AmeriWater CENTURION 1500+ User manual

CENTURION 1500+
OPERATING MANUAL
P/N 98-2010
REV. C

Revision C
December 2017
CENTURION 1500+/UF
OPERATING MANUAL
For L998374/5
DOCUMENT HISTORY
Revision Date of Change
A January 2013
B January 2016
C December 2017

CONTENTS
DOCUMENT HISTORY .............................................................................. 3
1.0 PREFACE....................................................................................... 1
2.0 CONTACT US.................................................................................. 2
3.0 HEALTH AND SAFETY....................................................................... 3
3.1 Explanation of expressions....................................................................................3
3.2 Explanation of labels .............................................................................................3
3.2.1 Rear panel labels...............................................................................................4
3.3 Safety considerations............................................................................................7
3.4 Intended Use.........................................................................................................8
3.4.1 Operating staff......................................................................................................8
3.4.2 Residual dangers...............................................................................................9
3.4.3 Handling.............................................................................................................9
3.5 Bringing the unit to an immediate STOP ...............................................................9
3.6 Disposal of consumables.....................................................................................10
3.6.1 Dealing with leaks from the unit.......................................................................10
3.7 Unauthorized conversion and manufacturing replacement parts.........................10
3.8 Warranty claims and liability................................................................................10
3.8.1 Product Warranty.............................................................................................10
4.0 ABOUT YOUR CENTURION 1500+.......................................................11
4.1 General views of the Centurion 1500+unit..........................................................11
4.2 Overview .............................................................................................................11
4.3 Standard features................................................................................................11
4.4 Detailed features and process of operation.........................................................12
4.5 Explanation of rear connections ..........................................................................13
5.0 OPERATING THE TOUCHSCREEN ......................................................14
5.1 Explanation of Buttons .......................................................................14
5.1.1 Using the screen ................................................................................................14
5.1.2 “MENU” button.................................................................................................14
5.1.3 “START” button...............................................................................................15
5.2 Operation.............................................................................................................15
5.2.2 Starting the unit................................................................................................15
5.2.3 Stopping the unit during normal operation .......................................................16
5.3 Explanation of the mimic screen..........................................................................16
5.3.1 Mimic symbols .................................................................................................17
5.3.2 Explanation of displayed functions...................................................................17
6.0 MENUS AND SETTINGS....................................................................18
6.1 User menu...........................................................................................................18
6.1.1 Set Time and Date...........................................................................................18
6.1.2 Pre-Filter replacement date..............................................................................20
6.1.3 Product Information..........................................................................................20
6.1.4 Engineer & Settings menu ...............................................................................21
7.0 CHEMICAL CLEANING AND HEAT DISINFECTION ..................................22
7.1 Chemical cleaning..................................................................................................22
7.2 Heat disinfection..................................................................................................23
8.0 MAINTENANCE AND CHECKS............................................................23
8.1 Maintenance........................................................................................................23
8.1.1 Schedule of regular checks & tasks ..................................................................24
8.2 Pre-Dialysis checks.............................................................................................25
8.3 Cleaning external surfaces..................................................................................25
8.4 Storage and preservation recommendations.......................................................26

9.0 TROUBLESHOOTING.......................................................................27
9.1 Troubleshooting Guide.......................................................................28
9.1.1 Warning & alarm messages..................................................................................28
9.1.2 Electrical & mechanical faults ..........................................................................33
9.1.3 Water quality non-compliance..........................................................................34
10.0 CONSUMABLES AND SPARES...........................................................35
11.0 Technical specification.......................................................................36
11.1 Services/ connections and physical properties....................................................36
11.1.1 Electrical specifications/connections................................................................36
11.1.2 Fuse rating/type...............................................................................................36
11.1.3 IP Rating..........................................................................................................37
11.1.4 Alarm port connection details...........................................................................37
11.1.5 Water quality and performance........................................................................37
11.1.6 Feed water requirements.................................................................................37
11.1.7 Water services connections.............................................................................37
11.1.8 Raw water break tank......................................................................................38
11.1.9 Weights and dimensions..................................................................................38
11.1.10 Main PCB battery.........................................................................................38
11.1.11 USB mass storage device............................................................................38
11.2 Environmental data..............................................................................................38
11.3 Guidance on electromagnetic emissions.............................................................39
11.4 Guidance on electromagnetic immunity...............................................................40
11.5 Guidance on electromagnetic immunity for non-life supporting equipment .........41
11.6 Separation distances for RF devices and Centurion............................................42
11.7 Classification and standards applied...................................................................42
11.8 Classification mark ..............................................................................................43
12.0 APPENDICES .................................................................................44
12.1 How to use the push-fit connectors .....................................................................44
12.2 E-Waste...............................................................................................................45
12.3 Flow schematic....................................................................................................46
12.4 Certificate of conformity.......................................................................................47

