AmeriWater CENTURION 1500+ User guide

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

1.0 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 how to 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.

1

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:……………………………….

2

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 manual to 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

3

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

4

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.

5

This label identifies the position of the

Supply m

ains

On/Off

isolating switch

I

O

I = Power On
O = Power Off

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.

6

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.

7

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 post­treatment 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 Ultra­filtration 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.

8

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.

9

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.

10

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.
11

• 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.

12

4.5 Explanation of rear connections

•

Cooling Fan

Key Switch

• Alarm Output

• USB port

• On/Off switch

• Fuses

• Power lead socket

• Acid cleaner inlet

• Water In

• Water Out

• Water Return

• Drain

13

5.0 OPERATING THE TOUCHSCREEN

Start

Menu Selection

USER

ENTER

15.04.12

Time & Date

Pre

Product Information

Engineer Menu

Settings Menu

CENTURION+

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.

Button

“Processing”

Button

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.

BACK

Clean

Filter Date

For details on each of the sub-menus and how to access them go to Section 6

14

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.

Status

Break
Tank

Inlet
Solenoid

Stop
Button

PROCESSING

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.

STOP

15.09.09 12:36

RO

Function

Permeate

Solenoid

Drain

Solenoid

RO Module

RO Pump

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.

15

5.2.3 Stopping the unit during normal operation

To stop the unit at any time press the “STOP” button on the screen. If the unit has
been running for two hours or more, the unit will perform a shut-down flush which
directs a high concentrate flow across the membrane to the drain for 30 seconds.
After the 30 second shut-down flush the screen will revert to the “Power On” display.

During the shut-down flush pressing the “STOP” button twice from the processing
screen will stop the unit immediately terminating the flush. (Refer to Section 3.5)

Warning: The supply mains isolation switch is located at the rear of the unit, ensure that is accessible
at all times and remains free from obstruction.
Ensure that the wall plug is accessible at all times as this can be used as a method of isolation.

5.2.4 Operation of screen function button

To access different performance values, while the mimic screen is displayed, press
the function button “” at the top right of the screen. This will in turn, display

“Permeate Quality”, “Temperature”, “Flow Rate”, “Pump Pressure”, “Feed
Quality and “ Salt Rejection”.

5.3 Explanation of the mimic screen

This screen is displayed during normal processing.

Status

Break
Tank

Inlet
Solenoid

Stop
Button

PROCESSING

Mimic screen

RO

STOP

15.09.09 12:36

Function

Permeate

Solenoid

Drain

Solenoid

RO Module

RO Pump

16

5.3.1 Mimic symbols

F”

“Salt Rejection

The symbols are presented on the screen below the “status bar”. The text
indicates the current operation and the stage reached within that operation. This text
will alternate with any warning or advisory messages that may be present.

The symbols represent the main components within the unit. Anything
coloured red indicates that it is closed or stopped. If the symbol is moving or flashing
it indicates it is powered.

5.3.2 Explanation of displayed functions

Each time you press the Function button, “

▼”, at the top right hand edge of

the screen you will be able to display information relating to the performance of the
unit. The information will be in the form of numbers and text and displayed on the
“status bar”. This information may be required by your Healthcare provider when
diagnosing a possible fault.

There are 6 selectable function values, an explanation of each is given in the table

below.

Displayed Function Explanation

Flow Rate

Permeate Quality

Temperature
Pump Pressure The unit contains a pump to process the water and

Feed Quality

Salt Rejection Again if enabled the

This is the volume of permeate the unit is producing
and is measured in “gallons/min”
This value indicates the quality of the permeate
water and is measured in microsiemens/cm or
µS/cm.
This tells you the temperature of the water being
produced and is displayed in, “

this displays the pressure the pump is running at in

“psi”.

If enabled the unit will constantly measure the quality
of the incoming water supply and display the reading
in microsiemens/cm or µS/cm.

quality of the purified water to the feed water and
expresses it as a “%”. This will be used by your
Healthcare provider to check the performance of the
unit.

0

.

” compares the

Note:

When diagnosing a fault on the unit your Healthcare provider may ask you for some of the readings above.
Make sure that you are familiar with the operation of the “Function” button and how to obtain the
information.
Always refer to Section 9.1 “Troubleshooting guide” when speaking to your Healthcare provider
regarding any fault.

Warning:

It is recommended that the key used to select CLEAN/SERVICE positions is removed to prevent anyone
from accidentally switching the unit to the wrong mode during use. The key is only required for use
during either Heat disinfection or Chemical clean.
Having the key switch in the wrong position could interrupt dialysis or the cleaning/disinfection of the unit.

17

6.0 MENUS AND SETTINGS

15.04.12 12:36

Time & Date

Set Date

ENTER

To return to the main

“USER

6.1 User menu

Pressing the “MENU” button from the POWER-ON screen will reveal the
“USER MENU”.

There are six sub menus which will allow you to adjust the “Time & Date” (see
Section 6.1.1), start a “Clean” (see Section 7), reset the internal Ultra-filter
replacement date (see Section 6.1.2), for “Product Information” refer to

Section 6.1.3 and for the “Engineer Menu” and “Settings Menu (see
Section 6.1.4), which are only provided for use by your Healthcare provider.

