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Haemonetics MCS+ Operation Manual

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Working with the Haemonetics
Printed in France
Haemonetics Corporation
400 Wood Road
Braintree, Massachusetts 02184, USA
- Operation Manual -
P/N 85213-30, Manual revision: B
®
MCS
0123
HAEMONETICS U.K. LTD
5 Ashley Drive, Bothwell
EC REP
Scotland G71 8BS
Great Britain
June 2006
®
+

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  • Page 1 ® ® Working with the Haemonetics - Operation Manual - 0123 HAEMONETICS U.K. LTD 5 Ashley Drive, Bothwell EC REP Printed in France Scotland G71 8BS Great Britain Haemonetics Corporation 400 Wood Road P/N 85213-30, Manual revision: B Braintree, Massachusetts 02184, USA...
  • Page 2 ©2002, 2006, Haemonetics Corporation. All rights reserved.
  • Page 3 + and eLynx are trademarks or registered trademarks of the Haemonetics Corporation in the United States, other countries, or both. Any information or descriptions contained in this manual may not be reproduced and released to any of the general public, or used in conjunction with any profes- sional instruction without written consent of Haemonetics Corporation, USA.
  • Page 4 Scheelegatan 17 Tel. [+86 21] 5066 3366 223 70 Lund, Sweden Fax [+86 21] 6841 3688 Tel. [+46 46] 286 2320 Haemonetics CZ, spol. s r.o. Fax [+46 46] 286 2321 Ptašínského C.8 Haemonetics (UK) Ltd. 60200 Brno, Czech Republic Beechwood House Tel.

  • Page 5: Table Of Contents

    What is apheresis technology? ....... . . xi What is the Haemonetics “Mobile Collection System”? ....xii What are the characteristics and special features of the MCS+? .
  • Page 6 Table of contents SIDE PANELS COMPONENTS ....... . . 2-12 Solution-bag poles (2) .
  • Page 7 Table of contents CENTRIFUGE BOWL ......... . 4-8 Explaining the general design of the bowl .
  • Page 8 viii Table of contents WARNINGS FOR THE OPERATOR....... 6-5 Electrical shock hazards ........6-5 Leakage current control .
  • Page 9 What is apheresis technology? ....... . xiii What is the Haemonetics “Mobile Collection System”? ... . . xiv What are the characteristics and special features of the MCS+? .
  • Page 10 Preface The Haemonetics MCS+ LN09000-220E/ED P/N 85213-30, Manual revision: B...

  • Page 11: Preface

    NTRODUCING THE TOTAL APHERESIS DEVICE What is the This manual is intended to supply anyone involved in using Haemonetics apher- esis equipment with the essential tool for safe and successful operation – infor- purpose of this mation. Using this tool of information, the operator can acquire knowledge to be manual? applied throughout all levels of operating experience.

  • Page 12: What Is The Haemonetics "Mobile Collection System

    Haemonetics has designed the MCS+ technology with a degree of automation which permits the operator to interact with the device. The operator should remain attentive to the screen messages while monitoring the status of the donor/ patient.

  • Page 13: What Are The Characteristics And Special Features Of The Mcs

    AC solution flow. The communication box and bar-code reader for data acquisition and procedure data transfer, either to a printer, or to the Haemonetics network, HaemoNet. Setting up the The following guidelines should be observed when setting up the MCS+ device: device Always place the device on a flat, stable surface.

  • Page 14: Symbols Found In This Document

    Note: provides useful information regarding a procedure or operating technique when using Haemonetics material. Caution: advises the operator against initiating an action or creating a situation which could result in damage to equipment, or impair the quality of the blood products;...
  • Page 15 Preface Alternating current Used to indicate on the rating plate that the device is suitable for alternating current only. Fuse symbol Used to identify fuse boxes or the location of a fuse box. Power OFF Position of the main power switch indicating disconnection from the mains. Power ON Position of the main power switch indicating connection to the mains.

