Disposable Grasping Foreceps
Contents
1. Page 10 Storage conditions Page 11 Chapter 4 Disposal of waste Page 11 Waste control 777 7 Page 11 The Disposal of the waste Page 11 Chapter 5 Service Information Page 11 Heyinovo Chapter 0 Notice upon Use of Product 0 1 Intend Use This instrument has been designed to be used with endoscopes to retrieve foreign bodies calculus or tissue specimens from the digestive tract Do not use this instrument 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 no2. 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 The product is special accessories of endoscopy can not be used alone shall not be altered without authorization or used for other purposes 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 Do not use this instrument for a calculus that is assumed impossible to be retrieved by this instrument preoperative diagnosis intraoperative contrast enhancing or after papillotomy papillary dilation Do not use this instrument when it is inevitable to grasp many calculus at a time The basket with calculus engaged may not be removed from the body Use this instrument by having the settings to switch to open surgery and the hospitalization plan ready in case this instrument with calculus engaged may not be removed from the body Heyinovo Chapter 1 Instrument Nomenclature and Specifications 1 1 Nomenclature W amp DIE 00 00 Le Code of Products Working Length Max Insertion Portion Diameter W wilson S sign of the sigle use product 1 2 Specifications Oval Fenestrated Cups
3. Heyinovo Disposable Grasping Forceps User Manual Technical Publications Document No WI RD 13 G07 Rev C C C 0187 Copyright By Wilson Instruments SHA Co Ltd Heyinovo Regulatory Requirement This product complies with regulatory requirements of the following European Directive 93 42 EEC concerning medical devices C C 0197 Revision History REV Complied by Approved by 02 i Mr i Jun 05 2010 Mr Yaodong Wang Mr Xin Huang Sep 13 2013 Ms xiaoping Qian Mr Xin Huang Heyinovo 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 Read and understand all instructions in this manual before attempting to use the Disposable Grasping Forceps 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 Heyinovo Table of Contents Regulatory Requirement co 0oo e Page 2 Revision History IIIIIIIIIIIIIee Page 2 Cengage tassi ese to vidt a eine ec punte remet eee SSS ESAS Page 3 Original
4. Section 1 2 Specifications and is not damaged Lightly run your fingertips over the entire length of the Insertion Portion to check for any crushed areas excessive bends etc 2 2 3 Inspect of the operation WARNING Check that no abnormality is detected in the action of the handle If there is any abnormality the calculus may not be retrieved and or the basket with calculus engaged may not be removed from the body If the Grasping Forceps does not operate smoothly and as intended do not use the instrument use a spare instead 1 Holding the instrument form a loop in the Insertion Portion approximately 20 cm in diameter 2 Operate the Grip and confirm that the Retrieval Basket opens and closes smoothly Heyinovo 2 3 Operation WARNING 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 Do not insert the instrument into the endoscope unless you have a clear endoscopic field of view If you cannot see the Distal End of the Insertion Portion in the endoscopic field of view or in X ray images do not use it This could pose a risk of punctures hemorrhages or mucous m
5. Storage Prior to storage inspect the sterile package as follows 1 Confirm that the sterile package is free of tears and inadequate sealing 2 Confirm that the sterile package is free from water damage 3 2 Storage requirement 10 could damage the Insertion Portion Heyinovo 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 9096 Atmospheric pressure 500hPa 1060hPa Chapter 4 Disposal of waste WARNING a he equipment is disposable products Do not reuse or attempt to sterilization again b 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
6. instructions please contact our by the following information ud 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 11
7. Documentation 2 eeu ore RIA Page 3 AUCMION S eua Sees Ehe S Gre ete Suede sues si eee eee ei scel Page 3 Chapter 0 Notice upon Use of Product LE GUIS Ges i e enero ve nde ae Bae Sree ee area Nue a Page 5 INSTUICHON Mana SSeS see ee eevee Senate es aos eile iS e ate eae 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 7 Page 6 Chapter 1 Instrument Nomenclature and Specifications Page 7 Nomenclature Page 7 Specification Page 7 Chapter 2 Preparation Inspection and Operation Page 8 as Oe to 0 0 Na kN a i cir ente Page 8 a S asses Ree lee eee LLL LL LLL LLL Page 8 Opel aon ese ues cele cus dece ae eS Cet ee ees a ep ee E Page 9 Chapter 3 Storage Page 10 lnspection betore Storage e eve cepe mpm terse e es er ems Page 10 Storage requirement
8. Forceps Elevator lower the Forceps Elevator Also keep the insertion portion of the endoscope straight 2 Withdraw the grasped foreign body calculus or resected tissue together with the endoscope from the patient while observing the endoscopic image 3 Push the Grip to open the Grasping Forceps 4 Remove the retrieved foreign body calculus or resected tissue from the Grasping Forceps 2 3 4 Withdrawing the Instrument From the Endoscope WARNING Do not withdraw the instrument from the endoscope quickly This could scatter blood mucous or other patient debris and pose an infection control risk CAUTION Do not withdraw the instrument from the endoscope while the Grasping Forceps is open This could damage the endoscope or Instrument 1 Pull the Grip to close the Grasping Forceps 2 Withdraw the instrument from the endoscope Chapter 3 Storage WARNING Do not store the instrument in a sterile package that is damaged wet or improperly sealed Otherwise the sterile condition of the instrument may be compromised and pose an infection control risk or cause tissue irritation may result Do not store the instrument in place where they will be damaged wet or improperly sealed Otherwise the sterile condition of the instrument may be compromised and pose an infection control risk or cause tissue irritation Do not coil the Insertion Portion with a diameter of less than 15 cm This CAUTION x 3 1 Inspection Before
