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Related Manuals for Bowa TissueSeal Plus
Summary of Contents for Bowa TissueSeal Plus
- Page 1 Operating Manual...
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Page 5: Legend
Legend Legend Jaws Disposable electrode tip Electrode surfaces Handle Ratchet Jaws holder Cable connector HF cable MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... - Page 6 Legend TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN...
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Page 7: Table Of Contents
Assembling the ligation instrument............18 Operation ....................... 19 5.1. Before use................... 19 5.2. During the operation................20 5.3. Withdrawal ..................22 5.4. After use....................23 Dismantling ....................24 6.1. Dismantling the ligation instrument ............. 24 MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... - Page 8 7.10. Functional test in the operating room ..........39 7.11. Recommended operating supplies............39 Technical specifications ................40 8.1. TissueSeal ..................40 8.2. TissueSeal PLUS ................40 Disposal ......................41 10. System overview................... 42 10.1. TissueSeal ..................42 10.2. TissueSeal PLUS ................43 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN...
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Page 9: 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 10: Icons And Labeling
Death or serious injuries WARNING Possible risk Death or serious injuries CAUTION Possible risk Minor injuries NOTE Possible risk Property damage 1.2.3. Tips Tips to make your work easier or supplementary explanatory information for a procedure. TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 11: Other Icons And Labeling
Result of preceding activity • List (first level) • List (second level) Emphasis Emphasis ..., see section xxx, Cross reference page xxx 1.2.5. Symbols on packaging Icon/ Labeling Meaning Manufacturer Comply with operating instruction MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 12: Safety
The ligature instruments are intended to be used with the bipolar ligation operating mode. They are intended to be used in connection with the ligation program of BOWA ARC generators. Do not use the ligation instruments if, in the opinion of a experienced physician or according to current professional... -
Page 13: General Safety Instructions
In case of cleaning in an ultrasound bath or manual precleaning, there is a risk of infection due to water spray and vapors: Wear a face mask and protective clothing. Adequate ventilation is recommended. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 14: Hf Device
The HF cable may cause interference to imagery on monitors: 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. TissueSeal / TissueSeal PLUS... -
Page 15: Active Electrodes
Dirty electrodes may cause a short circuit, thereby resulting in functional failure of the ligation instrument. Clean the jaw electrodes regularly with a moist cloth. 2.2.4. Repairs and servicing Do not repair or service defective devices: Discard or replace defective devices. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 16: Personal Safety Instructions
Ensure that the pacemaker does not come into contact with the HF electrode. Keep a fully operational defibrillator within reach Carry out a postoperative pacemaker check. Pos: 5 /679-BOWA/HF-Instrumente/Ligator "TissueSeal und TissueSeal Plus"/03. Funktionsweise @ 5\mod_1291718350323_6.doc @ 46097 @ 1 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 17: 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 MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 18: Assembly
Assembling the ligation instrument With TissueSeal: plug the disposable electrode tip A1 onto the holder for jaw B2. Connect the HF cable C to the cable connector B3 and check that it is attached securely. TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 19: Operation
18) and prepared (see section 7, page 25). WARNING Risk of patient injury! Use only approved BOWA ARC generators with ligation capability (see section 8, page 40). Use only genuine HF cables. Use only suitable products and accessories as described in the system overview. -
Page 20: During The Operation
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. Do not lay the ligation instrument on the patient. TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... - Page 21 • An alternating acoustic signal indicates the end of the sealing process. Release the foot switch to stop the supply of power. Using the handle B, open the jaws A. The tissue is coagulated. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS...
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Page 22: Withdrawal
A are clean and not worn out. 5.3. Withdrawal WARNING Risk of patient injury due to damaged or broken-off parts! Check the ligation instrument after each use. All parts must be present. TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 23: After Use
A1 if the electrodes are damaged. With TissueSeal PLUS: replace the ligation instrument if the electrodes are damaged. Prepare the ligation instrument after use (see section 7, page 25). Pos: 9 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/06.Demontage @ 5\mod_1277986204902_6.doc @ 40710 @ 1 MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 24: Dismantling
Disconnect the HF cable C from the handle B. 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 TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 25: 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 26 Soaking • Dismantling • Pretreatment in an ultrasonic bath • Manual removal of contamination • Automatic preparation in a CDM • Inspection • Packing • Autoclaving • Storage • Functional test in the operating room TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN...
