Ignition Adapter for ESU/APC
Contents
1. The product can be sterilized up to a maximum temperature of 280 F 138 C Do not sterilize in hot air oven 4 2 Reconditioning Limitation Frequent reconditioning can damage this product Observe the safety instructions for checking the product With visible dam age or functional impairment the product may no longer be used e ag WZ OBJ DOKU 184978 002 fm Seite 7 Montag 12 Dezember 2011 3 57 15 4 3 Recommended Processing Agents Equipment The listed cleaning disinfection agents and sterilization equip ment have been validated with the following processing proce dures e Manual cleaning disinfection with the detergent Cidezyme LF Enzol and disinfectant Cidex OPA John son amp Johnson Medical Limited Gargrave Skipton e Machine cleaning and disinfection in G 7836 CD disinfec tor Miele amp Cie KG G tersloh Germany with the cleaning agent neodisher mediclean forte Dr Weigert GmbH amp Co KG Hamburg Germany with the recommended wash ing program e Autoclave 4 4 Recommended Methods ERBE recommends the preparation procedures described be low Equivalent different procedures are possible if not explicitly excluded It is incumbent on the user to ensure the suitability of the actual procedures used by means of suitable measures e g validation routine monitoring check of material compatibility 4 5 Required Aids Reprocessing step Items Needed Precl2. Zs OBJ DOKU 184978 002 fm Seite 1 Montag 12 Dezember 2011 3 57 15 Notes use SIB Ignition Adapter for 20183 072 g WZ OBJ DOKU 184978 002 fm Seite 2 Montag 12 Dezember 2011 3 57 15 Table of Contents IMPORTANT 2 0 2 ce eee 3 1 Intended 3 2 Safety Instructions 3 Use ii w kaba leaped inated Lane ar 4 3 1 Check the product nannaa aaaea 4 32s JON NON T S e tise AA ee a 4 3 3 What should you do if the argon plasma does not VO EN LO Ze a aaa ak EE 5 4 Cleaning Disinfection Sterilization 6 4 1 Safety 1 5 6 4 2 Reconditioning Limitation 6 4 3 Recommended Processing Agents Equipment 7 4 4 Recommended Methods 7 4 5 Required Aids 7 4 6 PFEGIEANING s RIG bye VAR REAM BERS ES 8 4 7 Manual Cleaning and Disinfection 8 4 8 Cleaning and Disinfection by Machine 9 4 9 GheGK EE 10 4 10 10 4 11 5 10 2 e ag WZ OBJ DOKU 184978 002 fm Seite 3 Montag 12 Dezember 2011 3 57 15 IMPORTANT Please read all information carefully These notes on use do not replace the user manual of the APC un
3. 12 Dezember 2011 3 57 15 Manufacturer Distributed by USA Territory ERBE Elektromedizin GmbH ERBE USA Inc Waldh rnlestr 17 2225 Northwest Parkway 72072 Tubingen Germany Marietta GA 30067 Tel 49 7071 755 0 Customer Support 800 778 ERBE 3723 Fax 49 7071 755179 Tel 770 955 4400 EMail info erbe med com Fax 777 955 2577 www erbe med com EMail sales erbe usa com www erbe usa com ERBE Elektromedizin GmbH 30183 154 11 11 e
4. eaning Soft cloth Manual cleaning disinfection Soft disposable cloth lint free Compressed air gun 2 bar maximum e WZ OBJ DOKU 184978 002 fm Seite 8 Montag 12 Dezember 2011 3 57 15 4 6 Precleaning Use water for precleaning a non fixing disinfectant if neces sary 1 Remove surface contaminants with a soft cloth To do so place the product in a water bath and or rinse the product under running water 4 7 Manual Cleaning and Disinfection Use a liquid detergent suitable for soaking Use a disinfectant compatible with the detergent suitable for soaking If not otherwise specified use water for rinsing which is at least of drinking water quality Only disinfect clean products that have dried slightly 1 Prepare a cleaning bath according to the manufacturer s di rections 2 Place the product in the bath so that the surface is com pletely covered In doing so also make sure the product is not touching other instruments or parts of instruments Comply with the recommended action soaking time 3 If necessary clean off any remaining contaminants from the product with a clean soft cloth 4 Carefully remove the product from the bath 5 Rinse the product thoroughly for at least 1 minute under flowing water 6 Dry the product with compressed air 7 Prepare a disinfectant bath according to the manufacturer s directions 8 Place the product in the bath so that the s
5. en the probe and Ignition Adapter If it does not please read the next section N St Pe Once the plasma has ignited it normally ignites without delay for subsequent activations 8 Now connect the neutral electrode to the ESU 3 3 What should you do if the argon plasma does not ignite 1 Check the argon flow Is it sufficient 2 Check all the connections Are they okay intact and se cure 3 Inspect the tip of the APC probe Is it burned off plugged or soiled If possible clear the obstruction or use a new APC probe d WZ OBJ DOKU 184978 002 fm Seite 6 Montag 12 Dezember 2011 3 57 15 4 Cleaning Disinfection Sterilization To ensure that cross contamination doesn t take place the product may need to be cleaned disinfected and or sterilized For example in a situation where the Adapter has come into contact with biohazardous contaminant s like blood or other bodily fluids disinfection wiping may not be adequate In this case follow the reprocessing instructions below 4 1 Safety Instructions ERBE Elektromedizin recommends machine cleaning disinfection On no account use sharp or abrasive objects for cleaning pur poses It is essential to follow the cleaning agent and disinfectant man ufacturers instructions Disinfectants must be rinsed off thoroughly after use The product can be cleaned disinfected up to a maximum tem perature of 203 F 95 C
