Adapter for FiAPC probes
Contents
1. erbe med de http www erbe med de ce 12 05 ERBE Elektromedizin GmbH 30132 347 U2. nee Seite 1 Freitag 24 Februar 2006 8 26 Adapter for FiAPC probes 20132 228 Notes on use Important Please read all information carefully These notes on use are not intended as a substitute for the user manual of the de vice being used If in doubt read this user manual or ask an ERBE representative or your distributor for assistance 48 A OBJ_DOKU 184657 001 1 USA fm Seite 2 Freitag 24 Februar 2006 8 26 08 Intended Use This Adapter is intended to connect FiAPC probes with filter to an ERBE Argon Plasma Coagulator Models APC 300 and APC 2 that have an APC standard receptacle Maximum electrical capacity The maximum electrical capacity of this product is e 4300 Vp Safety Instructions WARNING This product may only be used by trained medical staff who have been instructed in its use on the basis of the notes on use Before each use check that the product is intact Verify that there are no signs of physical damage If damaged do not use this product Protect this product from any form of mechanical damage Do not throw Do not use force Do not use in the presence of combustible or explosive materials Never lay instruments on the patient or in his her direct vicinity ERBE Elektromedizin expressly warns against modifying the product Any modification exempts ERBE Elektromedizin from any and all liability 6 lt gt gt OBJ_DOKU 184657 001 1 USA fm Seite 3 Freitag 24 F
3. ade to achieve the desired tissue effect Nonetheless please ensure that the gas flow rate and power limitations for the probe being used are not exceeded Connection to an APC 2 Model with APC standard receptacle 1 Turn on the ESU i e the VIO Model and select the basic program 2 Screw the argon gas connection of the Adapter 2 into the argon gas port of the APC 3 Insert the HF connector of the Adapter 1 into the multi functional socket of the APC If connected properly a click should be heard zn zu s d ZIY SA Zi OBJ_DOKU 184657 001 1 USA fm Seite 5 Freitag 24 Februar 2006 8 26 08 4 Once the Adapter is connected to the APC 2 Model the most conservative settings for Mode Gas Flow Effect and Power are automatically set on the ESU in the Basic program regardless of which FiAPC probe with filter is being attached If programmed correctly a specific APC program may be selected Please observe the gas flow rate and power limita tions in the instructions for the FiAPC probes with filter for the specific probe being connected used Further adjustments to the settings can be made to achieve the desired tissue effect Nonetheless please ensure that the gas flow rate and power limitations for the probe being used are not exceeded After use The Adapter can remain attached to the APC after use and be cleaned and wipe disinfected together with the Coagulator In this case please follow the
4. der 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 surface is completely covered In doing so also make sure the product is not touch ing other instruments or parts of instruments Comply with the recommended action soaking time ne A OBJ_DOKU 184657 001 1 USA fm Seite 8 Freitag 24 Februar 2006 8 26 08 9 Carefully remove the product from the bath 10 Rinse the product thoroughly for at least 1 minute with ster ile deionized water 11 Dry the product with compressed air Cleaning and Disinfection by Machine Use alkaline detergents 1 Place the product in a suitable rinsing basket carefully In doing so make sure the product is not touching other instru ments or parts of instruments 2 Start a tested program with the following properties Thermal disinfection 10 minutes at 199 F 93 C Final rinse with distilled or deionized water Sufficient product drying Check 1 Check the product for visible damage and wear Damage to the product e g cracks rough surface splin tering discoloration Damage to the product insulation and or cable connector insulation e g cracks and breaks If damaged do not use this product Packaging 1 Pack the product in disposable sterilization packaging single or double packaging made from paper polyethylene a
