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Haemonetics MCS+ Operator And Maintenance Manual

Ln 9000
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MCS
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LN 9000 Operator and
Maintenance Manual
Printed in U.S.A.
©1995, Haemonetics Corporation
400 Wood Road
Braintree, Massachusetts 02184
(781) 848-7100
All Rights Reserved
June 2001
Part No. 39551, Rev. F

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  • Page 1 ® Haemonetics ® ® + Device LN 9000 Operator and Maintenance Manual Printed in U.S.A. ©1995, Haemonetics Corporation 400 Wood Road Braintree, Massachusetts 02184 (781) 848-7100 All Rights Reserved June 2001 Part No. 39551, Rev. F...
  • Page 2 P/N 39551-00, Rev. F...
  • Page 3 ARNING This manual provides certain basic information concerning the maintenance and operation of the Haemonetics MCS+ device and is intended to be used in con- junction with and as a supplement to the training supplied by a Haemonetics Clinical Specialist or other qualified personnel. Departures or deviations from the procedures contained in this manual should not be made except in conformity with official changes made to the manual by Haemonetics Corporation.
  • Page 4 The uses to which the Haemonetics ® products may be applied, and the results obtained therefrom, shall be the sole responsibility of the Buyer. Haemonetics expressly disclaims responsibility for the use of the products by the Buyer. NQUIRIES Please direct any written inquiries to the appropriate address:...
  • Page 5 Haemonetics Austria International Haemonetics (Austria) GmbH Berlagasse 45/B2-02 Austria - WIEN Telephone: +43-1-2942900 Fax: +43-1-2942905 Belgium Haemonetics (Belgium) SA Chaussée de Louvain/ Leuvensesteenweg 542 - B.14 Planet II Complex Belgium - 1930 ZAVENTEM Telephone: +32-2-7207484 Fax: +32-2-7207155 France Haemonetics (France) SARL 46 bis, rue Pierre Curie Z.1.
  • Page 6 Haemonetics (Italia) S.r.l. Via Donizetti, 30 Italy - 20020 LAINATE (Milano) Telephone: +39-2-93570113 Fax: +39-2-93572132 Japan Haemonetics Japan Co. Ltd. Shin-Kojimachi Building, 1F + 2 F 4-3-3, Kojimachi Japan - Chiyoda-ku, Tokyo 102 Telephone: +81-3-3237 72 60 Fax: +81-3-3237 72 20 Netherlands Haemonetics (Nederland) S.A.

  • Page 7: Table Of Contents

    Table of Contents CHAPTER ONE, INTRODUCTION OVERVIEW OF THE MCS+ Device ....... .1-2 CHAPTER TWO, SYSTEM DESCRIPTION GENERAL SYSTEM DESCRIPTION .
  • Page 8 Table of Contents Manual Vacuum Release Button ......2-26 Bowl Optics Sensor ........2-26 Fluid Detectors .
  • Page 9 Table of Contents CHAPTER SIX, MAINTENANCE GENERAL ...........6-2 MAINTENANCE AND CLEANING .

  • Page 11: Chapter One, Introduction

    Chapter INTRODUCTION OVERVIEW OF THE MCS ® + DEVICE ......1-2 P/N 39551-00, Rev. F...

  • Page 12: Overview Of The Mcs+ Device

    Introduction MCS+ D VERVIEW EVICE Using the latest computer and blood processing technology, the Haemonetics MCS®+ Device LN 9000 (see Figure 1-1) collects blood components, including platelets, and plasma. Figure 1-1, The Haemonetics MCS+ Device LN 9000 The MCS+ Device combines advanced technology with portability and ease-of- use.
  • Page 13 Introduction Among the characteristics of the MCS+ device are: • A third pump, referred to as the White Pump, that enables the MCS+ de- vice to maintain a more consistent “critical flow,” gaining better control of the platelet collection process. Note: The White Pump has also been referred to as the Plasma Pump and the Surge Pump.
  • Page 15 Chapter SYSTEM DESCRIPTION GENERAL SYSTEM DESCRIPTION ....... .2-3 POWER ENTRY MODULE ........2-4 USER PANEL.
  • Page 16 System Description SPECIFICATIONS ..........2-28 Dimensions (approximate) .

