STERILIZATION:
100% ETHYLENE OXIDE GAS:
1.
Clean and prepare as recommended on page 7.
Ensure the soaking cap is installed.
2.
Sterility has been validated using an ethylene oxide
sterilization unit for a cycle with the following
parameters:
temperature:
55°C
humidity:
70% RH±5%
vacuum:
21 in Hg
preconditioning time:
60 minutes
sterilant mixture:
100% ethylene oxide
sterilant concentration:
600±5 mg/L ethylene
oxide
exposure time:
120 minutes
aeration:
12 hours, 55°C
STERIS® SYSTEM:
1.
Clean and prepare as recommended on page 7.
Ensure the soaking cap is installed.
2.
Sterility has been validated using Steris® System 1 with
Steris® Sterilant 20.
STERRAD™ SYSTEM:
1.
Clean and prepare as recommended on page 7.
Ensure the soaking cap is installed.
2.
Sterility has been validated using Sterrad™ Sterilization
System.
NOTE
To increase the longevity of the camera head,
observe the following process limits:
maximum ethylene oxide exposure time:
3 hours
maximum temperature:
60°C (140°F)
maximum Cidex® Glutaraldahyde soak time: 24 hours
NOTE
If coupler and camera head are sterilized or
disinfected as a single unit, disconnecting the
coupler will compromise the sterility or
disinfection.
USE OF STERILE DRAPES
Use of sterile drapes will ensure maximum longevity of your
Stryker Endoscopy Model 988 Medical Video Camera.
Follow instructions provided by drape manufacturer when
using sterile drapes. Sterile camera drapes for use with the
Model 988 Medical Video Camera can be ordered under
Stryker product number 240-010-200.
CAUTION
Maximum performance and camera life is
extended by the consistent use of a single
sterilization method. Also, avoid leaving the
camera in the sterilization solutions longer than
necessary as this will accelerate normal
product aging.
DISPOSITION OF THE PRODUCT
The device must be disposed of according to local laws and
hospital practices. The device does not contain any
hazardous materials.
7
8
STERILIZATION AND DISINFECTION