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
Operation
WRO 300 H
This page is blank.
16
P/N 3027436 Rev. C
WRO 300 H
Regular Maintenance
3 Regular Maintenance
NOTE
The procedure below assume factory settings of the protocol.
NOTE
If the internal water temperature exceeds 45 °C when initiating the preferred procedure the display reverts to the CHEM SELECT menu.
This situation is resolved by initiating RUN and letting the WRO 300 H operate and perform an active cooldown until the temperature is below 45 °C.
3.1 Heat Disinfection
The required heat disinfection frequency to fulfil the desired microbio­logical requirements for the product water depends on several factors such as:
the quality of the feed water
SELECT menu or the
local regulations regarding the microbiological quality of dialysis water, etc.
No general rules can be given that cover all situations. The disinfection schedule should be based upon microbiological testing performed by the clinic. A maximum period between disinfections should then be established to ensure acceptable bacteriological quality of the product water according to the clinic’s standards.
MCP recommends a minimum frequency of weekly heat disinfection to ensure consistent microbiological quality of the product water.
If the WRO 300 H will not be used for an extended period of time, reg­ular automated heat disinfection preset by the time channels will main­tain the microbiological quality of the product water.
3.1.1 Heat Disinfection Procedure
The following paragraphs describe the heat disinfection of the WRO 300 H and the product water loop.
NOTE
The dialysis machine shall be turned off when the heat disinfection procedure is performed.
NOTE
The heat disinfection procedure can also be initiated by the time chan-
nels. Further information of time channel settings refer to the Service Manual.
P/N 3027436 Rev. C
17
Regular Maintenance
NOTE
If power failure occurs during heat disinfection procedure 301 INSUFFICIENT HEAT is displayed when the WRO 300 H restarts.
Press until the WRO 300 H either goes to standby or an active cooldown is initiated if it is preset.
Step 1 Press until SELECT is shown in the display and
WRO 300 H
starts to flash.
Step 2 From SELECT, press
dures.
Step 3 Select HEAT by using the .
Step 4 Initiate the heat disinfection by pressing until the light
goes on.
to enter the list of available proce-
3.1.2 Stop Heat Disinfection Sequence
Press until light goes on to stop the heat disinfection proce­dure. An active cooldown is initiated, then the WRO 300 H goes to
standby.
For more information about the settings of active cooldown, refer to
the Service Manual.
3.2 Chemical Disinfection
NOTE
Chemical disinfection is not required for WRO 300 H units. Heat dis­infection is the preferred method to maintain bacterial control.
NOTE
The MINNCARE® disinfection option is disabled at the factory and
can be re-enabled by referring to the Service Manual for instructions.
For certain peracetic acid disinfectants the manufacturer recommends that the WRO 300 H should be cleaned with an acid cleaning agent in accordance with the cleaning instructions prior to chemical disinfection
to preserve the RO membrane. Refer to the section, Cleaning on page 24.
The use of an ultrafilter on the dialysis machine will remove possible contaminants originating from the product water and may therefore be used as a method to extend the time between chemical disinfection of the WRO 300 H.
Contact MCP for suitable chemical disinfectant for the procedures.
18
P/N 3027436 Rev. C
WRO 300 H
Regular Maintenance
3.2.1 Approved Chemical Disinfectants
•MINNCARE® Cold Sterilant
Required amount: 50 ml of concentrated disinfectant
CAUTION
Disinfectants may be toxic. Refer to the manufacturer instruc­tions.
CAUTION
A test for residual disinfectant after rinse must be performed before the initiation of the next dialysis session. The residual concentration of the disinfectant in the fluid must be below lev­els specified by the clinic or by national standards. It is essen­tial to use an appropriate test method, either with proven sensitivity for the disinfectant or recommended by the manu­facturer of the disinfectant.
3.2.2 Test Kit Example
Minncare Residual Test Strips, MCP order number 185-40-004 (preferred).
®
STERICHEK
Residual Peroxide, MCP order number WT811905
(alternate).
3.2.3 Chemical Disinfection Procedure
Chemical disinfection of the WRO, including product water loop.
CAUTION
The chemical container must be located below the chemical intake.
CAUTION
When requested by the WRO unit, remove the disinfection wand from the chemical intake. Failure to remove the disinfection wand can cause siphoning of the chemical solution from the bot­tle resulting in the tank overflowing chemical solution through the back of the machine.
NOTE
If power failure occurs during chemical disinfection 404 RINSE REQUIRED is displayed when the WRO 300 H restarts (also 401
REMOVE WAND is displayed during the intake phase). Press until
light goes on, to initiate rinse.
Step 1 Place the WRO into standby mode.
Step 2 Disconnect the WRO 300 H from the dialysis machine with
the quick connector on the product water loop. Alternatively,
P/N 3027436 Rev. C
19
Regular Maintenance
Disconnect the quick connector
Nipple at the Dialysis machine
WRO 300 H
Insert the connector and press Turn to lock
WRO 300 H
the connector can be left in place. Refer to the caution mes­sage below.
CAUTION
If the WRO 300 H is not disconnected from the dialysis machine during the chemical disinfection procedure, the test for residuals after the chemical disinfection procedure must be
performed on the dialysis machine according to the Operator’s Manual of this device.
Step 3 Place a tag on the WRO 300 H, stating that chemical disin-
fection is in progress and what type of disinfectant is being used.
Step 4 Insert the wand connector into the chemical intake port of the
WRO 300 H (see figure below), press firmly and turn the con­nector downwards to lock. Check that the connector is securely in place.
