PCS2 Operation Manual Rev A April 2002

Preface

iii

CONSUMER INFORMATION Proprietary rights

The contents of this manual are property of the Haemonetics Corporation. Haemonetics® and PCS®2 are registered trademarks of the 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 Haemonetics S.A. Signy Center, P.O. Box 262 CH-1274 Signy 2 Switzerland Tel. +41-22-363-9011 Fax +41-22-363-9054

Legal disclaimer

Corporate Headquarters Haemonetics Corporation 400 Wood Road Braintree, MA, 02184, USA Tel. +1-781-848-7100 Fax +1-781-356-3558

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.

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Haemonetics worldwide locations

Preface

Haemonetics Asia Inc. Taiwan Branch 26F-1, No. 102 Roosevelt Road Sec. 2 Taipei, Taiwan Tel. +886-2-2369-0722 Fax +886-2-2364-3698

Haemonetics France S.A.R.L. 46 bis, rue Pierre Curie Z.I. Les Gatines F-78370 Plaisir, France Tel. +33-1-30-81-4141 Fax +33-1-30-81-4130

Haemonetics GesmbH Handelsges.m.b.H. Berlagasse 45/B2-02 A-1210 Wien, Austria Tel. +43-1-294-29-00 Fax +43-1-294-29-05

Haemonetics GmbH Rohrauerstrasse 72 D-81477 München, Germany Tel. +49-89-785-8070 Fax +49-89-780-9779

Haemonetics Belgium NV Leuvensesteenweg 542-BP. 14 Planet II Complex B-1930 Zaventem, Belgium Tel. +32-2-720-7484 Fax +32-2-720-7155 Haemonetics BV C/O CITCO - WTC, PB 7241 Strawinskylaan 1725 1007 JE 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. +86-21-506-63366 Fax +86-21-684-13688 Haemonetics CZ, spol. S.r.o Ptašínského C.8 60200 Brno, Czech Republic Tel. +42-05-412-122400 Fax +42-05-412-122399

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Haemonetics Hong Kong Ltd. Suite 1314, Two Pacific Place 88 Queensway, Hong Kong Tel. +852-286-89218 Fax +852-280-14380 Haemonetics Italia S.R.L. Via Donizetti, 30 20020 Lainate (MI), Italy Tel. +39-2-935-70113 Fax +39-2-935-72132 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 S-223 70 Lund, Sweden Tel. +46-46-286-2320 Fax +46-46-286-2321

Preface

v

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 S.A. Signy Centre P.O. Box 262 CH-1274 Signy 2, Switzerland Tel. +41-22-363- 9011 Fax +41-22-363- 9054

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

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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

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1-2

Explaining General Information

PROVIDING AN OVERVIEW What is apheresis technology?

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

Apheresis technology permits:

What is the purpose of this manual?

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: z

An awareness of the purpose of the device and the implications of its collection procedures for the donor and the apheresis center.

z

An understanding of how to safely operate the Haemonetics system, correctly 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.

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Explaining General Information

1-3

What is the Haemonetics Plasma Collection System 2?

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.

What are the characteristics and features of the PCS2?

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:

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.

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.

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What are the special features of the PCS2?

What is required to perform a procedure?

Explaining General Information

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.

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Explaining General Information

1-5

UNDERSTANDING THE USE OF SYMBOLS Symbols found in this document

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.

Symbols found on the device

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.

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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.

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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

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Symbols found on disposable packaging

Explaining General Information

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

CATALOG NUMBER

REF

EXPIRATION DATE

LOT

Lot Number

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

80%

Storage conditions, humidity level 8%

Storage conditions, temperature level

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Explaining General Information

1-9

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

Characteristics

Values Cabinet cover open

Cabinet cover closed

63 cm

44 cm

Height 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

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 Input voltage

Values (relative to input voltage) 230 VAC ± 10%

110 VAC ± 10%

~1.9 A

~ 2.6 A

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

Operating current Fuse rating

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

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Explaining General Information

Caution: The PCS2 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 PCS2 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 PCS2 device and accessories must not be placed directly adjacent to, or top of other equipment, unless specifically approved by Haemonetics.

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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 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

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Describing the PCS2 Device Components

A. Cabinet 1. Centrifuge 2. Line sensor 3. Weigher 4. Anticoagulant (AC) pump 5. Blood pump 6. Donor valve (red) 7. Plasma valve (yellow) 8. Saline valve (white) 9. Donor flow lights (x2) 10. Anticoagulant line air detector (ACAD) 11. Blood line air detector (BLAD) 12. Donor line air detector 1 (DLAD1) 13. Donor line air detector 2 (DLAD2) 14. Blood filter holder 15. AC solution pole 16. Saline solution pole 17. Donor pressure monitor (DPM) 18. System pressure monitor (SPM)

B 19

15

20 22

21 5

4

10 13.

24

9

11

1

17 6

16

3

2 9 7

12

8

18

14 B. Control Panel 19. Display screen 20. Mode control keys 21. Protocol key 22. Pump control keys 23. Programming keys 24. Cuff key 25. Valve control keys

13

A

Figure 2-1, PCS2 device components

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23

Describing the PCS2 Device Components

2-3

PRESENTING THE PCS2 DEVICE COMPONENTS The components of the PCS2 device will be presented in this chapter according to where they are located on the device:

1. Centrifuge system 2. Line sensor 3. Weigher 4. AC pump 5. AC pump tubing guide 6. Blood pump 7. Blood pump tubing guide 8. Donor valve (red) 9. Plasma valve (yellow) 10. Saline valve (white) 11. Donor flow lights (x2) 12. ACAD (Anticoagulant air detector). 13. BLAD (Blood line air detector). 14. DPM (Donor pressure monitor). 15. SPM (System pressure monitor). 16. DLAD X 2 (Donor line air detectors). 17. Blood filter brackets 18. Tubing guide 19. AC solution pole 20. Saline solution pole

z

The centrifuge system.

z

The cabinet components.

z

The control panel.

12 12

19

4

5

6

20

1

7 13 2

11

18

11 15

14 8 16

3

9

10

17

Figure 2-2, PCS2 top deck view The disposable set elements will be explained in greater detail in the chapter “Describing the PCS2 Disposable Collection Material”. As an explanation for the references made to the disposable tubing in this chapter: Donor-line tubing refers to the tubing which is either: z

Transporting blood away from the donor before entering the bowl.

z

Transporting blood from the bowl before return to the donor.

Effluent tubing refers to the tubing exiting the bowl in the direction of the plasma collection container.

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Describing the PCS2 Device Components

DESCRIBING THE CENTRIFUGE SYSTEM The centrifuge system of the PCS2 device is designed to hold a disposable bowl in which the blood components can be spun from a range of 3000 to 8000 revolutions per minute. This centrifugal force will separate anticoagulated whole blood into its various components. The PCS2 centrifuge system consists of:

1. 2. 3. 4. 5. 6. 7.

z

A system-sealing mechanism.

z

The centrifuge well.

z

The centrifuge base.

Split hinged lid Fluid detector Optical bowl sensor Locking knob Centrifuge well Centrifuge chuck Centrifuge base

1 1

2 4

3

6 5

7

Figure 2-3, PCS2 centrifuge system components

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