  • Page 17: General System Description

    System Description ENERAL YSTEM ESCRIPTION  The MCS is a lightweight, compact, blood processing instrument. The system consists of two parts: the machine and the single-use blood processing dispos- able. On the inside of the MCS+ device cover, there is a Display Screen on which mes- sages regarding the operation of the system are shown.

  • Page 18: Power Entry Module

    System Description In various locations on the deck are seven valves that control the fluid pathway. A Line Sensor monitors the density of fluid in the effluent line of the bowl. White Disposable Identification Centrifuge Pump AC Pump Cover Latch Drip Well Monitor...

  • Page 19: User Panel

    System Description INPUT POWER RECEPTACLE. This machine component allows the con- nection to the power cord. ANEL The MCS+ device is operated through the User Panel; the system provides infor- mation regarding the status of procedures through Donor Flow Lights and through the Display Screen.
  • Page 20 System Description Normal None Return Figure 2-4, Donor Flow Lights The four sets of Donor Flow Lights are located at the top of the panel, the sides of the cabinet, and the outside of the cover. These lights indicate status of the flow: Normal (green), Low (yellow), None (red), or Return (yellow).

  • Page 21: Screens

    System Description CREENS Screens in this section are shown for layout only. The displays shown on your MCS+ device may vary depending upon the protocol selected. Refer to the ap- plicable protocol section for actual screen contents. Main Screen The Display Screen provides frequent updates on the status of the particular pro- cedure in use.

  • Page 22: Haemocalculator

    System Description Haemo- From a Main Screen display, pressing HELP/HAEMOCALCULATOR once dis- Calculator plays the HaemoUpdate screen. Pressing HELP/HAEMOCALCULATOR a second time displays the HaemoCalculator screen, shown below. Procedure SDPS STOP Ready to Go Update Cycle 0 0 Platelet Volume 0 Volume Processed HAEMOCALCULATOR Target Plasma Vol...

  • Page 23: Modify

    System Description Modify Using the MODIFY key, it is possible to change a protocol parameter before or at any time during a procedure without interrupting the procedure. To view or change the default parameters, press the MODIFY key. To select a pa- rameter value, scroll through the list using the MODIFY key.

  • Page 24: Notice

    2-10 System Description Notice If the MCS+ device encounters an error, the machine stops its pumps, sounds an alarm and displays the Notice screen. The audible alarm can be turned off for up to one minute by pressing NO. Pressing HELP/HAEMOCALCULATOR displays the Help screen, which contains basic guidelines to help solve the problem.

  • Page 25: Control Panel

    Message 2. If air is present, turn AC pump CLOCKWISE to move air past ACAD. Message 3. Call Haemonetics Technical Service if problem persists. Number 4. Resume operation after air is cleared from ACAD. Press NO to Mute the Alarm.

  • Page 26: Keys

    2-12 System Description Mode Keys Prime Draw Return STOP Help Figure 2-6, Mode Keys PRIME When PRIME is pressed, the disposable set is primed with anticoagulant from the anticoagulant spike to the Donor Line Air Detector 1 (DLAD 1). DRAW When DRAW is pressed, the procedure is initiated.

  • Page 27: Pump Keys

    System Description 2-13 Press the STOP key only when the processing must be stopped immediately. When the pumps need to be stopped, but the centrifuge can keep turning, press the PUMP START/STOP Key. To continue processing, press the PUMP START/ STOP Key again.

  • Page 28: Cuff Key

    2-14 System Description Pressing the UP/DOWN arrows raises or lowers the Blood Pump speed of the current mode. Any change to the set speed made by using these keys is retained throughout the procedure until another change is made. Note: The MCS+ device will automatically adjust the pump speeds in poor flow conditions.

  • Page 29: Protocol Card

    System Description 2-15 The MCS+ device stores operating parameters. These parameters may be modi- fied through one of the two MCS+ device programming displays. The HaemoCal- culator display contains donor/patient and collection parameters and the Modify display contains processing parameters. MODIFY When the MCS+ device shows the Main Screen, pressing the MODIFY key dis- plays the Modify Parameters screen.
  • Page 30 2-16 System Description The MCS+ device checks to ensure that a valid card is properly installed before a protocol can be performed. The MCS+ device also checks the disposable set to ensure that the set installed is appropriate for the protocol selected. Figure 2-10, Protocol Card Inserted in Protocol Port To install the Protocol Card, ensure that the MCS+ device is powered off.

