Page 1
Working with the Haemonetics® MCS®+
- Operation Manual -
0123
Printed in France
Haemonetics Corporation
400 Wood Road P/N 85213-30, Manual revision: B
Braintree, Massachusetts 02184, USA June 2006
EC
HAEMONETICS U.K. LTD
5 Ashley Drive, Bothwell
REP
Scotland G71 8BS
Great Britain
Page 2
©2002, 2006, Haemonetics Corporation. All rights reserved.
Page 3
iii
CONSUMER INFORMATION
Proprietary rights The contents of this manual are property of the Haemonetics Corporation.
Haemonetics
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.
International Headquarters Corporate Headquarters
Haemonetics SA Haemonetics Corporation
Signy Centre, rue des Fléchères 400 Wood Road
P.O. Box 262, 1274 Signy 2, Switzerland Braintree, MA 02184, USA
Tel. [+41 22] 363 90 11 Tel. [+1 781] 848 7100
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.
®
, MCS®+ and eLynx™ are trademarks or registered trademarks of
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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iv
CONTACTING HAEMONETICS WORLDWIDE
Haemonetics Asia Inc.
Taiwan Branch
26F-1, No. 102 Roosevelt Road Sec. 2
Taipei , Ta iwan
Tel. [+886 2] 2369 0722
Fax [+886 2] 2364 3698
Haemonetics
Handelsges.m.b.H.
Berlagasse 45/B2-02
1210 Wien, Austria
Tel. [+43 1] 294 29 00
Fax [+43 1] 294 29 05
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.
陆家嘴环路
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
1000
号汇丰大厦
28032
室
Haemonetics France S.A.R.L.
46 bis, rue Pierre Curie
Z.I. Les Gatines
78370 Plaisir, France
Tel. [+33 1] 30 81 41 41
Fax [+33 1] 30 81 41 30
Haemonetics GmbH
Wolfratshauser Straße
81379 München, Germany
Tel. [+49 89] 785 8070
Fax [+49 89] 780 9779
Haemonetics Hong Kong Ltd.
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
Page 5
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
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vi Table of contents
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
Page 7
Table of contents vii
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
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viii Table of contents
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
Page 9
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
Page 10
x Preface
P/N 85213-30, Manual revision: B
The Haemonetics MCS+ LN09000-220E/ED
Page 11
Preface xi
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 – infor-
mation. 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 col-
lection procedures for the donor/patient and the apheresis center.
! An understanding of how to safely operate the Haemonetics system, cor-
rectly install the appropriate disposable material, and troubleshoot any difficulties.
! An ability to consistently apply the principles behind safe operation, prop-
er 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 medi-
um 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.
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xii Preface
What is the Haemonetics “Mobile Collection System”?
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.
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Preface xiii
What are the characteristics and special features of the MCS+?
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 cal-
culates processed procedure volumes based on individual donor/patient
characteristics and targeted product yields.
Setting up the device
! 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 well-
managed 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 cov-
er is closed when moving or transporting the device.
P/N 85213-30, Manual revision: B
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xiv Preface
Symbols found in this document
Symbols found on the device
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.
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Preface xv
~ 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).
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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
Symbols found on disposable packaging
Pressure cuff connection
Engraved centrifuge locking knob
Flow indicator lights
The following symbols are used by Haemonetics on disposable set packaging.
REF
CATALOG NUMBER
EXPIRATION DATE
P/N 85213-30, Manual revision: B
LOT
Lot Number
Page 17
Preface xvii
STERILE EO
STERILE
EO
STERILE R
STERILE R
!
Sterilized by exposure to Ethylene Oxide
Fluid path STERILE by exposure to Ethylene Oxide
Sterilized by exposure to Gamma irradiation
Fluid path STERILE by exposure to Gamma irradiation
DO NOT REUSE
Caution: consult operator manual for instructions
8%
8%
-20°C
-20˚C
80%
Storage conditions, humidity level
80%
50°C
Storage conditions, temperature level
50˚C
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xviii Preface
Specifications of the MCS+ device
The approximate weight and dimensions for the MCS+ device are as follows:
Values
Characteristics
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
Cabinet
cover open
Cabinet
cover closed
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.
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Preface xix
Note: The MCS+ device contains no user serviceable/repairable parts.
Note: The MCS+ device contains no user serviceable/repairable parts.
Caution: The MCS+ device must be operated in an environment compatible to
Caution: The MCS+ device must be operated in an environment compatible to
the requirements of the IEC 60601-1-2 Standard, Electromagnetic compatibility.
the requirements of the IEC 60601-1-2 Standard, Electromagnetic compatibility.
Mobile RF communication equipment not approved by Haemonetics and porta-
Mobile RF communication equipment not approved by Haemonetics and portable communication equipment can affect the 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. Therefore,
increase hazards and influence compatibility with EMC requirements. Therefore,
non-approved accessories and cables must not be used.
non-approved accessories and cables must not be used.
In addition, the MCS+ device and accessories must not be placed directly adja-
In addition, the MCS+ device and accessories must not be placed directly adjacent to, or top of other equipment, unless specifically approved by Haemonetics.
cent to, or top of other equipment, unless specifically approved by Haemonetics.
Caution: The MCS+ device must be operated in an environment compatible to
Caution: The MCS+ device must be operated in an environment compatible to
the requirements of IEC60601-1-1 Standard, Medical electrical equipment.
the requirements of IEC60601-1-1 Standard, Medical electrical equipment.
Any electrical equipment used inside or outside the “patient environment” (as de-
Any electrical equipment used inside or outside the “patient environment” (as defined in the Standard), whether connected or not connected to the MCS+ device,
fined 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 stan-
must provide a level of safety compliant with relevant IEC and ISO safety standards. Safe environmental conditions must be maintained for all devices inside
dards. Safe environmental conditions must be maintained for all devices inside
and outside of the patient environment.
and outside of the patient environment.
When properly operated and maintained, the MCS+ device provides a level of
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
safety compliant with the IEC 60601-1-1 Standard, both inside and outside the
patient environment.
patient environment.
The operator is responsible for making sure that the final configuration of the
The operator is responsible for making sure that the final configuration of the
MCS+ device complies with IEC 60601-1-1 Standard, Medical electrical equip-
MCS+ device complies with IEC 60601-1-1 Standard, Medical electrical equipment.
ment.
Note: Refer to the Postscript to the MCS+ Operation Manual (P/N 85270-30), for
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 exter-
information about Haemonetics approved devices, such as a printer or an external network, that can be connected to the MCS+ device.
nal network, that can be connected to the MCS+ device.
P/N 85213-30, Manual revision: B
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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
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1-2 Describing the MCS+ Centrifuge System
PRESENTING THE MCS+ 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.
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.
1. Locking knob
2. Optical sensor
3. Long fluid detector
4. Round fluid detector
5. Mechanical chuck
6. Vacuum chuck
2.
1.
3.
2.
4.
1.
NOTE:
Any system containing one or
two round fluid detector(s)
could be retrofitted with one
long fluid detector.
4.
5.
2.
1.
5.
5.
2.
4.
1.
6.
4.
Figure 1-1, Variations among the MCS+ centrifuge systems
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Describing the MCS+ Centrifuge System 1-3
CENTRIFUGE BASE
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.
Using a mechanical centrifuge chuck
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.
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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
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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
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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
3.
2.
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
1.
Figure 1-7, MCS+ optical bowl sensor and fluid detectors
Page 27
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-clockwise direction until the split halves can be separated, then lifted to open the lid.
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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.
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Describing the MCS+ Centrifuge System 1-9
Summarizing the
MCS+ centrifuge
The following table summarizes the combinations of centrifuge components
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
Centrifuge chuck Mechanical clips secure
the bowl or chuck adapter.
Fluid detector(s) One long or two round One round One round
Optical bowl
sensor
Split hinged lid Designed with semi-
Locking knob Knob engraved with either:
One One One
circularly shaped tabs,
pressed to close the sides
of the lid.
“PUSH TO OPEN” symbol or text.
Vacuum force secures the
bowl or chuck adapter.
Designed with cylindrically shaped tabs, pressed
to close the sides of the lid.
Requires series of turns to
lock or unlock the lid.
mechanically retrofitted
Mechanical clips secure
the bowl or chuck adapter.
Designed with cylindrically shaped tabs, pressed
to close the sides of the lid.
Requires series of turns to
lock or unlock the lid.
P/N 85213-30, Manual revision: B
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Page 31
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
Page 32
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)
1.
2.
3.
4.
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 cen-
trifuge 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
Page 33
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
10.
11.
9.
8.
12.
17.
13.
15.14.
9. AC pump
10. Transfer pump
11. Blood pump
12. Optical line sensor
13. Weigher
14. DPM
15. SPM
16. ACAD
17. BLAD
16.
1.
2.
3. 5.4. 6. 7.
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
Page 34
2-4 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.
A pump assembly consists of a pump rotor, housed in a well containing the pump
motor. The outer pump housing is designed to secure the correlating pump manifold of the disposable set. During installation of the disposable set, the MCS+ will
perform an autoload of the tubing onto the pumps.
1. Single-pump housing
2. Dual-pump housing
3. Dual-pump
identification window
4. AC pump rotor
5. Transfer pump rotor
6. Blood pump rotor
4.
5.
1.
2.
3.
6.
Figure 2-3, MCS+ pump assemblies
Single-pump assembly: Anticoagulant (AC) pump
The AC pump, designated by the color blue, moves AC solution from the solution
bag up to the needle connector of the donor line tubing. The AC pump housing
is designed to secure the corresponding single-pump manifold of the disposable
set.
Dual-pump assembly: Blood pump and Transfer pump
The Blood pump, designated by the color red, moves fluids between the donor
and the disposable centrifuge bowl.
The Transfer pump, designated by the color white, can serve a variety of functions
during a collection procedure, depending on the selected MCS+ protocol. This
pump can be used to “transfer” fluids such as collected plasma, saline, or platelets between the centrifuge bowl, collection bags or parts of disposable tubing.
These two pumps are grouped in a dual-pump housing, designed to hold the
disposable set pump manifold containing disposable set identification information.
Dual-pump identification window
The information on the dual-pump manifold of each specific disposable will be
scanned by the optical sensors located under the identification window.
