Haemonetics Cell Saver 5+ User manual

HAEMONETICS®
Working with the
Haemonetics®Cell Saver®5+
Autologous Blood Recovery System
– Operation Manual –
Printed in France
Haemonetics Corporation
400 Wood Road, Braintree, MA 02184, USA P/N 53063-30, Manual revision: B
©1993-2005, Haemonetics Corporation. All rights reserved. January 2005


P/N 53063-30, Manual revision: B iii
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 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
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 main-
tain Haemonetics produced equipment. The manual is to be used in
conjunction with instruction and training as supplied by qualified Haemon-
etics 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 oper-
ator 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 Haemon-
etics Clinical Specialist.
Safe utilization of Haemonetics material and equipment requires the oper-
ator to correctly handle and dispose of blood-contaminated material. The
operator of any Haemonetics equipment must fully understand and imple-
ment 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 proce-
dures, prior to further application or use. Haemonetics declines any respon-
sibility 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 physi-
cian.

P/N 53063-30, Manual revision: B
iv
Preface
Contacting Haemonetics worldwide
The operator should consult the following alphabetical list containing all
international branch addresses when contacting the appropriate Haemon-
etics 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
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: B v
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 . B o x 2 6 2
1274 Signy 2, Switzerland
Tel. [+41 22] 363 90 11
Fax [+41 22] 363 90 54

P/N 53063-30, Manual revision: B
vi
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 tech-
nique when using Haemonetics material.
Caution: Advises the operator against initiating an action or creating a situa-
tion 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 sit-
uation 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 electri-
cal shock, in particular pertaining to acceptable leakage
current and the reliability of the protective earth connec-
tion.
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 53063-30, Manual revision: B vii
Preface
Alternating current
Used to indicate on the rating plate that the device is suit-
able 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.
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 appli-
cable 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: B
viii
Preface
Symbols found on disposable packaging
The following symbols are used by Haemonetics on disposable set pack-
aging.
Catalog number
Expiration date
Lot number
Contents sterile by exposure to ethylene oxide
Fluid path sterile by exposure to ethylene oxide
Contents sterile by exposure to gamma irradiation
Fluid path sterile by exposure to gamma irradiation
Do not reuse
Caution: consult operator manual for instructions
Storage conditions, humidity level
Storage conditions, temperature level
REF
LOT
STERILE EO
EO
STERILE
STERILE R
STERILE R
80%
8%
50˚C
-20˚C

P/N 53063-30, Manual revision: B ix
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
225 mL bowl
!"#
""#


P/N 53063-30, Manual revision: B xi
Table of contents
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
Chapter Two Describing the Cell Saver 5+ System
Components
PRESENTING THE CELL SAVER 5+ SYSTEM COMPONENTS . . . . . . . . . . . . . . . 2-3
Power switch and power entry module . . . . . . . . . . . . . . . . . . . . . 2-3
DESCRIBING THE CELL SAVER 5+ CONTROL PANEL. . . . . . . . . . . . . . . . . . . 2-4
Display screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
DESCRIBING THE CELL SAVER 5+ HARDWARE ELEMENTS . . . . . . . . . . . . . . 2-10
Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Air detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Clamped line sensor (blue line sensor) . . . . . . . . . . . . . . . . . . . . . 2-11

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Table of Contents
Centrifuge well . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Fluid detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Optical bowl sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Effluent line sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Waste bag weigher . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Reservoir level sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
PRESENTING THE DISPOSABLE SET ELEMENTS . . . . . . . . . . . . . . . . . . . . . . 2-14
Harness tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Receptacles and collection containers . . . . . . . . . . . . . . . . . . . . . 2-15
Centrifuge bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Describing the operation of the bowl . . . . . . . . . . . . . . . . . . . . . . 2-17
Chapter Three Ensuring Safe Operation and Patient Care
UNDERSTANDING SAFE OPERATING PRACTICES . . . . . . . . . . . . . . . . . . . . . 3-2
Correctly storing and handling disposable material . . . . . . . . . . . . 3-2
Avoiding electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Working with rotating machinery. . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Power outlet connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Warning about communicable diseases . . . . . . . . . . . . . . . . . . . . . 3-3
PREVENTING PROBLEMS DURING ACELL SAVER 5+ PROCEDURE . . . . . . . . . 3-4
Avoiding the consequences of flow restriction . . . . . . . . . . . . . . . . 3-4
Understanding the risk of hemolysis. . . . . . . . . . . . . . . . . . . . . . . . 3-4
Inspecting for twists and kinks in the tubing . . . . . . . . . . . . . . . . . . 3-5
Avoiding bowl misalignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Controlling for overheating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Avoiding red blood cell spillage. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Managing the inventory of air . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
PROVIDING SAFE PATIENT CARE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Reinfusing blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Replacing depleted clotting factors . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Contraindications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
FACTORS AFFECTING PROCESSING TIME. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Cell Saving. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Sequestering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Chapter Four Preparing for a Cell Saver 5+ Procedure
UNDERSTANDING GENERAL SYSTEM OPERATION . . . . . . . . . . . . . . . . . . . . 4-2
Collecting blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Filling the centrifuge bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Separating and packing the cells in the bowl . . . . . . . . . . . . . . . . . 4-2
Washing the red blood cells. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Washing partial bowls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Emptying the bowl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

P/N 53063-30, Manual revision: B xiii
Table of Contents
INITIATING ACELL SAVER 5+ PROCEDURE . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Explaining the power on procedure . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Explaining the bowl type confirmation message. . . . . . . . . . . . . . . 4-7
INSTALLING ACELL 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 APROCEDURE 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
AutoCycle option. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Speed regulation option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
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 APROCEDURE 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 ASEQUESTERING 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. . . . . . . . . . . . . . . . . . . . . . . 8-2
Listing the recorded parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Explaining the output devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
EXPLAINING ON-LINE DATA ACQUISITION FEATURES . . . . . . . . . . . . . . . . . . 8-4
Viewing the current procedure data . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Transferring procedure data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Optionally entering certain data. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

P/N 53063-30, Manual revision: B xv
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. . . . . . . . . . . . . . . . 9-2
DESCRIBING SPECIFIC CLEANING PROCEDURES . . . . . . . . . . . . . . . . . . . . . . 9-3
Cleaning the optical lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Cleaning the centrifuge well . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Cleaning the fluid detectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Cleaning the blood pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Cleaning after a spill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Washing the air filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
PROVIDING CUSTOMER SERVICE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Field service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Installation and clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Returned goods authorization system. . . . . . . . . . . . . . . . . . . . . . . 9-5
Appendix A 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: B 1-1
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

P/N 53063-30, Manual revision: B
1-2
Presenting the Cell Saver 5+ System
Figure 1-1, The Haemonetics Cell Saver 5+

P/N 53063-30, Manual revision: B 1-3
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 opera-
tion, or as the result of trauma. The shed blood is collected in a sterile reser-
voir, then processed by the Cell Saver system in a centrifuge bowl to pack
red blood cells (RBCs), then washed to remove cell stroma, platelets, acti-
vated clotting factors, extracellular potassium, free hemoglobin, anticoagu-
lant, and cardioplegia.
The washed, packed RBCs may then be pumped to a bag for gravity reinfu-
sion to the patient, or, to the arterial line of an extracorporeal circuit for rein-
fusion to the patient
Indications for use
The CS5+ system should be considered for a procedure when it is antici-
pated 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: B
1-4
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 reinfu-
sion 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 recom-
mended 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.
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