Working with the Haemonetics® MCS®+ — Operation Manual —
Printed in France
Haemonetics Corporation
400 Wood Road
Braintree, Massachusetts 02184, USA
0123
HAEMONETICS U.K. LTD
5 Ashley Drive, Bothwell
EC REP Scotland G71 8BS
Great Britain
P/N 85213-30, Manual revision: B June 2006
©2002, 2006, Haemonetics Corporation. All rights reserved.
iii
CONSUMER INFORMATION
Proprietary rights The contents of this manual are property of the Haemonetics Corporation. Haemonetics®, MCS®+ 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 professional instruction without written consent of Haemonetics Corporation, USA. Please direct any written inquiries to the appropriate address.
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International Headquarters |
Corporate Headquarters |
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Haemonetics SA |
Haemonetics Corporation |
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Signy Centre, rue des Fléchères |
400 Wood Road |
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P.O. Box 262, 1274 Signy 2, Switzerland |
Braintree, MA 02184, USA |
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Tel. [+41 22] 363 90 11 |
Tel. [+1 781] 848 7100 |
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Fax [+41 22] 363 90 54 |
Fax [+1 781] 848 5106 |
Legal disclaimer This manual is intended for use as a guide, uniquely for material as supplied by the Haemonetics Corporation. It provides the operator with necessary information to safely carry out specific procedures and satisfactorily maintain Haemonetics produced equipment. The manual is to be used in conjunction with instruction and training as supplied by qualified Haemonetics personnel.
Haemonetics guarantees its products when correctly used by a properly trained operator. Any failure to respect the procedures as described could result in impaired function of the equipment, as well as in injury to the operator and/or patient/donor. Haemonetics accepts no responsibility for problems resulting from failure to comply with prescriptions as outlined by the company.
Any modifications estimated as necessary by the customer should be evaluated by a Haemonetics Clinical Specialist.
Safe utilization of Haemonetics material and equipment requires the operator to correctly handle and dispose of blood-contaminated material. The operator of any Haemonetics equipment must fully understand and implement the local prevailing policies and procedures of each facility in which Haemonetics products are used, concerning blood-contaminated material as well as blood products.
It remains solely the responsibility of the customer to fully assess and ensure the safety of any products obtained from Haemonetics prescribed procedures, prior to further application or use.
Haemonetics declines any responsibility for choices made by the consumer concerning the utilization of these products and by-products.
In addition, it is the responsibility of the apheresis center using Haemonetics equipment and material to provide information to the donor concerning the risks involved with any apheresis procedure. Prior to initiating any procedure, the apheresis center is responsible to verify that the donor understands these risks and consents to the procedure.
P/N 85213-30, Manual revision: B
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CONTACTING HAEMONETICS WORLDWIDE
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Haemonetics Asia Inc. |
Haemonetics France S.A.R.L. |
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Taiwan Branch |
46 bis, rue Pierre Curie |
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26F-1, No. 102 Roosevelt Road Sec. 2 |
Z.I. Les Gatines |
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Taipei, Taiwan |
78370 Plaisir, France |
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Tel. [+886 2] 2369 0722 |
Tel. [+33 1] 30 81 41 41 |
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Fax [+886 2] 2364 3698 |
Fax [+33 1] 30 81 41 30 |
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Haemonetics |
Haemonetics GmbH |
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Handelsges.m.b.H. |
Wolfratshauser Straße |
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Berlagasse 45/B2-02 |
81379 München, Germany |
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1210 Wien, Austria |
Tel. [+49 89] 785 8070 |
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Tel. [+43 1] 294 29 00 |
Fax [+49 89] 780 9779 |
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Fax [+43 1] 294 29 05 |
Haemonetics Hong Kong Ltd. |
Haemonetics Belgium NV
Leuvensesteenweg 542-BP. 14
Planet II Complex
1930 Zaventem, Belgium
Tel. [+32 2] 720 7484
Fax [+32 2] 720 7155
Haemonetics BV
Trinstraat 7
4823AA Breda
Netherlands
Tel. [+31 76] 544 9477
Fax [+31 76] 544 9357
Haemonetics Medical Devices (Shanghai) International Trading Co. Ltd.
1000 28032 Rm 032 28F No. 1000 Lujiazui Ring Rd. Shanghai 200120, P.R.C.
Tel. [+86 21] 5066 3366
Fax [+86 21] 6841 3688
Haemonetics CZ, spol. s r.o.
Ptašínského C.8
60200 Brno, Czech Republic Tel. [+42 05] 4121 2400 Fax [+42 05] 4121 2399
Suite 1314, Two Pacific Place
88 Queensway, Hong Kong
Tel. [+852] 2868 9218
Fax [+852] 2801 4380
Haemonetics Italia S.R.L.
Via Donizetti 30
20020 Lainate (MI), Italy
Tel. [+39 2] 9357 0113
Fax [+39 2] 9357 2132
Haemonetics Japan K.K.
Kyodo Building 3F
16, Ichiban-cho, Chiyoda-ku
Tokyo, Japan, 102-0082
Tel. [+81 3] 3237 7260
Fax [+81 3] 3237 7330
Haemonetics Scandinavia AB
Beta Huset, Ideon
Scheelegatan 17
223 70 Lund, Sweden
Tel. [+46 46] 286 2320
Fax [+46 46] 286 2321
Haemonetics (UK) Ltd.
