Bowa ARC 100 Operating Manual

Bowa ARC 100 Operating Manual

Electrosurgical unit
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OPERATING MANUAL
ELECTROSURGICAL UNIT

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Summary of Contents for Bowa ARC 100

  • Page 1 OPERATING MANUAL ELECTROSURGICAL UNIT...
  • Page 3 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 4: Legend

    Legend Legend Front of ARC 100 Multifunction connection socket for monopolar instruments with hand or foot switch or bipolar instruments with foot switch * Socket for the neutral electrode (NE) * Activation indicator for bipolar coagulation (blue) Activation indicator for monopolar cutting (yellow) Activation indicator for monopolar coagulation (blue) Key for "Pure"...
  • Page 5: Table Of Contents

    Monopolar/bipolar multifunction socket ................21 3.4. Connection socket for neutral electrode ................21 3.5. Activation and alarm signals in monopolar and bipolar mode .......... 21 3.6. Emergency stop ........................ 22 3.7. Monitoring functions ......................22 3.7.1. Self-test......................22 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 6 6.2.3. Changing the volume ..................31 6.3. Mode descriptions ......................31 6.3.1. Monopolar cutting, "Pure" .................. 31 6.3.2. Monopolar cutting, "Dry" ..................31 6.3.3. Monopolar coagulation, "Moderate" ..............32 6.3.4. Monopolar coagulation, "Forced" ..............32 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 7 Repairs ..........................37 9.3. Technical service ......................38 Storage ............................38 Technical specifications ........................ 39 11.1. Technical data for ARC 100 ....................39 11.2. Power, voltage and current charts ..................42 Accessories and replacement parts ..................... 47 EMC ..............................47 13.1.
  • Page 8: Using This Operating Manual

    Revision index Software version Last revised 2014/12 Pos : 5 /679-BOWA/HF-Geräte/ARC 300/350/1 U mgang mi t/Gültig keit @ 4\mod_1261040280413_258.doc @ 34386 @ 2 1.2. Scope of validity This operating manual applies only to the devices designated on the title page.
  • Page 9: 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. 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 10: Other Symbols And Notation

    List (second level) Emphasis Emphasis ...; see Section xxx, page xxx Cross reference ... "On/off switch" 25 Bolded numbers (here: 25) refer to a schematic diagram of the ARC 100 and the respective legend (page 4) ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 11: Safety

    BOWA requires that the HF device is operated under the supervision of qualified and authorized personnel. The surgeon and medical staff must...
  • Page 12: General Safety Instructions

    Section Technical service, page 38. To protect personnel, BOWA recommends the use of a smoke evacuator to extract electrosurgical smoke, e.g. BOWA SHE SHA. ARC 100 Operating Manual...
  • Page 13: Personal Safety Instructions

    Excessive leakage currents may create a risk of burns to the patient.  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. 2.3.2.
  • Page 14: Safe Positioning Of The Patient

    Ensure that no conductive fluids (e.g. blood, amniotic fluid) have penetrated the foot switch or the manual switch.  Ensure that the cables for the foot switch and manual switch are free from short circuits and broken leads. ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 15: Adjusting The Settings Of The Hf Device And Use Of The Accessories

    Do not remove hot electrodes from the patient's body directly after cutting or coagulation.  Ensure that there is sufficient distance between the patient cables and the cables of the HF device.  Do not run the patient cable across the patient. 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 16: Device-Related Safety Instructions

    2 Safety 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 17: Surgical Environment: Prevention Of Explosions And Ignition

    To prevent a rise in temperature at the current emergence point, the following conditions must be ensured:  sufficiently large contact surface between the neutral electrode and the patient's body  high electrical conductivity between the neutral electrode and the patient's body 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 18 Ensure that there are no implants (e.g. bone nails, bone plates, endoprostheses) in the current path.  Ensure that no short circuits can occur at the neutral electrode connection.  Avoid sites where liquids can collect. ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 19 For monitoring of the neutral electrode, see Section EASY neutral electrode monitoring (EASY monitoring), page 23. Pos : 15 /679-BOWA/HF- Ger äte/ARC 300/350/3 F unkti ons weis e/F unktions weis e @ 4\mod_1261040424241_258.doc @ 34595 @ 1 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 20: Functionality

     It is not necessary to apply a neutral electrode to the patient, which eliminates the associated risks to the patient. Instruments can be connected to the multifunction socket 1. ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 21: Monopolar/Bipolar Multifunction Socket