9. WS 2418GM3G WS 2423GM3G Oval Fenestrated Cups WS 2418GM3Q WS 2423GM3Q Oval Fenestrated Cups WS 2418GM4G WS 2423GM4G Oval Fenestrated Cups WS 2418GM4Q WS 2423GM4Q Max Insertion Portion Diameter mm 2 4 22 4 Max Insertion Portion Diameter mm 22 4 22 4 Max Insertion Portion Diameter mm 22 4 22 4 Max Insertion Portion Diameter mm 22 4 22 4 Working Channel Diameter mm 22 8 03 2 22 8 03 2 Working Channel Diameter mm 22 8 O3 2 22 8 O3 2 Working Channel Diameter mm 2 8 O3 2 2 8 O3 2 Working Channel Diameter mm 22 8 O3 2 22 8 O3 2 Working length mm 1800 2300 Working length mm 1800 2300 Working length mm 1800 2300 Working length mm 1800 2300 This device complies with the requirements of Directive 93 42 EEC concerning medical devices Class Ila Medical Device CE Directive Classification Heyinovo Chapter 2 Preparation Inspection and Operation WARNING Before every time use prepare and inspect the instrument as instructed below Inspect other equipment to be used with the instrument Damage or irregularity may result in patient or user safety such as infection control risk tissue irritation punctures hemorrhage or mucous membrane damage and may result in more This instrument was sterilized before shipment CAUTION Do not coil the Insertion Portion with a di
10. ameter of less than 15 cm This could damage the Insertion Portion Never use excessive force to open or close the Retrieval Basket This could damage the instrument 2 1 Preparation 1 Prepare all equipment and personal protective equipment which will be used with the instrument in accordance with their respective instruction manuals Appropriate personal protective equipment may include Eye wear a face mask moisture resistant clothing and chemical resistant gloves 2 Have a spare instrument available at any moment 2 2 Inspection 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 If any of following steps reveals irregularities do not use the instrument use a spare instead When operating the Grip to open and close the Retrieval Basket confirm that there is no peeling or looseness at the connecting section Open the Grasping Forceps Make sure that there are no unraveled wires disconnections sharp protrusions sharp edges or any other apparent abnormalities Confirm that the distal end of the instrument appears exactly as shown in the Table in
11. embrane damage It may also damage the endoscope and or Instrument Do not angulate the endoscope s bending Section or operate the Forceps Elevator while the Distal End of the Insertion Portion is extended from the Distal End of the endoscope This could result in punctures hemorrhages or mucous membrane damage Do not force the distal end of the Insertion Portion against body cavity tissue This could result in punctures hemorrhages or mucous membrane damage 2 3 14 Inserting Into the Endoscope WARNING Do not force the instrument if resistance to insertion is encountered Reduce the angulation or lower the Forceps Elevator until the instrument passes smoothly Forcing the instrument could result in punctures hemorrhages or mucous membrane damage It could also damage the endoscope and or instrument DOnotinsert the instrument into the endoscope if the Grasping Forceps is not completely retracted into the Insertion Portion The distal end of the Insertion Portion may extend from the endoscope tip abruptly This could result in punctures hemorrhages or mucous membrane damage It could also damage the endoscope or instrument When inserting the instrument into the endoscope make sure to hold the Grid firmly If the Grip is not held still the Grasping Forceps may open and extend from the endoscope tip abruptly This could result in punctures hemorrhages or mucous membrane damage It could also damage the endoscope or instru
12. ment Do not advance or extend the instrument abruptly This could result in punctures hemorrhages or mucous membrane damage It could also damage the endoscope or instrument 1 Pull the Grip until the Grasping Forceps is completely retracted into the Insertion Portion 2 Carefully insert the instrument into the opening of the forceps channel 3 Push the Grip until endoscopic vision appeared the insertion 2 3 2 Grasping WARNING Do not push the Grip abruptly The Basket may open abruptly This could result in punctures hemorrhages or mucous membrane damage It could also damage the endoscope or instrument 1 To grasp foreign bodies calculus or resected tissue operate the angulation of the endoscope Heyinovo and or advance the instrument the required distance Push the Grip to open the Retrieval Grasping Forceps 2 3 Surround the foreign body calculus or resected tissue with the opened Grasping Forceps 4 Pull the Grip to grasp the foreign body calculus or resected tissue 2 3 3 Retrieval WARNING Do not withdraw this instrument abruptly from the bile duct This could cause mucous membrane damage or edema CAUTION Do not retract retrieved foreign bodies calculus or resected tissue into the endoscope This could damage to the endoscope or instrument NOTE Toretrieve small calculus from the Bile Duct it may be useful to leave the Grasping Forceps open while withdrawing it 1 Ifthe endoscope is equipped with a
13. t explain or discuss clinical endoscopic procedures 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 Checkthe 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 C CE Mark Indicates that the device conforms to Council NITE Directive 93 42 EEC concerning medical devices Temperature limitation s Keep away from sunlight Heyinovo RU Keep dry T do ere Ce ee Qe edo qmm so o O 0 7 Sterilization method Sterilization of the product is sterilized with ethylene oxide
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