Quest Engineering ART-LAP-0008 User Manual Download

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Laparoscope

Instructions for Use

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Summary of Contents for ART-LAP-0008

Page 1: ...Laparoscope Instructions for Use ...

Page 2: ...Laparoscope Instructions for Use ...

Page 3: ...pport Email info quest mi com Phone 1 33 07 52 65 96 Fax 1 33 07 52 65 97 Document Identification Document QMI0024_IFU_EN_07052021_v1_1 Revision 1 1 Copyright statement 2021 Quest Medical Imaging B V All rights reserved No part of this document may be photocopied reproduced or translated in any way without the prior written consent of Quest Medical Imaging B V Every effort has been made to make th...

Page 4: ...Prior Use 4 2 3 Intraoperative Use 4 3 Assembly and Disassembly 5 3 1 Combinations 6 4 Cleaning Disinfection 6 4 1 Safe treatment 6 4 2 After every use 6 4 3 Manual cleaning disinfection 7 4 4 Machine cleaning disinfection 7 4 5 Maintenance checking 8 4 6 Packing 8 5 Sterilization 8 5 1 General Remarks 8 5 2 Sterilization method 9 5 3 Storage 9 5 4 Information on validation 9 6 Accessories spare p...

Page 5: ...arnings may result in injury to the patient or user CAUTION indicates risks to the equipment Failure to follow cautions may result in product damage Note provides special information to clarify instructions or present additional useful information 1 2 Indication for Use During the examination diagnosis and or in combination with endoscopic accessories treatment Laparoscopes serve exclusively to vi...

Page 6: ...pectrum Laparoscopes Patient or user injury and or instrument damage can result Let exclusively the respective dealer or a repair facility authorized by Quest Medical Imaging carry out repair works Use exclusively original spare parts for repair works Before sending it back Clean disinfect and sterilize the light guide cable and laparoscope thoroughly prior to returning for repair Note The guarant...

Page 7: ...disinfection and prior to every use check the laparoscope for cleanness function and damages e g insulation loose bent broken chapped rough worn broken off parts etc WARNING Do not use a damaged or defective laparoscope Contact Quest Medical Imaging 2 3 Intraoperative Use WARNING It is possible that light with a high radiation energy emerges from the viewing window and raises the temperature of th...

Page 8: ...roscope 1 Objective with sapphire window 2 Duct 3 Body 4 Eyepiece 5 Color code ring line of vision 6 Adapter for light guides removable 7 Adapter for light conductors removable 8 Connecting piece for light guides ACMI Note Only the light guide connector can be dissembled from the Laparoscope Table 2 overview of all laparoscopes provided by Quest Medical Imaging Article Number Line of vision Color ...

Page 9: ...leaning agent o vapor sterilization Use exclusively cleaning agents for complete protein dissolution WARNING Do not exceed maximum number of treatments see manual of respective product WARNING Do not use laparoscopes or accessories once their product lives are expired see manual of respective product WARNING Treat laparoscopes and accessories before the first and after every use WARNING Make sure ...

Page 10: ...cal disinfection always rinse sufficiently and thoroughly under clear running water Observe indications of disinfectant manufacturer 7 Remove stubborn dirt with a soft plastic brush Do not use abrasive cleaning agents or metal brushes 8 Clean lumens and channels using soft round plastic brushes and rinse thoroughly 9 Use fully desalinated water for final rinsing 10 Dry laparoscopes with an absorbe...

Page 11: ...essories for protein residue and dirt Clean contaminated or dirty laparoscopes and accessories again Lightly grease movable parts e g hinges and ends with serializable vapor permeable protective oil Use exclusively bio compatible paraffin oil based lubricants exception latex and rubber Assemble detachable laparoscopes and accessories After every cleaning disinfection check laparoscopes and accesso...

Page 12: ...per laminate sterilization bags Type Steriking Metal sterilization containers paper laminate sterilization bags Type Steriking Note Exclusively vapor sterilize laparoscopes marked autoclavable CAUTION Do not accelerate cooling of laparoscopes and accessories This will cause damage and reduce the product life Allow laparoscopes and accessories to cool down to room temperature 23 2 C Open packages a...

Page 13: ...rse endoscopes and accessories in a non corrosive non fixing disinfection bath that is changed daily Leave endoscopes and accessories in disinfection bath for a maximum of 8 hours Before machine cleaning and disinfection rinse endoscopes and accessories thoroughly under clear running water 8 1 2 Dry Disposal Machine clean endoscopes and accessories For the disposal mind the following Dispose of th...

Page 14: ...m Laparoscope bear the CE mark Quest Medical Imaging B V herewith declares that a We have verified the mutual compatibility of the devices of the Quest Spectrum Laparoscope in accordance with the manufacturers instructions and have carried out his operations in accordance with these instructions b We have packaged the Quest Spectrum Laparoscope and supplied relevant information to users incorporat...

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