P/N 85213-30, Manual revision: B
Page 35
Describing the MCS+ Cabinet Components 2-5
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.
! The Transfer pump will be active during certain MCS+ protocols.
During PRIME
! The AC pump and the Blood pump turn simultaneously to provide the inlet
side of the donor-line tubing with AC solution.
! The Transfer pump will be active during certain MCS+ protocols.
During DRAW
! The AC pump will deliver AC solution from the AC solution bag to the nee-
dle connector.
! The Blood pump will pull anticoagulated whole blood past the blood filter
of the disposable set and into the centrifuge bowl.
! The Transfer pump will be active during certain protocols. The Transfer
pump speed will vary in relation to the Blood pump speed and the donor
flow rate.
During RETURN
! The Blood pump pulls the remaining blood components from the centri-
fuge bowl and re-infuses the contents to the donor.
! The Transfer pump will be used to mix solutions with the uncollected
blood components, prior to re-infusion to the donor.
! The AC pump will be inactive.
Table 2-1, MCS+ pump function according to MCS+ operating mode
MCS+ mode AC pump Transfer pump Blood pump
PRIME Yes Protocol-specific Yes
DRAW Yes Protocol-specific Yes
RETURN No Protocol-specific Yes
Note: The Blood pump and the AC pump will rotate at different speeds during
DRAW, depending on the AC/Blood pump ratio parameter setting. Information
related to the function of the pumps during sub states, such as SURGE and
DWELL, will be provided in each relevant MCS+ protocol manual.
P/N 85213-30, Manual revision: B
Page 36
2-6 Describing the MCS+ Cabinet Components
Optical line sensor
Located on the right side of the MCS+ top deck is the optical line sensor which
monitors the blood components passing through the effluent tubing. This
measurement is important for the MCS+ software in controlling the final collection product.
Caution: The line sensor will not provide accurate readings if the optical lens is
obstructed in any way; thus the lens must be cleared of any extraneous substances to ensure proper functioning of the system.
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”.
When the Draw key is pressed to begin a procedure, the weigher will automatically tare, or set the weigher to zero. Thus, the weight of the container will not
be included in the weight displayed on the MCS+ screen.
To ensure optimal accuracy from the weigher during a collection procedure:
! The weigher arm must be fully extended, positioned at a 90 degree angle
to the MCS+ top deck, prior to the system self-tests.
! The collection container must hang freely, without any contact with the
MCS+ cabinet.
Caution: The operator must be careful to not touch the weigher once the weight
of the collection container has been set to zero. This could affect the collection
procedure and a warning will be provided to the operator.
P/N 85213-30, Manual revision: B
Figure 2-4, MCS+ weigher arm with collection bag installed
Page 37
Describing the MCS+ Cabinet Components 2-7
Pressure monitors
The electronically controlled pressure monitors function with the correlating
filter on the disposable set to measure pressure in the disposable tubing. The pressure monitors provide feedback to the system about the flow of blood components to and from the donor (DPM) as well as the centrifuge bowl (SPM). The
MCS+ programming will automatically regulate the speed of the pumps based on
this information.
Caution: Once the DPM/SPM and the disposable set filters have been connected,
they should not be disrupted at any point to ensure proper pressure readings.
Figure 2-5, Existing variations in pressure monitor style
(without and with filter installed)
Donor Pressure Monitor (DPM)
The DPM, located on the left side of the MCS+ top deck, measures pressure in
the donor-line tubing. The information is depicted on the display screen using a
bar graph. The bar graph is visible on the screen when donor pressure is adequate
to maintain the programmed pump speed. The bar graph will not be visible if
donor-line pressure is below what is required to maintain the programmed pump
speed.
Variations will exist in the readings, depending on the operating mode. The
MCS+ software is programmed to detect a range of “normal” values. If a pressure
reading varies outside of this range, the MCS+ safety system will stop the pumps
and provide an explanatory screen message, as well as an intermittent alarm.
DRAW mode
The pressure readings will vary as blood is drawn from the donor. If a significant
pressure decrease is detected and the DPM readings drop below a programmed
value, the pump speed will automatically decrease until a sufficient pressure
increase is measured.
If the donor-line pressure is measured as insufficient, the pumps will stop, the NO
FLOW indicator lights will be visible and an explanatory screen message will
appear with an alarm. Once pressure is measured to be within normal operating
range, the pumps will resume their programmed speed.
P/N 85213-30, Manual revision: B
Page 38
2-8 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. If pressure readings remain high, the Blood pump will stop,
and an explanatory screen message will appear with an alarm.
When pressure is measured to be within the normal operating range, the pumps
will resume operation until reaching the programmed pump speed.
Warning: The operator must remain aware of the fact that a high pressure warning can indicate a possible flow obstruction and could cause red blood cell
hemolysis, and/or damage the vein. Corrective action is necessary and the operator should intervene immediately, following the actions listed on the HELP
screen. The operator can also consult Chapter 6 for information about avoiding
flow restrictions.
System Pressure Monitor (SPM)
The SPM, located on the right side of the MCS+ top deck, measures pressure in
the effluent tubing. This measurement verifies that the sterile seal, between the
head and the body of the centrifuge bowl, remains intact.
Air detectors (top deck)
If the SPM detects that pressure in the system increases or decreases abnormally,
the MCS+ safety system will stop the pumps will stop and provide an explanatory
message with an alarm. Centrifuge function will remain unaffected.
The MCS+ is equipped with an assembly of ultrasonic sensors designed to detect
the presence of air, bubbles or foam in the fluids flowing through the disposable
set tubing.
If air is detected outside of the normal range during any mode (PRIME, DRAW or
RETURN), the detectors will:
! Activate the MCS+ safety system.
! Stop the operation in progress.
! Provide the operator with an error message and an audible alarm.
Caution: In the case of any air detection alarm, the operator must respond immediately, note the source and take immediate action, following the actions listed
on the HELP screen.
P/N 85213-30, Manual revision: B
Page 39
Describing the MCS+ Cabinet Components 2-9
Figure 2-6, MCS+ air detector
The following air detectors are located on the MCS+ top deck.
Anticoagulant Air Detector (ACAD)
The passage of AC solution from the solution bag into the system occurs over a
series of steps. The ACAD, located on the MCS+ top deck (adjacent to the AC
pump), will monitor the AC line throughout the entire collection procedure.
Warning: If the AC solution is depleted prior to the end of the collection procedure, 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.
Blood Line Air Detector (BLAD)
This air detector will serve a dual purpose to the operator. It is located on the top
deck of the MCS+ cabinet, to the right of the Blood pump. The BLAD will remain
“active” throughout the entire procedure but will provide a specific function at
the following moments:
! During a DRAW cycle, the BLAD will detect the presence of fluid passing
through the blood-line tubing. This allows the system to account for the
volume of blood being pumped.
! During a RETURN cycle, the BLAD will note the presence of any air in the
tubing leaving the centrifuge bowl. This line contains the blood being returned to the donor and will pass through the donor valve after the BLAD.
When the BLAD has detected air in the tubing within normal limits, this
will signal that the bowl is empty and the RETURN cycle will be terminated.
Warning: Air detected (or lack of air detection) by the BLAD, outside of normal
limits, will stop the collection procedure and alert the operator.
P/N 85213-30, Manual revision: B
Page 40
2-10 Describing the MCS+ Cabinet Components
FRONT PANEL COMPONENTS
1. DLAD1
2. DLAD2
3. Blood filter chamber
brackets
4. Re-circulation chamber
brackets
5. Disposable set pins
1.
5.
Air detectors (front panel)
3.
2.
4.
Figure 2-7, MCS+ front panel
Donor line air detectors (DLAD1 and DLAD2)
The two donor line air detectors are located on the left side of the MCS+ front
panel. Both air detectors monitor the donor line between the donor and the
disposable set blood filter.
! During PRIME, the pumps draw AC solution into the donor line up to the
DLAD. When the DLAD note fluid, the detectors signal to the MCS+ software that the line has been “primed” with AC solution and is prepared for
DRAW.
! During DRAW, the DLAD will monitor the tubing containing anticoagulat-
ed whole blood and alert the operator if any air has been introduced into
the system.
! During RETURN, the DLAD will monitor the donor line as it carries blood
Warning: In the case of any air detection alarm, the operator must respond immediately, note the source and take immediate action, according to the list on
the HELP screen. During RETURN, if either the DLAD1 and/or DLAD2 produce
an air detection alarm, this could indicate a failure of the BLAD. The operator
should carefully note the source of air detected – no blood should be sent to the
donor until all air bubbles have been removed from the line.
P/N 85213-30, Manual revision: B
components to be infused to the donor. The DLAD monitor the line for any
air which may have passed into the system undetected (probability very
low) by the BLAD.
Page 41
Describing the MCS+ Cabinet Components 2-11
Haemonetics recommends the following operator actions to remove any air
bubbles detected in the tubing between the BLAD, DLAD1 and the DLAD2.
The operator should:
" Press the Draw key until blood enters the bowl to send any air bubbles to
the bowl.
" Continue with a RETURN cycle only after any air bubbles have been re-
moved.
Warning: If, after attempting this procedure to remove any air, the DLAD1 and/
or DLAD2 detect air again, the operator should terminate the procedure, discontinue use of the device and contact the authorized Haemonetics representative.
Disposable set element holders
Located on the MCS+ front panel are the following various components used to
secure elements from the disposable set during a collection procedure:
! Blood filter chamber brackets.
! Re-circulation chamber brackets.
! Disposable set pins.
P/N 85213-30, Manual revision: B
Page 42
2-12 Describing the MCS+ Cabinet Components
SIDE PANELS COMPONENTS
Solution-bag poles (2)
Donor flow indicator lights
DRAW
1. Green
2. Yellow
3. Red
RETURN
4. Yellow
Located on either side of the MCS+ cabinet is a height-adjustable pole. These
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.
These color-coded lights indicate donor/patient blood flow status during DRAW
mode and RETURN mode. They are used in conjunction with either a text, or a
symbol.
3. 4.2.1.
Figure 2-8, MCS+ donor flow lights (symbol version)
There are four sets of colored lights on the MCS+ device:
! Two sets are contained on each of the MCS+ side panels.
