Lektrafuse HF Generator GN200 SOP-AIC-5001486
Contents
1. Or Procedure if a regrasp error occurs gt Do not cut the vessel gt Open the instrument gt Check the sealed vessel When correct hemostasis has occurred gt Cut the vessel manually with surgical scissors When hemostasis has not occurred in the correct way gt Place the instrument on the vessel again and lock it in place Note The regrasp error must not be confirmed Activating the hand switch or foot switch will start the next sealing process immediately Note In case of a regrasp error the active operating mode is not displayed The active operating mode can be displayed by pressing the operating mode selection button MODE 2 HF generator has reached its maximum sealing time and has not ascertained any complete seal Check the quality of the seal The user has ended HF discharge during sealing gt Start additional HF cycle gt If the additional HF cycle leads to a normal seal the vessel can be cut and the instrument can be opened and removed gt If a regrasp error occurs again do not cut the vessel open the instru ment and manually cut the sealed vessel with surgical scissors When so doing ensure that the hemostasis is correct Aesculap Lektrafuse HF generator GN200 7 2 Warnings A warning is indicated as follows E Individual tone different from a failure an error or normal HF opera tion m Warning message in the display 5 on the front side of the HF generator Gen2. Maximum peak output voltage Up Preparation and setup First use Working with the Lektrafuse HF generator GN200 System set up Function checks Safe operation Validated reprocessing procedure General safety instructions General information Preparations at the place of use Preparation before cleaning Cleaning disinfection Wipe disinfection for electrical devices without sterilization Inspection maintenance and checks Storage and transport Maintenance Safety inspection Troubleshooting list Regrasp error Warnings Error reports Failure messages Problem solving User maintenance Fuse replacement Technical Service Accessories Spare parts Technical data Ambient conditions Disposal Distributor in the US Contact in Canada for product information and complaints CO CO NN NN OO UU AH OH FS W a a a a a ee a a a a a a ee ee a a ee a ey Oo O CO CO CO WO AOAN NN DODO OT TW wWwWwWwWwHown re fe OO CO 1 Safe handling CAUTION Federal law restricts this device to sale by or on order of a physician Note These instructions for use only describe the set up function and operation of the Lektrafuse generator GN200 and is not suitable for initiating a beginner in high frequency surgery Risk of injury to patients due to inappropriate application DANGER gt The product and accessories should only be operated by qualified or trained and experi enced personnel Risk of injury and material damage
3. tance from the HF field so that they cannot WARNING amp Work with particular care on sensitive struc ignite tures Risk of interference with other devices HF generators create potentially harmful magnetic CAUTION fields during normal use A CAUTION gt Be sure that no electronic devices that could be damaged by an electromagnetic field are set up in the vicinity of the HF generator Restriction to view and or side effects due to the development of steam smoke during HF surgery gt If necessary use smoke suction Always be sure to do the following gt Position the patient in such a way that s he is not in contact with any metal parts that are grounded or have a significant electric capacity against ground e g operating table fixtures If necessary interpose antistatic drape gt Ensure that the patient will not be in contact with any damp cloths drapes or bedding gt Safeguard areas prone to strong perspiration against skin contact with the trunk of the patient s body by inserting antistatic tissue between such areas and the trunk gt Siphon off urine with a catheter gt For heart surgery ground the HF generator via the potential equaliza tion connection gt For patients with cardiac pacemaker or other active implants consult with the relevant medical specialist prior to applying HF surgery so that irreparable damage to the pacemaker or implant can be avoided gt If possible remove from the vic
4. 1 Temperature IEC DIN EN 60601 1 IEC DIN EN 60601 2 2 Ambient conditions 40 C 10 C 50 C 10 C Relative humidity 90 15 non condensing 90 10 non condensing Atmospheric pressure 1 060 hPa 1 060 hPa 700 M 500 M Note The atmospheric pressure of 700 hPa corresponds to a maximum operating altitude of 3 000 m Note After transporting or storing at temperature outside the operating temper ature range leave the HF generator for one hour before use so that it can reach room temperature 11 Note The user institution is obliged to process the product before its disposal see Validated reprocessing procedure Disposal Adhere to national regulations when disposing of or recy cling the product its components and its packaging The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number The recycling pass includes disassembling instructions for the product as well as information for proper disposal of components harmful to the environment Products carrying this symbol are subject to separate col lection of electrical and electronic devices Within the European Union disposal is taken care of by the manufac turer as a free of charge service gt Detailed information concerning the disposal of the product is avail able through your national B Braun Aesculap agency see Technical Service 12 Distributor