Beechwood House
Beechwood Estate
Elmete Lane, Roundhay
Leeds LS8 2LQ, United Kingdom
Tel. [+44 113] 273 7711
Fax [+44 113] 273 4055
P/N 85213-30, Manual revision: B
Table of Contents
Preface
INTRODUCING THE MCS+ TOTAL APHERESIS DEVICE . . . . . . . . . . . . . . . XI What is the purpose of this manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi What is apheresis technology? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi What is the Haemonetics “Mobile Collection System”? . . . . . . . . . . . . . . xii What are the characteristics and special features of the MCS+? . . . . . . . xiii Setting up the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii Symbols found in this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv Symbols found on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv Symbols found on disposable packaging . . . . . . . . . . . . . . . . . . . . . . . . xvi Specifications of the MCS+ device . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii
Chapter 1 Describing the MCS+ Centrifuge System
PRESENTING THE MCS+ CENTRIFUGE SYSTEM . . . . . . . . . . . . . . . . . . . . 1-2 CENTRIFUGE BASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Using a mechanical centrifuge chuck . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Using a vacuum centrifuge chuck. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Applications for a centrifuge chuck adapter . . . . . . . . . . . . . . . . . . . . . . 1-5 CENTRIFUGE WELL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6 SYSTEM-SEALING MECHANISM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Centrifuge cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Locking knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Summarizing the MCS+ centrifuge components . . . . . . . . . . . . . . . . . . . 1-9
Chapter 2 Describing the MCS+ Cabinet Components
PRESENTING THE MCS+ CABINET COMPONENTS . . . . . . . . . . . . . . . . . . 2-2 TOP DECK COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Valves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Pump assemblies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Optical line sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Weigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Pressure monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Air detectors (top deck). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8 FRONT PANEL COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Air detectors (front panel) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10 Disposable set element holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
P/N 85213-30, Manual revision: B
SIDE PANELS COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Solution-bag poles (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Donor flow indicator lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12 Anticoagulant (AC) drip monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13 Power entry module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Power cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Bar-code reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14 Platelet filter holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 Disposable set pins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15 Protocol card port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
REAR PANEL COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 Pressure cuff. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 Communication box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16 Wireless antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17 Manual vacuum release button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17 Biohazard waste bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Chapter 3 Describing the MCS+ Control Panel
PRESENTING THE MCS+ CONTROL PANEL . . . . . . . . . . . . . . . . . . . . . . . 3-2 UPPER CONTROL PANEL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Donor flow indicator lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Display screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Explaining the screen layout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Understanding an operating mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Defining the screen icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 LOWER CONTROL PANEL/KEYPAD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 Mode control keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 STOP key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Pump control keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7 Cuff control key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8 Programming keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Chapter 4 Describing the MCS+ Disposable Collection
Material
PRESENTING AN MCS+ DISPOSABLE SET . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Closed set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Bundled set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 Unbundled set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3 HARNESS-IN TUBING AND ELEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Donor-/Blood-line section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 DPM line section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 AC line section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
P/N 85213-30, Manual revision: B
CENTRIFUGE BOWL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Explaining the general design of the bowl . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Understanding bowl operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Managing the bowl air inventory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
HARNESS-OUT TUBING AND ELEMENTS . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Effluent line section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
SPM line section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
PROTOCOL-SPECIFIC SOLUTION LINE SECTIONS . . . . . . . . . . . . . . . . . 4-14
Solution line section(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
ILLUSTRATING TYPES OF MCS+ DISPOSABLE MATERIAL . . . . . . . . . . . . 4-15
Closed sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Bundled set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Unbundled set sections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Chapter 5 Maintaining the MCS+ Equipment
CLEANING PROCEDURES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Cabinet and control panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Pressure monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Air detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Optical sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Fluid detector(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Centrifuge components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Pumps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Filter screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Bar-code reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Pressure cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
CUSTOMER SERVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Field service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Returned Goods Authorization system . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Chapter 6 Ensuring Safety and Quality for an MCS+ Procedure
HANDLING THE MCS+ EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Storing the device and material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Inspecting the material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Transporting the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
PREVENTING PROBLEMS DURING AN MCS+ PROCEDURE . . . . . . . . . . . 6-3
Understanding the risk of hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Avoiding the consequences of flow restriction. . . . . . . . . . . . . . . . . . . . . 6-3
Avoiding bowl misalignment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Avoiding overheating due to mechanical situations. . . . . . . . . . . . . . . . . 6-4
Controlling for red cell overrun. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
P/N 85213-30, Manual revision: B
WARNINGS FOR THE OPERATOR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Leakage current control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Mechanical hazards/rotating parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 Power outlet connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 Communicable disease precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
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 . . . . . . . . . . . . 7-4 Power failure procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Manual gravity infusion procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Repeat venipuncture procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 AC depletion procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
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. . . . . . . . . . . . . 8-4 Estimating total blood volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Estimating the expected extra corporeal volume. . . . . . . . . . . . . . . . . . . 8-4 Determining final product volume(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 Calculating platelet yield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5 Calculating platelet collection efficiency . . . . . . . . . . . . . . . . . . . . . . . . 8-6
IEC 60601-1-2 STANDARD REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . 8-7 Operation precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7 Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
P/N 85213-30, Manual revision: B
Preface
INTRODUCING THE MCS+ TOTAL APHERESIS DEVICE . . . . . . . . . . . . . . xiii
What is the purpose of this manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
What is apheresis technology? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
What is the Haemonetics “Mobile Collection System”? . . . . . . . . . . . . . xiv
What are the characteristics and special features of the MCS+? . . . . . . . . xv
Symbols found in this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi
Symbols found on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi
Symbols found on disposable packaging . . . . . . . . . . . . . . . . . . . . . . . . xix
Specifications of the MCS+ device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xx
P/N 85213-30, Manual revision: B
The Haemonetics MCS+ LN09000-220E/ED
P/N 85213-30, Manual revision: B
INTRODUCING THE MCS+ TOTAL APHERESIS DEVICE
What is the purpose of this manual?
