Olympus A00010A, Instructions For Use Manual

Page 1: ...INSTRUCTIONS FOR USE HF CABLE A00010A A00011A A00012A A0335 1 A0355 A0357 A0358 A0391 A0392 A0393 A60000C A60001C A60002C A60003C O0120 1 WA00013A WA00014A...

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Page 3: ...t functions 12 3 3 Operating elements 12 3 4 Symbols 21 3 5 Warranty 22 4 Before use 23 4 1 Inspection 23 4 2 Attaching the neutral electrode 24 4 3 Connecting the HF cable not for WA00014A 25 4 4 Con...

Page 4: ...infection 43 8 5 Inspection 46 9 Sterilization 48 9 1 Safety notes for sterilization 48 9 2 Steam sterilization 48 10 Repair shipment and disposal 51 10 1 Repair 51 10 2 Shipment 51 10 3 Disposal 52 1...

Page 5: ...esentative Keep the instructions for use in a safe accessible location 1 2 Conventions throughout this document Convention Explanation This is the safety alert symbol It is used to alert the user to p...

Page 6: ...l safety notes are located at the beginning of the instructions for use They address safety issues that apply to the general use and handling of the product 1 3 2 Specific safety notes Specific safety...

Page 7: ...TION Indicates a potentially hazardous situation which if not avoided can result in minor or moderate injury NOTICE Indicates a property damage message 1 4 Trademarks STERRAD NX V PRO are trademarks o...

Page 8: ...A00013A WA00014A HF cables for electrosurgical use in laparoscopic endoscopic and open surgery in combination with compatible active accessories and compatible electrosurgical generators 2 1 2 Contrai...

Page 9: ...of a system The clinical benefit of the device lies in its functionality as described by its intended purpose 2 2 Contact 2 2 1 Manufacturer Olympus Winter Ibe GmbH Kuehnstr 61 22045 Hamburg Germany C...

Page 10: ...on can cause injury to the patient and the user Repairs may only be performed by qualified servicing personnel that has been authorized by Olympus Refer to the section Repair on page 51 for more detai...

Page 11: ...ning Replace a damaged product or a product with improper functioning WARNING Risk of injury to the patient Improperly assembled equipment can cause infection electrical mechanical and thermal injury...

Page 12: ...efore use check that all items listed below are available Contact an Olympus representative or an authorized service center if any items are missing or damaged Contents 1 HF cable Instructions for use...

Page 13: ...13 Product description A00010A 1 Plug female For instrument 2 Plug male For electrosurgical generator A00011A 1 Plug female For instrument 2 Plug male For electrosurgical generator...

Page 14: ...14 Product description A00012A 1 Plug female For instrument 2 Plug male For electrosurgical generator A0335 1 1 Plug female For instrument 2 Plug male For electrosurgical generator...

Page 15: ...15 Product description A0355 1 Plug female For instrument 2 Plug male For electrosurgical generator A0357 1 Plug female For instrument 2 Plug male For electrosurgical generator...

Page 16: ...16 Product description A0358 1 Plug female For instrument 2 Plug male For electrosurgical generator A0391 1 Plug female For instrument 2 Plug male For electrosurgical generator...

Page 17: ...17 Product description A0392 1 Plug female For instrument 2 Plug male For electrosurgical generator A0393 1 Plug female For instrument 2 Plug male For electrosurgical generator...

Page 18: ...18 Product description A60000C 1 Plug female For instrument 2 Plug male For electrosurgical generator A60001C 1 Plug female For instrument 2 Plug male For electrosurgical generator...

Page 19: ...19 Product description A60002C 1 Plug female For instrument 2 Plug male For electrosurgical generator A60003C 1 Plug female For instrument 2 Plug male For electrosurgical generator...

Page 20: ...cription O0120 1 1 Plug female For instrument 2 Plug male For electrosurgical generator WA00013A 1 Right angle plug For working element 2 Straight plug For working element 3 Plug male For electrosurgi...

Page 21: ...3 Plug male For electrosurgical generator 3 4 Symbols This section gives an explanation for each symbol used on the product and on the packaging of the product Symbol Explanation Consult instructions...

Page 22: ...ective on Waste Electrical and Electronic Equipment WEEE this symbol indicates that the product must not be disposed of as unsorted municipal waste but should be collected separately General symbol fo...

Page 23: ...cribed in the section Inspection on page 23 WARNING Risk of injury to the patient There is a risk of electric shock if the HF cable is connected to mains electricity Do not connect the HF cable to a m...

Page 24: ...ct must be visually clean 3 Only use the product if it is visually clean Reprocess the product again if necessary Replace if necessary If the instrument is damaged or does not function properly replac...

Page 25: ...f the electrosurgical generator can damage the HF cable and the electrosurgical generator Make sure to connect the HF cable to correct and intended socket on the electrosurgrical generator 1 Connect t...

Page 26: ...l generator 1 Connect the right angle plug of the HF cable to the respective HF connector of the working element 2 Connect the straight connector of the HF cable to the respective HF connector of the...

