Bowa NightKNIFE Operating Manual
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Bowa NightKNIFE Operating Manual

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Summary of Contents for Bowa NightKNIFE

  • Page 1 Operating Manual...
  • Page 3 B2 B3 B4...

  • Page 5: Legend

    Legend Legend Jaw insert (for NightKNIFE with blade) Jaws with electrode (1 fixed, 1 moveable) Seal ring Sliding tube Drawrod Shank tube Threaded bush Fluted knob Trigger Alignment spring Handle Ratchet lever Locking lever Cable connector HF cable Pushbuttons Holder for shank tube with jaw insert...
  • Page 6 Legend MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 7: Table Of Contents

    2.3.1. Patients with pacemakers ............. 16 Functionality....................17 Assembly....................... 18 4.1. Attaching the replaceable blade with the insertion aid (only for NightKNIFE with replaceable blade) ..........18 4.2. Assembling the ligation instrument............21 Operation ....................... 22 5.1. Before use................... 22 5.2.
  • Page 8 After use....................27 Dismantling ....................28 6.1. Dismantling the ligation instrument ............. 28 6.2. Removing the blade with the insertion aid (only for NightKNIFE with exchangeable blade)..........28 Preparation ....................31 7.1. Soaking ....................33 7.2. Dismantling ..................34 7.3.

  • Page 9: Using This Operating Manual

    1 Using this operating manual Pos: 1 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/00.Legende @ 5\mod_1279009043176_6.doc @ 43820 @ Pos: 2 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/01.Umgang_mit_ der_GA @ 3\mod_1242290964772_6.doc @ 21512 @ 1223333 Using this operating manual This operating manual is part of the device. BOWA-electronic GmbH & Co. KG assume no liability nor...

  • Page 10: Risk Levels In The Warning Instructions

    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. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 11: Other Icons And Labeling

    Activity with several steps in a binding sequence Result of preceding activity List (first level) List (second level) Emphasis Emphasis ..., see section xxx, Cross reference page xxx Pos: 3 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/02.Sicherheit @ 5\mod_1277974965855_6.doc @ 40598 @ 1223333323 MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 12: Safety

    They are intended to be used in connection with the ligation program of BOWA ARC generators, The NIghtKNIFE ligation instrument can also be used to cut tissue. Any other use of the ligation instruments is neither intended nor proper and must be effectively prevented.

  • Page 13: General Safety Instructions

    There is a risk of injury due to the sharp blade: Be careful with the blade during assembly and disassembly. Remove the replaceable blade before cleaning the jaw insert. To avoid punctures and lacerations, always use the insertion aid for assembly and dismantling. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 14: Hf Device

    Use only HF cables that are in perfect condition. Never use a defective HF cable. 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. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 15: Active Electrodes

    Clean the jaw electrodes regularly with a moist cloth. Replace the jaw insert if the electrodes are damaged. 2.2.4. Replaceable blade with insertion aid (only for NightKNIFE with replaceable blade) Do not recondition the replaceable blade and insertion aid. Replace or discard used blades and insertion aids. 2.2.5.

  • 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: 4 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/03.Funktionsweise @ 5\mod_1277975688511_6.doc @ 40617 @ 1 MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 17: Functionality

    The jaw insert can be turned and locked using the fluted knob on the shank tube (8x 45°). Pos: 5 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/04.Montage @ 5\mod_1277985233074_6.doc @ 40636 @ 1 MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 18: Assembly

    The ligation instrument is not sterile as delivered. Clean and sterilize the instrument before using it. Pos: 6 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/4.1 Montage der Klinge @ 5\mod_1277985392590_6.doc @ 40655 @ 2 4.1. Attaching the replaceable blade with the insertion aid (only for NightKNIFE with...
  • Page 19 A1 in the arrow direction until it reaches the stop. Ensure that the blade with insertion aid E is positioned in the middle at the marked position. If necessary, use your fingers to position the insertion aid E1 in the middle. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 20 10. Remove the insertion aid E1 from the fixed jaw in the direction of arrow 2. Keep the insertion aid in a safe place. You will need it to remove the blade. Pos: 7 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/4.2 Zusammensetzung des Ligationsinstruments @ 5\mod_1277985487074_6.doc @ 40673 @ 2 MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 21: Assembling The Ligation Instrument

    Connect the HF cable D to the handle C and check that it is securely attached. When plugging or unplugging the HF cable, always grasp the connector directly. Pos: 8 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/05.Bedienung @ 5\mod_1277985805824_6.doc @ 40691 @ 12222 MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 22: Operation

    18) and prepared (see section 7, page 31). WARNING Risk of patient injury! Use only approved BOWA ARC generators with ligation capability (see section 8, page 51). Use only genuine HF cables. Use only suitable products and accessories as described in the system overview.