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Page 27: Soaking
Never clean the HF cable in an ultrasonic bath. NOTE Risk of material damage to the ligation instrument from scouring agents and metal brushes! Never use scouring products to clean the ligation instrument. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 28: Dismantling
CE mark. The disinfectant used for soaking is intended solely for personal protection and does not replace subsequent disinfection. 7.2. Dismantling Dismantle the ligation instrument (see section 6, page 24). TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 29: Pretreatment In An Ultrasonic Bath
Use suitable cleaning and disinfection products for ultrasonic cleaning (see section 7.11, page 39). Follow the manufacturer’s instructions with regard to the concentration and exposure time of the cleaning and disinfection products. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 30: 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. HINWEIS Risk of material damage to the ligation instrument from metal brushes! Always use a plastic brush to clean the ligation instrument. - Page 31 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. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS...
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Page 32: Automatic Preparation In A Cdm
Sterile water or water with a low microorganism count (max. 10 germs/ml) and low endotoxin count (max. 0.25 endotoxin units per ml) is used for rinsing. • Drying air is filtered. • The CDM is serviced and tested at regular intervals. TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... - Page 33 The chemicals that are used are compatible with the instrument components (see section 7.11, page 39). • Follow the manufacturer’s instructions with regard to the concentration and exposure time of the cleaning and disinfection products. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS...
- Page 34 After the program is finished, remove the instrument components from the CDM. 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. TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN...
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Page 35: Inspection
Risk of patient burns with brittle or defective insulation! Replace instrument components with damaged insulation. Jaw insert Check the ratchet B1 for ease of motion. Check the jaw holder B2 and the cable connector B3 for damage and corrosion. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 36: Packing
(resistant to temperatures up to 137 °C, with sufficient steam permeability) • Serviced at regular intervals (sterilization container) Pack the ligation instrument in a suitable disposable sterilization package and/or a suitable sterilization container. Sterilization in the transportation packaging is not allowed. TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 37: Autoclaving
Minimum sterilization time 20 minutes at 121 °C or 5 minutes at 132 or 134 °C Using the less effective gravitation method must be secured by means of additional validation (longer sterilization times may be necessary). MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 38: Storage
The shipping box is not intended for storing the device. Storage conditions: Temperature: –20 to +50 °C Relative humidity: 0 to 75%, non-condensing Atmospheric pressure: 500–1600 mbar TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 39: Transport
Test the ligation instrument for proper operation (see section 7.5, page 35). 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 40: Technical Specifications
AC voltage > 330 kHz Maximum voltage 200 Vp sinusoidal Approved HF device BOWA ARC 350L Approved programs Approved programs for ligation with software above V2.6 Effect 2 (shorter ligation time) Effect 4 (longer ligation time) TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 41: Disposal
Infection hazard To avoid spreading germs and infections, disinfect 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. MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... -
Page 42: System Overview
Order from your specialist dealer 830-001 Handle • 760-019 ..• 760-023 ..• 760-028 ..Disposable electrode tip • 830-000 ..• 830-001 ..• 830-010 ..• 830-011 ..HF cable • 378-045 ..TissueSeal / TissueSeal PLUS MN031-443-S0-20110112-EN... -
Page 43: Tissueseal Plus
10 System overview 10.2. TissueSeal PLUS Order from your specialist dealer 760-123 Handle • 760-119 ..• 760-123 ..• 760-128 ..HF cable • 378-045 ..=== Ende der Liste für Textmarke Inhalt === MN031-443-S0-20110112-EN TissueSeal / TissueSeal PLUS... - Page 44 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...
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