Safety

Throughout the manual, signal words and icons appear where the nature of the
information warrants special attention.
NOTE: The note signal word appears adjacent to an important point of
information that is relevant to the current subject matter.
Operation, maintenance, and servicing of hematology systems may expose
individuals to potential safety and health hazards. All work must be performed as
described in the Operators Manual or as directed by an Abbott representative.
Information relating to potential hazards may be found in Section 8: Hazards.
WARNING: This equipment needs special precautions regarding general
requirements for safety. Please consult Section 7: Operational Precautions
and Limitations and Section 8: Hazards, before operating the
CELL-DYN Emerald.

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

NOTES

ii

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

Revision Status

Document Control
Number(s)

Revision Date

Section(s) Revised

Pages Revised and Added

New Release
9213300A
09H40-01

May/2008

Initial release: all

sections new.

Initial release: all sections

new.

9213300B

May/2008

9140859BRevision
Status

p. iii

9140846BInstallation
Procedures and Special
Requirements

pp. 2-6, 2-8 and 2-9, 2-14,

2-17, 2-19 and 2-20, 2-23
through 2-25, 2-27 and
2-28

9213300C

CELL-DYN Emerald Operators Manual

9140859DDecember 2009

February/2009

9140847BPrinciples of
Operation

pp. 3-1, 3-5, 3-10 through

9140848B
Performance
Characteristics and
Specifications

p. 4-7 and 4-8

9140849B
Operating Instructions

pp. 5-4, 5-17, 5-19

9140853B
Service and
Maintenance

p. 9-3

9140859CRevision
Status

pp. iii, iv

9140840BForeword

pp. vii, viii, ix, xi, xv

9140841BTable of
Contents

ALL

9140842BList of
Figures

ALL

9140843BList of
Tables

ALL

9140845BUse or
Function

pp. 1-2, 1-4, 1-11

9140846CInstallation
Procedures and Special
Requirements

pp. 2-4, 2-12, 2-13, 2-15

through 2-32

3-12, 3-16

iii

Document Control
Number(s)

9213300D

iv

Revision Date

December/2009

Section(s) Revised

Pages Revised and Added

9140847CPrinciples
of Operation

pp. 3-3 through 3-7, 3-9,

3-10, 3-12, 3-14, 3-15, 3-17,
3-19, 3-20

9140848C
Performance
Characteristics and
Specifications

pp. 4-7, 4-8, 4-10 through

4-18

9140849COperating
Instructions

pp. 5-1, 5-4 through 5-7, 5-9,

5-11 through 5-17, 5-19,
5-20, 5-23 through 5-33

9140850BCalibration

pp. 6-6 through 6-10

9140851BOperational
Precautions and
Limitations

pp. 7-4 through 7-10

9140852BHazards

pp. 8-8, 8-10

9140853CService and
Maintenance

pp. 9-2 through 9-24

9140854B
Troubleshooting

pp. 10-7 through 10-16

9140855BQuality
Control

pp. 11-4 through 11-8, 11-11

through 11-13, 11-15

9140861BAppendix A

pp. A-3, A-4

9140861BAppendix B

ALL

9140861BAppendix C

p. C-1

9140861BAppendix E

pp. E-2, E5 through E12

9140861BAppendix F

pp. F-5, F-6

9140863BAppendix G

ALL

9140872BGlossary

pp. 8-11

9140862BIndex

ALL

9140859DRevision
Status

ALL

9140840CForeword

ALL

9140841CTable of
Contents

ALL

9140842CList of
Figures

ALL

9140843CList of
Tables

ALL

CELL-DYN Emerald Operators Manual

9140859DDecember 2009

Document Control
Number(s)

CELL-DYN Emerald Operators Manual

9140859DDecember 2009

Revision Date

Section(s) Revised

Pages Revised and Added

9140844BHow to Use
This Manual

ALL

9140845CUse or
Function

ALL

9140846DInstallation
Procedures and Special
Requirements

ALL

9140847DPrinciples
of Operation

ALL

9140848D
Performance
Characteristics and
Specifications

ALL

9140849DOperating
Instructions

ALL

9140850CCalibration

ALL

9140851COperational
Precautions and
Limitations

ALL

9140852CHazards

ALL

9140853DService and
Maintenance

ALL

9140854C
Troubleshooting

ALL

9140855CQuality
Control

ALL

9140861CAppendix A

ALL

9140861CAppendix B

ALL

9140861CAppendix C

ALL

9140861CAppendix E

ALL

9140861CAppendix F

ALL

9140863CAppendix G

ALL

9140872CGlossary

ALL

9140862CIndex

ALL

NOTES

vi

CELL-DYN Emerald Operators Manual

9140859DDecember 2009

Revision Log
Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have
been added to this manual.
1. Record the document control number of the revised section in the first column. You will find the number
in the footer. Make an entry for each chapter you receive and place in the manual.
2. Record the revision date, also found in the footer, in the second column.
3. Record the current CELL-DYN Emerald software version in the third column.
4. Write your initials or signature in the fourth column to verify that you have placed the revised page(s) in
the manual.
5. Record the date that you added the revised section to the manual in the fifth column.
Document
Control Number

Revision Date

CELL-DYN Emerald Operators Manual

9140859DDecember 2009

Software Version

Revision
Incorporated by

Date
Incorporated

vii

NOTES

viii

CELL-DYN Emerald Operators Manual

9140859DDecember 2009

Foreword
Congratulations on your purchase of the CELL-DYN Emerald System. The
CELL-DYN Emerald, which uses state-of-the-art technology, is designed to
function consistently and dependably on a daily basis.
The CELL-DYN Emerald is backed by dedicated professionals who excel in
engineering, training, and technical expertise. As a valued Abbott customer, we
will teach you how to operate, maintain, and troubleshoot your system.
Abbott Hematology is dedicated to providing the highest quality, most reliable
instrumentation available. We look forward to working with you and serving your
needs.

Customer Service
If you need information or help in diagnosing a problem, technical assistance is
available by telephone. In the USA, this service is available 24 hours a day, seven
days a week by calling Abbott Diagnostics Customer Service.
United States: 1-877-4ABBOTT (1-877-422-2688).
For customer support in Canada 1-800-387-8378.
Outside of USA and Canada: contact your Country Service and Support
representative.
For correspondence, the address in the USA is:
Abbott Diagnostics Division
Customer Service
200 Abbott Park Road
Abbott Park, IL 60064, USA

Intended Use
The CELL-DYN Emerald System is an automated hematology analyzer designed
for in-vitro diagnostic use in clinical laboratories.