  • Page 16: Symbols Found On Disposable Packaging

    RS232 connection RS232 connection with power to one pin Pressure cuff connection Engraved centrifuge locking knob Flow indicator lights Symbols found on The following symbols are used by Haemonetics on disposable set packaging. disposable CATALOG NUMBER packaging EXPIRATION DATE Lot Number...
  • Page 17 Preface xvii STERILE EO Sterilized by exposure to Ethylene Oxide STERILE Fluid path STERILE by exposure to Ethylene Oxide STERILE R Sterilized by exposure to Gamma irradiation Fluid path STERILE by exposure to Gamma irradiation STERILE R DO NOT REUSE Caution: consult operator manual for instructions Storage conditions, humidity level 50°C...

  • Page 18: Specifications Of The Mcs+ Device

    Operating frequency range 50 - 60 Hz 50 - 60 Hz Note: Haemonetics will regulate the proper voltage setting upon installation. The power source used must be properly grounded. Warning: Equipment not suitable for use in the presence of a flammable anes- thetic mixture with air or with oxygen or nitrous oxide.
  • Page 19 MCS+ device. Any accessories and ble communication equipment can affect the MCS+ device. Any accessories and cables not approved by Haemonetics used in conjunction with the device may cables not approved by Haemonetics used in conjunction with the device may increase hazards and influence compatibility with EMC requirements.
  • Page 21 Chapter 1 Describing the MCS+ Centrifuge System PRESENTING THE MCS+ CENTRIFUGE SYSTEM ....1-2 CENTRIFUGE BASE ......... . 1-3 Using a mechanical centrifuge chuck .

  • Page 22: Chapter 1 Describing The Mcs+ Centrifuge System

    Describing the MCS+ Centrifuge System MCS+ RESENTING THE CENTRIFUGE SYSTEM The centrifuge system of the MCS+ device is designed to hold a disposable bowl which can be spun from a range of 3000 to 7000 revolutions per minute. This centrifugal force will separate anticoagulated whole blood in the bowl into its various components.

  • Page 23: Centrifuge Base

    Caution: The mechanical chuck clips must be kept clean, and should be thor- oughly cleaned after any spills. A dirty or blocked clip may no longer hold the bowl correctly. If a clip is not functioning properly, the operator must contact an authorized Haemonetics representative. P/N 85213-30, Manual revision: B...

  • Page 24: Using A Vacuum Centrifuge Chuck

    Describing the MCS+ Centrifuge System Using a vacuum If the MCS+ device contains a vacuum chuck, a vacuum force will be created centrifuge chuck between the base of the bowl and the chuck to hold the bowl in place. When installing a bowl, the operator should exert a downward pressure on the head of the bowl and ensure that the bowl is completely seated.

  • Page 25: Applications For A Centrifuge Chuck Adapter

    Describing the MCS+ Centrifuge System Applications for a When the selected MCS+ protocol uses a blow molded bowl (BMB), a centrifuge centrifuge chuck chuck adapter is required to secure the BMB in the centrifuge well, designed for the Latham bowl. adapter The chuck adapter is designed to be installed and removed using the same tech- niques as for the Latham bowl.

  • Page 26: Centrifuge Well

    Describing the MCS+ Centrifuge System ENTRIFUGE WELL The MCS+ centrifuge well is designed with the following components. Optical bowl sensor There is an optical sensor located on the upper portion of the centrifuge well. The sensor is aimed at the core of the bowl and will measure optical reflection as the various blood components pass in front of the optical beam.

  • Page 27: Centrifuge Cover

    Describing the MCS+ Centrifuge System YSTEM SEALING MECHANISM The MCS+ centrifuge contains a split, hinged lid (or cover) and a locking knob. These components “seal” the system by: Securing the contact of the disposable bowl with the centrifuge base. Isolating the spinning bowl from the operator. Centrifuge cover The centrifuge lid, referred to as the cover, has tabs located on the rimmed portion of each split side.
  • Page 28 Describing the MCS+ Centrifuge System The second style requires that the operator press the knob to separate the halves of the split lid when opening the centrifuge. The knob can be engraved with either the text “PUSH TO OPEN”, or a symbol of a lock. The centrifuge can be locked once the split halves of the lid have been firmly pressed together using the tabs.

