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OPERATING MANUAL
ARGON COAGULATION UNIT

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Содержание ARC PLUS

Страница 1: ...OPERATING MANUAL ARGON COAGULATION UNIT...

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Страница 3: ...ient conditions 12 2 3 2 Patients with pacemakers 13 2 3 3 Patient preparation 13 2 4 Device related safety instructions 14 2 4 1 Correct connection of the argon device 14 2 4 2 Correct use of the arg...

Страница 4: ...signals 29 5 2 Emergency stop 29 5 3 Settings and recommended parameter values 30 5 4 Selection and changeover of gas bottles 32 5 5 Purge function 33 5 6 Post surgery instructions 33 5 6 1 Shutting o...

Страница 5: ...Contents 900 001_IFU_V1 0_11270 S0 20130118 EN ARC PLUS Operating Manual 5 12 EMC 43 12 1 Guidelines and manufacturer s declaration in accordance with IEC 60601 1 2 Section 6 8 3 201 43 13 Disposal 45...

Страница 6: ...cope of delivery 6 ARC PLUS Operating Manual 900 001_IFU_V1 0_11270 S0 20130118 EN Scope of delivery ARC PLUS Fibre optic cables 2x 90 mm Extension power cable Y type Connector covers Operating manual...

Страница 7: ...sing this device Store the operating manual in a safe place throughout the service life of the device Keep the operating manual accessible to operating theatre personnel Give the operating manual to e...

Страница 8: ...risk NOTE Nature source and consequences of the hazard risk of property damage Measures for avoiding the risk 1 4 2 Hazard levels of warning instructions Symbol Hazard level Probability of occurrence...

Страница 9: ...or notation Meaning 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 Em...

Страница 10: ...tage of this is reduced smoke formation The ARC PLUS argon device is used in combination with the ARC 350 900 351 or ARC 400 900 400 HF generator for cutting and coagulation in open and endoscopic sur...

Страница 11: ...1 1 or Section 16 of the third edition of IEC 60601 1 as relevant Anyone who connects additional devices to medical electrical devices is perforce a system configurator and therefore responsible for...

Страница 12: ...be purged with argon gas before use Close the gas bottle s after every use Refill gas bottle in accordance with applicable national standards 2 3 Personal safety instructions 2 3 1 Ambient conditions...

Страница 13: ...pen vessels or apply them directly to tissue or open vessels Always keep the distal end of the electrode visible during surgery Due to the monopolar operating mode the HF current flows through the pat...

Страница 14: ...merse the device in water or cleaning agents Never use automatic equipment to disinfect the device Immediately drain any fluid that may have penetrated the device If the argon device has previously be...

Страница 15: ...tem is at the same time powered from the regular supply mains as otherwise galvanic isolation will no longer be present If a multiple socket outlet not powered from an isolation transformer is used co...

Страница 16: ...atmosphere can lead to oxygen deficiency and the associated consequences for the organism For this reason always check connections for leaks if you hear a persistent hissing sound Do not use leaky ga...

Страница 17: ...intentional activation Avoid direct contact with the patient Avoid indirect contact through electrically conductive objects or wet cloths Temporarily place HF instruments not currently being used use...

Страница 18: ...ensure that they have fully evaporated before using the HF surgical equipment Ensure that no flammable liquids collect beneath the patient or in body cavities e g the vagina Suction and or purge body...

Страница 19: ...tors 1 Luer Lock gas connector for argon instruments only 2 Operating state indicator Off Device switched off or no power connection Orange Sleep mode Green Standby mode 3 Purge button White Standby m...

Страница 20: ...ipotential bonding terminal 9 Bleed stub for pressure reducer connection hose 10 IEC chassis mount power connector 11 Connector for electronic pressure sensor gas bottle 1 12 Connector for pressure re...

Страница 21: ...nsor Bleed stub for pressure reducer Fibre optic signal output Fibre optic signal input Equipotential bonding Fuse Alternating current HF energy in the range of 9 kHz to 400 GHz is used when the HF de...

Страница 22: ...on gas bottle with pressure reducer Argon interconnect cable for rigid or flexible argon electrodes Rigid or flexible argon electrodes Two fibre optic cables HF generator including Argon option Neutra...

Страница 23: ...t fulfil the requirements of DIN VDE 0100 710 If the argon device has previously been stored or transported at temperatures below 10 C it will take approximately three hours to adjust to room temperat...

Страница 24: ...PLUS device to the equipotential rail with separate cables Use the provided Y extension power cable or a mains power cable of equal quality with the appropriate national mark of approval Connect the p...