5. Safe operation Risk of injury and or malfunction gt Always carry out a function check prior to using WARNING the product Risk of injury when using the product beyond the field of view WARNING gt Apply the product only under visual control gt Start the sealing process HF discharge by pressing the button on the instrument or foot switch once After completing the sealing process the HF discharge is automatically stopped During sealing process the message Sealing in Progress is shown on the display 5 Fig 12 To activate deactivate device gt Switch on switch off the device with the power OFF ON switch 12 Operating mode The Lektrafuse HF generator GN200 automatically recognizes the con nected instrument The internal device settings are loaded The user can choose between two operating modes Activating the HF current gt Be sure that the patient is prepared in such a way that the HF genera tor can be applied without any risk to the patient gt Make sure that the required operating mode is selected gt Ensure that the instrument and foot switch if used are correctly con nected gt Activate the HF generator via the hand switch or the foot switch gt Do not activate the hand switch or foot switch continually during HF discharge Note The vessel sealing process is started and ended by pressing the foot switch or hand switch on the instrument once After completing the sealing p
6. gt Switch off the HF generator immediately using gt When operating in the head or thoracic region the power OFF ON switch in the event that it is avoid using combustible anesthetics and accel activated accidentally erating gases e g nitrous oxide or oxygen or gt Always exercise particular care when operating when using such substances ensure they are the foot switch extracted from the region of operation gt If possible use incombustible cleaning and dis Risk of injury to the patient due to an unintended infecting agents rise of the HF output voltage due to a fault in the gt If combustible cleaning and disinfecting agents DANGER HF generator or solvents have to be used Verify that such gt Stop using the HF surgical device as soon as it agents have evaporated prior to commencing HF shows even the slightest anomaly surgery gt Be sure that no inflammable liquids accumulate Risk of injury to patients users due to defective under the patient s body or in body cavities e g power cord or missing protective ground connec the vagina Before using the HF generator wipe WARNING _ tions up all fluids gt Check the mains power cord protective ground gt Ensure the absence of any endogenous combus connections tible gases gt Check that oxygen soaked materials e g A Danger of injuries due to muscle contraction absorbent cotton or mull are kept at a safe dis caused by stimulation of the nerves and muscles
7. in the US Contact in Can ada for product information and com plaints Aesculap Inc 3773 Corporate Parkway Center Valley PA 18034 USA SOP AIC 5001486 Rev 1 08 15
8. plate of the device The device is fitted with a universal power supply unit which means that it automatically adapts to mains voltages ranging from 100 V to 240 V without having to switch between voltage ranges gt Ensure that the device is switched off If necessary switch off with the power OFF ON switch 12 gt Plug in the power cord in mains power input socket 13 in the rear panel of the HF surgical device gt Plug in the mains plug at the building mains power socket Switching on the device gt Switch on the device with the power OFF ON switch 12 Indicator lamp power ON is illuminated The device performs a self test see Continuous test cycle during operation If no instrument is connected the message Attach Instrument appears in the display 5 after the self test If the self test fails an error message is shown in the display 5 Attach Instrument Standard Ps o Fig 4 Connecting the foot switch Connecting the foot switch GN201 is optional Both the foot switch plug and connection socket foot switch 3 have a dot marking To connect the plug to the connection socket correctly these markings must be aligned Fig 5 gt Align the foot switch plug and insert it into the foot switch connection socket 3 until it engages When the device and the foot switch have been successfully con nected the message Footswitch attached appears for 3 seconds in the display 5 Fig 6 Note Do not a
