Cell Saver 5+ Operation Manual Rev A Oct 2004

Page 1

Working with the

Haemonetics® Cell Saver®5+

Autologous Blood Recovery System

– Operation Manual –

HAEMONETICS®

Printed in France

Haemonetics Corporation

400 Wood Road, Braintree, MA 02184, USA

©1993, 2004, Haemonetics Corporation. All rights reserved.

P/N 53063-30, Manual revision: A

October 2004

Page 3

Preface

IMPORTANT INFORMATION FOR THE CUSTOMER

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

Haemonetics® and Cell Saver® are registered trademarks of 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 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

Corporate Headquarters

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184, USA

Tel. [+1 781] 848 7100

Fax [+1 781] 848 5106

Understanding the purpose of this manual

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. When properly assembled, maintained and operated

properly, the Cell Saver systems can safely and adequately perform various

cell salvaging procedures.

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.

USA Federal Law restricts this device to sale by or on the order of a physician.

P/N 53063-30, Manual revision: A

iii

Page 4

Preface

Contacting Haemonetics worldwide

The operator should consult the following alphabetical list containing all

international branch addresses when contacting the appropriate Haemonetics representative for each locality.

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

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

Tinstraat 107

4823 AA Breda

The Netherlands

Tel. [+31 76] 544 9477

Fax [+31 76] 544 9357

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

iv

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

P/N 53063-30, Manual revision: A

Page 5

Preface

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 53063-30, Manual revision: A

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Page 6

Preface

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.

!

Text preceded by this bullet indicates an item on a list of information

for the operator.

"

Text preceded by this bullet indicates an action for the operator.

Symbols found on the device

!

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 patient) 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.

vi

P/N 53063-30, Manual revision: A

Page 7

Preface

~

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.

Symbol found on the chuck adapter

DO NOT DISCARD

The following symbols have been designed for devices manufactured by

Haemonetics

Bar-code reader connection

RS232 connection with power to one pin

P/N 53063-30, Manual revision: A

vii

Page 8

Preface

Symbols found on disposable packaging

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

Catalog number

REF

Expiration date

Lot number

LOT

STERILE EO

Contents sterile by exposure to ethylene oxide

STERILE EO

Fluid path sterile by exposure to ethylene oxide

STERILE

R

Contents sterile by exposure to gamma irradiation

STERILE

R

Fluid path sterile by exposure to gamma irradiation

Do not reuse

Caution: consult operator manual for instructions

80%

Storage conditions, humidity level

50˚C

Storage conditions, temperature level

8%

-20˚C

viii

P/N 53063-30, Manual revision: A

Page 9

Preface

Fragile, handle with care

Bowl symbol chart

During a procedure, the bowl icon on screen reflects the bowl size currently

in use. See below for bowl sizes and corresponding icons.

70 mL bowl

125 mL bowl

125

225 mL bowl

225

P/N 53063-30, Manual revision: A

ix

Page 12

Table of Contents

Centrifuge well . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fluid detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Optical bowl sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Effluent line sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Waste bag weigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reservoir level sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PRESENTING THE DISPOSABLE SET ELEMENTS . . . . . . . . . . . . . . . . . . . . . .

Harness tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Receptacles and collection containers . . . . . . . . . . . . . . . . . . . . .

Centrifuge bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Describing the operation of the bowl . . . . . . . . . . . . . . . . . . . . . .

Chapter Three

2-12

2-12

2-12

2-13

2-13

2-13

2-14

2-14

2-15

2-16

2-17

Ensuring Safe Operation and Patient Care

UNDERSTANDING SAFE OPERATING PRACTICES . . . . . . . . . . . . . . . . . . . . .

Correctly storing and handling disposable material . . . . . . . . . . . .

Avoiding electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . .

Working with rotating machinery. . . . . . . . . . . . . . . . . . . . . . . . . .

Power outlet connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Warning about communicable diseases . . . . . . . . . . . . . . . . . . . . .

