Bowa ARC PLUS Operating Manual
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Bowa ARC PLUS Operating Manual

Argon coagulation unit
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OPERATING MANUAL
ARGON COAGULATION UNIT

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Summary of Contents for Bowa ARC PLUS

  • Page 1 OPERATING MANUAL ARGON COAGULATION UNIT...

  • Page 3: Table Of Contents

    Front panel controls and indicators ..............19 3.1.2. Rear panel controls and connectors ..............20 3.2. Symbols on the device ...................... 21 3.2.1. Rating label ......................22 3.3. Components required for operation .................. 22 3.4. Operating conditions ......................22 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...
  • Page 4 Technical safety inspection (TSI) ..............37 8.2. Repairs ..........................38 8.3. Technical service ......................39 Storage ............................39 Technical Specifications ....................... 40 10.1. ARC PLUS technical data ....................40 Accessories and Spare Parts ......................42 ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 5: Arc Plus Operating Manual

    Contents EMC ..............................43 12.1. Guidelines and manufacturer's declaration in accordance with IEC 60601-1-2, Section 6.8.3.201 ......................43 Disposal ............................45 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...

  • Page 6: Scope Of Delivery

    Scope of delivery Scope of delivery  ARC PLUS  Fibre optic cables (2x 90 mm)  Extension power cable, Y-type  Connector covers  Operating manual ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 7: Using This Operating Manual

    Using this Operating Manual This operating manual is part of the product. BOWA-electronic GmbH & Co. KG, referred to in the following simply as BOWA, assume no liability nor provide any warranty whatsoever for any damage or consequential damages arising from non-compliance with the operating manual.

  • Page 8: Symbols And Notation

    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 ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 9: Other Symbols And Notation

    List (first level)  List (second level) Emphasis Emphasis .., see Section “xxx”, page Cross reference ... Purge button 3 Numbers in bold face (e.g. 3) refer to marked items on photos of the device 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...

  • Page 10: Safety

    With the aid of suitable electrodes, argon-assisted cutting is also possible. The main advantage 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 surgery.

  • Page 11: General Safety Instructions

    Always connect the HF device to a mains power system with a protective earth lead in order to prevent electric shock. NOTE The ARC PLUS device may only be operated with the ARC 350 (REF 900-351) and ARC 400 (REF 900-400) HF generators with software version 1.0.0.4.16.8 or later.

  • Page 12: Personal Safety Instructions

    Personal safety instructions 2.3.1. Ambient conditions  Do not operate the HF device in the immediate vicinity of the patient. Observe the minimum distances recommended by BOWA, as shown in the following figure. Figure 2-1: Patient environment ARC PLUS Operating Manual...

  • Page 13: Patients With Pacemakers

    Avoid skin-to-skin contact.  Place anti-static towels between areas of heavy sweating and skin-to-skin contact on the patient's trunk.  Ensure a suitable support surface in order to prevent pressure necrosis.  Drain urine via a catheter. 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...

  • Page 14: Device-Related Safety Instructions

    2.4. Device-related safety instructions Devices manufactured by BOWA are developed in accordance with the current state of technology and generally accepted safety rules. Despite this, risks to the life and health of the user or other parties and/or damage to the device and other objects can occur.

  • Page 15: Correct Use Of The Argon Device

    Section 16 of IEC 60601-1:2005 must be observed.  If a medical electrical system is formed with the ARC PLUS by use of a multiple socket-outlet as a separate unit, a warning must be present to indicate that this multiple socket-outlet may not be placed on the floor.
  • Page 16 Pressure reducer for ARC PLUS, CGA 580 900-904 Pressure reducer for ARC PLUS, BS 341 no. 3  900-906 Pressure reducer for ARC PLUS and ARC 400/350, DIN 477 no. 6  900-907 Pressure reducer for ARC PLUS and ARC 400/350, DIN 477 no. 10 ...

  • Page 17: Safe Handling (General Instructions)

    Always set the output power of the HF device as low as possible.  The ARC PLUS coagulation unit may alternatively be connected to a central argon supply system. Along with the device configuration, the argon gas purity grade specified by BOWA and the specifications for the maximum inlet pressure must be met.

