Gambro WRO 300 H Operator's Manual

Gambro WRO 300 H Operator's Manual

Wro 300 h water purification unit operator manual
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Preface
This manual provides the information needed to operate the
WRO 300 H water purification unit.
Valid program version
Other manuals for WRO 300 H
The list below shows all manuals related to this Operator's
Manual.
Service Manual
Installation Guide
Definitions of expressions in the manual
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.
HCEN12104 Rev 09.2010
4.x
WRO 300 / WRO 300 H, HCEN12073
WRO 300 / WRO 300 H, HCEN12115
Preface
WRO 300 H

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Table of Contents
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Summary of Contents for Gambro WRO 300 H

  • Page 1 Other manuals for WRO 300 H The list below shows all manuals related to this Operator’s Manual. Service Manual WRO 300 / WRO 300 H, HCEN12073 Installation Guide WRO 300 / WRO 300 H, HCEN12115 Definitions of expressions in the manual...
  • Page 2 • 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.
  • Page 3 • 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.
  • Page 4 WRO 300 H 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...
  • Page 5 WRO 300 H 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.
  • Page 6 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.
  • Page 7 WRO 300 H Trademarks ® ULTRASIL is a trademark of Ecolab registered in several countries includ- ing Australia and Canada Manufacturer Gambro Lundia AB Box 10101 Magistratsvägen 16 SE-220 10 LUND Sweden. Phone +46 46 16 90 00. Fax +46 46 16 96 96 www.gambro.com...
  • Page 8 WRO 300 H HCEN12104 Rev 09.2010...
  • Page 9: Table Of Contents

    WRO 300 H 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 .........
  • Page 10 WRO 300 H 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 ..............
  • Page 11: Introduction

    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.
  • Page 12: General

    WRO 300 H 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 •...
  • Page 13: Alarm Types

    WRO 300 H 1.2.1 Alarm types Notification Next time the WRO goes to Standby the buzzer sounds, flashes and the message text will be displayed. Buzzer Sound Description Notification Info The WRO continues in the current mode. The message text will be displayed.
  • Page 14: Conductivity Monitoring

    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. 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.
  • Page 15 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.
  • Page 16: Mains Power Switch

    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.
  • Page 17: Operator's Panel

    WRO 300 H 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).
  • Page 18: Description Of Indications

    WRO 300 H 1.3.2 Description of indications Indications Description Indicates that the WRO 300 H is energized. Green General RUN mode, Auto flush or Manual Flush in Steady light progress. The Auto flush function is activated. (only in Green Slow flash Standby mode) Insufficient feed water supply.
  • Page 19: Reminders

    WRO 300 H 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.
  • Page 20: Operational Data

    WRO 300 H 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 . Refer to “Troubleshooting” on page By using the operational data can be scrolled and viewed in the display.
  • Page 21: Operation

    WRO 300 H will start automatically when requested from the dialysis machine. 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.
  • Page 22: Stop

    WRO 300 H 2.2 Stop Press until light goes out and the WRO 300 H goes to Standby mode. STANDBY NOTE If power failure occurs during operation mode the procedure contin- ues in the same phase as when the power failure occurred when the WRO 300 H starts up again.
  • Page 23: Regular Maintenance

    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 prod- uct water.
  • Page 24: Heat Disinfection

    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. 1 Press until SELECT is shown in the display and starts to flash.
  • Page 25: Low Flow Heat

    Low Flow Heat starts to heat the water in the outlet product water line and supplies hot water to the dialysis machine’s inlet parts. For more detailed information on how to perform Low Flow Heat together with Gambro Dialysis machines, please refer to separate instructions for Low Flow Heat. Procedure NOTE If power failure occurs during Low Flow Heat procedure the Low Flow Heat restarts when the power is restored.
  • Page 26: Chemical Disinfection

    3.2 Chemical disinfection For certain peracetic acid disinfectants the manufacturer recom- mends that the WRO 300 H should be cleaned with an acid cleaning agent per the cleaning instructions prior to Chemical disinfection to preserve the RO membrane. Refer to “Cleaning”...
  • Page 27: Chemical Disinfection Procedure

    However note the caution below. CAUTION If the WRO 300 H is not disconnected from the dialysis machine dur- ing the Chemical disinfection procedure, the test for residuals after the Chemical disinfection procedure must be performed on the dialy- sis machine according to the operator’s manual of this device.
  • Page 28 WRO 300 H 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. Insert the connector and press...
  • Page 29 WRO 300 H 9 Initiate the disinfectant intake by pressing until light goes on. CHEM INTAKE μS NOTE The display shows present phase of the Chemical disinfection proce- dure. NOTE The container can be empty before the intake phase is finished.
  • Page 30 WRO 300 H 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.
  • Page 31: Residual Test After Chemical Disinfection