The various sub menu options can be selected by pressing the ▲/ ▼buttons

followed by “ENTER”

USER MENU

BACK

Clean

Pre Filter Date
Product information
Engineer Menu
Settings Menu

ENTER

6.1.1 Set Time and Date
From the USER MENU and by using the ▲/ ▼buttons select “Time &

Date”, then press the “ENTER” button. The first screen below will be

displayed.

Time Date Menu

BACK

Again by using the ▲/ ▼buttons

select from one of the entries listed
and press “ENTER”

Set Time

Set Format

MENU” simply press the “BACK”
button

18

Set Time

BACK

BACK

BACK

DD/MM/YYYY

MM/DD/YY

MM/DD/YYYY

Set Date

Should the format of the date be

If you select “Set Time” the
screen opposite will be displayed.
The flashing cursor identifies which
digit you can adjust.

14:46

HH:MM

Set Date

12/04/12

MM/DD/YY

NEXT

NEXT

By using the ▲/▼buttons you can

either increase or decrease the
number value. Once the correct
number has been selected, press
“NEXT” to move to the next
number. On pressing “NEXT” on
the final number a confirmation
screen will pop up, stating “Done”
and after a few seconds the screen
will revert back to the “Time Date

Menu”

To select “

menu use the ▲/▼ buttons and

press “ENTER”. The date will be
displayed and the cursor will flash
on the first number.

Use the ▲/▼ buttons to change

the number to the correct value,
then press “NEXT” to move to the
next one. On pressing “NEXT” on
the final number a confirmation
screen will pop up and after a few
seconds the screen will revert back
to the “Time Date Menu”

” from the

Set Format

Note: Pressing the “BACK” button prior to pressing the “ENTER” button will cancel changes

currently being made and return you to the “USER MENU”

DD/MM/YY

ENTER

19

wrong, by selecting the “Set
Format” menu and by pressing
“ENTER” the “Set Format” menu

will be displayed. Touch the box
that matches the correct format. A
tick will appear to confirm your
selection. Press “ENTER” a
confirmation screen will pop up
and after a few seconds the screen
will revert back to the “Time Date

Menu”

6.1.2 Pre-Filter replacement date

Type:

Centurion 1500

(Centurion 1500+UF variant L998374 only)

The Pre filter replacement date should be reset when the Ultra-filter
is replaced during maintenance. This would normally be carried out by your
Healthcare provider and will ensure that the Centurion unit will provide a
prompt message when the next filter change becomes due.

Pre Filter Date

12/04/12

6 MONTH INTERVAL

6.1.3 Product Information

Product Information

Serial Number: 000000

Unit ID: 00
Unit Version: R.1.2
Pod Version: R.1.2
Commission Date: 01/01/09
Memory Checksum: Ox5108
Data Memory Full: 2%
Address: 02

BACK

Pre Filter Date will be used to
provide users with a reminder
to replace the Ultra-filter
inside of the Centurion. The
reminder shall be set to a 6
month interval

RESET

BACK

This screen shows the product details and software version numbers
and is for information only.

20

6.1.4 Engineer & Settings menu

Warning:

The ‘Engineer and Settings Menus’ are only accessible for use by trained and authorized
personnel. If any data held within these menus is altered the performance/safety of the unit
and/or water quality may be seriously affected. An access PIN number is required to enter this
menu.

21

7.0 CHEMICAL CLEANING AND HEAT DISINFECTION

7.1 Chemical cleaning

To maximize the life and maintain the performance of the unit’s reverse
osmosis membrane and to ensure the permeate quality meets the
requirements for hemodialysis, chemical cleaning of the unit is recommended.

Note:

You will not be able start a chemical clean or heat disinfection unless you have been

provided with a key, the key allows you to switch the unit from normal processing ”Service” to
the “Clean” position. Once you have been trained and approved to carry out chemical cleans
and heat disinfection by your Healthcare provider you will then be given a key. Always keep
the key in a safe place when the unit is in normal operation and DO NOT leave the key in the
switch, to avoid someone inadvertently turning it during dialysis.

A separate “Chemical Cleaning & Heat Disinfection Instructions” document contains all

the necessary information required to carry out cleaning/disinfection of the unit. When
approved to do so ensure that the procedures detailed within this document are followed.

Warning:
Chemical cleaning of the unit MUST only be carried by an approved or person trained by
AmeriWater or your Healthcare provider. DO NOT attempt to clean the unit if you have not

been trained.
DO NOT use any other household cleaner to clean the unit, only use those cleaners supplied

by AmeriWater, or your Healthcare provider or you may risk causing severe damage to the
unit and its components and pose a serious risk to yourself or the person on dialysis.

If You wish to clean the unit and carry heat disinfections yourself please contact AmeriWater
or your Healthcare provider who will provide all the necessary instructional training, approved
cleaning chemicals, instruction leaflet and security key to enable the cleans to take place.

Your Healthcare provider will provide a cleaning program based on your specific requirements
and frequency of dialysis.