  • Page 29: Summarizing The Mcs+ Centrifuge Components

    Describing the MCS+ Centrifuge System Summarizing the The following table summarizes the combinations of centrifuge components MCS+ centrifuge which can be found among the MCS+ centrifuge systems in use. components Table 1-1, MCS+ Centrifuge component combinations Component Mechanical chuck Vacuum chuck Vacuum chuck mechanically retrofitted Centrifuge chuck...
  • Page 31 Chapter 2 Describing the MCS+ Cabinet Components PRESENTING THE MCS+ CABINET COMPONENTS ....2-2 TOP DECK COMPONENTS ........2-3 Valves.

  • Page 32: Presenting The Mcs+ Cabinet Components

    Describing the MCS+ Cabinet Components MCS+ RESENTING THE CABINET COMPONENTS The individual components located on the MCS+ cabinet will be presented to the operator in this chapter, grouped by the following sections: Top deck components. Front panel components. Side panel components. Rear panel components.

  • Page 33: Top Deck Components

    Describing the MCS+ Cabinet Components OP DECK COMPONENTS 1. to 8. MCS+ pinch valves Note: valve 3 is the “donor” valve or red-coded valve 9. AC pump 10. Transfer pump 11. Blood pump 12. Optical line sensor 13. Weigher 14. DPM 15.

  • Page 34: Pump Assemblies

    Describing the MCS+ Cabinet Components Pump assemblies Located on the left side of the MCS+ top deck are three pumps which use peri- staltic movements to displace fluids through the disposable set tubing. Each pump is designated by a color and will function at particular moments during the apheresis procedure, as determined by the selected MCS+ protocol.
  • Page 35 Describing the MCS+ Cabinet Components Understanding the function of the pumps The pumps function in a general manner during the different modes of MCS+ operation as follows: When loading the disposable tubing: The AC pump and the Blood pump turn simultaneously to thread the dis- posable tubing onto the pump rotors.

  • Page 36: Optical Line Sensor

    Weigher The “weigher” is the term used by Haemonetics to describe the MCS+ compo- nent which measures in grams the contents of the collection container(s) placed on the “weigher arm”.

  • Page 37: Pressure Monitors

    Describing the MCS+ Cabinet Components Pressure The electronically controlled pressure monitors function with the correlating monitors filter on the disposable set to measure pressure in the disposable tubing. The pres- sure monitors provide feedback to the system about the flow of blood compo- nents to and from the donor (DPM) as well as the centrifuge bowl (SPM).

  • Page 38: Air Detectors (Top Deck)

    Describing the MCS+ Cabinet Components RETURN mode The pressure readings will vary as blood is returned to the donor. If a significant pressure increase is detected, and the pressure readings rise above a programmed value, the pump speed will automatically decrease until a sufficient pressure change is measured.
  • Page 39 Warning: If the AC solution is depleted prior to the end of the collection proce- dure, the operator may receive a NOTICE message and an alarm, signifying that the ACAD has detected air in the AC line tubing. Haemonetics recommends that the collection of blood components be discontinued at this point.

  • Page 40: Front Panel Components

    2-10 Describing the MCS+ Cabinet Components RONT PANEL COMPONENTS 1. DLAD1 2. DLAD2 3. Blood filter chamber brackets 4. Re-circulation chamber brackets 5. Disposable set pins Figure 2-7, MCS+ front panel Air detectors Donor line air detectors (DLAD1 and DLAD2) (front panel) The two donor line air detectors are located on the left side of the MCS+ front panel.

  • Page 41: Disposable Set Element Holders

    Warning: If, after attempting this procedure to remove any air, the DLAD1 and/ or DLAD2 detect air again, the operator should terminate the procedure, dis- continue use of the device and contact the authorized Haemonetics represen- tative. Disposable set...

