Bowa TissueSeal PLUS COMFORT Series Operating Manual
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Bowa TissueSeal PLUS COMFORT Series Operating Manual

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Operating Manual
®
TissueSeal
PLUS COMFORT
®
TissueSeal
COMFORT
EN

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Summary of Contents for Bowa TissueSeal PLUS COMFORT Series

  • Page 1 Operating Manual ® TissueSeal PLUS COMFORT ® TissueSeal COMFORT...
  • Page 3 Legend MN031-543-S0 EN TissueSeal / TissueSeal PLUS COMFORT...
  • Page 4 TissueSeal / TissueSeal PLUS COMFORT MN031-543-S0 EN...

  • Page 5: Legend

    Legend Legend Jaws Handle Disposable electrode tip Ratschet Electrode surfaces Jaws holder HF cable MN031-543-S0 EN TissueSeal / TissueSeal PLUS COMFORT...

  • Page 6: Table Of Contents

    Contents Contents Legend ......................5 Contents ...................... 6 Using this operating manual .............. 8 1.1. Validity ..................8 1.2. Icons and labeling ..............9 1.2.1 Structure of warning instructions........9 1.2.2 Risk levels in the warning instructions ......9 1.2.3 Tips ................9 1.2.4 Other icons and labeling ...........
  • Page 7 Contents Dismantling ..................21 6.1. Dismantling the ligation instrument ........21 Preparation ..................22 7.1. Soaking .................. 23 7.2. Dismantling ................24 7.2.1. Pretreatment in an ultrasonic bath ....... 24 7.3. Manual removal of contamination .......... 25 7.4. Automatic preparation in a CDM ..........26 7.5.

  • Page 8: Using This Operating Manual

    1 Using this operating manual Using this operating manual This operating manual is part of the device. BOWA-electronic GmbH & Co. KG assume no liability nor provide any warranty whatsoever for any damage or consequential damage arising from non-compliance with this operating manual.

  • Page 9: Icons And Labeling

    1 Using this operating manual 1.2. Icons and labeling 1.2.1 Structure of warning instructions SIGNAL WORD "Risk type, source and consequences there of" (Personal injury)!  Measure for risk prevention. 1.2.2 Risk levels in the warning instructions Symbol Risk level Probability of Consequences of occurrence...

  • Page 10: Other Icons And Labeling

    1 Using this operating manual 1.2.4 Other icons and labeling Icon/Label Meaning  Prerequisite for an activity  Activity with one step Activity with several steps in a binding sequence  Result of preceding activity  List (first level)  List (second level) Emphasis Emphasis...

  • Page 11: Safety

    The connection cable is permanently connected to the handle for COMFORT items 760-216, 760-219, 760-223, 760-228, 760-319, 760- 323, 760-328. Generators with Plug’Cut COMFORT detect BOWA COMFORT instruments and automatically pre-select the respective parameters. It is not necessary to use a neutral electrode with bipolar ligation instruments.

  • Page 12: General Safety Instructions

    2 Safety General safety instructions The HF device may be used only by trained medical staff. The surgeon and medical staff must be trained in the fundamental principles, rules for use and risks of HF surgery and must be familiar with them.

  • Page 13: Hf Device

    Never route the HF cable alongside a camera cable.  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. MN031-543-S0 EN TissueSeal / TissueSeal PLUS COMFORT...

  • Page 14: Active Electrodes

    2 Safety 2.2.3. Active electrodes Defective or worn electrodes can cause burns on patients:  Never use or repair worn or defective electrode surfaces. Dispose of them. Hot electrode surfaces may cause patient injuries:  Maintain sufficient distance between the tips of the instrument and sensitive tissue structures, such as the pancreas or intestine.

  • Page 15: Personal Safety Instructions

    Carry out operations only with adequate visibility.  Never use ligation instruments with the AUTOSTART function.  Use only the ligation program of Bowa ARC generators with bipolar ligation current.  Prepare the tissue to be sealed so it is as free as possible in order to avoid unintentional clamping.

  • Page 16: Functionality

    The jaws can be opened and closed by actuating the handle. A ratchet mechanism in the handle provides reproducible mechanical pressure on the electrode tips when the handle is closed. Pos: 6 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/04.Montage @ 5\mod_1277985233074_6.doc @ 40636 @ 1 TissueSeal / TissueSeal PLUS COMFORT...

  • Page 17: Assembly

    The ligation instrument is assembled (see section 4) and prepared (see section 7, page 20). WARNING Risk of patient injury!  Use only approved BOWA ARC generators with ligation capability (see section 8, page 31).  Use only suitable products and accessories as described in the system overview.

  • Page 18: During The Operation

    5 Operation WARNING Risk of patient injuries from the combustion or explosion of flammable liquids and gases!  Avoid contact with flammable gases and liquids, such skin cleaners, disinfectants and anesthetic gases. Connect the HF cable B3 to the HF device and switch on the HF device.
  • Page 19 5 Operation WARNING Risk of patient injury due to hot electrode surfaces and vapor emission!  Maintain sufficient distance between the tips of the instrument and sensitive tissue structures, such as the pancreas or intestine.  Ensure that hot ligation instruments are not used for preparation.