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

ix

Proprietary Statement
The entire contents of this manual are copyrighted 2008, and 2009 by Abbott
Laboratories. All rights are reserved.
The software and manual were developed solely for use with the
CELL-DYN Emerald and for in vitro diagnostic applications as specified in the
operating instructions.
The information and related graphics published herein (the Information) are the
sole property of Abbott Laboratories. Permission to use the Information is granted,
provided that:

the copyright notice appears on all copies;

use of the Information is for operation of Abbott products by Abbott trained
personnel or informational use only;
the information is not modified in any way; and
no graphics are used separate from accompanying text.
Each person assumes full responsibility and all risks arising from use of the
Information. The Information is presented as is and may include technical
inaccuracies or typographical errors. Abbott Laboratories reserves the right to
make additions, deletions, or modifications to the Information at any time without
any prior notification.

Patent Statement
The following worldwide patents are relevant to the CELL-DYN Emerald or its
components. WO 200562015, WO 200510497. The following USA Patents are
relevant to the CELL-DYN Emerald or its components: 6,632,676. There are other
such patents and patent applications in the United States and worldwide.

Disclaimers
All samples (printouts, graphics, displays, screens, etc.) are for information and
illustration purposes only and shall not be used for clinical or maintenance
evaluations. Data shown in sample printouts and screens do not reflect actual
patient names or test results. Labels depicted in the manual may appear different
from actual product labels.
Abbott Laboratories makes no representations or warranties about the accuracy and
reliability of the information contained in the CELL-DYN Emerald Operators
Manual.
The information was developed to be used by Abbott Laboratories trained
personnel, by other persons knowledgeable or experienced with the operation and
service of the product identified, or under the direct supervision and with
cooperation from Abbott Laboratories technical sales or service representatives.

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

In no event shall Abbott Laboratories or its affiliates be liable for any damages or
losses incurred in connection with or arising from the use of the information on this
media by persons not fully trained by Abbott Laboratories. This limitation shall not
apply to those persons knowledgeable or experienced with the operation and
service of the product identified, or under the direct supervision and with
cooperation from Abbott Laboratories technical sales or service representatives.
No confidential relationship shall be established in the event that any user of the
Information should make any oral, written or electronic response to Abbott
Laboratories (such as feedback, questions, comments, suggestions, ideas, etc.).
Such response and any information submitted therewith shall be considered nonconfidential, and Abbott shall be free to reproduce, publish, or otherwise use such
information for any purposes whatsoever including, without limitation, the
research, development, manufacture, service, use, or sale of products incorporating
such information. The sender of any information to Abbott is fully responsible for
its content, including its truthfulness and accuracy and its non-infringement of any
other persons proprietary rights.
Abbott Laboratories is not engaged in rendering medical advice or services.
Updates to the information may be provided in either paper or electronic format.
Always refer to the latest documents for the most current information.
List numbers are unique identifiers that are used when ordering products. The list
number and quantity provided in Appendix A: Accessories are intended for
guidance only and are subject to change. Contact your Abbott representative for the
most current information regarding list numbers.
All operating instructions must be followed. In no event shall Abbott be
responsible for failures, errors, or other liabilities resulting from customers noncompliance with the procedures and precautions outlined herein.

Warranty Statement for USA Customers Only

Abbott Laboratories warrants CELL-DYN instruments sold by Abbott Sales
Representatives (the Instrument) to be free from defects in workmanship and
materials during normal use by the original purchaser. This warranty shall continue
for a period of one (1) year, commencing twenty-one (21) days from date of
shipment to the original purchaser, or until title is transferred from the original
purchaser, whichever occurs first (the Warranty Period).
If any defects occur during the Warranty Period, contact Abbott Diagnostics
Customer Service immediately and be prepared to furnish pertinent details
concerning the defect, the Instrument model number, and the serial number.
Abbotts Warranty coverage limits are as follows:
1. Abbott Diagnostics Customer Service: 24 hours per day, 7 days per week
phone support in the United States.
2. Field Service Representative support: 8:30 A.M. to 5:00 P.M. Monday through
Friday (excluding all Abbott-observed holidays).

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

xi

3. Any on-site service performed at other times and all service required to
correct defects or malfunctions not covered by this Warranty (as noted in the
paragraph below) will be billed at Abbotts labor rates then in effect.
This Warranty does not cover defects or malfunctions which:
1. Are not reported to Abbott during the Warranty Period and within one week
of occurrence.
2. Result from chemical decomposition or corrosion.
3. Are caused by customer or third party abuse, misuse, or negligence, or by
failure to comply with any requirement or instruction contained in the
applicable Abbott Operators Manual.
4. Result from maintenance, repair, or modification performed without Abbotts
authorization.
Abbotts liability for all matters arising from the supply, installation, use, repair, and
maintenance of the Instrument, whether arising under this Warranty or otherwise,
shall be limited solely to the repair or (at Abbotts sole discretion) replacement of
the Instrument or of components thereof. In no event shall Abbott be liable for
injuries sustained by third parties, incidental or consequential damages, or lost
profits. Replaced parts shall become the property of Abbott Laboratories.
THE FOREGOING IS THE SOLE WARRANTY MADE BY ABBOTT
LABORATORIES REGARDING THE INSTRUMENT, AND ABBOTT
SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR
IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND OF FITNESS FOR A PARTICULAR PURPOSE.
The CELL-DYN Emerald Hematology System is manufactured in France for
Abbott Diagnostics Division, Abbott Laboratories, 200 Abbott Park Road, Abbott
Park, IL, 60064, USA. Please direct all inquiries concerning information in this
manual to the foregoing address.
NOTE: Direct all inquiries regarding equipment problems to Abbott Diagnostics
Customer Service. (USA customers only.)

xii

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

Regulatory and Safety Agency Approvals

In Vitro Diagnostic Directive

98/79/EC

Legal Manufacturer

Abbott Laboratories
Abbott Park, IL 60064, USA

Authorized Representative

ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49 6122 580

UL

61010-1

Approved

CAN/CSA-C22.2

No. 61010-1

Approved

IEC 61010-1

Approved

UL

Listed

Trademark Statements
CELL-DYN and Emerald are trademarks of Abbott Laboratories in various
jurisdictions.
All other trademarks are the property of their respective owners.