9. with 1 8 Hz E In Plus mode Repetition with 2 8 Hz End of HF discharge 3 beeps 530 Hz When a sealing process has been successfully completed no failure reports or errors Power up self test 1 beep 2 KHz During the self test in order to check that the signal tone is 2 6 Monitoring functions Self test As soon as it is switched on the unit performs a self test of the control elements the acoustic warning signal the microprocessor and the hard ware function During this phase the message Performing Self Test appears in the display 5 Fig 1 Continuous test cycle during operation During operation safety relevant functions and signals are monitored through a continuous test cycle As soon as a critical error is detected the HF generator terminates the HF activation In display 5 the error number of the corresponding error is displayed and an acoustic warning signal is emitted see Troubleshooting list functioning 2 7 Representation of the output power as a function of the load resistance Output power diagrams Caiman 12 100 200 300 400 500 600 700 800 900 1000 RIQ Lektrafuse Caiman 12 Instrument Family Fig 2 Output power diagram Caiman 12 mm Seal amp Cut instrument family Caiman 5 100 200 300 400 500 600 700 800 900 1000 RLA Lektrafuse Caiman 5 Instrument Family Fig 3 Output power diagram Caiman 5mm Seal amp Cut instrument family 2 8 Maximum peak output v
10. Aesculap AESCULAP lektrafuse oO Aesculap Endoscopic Technology Valid for units with software version 2 0 and higher Instructions for use Technical description Lektrafuse HF generator GN200 B BRAUN SHARING EXPERTISE AESCULA 93 8 m A p oe SAY N mrt d 13 12 11 Aesculap Lektrafuse HF generator GN200 Legend O O NOO RAUN 11 12 13 Signal lamp HF ON surrounding ring Operating mode selection button MODE middle Connection socket foot switch Signal lamp regrasp Display Signal lamp error Signal ring instrument Connection socket instrument Indicator lamp power ON Equipotential connector Fuse holder with 2 fuses OFF ON switch Mains power input socket 14 Type plate 15 Ventilation slots Symbols on product and packages gt 1 SY y g lt e e NY gt 3 el al Contents 1 1 1 Z 2 1 22 23 2 4 2 5 2 6 2 7 2 8 3 3 1 4 4 1 4 2 4 3 5 5 1 52 53 5 4 5 5 5 6 5 7 5 8 6 6 1 7 7A 1 2 7 3 7 4 1 9 7 6 7 7 8 9 10 10 1 Ti 12 Safe handling Safe for use in conformance with IEC regulations Product description Scope of supply Components required for operation kaf fi kod oRdo Operating principle Acoustic warning signal Monitoring functions Output power diagrams
11. F generator 3 1 First use Risk of injury and or product malfunction due to incorrect operation of the electromedical system WARNING gt Adhere to the instructions for use of any medi cal device Aesculap Lektrafuse HF generator GN200 4 Working with the Lektrafuse HF gener ator GN200 4 1 System set up Connecting the accessories A DANGER Risk of injury due to unapproved configuration using additional components gt For all applied components ensure that their classification matches that of the application component e g Type BF or Type CF of the respective device Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application and if they do not compromise the perfor mance and safety characteristics of the products Only CAIMAN instruments can be used in conjunction with the Lektrafuse HF generator GN200 see Accessories Spare parts Connecting the power supply A DANGER Risk of death from electric shock gt Only connect the product to power mains with equipment grounding conductor gt Set up the device in a way that switching it off using the power OFF ON switch is possible and straightforward gt Set up the device in a way that disconnecting the power cord is straightforwardly possible The voltage of the mains power supply must correspond to the voltage indicated on the type
12. Inc Phone Attn Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO 63042 USA Aesculap Repair Hotline 1 800 214 3392 1 314 895 4420 Other service addresses can be obtained from the address indicated above Phone Fax 9 Accessories Spare parts TA02 1404 Fuse Caiman 5 instrument family Caiman 12 instrument family GN201 Foot switch Note Other accessories applied parts and replacement parts are described in Aesculap brochure C 304 81 and C 902 02 10 Technical data Classification acc to Directive 93 42 EEC GN200 High frequency surgical device Ilb Mains voltage ranges Current intake 100V 240 V 6 7 A 2 8 A Frequency 50 60 Hz Protection class acc to IEC DIN EN 60601 1 Foot switch circuit ignition safe acc to IEC DIN EN 60601 approved for use in medical environment Output power 2 x 150 W on 50 Ohm Device protection Time Current characteris tic Breaking capacity Construction T8 AH 250 V T Time lag H 1 500 A 5 mm x 20 mm HF operating frequency 460 kHz 1 Quasi Sinus Operating mode Int 10 s 30 s Weight 8 1 kg Dimensions L x W x H 400 mm x 355 mm x 100 mm Application part type acc CF to IEC DIN 60601 1 Recovery time of the defi 0 seconds brillation protected out put CISPR11 Class A EMC IEC DIN EN 60601 1 2 Conforming to standard 10