We advise that chemical cleans should be carried out within the confines of the Technician’s
area and not on the ward.

22

7.2 Heat disinfection

As a guide refer to Section 8.1 for recommendations as to when to carry out
heat disinfection on the unit.

Warning:

Heat disinfection should only be carried out if you have been trained by AmeriWater or by your
Healthcare provider. For security a key is provided once you have been trained which will
enable you to activate the heat disinfection cycle. DO NOT attempt to clean the unit if you have
not been trained.

If you wish to clean the unit and carry heat disinfections yourself please contact AmeriWater
or your Healthcare provider who will provide all the necessary instructional training, instruction
leaflet and security key to enable the heat disinfection to take place.

Failure to heat disinfect the unit or carry out recommended chemical cleans could result in a
deterioration of the water quality provided by the unit making it unsuitable for hemodialysis.

During heat disinfection of the unit there is a potential for water exceeding 1760F to be
discharged to drain, ensure the drain pipework is made of suitable material to tolerate this water
temperature

8.0 MAINTENANCE AND CHECKS

8.1 Maintenance

Your Centurion unit will be maintained and serviced regularly by your
Healthcare provider. The unit does not contain any serviceable parts that
require replacement on a regular basis but will require servicing at set intervals
in order to ensure the unit’s performance. Refer to the Service & Maintenance
manual for details

As part of the servicing program for the unit certain components will require
replacing. Your Healthcare provider will be responsible for replacing these
parts.

It is recommended that regular checks are carried out on the unit and its
performance to ensure safe and uninterrupted operation. Refer to table below
for details.

23

8.1.1 Schedule of regular checks & tasks

Typical range

Typical

Pre-Dialysis

Dialysis water

Bacterial

Purified wate

r

Hot water

Chemical clean

Electrical

Labels

Task detail

checks

quality:
Chemical
contaminants

growth and
Endotoxin
concentration
in dialysis
water

output

disinfection

safety
inspection

* Based on dialysing 3-4 times per week for 4-5 hours at a time.

** Based on an acid descale cleaning cycle, the choice of cleaning chemical will be determined by your
Healthcare provider and will depend on the quality of the mains feedwater.

of values

Refer to Section

8.2

Maximums as
listed in Tables 1
& 2 of
ANSI/AAMI/ISO
13959:2009

<100 cfu/ml
Bacteria
<0.25 EU/ml
Endotoxin
(as per
ANSI/AAMI/ISO
13959:2009)

Min 0.40
USgals/min @
500F

Min temp 1760F
Min hold time 10
mins

N/A Monthly** Refer to Section
Refer to Section

9.1.1 Service &
maintenance
manual

Refer to Section

3.2

frequency

Before each
dialysis
session

Yearly To be sampled

Monthly To be sampled

Monthly Check to be

Once per week
(min)*

Yearly or
following a leak
or electrical
repair

yearly Ensure all

Comments

Refer to
Healthcare
provider if
results are
unacceptable

by your
Healthcare
provider.
Refer to Section

9.1.3 if limits
unacceptable

by your
Healthcare
provider.
Refer to Section

9.1.3 is levels
are
unacceptable.

carried out by
Healthcare
provider.
Record of last
heat disinfection
cycle can be
viewed. Ref to
Section 4.3.1,
step 13
“Chemical
cleaning & heat
disinfection
instructions”
manual.

7.1
To be carried
out by approved
trained
technician or
your Healthcare
provider

labels are
present and
legible.

24

8.2 Pre-Dialysis checks

It is always recommended to carry out the following checks before starting
dialysis:

• Check that the electrical mains lead is securely clipped in place on the

unit and at the wall socket and that the lead is not damaged or likely to
cause anyone to trip over it.

• All the water connections are in place, not kinked and show no signs of

leaks.

• The “Blue” water tubing is connected to the “In/Entreé”, port; the

“Black” water tubing is connected to the “Drain” port.

• The water supply is turned on.

• There are no warning messages displayed on the touch-screen. (Refer

to Section 9, “Troubleshooting” if any messages are displayed.

• If the unit sounds unusually noisy or you are concerned about its

operation call you Healthcare provider for advice.

• There are no signs of water loss or leaks in or around the unit.

• Verify the conductivity on the Centurion display is below the alarm set

point.

Note: Do Not start dialysing if the unit appears to have a fault or the water quality is in
doubt, contact your Healthcare provider for advice and assistance.

8.3 Cleaning external surfaces

Clear up spillages from external equipment or other sources immediately.
Use a clean damp cloth to wipe up spillages from the exterior surface of the
unit. Take care not to get excess liquid on the control panel areas.

Do not use any solvent-based cleaners on the covers or front display. To
remove more persistent marks and to disinfect surfaces, you should be
provided with suitable surface disinfectant or surface cleaner by your
Healthcare provider. If unsure ask, or contact AmeriWater for advice.

Take the necessary precautions when wiping up any bodily fluids, your
Healthcare provider should be consulted if unsure.

