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7 Preparation

42

NightKNIFE / Ligator

MN031-447-S0-20101217-EN

7.5.

Automatic preparation in a CDM

Suitable cleaning and disinfection methods

X

Use a cleaning and disinfection machine (CDM) to clean
and disinfect the ligation instruments.

Manual methods are not recommend due to their
significantly lower effectiveness.

X

X

Ensure that the selected CDM fulfils the following
requirements:

x

(as shown by DGHM or FDA approval or a
CE mark in accordance with EN ISO 15883).

x

A proven program for thermal disinfection (at
least 5 minutes at 90 °C or an A

0

factor

greater than 3000). With chemical
disinfection, there is a risk that disinfectant
residues may be present on the instrument
components.

x

A program suitable for the instrument, with
adequate rinse cycles, is selected.

x

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.

x

Drying air is filtered.

x

The CDM is serviced and tested at regular
intervals.

MN031-447-S1 EN

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Summary of Contents for LIGATOR

Page 1: ...EN Operating Manual ...

Page 2: ......

Page 3: ...A1 A2 A3 A4 A B1 B2 B3 B4 B C C1 C3 C2 C4 D C5 C C1 C3 C2 C4 C5 E2 E1 E ...

Page 4: ...D A1 A4 A B1 B2 B B4 C C1 C3 C2 C C1 C3 C2 C4 C5 ...

Page 5: ...Sliding tube A4 Drawrod B Shank tube B1 Threaded bush B2 Fluted knob B3 Trigger B4 Alignment spring C Handle C1 Ratchet lever C2 Locking lever C3 Cable connector C4 Pushbuttons C5 Holder for shank tube with jaw insert D HF cable E Blade with insertion aid E1 Insertion aid E2 Blade HF cable E Blade with insertion aid E1 Insertion aid E2 Blade MN031 447 S1 EN ...

Page 6: ...Legend 6 NightKNIFE Ligator MN031 447 S0 20101217 EN MN031 447 S1 EN ...

Page 7: ...y instructions 13 2 2 1 HF device 14 2 2 2 HF cable 14 2 2 3 Active electrodes 15 2 2 4 Replaceable blade with insertion aid only for NightKNIFE with replaceable blade 15 2 2 5 Repairs and servicing 15 2 3 Personal safety instructions 16 2 3 1 Patients with pacemakers 16 3 Functionality 17 4 Assembly 18 4 1 Attaching the replaceable blade with the insertion aid only for NightKNIFE with replaceable...

Page 8: ... 3 Pretreatment in an ultrasonic bath 35 7 4 Manual removal of contamination 36 7 5 Automatic preparation in a CDM 42 7 6 Inspection 44 7 6 1 NightKNIFE inspection 45 7 6 2 LIGATOR inspection 46 7 7 Packing 47 7 8 Autoclaving 48 7 9 Storage 49 7 10 Functional test in the operating room 50 7 11 Recommended operating supplies 50 8 Technical specifications 51 8 1 NightKNIFE 51 8 2 LIGATOR 51 9 Dispos...

Page 9: ...l X Read the operating manual in particular the safety instructions see section 2 page 12 carefully and thoroughly before use X Store the operating manual in a safe place throughout the service life of the device X Keep the operating manual accessible to operating room personnel X Give the operating manual to each successive owner and or user of this device X Always update the operating manual whe...

Page 10: ...l Probability of occurrence Consequences of non compliance DANGER Immediate risk 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 ...

Page 11: ... an activity X Activity with one step 1 2 3 Activity with several steps in a binding sequence ª Result of preceding activity x List first level x List second level Emphasis Emphasis see section xxx page xxx Cross reference Pos 3 679 BOWA HF Instrumente Ligator NightKNIFE 02 Sicherheit 5 mod_1277974965855_6 doc 40598 1223333323 MN031 447 S1 EN ...

Page 12: ...sed with the bipolar ligation operating mode 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 It is not necessary to use a neutral electrode with bipolar ligation instruments MN031 447...