Step 5 CHEM SELECT is shown in the display and starts to flash.
20
P/N 3027436 Rev. C
WRO 300 H
Container
Disinfection Wand Connector
Correct
Wrong
Disinfection Wand Connector
Container
CHEM INTAKE
X μS/
cm
Regular Maintenance
Step 6 Insert the open end of the disinfection wand into a container
with sufficient amount of disinfectant (refer to Approved Chemical Disinfectants on page 19). Check that the open end
of the intake wand is below the solution level and that the clamp is open. The container must be below the level of the chemical intake port to prevent siphoning chemical into the WRO 300 H unit.
Step 7 From CHEM SELECT, press
to enter the list of available
cleaning and chemical disinfection programs.
Step 8 Select preferred chemical disinfection program by using the
arrow buttons.
MINNCARE
Step 9 Initiate the disinfectant intake by pressing until light goes
on.
NOTE
The display shows present phase of the chemical disinfection proce­dure.
NOTE
The container can be empty before the intake phase is finished.
CAUTION
The chemical disinfection has to be restarted if alarm 406 INSUFFICIENT INTAKE has appeared.
P/N 3027436 Rev. C
21
Regular Maintenance
The table below explains how to pause, interrupt or restart the proce­dure:
WRO 300 H
Action
Pause of chemical intake phase
Interrupt chemical disinfection procedure
Restart of intake phase
Press until light flashes. To continue the intake
press again until light goes on.
Disconnect the wand connector and press until
light goes on, to initiate rinse.
Remove the wand connector and insert it again
CHEM INTAKE RESTART appears on the dis-
play and flashes. Then press until light
goes on.
Step 10 401 REMOVE WAND is displayed and the buzzer sounds and
is flashing, press .
Step 11 Keep the wand in the container and disconnect the wand by
turning the connector a quarter of a turn and gently pull it out. Let the disinfectant liquid from the line and wand flow back into the container. Then clamp the line. Also check that cor­rect amount of disinfectant has been consumed.
CAUTION
When requested by the WRO unit, remove the disinfection wand from the chemical intake. Failure to remove the disinfection wand can cause siphoning of the chemical solution from the bot­tle resulting in the tank overflowing chemical solution through the back of the machine.
22
Step 12 Remove the disinfection wand from the container and flush
with water.
Step 13 The chemical disinfection procedure will now continue auto-
matically with DWELL PERIOD followed by RINSE. The remaining time to complete the chemical disinfection proce­dure is also displayed.
NOTE
The conductivity value is checked during the final five minutes of the rinse phase. If the value is above the conductivity notification limit
(refer to Conductivity Monitoring on page 10) when the preset rinse
time is finished it is prolonged 30 minutes. If the value decreases below the conductivity notification limit the prolonged rinse finishes.
If the level still is above the conductivity notification limit when the pro­longed rinse is finished the alarm 403 HIGH CONDUCTIVITY RINSE appears.
P/N 3027436 Rev. C
WRO 300 H
RUN
X
μS
/
cm
Regular Maintenance
Step 14 When the chemical disinfection program is completed the dis-
play will show PERFORM RESIDUAL TEST. The indication
will remain lighted and the will flash.
3.2.4 Residual Test After Chemical Disinfection
CAUTION
If the WRO 300 H has been connected to the dialysis machine during the chemical disinfection procedure, the test for resid­uals after the chemical disinfection procedure must be per-
formed on the dialysis machine according to the Operator’s Manual of the dialysis machine.
Step 1 Press until light goes on, to start WRO 300 H.
Indication will light and will flash.
Step 2 Collect a water sample either from the product water line or
from the dialysis machine according to the caution above.
Step 3 Test for disinfectant residuals with Minncare
®
Residual Per-
oxide test strips or other approved test strips or methods.
Step 4 Confirm by pressing until light goes out. Indication
remains on.
Step 5 Remove any tag indicating storage with disinfectant.
If residuals are detected after starting the WRO 300 H by pressing until light goes on, repeat the residual test every five minutes until no residuals can be detected.
P/N 3027436 Rev. C
23
Regular Maintenance
CENTR_CH_PHX
3.2.5 Central Chem
The central chem disinfects the WRO and also sends disinfectant into the dialysis machine. For more detailed information on how to perform
central chem together with Gambro Technical Service.
®
dialysis machines, please contact
CAUTION
If the produced disinfection solution is fed into a device other than Gambro
®
dialysis machines, it is the user’s responsibility to ensure that the connected device is compatible with perace­tic acid disinfectants and to establish the procedure for the WRO in combination with the connected device.
CAUTION
As the disinfection solution produced by the WRO will enter any device connected to the quick connector on the product water loop, residual test after disinfection must be performed
on the connected device in accordance with the Operator’s Manual for the connected device.
WRO 300 H
Follow the Chemical Disinfection Procedure on page 19, but start at
Step 3 and follow the instruction through Step 13. In Step 8 select the preferred central chem protocol in the CHEM
SELECT menu.
NOTE
During the intake phase of the central chem program, the product water loop will not be pressurized until the correct conductivity has been obtained, which will take a few minutes.
3.3 Cleaning
3.3.1 Warm Acid Cleaning
Warm acid cleaning should be performed when:
Rejection rate has decreased by more than 5 percent from initial value.
Sufficient output flow is not obtained.
As preventive measure when a softener is not used.