! A third set is located on the MCS+ control panel on interior of the MCS+
! A fourth set is found on the exterior of the MCS+ cabinet cover.
DRAW mode
! The GREEN LIGHT indicates that donor blood flow is sufficient for the
! The YELLOW LIGHT indicates that donor blood flow is decreasing and
! The RED LIGHT indicates that blood is not flowing adequately or not flow-
If the red flow light is lit, the Blood pump will automatically stop. The centrifuge
will continue to spin to ensure continued separation of the collected blood
components. When donor/patient blood flow is restored, the blood pump will
automatically restart. The Transfer pump will continue to function if required by
the selected MCS+ protocol.
P/N 85213-30, Manual revision: B
cabinet cover.
Blood pump to maintain an adequate speed.
may be insufficient to maintain an adequate Blood pump speed.
ing at all from the donor/patient.
Page 43
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
5.
6.
1. Solution bag pole
2. AC drip monitor
3. Power entry module
4. Power cord
5. Flow indicator lights
6. Handle (one on each
side)
7. Bar-code reader
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. The operator should instruct
the donor to observe the differences in the lights and act accordingly.
1.
2.
Anticoagulant (AC) drip monitor
7.
3.
4.
Figure 2-9, MCS+ left side panel
The AC drip monitor contains an optical sensor, used to detect the flow of AC
solution as it passes from the AC drip chamber into the AC tubing. If the AC drip
monitor detects a problem with the AC flow, the MCS+ pumps will stop. The
operator will receive an explanatory screen message, as well as an audible alarm.
! During PRIME and DRAW, it monitors the flow of AC solution being drawn
through the tubing by the AC pump.
! During DRAW, the flow corresponds with the programmed AC ratio. The
AC drip monitor works in conjunction with the ACAD to ensure the flow
of AC solution to the donor-line tubing.
! During RETURN, the AC drip monitor functions as a safety feature to en-
sure that no AC solution is passing into the donor-line tubing.
Caution: The lens of the optical sensor must be kept clean so that the AC drip
monitor can provide accurate readings.
P/N 85213-30, Manual revision: B
Page 44
2-14 Describing the MCS+ Cabinet Components
Power entry module
1. ON/OFF power switch
2. Power input receptacle
The power entry module (PEM) is located on the left side panel of the device.
Externally, the module consists of an ON/OFF switch and a power input receptacle for the power cord. Internally, the module contains the fuse panel. It will
interrupt power supply to the system in the event of an electrical current
surcharge.
The design of the power entry module also provides a filter-effect for the MCS+
device against the effects of a power surge.
In the case of an emergency, the ON/OFF switch can be used to stop all MCS+
function.
1.
2.
Figure 2-10, Power entry module (PEM)
Power cord The power cord provided is designed to connect the MCS+ device with an
external power source via the power input receptacle, located on the power entry
module on the left side panel.
Bar-code reader The bar-code reader is mounted on the left panel of the MCS+ device and can be
used to enter the following types of data directly into the data storage memory.
! Disposable set lot and list number.
! Anticoagulant and solution bag codes.
! Donation number, donor number and operator code.
Note: The Postscript to the MCS+ contains further information on the use of the
bar-code reader when entering data, as well as the role of the communication
box (discussed later in this chapter), in the transfer of this data to an external device or to HaemoNet, the Haemonetics communication network.
Warning: The class II bar-code reader emits laser radiation. Do not look directly
into the beam.
Handles Handles for lifting the MCS+ device are located on the side panels.
P/N 85213-30, Manual revision: B
Page 45
Describing the MCS+ Cabinet Components 2-15
Platelet filter holder
Disposable set pins
Protocol card port
A.
1. Pins
2. Protocol card insertion
into card port
Located on the right side of the MCS+ device are brackets used to secure the filter
contained on the MCS+ disposable sets designed for platelet collection.
The MCS+ right side panel contains pins designed to secure disposable bags from
the disposable collection set.
An MCS+ collection procedure is performed using the operating instructions
provided on the MCS+ protocol card. Prior to powering on the device, the
protocol card should be inserted into the card port located on the lower right side
of the MCS+ device.
Once the protocol card has been correctly inserted, the door of the card port can
be closed and should remain closed during the entire collection procedure. To
remove the card at the end of a procedure, the operator should open the door and
press the release tab above the card.
1.
4.
B.
3. Release tab
4. Platelet filter holder
5. Tubing guide
2.
A. B.
Figure 2-11, MCS+ right side panel
3.
5.
P/N 85213-30, Manual revision: B
Page 46
2-16 Describing the MCS+ Cabinet Components
REAR PANEL COMPONENTS
1. Pressure cuff with cuff
connection
2. Communication box
3. Biohazard waste bag
4. (Not shown) serial port
connection
5. (Not shown) wireless antennae
3.
1.
2.
Figure 2-12, MCS+ rear panel with external communication box
Pressure cuff The tourniquet-style pressure cuff is used to maintain an optimal venous blood-
flow from the donor during specific phases of the collection procedure. The cuff
should be attached to the MCS+ cuff connection located on the rear panel of the
MCS+ cabinet. The cuff meets the ANSI/AAMI SP-9 & SP-10 standards for accuracy and performance.
Communication box
Note: The communications box may not be present on all MCS+ devices. Refer
to the Postscript to the MCS+ Operation Manual (P/N 85270-30), for further information on the communication box and other communication options such as
the data card reader or wireless antenna.
The communication box (either internal or external) transfers data via a serial
connection from the MCS+ device to an external device such as a printer, or to
HaemoNet, the Haemonetics communication network. A Haemonetics trained
technician must configure the communication box to communicate with a
specific device. Refer to the Postscript for information about Haemonetics
approved devices that can be connected to the MCS+ device.
HaemoNet provides any establishment using Haemonetics equipment with the
possibility of linking several Haemonetics apheresis devices to a central monitoring computer. Using HaemoNet, procedure data can be exchanged and stored
in a database and/or viewed directly.
Note: The MCS+ communication box has been tested according to standards required by EN 60601-1-2 (EMC of medical electrical equipment). The measured
error rate of data communicated to HaemoNet at certain specific electromagnetic
P/N 85213-30, Manual revision: B
Page 47
Describing the MCS+ Cabinet Components 2-17
frequencies rises above the standards. However, there is no impact on the integrity of the procedure information stored in the database. HaemoNet communication is designed with CRC error checking, performed upon the reception of all
data.
Wireless antenna
Note: The wireless antenna may not be present on all MCS+ devices. Refer to the
Postscript to the MCS+ Operation Manual (P/N 85270-30), for further information
on the wireless feature and other communication options such as the data card
reader or communication box.
The antenna, located on the rear panel and protected by a hard plastic cover,
allows the transmission of procedure data to a wireless access point connected
to a handheld device, internal PC or network, the eLynx communication system,
or to an external computer network over the Internet.
Manual vacuum release button
Figure 2-13, Example of the wireless antenna located on the device rear panel
Any MCS+ device with a vacuum centrifuge contains this mechanism which can
interrupt the vacuum effect on the bowl. An MCS+ protocol functioning with the
vacuum centrifuge is designed to automatically release the vacuum force at a
specific point in the procedure. However, it may be necessary for the operator to
do this manually, as in the case of a power failure. In this type of situation, the
operator can depress the button to interrupt the vacuum force and release the
bowl, once the centrifuge and bowl have come to a complete stop.
P/N 85213-30, Manual revision: B
Page 48
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. Vacuum release button
2. Biohazard waste bag
connection and clamp
3. RS232 connection
4. Bar-code reader
connection
1.
2.
3. 4.
Biohazard waste bag
Figure 2-14, Lower rear panel
Caution: The operator must not use the manual vacuum release button during
routine MCS+ function, unless specifically warranted, as this could damage the
bowl and/or the centrifuge components.
The biohazard waste bag is designed to collect any biologically contaminated
material from the centrifuge well in the rare case of a spill or leak. Two biohazard
waste bags are supplied with the delivery of each MCS+ device.
A bag must be attached at all times to the centrifuge drain tube, located at the
rear of the device. The bag must hang freely, with the clamp open, visible to the
operator.
Warning: The biohazard waste bags are not to be used to collect or store apheresis products. When a bag contains evacuated waste products, it must be
clamped, removed and properly disposed of, according to the local standard operating procedure concerning biologically contaminated material. A new bag
must be placed before resuming operation.
P/N 85213-30, Manual revision: B
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
P/N 85213-30, Manual revision: B
Page 50
3-2 Describing the MCS+ Control Panel
PRESENTING THE MCS+ 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.
! Observe feedback about the status of the donor.
! Monitor continuously updated procedure statistics.
! Receive NOTICE messages from the MCS+ safety system.
! Obtain on-line assistance and troubleshoot with HELP messages.
A. Upper control panel
1. Flow indicator lights
2. Display screen
B. Lower control panel
3. Mode control keys
4. STOP key
5. Pump control keys
6. Cuff control key
7. Programming keys
1.
A.
B.
3.
5.
6.
7.
2.
4.
Figure 3-1, MCS+ control panel
The control panel is located on the inside of the hinged MCS+ cabinet cover and
contains:
! A set of flow indicator lights.
! A display screen.
! A keypad.
The upper portion of the control panel communicates information to the operator
by means of the flow indicator lights and the display screen. The lower portion
of the control panel allows the operator to directly interact with the device prior
to and during a procedure by using the keypad.
P/N 85213-30, Manual revision: B
Page 51
Describing the MCS+ Control Panel 3-3
UPPER 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 indicator lights
There is a set of flow indicator lights located on the top of the MCS+ control
panel, above the display screen. These lights provide the same information about
donor/patient blood flow status during the apheresis procedure as the other sets
of flow indicator lights located on the MCS+ cabinet side panels.
The lights are arranged as follows:
DRAW
1. Green
2. Yellow
3. Red
RETURN
4. Yellow
Figure 3-2, MCS+ control panel flow indicator lights (text version)
3. 4.2.1.
Note: The design of the fourth set of flow indicator lights, located on the exterior
of the MCS+ cabinet cover, is identical to those located on the control panel. All
of the lights provide the same information simultaneously throughout the MCS+
procedure.
