Instruction Manual. ErgoLAP BIPOLAR

Transcription

1 Instruction Manual ErgoLAP BIPOLAR EN

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3 Liability and guarantee This product complies with Directive 93/42 EEC concerning medical devices. Liability or guarantee is excluded, when the Instruction Manual indications and instructions are not observed, the product is not used as intended, Definition of use, page 4 other than original spare parts are used. Survey of references, page 18 The company BOWA accepts no liability for faulty functioning of our products connected with procedures used and disinfectant, including the effectivity of the disinfectant. The specifications of the manufacturer are to be adhered to during use, e.g., with machine cleaning, likewise the specifications of the rinsing machine manufacturer must be taken into consideration. Explanation of symbols WARNING information WARNING 1 Indicates a possibly dangerous situation, which can lead to severe bodily injuries or to death. All triangular symbols are WARNING symbols. Requirements All round symbols with a white pictogram on a dark background symbolize requirements. Prohibitions All round symbols with a struck-through pictogram symbolise prohibitions. Prohibitions are in addition represented with the aid of crossed-out illustrations. Symbols for handling instructions Indicates a handling instruction Indicates the result of handling Indicates a cross-reference 1 Classification of signal words per US Standard ANSI Z535.4 MN S2 EN 3

4 1. Product description 1.1. Definition of use The function of ErgoLAP BIPOLAR instruments is the coagulation of biological tissue by means of HF current in the areas of gynaecology and laparoscopy. ErgoLAP BIPOLAR instruments are intended for bipolar operating methods. Application, page 8 Intended as a medical device in accordance with the EC Directive concerning medical devices. This product complies with Directive 93/42/EEC concerning medical devices. The instruments are employed in connection with products used in endoscopy (trocars, optics, electrosurgical generators, etc.) inserted through natural or surgically-made entries. Intended for intermittent use under normal conditions for a period of less than 60 minutes. Invasive surgical product. Reusable surgical instrument. Active therapeutical medical device. Classification in product group IIb in accordance with the EG Directive concerning medical devices (93/42/EEC). Service life without recognisable limitation. During use as intended, these products are subject to lighter or heavier wear depending on intensity of use. The use of a return plate is unnecessary with bipolar instruments. Intended for connection to electrosurgical generators. Selection of recommended electrosurgical generators, page 17 4 MN S2 EN

5 1.2. Requirements regarding personnell These products may only be used by trained medical personnel in medical establishments. Before using the products, carefully read the Instruction Manual Terminology and identification of parts A B C D E Jaw Inner shaft tube Outer shaft tube Handle HF cable C1 D1 D2 D3 E Sealing (blue) Push button (red) Finger rings Sealing (black) HF cable MN S2 EN 5

6 1.4. Function Principle: The electrical resistance of tissue through which current is passing leads to heat generation. Through heat, tissue can be cut and bleeding staunched. What you should know when connecting the bipolar instrument, page 8 HF current With bipolar HF surgery, coagulation of tissue is effected by the application of a high frequency alternating current, thereby generating heat. The HF current flows from one branch of the instrument via the biological tissue to the second branch and achieves the desired locally restricted coagulation effect. Active electrodes (branches) Jaw Active electrodes (branches) are the uninsulated areas of the jaw. In the starting position, jaw A is closed. On operating the handle D, the jaw is opened. 6 MN S2 EN

7 1.5. Technical data HF current Alternating current Max. voltage >300 khz 530 V P for CUT instruments ( , ) 300 V P for COAG instruments ( , , , ) 2. On delivery Target group Only trained medical personnel in medical establishments. Delivered condition The product is originally packed by BOWA (delivery unsterile). Reading the Instruction Manual Before use, read this Instruction Manual thoroughly. Read the instruction manuals of other products used during the procedure thoroughly. Storing this Instruction Manual Store in a safe, easily accessible place. The storage location must be known. Storage and transportation Storage, page 17 Before use WARNING Use only sterilised products in perfect condition. Inspect and decontaminate product. Preparation, page 8 MN S2 EN 7

