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Caution: Federal law (U.S.A.) restricts this device to
sale by or on the order of a physician
MicroFrance
®
Product Information and Instructions
Monopolar Electrosurgical Instruments (Laparoscopic Use)
Manufacturer:
Integra MicroFrance SAS
Le Pavillon • 03160 Saint
Aubin Le Monial • France
integralife.com
Symbols
Catalog number
Lot Number
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician
Manufacturer
Date of Manufacture
Attention, see Instructions For Use
Consult Instructions for Use
Do not reuse
Do not use if package is damaged
Non-sterile
Product complies with the requirements of directive 93/42/EEC
Product complies with the requirements of Medical Device Regulation 2017/745 (Class I Devices Only)
Medical Device
MicroFrance, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
Neodisher is a trademark of Chemische Fabrik Dr. Weigert GmbH & Co. KG. ©2021 Integra LifeSciences Corporation. All Rights Reserved.
NT060US
Rev A - 2021-06 2027767-1
Product complies with the requirements of directive 93/42/EEC
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Related Manuals for Integra MicroFrance CP391
Summary of Contents for Integra MicroFrance CP391
- Page 1 Medical Device MicroFrance, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Neodisher is a trademark of Chemische Fabrik Dr. Weigert GmbH & Co. KG. ©2021 Integra LifeSciences Corporation. All Rights Reserved.
- Page 2 EN English / Product Information and Instructions DESCRIPTION OF THE DEVICES Monopolar electrosurgical instruments are available in different configurations to be used in laparoscopic and open surgery as indicated by surgical techniques. Electrical insulation is applied to selected portions of the instrument and a connector is provided to attach the instrument to a variety of currently available monopolar electrosurgical generators.
- Page 3 • Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD) exposure; Integra instruments have not been validated to withstand the chemical and thermal exposure recommended to eradicate prions.
- Page 4 RETURNS Contact Integra Customer Service to obtain a Return Goods Authorization number (RGA #) prior to shipping the product back to Integra. The RGA # should be prominently displayed on the outside of the return packaging and included on all paperwork enclosed with the return. All product returned should be decontaminated and cleaned, and all products should be safely packed in protective wrapping.
- Page 5 (5) Upon examination of the Product by Integra, Integra shall have determined that: (i) the Product was not repaired or altered by anyone other than Integra or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services have been performed on the Product.
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