Bowa ErgoLAP BIPOLAR User manual

EN
Instruction Manual
ErgoLAP®BIPOLAR

MN030-667-S2 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 MN030-667-S2 EN
Product description1.
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

MN030-667-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.
1.3. Terminology and identification of parts
A Jaw
B Inner shaft tube
C Outer shaft tube
D Handle
E HF cable
C1 Sealing (blue)
D1 Push button (red)
D2 “Finger rings”
D3 Sealing (black)
E HF cable

6 MN030-667-S2 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 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) Active electrodes (branches) are the
uninsulated areas of the jaw.
Jaw In the starting position, jaw A is closed. On
operating the handle D, the jaw is opened.

MN030-667-S2 EN 7
1.5. Technical data
HF current
Alternating current
>300 kHz
Max. voltage
530 VP for CUT instruments (760-033, 761-033)
300 VPfor COAG instruments(751-033, 752-033,
753-033, 754-033)
On delivery2.
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

8 MN030-667-S2 EN
Application3.
What you should know when connecting the bipolar instrument
3.1. Preparation
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.
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 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 (CO2).

MN030-667-S2 EN 9
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).
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.

10 MN030-667-S2 EN
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.

MN030-667-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.
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 MN030-667-S2 EN
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 12
3.4. After use
Decontaminate.
Preparation, page 8
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.

MN030-667-S2 EN 13
3.5.1. 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.

14 MN030-667-S2 EN
3.5.2. 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 hand-
tighten 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.
3.5.3. Disassembly
Carry out in reverse sequence

MN030-667-S2 EN 15
3.6. Repair
Do not repair or service defective devices.
Discard or replace defective devices.
Preparation4.
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

16 MN030-667-S2 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 17
8. Assemble parts/ inspect/ functionally test in operating theatre
Assembly, page 14
Application, page 8

MN030-667-S2 EN 17
Ambient conditions5.
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 recommended6. electrosurgical generators
BOWA ARC series
Erbe VIO / ICC / ACC / T series
MARTIN ME
BERCHTOLD Elektrotom
VALLEYLAB Force
Conmed Excalibur / Sabre
Disposal7.
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 MN030-667-S2 EN
Survey of references8.
Set 750-033 = (750-000 + 755-033 + 756-033 + 750-010)
Handle
750-000 ....
Outer shaft tube
755-033 ....
Inner shaft tube
756-033 ....
Jaw
751-033 ....
752-033 ....
753-033 ....
754-033 ....
760-033 ....
761-033 ....
Connecting Cables
101-245 (4,5 m) ....
287-245 (4,5 m) ....
351-245 (4,5 m) ....
350-245 (4,5 m) ....
351-345 (4,5 m) ....
Sealing spare parts
750-010 ....
Cleaning brush set
723-000 ....

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MN030-667-S2 07/2015 EN Printed in Germany │ Subject to technical and design changes Copyright by BOWA-electronic, Gomaringen │ Germany
BOWA-electronic GmbH & Co. KG
Heinrich-Hertz Strasse 4–10
D-72810 Gomaringen │ Germany
Phone: [phone]
Fax: [phone]
[e-mail] │
www.bowa-medical.com
CE marked according to
Medical Device 93/42/EWG