Page 13: ...igation instrument before each subsequent use X Use only cleaning disinfection and sterilization methods that have been adequately validated for the specific devices and products concerned X Comply with the validated parameters for each cycle X Observe the applicable legal requirements in your country and the hygiene regulations of the hospital In case of cleaning in an ultrasound bath or manual p...

Page 14: ...s CO2 X Avoid direct skin contact with HF cables X Avoid contact with flammable gases and liquids 2 2 2 HF cable Improper use of HF cables can lead to patient injuries X Never lay the HF cable on the patient s skin X Connect the ligation instrument for coagulation before switching on the HF generator X When plugging or unplugging the HF cable always grasp the connector directly X Use only HF cable...

Page 15: ...Inadvertent activation of the ligation instrument may cause patient injuries X Do not lay the ligation instrument on the patient Dirty electrodes may cause a short circuit thereby resulting in functional failure of the ligation instrument X Clean the jaw electrodes regularly with a moist cloth X Replace the jaw insert if the electrodes are damaged 2 2 4 Replaceable blade with insertion aid only fo...

Page 16: ...alfunctions or destruction of the pacemaker can endanger the life of the patient or result in irreversible injuries to the patient X Never perform ambulant operations on patients with pacemakers X In cases of patients with pacemakers consult the cardiologist before carrying out HF surgery X Set the demand pacemaker to a fixed frequency X Ensure that the pacemaker does not come into contact with th...

Page 17: ... to the other branch to produce the desired localized coagulation effect With this method sealing of a vessel or tissue segment carrying blood is achieved by HF current in combination with supplementary pressure The sealed location is hemostatically tight with respect to systolic blood pressure and permanently closed The integrated cutting function of the NightKNIFE allows the tissue under treatme...

Page 18: ...985392590_6 doc 40655 2 4 1 Attaching the replaceable blade with the insertion aid only for NightKNIFE with replaceable blade The blade and insertion aid have been cleaned and disinfected see section 7 5 page 42 1 Remove the blade and insertion aid E from the sterile package 2 Rotate the jaw insert A with the fixed jaw A1 facing upward to open the jaws 3 Insert the fixed jaw A1 between the blade E...

Page 19: ...E with the blade along the fixed jaw A1 in the arrow direction until it reaches the stop 3 2 1 5 Ensure that the blade with insertion aid E is positioned in the middle at the marked position 6 If necessary use your fingers to position the insertion aid E1 in the middle MN031 447 S1 EN ...

Page 20: ...into place ª The spring remains compressed 1 2 9 Pull the short arm of the insertion aid E1 downward arrow 1 to return the blade to its initial position 10 Remove the insertion aid E1 from the fixed jaw in the direction of arrow 2 X X 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 Ligationsinstrum...

Page 21: ...her x Let the shank tube B click into the handle C 4 Check the ligation instrument for proper gripping operation by actuating the handle C 5 Using the ratchet lever C1 open the jaws A1 6 With NightKNIFE check the initial position and ease of motion of the blade by actuating the trigger B3 7 Check that the fluted knob B2 can be turned 8 Connect the HF cable D to the handle C and check that it is se...

Page 22: ...ombustion or explosion of flammable liquids and gases X Carry out electrosurgical operations only with insufflation using a non flammable gas CO2 X Avoid contact with flammable gases and liquids such skin cleaners disinfectants and anesthetic gases MN031 447 S1 EN X X X Use only suitable products and accessories as described in the system overview X Use only intact sterilized products WARNING Risk...

Page 23: ...ettings and limited visibility X Set the output power of the HF device to the value necessary for the operation X Use only approved programs see section 8 page 51 X Carry out operations only with adequate visibility WARNING Risk of patient injury due to hot electrode surfaces and vapor emission X Maintain sufficient distance between the tips of the instrument and sensitive tissue structures such a...