  • Page 23: During The Operation

    Ensure that hot ligation instruments are not used for preparation. Do not lay the ligation instrument on the patient. Using visual control, insert the ligation instrument into the patient’s body. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 24 Close the jaws A1 to grasp the tissue. The tissue is grasped. Use the three-position ratchet of the handle C to adjust the pressure on the tissue to best match the amount of grasped tissue. The tissue is clamped. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...
  • Page 25 Release the foot switch to stop the supply of power. Using the ratchet lever C1, open the jaws A1. The tissue is coagulated. Cutting tissue (only with NightKNIFE) WARNING Strong bleeding may occur if the grasped tissue is cut before coagulation or ligation! With blood vessels, place at least two seals to the left and right of the cutting site.

  • Page 26: Withdrawal

    Risk of patient injury due to damaged or broken-off parts! Check the jaw insert after each withdrawal. All parts must be present. Close the jaws A1. Withdraw the ligation instrument from the trocar sleeve. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 27: After Use

    For NightKNIFE with exchangeable blade: replace the blade E2 after every operation. Prepare the ligation instrument after use (see section 7, page 31). Pos: 9 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/06.Demontage @ 5\mod_1277986204902_6.doc @ 40710 @ 1 MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 28: Dismantling

    6 Dismantling Dismantling Pos: 10 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/6.1 Demontage des Ligationsinstruments @ 5\mod_1277986236871_6.doc @ 40729 @ 2 6.1. Dismantling the ligation instrument Press and hold the buttons C4 and the locking lever C2 Disconnect the HF cable D from the handle C.
  • Page 29 Hold the insertion aid E1 by the sides in position 1 and move the sliding tube slowly in the arrow direction until the blade E2 distinctly clicks in place. With the blade attached, the spring remains compressed. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 30 Pull out the insertion aid and blade E in the arrow direction and dispose of the blade and insertion aid E. Reconditioning the blade and insertion aid is prohibited. Pos: 12 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/07.Aufbereitung @ 5\mod_1277986531480_6.doc @ 40765 @ 12222223322222 MN031-447-S1 EN NightKNIFE / Ligator...

  • Page 31: Preparation

    134 °C, the number of preparation cycles of the individual instrument components is: Jaw insert A: 20, Shank tube B: up to 200, Handle C: up to 200, 100. HF cable D: up to 300. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 32 Preparation of the ligation instrument comprises the following steps: 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 MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 33: Soaking

    Wear a face mask and protective clothing. Adequate ventilation is recommended. CAUTION With NightKNIFE: risk of injury due to the sharp blade! Be careful with the blade during cleaning. For NightKNIFE with exchangeable blade: remove the blade from the jaw insert before cleaning.

  • Page 34: Dismantling

    7.2. Dismantling Dismantle the ligation instrument (see section 6.1, page 28). For NightKNIFE with exchangeable blade: remove the blade from the ligation instrument and dispose of the blade (see section 6.2, page 28). MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 35: Pretreatment In An Ultrasonic Bath

    Use suitable cleaning and disinfection products for ultrasonic cleaning (see section 7.4, page 36). Follow the manufacturer’s instructions with regard to the concentration and exposure time of the cleaning and disinfection products. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 36: Manual Removal Of Contamination

