-
i -
CAUTION
The Food and Drug Administration has found this device (System) to be
substantially equivalent to devices (Systems) intended for use in specific
medical device applications. The System may not be modified,
reconfigured, or used in a medical application other than that for which it
is labeled. Modification of this system is a violation of federal law and will
void all warranties.
INDICATIONS
Use of the US Filter Reverse Osmosis System is indicated when water for use in the preparation of
dialysate fails to consistently meet the minimum requirements specified in the ANSI/AAMI approved
American National Standard for Hemodialysis Systems, RD5, 1981. The US Filter Reverse
Osmosis System may be used with any proportioning dialysis machine having a compatible water
demand.
CONTRAINDICATIONS
There are no absolute contraindications to reverse osmosis water treatment.
CAUTIONS AND WARNINGS
Procedures using the Reverse Osmosis System must be performed under the direction of a
physician.
Prior to operating or servicing this device, this manual must be read and understood. If something
is not clear, call for assistance before proceeding. Keep this and other associated manuals for
future reference and for new operators or qualified service personnel.
All electrical work should be performed by a qualified electrician in accordance with the latest
edition of the National Electrical Code, as well as local codes and regulations.
To avoid electrical shock hazard, do not remove covers or panels when power is supplied to the
device. Do not operate the device when covers or panels are removed.
WARNING
A faulty pump motor or wiring can be a serious shock hazard if it or
surrounding water are accessible to human contact. To avoid this danger,
DO NOT remove any grounding wire from the system.