BiClamp TM •CE0124
Contents
1. Before Use Clean disinfect and sterilize this product before using it for the first time and before every subsequent use After setting up the sterile field and just before the procedure perform an electrical continuity test on the product prior to use For example the product can be tested on the sterile field by us ing a sterile sponge or towel soaked with sterile saline solution Before every application check the coagulation surfaces i e jaws for signs of damage During Use WARNING The jaws can become warm if subjected to heavy loads e g prolonged high current application due to low contact impedance situations There is a risk of unintentional coagula tion if they come into contact with tissue accidentally e Avoid accidental contact with tissue e Maintain sufficient distance from tissue that is not involved in the operation Regularly remove excessive contamination occurring during the operation on the coagulation surfaces and the backs of the jaws e g after every coagulation cycle with a cloth moistened with sterile water For cleaning purposes never use sharp or scouring objects Scratched damaged insulation and or coagulation surfaces re strict operation of the product After Use Preclean the product directly after use see next chapter Cleaning Disinfection Sterilization Safety Instructions Clean disinfect and sterilize the product immediately after use On no account use sharp or abrasive ob2. 30195 095 Sheet 1 2 Manufacturer ERBE Elektromedizin GmbH Waldh rnlestr 17 D 72072 Tubingen Postfach 14 20 D 72004 Tubingen Tel 49 70 71 755 0 Fax 49 70 71 755 179 Email support erbe med de Distributed by USA Territory ERBE USA Inc 2225 Northwest Parkway Marietta GA 30067 Customer Support 800 778 ERBE 3723 Tel 770 955 4400 Email sales erbe usa com 01 08 Printed in Germany ERBE Elektromedizin GmbH 20195 286 20195 288 20195 298 Figure 1 20195 286 BiClamp Important Please read all information carefully These notes on use are not intended as a substitute for the User Manual of the device being used If in doubt read the equipment unit s User Manual or ask an ERBE representative or your distributor for as sistance Caution Federal law USA restricts this device to sale by or on the order of a physician 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 Intended Use The BiClamps are intended for use in general surgery gyneco logic urological and thoracic procedures where fusion of ves sels or tissues is desired The devices can be used on vessels up to 7 mm and bundles as large as will fit in the jaws of the in strument A vessel fusion is created by the application of bipolar electrosurgical RF energy coagulation to the vessels placed between the jaws of the inst
3. drying 3 Remove the instrument from the disinfector directly after the end of the program Check 1 Check the product for visible damage and wear Damage to the product e g cracks rough surface splin tering Damage to the product insulation and or cable connec tor insulation e g cracks and breaks Damage to the coating Bending of the product or parts of the product Do not attempt to straighten bent parts If damaged do not use this product Packaging The product must be protected against damage during steriliza tion 1 Pack the product in disposable sterilization packaging sin gle or double packaging made from paper polyethylene and or in a sterilization container 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 methods described below If other sterilization methods are used ERBE Elektromedizin shall bear no responsibility Steam Fractionated vacuum method holding time 5 minutes at 273 F to 280 F 134 C to 138 C Gravitation method holding time 8 minutes at 270 F to 273 F 132 C to 134 C
4. ed action time 4 If necessary clean off any still adhering contaminants with a clean soft cloth or a soft plastic brush 5 Carefully remove the instrument from the cleaning bath 6 Flush the instrument thoroughly under running tap water for at least 1 minute 7 Rinse the instrument hinge area thoroughly 8 Dry the instrument lightly using compressed air 9 Check the instrument for contaminating residues and if nec essary repeat the cleaning process Disinfection Only disinfect clean products that have dried slightly 1 Prepare a disinfectant bath according to the manufacturer s directions 2 Carefully lay the instrument in the disinfectant bath with the jaws of the instrument open so that it is completely immersed and does not come into contact with other instru ments 3 Leave the instrument in the disinfectant bath for the speci fied action time 4 Carefully remove the instrument from the disinfectant bath 5 Flush the instrument thoroughly with sterile distilled water 6 Dry the instrument thoroughly using compressed air Cleaning and Disinfection by Machine 1 Carefully place the instrument with open jaws in a suitable rinsing basket Ensure that instruments do not contact one another 2 Start a tested program with the following properties If possible thermal disinfection at 199 F 93 C for at least 10 minutes Final rinse with distilled or deionized water Sufficient product
