Mar Cor Purification WRO 300 H, WRO 300 Operator's Manual
Mar Cor Purification
WRO 300 H
Operator’s Manual
Important User Information
Copyright © 2012 by Mar Cor Purification, Inc.
All rights reserved. No part of the contents of this manual may
be reproduced, copied, or transmitted in any form or by any
means including graphic, electronic, or mechanical methods or
photocopying, recording, or information storage and retrieval
systems without the written permission of the publisher, unless
it is for the purchaser's personal use.
The information in this manual is subject to change without
notice and does not represent a commitment on the part of Mar
Cor Purification (MCP). MCP does not assume any responsibility for any errors that may appear in this manual. In no event
will MCP be liable for technical or editorial omissions made
herein, nor for direct, indirect, special, incidental, or consequential damages resulting from the use or defect of this manual.
The information in this document is not intended to cover all
possible conditions and situations that might occur. The end
user must exercise caution and common sense when installing, using, or maintaining MCP products. If any questions or
problems arise, call MCP Technical Services at 1-800-633-
3080.
Intended Use
MCP products are intended to be installed and used as
described in this manual and other related MCP literature.
WRO 300 H
Table of Contents
Table of Contents
Important User Information . . . . . . . . . . . . . . . . . . . . . . . 2
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table of Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Other Manuals for WRO 300 H. . . . . . . . . . . . . . . . . . . . 5
Definitions of Expressions in the Manual . . . . . . . . . . . . 5
Safety Considerations. . . . . . . . . . . . . . . . . . . . . . . . . . . 5
List of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Certification Marks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
IPR - Intellectual Property Rights . . . . . . . . . . . . . . . . . . 8
Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Alarm Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Notification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Info. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Conductivity Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . 10
Conductivity Notification (set at 20 µS/cm) . . . . . . . 10
Conductivity Alarm (set at 30 µS/cm) . . . . . . . . . . . 11
Conductivity Stop (set at 60 µS/cm) . . . . . . . . . . . . 11
Setting of Conductivity Limits . . . . . . . . . . . . . . . . . 11
Low Rejection Rate Notification. . . . . . . . . . . . . . . . 11
Mains Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Operator Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Description of Buttons . . . . . . . . . . . . . . . . . . . . . . . 12
Description of Indications . . . . . . . . . . . . . . . . . . . . 13
Definition of Flash Indications . . . . . . . . . . . . . . . . . 13
Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Operational Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Stop. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Regular Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Heat Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Heat Disinfection Procedure . . . . . . . . . . . . . . . . . . 17
P/N 3027436 Rev. C
3
Table of Contents
WRO 300 H
Stop Heat Disinfection Sequence . . . . . . . . . . . . . . 18
Chemical Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Approved Chemical Disinfectants . . . . . . . . . . . . . . 19
Test Kit Example . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Chemical Disinfection Procedure . . . . . . . . . . . . . . 19
Residual Test After Chemical Disinfection . . . . . . . 23
Central Chem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Warm Acid Cleaning . . . . . . . . . . . . . . . . . . . . . . . . 24
Alkaline Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Cleaning Procedure. . . . . . . . . . . . . . . . . . . . . . . . . 25
Test for Residuals . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Long Term Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Preservation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Rinse After Preservation . . . . . . . . . . . . . . . . . . . . . 26
Check for Complete Rinse-out . . . . . . . . . . . . . . . . 27
Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Manual Flush. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Auto Flush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Exterior Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Performance and Specification . . . . . . . . . . . . . . . . . . . 29
Chemical Disinfection and Cleaning . . . . . . . . . . . . . . . 33
Physical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Materials Contacting Product Water . . . . . . . . . . . . . . . 34
Environmental Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Electromagnetic Environment . . . . . . . . . . . . . . . . . . . . 35
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Alarms and Notifications . . . . . . . . . . . . . . . . . . . . . . . . 39
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Heat. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Chemical, Cleaning, Rinse and Preservation . . . . . 42
Boot Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Check List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4
P/N 3027436 Rev. C
WRO 300 H
Preface
Preface
This manual provides the information needed to operate the
WRO 300 H water purification unit.
Valid program version 4.x
Other Manuals for WRO 300 H
The list below shows all manuals related to this Operator’s Manual.
Service Manual WRO 300/300 H, 3027437
Installation Guide WRO 300/300 H, 3027502
Definitions of Expressions in the Manual
WARNING
Is used to alert the user not to take a certain action, which if
taken can cause a potential hazard and result in a serious
adverse reaction, injury or death. A warning may also be used
to alert the user to take a certain action to avoid the potential
hazard as above.