PREVENTING PROBLEMS DURING A CELL SAVER 5+ PROCEDURE . . . . . . . . .

Avoiding the consequences of flow restriction . . . . . . . . . . . . . . . .

Understanding the risk of hemolysis. . . . . . . . . . . . . . . . . . . . . . . .

Inspecting for twists and kinks in the tubing . . . . . . . . . . . . . . . . . .

Avoiding bowl misalignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Controlling for overheating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Avoiding red blood cell spillage. . . . . . . . . . . . . . . . . . . . . . . . . . .

Managing the inventory of air . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PROVIDING SAFE PATIENT CARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reinfusing blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Replacing depleted clotting factors . . . . . . . . . . . . . . . . . . . . . . . .

Contraindications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

FACTORS AFFECTING PROCESSING TIME. . . . . . . . . . . . . . . . . . . . . . . . . . .

Cell Saving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sequestering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter Four

Preparing for a Cell Saver 5+ Procedure

UNDERSTANDING GENERAL SYSTEM OPERATION . . . . . . . . . . . . . . . . . . . .

Collecting blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Filling the centrifuge bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Separating and packing the cells in the bowl . . . . . . . . . . . . . . . . .

Washing the red blood cells. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Washing partial bowls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Emptying the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

xii

3-2

3-2

3-2

3-3

3-3

3-3

3-4

3-4

3-4

3-5

3-5

3-5

3-6

3-6

3-7

3-7

3-7

3-7

3-8

3-8

3-8

4-2

4-2

4-2

4-2

4-3

4-3

4-3

P/N 53063-30, Manual revision: A

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Table of Contents

INITIATING A CELL SAVER 5+ PROCEDURE . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Explaining the power on procedure . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Explaining the bowl type confirmation message . . . . . . . . . . . . . . . 4-7

INSTALLING A CELL SAVER DISPOSABLE SET . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Preparing the collection system . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Preparing the device and disposable set . . . . . . . . . . . . . . . . . . . . . 4-9

Installing the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Installing the tubing harness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Installing the line sensor tubing . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Hanging the bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Connecting the reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14

Setting up the saline solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Inspecting the installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Entering the STANDBY state . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

Chapter Five

Cell Saving using Automatic Operation

PERFORMING A PROCEDURE IN THE AUTOMATIC MODE . . . . . . . . . . . . . 5-2

Explaining the STANDBY state. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Filling the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Washing the cells. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Emptying the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Monitoring the waste bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

Reinfusing processed blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Explaining the air sensor detection messages . . . . . . . . . . . . . . . . . 5-8

Explaining the recentrifugation delay . . . . . . . . . . . . . . . . . . . . . . . 5-8

DESCRIBING ADDITIONAL AUTO MODE FUNCTIONS . . . . . . . . . . . . . . . . . 5-10

Using the EMERGENCY mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Explaining the CONCENTRATE state option . . . . . . . . . . . . . . . . 5-11

Modifying certain processing parameters . . . . . . . . . . . . . . . . . . . 5-12

Automatic saving of modified parameters . . . . . . . . . . . . . . . . . . 5-13

Pump RBCs to (RETURN) option . . . . . . . . . . . . . . . . . . . . . . . . . 5-14

Minimum Wash Volume option. . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

NO WASH option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16

Reservoir Level and Resume at Level options . . . . . . . . . . . . . . . . 5-17

Level Sensor option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

Speed regulation option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17

VIEWING THE CELL SAVER 5+ SYSTEM STATUS . . . . . . . . . . . . . . . . . . . . . 5-19

Wash volume monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

Volume accounting function . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

SUMMARIZING SETTING VARIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

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Table of Contents

Chapter Six

Cell Saving using Manual Operation

PERFORMING A PROCEDURE IN THE MANUAL MODE . . . . . . . . . . . . . . . . 6-2

Explaining the manual control keys . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Selecting manual operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Modifying preset processing parameters. . . . . . . . . . . . . . . . . . . . . 6-4