What is apheresis technology?
This manual is intended to supply anyone involved in using Haemonetics apheresis equipment with the essential tool for safe and successful operation – information. Using this tool of information, the operator can acquire knowledge to be applied throughout all levels of operating experience. This body of information should be consulted whenever necessary, starting from the initial contact with Haemonetics technology, in order to attain:
!An awareness of the purpose of the device and the implications of its collection procedures for the donor/patient and the apheresis center.
!An understanding of how to safely operate the Haemonetics system, correctly install the appropriate disposable material, and troubleshoot any difficulties.
!An ability to consistently apply the principles behind safe operation, proper maintenance and correct handling to ensure optimal, quality apheresis results.
This manual covers MCS+ device information for list numbers LN9000-220-E, LN9000-220-ED, LN9000-220-EW, and LN9000-110-EWC. Information that is specific to a certain protocol (disposable set installation and how to run the protocol), is located in the protocol manuals.
Apheresis is the general term used to describe the selective removal and collection of one or more individual components which together form whole blood. This term can be subdivided into two categories:
!Cytapheresis: selective removal of one or more of the formed, cellular components of whole blood. These elements include erythrocytes, thrombocytes, leukocytes and stem cells.
!Plasmapheresis: selective removal of plasma, the liquid suspension medium of blood. Plasma contains elements referred to as fractional components, such as clotting proteins and immunoglobulins.
Apheresis Technology permits:
!The collection and separation of whole blood.
!The selective removal of specific components.
!The subsequent return of the remaining components to the donor/patient.
P/N 85213-30, Manual revision: B
xii
What is the Haemonetics “Mobile Collection System”?
Preface
Using updated apheresis technology, Haemonetics has produced the MCS+, a highly mobile, compact, lightweight total apheresis system which is as easy and safe to use, as it is technologically advanced.
The MCS+ automated apheresis technology provides the operator with a maximum degree of flexibility in any type of apheresis location. The components collected such as platelets, red cells, stem cells, and plasma may be designated for use in therapeutic transfusion. Plasma collected can also be conserved and subsequently fractionated into plasma-derived products.
The MCS+ (Haemonetics “Mobile Collection System Plus”), consists of distinctive “parts” which collectively function as a “whole” to produce a designated final product. These system elements can be explained using the following distinctions:
!The automated total apheresis device produced by Haemonetics called the “MCS+”.
!The single-use collection material manufactured by Haemonetics called a “disposable set”.
!The collection procedure designed by Haemonetics called a “protocol”.
Once the operator has initiated an MCS+ procedure, component collection will proceed automatically. The appropriate amount of anticoagulant solution will be mixed in the disposable tubing with whole blood from the donor/patient.
This anticoagulated blood will be drawn into a disposable collection bowl and separated by centrifugal force into its various components.
When the bowl reaches its collection capacity, the separated components will exit the bowl and be directed into collection containers for conservation, or returned to the donor/patient. This cycle is repeated until the desired amount of selected blood components have been collected.
The choice of the disposable material will depend on the selected MCS+ collection protocol. The MCS+ technology provides the operator with the option to infuse saline solution along with the blood components remaining in the bowl at the end of a procedure.
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. It is possible to modify the collection procedures, based on the needs and requirements of the individual donor/patient, as well as the apheresis center.
P/N 85213-30, Manual revision: B
Preface
What are the characteristics and special features of the MCS+?
Setting up the device
xiii
MCS+ collection procedures are quick and easy to initiate, requiring the operator simply to:
«Select a collection protocol among the interchangeable Protocol cards.
«Install the disposable set elements.
«Enter donor information and modify procedure parameters as needed.
«Perform a single venous puncture and initiate the MCS+ procedure.
Haemonetics has incorporated advanced technological features into the portable MCS+ design. Examples of these features which ensure safety for the donor/ patient and permit efficient time-management for the operator, are:
!A removable Protocol card: permits the operator to change between the various MCS+ collection procedures available without requiring extra technical service. Using this system, a collection procedure upgrade is very simple – a new MCS+ protocol card is provided when MCS+ procedure programming is revised.
