Gambro WRO 300 H Manual
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Gambro WRO 300 H Manual

Gambro WRO 300 H Manual

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Contact information
(To be filled in by the hospital/clinic)
If you need assistance in setting up, using or maintaining the
WRO 300 H; or if you want to report unexpected operation or
events, please refer to:
Postal address:
Phone number and/or web contact address:
HCEN12481-02/2012
WRO 300 H

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Summary of Contents for Gambro WRO 300 H

  • Page 1 Contact information (To be filled in by the hospital/clinic) If you need assistance in setting up, using or maintaining the WRO 300 H; or if you want to report unexpected operation or events, please refer to: Postal address: Phone number and/or web contact address:...
  • Page 2 WRO 300 H This page is intentionally left blank Contact information HCEN12481-02/2012...
  • Page 3 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, HCEN12482 Installation Guide WRO 300 / WRO 300 H, HCEN12479 Definitions of expressions in the manual...
  • Page 4 • 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 5 During transportation and storage the equipment must be kept in its original packing. • 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 6 ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function”. For WRO 300 H, the applied part is the product water. Handle with care This way up...
  • Page 7 Input /Output Manufacturer. Year of manufacturing Year of manufacturing The WRO 300 H is protected against solid foreign objects IP21 ≥ 12.5 mm Ø and vertically falling water drops This symbol indicates that the water purification unit WRO 300 H contains toxic or hazardous substances or elements.
  • Page 8 WRO 300 H Stacking limit by number (n = 3) Temperature limit Humidity limitation Atmospheric pressure limitation No pushing, risk for overbalance No sitting, risk for overbalance Serial number Catalogue number HCEN12481-02/2012...
  • Page 9 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 10 WRO 300 H 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 HCEN12481-02/2012...

  • Page 11: Table Of Contents

    3.2.4 Central Chem............34 3.3 Cleaning ................35 3.3.1 Warm Acid cleaning..........35 3.3.2 Acid Cleaning agents recommended by Gambro ..35 3.3.3 Alkaline cleaning ............. 36 3.3.4 Alkaline Cleaning agents recommended by Gambro..36 3.3.5 Cleaning procedure ..........37 3.4 Long time Storage...
  • Page 12 WRO 300 H 3.4.3 Check for complete rinse-out........39 3.5 Flush ................40 3.5.1 Manual Flush ............40 3.5.2 Auto flush..............40 3.6 Exterior cleaning ............. 40 4 Technical data ............... 41 4.1 Performance and specification ........41 4.2 Chemical disinfection and Cleaning .......

  • Page 13: Introduction

    WRO 300 H 1 Introduction 1.1 Intended use The WRO 300 H (including the loop), is designed to be used as a dialysis accessory device to produce product water by using the reverse osmosis concept. The device can be used in conjunc-...

  • Page 14: 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 15: Signal Types

    WRO 300 H 1.2.1 Signal types All signals belong to one of the two types Low priority alarm and Information signal. For details about specific low priority alarms and information signals, refer to“Low priority alarms and information signals” on page...

  • Page 16: 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 17 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 18: Mains Power Switch

    Mains power switch Fig.1.1 Mains power switch and fuses CAUTION Make sure not to position the WRO 300 H in a way that it becomes difficult to operate the mains power switch. 1.2.4 Fuses The fuses F1 and F2 (T10A250V or T15A125V) are located as depicted in Fig.1.1“Mains power switch and fuses”...

  • Page 19: 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).

  • Page 20: Description Of Indications

    WRO 300 H 1.3.2 Description of indications Indications Description Indicates that the WRO 300 H is ener- Green Steady light gized. RUN mode, Auto flush or Manual Flush in Steady light progress. Green The Auto flush function and/or automated Slow flash Run by Time channels are activated.

  • Page 21: Reminders

    WRO 300 H Definition of flash indications Time Flash indication Slow flash 0.4 sec 2.0 sec Medium flash 0.4 sec 0.4 sec 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.

  • Page 22: 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 “Troubleshooting” on page using the . Refer to By using , the operational data can be scrolled and viewed in the display.

  • Page 23: Operation

    If Remote start/stop is provided, WRO 300 H will start auto- matically 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).
  • Page 24 WRO 300 H This page is intentionally left blank Operation HCEN12481-02/2012...

  • Page 25: 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 pro- duct water.

  • Page 26: 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 27: 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 28: 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 29: Chemical Disinfection Procedure

    However note the caution below. WARNING If the WRO 300 H is not disconnected from the dialysis machine du- ring 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 30 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 31 WRO 300 H 9 Initiate the disinfectant intake by pressing until light goes on. CHEM INTAKE 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 32 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 33: Residual Test After Chemical Disinfection

    3.2.3 Residual test after Chemical disinfection WARNING 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 34: 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 35: Cleaning

    For procedure refer to “Cleaning procedure” on page NOTE Other cleaning agents may also be used for the WRO 300 H, pro- vided that they are approved by the manufacturer for cleaning of thin film composite reverse osmosis membranes made of modified polya- mide.

  • Page 36: Alkaline Cleaning

    “Cleaning procedure” on page For procedure refer to NOTE Other cleaning agents may also be used for the WRO 300 H, pro- vided that they are approved by the manufacturer for cleaning of thin film composite reverse osmosis membranes made of modified polya- mide.

  • Page 37: 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 Let the WRO run in normal operation for at least 5 minutes.

  • Page 38: 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. WARNING Preservation agents may be toxic.