1
1.0 PREFACE
Note: The Centurion 1500+ is an accessory in a Medical Electrical (ME) System in which the dialysis
equipment comprises the Medical Electrical Equipment.
This Operating Manual provides all of the information and instructions needed to
operate the Centurion 1500+single patient reverse osmosis unit.
Please read the instructions carefully and make sure that you fully understand the
information given before operating the unit.
A detailed Service & Maintenance Manual is available and will be held by your
Healthcare provider. The Service Manual provides all of the necessary information for a
qualified technician to maintain and service the unit.
Details on how to install & commission the Centurion 1500+can be found in the
Installation & Commissioning Guide. Installation of the unit would always be carried
out by your Healthcare provider or an approved trained technician.
Once trained and approved to do so by your Healthcare provider a detail step by step
guide on howto chemically clean and carry out routine heat disinfection cycles can found
in the Chemical Cleaning & Heat Disinfection Instructions document.
Warning:
Before operating the unit always check to see that the water and electrical connections are secure and not
likely to cause a trip hazard. If you have concerns about the unit or are unsure of its operation contact your
Healthcare provider for advice and assistance.

2
2.0 CONTACT US
Should you require any additional information relating to the servicing, maintenance,
spares and consumables, simply contact your Healthcare provider or AmeriWater or refer
to the relevant accompanying manuals and guides detailed in Section 1.0 PREFACE:
AmeriWater: Tel No. 800-535-5585
(Or your local authorized AmeriWater distributor dealer or Healthcare provider)
Useful Telephone Nos.
Healthcare Provider:
Tel No………………………………Contact Name:……………………………….
Tel No………………………………Contact Name:……………………………….

3
3.0 HEALTH AND SAFETY
3.1 Explanation of expressions
WARNING
This symbol is used to alert the user not to take a certain action, which if taken could cause a potential
hazard and result in a serious adverse reaction, injury or even death. The warning symbol may also be
used to alert the user to take a certain action to avoid a potential hazard.
In all cases within this document, where this symbol is used it is important that you familiarise yourself with
the nature of the potential HAZARD and any action that needs to be taken. If in doubt ask your Healthcare
provider.
Note:
A reminder or useful information that can be used to help explain a command or action or give guidance.
3.2 Explanation of labels
There are a number of labels applied to the outside of the Centurion 1500+unit which
identify hazards, advise caution or instruct the operator to seek reference before
proceeding with an action. These are identified below.
No Pushing: The unit has been designed as a stationary device during normal
operation. Do not push the unit when in operation as this may cause the integral tilt
detector to shut the unit down.
Refer to Manual: is used when reference should be made to the manualto obtain advice
and or information before carrying out a task. Please read the information given in the
operating instructions carefully before proceeding. If in doubt contact AmeriWater or
your Healthcare provider

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Trip Hazard: There are a number of water and electrical connections from the rear of
the unit to the renal replacement equipment and general services. To warn anyone from
inadvertently tripping over these service lines the label above is used as a visual warning.
Hot Surface: This label is used to indicate that the surface labelled may be hot to touch
under certain circumstances during the operation of the unit and in particular during the
heat disinfection cycle. Avoid handling any part with this label during heat disinfection or
take suitable measures to protect yourself from the heat.
Do Not Sit: Under no circumstances should the unit be sat on or objects placed on the
top sloping cover as the stability of the unit may be affected.
Do Not Step: The unit should under no circumstances be stood upon or used as step.
Note: The Centurion 1500+unit is supplied with several detachable parts. Only use
those parts that are identified with the following labels. DO NOT use alternative parts or
this may invalidate the warranty or compromise the performance and or safety of the
unit. Refer to Section 3.7 “ Unauthorized conversion and manufacturing
replacement parts”
3.2.1 Rear panel labels

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Placed above the main cooling fan, the label is
used to warn user not to cover the vent which
is essential for safe operation.
This label identifies the model of the unit, its
part number, unique serial no.
year of manufacture, the original
manufacturer’s details, supply mains rating,
feedwater pressure range and temperature.
For safety a key is provided to operate the unit
and prevent the unit accidentally being placed
into a clean. This label identifies the position of
the key. When approved/trained to do so
always refer to the “Chemical cleaning and
heat disinfection instructions” if unsure
about when and how to use this key.
External DIN socket connection. To be used by
your Healthcare provider for connection to an
external alarm device. DO NOT connect any
unapproved devices to this point. Refer to
Section 11.1.4 for further details
The black cap provides protection of the USB
outlet used for essential programming of the
unit. DO NOT remove the cap or connect to
any external device or mass storage device. To
be used only by your Healthcare provider.

