GE F-801 - Manual (Page 29)

F-801 Internal RO System by GE Osmonics
12552e - 27 Feb 04 2 - 5 Installation Guidelines and Instructions
12. Perform the following checks:
Pump pressure gauge: between 140 – 160 PSI
Pre-filter pressure differential: Both above 30 PSI, no greater difference
than 8 PSI above clean filter readings.
Product pressure: between 35-40 PSI.
Percent rejection: greater than 95%, continue to rinse if lower.
TDS at normal for region.
13. The RO product may be used in conjunction with hemodialysis treatment
equipment only after obtaining test results which validate compliance with
excepted standards.
AAMI Product Water Panel
Microbiological Culture (colony count) results
Endotoxin (pyrogen) level testing (if applicable)
14. The F-801 RO is now ready for use.
2.3 Product Water Analysis Procedure:
In order to ensure that the RO is performing at or above AAMI (Association for the
Advancement of Medical Instrumentation) Standards, it is necessary to perform an
AAMI Water Quality Analysis test. For new units, the RO must be operated (rinsed to
drain) for at least two hours before taking a sample, to ensure that the membranes are
free of preservative or other contaminants which would invalidate the test.
WARNING:
There are many documented clinical risks in using less than AAMI Standard
product water (refer to Technote 103, "AAMI Hemodialysis Water Quality
Standards").
NOTE:
Follow the procedures recommended by your water quality-testing laboratory if
they vary from the following steps.
Materials Required: Produce water sampling kit, sterile gauze, tape, and container
(such as a small bucket).
1.
Ensure that all pre-RO devices are operating correctly and are performance
verified by the appropriate testing.
2. Connect the RO unit to the required utilities (feed water, drain, power).
3. With the dialysis machine on, operate the RO unit with product and waste flows
to drain for at least 15 minutes after the product water quality has stabilized
before drawing the water sample.