13. ace Date Inspector Signature Responsible Organization The listed allowable values comply with the requirements of the IEC60601 1 1988 A1 1991 A2 1995 and IEC60601 1 2005 Fig 13 Inspection protocol form Safety inspection 14 7 Troubleshooting list 7 1 A regrasp error i e potentially insufficient sealing of the vessels is dis played as follows Regrasp error m Unambiguous sound sequence and interruption of the sound sequence of HF operation also stops HF discharge E The yellow regrasp error light 4 on the front side of the HF generator lights up m Warning message in the display 5 on the front side of the HF generator REGRASP INDICATOR OPEN Visually check seal Manually cut Clean jaws or Check the vessel sealing Contact areas of the jaw part must be covered with dried vessel residue or bodily fluids Clean contact areas with sterile water and a sponge Grip a thicker tissue bundle OR The gripped bundle of tissue is too thin Regrasp thicker tissue REGRASP INDICATOR SHORT Visually check seal Manually cut Check for metal or occlusion in jaw Remove excess fluids There is metal e g staples or other foreign material between the electrodes in the jaw part Open and check jaw part Remove any foreign material Remove excess suction fluids in the operat ing area REGRASP INDICATOR TIME Visually check seal Reseal as needed Seal cycle interrupted Seal endpoint not reached
14. ado dil k fp nbad Gg ba b absf bp k _b rga Ik shqbip rmd ka fk irafkd 4j j ka_rkaibp pi ab pt fii dqfk bgt pl coqeb popj bkq f k Pot ka q kl ildv e pkq bbk pltk q bbhabdsbdog 7 edidi k log 7 1 dri k d opdim k nd bar dAl kl gro b phj d ocebdb nd bar dop 2 4 Operating principle The Lektrafuse HF generator GN200 works on a micro processor con trolled basis and converts the voltage of the mains supply into a high fre quency alternating current for bipolar vessel sealing The sealing process is carried out via a closed control circuit The sealing can be started and stopped via a button on the instrument or a foot switch The Lektrafuse HF generator GN200 has two operating modes m Standard mode Pre set operating mode m Plus mode Operating mode with increased energy output Aesculap Lektrafuse HF generator GN200 2 5 Acoustic warning signal System failure 3 repetitions of 1 long beep 3 KHz 1 beep 2 KHz Following each system failure if identified F001 REGRASP error 3 repetitions of 1 beep 2 KHz Following each regrasp error if identified 1 beep 3 KHz System error 3 beeps 3 KHz Following each failure report if identified E001 System warning 3 beeps 3 KHz Following each warning if identified Start HF discharge 2 beeps 480 Hz When starting the HF discharge HF discharge active 1 beep 480 Hz Continually during HF discharge E In Standard mode Repetition
15. correctly plugged into the power supply 13 of the HF generator Ensure that the power cord is connected to a functioning power source Ensure that the power OFF ON switch 12 of the HF generator is in the power ON position Check the fuse in the fuse box and replace if necessary see Fuse replacement If the error continues replace power cord The device is switched on but no displays are illumi Switch off HF generator wait 5 s switch HF generator on again nated and the self test is not being carried out If the error continues contact your national B Braun Aesculap agency see Technical Ser vice Self test fails Switch off HF generator wait 5 s switch HF generator on again If the error continues contact your national B Braun Aesculap agency see Technical Ser vice HF generator is active power ON signal lamp 9 lights Verify that the required foot switch if used is properly connected and plugged in up and accessories are connected but there is no HF Ensure that the Caiman Seal amp Cut Instrument is correctly connected and plugged in green discharge ring 1 is lit up In order to start the HF discharge activate the button on the instrument or the foot switch If the error continues replace Caiman instrument Aesculap Lektrafuse HF generator GN200 7 6 User maintenance gt Incase of error follow the instructions in the display and note the error code gt If the error continues after following the inst
16. ctivate the foot switch continually during HF discharge HF dis charge is started and stopped by pressing once on the foot switch and then releasing Remove the foot switch gt Turn the locking ring counter clockwise and withdraw the connecting plug at the same time The message Footswitch removed appears in the display 5 for 3 sec onds Connecting the instrument Only instruments of the CAIMAN Seal amp Cut product family can be used in conjunction with the Lektrafuse HF generator GN200 The instrument connector has an arrow marking and the connection socket 8 has a dot marking To connect the plug to the connection socket correctly these markings must be aligned Fig 8 gt Connect the instrument with the connection socket 8 The green signal ring 7 around the instrument connector lights up The message Ready to Seal appears in the display 5 Aesculap Lektrafuse HF generator GN200 Selecting the operating mode The Lektrafuse HF generator has two operating modes for the sealing pro cess The selected operating mode will be retained until the HF generator is switched off The operating mode can be changed during the procedure gt Changing the operating mode Press operating mode selection button MODE 2 E Standard mode Pre set operating mode Plus mode Operating mode with increased energy output The operating mode is independent from the connected instrument Changing or reconnecting the instr