Page 24: ...th the tissue to be coagulated 1 Place the jaw insert A on the operation site The jaw insert A can be rotated and locked in steps of 45 2 Turn the fluted knob B2 to set the angle of the jaw insert A 3 Place the tissue to be sealed between the electrodes of the jaws A1 4 Close the jaws A1 to grasp the tissue ª The tissue is grasped 5 Use the three position ratchet of the handle C to adjust the pres...

Page 25: ... power 8 Using the ratchet lever C1 open the jaws A1 ª The tissue is coagulated Cutting tissue only with NightKNIFE WARNING Strong bleeding may occur if the grasped tissue is cut before coagulation or ligation X With blood vessels place at least two seals to the left and right of the cutting site X Before cutting ensure that the tissue has been reliably sealed X Cut only in the sealed area The tis...

Page 26: ...e HF device x the foot switch works properly x the insulation of the HF cable D the jaws A1 the shank tube B and the trocar sleeve is in good condition x the active electrodes of the jaws A1 are clean and not worn out 5 3 Withdrawal WARNING Risk of patient injury due to damaged or broken off parts X Check the jaw insert after each withdrawal All parts must be present 1 Close the jaws A1 2 Withdraw...

Page 27: ...ectrodes of the jaws A1 regularly with a moist cloth X Replace the jaw insert A if the electrodes are damaged X For NightKNIFE with exchangeable blade replace the blade E2 after every operation 1 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 ...

Page 28: ... exchangeable blade 1 Rotate the jaw insert A with the fixed jaw A1 facing upward to open the jaws 2 Grasp the insertion aid E1 firmly by the sides and slide it onto the fixed jaw A1 in the arrow direction until it reaches the stop MN031 447 S1 EN 2 Press and hold the buttons C4 and the locking lever C2 on the handle C then pull the handle off the shank tube B 3 Unscrew the jaw insert A from the s...

Page 29: ...of the fixed jaw A1 at position 1 4 If necessary use your fingers to align insertion aid E1 in the middle 5 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 ª With the blade attached the spring remains compressed MN031 447 S1 EN ...

Page 30: ...he spring relaxes and the sliding tube snaps back 7 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 ...

Page 31: ...ion and that the validated parameters are complied with in each cycle 2 Observe the applicable national legal regulations and the hygiene regulations of the hospital or clinic The following information on the possible number of preparation cycles should be regarded as a guideline The actual number may vary depending on the stress level With a sterilization time of 20 minutes and a sterilization te...

Page 32: ... ligation instrument comprises the following steps x Soaking x Dismantling x Pretreatment in an ultrasonic bath x Manual removal of contamination x Automatic preparation in a CDM x Inspection x Packing x Autoclaving x Storage x Functional test in the operating room MN031 447 S1 EN ...

Page 33: ...he blade during cleaning X For NightKNIFE with exchangeable blade remove the blade from the jaw insert before cleaning NOTE Risk of material damage to the HF cable by the ultrasonic bath X Never clean the HF cable in an ultrasonic bath NOTE Risk of material damage to the jaw insert by scouring products and metal brushes X Never use scouring products to clean the jaw insert MN031 447 S1 EN X X X X ...

Page 34: ...itable for disinfecting ligation instruments such DGHM or FDA approved products or products with the CE mark The disinfectant used for soaking is intended solely for personal protection and does not replace subsequent disinfection 7 2 Dismantling 1 Dismantle the ligation instrument see section 6 1 page 28 2 For NightKNIFE with exchangeable blade remove the blade from the ligation instrument and di...

Page 35: ... the jaw insert A shank tube B and handle C in the ultrasound bath for at least 5 minutes Position instrument parts with large surface areas in the ultrasonic bath such that they will not be damaged by the ultrasonic energy 2 Use suitable cleaning and disinfection products for ultrasonic cleaning see section 7 4 page 36 3 Follow the manufacturer s instructions with regard to the concentration and ...