Explaining the recentrifugation delay . . . . . . . . . . . . . . . . . . . . . . . 6-5

Collecting fluid in the reservoir . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Filling the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Using the CONCENTRATE state. . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Washing the cells. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Emptying the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Reentering the STANDBY state . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

SUMMARIZING PARAMETER VARIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Chapter Seven

Sequestering using the Cell Saver 5+ System

PRESENTING THE CELL SAVER 5+ SEQUESTERING PROTOCOL . . . . . . . . . . . . 7-2

Describing method of sequestering . . . . . . . . . . . . . . . . . . . . . . . . 7-2

INITIATING A SEQUESTERING PROCEDURE . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Selecting the sequestering protocol . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Setting the processing parameters . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

PROCESSING FROM BLOOD BAGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Filling the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6

Emptying the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Transferring the RBCs for reinfusion . . . . . . . . . . . . . . . . . . . . . . . . 7-8

COMPLETING THE SEQUESTERING PROCEDURE . . . . . . . . . . . . . . . . . . . . . 7-10

Removing the plasma product . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10

Removing the sequestering disposable set . . . . . . . . . . . . . . . . . . 7-10

Selecting the cell saving protocol. . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Chapter Eight

Using Data Acquisition Features

PROVIDING AN OVERVIEW OF THE FEATURES . . . . . . . . . . . . . . . . . . . . . . .

Listing the recorded parameters . . . . . . . . . . . . . . . . . . . . . . . . . . .

Explaining the output devices . . . . . . . . . . . . . . . . . . . . . . . . . . . .

EXPLAINING ON-LINE DATA ACQUISITION FEATURES . . . . . . . . . . . . . . . . . .

Viewing the current procedure data . . . . . . . . . . . . . . . . . . . . . . . .

Transferring procedure data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Optionally entering certain data. . . . . . . . . . . . . . . . . . . . . . . . . . .

xiv

8-2

8-2

8-3

8-4

8-4

8-5

8-6

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Table of Contents

EXPLAINING OFF-LINE DATA ACQUISITION FEATURES . . . . . . . . . . . . . . . . . 8-7

Accessing off-line data acquisition . . . . . . . . . . . . . . . . . . . . . . . . . 8-7

Working with the Transfer Data function . . . . . . . . . . . . . . . . . . . . 8-9

Working with the View Data function . . . . . . . . . . . . . . . . . . . . . 8-10

Working with the Set Time function . . . . . . . . . . . . . . . . . . . . . . . 8-11

Working with the Clear Data function . . . . . . . . . . . . . . . . . . . . . 8-12

LISTING DATA OUTPUT DEVICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13

Chapter Nine

Maintaining the Cell Saver 5+ Device

PROVIDING AN OVERVIEW OF NORMAL MAINTENANCE. . . . . . . . . . . . . . . .

DESCRIBING SPECIFIC CLEANING PROCEDURES . . . . . . . . . . . . . . . . . . . . . .

Cleaning the optical lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cleaning the centrifuge well . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cleaning the fluid detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cleaning the blood pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cleaning after a spill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Washing the air filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PROVIDING CUSTOMER SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Field service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Installation and clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . .

Returned goods authorization system . . . . . . . . . . . . . . . . . . . . . . .

Appendix A

9-2

9-3

9-3

9-3

9-3

9-3

9-4

9-4

9-5

9-5

9-5

9-5

Providing Reference Information

COMPLICATIONS OF AND CONTRAINDICATIONS TO PERIOPERATIVE

BLOOD RECOVERY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

DESCRIBING CELL SAVER 5+ ERROR CODES . . . . . . . . . . . . . . . . . . . . . . . . A-7

PRESENTING THE CS5+ COMPATIBLE PRINTER . . . . . . . . . . . . . . . . . . . . . A-11

Non-thermal printer overview . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11