  • Page 31: Protocol Card Pouch

    System Description 2-17 Protocol Card The Protocol Card Pouch provides convenient storage for protocol cards that are Pouch not in use. The Protocol Card Pouch may be hung on the two rear bag pins lo- cated on the Protocol Card door side of the MCS+ device. ALVES There are seven color-coded valves on the MCS+ device deck.
  • Page 32 2-18 System Description In the presence of insufficient flow from the donor/patient, measured as a nega- tive pressure of -80 mmHg, the DPM stops the pumps, the donor/patient NO FLOW indicator illuminates, and an audible signal alerts the operator to initiate corrective action.

  • Page 33: System Pressure Monitor (Spm)

    System Description 2-19 System The System Pressure Monitor (SPM) ensures that the functionally closed sterile Pressure barrier of the rotary seal of the bowl has not been compromised by abnormal pressure. Monitor (SPM) The SPM alerts the operator if pressure is increasing or decreasing at the bowl seal.

  • Page 34: Donor Line Air Detector 1 (Dlad 1)

    2-20 System Description During Draw, the presence of fluid in the blood line within the BLAD allows the machine to account for blood pumped. This volume is displayed as “Volume Processed” on the display screen during Draw and Return. Donor Line Air The Donor Line Air Detector 1 (DLAD 1) monitors the donor/patient line.

  • Page 35: Pumps

    System Description 2-21 Warning! An air detection by the DLAD 2 during Return may indicate a failure of the BLAD. The operator must carefully note the source of air detected. Remove the air from the line, follow- ing the procedures given in Chapter 5, Notice Messages and Troubleshooting.

  • Page 36: Anticoagulant Pump

    2-22 System Description The MCS+ device also continuously controls the speed of the White Pump so that the critical flow remains constant even if the speed of the Blood Pump changes during the procedure. For example, if donor flow decreases and the Blood Pump speed decreases, the White Pump speed automatically increases to maintain the desired critical flow.

  • Page 37: Centrifuge

    The silicone grease used in vacuum centrifuges should never be applied to a mechanical centrifuge. Do not grease any part of the mechanical centrifuge. If grease has been applied to the mechanical chuck, contact Haemonetics Field Service immediately. Mechanical The bowl is held in the Mechanical Centrifuge by six mechanical clips in the Chuck chuck.
  • Page 38 Do not attempt to reseat the bowl or continue the procedure. Do not return the contents of the bowl to the donor. Contact Haemonetics Technical Hot Line at (800) 537-2802, and dis- card the bowl contents and disposable per the facility’s SOP.

  • Page 39: Vacuum Chuck

    Do not attempt to reseat the bowl or continue the procedure. Do not return the contents of the bowl to the donor. Contact Haemonetics Technical Hot Line at (800) 537-2802, and dis- card the bowl contents and disposable per the facility’s SOP.

  • Page 40: Manual Vacuum Release Button

    2-26 System Description Manual The Manual Vacuum Release Button allows for emergency release of the centri- Vacuum fuge vacuum in MCS+ device units containing a vacuum centrifuge. Upon press- ing the Vacuum Release Button, vacuum is bled off from the Centrifuge allowing Release Button the Centrifuge bowl to be removed.

  • Page 41: Pressure Cuff

    CCESSORIES Each item described below is available for purchase; please consult a published price list or your Haemonetics Sales Representative for additional information. For protection and convenience, a transport case and a stand for use with the MCS+ device are available from Haemonetics.