As a method to remove transitional metals from the RO membrane prior to chemical disinfection.
24
P/N 3027436 Rev. C
WRO 300 H
Regular Maintenance
Dissolve 100 ml of citric acid in 200 ml of product water from the WRO 300 H. This will result in a 2 percent solution in the WRO 300 H.
Refer to Cleaning Procedure below.
NOTE
Other acid membrane cleaners may be used as an alternative cleaner for the WRO 300 H. Follow the manufacturer’s guidelines to prepare the cleaning solution.
3.3.2 Alkaline Cleaning
Alkaline cleaning should be performed when:
Product performance is affected and cleaning with citric acid does not improve performance.
Organic fouling is suspected.
®
Use MINNCLEAN
Refer to Cleaning Procedure below.
TF according to manufacture’s instruction.
3.3.3 Cleaning Procedure
Step 1 Press until the display shows RUN. Wait until the product
water conductivity stabilizes and record the value. Press until light goes out to stop the WRO.
Step 2 Follow the chemical disinfection procedure, but instead select
WARM CITRIC, or ALKALINE CLEAN in the CHEM SELECT menu. Refer to Chemical Disinfection Procedure on page 19.
CAUTION
If the temperature is not achieved during Warm Acid cleaning, alarm 407 INSUFFICIENT TEMPERATURE will appear and the cleaning procedure has to be restarted.
NOTE
The container can be empty before the intake phase is finished.
3.3.4 Test for Residuals
Step 1 Press until light goes on, to start the WRO 300 H.
Indication will light and will flash.
Step 2 Collect a water sample from the product water line.
Step 3 The absence of cleaning chemical in the product water is
confirmed if the pH is within 1.0 pH unit of the feed water value (checked with a suitable method) and if the conductivity of the product water corresponds to the previously recorded value.
P/N 3027436 Rev. C
25
Regular Maintenance
RINSE
hh:mm
Step 4 Confirm by pressing until light goes out. Indication
3.4 Long Term Storage
If the WRO 300 H will not be used for an extended period of time, reg­ular automated heat disinfection preset by the time channels, will main­tain the microbiological quality in the WRO.
3.4.1 Preservation
If automated heat disinfection is not possible to perform when the WRO 300 H is taken out of operation for an extended period of time, a chemical preservation must be done. For example, perform preserva­tion if electrical and water connections are disconnected.
3.4.1.1 Preservation agents
Use MEMSTOR and dissolve 100 ml in two liters of potable tap water. Warm water (35-40°C) speeds up dissolution.
3.4.1.2 Preservation Procedure
Step 1 Follow the chemical disinfection procedure (refer to Chemical
WRO 300 H
remains lighted.
Disinfection Procedure on page 19) Step 2 to Step 12, but instead select MEMSTOR in the CHEM SELECT menu.
CAUTION
If the conductivity limit is not achieved, alarm 406 INSUFFI­CIENT INTAKE will appear and the preservation procedure has
to be restarted.
Step 2 After Step 12: the display will show 404 RINSE REQUIRED
and the buzzer will now sound and the indications and
will flash. Press , or acknowledge the alarm
and the alarm list will be unlocked.
Step 3 Switch off the WRO 300 H with the mains power switch
behind the detachable cover.
3.4.2 Rinse After Preservation
Step 1 Turn on the WRO 300 H with the mains power switch behind
the detachable cover.
Step 2 The indication and flashes and the display shows
404 RINSE REQUIRED.
Step 3 Press until light goes on to initiate rinse.
26
P/N 3027436 Rev. C
WRO 300 H
Regular Maintenance
Step 4 When the rinse program is completed the display will show
PERFORM RESIDUAL TEST. The indication will remain
lighted and the will flash.
3.4.3 Check for Complete Rinse-out
The required rinse program in the WRO has been designed and vali­dated to ensure complete rinse-out of the preservation.
Step 1 Press until light goes on, to start the WRO.
Indication will light and will flash.
Step 2 Let the WRO run in normal operation for at least 5 minutes.
Then press or to show the conductivity value in the display (within 15 seconds the display will return to PERFORM RESIDUAL TEST). Check and verify that the product water conductivity remains stable and constant.
Step 3 Confirm by pressing until light goes out. Indication
remains lighted.
Step 4 The WRO is now ready to use.
3.5 Flush
3.5.1 Manual Flush
This mode provides a short flush of the WRO at elevated flow rate (5 minutes preset).
Step 1 Press until SELECT appears
Step 2 Scroll with to select MANUAL FLUSH.
Step 3 Press to initiate Manual Flush (MANUAL FLUSH will be
displayed and will light).
3.5.2 Auto Flush
During standby, auto flush is regularly performed to exchange water in the WRO, if enabled in preset. At specified intervals the water circu­lates in the WRO and some water goes to drain.
3.6 Exterior Cleaning
Wipe the outside of the WRO 300 H with a cloth moistened with etha­nol (70 percent) or isopropanol (60 percent).
NOTE
Do not use iodine-based or tenside-containing disinfectants as these may crack or discolor the plastic materials.
P/N 3027436 Rev. C
27
WRO 300 H
Regular Maintenance
This page is blank.