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

xiii

Symbols
The symbols listed below are used in labeling, including the instrument, reagents,
calibrators, controls, and this manual. Please note that Warning and Caution
symbols and statements are in this manual in Section 8: Hazards.
Table 1

Instrument/Power-related
Symbol

-5A

DILUENT

REF

REV
SN

WASTE
APPLICATION SOFTWARE

xiv

Definition/Use

Location of Label

Direct Current 24V-3A

Rear panel

Barcode/Barcode scanner
connection

Rear panel

Caution, risk of electric shock

Behind flow panel, interior of

instrument

Diluent

Rear panel

Equipotentiality

Rear panel

Ethernet/Ethernet connection

Rear panel

Catalog Number

Serial Number Label

Stand by /
Power On/Off

Front

Printer/Printer serial connection

Rear panel

Revision

Serial Number Label

Serial Number

Serial Number Label

Serial Interface RS 232C/Serial

Port connection

Rear panel

USB ports, 1 and 2

Rear panel

Waste

Rear panel

Application Software

On Flash Drive

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

Table 2

Reagent-related
Symbol

Definition/Use

CLEANER

Cleaner Reagent

DILUENT

Diluent Reagent

KEY

Key

LOT

Batch Code

LYSE

Lyse

SN

Serial Number
Use By

Table 3

Calibrator/Control-related
Symbol

Definition/Use

ASSAY VALUE

Assay Value

MEAN RANGE

Mean Range

MEAN VALUE

Mean Value

PARAMETER

Parameter

SYSTEM
TOLERANCE LIMIT
WB CAL
WB CONTROL TRI-LEVEL
WB CONTROL L/N/H or I//II/III

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

System
Tolerance Limit
Whole Blood Calibrator
Whole Blood Control, Tri-Level
Whole Blood Control, Low, Normal or High Level; or
Whole Blood Control Level I, II or III.

xv

Table 4

Miscellaneous
Symbol
EC REP

ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580

Definition/Use
Authorized Representative in the European
Community

Biohazard

Caution, consult accompanying documents

IVD

For In Vitro Diagnostic Medical Device

Manufacturer

i
MODEL

Consult instructions for use

Model number
Temperature limitation

Separate collection for electrical and electronic

equipment waste per Directive 2002/96/EC in the
European Union
Identifies an area where electrostatic discharge may
be present. A ground strap must be worn while
servicing the system.
Indicates that the material is Harmful (Xn) or
Irritant (Xi)

xvi

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

Labeling
The following labels are affixed to the CELL-DYN Emerald System:
The CELL-DYN Emerald is CE Marked to the European In Vitro Diagnostic
Directive, which encompasses the requirements of the EMC and Safety Directives,
and have the following labels:
Shipping Container

Figure 1:

Shipping Container Label

Analyzer Front Panel

Figure 2:

Biohazard Label

Analyzer Flow Panel

Figure 3:

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

Hazard Label

xvii

Analyzer Rear Panel

xviii

Figure 4:

Serial Number Label

Figure 5:

Technical Service Bulletin Record Label

Figure 6:

Biohazard Label

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

Figure 7:

Rear Panel

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

xix

NOTES

xx

CELL-DYN Emerald Operators Manual

9140840CDecember 2009

Master Table of Contents

Master Table of Contents

Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Revision Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Revision Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Proprietary Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Patent Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Warranty Statement for USA Customers Only. . . . . . . . . . . . . . . . . . . . . xi
Regulatory and Safety Agency Approvals . . . . . . . . . . . . . . . . . . . . . . . xiii
Trademark Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv
Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Shipping Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Analyzer Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Analyzer Flow Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Analyzer Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii
How to Use This Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manual Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Text Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Menu Name. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Touch Screen Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Data Entry Field Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Keypad (Keys) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screen Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-1
1-3
1-3
1-3
1-3
1-3
1-3

Use or Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
White Blood Cell measurands: . . . . . . . . . . . . . . . . . . . . . . . . . .
Red Blood Cell measurands:. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Hemoglobin measurands: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Platelet measurands: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Display and Numeric Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . .
Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Main PCB Board. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CELL-DYN Emerald Operators Manual

9140841CDecember 2009

1-1
1-2
1-2
1-2
1-2
1-3
1-3
1-4
1-5
1-8

Table of Contents-1

Master Table of Contents

AC Adapter/Transformer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Reagent Tray. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Reagent System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
CELL-DYN Emerald Diluent Reagent. . . . . . . . . . . . . . . . . . . 1-10
CELL-DYN Emerald CN-Free Lyse Reagent . . . . . . . . . . . . . 1-11
CELL-DYN Emerald Cleaner Reagent . . . . . . . . . . . . . . . . . . 1-11
Reagent Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Reagent Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Calibrator and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Installation Procedures and Special Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Site Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Space Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Place the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Waste Disposal Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Installation Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Inventory and Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Instrument Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Electrical Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Printer installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Reagent installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Instrument Start Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Instrument Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Operator Log In and Log Out . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
System Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Loading or Replacing Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Replacing the Reagents Diluent, Lyse, Cleaner . . . . . . . . . . . . . . . . . . . 2-15
Using Reagent Bar Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Manual Entry of Reagent Information . . . . . . . . . . . . . . . . . . . . . . 2-16
Replacing or Emptying the Waste Container . . . . . . . . . . . . . . 2-17
Other Reagent Menu functions . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Advanced Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Printer Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Interpretive Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Communication Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Reporting Options Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Lab Preferences Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
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Master Table of Contents

Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SPECIMEN CAL. ADJUSTMENTS . . . . . . . . . . . . . . . . . . . .
Thresholds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Rename Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Version Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setup Configuration Printout . . . . . . . . . . . . . . . . . . . . . . . . . .
Instrument Quality Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Background Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-26
2-27
2-27
2-27
2-27
2-28
2-29
2-30
2-32
2-32
2-32
2-33
2-34
2-34
2-34
2-34

Principles of Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Sample Analysis Cycle Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Measurement Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Impedance Counting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
WBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
RBC Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Platelet Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Absorption Spectrophotometry and Hemoglobin Measurement 3-5
Measurand Reporting Conventions . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Instrument Alarms, Operational Alerts, and Measurand
Data Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Instrument Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Operational Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Measurand Data Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Dispersional Data Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
WBC Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
WBC Suspect Measurand Flags . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Platelet (PLT) Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
PLT Suspect Measurand Flags . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Count Invalidating Flags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Warning, Information, and Input Error Pop-Ups . . . . . . . . . . . 3-17
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Interpretive Messages (Interpretive Report) . . . . . . . . . . . . . . . 3-20