!A large, interactive control panel: provides the operator with feedback and on-line assistance.
!The Haemo Calculator: an integral facet of the MCS+ function which calculates processed procedure volumes based on individual donor/patient characteristics and targeted product yields.
!The Haemo Update function: allows the operator to consult updated statistics at any time during the MCS+ procedure.
!The centrifuge chuck adapter: permits the operator to use a wide variety of disposable sets containing either the Haemonetics Latham bowl or the Haemonetics blow molded bowl.
!Self-loading pumps (including the Transfer pump): contribute to a wellmanaged collection procedure.
!Advanced optical sensor technology, including the anticoagulant drip monitor which counts drops and monitors 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.
The following guidelines should be observed when setting up the MCS+ device:
!Always place the device on a flat, stable surface.
!Allow the device to equilibrate to room temperature before use.
!Always ensure the IV poles are in the “down” position and the cabinet cover is closed when moving or transporting the device.
P/N 85213-30, Manual revision: B
xiv
Symbols found in this document
Symbols found on the device
Preface
The terms Note, Caution and Warning are used in this manual with the following symbols to emphasize certain details for the operator.
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; personal injury is unlikely.
Warning: advises the operator against initiating an action or creating a situation which could result in serious personal injury to either the donor or the operator.
The descriptions of the following symbols are based on information provided in the following documents:
!IEC 60601-1 Standard, Medical Electrical Equipment, Part 1: General requirements for safety.
!IEC 60417-1 Standard, Graphical symbols for use on equipment, Part 1: Overview and application.
Type BF applied part
This symbol indicates that the applied portion (i.e. the part which comes in contact with the donor) of the device is electrically isolated. The device has an internal electrical power source providing adequate protection against electrical shock, in particular pertaining to acceptable leakage current and the reliability of the protective earth connection.
Protective earth (ground)
Used to identify any terminal intended for connection to an external conductor, for protection against electrical shock in case of a fault.
P/N 85213-30, Manual revision: B
~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.
|
IPX1 |
Protection against ingress of liquid |
Indicates that the enclosure of the device is designed to provide a specified degree of protection against harmful ingress of water or liquid into the equipment (under applicable conditions).
Attention (Consult accompanying documents)
Non-ionizing electromagnetic radiation
Used to specify RF transmission for data communication.
Electrical and Electronic Equipment Waste
Dispose of the device using a separate collection method (according to EU and local regulation for waste electrical and electronic equipment).
P/N 85213-30, Manual revision: B
|
xvi |
Preface |
|
The following symbols have been designed for devices manufactured |
|
|
by Haemonetics: |
|
|
Bar-code reader connection |
|
|
RS232 connection |
|
|
RS232 connection with power to one pin |
|
|
Pressure cuff connection |
|
|
Engraved centrifuge locking knob |
|
|
Flow indicator lights |
Symbols found on disposable packaging
The following symbols are used by Haemonetics on disposable set packaging.
EXPIRATION DATE
P/N 85213-30, Manual revision: B
|
STERILE |
EO |
Sterilized by exposure to Ethylene Oxide |
|||
|
STERILE |
EO |
Fluid path STERILE by exposure to Ethylene Oxide |
|||
|
STERILE |
R |
Sterilized by exposure to Gamma irradiation |
|||
|
STERILE |
R |
Fluid path STERILE by exposure to Gamma irradiation |
|||
|
DO NOT REUSE |
!Caution: consult operator manual for instructions
80%
8%
Storage conditions, humidity level
80%
8%
50°C
-20°C
Storage conditions, temperature level
50˚C
-20˚C
P/N 85213-30, Manual revision: B
Specifications of the MCS+ device
The approximate weight and dimensions for the MCS+ device are as follows:
|
Characteristics |
Values |
||
|
Cabinet |
Cabinet |
||
|
cover open |
cover closed |
||
|
Height |
68.5 cm |
44 cm |
|
|
Width |
56.5 cm |
||
|
Depth |
56.5 cm |
36.5 cm |
|
|
Depth with communication box |
56.5 cm |
38.5 cm |
|
|
Weight |
27.5 kg |
||
|
Weight with communication box |
28.5 kg |
||
The following environmental conditions should be respected pertaining to operation and storage of the MCS+ device:
|
Conditions |
Values |
|
Ambient operating temperature |
+18° C to +27° C |
|
Tested storage temperature |
-20° C to +50° C |
|
Storage humidity level |
8% to 80%, non-condensing |
The electrical specifications for operating the MCS+ device are as follows:
|
Characteristics |
Values |
|
|
(relative to input voltage) |
||
|
Input voltage |
230 VAC ± 10% |
110 VAC ± 10% |
|
Operating current |
~1.9 A |
~ 2.6 A |
|
Fuse rating |
F2.5 A @ 250 V |
F5.0 A @ 250 V |
|
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 anesthetic mixture with air or with oxygen or nitrous oxide.
The shipping/ storage temp are -20C to 50C at 8% to 80% humidity. The artwork for the carton is only in the old film style.
P/N 85213-30, Manual revision: B
Note: The MCS+ device contains no user serviceable/repairable parts.
Caution: The MCS+ device must be operated in an environment compatible to the requirements of the IEC 60601-1-2 Standard, Electromagnetic compatibility.