17. due to inappro priate use of the product WARNING gt Use the product only in accordance with the intended use Risk of injury and material damage due to improper handling of the product WARNING The Lektrafuse HF generator together with the accessories forms a system gt Follow the instructions for use of the Lektrafuse HF generator accessories gt Follow the instructions for use of all products used General risk factors associated with surgical procedures are not described in this documentation lm It is the operating surgeon s responsibility to ensure that the surgical procedure is performed correctly Mm The operating surgeon must have a thorough understanding of both the hands on and conceptual aspects of the established operating techniques gt Transport the product only in its original box gt Prior to use check that the product is in good working order gt Observe Notes on Electromagnetic Compatibility EMC see TAO22130 gt The Lektrafuse HF generator GN200 fulfills the requirements of CISPR 11 Class A gt To prevent damage caused by improper setup or operation and in order not to compromise warranty and manufacturer liability Use the product only according to these instructions for use Follow the safety and maintenance instructions Only combine Aesculap products with each other Adhere to application instructions according to relevant norms see Safe for use in conformanc
18. e metal cleaning brushes or other abrasives that would dam age the product surfaces and could cause corrosion gt Further detailed advice on hygienically safe and material value pre serving reprocessing can be found at www a k i org link to Publica tions Red Brochure Proper maintenance of instruments 5 3 gt Remove any visible surgical residues to the extent possible with a damp lint free cloth Preparations at the place of use gt Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours 5 4 gt Disconnect the unit from mains power Preparation before cleaning gt Remove accessories Aesculap Lektrafuse HF generator GN200 5 5 Cleaning disinfection Product specific safety instructions for the reprocessing procedure Risk of electric shock and fire hazard gt Unplug the device before cleaning DANGER gt Do not use flammable or explosive cleaning or disinfecting solutions gt Ensure that no fluids will penetrate the product Damage to or destruction of the product caused by mechanical cleaning disinfection CAUTION gt Only clean and disinfect the product manually gt Do not sterilize the product under any circum stances Damage to the product due to inappropriate clean ing disinfecting agents CAUTION gt Only use cleaning disinfecting agents approved for surface cleaning Follow the manufacturer s instructions for the respective clean
19. e with IEC regulations Aesculap Lektrafuse HF generator GN200 gt Inspect the accessories regularly Electrode cables and endoscopic accessories in particular must be checked for possible damage to the insulation gt Ensure that the device does not come in direct contact with the patient or in the sterile area respectively gt Ensure that the user does not come into direct contact with the patient gt Keep the instructions for use accessible for the user and HF generator at the same time gt Always adhere to applicable standards Patient safety 1 1 Safe for use in conformance with IEC regulations Danger to life from inadequate preparation or operational errors in the HF generator The operating environment DANGER gt Be sure that the HF generator is in perfect A Risk of death by electric shock gt Do not open the product working order gt Ensure that neither the foot switch nor the hand switch has been penetrated by conductive fluids DANGER Only ever connect the product to power mains e g blood amniotic fluid with equipment grounding conductor gt Ensure there is no short circuit in the foot or hand switch cables A Risk of injury from ignition or explosion of flam mable gases Sparks may occur when using the HF Risk of burns suffered by the patient due to inad WARNING generator as directed AN vertent activation of the HF generator gt Do not use the device in explosion hazard zones DANGER
20. erator Cooling generator temperature too high Check the airflow around the generator Please Wait Generator Too Cold Generator must first warm up Do not switch off the generator whilst it is warming up Please Wait 7 3 Error reports An error is indicated as follows m Unambiguous tone sequence different from a failure or normal HF operation E Failure message in the display 5 on the front side of the HF generator E001 ERROR E001 Instrument HF activation button is Release the HF activation button Instrument HF activation button error pressed while the instrument is con Remove instrument and reconnect it Release Instrument RF ON Button nected to the HF generator Remove and reattach instrument E002 ERROR E002 HF generator cannot find instrument Remove instrument and reconnect it Instrument Error or or Remove and reattach OR Instrument is defective and must be Replace instrument Remove and replace instrument replaced E003 ERROR E003 Foot switch is pressed while the foot Release foot switch Footswitch Error switch is connected to the HF generator Remove foot switch and reconnect it Release footswitch Remove and reattach footswitch 16 7 4 Failure messages A failure is indicated as follows Note E Clear sound sequence as necessary may interrupt the sound of the HF Ifthe failure occurs during HF discharge the vessel sealing may be incom discharge plete or insufficient E The red error light 6 on the front side o
