Steam Sterilization - Stryker 0206-600-000 Instrucciones De Uso

EN
Sterilization
WARNINGS:
▪ ALWAYS use a chemical indicator within every sterilization load to
make sure the proper sterilization conditions of time, temperature,
and saturated steam or hydrogen peroxide are achieved.
▪ Prior to sterilization, separate all detachable components from the
cement gun.
▪ ALWAYS use new sterilization wrap to enclose the equipment. Do
not reuse sterilization wrap.
▪ Sterilize the equipment as indicated before first and every use.
▪ Use the sterilization methods as indicated in these instructions.
Using other sterilization methods may prevent proper sterilization
of the equipment and/or damage the equipment.
▪ Follow the recommended dry times to prevent moisture from
accumulating inside the equipment. Moisture may prevent proper
sterilization and/or damage the equipment.
▪ After sterilization, allow the equipment to cool to room
temperature prior to use. Failure to comply may result in a burn
injury and/or damage to the equipment.
NOTES:
▪ Stryker has validated several sterilization cycles for the
sterilization of this equipment. However, sterilizer design and
performance can affect the efficacy of the process. Healthcare
facilities should verify the process they use, employing the actual
equipment and operators that routinely process the equipment.
▪ The final responsibility for verification of sterilization techniques
lies directly with the hospital. To ensure the efficacy of hospital
processing, all cycles and methods should be verified for different
sterilization chambers, wrapping methods, and/or various loading
configurations.
▪ If wet trays or equipment are discovered after sterilization, a
change in the product load configuration or a longer dry time may
be necessary.
▪ The packaging material will maintain the sterility of the equipment
after exposure.
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Printed Date: Jul 03, 2018 22:39:49 GMT
0000003147, Rev. E Effective Date: Jul 21, 2017 11:19:40 AM

Steam Sterilization

1. Enclose the equipment using a sterilization wrap that is suitable
for the equipment, such as a grade 500 or higher, before sterile
processing. Follow the AAMI and Association of periOperative
Registered Nurses (AORN) recommended guidelines for
appropriate wrapping configurations.
2. Perform one of the following validated steam sterilization cycles:
Wrapping Sterilization
Cycle
Method Temperature
Dynamic
[270 °F]
Air Removal
(Pre-
vacuum)
[273 °F]
Double
Wrapped
[250 °F]
Gravity
[270 °F]
*Minimum exposure time may be extended to 18 minutes.
Immediate-Use Steam Sterilization
WARNINGS:
▪ DO NOT place equipment into a sterilization case or sterilization
container for immediate-use steam sterilization.
▪ After cooling to room temperature, ALWAYS immediately use
equipment sterilized by immediate-use steam sterilization. Sterility
assurance cannot be maintained for unwrapped equipment.
CAUTION: Stryker does not recommend immediate-use steam
sterilization for routine sterilization of medical devices. Immediate-
use steam sterilization should only be used when individual devices
require immediate sterilization and use.
Perform one of the following validated steam sterilization cycles:
Wrapping Sterilization
Cycle
Method Temperature
Dynamic
[270 °F]
Air Removal
(Pre-
Un-
vacuum)
wrapped [273 °F]
Gravity
[270 °F]
0206-600-700 Rev-E
Minimum
Minimum
Exposure
Dry Time
Time
132 °C
4 minutes 30 minutes
134 °C
3 minutes* 30 minutes
121 °C
30 minutes 30 minutes
132 °C
15 minutes 30 minutes
Minimum
Minimum
Exposure
Dry Time
Time
132 °C No dry
4 minutes
time
134 °C No dry
3 minutes
time
132 °C No dry
10 minutes
time
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