Integra LifeSciences Laparoscopic Instrument Care and Cleaning - Manual (Page 3)

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4.1. GAS STERILIZATION (cont.)
Sterilization parameters
Ethylene Oxide Carrier: Oxyfume 2002
Temperature: 55 ± 2°C (131 ± 5°F)
Relative Humidity: ≥ 35%
Pressure (PSIG Start): 19 ± 1 PSIG
Ethylene Oxide concentration: 736 mg/L
Gas Exposure Time (Full cycle): 4 hours
Aeration: 11 hours at 54°C
(129°F) minimum
4.2. AUTOCLAVING
Caution: Scopes cannot be steam autoclaved unless
“AUTOCLAVABLE” is engraved on the endoscope body.
This method would otherwise permanently damage the
optical components.
Before each endoscope is autoclaved, make sure that all optical
surfaces of the instrument are clean and free from foreign
particles (refer to Section 2). Lack of cleanliness before
autoclaving can result insevere damage to the endoscope
and/or reduced optical performance and shortened service life.
Always follow the standard hospital procedures
for sterilization.
Place the clean endoscope in a suitable sterilization tray.
A suitable tray should hold the endoscope firmly but gently in place.
Note: Verify that there is NO contact between the
endoscope and any other metal parts during the
sterilization process. This will result in direct heat
transfer from the tray to the instrument. Use gauze or
loosely woven cloth inserts folded around each item to
prevent contact with metal surfaces and to avoid
movement.
Important: NEVER immerse the endoscope into cold
water after it has been autoclaved. Rapid temperature
changes may damage the optical system and will
ultimately void the warranty.
Note: Biological indicators should be used on a regular basis to
ensure validated sterilization conditions.
4.2.1. GRAVITY STEAM STERILIZATION
Follow standard hospital procedure for gravity steam
sterilization (double wrapped in muslin) at 132°C (270°F) for
10 minutes.
4.2.2. PREVACUUM STERILIZATION
Follow standard hospital procedure for prevacuum steam
sterilization (double wrapped in muslin) at 132°C (270°F) for
3 minutes.
After completing the sterilization, the endoscope should be
cooled slowly to room temperature in the autoclave.
DO NOT IMMERSE OR RINSE INSTRUMENTS IN
COLD WATER OR ANY OTHER LIQUID TO
ACCELERATE COOLING.
5. ELECTRICAL SAFETY
Miltex ® endoscopes are primarily of metallic construction. The
level of electrical isolation is determined by the manufacturer
of all equipment used with Miltex ® endoscopes and accessories.
Experience with predicate devices has shown no safety hazards.
6. STORAGE
a. Miltex ® scopes should be stored with the plastic tip
protectors covering the distal working end. This will help to
protect the delicate portion of the optics.
b. The scope and accessories should be stored either in their
shipping box or in a sterilization tray. In either case, proper
care should be taken to ensure that the scope is secured from
falling or touching other instruments.
Note: Any mechanical manipulation of the eyepiece may result in
seal breakage; therefore, do not attempt to remove the eyepiece.
7. SERVICE
Contact the Miltex Repair department at toll free phone
number 1-866-854-8300. Miltex does not supply its optical and
mechanical parts to any outside company; therefore, only
Miltex or its subsidiaries are able to repair Miltex ® brand
medical endoscopes with original parts and to guarantee the
original technical specification and safety of the product.
Additionally, this warranty is void for Miltex ® instruments
and products serviced by any person or facility other than
the Miltex Instrument Repair Services.
8. WARRANTY
Miltex ® endoscopes have a 2-year warranty against defects in
workmanship and material. Any Miltex endoscopes that
prove defective in workmanship or material will either be
repaired or replaced at our discretion, without charge. Our
liability under this warranty shall be limited to repair or
replacement of defective merchandise. This warranty is a limited
warranty and is the only warranty made by Miltex. Miltex makes
no other warranty, expressed or implied, including any warranty
of merchantability and fitness for a particular purpose.
INSTRUCTIONS FOR CARE & CLEANING OF
MILTEX ® ENDOSCOPES AND LAPAROSCOPIC
SURGICAL HAND INSTRUMENTS
Instructions for Use/English