CAUTION
Is used to alert the user/operator to take a certain action to
protect against a potential hazard which, if ignored, could
have an adverse effect on the patient or the device. A caution
may also be used to alert the user not to take a certain action
to avoid the potential hazard as above.
NOTE
A reminder to the user on normal treatment activity and on what is a
suitable action in a particular situation.
Safety Considerations
WARNING
Unauthorized installation, modifications, alterations or repair
of the WRO 300 H may result in malfunctioning or have other
serious consequences for the safe operation of the equipment.
WARNING
Dialysis machines that are supplied with water from the
WRO 300 H water purification unit must comply with IEC
60601-2-16.
P/N 3027436 Rev. C
5
Preface
WRO 300 H
CAUTION
• WRO 300 H may be operated only by persons who have studied
the instructions in these manuals and the manual for the dialysis
monitor. If the system does not perform as described in this manuals, it should not be used until the condition is rectified.
• The operator should pay attention to alarms and follow the
instructions, warnings, cautions and notes given in the manual.
• The WRO 300 H will perform as designed only if it is used and
maintained in accordance with MCP´s written instructions. Any
warranties made by MCP with respect to the WRO 300 H are
voided if the equipment is not used in accordance with the written
instructions provided. MCP will not accept responsibility for any
damage or injury resulting from improper use or maintenance or
unauthorized repair.
• The use of mobile telephones or communication equipment in
the vicinity of the WRO 300 H could adversely influence the performance of the machine. See specification.
• The WRO 300 H is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• WRO 300 H needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC
information provided in the Operator’s and Service manual.
• U.S. Federal law restricts this device to sale by or on the order of
a physician.
NOTE
• During transportation and storage the equipment must be kept in its original packing. If transportation or storage time is more than 15 weeks the
environmental data relating to the operation must be followed.
• For the qualified technician the WRO 300/300 H Service Manual is available. The Service Manual provides all of the necessary information for the
safe and required maintenance of the machine.
• The WRO 300 H is intended for continuous operation.
• The WRO 300 H has a feature called Low Flow Heat that is used in con-
junction with certain dialysis machines. This feature is not approved in the
US by the FDA or currently compatible with any US dialysis machines.
List of Symbols
Alternating current
Protective earth (ground)
Warning, consult accompanying documents
Off (power, disconnection from the mains)
6
P/N 3027436 Rev. C
WRO 300 H
CB
Preface
On (power, connection to the mains)
Type B, applied part
Handle with care
This way up
Keep dry
Separate collection for electrical and electronic equipment
Input /Output
Year of manufacturing
The WRO 300 H is protected against dripping water
Recycling symbol -General
Reject water connection
Feed water inlet connection
Loop connections (Product water outlet and return)
ME equipment and ME systems that include RF transmitters or that intentionally apply RF electromagnetic energy
for diagnosis or treatment shall be labeled with this symbol.
P/N 3027436 Rev. C
7
Preface
Certification Marks
The CSA(C-US) mark indicates that the WRO 300 H
water purification unit conforms to the requirements
related to safety of medical devices for the US and Canada. The C and the US adjacent to the CSA mark indicates that the WRO 300 H water purification unit has been
evaluated to the applicable ANSI/UL and CSA standards
for use in the US and Canada.
IPR - Intellectual Property Rights
Copyright
© 2012 Mar Cor Purification, Inc.
Trademarks
•DIALOX® is a trademark registered in several countries, including
Sweden, United Kingdom and Japan by their respective owners
®
•MINNCARE
countries including United States and United Kingdom
• MINNCLEAN
countries including the United States
• STERICHECK
including the United States and Japan by their respective owners
•ULTRASIL
tries including Australia and Canada
is a trademark of Minntech registered in several
®
is a trademark of Minntech registered in several
®
is a trademark registered in several countries
®
is a trademark of Ecolab registered in several coun-
WRO 300 H
Manufacturer
Mar Cor Purification, Inc.
14550 28th Avenue North
Plymouth, MN 55447
USA
Phone: 1-800-633-3080
Fax (Customer Service): 1-763-210-3868
www.mcpur.com
8
P/N 3027436 Rev. C
WRO 300 H
Introduction
1 Introduction
1.1 Intended Use
The MCP WRO 300 H Water Purification Unit is intended to be used
as a dialysis accessory to produce water through reverse osmosis for
one hemodialysis equipment.