  • Page 18: Surgical Environment: Prevention Of Explosions And Ignition

    Do not use the device if even the smallest irregularity is present. 2.5.2. Application of the neutral electrode Observe the instructions for use of the neutral electrode in the operating instructions of the HF device and the instructions on the packaging of the neutral electrode. ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 19: Description

    Orange: Sleep mode Green: Standby mode Purge button White: Standby mode Green: Purging Gas status indicator White: Self-test Green: Purging Yellow: Cutting Blue: Coagulating Red: Fault condition Fault indicator Red: Fault 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...

  • Page 20: Rear Panel Controls And Connectors

    Connector for electronic pressure sensor (gas bottle 1) Connector for pressure reducer (gas bottle 1) Connector for electronic pressure sensor (gas bottle 2) Connector for pressure reducer (gas bottle 2) UART Serial communication port Power switch ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 21: Symbols On The Device

    HF device is activated. This energy generates electromagnetic radiation. Labelling of electrical and electronic devices in accordance with Directive 2002/96/EC (WEEE); see "Disposal" Manufacturer Date of manufacture Observe operating instructions UART Serial communication port 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...

  • Page 22: Rating Label

    3 Description 3.2.1. Rating label Figure 3-1: ARC PLUS rating label 3.3. Components required for operation  Power cable  Filled argon gas bottle with pressure reducer  Argon interconnect cable for rigid or flexible argon electrodes  Rigid or flexible argon electrodes ...

  • Page 23: Preparation

     The HF device, ARC PLUS device and argon bottle are usually fitted on an ARC CART equipment trolley with a gas bottle holder. Figure 4-1: ARC CART 900-001_IFU_V1.0_11270-S0-20130118-EN...
  • Page 24  Connect the power cable of the HF device to the supplied Y extension power cable and connect it to the HF device and the ARC PLUS, and connect to the power cable to the AC mains. NOTE Verify that the actual AC mains voltage matches the rated voltage range specified for the device.

  • Page 25: Switching On The Argon Device

    Section “Detecting and Correcting Faults“, page 34. Connect the sterile filter, the argon interconnect cable and the instruments. Switch on power switch 16 on the rear panel of the ARC PLUS. Switch on the ARC 350 or ARC 400 and select an argon operating mode.
  • Page 26 The argon device is de-activated automatically when an argon mode is not selected on the HF generator. The operating mode indicator 2 changes from green (Standby) to orange (Sleep). NOTE Observe the manufacturer’s warnings and instructions for the accessories before connecting them to the device. ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 27: Connecting Instruments

    ARC PLUS. Recommended settings:  80 W coagulation power, Argon Open mode, or 100 W cutting power; Argon Open mode, on HF device  3.5 l/min Coag Flow or 4.0 l/min Cut Flow on ARC PLUS 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...

  • Page 28: Using A Sterile Filter

    Screw the sterile filter into the gas outlet connector 1.  Screw the gas connector of the argon interconnect cable into the corresponding threaded coupling of the sterile filter. Figure 4-6: Fitting the sterile filter and argon interconnect cable on the ARC PLUS ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 29: Functional Test

    Operation 5.1. Activation and alarm signals When the purging process is active, the ARC PLUS emits a continuous acoustic signal at a fixed volume. Activation and alarm signals are generated by the HF generator. The volume of the activation signal should be increased as necessary for use in relatively noisy surroundings.

  • Page 30: Settings And Recommended Parameter Values

    With argon plasma coagulation, 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. The coagulation effect is self-limiting both in depth and on the surface.
  • Page 31 The length of the argon probe that is used depends on the length of the endoscope and the location of the surgery in the patient’s body. Generators with Plug’n Cut COMFORT recognise BOWA COMFORT instruments and automatically select the appropriate parameter values.

  • Page 32: Selection And Changeover Of Gas Bottles

    If a connected gas bottle is empty, a warning message is shown on the display of the ARC generator and an acoustic signal is emitted. The Purge button 3 on the ARC PLUS blinks red. In this way surgical staff are altered to the need for replacing the empty argon bottle with a full one.