  • Page 39: 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 40: 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 41: 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 42 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 43 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 44 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 HCEN12481-02/2012...
  • Page 45 WRO 300 H Values Mains Voltage 100/115/220-240V (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 46 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- External equipment tems should comply with IEC 60601-1-1.

  • Page 47: 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 ® - Minncare Cold Sterilant Disinfection - 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.

  • Page 48: 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 49: 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 50 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 51 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 52 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 53 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 54 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 55: Safety

    2 % Memstor™, at least 9 % gly- cerol and remaining part RO- water. At least eight (8) years when handled and maintained according WRO 300 H expected service life to procedures recommended by the manufacturer. Technical data HCEN12481-02/2012...
  • Page 56 WRO 300 H This page is intentionally left blank Technical data HCEN12481-02/2012...

  • Page 57: Troubleshooting

    WRO 300 H 5 Troubleshooting In alarm situations, one of the two signal types Low priority alarm and Information signal will be issued. Also, message text will appear in the display. Only the latest message will be visi- ble in the display. By using the buttons the display will be unlocked and the alarm list can be scrolled.

  • Page 58: General

    Press to silence buzzer Restart unit, or notify technical personnel. : N INTERNAL WRO 300 H WRO 300 H stops, low priority alarm or infor- ERROR mation signal is issued, flashes, message text is displayed. Alarm sys- Between 5 seconds and 60 minutes.
  • Page 59 WRO 300 H Alarm No. Display text Definition type 104 INVALID WRO 300 H WRO 300 H stops, low priority alarm is WATER LEVEL issued, flashes, message text is displayed. Alarm sys- 45 seconds tem delay Reason Failure of level switch in tank.

  • Page 60: Operation

    WRO 300 H 5.1.3 Operation Alarm No. Display text Definition type 201 CONDUC- WRO 300 H When entering Standby mode, information TIVITY NOTIFI- signal is issued, flashes, message text CATION is displayed. Alarm sys- 30 seconds tem delay Reason The conductivity value has exceeded the notification limit for more than 30 consecutive seconds during previous run period.
  • Page 61 WRO 300 H Alarm No. Display text Definition type 203 CONDUC- WRO 300 H WRO 300 H stops, low priority alarm is TIVITY STOP issued, flashes, message text is displayed. Alarm sys- 30 seconds tem delay Reason The conductivity value has exceeded the stop limit for more than 30 consecutive sec- onds.
  • Page 62 WRO 300 H Alarm No. Display text Definition type 205 LOW WRO 300 H When entering Standby mode, information REJECTION signal is issued, flashes, message text RATE is displayed. Alarm sys- 5 minutes tem delay Reason Decreased membrane performance. Action...

  • Page 63: Heat And Low Flow Heat

    Press until WRO 300 H either goes to Standby or an Active Cooldown. 302 INSUFFI- WRO 300 H WRO 300 H stops, low priority alarm is CIENT WATER issued, flashes, message text is SUPPLY displayed. Alarm sys-...
  • Page 64 Alarm sys- None tem delay 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 65: Chemical, Cleaning, Rinse And Preservation

    Chemical intake. Action Press to silence buzzer Remove wand from disinfectant intake port. 402 INSUFFI- WRO 300 H WRO 300 H stops, low priority alarm is CIENT WATER issued, flashes, message text is SUPPLY displayed. Alarm sys- None...
  • Page 66 WRO 300 H Alarm No. Display text Definition type 403 HIGH CON- WRO 300 H Low priority alarm is issued, flashes, DUCTIVITY message text is displayed. RINSE Alarm sys- None tem delay Reason Conductivity value is above Conductivity. Notification limit after a prolonged rinse.
  • Page 67 WRO 300 H Alarm No. Display text Definition type 405 INCOR- WRO 300 H Low priority alarm is issued, RECT WATER flash, message text is displayed. LEVEL Alarm sys- None tem delay Reason Water level in tank is lower than expected.
  • Page 68 Action Press to silence buzzer Notify technical personnel. 408 INSERT WRO 300 H WRO 300 H stops, low priority alarm is WAND issued, flashes, message text is displayed. Alarm sys- None tem delay...

  • Page 69: Perform Residual Test

    5.1.6 Perform residual test Alarm Display text Definition type “None” PERFORM WRO 300 H The WRO 300 H unit stops, low priority RESIDUAL alarm is issued, flashes, message TEST text is displayed. The indication will remain steady lit and the will flash.

  • Page 70: Start Up Error

    WRO 300 H 5.1.8 Start up error Alarm Display text Definition type “None” WRO 300 WRO 300 H The display will show “WRO 300” and the LED’s on the operator’s panel will be lit. Alarm system None delay Reason One reason could be:...

  • Page 71: Check List

    WRO 300 H 6 Check list Serial no:....... Check conductivity with separate instrument Feed water Product water Reject Check list HCEN12481-02/2012...
  • Page 72 WRO 300 H Feed water Product water Reject Check list HCEN12481-02/2012...

  • Page 73: Index

    WRO 300 H Index Acid cleaning Heat disinfection Alarm types Alarms and notifications Indications Chemical Intended use General Interrupt Heat and Low Flow Heat Operation Preservation Long time Storage Rinse Low Flow Heat Alkaline cleaning Low rejection rate Auto flush...
  • Page 74 WRO 300 H Technical data Chemical disinfection Cleaning Environmental data Performance and specification Physical data Safety Troubleshooting Warm Acid cleaning Index HCEN12481-02/2012...

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