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Table of Contents-3

Master Table of Contents

Performance Characteristics and Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Power Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Operational Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Bar Code Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Performance Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Background Counts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Carryover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Display Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Linearity/Analytical Measurement Range (AMR) . . . . . . . . . . . 4-8
Imprecision (Reproducibility). . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Repeatability and Within-Device Imprecision
(Long-Term Precision) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Comparability (Correlation) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Reference Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Operating Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Instrument Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Software Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Instrument Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Operator Log In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Specimen Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Specimen Collection and Handling . . . . . . . . . . . . . . . . . . . . . . 5-5
Specimen Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Specimen Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Routine Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Daily Start Up Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Running Specimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
DATALOG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Daily Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Auto Rinse Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
USB Flash Drive (Thumb Drive) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Characteristics of CELL-DYN Emerald USB Drives . . . . . . . 5-17

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Formatting the USB drive for use on the

CELL-DYN Emerald. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
USB File Folder Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Available Functions for the USB Drive . . . . . . . . . . . . . . . . . .
Use of the USB drive in the EVENT LOG menu. . . . . . . . . . .
Use of the USB drive in the REAGENT menu. . . . . . . . . . . . .
Installing a Printer Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Use of the USB drive in the CALIBRATION menu. . . . . . . . .
Saving current calibration data. . . . . . . . . . . . . . . . . . . . . . . . .
Use of the USB drive in the QC menu.. . . . . . . . . . . . . . . . . . .
Uploading commercial Quality Control material information.
Saving Current QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Save QC data for eQC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Saving QC data to the USB key for eQC . . . . . . . . . . . . . . . . .
Restore previously saved QC data. . . . . . . . . . . . . . . . . . . . . . .
Use of the USB drive in the DATALOG menu.. . . . . . . . . . . .
Use of the USB drive in the SET UP menu.. . . . . . . . . . . . . . .
Restoring SETUP information from the USB drive. . . . . . . . .
Use of the USB drive in the MAINTENANCE
and RUN SAMPLE menus. . . . . . . . . . . . . . . . . . . . . . . . . . .
Bar Code Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5-18
5-19
5-20
5-20
5-20
5-20
5-22
5-22
5-23
5-23
5-26
5-26
5-27
5-28
5-29
5-30
5-31
5-32
5-32
5-32
5-33

Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
When to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Calibration Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Pre-Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Calibration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Automated Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Entering Calibrator Information . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Calibration Verification Procedure . . . . . . . . . . . . . . . . . . . . . . 6-10
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
Operational Precautions and Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Precautions and Requirements for System Operation . . . . . . . . . . .
Precautions Before Operation . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements Before Operation . . . . . . . . . . . . . . . . . . . . . . . . .
Precautions During Operation . . . . . . . . . . . . . . . . . . . . . . . . . .
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7-3
7-4
7-4
7-4
7-4

Table of Contents-5

Master Table of Contents

Battery Disposal Information . . . . . . . . . . . . . . . . . . . . . . . . . . .

Requirements for Handling Consumables . . . . . . . . . . . . . . . . .
Requirements for Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements for Handling Specimens . . . . . . . . . . . . . . . . . . .
Requirements for Collecting, Preparing and Storing Specimens
Interfering Substances and Conditions . . . . . . . . . . . . . . . . . . . .
Limitations of Result Interpretation . . . . . . . . . . . . . . . . . . . . . .
Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7-5
7-5
7-5
7-5
7-6
7-6
7-6
7-7
7-9

Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Operator Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Safety Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Biological and Chemical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Biological Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Chemical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Spill Clean-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Waste Handling and Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Decontamination Procedure Requirements . . . . . . . . . . . . . . . . 8-8
Electrical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Mechanical Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Physical Hazards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Aspiration Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Heavy Objects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Tripping Hazard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Service and Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Saving and Printing the Event Log . . . . . . . . . . . . . . . . . . . . . . . 9-4
Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Special Modes Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Fluidics Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Preventive Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Monthly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Bleach Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-11
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Table of Contents-6

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Master Table of Contents

Semi-Annual Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lubricating the Pistons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
As Needed Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Emergency Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Initialize System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cleaning the cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Material Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preparing for Storage, Relocation or Shipping. . . . . . . . . . . . .
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Decontamination Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . .
Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Backflush . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sample Probe Removal and Replacement . . . . . . . . . . . . . . . . . . .
Materials Required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sample Probe Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Sample Probe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . .
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9-13
9-13
9-13
9-13
9-14
9-14
9-14
9-15
9-15
9-15
9-15
9-16
9-17
9-17
9-18
9-18
9-18
9-22
9-23

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Troubleshooting Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Troubleshooting Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
When to Run QC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Quality Control Methods and Materials . . . . . . . . . . . . . . . . . . . . . 11-3
QC File Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Entering QC Assay Values and Limits . . . . . . . . . . . . . . . . . . . 11-7
QC Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Control Material Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Normal Specimen Guideline: The Rule of Three . . . . . . . . . . . 11-9
Running Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-10
Use of Tools in the QC Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Printing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Sending QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Deleting QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
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Table of Contents-7

Master Table of Contents

Saving QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Viewing Results in the QC Menu . . . . . . . . . . . . . . . . . . . . . .
Viewing all QC Runs Within a File . . . . . . . . . . . . . . . . . . . .
Viewing all Measurands Within the QC File . . . . . . . . . . . . .
Viewing QC Statistics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Levey-Jennings Graphs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

11-14
11-14
11-14
11-14
11-14
11-16
11-17

Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Potential Causes of Spurious Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1
Preparation of diluted sodium hypochlorite solutions . . . . . . . . . . . . . . . . . C-1
Appendix D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1
CBC Reference Intervals: Literature Sources. . . . . . . . . . . . . . . . . . . . . . . . D-1
Appendix E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Sample Logs and Worksheets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1
Worksheet E.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-2
Pre-Calibration Procedure Checklist . . . . . . . . . . . . . . . . . . . . . E-2
Worksheet E.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-8
Calibration Verification Worksheet . . . . . . . . . . . . . . . . . . . . . . E-8
Worksheet E.3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-9
Training Checklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-9
Worksheet E.4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-11
Manual Calibration Factor Entry Worksheet . . . . . . . . . . . . . . . . . E-11
Appendix F. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1
Manual Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Requirements for Whole Blood Specimens . . . . . . . . . . . . . . . .
Requirements for Whole Blood Calibration . . . . . . . . . . . . . . . .
Reference Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WBC, RBC and PLT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HGB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
MCV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table of Contents-8

