Philips IntelliVue TRx Instructions For Use Manual page 189

Aeration
Procedure
Warning Warning
To avoid chemical burns and toxic effects, the equipment must be aerated
after sterilization, as described. The aerator must have bacterial filters and
outdoor venting.
See "References" on page 11-9.
Aerate the processed equipment by performing the following steps:
Step
1
These values will produce EO and Ethylene Chlorohydrin residual levels in the
transceiver and patient cable plastic that meet ISO 10993-7 in conjunction with
AAMI Technical Information Report 19, that the FDA currently endorses.
References
OSHA: Standard for acceptable levels of personnel exposure to Ethylene Oxide
Gas: 1 ppm on an eight-hour time-weighted average basis.
Reference: U.S.A. Federal Regulations 49 FR 25734/29 CFR Part 1910.1047,
June 22, 1984; final approval 50 FR 9800/2- CFR Part 1910.1047, March 12,
1985.
*
Action
1 To dissipate residual EO, aerate the processed equipment with air
that has been bacterially filtered, using a mechanical aerator or
combination sterilizer/aerator as follows:
Time: 8-9 hours
Temperature: 54.4 +/- 2.8
Ventilation Frequency: At least 30 air exchanges per hour.
2 Continue with the "Test Procedure" (following).
1
o
C (130 +/- 5
Maintenance, Cleaning & Troubleshooting
Cleaning and Sterilization
o
F)
11-9