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

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Instructions for use
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MN031-554-S3

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Summary of Contents for Bowa ERGO 315R

  • Page 1 Instructions for use MN031-554-S3...

  • Page 2: Key

    Blade with blade holder Mounting aid Blade Grip area Blade holder Cleaning tip Blade mount Blade rod Spring latch Teeth Push rod Slotted ring for blade rod latching Electrodes Mounting marking BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 3 Handle Rotation wheel Mounting Locking mechanism marking Push buttons Blade trigger Jaw holder Jaw actuation lever Cable with handswitch Handswitch Connector for BOWA ARC generator BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 4 Cleaning adapter Cleaning adapter jaw / handle Cleaning adapter push rod Cleaning brush Reprocessing basket & lid BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 5: Table Of Contents

    6.2. Function test in the operating theatre ....... 25 6.3. During surgery ..............25 6.4. Removal ................27 6.5. After use ................27 Dismantling ..............28 7.1. Dismantling the vessel sealing instrument ......28 7.2. Deviating from the assembly ..........29 7.3. Removing the blade ............31 BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 6 8.6. Inspection ................. 41 8.7. Packing ................42 8.8. Autoclaving ............... 43 8.9. Environmental conditions ..........44 8.9.1. Storage and transport ............44 8.9.2. Operation ................. 44 Technical data ..............45 Disposal ................45 Symbols on packaging ..........46 BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 7: Using These Instructions For Use

    Always update the instructions for use whenever you receive additional information from the manufacturer. 1.1. Scope of validity These instructions for use apply only to the parts of the ERGO 315R instrument listed below. Designation 770-510 ERGO 315R Handle 770-522 ERGO 315R Jaw 275 mm...

  • 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-S3-EN-20210219...

  • Page 9: Intended Purpose

    Risk of injury from sharp blade  Discard and replace used blades and blade holders. • The device must not be operated in AUTOSTART mode. • As part of your responsibility for the sterility of the instruments used, please note: BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 10: Use-Related

    3 Safety instructions  Clean and sterilise the ERGO 315R handle and the associated electrode before each use.  Use only cleaning, disinfection and sterilisation methods that have been validated for the specific devices and products concerned.  Comply with the validated parameters for each cycle.
  • Page 11 Never route the HF cable alongside a camera cable.  Do not lay the HF cable in loops.  Consult the instructions for use of the BOWA HF generators for additional information on interference with other devices. • Do not repair or service defective devices: ...

  • Page 12: Patients With Pacemakers

    EMC information Medical electrical devices are subject to special EMC precautions, so please observe the following directions. 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 13: 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 14: Assembly

    5 Assembly Assembly Assembling the vessel sealing instrument Assemble the vessel sealing instrument in the sequence shown below: Inserting the push rod into the jaw BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 15 5 Assembly  Insert the push rod into the completely opened jaw with the electrodes fully opened. Align the teeth of the push rod with the orange marking on the jaw Attaching the mounting aid BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 16 The blade with blade holder and mounting aid are supplied sterilised. Remove the blade with blade holder and mounting aid from the sterile package. Insert the jaw with mounted push rod and closed electrodes into the mounting aid on the blade holder. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 17 5 Assembly Separate the blade holder from the mounting aid by pressing down the blade holder in the grip area. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 18  Lift the blade rod with the mounted blade slightly and pull it out of the blade holder. Avoid bending the blade in the process. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 19 5 Assembly Visually check the blade for correct assembly. The blade holder has a cleaning tip for cleaning the blade groove. Keep it until the end of the surgery to clean the groove if necessary. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 20  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 audibly engages. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 21 Assemble the jaw and handle Insert the jaw into the handle until it audibly engages Ensure that the mounting aid keeps the jaws closed and that the orange marking on the handle is aligned with the marking on the BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 22 Check the vessel sealing instrument for proper opening, gripping and latching by actuating the handle. Check the blade for ease of motion by actuating the blade trigger. Unlatch the jaw by again actuating the handle. Check whether the rotation wheel can be turned when the handle is unlocked. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 23 Attaching 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-S3-EN-20210219...

  • Page 24: Operation

    14) and reprocessed (see section 8, page 32). WARNING Risk of patient injury!  Use only approved BOWA ARC generators with vessel sealing capability (see section 9, page 45).  Select the settings of the HF device according to the requirements of the intervention.

