Mar Cor Purification WRO 300 H Operator’s Manual
Important User Information Copyright © 2012 by Mar Cor Purification, Inc. All rights reserved. No part of the contents of this manual may be reproduced, copied, or transmitted in any form or by any means including graphic, electronic, or mechanical methods or photocopying, recording, or information storage and retrieval systems without the written permission of the publisher, unless it is for the purchaser's personal use.
Table of Contents WRO 300 H Table of Contents Important User Information . . . . . . . . . . . . . . . . . . . . . . . 2 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Manuals for WRO 300 H. . . . . . . . . . . . . . . . . . . . Definitions of Expressions in the Manual . . . . . . . . . . . .
Table of Contents WRO 300 H Stop Heat Disinfection Sequence . . . . . . . . . . . . . . Chemical Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . Approved Chemical Disinfectants . . . . . . . . . . . . . . Test Kit Example . . . . . . . . . . . . . . . . . . . . . . . . . . . Chemical Disinfection Procedure . . . . . . . . . . . . . . Residual Test After Chemical Disinfection . . . . . . . Central Chem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning . . . . . . . . . . .
Preface WRO 300 H Preface This manual provides the information needed to operate the WRO 300 H water purification unit. Valid program version 4.x Other Manuals for WRO 300 H The list below shows all manuals related to this Operator’s Manual.
Preface WRO 300 H CAUTION • • • • • • • WRO 300 H may be operated only by persons who have studied the instructions in these manuals 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.
Preface WRO 300 H 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 Year of manufacturing The WRO 300 H is protected against dripping water Recycling symbol -General CB Reject water connection Feed water inlet connection Loop connections (Product water outlet and return) ME equipment and ME systems that include RF transmitters or that intentionally apply RF electromagnetic energy
Preface WRO 300 H Certification Marks 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. IPR - Intellectual Property Rights Copyright © 2012 Mar Cor Purification, Inc.
Introduction WRO 300 H 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.
Introduction WRO 300 H 1.3 Alarm Types 1.3.1 Notification Next time the WRO goes to Standby the buzzer sounds, and the message text will be displayed. Buzzer Sound flashes Description Notification 1.3.2 Info The WRO continues in the current mode. The message text will be displayed. 1.3.3 Alarm The WRO continues in the current mode. The buzzer sounds, flashes and the message text will be displayed. Buzzer Sound Description Alarm 1.3.4 Stop The WRO stops.
Introduction WRO 300 H 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. 1.4.2 Conductivity Alarm (set at 30 µS/cm) The clinic's predefined maximum product water conductivity for water for dialysis has been exceeded for more than 30 consecutive seconds.
Introduction WRO 300 H 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 percent 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.
Introduction WRO 300 H Buttons Description 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. 1.6.2 Description of 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.
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 additional information about Reminders, refer to the Service Manual. NOTE After the reminder time has expired the notification message will only appear once! 1.6.
Operation WRO 300 H 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.
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Regular Maintenance WRO 300 H 3 Regular Maintenance NOTE The procedure below assume factory settings of the protocol. NOTE If the internal water temperature exceeds 45 °C when initiating the preferred procedure the display reverts to the SELECT menu or the CHEM SELECT menu. This situation is resolved by initiating RUN and letting the WRO 300 H operate and perform an active cooldown until the temperature is below 45 °C. 3.
Regular Maintenance WRO 300 H NOTE 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. Step 1 Press until SELECT is shown in the display and starts to flash. Step 2 From SELECT, press dures. Step 3 Select HEAT by using the Step 4 Initiate the heat disinfection by pressing goes on. to enter the list of available proce.
Regular Maintenance WRO 300 H 3.2.1 Approved Chemical Disinfectants • MINNCARE® Cold Sterilant Required amount: 50 ml of concentrated disinfectant CAUTION Disinfectants may be toxic. Refer to the manufacturer instructions. CAUTION A test for residual disinfectant after rinse must be performed before the initiation of the next dialysis session. The residual concentration of the disinfectant in the fluid must be below levels specified by the clinic or by national standards.
