Preparation For Sterilization; Recommended Placement Of Chemical Indicators; Packaging; To Package Individual Devices - Stryker SYSTEM G Manual De Instrucciones

7300-001-700 Rev-B

Preparation for Sterilization

WARNINGS:
▪ Prior to sterilization, remove single use cutting and
fixation tools, attachments, transfer shields, and power
modules from the handpieces.
▪ ALWAYS verify that the power module has been
removed from the handpiece before sterilization.
▪ ALWAYS open the door on the bottom of the
handpiece before sterilization and take steps to make
sure that it will remain open during sterilization.
▪ ALWAYS separate the transfer shield from the
handpiece before sterilization.
▪ ALWAYS make sure the equipment is clean and
completely dry before sterilization.
Recommended Placement of
Chemical Indicators
WARNING: ALWAYS use a chemical indicator within
every sterilization load to make sure the proper
sterilization conditions of time, temperature, and
saturated steam are achieved.
Place a chemical indicator in a corner of the sterilization
case.

Packaging

WARNING: When using sterilization wrap, ALWAYS
use new sterilization wrap to enclose the equipment.
Do not reuse sterilization wrap.
NOTES:
▪ Follow the AAMI and the Association of periOperative
Registered Nurses (AORN) recommended guidelines
for appropriate wrapping configurations.
▪ The packaging material will maintain the sterility of the
equipment after exposure.

To Package Individual Devices

Enclose the equipment using a sterilization wrap that is
suitable for the equipment, such as a grade 500 or higher,
before sterile processing.

To Package a Sterilization Case

1. Place the devices into the base of the sterilization
case.
2. Install the lid of the sterilization case and close the
latches to secure the lid to the base.
3. Enclose the equipment using a sterilization wrap that
is suitable for the equipment, such as a grade 500 or
higher, before sterile processing.
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Stacking and Constraints

WARNINGS:
▪ DO NOT stack multiple sterilization cases during sterile
processing. Stacking multiple cases may damage the
sterile barrier provided by the sterilization wrap.
▪ ALWAYS stack non-sterile cases in a safe and secure
manner.
▪ DO NOT stack wrapped or unwrapped sterilization
cases during transport.

Sterilization

WARNINGS:
▪ Sterilize the equipment as indicated before first and
every use.
▪ DO NOT sterilize power modules.
▪ 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 the equipment.
NOTES:
▪ Stryker has validated several 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 cases or equipment are discovered after
sterilization, a change in the product load configuration
or a longer dry time may be necessary.
▪ Validation is based on the AAMI protocol.
▪ International sterilization parameters are per the
following standards:
▪ Australia/New Zealand per AS/NZS 4187
▪ Netherlands per Field Standard for Loaner
Instruments, Revision 03.02, April 2008.
▪ Europe and the United Kingdom per EN ISO 17664.
▪ Canada per CSA ISO 17664.
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