    3.2.3 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 performed on the dialysis machine according to the operator’s manual of the dialysis machine.
  • Page 32: Central Chem

    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.
  • Page 33: Cleaning

    RO membrane prior to Chemical disinfection. Dissolve 100 ml of citric acid in 200 ml of product water from the WRO 300 H. This will result in a 2 % solution in the WRO 300 H. For procedure refer to “Cleaning procedure”...
  • Page 34: Cleaning Procedure

    NOTE The container can be empty before the intake phase is finished. Test for residuals 1 Press until light goes on, to start the WRO 300 H. Indication will be steady lit and will flash. 2 Collect a water sample from the product water line.
  • Page 35: Long Time Storage

    WRO 300 H 3.4 Long time 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...
  • Page 36: Rinse After Preservation

    WRO 300 H 3.4.2 Rinse after preservation 1 Turn on the WRO 300 H on the mains power switch behind the detachable cover. 2 The indication flashes and the display shows 404 RINSE REQUIRED. 3 Press until light goes on to initiate rinse.
  • Page 37: Flush

    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 %) or isopropanol (60 %). NOTE Do not use iodine-based or tenside-containing disinfectants as these may crack or discolour the plastic materials.
  • Page 38 WRO 300 H Regular maintenance HCEN12104 Rev 09.2010...
  • Page 39: Technical Data

    Maximum 20 metres (2 x 10 m) insulated* *under the following conditions; - by Gambro recommended insulation shall be used - the minimum feed water temperature is + 10 °C Product water - the minimum ambient temperature is + 18 °C Product water pressure 0.12 to 0.6 MPa (15 to 85 PSI) dur-...
  • Page 40 WRO 300 H Values Input Min. 3.0 l/min required Feed Water Pressure During operation 0.15 to 0.3 MPa (20 to 45 PSI) There is an inlet flow of water into the WRO unit. Maximum design pressure: 0.8 MPa (115 PSI) If the feed water pressure exceeds 0.3 MPa (45 PSI), a flow regulator,...
  • Page 41 WRO 300 H Values Drain output flow during 1.2 ± 0.1 l/min RUN mode Height difference Max. 1.0 m between the drain hose outlet and the WRO Drain 300 H drain outlet. Drain (length of hose) Max. 5 m Drain flow capacity Min.
  • Page 42 WRO 300 H Values Operating range 0 to 105 ºC Temperature measurement Accuracy ± 4 ºC Membrane material Polyamide, thin film composite Reverse osmo- Membrane configuration Spiral wound sis module Membrane pH tolerance 2 to 11 Technical data HCEN12104 Rev 09.2010...
  • Page 43 WRO 300 H Values Mains Voltage 100 to 240 V AC (line voltage range 85 to 264 V AC) Frequency 50 or 60 Hz (line frequency range 45 to 65 Hz) Power Consumption Max 1500 W (100 V AC) 1380 W (115 V AC)
  • Page 44 Max Current ±5 mA DC External connector 8 pins REDEL, green. Accessory equipment connected to the WRO 300 H should comply with relevant standards (e.g. IEC 60950 for data processing equip- ment). Furthermore, medical sys- tems should comply with IEC External equipment 60601-1-1.
  • Page 45: Chemical Disinfection And Cleaning

    WRO 300 H 4.2 Chemical disinfection and Cleaning The following disinfectants may be administered via the chemical intake ® - DIALOX , undiluted (Not available for sale in the USA) ® Disinfection - MINNCARE Cold Sterilant - Other peracetic acid disinfectants, provided that they...
  • Page 46: Physical Data

    WRO 300 H 4.3 Physical data Measurements Values 33 kg Weight 563 mm Height Max 520 mm Depth Footprint 380 mm Max 205 mm Width Footprint 185 mm Approximately 3.5 litres excluding the product Internal fluid volume water loop 4.3.1...
  • Page 47: Environmental Data

    4.4.1 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 Compliance...
  • Page 48 WRO 300 H Value RF emissions Class B The WRO 300 H is suitable for use in all establish- CISPR 11 ments, including domestic establishments and those directly connected to the public low-voltage power Harmonic Class A (Not supply network that supplies buildings used for...
  • Page 49 WRO 300 H Value Power fre- 3 A/m 3 A/m Power frequency magnetic fields quency should be at levels characteristic of (50/60 Hz) a typical location in a typical com- magnetic field mercial or hospital environment. IEC 61000-4-8 Electromagnetic environment-...
  • Page 50 WRO 300 H Value Radiated RF 30 V/m Field strengths from fixed RF mobile phones transmitters, as determined by an electromagnetic site survey should be less than the compli- ance level in each frequency range Interference may occur in the vicin-...
  • Page 51 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 port-...
  • Page 52: Safety