  • Page 42: Side Panels Components

    2-12 Describing the MCS+ Cabinet Components IDE PANELS COMPONENTS Solution-bag Located on either side of the MCS+ cabinet is a height-adjustable pole. These poles (2) poles are used to hang the solution bags during the collection procedure. The left pole should be used to hang the AC solution bag, whereas the right pole should be used to hang the saline solution and other bags.

  • Page 43: Anticoagulant (Ac) Drip Monitor

    Describing the MCS+ Cabinet Components 2-13 RETURN mode The YELLOW LIGHT indicates that the non-selected blood components are being returned to the donor. Note: If any of the DRAW mode lights are lit, the donor can promote blood flow by clenching and relaxing the hand below the needle site. When the RETURN yellow light is lit, the donor should not do this, because the blood components in the bowl are being returned.

  • Page 44: Power Entry Module

    (discussed later in this chapter), in the transfer of this data to an external de- vice or to HaemoNet, the Haemonetics communication network. Warning: The class II bar-code reader emits laser radiation. Do not look directly into the beam.

  • Page 45: Platelet Filter Holder

    Describing the MCS+ Cabinet Components 2-15 Platelet filter Located on the right side of the MCS+ device are brackets used to secure the filter holder contained on the MCS+ disposable sets designed for platelet collection. Disposable set The MCS+ right side panel contains pins designed to secure disposable bags from pins the disposable collection set.

  • Page 46: Rear Panel Components

    MCS+ device. HaemoNet provides any establishment using Haemonetics equipment with the possibility of linking several Haemonetics apheresis devices to a central moni- toring computer. Using HaemoNet, procedure data can be exchanged and stored in a database and/or viewed directly.

  • Page 47: Wireless Antenna

    Describing the MCS+ Cabinet Components 2-17 frequencies rises above the standards. However, there is no impact on the integ- rity of the procedure information stored in the database. HaemoNet communica- tion is designed with CRC error checking, performed upon the reception of all data.

  • Page 48: Biohazard Waste Bag

    2-18 Describing the MCS+ Cabinet Components Note: If the MCS+ device is equipped with a retrofitted mechanical centrifuge, this release button will still be present, but will no longer be functional. A device equipped with a factory-origin mechanical chuck does not have this component. 1.
  • Page 49 Chapter 3 Describing the MCS+ Control Panel PRESENTING THE MCS+ CONTROL PANEL......3-2 UPPER CONTROL PANEL ........3-3 Donor flow indicator lights.

  • Page 50: Chapter 3 Describing The Mcs+ Control Panel

    CONTROL PANEL The MCS+ control panel provides the operator with the means to interact with the Haemonetics total apheresis device by allowing the operator to: Enter data into the system prior to a procedure. Modify program parameters to provide an optimal procedure result.

  • Page 51: Upper Control Panel

    Describing the MCS+ Control Panel PPER CONTROL PANEL The upper section of the MCS+ control panel will provide the operator with visual information concerning the status of the donor and donor blood flow, as well updated procedure statistics throughout the entire MCS+ collection protocol. Donor flow There is a set of flow indicator lights located on the top of the MCS+ control indicator lights...

  • Page 52: Explaining The Screen Layout

    Describing the MCS+ Control Panel Explaining the The information and data, updated throughout the procedure, is displayed on screen layout specific areas of the MCS+ display screen. The following screen illustrates the MCS+ display screen as it could appear during an apheresis procedure. DRAW Filling Bowl Generic information...

  • Page 53: Understanding An Operating Mode

    Describing the MCS+ Control Panel Understanding An MCS+ mode can be described as the operating state of the device during an operating specific phases of the apheresis process. Each MCS+ protocol will: mode Prepare the disposable set with AC solution during PRIME. Collect donor whole blood, mix the whole blood with AC solution and spin the anticoagulated blood in the centrifuge bowl, then selectively re- move the desired components during DRAW.

  • Page 54: Lower Control Panel/Keypad

    Describing the MCS+ Control Panel OWER CONTROL PANEL KEYPAD The lower section of the MCS+ control panel consists of a keypad, located directly below the display screen. There is a protective plastic coating on the keypad, which allows for efficient cleaning and disinfecting. The keys are grouped on the MCS+ keypad according to function, as depicted in the following illustration: Figure 3-4, MCS+ keypad...

