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APC-handles

1. 60 ml disposable syringe with male luer lock connection Soft cloth Manual cleaning disinfection Female to female luer lock adapter irrigation adapter 60 ml disposable syringe with male luer lock connection Soft cloth Cleaning brushes for medical devices 1 diameter 0 05 1 5 mm length min 200 cm for lumen clean ing and 2 short handle brush for external cleaning Compressed air gun 29 psi maximum Machine cleaning disinfec Female to female luer lock tion adapter irrigation adapter 6 6 Disassembly 1 Disconnect the APC applicator HF electrode from the APC handle 12 c cse SZ eS e OBJ DOKU 185032 005 fm Seite 13 Montag 18 November 2013 1 33 13 e 6 7 Precleaning Use water for precleaning a non fixing disinfectant if neces sary 1 Rinse the product under running water 2 Remove surface contaminants with a soft cloth 3 Screw the luer lock adapter onto the argon gas connection of the handle 4 Fill up the syringe completely with irrigation liquid Screw the syringe onto the luer lock adapter Flush the internal lumen of the product to remove as much contamination as possible 7 Remove the syringe Leave the luer lock adapter on the product for the next reprocessing steps ou 6 8 Manual Cleaning and Disinfection Use a liquid detergent suitable for the preparation of a dipping bath Use a disinfectant compatible with the detergent su
2. WES e OBJ DOKU 185032 005 fm Seite 1 Montag 18 November 2013 1 33 13 Notes on use APC handles 20132 208 20132 209 e M 09 SZ e OBJ DOKU 185032 005 fm Seite 2 Montag 18 November 2013 1 33 13 Table of Contents VI BWN IMPORTANT 2 0 ee Product Description Normal Maximum Electrical Capacity Safety Instructions Howto Use ses athena s RR apa 5 1 Only use sterile products 5 2 Check the product 5 3 Assembling the product 5 4 Connectthe product 5 5 Conducting a performance test Cleaning Disinfection Sterilization 6 1 5 1 lt 6 2 Reconditioning Limitation 6 3 Recommended Processing Agents Equipment 6 4 Recommended 6 5 Required Aids 6 6 5 6 7 Precleaning s eo deu tse ge n eva es 6 8 Manual Cleaning and Disinfection 6 9 Cleaning and Disinfection by Machine 6 10 Check sac RE hehe sare ad 6 11 Packaging d pk a wh deb eae alse nae da 6 12 SterilizatiOnz ace redes aee e A AS T eS e OBJ DOKU 185032 005 fm Seite 3 Mon
3. do not use this product 4 4 Danger of fire in bodily cavities Before using the ESU APC system it is essential to ensure that there are no combustible or combustion promoting gases in the lumen of the organ s involved in the procedure cc cse SZ eS e OBJ DOKU 185032 005 fm Seite 6 Montag 18 November 2013 1 33 13 e 4 5 Gas embolisms gas emphysema To prevent gas embolisms the argon flow rate must not be set high enough that argon is blown into open vessels To prevent gas embolisms or emphysema never point the distal end of APC applicators directly towards open vessels or press against tissue 4 6 Danger of unintentional damage to nerve structures Bear in mind that during an APC application in the direct vicinity of nerve structures stimulation may be induced by electric cur rents In the case of nerves which require protection it is advisable to keep the APC activation time short and adapt minimum power output to the required indication 4 7 Danger of burns Argon plasma can strongly heat electrically conductive materi als e g metal To avoid burns never direct argon plasma to wards electrically conductive materials 4 8 Risk of accidental tissue damage with the APC 300 Model If the gas tanks of the APC 300 Model are not opened or are completely empty a spray coagulation without argon plasma is performed with the instrument after each activation There is an audible warning signal the tanks on th
4. PC 300 ICC The respective COAG mode must be activated on APC 300 and ICC If this is not the case the handle is damaged SZ eS e OBJ DOKU 185032 005 fm Seite 10 Montag 18 November 2013 1 33 13 e For APC 2 VIO The COAG mode must be activated on the VIO If this is not the case the handle is damaged 3 Testing the ReMode button Switch on a program with two setting options on the VIO Press the black ReMode button several times Each time it must be switched back and forth between both setting options of the program on the VIO If this is not the case the handle is damaged If damaged do not use this product 6 Cleaning Disinfection Sterilization 6 1 Safety Instructions ERBE Elektromedizin recommends machine cleaning disinfection May be cleaned in an ultrasonic bath On no account use sharp or abrasive objects for cleaning pur poses Disinfectants must be rinsed off thoroughly after use Maximum air pressure during drying 29 psi 2 bar Maximum water pressure during rinsing 29 psi 2 bar During machine cleaning and disinfection do not exceed 203 F 95 C It is essential to follow the cleaning agent and disinfectant man ufacturers instructions During sterilization do not exceed 280 F 138 C Do not sterilize in hot air oven 1 Can only be tested with handle 20132 208 and connection of the handle on an APC 2 in combination with a VIO D unit 10 c cs
