Haemonetics® ACP™215
Automated Cell Processing System
– Operation Manual –
0123
Printed in France
Haemonetics Corporation
400 Wood Road, Braintree, MA 02184, USA P/N 85271-30, Manual revision: C
©2003, Haemonetics International. All rights reserved. January 2003
Preface iii
CONSUMER INFORMATION
Proprietary rights The contents of this manual are property of the Haemonetics
Haemonetics
Corporation. 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
®
and ACP™215 are registered trademarks of the Haemonetics
Corporation.
Legal disclaimer This manual is intended for use as a guide, uniquely for material as supplied by
the Haemonetics Corporation. It provides the operator with necessary information to safely carry out specific procedures and satisfactorily maintain Haemonetics produced equipment. The manual is to be used in conjunction with
instruction and training as supplied by qualified Haemonetics personnel.
Haemonetics guarantees its products when correctly used by a properly trained
operator. Any failure to respect the procedures as described could result in
impaired function of the equipment, as well as in injury to the operator. 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 is responsible for understanding and implementing
the local policies and standard operating procedures concerning the handling of
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 customer concerning the utilization of products and by-products.
P/N 85271-30, Manual revision: C
iv Preface
Haemonetics worldwide locations
Haemonetics Asia Inc.
Taiwan Branch
26F-1, No. 102 Roosevelt Road Sec. 2
Taip ei, Taiwa n
Tel. [+886 2] 2369 0722
Fax [+886 2] 2364 3698
Haemonetics GesmbH
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
Naritaweg 16
Telestone 8
1043 BW Amsterdam
The Netherlands
Tel. [+31 35] 602 3425
Fax [+31 35] 602 4198
Haemonetics Medical Devices
(Shanghai) International
Trading Co. Ltd.
Room 28032, Shanghai HSBC Tower
101 Yin Cheng East Road
Shangai 200120, PRC
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
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
Rohrauerstrasse 72
81477 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
Haemonetics SA
Signy Centre, rue des Fléchères
P.O. Box 262
1274 Signy 2, Switzerland
Tel. [+41 22] 363 90 11
Fax [+41 22] 363 90 54
P/N 85271-30, Manual revision: C
Table of Contents
Chapter 1 Explaining General Information
Providing an overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
What is the ACP 215 system ? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
What is the purpose of this manual ? . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
What is required to perform a procedure ? . . . . . . . . . . . . . . . . . . . . . . . 1-2
Understanding the use of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Symbols found in this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Symbols found on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Symbols found on disposable packaging . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Listing ACP 215 device specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Chapter 2 Presenting the ACP 215 Equipment
DESCRIBING THE ACP 215 CONTROL PANEL. . . . . . . . . . . . . . . . . . . . . . 2-3
Display screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
DESCRIBING THE ACP 215 CABINET COMPONENTS . . . . . . . . . . . . . . . . 2-4
Centrifuge system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Pressure monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Valves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Air detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Optical line sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Solution bag pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Power entry module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Power cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Biohazard waste bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
DESCRIBING THE SHAKER AND THE PRINTER . . . . . . . . . . . . . . . . . . . . . 2-8
Shaker . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
P/N 85271-30, Manual revision: C
vi Table of Contents
Chapter 3 Maintaining the ACP 215 Equipment
CLEANING PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Listing tools and cleaning supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Exterior surfaces, valves, shaker and printer . . . . . . . . . . . . . . . . . . . . . . 3-3
Pressure monitors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Air detectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Optical line sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Fluid detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Centrifuge components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Filter screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
CUSTOMER SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Field service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Returned Goods Authorization system . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Haemonetics
®
Cleaning and maintenance record . . . . . . . . . . . . . . . . . 3-8
Chapter 4 Ensuring Safety and Quality for an ACP 215
Procedure
HANDLING THE ACP 215 EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Storing the device and material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Inspecting the material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
PREVENTING PROBLEMS DURING AN ACP 215 PROCEDURE . . . . . . . . 4-3
Understanding the risk of hemolysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Avoiding the consequences of flow restriction . . . . . . . . . . . . . . . . . . . . 4-3
Avoiding bowl misalignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Avoiding overheating due to mechanical situations . . . . . . . . . . . . . . . . 4-4
WARNINGS FOR THE OPERATOR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Leakage current control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Mechanical hazards/rotating parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Power outlet connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Communicable disease precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Chapter 5 Troubleshooting for the ACP 215 Device
LISTING SYSTEM ERROR MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
LISTING INTERRUPT SAFETY SYSTEM MESSAGES . . . . . . . . . . . . . . . . . . . 5-5
P/N 85271-30, Manual revision: C
Chapter 1
Explaining General Information
Providing an overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
What is the ACP 215 system ?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
What is the purpose of this manual ?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
What is required to perform a procedure ? . . . . . . . . . . . . . . . . . . . . . . . 1-2
Understanding the use of symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Symbols found in this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Symbols found on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Symbols found on disposable packaging. . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Listing ACP 215 device specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Dimensions and weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Power requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
P/N 85271-30, Manual revision: C
1-2 Explaining General Information
PROVIDING AN OVERVIEW
What is the ACP 215 system ?