Regular Maintenance WRO 300 H the connector can be left in place. Refer to the caution message below. CAUTION If the WRO 300 H is not disconnected from 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 this device.
Regular Maintenance WRO 300 H Step 6 Insert the open end of the disinfection wand into a container with sufficient amount of disinfectant (refer to Approved Chemical Disinfectants on page 19). Check that the open end of the intake wand is below the solution level and that the clamp is open. The container must be below the level of the chemical intake port to prevent siphoning chemical into the WRO 300 H unit.
Regular Maintenance WRO 300 H The table below explains how to pause, interrupt or restart the procedure: Action Pause of chemical intake phase Press until light flashes. To continue the intake press again until light goes on. Interrupt chemical disinfection procedure Disconnect the wand connector and press Restart of intake phase Remove the wand connector and insert it again CHEM INTAKE RESTART appears on the dis- until light goes on, to initiate rinse. play and flashes.
Regular Maintenance WRO 300 H Step 14 When the chemical disinfection program is completed the display will show PERFORM RESIDUAL TEST. The indication will remain lighted and the will flash. 3.2.
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.
Regular Maintenance WRO 300 H 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. Follow the manufacturer’s guidelines to prepare the cleaning solution. 3.3.
Regular Maintenance WRO 300 H Step 4 Confirm by pressing remains lighted. until light goes out. Indication 3.4 Long Term 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 Preservation If automated heat disinfection is not possible to perform when the WRO 300 H is taken out of operation for an extended period of time, a chemical preservation must be done.
Regular Maintenance WRO 300 H Step 4 When the rinse program is completed the display will show PERFORM RESIDUAL TEST. The indication lighted and the will remain will flash. 3.4.3 Check for Complete Rinse-out The required rinse program in the WRO has been designed and validated to ensure complete rinse-out of the preservation. Step 1 Press Indication until light goes on, to start the WRO. will light and will flash. Step 2 Let the WRO run in normal operation for at least 5 minutes.
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Technical Data WRO 300 H 4 Technical Data 4.1 Performance and Specification Values Product water Output flow Minimum. 1.1 l/min • at +10 °C feed water temperature • at 0.
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 MPa (45 PSI), a flow regulator, order number WTW522001001, should be installed. Feed Water Temperature +5 to +30 °C Feed Water Quality Potable water should be used.
Technical Data WRO 300 H Values Tank Air Vent 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. NOTE Air will move back and forth in this line because of the variation of the level in the tank. Chemical intake The machine is designed to bring in disinfectant-cleaning agent through the chemical intake.
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 Max 1500 W (100 VAC) 1380 W (115 VAC) 1850 W (220-240 VAC) Appliance inlet According to IEC 60320; C14 Cable Cable with protective earth Conductor length max. 3.
Technical Data WRO 300 H 4.2 Chemical Disinfection and Cleaning The following disinfectants may be administered via the chemical intake. Disinfection • • MINNCARE® Cold Sterilant 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. Follow the manufacturer´s instructions for Use for the specific disinfectant.
Technical Data WRO 300 H 4.4 Materials Contacting Product Water Type Material Polymers PA (Polyamide) PEEK (Polyetheretherketone) PEI (Polyetherimide) PE (Polyethylene) PFA (Fluorocarbon) POM (Polyoxymethylene) PP (Polypropylene) PPS (Polyphenylensulphite) PVC (Polyvinylchloride) PVDF (Polyvinyliden fluorid) Rubber Q (Silicone) Metals Titanium Stainless steel Others Ceramic 4.
Technical Data WRO 300 H 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 environment. Emissions test RF emissions CISPR 11 Group1 The WRO 300 H uses RF energy only for its internal function.
Technical Data WRO 300 H Value 36 Immunity test IEC 60601 test level Compliance Electromagnetic level environment —guidance2 Conducted RFIEC 610004-6 3 Vrms 150 kHz to 80 MHz 3V Portable and mobile RF communications equipment should be used no closer to any part of the WRO 300 H, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance, d = 1.
Technical Data WRO 300 H Value Recommended separation distances between portable and mobile RF communications equipment and the WRO 300 H The WRO 300 H is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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. 38 P/N 3027436 Rev.