21. f the HF generator lights up In order to ensure that sufficient hemostasis has been achieved follow the E Error message in the display 5 on the front side of the HF generator procedure for regrasp errors see Regrasp error Note If the failure continues after turning the device off and on again twice con tact your national B Braun Aesculap agency see Technical Service F001 Software error on the HF generator Switch off HF generator wait 5 s switch HF generator on F002 Dosage error of HF generator Switch off HF generator wait 5 s switch HF generator on F003 Hardware error Switch off HF generator wait 5 s switch HF generator on F004 Internal communication error of the HF generator Switch off HF generator wait 5 s switch HF generator on F005 Overheating of HF generator Switch off HF generator and leave to cool down Check the air stream around the generator F006 Error in the operating mode selection button MODE 2 activated Switch off HF generator wait 5 s release operating mode when switching on selection button MODE 2 switch HF generator on F007 Error with HF energy output Switch off HF generator wait 5 s switch HF generator on F008 Fault HF outside the calibration Switch off HF generator wait 5 s switch HF generator on F009 Fault Internal power supply Switch off HF generator wait 5 s switch HF generator on 7 5 Problem solving HF generator does not switch on Ensure that the power cord has been
22. ing disin fecting agent Damage to the product due to inappropriate clean ing disinfecting agents and or excessive tempera CAUTION _ tures gt Use cleaning agents and disinfectants according to the manufacturer s instructions gt Observe specifications regarding concentration temperature and exposure time Validated cleaning and disinfection procedure Wipe disinfection for Chapter Wipe disinfec electrical devices with tion for electrical devices out sterilization without sterilization 12 5 6 Wipe disinfection RT Room temperature Phase gt Remove any visible residues with a disposable disinfectant wipe gt Wipe all surfaces of the optically clean product with a fresh disposable disinfectant wipe gt Observe the specified application time 1 min minimum 5 7 gt Inspect the product after each cleaning and disinfecting cycle to be sure it is clean functional and undamaged Inspection maintenance and checks gt Set aside the product if it is damaged gt Perform a safety inspection annually see Maintenance 5 8 Storage and transport A CAUTION Damage to the product caused by switch on too early after storage transport at temperature below 10 C 50 F gt Allow the HF generator to acclimate at room temperature for about 1 hour gt Transport the product only in its original box gt For storage and transport conditions see Ambient conditions 6 Maintena
23. inity of HF electrodes any electrodes from physiological monitoring devices that are not equipped with pro tective resistors or HF dampers gt Do not use needle electrodes for intraoperative monitoring gt Arrange the wires and cables of monitoring devices in such a way that they do not come in contact with the patient s skin gt Keep the leads to the HF electrodes as short as possible and arrange them in such a way that they do not touch the patient or any other wires or cables gt Should the output power appear insufficient with the usual settings check that the working electrodes are clean all plug connections are properly in place gt Never lay active electrodes on or next to the patient gt Put down active electrodes that are not needed at any particular moment in such a way that they will not touch the patient gt For operations involving unavoidable continuous contact between the electrodes and the patient e g endoscopic procedures press the power OFF ON switch 12 to switch off the HF generator immediately after any inadvertent activation of the electrode gt Do not remove hot electrodes from the patient s body immediately after performing cutting or coagulation procedures gt During operation of the generator do not touch the electrodes on the instrument on the upper or lower side as the electrodes can heat up and this may lead to burns or injuries gt With respect to the electric shock hazard the Lektraf
