Haemonetics PCS2 Operation manual

R

2

PCS

Working with the Haemonetics® PCS®2

- Operation Manual -

0123

Printed in France
Haemonetics Corporation
400 Wood Road
Braintree, MA, 02184, USA P/N 85266-30, Manual revision: A
©2002, Haemonetics International. All rights reserved. April 2002

Preface iii

CONSUMER INFORMATION

Proprietary rights The contents of this manual are property of the Haemonetics Corporation.

Haemonetics
ration. 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 Corpo-

ration, USA. Please direct any written inquiries to the appropriate address:

®

and PCS®2 are registered trademarks of the Haemonetics Corpo-

International Headquarters

Haemonetics S.A.
Signy Center, P.O. Box 262
CH-1274 Signy 2 Switzerland
Tel. [phone]
Fax [phone]

Corporate Headquarters

Haemonetics Corporation
400 Wood Road
Braintree, MA, 02184, USA
Tel. [phone]
Fax [phone]

Legal disclaimer This manual is intended for use as a guide, uniquely for material as supplied by

the Haemonetics Corporation. It provides the operator with necessary informa­tion to safely carry out specific procedures and satisfactorily maintain Haemo­netics-produced equipment. The manual is to be used in conjunction with
instruction and training as supplied by qualified Haemonetics personnel.

Haemonetics guarantees its products when correctly used by a properly trained
operator. Any failure to respect the procedures as described could result in
impaired function of the equipment, as well as in injury to the operator and/or
patient /donor. Haemonetics accepts no responsibility for problems resulting
from failure to comply with prescriptions as outlined by the company. Any modi­fications estimated as necessary by the customer should be evaluated by a
Haemonetics Clinical Specialist.

Safe utilization of Haemonetics material and equipment requires the operator to
correctly handle and dispose of blood-contaminated material. The operator of
any Haemonetics equipment must understand and implement 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 consumer concerning the utilization of products and by-products.

In addition, it is the responsibility of the apheresis center using Haemonetics
equipment and material to inform the donor about 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 85266-30, Manual revision: A

iv Preface

Haemonetics worldwide locations

Haemonetics Asia Inc.

Taiwan Branch
26F-1, No. 102 Roosevelt Road Sec. 2
Taipei, Taiwan
Tel. [phone]
Fax [phone]

Haemonetics GesmbH

Handelsges.m.b.H.
Berlagasse 45/B2-02
A-1210 Wien, Austria
Tel. [phone]
Fax [phone]

Haemonetics Belgium NV

Leuvensesteenweg 542-BP. 14
Planet II Complex
B-1930 Zaventem, Belgium
Tel. [phone]
Fax [phone]

Haemonetics BV

C/O CITCO - WTC, PB 7241
Strawinskylaan 1725
1007 JE Amsterdam
The Netherlands
Tel. [phone]
Fax [phone]

Haemonetics Medical Devices
(Shanghai) International
Trading Co. Ltd.

Room 28032, Shanghai HSBC Tower
101 Yin Cheng East Road
Shangai 200120, PRC
Tel. [phone]
Fax [phone]

Haemonetics CZ, spol. S.r.o

Ptašínského C.8
60200 Brno, Czech Republic
Tel. [phone]
Fax [phone]

Haemonetics France S.A.R.L.

46 bis, rue Pierre Curie
Z.I. Les Gatines
F-78370 Plaisir, France
Tel. [phone]
Fax [phone]

Haemonetics GmbH

Rohrauerstrasse 72
D-81477 München, Germany
Tel. [phone]
Fax [phone]

Haemonetics Hong Kong Ltd.

Suite 1314, Two Pacific Place
88 Queensway, Hong Kong
Tel. [phone]
Fax [phone]

Haemonetics Italia S.R.L.

Via Donizetti, 30
20020 Lainate (MI), Italy
Tel. [phone]
Fax [phone]

Haemonetics Japan K.K.

Kyodo Building 3F
16, Ichiban-cho, Chiyoda-ku
Tokyo, Japan, 102-0082
Tel. [phone]
Fax [phone]

Haemonetics Scandinavia AB

Beta Huset, Ideon
Scheelegatan 17
S-223 70 Lund, Sweden
Tel. [phone]
Fax [phone]

P/N 85266-30, Manual revision: A

Preface v

Haemonetics (UK) Ltd.

Beechwood House
Beechwood Estate
Elmete Lane, Roundhay
Leeds LS8 2LQ, United Kingdom
Tel. [phone]
Fax [phone]

Haemonetics S.A.