  • Page 55: Stop Key

    Describing the MCS+ Control Panel STOP key This key is used to immediately stop the centrifuge and pumps. Caution: If the STOP key has been used, the bowl contents should be returned to the donor before resuming the collection procedure. Stopping the procedure could affect the separation of the blood components in the bowl.

  • Page 56: Cuff Control Key

    RETURN. Figure 3-7, MCS+ cuff control key Programming Certain system operating parameters have been selected by Haemonetics as keys default values. These parameters provide optimal results in MCS+ apheresis procedures with the average donor, as well as for average collection require- ments.
  • Page 57 Describing the MCS+ Control Panel This section of the MCS+ keypad consists of: Four keys which enable the operator to modify and save specific MCS+ protocol parameters. A Help/Haemo Calculator key which provides the operator with access to the Haemo Calculator screen and the Haemo Update screen. Figure 3-9, MCS+ programming keys Modify program key This key is used to view the existing parameters and can be pressed during any...
  • Page 58 " Press No – to decrease the value. The parameters will be altered according to specific increments as determined by Haemonetics. Default values and increments for modification will be listed in each respective protocol manual. Help/Haemo Calculator key This key is used during MCS+ operation for different purposes, depending on the operating state of the device.
  • Page 59 Chapter 4 Describing the MCS+ Disposable Collection Material PRESENTING AN MCS+ DISPOSABLE SET ......4-3 Closed set..........4-3 Bundled set .

  • Page 60: Chapter 4 Describing The Mcs+ Disposable Collection Material

    Describing the MCS+ Disposable Collection Material Figure 4-1, Example of an MCS+ disposable set tub Figure 4-2, The MCS+ disposable set tub is tailored for practical installation P/N 85213-30, Manual revision: B...

  • Page 61: Presenting An Mcs+ Disposable Set

    These elements can be combined in different ways to meet specific apheresis center procedure requirements. Note: Certain disposable sets used for MCS+ plasmapheresis applications will re- quire the use of pump manifold adapters, ordered separately from Haemonetics. P/N 85213-30, Manual revision: B...

  • Page 62: Donor-/Blood-Line Section

    Describing the MCS+ Disposable Collection Material ARNESS IN TUBING AND ELEMENTS The “harness-in” tubing extends from the donor to the disposable bowl. It contains distinct sections of disposable tubing, plus various combinations of disposable elements. Donor-/Blood- This section will deliver blood from the donor to the centrifuge bowl. Donor line section whole blood is drawn through the needle into a single lumen section to a junc- tion where the tubing splits into two sections: one for donor blood, the other for...
  • Page 63 Describing the MCS+ Disposable Collection Material Injection port This branch of the three-way connector should only be used for the emergency administration of medication or fluids, as the “closed” system can be altered. Donor-line sample pouch This element branches from the three-way connector and permits the operator to collect a donor/patient blood sample without the need for a separate venipunc- ture.

  • Page 64: Dpm Line Section

    Describing the MCS+ Disposable Collection Material Blood pump “stops” and tubing These elements, found on disposable sets which do not utilize the Transfer pump, will secure the pump tubing in preparation for pump autoloading. Note: Pump tubing can be easily distinguished because it is more elastic. This elasticity helps to reduce twists and occlusions when the tubing is thread around the pump rotors.

  • Page 65: Ac Line Section

    This element permits the operator to attach the AC solution bag to the disposable set. Note: Haemonetics recommends spiking the AC solution bag prior to hanging it on the solution pole, to avoid any possible AC solution drops on the device. AC solution becomes “sticky”...

  • Page 66: Centrifuge Bowl

    Describing the MCS+ Disposable Collection Material ENTRIFUGE BOWL The Haemonetics disposable centrifuge bowl is the central element of any MCS+ disposable set. Two types of disposable bowls exist for the various MCS+ proce- dures: the bell-shaped Latham bowl and the cylindrically-shaped blow molded bowl (BMB).
  • Page 67 Describing the MCS+ Disposable Collection Material 1. Inlet port 2. Outlet port Figure 4-6, Latham centrifuge bowl 3. Header shield 4. Bowl seal 5. Processing chamber 6. Bowl core 7. Feed tube 8. Bowl body Figure 4-7, Blow molded centrifuge bowl P/N 85213-30, Manual revision: B...

