Applicator with coagulation and suction
Contents
1. 7 7 Using the product The Water Jet is employed via the Footswitch of the ERBEJET 2 Note If using the ESM 2 see User Manual for employing suc tion The HF current COAG only is delivered from the ESU by press ing the fingerswitch on the applicator or by pressing the blue pedal of the footswitch for the ESU The modalities of the Water Jet and HF current are applied al ternately 7 8 Use suction correctly In order to prevent blockages of the aspirator tube or detect them early on look out for adequate and constant suction dur ing use WZ e 4 A OBJ DOKU 191866 001 fm Seite 10 Dienstag 3 Mai 2011 1 27 13 10 N aus e a OBJ DOKU 191866 001 fm Seite 11 Dienstag 3 Mai 2011 1 27 13 N aus A ou ae OBJ DOKU 191866 001 fm Seite 12 Dienstag 3 Mai 2011 1 27 13 ul 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 Internet http www erbe med com Telephone 770 955 4400 Email sales erbe usa com Customer Support Telephone 0049 0 70 71 755 123 Telefax 0049 0 70 71 755 51 23 E Mail support erbe med com C 0124 12 10 ERBE Elektromedizin GmbH 30150 206 t WZ2. Read the User Manuals of the units and ask ERBE or your distributor in case of doubt Caution Federal law USA restricts this device to sale by or on the order of a physician 1 Intended Use The Applicator is intended to cut and dissect soft tissue such as the liver kidney etc within the abdomen including Total Me sorectal Excision TME as well as to provide suction and mono polar coagulation of the target tissue in open surgery 2 Normal Use The Applicator is used with a designated Water Jet Unit Suction Module and Electrosurgical Unit for the clincial applications per the intended use e ERBE electrosurgical units of series VIO with a monopolar 3 PIN receptacle e Water Jet Unit ERBEJET 2 External suction e g the ERBE ESM 2 The suction pressure may be max 11 6 psi C800 mbar independent of the unit used N aus 4 A dus _ ae OBJ DOKU 191866 001 fm Seite 4 Dienstag 3 Mai 2011 1 27 13 3 Maximum Electrical Capacity The maximum electrical capacity of this product is e 2500 Vp 4 Safety Instructions WARNING This product may only be used by medical personnel who have been trained per these instructions ERBE recommends that the product not be reprocessed after use High temperatures in particular e g in the autoclave can affect material properties and product function making its In tended Use no longer possible Materials and design of this product are intended for single use
3. Resterilization of the product can affect the performance of the product adequate sterilization also cannot be ensured There fore properly dispose of the product after 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 When using and handling the product the involved medical staff should wear personal protective equipment e g gown faceshield or eye protection mask gloves etc to minimize the risk of exposure to infectious agents due to undesirable unex pected spraying or splashing mishandling of the contaminated accessory etc N aus 4 ae OBJ DOKU 191866 001 fm Seite 5 Dienstag 3 Mai 2011 1 27 13 When using the HF current portion of the product the cutting medium can act as a conductor Therefore do not use metal ac cessories such as connectors unless they are insulated If in con tact any conductive item could inadverently burn the patient or personnel 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 Protect this product from any form of mechanical damage Do not throw Do not use force Do not kink or wrap the cable or tubing ERBE Elektromedizin expressly warns against modifying the product Any modification exempts ERBE Elektromedizin from any and all liability 5 Recommended Unit Settings This chapter descr
4. HF electrosurgical unit 2 The system is suited for use in environments other than domestic areas and in ones directly connected to a public power supply sys tem that also supplies buildings being used for domestic purposes The customer or the user of the system should ensure that it is used in such an environment s 4 A dus _ ae OBJ DOKU 191866 001 fm Seite 7 Dienstag 3 Mai 2011 1 27 13 7 How to Use 7 1 Sterile product for single use ERBE recommends that the product not be reprocessed after use High temperatures in particular e g in the autoclave can affect material properties and product function making its In tended Use no longer possible Materials and design of this product are intended for single use