5. applicators This product may be used with ERBE HF electrodes with a shaft diameter of 4 mm Please see the Safety Instructions chapter for guidance on using non ERBE HF electrodes 1 Screw an ERBE APC applicator on the APC handle or insert an ERBE HF electrode into the APC handle 5 4 Connect the product Connection to an APC 2 Model After connecting this product to an APC 2 all required operat ing parameters are automatically set on the VIO electrosurgical unit If you have called up the basic program the default values specified at the factory for the product are set If you have called up an individual program the values of this program are set 1 Screw the argon gas connection of the handle into the ar gon receptacle of the APC unit ERBE recommends using the additional membrane filter Art No 20132 059 2 Insert the HF connector of the handle into the multifunc tional receptacle of the APC unit 3 Make sure that the handle of the VIO electrosurgical unit was detected and the desired operating parameters are set 4 Only when using an HF electrode Switch the argon flow to the electrosurgical unit off argon flow 0 l min Other wise an error tube obstruction is reported when activat ing the handle of the electrosurgical unit Connection to an APC 300 Model After connecting this product to an APC 300 the gas flow is au tomatically set on the APC 300 If you have called up program 0 the default value
6. contamination as possible Lastly brush off the outer surface of the product Note Use a short handle brush 3 Flush out and rinse the product with warm water to remove any contaminants and cleaning agent residue Screw the luer lock adapter back onto the argon gas connection of the handle Use a syringe to flush out the internal lumen until the water runs clear Thoroughly rinse the outer surface of the product 4 Flush out and rinse the product with sterile water Proceed as in the previous step 5 Remove the syringe and luer lock adapter 6 Dry the inside and outside of the product Use a syringe or compressed air max 29 psi to blow out the internal lumen until no more liquid is dis charged Completely dry the outer surfaces of the product 14 SZ eS e OBJ DOKU 185032 005 fm Seite 15 Montag 18 November 2013 1 33 13 e 7 If contaminants are still visible on the product or come out of the product after cleaning disinfection repeat the entire process 6 9 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 12 3 Prohibited ingredients organic solvents oxidizing agents halogens aromatic halogenated hydrocarbons It is essential to f
7. e SZ eS e OBJ DOKU 185032 005 fm Seite 11 Montag 18 November 2013 1 33 13 e 6 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 6 3 Recommended Processing Agents Equipment The listed cleaning disinfection agents and sterilization equip ment have been validated with the following processing proce dures Manual cleaning disinfection with Cidezyme Enzol En zymatic Detergent Johnson amp Johnson Medical Limited Gargrave Skipton e Cleaning disinfection by machine in disinfector G 7836 CD Miele amp Cie KG G tersloh Germany using neodisher amp mediclean forte detergent Dr Weigert GmbH amp Co KG Hamburg Germany in accordance with the rec ommended washing program 6 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 11 cc cse SZ eS e OBJ DOKU 185032 005 fm Seite 12 Montag 18 November 2013 1 33 13 A 6 5 Required Aids Reprocessing step Items Needed Precleaning Female to female luer lock adapter irrigation adapter