P/N 3027436 Rev. C
28
WRO 300 H
4 Technical Data
4.1 Performance and Specification
Values
Output flow Minimum. 1.1 l/min
at +10 °C feed water temperature
at 0.15 MPa (22 psi) pressure in the product water loop
Product water loop Maximum 2 metres (2 x 1 m) uninsu-
lated Maximum 20 metres (2 x 10 m) insu-
lated*
*under the following conditions;
MCP recommended insulation shall be used
Product water
the minimum feed water temperature is +10 °C
the minimum ambient temperature is +18 °C
Product water pressure 0.12 to 0.6 MPa (17 to 87 PSI) during
RUN mode (depending of the con­sumption from product water loop)
Quality Dependent on feed water quality. If
potable water is used, the following rejection rates will be obtained:
Total dissolved salts: >96% (based on conductivity); at +10 °C feed water temperature
Bacteria and endotoxins: >99%
Technical Data
P/N 3027436 Rev. C
29
Technical Data
Water Supply
Drain
Values
Input Min. 3.0 l/min required
Feed Water Pressure During operation — there is an inlet
flow of water into the WRO unit.
0.15 to 0.3 MPa (22 to 45 PSI)
Maximum design pressure:
0.8 MPa (115 PSI)
If the feed water pressure exceeds 0.3 MPa (45 PSI), a flow regulator, order number WTW522001001, should be installed.
Feed Water Tempera­ture
Feed Water Quality Potable water should be used.
Hardness <0.3 °dH (6 ppm as CaCO
Iron <0.1 mg/l
Manganese <0.1 mg/l
Turbidity <1 JTU
Total dissolved salts (TDS)
Fouling index (silt den­sity index)
Chlorine (total) <0.1 mg/l
Drain output flow dur­ing RUN mode
Height difference between the drain hose outlet and the WRO 300 H drain outlet.
Drain (length of hose) Maximum 5 m
Drain flow capacity Minimum 3.0 l/min required
Max temperature 85 °C
+5 to +30 °C
Particle filtration shall be used (< 5m)
Carbon filtration shall be used if water is chlorinated, see limits below.
Membrane life expectancy might be reduced if the unit is operated outside of the following limits. For example, additional maintenance such as clean­ing to remove scale from hard water buildup may be required if the hard­ness level is exceeded.
)
3
<1500 mg/l
<5
1.2 ±0.1 l/min
Maximum 1.0 m
WRO 300 H
30
P/N 3027436 Rev. C
WRO 300 H
Tank Air Vent
Chemical intake
Fluid Connections
Conductivity measurement (Temperature compensated)
Temperature measurement
Technical Data
Values
This outlet connects the tank to the atmosphere. This outlet must be connected with an air gap if plumbed to a
drain. If a hose is connected to the Tank air vent, the hose shall have a constant slope.
NOTE
Air will move back and forth in this line because of the variation of the level in the tank.
The machine is designed to bring in disinfectant-cleaning agent through the chemical intake.
The maximum suction height from chemical intake is 600 mm.
Designed for flexible, reinforced tubing 8 mm x 2.5 mm (5/16" I.D.)
The product water loop is designed for flexible, reinforced tubing 5 mm x 3 mm.
Operating range 1–500 µS/cm
Product water conduc­tivity
Feed water conductiv­ity
Operating range 0 to 105 ºC
Accuracy ±4 ºC
Accuracy ±10%
or ±10 µS/cm Whichever is greater
Operating range 10 - 2000 µS/cm
Accuracy ±10% or ±10 µS/
cm Whichever is
greater
Reverse osmosis module
Membrane material Polyamide, thin film composite
Membrane configura­tion
Membrane pH toler­ance
Spiral wound
2 to 11
P/N 3027436 Rev. C
31
Technical Data
Power supply
Values
Mains Voltage 100 to 240 VAC (line voltage range 85
to 264 VAC)
Frequency 50 or 60 Hz (line frequency range 45
to 65 Hz)
Power Consumption Max
Appliance inlet According to IEC 60320; C14
Cable Cable with protective earth
Mains plug North America type—100 and 115
Fuses 15 A slo blo (115 VAC)
Earth Leakage Current Max. 250 µA (220–240 VAC)
1500 W (100 VAC) 1380 W (115 VAC) 1850 W (220-240 VAC)
Conductor length max. 3.5 m minimum 1 mm² (220-240 VAC) AWG 16 at 100 and 115 VAC
VAC, Hospital grade, earthed plug, type IEC 60 083; A5-15
15 A slo blo (100 VAC)
Max. 145 µA (115 VAC) Max. 140 µA (100 VAC)
WRO 300 H
Connection of external equipment
Sound
External connector 8 pins REDEL, yellow.
Not used.
External connector 8 pins REDEL, black. RS-232
Max input voltage ±15 VDC
Logging interface
High level min output voltage
Low level max output voltage
Max Current ±5 mA DC
5.0 VDC
5.0 VDC
External connector 8 pins REDEL, green.
Not used.
Sound power level Less than 65 dBa during normal oper-
ation
32
P/N 3027436 Rev. C
WRO 300 H
4.2 Chemical Disinfection and Cleaning
The following disinfectants may be administered via the chemical intake.
®
Cold Sterilant
Disinfection
Cleaning agents
Preservation
Exterior cleaning
MINNCARE
Other peracetic acid disinfectants, provided that they are approved by the manufacturer for disinfection of thin film composite reverse osmosis membranes made of modified polyamide. Follow the manufacturer´s instructions for Use for the specific disinfectant.
The following cleaning agents may be administered via the chemical intake:
Citric acid
•Minnclean® AC
•Minnclean® TF
•Acetic Acid (5%)
Other cleaning agents may also be used, provided that they are approved by the manufacturer for cleaning of thin film composite reverse osmosis membranes made of modified polyamide. Follow the manufacturer's instructions for use for the specific cleaning agent.
