Bowa ERGO 315R Instructions For Use Manual
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Bowa ERGO 315R Instructions For Use Manual

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Instruction for use
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MN031-554-S0

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Summary of Contents for Bowa ERGO 315R

  • Page 1 Instruction for use MN031-554-S0...

  • Page 2: Key

    Sterile blade Blade Grip area Blade holder Blade rod Blade holder Spring latch Push rod Teeth Slotted ring for blade rod latching Electrodes Mounting marking BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 3 Handle Rotation wheel Mounting Locking knob marking Pushbuttons Blade trigger Jaw holder Jaw actuation lever Cable with handswitch Handswitch Connector for BOWA ARC generator BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 4 Cleaning adapter Cleaning adapter for jaw / handle Cleaning adapter for push rod Cleaning brush Reprocessing basket & lid BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 5: Table Of Contents

    Mounting the blade with the blade holder ........13 Assembling the vessel sealing instrument ........15 Operation ..................21 Before use ................... 21 Function test in the OR ..............21 During the operation ..............22 Withdrawal ................... 24 After use ..................24 BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 6 8.5.2 Placing the parts in the cleaning and reprocessing basket ..35 Inspection ..................37 Packing ..................39 Autoclaving .................. 39 Recommended operating supplies ..........40 Storage ..................41 Transport ..................41 Technical specifications ............42 Disposal ..................42 Symbols on packaging ............. 43 BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 7: Using This Operating Manual

    1 Using this operating manual Using this operating manual This operating manual is part of the product. BOWA-electronic GmbH & Co. KG assumes no liability and provides no warranty whatsoever for any damage or consequential damage arising from non-compliance with this operating manual.

  • Page 8: Symbols And Notation

     Prerequisite for an activity  Activity with one step Activity with several steps in strict sequence  Result of preceding activity • List (first level) • List (second level) Emphasis Emphasis ..., see section xxx, page xxx Cross-reference BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 9: Intended Use

    2 Intended use Intended use Indications The ERGO 315R instrument is intended to be used to seal arterial and venous blood vessels and vascular tissue structures in laparoscopic and open surgical procedures in varied surgical disciplines (including but not limited to general surgery, gynecology, urology, thoracic surgery and other).

  • Page 10: Safety

     Do not lay the HF cable in loops.  Consult the operating manuals of the BOWA HF generators for additional information on interference with other devices. Replaceable blade in blade holder Do not recondition the replaceable blade and blade holder.

  • Page 11: Patients With Pacemakers

    Medical electrical devices are subject to special precautionary measures with regard to EMC. Observe the following instructions:  The BOWA accessory is only intended to be connected to BOWA specified HF devices.  Using the accessory with medical devices from other manufacturers can result in higher emission levels or reduced interference immunity.

  • Page 12: Mode Of Operation

    The instrument can be used for vessels with diameters up to 7 mm. The integrated cutting function of the ERGO 315R allows the tissue to be cut under treatment immediately after sealing without first changing instruments.

  • Page 13: Assembly

    To mount the blade, grasp the blade holder in the grip area. Position the blade rod on the blade holder as indicated by the markings on the blade holder and slide the blade rod in the direction indicated by the arrow until the blade clicks into place. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 14 5 Assembly Lift the blade rod with the mounted blade slightly and pull it out of the blade holder. Discard the blade holder. Avoid bending the blade in the process. Visually check the blade for correct assembly. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 15: Assembling The Vessel Sealing Instrument

    5 Assembly Assembling the vessel sealing instrument Assemble the vessel sealing instrument in the sequence shown below. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 16 Insert the blade rod with the assembled blade into the push rod.  Align the spring latch of the blade rod with the slotted ring of the push rod and insert the blade rod until it clicks in place. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 17 5 Assembly Insert the push rod into the jaw  Insert the push rod with the assembled blade rod into the completely opened jaw.  Align the teeth of the push rod with the orange marking on the jaw. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 18 Assemble the jaw and handle. Close the jaws with your fingers and guide the jaw into the handle until it latches with a click. Ensure that the orange marking on the handle is aligned with the marking on the jaw. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 19 Check the blade for ease of motion by actuating the blade trigger. Unlatch the jaws by again actuating the handle. Check whether the rotation wheel can be turned when the handle is unlocked. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 20 Attach the cable with the handswitch Attach the connection cable by inserting the handswitch in the handle. Clamp the cable in the guide groove of the handle. The handswitch can be operated from either side, making it suitable for both left-handed and right-handed use. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 21: Operation

    13) and cleaned (see section 8, page 29). WARNING Risk of patient injury due to incorrect device settings  Use only approved BOWA ARC generators with vessel sealing capability (see section 11, page 42).  Select the settings of the HF generator according to the requirements of the procedure.

