Haemonetics ACP-215 User manual

Haemonetics® ACP™215

Automated Cell Processing System

– Operation Manual –

0123

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

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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.

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Haemonetics France S.A.R.L.

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Haemonetics GmbH

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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.

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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

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

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

+ 31 hidden pages