Signy Centre
P. O. B o x 2 6 2
CH-1274 Signy 2, Switzerland
Tel. [phone]
Fax [phone]

P/N 85266-30, Manual revision: A

Table of Contents

Chapter 1 Explaining General Information

PROVIDING AN OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

What is apheresis technology? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

What is the purpose of this manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

What is the Haemonetics Plasma Collection System 2?. . . . . . . . . . . . . 1-3

What are the characteristics and features of the PCS2? . . . . . . . . . . . . . 1-3

What are the special features of the PCS2? . . . . . . . . . . . . . . . . . . . . . . 1-4

What is required to perform a procedure? . . . . . . . . . . . . . . . . . . . . . . . 1-4

UNDERSTANDING THE USE OF SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Symbols found in this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Symbols found on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Symbols found on disposable packaging. . . . . . . . . . . . . . . . . . . . . . . . 1-8

LISTING DEVICE SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Chapter 2 Describing the PCS2 Device Components

PRESENTING THE PCS2 DEVICE COMPONENTS . . . . . . . . . . . . . . . . . . . 2-3

DESCRIBING THE CENTRIFUGE SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

System-sealing mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Centrifuge well . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Centrifuge base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

DESCRIBING THE PCS2 CABINET COMPONENTS . . . . . . . . . . . . . . . . . . 2-7

Optical line Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Weigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Pumps. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Valves. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Donor flow lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Air detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Pressure monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Blood filter holder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Solution-bag poles (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Power entry module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Power cord . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Pressure cuff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Biohazard waste bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15

Communication box/data card (optional) . . . . . . . . . . . . . . . . . . . . . 2-16

Bar code reader (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

P/N 85266-30, Manual revision: A

viii Table of Contents

DESCRIBING THE PCS2 CONTROL PANEL . . . . . . . . . . . . . . . . . . . . . . . 2-17

Display screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Mode control keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Protocol key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Pump control keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Programming keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

Cuff key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Valve control keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Chapter 3 Maintaining the PCS2 Equipment

CLEANING PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Cabinet, control panel and valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Pressure monitors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Air detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Optical sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

Fluid detector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Centrifuge components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Filter screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Barcode reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 a PCS2 Procedure

HANDLING THE PCS2 EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Storing the PCS2 device and material. . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Inspecting the material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

PREVENTING PROBLEMS DURING A PCS2 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

Controlling for Red Cell Overrun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

P/N 85266-30, Manual revision: A

Chapter 1

Explaining General Information

PROVIDING AN OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

What is apheresis technology? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

What is the purpose of this manual? . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

What is the Haemonetics Plasma Collection System 2? . . . . . . . . . . . . 1-3

What are the characteristics and features of the PCS2? . . . . . . . . . . . . . 1-3

What are the special features of the PCS2? . . . . . . . . . . . . . . . . . . . . . . 1-4

What is required to perform a procedure?. . . . . . . . . . . . . . . . . . . . . . . 1-4

UNDERSTANDING THE USE OF SYMBOLS. . . . . . . . . . . . . . . . . . . . . . . . 1-5

Symbols found in this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Symbols found on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Symbols found on disposable packaging . . . . . . . . . . . . . . . . . . . . . . . 1-8

LISTING DEVICE SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

P/N 85266-30, Manual revision: A

1-2 Explaining General Information

PROVIDING AN OVERVIEW

What is apheresis technology?

What is the purpose of this manual?

Apheresis is the general term used to describe the separation, selective removal

and collection of one or more of the individual components which together form
whole blood. This term can be subdivided into two categories:

z Cytapheresis: selective removal of one or more of the formed, cellular

components of whole blood. These elements include erythrocytes,
thrombocytes and leukocytes.

z Plasmapheresis: selective removal of plasma, the liquid suspension me-

dium of blood. Plasma contains elements referred to as fractionable
components, such as clotting proteins and immunoglobulins.

Apheresis technology permits:

z The collection and separation of whole blood.

z The selective removal and collection of specific components.

z The subsequent return of the non-selected components to the donor

or patient.

This manual is intended to supply anyone involved in using Haemonetics equip­ment with the essential tool for safe and successful operation – information.
Using this tool of information, the operator can acquire knowledge to be applied
throughout all levels of operating experience. This body of information should be
consulted whenever necessary, starting from the initial contact with Haemonetics
technology to attain:

P/N 85266-30, Manual revision: A

z An awareness of the purpose of the device and the implications of its col-

lection procedures for the donor and the apheresis center.

z An understanding of how to safely operate the Haemonetics system, cor-

rectly install the appropriate disposable material, and troubleshoot any
difficulties.

z An ability to consistently apply the principles behind safe operation,

proper maintenance and correct handling to ensure optimal, quality
apheresis results.

Explaining General Information 1-3

What is the
Haemonetics

Plasma
Collection
System 2?

What are the characteristics and features of the PCS2?

Using updated apheresis technology, Haemonetics has produced the PCS2 - a
compact, lightweight plasmapheresis system which is as easy and safe to use as
it is technologically advanced.

The PCS2 automated apheresis technology provides the operator with a
maximum degree of flexibility in any type of plasmapheresis location. The
plasma collected may be designated for use in therapeutic transfusion. It may also
be conserved, used as source plasma and subsequently fractionated into plasma­derived products.