5. jects 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 The product can be sterilized up to a maximum temperature of 280 F 138 C Do not sterilize with gamma radiation Do not sterilize in hot air oven Reconditioning Limitation The product has been found to work as intended after at least 30 cleaning disinfection and sterilization cycles Recommended Processing Agents Equipment The listed cleaning disinfection agents and sterilization equipment have been validated with the following processing procedures e Manual cleaning disinfection with the detergent Cidezyme LF Enzol and disinfectant Cidex OPA Johnson amp Johnson Medical Limited Gargrave Skipton e Cleaning disinfection by machine in a disinfector G 7736 CD Miele amp Cie GmbH amp Co Giitersloh Germany using neodisher mediclean forte detergent Dr Weigert GmbH amp Co KG Hamburg Germany in accordance with the rec ommended washing program e Autoclave Precleaning Preclean the product up to a maximum of 2 hours after use For heavy soiling ERBE Elektromedizin recommends an approx 3 percent hydrogen peroxide bath When using a soft plastic brush ensure that the brush is moved only in parallel with the coagulation s
6. not touch any tissue with the jaws accidentally Protect this product from any form of mechanical damage Do not throw Do not use force If there is a cable and unless stated otherwise do not kink it or wrap it around the accompanying product ERBE Elektromedizin expressly warns against modifying the product Any modification exempts ERBE Elektromedizin from any and all liability CAUTION Vessel fusion can be affected by patient factors such as age elasticity of vessels thickness of vessel walls etc therefore the physician should review each vessel fusion for seal integrity This device is not effective for use in tubal sterilization tubal co agulation for sterilization purposes Do not use this device on vessels in excess of 7 mm in diameter Recommended against the use of electrosurgery for circumci sions How to Use The following factors can shorten the service life of the product considerably e scratching damaging the insulation and or coagulation sur faces during the operation e g caused by other instruments e failure to remove dried coagulation remnants from the sur faces during the operation e incorrect procedure when cleaning the product during and after the operation This product possesses an electronic identifier i e the product and its specifications are recognized by the VIO ESU after the connecting cable has been inserted and several default settings are executed automatically on the ESU
7. rument The BiClamps are designed for use with an ERBE VIO ESU electrosurgical unit having an Optional Bipolar Mode BiClamp upgrade and the multifunctional receptacle Not recommended for use with other manufacturer s generators Indications for Use The indications for use include general surgery gynecologic urological and thoracic procedures where fusion of vessels and tissue bundles is performed including such procedures as bowel resections hysterectomies both vaginal and abdominal Nis sen fundoplication adhesiolysis lysis of adhesions oophorec tomy etc 82014 003 Maximum Electrical Capacity The maximum electrical capacity is shown on the instrument in Vp Safety Instructions WARNING Before each use check the insulation or coating of the product for damage and look for signs of mechanical damage If the cable conductor is broken or the electrical continuity of the cable is interrupted in any other manner it can cause arcing in the patient return system or in the active circuit this can lead to the patient suffering burns or the outbreak of a fire If damaged do not use this product Do not use in the presence of combustible or explosive materials Never lay this product on the patient or in his her direct vicinity If subjected to heavy loads e g prolonged high current applica tion due to low contact impedance situations the jaws will be come warm In order to prevent undesirable coagulations do
8. urface of the BiClamp or from the backs of the jaws in the direction towards the coagulation sur face On no account brush from the coagulation surface in the di rection of the backs of the jaws See also the following illustration 30195 095 Sheet 2 2 Manufacturer ERBE Elektromedizin GmbH Waldh rnlestr 17 D 72072 Tubingen Postfach 14 20 D 72004 Tubingen Tel 49 70 71 755 0 Fax 49 70 71 755 179 Email support erbe med de Distributed by USA Territory ERBE USA Inc 2225 Northwest Parkway Marietta GA 30067 Customer Support 800 778 ERBE 3723 Tel 770 955 4400 Email sales erbe usa com 01 08 Printed in Germany ERBE Elektromedizin GmbH 20195 286 20195 288 20195 298 1 If required place the product in an approx 3 percent hydro gen peroxide bath 2 Carefully remove excessive soiling with a clean soft cloth or a soft plastic brush under running water or using a suitable aldehyde free disinfectant Manual Cleaning and Disinfection Use a liquid detergent suitable for soaking Use a disinfectant compatible with the detergent suitable for soaking Cleaning 1 Prepare a cleaning bath according to the manufacturer s directions 2 Carefully lay the instrument in the cleaning bath with the jaws of the instrument open so that it is completely immersed and does not come into contact with other instru ments 3 Leave the instrument in the cleaning bath for the specifi
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