1
1.0 RESTRICTIONS ON USE
Federal law restricts this device for sale by or on the order of a physician when used as
a water treatment device for hemodialysis.
2.0 THEORY OF OPERATION
The Endotoxin-Retentive Filters are the final purification process prior to distribution of
the product water. They are sub-micron filters with the ability to remove bacteria and
endotoxin. The filters are enclosed in an opaque housing to inhibit the proliferation of
algae. Water flows through the filter assembly, which traps bacteria and endotoxin.
3.0 INSTALLATION
Locate and install the Endotoxin-Retentive Filter assembly on a level floor.
Inlet water supply piping should be
≥
the inlet piping on the filter assembly header.
Outlet piping from the ultra filter should be
≥
the outlet pipe on the filter assembly
outlet
.
Follow all local plumbing codes.
Follow local codes for securing the assembly to the floor.
4.0 MONITORING
Monitor/ record pressure drop across filters daily for a pressure differential (
Δ
P) of less
than 15 psi between the inlet and outlet pressure gauges.
Test samples of pre- and post-filter water for bacteria and endotoxin when the filter is
installed and whenever the specific type of filter is changed. Results should indicate
that bacteria and endotoxin are reduced as stated by the manufacturer.
AmeriWater recommends that Endotoxin-Retentive Filters (Part Number
20-3048
) be
changed at least every (12) months or when the (
Δ
P) increases by 15 psi.
WARNING:
ENDOTOXIN-RETENTIVE FILTERS ARE ESSENTIAL
TO PATIENT SAFETY AND SHOULD NEVER BE
BYPASSED OR REMOVED DURING TREATMENT!
