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0123

900

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-20131023

-EN

Pri

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Ger

Cop

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-e

rin

│

Germ

BOWA-electronic GmbH & Co. KG
Heinrich-Hertz Strasse 4–10
D-72810 Gomaringen │ Germany

Phone:

+49 (0) 7072-6002-0

Fax:

+49 (0) 7072-6002-33

[email protected] │ www.bowa-medical.com

CE marked according to Medical
Device 93/42/EWG

Содержание ARC 250

Страница 1: ...OPERATING MANUAL ELECTROSURGICAL UNIT...

Страница 2: ......

Страница 3: ...900 301_IFU V2 2_11316 S0 20131023 EN Operating Manual ARC 250 303 3...

Страница 4: ...4 Operating Manual ARC 250 303 900 301_IFU V2 2_11316 S0 20131023 EN...

Страница 5: ...900 301_IFU V2 2_11316 S0 20131023 EN Operating Manual ARC 250 303 5...

Страница 6: ...gram key 18 Error status indicator 19 EASY monitoring for one piece neutral electrode EASY one piece monitoring 20 EASY monitoring for split neutral electrode EASY split monitoring 21 Indicator arrow...

Страница 7: ...tor for foot switch for sockets 30 and 31 33 Fibre optic signal output socket connector with ARC 250 303 with GastroCut option 34 Fibre optic signal output socket connector with ARC 250 303 with Gastr...

Страница 8: ...Legend 8 Operating Manual ARC 250 303 900 301_IFU V2 2_11316 S0 20131023 EN...

Страница 9: ...ns 18 2 3 2 Patients with pacemakers 18 2 3 3 Safe positioning of the patient 19 2 3 4 Correct connection of the HF device 19 2 3 5 Correct use of the HF device 19 2 3 6 Adjusting the settings of the...

Страница 10: ...ents required for operation 33 4 4 Operating conditions 33 5 Preparation 34 5 1 Setting up the HF device 34 5 2 Switching on the HF device 35 5 3 Connecting instruments 35 5 3 1 Instruments for monopo...

Страница 11: ...ram 3 Forced Coag Mode 46 6 4 5 Menu program 3A GastroCut Modes 47 6 4 6 Menu program 4 Show Prev Inf No 48 6 4 7 Menu program 5 Hide Fix Prog 48 6 4 8 Menu program 6 Autostart Delay 49 6 4 9 Menu pro...

Страница 12: ...Manual ARC 250 303 900 301_IFU V2 2_11316 S0 20131023 EN 12 Accessories and replacement parts 85 13 EMC 86 13 1 Guidelines and manufacturer s declaration in accordance with IEC 60601 1 2 Section 6 8 3...

Страница 13: ...operating manual accessible to operating room personnel Give the operating manual to each successive owner and or user of this device Always update the operating manual whenever you receive additiona...

Страница 14: ...e for risk prevention NOTE Risk type source and consequences there of Property damage Measure 1 4 2 Risk levels in the warning instructions Symbol Risk level Probability of occurrence Consequences of...

Страница 15: ...Activity with several steps in a binding sequence Result of preceding activity List first level List second level Emphasis Emphasis see section xxx page xxx Cross reference Monopolar output 29 30 Bold...

Страница 16: ...thopedics urology including transurethral resection TUR Do not use the HF device if in the opinion of an experienced physician or according to current professional literature such use would cause enda...

Страница 17: ...devices Furthermore all configurations must comply with the standardised requirements for medical systems see IEC 60601 1 1 or Section 16 of the 3rd edition of IEC 60601 1 as relevant Anyone who conn...

Страница 18: ...gure 2 3 2 Patients with pacemakers Malfunctions or destruction of the pacemaker can endanger the life of the patient or result in irreversible injuries to the patient In cases of patients with pacema...

Страница 19: ...ements of chapter 8 6 7 of ISO 60601 1 for medical electrical systems Do not use any needle electrodes for monitoring Attach electrodes of physiological monitoring devices without protective resistors...

Страница 20: ...o prevent inadvertent thermal tissue damage during operations on body parts with small cross sections and in areas with high resistance bones or joints use the bipolar method in these areas Set the ac...

Страница 21: ...nts Never boil the device and never disinfect it mechanically Immediately drain any fluid that might have penetrated the device A malfunction can result in an undesired increase of the output power if...

Страница 22: ...quids collect beneath the patient or in body cavities e g the vagina Suction and or flush body cavities before activating the device Wipe off all liquids before using the HF device Ensure that no endo...

Страница 23: ...self adhesive disposable electrodes comply with any further manufacturer specifications regarding the point of application Ensure that the application point is free of scar tissue bony protuberances...

Страница 24: ...oids excessive current concentration on the short side Using both hands press the self adhesive disposable electrode firmly against the patient s skin Clamp the electrode tab to the neutral electrode...