    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.
  • Page 53: Troubleshooting

    Check that the product water conductivity is within normal range. If so, continue as normal but notify technical personnel. HIGH LEVEL WRO 300 H WRO 300 H stops, buzzer sounds with Stop SENSOR FAIL- sound, flashes, message text is displayed.
  • Page 54 WRO 300 H Alarm and Definition notifications : N INTERNAL WRO 300 H WRO 300 H stops, buzzer sounds with Stop sound, flashes, ERROR message text is displayed. Reason Control unit failure. Action Press to silence buzzer Restart unit, or notify technical person- nel.
  • Page 55: Operation

    WRO 300 H 5.1.2 Operation Alarm and Definition notifications CONDUCTIVITY WRO 300 H When entering Standby mode, buzzer NOTIFICATION sounds with Notification sound, flashes, message text is displayed. Reason The conductivity value has exceeded the notification limit for more than 30 consecutive seconds during previous run period.
  • Page 56 WRO 300 H Alarm and Definition notifications CONDUCTIVITY WRO 300 H WRO 300 H stops, buzzer sounds with Alarm STOP sound, flashes, message text is displayed. Reason The conductivity value has exceeded the stop limit for more than 30 consecutive sec- onds.
  • Page 57 WRO 300 H Alarm and Definition notifications LOW PRODUCT WRO 300 H When entering Standby mode, buzzer FLOW sounds with Notification sound, flashes, message text is displayed. Reason The product water flow is below the preset notification limit which indicates that the per- formance of the membrane is reduced.
  • Page 58: Heat And Low Flow Heat

    Power failure. Action Press to silence buzzer Press until light goes on. The WRO 300 H either goes to Standby or an Active Cooldown. INSUFFICIENT WRO 300 H WRO 300 H stops, buzzer sounds with Alarm WATER SUPPLY sound, flashes,...
  • Page 59 Notification sound, flashes, message text is displayed. Reason Heat disinfection procedure is activated auto- matically by time channel settings but cannot be started because the WRO 300 H is not in Standby mode. Action Press to silence buzzer Activate Heat disinfection procedure manually.
  • Page 60: Chemical, Cleaning, Rinse And Preservation

    Chemical intake. Action Press to silence buzzer Remove wand from disinfectant intake port. INSUFFICIENT WRO 300 H WRO 300 H stops, buzzer sounds with Alarm WATER SUPPLY sound, flashes, message text is displayed. Reason Lack of feed water Action Press...
  • Page 61 Perform rinse by pressing until rinse starts. INCORRECT WRO 300 H WRO 300 H stops, buzzer sounds with Alarm WATER LEVEL sound, flashes, message text is displayed Reason Water level in tank is lower than expected. Action...
  • Page 62 Press to silence buzzer Notify technical personnel. INSERT WAND WRO 300 H WRO 300 H stops, buzzer sounds with Alarm sound, flashes, message text is dis- played. Reason A Central Chemical disinfection has been ini- tiated via the remote control and the Disinfec- tion Wand is not inserted.
  • Page 63: Boot Loader

    WRO 300 H 5.2 Boot loader This alarm indicate that the software is corrupt. Alarm and Definition notifications LOAD APPLICA- WRO 300 H LOAD APPLICATION FAILED is shown on TION FAILED the display Reason Software malfunction Action Notify technical personnel.
  • Page 64 WRO 300 H Troubleshooting HCEN12104 Rev 09.2010...
  • Page 65: Check List

    WRO 300 H 6 Check list Serial no:....... Check conductivity with separate instrument Feed water Product water Reject Check list HCEN12104 Rev 09.2010...
  • Page 66 WRO 300 H Feed water Product water Reject Check list HCEN12104 Rev 09.2010...
  • Page 67: Index

    WRO 300 H Index Acid cleaning Flash indications Alarm types Alarms and notifications Heat disinfection Chemical General Heat and Low Flow Heat Indications Operation Intended use Preservation Interrupt Rinse Alkaline cleaning Auto flush Long time Storage Low Flow Heat Low rejection rate...
  • Page 68 WRO 300 H Rinse Preservation Technical data Chemical disinfection Cleaning Environmental data Performance and specification Physical data Safety Troubleshooting Warm Acid cleaning Index HCEN12104 Rev 09.2010...

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