Mobile RF communication equipment not approved by Haemonetics and portable communication equipment can affect the MCS+ device. Any accessories and cables not approved by Haemonetics used in conjunction with the device may increase hazards and influence compatibility with EMC requirements. Therefore, non-approved accessories and cables must not be used.
In addition, the MCS+ device and accessories must not be placed directly adjacent to, or top of other equipment, unless specifically approved by Haemonetics.
Caution: The MCS+ device must be operated in an environment compatible to the requirements of IEC60601-1-1 Standard, Medical electrical equipment.
Any electrical equipment used inside or outside the “patient environment” (as defined in the Standard), whether connected or not connected to the MCS+ device, must provide a level of safety compliant with relevant IEC and ISO safety standards. Safe environmental conditions must be maintained for all devices inside and outside of the patient environment.
When properly operated and maintained, the MCS+ device provides a level of safety compliant with the IEC 60601-1-1 Standard, both inside and outside the patient environment.
The operator is responsible for making sure that the final configuration of the MCS+ device complies with IEC 60601-1-1 Standard, Medical electrical equipment.
Note: Refer to the Postscript to the MCS+ Operation Manual (P/N 85270-30), for information about Haemonetics approved devices, such as a printer or an external network, that can be connected to the MCS+ device.
P/N 85213-30, Manual revision: B
Chapter 1
Describing the MCS+ Centrifuge
System
PRESENTING THE MCS+ CENTRIFUGE SYSTEM . . . . . . . . . . . . . . . . . . . . 1-2
CENTRIFUGE BASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Using a mechanical centrifuge chuck . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Using a vacuum centrifuge chuck . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Applications for a centrifuge chuck adapter . . . . . . . . . . . . . . . . . . . . . . 1-5
CENTRIFUGE WELL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
SYSTEM-SEALING MECHANISM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Centrifuge cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Locking knob . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Summarizing the MCS+ centrifuge components . . . . . . . . . . . . . . . . . . 1-9
P/N 85213-30, Manual revision: B
|
1-2 |
Describing the MCS+ Centrifuge System |
PRESENTING THE MCS+ CENTRIFUGE SYSTEM
1.Locking knob
2.Optical sensor
3.Long fluid detector
4.Round fluid detector
5.Mechanical chuck
6.Vacuum chuck
NOTE:
Any system containing one or two round fluid detector(s) could be retrofitted with one long fluid detector.
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.
There are two types of centrifuge systems for the MCS+ devices currently in use. One system uses mechanical clips to secure the disposable bowl in place during operation; the other uses a vacuum effect for the same purpose.
The MCS+ centrifuge components consist of:
!The centrifuge base.
!The centrifuge well.
!The system-sealing mechanism.
All MCS+ centrifuge systems contain a split hinged lid as a cover to seal the system, however variations exist among the elements of the base and well.
|
2. |
2. |
|
|
3. |
4. |
|
|
1. |
||
|
1. |
||
|
4. |
||
|
5. |
5. |
|
|
2. |
2. |
|
|
4. |
4. |
|
|
1. |
1. |
|
|
5. |
6. |
Figure 1-1, Variations among the MCS+ centrifuge systems
P/N 85213-30, Manual revision: B
|
Describing the MCS+ Centrifuge System |
1-3 |
CENTRIFUGE BASE
Using a mechanical centrifuge chuck
The centrifuge base contains a chuck designed to hold a disposable centrifuge bowl in place during operation. The MCS+ disposable set can contain either a Latham bowl, or a blow molded bowl (BMB). The type of bowl used will depend on the final collection product.
The technique used to install a bowl will depend on the design of the centrifuge chuck. The following variations exist among MCS+ devices in use:
!Centrifuge base with a mechanical chuck/factory origin.
!Centrifuge base with a vacuum chuck/factory origin.
!Centrifuge base with a mechanical chuck, retrofitted from a vacuum chuck/factory-origin.
If the MCS+ device contains a mechanical chuck, the clips on the centrifuge base will 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. The operator will hear a “click” after applying the proper downward force.
To remove the bowl at the end of the procedure, the operator should grasp the head of the bowl and pull sideways to release the bowl from the clips while lifting the bowl out of the centrifuge well.
Figure 1-2, MCS+ mechanical centrifuge chuck
Caution: The mechanical chuck clips must be kept clean, and should be thoroughly 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
|
1-4 |
Describing the MCS+ Centrifuge System |
Using a vacuum centrifuge chuck
If the MCS+ device contains a vacuum chuck, a vacuum force will be created 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. The bowl will be completely secured once the operator has locked the centrifuge lid.
To remove a bowl at the end of a procedure, the operator should simply pull upward on the bowl until the vacuum force is disrupted. The bowl can then be lifted out of the centrifuge well.
Figure 1-3, MCS+ vacuum centrifuge chuck
Caution: If any residual vacuum force remains and the operator cannot remove the bowl using this technique, the manual vacuum release button can be used (refer to Manual vacuum release button in Chapter 2). However, the operator should not use this mechanism during routine MCS+ function, as this could damage the bowl and/or centrifuge components.