  • Page 42: Specifications

    2-28 System Description PECIFICATIONS Dimensions In Operation (approximate) Height: 27 inches (68.5 cm) Width: 22.25 inches (56.5 cm) Depth: 22.25 inches (56.5 cm) Closed Height: 17.25 inches (44 cm) Width: 22.25 inches (56.5 cm) Depth: 13.38 inches (36.5 cm) Weight Approximately 56 lbs.
  • Page 43 95%, noncondensing. There is an explosion risk if the machine is used in the presence of flammable anesthetics. Note: Haemonetics recommends preventive maintenance by a Haemonetics service engineer or manufacturer-trained biomedical technician once per year ± 30 days). A series of equipment and safety system checks will be performed to assure continued trouble-free performance.
  • Page 45 Chapter Three DISPOSABLES GENERAL ...........3-2 DISPOSABLE SET STORAGE AND HANDLING .

  • Page 46: General

    Disposables ENERAL  The MCS utilizes single-use disposable sets to separate and collect blood. All sets contain a processing chamber, the “bowl,” and tubing and bags, the “harness.” ISPOSABLE TORAGE AND ANDLING Store all disposables in a dry, well-ventilated area that is free from exposure to chemical vapors.

  • Page 47: Bowls

    The bell-shaped bowl used for cellular collections is called the Latham bowl (Figure 3-1), named after the inventor of the original Haemonetics centrifugal processing chamber, Allen Latham, Jr., the founder of Haemonetics Corporation.
  • Page 48 Disposables The rotary seal provides a barrier between the sterile interior sections of the bowl and the outside environment. It is the only point within the Latham bowl struc- ture where the stationary and rotating sections make contact. During Draw (Figure 3-2), anticoagulated whole blood enters the inlet port and is directed down the feed tube to the bottom of the bowl.

  • Page 49: The Latham Bowl "Surge" Process

    Disposables Note: The nature of centrifugal separation is such that the lines of definition between blood components are not distinct. A minimal contamination of an un- desired component with the desired component is to be expected. For example, some platelets may be present in the plasma in a PLP procedure. When the bowl is filled, plasma, the lightest component (and therefore closest to the core) begins to overflow through the effluent path and outlet port (Figure 3-3).
  • Page 50 Once collection is completed, the bowl stops spinning. Due to the loss of cen- trifugal force, the blood remixes. When the bowl is spinning, it appears to be full. However, all Haemonetics bowls are designed with an inner core in which some sterile air is trapped during centrifugation.

  • Page 51: The Role Of The White Pump

    Disposables Once the bowl stops spinning, the Blood Pump reverses and returns the remain- ing blood components to the donor, as shown in Figure 3-5. Uncollected Components Air from Plasma Bag Figure 3-5, The Return Mode The Role of the In the platelet collection protocols, the White Pump pulls plasma from the plas- White Pump ma bag of the disposable set and pumps it into the bowl located within the Cen-...

  • Page 52: Elements Of The Harness

    Disposables ARNESS OMPONENTS Elements of the The elements of the harness used depend upon the component to be collected. Harness Some of the typical elements of a set are described below. Pump Cartridge DPM Luer Connector Air Bag SPM Luer Plasma Bag Bowl Connector...
  • Page 53 Disposables Injection Port (near needle) The injection port on the MCS+ device 5-day disposable sets is intended only for emergency situations requiring administration of fluids or drugs. Warning! If the injection site is used before removing the platelet concentrate from the collection set, the storage life of the platelet product is reduced to 24 hours.
  • Page 54 3-10 Disposables System Pressure Monitor (SPM) Luer Connector This element of the disposable set contains a 0.22µ filter to prevent the infiltra- tion of contaminants into the disposable. It is intended to be coupled with the receptor on the SPM to assist in the monitoring of pressures within the bowl. Warning! If at any time during a collection, the SPM connec- tor becomes wet, the MCS+ device may no longer be able to...

  • Page 55: Other Disposable Set Elements

    Disposables 3-11 Other Disposable sets for protocols that do not require extended dating may include Disposable Set other elements and may not include the previously listed elements. Elements Additional details about the disposable sets are included in the protocol chapters as well as in the Directions for Use that accompany each device.

  • Page 57: Care Precautions

    Chapter Four SAFETY AND DONOR/PATIENT CARE PRECAUTIONS SAFETY PRECAUTIONS ........4-2 Storage and Handling of Disposables .

  • Page 58: Safety Precautions

    Safety And Donor/Patient Care Precautions AFETY RECAUTIONS This section outlines precautions that must be taken in order to ensure safe operation of the MCS+ device. Storage and Many plastics are sensitive to chemicals such as solvents, refrigerants, and deter- Handling of gents.