    Frequency (Hz) Signal type Monopolar Cut Continuous sound Monopolar Coag Continuous sound Bipolar Coag Continuous sound Alarm Beep sound Pos : 19 /679-BOWA/HF- Ger äte/ARC 200/250/300e/3 F unkti ons weis e/N ot-Aus @ 4\mod_1270107171492_258.doc @ 38126 @ 2 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 22: Emergency Stop

    For further information, see Section Detecting and correcting faults, page 33. Pos : 21 /679-BOWA/HF- Ger äte/ARC 300/350/3 F unkti ons weis e/ARC C ontrol-Technol ogie @ 4\mod_1261040479928_258.doc @ 34728 @ 2 3.8.
  • Page 23: Easy Neutral Electrode Monitoring (Easy Monitoring)

    In addition to the manual switch, the foot switch can be used to activate various operating modes. The foot switches are connected to socket connector 30. The following foot switch can be connected to the HF device: Article No. Designation 901-012 Single pedal foot switch 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 24: Description

    Directive 2002/96/EC (WEEE); see "Disposal" Identification of (active) HF output;
 caution: dangerous electrical voltage! Manufacturer Date of manufacture Observe operating instructions Foot switch Volume adjustment range Volume control 4.1.1. Rating label Figure 4-1: ARC 100 rating label ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 25: Scope Of Delivery

     Bipolar instrument - and / or-  Foot switch Pos : 30 /679-BOWA/HF- Ger äte/ARC 200/250/300e/11 T echnisc he Daten/Betriebs beding ungen @ 6\mod_1298553863128_258.doc @ 48688 @ 2 4.4. Operating conditions Temperature: +10 °C to +40 °C Relative humidity:...
  • Page 26: Preparation

    Position the HF device with the front of the device facing the patient and surgeon. Do not place any other objects on or above the HF device. Do not place the HF device on top of other devices. ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 27: Switching On The Hf Device

    The HF device is ready for operation.  The parameters for the most recently selected program appear on the front panel. Pos : 34 /679-BOWA/HF- Ger äte/ARC 200/250/300e/5 Vor ber eitung/Z ubehör ansc hließ en @ 6\mod_1297066132449_258.doc @ 47913 @ 233 5.3. Connecting instruments ...
  • Page 28: Connecting The Foot Switch

    “Cut” and “Coag”. Check the settings on the display. Connect a bipolar forceps to the multifunction socket 1 and activate coagulation on a piece of wet gauze using the foot switch. ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 29: Actions In Case Of Problems

    EASY monitoring of the split neutral HF device. electrode 15 light up green, but the type of neutral electrode is not correctly detected. 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 30: Operation

    Medicine is continuously evolving and growing due to R&D and clinical practice. These developments may also make deviations from the specified data necessary. Please contact the medical product consultants authorized by BOWA regarding recommendations for settings. ARC 100 Operating Manual...
  • Page 31: Basic Settings

    Spatula electrodes  Sling electrodes Pos : 43 /679-BOWA/HF- Ger äte/ARC 200/250/300e/6 Bedi enung/Programm 1 "Macr o" @ 6 \mod_1297072010043_258.doc @ 48027 @ 3 6.3.2. Monopolar cutting, "Dry" This mode is used for monopolar dry cutting. A large, controlled arc is generated, which allows significantly deeper coagulation to be obtained.
  • Page 32: Monopolar Coagulation, "Moderate

    Application areas Bipolar coagulation Suitable instruments  Bipolar forceps  Bipolar scissors Pos : 47 /679-BOWA/HF- Ger äte/ARC 200/250/300e/6 Bedi enung/Programm 5 "Argon Fl ex" (nur mit Opti on GastroCUT) @ 6\mod_1297072401699_258.doc @ 48065 @ 3 ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 33: Detecting And Correcting Faults

    The combination with the lit display 23 indicates the corresponding error. 7.1.1. Error list Pos : 63 /679-BOWA/HF- Ger äte/ARC 200/250/300e/7 F ehler/F ehl er-Liste @ 6\mod_1297147333340_258.doc @ 48257 @ 2 Errors not listed  Please contact the service centre in the event of errors that do not appear in the error list;...
  • Page 34: Fault Indications For Easy Monitoring

    Correct the position of the The Easy indicator 16 Loosened electrode neutral electrode. In the lights up red. case of continuing error The device electronics messages, replace the switch the output neutral electrode. socket 1 off. ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 35: Cleaning

    8.2. Disinfection and cleaning Pos : 66 /679-BOWA/HF- Ger äte/ARC 200/250/300e/ 8 Aufberei tung/Desinfizi eren und R ei nigung @ 6\mod_1297072881168_258.doc @ 48122 @ NOTE Incorrect use of the HF device can cause damage to the unit ...
  • Page 36: Maintenance And Repair

