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1 Using this operating manual

900-100_IFU-V1.0_11587-S0-20141209-EN

ARC 100 Operating Manual

1.4.

Symbols and notation

1.4.1.

Structure of warning instructions

SIGNAL WORD

Type, source and consequences of the risk (personal injury)!



Measure for avoiding the risk.

NOTE

Type, source and consequences of the risk (property damage)!



Measure.

1.4.2.

Hazard levels of warning instructions

Symbol

Hazard level

Probability of
occurrence

Consequences of
non-compliance

DANGER

Immediate risk

Death or serious
injuries

WARNING

Possible risk

Death or serious
injuries

CAUTION

Possible risk

Minor injuries

NOTE

Possible risk

Property damage

1.4.3.

Tips

Tips and additional information for easier working.

Содержание ARC 100

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

Страница 2: ......

Страница 3: ...900 100_IFU V1 0_11587 S0 20141209 EN ARC 100 Operating Manual 3...

Страница 4: ...nt 11 Indicator for Dry monopolar cutting current 12 Indicator for Moderate monopolar coagulation current 13 Indicator for Forced monopolar coagulation current 14 Neutral electrode monitoring non spli...

Страница 5: ...2 Patients with pacemakers 13 2 3 3 Safe positioning of the patient 14 2 3 4 Correct connection of the HF device 14 2 3 5 Correct use of the HF device 14 2 3 6 Adjusting the settings of the HF device...

Страница 6: ...device 27 5 3 Connecting instruments 27 5 3 1 Instruments for monopolar applications 27 5 3 2 Instruments for bipolar applications 27 5 3 3 Connecting the foot switch 28 5 3 4 Assigning a foot switch...

Страница 7: ...tion of the accessories 35 8 2 Disinfection and cleaning 35 9 Maintenance and repair 36 9 1 Maintenance 36 9 1 1 Safety inspection 36 9 2 Repairs 37 9 3 Technical service 38 10 Storage 38 11 Technical...

Страница 8: ...the operating manual accessible to operating theatre personnel Give the operating manual to each successive owner and or user of this device Always update the operating manual whenever you receive add...

Страница 9: ...avoiding the risk NOTE Type source and consequences of the risk property damage Measure 1 4 2 Hazard levels of warning instructions Symbol Hazard level Probability of occurrence Consequences of non c...

Страница 10: ...aning Prerequisite for an activity Activity with one step 1 2 3 Activity with several steps in strict sequence Result of preceding activity List first level List second level Emphasis Emphasis see Sec...

Страница 11: ...NT Do not use the HF device if in the opinion of an experienced physician or according to current professional literature such use would endanger the patient due for example to the general condition o...

Страница 12: ...the relevant IEC or ISO standards e g IEC 60950 for data processing devices Furthermore all configurations must comply with the standardised requirements for medical systems see IEC 60601 1 1 or Sect...

Страница 13: ...Patients with pacemakers Malfunction 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 pacemakers consul...

Страница 14: ...electrodes Attach lines from monitoring devices so that they do not lie on the patient s skin Keep the leads to the HF electrodes as short as possible and position them so that they do not touch the...

Страница 15: ...d so that it is always clearly audible Nerve and muscle stimulation by low frequency currents In HF surgical applications especially applications in which an arc is formed part of the HF current is co...

Страница 16: ...rface cleaning See Section Disinfection and cleaning page 35 Never immerse the device in water or cleaning agents Never boil the device and never disinfect it mechanically Immediately drain any fluid...

Страница 17: ...ammable liquids 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 th...

Страница 18: ...cic region do not run the current path transversely across the patient s body and ensure that the patient s heart is never in the path of the current Depending on the surgical site apply the neutral e...

Страница 19: ...HF device Example application using a disposable electrode Remove the protective film and attach the self adhesive disposable electrode to the patient Ensure that the long side of the disposable elec...

Страница 20: ...odes Pure for cutting in low resistance tissue Dry for cutting with strong haemostasis Moderate for contact coagulation Forced for coagulation with light contact Instruments can be connected to the mu...

Страница 21: ...ection 3 4 Connection socket for neutral electrode US type neutral Applied part of Type F according to IEC 60601 1 The neutral electrode connector socket is suitable for neutral electrode plugs with t...

Страница 22: ...y For further information see Section Detecting and correcting faults page 33 Pos 21 679 BOWA HF Ger te ARC 300 350 3 Funkti onsweise ARC C ontrol Technol ogie 4 mod_1261040479928_258 doc 34728 2 3 8...

Страница 23: ...urpose a split neutral electrode with corresponding contact surfaces and suitable transition resistances which is attached to the patient according to the manufacturer s instructions is required The E...

Страница 24: ...On off switch HF energy in the range of 9 kHz to 400 GHz is used when the HF device is activated This energy generates electromagnetic radiation Labelling of electrical and electronic devices in accor...

Страница 25: ...le Monopolar accessories Monopolar connecting cable Monopolar instrument Neutral electrode Connecting cable for neutral electrode Bipolar accessories Bipolar connecting cable Bipolar instrument and or...