8. e display of the APC 300 Model blink and an error message appears In the spray coagulation mode there is a danger of unintentional tis sue damage the instrument can also be damaged c cse SZ e OBJ DOKU 185032 005 fm Seite 7 Montag 18 November 2013 1 33 13 e Before using the APC 300 Model always open the gas tanks Observe the self check performed by the Unit How much gas is there left in the tanks The tank symbols on the display of the APC 300 Model give an approximate indication of the quantity of gas remaining Never work with two gas tanks which are almost completely empty When one gas tank is empty the APC 300 Model switches over to the second gas tank automatically once the regulator is connected Always observe the warning signals and error messages 4 9 Modification of the product by the user ERBE Elektromedizin expressly warns against modifying the product Any modification exempts ERBE Elektromedizin from any and all liability 5 How to Use 5 1 Onlyuse sterile products Clean disinfect and sterilize this product before using it for the first time and before every subsequent use 5 2 Check the product The product and in particular the connecting cable s insulation must be checked for damage before each use If damaged do not use this product M 0 e SZ eS e OBJ DOKU 185032 005 fm Seite 8 Montag 18 November 2013 1 33 13 e 5 3 Assembling the product Use this product with ERBE APC
9. erbe erbe india com Italia Milano Tel 39 02 647468 1 E Mail info erbe italia com Latin America Peru Tel 51 1 273 7448 E Mail info Qerbe peru com Middle East Africa Lebanon Tel 961 9 644 777 E Mail info Qerbe lebanon com Nederland LJ Werkendam Tel 31 183 509 755 E Mail klantenservice Q erbe nl a ep OBJ DOKU 185032 005 fm Seite 18 Montag 18 November 2013 1 33 13 Osterreich Wien Tel 43 1 893 24 46 E Mail info erbe austria com Polska Warszawa Tel 48 22 642 25 26 E Mail sales erbe pl 7 495 287 9539 info erbe russia com Schweiz Suisse Svizzera Winterthur Tel 41 52 233 37 27 E Mail info Q erbe swiss ch South East Asia Singapore Tel 65 65 6283 45 E Mail info erbe singapore com United Kingdom Leeds Tel 44 113 253 0333 E Mail sales erbe uk com USA Marietta GA Tel 1 770 955 4400 E Mail info erbe usa com C 0124 ERBE Elektromedizin GmbH 30132 320 09 13
10. itable for the preparation of a dipping bath 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 12 3 Prohibited ingredients organic solvents oxidizing agents halogens aromatic halogenated hydrocarbons It is essential to follow the cleaning agent and disinfectant man ufacturers instructions 1 Prepare dipping bath soak product Use the cleaning solution to flush the internal lumen several times Fill the internal lumen with cleaning solution Remove the syringe and luer lock adapter 13 SZ eS e OBJ DOKU 185032 005 fm Seite 14 Montag 18 November 2013 1 33 13 e Submerge the product into the cleaning solution com pletely The immersion time must be at least 5 minutes Take the product out of the dipping bath and extend the cable as far as possible for the next work step 2 Brush off internal and external contaminants Insert the cleaning brush into the proximal argon gas connection as far as it will go and pull out again Clean the brush if necessary Then repeat the brushing step at least twice thereby re moving as much contamination as possible Switch to the distal instrument connection Insert the cleaning brush into the instrument connec tion as far as it will go and pull out again Clean the brush if necessary Then repeat the brushing step at least twice thereby re moving as much
11. ollow the cleaning agent and disinfectant man ufacturers instructions 1 Place the product in a suitable rinsing basket carefully In doing so make sure that the product does not touch other instruments or parts of instruments and that the cable of the handle is only rolled up loosely 2 Connect the product via the irrigation adapter 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 with a tolerance in accordance with DIN EN ISO 17665 Ag gt 3000 Final rinse with distilled or deionized water Sufficient product drying 4 If contaminants are still visible on the product after the end of the routine repeat precleaning and machine cleaning and disinfection 5 Disconnect the irrigation adapter from the product upon the completion of the washing cycle 15 SZ eS e OBJ DOKU 185032 005 fm Seite 16 Montag 18 November 2013 1 33 13 e 6 10 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 2 Check the mechanical functionality of the product Can all buttons be pressed If damaged do not use this product 6 11 Packaging 1 Pack the product in disposable sterilization packaging sin gle or double packaging made from
12. paper polyethylene and or in a sterilization container 6 12 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 Holding time 3 to 18 minutes at 270 to 275 F 132 to 135 with a tolerance in accordance with DIN EN ISO 176655 Sterilizers in accordance with applicable national standards and regulations e g DIN EN 13060 or DIN EN 285 Sterilization process validated according to DIN EN ISO 17665 Please follow the recommendations issued by the sterilizer manufacturer concerning loading handling etc 16 cc cse Zs OBJ DOKU 185032 005 fm Seite 17 Montag 18 November 2013 1 33 13 d ud Manufacturer ERBE Elektromedizin GmbH Waldh rnlestr 17 72072 T bingen Deutschland Tel 49 7071 755 0 Fax 449 7071 755 179 E Mail info Qerbe med com www erbe med com Customer Hotline Tel 49 7071 755 123 Fax 449 7071 755 5123 E Mail support erbe med com Distributors Belgi Belgique Belgien Diegem Tel 32 2 403 1360 E Mail info Qerbe belgium com PE EHE if 86 21 62758 440 86 info erbechina com France Limonest T l 33 4 78 64 92 55 E Mail erbe erbe france com India Chennai Tel 91 44 7155 5100 01 E Mail