  • Page 59: Rotating Machinery

    Safety And Donor/Patient Care Precautions The owner should have a current leakage test performed regularly to ensure that the machine continues to meet the 100/500 microampere or less standard. Par- ticular attention should be given to current leakage after an event such as a saline spill or major voltage surge in the house electrical system.

  • Page 60: Twists And Kinks In Tubing

    Safety And Donor/Patient Care Precautions Twists and After loading the harness set on the machine, a careful recheck of the loaded Kinks in Tubing disposable set should be completed to make certain that each section is in the correct position on the machine and that all tubing is free of twists or kinks. Twists and kinks in the tubing can result in hemolysis with high levels of plasma hemoglobin.
  • Page 61 Chapter Five NOTICE MESSAGES AND TROUBLESHOOTING PROCESS MESSAGES ......... .5-2 INTERLOCK MESSAGES .

  • Page 62: Process Messages

    Notice Messages and Troubleshooting ROCESS ESSAGES  During normal operation, the MCS provides information on the progress of a protocol. Process messages are displayed as a normal part of system operation. Donor pressure is continually displayed, as is the current operating mode (Prime, Draw, or Return).

  • Page 63: Notice Messages

    Notice Messages and Troubleshooting For example, as part of the power-on self test, the following display is shown. SELF TEST SDPS SELF TEST PLEASE CLOSE THE CENTRIFUGE COVER LATCH Press HELP for More Information. In order for the MCS+ device to pass this interlock test, the operator must open and close the Centrifuge Cover.
  • Page 64 Message 2. If air is present, turn AC pump CLOCKWISE to move air past ACAD. Message 3. Call Haemonetics Technical Service if problem persists. Number 4. Resume operation after air is cleared from ACAD. Press NO to Mute the Alarm.

  • Page 65: Recovery Procedure

    Notice Messages and Troubleshooting ECOVERY ROCEDURE If, for any reason, the system has been powered off or reset during a procedure, the following screen will be displayed: PROCEDURE RECOVERY The POWER has been OFF for a short time. The POWER has been OFF for a short time. Press YES for PROCEDURE RECOVERY.
  • Page 66 Notice Messages and Troubleshooting Note: Haemonetics recommends that a 16g needle with tubing extension is used to ensure optimal flow conditions. 1. Hermetically seal the needle line close to the needle. 2. When applicable, remove the product bags per the procedures given in the appropriate section of the applicable protocol manual.