Page 36: ...r MN031 447 S0 20101217 EN 7 4 Manual removal of contamination The NightKNIFE ligation instrument is described as an example in this section Jaw insert 2 1 1 Slide the drawrod 2 in the arrow direction to open the jaws 1 MN031 447 S1 EN ...

Page 37: ...lean the jaw insert 2 Using a plastic brush and a steam sprayer remove contamination from the areas shaded in grey x Jaws 1 exterior surfaces top and bottom electrode surfaces x Mechanism 2 openings top and bottom x With NightKNIFE ratchet mechanism 3 x With NightKNIFE spring 5 3 With NightKNIFE using a sharp object clean the inner edges of both grooves 6 MN031 447 S1 EN ...

Page 38: ...217 EN 4 With NightKNIFE using a sharp object remove contamination under seal ring 4 Avoid damaging the ring in the process 2 1 5 Move the sliding tube 1 in the arrow direction and use a steam sprayer to clean the exposed contact surfaces 2 MN031 447 S1 EN ...

Page 39: ...am sprayer for cleaning 2 3 1 1 Use the small cleaning brush to clean the inside of the proximal end 3 of the shank tube 2 Use the large cleaning brush to clean the inside of the distal end 1 of the shank tube 3 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 ...

Page 40: ... a steam sprayer for cleaning 6 3 2 1 4 1 Actuate the handle until it latches and use the cleaning brush to clean the guide rails 6 2 Using the cleaning brush clean all of the marked positions on the handle from the inside MN031 447 S1 EN 6 3 1 4 X X 1 Actuate the handle until it latches and use the cleaning brush to clean the guide rails 6 2 Using the cleaning brush clean all of the marked positi...

Page 41: ...ide Rinsing X X After pre cleaning rinse all parts of the instrument thoroughly with fully demineralized or distilled water MN031 447 S1 EN 5 7 3 Release the handle ratchet 4 Using the cleaning brush clean the ratchet teeth and guide rails 7 at the rear of the handle 5 Using the cleaning brush clean the marked positions 5 on the handle from the inside Rinsing X X After pre cleaning rinse all parts...

Page 42: ...or FDA approval or a CE mark in accordance with EN ISO 15883 x A proven program for thermal disinfection at least 5 minutes at 90 C or an A0 factor greater than 3000 With chemical disinfection there is a risk that disinfectant residues may be present on the instrument components x A program suitable for the instrument with adequate rinse cycles is selected x Sterile water or water with a low micro...

Page 43: ...ction 7 4 page 36 X Follow the manufacturer s instructions with regard to the concentration and exposure time of the cleaning and disinfection products Cleaning and disinfection NOTE Risk of damage to the HF cable due to incorrect placement in the CDM X Ensure that the HF cable is not kinked or pinched 1 Place the instrument components in the CDM Ensure that x the instrument components are positio...

Page 44: ...ssed air pressure to 3 bar or less for handle drying 5 Use filtered compressed air to dry the instrument components 7 6 Inspection These products are subject to wear when used as intended depending on the intensity of use This wear arises from the design and construction of the instruments and is unavoidable Replace the product if it shows externally visible defects or does not function as describ...

Page 45: ...rt A to check for ease of motion and the initial position of the blade E2 5 Visually inspect the blade E2 for damage 6 Check the insulation of drawrod A4 for damage 7 Check the coating of jaw insert A for damage 8 Check the seal ring A2 for damage 9 Check whether the drawrod A4 or sliding tube A3 is bent Shank tube 1 Visually inspect the insulation for damage 2 Check whether the shank tube is bent...

Page 46: ...pect the ball on drawrod A4 for damage 3 Check the insulation of drawrod A4 for damage 4 Check whether the shank tube A4 is bent Shank tube 1 Visually inspect the insulation for damage 2 Check whether the shank tube B is bent Handle 1 Check the ratchet lever C1 locking lever C3 and buttons C4 for ease of motion 2 Check cable connector C2 for damage and corrosion HF cable 1 Check the connector for ...

