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 equip- ment. WARNING Dialysis machines that are supplied with water from the WRO 300 H water purification unit must comply with IEC 60601-2-16.
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.
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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)
US and Can- ada. The C and the US adjacent to the CSA mark indi- cates 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.
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...
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 noti- fication limit has been exceeded for more than 30 consecutive seconds during the previous run period.
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 con- tinue operation to allow for finishing the dialysis treatment. The buzzer can be muted indefinitely by pressing .
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.
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 Indicates that the WRO 300 H is energized. Green General RUN mode, auto flush or manual flush in Green Steady light progress.
Introduction WRO 300 H 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.
μS 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 pro- cedure will continue until the temprature is below 45 °C.
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Operation WRO 300 H This page is blank. P/N 3027436 Rev. C...
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, reg- ular automated heat disinfection preset by the time channels will main- tain the microbiological quality of the product water.
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.
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.
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Disconnect the quick connector WRO 300 H Nipple at the Dialysis machine 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...
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The container must be below the level of the chemical intake port to prevent siphoning chemical into the WRO 300 H unit. Container Disinfection Wand...
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Regular Maintenance WRO 300 H The table below explains how to pause, interrupt or restart the proce- dure: Action Pause of chemical Press until light flashes. To continue the intake intake phase press again until light goes on. Disconnect the wand connector and press...
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 resid- uals after the chemical disinfection procedure must be per- formed on the dialysis machine according to the Operator’s Manual of the dialysis machine.
Regular Maintenance WRO 300 H 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 dialysis machines, please contact Technical Service.
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.
3.4 Long Term Storage If the WRO 300 H will not be used for an extended period of time, reg- ular automated heat disinfection preset by the time channels, will main- tain the microbiological quality in the WRO.
WRO, if enabled in preset. At specified intervals the water circu- lates 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 etha- nol (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.
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WRO 300 H Regular Maintenance This page is blank. P/N 3027436 Rev. C...
WRO 300 H Technical Data 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...
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Technical Data WRO 300 H 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...
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WRO 300 H 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.
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Technical Data WRO 300 H 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 1500 W (100 VAC) 1380 W (115 VAC)
WRO 300 H Technical Data 4.2 Chemical Disinfection and Cleaning The following disinfectants may be administered via the chemical intake. ® • MINNCARE Cold Sterilant • Other peracetic acid disinfectants, provided that they are Disinfection approved by the manufacturer for disinfection of thin film composite reverse osmosis membranes made of modified polyamide.
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. Transportation...
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 envi- ronment. Emissions Electromagnetic environment —...
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Technical Data WRO 300 H Value Electromagnetic Immunity IEC 60601 Compliance test test level level environment —guidance Conducted 3 Vrms Portable and mobile RF communi- RFIEC 61000- cations equipment should be used 150 kHz to 80 no closer to any part of the WRO...
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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 pre- vent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the WRO 300 H as recom- mended below, according to the maximum output power of the communications equipment.
Technical Data WRO 300 H 4.7 Safety 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. P/N 3027436 Rev. C...
2 Check that the product water conductivity is within normal range. If so, continue as normal but notify technical personnel. HIGH LEVEL SEN- WRO 300 H WRO 300 H stops, buzzer sounds with Stop SOR FAILURE sound, flashes, message text displays.
1 Press to silence buzzer. 2 Inform responsible medical staff according to local procedures. 3 The WRO 300 H can be restarted by press- . It will stop again if the problem per- sist. 4 If problem persists discontinue dialysis.
Power failure. Action 1 Press to silence buzzer. 2 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 WATER SUPPLY alarm 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. Action 1 Press to silence buzzer. 2 Activate heat disinfection procedure manually.
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1 Press to silence buzzer. 2 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 displays. Reason Water level in tank is lower than expected.
1 Press to silence buzzer. 2 Notify technical personnel. INSERT WAND WRO 300 H WRO 300 H stops, buzzer sounds with alarm sound, flashes, message text displays. Reason A central chemical disinfection has been initi- ated via the remote control and the disinfection wand is not inserted.