Changing the paper roll during a printing procedure . . . . . . . . . . A-11

Ribbon installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12

Ordering references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-12

EXPLAINING IEC 60601-1-2:2001 STANDARD REQUIREMENTS . . . . . . . . . A-13

Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13

P/N 53063-30, Manual revision: A

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Chapter One

Presenting the Cell Saver 5+ System

INTRODUCING THE CELL SAVER 5+ SYSTEM . . . . . . . . . . . . . . . . . . . . . . . 1-3

Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Contraindications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

EXPLAINING AUTOLOGOUS BLOOD TRANSFUSION . . . . . . . . . . . . . . . . . . . 1-5

Autologous versus homologous transfusion . . . . . . . . . . . . . . . . . . 1-5

Cell Saver systems and autologous transfusion . . . . . . . . . . . . . . . . 1-5

Historical overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Haemonetics Cell Saver systems . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

PRESENTING SPECIAL CELL SAVER 5+ FEATURES . . . . . . . . . . . . . . . . . . . . . 1-8

Automated operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Computer guided setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Final blood product quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Performance readouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Data acquisition tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Emergency mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

LISTING THE CELL SAVER 5+ SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . 1-10

Fluid management systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Processing speeds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Maneuverability and portability . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

ORDERING CELL SAVER 5+ DISPOSABLE SETS. . . . . . . . . . . . . . . . . . . . . . 1-13

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

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Page 18

Presenting the Cell Saver 5+ System

Figure 1-1, The Haemonetics Cell Saver 5+

1-2

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Page 19

Presenting the Cell Saver 5+ System

INTRODUCING THE CELL SAVER 5+ SYSTEM

The Haemonetics Cell Saver 5+ Autologous Blood Recovery System (CS5+)

represents the fifth generation since the introduction of the first successful

autologous blood collection system, the original Cell Saver 1 System.

Using the latest microprocessor technology, the Cell Saver 5+ system

delivers a high level of automation in the processing of autologous blood.

Operator interaction and surveillance are minimized by the use of a sensor

which automatically detects the level of fluid in the reservoir and initiates

device operation. Processing time has also been reduced while maintaining

the highest quality end product.

The Haemonetics Cell Saver 5+ system and its related accessory devices are

intended to be used for the recovery of blood shed during or after an operation, or as the result of trauma. The shed blood is collected in a sterile reservoir, then processed by the Cell Saver system in a centrifuge bowl to pack

red blood cells (RBCs), then washed to remove cell stroma, platelets, activated clotting factors, extracellular potassium, free hemoglobin, anticoagulant, and cardioplegia.

The washed, packed RBCs may then be pumped to a bag for gravity reinfusion to the patient, or, to the arterial line of an extracorporeal circuit for reinfusion to the patient

Indications for use

The CS5+ system should be considered for a procedure when it is anticipated that blood will be shed from a clean wound and retrieved at a rate

permitting aspiration without undue hemolysis. The presence of any of the

following criteria may be an indication for blood salvage:

!

Anticipated blood loss is 15% or more of the patient’s estimated

blood volume.

!

Blood would ordinarily be crossmatched.

!

More than 10% of the patients undergoing the type of procedure

require transfusion.

!

The mean transfusion rate for the type procedure exceeds one unit.

Specific types of surgery for which the technique is especially useful

include:

!

Open heart and vascular surgery.

!

Total joint replacements and spinal surgery.

!

Liver transplantation.

!

Ruptured ectopic pregnancy.

!

Selected neurosurgical procedures.

Post-operative salvage is employed most often following cardiac and certain

types of orthopedic procedures 1.

P/N 53063-30, Manual revision: A

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Page 20

Presenting the Cell Saver 5+ System

A disposable bowl called the 70mL Bowl has been designed specifically for

low volume peri-operative cell salvage. This new step in cell saving is very

well adapted for every type of low volume blood loss situation, including

peri-operative pediatric cell salvage and post-operative orthopedic cell

salvage. Use of this bowl will allow blood to be available earlier for reinfusion to the patient.

The Haemonetics Cell Saver 5+ system may also be used for pre-operative

plasma sequestration.