24. itch for visually detectable damage 1 3 Type plate still present and readable a 1 4 Check fuse links for prescribed values 1 5 Overall condition of device dirt damage 2 ELECTRICAL INSPECTION ass Fail Protective earth resistance incl mains cable Al according IEC62353 2007 Rna 0 3 Q at gt 02 A nn gt gt Earth leakage current is l according IEC60601 1 S F C a 1 00 mA Enclosure leakage current touch current eram according IEC60601 1 0 50 mA 54 Patient leakage current N lax 0 01 mA according IEC60601 1 nax 0 05 mA Equipment leakage current alternative method aa rite Le woe BOUMA Applied part leakage current alternative method according IEC62353 2007 0 05 mA 2 3 2 7 HF leakage current bipolar according IEC60601 2 2 2009 Inax 122 mA 2 8 Insulation resistance f test volt 500 V DC according IEC62353 2007 Preparation according Service Manual ci nn 2 8 1 Mains against HF output 7MO 2 8 2 Mains against housing 2 Ma 2 8 3 HF output against housing QQ HF output power measurement with induction resistor acumen Rated value 145 Watt 20 z a 50 isowatt 20 a a 2 10 DC resistance between the two HF output poles 2 MQ according IEC60601 2 2 2009 section 201 8 4 102 Rmin 2 11 Function test according to instructions for use Performed TEST RESULT Deficiencies were determined by which patient user or other individuals can be endangered Yes O Pl
25. ld not exceed 6 h also neither fixating pre cleaning temperatures gt 45 C nor fixating disinfecting agents active ingredient aldehydes alcohols should be used Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and or to fading and the laser marking becoming unreadable visually or by machine for stainless steel Residues containing chlorine or chlorides e g in surgical residues medi cines saline solutions and in the service water used for cleaning disinfec tion and sterilization will cause corrosion damage pitting stress corro sion and result in the destruction of stainless steel products These must be removed by rinsing thoroughly with demineralized water and then dry ing Additional drying if necessary Only process chemicals that have been tested and approved e g VAH or FDA approval or CE mark and which are compatible with the product s materials according to the chemical manufacturers recommendations may be used for processing the product All the chemical manufacturer s application specifications must be strictly observed Failure to do so can result in the following problems E Optical changes of materials e g fading or discoloration of titanium or aluminum For aluminum the application process solution only needs to be of pH gt 8 to cause visible surface changes m Material damage such as corrosion cracks fracturing premature aging or swelling gt Do not us
26. nce No servicing is required for the Lektrafuse HF generator GN200 Note Maintenance must only be carried out by authorized personnel If neces sary the circuit diagrams and the service manual which contains all the necessary documents are provided for this Wipe disinfection for electrical devices without sterilization Meliseptol HBV wipes 50 Propan 1 ol 6 1 A safety inspection must be carried out annually Safety inspection The person in charge of the inspection will document the inspection find ings and measurement values according to the printed inspection proto col gt Only have the product and its accessories inspected by persons who possess the requisite training knowledge and experience and who are authorized to do so gt If there are significant deviations from the inspection protocol values or if the prescribed maximum values are exceeded Send in the device For technical service please contact your national B Braun Aesculap agency see Technical Service Aesculap Lektrafuse HF generator GN200 B BRAUN Inspection protocol safety inspection SHARING EXPERTISE TEST INTERVAL 1 Year TYPE OF DEVICE Bipolar Electrosurgical Unit GN200 MANUFACTURED BY Aesculap AG Am Aesculap Platz 78532 Tuttlingen Germany RESPONSIBLE INVENTORY NO ORGANIZATION Measurement equipment 1 VISUAL INSPECTION 1 1 Inspection of power cable for visually detectable damage 1 2 Inspection of foot sw
27. oltage Up Note The following data allow the user to judge whether the HF generator GN200 is suitable for a given accessory insulation rating WARNING Risk of injury to patient or user caused by inade quate accessories insulation rating gt Make certain that the accessory voltage rating specified in the product documentation is higher than maximum peak output voltage Maximum peak output voltage U 200 V 3 Preparation and setup Non compliance with the following instructions will preclude all respon sibility and liability in this respect on the part of Aesculap gt When setting up and operating the product adhere to national regulations for installation and operation national regulations on fire and explosion protection Note For the safety of patients and users it is essential that the mains power cord and especially the protective earth connection are intact In many cases defective or missing protective earth connections are not registered imme diately gt Connect the device via the potential equalization terminal at the rear panel of the device to the potential equalization system of the room used for medical purposes Note The potential equalization lead can be ordered from the manufacturer as article no GK535 4 m length or TAO08205 0 8 m length gt In order to ensure sufficient ventilation and cooling of the HF genera tor leave at least 10 cm to 15 cm of space around the H