Note: The unit has an IP rating =21, refer to Section 11.1.3 for details

25

8.4 Storage and preservation recommendations

Time not in

Recommendations

Power

-

On

Use the guide below to determine the best method to store your unit if it is not
be used for any length of time.

use

Up to 1 month

>1 month up to
3 months

>3 months- 6
months+

Ideally the unit should be left in
Standby mode such that it will run for 10 minutes
every 2 hours. If the unit is to be left ensure the
room temperature does not fall below freezing
point, 320F. On starting the unit up after standing
run for 10 minutes disconnected from the dialysis
machine and carryout a heat disinfection. Your
Healthcare provider will advise you on the best
method of maintaining your unit during periods of

Short term storage

non-use.
For extended periods of non-use if the unit cannot
be left in “Standby” mode it is recommended that
the unit is either returned to your Healthcare
provider for them to look after the unit or
alternatively the unit should be left in preservative

Medium

solution. Contact your Healthcare provider to
discuss the best option.

1. As above
.

Long

Term

26

9.0 TROUBLESHOOTING

Warning:

There are several safety features built into the controls of the unit and they are

designed to protect the unit from damage and to warn of any malfunction.

The operator should pay attention to warning messages and follow the instructions,

warnings, cautions and notes given in this manual

If the unit develops a fault, follow the instructions in Section 5.2.3 to shut
the unit down safely and in a controlled manner.

In the event of an emergency follow the instructions in Section 3.5 to shut the

unit down quickly.

Once the unit has been safely shut down and the water supply turned off, make

a note of any messages that were displayed on the screen as these will be
needed to assist your Healthcare provider in diagnosing the fault.

Contact your Healthcare provider or AmeriWater and provide them with the

details of the fault.

Warning:
DO NOT attempt to fix the fault yourself.
DO NOT remove the covers.
DO NOT attempt to run the unit with the side covers off.
DO NOT continue to run the unit with a warning message displayed unless the Operating

manual or Healthcare provider says that it is safe to do so.

IF IN DOUBT ASK.

27

9.1 Troubleshooting Guide

1.

1.

1.

1.

DO NOT

1.

1.

1.

1.

9.1.1 Warning & alarm messages

Displayed Message or

notification

“Tank Low Level”

“High Pressure”

Reason Checks Proposed Actions

The internal water
break tank has
insufficient water
to run the unit.

The unit has
detected an
unsafe operating
pressure.

Make sure the
feedwater supply is
turned on and
flowing. Check
other taps to
confirm.

There are no
checks to made,
simply switch the
unit off using the
switch at the rear
and turn off the
water supply.

If the feedwater supply is
not a problem and the unit
still does not run and this
message is frequently seen
contact your Healthcare
provider.

2. If the water supply has
stopped contact your water
utility company.

try to run the unit
in this condition, contact your
Healthcare provider for
assistance.

“Low Pressure”

“Perm-Line Cell
Error”

The unit has
detected
insufficient
pressure to
operate.

The unit has
detected a fault
with the sensor
measuring the
water quality.

28

Check that the
feedwater is still
flowing.

2. Check that there
are no leaks.

3. Check for any
other messages on
the display.

There are no
checks to be made.

If the checks do not show
any problems, press the
“START” button. After a few
minutes, if the pressure in
unit has returned to normal
the unit will run. If the
message returns then switch
the unit off, turn off the water
supply and contact your
Healthcare provider for
advice.

For safety the unit will
have stopped running as the
quality of water being
produced cannot be
monitored accurately.
Contact your Healthcare
provider to resolve the
problem.

“Temperature High”

1.

1.

“Temperature Sensor

1.

1.

1.

1.

1.

Error”

The water being
produced has a
temperature
above the entered
set point of 95
Deg F

There is a fault
with the
temperature
sensor.

Check the
temperature of the
incoming water
supply.

2. Check that the
unit is not next to a
source of heat, eg,
radiator or room
heater.

3. Check that the
unit is in
“Processing” mode.

Make a note of
any other
messages
displayed on the
screen.

If the feedwater has a high
temperature, investigate or
change supply.

2. Remove any local external
heat source.

3. If the problem persists call
your Healthcare provider to
investigate.

1. The unit can still be
operated but if the fault
persists contact your
Healthcare provider before
you next dialyse or carryout
a heat disinfection.

“Level Switch Error”

“Water leak”

The unit has
detected a
problem with the
level sensors in
the internal water
break tank.

The leak detector
in the bottom of
the unit has
detected water.
The unit will stop
running and the
buzzer will sound.

Ensure the unit
has no other
displayed
messages.

2. Check the unit is
level and not tilted
over.

The unit has
developed an
internal leak, check
that the unit is
upright and level
and has not been
recently toppled or
knocked.

2. Check to see if
water is leaking
from the unit at a
constant rate.

3. Check for
excessive
feedwater pressure
causing splashing.

To prevent the possibility
of water leakage due to the
internal tank overflowing for
safety it will have stopped
running.

2. No other warning
messages are displayed and
the unit appears to be as
normal but the problem
persists, call your local
Healthcare provider for
assistance.

If the unit has been
toppled some water may
have overflowed from the
internal water break tank.
Drain the water off from the
unit. At the front underside of
the unit is a black drain plug,
unscrew the plug and let any
water drain from the unit
Then press “START”.