6
I
O
This label identifies the position of the
unit’s two external fuses. UNDER NO
CIRCUMSTANCES try to remove or replace
these fuses, always refer to your Healthcare
provider. Refer to Section 11.1.2 for Fuse
details
The supply mains electrical power lead is
plugged in at this point. The label gives
details of the electrical supply rating suitable
to operate the unit. See Section 11.1.1.
The, “Refer to the manual” symbol will
direct your Healthcare provider installer to
the Installation & Commissioning guide.
This label provides details of all the water
connections. If more details are required refer to the
“Installation and Commissioning guide.
ACID/ACIDE Cleaning chemical
injection port.
IN/ENTREÉ Mains feedwater
connection.
OUT/SORTIÈ Purified water outlet to
dialysis machine.
RETURN/RETOUR Purified water return
from dialysis machine.
DRAIN/DRAIN Waste water from unit to be
connected to drain.
Supply m
ains
On/Off
isolating switch
I = Power On
O= Power Off

7
3.3 Safety considerations
Requirements, standards and regulations specific to the country in which the unit is used
must be observed. Contact the local regulatory body for confirmation of these regulations
and standards.
CAUTION: When used as a medical device Federal Law restricts this device to sale by or
on the order of a physician as per 21CFR 801.109(b)(1)
Warning: To avoid risk of electric shock, this equipment must be connected to supply mains with
protective earth. For permanent installations the mains supply must be provided with a Branch Circuit
Breaker, refer to Section 4.6.2 of the Installation & Commissioning Guide for details of rating and
specification of Branch Circuit Breaker.`
Warning:
•The unit is not for use in explosive or oxygen rich atmospheres.
•The unit is for indoor use only and must not be washed down.
•The unit must not be allowed to freeze or be stored at temperatures below 410F or above 1580F
•Always operate in a well ventilated area and ensure the cooling fan vents are not covered.
•DO NOT SIT on the unit, place items on top of it or use it as a step. Always operate the unit on a firm and
level surface.
•DO NOT DRINK the purified water produced by the unit; it should only be used for the purposes intended
as stated in Section 3.4 “Intended Use”
•Spillages from external equipment or other sources should be wiped off immediately, take the necessary
precautions if the spillage contains bodily fluids. Refer to Section 8.3 “Cleaning external surfaces” when
dealing with spillages.
•If the unit develops a leak follow the procedure in Section 3.6.1, DO NOT continue to operate the
equipment.
•On no account must the unit be connected to the electrical supply when the side panels have been
removed.
•If the unit’s performance becomes impaired and any remedial work appears to be outside the scope of this
manual, do not operate the unit and seek advice from AmeriWater or your Healthcare provider.
•The unit must only be serviced and maintained by AmeriWater or by your Healthcare provider.
•Failure to observe the instructions contained in this manual may compromise the safety, performance and
reliability of the unit and may void any warranties.
•Under no circumstances try to service or repair the unit yourself; this will be the responsibility of your
Healthcare provider.
•The unit must only be used as per it’s “Intended use” to feed hemodialysis equipment as specified in
Section 3.4
Note:
•It is possible that sensitive equipment/devices located in close proximity to the RO unit may be affected
by electromagnetic or other interference generated from the RO unit. If this is so relocate the relevant
equipment/device. Refer to Sections 11.4, 11.5, 11.6 and 11.7 for further details.
•Care must be taken not to place near the RO unit any source of RFI/EMI, which is liable to cause electromagnetic
disturbance. If the RO is affected by such disturbance, the source must be suppressed or moved.

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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.