8 3. Application What you should know when connecting the bipolar instrument 3.1. Preparation HF cable Active electrodes Avoid monitor display interference: Do not run HF cable directly parallel to camera cables. Do not lay HF cable in loops. Never place HF cable onto the skin of the patient. Connect instrument for coagulation and switch on electrosurgical generator. Grasp HF cable only by the connector when plugging in and unplugging. WARNING Risk of unintended burns. Never use worn out or faulty active electrodes. Dispose of worn out or faulty active electrodes - never repair! HF unit Pay attention to the electrosurgical generator instruction manual and to general information on electrosurgical procedures. Technical data, page 7 WARNING Improper use of HF current can cause endogenous and exogenous burns as well as explosions. Carry out electrosurgical procedures only with insufflation of incombustible gases (CO 2). 8 MN S2 EN

9 Endogenous burns Exogenous burns Interactions Cardiac pacemakers Endogenous burns are burns caused by high local current density in the tissue of the patient. Causes can include: With direct skin contact by HF cables, capacitive effects can lead to burns. Exogenous burns are burns caused by the heat of ignited liquids or gases. Even explosions are possible, through detonation. Causes can include: Ignition of skin cleaning solution and disinfectant. Ignition of anaesthetic gases. Ignition of insufflated gases. Only insufflate incombustible gases! Ignition of endogenous gases (e.g. in the intestine). Cardiac pacemakers can be damaged or destroyed by HF current. A cardiologist should be consulted before the procedure. Never carry out out-patient procedures using HF current on patients with cardiac pacemakers. MN S2 EN 9

10 Adjusting the output power of the electrosurgical generator WARNING Risk of unwanted burns. Before the procedure, try out suitable approximate values extracorporally. Set the output power of the electrosurgical generator only to the value absolutely required for the procedure. Technical data, page 7 Before increasing the output power due to insufficient coagulation, without fail check: Perfect contact of all HF cables and connectors. Foot switch function. Insulation of the HF cable, active electrodes, trocar sleeve or shaft, Cleanliness and wear of the distal end of the active electrodes. Safety measures Switch on the HF current only when the active electrodes are in contact with the tissue to be coagulated (don t use Auto Start). Active HF instruments must not be placed upon the pacient: this may lead to burns. Using plastic trocars increases the electrical safety. 10 MN S2 EN

11 3.2. Before use WARNING Risk of injury to patients. Select the HF cable and the electrosurgical generator in accordance with the bipolar operating mode. Survey of references, page 18 Selection of recommended electrosurgical generators, page 17 Use only suitable products and accessories. Survey of references, page 18 Use only sterilised products in perfect condition. Before using each time, carry out a thorough visual inspection and functional check. Inspecting products, page 12 Attach HF cable. Introduce the jaw in closed condition into the trocar sleeve. Introduce the bipolar instrument into the body under visual control During use WARNING Risk of injury to patients. Improper use of an instrument and limited view can lead to injuries to patients. Use only a suitable instrument. Operate only with adequate view. MN S2 EN 11

12 Procedure Open jaw. Position the jaw at the operating field. Close jaw. Activate HF current for coagulation (don t use Auto Start). Open jaw. Remove jaw from the coagulated tissue (The tips may still be so hot just after activation that it can cause burns). Extraction Close jaw. Remove the bipolar instrument from the trocar sleeve. WARNING It cannot be excluded that a movable part of the jaw will be damaged through excessive force and where possible even broken off. After every procedure, inspect the jaw. All parts must be present. Inspecting products, page After use Decontaminate. Preparation, page Inspecting products WARNING During use as intended, these products are subject to lighter or heavier wear depending on intensity of use. This wear has technical causes and is unavoidable. Inspect and decontaminate product. If the product reveals externally-recognisable faults or does not function as described in this Instruction Manual, without delay advise the manufacturer or its authorised representatives. Replace faulty products. 12 MN S2 EN

13 Inspecting parts A Jaw Check straigtness. Check the distal and proximal insulation visually for possible damage (fractures, breaks). B Inner shaft tube Check straigtness. C Outer shaft tube Check straigtness. D Handle D1 Push button (red) D3 Sealing (black) Install D1 and D3. Check: Does D1 operate smoothly? Discard or replace defective devices. E HF cable Check insulation visually. Dispose of HF cables with worn or faulty insulation. MN S2 EN 13