Display screen The MCS+ screen will display different types of information to the operator
throughout a collection protocol. All MCS+ protocols will use the same screen
layouts and provide the operator with the same types of information on the
display screen. This information will concern:
! MCS+ self-testing protocol option selection.
! Disposable set installation.
! Procedure parameter modification.
! Haemo Calculator and Haemo Update information.
! MCS+ anticoagulant priming sequence.
! MCS+ operating mode and sub state.
! NOTICE messages and related HELP messages.
Note: Protocol-specific screen data will be explained in each MCS+ protocol
manual.
P/N 85213-30, Manual revision: B
Page 52
3-4 Describing the MCS+ Control Panel
Explaining the screen layout
Generic information
1. Current selected protocol
2. Operating mode
3. Current phase
4. Pump(s) state(s)
5. Donor Pressure Monitor
6. Current procedure and
product statistics
Specific information
7. Caution message area
8. Last Cycle indication
(appears during the last
Return phase)
The information and data, updated throughout the procedure, is displayed on
specific areas of the MCS+ display screen. The following screen illustrates the
MCS+ display screen as it could appear during an apheresis procedure.
LDP DRAW Filling Bowl
1 2 3
Last
Cycle
DRAW 90
Transfer 0ml/min
8
Drip Monitor Disabled
7
4
100 0
Cycle g Plasma g Platelet ml Processed
Figure 3-3, Example of an MCS+ display screen layout (platelet protocol)
The upper screen area will provide information for the operator identifying the
selected MCS+ protocol, as well as describe the mode of operation in progress.
The center screen area contains an icon (to represent the donor), the current
mode of operation, the relevant pump speed and a visual representation of the
pressure reading in the donor-line tubing, depicted by the DPM bar graph (when
visible).
ml/min
5
DPM
6
Note: The contrast between filled and non-filled area in the DPM bar graph column will vary to depict the fluctuations registered in the donor-line pressure readings.
The lower screen area communicates data to the operator concerning the cycle
in progress, as well as the volume of blood processed during the MCS+ procedure. Other protocol-specific measurements will made be by the system and will
be displayed in this procedure statistics portion of the screen.
Note: There will also be slight variations present with the display screen layout
when the Haemo Update and Haemo Calculator messages appear. The procedure statistics from the lower portion of the screen will be visible with the upper
portion information, when an operator-action HELP menu is displayed.
P/N 85213-30, Manual revision: B
Page 53
Describing the MCS+ Control Panel 3-5
Understanding an operating mode
Defining the screen icons
An MCS+ mode can be described as the operating state of the device during
specific phases of the apheresis process. Each MCS+ protocol will:
! 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 remove the desired components during DRAW.
! Re-infuse the non-collected blood components to the donor during RE-
TURN.
Note: Certain MCS+ protocols, designed to collect components such as platelets,
will contain sub states which are part of the DRAW mode, referred to as SURGE
and DWELL.
These symbols, located on the left side of the center screen area, provide a pictorial representation of the MCS+ mode in progress.
Table 3-1, Display screen icons
Screen icons Explanation State
Displayed during AC and saline solution
priming sequences.
PRIME
Displayed prior to initiating the first cycle.
Displayed when the device is in a non-active
state, ready for an operator command.
Displayed as donor/patient blood is being
drawn into the centrifuge bowl.
Displayed as collected plasma is being
recirculated through the disposable set.
Displayed as blood components/fluids are
being returned to the donor/patient.
Displayed on all operator warning screens.
Displayed when the centrifuge is stopping.
READY
DRAW
DWELL/
SURGE
(sub states)
RETURN
NOTICE
P/N 85213-30, Manual revision: B
Page 54
3-6 Describing the MCS+ Control Panel
LOWER 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:
Mode control keys
Figure 3-4, MCS+ keypad
Prime key
This key is used to initiate the PRIME mode of operation. The PRIME mode will
bring anticoagulant solution from the anticoagulant line tubing into the donorline tubing.
Draw key
This key is used to initiate the first DRAW cycle, or resume the DRAW mode of
operation. The DRAW mode will move anticoagulated whole blood from the
donor through the donor-line tubing into the centrifuge bowl, where apheresis
will be initiated.
Return key
This key is used to initiate, or resume, the RETURN mode of operation. During
RETURN, the MCS+ device will return the non-selected blood components in the
disposable set to the donor. During standard protocol function, a RETURN cycle
will automatically be initiated. However, the operator can press this key if it
becomes necessary to return of the contents of the bowl to the donor before the
end of a cycle.
P/N 85213-30, Manual revision: B
Page 55
Describing the MCS+ Control Panel 3-7
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. This could
eventually interfere with the quality of the final collection product (and/or the
collection procedure).
Figure 3-5, MCS+ mode control keys and STOP key
Pump control keys
These keys can be used by the operator to manually change the programmed
pump speed during a collection procedure.
Figure 3-6, MCS+ pump control keys
Pump arrow keys
These keys can be used to temporarily modify the default parameter settings by
respectively increasing (arrow up) or decreasing (arrow down) the speed in which
the pumps will rotate. The adjustment should be made based on individual donor
needs during a specific collection procedure.
Caution: The operator should observe the DPM bar graph and flow indicator
lights in order to correctly asses for “low” donor blood flow. However, before using the arrow keys to adjust for “low” donor flow, it is important that the operator
allow the MCS+ device to first reach the target pump speed.
P/N 85213-30, Manual revision: B
Page 56
3-8 Describing the MCS+ Control Panel
Pump Start/Stop key
This key can be used to either stop the pumps, or re-start the pumps (if stopped
by the operator). Pressing this key does not affect centrifuge operation.
Caution: If the pumps have been stopped using this key, and remain stopped for
longer than two to three minutes during DRAW later, the bowl may become overpacked with red cells, because the centrifuge will continue to spin. This can create a potential flow problem during RETURN. The operator should return the
bowl contents to the donor before proceeding with DRAW.
Cuff control key During normal MCS+ operation, the cuff will automatically inflate during DRAW
and deflate during RETURN. The operator can use the cuff key to manually
control the pressure cuff prior to a procedure when performing the venipuncture,
or during READY or DRAW mode to modify cuff pressure. The cuff cannot be
inflated during RETURN.
Programming keys
Figure 3-7, MCS+ cuff control key
Certain system operating parameters have been selected by Haemonetics as
default values. These parameters provide optimal results in MCS+ apheresis
procedures with the average donor, as well as for average collection requirements. However, it is possible to alter and subsequently retain the altered parameters for specific collection requirements using the MCS+ programming keys.
LDP STOP
Cycle 0 0 Platelet Weight 0 ml Processed
MODIFY PARAMETERS
Cuff Pressure 50 mmHg
Draw Speed 90 ml/min
Return Speed 120 ml/min
NaCl Vol/Cycle 0 ml
Press MODIFY to select, +/- to change values.
Press SAVE to save all values.
Press HELP to return to Main display.
Figure 3-8, Example of MCS+ program parameters display screen
Min Plt Weight 0 g
AC Ratio 1: 9
Note: Further explanation about these parameters is provided in each respective
MCS+ protocol manual.
P/N 85213-30, Manual revision: B
Page 57
Describing the MCS+ Control Panel 3-9
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
of the operating modes. Each time that this key is pressed, a different program
parameter will be highlighted on the screen, along with the currently selected
value for that parameter.
Note: This key can be used to access the Modify Parameter screen and adjust the
program parameters, or to scroll through the parameters when listed on the
Haemo Calculator screen.
Save program key
The operator can use this key to retain all modified values in the MCS+ memory.
If this key is pressed after any modification, the selected value will become the
new system value until any further modification is made during a subsequent
MCS+ collection procedure.
Note: Once the program parameters have been consulted and/or modified, the
operator can return to the screen depicting the current mode of operation by
pressing the respective MODE key, without interruption to the collection procedure.
P/N 85213-30, Manual revision: B
Page 58
3-10 Describing the MCS+ Control Panel
Yes +/No – program keys
To modify a displayed parameter value as it appears on the MCS+ display screen,
the operator should:
" Press Yes + to increase the value.
" 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.
During normal MCS+ protocol operation, the operator can:
" Consult the Haemo Update display screen by pressing this key once.
LDP STOP
Cycle 0 0 Platelet Weight 0 ml Processed
HAEMO UPDATE
AC Volume Used 28 ml
Elapsed Time 0 min
Target Cycles 8
NaCl Volume Used 0 ml
Plasma Weight 0 g
Platelet Weight 0 g
Estimated Yield 0.0 10e11
Target Yield 5.0 10e11
Press STOP to return to Main display.
Press HELP for the Haemo Calculator.
" Consult the Haemo Calculator display screen by pressing this key twice.
LDP STOP
Cycle 0 0 Platelet Weight 0 ml Processed
HAEMO CALCULATOR
Sex M
Height 170 cm
Weight 65 kg
Blood Volume 4800 ml
HCT 40 %
Plt Pre-Count 250 10e3
Press MODIFY to select, +/- to change values.
Press SAVE to save all values.
Press HELP to return to Main display.
If the operator receives a NOTICE display screen due to an error detection by the
MCS+ safety system, the operator can press this key to receive the HELP screen
display.
The HELP screen will contain the most likely source of error and a list of the
appropriate operator actions.
Note: A complete listing of all MCS+ operating NOTICE messages and related
HELP messages is provided in the Section 1 of the Postscript to the MCS+.
Target Plasma Wgt 0 g
Target Yield 5.0 10e11
*Process Volume 4000 ml
Target Cycles 8
Time (estimated) 80 min.
P/N 85213-30, Manual revision: B
Page 59
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
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
P/N 85213-30, Manual revision: B
Page 60
4-2 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
Describing the MCS+ Disposable Collection Material 4-3
PRESENTING AN MCS+ DISPOSABLE SET
Haemonetics has designed single-use, disposable elements for MCS+ apheresis
procedures. The disposable elements, when grouped together, are referred to as
the disposable set. The disposable sets are described in greater detail in each
specific protocol manual.
All disposable sets will contain three basic sections:
! A disposable centrifuge bowl.
! “Harness-in” tubing and elements.
! “Harness-out” tubing and elements.
The centrifuge bowl is the central element of any disposable set. The “harness-in”
section is attached to the inlet port of the bowl and extends to the donor. The
“harness-out” section is attached to the outlet port of the bowl and extends to the
final collection product(s).