  • Page 68: Understanding Bowl Operation

    4-10 Describing the MCS+ Disposable Collection Material Understanding Both types of centrifuge bowls will function during the first part of the DRAW bowl operation cycle in the following way: The head of the bowl remains stationary during operation. The body of the bowl, held in the centrifuge chuck by the system-sealing mechanism will be spun between 3000 and 7000 rpm, depending on the selected MCS+ protocol.

  • Page 69: Managing The Bowl Air Inventory

    Describing the MCS+ Disposable Collection Material 4-11 Managing the The disposable bowl contains sterile air which is displaced into a collection bowl air container as the bowl is filled during a DRAW cycle. This same air returns to the bowl when the non-collected components are returned to the donor during a inventory RETURN cycle.
  • Page 70 4-12 Describing the MCS+ Disposable Collection Material A. Filling the bowl 1. Anticoagulated whole blood 2. Air B. Collecting plasma 1. Anticoagulated whole blood 2. Plasma C. Returning components 1. Non-collected blood components 2. Air Figure 4-9, Blow molded bowl operation P/N 85213-30, Manual revision: B...

  • Page 71: Effluent Line Section

    Describing the MCS+ Disposable Collection Material 4-13 ARNESS OUT TUBING AND ELEMENTS Effluent line This section of disposable tubing extends from the centrifuge bowl to the collec- section tion container(s). It will transport centrifuged blood components through the line sensor before being collected. The following elements will be present on the MCS+ effluent tubing section.

  • Page 72: Protocol-Specific Solution Line Sections

    4-14 Describing the MCS+ Disposable Collection Material ROTOCOL SPECIFIC SOLUTION LINE SECTIONS Solution line These sections of disposable harness tubing are designed for use with MCS+ section(s) protocol-specific additives and solutions. A solution line on a “closed” set will contain a bacteriological filter separating the spike, or solution bag connector, from the rest of the disposable set.

  • Page 73: Illustrating Types Of Mcs+ Disposable Material

    Describing the MCS+ Disposable Collection Material 4-15 MCS+ LLUSTRATING TYPES OF DISPOSABLE MATERIAL Closed sets Latham bowl closed set 1. Centrifuge bowl 2. Collection bags 3. Blood filter chamber 4. DPM line 5. Dual-pump manifold 6. Solution line with filter 7.

  • Page 74: Bundled Set

    4-16 Describing the MCS+ Disposable Collection Material Bundled set Bundled set with NaCl spike 1. Centrifuge bowl 2. Collection bag 3. Blood filter 4. DPM line 5. Blood pump “stops” 6. AC pump “stops” 7. AC solution line 8. Needle connector 9.
  • Page 75 Chapter 5 Maintaining the MCS+ Equipment CLEANING PROCEDURES ........5-2 Cabinet and control panel .

  • Page 76: Chapter 5 Maintaining The Mcs+ Equipment

    A record of routine cleaning schedule can be kept along with any routine or preventive service maintenance performed by a Haemonetics representative. The frequency of cleaning each individual MCS+ device will depend on the number of procedures performed.

  • Page 77: Pressure Monitors

    Maintaining the MCS+ Equipment Pressure The pressure monitors (DPM/SPM) should be cleaned daily in the following monitors manner: Depress and hold the white ring (as if installing the disposable filter). " Wipe the silver rod thoroughly with a damp, lint-free cloth, using a circular "...

  • Page 78: Fluid Detector(S)

    This includes the centrifuge well and chuck, chuck adapter, hinged lid and locking knob. Haemonetics Technical Services provides silicon lubricant for the “L” gasket, located at the base of the vacuum centrifuge chuck. After a major cleaning, the operator should apply a small amount of the lubricant to the gasket to prevent it from cracking.