Troubleshooting WRO 300 H 5 Troubleshooting In alarm situations the message text will appear in the display. Only the latest message will be visible in the display. By using the , or the display will be unlocked and the alarm list can be scrolled. The main view will reappear after a time period. 5.1 Alarms and Notifications 5.1.1 General Alarm and No. notifications Definition 101 WRO 300 H Buzzer sounds with alarm sound, CONDUCTIVITY SENSOR FAILURE flashes, message text displays.
Troubleshooting WRO 300 H 5.1.2 Operation Alarm and No. notifications Definition 201 WRO 300 H CONDUCTIVITY NOTIFICATION When entering standby mode, buzzer sounds with notification sound, flashes, message text displays. Reason The conductivity value has exceeded the notification limit for more than 30 consecutive seconds during previous run period. Action 1 Press 2 Perform cleaning according to local procedures. If problem persists notify technical personnel.
Troubleshooting WRO 300 H Alarm and No. notifications Definition 205 WRO 300 H LOW REJECTION RATE When entering standby mode, buzzer sounds with notification sound, flashes, message text displays. Reason Decreased membrane performance. Action 1 Press 2 Perform cleaning according to local procedures. If problem persists notify technical personnel. 3 206 LOW PRODUCT FLOW WRO 300 H , or to silence buzzer.
Troubleshooting WRO 300 H Alarm and No. notifications Definition 303 WRO 300 H OVERDUE HEAT When entering standby mode, buzzer sounds with notification 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 2 304 INCORRECT WATER LEVEL WRO 300 H Press , or to silence buzzer. Activate heat disinfection procedure manually.
Troubleshooting WRO 300 H Alarm and No. notifications Definition 403 WRO 300 H 404 HIGH CONDUCTIVITY RINSE RINSE REQUIRED Buzzer sounds with alarm sound, flashes, message text displays. Reason Conductivity value is above conductivity notification limit after a prolonged rinse. Action 1 Press 2 Perform an extra rinse by pressing 3 until rinse starts. If problem persists notify technical personnel. WRO 300 H , or to silence buzzer.
Troubleshooting WRO 300 H Alarm and No. notifications Definition 407 WRO 300 H INSUFFICIENT TEMPERATURE Action INSERT WAND flashes, message text displays. Reason 408 Buzzer sounds with alarm sound, The temperature during Warm acid cleaning has not reached above the preset limit. 1 Press 2 Notify technical personnel. , or to silence buzzer. WRO 300 H WRO 300 H stops, buzzer sounds with alarm sound, flashes, message text displays.
Check List WRO 300 H 6 Check List Serial no Check conductivity with separate instrument P/N 3027436 Rev.
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Index WRO 300 H Index A Acid cleaning . . . . . . . . . . . . . . . . . . . . Alarm Types Alarm . . . . . . . . . . . . . . . . . . . . . . . Info . . . . . . . . . . . . . . . . . . . . . . . . . Notification . . . . . . . . . . . . . . . . . . . Stop . . . . . . . . . . . . . . . . . . . . . . . . Alarm types . . . . . . . . . . . . . . . . . . . . . Alarms and notifications . . . . . . . . . . . . Chemical . . . . . . . . . . . . . . . . . . . . General . . . . . . . . . . . . . . . . . . . . . Heat .
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Mar Cor Purification 4450 Township Line Road Skippack, PA 19474-1429 Tel: (484) 991-0220 Toll Free: (800) 633-3080 Fax: (484) 991-0230 Mar Cor Purification 14550 28th Avenue North Plymouth, MN 55447 Tel: (484) 991-0220 Toll Free: (800) 633-3080 Fax: (763) 210-3868 Mar Cor Purification 1119 Paulsun Street San Antonio, TX 78219 Tel: (210) 227-3601 Toll Free: (800) 268-5035 Fax: (210) 227-0735 Mar Cor Purification 160 Stedman Street Lowell, MA 01851 Tel: (978) 453-9600 Toll Free: (800) 633-3080 Fax: (978) 4