F-1
F-1
F-2
F-2
F-2
F-2
F-2

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Master Table of Contents

Manual Calibration Factor Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . F-4

Manual Calibration Factor Entry Procedure
Fresh Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-4
Manual Calibration Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . F-5
Appendix G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1
CELL-DYN Emerald Quick Reference Card . . . . . . . . . . . . . . . . . . . . . . . . G-1
Power on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1
Daily Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1
Manual Daily Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1
Running Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-1
Running a Patient Sample. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-2
Background Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-2
Replacing Reagents-Diluent, Lyse, and Cleaner . . . . . . . . . . . . G-2
Replacing Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . G-2
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-13
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

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Table of Contents-9

Master Table of Contents

NOTES

Table of Contents-10

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9140841CDecember 2009

List of Figures

List of Figures
Figure 1:
Figure 2:
Figure 3:
Figure 4:
Figure 5:
Figure 6:
Figure 7:

Shipping Container Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Biohazard Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Hazard Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii
Serial Number Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii
Technical Service Bulletin Record Label . . . . . . . . . . . . . . . . . . . . xviii
Biohazard Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii
Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix

Use or Function
Figure 1.1
Figure 1.2
Figure 1.3
Figure 1.4
Figure 1.5
Figure 1.6
Figure 1.7
Figure 1.8
Figure 1.9

CELL-DYN Emerald . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Front Panel Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Sampling Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Syringe Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Counting Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
AC Adapter/Transformer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Reagent Tray. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Installation Procedures and Special Requirements

Figure 2.1
Figure 2.2
Figure 2.3
Figure 2.4
Figure 2.5
Figure 2.6
Figure 2.7
Figure 2.8
Figure 2.9
Figure 2.10
Figure 2.11
Figure 2.12
Figure 2.13
Figure 2.14
Figure 2.15
Figure 2.16
Figure 2.17
Figure 2.18
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Instrument Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Electrical Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Lyse and Cleaner Reagent Connections . . . . . . . . . . . . . . . . . . . . . 2-10
Diluent Reagent and Waste Connections . . . . . . . . . . . . . . . . . . . . 2-11
Power ON . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Language Selection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Operator Log In/Out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
System Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Reagent Bar Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Manual Entry of Reagent Information . . . . . . . . . . . . . . . . . . . . . . 2-16
Changing the Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
CYCLE COUNTER Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Date/Time Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
Advanced Set Up Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Printer Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Reporting Options Set Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Modify Specimen Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
Limits Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
List of Figures-1

List of Figures

Figure 2.19
Figure 2.20
Figure 2.21
Figure 2.22

Calibration Factor Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Specimen Types Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changing Calibration Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other Settings Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-28
2-28
2-29
2-31

Principles of Operation
Figure 3.1
Figure 3.2
Figure 3.3
Figure 3.4
Figure 3.5
Figure 3.6

WBC Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

RBC Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Platelet Graph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
WBC Flags and Possible Causes . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
PLT Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Warning, Information and Input Error Pop-Ups. . . . . . . . . . . . . . . 3-18

Operating Instructions
Figure 5.1
Figure 5.2
Figure 5.3
Figure 5.4
Figure 5.5
Figure 5.6
Figure 5.7
Figure 5.8
Figure 5.9
Figure 5.10
Figure 5.11
Figure 5.12
Figure 5.13
Figure 5.14
Figure 5.15
Figure 5.16
Figure 5.17
Figure 5.18
Figure 5.19
Figure 5.20
Figure 5.21
Figure 5.22
Figure 5.23
Figure 5.24
Figure 5.25
Figure 5.26
Figure 5.27
List of Figures-2

Software Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Entering Specimen Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Results Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Printing Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13
Datalog Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
View Record Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
DATALOG Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15
Autorinse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Delete Data from External Device . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
USB File Folder Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Save EVENT LOG to USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Printer Driver Upload . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Printer Driver Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Save Calibration Data to USB . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Confirm Save of Calibration Report . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Selection of QC File for Upload . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23
Display of Current QC Lot Information . . . . . . . . . . . . . . . . . . . . . 5-24
Select QC Lot and Level for Upload . . . . . . . . . . . . . . . . . . . . . . . 5-24
Confirmation of QC Upload . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Upload QC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25
Enter Lab ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
Alpha keypad for Lab ID Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Selection of QC file(s) for eQC . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Restore Saved QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Selection of QC Lot and Level to Restore . . . . . . . . . . . . . . . . . . . 5-29
DATALOG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
DATALOG Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
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List of Figures

Figure 5.28
Figure 5.29

Saving to USB Drive Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Restoring Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

Figure 6.1
Figure 6.2
Figure 6.3

Calibration Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Calibration Entry Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Calibration Result Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

Figure 8.1
Figure 8.2
Figure 8.3

Biohazard label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Biohazard Label location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Waste Outlet Biohazard Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6

Calibration

Hazards

Service and Maintenance

Figure 9.1
Figure 9.2
Figure 9.3
Figure 9.4
Figure 9.5
Figure 9.6
Figure 9.7
Figure 9.8
Figure 9.9
Figure 9.10
Figure 9.11
Figure 9.12
Figure 9.13
Figure 9.14

EVENT LOG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3

Saving and Printing the Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
The Precision Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
Precision Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6
The Precision Run Screen (shown with an empty file). . . . . . . . . . . 9-6
The Linearity Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
The Linearity Run Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Fluidics Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Bleach Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Mechanical Checks Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Lubricating the Syringe Pistons . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Maintenance Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Sample Probe Removal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Sample Probe Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22

Quality Control
Figure 11.1
Figure 11.2
Figure 11.3
Figure 11.4
Figure 11.5
Figure 11.6
Figure 11.7
Figure 11.8

QC Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
Lab ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Restoring a QC file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Targets and Limits Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8
QC Results Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
Manually Deleting QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13
QC Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15
Levey-Jennings Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16

Manual Calibration Procedure

Figure F.1
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Manual Calibration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-5

List of Figures-3

List of Figures

NOTES

List of Figures-4

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List of Tables

List of Tables
Foreward
Table 1
Table 2
Table 3
Table 4

Instrument/Power-related . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv
Reagent-related . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
Calibrator/Control-related. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvi

