 3 PUCHION S 96 needs soe cosa ese Sae
4. ccessories of endoscopy can not be used alone shall not be altered without authorization or used for other purposes e Before use thoroughly review the method of use for this instrument in accordance with the instruction manuals Using the instrument without learning such information could cause patient injury Chapter 1 Instrument Nomenclature and Specifications 1 1 Nomenclature WS YO GODO E Ll E sign for sterile Code of the product Bite block W wilsion S sign for sign use product 1 2 Specifications Oval Fenestrated Cups Caliber Min Size Sterile Application WS YO 01 16mm NO For adults WS YO 01E 16mm YES No headband Oval Fenestrated Cups Caliber Min Size Sterile Application For adults WS YO 02 20mm NO l Optional WS YO 02E 20mm YES Headband Oval Fenestrated Cups Caliber Min Size Sterile Application WS YO 03 20mm NO For adults WS YO 03E 20mm YES With Headband Oval Fenestrated Cups Caliber Min Size Sterile Application WS YO 04 16mm NO For children WS YO 04E 16mm YES With Headband This device complies with the requirements of Directive Medical Device 93 42 EEC concerning medical devices Directive 0197 Classification Class l 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 an
5. ction 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 es ee e rr ef so o O O 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 Pressure 700 to 1060hPa 0 9 Attention Follow the warnings given below when handing the instrument This information is to be supplemented by the warnings and cautions described in each section e The product is special a
6. d 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 replace 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 models Understand the patient s actual needs and select the appropriate model of the bite block 2 2 2 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 3 Inspect of the appearance Inspect that there are no crac
7. e det S di suere due tea e eir Page 3 Chapter 0 Notice upon Use of Product laterid ijeesu s bre ee ect modu ER EE b E S mE Ce Eee Page 5 Instruction Mandl assessor monte eae donec me Ceres eee eee 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 ee ee eee ee eee ee Page 6 Chapter 1 Instrument Nomenclature and Specifications Page 7 Nomenclature Page 7 Specification Page 7 Chapter 2 Preparation Inspection and Operation Page 8 Preparallorie s sus sse aieea eos ene en e dulce ie eRe eae Sate ee ate ee Page 8 AS PECON E eee eae ae a Sees ae eee LL tbc DE Page 8 ORGAN oes e eee eS rcd ec psum ar A aes Page 8 Chapter 3 Storage Page 9 liisDpeello n Belore Storages senes eter or Sten etes ed e eee eet nece etes Page 9 Storage requirement
8. ks tears or deformation of the bite block 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 mask moisture resistant clothing and chemical resistant gloves that fit properly and are long enough so that your skin is not exposed When using the instrument always wear appropriate personal protective equipment Place the bite block on patient s articulate part Endoscopic instrument inserted into the body s natural through the bite block 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 tissue 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 CAUTION e Do not store the Bite Block in the carrying case Use the carrying case only for shipping the endoscope Routinely storing the Bite Block in a humid non ventilated environment such as the carrying case may present an infection control risk 3 1 Inspectio
9. n 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 he 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 according 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
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