The following preservations may be administered via the chemi­cal intake and feed water inlet:
MEMSTOR ®
MEMSTOR ® in combination with 9 % glycerol
•Formalin
Ethanol (70%)
Isopropanol (60%).
Technical Data
4.3 Physical Data
Measurements Values Weight Height
Depth
Width
Internal fluid volume
33 kg (72.8 lb)
563 mm (22.2 inch)
Max 520 mm (20.5 inch)
Footprint 380 mm (15.0 inch)
Max 205 mm (8.1 inch)
Footprint 185 mm (7.3 inch)
Approximately 3.5 litres excluding the product water loop
P/N 3027436 Rev. C
33
Technical Data
4.4 Materials Contacting Product Water
Type Material
PA (Polyamide) PEEK (Polyetheretherketone) PEI (Polyetherimide) PE (Polyethylene)
Polymers
Rubber
PFA (Fluorocarbon) POM (Polyoxymethylene) PP (Polypropylene) PPS (Polyphenylensulphite) PVC (Polyvinylchloride) PVDF (Polyvinyliden fluorid)
Q (Silicone)
WRO 300 H
Metals Others
Titanium Stainless steel
Ceramic
4.5 Environmental Data
Ambient Temperature range +10 to +40 °C
Operation
Transportation and storage
Relative Humidity range 30 to 85% RH
Air Pressure range 700 to 1060 hPa
Ambient Temperature range -10 to +40 °C
Relative Humidity range 10 to 95% RH
Air Pressure range 500 to 1060 hPa
For transportation and storage below the freezing point, the WRO 300 H must be filled with a preservation solution of 2% MEMSTOR, at least 9% glycerol and the remaining parts RO water.
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.
If condensation occurs when moving the equipment between locations with different temperatures and high relative humidity (for example. outdoor and indoor locations), the inside of the equipment must be allowed to dry before switching on the equipment.
Value
34
P/N 3027436 Rev. C
WRO 300 H
Technical Data
4.6 Electromagnetic Environment
Value
The WRO 300 H is intended for use in the electromagnetic environment specified below. The customer or the user of the WRO 300 H should assure that it is used in such an envi­ronment.
Emissions test Compliance
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emis­sions IEC 61000-3-2
Voltage fluctua­tions/flicker emissions IEC 61000-3-3
Immunity test
Electrostatic discharge (ESD)IEC 61000-4-2
Surge IEC 61000-4-5
Voltage dips, short interrup­tions and volt­age variations on power sup­ply input lines.
IEC 61000-4-11
Power fre­quency
(50/60 Hz) magnetic field IEC 61000-4-8
Group1 The WRO 300 H uses RF energy only for its internal
Class B The WRO 300 H is suitable for use in all establish-
Class A (Not applicable for 115 V vers io n)
Complies (Not applicable for 115 V version)
IEC 60601 test level
±6 kV contact ±8 kV Air
±1 kV for differ­ential mode
±2 kV for com­mon mode
<5% U dip in U cycle
40% U in U cycles
70% U in U cycles
<5% U dip in U sec
3 A/m 3 A/m Power frequency magnetic fields
1
T
) for 0.5
T
(60% dip
T
) for 5
T
(30% dip
T
) for 25
T
(>95%
T
) for 5
T
(>95%
Electromagnetic environment — guidance
function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment
ments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes
Compliance level
±6 kV contact ±8 kV Air
1kV for differ­ential mode
± 2kV for com­mon mode
<5% U dip in U cycle
40% U dip in U cycles
70% U dip in U cycles
<5% U dip in U sec
(>95%
T
) for 0.5
T
(60%
T
) for 5
T
(30%
T
) for 25
T
(>95%
T
) for 5
T
Electromagnetic environment—guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment
Mains power quality should be that of a typical commercial or hospital environment.
should be at levels characteristic of a typical location in a typical com­mercial or hospital environment.
P/N 3027436 Rev. C
35
Technical Data
d 1.2 P=
d 1.2 P =
d 2.3 P =
WRO 300 H
Value
Immunity test
Conducted RFIEC 61000­4-6
Radiated RFIEC 61000­4-3
Radiated RF mobile phones
IEC 60601 test level
3 Vrms 150 kHz to 80
MHz
3 V/m 80 MHz to 3.0
GHz
- 30 V/m Field strengths from fixed RF
Compliance level
3 V Portable and mobile RF communi-
3 V/m
Electromagnetic environment —guidance
cations equipment should be used no closer to any part of the WRO 300 H, including cables, than the recommended separation distance calculated from the equation appli­cable to the frequency of the trans­mitter.
Recommended separation dis­tance,
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).
80 to 800 MHz
800 MHz to 2.5 GHz
transmitters, as determined by an
electromagnetic site survey should be less than the compli­ance level in each frequency
5
range
.
Interference may occur in the vicin­ity of equipment marked with the following symbol:
3
2
4
,
36
P/N 3027436 Rev. C
WRO 300 H
d
3.5 3
-------
P=
d
3.5 3
-------
P=
d
7 3
-- -
P=
d
7
30
----- -
P=
Technical Data
Value
Recommended separation distances between portable and mobile RF communications equipment and the WRO 300 H
The WRO 300 H is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the WRO 300 H can help pre­vent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the WRO 300 H as recom­mended below, according to the maximum output power of the communications equipment.