The disposable tubing sections manufactured by Haemonetics contain various
combinations of elements and the choice of disposable material depends on:
! The final blood components to be collected.
! The selected MCS+ protocol.
The following general categories exist among the types of disposable set material
which can be used for an MCS+ collection protocol.
Closed set This type of disposable set will contain the basic elements required for blood
component collection as well as a pre-attached needle and a bacteriological filter
on each solution line tubing section. These factory-attached elements will guarantee an extra measure of sterility and security for the final collection product(s).
Bundled set A bundled set contains disposable material with a pre-connected bowl. Various
pre-assembled combinations of elements can be used, depending on the type of
final plasma product to be collected.
Unbundled set It is possible to combine individually packaged MCS+ disposable elements to
form a collection 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 require the use of pump manifold adapters, ordered separately from Haemonetics.
P/N 85213-30, Manual revision: B
Page 62
4-4 Describing the MCS+ Disposable Collection Material
HARNESS-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-/Bloodline section
1. Pre-attached needle
2. Ratchet clamp (x 2)
3. Needle connector
4. Three-way connector
5. Injection port
6. Donor-line sample pouch
This section will deliver blood from the donor to the centrifuge bowl. Donor
whole blood is drawn through the needle into a single lumen section to a junction where the tubing splits into two sections: one for donor blood, the other for
anticoagulant solution.
Donor whole blood is mixed with AC from the AC tubing section and continues
up to the blood filter. On the opposite side of the blood filter are two sections of
tubing. One section leads to the DPM filter. The other section contains the blood
drawn into the centrifuge bowl by the Blood pump.
2.
1.
Figure 4-3, MCS+ needle tubing/sample pouch section
5.
2.
6.
3.
4.
Pre-attached needle/tubing
This section of tubing will contain a 16G needle, a ratchet clamp and a female
luer connection. The established sterile needle connection can eliminate a
certain degree of potential contamination and contribute to the storage life of the
collection product.
Needle connector
This male luer connector attaches the needle tubing, containing a female luer
connector, to the rest of the donor/blood-line tubing.
Y-connector/three-way connector
These connectors create the junction in which the single lumen needle tubing
section can branch into multiple sections.
P/N 85213-30, Manual revision: B
Page 63
Describing the MCS+ Disposable Collection Material 4-5
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 venipuncture.
Caution: The sample pouch tubing must clamped, then sealed before drawing the
sample, in order to isolate it from the rest of the disposable tubing and maintain
a “closed” system.
Blood filter/chamber
The 170 µm blood filter is contained in a chamber located between the needle
adapter and the disposable bowl. The filter will eliminate aggregates; the
chamber will serve as a reservoir for blood being drawn into the bowl.
Dual-pump manifold and tubing
This element has a dual function. It will secure the blood-line tubing as it is
loaded onto the Blood pump and the Transfer pump, as well as during MCS+
operation. It identifies the type of disposable set being installed when the information printed on the manifold is scanned by identification window.
Note: This provides a safety feature for the operator. It is not possible to install a
disposable set containing a dual-pump manifold which does not correspond with
the inserted MCS+ protocol card, without receiving a NOTICE message.
Figure 4-4, Examples of MCS+ pump manifolds
P/N 85213-30, Manual revision: B
Page 64
4-6 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.
Dual-pump manifold adapter
The adapter is necessary when using MCS+ disposable sets which do not require
the Transfer pump. It adapts the tubing which contains pump “stops”, so that it
can be secured on the dual-pump housing, during autoloading and operation of
the MCS+ Blood pump. It also contains specific identification information.
Figure 4-5, Examples of MCS+ pump manifold adapters
Note: These elements should not be discarded after use, but saved for subsequent
MCS+ collection procedures.
Bowl connector
This element on the harness-in section attaches the donor-line tubing assembly
to the inlet port of the centrifuge bowl.
DPM line section The 0.22 µm hydrophobic filter on this section links the disposable set to the
MCS+ donor pressure monitor. The filter also provides a bacteria-free connection
between the disposable set and the DPM.
There is a slide clamp on the tubing leading to the DPM filter. The clamp is used
when connecting and disconnecting the filter from the DPM.
P/N 85213-30, Manual revision: B
Page 65
Describing the MCS+ Disposable Collection Material 4-7
AC line section This section of the disposable tubing will deliver AC solution to the section of
tubing containing donor whole blood. The elements found on the AC line section
can vary according to the selected disposable set.
Anticoagulant spike
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” as it dries and can become difficult to properly clean.
Anticoagulant drip chamber
A drip chamber for the AC solution is present on the “closed” MCS+ disposable
sets. It is also available on certain bundled and unbundled harness-in sections.
Bacterial filter
This element can be found on a “closed” set. The 0.22 µm filter can eliminate
bacteria from entering the system, due to spiking the AC solution bag.
Single-pump manifold and tubing
This element will secure the AC tubing as it is autoloaded on the AC pump, as
well as during MCS+ operation.
AC 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.
Single-pump manifold adapter
The adapter will provide a means to secure tubing containing AC pump “stops”
onto the MCS+ single-pump housing, during autoload and operation of the AC
pump.
P/N 85213-30, Manual revision: B
Page 66
4-8 Describing the MCS+ Disposable Collection Material
CENTRIFUGE 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+ procedures: the bell-shaped Latham bowl and the cylindrically-shaped blow molded
bowl (BMB).
An MCS+ disposable centrifuge bowl is comprised of the following sections:
! The stationary section referred to as the “head” of the bowl.
! The rotating section referred to as the “body” of the bowl.
! The seal between these two sections.
Explaining the general design of the bowl
The head of the bowl, containing an inlet port and an outlet port, provides a
shield for the seal of the bowl. When the bowl is held upright, the inlet port is
located above the outlet port.
Note: When installing a bowl, the inlet port should be positioned facing the left
side of the centrifuge, and the outlet port should be positioned facing the right
side of the centrifuge.
The inlet port is used for attaching the donor-line disposable tubing. The inlet port
leads to the feed tube which passes through the core and transports blood into
the processing chamber.
The feed tube also allows non-selected elements to exit the inlet port as they are
returned to the donor. The outlet port provides the exit for the collected blood
components and connects to the effluent tubing of the disposable set.
The body of the bowl contains a core and the processing chamber for the blood
components.
The rotary seal of the bowl is attached to the body of the bowl by a ceramic
section. A properly functioning rotary seal is essential to MCS+ operation.
Caution: The functional characteristics of the rotary seal can be altered if the pressure in the bowl becomes excessive. This can cause the seal to be raised like a
pressure valve. The operator must remain attentive to avoid twists or occlusions
in the effluent tubing, which could obstruct either the flow of air or fluids in the
effluent pathway.
P/N 85213-30, Manual revision: B
Page 67
Describing the MCS+ Disposable Collection Material 4-9
1. Inlet port
2. Outlet port
3. Header shield
4. Bowl seal
5. Processing chamber
6. Bowl core
7. Feed tube
8. Bowl body
1.
2.
3.
4.
5.
8.
6.
7.
Figure 4-6, Latham centrifuge bowl
1. 2.
8.
Figure 4-7, Blow molded centrifuge bowl
3.
4.
5.
6.
7.
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Page 68
4-10 Describing the MCS+ Disposable Collection Material
Understanding bowl operation
Both types of centrifuge bowls will function during the first part of the DRAW
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. The header shield covers the rotary seal between the head and
body of the bowl and slightly compresses the seal when the bowl is installed.
! Anticoagulated whole blood arrives from the donor-line tubing, passes the
inlet port, moves through the feed tube and enters the processing chamber
at the base of the bowl.
! As the bowl spins, the centrifugal force inside of the bowl separates the
products into the cellular components and plasma. The denser cellular
components move to the outside of the bowl, while the lighter components move toward the center.
! When the bowl is full, plasma, the lightest of the separated blood compo-
nents, will exit the bowl first through the outlet port, pass through the effluent tubing and be collected. The red blood cells, being the densest of
the cellular components, will exit the bowl last.
Applications for the Latham bowl
During the DRAW cycle, the design of Latham bowl permits the MCS+ device to
conduct the “surge” process when the optical bowl sensor has detected the buffy
coat at the appropriate level.
Surge involves the elutriation (or extraction) of platelets from the buffy coat, by
re-circulating collected plasma through the bowl at a high speed. The “surging”
plasma passes through the cellular layers of the blood components and promotes
separation between the layers. This allows the platelets, being the lightest of the
cellular components, to exit the bowl with the plasma. The other heavier cellular
components remain in the bowl.
Once the desired components have been collected, the bowl will stop spinning.
The remaining components will settle to the base, re-mix and subsequently be
returned to the donor/patient.
Applications for a Blow Molded bowl
Once a DRAW cycle has been completed, the bowl will stop spinning and the
uncollected cellular components in the bowl will be pumped through the feed
tube and returned to the donor. The cycle will be repeated until the programmed
target volume of the selected blood component has been collected.
P/N 85213-30, Manual revision: B
Page 69
Describing the MCS+ Disposable Collection Material 4-11
Managing the bowl air inventory
A. Filling the bowl
1. Anticoagulated whole
blood
2. Air
3. Plasma
4. Red blood cells
B. Collecting plasma
1. Anticoagulated whole
blood
2. Plasma
C. Surge (elutriation)
1. Plasma
2. Platelets and plasma
3. Buffy coat
D. Returning
components
1. Non-collected blood
components
2. Air from plasma
bag
The disposable bowl contains sterile air which is displaced into a collection
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
RETURN cycle. It is important that this air return to the bowl from the collection
container in order to avoid negative pressure in the bowl.
A.
1.
3.
4.
C.
1. 1.
2.
1.
B.
2.2.
D.
2.
3.
Figure 4-8, Latham bowl operation
P/N 85213-30, Manual revision: B
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
1.
A.
B.
1.
2.
2.
C.
1.
2.
Figure 4-9, Blow molded bowl operation
P/N 85213-30, Manual revision: B
Page 71
Describing the MCS+ Disposable Collection Material 4-13
HARNESS-OUT TUBING AND ELEMENTS
Effluent line section
This section of disposable tubing extends from the centrifuge bowl to the collection 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.