The WRO 300 H can be connected to hemodialysis equipment used
both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet applicable regulations or standards for water for
dialysis, for example current AAMI and Federal (U.S.) standards.
CAUTION
The water produced by WRO 300 H should be analysed at
installation and on a regular basis to verify that it conforms to
applicable regulations or standards for water for dialysis.
P/N 3027436 Rev. C
1.2 General
The WRO 300 H has been designed to fulfil the special requirements
within a dialysis setting. This device has the following features:
• Simple user interface
• Automated heat disinfection
• Chemical disinfection and cleaning modes
• Auto flush function during standby periods to minimize stagnant
water.
This manual for WRO 300 H includes instructions for operating, monitoring, cleaning, disinfecting and troubleshooting this device from an
operator’s perspective. For installation instructions refer to separate
Installation Guide.
9
Introduction
WRO 300 H
1.3 Alarm Types
1.3.1 Notification
Next time the WRO goes to Standby the buzzer sounds, flashes
and the message text will be displayed.
Buzzer Sound Description
Notification
1.3.2 Info
The WRO continues in the current mode. The message text will be displayed.
1.3.3 Alarm
The WRO continues in the current mode. The buzzer sounds,
flashes and the message text will be displayed.
Buzzer Sound Description
Alarm
1.3.4 Stop
The WRO stops. The buzzer sounds, flashes and the
message text will be displayed.
Buzzer Sound Description
Stop
1.4 Conductivity Monitoring
The conductivity monitoring system in the WRO 300 H has three limits,
allowing for individual adaptation of alarm settings to local preferences
and regulations. The three limits are described in the sections below.
All three limits are set at the factory.
NOTE
If the notification, alarm and stop limits are set to the same value as
the priority of the action are in the order of stop, alarm and notification.
1.4.1 Conductivity Notification (set at 20 µS/cm)
Indicates that the product water conductivity is above normal reading.
It will be issued when the WRO 300 H enters standby mode if the notification limit has been exceeded for more than 30 consecutive seconds
during the previous run period. It may be caused by several reasons
10
P/N 3027436 Rev. C
WRO 300 H
Introduction
such as incipient fouling, degradation of the RO membrane or change
in the feed water quality.
NOTE
If the feed water conductivity is known to vary significantly, the conductivity notification limit should be inactivated by setting it at the
same value as the conductivity alarm, see below.
1.4.2 Conductivity Alarm (set at 30 µS/cm)
The clinic's predefined maximum product water conductivity for water
for dialysis has been exceeded for more than 30 consecutive seconds.
An audible and visual alarm will be issued. The WRO 300 H will continue operation to allow for finishing the dialysis treatment. The buzzer
can be muted indefinitely by pressing , or . The button
remains lighted to indicate that the alarm persists.
1.4.3 Conductivity Stop (set at 60 µS/cm)
The clinic's predefined maximum permissible product water conductivity has been exceeded for more than 30 consecutive seconds. An
audible and visual alarm will be issued and WRO 300 H will stop. The
alarm can be acknowledged by pressing , or . The
WRO 300 H can be restarted. The alarm will reappear and the
WRO 300 H will stop after 30 seconds if the conductivity remains over
the limit.
1.4.4 Setting of Conductivity Limits
• If the intention is to have an early warning of a change in the product water conductivity, set the notification limit at a value between
the normal product water reading and the set alarm limit.
• If the intention is to stop operation in case of a conductivity alarm,
set alarm and stop limits to the same value.
• If, in case of a conductivity alarm, the intention is to allow for continued dialysis in order to finish the ongoing dialysis treatment, set
the alarm limit at the desired limit. The stop limit at which the WRO
300 H will stop then has to be set at a higher value.
To adjust the limits, refer to the Service Manual.
1.4.5 Low Rejection Rate Notification
The rejection rate is the reduction (in percent) of the conductivity of the
water in a reverse osmosis system. It depends on a number of factors
such as conductivity, pH and temperature of the feed water and may
vary significantly from one location to the other. It should therefore not
be considered as an absolute measure of the quality of the water but
rather as an indicator that can help to detect changes in performance
of the WRO 300 H which may be caused by incipient fouling or degradation of the RO-membrane.
The low rejection rate notification default setting of 90 percent is relevant for most inlet water supplies. It may, however, need to be
P/N 3027436 Rev. C
11
Introduction
Mains power switch
WRO 300 H
adjusted at installation to a lower value by a qualified technician to fit
local conditions, especially in cases of low feed water conductivity
(<100 µS/cm). The limit should be set at least 5 percent lower than the
initial value recorded at installation.
