Gambro WRO 300 User manual

WRO 300 H
HCEN12104 Rev 09.2010 Preface
Preface
This manual provides the information needed to operate the
WRO 300 H water purification unit.
Other manuals for WRO 300 H
The list below shows all manuals related to this Operator’s
Manual.
Definitions of expressions in the manual
Valid program version 4.x
Service Manual WRO 300 / WRO 300 H, HCEN12073
Installation Guide WRO 300 / WRO 300 H, HCEN12115
WARNING
Is used to alert the user/operator 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/operator 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/operator not to take a certain action to avoid the potential
hazard as above.
NOTE
A reminder to the user/operator on normal treatment activity and on
what is a suitable action in a particular situation.

WRO 300 H
Preface HCEN12104 Rev 09.2010
Safety considerations
WARNING
Unauthorized installation, modifications, alterations or repair of the
WRO 300 H may result in malfunctioning or have other serious con-
sequences 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.
CAUTION
• WRO 300 H may be operated only by persons who have studied the
instructions in this manual 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 Gambro´s written instructions. Any warranties made
by Gambro with respect to the WRO 300 H are voided if the equipment is
not used in accordance with the written instructions provided. Gambro 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.
• For USA: US Federal law restricts this device to sale by or on the order of
a physician.

WRO 300 H
HCEN12104 Rev 09.2010 Preface
NOTE
• During transportation and storage the equipment must be kept in its orig-
inal 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 / WRO 300 H Service Manual
is available. The Service Manual provides all of the necessary informa-
tion for the safe and required maintenance of the machine.
• The WRO 300 H is intended for continuous operation

WRO 300 H
Preface HCEN12104 Rev 09.2010
List of symbols
Alternating current
Protective earth (ground)
Warning, consult accompanying documents
Off (power, disconnection from the mains)
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

WRO 300 H
HCEN12104 Rev 09.2010 5
Year of manufacturing
The WRO 300 H is protected against dripping water
This symbol indicates that the water purification unit
WRO 300 H contains toxic or hazardous substances or
elements.
The figure 25 indicates the corresponding
environmental protection use period of the water
purification unit WRO 300 H.
(Valid for Main land China only)
Recycling symbol -General
Reject water connection
Feed water inlet connection
Loop connections (Product water outlet and return)
25
CB

WRO 300 H
6HCEN12104 Rev 09.2010
Certification marks
IPR - Intellectual Property Rights
The CE-conformity mark indicates that the WRO 300 H
water purification unit conforms to the requirements in the
EC Council Directive 93/42/EEC of 14 June, 1993 con-
cerning medical devices. It also indicates that the notified
body British Standards Institution (BSI, No. 0086) has
approved the Quality Management System. The CE con-
formity mark is only valid for the WRO 300 H water purifi-
cation unit. Disposables and any accessories specified
for use with the WRO 300 H water purification unit are
marked with CE conformity marks in their own right.
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.
Copyright
© 2005, 2007, 2010 Gambro Lundia AB
Trademarks
DIALOX®is a trademark registered in several countries, including Sweden,
United Kingdom and Japan by their respective owners
MINNCARE®is a trademark of Minntech registered in several countries
including United States and United Kingdom
MINNCLEAN®is a trademark of Minntech registered in several countries
including the United States
STERICHECK®is a trademark registered in several countries including the
United States and Japan by their respective owners

WRO 300 H
HCEN12104 Rev 09.2010 7
Manufacturer
Gambro Lundia AB
Box 10101
Magistratsvägen 16
SE-220 10 LUND
Sweden.
Phone [phone].
Fax [phone]
www.gambro.com
ULTRASIL®is a trademark of Ecolab registered in several countries includ-
ing Australia and Canada
Trademarks

WRO 300 H
8HCEN12104 Rev 09.2010

WRO 300 H
HCEN12104 Rev 09.2010 Content
Content
1 Introduction..................................................................... 11
1.1 Intended use .................................................................... 11
1.2 General ........................................................................... 12
1.2.1 Alarm types ............................................................. 13
1.2.2 Conductivity monitoring ........................................... 14
1.2.3 Mains power switch ................................................. 16
1.3 Operator’s panel .............................................................. 17
1.3.1 Description of buttons .............................................. 17
1.3.2 Description of indications ......................................... 18
1.3.3 Reminders ............................................................... 19
1.3.4 Operational data....................................................... 20
2 Operation ........................................................................ 21
2.1 Start ................................................................................. 21
2.2 Stop ................................................................................. 22
3 Regular maintenance .................................................. 23
3.1 Heat disinfection and Low Flow Heat ............................ 23
3.1.1 Heat disinfection ...................................................... 24
3.1.2 Low Flow Heat ........................................................ 25
3.2 Chemical disinfection ..................................................... 26
3.2.1 Approved chemical disinfectants ............................... 26
3.2.2 Chemical disinfection procedure................................ 27
3.2.3 Residual test after Chemical disinfection .................... 31
3.2.4 Central Chem........................................................... 32
3.3 Cleaning .......................................................................... 33
3.3.1 Warm Acid cleaning................................................. 33
3.3.2 Alkaline cleaning ..................................................... 33
3.3.3 Cleaning procedure .................................................. 34
3.4 Long time Storage ........................................................... 35
3.4.1 Preservation............................................................. 35
3.4.2 Rinse after preservation ............................................ 36
3.4.3 Check for complete rinse-out..................................... 36