5. ebruar 2006 8 26 08 How to Use Only use cleaned and disinfected products Clean and disinfect this product before using it for the first time and before every subsequent use The surface of the product may be cleaned and disinfected by wip ing Follow the same instructions for cleaning and disinfection of the APC Unit per its User Manual If needed the product by itself may be cleaned disinfected and or sterilized as outlined in later sections of these instructions Check the product Check the product before every occasion of use If damaged do not use this product Connect the product Connection to an APC 300 Model 1 Turn on the ESU and APC 2 Screw the argon gas connection of the Adapter 2 into the argon gas port of the APC IN P PEE as OBJ_DOKU 184657 001 1 USA fm Seite 4 Freitag 24 Februar 2006 8 26 08 3 Insert the HF connector of the Adapter 1 into the multi functional socket of the APC If connected properly a click should be heard 4 Once the the Adapter is connected to the APC 300 Model a conservative default Gas Flow is automatically set regardless of the FiAPC probe with filter being attached As needed this level can be changed You have to set the Mode and Power on the ESU manually Please observe the gas flow rate and power limitations in the instructions for the FiAPC probes with filter for the specific probe being connected used Fur ther adjustments to the settings can be m
6. infection and sterilization cycles 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 Johnson amp Johnson Medical Limited Gargrave Skipton e 6 A OBJ_DOKU 184657 001 1 USA fm Seite 7 Freitag 24 Februar 2006 8 26 08 e Cleaning disinfection by machine in a disinfector G 7736 CD Miele amp Cie GmbH amp Co G tersloh Germany using neodisher mediclean forte detergent Dr Weigert GmbH amp Co KG Hamburg Germany in accordance with the recom mended washing program e Autoclave Manual Cleaning and Disinfection Use a liquid detergent suitable for soaking Use a disinfectant compatible with the detergent suitable for soak ing Only disinfect clean products that have dried slightly 1 Prepare a cleaning bath according to the manufacturer s direc tions 2 Place the product in the bath so that the surface is completely covered In doing so also make sure the product is not touch ing 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 Carefully remove the product from the bath 5 Rinse the product thoroughly for at least 1 minute un
7. nd or in a sterilization container ne a OBJ_DOKU 184657 001 1 USA fm Seite 9 Freitag 24 Februar 2006 8 26 08 Sterilization Only sterilize products that have been cleaned disinfected Please follow the sterilizer manufacturer s recommendations on loading and handling instruments for the autoclave process ERBE Elektromedizin recommends steam sterilization with the method described below If other sterilization methods are used ERBE Elektromedizin shall bear no responsibility Steam Fractionated vacuum method holding time 5 minutes at 270 to 273 F 132 to 134 C or Fractionated vacuum method holding time 20 minutes at 250 F 121 C nz 6 gt OBJ_DOKU 184657 001 1 USA fm Seite 10 Freitag 24 Februar 2006 8 26 08 10 AV gt OBJ_DOKU 184657 001 1 USA fm Seite 11 Freitag 24 Februar 2006 8 26 08 11 KIB lt gt 7 I OBJ_DOKU 184657 001 1 USA fm Seite 12 Freitag 24 Februar 2006 8 26 08 Manufacturer Distributed by ERBE Elektromedizin GmbH Waldh rnlestr 17 ERBE USA Inc 72072 T bingen Germany 2225 Northwest Parkway P O Box 14 20 Marietta GA 30067 72004 T bingen Germany Customer Support 800 778 ERBE Telephone 0049 0 70 71 755 0 3723 Telefax 0049 0 70 71 755 179 Telephone 770 955 44 00 Email sales erbe usa com Customer Support Telephone 0049 0 70 71 7 55 123 Telefax 0049 0 70 71 7 55 51 23 Email support
8. same instructions for cleaning and disin fection of the APC Unit in its User Manual To ensure that cross contamination doesn t take place the product may need to be cleaned disinfected and or sterilized by itself For example in a situation where the Adapter has come into contact with biohazardous contaminant s like blood or other bodily flu ids disinfection wiping may not be adequate In this case follow the reprocessing instructions below Disconnect the product from the unit 1 Lateral forces can damage the receptacle Therefore ensure you pull the HF connector of the Adapter out of the multi functional socket in a straight line 2 Unscrew the argon gas connection of the Adapter and pull it out of the argon gas port in a straight line NW AY A OBJ_DOKU 184657 001 1 USA fm Seite 6 Freitag 24 Februar 2006 8 26 08 Cleaning Disinfection Sterilization if Needed Safety Instructions On no account use sharp or abrasive objects for cleaning purposes It is essential to follow the cleaning agent and disinfectant manu facturers instructions Disinfectants must be rinsed off thoroughly after use The product can be cleaned disinfected up to a maximum temper ature of 203 F 95 C The product can be sterilized up to a maximum temperature of 280 F 138 C Do not sterilize in hot air oven Reconditioning Limitation The product has been found to work as intended after at least 50 cleaning dis
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