Страница 25: ...contact coagulation Forced Coag for coagulation with light contact Spray Coagulation for contactless surface coagulation Instruments can be connected to monopolar output socket connector 29 30 3 1 1 C...

Страница 26: ...s at the same time Handles with finger switches can be connected to connection ports 29 30 The handles are activated with the Coag button on the handle Both handles can be switched on or off independe...

Страница 27: ...The following applies Blend 0 low coagulation rate Blend 9 high coagulation rate Three sub modes are available in GastroCut mode Mode Characteristics Application Slow Cutting characteristics Slower p...

Страница 28: ...not necessary If an output operating in AUTOSTART mode is activated using the foot switch AUTOSTART mode is deactivated and the foot switch signal is used This type of current can be used for bipolar...

Страница 29: ...Funkti onsweise N ot Aus 4 mod_1270107171492_6 doc 38127 2 3 4 Emergency shutoff The HF device can be switched off at any time by using on off switch 27 for emergency shutoff Pos 19 679 BOWA HF Ger te...

Страница 30: ...3 7 Neutral electrode monitoring Always use the largest possible electrode when attaching a neutral electrode 3 7 1 General information BOWA recommends using split neutral electrodes since only this...

Страница 31: ...the manual switch the foot switch can be used to activate various operating modes A foot switch can be connected to socket connector 32 The HF device automatically detects whether a foot switch is con...

Страница 32: ...which produces electromagnetic radiation Labeling of electrical and electronic devices in accordance with Directive 2002 96 EC WEEE see Disposal Identification of active HF output caution dangerous e...

Страница 33: ...r cable Foot switch Neutral electrode Electrode handle for monopolar applications with finger keys or activation via foot switch Working electrode Connection cable Pos 29 679 BOWA HF Ger te ARC 200 25...

Страница 34: ...excessive leakage current Do not place the HF device in the immediate vicinity of the patient see section Ambient conditions page 18 HF devices may be used only in rooms used for medical purposes that...

Страница 35: ...see section Menu programs page 45 2 Check whether all the indicators 2 7 9 12 13 14 15 22 25 26 and LEDs 1 8 18 19 20 21 on the front panel light up and flash alternately with the display 3 Press any...

Страница 36: ...able to the Bovie jack on connection port 30 or Connect the monopolar cable for endoscopy to the socket connector for monopolar instruments 30 left 5 3 2 Instruments for bipolar applications 1 Connect...

Страница 37: ...52619_6 doc 48300 3333 5 4 1 Autotest function The HF device automatically carries out a self test after being switched on and a cyclical test during operation If errors occur see section Detecting an...

Страница 38: ...eutral electrode with regard to size adhesive properties and full surface contact of the complete electrode The following functions can be tested for split and one piece neutral electrodes Actual stat...

Страница 39: ...n The data about settings points of application application duration and the application of instruments are based on clinical practice However these are only basic guidelines which must be tested and...

Страница 40: ...26 and keeping it pressed Programs 8 to 99 are fully user configurable These programs output standard types of current You can change the following factory settings Select cutting settings Press the p...

Страница 41: ...for microscopic tissue structures Pos 44 679 BOWA HF Ger te ARC 200 250 300e 6 Bedi enung Programm 3 Resekti on 6 mod_1297071204215_6 doc 48009 3 6 3 4 Program 3 Resection Both cutting and coagulation...

Страница 42: ...ARC 200 250 300e 6 Bedi enung Programm 5 Argon Fl ex nur mit Opti on GastroCut 6 mod_1297072401699_6 doc 48066 3 6 3 6 Program 5 Argon Flex only with GastroCut option This program is used in argon el...

Страница 43: ...econd For more information on GastroCut mode see section GastroCut mode page 27 The key display Monopolar Output 30 is preconfigured 1 Connect the polypectomy snares to the socket for Monopolar Output...

Страница 44: ...second For more information on GastroCut mode see section GastroCut mode page 27 The key display Monopolar Output 30 is preconfigured 1 Connect the papillotome to the socket for Monopolar Output 30 us...

Страница 45: ...gram 8 Restore Programs Menu program 9 Panel Check Selecting a menu program 1 When switching on the device simultaneously press the on off switch 27 and the program selection switch 17 to see the list...

Страница 46: ...Sound Level Use Sound Level to set the volume of the individual activation signals 1 Press the power limitation key for monopolar cutting 4 2 Press the key for scabbing level 5 6 to change the volume...

Страница 47: ...n key for monopolar cutting 3 to return to the menu programs Changing the cutting speed for GastroCut Pap 1 Press the power limitation key for monopolar cutting 4 2 Press the key for monopolar coagula...

Страница 48: ...ide Fix Prog The Hide Fix Prog menu program hides standard programs that are not required 1 Press the power limitation key for monopolar cutting 4 2 Press the power limitation key for bipolar coagulat...

