WRO 300 Water Purification Unit Operators Manual Rev 03.2007

WRO 300

Safety considerations WARNING Unauthorized installation, modifications, alterations or repair of the WRO 300 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 water purification unit must comply with IEC 60601-2-16.

CAUTION •

• •

•

•

•

WRO 300 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 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 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 could adversely influence the performance of the machine. See specification. WRO 300 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.

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 / WRO 300 H Service Manual is available. The Service Manual provides all of the necessary information for the safe and required maintenance of the machine.

Preface

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List of symbols NOTE All symbols in this list may not be represented on this product. 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

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Preface

WRO 300

Input /Output

Year of manufacturing

Reject water connection

Feed water inlet connection Loop connections (Product water outlet and return)

Certification marks The CE-conformity mark indicates that the WRO 300 water purification unit conforms to the requirements in the EC Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices. It also indicates that the notified body British Standards Institution (BSI, No. 0086) has approved the Quality Management System. The CE conformity mark is only valid for the WRO 300 water purification unit. Disposables and any accessories specified for use with the WRO 300 water purification unit are marked with CE conformity marks in their own right. The CSA(C-US) mark indicates that the WRO 300 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 water purification unit have been evaluated to the applicable ANSI/UL and CSA standards for use in the US and Canada.

Preface

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IPR - Intellectual Property Rights Copyright © 2004-2007 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 ULTRASIL® is a trademark of Ecolab registered in several countries including Australia and Canada

Manufacturer Gambro Lundia AB Box 10101, SE-220 10 LUND, Sweden. Phone +46 46 16 90 00.

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Declaration of Conformity

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Content 1 Introduction ... 9 1.1 Intended use ... 9 1.2 General ... 10

1.2.1 Alarm types ... 10 1.2.2 Conductivity monitoring ... 11 1.2.3 Mains power switch ... 13 1.3 Operator’s panel ... 14 1.3.1 Description of buttons ... 14 1.3.2 Description of indications ... 15 1.3.3 Reminders ... 16 1.3.4 Operational data... 17

2 Operation ... 19 2.1 Start ... 19 2.2 Stop ... 19

3 Regular maintenance ... 21 3.1 Chemical disinfection ... 21

3.1.1 Approved chemical disinfectants ... 22 3.1.2 Chemical disinfection procedure... 23 3.1.3 Residual test after Chemical disinfection ... 27 3.1.4 Central Chem (Not available in the USA) ... 28 3.2 Cleaning ... 29 3.2.1 Acid cleaning... 29 3.2.2 Alkaline cleaning ... 29 3.2.3 Cleaning procedure ... 30 3.3 Long time Storage ... 31 3.3.1 Preservation... 31 3.3.2 Rinse after preservation ... 32 3.3.3 Check for complete rinse-out... 32 3.4 Flush ... 33 3.4.1 Manual Flush... 33 3.4.2 Auto flush ... 33

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3.5 Exterior cleaning ... 33

4 Technical data ... 35 4.1 Performance and specification ... 35 4.2 Chemical disinfection and Cleaning ... 40 4.3 Physical data ... 40 4.3.1 Materials in contact with product water ... 41

4.4 Environmental data ... 41

4.4.1 Electromagnetic environment ... 43 4.5 Safety ... 47

5 Troubleshooting... 49 5.1 Alarms and notifications ... 49

5.1.1 General ... 49 5.1.2 Operation ... 51 5.1.3 Chemical, Cleaning, Rinse and Preservation ... 54 5.2 Boot loader ... 57

6 Check list ... 59 1 Index ... 61

Content

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1

Introduction

1.1 Intended use The Gambro WRO 300 water purification unit is designed to be used as a dialysis accessory device to produce water, by using the reverse osmosis concept, used to dilute dialysis concentrate to prepare dialysis fluid. WRO 300 is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure requirement corresponds to the output of the WRO 300 unit. CAUTION The water produced by WRO 300 should be analysed at installation and on a regular basis to verify that it conforms to applicable regulations or standards for water for dialysis.

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1.2 General The WRO 300 has been designed to fulfil the special requirements of dialysis setting. For this purpose this device has the following features: • Simple user interface • Chemical disinfection and cleaning modes • Auto flush function during Standby periods to minimize stagnant water. This manual for WRO 300 includes instructions for operating, monitoring, cleaning, disinfecting and troubleshooting this device from an operator’s perspective. For installation instructions refer to separate Installation Guide.

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, sage text will be displayed.

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Introduction

flashes and the mes-

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1.2.2

Conductivity monitoring

The conductivity monitoring system in the WRO 300 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 setting the WRO 300 will stop without any previous warning if the product water conductivity exceeds this value. 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.

Conductivity notification Indicates that the product water conductivity is above normal reading. It will be issued when the WRO 300 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, 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.

Conductivity alarm 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 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.

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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 will stop. The alarm can be acknowledged by pressing , or . The WRO 300 can be restarted, but the alarm will reappear and the WRO 300 will stop after 30 seconds if the conductivity remains over the limit. • 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 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 which may be caused by incipient fouling or degradation of the RO-membrane.

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Introduction

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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 technician 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 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

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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 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 information in the display. Press any arrow buttons to release the locking function.

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Introduction

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1.3.2

Description of indications

Indications Green

Green

Description General

Indicates that the WRO 300 is energized.

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)

Steady light

Chemical disinfection or Cleaning is in progress. The disinfection wand connector is inserted into the chemical intake.

Yellow

Medium flash

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.

Definition of flash indications 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

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1.3.3

Reminders

Reoccurring notifications can be preset to remind the user to take certain actions, for example exchange cartridge in the prefilter. 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!

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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 49. 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 PRODUCT WATER FLOW

X% X ml/min

a

PRODUCT WATER TEMP

X °C X

CHEM, ACID CLEAN,

DAYS SINCE LAST b

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

a. A flow meter kit has to be installed b. 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.

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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.

RUN X µS/cm

If Remote start/stop is provided (not available in the USA), WRO 300 will start automatically when requested from the dialysis machine.

2.2 Stop Press mode..

until light goes out and the WRO 300 goes to Standby

STANDBY

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 starts up again.

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Operation

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