AmeriWater CENTURION 1500+, Operating Manual

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3.4 Intended Use
The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment
systems intended for use in hemodialysis applications. They are designed to pre-treat
and purify potable water for use in making dialysate for hemodialysis and to meet
current AAMI and Federal (U.S.) standards. The device is intended to be a component
in a complete water purification system, and is not a complete water treatment system.
It must be preceded by pre-treatment devices, and may need to be followed by post-
treatment devices as well to meet current AAMI and Federal (U.S.) standards. The
Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic,
dialysis center, or for home care for single patient use. The device includes an
integrated heat sanitization process.
The Centurion 1500
+
unit is a Class III (Health Canada) / Class II (USA) Medical
Device intended for use in hemodialysis applications. It should only be used to feed
hemodialysis equipment that complies with the current IEC 60601-2-16 standard.
The unit has been designed to pre-treat and purify potable water for use in the
preparation of dialysate solution suitable for hemodialysis and related therapies in
accordance with current
AAMI/ANSI/ISO and Federal (US and Canadian) standards.
The Centurion 1500
+
unit is intended as a stationary device for indoor use only in
hospitals, clinics, dialysis centres or for home care for single patient use as part of a
Medical Electrical (ME) system . The unit should not be stacked on top off or placed
directly adjacent to other electrical/electronic equipment.
The Centurion 1500
+
water purifier works on the principle of reverse osmosis and Ultra-
filtration to provide purified water suitable for both hemodialysis and Hemodiafiltration
and has been designed for continuous operation.
CAUTION: When used as a medical device, Federal law restricts this device to sale by or
on the order of a physician per 21CFR 801.109(b)(1).
3.4.1 Operating staff
Warning:
The unit must only be operated and installed by persons who have been suitably trained and have studied
and understood the instructions within this manual and who are familiar and confident with the operation
of the unit.
Maintenance is restricted to carrying out chemical cleans and heat disinfections, once approved and
trained to do so by your Healthcare provider. There are no operator serviceable parts to be replaced.
It is essential that in the event of an emergency the location of the Circuit Breaker or other supply n mains
isolation device protecting the equipment is known.
If at any time you are unsure about the electrical safety of the unit or have reason to believe that it is
potentially unsafe to use you should switch the unit off, isolate it at the Circuit Breaker and seek advice
from your Healthcare provider.
The supply mains isolation switch is located at the rear of the unit ensure that it is accessible at all times
and remains clear from obstruction. Ensure that the wall plug is accessible at all times as this can be used
as a method of isolation.