Product Description; Definition Of Use - Bowa ErgoLAP Manual Del Usuario

1.

Product description

1.1.

Definition of use

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The function of ErgoLAP
tissue by means of HF current in the areas of gynaecology and laparoscopy.
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ErgoLAP BIPOLAR instruments are intended for bipolar operating methods.
 Application, page 8
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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.
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The instruments are employed in connection with products used in endoscopy
(trocars, optics, electrosurgical generators, etc.) inserted through natural or
surgically-made entries.
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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).
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Service life without recognisable limitation. During use as intended, these
products are subject to lighter or heavier wear depending on intensity of use.
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The use of a return plate is unnecessary with bipolar instruments.
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Intended for connection to electrosurgical generators.
 Selection of recommended electrosurgical generators, page 17
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BIPOLAR instruments is the coagulation of biological
MN030-667-S2 EN