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3.4.2 Residual dangers
Warning:
Electrical Shock.
Do Not remove the side covers or touch or interfere with any of the electrical components.
Mechanical force.
Some parts of the system can be under pressure of up to 215 psi (15 bar). Do Not remove the side covers
and interfere with the water pipework or any water connections, as you could risk the possibility of injury
to yourself or others or cause damage to surrounding equipment.
Hot Surfaces. During the heat disinfection cycle the external distribution pipework and connector to
the dialysis machine will become hot to touch, avoid touching these components and warn others.
3.4.3 Handling
Warning:
The unit has been specifically designed as a stationary device. Should the unit need to be relocated it
must be decommissioned before moving. Refer to Section 4.14 “Decommissioning for relocation
procedure” in the Installation & Commissioning Guide. The dry weight of the unit is 86 pounds. A
transport cart or other suitable device should be used when moving the unit. Precautions should be
taken to secure the unit from toppling during relocation.
Do Not pick the unit up by the side covers; they are not designed to take the weight of the unit. Support
the unit by holding the underside of the chassis while steadying the body.
When relocating the unit always ensure the unit has performed its full drain down routine. To do this switch
the unit on, isolate the incoming mains water supply, press “START” and run the unit until it stops due to
‘Low Tank Level’ then switch off.
Do Not move the unit while it is still in operation.
3.5 Bringing the unit to an immediate STOP
If you need to stop the unit immediately at any time, simply press the black rocker switch
on the back of the unit to the “O” position. Then as a precaution, turn off the water supply
at source. Alternatively press the red “STOP” button on the touch-screen twice.
Unless safe to do so Do Not restart the unit until you have spoken to AmeriWater or
your Healthcare provider for advice or assistance, contact telephone numbers can be
found in Section 2.
Warning:
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.
If the unit was stopped due to a leak, before reinstating the power to the unit carry out an electrical safety
inspection as detailed in Section 9.1.1 of the “Service & Maintenance” manual.

10
3.6 Disposal of consumables
The disposal of consumables will be the responsibility of either AmeriWater or your
Healthcare provider.
3.6.1 Dealing with leaks from the unit
In the event of a leak from the unit, shut the unit down by following the procedure in
Section 3.5.
If water has leaked from the unit follow in-house clinical practices that relate to the
clearing up of spillages or leaks. If the leak cannot be cleared up immediately as a
guide we recommend that the area affected is clearly identified and suitable
warning signs erected to warn passers-by of a “potential slip hazard”.
3.7 Unauthorized conversion and manufacturing replacement parts
DO NOT under any circumstance, modify, remove or replace parts on the unit or attempt
to change/alter its operation or functionality.
If the unit requires attention always contact AmeriWater or your Healthcare provider for
assistance and advice.
Warning:
The Centurion 1500+unit should only be used in accordance with its intended use and should be
maintained and operated according to the instructions contained within this Operating manual and
supporting documents. AmeriWater/Healthcare provider will not accept any responsibility for any damage
or injury resulting from improper use, maintenance, unauthorized repair or use of any un-approved parts.
3.8 Warranty claims and liability
This product has been manufactured in accordance with ISO 9001:2008 and ISO
13485:2012 procedures, after which it was subjected to a quality control process.
3.8.1 Product Warranty
This product has been manufactured in accordance with ISO 9001:2008 and ISO
13485:2012 procedures, after which it was subjected to a quality control process. If,
however, you are unsatisfied with the unit, please contact AmeriWater or your
Healthcare provider. Any warranties guaranteed by AmeriWater/Healthcare provider
with respect to the Centurion 1500+will be voided if the equipment is not
installed/operated/serviced or maintained in accordance with the written instructions
provided within the accompanying product manuals, or if the unit is serviced and
maintained by a third party not approved or recognised by AmeriWater or the location
of the unit is changed without notification to AmeriWater.

11
4.0 ABOUT YOUR CENTURION 1500+
4.1 General views of the Centurion 1500+unit
Side view Front view Rear view
4.2 Overview
The Centurion 1500+water purification unit has been specifically designed as a single
patient, reverse osmosis (RO) unit to supply purified water suitable for hemodialysis or
renal replacement therapies.
The unit is capable of producing purified water up to 0.40 USGPM (1.5 litres per minute)
based on a feedwater supply at 50oF. (Refer to Section 11.3.5 for more details relating
to the performance of the unit)
The unit is fitted with an internal pump that pressurises the water supply and forces it
through a membrane which then separates out all of the impurities from the feedwater.
Purified water, termed “permeate” passing through the membrane feeds the dialysis
machine whilst the rejected impurities are flushed to drain in the “Concentrate” stream.
4.3 Standard features
•Product water output up to 23.7 USgals/hr (0.40 USgals/min)
•Product water exceeding all recognised hemodialysis standards.
•Integrated hot water disinfection up to point of use.
•Multi-colored touch screen display for easy control.
•Instrumentation providing display of water quality, temperature, flow, pressure
and salt rejection.
•Quiet running option for quiet operation.