2. If draining the unit does
not clear the message call
your Healthcare provider.

3. If the unit is losing a lot of
water turn of the water
supply and call you
Healthcare provider
immediately.

29

“Tilt”

1.

1.

1.

1.

1.

1.

“Reset Error”

“Feed-Line Cell
Error”

The unit has been
moved or knocked
whilst running to
such an extent
that the internal tilt
switch has been
activated.

The unit has
switched on and
off more than 3
times in one
minute.

The unit has
detected a fault
with the line cell
used to measure
the quality of the
incoming
feedwater supply.

Check that the
unit is upright and
standing on a firm
flat surface.

2. Make sure that
there is nothing
located near the
unit that might
knock it .

3. Check that the
unit is not placed
next to a door or
could be knocked
over by children or
pets.

Make sure the
mains electrical
lead is secure at
the connection to
the unit at the wall
socket.

2. Check that
you’re household
circuit breaker has
not tripped out or
has a fault.

3. Are you
experiencing power
cuts to your
property?

4. Is the unit being
serviced and the
Engineer has
switched the unit off
many times to
repair a fault.

Check that there
are no other
displayed alarm
messages, if there
are make a note of
them.

At the front underside of
the unit is a black drain plug,
unscrew the plug and let any
water drain from the unit,
then with the unit upright and
all potential hazards
removed, switch the unit off
and on using the on/off
power switch at the back of
the unit, the unit should now
run. If not and the message
remains call your Healthcare
provider for advice.

Ensure that the mains
electrical lead is secure and
fixed.

2. Check the condition of
your circuit breaker and any
other household appliances
being used. This may have
to be carried out you’re your
Healthcare provider.

3. Check with your local
power company if they are
experiencing any power
losses in your area.

4. If the problem persist and
none of the above are the
cause then contact your
Healthcare provider for
assistance.

Contact your Healthcare
provider and give them the
details of all messages
displayed in order for them
to diagnose the problem and
advise you if the unit can be
operated with this fault.

“Clean Due”

The time period
set by your
Healthcare
provider for the
next chemical
clean has expired
and the unit now
requires a
chemical clean.

30

No checks
required.

If you are trained and
approved to do so carryout a
chemical clean on the unit at
the next convenient time. If
you are not authorized to
clean the unit then contact
your Healthcare provider to
clean the unit.

“HeatSan Due”

1

1.

The time period
set by your
Healthcare
provider for the
next Heat
disinfection has
expired and the
unit now requires
full heat
disinfection.

No checks
required.

If you are trained and
approved to do so carryout a
heat disinfection on the unit
at the next convenient time.
If you are not authorized to
clean the unit then contact
your Healthcare provider to
heat disinfect the unit.

“Service Due”

“Poor Water Quality”

Poor Permeate
Quality”

The unit has
detected that the
quality of the
water being
produced by the
unit has exceeded
the set limit.

The unit has
detected that the
quality of the
permeate water is
above 200µS/cm

The unit has failed
to recover the
water quality back
to acceptable
limits and has as
a matter of safety
shut down.

. Using the touch
screen check the
water conductivity
reading.

2. Check that the
feedwater complies
with the
requirements in

Section 11.1.6

Refer to “Service
Due” message
previously detailed.
Note: Should the
permeate quality
reach a value of
200 µS/cm for a
period of more than
20 seconds, the
flow will be
interrupted and
returned to the
integral tank.

Refer to “Poor
Water quality”.
If after 10 minutes
the quality does not
improve and
remains above 100
µS/cm the unit will
shut down and
display the ‘Quality
Alarm’. Should the
quality fall below
100 µS/cm, within
10 minutes the unit
will return to normal
operation.

If the water quality does
not recover contact your
Healthcare provider for
advice.

If the water quality does not
recover contact your
Healthcare provider for
advice.

If the water quality does not
recover contact your
Healthcare provider for
advice.

31

. Over Temperature

Pump fault

During heat
disinfection the
unit has detected
a temperature of
the circulating
water that is
above the
maximum limit
and has aborted
the cycle for
safety

The unit has
detected a fault
with the internal
boost pump.

1. The fault may lie
with the heater,
circulating pump or
one of the
temperature
sensors. Only your
Healthcare provider
can check these
items.

2. To help check to
make sure that the
unit’s ventilation fan
is not obstructed or
the unit covered by
anything and
placed in a well
ventilated area at
ambient
temperature away
from any heat
sources.

1. Switch the unit off
and isolate from the
mains electrical
supply and turn the
water supply off.

1. Advise your Healthcare
Provider immediately, do not
try to carry out another heat
disinfection cycle

1. Do not try to restart the
unit, contact your Healthcare
provider immediately for
advice and assistance.

indicates that a buzzer will sound

32

9.1.2 Electrical & mechanical faults

The unit will not

There is insufficient

Observed Fault Reason/s Checks Proposed Actions

switch on and the
screen is blank.