Installation Procedures and Special Requirements

Table 2.1
Table 2.2
Table 2.3

Accessories Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Installation Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Service Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Principles of Operation
Table 3.1
Table 3.2
Table 3.3
Table 3.4
Table 3.5
Table 3.6
Table 3.7

Exponents Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Report Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Dispersional Data Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
WBC Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Platelet Flags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Count Invalidating Flags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Interpretive Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Performance Characteristics and Specifications

Table 4.1
Table 4.2
Table 4.3
Table 4.4
Table 4.5
Table 4.6
Table 4.7
Table 4.8
Table 4.9
Table 4.10
Table 4.11
Table 4.12
Table 4.13
Table 4.14
Table 4.15

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Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Dimensions in Shipping Carton . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Dimensions for the AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Instrument Power Source Requirements. . . . . . . . . . . . . . . . . . . . . . 4-4
Reagent Consumption (in mL) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Background Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Carryover Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Display Range and Analytical Measurement Range . . . . . . . . . . . . 4-9
Fresh Blood Imprecision Specifications . . . . . . . . . . . . . . . . . . . . . 4-10
Long-Term Commercial Control Imprecision: CBC . . . . . . . . . . . 4-11
Long-Term Commercial Control Imprecision: WBC Differential . 4-13
Comparability (Correlation) to CELL-DYN 1800 Internal Site. . . 4-14
Comparability (Correlation) to CELL-DYN 1800 External Site . . 4-15
Comparability (Correlation) of WBC Differential to Microscopy . 4-15
Reference Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16

List of Tables-1

List of Tables

Hazards
Table 8.1

Safety Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Troubleshooting
Table 10.1
Table 10.2
Table 10.3

Measurand-Related Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-5

Instrument-Related Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-7
Alarm Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8

Table A.1
Table A.2
Table A.3
Table A.4

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Consumables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Calibrator and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Accessories

Potential Causes of Spurious Results

Table B.1

Potential Causes of Spurious Results with

Automated Cell Counters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Sample Logs and Worksheets

Table E.1
Table E.2

List of Tables-2

Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3

Troubleshooting Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

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How to Use This Manual

Manual Organization
The major sections of the manual and their contents are as follows:
Front Matter
The pages following the Master Table of Contents contain a Foreword that includes
customer support information, and proprietary, patent, and trademark statements.
Section 1: Use or Function
This section provides an overall description of the system. It names the major
system components and describes their uses or functions.
Section 2: Installation Procedures and Special Requirements
This section provides detailed instruction for system setup and configuration. It
explains proper location, requirements, and steps for installation.
Section 3: Principles of Operation
This section explains the principles behind the systems operation. It describes
what the system measures and how those measurements are made. It also explains
the translation of those measurements into useful data and reports for the user.
Section 4: Performance Characteristics and Specification
This section contains useful details on the dimensions of the instrument, proper
operating environment, and performance specifications.
Section 5: Operating Instructions
This section explains the procedures for daily startup and shutdown, sample
collection and handling, and the routine operation of the instrument including use
of the data log and sample analysis.
Section 6: Calibration Procedures
This section describes the calibration process. It discusses calibration materials,
guidelines, and methods.
Section 7: Operational Precautions and Limitations
This section contains a summary of the known factors that may adversely affect the
proper operation of the instrument or the quality of the output.
Section 8: Hazards
This section covers possible hazards arising from the operation of the instrument,
as well as decontamination and waste handling procedures.

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How to use this Manual - 1

Section 9: Service and Maintenance

This section discusses routine maintenance and cleaning. Also included are
detailed instructions for removing and cleaning certain components to ensure
proper system performance.
Section 10: Troubleshooting and Diagnostics
This section discusses the diagnostics capability of the instrument. It contains a
troubleshooting guide to help users identify probable causes of a system
malfunction or of suspect data, and to suggest the proper corrective action.
Section 11: Quality Control
This section covers the proper mixing, handling and running of control material,
setting up QC files, and using the QC capabilities of the instrument.
Glossary
This appendix contains the words and terms used in hematology as they apply to
the CELL-DYN Emerald, as well as terms that describe the actual operation,
principles of operation, and components of the instrument.

Appendices
Appendix A
This appendix lists the part numbers of components, accessories, controls, reagents
and consumables associated with the CELL-DYN Emerald System for user
convenience when placing orders.
Appendix B
This appendix contains a table on potential causes of erroneous results.
Appendix C
This appendix contains step-by-step instructions for preparing sodium
hypochlorite (bleach) solutions for use on the CELL-DYN Emerald.
Appendix D
This appendix contains a list of literature sources relating to CBC Reference
Intervals (Patient Limits).
Appendix E
This appendix contains sample logs and worksheets to copy and use for your
convenience in constructing an instrument log for your laboratory.
Appendix F
This appendix contains information about whole blood calibration and manual
calculation of calibration factors.
Index
This section contains an alphabetical listing of subject matter to help users quickly
locate specific information about the system.
How to use this Manual - 2

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Text Conventions
Text Conventions Used in This Manual
In this manual, procedural instructions are explained in logical groups, using
numbered steps. Illustrations and drawings appear where they are useful to the
explanation. Text conventions are as follows:
Menu Name
The menu name is printed in bold, uppercase, sans serif letters; for example, MAIN
menu.
Touch Screen Buttons
The CELL-DYN Emerald user interface includes a LCD touch screen where
buttons are selected by touching the corresponding area of the display. When
referring to these, the manual uses the term button. Touching one of these buttons
initiates an action. Touching other (non-button) areas on the display make
selections or inserts a cursor for entry. Detailed descriptions of the actions initiated
by the buttons are found in the applicable section(s) of this manual. Screen labels
are shown in bold, uppercase, sans serif letters enclosed in brackets; for example,
[QUALITY CONTROL].
Data Entry Field Names
Fields that accept data entered by the Operator have their names shown in regular,
mixed-case font enclosed within carats < >.
Keypad (Keys)
In addition to the display touch screen, the user interface for the
CELL-DYN Emerald includes keys on the front panel of the instrument. When
referring to these, the manual uses the term key. Special function keys, such as
the arrow keys, may appear as a symbol substituted for the word. Instructions for
special function keys will read, for example Press the [] arrow key.
Screen Messages
Screen messages or other screen displays will appear in bold, Courier letters, for
example, Do you wish to continue?. If the screen message requires a
response from the user, the touch screen button(s) will follow the convention as
described in Touch Screen Buttons.

