Philips IntelliVue TRx, Instructions For Use Manual

Page: 231 / 274

Draft - 1 Aug 08
Cleaning and Sterilization
Maintenance, Cleaning & Troubleshooting 11-11
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 11-11.
Aerate the processed equipment by performing the following steps:
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.
Step 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:
1
Time: 8-9 hours
Temperature: 54.4 +/- 2.8
o
C (130 +/- 5
o
F)
Ventilation Frequency: At least 30 air exchanges per hour.
2 Continue with the “Test Procedure” (following).