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Bowa TissueSeal, Руководство по эксплуатации

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2  Safety 

 

12 

TissueSeal / TissueSeal PLUS 

MN031-443-S0-20110112-EN 

2. Safety 

2.1. Intended 

use 

The ligature instruments are intended to be used to seal 
arterial and venous blood vessels and vascular tissue 
structures in open surgical procedures in gynecology, 
urology, general surgery, and other surgical disciplines with 
the aid of an HF current and mechanical pressure. 

In addition, the ligature instruments are suitable for 
conventional bipolar coagulation. 

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 
literature, such use would cause endangerment of the patient 
due, for example, to the general condition of the patient, or if 
other contraindications are present.  

  

 

It is not necessary to use a neutral electrode with bipolar 
ligation instruments. 

 

Содержание TissueSeal

Страница 1: ...EN Operating Manual ...

Страница 2: ......

Страница 3: ......

Страница 4: ......

Страница 5: ...Legend MN031 443 S0 20110112 EN TissueSeal TissueSeal PLUS 5 Legend A Jaws A1 Disposable electrode tip A2 Electrode surfaces B Handle B1 Ratchet B2 Jaws holder B3 Cable connector C HF cable ...

Страница 6: ...Legend 6 TissueSeal TissueSeal PLUS MN031 443 S0 20110112 EN ...

Страница 7: ...ing 11 1 2 5 Symbols on packaging 11 2 Safety 12 2 1 Intended use 12 2 2 General safety instructions 13 2 2 1 HF device 14 2 2 2 HF cable 14 2 2 3 Active electrodes 15 2 2 4 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 Assembling the ligation instrument 18 5 Operation 19 5 1 Before use 19 5 2 During the operatio...

Страница 8: ... of contamination 30 7 4 Automatic preparation in a CDM 32 7 5 Inspection 35 7 6 Packing 36 7 7 Autoclaving 37 7 8 Storage 38 7 9 Transport 39 7 10 Functional test in the operating room 39 7 11 Recommended operating supplies 39 8 Technical specifications 40 8 1 TissueSeal 40 8 2 TissueSeal PLUS 40 9 Disposal 41 10 System overview 42 10 1 TissueSeal 42 10 2 TissueSeal PLUS 43 ...

Страница 9: ...he 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 whenever you ...

Страница 10: ...X 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 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...

Страница 11: ...ng Prerequisite for an activity X Activity with one step 1 2 3 Activity with several steps in a binding sequence ª Result of preceding activity List first level List second level Emphasis Emphasis see section xxx page xxx Cross reference 1 2 5 Symbols on packaging Icon Labeling Meaning Manufacturer Comply with operating instruction ...

Страница 12: ...uments are suitable for conventional bipolar coagulation 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 literature such use would cause endangermen...

Страница 13: ... 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 X Clean and sterilize the ligation 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 validate...

Страница 14: ...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 cables that are in perfect condition Never use a defective HF cable The HF cable may cause inte...

Страница 15: ...ent and sensitive tissue structures such as the pancreas or intestine X Ensure that hot instruments are not used for preparation 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 regul...

Страница 16: ...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 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 d...

Страница 17: ...gh the biological tissue to the other electrode surface and 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 sealed location is hemostatically tight with respect to systolic blood pressure and permanently closed Applies only to vessels up to 7 mm in d...

Страница 18: ...ion instruments X The ligation instrument is not sterile as delivered Clean and sterilize the instrument before using it 4 1 Assembling the ligation instrument 1 With TissueSeal plug the disposable electrode tip A1 onto the holder for jaw B2 2 Connect the HF cable C to the cable connector B3 and check that it is attached securely ...

Страница 19: ... capability see section 8 page 40 X Use only genuine HF cables X Use only suitable products and accessories as described in the system overview X Use only intact sterilized products WARNING Risk of patient injuries from the combustion 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 flammabl...

Страница 20: ...o incorrect device settings 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 40 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 tiss...

Страница 21: ...e electrodes of the jaws A 3 Close the jaws A to grasp the tissue ª The tissue is grasped 4 Use the two position ratchet of the handle B to adjust the pressure on the tissue to best match the amount of grasped tissue ª The tissue is clamped 5 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 indic...

Страница 22: ...s are properly connected the ligation instrument is properly connected see the operating instructions of the HF device the foot switch works properly the insulation of the HF cable C the active electrodes of the jaws A are clean and not worn out 5 3 Withdrawal WARNING Risk of patient injury due to damaged or broken off parts X Check the ligation instrument after each use All parts must be present ...