1. The mains
incoming power
supply has been
disconnected.

2. The circuit breaker
or other isolation
device in your house
has tripped out.

3. The power cord on
the unit has become
disconnected from
either the unit or the
wall socket.

4. The unit has
developed a fault that
requires assistance
from your Healthcare
provider.

5. The external fuses
that protect the supply
mains may have
“blown”

1. Check that your
area is not
experiencing power
cuts.

2. Check to see if the
circuit breaker or
other isolating device
in your house has
tripped and check
other household
appliances being
used as they may e
responsible for
interrupting the power
supply.

3. Check that the
power cord is secure
at both ends and
check that it has not
been damaged or cut.

4. Arrange for a
qualified electrical
engineer or your
Healthcare provider to
check the condition of
the external fuses.

1. If checks 1 – 3
have not proved to
be the cause then
contact your
Healthcare provider.
DO NOT attempt to
fix the fault or
remove the side
covers.

2. Replace the
external fuses. (Only
to be carried out by
HCP or trained
/qualified electrical
engineer that is
familiar with this
equipment.

flow to run the
dialysis machine.

1. A fault has
occurred with the unit
that has either
stopped the unit or
intermittently
interrupts the
production of purified
water.

2. The incoming
mains water supply
has been cut off or
has reduced
pressure.

3. If fitted an external
pre-treatment filter
may have become
blocked.

4. The reverse
osmosis membrane
may have become
blocked or fouled.

5. The incoming
feedwater supply

1. Check for any
displayed warning or
alarm messages.
Make a note of any
displayed and refer to
Section 9.1.2 for
details.

2. Check your tap
water to see if it is still
running at a rate that
seems to be normal
and at an expected
pressure.

3. If any pre-treatment
filters or devices are
fitted check to see if
there are any leaks or
faults. By
disconnecting the
feed water to the unit,
there should be a flow
after the pre­treatment equipment.

1. If the unit is not
showing any
displayed messages
but the problem
persists carryout the
checks 2-5. If any of
the checks reveal a
fault or you are not
sure of what you
have seen or feel the
unit should be
cleaned then contact
your Healthcare
provider with all the
details and they will
assist you.

2. If the fault is not
related to items 1-5
then it may be due to
the internal pressure
sustaining valves,
contact your
Healthcare provider
for assistance.

33

temperature has

The unit will

not run

Possible

Proposed

Bacterial count

dropped significantly.

6. One of the internal
pressure sustaining
valves may be
incorrectly set or at
fault.

7. Check all hydraulic
connections are in
their correction
positions.

4. Check the last time
the unit was
chemically cleaned
and make a note of
the date.

5. Only during
extreme winter
months would
reduced water
temperature be an
issue.

1. The key switch at

when pressing the
“START” button

the rear of the unit is
in the “CLEAN”
position or there is a
fault with the key
switch itself.

9.1.3 Water quality non-compliance

Non-compliance

and/or Endotoxin
levels in dialysis
water exceed
recommended
guidelines

causes

1. Fault with
Heat disinfection
cycle

2. Period
between Heat
disinfections too
long.

3. Increase in
bacterial levels in
feedwater.

4. Unit left for
long periods idle.

5. RO membrane
damaged.

6. Contaminated
sample or poor
sampling technique.

1. Check the position
of the key at the rear
of the unit.

Checks

1. Monitor full
Heat disinfection
cycle, ensure unit
completes
successfully and
displays “Pass”. Refer
to Section 4.1.3
Chemical cleaning &
heat disinfection
Instructions” manual.

2. Refer to
Section 8.1.1 for
recommendations
regarding sanitisation
frequency.

3. Obtain samples
of feedwater for
analysis and/or
contact local water
supplier for updates
on water quality.

4. Refer to
Section 8.4 “Storage
and preservation” for

1. If the key is not in
the “SERVICE”
position, then turn
the key to the
“SERVICE” position.
If the key is in the
correct position and
the unit still does not
run then contact your
Healthcare provider.

actions

1. It will be the
responsibility of your
healthcare provider to
carry out these
checks and diagnose
the problem/s and
rectify any faults
founds. DO NOT use
the unit if the water
quality is
unacceptable until
you are told to do so
by your Healthcare
provider.

34

Dialysis water

quality: One or more
of the Chemical
contaminants
exceed their
permitted maximum
concentration

1. Excessive
increase in
concentration of
contaminant/s in
feedwater.

2. RO membrane
damaged

3. Contaminated
sample or poor
sampling technique.

4. Malfunction of
pre-treatment system

5.
Recommended
Chemical clean
frequency not being
followed or change in
chemical cleaner
required.

guidance when not
using the unit.

5. Refer to
section 8.2 “Pre­dialysis checks” to
assess RO
membrane
performance.

6. Repeat
analysis to confirm
result.

1. Obtain sample
of feedwater to
assess level of
contaminants.
Contact local water
authority if outside
standards for drinking
water.

2. Refer to
section 8.2 Pre­dialysis checks to
assess performance
of RO membrane.

3. Repeat
samples to confirm
levels.

4. Check pre­treatment is
functioning correctly.

5. Refer to
Section 8.1.1 for
detail of chemical
clean frequency.

1. It will be the
responsibility of your
healthcare provider to
carry out these
checks and diagnose
the problem/s and
rectify any faults
founds. DO NOT use
the unit if the water
quality is
unacceptable until
you are told to do so
by your Healthcare
provider.