  • Page 67: Gravity Reinfusion Procedure

    Notice Messages and Troubleshooting In case the procedure is to be discontinued: 10. Once all blood has been returned and the MCS+ device initiates the next Draw mode, press the STOP key to discontinue the procedure. Press the HELP key to enter the HaemoUpdate screen and obtain procedure statistics. In case the procedure is to be continued: 11.
  • Page 68 1. Power off and complete a Procedure Recovery. THE COMPUTER HAS ENCOUNTERED AN ERROR. NOTE: If problem persists, call Haemonetics Technical Hot Line. BLAD DETECTS AIR BLOOD LINE AIR DETECTOR 1. Check tubing installation in BLAD. 2. Check donor line for flow restriction.
  • Page 69 1. Discontinue the procedure. FLUID HAS BEEN DETECTED IN THE CENTRIFUGE. 2. Note the condition of the disposable before disposing of it. 3. Contact Haemonetics Technical Hot Line. NOTE: The disposable should be returned to Haemonetics for analysis. SYSTEM PROBLEM A CPU error caused the MCS+ device to reset.
  • Page 70 5-10 Notice Messages and Troubleshooting Notice Messages Help Messages PUMP PROBLEM A restriction may have occurred. 1. Check pump for restrictions. 2. Check pump for kinked tubing. AC PUMP WAS TURNING TOO SLOW. 3. Resume operation. PUMP PROBLEM A restriction may have occurred. 1.
  • Page 71 1. Toggle the valve manually. 2. Resume operation. NOTE: If problem persists, THE RED VALVE WAS DETECTED OUT OF POSITION. call Haemonetics Technical Hot Line. SYSTEM PROBLEM A CPU error caused the MCS+ device to reset. 1. Power off and complete a Procedure Recovery.
  • Page 72 2. Power off and complete a THE SAFETY SYSTEM HAS ENCOUNTERED AN ERROR. Procedure Recovery. NOTE: If problem persists, call Haemonetics Technical Hot Line. SYSTEM PROBLEM A State Fault caused the MCS+ device to reset. 1. Power off and complete a Procedure Recovery.
  • Page 73 1. Check tubing installation in ACAD. 2. If air is present, turn AC pump CLOCKWISE to ANTICOAGULANT AIR DETECTOR move air past ACAD. 3. Call Haemonetics Technical Service if problem persists. 3. Resume operation after air is cleared from ACAD. P/N 39551-00, Rev. F...
  • Page 74 VALVE PROBLEM 1. Toggle the valve manually. 2. Resume operation. NOTE: If problem persists, THE PURPLE VALVE WAS DETECTED OUT OF POSITION. call Haemonetics Technical Hot Line. VALVE PROBLEM 1. Toggle the valve manually. 2. Resume operation. NOTE: If problem persists, THE ORANGE VALVE WAS DETECTED OUT OF POSITION call Haemonetics Technical Hot Line.
  • Page 75 Notice Messages and Troubleshooting 5-15 Notice Messages Help Messages PRESSURE PROBLEM The DPM high pressure limit was exceeded. 1. Check tubing for occlusions. 2. Check tubing for closed clamps. HIGH PRESSURE ERROR AT THE DPM. 3. Check tubing at valves. 4.
  • Page 76 5-16 Notice Messages and Troubleshooting Notice Messages Help Messages BLAD DETECTS AIR BLOOD LINE AIR DETECTOR 1. Check tubing installation in BLAD. 2. Check donor line for flow restriction. BLOOD LINE AIR DETECTOR 3. Resume operation after air is cleared from BLAD. AIR REMOVED The Air Detector detects fluid.
  • Page 77 1. Check tubing installation in ACAD. 2. If air is present, turn AC pump CLOCKWISE to ANTICOAGULANT AIR DETECTOR move air past ACAD. 3. Call Haemonetics Technical Service if problem persists. 4. Resume operation after air is cleared from ACAD. BLAD AIR REMOVED BLOOD LINE AIR DETECTOR 1.
  • Page 78 5-18 Notice Messages and Troubleshooting Notice Messages Help Messages WEIGHER PROBLEM No change in bag weight was detected. 1. Check that bags are properly installed. 2. Check tubing for occlusions. EXPECTED FLUID FLOW TO WEIGHER NOT DETECTED. 3. Check tubing at valves. 4.
  • Page 79 2. Press NO to continue to draw from Buffy Bag. SELF TEST PROBLEM 1. Turn power OFF, then ON and try again. NOTE: If problem persists, call Haemonetics Technical Hot Line. THE COMPUTER CPU TEST FAILED. SELF TEST PROBLEM 1. Turn power OFF, then ON and try again.
  • Page 80 3. Clean the disposable ID window. SELF TEST PROBLEM Turn power OFF, then ON and try again. NOTE: If problem persists, call Haemonetics Technical Hot Line. ANTICOAGULANT AIR DETECTOR (ACAD) TEST FAILED. SELF TEST PROBLEM 1. Turn power OFF, then ON and try again.
  • Page 81 1. Toggle the valve manually. 2. Turn power OFF, then ON and try again. NOTE: If problem persists, GREEN VALVE SELF TEST FAILED. call Haemonetics Technical Hot Line. SELF TEST PROBLEM 1. Turn power OFF, then ON and try again. NOTE: If problem persists, call Haemonetics Technical Hot Line.
  • Page 82 1. Turn power OFF, then ON and try again. THE DPM IS OUT OF TOLERANCE. NOTE: If problem persists, call Haemonetics Technical Hot Line. SELF TEST PROBLEM The Pressure Monitor signal is out of the allowed range.
  • Page 83 Help Messages SELF TEST PROBLEM 1. Turn power OFF, then ON and try again. NOTE: If problem persists, call Haemonetics Technical Hot Line. LOW PRESSURE ERROR AT THE DPM. SELF TEST PROBLEM 1. Turn power OFF, then ON and try again.
  • Page 84 THE CENTRIFUGE VACUUM SYSTEM IS OBSTRUCTED. Chuck base is dry. 3. Turn power OFF, then ON and try again. NOTE: If problem persists, call Haemonetics Technical Hot Line. SELF TEST PROBLEM 1. Remove white pump manifold. 2. Clean disposable ID reader window.
  • Page 85 SOFTWARE WATCHDOG — The computer has sensed an incorrect Software Watchdog ID sequence. INVALID ID SEQUENCE. Please turn the power off and contact Haemonetics Technical Hot Line. — SOFTWARE WATCHDOG The computer has sensed a Software Watchdog ID timeout. ID TIMEOUT.
  • Page 87 Chapter MAINTENANCE GENERAL ...........6-2 MAINTENANCE AND CLEANING .