Resterilization of the product can affect the performance of the product adequate sterilization also cannot be ensured There fore properly dispose of the product after use 7 2 Check the expiration date An expiration date is printed on the packaging of the product Do not use any product beyond its expiration date 7 3 Control and open packaging Use this product only if the packaging has not been opened or damaged If the packaging is open or damaged the product is no longer sterile and must not be used In this case throw the product away Use aseptic techniques when removing the product from the packaging 7 4 Check the product Before each use check that the product is intact Ver
5. e OBJ DOKU 191866 001 fm Seite 1 Dienstag 3 Mai 2011 1 27 13 e Notes on use Applicator with coagulation and suction 20150 236 Single use only Sterility not guaranteed if package has been opened or damaged Discard if package is damaged stereo A dun ae OBJ DOKU 191866 001 fm Seite 2 Dienstag 3 Mai 2011 1 27 13 Table of Contents Normal Use 2 0 0 000 cece enn Maximum Electrical Capacity Safety Instructions Recommended Unit Settings 5 1 ERBEIET 2 ue oor rn ra 5 2 ERBEVIO oou area era Information on electromagnetic compatibility EMC of the lt How to Use 5 iv cs ox nin na 7 1 Sterile product for single use 7 2 Check the expiration 7 3 Control and open packaging 7 4 1 7 5 Obtain needed ERBEJET 2 accessory and cutting MEGIUM eee dA ERR Yo ene m a eere 7 6 1 7 7 7 8 Use suction correctly WZ U ae OBJ DOKU 191866 001 fm Seite 3 Dienstag 3 Mai 2011 1 27 13 IMPORTANT Please read all information carefully These notes on use do not replace the User Manuals of the Wa ter Jet System and ElectroSurgical Unit ESU used
6. ibes unit settings that may be used to operate the product without causing damage 5 1 ERBEJET 2 All effect levels of the ERBEJET 2 may be used Cutting Dissect ing with too high of a pressure can lead to tissue damage Therefore use the lowest possible settings to achieve the de sired surgical outcome Note External suction e g the ESM 2 The suction pressure may be max 11 6 psi C800 mbar independent of the unit used N aus 4 ae OBJ DOKU 191866 001 fm Seite 6 Dienstag 3 Mai 2011 1 27 13 5 2 ERBE VIO For a monopolar COAG mode e Effect Effect with an HF peak voltage U HF lt 2500 Vp Power No restriction e Use the lowest possible setting s to achieve the desired clinical outcome However power settings that are too low can be dangerous Note ERBE electrosurgical units of series VIO with a monopolar 3 PIN receptacle are to be used 6 Information on electromagnetic compatibility EMC of the units Notwithstanding the specifications in the ERBEJET 2 ESM 2 and VIO User Manuals HF emissions are classified as Class 2 ac cording to CISPR 11 for common use of the product with the units All other ECM specifications in the User Manuals for the respective units apply for their common uses 1 The HF peak voltage of an effect depends on the mode selected and the power setting watts used More information about select ing an appropriate effect is available in the User Manual for the VIO
7. ify that there are no signs of physical damage If damaged do not use this product 4 WZ e ae OBJ DOKU 191866 001 fm Seite 8 Dienstag 3 Mai 2011 1 27 13 7 5 Obtain needed ERBEJET 2 accessory and cutting medium e Pump cartridge Art No 20150 300 Cutting medium to select the suitable cutting medium please read the Notes on use for the pump cartridge 7 6 Connect up the product 2 MN Jl yq 3 E 1 Establish the water jet connection On the sterile field plug the extension tubing connector 3 into a pump cartidge by snapping it into place until it clicks The attached pump car tridge is then inserted into the Water Jet System ERBEJET 2 2 Connect the suction Using aspetic technique connect the suction hose 2 to the suction device If using the ESM 2 connect the Applicator s suction hose to the patient port of the suction bag or lid of the suction con tainer Note Ensure that ERBEJET 2 and ESM 2 are connect ed via the ECB cable and the suction container is connected to the suction connection port of the ESM 2 To proceed fol low the User Manual of the ESM 2 N aus 4 A dus _ ae OBJ DOKU 191866 001 fm Seite 9 Dienstag 3 Mai 2011 1 27 13 3 Establish HF connection Plug the HF connector 1 into the 3 pin monopolar receptacle of the ESU VIO Model To op erate the VIO ESU please read its User Manual
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