Страница 25: ...ting Faults page 34 1 Connect the sterile filter the argon interconnect cable and the instruments 2 Switch on power switch 16 on the rear panel of the ARC PLUS 3 Switch on the ARC 350 or ARC 400 and s...

Страница 26: ...the ARC 400 The electronic pressure sensor reports the fill level which is shown on the display of the associated HF generator e g ARC 400 If the fill level of the bottle is adequate the surgery can...

Страница 27: ...perly connected to the ARC PLUS Recommended settings 25 W Argon Flexible mode on HF device 0 4 l min Coag Flow on ARC PLUS Perform a functional test before inserting the flexible probe into the workin...

Страница 28: ...4 3 3 Using a sterile filter If there is height difference between the argon device and the tip of the electrode body fluid may reach the argon device For this reason a sterile filter 830 050 must be...

Страница 29: ...evant functions and signals are tested cyclically If serious faults are detected the argon device switches off and the fault indicator on the display lights up red For further information see Section...

Страница 30: ...n the combination of the spray voltage from the HF generator in the instrument or probe and the argon flow from the ARC PLUS forms a plasma jet This plasma jet has a broad contact area on the tissue T...

Страница 31: ...status indicator 4 lights up blue when this mode is active The following table summarises the recommended parameter settings for the HF device Always set the power and the gas flow rate to the lowest...

Страница 32: ...u of the ARC 350 or ARC 400 In this case changeover to the spare bottle occurs automatically when the gas pressure in the bottle being used drops below a specific level The user can recognise this fro...

Страница 33: ...uctions The procedure described below is recommend after completion of surgery 5 6 1 Shutting off the argon gas Check the primary gas pressure on the pressure gauge of the pressure reducer If it is le...

Страница 34: ...ading Fault message ARC PLUS Fault Please check if the argon bottles are connected and open Empty bottles should be replaced Subsequently restart ARC PLUS by activating the flashing Purge button ARC P...

Страница 35: ...ou can connect two argon bottles The unit shifts automatically to the second bottle ARC PLUS Notice The argon bottle is empty The unit has shifted automatically to the replacement bottle Please make s...

Страница 36: ...stead clean or disinfect it WARNING Risk of electric shock and fire Unplug the power cable before cleaning the device For cleaning surfaces use the approved cleaning agents or disinfectants only as sp...

Страница 37: ...ely Have the safety inspection for the device performed once a year Consult the appropriate service manual for additional technical information 8 1 1 Technical safety inspection TSI Safety inspections...

Страница 38: ...ons authorised by BOWA to do this work The electrical distribution system in the relevant room complies with local regulations and statutory provisions Maintenance of the device is necessary whenever...

Страница 39: ...r visit our website www bowa medical com 9 Storage If the HF device is stored longer than one year observe in particular the functional test indications described in Section Functional test page 29 Cl...

Страница 40: ...rds IEC 60601 1 2005 Cor 1 2006 Cor 2 2007 IEC 60601 1 2 IEC 2007 2007 Cor 2010 IEC 60601 2 2 2009 IEC 62366 2007 ISO 14971 2007 ISO 13485 2003 Cor 1 2009 Classification according to EC Directive 93 4...

Страница 41: ...F generator Advance visual acoustic warning of gas shortage Dimensions and weight External dimensions width x height x depth mm 433 x 97 x 489 Weight approx 7 7 kg Controls and indicators One capaciti...

Страница 42: ...riginal BOWA accessories are suitable for use with devices in the ARC and ARC PLUS families When using accessories made by other manufacturers the user must ensure that they are designed for and compa...

Страница 43: ...ions or flicker as specified in IEC 61000 3 3 Conforms Electromagnetic immunity IEC 60601 1 2 Table 202 The ARC PLUS is intended for operation in the electromagnetic environment described below The cu...

Страница 44: ...transmission frequency Recommended protective distance d 0 35 P d 0 35 P for 80 MHz to 800 GHz d 0 35 P for 800 MHz to 2 5 GHz where P is the nominal transmitter output in watts W specified by the tr...

Страница 45: ...100 3 5 11 70 23 30 For transmitters whose maximum nominal output power is not listed in the table above the recommended protective distance d in metres m can be determined using the formulas in the...

Страница 46: ...and design changes Copyright by BOWA electronic Gomaringen Germany BOWA electronic GmbH Co KG Heinrich Hertz Stra e 4 10 D 72810 Gomaringen Germany Phone 49 0 7072 6002 0 Fax 49 0 7072 6002 33 info bo...

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