  • Page 88: General

    + devise requires minimal maintenance. Most maintenance will con- sist of cleaning the system. A record of the type and date of maintenance per- formed should be kept. Haemonetics also recommends that a full preventive maintenance checkup be performed annually by a Haemonetics Service Repre- sentative or qualified biomedical engineer to ensure maximum machine perfor- mance.

  • Page 89: Centrifuge Maintenance

    When any Haemonetics product (equipment or disposables) that has been used during a procedure is returned to Haemonetics for any reason, you must decon- taminate and repackage the product in compliance with the medical facility’s Ex- posure Control Plan and U.S. Department of Transportation regulations for interstate shipping of blood-contaminated products.
  • Page 90 Maintenance Cover Bowl Optics Fluid Detectors Cover Latch Centrifuge Well Mechanical Clips Mechanical Chuck Figure 6-1 , Mechanical Centrifuge Warning! In order to function properly, the Bowl Optics must be clean and clear. A dirty or clouded lens on the Bowl Optics could interfere with its proper function.
  • Page 91 4. Close the slide clamp of the used waste bag. Remove the bag and discard it according to the facility’s SOP for disposition of biohazardous wastes. Re- place the bag with the spare and call Haemonetics to report the spill and re- quest another waste bag.
  • Page 92 Maintenance Cover Bowl Optics Cover Latch Fluid Detector Centrifuge Well “L” Shaped Ring Vacuum Chuck Figure 6-2, Vacuum Centrifuge Warning! If the cleaning solution should come in contact with the Bowl Optics, the operator should rinse the lens with clear water and dry it so that the lens is not clouded. The Vacuum Centrifuge Well and Cover should be cleaned monthly as well as any time a spill occurs.
  • Page 93 Maintenance For routine cleaning: 1. During machine operation and Centrifuge maintenance, ensure that a waste bag is attached to the Centrifuge Drain Tube (a plastic tube exiting the base of the machine) and that it hangs freely at the back of the machine. 2.

  • Page 94: Cleaning The Optics Lens

    5. Close the slide clamp of the used waste bag. Remove the bag and discard it according to the facility’s SOP for disposition of biohazardous wastes. Re- place the bag with the spare and call Haemonetics to report the spill and re- quest another waste bag.

  • Page 95: Cleaning The Blood, White, And Anticoagulant Pumps

    Maintenance Cleaning the The pumps should be cleaned monthly or more frequently if needed. Always Blood, White, clean the pumps after a fluid spill. A build-up of tubing debris or fluids may in- terfere with pump efficiency. The following cleaning method is recommended. Anticoagulant Pumps Pump Rotor...

  • Page 96: Cleaning The Air Detectors

    6-10 Maintenance Cleaning the The Air Detectors should be cleaned monthly. Air Detectors 1. Gently wash the grooves of the Anticoagulant Line Air Detector, Donor Line Air Detectors, and Blood Line Air Detector monthly with a lint-free cloth moistened with clear, warm water. 2.

  • Page 97: Cleaning The Exterior Surfaces And User Panel

    Maintenance 6-11 Stand B: 1. Unplug the MCS+ device. 2. Reach through the access holes on the top shelf and grasp the filters from the bottom of the machine. 3. Rinse each filter under warm running water until it is clean. Do not use soap or any cleaning solution.

