User's Manual

Cleaning and Sterilization
Maintenance, Cleaning & Troubleshooting
11-7
Use the following equipment and material to process the transceiver:
1. Ethylene Oxide gas (Allied Signal Oxyfume-2002™ or equivalent).
2. Gas sterilizer manufactured by American Sterilizer Company or other
appropriate manufacturer.
EO
Sterilization
The following generic procedure can be used to supplement the sterilizer
manufacturer’s instructions, although the processing times, temperatures, and
EO concentrations must be equivalent to those given in this procedure in order
to achieve a sterility level of 10E-6.
Step Action
1 Remove any obvious contamination from the equipment to be
processed using approved cleaners.
2 Individually package each transceiver in standard central supply
room (CSR) wrapping material secured with EO color-change indi-
cator tape.
3 Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the empty
sterilizer chamber two times, to remove any residual EO or mois-
ture. Vent the vacuum pump to the outdoors to avoid toxic hazards
to personnel.
4 Insert the equipment to be processed into the gas sterilizer.
5 Heat the chamber and its contents to 54.4 +/- 2.8
o
C (130 +/- 5
o
F).
6 Apply -26 inHg +/- 1 (-12.77 psig +/- .49) vacuum to the sterilizer
chamber.
7 Humidify the chamber at 50% +/- 10% relative humidity for 20 to
30 minutes.
8 Taking a minimum of five minutes, slowly introduce EO sterilant
until the sterilizer unit pressure gauge reaches 11 +/- 1 psig.
Note—At this pressure, the concentration of sterilant in the chamber
will be 600 +/- 50 mg/liter, regardless of the chamber size.