Millenium™ RO System by GE Osmonics

2.3Product 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.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.

4.Hold the product line over the container and run product water for 60 seconds.

5.Aseptically remove the lid from the sample bottle and rinse the bottle twice with RO product water.

6.Fill the bottle completely with RO product water and cap it immediately.

7.Fill out the laboratory requisition form. Ensure the requisition form has, at a minimum, information to identify the facility or location of the RO, the serial number or facility equipment number to ensure which RO was tested and name, phone number and address of whom to contact.

8.Place the bottle and the completed requisition in the pre-addressed mailer and mail it directly to the laboratory.

NOTE:

Total chlorine must be measured on-site. Tests for Chlorine/Chloramine (total chlorine) are not typically reported on the AAMI Analysis. Chlorine and chloramine dissipate from the water sample over time and reported results will be inaccurate.

NOTES:

14693e - 31 Mar 03

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Installation Guidelines and Instructions