Integra LifeSciences Hemorrhoidal Ligator, McGivney - Manual (Page 2)

Automated Cleaning
1. Place instruments in a wire basket that is suitable for cleaning.
• Ensure instruments are in the open position and that water can flow out of
the openings.
• Components with lumens and channels should be placed directly on the injector
carriage attachment.
• Keep different metal types separated (i.e., separate stainless steel from
non-anodized aluminum, brass, copper and chrome-plating to avoid possible
transfer of one metal plating to another).
2. Place wire baskets in an automatic washer-sterilizer or washer-disinfector.
Follow the parameters and detergent recommendations provided by the
washer-disinfector manufacturer.
When carrying out the reprocessing cycle, the minimum requirements
are recommended:
• Use an appropriate cleaning/disinfecting agent according to its
manufacturer´s instructions.
• Observe the maximum washing temperature of 55°C (131°F).
• Wash the product for at least ten (10) minutes.
• Neutralize, if necessary.
• Carry out intermediate rinse for at least two (2) minutes.
• Carry out intensive final rinse with deionized, demineralized water.
• For thermal disinfection: Rinse for ten (10) minutes at 93°C (199.4°F) with
deionized, demineralized water.
• Complete the program with a drying phase of at least twenty (20) minutes at a
temperature of not more than 110°C (230°F).
3. Remove instruments from automatic washer.
4. Visually inspect instruments for cleanliness and ensure all parts are in proper
working order.
5. Visually inspect instruments to ensure they are dry.
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 medical self-seal pouches
and seal the pouches. Make sure the instrument is opened 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:
For Instruments inside a Tray
1. Place the clean, dry instruments in tray and double-wrap the tray with
Convertors Bio-Shield Sterilization Wraps.
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: Make certain that all surfaces of the product will be exposed to the
sterilizing agent. When sterilizing several products at the same time in one steam
sterilizer: Make sure that the maximum allowable load capacity of the steam
sterilizer, as specified by the manufacturer, is not exceeded.
Allow the product to cool down to room temperature.
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 • Calcium chloride
• Mercury chloride • Saline
• Barium chloride • Carbolic acid
• Potassium permanganate • Sodium hypochlorite
• Bichloride of mercury • Chlorinated lime
• Potassium thiocyanate • Stannous chloride
• Dakin’s solution
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 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
an 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. SURG-HEM-INST Rev. D 2/14
EC REP
Symbols used on labeling
Sterilizer Type Configuration Temperature Exposure Time
Pre-Vacuum Wrapped 134°C (273.2°F) 5 minutes
0123
Sterilizer Type Configuration Temperature Exposure Time
Pre-Vacuum Wrapped 134°C (273.2°F) 5 minutes