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How to use this Manual - 3

NOTES

How to use this Manual - 4

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Section 1 Use or Function

Section 1

Use or Function

Overview
The CELL-DYN Emerald is an automated hematology analyzer intended for in
vitro diagnostic use in the clinical laboratory. It is menu-driven and controlled by
a microprocessor.

Figure 1.1

CELL-DYN Emerald

The CELL-DYN Emerald aspirates blood from an opened collection tube held up
to the aspiration probe. The CELL-DYN Emerald can aspirate blood from several
types of collection devices which contain K2EDTA. Refer to Section 5: Operating
Instructions, Subsection: Specimen Collection and Handling.

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Use or Function
Section 1

Overview

The CELL-DYN Emerald provides the following:

White Blood Cell measurands:
WBC
White Blood Cell or leukocyte count
LYM %

Lymphocyte percent

LYM #

Lymphocyte absolute number

MID %

Mid Cells percent

MID #

Mid Cells absolute number

GRA %

Granulocyte percent

GRA #

Granulocyte absolute number

Red Blood Cell measurands:

RBC
Red Blood Cell or erythrocyte count
HCT

Hematocrit

MCV

Mean Cell Volume

RDW

Red Blood Cell Distribution Width

Hemoglobin measurands:
HGB
Hemoglobin concentration
MCH

Mean Cell Hemoglobin

MCHC

Mean Cell Hemoglobin Concentration

Platelet measurands:
PLT
Platelet count
MPV

1-2

Mean Platelet Volume

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Use or Function
Section 1

Overview

System Components
The CELL-DYN Emerald consists of eight main components:
1.
2.
3.
4.
5.
6.
7.
8.

Front Panel with LCD Display and Numeric Keypad

Fluidics
Main PCB Board
AC Adapter/Transformer
Reagent Tray
Rear Panel
Printer
Barcode Reader

Display and Numeric Keypad

1. LCD Touch Screen Display.
2. LED Red when cycle in
process or not ready; Green
when ready for next cycle;
flickering Red during aspiration.
3. ESCAPE Exits the current
menu.
4. Arrow Keys The Up and
Down arrow keys move the
cursor to the next line (when
present). The Right and Left
arrow keys move the cursor
within an entry field.
5. Numeric Keypad Used to
enter numeric information.
6. ENTER Used to enter typed
information.
7. DEL (delete) Used to delete
entered information.
8. ON/OFF Brings the system
out of Standby, and system halt.
Figure 1.2

2
3

5
7

4
8

Front Panel Components

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Use or Function
Section 1

Overview

Main Menu
Menu items are discussed in detail in subsequent Sections.
1. Date/Time Displays current date
and time/
2. TOOLS ICON (Wrench) Accesses
the TOOLS menu containing
context-specific options, such as
Print and Send.
3. RETURN ICON (Curved Arrow)
Returns to the previous menu.
4. HOME ICON (House) - Returns to
the MAIN menu.
5. START UP Initiates the Start Up
Cycle.
6. EVENT LOG Accesses the Event
Log.
7. OPER. LOG IN/OUT Accesses
the Log In/Log Out screen.
8. REAGENTS Accesses the
REAGENTS menu.
9. SHUT DOWN Initiates the Shut
Down Cycle.
10.CALIBRATION Accesses the
CALIBRATION menu.
11. QUALITY CONTROL Accesses
the QUALITY CONTROL menu.
12.DATALOG Accesses stored
results.
13.SET UP Accesses the SET UP
menu.
14.MAINTENANCE Accesses the
MAINTENANCE and SERVICE
menu.
15.RUN SAMPLE Accesses the Run
Screen.
Figure 1.3

1-4

1
2
3
4

10

11

12

13

14
15

Main Menu

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Use or Function
Section 1

Overview

Fluidics
1. Sampling Module
2. Syringe Module
3. Counting Module

Figure 1.4

Fluidics

The fluidic components are located on the right side of the instrument and contain
the following three modules:

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Use or Function
Section 1

Overview

Figure 1.5

Sampling Module

1. Sampling Module consists of the rocker that performs the up/down and
forward/back movement of the aspiration probe and the aspiration probe
itself.

1-6

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Use or Function
Section 1

Overview

1
Figure 1.6

3 4

Syringe Module

2. Syringe Module This module performs the following functions:

Moves the sample aspiration syringe down to aspirate a sample
Distributes the reagents
Drains the baths
Provides the vacuum for counting
Moves the waste to the waste container
This module contains a manifold for the fluidic valves, the syringe pistons and
the syringe block. The syringe block combines five syringes which are driven by
one motor:
Sample aspiration syringe (1)
Lyse syringe (2)
Two vacuum/pressure and waste syringes (3)
Diluent syringe (4)
The diluent input and waste output connections are located on the rear panel.

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Use or Function
Section 1

Overview

WBC/HGB
RBC/PLT
Counting Chamber Counting Chamber

Figure 1.7

Counting Module

3. Counting Module This module counts the WBCs, RBCs, and PLTs and
measures the HGB. It includes:
WBC/HGB Counting Chamber with the WBC Aperture and the Hemoglobin
LED. Left bath.
RBC/PLT Counting Chamber with the RBC/PLT Aperture. Right bath.
Liquid valve manifold assembly with associated tubing. Below baths.
Main PCB Board
The Main PCB Board is located between the Fluidics and the Reagent Tray. It is
driven by a 32-bit microprocessor and manages the following components:
Aspiration probe, Rocker, and Syringe Block motors
Display and Keyboard
LIS Connection (RS232, Ethernet, etc.)
Cell counting and Hemoglobin measurement
Data Processing
Bar code reader
USB connections

1-8

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Use or Function
Section 1

Overview

WARNING: Internal Shock Hazard: Only qualified personnel should

service the instrument.
AC Adapter/Transformer

Figure 1.8

AC Adapter/Transformer

The CELL-DYN Emerald is supplied with an external AC Adapter/Transformer.

The use of another external AC Adapter/Transformer is not recommended. If
necessary, contact Abbott Customer Service for assistance.
Two power cords are provided with the CELL-DYN Emerald: one for 110 Voltage
(USA) and one for 220V. Replacement cords must comply with local regulations.