Contraindications for use

The risk/benefit ratio of blood salvage must be determined on an individual

basis by the surgeons, anaesthetists and transfusion medicine specialists

involved in the patient care. The Appendix A provides a list of recommended contraindications.

Warning: The use of reinfused blood from the Cell Saver 5+ system may be

contraindicated, for example, in the case of sepsis or malignancy. The

responsibility for the use of this device belongs solely to the physician in

charge.

1-4

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Page 21

Presenting the Cell Saver 5+ System

EXPLAINING AUTOLOGOUS BLOOD TRANSFUSION

Autologous blood is now widely accepted as the first choice for transfusion,

whenever possible. The term autologous blood refers to blood which is

derived from one individual. An autologous blood transfusion can be

defined as a procedure in which a patient receives his or her own blood. The

blood may have been collected earlier or salvaged from shed blood intraoperatively or postoperatively.

Homologous blood is blood of the same type, donated or derived from

sources other than the patient who is receiving the transfusion.

Autologous versus homologous transfusion

The advantages of autologous transfusion are well documented. The major

advantages are as follows:

!

No risk of disease transmission.

!

No transfusion reactions.

!

Requires minimal compatibility testing.

!

Reduces demand on blood bank inventory.

Cell Saver systems and autologous transfusion

In addition to the general benefits of autologous transfusion, the Cell Saver

systems provide the following benefits:

!

Portability.

!

Rapid setup.

!

Rapid return of patient’s own cells.

!

Reduction of net blood loss.

!

Removal of red cell stroma.

!

Removal of plasma-free hemoglobin.

!

Removal of anticoagulant solution.

!

Removal of activated clotting factors.

!

Removal of extracellular potassium.

!

Cost-effectiveness.

!

General acceptance by Jehovah’s witnesses.

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Presenting the Cell Saver 5+ System

Historical overview

The following paragraphs summarize the history of transfusion methods.

Early experiments with transfusion

Some of the earliest recorded attempts at transfusion were undertaken by a

French physician, Jean Denys, who in the 1660’s performed transfusions

between animals and humans with predictably disastrous results 2.

Quite reasonably, the French government stepped in and forbade the transfusion of blood except with the permission of a member of the Faculty of

Medicine of Paris (which was strongly opposed to the practice). Rumors of

Denys’ experiments and his results were circulated throughout Europe, and

fear of such practices spread to other countries.

In 1818 an English surgeon, James Blundell, reported on a human-to-human

transfusion which he had performed (though unsuccessfully).

Blundell later did perform successful transfusions, and his are the first

recorded successes 3.

More importantly, Blundell’s attempts were relatively scientific and he

recorded a great deal of useful information on transfusion. He also noted

that the donation of a small quantity of blood produced no harmful effects

on the donor 4.

First recorded uses of autologous transfusion

In the late 1800’s, an English surgeon named James Highmore proposed the

use of autotransfusion (another term used for autologous transfusion) and

suggested that a patient’s own shed blood was an overlooked source which

could be used to great advantage. His article which appeared in The Lancet

in 1874, advocated intra-operative autotransfusion, specifically in the case

of post-partum hemorrhage 5. Highmore later recorded his successful use of

autotransfusion in a variety of cases 6.

The use and acceptance of homologous blood

In the early 1900’s, techniques for typing and matching blood were developed. Homologous transfusions gradually became accepted, though the

general method remained the transfusion of blood directly from donor to

recipient, rather than the use banked blood.

The first blood bank was established at Cook County Hospital, Chicago on

March 15, 1937. However, the real rise of homologous transfusions came

during World War II 7. There was a great need for blood during the war, as

would be expected, and the donor pool in the United States grew enormously to meet this need. Using banked blood was quite simply the easiest

alternative and homologous transfusions became the norm.

1-6

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Presenting the Cell Saver 5+ System

Naturally, doctors returning from the war continued to rely on donor blood,

although several factors were developing which would make this less and

less practical. The Korean and Vietnam wars which followed World War II

placed the usual high demands on the donor pool. Concurrently, other large

demands were being placed on the donor pools by the development and

refinement of sophisticated surgical procedures such as open heart surgery.