  • Page 22: During The Operation

    Do not switch on the HF current before the active electrodes are in contact with the tissue to be coagulated and the handle is latched.  Accidental activation of the vessel sealing instrument may cause injury to the patient. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 23 Release the actuated switch. 10. Press the handle all the way to release the ratchet and open the electrodes.  The tissue is coagulated. Tissue separation  The tissue has been grasped by the jaws and is coagulated. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 24: Withdrawal

     Clean the electrodes regularly with a moist cloth.  Replace the jaw if the electrodes are damaged.  Replace the blade after every operation.  Prepare the vessel sealing instrument after use (see section 8, page 29). BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 25: Dismantling

    Do not touch the electrode surfaces immediately after use. Risk of burns from current-carrying parts  Disconnect the cable from the HF generator before dismantling.  Disassemble the instrument in the reverse order of assembly (see section 5, page 13). BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 26: Disassembley

    Disassembley Dismantle the handswitch  Press the connection cable handswitch out of the rear of the handle. Dismantle the handle and jaw Unlock the handle. Press the locking knob on the back of the handle to open the jaw. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 27 7 Dismantling Then press the two push buttons on the rotation wheel simultaneously and pull the handle off the jaw. Dismantle the jaw and push rod  With the electrodes fully open, pull the push rod out of the jaw. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 28: Remove The Blade

    Risk of blade breakage due to incorrect dismantling  Carefully pull the blade free to avoid breaking the blade.  Use a suitable aid (needle holder, clamp, forceps, etc.) to remove the blade in the same way as a scalpel blade. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 29: Cleaning

    Observe the applicable national legal regulations and the hygiene regulations of the hospital or clinic. BOWA-electronic GmbH & Co. KG assumes no warranty for malfunction of the vessel sealing instruments in connection with disinfectants or the method used, including the effectiveness of the disinfectant.

  • Page 30: Dismantling

    (see section 7.3, page 28) Soaking  If necessary, first use a non-woven cloth or plastic brush to remove residual dirt.  Soak the vessel sealing instrument immediately after use, not more than 2 hours after use. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 31: Manual Removal Of Contamination

    8 Cleaning To soak the distal jaw part, BOWA recommends a small tube filled with liquid, e.g. the Leonardo-Wet-Set® from Interlock Medizintechnik GmbH, which you push over the branches of the jaw part immediately after use.  Use only aldehyde-free disinfectants (e.g.

  • Page 32: Pretreatment In An Ultrasonic Bath

    Use suitable cleaning and disinfection products for ultrasonic cleaning (see section 8.9, page 40). Follow the manufacturer’s instructions with regard to the concentration and exposure time of the cleaning and disinfection products. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 33: Automatic Preparation In A Cdm

    Automatic preparation in a CDM NOTE Cleaning adapter & reprocessing basket  BOWA has validated the automatic reprocessing using the cleaning adapters in the reprocessing basket. (optionally available) 8.5.1 Preparation for automatic cleaning – cleaning adapter Mounting the cleaning adapter on the jaw...
  • Page 34 8 Cleaning Mounting the cleaning adapter on the handle Mounting the cleaning adapter on the push rod BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 35: Placing The Parts In The Cleaning And Reprocessing Basket

    Place the instrument components with the attached cleaning adapters in the corresponding recesses in the cleaning and reprocessing basket as indicated by the symbols. Feed the hoses out of the reprocessing basket through the openings in the end of the reprocessing basket provided for that purpose. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 36 The cleaning agent is suitable for the vessel sealing instrument. • If thermal disinfection is not used, a suitable disinfectant with proven effectiveness (e.g. DGHM or FDA approval or CE mark) and compatible with the cleaning agents is also used. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 37: Inspection

     After cleaning, visually inspect each of the instruments and test them for proper operation.  Replace any damaged parts. DANGER Risk of patient burns with brittle or defective insulation  Replace instrument components with damaged insulation. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 38 Check the jaw holder for damage and corrosion. Check the electrode surfaces and the blade groove for cleanliness and damage. Check the cable in the joint area of the jaw for damage. HF cable Check the connector for damage and corrosion. Inspect the insulation for damage. BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 39: Packing

    Autoclaving NOTE Risk of destruction of the vessel sealing instrument from hot-air sterilization  Use a suitable sterilization method. Use only steam sterilization with the following specifications: • Fractional vacuum method (with adequate device drying) BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...

  • Page 40: Recommended Operating Supplies

    (including investigation of sterilization medium residues if appropriate). Recommended operating supplies BOWA recommends the use of neutral to slightly alkaline cleaning agents or cleaning and disinfection agents free from potentially harmful ingredients. Alcoholic and/or aldehydic ingredients may be permissible, depending on the concentration.

  • Page 41: Storage

    (90°C, 5 minutes) and an alkali cleaning product with a surfactant additive (neodic MediClean forte) has been demonstrated by BOWA. The manufacturer accepts no responsibility for the use of other cleaning and disinfection products.

  • Page 42: Technical Specifications

    11 Technical specifications 11 Technical specifications Technical specifications Maximum voltage 200 Vp sinusoidal BOWA ARC generators with vessel Approved HF device sealing software: • ARC 350 REF 900-351 • ARC 400 REF 900-400 Approved modes Ligation, ARCSeal 12 Disposal DANGER Infection hazard ...

  • Page 43: Symbols On Packaging

    Expiry date Sterilized using ethylene oxide Single use only Do not resterilize Do not use if packaging is damaged Keep away from sunlight Keep dry Manufacturer CE mark and identification number of notified body 0123 Conforms to Russian standards BOWA-IFU-MN031-554-ERGO315R-S0-EN-20190103...
  • Page 44 0123 BOWA-electronic GmbH & Co. KG CE marked according to Heinrich-Hertz Strasse 4-10 Medical Device 93/42/EWG 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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