Bowl connector
This element on the harness-out section attaches the effluent tubing assembly to
the outlet port of the centrifuge bowl.
Y-connector/three-way connector
These connectors create the junction in which the single-lumen needle tubing
section can branch into multiple sections.
Collection bags
The blood components can be collected in a variety of sizes and forms of bags,
depending on the MCS+ protocol requirements.
Plasma collection container(s)
Plasma can be collected in either a bag or a bottle. The type and number of
plasma collection containers used for a procedure will depend on the disposable
material chosen by the apheresis center. The plasma collection bags vary in total
volume capacity.
Leukocyte reduction filter
A PALL membrane filter can be found in various combinations of size, number
and location on certain MCS+ disposable sets. This type of filter will reduce the
quantity of leukocytes which pass into the final collection product(s).
SPM line section The hydrophobic 0.22 µm filter on this section links the disposable set to the
MCS+ system pressure monitor. It is located on the harness-out section of a
“closed” set and provides a bacteria-free connection between the disposable set
and the SPM.
P/N 85213-30, Manual revision: B
Page 72
4-14 Describing the MCS+ Disposable Collection Material
PROTOCOL-SPECIFIC SOLUTION LINE SECTIONS
Solution line section(s)
These sections of disposable harness tubing are designed for use with MCS+
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. This filter
will eliminate bacteria from entering the collection system as the operator
connects the solution/additive bag(s).
A saline solution line section can also be included in the preparation of an
unbundled set, if the selected MCS+ plasmapheresis application uses saline
compensation.
Note: The saline solution line designed for an MCS+ unbundled set does not contain a bacteriological filter.
P/N 85213-30, Manual revision: B
Page 73
Describing the MCS+ Disposable Collection Material 4-15
ILLUSTRATING TYPES OF MCS+ 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. Single-pump manifold
8. AC line with filter
9. Pre-connected needle
10. Sample pouch
11. Recirculation chamber
12. Leukocyte reduction filter
13. SPM line
5.
4.
8.
6.
1.
13.
12.
2.
2.
3.
10.
11.
2. 2.
BMB closed set
1. Centrifuge bowl
2. Collection bags
3. Blood filter
4. DPM line
5. Blood pump “stops”
6. AC pump “stops”
7. AC line with filter
8. Pre-connected needle
9. Sample pouch
10. SPM line
7.
9.
10.
7.
3.
6.
5.
4.
8.
1.
2.
10.
9.
P/N 85213-30, Manual revision: B
Page 74
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. NaCl spike
7.
5
4.
1.
9.3.
6.
2.
8.
Unbundled set sections
Commonly used set
elements
1. Centrifuge bowl (Latham
LN5810 & BMB LN625B)
Harness-in
2. Plasma collection set
(LN799)
3. Plasma collection set
(LN620)
4. Plasma collection set
(LN620E)
Harness-out
5. PPP collection bag
(vented cap) (LN690)
6. Collection set - EVA
(LN691)
7. Collection bag with NaCl
adapter (LN692)
8. Saline adaptor (LN695)
9. Effluent line adaptor
(LN697)
10. Effluent line with bottle
spike (LN698)
2.
3.
1.
4.
5.
8.
6.
7.
9.
10.
P/N 85213-30, Manual revision: B
Page 75
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
P/N 85213-30, Manual revision: B
Page 76
5-2 Maintaining the MCS+ Equipment
CLEANING PROCEDURES
The MCS+ device has been designed to require minimal maintenance for the
operator. To maintain the precision function of the MCS+ device, the operator
needs to primarily perform routine cleaning procedures of certain key components. 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. Special cleaning needs may arise and should
be dealt with promptly. Haemonetics recommends the following routine
cleaning schedule for each MCS+ device, based on an average of three collec-
tion procedures per day, or approximately sixty per month.
! Daily: Clean the exterior surfaces as well as the pressure monitors.
! Weekly: Clean the air detectors, the optical sensors (line sensor and optical
bowl sensor), the fluid detector, and the inside of the centrifuge well.
! Monthly: Clean the pump rotors and the pump wells.
! Quarterly: Clean the filter screens.
Cabinet and control panel
Warning: To eliminate the potential danger of electrical shock, the operator
must clean the MCS+ device only when it is disconnected from an external power source.
The following list describes the basic material required for routine cleaning.
! Disinfectant cleaning solution, specific for blood-born pathogens.
! Warm water.
! 70% Isopropyl alcohol.
! Lint-free gauze or cloth (for cleaning and drying).
! Cotton swabs.
! Protective gloves.
! Hexagonal-head wrench #10 (provided with the device).
! Silicon lubricant (for the “L” gasket of the centrifuge vacuum chuck).
! Phillips-head screwdriver.
The exterior cabinet, valves, keypad and display screen should be wiped daily,
(as well as following any spill), using the cleaning solution.
P/N 85213-30, Manual revision: B
Page 77
Maintaining the MCS+ Equipment 5-3
Pressure monitors
The pressure monitors (DPM/SPM) should be cleaned daily in the following
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
motion. Cloth may be dampened with water, disinfectant solution or alcohol per the site’s local standard operating procedures.
" Dry the rod and release the pressure on the ring.
Caution: Ensure that the pressure monitor is allowed to dry completely before installing the disposable set.
Air detectors The air detectors are designed with a groove to hold the disposable tubing. The
contents of the tubing are monitored by the sensors, which are located internally
on either side of this groove.
The operator should use warm water and lint-free gauze to clean and dry in
between the tubing groves. The groove should be kept free of any particles, such
as powder residue from disposable gloves, since this could lead to an erroneous
detection of air.
Note: If a procedure is interrupted due to an air detector alarm and no air bubble(s) are visible, the operator should remove the tubing and clean the groove before continuing the collection procedure.
Optical sensors The lenses of the optical sensors must be kept completely free of particles or
debris, which could produce inaccurate readings and influence the MCS+ performance. The operator should use only water and lint-free gauze to clean and dry
the lenses.
Caution: If any cleaning solution should come into contact with the optical sensor lenses, they should be immediately cleaned with lint-free gauze and warm
water, then thoroughly dried. Cleaning solution can leave a “opaque” film on the
lens.
Anticoagulant drip monitor
The optical sensor of the AC drip monitor is located on the interior of the drip
chamber holder. The operator should immediately wipe away any AC solution
or other liquid which may have dripped on the lens to avoid erroneous readings.
P/N 85213-30, Manual revision: B
Page 78
5-4 Maintaining the MCS+ Equipment
Line sensor
The line sensor, located on the MCS+ top deck, contains two very small lenses
which are centered on either side of the disposable tubing groove. The operator
should carefully pass the gauze through this groove to clean and dry the lenses.
Optical bowl sensor
The optical bowl sensor lens is located in the upper portion of the centrifuge well.
The operator should ensure that no spots remain after it has been cleaned and
dried.
Dual-pump identification window
The dual-pump identification window should be wiped clean immediately after
any spills to ensure that the information can be read from the disposable set
pump manifold.
Fluid detector(s) The fluid detector(s) is/are located inside of the centrifuge well. The surface of the
detector should be cleaned using a cotton swab moistened with 70% alcohol.
Centrifuge components
Except for the optical sensor and fluid detector(s), the other centrifuge components can be wiped routinely using the cleaning solution and a lint-free cloth.
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. It is not necessary to remove the gasket when applying the lubricant.
If a fluid spill should occur, the operator should:
" Power off the device and disconnect it from the external power source be-
fore cleaning.
" Ensure that the biohazard waste bag is attached to the drain tube and hang-
ing freely.
" Wipe the centrifuge lid with cleaning solution.
" Clean the centrifuge chuck and well, (avoiding the optical bowl sensor
lens), using the disinfectant solution and a lint-free cloth until all traces of
blood components are removed.
" Lubricate the “L” gasket with a small amount of the silicon lubricant.
P/N 85213-30, Manual revision: B
Page 79
Maintaining the MCS+ Equipment 5-5
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. The operator should complete the following additional
steps and contact the local Haemonetics representative for further instructions
before using the device:
" Irrigate the centrifuge drain holes with cleaning solution, until the drain
tube is rinsed clear of the spilled material.
" Remove the bag and replace it with a new bag.
" Dispose of the used waste bag according to local established policies con-
cerning the disposal of biohazard waste.
Note: A 50 ml syringe of attached to a 20 cm section of disposable tubing placed
in the drain holes can be used for irrigation. The biohazard waste bag should be
monitored to avoid overfilling.
Warning: An authorized Haemonetics technician should perform a leakage current control after any major fluid spill involving the MCS+ device. Leakage current represents a primary indication of electrical shock hazard and should be
checked according to guidelines as described in local standard operating procedures.
Pumps The pump rotors should be removed from the well with the hexagonal head
wrench.
Debris should be removed from the rotors and the pump wells on a routine basis,
as well as after any spills, to contribute to efficient MCS+ operation.
For routine cleaning, the operator should:
" Remove the pump rotor from the housing, using the hexagonal head
wrench to remove the pump screw.
" Wipe the rotor and remove all debris from the rollers, using warm water
and lint-free cloth or gauze.
" Dry with lint-free cloth (or compressed air, if is available).
" Clean and dry the pump well using the same method.
" Ensure that all of the rollers spin freely and replace the pump rotor in the
well, aligning the cross pin in the rotor with the pump shaft.
" Replace and tighten the hexagonal head screw.
In the case of a fluid spill, the same cleaning method should be followed;
however, disinfectant cleaning solution should be used, followed by a clear
water rinse. The pump rotor should not be immersed in water.
P/N 85213-30, Manual revision: B
Page 80
5-6 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:
" Remove the retainer plates using a Phillips-head screwdriver.
" Remove the filter screens from the panel.
" Rinse the screens under running water – DO NOT use any cleaning agents.
" Gently squeeze the screens to remove excess water.
" Place the screens on a clean, dry cloth and allow to dry completely.
" Reinsert the screens into the panel, ensuring that all openings are com-
pletely covered by the filter.
" Replace the retainer plates and tighten the screws.
Warning: To avoid electrical shock, the filter screen should be completely dry
before it is reinstalled on the MCS+ cabinet.