10.0 CONSUMABLES AND SPARES

Note: The unit does not contain any user replaceable spares or consumables items. Your

Healthcare provider will be responsible for replacing any components or consumable item and
maintaining and servicing the unit, this will include the internal Ultra-filter device. For more
information on Ultra-filter replacement interval, see the Service and Maintenance manual.

35

11.0 Technical specification

Max Power

11.1 Services/ connections and physical properties

11.1.1 Electrical specifications/connections

Mains supply

Electrical

supply

Single
phase

115V 60Hz

plus earth

Warning: To avoid risk of electric shock, this equipment must be connected to a supply main
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.`

Operation

Standby 10

Normal

operation

During heat
disinfection

consumption

(Watts)

160

1000

11.1.2 Fuse rating/type

External: (Located at the rear of the unit)
Type: 2 off 12 AmpT12AH115V- 5mm x 20mm,

Ceramic, time delay

Internal: (Located in main electrical tray)
Type: 2 off 5 Amp T5AH115V – 5mm x 20mm, Ceramic, time delay

Note: Fuses must only be replaced with those approved and supplied by the

manufacturer, refer to Service and Maintenance Manual for details.

36

11.1.3 IP Rating

Max drain flow

-

Permeate

Pre-filtration

Total Hardness

Temperature

Chlorine (Total)

Total dissolved solids (max)

Fouling index

Feed water pressure

Feed water flowrate

Connection

Description

Size

Type

The unit has an IP21 rating.
2 = Protected against solid objects greater than 0.492" (12.5mm)

1= Protected from vertically dripping water

11.1.4 Alarm port connection details

Type: Volt free/dry changeover contacts
Minimum applied Voltage: 34Vdc/24Vac
Maximum applied current: 1 Amp

Details of this connection shall be provided upon request, contact

AmeriWater or your Healthcare provider.

11.1.5 Water quality and performance

rate @ 10oC

USgals/min

0.29 0.4 60%

output @ 10oC

USgals/min

11.1.6 Feed water requirements

11.1.7 Water services connections

Recovery

%

Output water quality

Will meet the requirements of

current AAMI/ANSI/ISO:13959

standard for “water for

hemodialysis and related

therapies”

Filtered to 5 microns
Maximum 400 ppm as CaCO

3

34 – 95oF (1-35oC)
<0.1 ppm free Cl

2

1500 mg/l
<5
2-6 bar (30-90 psi)
1-1.5USgals/min (3.8-5.7ltrs/min)

Drain Unit waste water-out 8mm Push fit
In Feedwater supply-in 8mm Push fit
Out Permeate-out 8mm Push fit
Return Returned permeate-in 8mm Push fit
Acid Chemical disinfectant-in 4mm Push fit

37

11.1.8 Raw water break tank

Width

Depth

Normal

Storage

Transport

Working volume: 0.092USgals (350 mls)
Classification: 20mm air gap to provide backflow prevention
Material: 316 Stainless steel

11.1.9 Weights and dimensions

Weight (Lbs) Height (inches)

86 (Dry)
99 (Working) 34 11 19

11.1.10 Main PCB battery

Voltage: 3V
Type: Lithium, CR2032

11.1.11 USB mass storage device

Specification: FAT 16 formatted USB memory stick
Memory size: Must be less than 2GB

11.2 Environmental data

Parameter

Temperature range

Operation

50-1040F

(10 to 400C)

(inches)

410F-1580F

(5 to 700C)

(inches)

230F -1580F

(-5 to +700C)

Relative humidity

Atmospheric pressure range
(altitude)

30 to 75% 10-100% 10-100%

80 to 106 KPa

(sea level-2000m

or 0-6,562 ft)

50 to 106 KPa

(sea level-5000m

or 0-16,404 ft)

50 to 106 KPa

(sea level-5000m

or 0-16,404 ft)

38

11.3 Guidance on electromagnetic emissions

Guidance and manufacturer’s declaration

–

electromagnetic emissions

The Centurion 1500+ is intended for use in the electromagnetic environment specified below.
AmeriWater or Healthcare Provider should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment - guidance

The Centurion 1500+ uses RF energy only for its
RF emissions
CISPR 11 Group 1

internal function. Therefore, its RF emissions are

very low and are not likely to cause any

interference in nearby electronic equipment.

RF emissions
CISPR 11

Harmonic emissions
IEC 61000-3-2

Voltage fluctuations /
Flicker emissions
IEC 61000-3-3

Class B The Centurion 1500+ is suitable for use in all

establishments, including domestic establishments

and those directly connected to the public low-

Class A

Complies

voltage power supply network that supplies building

used for domestic purposes.

39

11.4 Guidance on electromagnetic immunity

Guidance and manufacturer’s declaration

–

electromagnetic immunity

Centurion 1500

+

The

is intended for use in the electromagnetic environment specified below.
AmeriWater or your Healthcare Provider should assure that it is used in such an environment.
Immunity test IEC 60601 test

level
Electrostatic
discharge (ESD)

± 6 kV contact

Compliance
Level

B

Electromagnetic environment ­guidance
Floors should be wood, concrete, or
ceramic tile. If floors are covered with

synthetic material, the relative
IEC 61000-4-2
Electrical fast transient /
burst

IEC 61000-4-4

± 8 kV air
± 2 kV for
power supply
lines

A
A

N/A

humidity should be at least 30%.