Страница 49: ...it the text shown on the display main display for user defined programs Press the power limitation key for monopolar cutting 4 Editing text in the display main display 1 Press the program key 16 17 to...

Страница 50: ...estore Programs Menu program Restore Programs resets all modified parameters of standard programs in the HF device to the factory default settings 1 Press the power limitation key for monopolar cuttin...

Страница 51: ...s not listed Contact the service center in case of errors not shown in the error list see section Technical service page 59 If the expected change in the tissue does not occur and no error message app...

Страница 52: ...recurs contact the service center 40 Additional device ARC PLUS not connected not switched on offline Switch the additional device ARC PLUS on Check the connection to the interface 43 Key on front pa...

Страница 53: ...nstrument from the tissue and re activate AUTOSTART 90 Papillotome or snare is not applied Apply the papillotome or the snare 91 Instrument for GastroCut application defective or short circuit Replace...

Страница 54: ...f the handpiece has been inserted incorrectly Handpiece possibly defective Monopolar 4 mm connecting cable plugged into the right hand monopolar output socket 29 30 Check the handpiece Replace the han...

Страница 55: ...oblem occurs An acoustic signal sounds A corresponding INF xxx message appears on the Monopolar Cut 7 segment display 2 and the Monopolar Coag 7 segment display 9 Check the neutral electrode and the n...

Страница 56: ...nit Never sterilize the ARC 250 303 device Instead clean or disinfect it WARNING Risk of electric shock and fire Unplug the power connection before cleaning the device For cleaning surfaces use the ap...

Страница 57: ...r damaged accessories Replace defective accessories immediately Have the safety inspection for the device performed once a year Please consult and comply with the respective service instructions for a...

Страница 58: ...d purpose contained in this operating manual was maintained changes repairs new settings and similar procedures were carried out only by persons authorized to do this work by BOWA the electrical insta...

Страница 59: ...g service center for maintenance and repair work BOWA electronic GmbH Co KG Heinrich Hertz Strasse 4 10 72810 Gomaringen Germany Phone 49 0 7072 6002 0 Fax 49 0 7072 6002 33 E Mail service bowa de or...

Страница 60: ...ndicators during automatic functional testing see section Functional test page 37 Clean the HF device thoroughly before you put it into storage Store the HF device in a clean dry place in accordance w...

Страница 61: ...2 2007 IEC 60601 2 2 2009 ISO 14971 2007 ISO 13485 2003 Cor 1_2009 Classification as per EC Directive 93 42 EEC IIb Power connection Power consumption in standby mode 25 VA Line frequency 50 60 Hz Max...

Страница 62: ...neutral electrode CM continuity monitor Maximum resistance between the sections of split electrodes CQM 999 Maximum allowable resistance between the sections of split electrodes 220 Warning signal in...

Страница 63: ...al interface for communication with the ARC PLUS External PC interface using BOWA software Service support using BOWA software Service support Service support integrated in the device via service prog...

Страница 64: ...11 Technical specifications 64 Operating Manual ARC 250 303 900 301_IFU V2 2_11316 S0 20131023 EN...

Страница 65: ...11 Technical specifications 900 301_IFU V2 2_11316 S0 20131023 EN Operating Manual ARC 250 303 65...

Страница 66: ...W 150 W and 100 W Values measured on ohmic resistances with prior arc formation for ARC 303 Output power P W versus load resistance R with Monopolar Cut settings 300 W 200 W 150 W and 100 W Values mea...

Страница 67: ...ual ARC 250 303 67 Setting Program Monopolar CUT 0 3 8 99 Output power P W versus Monopolar Cut setting Rated load resistance 500 Blend HF voltage U Vp 0 590 1 590 2 680 3 760 4 760 5 760 6 880 7 880...

Страница 68: ...CUT 2 Values measured on ohmic resistances Output power P W versus load resistance R with MicroCUT settings 30 W and 15 W Ouptut power P W versus MicroCUT setting Rated load resistance 500 Blend HF vo...

Страница 69: ...red on ohmic resistances Output power P W versus load resistance R with MacroCUT settings 75 W and 38 W Values measured on ohmic resistances Output power P W versus MacroCUT setting Rated load resista...

Страница 70: ...istance R with Gastro LOOP Blend 0 9 setting CUT phase Blend Coag share in W Cut share in W 0 36 370 1 36 370 2 36 370 3 36 370 4 36 370 5 36 370 6 36 370 7 36 370 8 36 370 9 36 370 Output power P W v...

Страница 71: ...ance R with Gastro KNIFE setting during Cut phase Blend Coag share in W Cut share in W 0 11 390 1 20 390 2 22 390 3 22 390 4 22 390 5 22 390 6 22 390 7 22 390 8 22 390 9 22 390 Output power P W versus...