    In the case of severe deviations from the values of the attached final acceptance report, or if the specified maximum values were exceeded:  Send the HF device to the service centre; see Section Technical service, page 38. ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 37: Repairs

    If a repair is necessary, have it done only by the service centre specified below.  Never carry out any repairs yourself. BOWA is liable for safety, reliability and performance of the HF device under the following conditions:  full compliance with all instructions regarding the installation and proper use for the intended purpose contained in this operating manual was maintained.
  • Page 38: Technical Service

    Storage Pos : 71 /679-BOWA/HF- Ger äte/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 indicators of the automatic function tests; see Section Functional test, page 28.
  • Page 39: Technical Specifications

    11 Technical specifications Technical specifications 11.1. Technical data for ARC 100 Insulation type / Classification IEC 60601-1-2: 2007 Level of protection provided by the housing IP 21 Protection class according to EN 60601-1 Type of application component as specified in EN...
  • Page 40 +10°C to +40°C -10°C to +60°C Relative humidity 30 to 75%, non- 10 to 85%, non- condensing condensing Atmospheric pressure 700 to 1060 hPa 500 to 1060 hPa Operating altitude (max.) 3600 m above sea level ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 41 2210 Vp 2340 Vp Bipolar Mode Coagulation 117 Vp 158 Vp 195 Vp 227 Vp Sinusoidal 246 Vp Bipolar 10 W - 100 W constant 270 Vp 290 Vp 315 Vp 335 Vp 346 Vp 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 42: Power, Voltage And Current Charts

    Graph of output power P [W] as a 1380 function of the "Monopolar Cutting Pure" setting. Design load resistance = 500   Table of HF output voltage U [Vp] as a function of the "Monopolar Cutting Pure" setting (no load) ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 43 Graph of output power P [W] as a 1500 function of the "Monopolar Cutting Dry" setting. Design load resistance = 500   Table of HF output voltage U [Vp] as a function of the "Monopolar Cutting Dry" setting (no load) 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 44 Graph of output power P [W] as a function of the "Monopolar Coagulation Moderate" setting. Design load resistance = 100   Table of HF output voltage U [Vp] as a function of the "Monopolar Coagulation Moderate" setting (no load) ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 45 Graph of output power P [W] as a 2340 function of the "Monopolar Coagulation Forced" setting. Design load resistance = 500   Table of HF output voltage U [Vp] as a function of the "Monopolar Coagulation Forced" setting (no load) 900-100_IFU-V1.0_11587-S0-20141209-EN ARC 100 Operating Manual...
  • Page 46 Graph of output power P [W] as a function of the "Bipolar Coagulation" setting. Design load resistance = 100   Table of HF output voltage U [Vp] as a function of the "Bipolar Coagulation" setting (no load) ARC 100 Operating Manual 900-100_IFU-V1.0_11587-S0-20141209-EN...
  • Page 47: Accessories And Replacement Parts

    6.8.3.201 Electromagnetic interference (IEC 60601-1-2, Table 201) The ARC 100 is intended for operation in an electromagnetic environment as described below. The customer or user of the ARC 100 should ensure that it is operated in such an environment. Electromagnetic environment...
  • Page 48 13 EMC Electromagnetic immunity (IEC 60601-1-2, Table 202) The ARC 100 is intended for operation in the electromagnetic environment described below. The customer or user of the ARC 100 should ensure that it is operated in such an environment. Tests for resistance to...
  • Page 49 13 EMC Electromagnetic immunity (IEC 60601-1-2, Table 204) The ARC 100 is intended for operation in the electromagnetic environment described below. The customer or user of the ARC 100 should ensure that it is operated in such an environment. Tests for resistance to...
  • Page 50 The ARC 100 is designed for operation in an electromagnetic environment in which HF interference is monitored. The customer or user of the ARC 100 can help to prevent electromagnetic interference by complying with the minimum clearance between portable and mobile HF telecommunication devices (transmitters) and the ARC 100.
  • Page 51: Disposal

    14 Disposal Disposal Pos : 80 /679-BOWA/HF- Ger äte/ARC 300/350/14 Entsorgung/Entsorgung @ 4\mod_1261040829522_258.doc @ 35450 @ Always comply with the national regulations of the 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 electronic devices.
  • Page 52 0123 BOWA-electronic GmbH & Co. KG CE-Kennzeichnung gemäß Heinrich-Hertz Strasse 4-10 Richtlinie 93/42/EWG D-72810 Gomaringen │ Germany Phone: +49 (0) 7072-6002-0 Fax: +49 (0) 7072-6002-33 info@bowa-medical.com │ www.bowa-medical.com...

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