The low rejection rate notification will be displayed when the
WRO 300 H enters standby if the set limit has been exceeded for more
than 5 consecutive minutes during the previous run period.
1.5 Mains Power Switch
The mains power switch is only used in service situations to turn off the
power. The mains power switch is located on the rear side behind a
detachable cover.
1.6 Operator Panel
1.6.1 Description of Buttons
Buttons Description
Press to start operation (RUN).
Press to stop operation (STANDBY).
Press to stop heat disinfection procedure and low flow heat.
Press to enter
Press to start the selected procedure (SELECT or CHEM SELECT).
Press during the chemical intake procedure to pause.
Press during dwell period to initiate rinse.
Press to silence audible alarms.
Press to unlock the display and enter the alarm list.
SELECT (only in Standby mode)
12
P/N 3027436 Rev. C
WRO 300 H
Introduction
Buttons Description
Used to scroll and view data in the display.
Press any of the arrow buttons to unlock the display and enter the alarm
list.
Pressing both arrow buttons simultaneously will lock current information
in the display. Press any arrow buttons to release the locking function.
1.6.2 Description of Indications
Indications Description
Green General
Green Steady light
Slow flash
Fast flash
Yellow Steady light
Slow flash
Medium flash
Red Medium flash
Steady light
Indicates that the WRO 300 H is energized.
RUN mode, auto flush or manual flush in
progress.
The auto flush function is activated. (only in
standby mode)
Insufficient feed water supply. (only in RUN
mode)
Chemical disinfection, heat disinfection, low
flow heat or cleaning is in progress.
The automated heat disinfection by time channels is activated. (only in standby mode)
The disinfection wand connector is inserted into
the chemical intake.
During selection of procedure in SELECT or
CHEM SELECT
The chemical intake phase is paused.
Forced rinse is required (
REQUIRED
Unconfirmed notification, info, alarm or stop
conditions are present.
Notification, info, alarm or stop condition has
been confirmed.
).
404 RINSE
1.6.3 Definition of Flash Indications
P/N 3027436 Rev. C
Flash indication Time
On Off
Slow flash 0.4 sec 2.0 sec
Medium flash 0.4 sec 0.4 sec
Fast flash 0.2 sec 0.2 sec
13
Introduction
1.6.4 Reminders
Recurring notifications can be preset to remind the user to take certain
actions, for example exchange cartridge in the pre-filter. When the
reminder time expires, the notification message will display. For addi-
tional information about Reminders, refer to the Service Manual.
NOTE
After the reminder time has expired the notification message will only
appear once!
1.6.5 Operational Data
If any alarm (stop, alarm, info, or notification) has been issued, the
alarm list will appear first and can be scrolled and viewed by using the
or . Refer to Troubleshooting on page 39.
By using or the operational data can be scrolled and viewed in
the display.
Operational data Unit
PRODUCT WATER X µS/cm
FEED WATER X µS/cm
REJECTION RATE X %
PRODUCT WATER FLOW X ml/min
PRODUCT WATER TEMP X °C
HEAT,
CHEM, X
ACID CLEAN, X
ALKALINE CLEAN, X
PROGRAM VERSION X.y
TOTAL RUN TIME X hr
DATE yyyy-mm-dd
TIME hh:mm:ss
INTERNAL SERVICE Not applicable
DAYS SINCE
LAST
1
X
WRO 300 H
1. Visible depending on settings
Main view will reappear automatically after 15 seconds. It is also possible to return to the main view, by using either or to scroll
through the alarm list and the operational data until main view is displayed.
14
P/N 3027436 Rev. C
WRO 300 H
RUN
X
μS
/
cm
STANDBY
Operation
2 Operation
WARNING
This device does not remove chlorine and chloramines. If
these substances are present in the feed water, carbon filtration is required to remove these substances. Severe patient
injury may otherwise occur. A test for total chlorine of the pretreated water must be performed prior to initiating dialysis
treatment. The level of total chlorine must be below 0.1 mg/l
(ppm).
2.1 Start
Press until light goes on.
NOTE
will light up and the WRO 300 H will go into active cooldown if the
internal water temperature exceeds 45 °C ( will still be lit). The procedure will continue until the temprature is below 45 °C.
2.2 Stop
Press until light goes out and the WRO 300 H goes to standby
mode.
NOTE
If power failure occurs during operation mode the procedure continues in the same phase as when the power failure occurred when the
WRO 300 H starts up again.
P/N 3027436 Rev. C
15
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