Bowa ErgoLAP MONOPOLAR Mode D'emploi page 24

1. Product description
1.1. Definition of use
•
The function of ErgoLAP
means of HF current and without current to grasp or cut biological tissue or
sutures in the fields of gynaecology and laparoscopy.
®
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ErgoLAP instruments are intended for operating in monopolar mode.
 Application, page 7
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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.
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Invasive surgical product.
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Reusable surgical instrument.
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Active therapeutical medical device.
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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.
4
®
instruments is the coagulation of biological tissue by
MN030-616-S1 EN