Rated maximum output power of
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
80 MHz to
800 MHz
6
800 MHz to 3 GHz
transmitter W
0,01 0.11 0.11 0.23
0,1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
Rated maxi­mum output power of mobile phone
2W GSM/3G - - 0.33
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.
--
1. NOTE: UT is the AC mains voltage prior to application of the test level.
2. NOTE: These guidelines may not apply in all situations. Electromagnetic propa­gation is affected by absorption and reflection from structures, objects and peo­ple.
3. NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
4. 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 WRO 300 H is used exceeds the applicable RF compli­ance level above, the WRO 300 H should be observed to verify normal opera­tion. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the WRO 300 H.
5. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
6. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher fre­quency range applies.
P/N 3027436 Rev. C
37
Technical Data
4.7 Safety
WRO 300 H
The machine complies with the following standards:
IEC 60601-1 General requirements for safety, Class I, type B, and IPX1.
IEC 60601-1-2 Electromagnetic compatibility.
38
P/N 3027436 Rev. C
WRO 300 H
5 Troubleshooting
In alarm situations the message text will appear in the display. Only the
latest message will be visible in the display. By using the , or
the display will be unlocked and the alarm list can be scrolled.
The main view will reappear after a time period.
5.1 Alarms and Notifications
5.1.1 General
Alarm and
No.
notifications Definition
Troubleshooting
101 CONDUCTIVITY
SENSOR FAILURE
102 HIGH LEVEL SEN-
SOR FAILURE
103 : N INTERNAL
ERROR
104 INVALID WATER
LEVEL
1
WRO 300 H
Reason The initial conductivity system check failed.
Action
WRO 300 H WRO 300 H stops, buzzer sounds with Stop
Reason Failure of high level sensor in tank.
Action
WRO 300 H WRO 300 H stops, buzzer sounds with stop
Reason Control unit failure.
Action
WRO 300 H WRO 300 H stops, buzzer sounds with alarm
Buzzer sounds with alarm sound,
flashes, message text displays.
1 Press , or to silence
buzzer.
2 Check that the product water conductivity
is within normal range. If so, continue as normal but notify technical personnel.
sound, flashes, message text displays.
1 Press , or to silence
buzzer.
2 Notify technical personnel.
sound, flashes, message text displays.
1 Press , or to silence
buzzer.
2 Restart unit, or notify technical personnel.
sound, flashes, message text displays.
1. The number (N) shown before the alarm text identifies which specific kind of
alarm that has occurred. Reference list for those number refer to Service Man-
ual.
P/N 3027436 Rev. C
Reason Failure of level sensors in tank
Action
1 Press ,
buzzer.
2 Check that no water has flooded from
Tank air vent.
3 The WRO 300 H can be restarted by
pressing .
4 Otherwise notify technical personnel.
or to silence
39
Troubleshooting
5.1.2 Operation
No.
WRO 300 H
Alarm and notifications Definition
201 CONDUCTIVITY
NOTIFICATION
202 CONDUCTIVITY
ALARM
203 CONDUCTIVITY
STOP
WRO 300 H When entering standby mode, buzzer sounds
with notification sound, flashes, message
text displays.
Reason The conductivity value has exceeded the notifi-
cation limit for more than 30 consecutive sec­onds during previous run period.
Action
WRO 300 H
Reason The conductivity value has exceeded the alarm
Action Before treatment:
WRO 300 H WRO 300 H stops, buzzer sounds with alarm
1 Press , or to silence buzzer.
2 Perform cleaning according to local proce-
dures.
3 If problem persists notify technical person-
nel.
Buzzer sounds with alarm sound, flashes,
message text displays.
limit for more than 30 consecutive seconds.
1 Press , or to silence buzzer.
2 Note down the conductivity value. 3 Continue treatment. After treatment:
1 Inform responsible medical staff according
to local procedures.
2 Notify technical personnel for further
actions.
sound, flashes, message text displays.
40
204 INSUFFICIENT
WATER SUPPLY
Reason The conductivity value has exceeded the stop
limit for more than 30 consecutive seconds.
Action
WRO 300 H
Reason Lack of feed water.
Action 1 Check the feed water supply.
1 Press , or to silence buzzer.
2 Inform responsible medical staff according
to local procedures.
3 The WRO 300 H can be restarted by press-
ing . It will stop again if the problem per-
sist. 4 If problem persists discontinue dialysis. 5 Notify technical personnel.
WRO 300 H stops, flashes fast, message text displays.
2 Notify technical personnel.
P/N 3027436 Rev. C
WRO 300 H
Alarm and
No.
notifications Definition
Troubleshooting
205 LOW REJECTION
RATE
206 LOW PRODUCT
FLOW
5.1.3 Heat
WRO 300 H When entering standby mode, buzzer sounds
with notification sound, flashes, message
text displays.
Reason Decreased membrane performance.
Action
WRO 300 H When entering standby mode, buzzer sounds
Reason The product water flow is below the preset noti-
Action
1 Press , or to silence buzzer.
2 Perform cleaning according to local proce-
dures. 3 If problem persists notify technical person-
nel.
with notification sound, flashes, message
text displays.
fication limit which indicates that the perform­ance of the membrane is reduced.
1Press ,
2 Perform cleaning according to local proce-
dures. 3 Notify technical personnel.
or to silence buzzer.
Alarm and
No.
notifications Definition
301 INSUFFICIENT
HEAT
302 INSUFFICIENT
WATER SUPPLY
WRO 300 H WRO 300 H stops, buzzer sounds with
alarm sound, flashes, message text
displays.
