Integra LifeSciences Forceps, Gynecological Surgical - Manual (Page 2)

Sterilization
After cleaning the reusable instruments, sterilize them using the following procedure.
For Double-Wrapped Instruments
1. Individually double-wrap the clean, dry instruments in Cardinal Health self-seal
pouches and seal the pouches. Make sure the instrument is in an open position
inside the pouch.
2. Place pouches in a pre-vacuum sterilization chamber using the following
parameters to achieve Sterility Assurance Level (SAL) of 10
-6 :
Recommended steam sterilization parameter to achieve Sterility Assurance Level
(SAL) of 10
-6 :
Note 8: Other sterilization pouches may be appropriate for the
steam method of sterilization but have not been validated for
use with Integra® Gynecological Surgical Forceps.
For Instruments inside a Tray
1. Place the clean, dry instruments in Jarit® tray and double-wrap the tray with
Convertors Bio-Shield Sterilization Wraps. Make sure the instrument is in an
open position inside the tray.
2. Place tray in a pre-vacuum sterilization chamber using the following parameters
to achieve Sterility Assurance Level (SAL) of 10
-6 :
Recommended steam sterilization parameter to achieve Sterility Assurance Level
(SAL) of 10
-6 :
Note 9: Other sterilization wrappers, such as polypropylene wrap or cotton muslin
may be appropriate for the steam method of sterilization but have not been
validated for use with Integra® Gynecological Surgical Forceps.
Note 10: Other sterilization trays may be appropriate for the steam method of
sterilization but have not been validated for use with Integra® Gynecological
Surgical Forceps.
Storage Conditions:
Store suitably packaged and sterilized instruments in a dry, clean, and
dust-free environment.
Maintenance Procedures:
Improper, ineffective and insufficient maintenance can reduce the life of an instrument
and will invalidate the instrument’s warranty.
Protect Instruments: The use of deionized water, careful preliminary cleaning, use
of neutralized pH solutions, adherence to manufacturer’s instructions and visual
inspection, will help to keep instruments performing accurately and free of stains.
Certain compounds are highly corrosive to stainless steel and will cause serious
damage. Instruments should never be exposed to:
• Aqua regia • Sulfuric acid
• Iodine • Hydrochloric acid
• Ferric chloride
The following substances should be avoided whenever possible; rinse with copious
amounts of water immediately if instruments are inadvertently exposed to any of the
following substances:
• Aluminum chloride • Potassium thiocyanate
• Mercury chloride • Calcium chloride
• Barium chloride • Saline
• Carbolic acid • Carbolic acid
• Potassium permanganate • Sodium hypochlorite
• Bichloride of mercury • Dakin’s solution
• Chlorinated lime • Stannous chloride
Any kind of corrosion will lead to rust on steel. Rust particles can be transferred from
one instrument to another, therefore, remove corroding instruments from service to
prevent formation of rust on other instruments.
Protect sharp cutting edges and fine working ends of inserts during all maintenance
procedures. Avoid loading heavy items on top of delicate and hollow instruments.
Diagnosing Spots and Stains: It is common for instruments to become stained or
spotted. Adhering to proper technique during cleaning and sterilizing procedures
will prevent most staining occurrences. The following identifies some of the various
instrument-related problems hospitals may encounter.
• Brown Stains: Detergents containing polyphosphates may dissolve copper
elements in the sterilizer resulting in brown stains. A dull blue or brown stain
is the result of oxidation on the surface.
• Black Stains: Black stains may be the result of contact with ammonia.
• Light or Dark Spots: Spots are often the result of the mineral content in the water
used for rinsing, use of non-neutral instrument cleaner or an unclean
sterilizer chamber.
• Rust Deposits: It is very unlikely for surgical grade steel to rust. Rust colored spots
usually appear in localities where water has high iron content.
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. Products will not be
accepted for replacement if they have been in the possession of the customer for more
than 90 days.
Repairs and Maintenance
Should your instruments require repair or maintenance, contact Integra for return
authorization and address. Instruments returned to Integra for repair must have a
statement testifying that each instrument has been thoroughly cleaned and sterilized.
Failure to supply evidence of cleaning and disinfection will result in a cleaning charge
and delayed processing of your instrument repair.
Warranties and Guarantees
In order to ensure warranties and guarantees, instruments in need of repair should be
sent to Integra.
Failure to follow these procedures will invalidate instrument’s warranty and can cause
instrument to fail.
Product Information Disclosure
INTEGRA AND ITS SUBSIDIARIES (“INTEGRA”) AND MANUFACTURER EXCLUDE ALL
WARRANTIES, EXCEPT INTEGRA’S APPLICABLE STANDARD WARRANTY 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.
Consult Instruction for Use
CAUTION: Federal (USA) law
restricts this device to sale by or
on the order of a physician
Product complies with
requirements of directive
93/42/EEC for medical devices
Manufacturer 1
European Authorized
Representative
Catalog number
Lot Number
Caution! See Warnings
and Precautions
1 Company responsible for a device marketed under its own name regardless of
whether “manufactured for” or “manufactured by” the company.
EC REP
REF
LOT
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
Manufacturer
Integra York PA, Inc.
i 589 Davies Drive, York, PA 17402
866-854-8300 USA i +1 717-840-2763 outside USA i +1 717-840-9347 fax
integralife.com/integra-miltex
Integra, the Integra logo, Miltex and EZ-Zyme are registered trademarks of Integra LifeSciences
Corporation or its subsidiaries in the United States and/or other countries. ©2014 Integra
LifeSciences Corporation. All Rights Reserved. SURGGYNFCPSDFU Rev. A 06/14
EC REP
Symbols used on labeling
0123
Sterilizer Type Configuration Temperature Exposure Time Dry Time
Pre-Vacuum Wrapped 132°C (270°F) 4 minutes 20 minutes
Gravity Wrapped 132°C (270°F) 15 minutes 15 minutes
Sterilizer Type Configuration Temperature Exposure Time Dry Time
Pre-Vacuum Wrapped 132°C (270°F) 4 minutes 20 minutes
Gravity Wrapped 132°C (270°F) 15 minutes 15 minutes