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