Integra LifeSciences Forceps, Gynecological Surgical User Manual

Integra, Gynecological surgical forceps

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Description

Integra® Gynecological Surgical Forceps are designed to provide a secure grip on tissue
during vaginal and abdominal hysterectomy procedures. These atraumatic instruments
are designed to minimize laceration or perforation of the tissue even when required
retraction is exerted. Due to differences in anatomy of the site and types of surgical
procedures, a variety of configurations and models are offered to provide the surgeon
with options to ensure clinical needs are met.


Indications For Use

Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades
that are indicated for pulling, grasping, holding, or compressing tissue during
gynecological procedures.


Contraindications

None known

Warnings

• DO NOT flash sterilize the Integra® Gynecological Surgical Forceps.
The instruments have not been validated for flash sterilization.

• Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD) exposure.

• The Integra® Gynecological Surgical Forceps have not been validated to withstand
the chemical and thermal exposures recommended to eradicate prions.

Precautions

• Read the Instructions for Use and keep them in a safe place.

• Use the product only in accordance with its intended use,
see

INDICATIONS FOR USE.

• Use of an instrument for a task other than that for which it is intended could
result in a damaged or broken instrument, or one which provides an
unsatisfactory performance.

• Instruments should be handled and operated by personnel completely familiar
with their use, assembly and disassembly.

• Instruments must be rendered safe for handling, inspection and assembly by
wearing appropriate personal protection equipment (PPE) as promulgated by
OSHA & AORN.

• Inappropriate use of instruments will lead to damage that is usually not repairable.

• Instruments must be thoroughly inspected upon receipt and prior to use to assure
proper functioning. Failure to make a complete inspection to assure proper
operation and function of instrument may result in unsatisfactory performance.

• Integra® Gynecological Surgical Forceps are supplied non-sterile and must be
pre-cleaned, cleaned, lubricated, visually examined and sterilized prior to use.
Please see pre-cleaning, cleaning, visual examination, and sterilization
procedures below.

• Check screws on instruments after ultrasonic cleaning. Vibration from ultrasonic
cleaning may cause them to loosen or fall out.

• Prior to each use, inspect the product for: loose, bent, broken, cracked, worn,
or fractured components.

• Do not use the product if it is damaged or defective.

Integra

®

Gynecological
Surgical Forceps

Rx Only CAUTION: Federal (USA) law restricts this device to sale by or on the order of a surgeon.

Instructions for Use/English

• Replace any damaged components immediately with original spare parts.

• Store products in a dry, clean and safe place.

Pre-Cleaning, Cleaning, and Sterilization Procedures

Before using the instruments pre-clean, clean (manual or automated), dry, visually
examine, and sterilize following the procedures below.

Personnel should follow accepted guidelines as recommended in ANSI/AAMI
ST79:2006, A1:2008, A2:2009 -Comprehensive guide to steam sterilization and
sterility assurance in health care facilities.

Pre-Cleaning
Pre-cleaning should occur as soon as possible after instrumentation is used.

1. Remove gross debris from surgical instruments with a sponge and sterile water
after use to prevent drying of blood and body fluids on the instruments.

2. Place instruments in an instrument tray/container and saturate all surfaces for five
(5) minutes with a pre-cleaning enzymatic product such as Miltex Instrument Prep
Enzyme Foam.

Note 1: Other foam, spray or gel products, intended for use with surgical
instruments, are available to keep soil moist but have not been validated for
use with Integra® Gynecological Surgical Forceps.

Cleaning:

Cleaning should occur as soon as possible after instrumentation is pre-cleaned.

After performing steps 1-6 below, perform either “Manual Cleaning” or
“Automated Cleaning”
.

1. Rinse instrument with deionized water for two (2) minutes.

2. Use a clean, soft bristled brush to clean and remove visible soil from the surfaces
of the instruments.

3. Prepare Miltex® EZ-Zyme® All-Purpose Enzyme Cleaner solution per manufacturer’s
recommendations/instructions for correct dilution and temperature.

4. Immerse fully opened instruments in the prepared Miltex EZ-Zyme All-Purpose
Enzyme Cleaner solution for ten (10) minutes.

5. Rinse instrument and hinge with deionized water for two (2) minutes.

6. Proceed either to “Manual Cleaning” or “Automated Cleaning” procedures below:

Manual Cleaning

1. Prepare Miltex EZ-Zyme All-Purpose Enzyme Cleaner solution per manufacturer’s
recommendations/instructions for correct dilution and temperature.

Note 2: Other cleaning reagents/detergents are available but have not been
validated for use with Integra® Gynecological Surgical Forceps.

2. Using a small, clean hand-held brush, remove soil from all surfaces of instrument
while fully immersed in solution.

Note 3: Never use steel wool, wire brushes, scalpel blades or highly abrasive
detergent or cleansers to remove soil as these will damage the instruments’
protective surface and lead to corrosion.

3. Rinse thoroughly and aggressively for two (2) minutes with deionized water.

4. Using a Branson 8510 ultrasonic cleaner sonicate instruments for ten (10) minutes.

• Prepare Miltex EZ-Zyme All-Purpose Enzyme Cleaner solution per manufacturer’s
recommendations/instructions for correct dilution and temperature and place in
the Branson 8510 ultrasonic cleaner.

• Condition (de-gas) ultrasonic cleaner for 5 minutes.

• Place instruments in the ultrasonic cleaner manufacturer’s instrument tray.

• Ensure instruments are in the open position.

• 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).

• Place tray with the instruments into the Branson 8510 ultrasonic cleaner.

• Sonicate instruments for ten (10) minutes.

Note 4: Other ultrasonic cleaners may be available but have not been validated
for use with Integra® Gynecological Surgical Forceps.

5. Remove instruments from sonicator and rinse for two (2) minutes with
distilled water.

6. Visually inspect instrument for cleanliness and ensure all parts are in proper
working order.

7. Apply Miltex Spray Lube to all joints and moveable mating surfaces.

8. Allow instruments to dry on lint-free cloth for 60 minutes at
24°C (75°F) temperature.

Note 5: Other drying methods may be available but have not been validated for
use with Integra® Gynecological Surgical Forceps.

9. Inspect instruments for visual dryness.

10. Apply Miltex Spray Lube to all joints and moveable mating surfaces as per
manufacturer’s instructions.

Automated Cleaning

1. Place instruments in a wire basket.

• Ensure instruments are in the open position.

• 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, such as
a Steris Amsco Reliance 444 single-chamber washer/disinfector. Using the
parameters/detergents listed in the table below clean the instruments.

Note 6: Other automatic washer-sterilizer or washer-disinfector specific
parameters may be available but have not been validated for use with
Integra® Gynecological Surgical Forceps.

3. Remove instruments from automatic washer.

4. Visually inspect instrument for cleanliness and ensure all parts are in proper
working order.

5. Visually inspect instrument to ensure it is dry.

Note 7: Other drying methods may be available but have not been validated for use
with Integra® Gynecological Surgical Forceps.

6. Apply Miltex Spray Lube to all joints and moveable mating surfaces as per
manufacturer’s instructions.

Treatment

Time (mm:ss)

Temperature

Cleaner

Presoak

02:00

Cold (10°C±2)

Water

Enzymatic
Wash

04:00

Hot (minimal
43°C/109°F)

Endozime A W Plus®,

Enzymatic Detergent

Wash
(Cleaning)

02:00

60°C (140°F)

Endozime A W Plus®,

Enzymatic Detergent

Rinse

02:00

70°C (158°F)

Water

Dry

15:00

80°C (176°F)

N/A

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