Figure 1-4, MCS+ vacuum centrifuge retrofitted with the mechanical chuck
P/N 85213-30, Manual revision: B
|
Describing the MCS+ Centrifuge System |
1-5 |
Applications for a centrifuge chuck adapter
When the selected MCS+ protocol uses a blow molded bowl (BMB), a centrifuge chuck adapter is required to secure the BMB in the centrifuge well, designed for the Latham bowl.
The chuck adapter is designed to be installed and removed using the same techniques as for the Latham bowl. The adapter will be secured by either vacuum force, or the mechanical clips, depending on the type of centrifuge chuck.
Once the adapter has been securely positioned, the BMB can be installed in the adapter, using a downward pressure to fully seat the bowl. A suction force will be created between the base of the adapter and the bowl. To remove a BMB at the end of a procedure, the operator should simply pull upward on the head of the bowl. The adapter can be removed from the centrifuge well using the same technique as when removing the Latham bowl.
Figure 1-5, MCS+ centrifuge with chuck adapter for blow molded bowl
Note: The chuck adapter is not a disposable element and should not be discarded after use. It is to be re-used for subsequent MCS+ procedures.
Figure 1-6, MCS+ centrifuge chuck adapter
P/N 85213-30, Manual revision: B
|
1-6 |
Describing the MCS+ Centrifuge System |
CENTRIFUGE 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.
Note: The interface between the optical sensor in the centrifuge well and the contents of the bowl is often referred to as “bowl optics” and will be discussed in further detail in each respective MCS+ protocol manual.
1.Optical sensor
2.Long fluid detector
3.Round fluid detectors
2. 3.
1.
Figure 1-7, MCS+ optical bowl sensor and fluid detectors
Caution: The optical bowl sensor must be kept clean, and should be cleared after any spills. A dirty or clouded lens will interfere with proper functioning of the MCS+ device.
Fluid detector(s)
The MCS+ centrifuge well is equipped with an electronic fluid detection system designed to detect the presence of liquid. Depending on the style of centrifuge in use, there will be either one long fluid detector, or one or two round fluid detector(s) mounted on the wall of the centrifuge well. The MCS+ safety system will automatically stop the centrifuge (and the pumps) if there is contact between liquid of any sort and the fluid detector(s).
P/N 85213-30, Manual revision: B
|
Describing the MCS+ Centrifuge System |
1-7 |
SYSTEM—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. The split halves are attached to the centrifuge rim by a hinge. As the halves of the lid are lowered to meet the rim, the tabs must be firmly pressed together in order to completely close the lid and provide a seal around the stationary head of the disposable bowl.
The split halves of the lid are made from a durable, transparent material, allowing the operator to observe changes in the bowl contents as the centrifuge spins.
Locking knob
The locking knob is positioned on the rim of the centrifuge well. Two types of locking knobs exist among the MCS+ devices in use.
Figure 1-8, Locking knob (turn to open/close)
One style of knob requires a series of turns to lock or unlock the lid. Once the lid has been fully closed, the knob should be turned in a clockwise direction to lock the centrifuge and thus completely seal the system. The operator will be cued by the MCS+ display screen.
To unlock the centrifuge, the operator should turn the knob in a counter-clock- wise direction until the split halves can be separated, then lifted to open the lid.
P/N 85213-30, Manual revision: B
|
1-8 |
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. This knob is incorporated into an elevated base. The knob needs to be turned and aligned with the appropriate symbol on the base to place it in the locked or unlocked position.
Figure 1-9, Locking knob “PUSH TO OPEN”, symbol version
Figure 1-10, Locking knob “PUSH TO OPEN”, text version
Warning: The MCS+ device is equipped with a safety feature which will not allow the centrifuge to spin if the lid has been improperly closed. It is unlikely that a properly installed centrifuge bowl will become unaligned as it spins. However, if the operator should notice anything unusual about the bowl, under no circumstances, should the operator attempt to open the centrifuge lid if the bowl is still spinning. The operator must ensure that the centrifuge has come to a complete stop before attempting to open the lid for any reason.
P/N 85213-30, Manual revision: B
|
Describing the MCS+ Centrifuge System |
1-9 |
Summarizing the MCS+ centrifuge components
The following table summarizes the combinations of centrifuge components which can be found among the MCS+ centrifuge systems in use.