WRO 300 H
Content HCEN12104 Rev 09.2010
3.5 Flush ............................................................................... 37
3.5.1 Manual Flush ........................................................... 37
3.5.2 Auto flush................................................................ 37
3.6 Exterior cleaning ............................................................. 37
4 Technical data ............................................................... 39
4.1 Performance and specification ........................................ 39
4.2 Chemical disinfection and Cleaning ............................... 45
4.3 Physical data ................................................................... 46
4.3.1 Materials in contact with product water ...................... 46
4.4 Environmental data ......................................................... 47
4.4.1 Electromagnetic environment .................................... 47
4.5 Safety .............................................................................. 52
5 Troubleshooting............................................................. 53
5.1 Alarms and notifications ................................................. 53
5.1.1 General ................................................................... 53
5.1.2 Operation ................................................................ 55
5.1.3 Heat and Low Flow Heat .......................................... 58
5.1.4 Chemical, Cleaning, Rinse and Preservation ............... 60
5.2 Boot loader ...................................................................... 63
6 Check list......................................................................... 65
1 Index................................................................................. 67

WRO 300 H
HCEN12104 Rev 09.2010 Introduction 11
1 Introduction
1.1 Intended use
The Gambro 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, e.g. current AAMI and Federal
(U.S.) standards.
CAUTION
The water produced by WRO 300 H should be analysed at installa-
tion and on a regular basis to verify that it conforms to applicable reg-
ulations or standards for water for dialysis.

WRO 300 H
12 Introduction HCEN12104 Rev 09.2010
1.2 General
The WRO 300 H has been designed to fulfil the special require-
ments of dialysis setting. For this purpose 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 operat-
ing, monitoring, cleaning, disinfecting and troubleshooting this
device from an operator’s perspective. For installation instruc-
tions refer to separate Installation Guide.

WRO 300 H
HCEN12104 Rev 09.2010 Introduction 13
1.2.1 Alarm types
Notification
Next time the WRO goes to Standby the buzzer sounds,
flashes and the message text will be displayed.
Info
The WRO continues in the current mode. The message text will
be displayed.
Alarm
The WRO continues in the current mode. The buzzer sounds,
flashes and the message text will be displayed.
Stop
The WRO stops. The buzzer sounds, flashes and the
message text will be displayed.
Buzzer Sound Description
Notification
Buzzer Sound Description
Alarm
Buzzer Sound Description
Stop

WRO 300 H
14 Introduction HCEN12104 Rev 09.2010
1.2.2 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 to 60 µS/cm from factory. With this set-
ting the WRO 300 H will stop without any previous warning if
the product water conductivity exceeds this value.
Conductivity notification
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 such as incipient fouling, degrada-
tion of the RO membrane or change in the feed water quality.
Conductivity alarm
The clinic's predefined maximum product water conductivity
for water for dialysis has been exceeded for more than 30 con-
secutive seconds. An audible and visual alarm will be issued.
The WRO 300 H will, however, continue in operation to allow
for finishing the dialysis treatment. The buzzer can be muted
indefinitely by pressing , or , however the button
remains lit to indicate that the alarm persists.
NOTE
If the notification, alarm and stop limits are set to the same value the
priority of the action are in the order of stop, alarm and notification.
NOTE
If the feed water conductivity is known to vary significantly, the con-
ductivity notification limit should be inactivated by setting it at the
same value as the conductivity alarm, see below.

WRO 300 H
HCEN12104 Rev 09.2010 Introduction 15
Conductivity stop
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, but
the alarm will reappear and the WRO 300 H will stop after 30
seconds if the conductivity remains over the limit.
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.
Low rejection rate notification
The rejection rate is the reduction (in %) 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-mem-
brane.

WRO 300 H
16 Introduction HCEN12104 Rev 09.2010
The Low rejection rate notification default setting of 90 % is
relevant for most inlet water supplies. It may, however, need to
be adjusted at installation to a lower value by a qualified techni-
cian to fit local conditions, especially in cases of low feed water
conductivity (<100 µS/cm). The limit should be set at least 5 %
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.
1.2.3 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.
Mains power switch

WRO 300 H
HCEN12104 Rev 09.2010 Introduction 17
1.3 Operator’s panel
1.3.1 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 SELECT (only in Standby mode)
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.
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 infor-
mation in the display. Press any arrow buttons to release the lock-
ing function.

WRO 300 H
18 Introduction HCEN12104 Rev 09.2010
1.3.2 Description of indications
Definition of flash indications
Indications Description
Green General Indicates that the WRO 300 H is energized.
Green
Steady light RUN mode, Auto flush or Manual Flush in
progress.
Slow flash The Auto flush function is activated. (only in
Standby mode)
Fast flash Insufficient feed water supply. (only in RUN
mode)
Yel-
low
Steady light Chemical disinfection, Heat disinfection,
Low Flow Heat or Cleaning is in progress.
Slow flash
The automated Heat disinfection by time
channels is activated. (only in Standby
mode)
Medium
flash
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 (404 RINSE
REQUIRED).
Red
Medium
flash
Unconfirmed notification, info, alarm or stop
conditions are present.
Steady light Notification, info, alarm or stop condition
has been confirmed.
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

WRO 300 H
HCEN12104 Rev 09.2010 Introduction 19
1.3.3 Reminders
Reoccurring 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 be displayed. Further information of setting the Reminders,
refer to Service Manual.
NOTE
After the reminder time has expired the notification message will only
appear once!

WRO 300 H
20 Introduction HCEN12104 Rev 09.2010
1.3.4 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 53.
By using or the operational data can be scrolled and
viewed in the display.
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.
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,
DAYS SINCE LAST a
a. Visible depending on settings
X
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