12
•Audible alarm.
•Data logging facility.
•Internal leak and water loss detection system.
•Recirculation up to point of use.
•Ultra-filter
•Tilt detection.
•Built in backflow prevention.
•Semi-automatic chemical cleaning program.
4.4 Detailed features and process of operation
To reduce the risk of accidental damage all external water and electrical connections can
be found at the back of the unit.
The feed water enters the unit, passes through the inlet solenoid valve and fills the
internal feed water break-tank. The level in the tank is controlled by three level switches,
one at the high water level and one at the mid water level. The mid-level switch controls
the opening of the inlet solenoid and the high-level switch controls the closing of the inlet
valve.
If the feed water stops for whatever reason, or there is insufficient flow, the third bottom
level switch turns off the high-pressure Reverse Osmosis (RO) boost pump to protect it
from running dry and damaging itself.
The (RO) pump takes water from the internal break tank and boosts the water pressure
to the RO membrane. There is a pressure sensor situated immediately after the pump,
which will display a warning message on the touch screen, should the maximum system
pressure be exceeded.
The pressurized water is forced through the membrane which then separates out up to
98% of the impurities. The purified or “Permeate” water then goes on to feed the dialysis
machine. The water containing the rejected impurities or “Concentrate” is flushed to
drain.
The quality, temperature and flowrate of permeate water produced from the RO module
is monitored and displayed on the touch screen.
Ultra-filter used to reduce the endotoxin level to less than 0.03 EU/ml and the TVC to a
level of <0.1cfu/ml.
To ensure the quality of water is maintained every time the unit starts up it carries out a
flush to clear the unit of any standing water before producing fresh permeate water.
The microprocessor control system constantly monitors the unit’s performance and water
quality. If any parameter is exceeded at any time the unit will respond with a warning or
advisory message on the touch screen.
If the unit detects an unsafe condition it will automatically shut down in a safe and
controlled manner.

13
4.5 Explanation of rear connections
•
Key Switch
•Alarm Output
•USB port
•On/Off switch
•Fuses
•Power lead socket
•Acid cleaner inlet
•Water In
•Water Out
•Water Return
•Drain
Cooling Fan

14
5.0 OPERATING THE TOUCHSCREEN
5.1 Explanation of Buttons
The operation of the Centurion 1500+is controlled via the touch screen display which
can be found on the top of the unit. The picture below shows an interpretation of the
display.
5.1.1 Using the screen
In normal operation the screen will display a diagram which mimics the flow path of the
water purification along with any messages. See Section 5.3 for more details.
To select an action simply touch the screen on the appropriate button once with your
finger.
Note:
Do Not use sharp or pointed implements, such as pens, pencils etc... to operate the screen as this will
damage the sensitive surface of the display, always operate the screen using your finger tips.
Do Not press more than one button at a time
5.1.2 “MENU” button
Pressing the “MENU” button will bring up the following “USER MENU” screen.
For details on each of the sub-menus and how to access them go to Section 6
Start
“Processing”
Button
Menu Selection
Button
USER
ENTER
BACK
15.04.12
Clean
Time & Date
Pre
Filter Date
Product Information
Engineer Menu
Settings Menu
CENTURION+

15
Status
Break
Tank
Inlet
Solenoid
Stop
Button RO Pump
Function
Drain
Solenoid
RO Module
Permeate
Solenoid
STOP
RO
PROCESSING 15.09.09 12:36
5.1.3 “START” button
Pressing the “START” button the unit will go into “PROCESSING” mode and start
to produce purified water and the screen below will be displayed.
Refer to Section 5.3 for explanation of the mimic screen.
5.2 Operation
5.2.1 Initial Start up Procedure
Carryout the Pre-Dialysis checks listed in Section 8.2.
Once you have completed the above checks switch on the unit using the, I/O (on/off)
switch at the rear of the unit. Switch to the "I" position.
When powered the unit’s HMI screen will illuminate and display both text and a visual
mimic of the units operation.
The touch screen will initially display ”Intialization” for a few seconds before
showing the Power On screen, which displays the current date, time, model type and
any active messages.
During “Intialization”, two “bleeps” will sound indicating that the audible alarm is
functioning correctly.
5.2.2 Starting the unit
To Start the unit select the “START” button, the screen will then change to the
“PROCESSING” screen which will display a mimic of the unit’s operation.
The unit will then carry out a high flow flush to drain, followed by an internal permeate
rinse. After 90 seconds the permeate will automatically flow to the dialysis machine,
if connected.