Page 27: ...27 Before use 4 Insert the plug into the socket Universal of the electrosurgical generator Make sure that the markings on the plug and the socket are aligned...

Page 28: ...nstruments is limited There is a risk of sparkover leading to electrical injury thermal injury and unintended nerve stimulation Use a maximum output voltage of 1000 Vp For the maximum output voltage r...

Page 29: ...physiological monitoring electrodes as far away as possible from the electrodes of the HF instrument Do not use needle monitoring electrodes Use physiological monitoring equipment with HF current lim...

Page 30: ...E Risk of damage to the product Coiling the HF cable can damage the product Do not coil the HF cable into a circle of less than 10 cm 4 inch in diameter NOTICE Electromagnetic interference Using this...

Page 31: ...n the cable to disconnect the plug Always pull on the plug to avoid arcing The presettings may not produce optimum results for all tissue types and procedures If necassary adjust the settings to the p...

Page 32: ...roduct for reprocessing at the point of use These steps need to be performed immediately after use Preparation at the point of use 1 Remove patient debris from the product immediately after use by wip...

Page 33: ...to the instructions in this chapter Only use reprocessing methods which have been validated for the product Only use detergents which have been validated for the product Avoid any protein fixation pri...

Page 34: ...he reprocessing process is important because improper and incomplete reprocessing can cause infections and can damage the product The following sections of these instructions for use include detailed...

Page 35: ...A60003C O0120 1 WA00013A WA00014A Refer to section Manual cleaning on page 40 Automated cleaning and thermal disinfection Refer to section Automated cleaning and thermal disinfection on page 43 Manual...

Page 36: ...sterilization Olympus recommends to use steam sterilization for the product 7 2 Validated reprocessing methods In accordance with ISO 17664 the following table provides an overview over the reprocess...

Page 37: ...paration Selection according to the reprocessing method Cleaning Manual Ultrasonic Alkaline detergent Acidic detergent Neutral detergent Automated Alkaline detergent Acidic detergent Neutral detergent...

Page 38: ...38 General information for reprocessing Detailed instructions on the individual reprocessing methods are located in the following chapters of these instructions for use...

Page 39: ...t damage to the product Personal protective equipment Patient debris and reprocessing chemicals are hazardous If these substances come into contact with exposed skin they can cause infections or irrit...

Page 40: ...brushes Brushes must be intended for cleaning of medical devices Brushes must not have metal bristles or any other types of bristles that can scratch and damage the product Surface brushes Select a s...

Page 41: ...are no air bubbles on the HF cable while immersed 3 Thoroughly brush every gap at least 10 times with a surface brush 4 Using a syringe thoroughly rinse the HF cable and every gap at least 10 times w...

Page 42: ...ts Refer to the section Automated cleaning and thermal disinfection on page 43 8 3 1 Validated disinfectant Olympus has validated manual disinfection of the product with the following disinfectant Cid...

Page 43: ...least 100 ml of sterile deionized water 3 Repeat steps 1 and 2 twice for a total of 3 rinses Always use fresh portions of sterile deionized water for each rinse Drying 1 Dry the product using a clean...

Page 44: ...will be insuffificient and can cause infections Reprocess the product according to the instructions in these instructions for use 8 4 1 Validated detergents Olympus has validated automated cleaning of...

Page 45: ...ust be suitable for cleaning medical devices and deliver a minimum pressure of 1 bar 14 5 psi 4 Connect the rinsing device to a supply of deionized water Do not use tap water for rinsing because it ca...

Page 46: ...31 F Neutralization for 6 min Final rinsing for 3 min Removing from washer disinfector 1 Remove the product from the washer disinfector 2 Let the product cool down at room temperature 3 If the product...

Page 47: ...product has been properly reprocessed 2 Visually inspect the product thoroughly The product must be visually clean 3 Only use the product if it is visually clean Reprocess the product again if necess...

Page 48: ...affect the sterilization process and lead to insufficient reprocessing The product must be completely dry before sterilization Steam sterilization in Olympus plastic instrument trays Olympus plastic i...

Page 49: ...Do not stack instrument trays Do not load instrument trays on their side edges Validated sterilization accessories Olympus has validated steam sterilization of the product with the following steriliz...

Page 50: ...instructions for use of the autoclave 9 2 3 After sterilization Removing from the autoclave 1 Remove the product from the autoclave 2 Let the product cool down at room temperature Do not use addition...

Page 51: ...ion Otherwise Olympus can not be held responsible for the safety reliability and performance of the product There is no repair service for this product Loss of warranty Any guarantee or warranty claim...

Page 52: ...paper or sheets of foamed material and place them in a cardboard box If applicable use the respective transport protection e g instrument tray of the product Service centers do not accept warranty cl...

Page 53: ...12A HF cable monopolar A0335 1 HF cable monopolar A0355 HF cable monopolar A0357 HF cable monopolar A0358 HF cable monopolar A0391 HF cable monopolar A0392 HF cable monopolar A0393 HF cable bipolar A6...