  • Page 79: Pumps

    Maintaining the MCS+ Equipment Haemonetics recommends that the operator wear protective gloves to avoid direct contact with the cleaning solution and/or any spilled blood which may be present. In the case of a larger spill, fluid and/or blood may be evacuated into the biohazard waste bag.

  • Page 80: Filter Screens

    Maintaining the MCS+ Equipment Filter screens The MCS+ device is equipped with filter screens on the bottom of the cabinet, which eliminate dust from incoming cool air. The filters should be cleaned routinely, especially if dust becomes visible on the screens. To clean the filters, the operator should: "...
  • Page 81 Maintaining the MCS+ Equipment P/N 85213-30, Manual revision: B...

  • Page 82: Customer Service

    Maintaining the MCS+ Equipment USTOMER SERVICE Clinical training Haemonetics employs a staff of Clinical Specialists to provide training for apher- esis personnel concerning the use of the MCS+ equipment. The local Haemo- netics representative will schedule staff training upon delivery of MCS+ equip- ment and should be contacted to organize further instruction when needed.

  • Page 83: Disposal

    Maintaining the MCS+ Equipment In some cases, it may be necessary to dispose of the contaminated goods after reporting the problem to the Haemonetics representative. This should be done according to the locally established guidelines pertaining to the disposal of biologically contaminated material.
  • Page 86 5-12 Maintaining the MCS+ Equipment P/N 85213-30, Manual revision: B...
  • Page 87 Chapter 6 Ensuring Safety and Quality for an MCS+ Procedure HANDLING THE MCS+ EQUIPMENT ......6-2 Storing the device and material .

  • Page 88: Chapter 6 Ensuring Safety And Quality For An Mcs+ Procedure

    Ensuring Safety and Quality for an MCS+ Procedure MCS+ ANDLING THE EQUIPMENT Safe and successful MCS+ operation will depend in part on the proper routine handling of the MCS+ equipment. The operator should be aware of the problems which could result if the device or disposable material is stored, installed or used incorrectly.

  • Page 89: Preventing Problems During An Mcs+ Procedure

    “high return pressure alarms” during MCS+ operation. If there is any suspicion that hemolysis has occurred, the operator should not return the contents of the bowl to the donor. The local Haemonetics representa- tive should be informed of the problem to provide the operator with further instruction.

  • Page 90: Avoiding Bowl Misalignment

    Overheating could also result from a mechanical or maintenance-related overheating due problem, such as a defective bearing or seal within the centrifuge well. In this case, the operator should contact the local Haemonetics representative and to mechanical discontinue use of the MCS+ device until it is serviced.

  • Page 91: Warnings For The Operator

    The operator should never remove any of the MCS+ cabinet panels. Maintenance requiring access to the inner cabinet remains the responsibility of a Haemonetics- trained technician. The operator should not touch any internal parts of a non-medical device that, after the removal of covers, connectors, etc., without a tool, could result in an...

  • Page 92: Mechanical Hazards/Rotating Parts

    In addition, do not power the MCS+ device using a power cord other than the one originally supplied by Haemonetics for your instrument. Always ensure the power cord is connected to an appropriately grounded power source.
  • Page 93 Chapter 7 Troubleshooting during an MCS+ Procedure UNDERSTANDING A NOTICE AND RELEVANT HELP MESSAGE ..7-2 PERFORMING A RECOVERY PROCEDURE......7-3 APPLYING SPECIFIC TROUBLESHOOTING TECHNIQUES .

  • Page 94: Chapter 7 Troubleshooting During An Mcs+ Procedure

    If this occurs, the operator should record the error detected and immediately power off the device. The oper- ator should discontinue use of the device and inform the local Haemonetics representative, who will provide further instruction.

  • Page 95: Performing A Recovery Procedure

    Troubleshooting during an MCS+ Procedure ERFORMING A RECOVERY PROCEDURE The MCS+ programming will provide the operator with a particular screen message in certain situations called PROCEDURE RECOVERY. The Procedure Recovery screen message will appear: If the power supply to the device has been interrupted as in the case of an external power failure.