Страница 23: ...rodes of the jaws A regularly with a moist cloth X With TissueSeal replace the disposable electrode tip A1 if the electrodes are damaged X With TissueSeal PLUS replace the ligation instrument if the electrodes are damaged X 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 ...

Страница 24: ...urns from hot electrode surfaces X Do not touch the electrode surfaces immediately after use 1 Disconnect the HF cable C from the handle B 2 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 ...

Страница 25: ...he 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 The following information on the possible number of preparation cycles should be regarded as a guideline The actua...

Страница 26: ... EN 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 ...

Страница 27: ...manual cleaning X Wear a face mask and protective clothing X Adequate ventilation is recommended 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 ligation instrument from scouring agents and metal brushes X Never use scouring products to clean the ligation instrument ...

Страница 28: ... use or no later than 2 hours after use X Use only aldehyde free disinfectants suitable 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 X Dismantle the ligation instrument see section 6 page 24 ...

Страница 29: ...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 such that they will not be damaged by the ultrasonic energy 2 Use suitable cleaning and disinfection products for ultrasonic cleaning see section 7 11 page 39 3 Follow the manufacturer s instructions with regard to the concentration ...

Страница 30: ...3 Manual removal of contamination The TissueSeal PLUS ligation instrument is described as an example in this section X Open the jaw A HINWEIS Risk of material damage to the ligation instrument from metal brushes X Always use a plastic brush to clean the ligation instrument ...

Страница 31: ...m brushes and scouring products X Use a damp swab for cleaning X 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 X After pre cleaning rinse all parts of the instrument thoroughly with fully demineralized or distilled water ...

Страница 32: ... shown by DGHM or FDA approval or a CE mark in accordance with EN ISO 15883 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 A program suitable for the instrument with adequate rinse cycles is selected Sterile water or water with a ...

Страница 33: ...on 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 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 ...

Страница 34: ...nsure that the instrument components are positioned to allow exposure to the rinsing media clean the handle in the unlatched position the HF cable is located in a sieve tray with a cover 2 Restart the program 3 After the program is finished remove the instrument components from the CDM NOTE Risk of handle damage due to compressed air X Restrict compressed air pressure to 3 bar or less for handle d...

Страница 35: ...thorized representative in such cases X After cleaning visually inspect each of the instruments and test them for proper operation X Replace any damaged parts We recommend that instrument oil not be used on moving or pivoting parts such as the pliers handles Instrument oil may cause a tendency to swelling in certain plastics and impair the ease of motion of the instruments DANGER Risk of patient b...

Страница 36: ...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 EN 868 ANSI AAMI ISO 11607 Suitable for steam sterilization resistant to temperatures up to 137 C with sufficient steam permeability Serviced at regular intervals sterilization container X Pack the ligation instrument in a suitable disposable sterili...

Страница 37: ...drying Compliant with EN 13060 or EN 285 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 Maximum sterilization temperature 134 C plus tolerance in accordance with EN ISO ANSI AAMI ISO 17665 formerly EN 554 ANSI AAMI ISO 11134 Minimum sterilization time 20 minutes at 121 C...

Страница 38: ...ic product geometry in the context of validation including investigation of sterilization 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 sunlight X ray radiation 2 Store the ligation instrument in a dry place at room temperature The storage life of t...

Страница 39: ...ally harmful ingredients Alcoholic and or aldehydic ingredients may be permissible depending on the concentration Pretreatment 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 ...

Страница 40: ...oved HF device BOWA ARC 350L Approved programs Ligation with software V2 6 Effect 2 shorter ligation time to Effect 4 longer ligation time 8 2 TissueSeal PLUS Technical specifications HF current 4 A 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 to Effect ...

Страница 41: ... DANGER Infection hazard X 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 ...

Страница 42: ...Seal TissueSeal PLUS MN031 443 S0 20110112 EN 10 System overview 10 1 TissueSeal Order from your specialist dealer X 830 001 Handle 760 019 760 023 760 028 Disposable electrode tip 830 000 830 001 830 010 830 011 HF cable 378 045 ...

Страница 43: ...overview MN031 443 S0 20110112 EN TissueSeal TissueSeal PLUS 43 10 2 TissueSeal PLUS Order from your specialist dealer X 760 123 Handle 760 119 760 123 760 128 HF cable 378 045 Ende der Liste für Textmarke Inhalt ...

Страница 44: ...sign 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 medical com www bowa medical com CE marked according to Medical Device 93 42 EWG ...

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