Better Water LLC; rev. Apr 2017
Page 3 of 20
Cartridge Based Pyrogen Filtration System
(2-4 Filters)
Operator Manual
WARNINGS
1.
It is unsafe to operate or service this device without first reading and understanding the
entire
Operator's Manual. Keep this manual and other associated documentation for future reference.
2.
Misuse, improper operation, and/or improper monitoring of this system could result in serious
injury, death, or other serious reactions to patients undergoing hemodialysis treatment.
3.
Misuse, improper use or handling of disinfectants and chemical cleaning solutions could result
in serious injury or even death. You must comply with the information contained in the Material
Safety Data Sheet (MSDS) for the chemical being used.
CAUTIONS
1.
When used as a medical device, federal law restricts this device to sale by or on the authority
of a physician. Per CFR 801.109 (b)(1).
2.
Improper operation of this device could result in a low or no-flow alarm on the dialysis
machines.
3.
Misuse or improper operation of this device will void any warranty.
4.
Where water is mentioned, unless otherwise noted, it must be AAMI standard quality water.
5.
Plumbing connections must adhere to local statutes and any facility codes.
6.
Do not remove any Caution, Warning or any other descriptive labels from the device.
7.
Do not operate this device in an explosive environment or in the presence of flammable
materials. Do not use this device to store, mix, or transfer flammable liquids.
8.
Movement or vibrations during shipment may cause connections to loosen.
9.
Do not operate this unit in an environment where temperatures may be below 50
o
F or above
90
o
F.
10.
This device should not be used for purposes outside the device’s stated applications,
specifications, or limitations.
