Integra LifeSciences Bipolar Forceps User Manual

Page 2

STANDARD STERILIZATION METHOD

Use steam autoclave sterilization only.
Bipolar Forceps (Unwrapped):

Sterilization Cycle

Temperature

Exposure Time

Min. Dry Time

Prevacuum, flash

270° F (132° C)

3 minutes

---

Other time and steam temperature cycles may also be used. However,
user must validate any deviation from the recommended time and
temperature.

(Note: Contact the manufacturer of your steam autoclave

to confirm appropriate temperatures and sterilization times.)
Caution: Autoclave temperatures should not exceed 279°F (137°C);
handles, insulation or other non-metallic parts may be damaged.
Do not sterilize with hot air.

HANDLING

All surgical instruments must be handled with the greatest care when
being transported, cleaned, treated, sterilized and stored. This is
especially true for blades, fine points and other sensitive areas. Surgical
instruments corrode and their functions are impaired if they come
into contact with aggressive materials. The instruments must not be
exposed to acids or other aggressive cleaning agents.

PRODUCT INFORMATION DISCLOSURE

INTEGRA AND MANUFACTURER EXCLUDE ALL WARRANTIES, WHETHER
EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. NEITHER INTEGRA NOR MANUFACTURER
SHALL BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS,
DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE
OF THIS PRODUCT. NEITHER INTEGRA NOR MANUFACTURER ASSUME
NOR AUTHORIZE ANY PERSON TO ASSUME FOR THEM ANY OTHER
OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH
THESE PRODUCTS.

RETURNED GOODS POLICY

Products must be returned in unopened packages with manufacturer’s
seals intact to be accepted for replacement or credit unless returned
due to a complaint of product defect. Determination of a product defect
will be made by Integra LifeSciences. Products will not be accepted for
replacement if they have been in the possession of the customer for
more than 90 days.

SYMBOLS USED ON LABELING

Manufacturer

Authorized Representative in the European Community

Catalog number

Lot number

See instructions for use

Non-sterile - Sterilize prior to use

Consult instructions for use

US Federal Law restricts this device to sale by or on the
order of a physician only.

Product complies with requirements of directive 93/42/EEC
for medical devices

CAUTION

Federal (USA) law restricts this device to sale by or on the order of a
physician.

Integra York PA, Inc.

589 Davies Drive

York, PA 17402 USA

www.integralife.com/Jarit

Integra LifeSciences Services (France) SAS Immeuble Sequoia 2

97 allée Alexandre Borodine

Parc Technologique de la Porte des Alpes

69800 Saint Priest–France

Telephone: 33 (0) 4 37 47 59 10

Fax: 33 (0) 4 37 47 59 29

JL-00010 Rev 6 9/30/2014

REF

NON

STERILE