Reason Power failure.
Action
WRO 300 H WRO 300 H stops, buzzer sounds with
Reason Lack of feed water.
Action
1 Press , or to silence
buzzer.
2 Press until light goes on. The
WRO 300 H either goes to standby or an active Cooldown.
alarm sound, flashes, message text
displays.
1 Press , or to silence
buzzer. 2 Check the feed water supply. 3 Check for leakage. 4 Restart by pressing .
P/N 3027436 Rev. C
5 Notify technical personnel if problem per-
sists.
41
Troubleshooting
Alarm and
No.
notifications Definition
303 OVERDUE HEAT WRO 300 H When entering standby mode, buzzer
sounds with notification sound, flashes,
message text displays.
Reason Heat disinfection procedure is activated
automatically by time channel settings but cannot be started because the WRO 300 H is not in standby mode.
304 INCORRECT
WATER LEVEL
Action
WRO 300 H WRO 300 H stops, buzzer sounds with
Reason Water level in tank is lower than expected.
Action
1 Press , or to silence
buzzer. 2 Activate heat disinfection procedure
manually. Refer to Heat Disinfection on
page 17.
alarm sound, and flashes, mes-
sage text displays.
1 Press , or to silence
buzzer. 2 Check that the dialysis machine is turned
off.
3 Press until the WRO 300 H either
goes to standby or an active cooldown. 4 If the problem still persists notify techni-
cal personnel.
WRO 300 H
5.1.4 Chemical, Cleaning, Rinse and Preservation
Alarm and
No.
notifications Definition
401 REMOVE WAND WRO 300 H
Reason Wand connector not removed after completion
Action
402 INSUFFICIENT
WATER SUPPLY
WRO 300 H WRO 300 H stops, buzzer sounds with alarm
Reason Lack of feed water.
Action
Buzzer sounds with alarm sound, flashes,
message text displays.
of chemical intake.
1 Press , or to silence buzzer.
2 Remove wand from disinfectant intake port.
sound, flashes, message text displays.
1 Press , or to silence buzzer.
2 Check the feed water supply. 3 Check for leakage. 4 Restart by pressing .
5 Notify technical personnel if problem per-
sists.
42
P/N 3027436 Rev. C
WRO 300 H
Alarm and
No.
notifications Definition
Troubleshooting
403 HIGH CONDUC-
TIVITY RINSE
404 RINSE
REQUIRED
405 INCORRECT
WATER LEVEL
WRO 300 H
Reason Conductivity value is above conductivity notifi-
Action
WRO 300 H
Reason The WRO is filled with chemicals.
Action
WRO 300 H WRO 300 H stops, buzzer sounds with alarm
Reason Water level in tank is lower than expected.
Action
Buzzer sounds with alarm sound, flashes,
message text displays.
cation limit after a prolonged rinse.
1 Press , or to silence buzzer.
2 Perform an extra rinse by pressing
until rinse starts.
3 If problem persists notify technical person-
nel.
Buzzer sounds with alarm sound, and
flashes, message text displays.
1 Press , or to silence buzzer.
2 Perform rinse by pressing until rinse
starts.
sound, and flashes, message text
displays.
1 Press , or to silence buzzer.
2 Check that the dialysis machine is turned
off
406 INSUFFICIENT
INTAKE
3 Press to restart. 4 If the problem persists notify technical per-
sonnel.
WRO 300 H
Reason The product water conductivity is below the
Action
Buzzer sounds with alarm sound,
flashes, message text displays.
minimum intake conductivity limit.
1Press ,
2 If the disinfection wand is inserted and
is pressed a second intake phase is started.
3 If the disinfection wand is not inserted and
is pressed the WRO continues to
dwell period.
or to silence buzzer.
and
P/N 3027436 Rev. C
43
Troubleshooting
No.
WRO 300 H
Alarm and notifications Definition
407 INSUFFICIENT
TEMPERATURE
408 INSERT WAND WRO 300 H WRO 300 H stops, buzzer sounds with alarm
WRO 300 H
Reason The temperature during Warm acid cleaning
Action
Reason A central chemical disinfection has been initi-
Action
Buzzer sounds with alarm sound, flashes,
message text displays.
has not reached above the preset limit.
1Press ,
2 Notify technical personnel.
sound, flashes, message text displays.
ated via the remote control and the disinfection wand is not inserted.
1Press , or to silence buzzer.
2 Insert the disinfection wand to continue the
central chemical disinfection procedure.
or to silence buzzer.
5.2 Boot Loader
This alarm indicates that the software is corrupt.
Alarm and
No.
notifications Definition
LOAD APPLICA­TION FAILED
WRO 300 H LOAD APPLICATION FAILED is
shown on the display.
Reason Software malfunction.
Action Notify technical personnel.
44
P/N 3027436 Rev. C
WRO 300 H
Check List
6 Check List
Serial no
Check conductivity with separate instrument
Feed water Product water Reject
Date
Hours in operation
Conductivity S/cm
Temp °C
Conductivity S/cm
Flow l/min
Flow l/min
Rejection rate %
Remarks
P/N 3027436 Rev. C
45
Check List
WRO 300 H
This page is blank.