The shortages of donor blood during the Vietnam War revived interest in

autotransfusion. In Vietnam, an American military surgeon named Klebanoff

began using the open heart pump to capture, anticoagulate, filter, and reinfuse the blood lost in surgery 8.

Klebanoff’s device was introduced commercially in the 1970’s by Bentley

Laboratories. The device was effective though unsophisticated, as blood was

simply anticoagulated, filtered, and reinfused. The Bentley device was the

first attempt to modernize autologous blood recovery in decades.

Haemonetics Cell Saver systems

Haemonetics Cell Saver systems are aptly named since the primary purpose

is the recovery of red blood cells (RBCs). The RBCs are recovered shed

blood which in the past was simply discarded after an operation. Cell Saver

systems trap and wash the RBCs, removing unwanted components, then

pack the RBCs and return them to a transfer container for reinfusion.

The first Haemonetics Cell Saver system was released in 1975. With each

generation of the Cell Saver systems, Haemonetics has improved performance and increased automation. Haemonetics offers a variety of Cell Saver

systems to be used for a wide range of surgical procedures.

P/N 53063-30, Manual revision: A

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Page 24

Presenting the Cell Saver 5+ System

PRESENTING SPECIAL CELL SAVER 5+ FEATURES

The CS5+ model improves upon the design and performance of its predecessors by processing shed blood faster without compromising the quality of

the end product (packed RBCs). Haemonetics has improved and streamlined

the features and functions of earlier units to meet the demands and needs of

the modern operating room. An onboard computer (microprocessor) uses

data from a variety of sensors to control the processing of blood, allowing an

unprecedented level of automation.

Automated operation

Through the use of an effluent line sensor, the CS5+ device determines the

optimal processing parameters by procedure. These parameters have been

thoroughly tested and carefully calculated to produce consistently optimal

results under most operating conditions. Although it is possible to reprogram

the parameters, changes should be carefully considered.

An optical RBC sensor in the centrifuge well, an ultrasonic air detector on

the tubing line and an optical effluent line sensor provide information to the

CS5+ microprocessor which then regulates the cycles of the device based

on this information.

The ultrasonic air detector monitors the flow in the tubing. When air in the

pump tubing is detected, the pump is stopped, the appropriate tubing is

clamped and a message is sent to the display. The centrifuge well optical

sensor monitors the red blood cell level in the bowl. This sensor initiates

tripping to the WASH state when the RBC level indicates a high hematocrit.

The effluent line sensor monitors the quality of the effluent blood as it leaves

the bowl. As a result of these readings, the system could initiate one of the

following actions:

!

Determining when the RBCs are adequately washed.

!

Slowing the pump rate in the WASH state if RBC spillage is detected.

Computer guided setup

The on-board microprocessor guides the operator in setting up the system

through a list of installation instructions. For assistance in setting up the

CS5+ system, the operator can use the Help key on the control panel (as

described in Chapter Four) to receive a list of instructions as follows:

1-8

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Presenting the Cell Saver 5+ System

HELP

1.

2.

3.

4.

5.

6.

7.

Prepare the Collection

Ready the machine and bowl disposable

Install the bowl

Hang the bags

Install the tubing harness

Set up the saline

Inspect and Finish

Press START to resume

Figure 1-2, Help display installation instructions

Operators with multiple responsibilities involving frequent interruptions find

the setup instructions useful as a checklist. If called away to attend to

another duty, the operator can leave the setup instructions as a reminder,

then return to the instruction list and continue from that point.

Final blood product quality

The final blood product of the CS5+ standard volume (225 ml) bowl consists

of red blood cells suspended in saline with a hematocrit of at least 50%.

Performance readouts

The right side of the display panel provides information relative to CS5+

operation which is constantly updated. System status is available at a glance.