Mains power quality should be that of

a typical commercial or hospital

environment.

±1 kV for input /
output lines

Surge
IEC 61000-4-5

± 1 kV line(s) to
line(s)

A
A

Mains power quality should be that of

a typical commercial or hospital

environment.

± 2 kV line(s) to
earth

<5% U

T

(> 95% dip in

Voltage, dips, short
interruptions and voltage
variations on power
supply input lines

UT)
for 0.5 cycle

40% U

T

(60% dip in UT)
For 5 cycles

B

B

Mains power quality should be that of

a typical commercial or hospital

environment. If the user of the unit

requires continued operation during

power mains interruptions, it is

recommended that the Centurion be
IEC 61000-4-11

70% U

T

(30% dip in UT)

B

powered from an uninterruptable

power supply.

For 25 cycles
<5% UT)

B
(>95% dip in
UT)
For 5s

Power frequency (50/60
HZ)
magnetic field

3 A/m A

Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial

or hospital environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

40

11.5 Guidance on electromagnetic immunity for non-life supporting

Guidance and manufacturer’s

declaration

–

electromagnetic immunity

NOTE 1

NOTE 2

equipment

The Centurion 1500+ is intended for use in the electromagnetic environment specified below. AmeriWater
or your Healthcare Provider should assure that it is used in such an environment.
Immunity test IEC 60601 test

level

3 Vrms

Conducted RF

150 kHz to 80

IEC 61000-4-6

MHz

Compliance
Level

3V

Electromagnetic environment - guidance
Portable and mobile RF communications

equipment should be used no closer to
any part of the Centurion, including
cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.

Recommended separation distance

d = [1.17] √P

Radiated RF
IEC 61000-4-3

At 80 MHz and 800 MHz, the higher frequency applies.

These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the Centurion is used exceeds the applicable RF compliance level above, the Centurion should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the Centurion unit.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

3 V/m
80 MHz to 2.5

GHz

3V/m

d = [1.17] √P 80 MHz to 800 MHz

d = [2.33] √P 800 MHz to 2.3 GHz

Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strength from fixed RF transmitters,
as determined by an electromagnetic site
survey, a should be less than the
compliance lever in each frequency

b

range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:

41

11.6 Separation distances for RF devices and Centurion

Recommended separation distances between portable and mobile RF communications equipment

Separation distance according to fre

quency of transmitter

and the Centurion 1500+.

The Centurion 1500+ is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. AmeriWater or your Healthcare Provider will help prevent electromagnetic
interference by calculating and maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Centurion unit as recommended below, according to
the maximum output power of the communication equipment.

Rated maximum output

power of transmitter

W

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74
1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

150 kHz to 80 MHz

d = [1.17] √P

80 MHz to 800 MHz

m

d = [1.17] √P

800 MHz to 2.5 GHz

d = [2.33] √P

11.7 Classification and standards applied

Electrical Class I Equipment (see Note1)
Overvoltage category – Fixed installation Category II
Overvoltage category – Permanently installed Category III
Pollution degree classification Degree 2
IP Classification IP21
Medical class - USA Class II
Medical class - Canada Class III

Radio Performance - USA

Radio Performance - Canada
Designed in general accordance with the requirements of BS EN 60601-1-2 :2007

Medical Electrical Equipment – Part 1-2: general requirements for basic safety and essential
performance

To FCC Part 18 (industrial, Scientific
and Medical)
To ICES-001 (Industrial, Scientific and
Medical (ISM) Radio Frequency
Generators.

Warning: Note 1, To avoid risk of electric shock, this equipment must be connected to a supply
main with protective earth.

42

11.8 Classification mark

CLASSIFIED BY UNDERWRITERS LABORATORIES INC.

The device bears the following UL mark:

WITH RESPECT TO ELECTRIC SHOCK, FIRE,

MECHANICAL HAZARDS ONLY

IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005, 3rd ed.)

and CAN/CSA-C22.2 No. 60601-1

E351652

43

12.0 APPENDICES

12.1 How to use the push-fit connectors

To make a connection, simply push to tube in by hand; the pushfit collet
locking system then holds the tube firmly in place without deforming it or
restricting flow

Push the tube into the connector until the
tube stops.

Ensure the tube is pushed in as far as the
tube stop; pull on the tube slightly to check
that it is secured.

To remove the tubing, push the collet against
the body of the connector, as shown in the
diagram opposite and slide the tube out of its
fitting. A release tool may be required to do
this.

44

12.2 E-Waste

Disposal of the unit or any electrical component from the unit must be in
accordance with local requirements in your province or state for the disposal of
electrical waste (E-Waste).

Your Healthcare provider will be responsible for the disposal of any such items
and for the disposal of the unit if required.

45

12.3 Flow schematic

46

12.4 Certificate of conformity

47