The PCS2 is appropriately called a Plasma Collection System because it consists
of distinctive parts which collectively function as a whole system to produce a
designated final product:

z The automated plasmapheresis device developed by Haemonetics

called the PCS2.

z The process designed by Haemonetics to gather plasma from a donor

called a collection procedure.

z The single-use collection material manufactured by Haemonetics called

a disposable set.

Once the operator has initiated a PCS2 procedure, plasma collection will
proceed automatically. The appropriate amount of anticoagulant solution will be
mixed in the disposable tubing with whole blood from the donor. 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 plasma component will exit
the bowl and be directed into a plasma collection container for conservation.
Non-selected blood components will be returned to the donor. This cycle will be
repeated until the desired amount of plasma is collected.

The choice of the disposable collection material will depend on the desired
collection product. The PCS2 technology also provides the operator with the
option to infuse saline solution along with the blood components to the donor at
different points of a procedure, depending on the type of disposable bowl in use.

Haemonetics has designed the PCS2 technology with a degree of automation
which permits the operator to interact with the device. The operator should
remain attentive to the display screen messages while monitoring the status of the
donor. It is possible to modify certain aspects of the collection procedures, based
on the needs and requirements of the individual donor and the selected material.

P/N 85266-30, Manual revision: A

1-4 Explaining General Information

What are the special features of the PCS2?

What is required to perform a procedure?

Haemonetics has incorporated advanced technological features into the portable
PCS2 design. Examples of these features, which ensure safety for the donor and
permit efficient time-management for the operator, are:

z Self-loading pumps.

z Advanced optical sensors.

z Donor-line tubing pressure monitor.

z Communication data box or internal data card.

z Barcode reader.

PCS2 collection procedures are quick and simple to perform. The following
material is required to perform a PCS2 procedure:

z A PCS2 disposable set designed for the selected procedure.

z Venipuncture materials and hemostats.

z Appropriate anticoagulant solution.

z 0.9% normal saline (optional).

The operator will need to:

Î Install the appropriate disposable set.

Î Modify any settings if necessary.

Î Perform a single venous puncture, prior to initiating a procedure.

Plasma collection will proceed automatically until the end-collection target has
been reached.

P/N 85266-30, Manual revision: A

Explaining General Information 1-5

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 donor or
the operator.

The descriptions of the following symbols are based on information provided in
the following documents:

z IEC Standard 60601-1, Medical Electrical Equipment,

Part 1: General requirements for safety.

z IEC Standard 60417-1, Graphical symbols for use on equipment,

Part 1: Overview and application.

Type BF applied part

This symbol indicates that the applied portion (i.e. the part which comes in
contact with the donor) of the device is electrically isolated. The device has
an internal electrical power source providing adequate protection against
electrical shock, in particular pertaining to acceptable leakage current and
the reliability of the protective earth connection.

Protective earth (ground)

Used to identify any terminal intended for connection to an external
conductor, for protection against electrical shock in case of a fault.

P/N 85266-30, Manual revision: A

1-6 Explaining General Information

~ 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.

P/N 85266-30, Manual revision: A

Explaining General Information 1-7

The following symbols have been designed for devices manufactured
by Haemonetics:

Bar-code reader connection

RS232 connection

RS232 connection with power to one pin

Pressure cuff connection

P/N 85266-30, Manual revision: A

1-8 Explaining General Information

Symbols found on disposable packaging

The following symbols are used by Haemonetics on disposable set packaging.

REF

LOT

CATALOG NUMBER

EXPIRATION DATE

Lot Number

Sterilized by exposure to Ethylene Oxide

Fluid path STERILE by exposure to Ethylene Oxide

8%

Sterilized by exposure to Gamma irradiation

Fluid path STERILE by exposure to Gamma irradiation

DO NOT REUSE

Caution: consult operator manual for instructions

80%

Storage conditions, humidity level

Storage conditions, temperature level

P/N 85266-30, Manual revision: A

Explaining General Information 1-9

LISTING DEVICE SPECIFICATIONS

The approximate weight and dimensions of the PCS2 device are as follows:

Values

Characteristics

Height 63 cm 44 cm

Width 55 cm

Depth 55 cm 32 cm

Depth with communication box 55 cm 37 cm

Weight 26.4 kg

Weight with communication box 27.4 kg

Cabinet

cover open

Cabinet

cover closed

The following environmental conditions should be respected pertaining to oper­ation and storage of the PCS2 device:

Conditions Values

Ambient operating temperature +18° C to +27° C

Tested storage temperature 0° C to + 40° C

Storage humidity level Maximum relative humidity rate of 90%,

non-condensing

The electrical specifications for operating the PCS2 device are as follows:

Characteristics Values

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

Maximum leakage current 500 µA 100 µA

(relative to input voltage)

Note: Haemonetics will regulate the proper voltage setting upon installation.
The power source used must be properly grounded.

P/N 85266-30, Manual revision: A