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8 Technical specifications

MN031-543-S0 EN

TissueSeal / TissueSeal PLUS COMFORT

33

8. Technical specifications

8.1.

TissueSeal / TissueSeal PLUS COMFORT

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

LIGATION
For BOWA ARC 350L (900-350):
LIGATION from software V2.6
Effect 2 to Effect 4
760-216: Effect 4

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Содержание TissueSeal CCOMFORT Series

Страница 1: ...EN Operating Manual TissueSeal PLUS COMFORT TissueSeal COMFORT...

Страница 2: ......

Страница 3: ...Legend MN031 543 S0 EN TissueSeal TissueSeal PLUS COMFORT 3...

Страница 4: ...4 TissueSeal TissueSeal PLUS COMFORT MN031 543 S0 EN...

Страница 5: ...gend MN031 543 S0 EN TissueSeal TissueSeal PLUS COMFORT 5 Legend A Jaws B Handle A1 Disposable electrode tip B1 Ratschet A2 Electrode surfaces B2 Jaws holder B3 HF cable B3 B1 A B A2 B A B2 B1 B3 A2 A...

Страница 6: ...1 2 4 Other icons and labeling 10 1 2 5 Symbols on packaging 10 2 Safety 11 2 1 Intended use 11 2 2 General safety instructions 12 2 2 1 HF device 13 2 2 2 HF cable 13 2 2 3 Active electrodes 14 2 2 4...

Страница 7: ...4 7 3 Manual removal of contamination 25 7 4 Automatic preparation in a CDM 26 7 5 Inspection 28 7 6 Packing 29 7 7 Autoclaving 30 7 8 Storage 31 7 9 Transport 32 7 10 Functional test in the operating...

Страница 8: ...the operating manual in particular the safety instructions see section 2 page 9 carefully and thoroughly before use Store the operating manual in a safe place throughout the service life of the devic...

Страница 9: ...Measure for risk prevention 1 2 2 Risk levels in the warning instructions Symbol Risk level Probability of occurrence Consequences of non compliance DANGER Immediate risk Death or serious injuries WA...

Страница 10: ...ng Prerequisite for an activity Activity with one step 1 2 3 Activity with several steps in a binding sequence Result of preceding activity List first level List second level Emphasis Emphasis see sec...

Страница 11: ...sed in connection with the ligation program of BOWA ARC generators Do not use the ligation instruments if in the opinion of an experienced physician or according to current professional literature suc...

Страница 12: ...n instrument before using it for the first time It is not sterile as delivered With TissueSeal the disposable electrode tips are supplied in sterile condition Clean and sterilize the ligation instrume...

Страница 13: ...d liquids 2 2 2 HF cable Improper use of HF cables can lead to patient injuries Never lay the HF cable on the patient s skin Connect the ligation instrument for coagulation before switching on the HF...

Страница 14: ...ment and sensitive tissue structures such as the pancreas or intestine Ensure that hot instruments are not used for preparation Inadvertent activation of the ligation instrument may cause patient inju...

Страница 15: ...it is as free as possible in order to avoid unintentional clamping 2 3 1 Patients with pacemakers Malfunctions or destruction of the pacemaker can endanger the life of the patient or result in irrever...

Страница 16: ...produces the desired coagulation in a localized region With this method sealing of a vessel or tissue segment carrying blood is achieved by HF current in combination with supplementary pressure The se...

Страница 17: ...mbling the ligation instrument 1 With TissueSeal plug the disposable electrode tip A1 onto the holder for jaw B2 5 Operation 5 1 Before use The ligation instrument is assembled see section 4 and prepa...

Страница 18: ...F device and switch on the HF device 2 Set the output power of the HF device 3 Perform a thorough visual inspection and functional test each time before using the ligation instrument see section 7 5 p...

Страница 19: ...ling tissue WARNING Risk of patient injury due to inadvertent activation of the ligation instrument Never use the AUTOSTART function Do not switch on the HF current before the active electrodes are in...

Страница 20: ...Using the handle B open the jaws A The tissue is coagulated Changing the output power of the HF device Before increasing the output power of the HF device check all HF cables and connectors are prope...

Страница 21: ...rument if the electrodes are damaged Prepare the ligation instrument after use see section 7 page 20 Pos 9 679 BOWA HF Instrumente Ligator NightKNIFE 06 Demontage 5 mod_1277986204902_6 doc 40710 1 6 D...

Страница 22: ...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 Th...

Страница 23: ...ial damage to the ligation instrument from scouring agents and metal brushes Never use scouring products to clean the ligation instrument If necessary first use a nonwoven cloth to remove residual dir...

Страница 24: ...e clothing Adequate ventilation is recommended 1 Place the ligation instrument in the ultrasonic bath for at least 5 minutes Position instrument parts with large surface areas in the ultrasonic bath s...

Страница 25: ...tion 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 in...

Страница 26: ...e not recommended due to their significantly lower effectiveness Ensure that the selected CDM fulfils the following requirements as shown by DGHM or FDA approval or a CE mark in accordance with EN ISO...

Страница 27: ...he instrument components see section 7 11 page 30 Follow the manufacturer s instructions with regard to the concentration and exposure time of the cleaning and disinfection products Cleaning and disin...

Страница 28: ...e the product if it shows externally visible defects or does not function as described in this manual Please advise the manufacturer or the manufacturer s authorized representative in such cases After...

Страница 29: ...e 1 Check the connector for damage and corrosion 2 Visually inspect the insulation for damage 7 6 Packing The packaging must meet the following requirements EN ANSI AAMI ISO 11607 EN 868 2 10 formerly...

Страница 30: ...formerly EN 554 ANSI AAMI ISO 11134 with applicable IQ OQ commissioning and product specific performance assessment PQ Maximum sterilization temperature 134 C plus tolerance in accordance with EN ISO...

Страница 31: ...ion medium residues if appropriate 7 8 Storage 1 Store the ligation instrument in a location where it is protected against strong mechanical stresses such as shocks falling or blows direct exposure to...

Страница 32: ...isinfection agents free from potentially harmful ingredients Alcoholic and or aldehydic ingredients may be permissible depending on the concentration Pretreatment in an ultrasonic bath The suitability...

Страница 33: ...1 TissueSeal TissueSeal PLUS COMFORT 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...

Страница 34: ...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...

Страница 35: ...1 543 S0 EN TissueSeal TissueSeal PLUS COMFORT 35 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 8...

Страница 36: ...overview 36 TissueSeal TissueSeal PLUS COMFORT MN031 543 S0 EN 10 2 TissueSeal PLUS COMFORT Order from your specialist dealer 760 223 Handle 760 216 760 219 760 223 760 228 Ende der Liste f r Textmar...

Страница 37: ......

Страница 38: ...n changes Copyright by BOWA electronic Gomaringen Germany BOWA electronic GmbH Co KG Heinrich Hertz Strasse 4 10 D 72810 Gomaringen Germany Phone 49 0 7072 6002 0 Fax 49 0 7072 6002 33 info bowa medic...

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