Table 1-1, MCS+ Centrifuge component combinations
|
Component |
Mechanical chuck |
Vacuum chuck |
Vacuum chuck |
|
mechanically retrofitted |
|||
|
Centrifuge chuck |
Mechanical clips secure |
Vacuum force secures the |
Mechanical clips secure |
|
the bowl or chuck adapter. |
bowl or chuck adapter. |
the bowl or chuck adapter. |
|
|
Fluid detector(s) |
One long or two round |
One round |
One round |
|
Optical bowl |
One |
One |
One |
|
sensor |
|||
|
Split hinged lid |
Designed with semi- |
Designed with cylindri- |
Designed with cylindri- |
|
circularly shaped tabs, |
cally shaped tabs, pressed |
cally shaped tabs, pressed |
|
|
pressed to close the sides |
to close the sides of the lid. |
to close the sides of the lid. |
|
|
of the lid. |
|||
|
Locking knob |
Knob engraved with either: |
Requires series of turns to |
Requires series of turns to |
|
“PUSH TO OPEN” sym- |
lock or unlock the lid. |
lock or unlock the lid. |
|
|
bol or text. |
|||
P/N 85213-30, Manual revision: B
Chapter 2
Describing the MCS+ Cabinet
Components
PRESENTING THE MCS+ CABINET COMPONENTS . . . . . . . . . . . . . . . . . . 2-2
TOP DECK COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Valves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Pump assemblies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Optical line sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Weigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Pressure monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Air detectors (top deck). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
FRONT PANEL COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Air detectors (front panel) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Disposable set element holders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
SIDE PANELS COMPONENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Solution-bag poles (2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Donor flow indicator lights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Anticoagulant (AC) drip monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Power entry module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Power cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Bar-code reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Handles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Platelet filter holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Disposable set pins. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Protocol card port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
REAR PANEL COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Pressure cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Communication box. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Wireless antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Manual vacuum release button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Biohazard waste bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
P/N 85213-30, Manual revision: B
|
2-2 |
Describing the MCS+ Cabinet Components |
PRESENTING THE MCS+ 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.
Note: Any references made to “left”, “right”, “top”, or “rear” are from the perspective of an operator facing the MCS+ device during an apheresis procedure.
1.Top deck
2.Front panel
3.Right side
4.Rear panel (not visible)
4.
2.
Figure 2-1, MCS+ section distinctions
The disposable elements will be explained in greater detail in Chapter 4 and in each respective MCS+ protocol manual. As an explanation for the operator concerning any references made to disposable set elements in this chapter:
Donor line tubing refers to the tubing which is either:
!Transporting blood away from the donor before the blood enters the centrifuge bowl, or,
!Transporting blood from the bowl prior to re-infusion to the donor. Effluent tubing refers to the tubing which is either:
!Exiting the bowl in the direction of the collection container(s), or,
!Transporting non-selected blood components back to the centrifuge bowl.
P/N 85213-30, Manual revision: B
|
Describing the MCS+ Cabinet Components |
2-3 |
TOP 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.SPM
16.ACAD
17.BLAD
|
9. |
||||
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16. |
||||
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1. |
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10. |
||||
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2. |
8. |
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11. |
12. |
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17. |
13. |
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14. |
15. |
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3. |
4. |
5. |
6. |
7. |
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Figure 2-2, MCS+ top deck |
Valves
There are eight valves located on the MCS+ top deck which automatically control the flow of fluids through the disposable set tubing. The valves are color-coded and correspond with specific sections of disposable set tubing. Each valve also contains a light to indicate an open (lit) or closed (not lit) state. The MCS+ safety system will control the valves during the power-up self-diagnostic tests. Once the operator has selected a collection protocol, the appropriate valves will open automatically and be lit, in preparation for loading the disposable tubing.
Note: The function of each valve will depend on the selected MCS+ protocol, however the red-coded valve (N° 3) is consistently used as the “donor“ valve.
During the different modes of the selected MCS+ protocol, the valves will operate automatically, opening and closing depending on the passage of fluids. However, the valves can be opened manually if the disposable tubing should need to be adjusted during a procedure, by pressing the pinch-lever on each valve toward the cabinet.
Warning: Any manual adjustment to a valve should be attempted only if the MCS+ device is POWERED OFF, in the READY state, or when the pumps are stopped. At any other time, the MCS+ safety system will be alerted and will interrupt the procedure. Manipulating a valve could lead to flow problems, and eventually cause hemolysis. Chapter 6 will discuss hemolysis in further detail.
P/N 85213-30, Manual revision: B
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Аферезный аппарат MCS+ использует принцип центрифугирования прерывистого потока крови в разделительной камере, именуемой колоколом. В нем происходит разделение крови на составляющие под действием сил центрифугирования.
Выходящий из колокола поток проходит через оптический датчик, называемый линейным сенсором. Он определяет оптическую плотность и собирает полученные компоненты в соответствующие мешки, в результате аппарат может автоматически выделять разные составляющие крови: плазму, тромбоциты, эритроциты, лейкоциты , стволовые клетки.
Каждый раз набирается небольшое количество крови и собирается заданный компонент, остальная кровь возвращается в русло, после чего начинается следующий цикл. Количество циклов и объем продукта программируются оператором.
Скорость забора и возврата крови постоянно контролируются высокочуствительным датчиком давления, поэтому дискомфорт процедуры минимален.
Для оптимизации процедуры афереза имеются настройки под индивидуальные особенности донора/пациента, для облегчения программирования — встроенный гемокалькулятор.
Дублированая система безопасности контролирует подачу антикоагулянта, экстракорпоральный объем крови, следит за отсутсвием воздуха в магистралях.
Русифицированная модель аппарата MCS+ LN 9000-220-EW-RU имеет русифицированный дисплей и русифицированный протокол получения тромбоцитов донора .
Аппарат транспортабелен и может использоваться на выезде, в том числе в специализированном транспорте.
Характеристики:
- Размеры: глубина 37см, ширина 57см, высота 44см (в закрытом виде), 67см (в рабочем состоянии).
- Источник питания: 220 В, 60 Гц.
