Mar Cor Purification WRO 300 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.
WRO 300 Table of Contents Table of Contents Important User Information . . . . . . . . . . . . . . . . . . . . . . . 2 Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Manuals for WRO 300 . . . . . . . . . . . . . . . . . . . . . Definitions of Expressions in the Manual . . . . . . . . . . . .
Table of Contents WRO 300 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Acid Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alkaline Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . Cleaning Procedure. . . . . . . . . . . . . . . . . . . . . . . . . Test for Residuals . . . . . . . . . . . . . . . . . . . . . . . . . . Long Term Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preservation . . . . . . . . . . . . . . . . . .
WRO 300 Preface Preface This manual provides the information needed to operate the WRO 300 water purification unit. Valid program version 4.x Other Manuals for WRO 300 The list below shows all manuals related to this Operator’s Manual.
Preface WRO 300 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 these 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 in the manual.
WRO 300 Preface 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 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 for diagnosis or treatment shall be labeled
Preface WRO 300 Certification Marks 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 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.
WRO 300 Introduction 1 Introduction 1.1 Intended use The MCP WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water by reverse osmosis for one hemodialysis equipment. The WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments with appropriate pre and post treatment units as a part of a water treatment system designed to meet regulations or standards for water for dialysis, for example current AAMI and Federal (U.S.
Introduction WRO 300 1.3 Alarm types 1.3.1 Notification Next time the WRO goes to Standby the buzzer sounds, and the message displays. 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 displays. Buzzer Sound Description Alarm 1.3.4 Stop The WRO stops. The buzzer sounds, text displays.
WRO 300 Introduction 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 30µS/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 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.
WRO 300 Introduction 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 is energized. Green Steady light RUN mode, auto flush or manual flush in progress.
Introduction WRO 300 1.6.4 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 the Service Manual. NOTE After the reminder time has expired the notification message will only appear once! 1.6.
WRO 300 Operation 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 2.2 Stop Press mode.
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WRO 300 Regular Maintenance 3 Regular Maintenance NOTE The procedure below assume factory settings of the protocol. 3.1 Chemical Disinfection The required chemical disinfection frequency to achieve the desired microbiological requirements for the product water depends on several factors, such as: • The quality of the feed water. • Local regulations regarding the microbiological quality of dialysis water, etc. • Local preferences, for example regarding the use of chemicals.
Regular Maintenance WRO 300 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. It is essential to use an appropriate test method, either with proven sensitivity for the disinfectant or recommended by the manufacturer of the disinfectant. 3.1.
WRO 300 Regular Maintenance Disconnect the quick connector WRO 300 Nipple at the Dialysis machine Step 3 Place a tag on the WRO 300, stating that chemical disinfection is in progress and what type of disinfectant is being used. Step 4 Insert the wand connector into the chemical intake port of the WRO 300 (see the illustration below), press firmly and turn the connector downwards to lock. Check that the connector is securely in place.
Regular Maintenance WRO 300 Step 7 From CHEM SELECT, press to enter the list of available Cleaning and chemical disinfection programs. Step 8 Select preferred chemical disinfection program by using the arrow buttons. MINNCARE Step 9 Initiate the disinfectant intake by pressing on. until light goes CHEM INTAKE X μS/cm NOTE The display shows present phase of the chemical disinfection procedure. NOTE The container can be empty before the intake phase is finished.
WRO 300 Regular Maintenance Step 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. CAUTION When requested by the WRO unit, remove the disinfection wand from the chemical intake.
Regular Maintenance WRO 300 Step 2 Collect a water sample either from the product water line or from the dialysis machine according to the caution above. Step 3 Test for disinfectant residuals with Minncare® Residual Peroxide test strips or other approved test strips or methods. Step 4 Confirm by pressing remains on. until light goes out. Indication RUN X μS/cm Step 5 Remove any tag indicating storage with disinfectant.
WRO 300 Regular Maintenance NOTE During the intake phase of the central chem program, the product water loop will not be pressurized until the correct conductivity has been obtained, which will take a few minutes. 3.2 Cleaning 3.2.1 Acid Cleaning Acid cleaning should be performed when: • Rejection rate has decreased by more than 5 percent from initial value. • Sufficient output flow is not obtained. • As preventive measure when a softener is not used.
Regular Maintenance Step 2 WRO 300 Follow the chemical disinfection procedure, but instead select ACID CLEAN, or ALKALINE CLEAN in the CHEM SELECT menu. Refer to Chemical Disinfection Procedure on page 18. NOTE The container can be empty before the intake phase is finished. 3.2.4 Test for Residuals Step 1 Press until light goes on to start the WRO 300. Indication lights and flashes. Step 2 Collect a water sample from the product water line.