  • Page 33: Purge Function

    Exchanging the gas bottle Close the bottle valve by hand and disconnect the pressurised gas line from gas connector 12 or 14 on the rear panel of the ARC PLUS, and disconnect the electronic pressure sensor (if present) from connector 11 or 13.

  • Page 34: Detecting And Correcting Faults

    6 Detecting and Correcting Faults Detecting and Correcting Faults Figure 6-1: Internal fault The ARC PLUS enables continuous monitoring of all relevant device functions. The fault indicator 5 lights up red when a serious fault condition is signalled. 6.1. Fault list...
  • Page 35 Fault should be replaced. Subsequently restart ARC PLUS by activating the flashing "Purge" button TSI ARC The annual Technical Safety Inspection (TSI) for ARC PLUS is due. PLUS Initiate this inspection as soon as possible. Warning Any further use of the unit is at the user's risk.

  • Page 36: Cleaning

    Wipe the agent off with a sponge or cloth moistened with clean water. Dry the device using a clean, lint-free cloth. Do not sterilise the pressure reducer or the gas hose. Use wiping disinfection to clean and disinfect the surfaces. ARC PLUS Operating Manual 900-001_IFU_V1.0_11270-S0-20130118-EN...

  • Page 37: Maintenance And Repair

    In the case of severe deviations from the values on the final acceptance report, or if the stated maximum values have been exceeded:  Send the ARC PLUS to a service centre (see Section “Technical service“, page 39). 900-001_IFU_V1.0_11270-S0-20130118-EN ARC PLUS Operating Manual...

  • Page 38: Repairs

    8 Maintenance and Repair 8.2. Repairs NOTE The ARC PLUS may be damaged if you attempt to do your own repairs or modifications.  If a repair is necessary, always have it done by the service centre specified below. ...

  • Page 39: Technical Service

    9 Storage 8.3. Technical service Contact the following service centre for maintenance and repairs: 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 or visit our website: www.bowa-medical.com 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.

  • Page 40: Technical Specifications

    10 Technical Specifications Technical Specifications 10.1. ARC PLUS technical data Compatibility ARC 400 (item no. 900-400), V1.0.0.4.16.8 or BOWA HF generators later, ARC 350 (item no. 900-351) Item no. 900-901, 900-902, 900-903, 900- BOWA pressure reducers 904, 900-906, 900-907, 900-908, 900-909 Insulation type / Classification IEC 60601-1-2:2007 + Cor.
  • Page 41 900-906, 900-907, 900-908, or 900-909 Gas outlet pressure Max. 2 bar  /  (manual using BOWA HF generator) Gas bottle changeover automatic/manual  (by BOWA HF generator) Gas bottle fill level indication Advance visual/acoustic warning of gas ...

  • Page 42: Accessories And Spare Parts

    Continuous operation Accessories and Spare Parts Original 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 compatible with the maximum HF peak voltage of the HF device.
  • Page 43 Electromagnetic interference (IEC 60601-1-2, Table 201) The ARC PLUS is intended for operation in an electromagnetic environment as described below. The customer or user of the ARC PLUS should ensure that it is operated in such an environment. Electromagnetic environment...
  • Page 44 Electromagnetic immunity (IEC 60601-1-2, Table 204) The ARC PLUS is intended for operation in the electromagnetic environment described below. The customer or user of the ARC PLUS should ensure that it is operated in such an environment. Immunity test IEC 60601...

  • Page 45: Disposal

    The ARC PLUS is designed for operation in an electromagnetic environment with controlled HF interference. The customer or user of the ARC PLUS can help to prevent electromagnetic interference by complying with the minimum distance between portable and mobile HF telecommunication devices (transmitters) and the ARC PLUS.
  • Page 46 0123 BOWA-electronic GmbH & Co. KG CE mark in accordance with Heinrich-Hertz Straße 4-10 Directive 93/42/EEC D-72810 Gomaringen │ Germany Phone +49 (0) 7072-6002-0 +49 (0) 7072-6002-33 info@bowa-medical.com │ www.bowa-medical.com...

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