Bar-code reader The bar-code reader window should be wiped using a lint-free cloth or gauze
and water, then dried. It should be cleaned whenever there is an accumulation
of dust or spilled fluid. For optimal cleaning, the operator should remove the
protector around the window and replace it once the window has been cleaned.
Pressure cuff If it is determined that the cuff has been contaminated, clean the affected area
with a 10% bleach solution (or equivalent). If this cleaning is determined to be
insufficient based on the severity of the contamination, a replacement cuff may
be ordered and installed by the user.
P/N 85213-30, Manual revision: B
Page 81
Maintaining the MCS+ Equipment 5-7
P/N 85213-30, Manual revision: B
Page 82
5-8 Maintaining the MCS+ Equipment
CUSTOMER 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 Haemonetics representative will schedule staff training upon delivery of MCS+ equipment and should be contacted to organize further instruction when needed.
Field service Haemonetics maintains a worldwide network of company-trained service repre-
sentatives responsible for responding to technical needs concerning equipment.
These technical specialists are available to diagnose and repair any malfunctions,
as well as provide routine annual or semi-annual maintenance of the apheresis
equipment, including leakage current tests. If service beyond the routine maintenance and cleaning described in this manual is required, the local Haemonetics
representative should be contacted to provide specific instruction.
Returned Goods Authorization system
Haemonetics seeks to provide the apheresis customer with equipment and material which respects the highest established standards of quality in design and
manufacturing. If for any reason merchandise must be returned to the company,
the customer should refer to the Haemonetics Returned Goods Authorization
(RGA) system procedure to ensure proper handling and subsequent analysis of
the material.
First, the customer should contact the local Haemonetics representative [or the
Haemonetics Customer Service Department] and provide the following information:
! Product list number, lot number and manufacture date.
! Number of articles to be returned.
! Description of defect.
! Number of parcels being shipped.
The Haemonetics representative may ask for additional details, depending on the
nature of the problem. The customer should be prepared to provide a thorough
description of the problem encountered, as well as the product information listed
above.
If a contaminated disposable set must be returned by courier services, the
Haemonetics representative may provide specific instructions concerning preparation for shipping blood-contaminated products. In addition to the Haemonetics
guidelines, the consumer should strictly follow the local standard operating
procedure related to the shipment of blood-contaminated materials and thus
minimize any potential health hazards involved.
P/N 85213-30, Manual revision: B
Page 83
Maintaining the MCS+ Equipment 5-9
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.
Warning: Haemonetics products must be properly cleaned and packed prior to
their return. It remains an important responsibility of the customer to reduce
this serious potential health hazard, by being aware of the risks involved in the
shipping, handling and testing of this material.
Disposal Follow all local standard regulations for the disposal of medical equipment when
disposing of the MCS+ device.
P/N 85213-30, Manual revision: B
Page 84
Jan. Feb. March April May June July Aug. Sept. Oct. Nov. Dec.
®
HAEMONETICS
Cleaning and maintenance record for the year
Action
MCS+ device serial number ..................................................................................................
Clean cabinet and control panel
Clean air detectors
Clean optical line sensor
Clean DPM and SPM
Clean anticoagulant drip moni-
tor
Clean centrifuge cover and well
Inspect “L”-gasket and apply
silicon lubricant
Clean optical bowl sensor
Clean dual-pump identification
window
Clean pump rotors
Clean air filters
Verify biohazard waste bag
Maintenance performed by
(date and initials)
Reviewed by
(date and initials)
Annual preventive maintenance should be scheduled by a supervisor when appropriate and performed by a Haemonetics service representative
or a qualified biomedical engineer.
Name of person performing preventive maintenance: .......................................................... Date performed: ..................................................................
Reviewed by: ....................................................................................................................... (Date and supervisor initials)
Page 85
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
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
P/N 85213-30, Manual revision: B
Page 88
6-2 Ensuring Safety and Quality for an MCS+ Procedure
HANDLING THE MCS+ 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.
Storing the device and material
Inspecting the material
Transporting the device
The MCS+ device must not be operated or stored in an area where flammable
gases or vapors are present. The MCS+ disposable set material should be kept in
a dry, well-ventilated area and isolated from any chemical vapors. The operator
should handle the disposable set elements with clean, dry hands or gloves
The ranges for storing the material should be within 8% to 80% rh and –20° C to
+50° C. The recommended temperature for the working environment is between
18° C to 27° C.
Prior to installation, the operator should complete a visual inspection of the
disposable set elements and control for twisted or flattened sections.
After installing the disposable set, the operator should verify the correct placement of the individual elements, prior to initiating a collection procedure. It is
important that the tubing remain free of any twists or occlusions which could
cause a flow obstruction.
Use caution when lifting and transporting the device. Lift the device only by the
handles. Always ensure that the IV poles are in the “down” position and the
cabinet cover is closed before transporting or moving the device. Do not hold or
lift the device by the IV poles or weigher arm. Two people should lift the device
in order to avoid injury.
P/N 85213-30, Manual revision: B
Page 89
Ensuring Safety and Quality for an MCS+ Procedure 6-3
PREVENTING PROBLEMS DURING AN MCS+ PROCEDURE
Understanding the risk of hemolysis
Avoiding the consequences of flow restriction
Hemolysis involves the destruction of red blood cell membranes, with the release
of free hemoglobin into the plasma portion of the blood. Free hemoglobin does
not have the capacity to transport oxygen and can produce serious problems. The
remnants of the red cell can stimulate clot formation and damage the vascular
nature of the lungs and the kidneys. This could lead to respiratory complications
and/or renal failure.
Hemolysis of red cells can occur during an apheresis procedure in the rare event
of a mechanically induced situation, such as overheating, or excessive pressure.
Warning: Forcing a pump to work against a severe flow restriction can lead to
hemolysis, and thus, consequently high levels of free hemoglobin in the plasma.
It is important that the operator remain attentive to this fact in the case of any
“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 representative should be informed of the problem to provide the operator with further
instruction.
During DRAW, a flow restriction in the effluent tubing can create pressure on the
outlet port of the disposable bowl. This unrelieved pressure can deform the rotary
seal of the disposable bowl. If the functional characteristics of the rotary seal are
altered, the increased friction and excessive heat can make the contents of the
bowl unsuitable for return to the donor.
During RETURN, a flow restriction in the effluent tubing can cause the pressure
in the centrifuge bowl to drop severely. This sudden drop in pressure could potentially produce hemolysis.
To eliminate these potential problems, the operator should:
" Ensure against inadvertent clamping of the effluent tubing.
" Observe the following changes in flow rate (possible indications of a flow
restriction):
! Decreased donor flow rate during DRAW.
! Abnormally increased time required to return the disposable bowl con-
tents to the donor.
P/N 85213-30, Manual revision: B
Page 90
6-4 Ensuring Safety and Quality for an MCS+ Procedure
Avoiding bowl misalignment
Avoiding overheating due to mechanical situations
An improperly installed disposable bowl can become misaligned as it spins. This
can create excessive friction, and consequently overheat the bowl contents. The
operator should verify the alignment of the bowl at the time of installation.
Note: In certain MCS+ protocols, the programming will instruct the centrifuge to
spin the bowl during PRIME, as a control for proper bowl placement.
Warning: The operator must not use any bowl which cannot be properly seated
in the centrifuge chuck. Overheating can occur (subsequently leading to hemolysis) and make any blood being processed unsafe for re-infusion. During MCS+
operation, the operator should interrupt the collection procedure if an abnormal or excessive noise appears, related to the spinning bowl.
Overheating could also result from a mechanical or maintenance-related
problem, such as a defective bearing or seal within the centrifuge well. In this
case, the operator should contact the local Haemonetics representative and
discontinue use of the MCS+ device until it is serviced.
Warning: If any component of the MCS+ device has become overheated during
a procedure, and thus overheats the blood being processed, the blood components cannot be considered safe for re-infusion.
Controlling for red cell overrun
Red Cell Overrun is the term used to describe the presence of erythrocytes in the
effluent tubing and/or product collection container during an apheresis procedure. It is important that the operator observe the appearance of the plasma as it
is collected. A pink or reddish hue could indicate a possible red cell spillage
which should be investigated immediately.
If the cause of the reddish hue cannot be determined to be a normal result of the
selected MCS+ protocol, the procedure should be discontinued immediately and
the blood components in the bowl must not be returned to the donor/patient.
P/N 85213-30, Manual revision: B
Page 91
Ensuring Safety and Quality for an MCS+ Procedure 6-5
WARNINGS FOR THE OPERATOR
Electrical shock hazards
Leakage current control
The operator should always use the MCS+ device with clean dry hands, or gloves.
The internal parts of the MCS+ device contain various electrical components.
Contact with any of these components, when the device is connected to an
external powered source, could result in an electrical shock to the operator and/
or donor/patient.
The operator should never remove any of the MCS+ cabinet panels. Maintenance
requiring access to the inner cabinet remains the responsibility of a Haemoneticstrained 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
electrical shock. Likewise, the operator should not simultaneously touch the
donor/patient and any internal parts of a non-medical device that, after the
removal of covers, connectors, etc., without a tool, could result in an electrical
shock to the operator and/or donor patient.
Equipment in which protection against electric shock relies on basic insulation
only should not be used with the MCS+ device.
Each MCS+ device receives a careful inspection for leakage current prior to
leaving the factory. Haemonetics recommends that a control be performed for
current leakage by an authorized representative as part of the annual preventative
maintenance. It remains the responsibility of the apheresis center to ensure that
this control is performed.
In the event of any major spill in which fluid may enter the cabinet, or an important voltage surge, the operator is responsible to ensure that a leakage current test
is performed before re-using the device. The control is necessary to avoid the risk
of electrical shock and should be conducted by an authorized Haemonetics
representative.
The operator is responsible for making sure that the leakage current of the final
configuration (the MCS+ device and any ancillary equipment attached to the
MCS+ device), comply with IEC 60601-1-1 Standard, Medical electrical equipment in normal and single fault conditions.
P/N 85213-30, Manual revision: B
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6-6 Ensuring Safety and Quality for an MCS+ Procedure
Mechanical hazards/rotating parts
Power outlet connection
Communicable disease precautions
As with any equipment containing rapidly rotating parts, the potential for severe
injury exists if personal contact is made, or if clothing becomes entangled with
the moving parts. The MCS+ device contains a safety feature, designed to prevent
the centrifuge from spinning if the system has not been properly secured.