Page 47: ...NSI AAMI ISO 11607 x Suitable for steam sterilization resistant to temperatures up to 137 C with sufficient steam permeability x Serviced at regular intervals sterilization container X 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 ...

Page 48: ...pliant with EN 13060 or EN 285 x Validation in accordance with EN ISO ANSI AAMI ISO 17665 formerly EN 554 ANSI AAMI ISO 11134 with applicable IQ OQ commissioning and product specific performance assessment PQ x Maximum sterilization temperature 134 C plus tolerance in accordance with EN ISO ANSI AAMI ISO 17665 formerly EN 554 ANSI AAMI ISO 11134 x Minimum sterilization time 20 minutes at 121 C or ...

Page 49: ...s of the method taking into account the specific product geometry in the context of validation including investigation of sterilization medium residues if appropriate 7 9 Storage 1 Store the ligation instrument in a location where it is protected against x strong mechanical stresses such as shocks falling or blows x direct exposure to sunlight x X ray radiation 2 Store the ligation instrument in a...

Page 50: ...in an ultrasonic bath The suitability of the ligation instruments for effective pretreatment in an ultrasonic bath 5 minutes with the use of an aldehyde free combined cleaning and disinfection product Gigasept Instru AF has been demonstrated by BOWA Automatic cleaning The suitability of the ligation instruments for effective cleaning and or disinfection with an automated method 90 C 5 minutes and ...

Page 51: ...8 2 LIGATOR Technical specifications HF current 4 A AC voltage 330 kHz Maximum voltage 200 Vp sinusoidal Approved HF device BOWA ARC generators with ligation software Approved programs For BOWA ARC 350L Ligation Pos 15 679 BOWA HF Instrumente Ligator NightKNIFE 09 Entsorgung 2 mod_1236861483293_6 doc 19816 1 MN031 447 S1 EN NightKNIFE and LIGATOR Technical specifications HF current AC voltage Maxi...

Page 52: ...isposal 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 ...

Page 53: ...e blade x 770 300 360 mm 770 000 770 336 771 136 723 030 723 020 x 770 200 200 mm 770 000 770 320 771 120 723 030 723 020 With replaceable blade x 770 201 200 mm 770 000 770 336 771 121 723 030 723 020 x 770 301 360 mm 770 000 770 336 771 137 723 030 723 020 Order from your specialist dealer X X 723 020 MN031 447 S1 EN ...

Page 54: ...6 x 770 320 Handle x 770 000 HF cable x 358 045 Cleaning brush set x 723 030 Spare parts for handle x 723 020 Replaceable blades set of 5 x 770 999 Pos 17 679 BOWA HF Instrumente Ligator LIGATOR Systemübersicht 5 mod_1277987846574_6 doc 40821 2 MN031 447 S1 EN Cleaning brush set x 723 030 Spare parts for handle x 723 020 Replaceable blades set of 5 x 770 999 Handle with HF cable 771 137 771 121 ...

Page 55: ...X X 723 020 Jaw insert x 771 036 x 772 036 x 771 011 x 772 011 Shank tube x 770 236 x 770 211 Handle x 770 000 new x 770 010 old HF cable x 358 045 Cleaning brush set x 723 000 Spare parts for handle x 723 020 Ende der Liste für Textmarke Inhalt MN031 447 S1 EN X x 358 045 Cleaning brush set x 723 000 Spare parts for handle x 723 020 Handle with HF cable ...

Page 56: ...opyright by BOWA electronic Gomaringen Ň Germany BOWA electronic GmbH Co KG Heinrich Hertz Strasse 4 10 D 72810 Gomaringen Ň Germany Phone 49 0 7072 6002 0 Fax 49 0 7072 6002 33 info bowa medical com Ň www bowa medical com CE marked according to Medical Device 93 42 EWG MN031 447 S1 12 12 EN ...

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