- Скорость работы насоса: от 20 до 250 мл/мин.
- Скорость центрифуги: от 3000 до 7000 об/мин.
- Соотношение антикоагулянта: от 1:8 до 1:16.
- Одноигольный венозный доступ.
- Вес: 47,5 кг
КАРТЫ ПРОТОКОЛОВ
С аппаратом бесплатно идет одна русифицированная карта для получения тромбоцитов UPP и одна карта донорского плазмафереза PPP\FFP и адаптер насосов для плазмафереза 52444-00 .
|
UPP |
Получение тромбоцитов со сниженным содержание лейкоцитов |
|
SDR |
Получение двух доз эритроцитов донора |
|
RBCP+ |
Получение эритроцитов и плазмы донора |
|
FFP/PPP |
Получение плазмы донора (в том числе лейкоредуцированной) — данная карта входит в стандартный комплект поставки аппарата |
| Адаптер насосов 52444-00 | Предназначен для получения плазмы донора с картой протокола PPP/FFP.Входит в стандартную комплектацию аппарата |
|
TAE |
Проведение терапевтического и аутологичного эритроцитафереза |
|
PBSC |
Получение периферических стволовых клеток и лейкоцитов. Терапевтический аферез лейкоцитов (лимфоцитов, гранулоцитов) и тромбоцитов. |
|
TPE |
Проведение лечебного плазмафереза |
Каждый из вышеперечисленных протоколов располагается на отдельной карте памяти, которая вставляется в аппарат перед началом работы. По мере разработки новых процедур, выпускаются новые виды карт, которые могут быть использованы на уже имеющихся аппаратах MCS+.
Аппарат для цитоплазмафереза MCS+
Производитель: Haemonetics Corporation (США)
Аппарат для цитоплазмафереза MCS+ позволяет производить терапевтические процедуры (лимфоцитаферез, эритроцитаферез, тромбоцитаферез, плазмообмен, плазмаферез), донорские процедуры (тромбоцитаферез, плазмаферез, эритроцитаферез), сбор стволовых клеток, а также аутологические процедуры.
Принцип работы:
Аппарат забирает установленное программой небольшое количество крови у донора, которая подвергается центрифугированию. В центрифужной разделительной камере, именуемой колоколом, происходит разделение компонентов крови и плазмы, основываясь на их различной удельной плотности. Выходящий из колокола поток проходит через оптический датчик, называемый линейным сенсором. Он определяет оптическую плотность и собирает полученные компоненты в соответствующие мешки, в результате аппарат может автоматически выделять разные составляющие крови: плазму, тромбоциты, эритроциты, лейкоциты, стволовые клетки. Оставшаяся часть крови возвращается донору и начинается следующий цикл. Количество циклов и конечный объем продукта программируются оператором.
MCS+ оснащен встроенным гемокалькулятором, который позволяет оператору оптимизировать процесс афереза в зависимости от индивидуальных особенностей донора или пациента.
MCS+ снабжен высокочувствительным датчиком давления, контролирующим скорость забора и возврата крови, что очень важно при работе с пациентами с ограниченным венозным доступом и невозможностью проведения процедуры на других аппаратах.
Уникальная система безопасности контролирует подачу антикоагулянта, экстракорпоральный объем крови, обнаруживает наличие воздуха в магистралях.
Компьютерная программа Haemonet позволяет оператору контролировать работу девяти аппаратов MCS+ с помощью одного компьютера. Полученная информация может быть распечатана на принтере и занесена в банк данных учреждения службы крови, облегчая процесс передачи данных.
По выбору пользователя, MCS+ может оснащаться следующими протоколами, содержащимися на специальных карточках памяти:
|
PPP/FFP |
Чистая плазма (тромбоцитов менее 20000 1/мкл), плазма для заморозки (тромбоцитов менее 1000 1/мкл) |
|
LDP |
Тромбоконцентрат с удаленным лейкослоем (загрязнение лейкоцитами менее 1х106) |
|
LDP&RBC |
Тромбоконцентрат с удаленным лейкослоем и эритромассы (в другой мешок) |
|
SDR |
Эритромасса (2 дозы) с удаленным лейкослоем (менее 1х106) или со сниженным содержанием лейкоцитов (менее 1,2х109) |
|
RBCP+ |
Эритромасса (1 доза) с удаленным лейкослоем (менее 1х106) или со сниженным содержанием лейкоцитов (менее 1,2х109); и плазма (2 дозы) качества FFP |
|
PBSC |
Сбор периферических стволовых клеток, а также лечебный лейкоферез и лечебный тромбоцитаферез |
|
TPE |
Терапевтический плазмаферез с возможностью полного плазмазамещения для взрослых и детей |
|
TAE |
Терапевтический эритроферез и заготовка аутоэритромассы |
Характеристики:
Размеры: 37х57х44 см (в закрытом виде), 37х57х67 см (в рабочем состоянии).
Вес: 28 кг
Источник питания: 220 В, 60 Гц
Скорость работы насоса: от 20 до 250 мл/мин.
Скорость центрифуги: от 3000 до 7000 об/мин.
Соотношение антикоагулянта: от 1:8 до 1:16.
Одно-игольный венозный доступ.