However, the operator should respect the usual precautions taken when working
with equipment containing rotating mechanical parts.
To comply with the IEC 60601-1-1:2000 Standard for Medical Electrical Equipment, general requirements for safety do not connect more than one multiple
portable socket outlet or extension cord to the system. 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.
Despite testing and screening to detect communicable diseases such as hepatitis,
syphilis or HIV, the risk remains that the blood being processed may be infected.
The operator must take the appropriate precautions when handling blood products and disposing of blood-contaminated material, to ensure personal safety as
well as the safety of others who may come in contact with the material.
Proper handling of blood-contaminated material
If a leak or blood-spill should occur, it should be cleaned immediately. The operator should follow the local standard operating procedure outlining the steps to
follow and product(s) to be used for the disinfection of material contaminated by
blood.
If any blood-contaminated material must be returned to Haemonetics for further
inspection, the operator should consult the “RGA” Procedure, described in
Chapter 5.
Proper disposal of biologically contaminated materials
Any MCS+ disposable material used during an apheresis process is considered as
biologically contaminated. It must be disposed of according to local standard
operating procedure for the removal of such material and should not be mixed
with non-biologically contaminated waste.
P/N 85213-30, Manual revision: B
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 . . . . . . . . . . . . 7-4
Power failure procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Manual gravity infusion procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Repeat venipuncture procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
AC depletion procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
P/N 85213-30, Manual revision: B
Page 94
7-2 Troubleshooting during an MCS+ Procedure
UNDERSTANDING A NOTICE AND RELEVANT HELP MESSAGE
The MCS+ device is monitored from the moment it is powered on by two safety
systems- a “hardware” based safety system and a “software” based safety system.
The operator is notified of any irregularities by a display screen message and an
audible alarm. This type of message is referred to as a NOTICE message.
In the case of a rare major system malfunction, the operator will receive a
message on the screen and hear a continuous alarm. If this occurs, the operator
should record the error detected and immediately power off the device. The operator should discontinue use of the device and inform the local Haemonetics
representative, who will provide further instruction.
For other system alerts, the operator will receive a screen message and hear an
intermittent alarm. The operator can use troubleshooting techniques provided on
the Haemonetics HELP screen display and attempt to resolve these “errors”.
An MCS+ NOTICE message will describe the problem to the operator and display
a reference number. A numerical listing of MCS+ NOTICE messages, along with
each related HELP message is provided in the Postscript to the MCS+.
LDP DRAW Filling bowl
175
Press NO to mute the alarm.
Press HELP for more information.
LDP DRAW Filling bowl
175
Press NO to mute the alarm.
Press HELP for more information.
AIR DETECTED BY
THE ANTICOAGULANT AIR DETECTOR (ACAD)
Figure 7-1, Example of an MCS+ NOTICE message
THE ANTICOAGULANT AIR DETECTOR (ACAD)
The Air Detector detects air.
1. Check tubing installation in detector.
2. Remove air bubbles.
3. Resume operation.
P/N 85213-30, Manual revision: B
Figure 7-2, Example of an MCS+ HELP message
Page 95
Troubleshooting during an MCS+ Procedure 7-3
PERFORMING 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.
! If the operator has powered-off the device for any reason before the normal
termination of a collection procedure.
If at any point during a collection procedure, the operator should receive a HELP
message indicating that the device should be powered-off, then powered-on in
an attempt to “recover” the procedure, the following screen will be displayed:
PROCEDURE RECOVERY
The POWER has been OFF for a short time.
Press YES for PROCEDURE RECOVERY.
Press NO for NEW PROCEDURE.
Press HELP for More Information.
Figure 7-3, MCS+ Procedure Recovery Screen
(refer to message 375)
If the donor/patient has remain connected to the system, and the disposable set
has remained fully installed, the operator can resume the procedure simply by
pressing the Yes key.
The MCS+ safety features will conduct the necessary testing to ensure that the
procedure can be continued. The device will first conduct a RETURN cycle of
components remaining in the disposable set and bowl, then proceed with the
next DRAW cycle.
The on-line HELP screen will provide further information. Full procedure statistics can be retrieved from the Haemo Update screen by pressing the Help key
twice.
Note: If the operator presses the No key to begin a new procedure, rather than
the Yes key to attempt a Procedure Recovery, new disposable material must be
installed.
P/N 85213-30, Manual revision: B
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7-4 Troubleshooting during an MCS+ Procedure
APPLYING SPECIFIC TROUBLESHOOTING TECHNIQUES
Power failure procedure
Policies may vary among apheresis centers concerning the procedure to follow
in the event of a power failure.
It is important for the operator to remember that during DRAW, the blood in the
needle tubing is not anticoagulated. All needles should be considered as
containing non-anticoagulated blood, in the event that processing should be
interrupted during DRAW.
The operator can bring anticoagulated blood to the needle site by the following
actions:
" Place the power ON/OFF switch in the OFF position.
" Press the donor valve lever to hold the valve open.
" Manually turn the blood pump in a counter-clockwise direction, providing
5 full, slow rotations.
This will bring approximately 5 ml of anticoagulated blood through the needle
tubing to the venipuncture site. If power has not been restored within 5 minutes,
the operator should begin to manually return the blood components in the bowl
and tubing to the donor using the “Manual Gravity Infusion” procedure.
If power is restored, and the original venipuncture has been maintained open for
blood to flow freely, the operator can re-install the tubing in the valves and
attempt to recover the procedure and continue component collection.
Manual gravity infusion procedure
P/N 85213-30, Manual revision: B
During an apheresis procedure, an unusual circumstance may arise (such as a
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
suggests a technique using gravity to manually infuse the remaining contents.
This can eliminate unnecessary blood loss for the donor.
This procedure is applicable for all of the MCS+ protocol options. Policies may
vary among apheresis centers concerning the return of cells by gravity. The operator should consult and apply the local standard operating procedure for gravity
infusion of cells if variation in procedure exists.
Without an external power source, the MCS+ valves must be opened manually
to release the tubing. To do this, the operator must press the lever of the pinch
valve toward the cabinet until the tubing can be removed.
Warning: The operator should carefully monitor the venipuncture site. If infiltration of the vein is observed at any point, the procedure should be discontinued.
Page 97
Troubleshooting during an MCS+ Procedure 7-5
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-
nor.
" Clamp the solution line(s) and remove the tubing from the valve(s).
" Remove the tubing from plasma valve, the donor valve, the line sensor and
the BLAD to provide necessary slack in the tubing.
" Clamp the DPM and SPM lines and remove the filters from the pressure
monitors.
" Remove the tubing from the Blood and Transfer pumps.
Caution: Turn the pump rotors clockwise until the groove on each pump rotor is
aligned with the tubing guide, then pull the tubing upward. The operator should
verify that the tubing remains in the groove as the pump rotor is turned, in order
to avoid pinching or tearing the tubing.
" Remove the tubing from the DLAD1, DLAD2 and the tubing guide.
Removing the bowl/beginning re-infusion
" Unlock the centrifuge and open the lid.
" Remove the disposable bowl from the centrifuge well and the blood filter
from the brackets.
Caution: The operator should hold the disposable bowl and blood filter upright
and higher than the donor at all times.
" Unclamp the donor line tubing. Allow gravity force to infuse the entire
contents of the bowl up to the point of the needle connector.
" Re-clamp the double lumen tubing approximately 5 cm from the Y- con-
nector to prevent blood from returning in the direction of the bowl.
Discontinuing the procedure
" Remove the needle from donor, disconnect the needle tubing from the dis-
posable harness and dispose of appropriately.
" Clamp the effluent line close to the centrifuge bowl and disconnect the
collection product(s). Handle any collection products according to local
standard operating procedure.
" Remove the remaining disposable set elements and dispose of appropri-
ately.
P/N 85213-30, Manual revision: B
Page 98
7-6 Troubleshooting during an MCS+ Procedure
Repeat venipuncture procedure
If a vein becomes infiltrated at any point during a collection procedure, and
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
using a new intravenous pathway.
The MCS+ operator should be familiar with the local standard operating procedures when repeating a venipuncture, as well as product storage-duration
requirements when changing a needle.
This procedure as described by Haemonetics must be performed using strict
aseptic technique or a sterile connection device.
" Press the STOP key on the control panel.
" Hermetically seal the donor-line tubing by clamping both sides of the nee-
dle connector as follows:
! Close the ratchet clamp on the needle tubing.
! Place a second clamp on the double-lumen tubing on the opposite side
of the Y-connector.
! Remove the needle from the donor, cut the contaminated needle and
dispose of correctly.
! Place the donor-line tubing aside to prevent contamination.
Caution: At this point, the operator should remove the pressure cuff from the donor and appropriately treat the vein, if infiltrated.
" Prepare and perform a new venipuncture, securing the new needle and
tubing.
" Prime the new needle tubing with donor blood and close the ratchet
clamp.
" Disconnect the old needle tubing (minus the needle) from the disposable
set and dispose of correctly.
" Connect the new needle tubing to the disposable harness and unclamp at
both sites.
If aseptic technique has been used, any air in the tubing is considered as sterile,
and the collection product will remain viable. Any air in the tubing can be
displaced toward the blood filter or disposable bowl by the following actions:
" Press the Draw key to advance any air present from the needle through the
DLAD1 and DLAD2 into the blood filter.
Note: Depending on the quantity of blood already present in the bowl, the operator may receive the NOTICE message “DRAW not allowed, press RETURN to
continue”. If this should occur, the operator should press the STOP key, followed
by the Draw key. The MCS+ DRAW mode will then be initiated automatically.
Once any air from the needle has reached the bowl, the operator should:
" Press the Return key to re-infuse the blood components in the bowl.
P/N 85213-30, Manual revision: B
Page 99
Troubleshooting during an MCS+ Procedure 7-7
AC depletion procedure
During an MCS+ collection procedure, the anticoagulant solution may be
depleted before the target collection product volume has been reached. If the AC
solution bag is empty, the operator will hear an alarm and receive the screen
message “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.
P/N 85213-30, Manual revision: B
Page 100
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