Страница 26: ...sed for medical purposes that meet the requirements of DIN VDE 0100 710 If the HF device was previously stored or transported at temperatures below 10 C or at a relative humidity above 75 non condensi...

Страница 27: ...hey are explicitly designed for the intended use Performance features as well as safety requirements must always be taken into account The insulation of the accessories e g HF cables instruments must...

Страница 28: ...faults page 33 5 4 2 Functional test execution Perform the following functional test before putting the device into service 1 Connect a split single use neutral electrode and attach it to the patient...

Страница 29: ...and one piece neutral electrodes Actual status Output Measure Cable for one piece or split neutral electrode not connected Indicators for monitoring of non split neutral electrode 14 or EASY monitorin...

Страница 30: ...bout points of application and the use of instruments is based on clinical practice However these are only basic guidelines which must be tested and approved for suitability by the operator Depending...

Страница 31: ...mpirical values and must be verified in each individual case by the surgeon Pos 42 679 BOWA HF Ger te ARC 200 250 300e 6 Bedi enung Programm 0 Standard 5 mod_1270108364476_258 doc 38299 3 6 3 1 Monopo...

Страница 32: ...tion with high penetration little adhesion of the electrode to the tissue Suitable instruments Electrodes with large contact area e g ball type electrodes 6 3 4 Monopolar coagulation Forced This mode...

Страница 33: ...the service centre if the suggested corrective measure does not eliminate the error see Section Technical service page 38 Errors are signalled with a lit Error LED 24 and Power LED 23 LED code Cause C...

Страница 34: ...rked increase in the resistance Depending on the indication there may be heating under the neutral electrode An acoustic signal sounds The Easy indicator 16 lights up red Check the neutral electrode a...

Страница 35: ...ng 6 mod_1297072881168_258 doc 48122 NOTE Incorrect use of the HF device can cause damage to the unit Never sterilize the ARC 100 HF device Instead clean or disinfect it WARNING Risk of electric shock...

Страница 36: ...mediately Have the safety inspection for the device performed once a year Consult the appropriate service manual for additional technical information 9 1 1 Safety inspection Safety inspections must be...

Страница 37: ...the installation and proper use for the intended purpose contained in this operating manual was maintained Changes repairs new settings and similar procedures have been carried out only by persons aut...

Страница 38: ...edical com 10 Storage Pos 71 679 BOWA HF Ger te ARC 300 350 10 Lag erung Lagerung 4 mod_1261040715569_258 doc 35279 If you store the HF device longer than one year pay particular attention to the indi...

Страница 39: ...2007 ISO 14971 2007 ISO 13485 2003 Cor 1 2009 Classification according to EC Directive 93 42 EEC IIb Power connection Power consumption in standby mode 100 V 14 VA Power consumption in standby mode 2...

Страница 40: ...rvice support Service support via ISSys Cooling Convection Duty factor Intermittent 10 sec 30 sec on off Characteristics Max CUT power 100 W at 500 Max COAG power 100 W at 100 Output frequency 500 kHz...

Страница 41: ...ed 1 2 3 4 5 6 7 8 9 10 10 W 100 W 390 Vp 635 Vp 775 Vp 940 Vp 1100 Vp 1200 Vp 1250 Vp 1350 Vp 1440 Vp 1500 Vp Monopolar Modes Coagulation Moderate Sinusoidal constant 1 2 3 4 5 6 7 8 9 10 10 W 100 W...

Страница 42: ...the Monopolar Cutting Pure setting 50 W Values measured using non inductive resistors Graph of output power P W as a function of the load resistance R for the Monopolar Cutting Pure setting 100 W Gra...

Страница 43: ...ing Dry setting 50 W Values measured using non inductive resistors Graph of output power P W as a function of the load resistance R for the Monopolar Cutting Dry setting 100 W Graph of output power P...

Страница 44: ...derate setting 50 W Values measured using non inductive resistors Graph of output power P W as a function of the load resistance R for the Monopolar Coagulation Moderate setting 100 W Graph of output...

Страница 45: ...ed setting 50 W Values measured using non inductive resistors Graph of output power P W as a function of the load resistance R for the Monopolar Coagulation Forced setting 100 W Graph of output power...

Страница 46: ...Coagulation setting 50 W Values measured using non inductive resistors Graph of output power P W as a function of the load resistance R for the Bipolar Coagulation setting 100 W Graph of output power...

Страница 47: ...tion on accessories and replacement parts is available in the current accessories catalogue 13 EMC 13 1 Guidelines and manufacturer s declaration in accordance with DIN EN 60601 1 2 para 6 8 3 201 Ele...

Страница 48: ...cal 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 kV voltage outer conduct...

Страница 49: ...ower 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 per IEC 61000 4 3 3 V m 80 MHz to 2 5...

Страница 50: ...ied below Nominal transmitter output W Protective distance m depending on transmission frequency 150 kHz to 80 MHz d 0 35 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 2 5 GHz d 0 7 P 0 01 0 035 0 035 0 07...

Страница 51: ...relevant 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 elec...

Страница 52: ...l and 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...

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