46
P/N 3027436 Rev. C
WRO 300 H
Index
Index
A
Acid cleaning . . . . . . . . . . . . . . . . . . . . 24
Alarm Types
Alarm
. . . . . . . . . . . . . . . . . . . . . . . 10
Info . . . . . . . . . . . . . . . . . . . . . . . . . 10
Notification Stop
Alarm types . . . . . . . . . . . . . . . . . . . . . 10
Alarms and notifications
Chemical
General . . . . . . . . . . . . . . . . . . . . . 39
Heat Operation Preservation
Rinse . . . . . . . . . . . . . . . . . . . . . . . 42
Alkaline cleaning Auto flush
. . . . . . . . . . . . . . . . . . . 10
. . . . . . . . . . . . . . . . . . . . . . . . 10
. . . . . . . . . . . . 39
. . . . . . . . . . . . . . . . . . . . 42
. . . . . . . . . . . . . . . . . . . . . . . . 41
. . . . . . . . . . . . . . . . . . . . 40
. . . . . . . . . . . . . . . . . . 42
. . . . . . . . . . . . . . . . . 25
. . . . . . . . . . . . . . . . . . . . . 9, 27
B
Boot loader . . . . . . . . . . . . . . . . . . . . . 44
Buttons
. . . . . . . . . . . . . . . . . . . . . . . . . 12
C
Central Chem . . . . . . . . . . . . . . . . . . . . 24
Check list . . . . . . . . . . . . . . . . . . . . . . . 45
Chemical disinfection
Central Chem
Cleaning . . . . . . . . . . . . . . . . . . . . . 24, 42
Acid
. . . . . . . . . . . . . . . . . . . . . . . . 24
Alkaline
Complete rinse-out . . . . . . . . . . . . . . . 27
Conductivity
Alarm
. . . . . . . . . . . . . . . . . . . . . . . 11
Monitoring
Notification . . . . . . . . . . . . . . . . . . . 10
Stop
. . . . . . . . . . . . . . . . . . . . . . . . 11
. . . . . . . . . . . . . . . . . 24
. . . . . . . . . . . . . . . . . . . . . . 25
. . . . . . . . . . . . . . . . . . . 10
M
Mains power switch . . . . . . . . . . . . . . . 12
Maintenance
Chemical disinfectants
Chemical disinfection . . . . . . . . . . . 18
Heat Disinfection
Manual Flush
. . . . . . . . . . . . . . . . . . . . . 17
. . . . . . . . . . 19
. . . . . . . . . . . . . . 17
. . . . . . . . . . . . . . . . . . . . 27
O
Operation . . . . . . . . . . . . . . . . . . . . . . . 15
Start
. . . . . . . . . . . . . . . . . . . . . . . . 15
Stop
. . . . . . . . . . . . . . . . . . . . . . . . 15
Operational data
Operator’s panel . . . . . . . . . . . . . . . . . . 12
. . . . . . . . . . . . . . . . . . 14
P
Preservation . . . . . . . . . . . . . . . . . . . . . 26
Preservation Procedure
. . . . . . . . . . . . 26
R
Reminders . . . . . . . . . . . . . . . . . . . . . . 14
Residual test
Chemical disinfection
Cleaning . . . . . . . . . . . . . . . . . . . . . 25
Restart
. . . . . . . . . . . . . . . . . . . . . . . . . 22
Rinse
Preservation
. . . . . . . . . . . . . . . . . . 26
. . . . . . . . . . . 23
T
Technical data . . . . . . . . . . . . . . . . . . . 29
Chemical disinfection and Cleaning
Environmental data . . . . . . . . . . . . . 34
Performance and specification Physical data Safety
Troubleshooting . . . . . . . . . . . . . . . . . . 39
. . . . . . . . . . . . . . . . . 33
. . . . . . . . . . . . . . . . . . . . . . . 38
33
. . . . 29
E
Exterior cleaning . . . . . . . . . . . . . . . . . 27
F
Flash indications . . . . . . . . . . . . . . . . . 13
I
Indications . . . . . . . . . . . . . . . . . . . . . . 13
Intended use
Interrupt . . . . . . . . . . . . . . . . . . . . . . . . 22
. . . . . . . . . . . . . . . . . . . . . 9
L
Long time Storage . . . . . . . . . . . . . . . . 26
Low rejection rate
Notification
P/N 3027436 Rev. C
. . . . . . . . . . . . . . . . . . . 11
W
Warm Acid cleaning . . . . . . . . . . . . . . . 24
47
Index
WRO 300 H
This page is blank.
48
P/N 3027436 Rev. C
Mar Cor Purification 4450 Township Line Road Skippack, PA 19474-1429 Tel: (484) 991-0220 Toll Free: (800) 633-3080 Fax: (484) 991-0230
Mar Cor Purification 14550 28th Avenue North Plymouth, MN 55447 Tel: (484) 991-0220 Toll Free: (800) 633-3080 Fax: (763) 210-3868
Visit http://www.mcpur.com or call 1-800-633-3080 for more information.
Mar Cor Purification 1119 Paulsun Street San Antonio, TX 78219 Tel: (210) 227-3601 Toll Free: (800) 268-5035 Fax: (210) 227-0735
Mar Cor Purification 160 Stedman Street Lowell, MA 01851 Tel: (978) 453-9600 Toll Free: (800) 633-3080 Fax: (978) 453-1223
©2012 Mar Cor Purification, Inc. All rights reserved P/N 3027436 Rev. C
Mar Cor Purification 6351 Orangethorpe Ave. Buena Park, CA 90620 Tel: (714) 736-9990 Toll Free: (800) 633-3080 Fax: (714) 736-9402
Loading...