What is the purpose of this manual ?
In the tradition of its innovative technology, Haemonetics has produced the
ACP 215 - a compact, lightweight, automated cell processing system which is
simple to operate.
The ACP 215 system can perform the following types of procedures:
! Prepare collected red blood cell products with glycerol for freezing.
! Deglycerolize thawed red blood cell products, removing extra cellular
components, and resuspend the red blood cells in an additive solution.
! Wash red blood cell units stored in commonly used AC and additive solu-
tions to remove plasma and extra cellular components.
The ability to process-control the addition and removal of cryroprotectant solution as well as wash banked blood in a closed system significantly improves the
safety and availability of blood products.
This manual is intended to supply anyone involved in using the ACP 215 equipment with information to attain:
! An awareness of the purpose of the device and the implications of its
procedures.
! An understanding of how to safely operate the system, correctly install the
appropriate disposable material, and troubleshoot any difficulties.
! An ability to consistently apply the principles behind safe operation,
What is required to perform a procedure ?
P/N 85271-30, Manual revision: C
The following material is required to perform an ACP 215 procedure:
! The ACP 215 device, to process the collected red blood cell products.
! A dedicated shaker, to properly mix the blood with procedure-specific
! A disposable set designed for the selected procedure.
! Appropriate solutions.
! A printer, to provide the operator with printed procedure data.
! A sterile connection device, to ensure proper tubing welds.
proper maintenance and correct handling, to ensure optimal results.
solutions.
Explaining General Information 1-3
UNDERSTANDING THE USE OF SYMBOLS
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
by-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 operator or the
recipient of the product.
! Text preceded by this bullet indicates an action for the operator.
" Text preceded by this bullet indicates an item on a list of information for
the operator.
The following symbols are found on the ACP 215 device.
Typ e B
Protection against electric shock, particularly regarding: allowable leakage current and 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.
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.
P/N 85271-30, Manual revision: C
1-4 Explaining General Information
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.
Protection against ingress of liquid
IPX1
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)
Symbols found on
disposable packaging
The following symbols are used by Haemonetics on disposable set packaging.
REF
LOT
STERILE EO
STERILE
EO
Catalog number
Expiration date
Lot Number
Contents sterile by exposure to ethylene oxide
Fluid path sterile by exposure to ethylene oxide
STERILE R
P/N 85271-30, Manual revision: C
Contents sterile by exposure to gamma irradiation
Explaining General Information 1-5
STERILE R
-yy˚C
yy˚C
Fluid path sterile by exposure to gamma irradiation
Do not reuse
Caution: consult operator manual for instructions
KEEP DRY [storage conditions]
Storage conditions, temperature level
P/N 85271-30, Manual revision: C
1-6 Explaining General Information
LISTING ACP 215 DEVICE SPECIFICATIONS
Dimensions and weight
Environmental conditions
The approximate weight and dimensions of the ACP 215 device are as follows:
Value (approximate)
Characteristic
Cabinet cover open Cabinet cover closed
Height 67.5 cm [26.5 inches] 43 cm [17 inches]
Width 55 cm [21.5 inches]
Depth 55 cm [21.5 inches] 30.5 cm [12 inches]
Weight 25 kg [56 lb]
The following environmental conditions should be respected pertaining to operation and storage of the ACP 215 device.
Condition Value
Operating Temperature 18° C to 35° C
Humidity 95% maximum, non-condensing
Tested storage temperature range 5° C to 45° C, non-condensing environ-
ment
Power requirements
P/N 85271-30, Manual revision: C
The power is supplied to the device from an external AC power source. The
power source must be properly grounded. Haemonetics will regulate the proper
voltage setting upon installation.
Characteristics Values (relative to input voltage)
Input voltage 230 VAC ± 10% 110 VAC ± 10%
Operating current ~1.9 A ~ 2.6 A
Maximum input current 2.5 A 5.0 A
Fuse rating F2.5 A @ 250 V F5.0 A @ 250 V
Operating frequency range 50 - 60 Hz 50 - 60 Hz
Maximum leakage current 500 µA 100 µA
Explaining General Information 1-7
Caution: The ACP 215 device must be operated in an environment compatible to
the requirements of the IEC 60601-1-2 Standard, Electromagnetic compatibility.
Mobile RF communication equipment not approved by Haemonetics and
portable communication equipment can affect the ACP 215 device. Any accessories and cables not approved by Haemonetics used in conjunction with the
device may increase hazards and influence compatibility with EMC requirements. Therefore, non-approved accessories and cables must not be used.
In addition, the ACP 215 device and accessories must not be placed directly adjacent to, or top of other equipment, unless specifically approved by Haemonetics.
P/N 85271-30, Manual revision: C
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