  • Page 20: Withdrawal

    5 Operation Using the foot switch of the HF device, activate the HF current for coagulation:  A continuous acoustic signal sounds during the entire sealing process to indicate that power is being supplied.  An alternating acoustic signal indicates the end of the sealing process.

  • Page 21: After Use

    Do not touch the electrode surfaces immediately after use.  With TissueSeal: remove the disposable electrodes A1 from the handle B. Pos: 11 /679-BOWA/HF-Instrumente/Ligator "TissueSeal und TissueSeal Plus"/07. Aufbereitung @ 5\mod_1291704309651_6.doc @ 46021 @ 1223222222222 MN031-543-S0 EN TissueSeal / TissueSeal PLUS COMFORT...

  • Page 22: Preparation

    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 ligation instruments in connection with disinfectants or the method used, including the effectiveness of the disinfectant.

  • Page 23: Soaking

    7 Preparation  Inspection  Packing  Autoclaving  Storage  Functional test in the operating room 7.1. Soaking CAUTION Risk of infection due to water spray and vapors from the ultrasonic bath or with manual cleaning!  Wear a face mask and protective clothing. ...

  • Page 24: Dismantling

    7 Preparation 7.2. Dismantling  Dismantle the ligation instrument (see section 6, page 19). 7.2.1. Pretreatment in an ultrasonic bath CAUTION Risk of infection due to water spray and vapors from the ultrasonic bath!  Wear a face mask and protective clothing. ...

  • Page 25: Manual Removal Of Contamination

    7 Preparation 7.3. Manual removal of contamination The TissueSeal PLUS ligation instrument is described as an example in this section.  Open the jaw A. NOTE Risk of material damage to the ligation instrument from metal brushes!  Always use a plastic brush to clean the ligation instrument.

  • Page 26: Automatic Preparation In A Cdm

    7 Preparation  Using a plastic brush and a steam jet cleaner, remove contamination from the top and bottom outer surfaces of the jaws A and the electrode surfaces A2. Rinsing  After pre-cleaning, rinse all parts of the instrument thoroughly with fully demineralized or distilled water.
  • Page 27 7 Preparation Suitable cleaning agents  Ensure that the selected cleaning agent system fulfils the following requirements:  The cleaning agent is suitable for the ligation instrument.  If thermal disinfection is not used, a suitable disinfection agent with proven effectiveness (e.g. DGHM or FDA approval or CE mark) and compatible with the cleaning agents is also used.

  • Page 28: Inspection

    7 Preparation NOTE Risk of handle damage due to compressed air!  Restrict compressed air pressure to 3 bar or less for handle drying. Use filtered compressed air to dry the instrument components. 7.5. Inspection These products are subject to wear when used as intended, depending on the intensity of use.

  • Page 29: Packing

    7 Preparation Jaw insert Check the ratchet B1 for ease of motion. Check the jaw holder B2 for damage and corrosion. Jaws Check the electrode surfaces A2 for cleanliness. Check the gap between the electrode surfaces A2 in the closed position for uniformity.

  • Page 30: Autoclaving

    7 Preparation 7.7. Autoclaving  Autoclave the handle only in the unlatched position. NOTE Risk of destruction of the ligation 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) ...

  • Page 31: Storage

    7 Preparation Observe the following if such methods are used:  EN ISO 14937 / ANSI AAMI ISO 14937;  standards relevant to the method. Demonstrate the suitability and effectiveness of the method, taking into account the specific product geometry in the context of validation (including investigation of sterilization medium residues if appropriate).

  • Page 32: Transport

    Test the ligation instrument for proper operation (see section 7.5, page 26. 7.11. 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 33: Technical Specifications

    Maximum voltage 200 Vp sinusoidal Approved HF device BOWA ARC generators with LIGATION software Approved programs LIGATION For BOWA ARC 350L (900-350): LIGATION from software V2.6 Effect 2 to Effect 4 760-216: Effect 4 MN031-543-S0 EN TissueSeal / TissueSeal PLUS COMFORT...

  • Page 34: Disposal

    9 Disposal Disposal DANGER Infection hazard  To avoid spreading germs and infections, sterilize the instrument before it leaves the hospital or surgical practice. Always dispose of medical products, packaging materials and accessories in accordance with applicable national regulations and statutes.

  • Page 35: 10. System Overview

    10 System overview 10. System overview 10.1. TissueSeal COMFORT Order from your specialist dealer  830-001 Handle  760-319 .. 760-323 .. 760-328 ..Disposable electrode tip  830-000 .. 830-001 .. 830-010 .. 830-011 ..

  • Page 36: Tissueseal Plus Comfort

    10 System overview 10.2. TissueSeal PLUS COMFORT Order from your specialist dealer  760-223 Handle  760-216 .. 760-219 .. 760-223 .. 760-228 ..=== Ende der Liste für Textmarke Inhalt === TissueSeal / TissueSeal PLUS COMFORT MN031-543-S0 EN...
  • Page 38 0123 BOWA-electronic GmbH & Co. KG CE marked according to Heinrich-Hertz Strasse 4–10 Medical Device 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...

This manual is also suitable for:

Tissueseal ccomfort series

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