  • Page 25: Function Test In The Operating Theatre

     Ensure that hot vessel sealing instruments are not used for preparation.  Do not lay the vessel sealing instrument on the patient. Introducing the instrument Using the handle, close the electrodes. Insert the instrument into the trocar sleeve. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 26 They can affect energy output and lead to undesired effects. Release the actuated switch. 10. Press the handle all the way to release the ratchet and open the electrodes.  The tissue is coagulated. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 27: Removal

     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 32). BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 28: 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 14). BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 29: Deviating From The Assembly

    Deviating from the assembly Dismantling the handswitch  From the back, press the connection cable handswitch out of the handle. Dismantling the handle and jaw Unlock the handle. Press the push button on the back of the handle, the jaw opens. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 30 7 Dismantling Then press the two push buttons on the rotation wheel simultaneously and pull the handle off the jaw. Dismantling the jaw and push rod  With the electrodes fully open, pull the push rod out of the jaw. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 31: Removing The Blade

    Use a suitable aid (needle holder, clamp, forceps, etc.) to remove the blade in the same way as a scalpel blade.  The blade is for single use. Do not resterilise and dispose of according to section 10, Disposal. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 32: Reprocessing

    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 33: Dismantling

    • Inspection • Packing • Autoclaving • Storage 8.1. Dismantling  Disassemble the vessel sealing instrument (see section 7, page 28).  Remove the blade from the vessel sealing instrument and discard it (see section 7.3, page 31) BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 34: Soaking

    2 hours, and remove coarse dirt residues with a plastic brush. To soak the jaw, 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 immediately after use.

  • Page 35: Manual Removal Of Contamination

    Rinse all individual parts from the inside and outside after the ultrasonic bath with a suitable rinsing gun for at least 15 s (5 pulses of 3 s) and 1.8 – 2 bar water pressure. Validation: for 10 minutes, 35°C ±2°C, 35 kHz, 0.3% neodic MediClean forte BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 36: Machine-Based Reprocessing In A Cdm

    8.5. Machine-based reprocessing in a CDM NOTE Cleaning adapter and reprocessing basket  BOWA has validated machine-based reprocessing using the cleaning adapters in the reprocessing basket. (optionally available) Preparation for machine-based reprocessing – cleaning adapter 8.5.1. Mounting the cleaning adapter on the jaw...
  • Page 37 8 Reprocessing Mounting the cleaning adapter on the handle Mounting the cleaning adapter on the push rod BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 38: Placing The Parts In The Reprocessing Basket

    Feed the hoses out of the reprocessing basket through the openings in the end of the reprocessing basket provided for that purpose. Ensure that: • The instrument components are positioned to ensure exposure to the cleaning media BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 39 Validation for pre-rinsing (with cold deionised water for 2 minutes), cleaning (at 55°C for 5 minutes with 0.3% neodic Mediclean forte (Dr Weigert, Hamburg)), rinsing (with cold deionised water for 3 minutes), thermal disinfection (at 90°C for 5 minutes) and drying (at 100°C for 25 minutes). BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 40 (see section 8.5.1, page 36). Use filtered compressed air to dry the instrument components and remove any residual moisture. NOTE Risk of handle damage due to compressed air!  Restrict compressed air pressure to 3 bar or less for handle drying. BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 41: Inspection

    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-S3-EN-20210219...

  • Page 42: Packing

    Autoclave the handle only in the unlatched position.  Place the components in the reprocessing basket as shown in the following figure:  Pack the reprocessing basket with the components in a suitable disposable sterilisation package and/or a suitable sterilisation container BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 43: Autoclaving

    Verify the suitability and effectiveness of the method, taking into account the specific product geometry in the context of validation (including investigation of sterilisation medium residues if appropriate). Validation: Half cycle with 3 pre-vacuum phases at 132°C for 1.5 minutes, Packaging: double in sterilisation foil BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...

  • Page 44: Environmental Conditions

    8.9. Environmental conditions 8.9.1. Storage and transport BOWA recommends storing the products in their original packaging until their first use. Store the products in a location where they are protected against: • Strong mechanical stresses such as shock, fall or impact •...

  • Page 45: Technical Data

    9 Technical data Technical data Technical data Maximum voltage 200 Vp sinusoidal Approved HF device BOWA ARC generators with vessel sealing software: • ARC 350 - REF 900-351 • ARC 400 - REF 900-400 The BOWA COMFORT instruments COMFORT recognition with instrument identification Plug’n Cut COMFORT are compatible...

  • Page 46: 11 Symbols On Packaging

    Single use only Do not resterilise Do not use if packaging is damaged Keep away from direct sunlight Keep dry Manufacturer CE mark and identification number of notified body 0123 Conforms to Russian standards Date of manufacture Caution Medical device BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219...
  • Page 48 0123 BOWA-electronic GmbH & Co. KG CE mark as per Heinrich-Hertz Strasse 4–10 regulation 2017/745 72810 Gomaringen │ Germany Phone: +49 7072-6002-0 Fax: +49 7072-6002-33 info@bowa-medical.com www.bowa-medical.com...

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