13. specified at the factory for the product is c cse SZ eS e OBJ DOKU 185032 005 fm Seite 9 Montag 18 November 2013 1 33 13 e set If however you have called up an individual program the gas flow for this program is set All other operating parameters are not automatically set 1 Screw the argon gas connection of the handle into the ar gon receptacle of the APC unit ERBE recommends using the additional membrane filter Art No 20132 059 2 Insert the HF connector of the handle into the multifunc tional receptacle of the APC unit 3 Make sure that instrument number 4 is displayed on the APC unit 4 Only when using an HF electrode Switch the argon flow to the APC unit off argon flow 0 l min Otherwise a warn ing signal is emitted when activating the handle and an er ror message appears 5 5 Conducting a performance test Before every use conduct a performance test The APC handle can be activated with a finger switch or foot Switch These instructions describe the function test with finger Switch activation It is just as good to conduct the function test with foot switch activation 1 Press the yellow CUT button For APC 300 ICC The respective CUT mode must be activated on 300 and ICC If this is not the case the handle is damaged For 2 VIO The CUT mode must be activated on the VIO If this is not the case the handle is damaged 2 Press the blue COAG button For A
14. tag 18 November 2013 1 33 13 e p SN IMPORTANT Please read all information carefully These notes on use do not replace the user manual of the APC unit 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 Caution Federal law USA restricts this device to sale by or on the order of a physician 1 Product Description Yellow button Activates CUT Blue button Activates COAG 3 ReMode button for handle 20132 208 only Toggles be tween two setting options of a program Argon gas connection HF connector N AT SZ e OBJ DOKU 185032 005 fm Seite 4 Montag 18 November 2013 1 33 13 e 2 Normal Use No 20132 208 VIO APC handle with 3 buttons w ReMode function can only be used on ERBE Electrosurgical Generator ESU VIO Models in combination with the ERBE Argon Plasma Coagulator APC Model APC 2 No 20132 209 APC handle with 2 buttons can be used on ERBE VIO ESUs in combination with the ERBE APC 2 as well as ERBE ICC ESUs in combination with the ERBE 300 Use this product with ERBE APC applicators This product may be used with ERBE HF electrodes with a shaft diameter of 4 mm Please see the Safety Instructions chapter for guidance on using non ERBE HF electrodes 3 Maximum Electrical Capacity The maximum electrical capacity is shown on the instrument in va 4 Safet
15. y Instructions WARNING 4 1 User requirements This product may only be used by medical personnel who have been trained per these instructions Do not use the product if you are unfamiliar with its operation in conjunction with the ESU and the Argon Plasma Coagulator M 0 e SZ eS e OBJ DOKU 185032 005 fm Seite 5 Montag 18 November 2013 1 33 13 e 4 2 Selecting a suitable HF electrode This product may be used with ERBE HF electrodes with a shaft diameter of 4 mm The use of ERBE HF electrodes is recommended Non ERBE elec trodes may appear to fit the ERBE handle However differences in materials dimensions tolerances insulation types etc could cause hazardous conditions Therefore as requested ERBE Elek tromedizin will provide specifications for compatibility purpos es 4 3 General information about protection of the user patient and product Do not use in the presence of combustible or explosive materi als Never lay this product on the patient or in his her direct vicinity ERBE recommends carrying out an electrical continuity test be fore each sterilization Note If the cable conductor is broken or the electrical continu ity of the cable is interrupted in any other manner it can cause arcing in the patient return system or active circuit This could possibly result in a patient burn or fire Protect this product from any form of mechanical damage Do not throw Do not use force If damaged

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