Data acquisition tools

The CS5+ device provides helpful data acquisition tools designed to provide

efficient support for quality assurance in anesthesiology.

Emergency mode

The CS5+ device provides easy and quick access to an emergency protocol

to allow high speed blood processing (800 ml/min) while continuing with

automatic operation in high blood loss procedures.

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Presenting the Cell Saver 5+ System

LISTING THE CELL SAVER 5+ SPECIFICATIONS

The CS5+ device is destined for continuous operation.

Caution: The CS5+ equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with nitrous oxide.

The dimensions and weight of the CS5+ device are as follows:

Characteristics

Depth (cm)

Height (cm)

Width (cm)

Pole extended

37

189

41

Pole retracted

37

86

41

Pole extended

58.5

230

48

Pole retracted

58.5

127

48

Device alone

Device with cart

Weight of the device: 34.0 kg

Weight of the cart: 20.4 kg

The following environmental conditions should be respected pertaining to

operation, transport and storage of the CS5+ device:

Conditions

Values

Ambient operating temperature

10° C to 27° C

(50° F to 80° F)

Storage temperature

–20° C to 50° C

Storage humidity level

Maximum relative humidity

rate of 90%, non-condensing

The electrical specifications for operating the CS5+ device are as follows:

Characteristics

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

1-10

Values

(relative to input voltage)

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Presenting the Cell Saver 5+ System

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

Caution: The Cell Saver 5+ device must be operated in an environment

compatible to the requirements of the IEC 60601-1-2:2001 Standard, Electromagnetic compatibility.

Mobile RF communication equipment not approved by Haemonetics and

portable communication equipment can affect the Cell Saver 5+ 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 Cell Saver 5+ device and accessories must not be placed

directly adjacent to, or top of other equipment, unless specifically approved

by Haemonetics.

Fluid management systems

The device is equipped with a pole for hanging the saline solution, reservoir,

reinfusion bag, anticoagulant solution and transfer packs. The pole may be

raised and lowered by loosening the lower knob. The top portion can be

extended by releasing the upper knob. The movable pole hooks are used for

hanging the saline and reinfusion bags.

The waste bag weigher provides three hooks on the front of the device for

hanging and monitoring the level in the waste bag.

Processing speeds

!

Typical processing time: 5 minutes.

!

Centrifuge speed:

!

P/N 53063-30, Manual revision: A

!

For the Latham bowls: 5650 rpm, programmable from 2050 rpm

to 5650 rpm in 100 rpm increments.

!

For the 70mL Bowl: 7000 rpm, programmable from 2050 rpm to

7000 rpm in 100 rpm increments.

Pump speed:

!

For the Latham bowls: programmable from 25 to 1000 ml/min in

25 ml/min increments.

!

For the 70mL Bowl: programmable from 25 to 300 ml/min in 25 ml/

min increments.

!

May be temporarily reset with Pump Control arrow keys.

1-11

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Presenting the Cell Saver 5+ System

Maneuverability and portability

The CS5+ device is provided with a cart which has four caster wheels to

ensure maneuverability. The unit may be tipped back on the rear wheels to

roll over power cords, door sills, and other obstructions. The front two

casters may be locked to secure the CS5+ cart in position. The device can be

removed from the cart for easy transport in cars and vans.

Note: The following description is for an operator facing the rear of the cart.

!

To remove the device from the cart, depress the release button

located to the right of the latch, as illustrated in Figure 1-3. A handle

will pivot outward from the left side of the latch. Pull on the handle to

ensure that the lock is completely disengaged. Lift the device off of

the cart.

!

To replace the device on the cart, depress the release button located

to the right of the latch. If necessary, pull on this handle until it is in

the fully open position. Replace the device on the cart and push the

latch handle toward the device until it locks into place.

Figure 1-3, The Cell Saver 5+ cart

Construction

1-12

!

Cabinet and cart materials: fabricated sheet metal and cast aluminum.

!

Control panel: membrane switch technology, environmentally sealed

with backlit option keys.

P/N 53063-30, Manual revision: A