Page 54: ...kes the full responsibility Future equipment can also be compatible For more information contact an Olympus representative Some of the products listed in this chapter may not be available in all sales...

Page 55: ...lectrosurgical generators satisfying the interface requirements can be connected to the HF cable For non Olympus electrosurgical generators refer to the below interface requirements A00010A A37014A A2...

Page 56: ...nerators non Olympus A00010A Pin diameter 6 mm Maximum rated voltage 2000 Vp Maximum crest factor 6 5 A00011A Pin diameter 4 mm spring basket Maximum rated voltage 2000 Vp Maximum crest factor 6 5 A00...

Page 57: ...e HF cable For non Olympus electrosurgical generators refer to the below interface requirements A6280 A6281 A6282 A6283 A6284 A6289 A6292 A6293 A6294 A6299 WA51138A A0355 A60101A A60102A A60201A A6021...

Page 58: ...generators non Olympus A0355 Pin diameter 6 mm Maximum rated voltage 2000 Vp Maximum crest factor 6 5 A0357 Pin diameter 4 mm spring basket Maximum rated voltage 2000 Vp Maximum crest factor 6 5 A035...

Page 59: ...ectrosurgical generators satisfying the interface requirements can be connected to the HF cable For non Olympus electrosurgical generators refer to the below interface requirements A0391 WA22066A WA22...

Page 60: ...generators non Olympus A0391 Pin diameter 6 mm Maximum rated voltage 2000 Vp Maximum crest factor 6 5 A0392 Pin diameter 4 mm spring basket Maximum rated voltage 2000 Vp Maximum crest factor 6 5 A039...

Page 61: ...us electrosurgical generators refer to the below interface requirements WA60800C WA60801C WA64050C WA64120C WA64200C WA64210C WA64310C WA64320C WA64360C WA64051C WA64121C WA64201C WA64211C WA64311C WA...

Page 62: ...62 Compatible equipment HF cable Interface requirements for electrosurgical generators non Olympus A60000C Pin diameter 4 mm 8 mm bushing Maximum rated voltage 1000 Vp Maximum crest factor 2 0...

Page 63: ...0C WA64200C WA64210C WA64310C WA64320C WA64360C WA64051C WA64121C WA64201C WA64211C WA64311C WA64321C WA64361C WA69410M WA69412M WA69414M WA69416M WA69418M WA69420M WA69422M WA69424M WA69002M WA69003L...

Page 64: ...ents HF cable Interface requirements for electrosurgical generators non Olympus A60001C Pin diameter 2 4 mm spring basket Pin spacing 22 mm Maximum rated voltage 1000 Vp Maximum crest factor 2 0 A6000...

Page 65: ...erators refer to the below interface requirements HF cable Interface requirements for electrosurgical generators non Olympus O0120 1 Pin diameter 4 mm spring basket Maximum rated voltage 2000 Vp Maxim...

Page 66: ...66 Compatible equipment WA00013A WA00014A Olympus electrosurgical generators with a Universal socket WA00014A WA22366A WA22367A WA00013A UES 40 UES 40S OLYMPUS UNIVERSAL...

Page 67: ...ngth Maximum outer diameter A00010A 4200 mm 3 2 mm A00011A 4200 mm 3 2 mm A00012A 4200 mm 3 2 mm A0335 1 3600 mm 3 9 mm A0355 3700 mm 4 0 mm A0357 3600 mm 3 9 mm A0358 3600 mm 3 9 mm A0391 4200 mm 3 2...

Page 68: ...91 A0392 A0393 O0120 1 A60000C 1000 Vp A60001C A60002C A60003C WA00013A WA00014A 13 3 Ambient conditions Operating conditions Ambient temperature 10 to 40 C 50 to 104 F Relative humidity 30 to 85 Stor...

Page 69: ...peak values to the effective value High crest factors indicate peaks To give a reliable statement on the effect that the height of a crest factor has it is necessary to distinguish if a cutting mode o...

Page 70: ...r approved by Olympus to perform certain tasks Radio frequency identification Radio frequency identification RFID uses electromagnetic fields to automatically identify and track electronically stored...

Page 71: ...bbreviation for Unique Device Identifier The Unique Device Identifier is a label on the medical device with human and machine readable information which allows to uniquely identify the device through...

Page 72: ...efore use 23 C Checking for mechanical defects 24 46 Checking for performed reprocessing 24 46 Cleaning 39 Cleaning brushes 40 Clinical benefits 9 Compatible equipment 54 Connecting the HF cable 25 Co...

Page 73: ...eutralizer 44 O Operating conditions 68 Operating elements 12 Ordering information 53 P Patient target group 8 Personal protective equipment 39 Preparation for reprocessing at the point of use 32 Prep...

Page 74: ...lization 48 Steam sterilization conditions 49 Sterilization 48 Storage conditions 68 Symbols 21 T Technical data 67 Trademarks 7 Transport conditions 68 U Use 28 Using the product 30 V Validated deter...

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Page 76: ...W7089000_09 2021 01 19 en Copyright 2021 Olympus Winter Ibe GmbH...