28. ro cess the device stops the HF discharge automatically The sealing process can be interrupted by pressing the button once more 5 Validated reprocessing procedure 5 1 Note Adhere to national statutory regulations national and international stan dards and directives and local clinical hygiene instructions for sterile pro cessing General safety instructions Note For patients with Creutzfeldt Jakob disease CJD suspected CJD or possi ble variants of CJD observe the relevant national regulations concerning the reprocessing of products Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results Note Successful processing of this medical device can only be ensured if the pro cessing method is first validated The operator sterile processing techni cian is responsible for this The recommended chemistry was used for validation Note If there is no final sterilization then a virucidal disinfectant must be used Note For up to date information about reprocessing and material compatibility see also the Aesculap Extranet at https extranet bbraun com The validated steam sterilization procedure was carried out in the Aesculap sterile container system 5 2 General information Dried or affixed surgical residues can make cleaning more difficult or inef fective and lead to corrosion Therefore the time interval between appli cation and processing shou
29. ructions in the display contact your national B Braun Aesculap agency see Technical Service 7 7 Fuse replacement A DANGER Risk of death by electric shock gt Unplug the device before changing the fuses Specified fuses 2 units Aesculap art no TA021404 G fuse link time lag T 8 A breaking capacity H 1 500 A gt Use a small screwdriver to release the clip on the fuse holder 11 and tilt up cover gt Use a small screwdriver to release the fuse holder 11 and pull it out gt Replace both fuses gt Reinsert the fuse holder 11 gt Close the cover Fig 14 Note If the fuses burn out frequently the device is faulty and should be repaired see Technical Service 8 Technical Service A DANGER Danger to life of patients and users if the product malfunctions and or protective measures fail or are not used gt Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient gt Do not modify the product gt For service and repairs please contact your national B Braun Aesculap agency Modifications carried out on medical technical equipment may result in loss of guarantee warranty rights and forfeiture of applicable licenses 18 Service addresses Aesculap Technischer Service Am Aesculap Platz 78532 Tuttlingen Germany 49 7461 95 1601 Fax 49 7461 14 939 E Mail ats aesculap de Or in the US Aesculap
30. ument does not change the operating mode The active operating mode is indicated in the display as follows E Border E Bold font Fig 10 Fig 11 Note In case of a regrasp error the active operating mode is not displayed The active operating mode can be displayed by pressing the operating mode selection button MODE 2 Note The Plus mode can be distinguished from Standard mode by the higher fre quency of the beep during HF discharge Shutting down gt Switch off the device with the power OFF ON switch 12 All the poles of the device are disconnected from the power supply gt Withdraw mains cable The device is completely disconnected from the power supply 10 4 2 Function checks Prior to each use carry out a functional test of the device gt Check that the accessories have no visible damage gt Prepare and set up the unit see Preparation and setup gt Check the functionality of the following elements one after the other in the following sequence Switch on the power OFF ON switch 12 the power on signal lamp 9 lights up Automatic self test after each time the device is switched on brief acoustic signal all display elements light up briefly Operating mode selection see Selecting the operating mode foot switch see Connecting the foot switch Instrument see Connecting the instrument Activation with instrument button and foot switch Switch off the power OFF ON switch 12
31. use HF generator j bbp b iad Ai k ka prYbq dorr fdg bkal c qnb GLabsf b gt The Lektrafuse HF generator is intended only for indoor operation and od oub 2 Product description 2 1 Scope of supply High frequency surgical device GN200 Instructions for use TA022414 Notes on Electromagnetic Compatibility TA022130 2 2 Components required for operation E Power cord E Foot switch optional E Caiman Instrument 2 3 Indications for Use f k Pot ka q ekl il dv I kapp Ic abaf tha _fnhi o bib od pra 7 fke j bk fkqkaba do rp fk dbkboi palby ka dwkb lild paf 7 nd bar doo t ebdo ifd fi k ka afsfidi k c shgdip fp abddoa Gpb fke j bkcp pov b Mif dl k c_fnhi obib of praf OCbkbadv amp rif k d spri pop qdo Ghai fkcbothpba bd bbk b gt p Ic ob absf b gt rafkd _i abfp q tha d oceb afsfdi k cdg b kopj bkqp 1 j fk ibkdoe tb fkaf tha d ol nbk nd bar dop ka fka j bkqp 03 j kall j fk ibkdoe tb fkaf tha d oi fd pI nf nd bar dopt b fkaf dl kp d orp fk irab dkkbot paf i nd bar doot amp ir afkd rd il dF spri al oF C ka cel o l pl nfi ka dvkb il d nd bardptebd ifdfi k ka afsfdl k Ic Sbadbip fp nbad g ba h nd bar doo fk irab7 s fk evpdodo d j float Kfgdk r kal nif dl k l ibd j ve7aebdl ivefpc_ t hi dodo dil k ka I I nel dodj v bg lo kv nd bar dot ebdosbgd ifd k Gdo t ka r ddagr b do nfkdc ka aff
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