WRO 300 Regular Maintenance 3.3.1.2 Preservation Procedure Step 1 Follow the chemical disinfection procedure (refer to Chemical Disinfection on page 17) Step 2 through Step 12, but instead select MEMSTOR in the CHEM SELECT menu. CAUTION If the conductivity limit is not achieved, alarm 406 INSUFFICIENT INTAKE will appear and the Preservation procedure has to be restarted. Step 2 After Step 12: the display will show 404 RINSE REQUIRED and the buzzer will sounds and the indications flash.
Regular Maintenance WRO 300 Step 3 Confirm by pressing remains lighted. until light goes out. Indication Step 4 The WRO is now ready to use. 3.4 Flush 3.4.1 Manual Flush This mode provides a short flush of the WRO at elevated flow rate (5 minutes preset). Step 1 Press until SELECT appears. Step 2 Scroll with Step 3 Press and to select MANUAL FLUSH. to initiate manual flush (MANUAL FLUSH shows lights). 3.4.
WRO 300 Technical Data 4 Technical Data 4.1 Performance and Specification Values Output flow Min. 1.1 l/min • • Product water loop Maximum 20 meters (2 x 10 m) Product water pressure 0.12 to 0.6 MPa (17 to 87 PSI) during RUN mode (depending of the consumption from product water loop) Quality Depends on feed water quality.
Technical Data WRO 300 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.
WRO 300 Technical Data 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 Values External connector 8 pins REDEL, yellow. Not used. External connector 8 pins REDEL, black. USB Connection of external equipment Max input voltage Logging interface ±15 VDC High level min out- 5.0 VDC put voltage Low level max out- 5.0 VDC put voltage Max Current ±5 mA DC External connector 8 pins REDEL, green. Not used. Sound 30 Sound power level Less than 65 dBa during normal operation P/N 3027435 Rev.
WRO 300 Technical Data 4.2 Chemical Disinfection and Cleaning Disinfection The following disinfectants may be administered via the chemical intake. • • Cleaning agents Preservation Exterior cleaning 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 instructions for Use for the specific disinfectant.
Technical Data WRO 300 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.
WRO 300 Technical Data 4.6 Electromagnetic Environment Value The WRO 300 is intended for use in the electromagnetic environment specified below. The customer or the user of the WRO 300 should assure that it is used in such an environment. Emissions test Electromagnetic environment — Compliance guidance RF emissions CISPR 11 Group1 The WRO 300 uses RF energy only for its internal function. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Technical Data WRO 300 Value 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, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.
WRO 300 Technical Data Value Recommended separation distances between portable and mobile RF communications equipment and the WRO 300 The WRO 300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Technical Data WRO 300 5. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 6. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. 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. 36 P/N 3027435 Rev.
WRO 300 Troubleshooting 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 101 Definition CONDUCTIVITY WRO 300 SENSOR FAILURE Buzzer sounds with alarm sound, flashes, message text displays.
Troubleshooting WRO 300 5.1.2 Operation Alarm and No. notifications Definition 201 WRO 300 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.
WRO 300 Troubleshooting Alarm and No. notifications Definition 205 WRO 300 LOW REJECTION RATE When entering standby mode, buzzer sounds with notification sound, flashes, adn mes- sage 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 , or to silence buzzer.
Troubleshooting WRO 300 Alarm and No. Notifications Definition 403 WRO 300 404 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 , or to silence buzzer.
WRO 300 Troubleshooting Alarm and No. Notifications Definition 408 WRO 300 WRO 300 stops, buzzer sounds with alarm flashes, message text displays. sound, Reason A central chemical disinfection has been initiated via the remote control and the disinfection wand is not inserted. INSERT WAND Action 1 Press 2 Insert the disinfection wand to continue the central chemical disinfection procedure. , or to silence buzzer. 5.2 Boot loader This alarm indicate that the software is corrupt.
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WRO 300 Check List 6 Check List Serial no: Check conductivity with separate instrument P/N 3027435 Rev.
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Index WRO 300 Index O A Acid cleaning . . . . . . . Alarm types . . . . . . . . Alarms and notifications Chemical . . . . . . . General . . . . . . . . Operation . . . . . . Preservation . . . . . Rinse . . . . . . . . . Alkaline cleaning . . . . . Auto flush . . . . . . . . . . . . . . . . 23 . . . . . . . 10 . . . . . . . 37 . . . . . . . 39 . . . . . . . 37 . . . . . . . 38 . . . . . . . 39 . . . . . . . 39 . . . . . . . 23 . . . . . 9, 26 . . . . . . . . . . . . .15 . . . . . . . . . . . . .15 . .
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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