Страница 72: ...oderate COAG Standard 0 1 3 4 6 99 Values measured on ohmic resistances Output power P W versus load resistance R with Moderate COAG Standard settings 120 W and 60 W Output power P W versus Moderate C...

Страница 73: ...ng Program Micro Moderate COAG 2 Values measured on ohmic resistances Output power P W versus load resistance R with Micro Moderate COAG settings 30 W and 15 W Output power P W versus Micro Moderate C...

Страница 74: ...ced COAG Non Cutting 0 1 3 4 8 99 Values measured on ohmic resistances Output power P W versus load resistance R with Forced COAG Non Cutting settings 120 W and 60 W Output power P W versus Forced COA...

Страница 75: ...gram Forced COAG Cutting 0 1 3 4 8 99 Values measured on ohmic resistances Output power P W versus load resistance R with Forced COAG Cutting settings 75 W and 38 W Output power P W versus Forced COAG...

Страница 76: ...Program Forced COAG Mixed 0 1 3 4 8 99 Values measured on ohmic resistances Output power P W versus load resistance R with Forced COAG Mixed settings 120 W and 60 W Output power P W versus Forced COA...

Страница 77: ...orced COAG Micro Cutting 2 Values measured on ohmic resistances Output power P W versus load resistance R with Forced COAG Micro Cutting settings 30 W and 15 W Output power P W versus Forced COAG Micr...

Страница 78: ...AG Micro Non Cutting 2 Values measured on ohmic resistances Output power P W versus load resistance R with Forced COAG Micro Non Cutting settings 30 W and 15 W Output power P W versus Forced COAG Micr...

Страница 79: ...am Forced COAG Micro Mixed 2 Values measured on ohmic resistances Output power P W versus load resistance R with Forced COAG Micro Mixed settings 30 W and 15 W Output power P W versus Forced COAG Micr...

Страница 80: ...Program GastroCut ForcedCOAG 6 7 Values measured on ohmic resistances Output power P W versus load resistance R with GastroCut ForcedCOAG settings 50 W and 25 W Output power P W versus GastroCut Force...

Страница 81: ...Setting Program Micro Spray COAG 2 Values measured on ohmic resistances Output power P W versus load resistance R with Micro Spray COAG settings 30 W and 15 W Output power P W versus Micro Spray COAG...

Страница 82: ...es Output power P W versus load resistance R with Spray COAG Argon Flex Spray COAG I Argon Spray COAG II settings 120 W and 60 W Output power P W versus Spray COAG Argon Flex Spray COAG I Argon Spray...

Страница 83: ...303 83 Setting Program Bipolar COAG 0 1 3 99 Values measured on ohmic resistances Output power P W versus load resistance R with Bipolar settings 120 W and 60 W Output power P W versus Bipolar COAG s...

Страница 84: ...resistances Output power P W versus load resistance R with Bipolar Micro COAG settings 30 W and 15 W Output power P W versus Bipolar Micro COAG setting Rated load resistance 75 HF output voltage U Vp...

Страница 85: ...ARC PLUS devices When using accessories made by other manufacturers the user must ensure that they are designed for and compatible with the maximum HF peak voltage of the HF device For the use and co...

Страница 86: ...es are operated in such an environment Interference measurements Interference measurements Interference measurements HF emissions as per CISPR 11 Group 2 The ARC 250 and ARC 303 must emit electromagne...

Страница 87: ...spond to that of a typical business or hospital environment 1 kV for input and output lines 1 kV for input and output lines Surges as per IEC 61000 4 5 1 kV voltage outer conductor outer conductor 1 k...

Страница 88: ...by on site measurements a should be lower than the compliance level b at all frequencies Interference is possible in the vicinity of devices that bear the following symbol Radiated HF interference as...

Страница 89: ...output W Protective distance m depending on transmission frequency 150 kHz to 80 MHz d 0 35 P 80 MHz bis 800 MHz d 0 35 P 800 MHz to 2 5 GHz d 0 7 P 0 01 0 01 0 01 0 01 0 1 0 1 0 1 0 1 1 1 1 1 10 10 1...

Страница 90: ...t country when disposing of or recycling the device or its components Symbol Designation A device marked with this symbol must be put into the separate waste collection for electrical and electronic d...

Страница 91: ...ch 36 Foot switch operation 31 General safety instructions 17 Key 46 Maintenance 57 Menu programs 45 Monopolar modes 25 National language 46 Neutral electrode 22 Neutral electrode cable 36 Neutral ele...

Страница 92: ...nd design changes Copyright by BOWA electronic Gomaringen Germany BOWA electronic GmbH Co KG Heinrich Hertz Strasse 4 10 D 72810 Gomaringen Germany Phone 49 0 7072 6002 0 Fax 49 0 7072 6002 33 info bo...

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