EN

Instruction Manual

ErgoLAP®MONOPOLAR

MN030-616-S1 EN 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

4 MN030-616-S1 EN

Product description 1.

1.1. Definition of use

• The function of ErgoLAP ® instruments is the coagulation of biological tissue by

means of HF current and without current to grasp or cut biological tissue or sutures in the fields of gynaecology and laparoscopy.

• ErgoLAP ® instruments are intended for operating in monopolar mode.

Application, page 7 • 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). • During use as intended, these products are subject to lighter or heavier wear

depending on intensity of use. • Intended for connection to electrosurgical generators.

Selection of recommended electrosurgical generators, page 17

1.2. Requirements regarding personnel

These products may only be used by trained medical personnel in medical

establishments.

Before using the products, carefully read the Instruction Manual.

MN030-616-S1 EN 5

1.3. Terminology and identification of parts

A Jaw

B Shaft tube

C Handle

D HF cable

C1 Push buttons

C2 Notch arm

C3 Locking lever

C4 “Finger rings”

D HF cable

6 MN030-616-S1 EN

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 7 HF current In monopolar electrosurgery, the tissue

coagulation occurs by applying a high frequency alternating current, which generates heat. The HF current flows from the acicular or planiform “active” electrode (A) to the larger-area “return plate” (P). At the surface of the active electrode, high current density occurs, producing so much heat that tissue coagulates or is cut.

Jaws/ shaft tube (active electrodes) Active electrodes are monopolar forceps,

scissors and shaft tubes. Current flow in the body

What you should know when connecting the bipolar instrument, page 7

Jaw In its home position the jaw A1 is opened. On operating the handle C, the jaw is closed. To lock A1, operate the notch arm C2.

Handle The shaft tube C can be rotated and can be

locked at 8 x 45° positions.

For this turn star wheel B1.

Details:

Assembly, page 15

1.5. Technical data

HF current

Alternating current >300 kHz

Max. voltage 5700 Vp

MN030-616-S1 EN 7

On delivery 2.

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 15

Application 3.What you should know when connecting the bipolar instrument

3.1. Preparation

Applying the return plate

Attach return plate close to operation area, if possible on upper arm or thigh.

Render the skin at this location as far as possible free from hair and fats.

Ensure contact over the entire area.

8 MN030-616-S1 EN

Current flow in the body WARNING

Risk of unintended burns.

The current paths in the body of the patient should be as short as possible and run in a diagonal direction. Never allow current paths to run right through the body and

under no circumstances via the thorax. Correctly apply return plate (black) and use permissible

application areas (grey) for the active electrodes.

Insulating the patient The operating table must be earthed.

Insulate the patient from all electrically-conductive objects. For this, place patient onto a dry, electrically-insulating underlay. Avoid skin-to-skin contact (arms, legs); insert dry mull.

Finally, connect the return plate, the foot switch and the HF cable to the electrosurgical generator.

HF cable

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.

MN030-616-S1 EN 9

Active electrodes 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 6

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 (CO2).

Endogenous burns 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 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).

10 MN030-616-S1 EN

Interactions Cardiac pacemakers 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.

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 6 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.

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

Safety measures Only switch on HF current when the active electrode is in contact with the tissue to be coagulated. The distance to other endoscopic instruments within the patient must be at least 10 mm. Tissue sections grasped by the active electrode may not contact other tissue sections over a small area.

Coagulate cordlike tissue sections at the thinnest location. Otherwise, unwanted coagulation can be caused.

Active HF instruments must not be placed upon the patient: this may lead to burns.

Using plastic trocars increases the electrical safety.

MN030-616-S1 EN 11

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 monopolar instrument into

the body under visual control.

3.3. 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.

12 MN030-616-S1 EN

Procedure Position the jaw at the operating field. Close jaw. Activate HF current for coagulation. 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 monopolar 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 12

3.4. After use

Decontaminate.

Preparation, page 7

3.5. 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.

MN030-616-S1 EN 13

3.5.1. Inspecting parts

A Jaw A1 A2 A3

Jaw OPEN/CLOSE Check straightness. Check condition of ball

(distortion, fracture, or similar).

Check jaw function. Discard or replace defective

devices.

B Shaft tube Check Check the insulation

visually for possible damage.

Discard or replace defective devices.

C Handle Install C1 Check: • Do C1, C2, C3 move

freely? Discard or replace

defective devices.

D HF cable Check insulation visually.

Dispose of HF cables with worn or faulty insulation.

14 MN030-616-S1 EN

3.5.2. Assembly

A Jaw B Shaft tube

Step 1: Introduce A into B.

Step 2: Push A up to stop, if

necessary while turning A.

Step 3: Turn A by 90°.

Engagement noticeable.

Step 4: Visually check:

surface to surface?. Check firmly seated, for

this, pull A.

Introduce A/B into C. During this, simultaneously press C1 and C3 and hold A1 closed.

D HF cable Check firmly seated.

3.5.3. Disassembly

Carry out in reverse sequence

C C2

Open and close A1. Try stopping A1, for this

operate C2.

MN030-616-S1 EN 15

3.6. Repair

Do not repair or service defective devices. Discard or replace defective devices.

Preparation 4.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, 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 and handles in the ultrasonic bath.

2. Disasembly Demontage, Seite 14

16 MN030-616-S1 EN

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 12

5. 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: 134-137 °C

7. Store for use Ambient conditions, page 15

8. Assemble parts/ inspect/ functionally test in operating theatre Assembly, page 14

Application, page 7

MN030-616-S1 EN 17

Ambient conditions 5. 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: 0 to 75 %, non-condensing

Atmospheric pressure: 500 to 1060 hPa

Selection of recommended 6.electrosurgical generators

BOWA ARC series Erbe VIO / ICC / ACC / T series MARTIN ME BERCHTOLD Elektrotom VALLEYLAB Force Conmed Excalibur / Sabre

Disposal 7.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.

18 MN030-616-S1 EN

Survey of references 8.

Set 736-005 = (720-000 + 722-530 + 723-020)

Handle

720-000 ....

Shaft tube

722-530 ....

Jaw

721-301 ....

721-302 ....

721-303 ....

721-304 ....

721-306 ....

721-307 ....

721-308 ....

721-309 ....

721-310 ....

Connecting Cables

101-145 (4,5 m) ....

270-145 (4,5 m) ....

360-145 (4,5 m) ....

360-245 (4,5 m) ....

480-145 (4,5 m) ....

Sealing spare parts

723-020 ....

Cleaning brush set

723-000 ....

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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