  • Page 98: Leakage Current

    The Clinical Hot Line number is (800) 433-3431. The Technical Hot Line number is (800) 537-2802. Outside North America, the apheresis operator should contact his or her local Haemonetics representative to determine the ap- propriate channel of communication. P/N 39551-00, Rev. F...

  • Page 99: Returned Goods Authorization (Rga) System

    All disposables to be picked up by courier for return to Haemon- etics should be handled according to the coordinator’s instructions. Merchandise shipped in error by Haemonetics will be handled by the Customer Services De- partment, at (800) 225-5297.

  • Page 100: Maintenance Schedule

    6-14 Maintenance Table 6-1, Maintenance Schedule Clean centrifuge cover and well Monthly and with a spill Inspect L gasket and apply silicone grease Monthly (Vacuum centrifuge only) Clean bowl optics lens Monthly and with a spill Clean disposable ID window Monthly Clean pumps Monthly and with a spill...
  • Page 101 Maintenance 6-15 P/N 39551-00, Rev. F...
  • Page 103 Chapter Seven REFERENCE INFORMATION REFERENCE CALCULATIONS ........7-2 Anticoagulant in Product .

  • Page 104: Reference Calculations

    Reference Information EFERENCE ALCULATIONS Anticoagulant The concentration of anticoagulant in a platelet or plasma product is a function in Product of the Anticoagulation Ratio (“AC Ratio”) and Donor Hematocrit. Table 7-1 gives the concentration of anticoagulant in the collected plasma or platelet product. To determine the total volume of anticoagulant in a plasma or platelet product use the following procedure: •...

  • Page 105: Ac Volume Returned To The Donor Or Patient

    Reference Information Table 7-1: Concentration of anticoagulant in plasma or platelet products AC Ratio 1:10 1:11 1:12 1:16 Donor Hematocrit % Anticoagulant in the plasma or platelet product 19.8% 17.7% 16.1% 14.7% 13.6% 10.3% 20.0% 18.0% 16.3% 14.9% 13.8% 10.5% 20.3% 18.2% 16.6%...

  • Page 106: Total Blood Volume Calculations

    Reference Information Total Blood The MCS+ device displays the estimated total blood volume of the donor on Volume screen. The method used by the MCS+ device is the Nädler equation as given by the AABB Technical Manual (12th edition, page 741). Charts 7-1 and 7-2 depict Calculations the estimated blood volume.
  • Page 107 Reference Information 5800 5600 5400 5200 5000 4800 4600 4400 4200 4000 3800 3600 , Rev. F P/N 39551-00...
  • Page 108 Reference Information 6600 76777 5000 4800 4600 4400 4200 4000 3800 3600 3400 3200 3000 , Rev. F P/N 39551-00...

  • Page 109: Expected Extracorporeal Volume

    Reference Information Expected The maximum Extracorporeal Volume (ECV) per cycle can be estimated by sub- Extracorporeal tracting the volume of anticoagulant used from the volume processed and divid- ing by the cycle number. The most accurate estimation is obtained during the Volume first return mode.

  • Page 110: Determining Product Volume

    Reference Information To determine the expected maximum % ECV out, divide the expected maximum ECV by the estimated total blood volume of the donor. Expected Maximum ECV Expected % ECV = 100 x Estimated Blood Volume For a platelet procedure a 5’0”, 110 lb. female (estimated blood volume is 3500 ml) with a hematocrit of 38% is expected to have a maximum ECV of 480 ml, and a % ECV of 100 x 480/3500 = 13.7%.

  • Page 111: Calculating Platelet Efficiencies

    Reference Information Calculating The platelet collection efficiency can be calculated by dividing the platelet yield Platelet by the total number of platelets that have been processed. The preferred method of calculating the Platelet Collection Efficiency is based on the average of donor Efficiencies pre- and donor post-platelet counts.

  • Page 112: Anticoagulants

    7-10 Reference Information NTICOAGULANTS ACD-A ACD-A is the most commonly used anticoagulant. The anticoagulant ratio used depends on which component is being collected. The anticoagulant ratio is typ- ically between 1:8 and 1:12. Refer to the appropriate protocol manual for opti- mal anticoagulant ratios.

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