  • Page 96: Applying Specific Troubleshooting Techniques

    During an apheresis procedure, an unusual circumstance may arise (such as a infusion power failure or other technical reason) in which the MCS+ device cannot pump the contents of the disposable bowl and tubing back to the donor. Haemonetics procedure suggests a technique using gravity to manually infuse the remaining contents.
  • Page 97 Troubleshooting during an MCS+ Procedure Preparing the tubing " Disconnect the MCS+ device from the external power source. Clamp the donor-line double lumen tubing close to the Y-connector. " Clamp the AC line above the Y-connector to isolate the tubing from the do- "...

  • Page 98: Repeat Venipuncture Procedure

    If a vein becomes infiltrated at any point during a collection procedure, and venipuncture blood can no longer flow through the needle, Haemonetics recommends that the uncollected blood components in the bowl and tubing be returned to the donor procedure using a new intravenous pathway.

  • Page 99: Ac Depletion Procedure

    “AIR DETECTED BY THE ACAD”. Warning: Haemonetics recommends that the collection of blood components be discontinued at this point. The operator can attempt to return any blood components remaining in the bowl using manual gravity infusion.
  • Page 101 Chapter 8 Consulting Reference Information EXPLAINING COMMONLY USED CALCULATIONS ....8-2 Calculating AC concentration in the final product ....8-2 Calculating the AC volume infused to the donor/patient .

  • Page 102: Chapter 8 Consulting Reference Information

    Consulting Reference Information XPLAINING COMMONLY USED CALCULATIONS Calculating AC The concentration of anticoagulant solution found in an MCS+ platelet or plasma concentration in product depends on a combination of the following two variables: the final product The selected anticoagulation ratio (or AC ratio) for the procedure. The individual donor hematocrit.
  • Page 103 Consulting Reference Information Table 8-1, AC solution concentration in MCS+ final collection products AC Ratio 1:10 1:11 1:12 1:16 Donor Hematocrit % Anticoagulant in the plasma or platelet product 15.2 13.5 12.2 11.1 10.2 15.5 13.8 12.5 11.4 10.4 15.8 14.1 12.8 11.6...

  • Page 104: Calculating The Ac Volume Infused To The Donor/Patient

    Consulting Reference Information Calculating the The volume of AC solution infused to the donor/patient can be calculated as AC volume follows: infused to the Consult the “Haemo Update” or “Procedure Complete Screen” to deter- " donor/patient mine the volume of AC solution used (AC Used) during the collection pro- cedure.

  • Page 105: Determining Final Product Volume(S)

    Consulting Reference Information To determine if the 15% ECV limit may be exceeded, the estimated maximum ECV should be divided by the Estimated Total Blood Volume of the donor/patient. A donor/patient with a hematocrit of less than 38% and an estimated blood volume of less than 3600 ml can be expected to reach the 15% ECV limit during the procedure.

  • Page 106: Calculating Platelet Collection Efficiency

    The mean platelet collection efficiency of the MCS+ device can be entered by an authorized Haemonetics representative, once a sufficient number of platelet collection procedures have been completed. To calculate the platelet collection efficiency: Determine the average platelet count of the donor.

  • Page 107: Operation Precautions

    In addition, do not power the MCS+ device using a power cord other than the one originally supplied by Haemonetics for your instrument. Always ensure the power cord is connected to an appropriately grounded power source.
  • Page 108 U ) for 0.5 dip in U ) for 0.5 tions, voltage If the operator of the Haemonetics system cycles cycles variations on requires continued operation during power power supply mains interruptions, it is recommended that...
  • Page 109 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Haemonetics system is used exceeds the applicable RF compliance level above, the Haemonetics system should be observed to verify normal operation.
  • Page 110 8-10 Consulting Reference Information The Haemonetics system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Haemonetics system can help prevent electromagnetic interference by maintain- ing a minimum distance between portable and mobile RF communications equipment (transmitters) and the Haemonetics system as recommended below, according to the maximum output power of the communications equipment.

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