6. f the product still shows visible contamination after the program has ended e ag WZ OBJ DOKU 184978 002 fm Seite 10 Montag 12 Dezember 2011 3 57 15 4 9 Check 1 Check the product for visible damage and wear Damage to the product e g cracks rough surface splintering Damage to the product insulation and or cable connec tor insulation e g cracks and breaks If damaged do not use this product 4 10 Packaging 1 Pack the product in disposable sterilization packaging sin gle or double packaging made from paper polyethylene and or in a sterilization container 4 11 Sterilization Only sterilize products that have been cleaned and disinfected ERBE Elektromedizin recommends steam sterilization with the method described below If other sterilization methods are used ERBE Elektromedizin shall bear no responsibility Steam sterilization e Pre vacuum method with adequate product drying e Holding time 3 to 18 minutes at 270 to 273 F 132 to 134 C e Sterilizers in accordance with applicable national standards and regulations e g DIN EN 13060 or DIN EN 285 e Sterilization process validated according to DIN EN ISO 17665 Please follow the recommendations issued by the sterilizer manufacturer concerning loading handling etc 10 WZ OBJ DOKU 184978 002 fm Seite 11 Montag 12 Dezember 2011 3 57 15 d WWG p OBJ DOKU 184978 002 fm Seite 12 Montag
7. it and Electrosurgical unit used Read the user manuals of the APC unit and Electrosurgical unit and ask ERBE or your distribu tor in case of doubt 1 Intended Use The Ignition Adapter for ESU APC is intended to perform an ignition test with flexible ERBE APC probes The Ignition Adapter can only be used on the following ERBE Elektromedizin units e ElectroSurgical Unit ESU ICC 200 or 350 in conjunction with an Argon Plasma Coagulator Model APC 300 ESU VIO Model in conjunction with an Argon Plasma Co agulator Model APC 2 2 Safety Instructions WARNING This product may only be used by medical personnel who have been trained per these instructions Before each use check that the product is intact including all the insulation Verify that there are no signs of physical dam age If damaged do not use this product 1 In User Manuals the Ignition Adapter for ESU APC is referred to as tester GES WZ n OBJ DOKU 184978 002 fm Seite 4 Montag 12 Dezember 2011 3 57 15 Do not use in the presence of combustible or explosive materi als Protect this product from any form of mechanical damage Do not throw Do not use force ERBE Elektromedizin expressly warns against modifying the product Any modification exempts ERBE Elektromedizin from any and all liability 3 How to Use Clean disinfect and or sterilize this product before using it for the first time and before every subseq
8. uent use 3 1 Check the product Before each use check that the product is intact including all the insulation Verify that there are no signs of physical dam age If damaged do not use this product 3 2 Ignition test Before and during the ignition test do not touch any non sterile objects with the the APC probe You must not touch the Ignition Adapter or the beam plasma stream during the testing Do not ignite fire the APC probe at the Ignition Adapter for lon ger than 5 seconds Continuous activation or several consecu tive activations may damage the Ignition Adapter or APC probe For ESU ICC Models Only use the neutral electrode settings split neutral electrode or any neutral electrode GES WZ OBJ DOKU 184978 002 fm Seite 5 Montag 12 Dezember 2011 3 57 15 Switch on unit s Select the following unit settings on the ESU On VIO Models FORCED APC 25 50 Watt On ICC 350 SPRAY COAG 40 60 Watt On ICC 200 APC Mode coded for by Display two digits for the power 40 60 Watt Connect the APC probe to the Argon Plasma Coagulator Plug the Ignition Adapter into the NE receptacle on the ESU Press the Purge button of the Argon Plasma Coagulator Hold the tip of the the APC probe at a distance of 1 4 mm toward the middle of the Ignition Adapter 7 Depress the blue pedal of the footswitch to activate the APC probe A plasma stream should form betwe
9. urface is com pletely covered In doing so also make sure the product is e WZ OBJ DOKU 184978 002 fm Seite 9 Montag 12 Dezember 2011 3 57 15 not touching other instruments or parts of instruments Comply with the recommended action soaking time 9 Carefully remove the product from the bath 10 Rinse the product thoroughly for at least 1 minute with sterile deionized water 11 Dry the product with compressed air 4 8 Cleaning and Disinfection by Machine The washer disinfector must have fundamentally certified effec tiveness e g CE marking according to DIN EN ISO 15883 The detergent and disinfectant must be suitable for medical de vices made of plastic and metal and have a pH value between 5 5 and 11 If highly alkaline cleaners are used metal surfaces may be dis colored However this does not affect the integrity of the prod uct It is essential to follow the cleaning agent and disinfectant man ufacturers instructions 1 Place the product in a suitable rinsing basket carefully In doing so make sure the product is not touching other in struments or parts of instruments 2 Connect the product to a rinsing station 3 Start a tested program with the following properties Thermal disinfection 5 to 10 minutes at 194 to 199 F 90 to 93 Final rinse with distilled or deionized water Sufficient product drying 4 Repeat the machine cleaning disinfection process i
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