    7 Preparation 7.4. Manual removal of contamination The NightKNIFE ligation instrument is described as an example in this section. Jaw insert Slide the drawrod 2 in the arrow direction to open the jaws 1. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...
  • Page 37 Jaws 1: exterior surfaces top and bottom; electrode surfaces Mechanism 2: openings top and bottom With NightKNIFE: ratchet mechanism 3 With NightKNIFE: spring 5 With NightKNIFE: using a sharp object, clean the inner edges of both grooves 6. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 38 7 Preparation With NightKNIFE: using a sharp object, remove contamination under seal ring 4. Avoid damaging the ring in the process. Move the sliding tube 1 in the arrow direction and use a steam sprayer to clean the exposed contact surfaces 2.
  • Page 39 Rinse the distal end of the shank tube B with fully demineralized water or distilled water to clean the inside of the housing. At the same time, actuate the trigger 2 to clean the actuation mechanism inside the housing. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 40 Actuate the handle until it latches, and use the cleaning brush to clean the guide rails 6. Using the cleaning brush, clean all of the marked positions on the handle from the inside. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...
  • Page 41 Using the cleaning brush, clean the marked positions 5 on the handle from the inside. Rinsing After pre-cleaning, rinse all parts of the instrument thoroughly with fully demineralized or distilled water. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 42: 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. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...
  • Page 43 MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 44: Inspection

    HF cable is located in a sieve tray with a cover. For NightKNIFE with exchangeable blade: remove a new blade with insertion aid from its package and place the blade and insertion aid in a sieve tray with a cover.

  • Page 45: Nightknife Inspection

    Replace instrument components with damaged insulation. Jaw insert For NightKNIFE with exchangeable blade: install a new blade (see section 4.1, page 18). Check the jaws A1 for proper opening and closing. Visually inspect the ball on drawrod A4 for damage.

  • Page 46: Ligator Inspection

    Check cable connector C2 for damage and corrosion. HF cable HF cable Check the connector for damage and corrosion. Check the connector for damage and corrosion. Visually inspect the insulation for damage. Visually inspect the insulation for damage. MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 47: 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. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 48: 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). MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 49: Storage

    Store the ligation instrument in a dry place at room temperature. The storage life of the sterilized ligation instrument depends on the type of packaging and the storage conditions. The shipping box is not intended for storing the device. MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...

  • Page 50: Functional Test In The Operating Room

    (neodic MediCLean forte) has been demonstrated by BOWA. The manufacturer accepts no responsibility for the use of other cleaning and disinfection products. Pos: 13 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/08.Technische_Daten @ 3\mod_1242290599991_6.doc @ 21494 @ 12 MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 51: Technical Specifications

    Approved programs LIGATION Ligation (software V2.6 or later) For BOWA ARC 350L (900-350): LIGATION software V2.6 Pos: 14 /679-BOWA/HF-Instrumente/Ligator "LIGATOR"/Technische Daten @ 5\mod_1277987566168_6.doc @ 40784 @ 2 8.2. LIGATOR or later Effect 2 to Effect 4 Technical specifications HF current AC voltage >...

  • Page 52: Disposal

    9 Disposal Disposal Always dispose of medical products, packaging materials and accessories in accordance with applicable national regulations and statutes. Pos: 16 /679-BOWA/HF-Instrumente/Ligator "NightKNIFE"/10.Systemübersicht @ 5\mod_1277987768511_6.doc @ 40802 @ 12 MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 53: System Overview

    10.1. NightKNIFE Without replaceable blade: 770-300 = 360 mm (770-000+770-336+771-136+723-030+723-020) 770-200 = 200 mm (770-000+770-320+771-120+723-030+723-020) With replaceable blade: 770-201 = 200 mm (770-000+770-336+771-121+723-030+723-020) 770-301 = 360 mm (770-000+770-336+771-137+723-030+723-020) Order from your specialist dealer 723-020 MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 54 Spare parts for handle 723-020 ..Spare parts for handle Replaceable blades (set of 5) 723-020 ..770-999 ..Replaceable blades (set of 5) 770-999 ..Pos: 17 /679-BOWA/HF-Instrumente/Ligator "LIGATOR"/Systemübersicht @ 5\mod_1277987846574_6.doc @ 40821 @ 2 MN031-447-S1 EN NightKNIFE / Ligator MN031-447-S0-20101217-EN...

  • Page 55: Ligator

    HF cable Cleaning brush set 358-045 ..723-000 ..Cleaning brush set Spare parts for handle 723-000 ..723-020 ..Spare parts for handle 723-020 ..=== Ende der Liste für Textmarke Inhalt === MN031-447-S1 EN MN031-447-S0-20101217-EN NightKNIFE / Ligator...
  • Page 56 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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