14 Assembly B Inner shaft tube C Outer shaft tube C1 Sealing (blue) Step 1: Install C1 onto C. Step 2: Introduce B into C. Step 3: Introduce B/C into D and handtighten each. Step 4: Introduce A. Push A in until audible latching occurs. If necessary, press D1 slightly. Latching noticeable Align A as required. For this, turn A until further latching is heard. To facilitate this, operate D. Check firmly seated. Step 5: Operate D. A must close together completely. A may not be kinked or bent. E HF cable Check firmly seated Disassembly Carry out in reverse sequence 14 MN S2 EN

15 3.6. Repair Do not repair or service defective devices. Discard or replace defective devices. 4. Preparation Ensure that insulated parts do not come in contact with hard, pointed or heavy objects during preparation, as such objects may damage the insulation and render the product unsuitable. Preparations cycles: Handle, outer and inner shaft tube: 200 cycles Jaw: 75 cycles 1. Soaking Soak the instrument immediately after use, or no later than 2 hours after use. Use only aldehyde-free disinfectants (recommended: Gigasept Instru AF) designed for the disinfection of instruments (e.g. DGHM or FDA approval, or CE mark). Place the instrument in an ultrasonic bath for at least 5 minutes. Use a cleaning solution to soften coagulation residues (encrustations) at the jaws and remove them with a soft cleaning cloth. A synthetic feece or plastic cleaning brush can be used if necessary for the preliminary removal of residues. Do not pre-clean HF cables in the ultrasonic bath. 2. Disasembly Disasembly, page 14 MN S2 EN 15

16 3. Cleaning / Disinfection Recommendation: Machine cleaning in a cleaning/disinfection machine and thermal disinfection. Parameters: At least 5 minutes at 90 C or A0 value > 3,000. BOWA recommends the use of neutral to slightly alkaline cleaning agents or cleaning and disinfection agents which are suitable for medical devices made of plastic and metal. Alcoholic and/or aldehydic ingredients may be permissible, depending on the concentration. If necessary, blow off with filtered compressed air. Only dry the products with compressed air at pressures below 3 bar, to avoid possible damage. The manual method is not suitable for the designated products. Effective cleaning proven by BOWA: Machine cleaning (90 C, 5 minutes) using an alkaline cleaning agent with surfactant additive (Neodisher MediClean forte) The manufacturer accepts no responsibility if other types of cleaning and disinfection agents are used. Follow the recommendations of the cleaning agent manufacturer. 4. Inspection Inspect parts Inspecting products, page Packing Before sterilisation, the dismantled instruments must be packed in a suitable single-use sterilisation pack (single or double pack) and/or a suitable sterilisation container. 6. Autoclaving Fractionated vacuum process Holding time: 3-20 minutes Sterilisation temperature: C 7. Store for use Ambient conditions, page Assemble parts/ inspect/ functionally test in operating theatre Assembly, page 14 Application, page 8 16 MN S2 EN

17 5. Ambient conditions 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. 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. Ambient conditions Operation and storage Transport Temperature: + 10 C to + 40 C - 20 C to + 50 C Relative humidity: Atmospheric pressure: 0 to 75 %, non-condensing 500 to 1060 hpa 6. Selection of recommended electrosurgical generators BOWA ARC series Erbe VIO / ICC / ACC / T series MARTIN ME BERCHTOLD Elektrotom VALLEYLAB Force Conmed Excalibur / Sabre 7. Disposal 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, packing materials and accessories in accordance with applicable national regulations and statutes. MN S2 EN 17

18 8. Survey of references Set = ( ) Handle Outer shaft tube Inner shaft tube Jaw Connecting Cables (4,5 m) (4,5 m) (4,5 m) (4,5 m) (4,5 m)... Sealing spare parts Cleaning brush set MN S2 EN

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20 MN S2 07/2015 EN Printed in Germany Subject to technical and design changes Copyright by BOWA-electronic, Gomaringen Germany 0123 BOWA-electronic GmbH & Co. KG Heinrich-Hertz Strasse 4 10 D Gomaringen Germany Phone: +49 (0) Fax: +49 (0) info@bowa-medical.com CE marked according to Medical Device 93/42/EWG