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Use or Function
Section 1

Overview

Reagent Tray
The Reagent Tray holds the Cleaner and Lyse reagent bottles.
1. Cleaner Reagent
2. Cleaner Reagent line (green
collar)
3. Lyse Reagent
4. Lyse Reagent line (blue collar)

Figure 1.9

4
3

Reagent Tray

Reagent System
A reagent system, specifically formulated for the CELL-DYN Emerald instrument,
provides optimal system performance. Use of reagents other than those specified
in this manual is not recommended as instrument performance can be affected.
Each instrument is tested at the factory using the specified reagents. All
performance claims are generated using these reagents. Refer to Appendix A:
Accessories for information on ordering CELL-DYN Reagents.
CELL-DYN Emerald Diluent Reagent
CELL-DYN Emerald Diluent Reagent is formulated to do the following:
Act as the diluent for WBC, RBC, PLT, and Hemoglobin measurements
Maintain cell volume during the counting and sizing portion of the
measurement cycle
Provide a conductive medium for impedance counting and sizing of cells and
platelets
Rinse the Aspiration Probe and fluidics

1-10

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Use or Function
Section 1

Overview

CELL-DYN Emerald CN-Free Lyse Reagent

CELL-DYN Emerald Cyanide-Free Lyse Reagent is formulated to meet the
following requirements:
Rapidly lyse the RBC and minimize resultant cell stroma
Alter the WBC membrane to allow the cytoplasm to diffuse and shrink the
membrane around the nucleus and any granules that may be present
Convert hemoglobin to a modified hemoglobin complex that is measurable
at 555 nm. (The quaternary ammonium lysate participates to form a
chromagen for hemoglobin measurement.)
CELL-DYN Emerald Cleaner Reagent
CELL-DYN Emerald Cleaner Reagent is an enzymatic cleaner used to clean the
measurement system and the fluidics.
Reagent Storage
Reagents must be stored as labeled to ensure optimal performance.
Each length of reagent inlet tubing is attached to a cap that minimizes reagent
evaporation and contamination during use. Ensure that all reagent caps are
undamaged and are securely attached to containers during use. If a waste container
is used, ensure that the cap is securely attached during use. If a drain is used, ensure
that the waste tubing is securely inserted in the drain.
Reagent quality can deteriorate with time; therefore, use all reagents before the
expiration date on the label.
Reagent Handling
When handling reagents, pay special attention to the following:
Wear lab coat, gloves, and protective eyewear when handling reagents.
Never transfer the contents of a reagent container to an unmarked container
or another reagent container.
Thoroughly clean all spills. Remove any dried residue in and around the
Diluent Inlet connector located on the rear panel.
Dispose of reagents and waste fluids in accordance with local, state, and
federal regulations.
Always wash your hands after handling reagents.

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Use or Function
Overview

Section 1

Calibrator and Controls

Calibrator and Controls are reference materials used to set, test, and monitor the
CELL-DYN Emerald performance. Refer to Appendix A: Accessories for
information on ordering CELL-DYN Calibrator and Controls.
CELL-DYN Calibrator is used to calibrate the WBC, RBC, HGB, MCV, and PLT
measurands. Calibration is discussed in Section 6: Calibration.
Day-to-day verification of system calibration is performed using CELL-DYN
controls. Each laboratory should determine the frequency of performing quality
control. This may be specified by local regulatory agencies.

1-12

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Section 2 Installation Procedures and Special Requirements

Section 2

Installation Procedures and Special Requirements

Overview
An Abbott-authorized representative should perform installation of the
CELL-DYN Emerald System. This is to ensure that all system components are
functioning correctly and to verify system performance. Installation procedures
must be repeated if the instrument is moved from the original installation site.
This section provides information about installation and customization of the
CELL-DYN Emerald. The beginning of this section provides the following
requirements and guidelines for installing the system:
Site requirements
Guidelines for unpacking and inspection, connection and start up, and
relocation
Guidelines for instrument set up by the Operator

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2-1

Installation Procedures and Special Requirements

Section 2

Overview

NOTES

2-2

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Section 2

Installation Procedures and Special Requirements

Site Requirements
Site requirements for installation include the following:
Space requirements
Power requirements
Waste disposal requirements
Installation environment
NOTE: Refer to Section 7: Operational Precautions and Limitations for general
requirements and precautions for system operation.
Space Requirements
Select an appropriate location for the CELL-DYN Emerald System. The
instrument, printer and reagents weigh approximately 88 pounds (40 kg) and
should be placed on a surface that is adequate to support the weight. Allow for
sufficient space on the counter top to place the diluent at the same level as the
instrument.
CAUTION: Diluent must be placed at the same level as the instrument for
proper operation and to prevent bubbles from entering the diluent line.
Allow at least 4 inches (10 cm) of space behind the instrument for airflow. Make
sure there is adequate space around the instrument to perform necessary procedures
or service and allow the instrument to be easily disconnected from the power
source.
NOTE: To ensure the instrument and reagents function properly, it is important to
maintain the temperature between 64o 90o F (18o 32o C).
Place the instrument:
On a stable, level surface.
On a non-porous, non-absorbing work surface and flooring that can be easily
cleaned and disinfected using recommended procedures.
In an area that will not block the ventilation openings.
Away from direct sunlight.
Do not place the instrument near a centrifuge, X-ray equipment, video
display terminal, computer, or copier.
CAUTION: Do not use mobile telephones, wireless telephones, mobile
radios, or any other radio frequency (RF) transmitting devices in the same
room as the instrument.

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Section 2

Site Requirements

Power Requirements
CAUTION: When connections are made, check all connectors for
particles or foreign material that can impair electrical contact.
Refer to Section 4: Performance Characteristics and Specifications for specific
power requirements.
Waste Disposal Requirements
WARNING: Potential Biohazard. Observe all biosafety and chemical
hazard precautions for waste disposal. For a detailed description of the
hazards associated with the CELL-DYN Emerald, refer to Section 8:
Hazards.
Observe the following requirements for waste routing and disposal:
Users are responsible for disposing of waste in accordance with local, state,
and federal regulations.
If a waste container is used, it must be labeled as biohazardous waste.
If a drain is used, it must be suitable for waste that could present a biological
or chemical hazard.
CAUTION: If routing waste to a sink, be sure that the waste outlet tube
is placed securely in the drain hole. To prevent a possible hazard, ensure
that all system components are located away from potential waste
overflow.
Installation Environment
The following are environmental requirements:
Indoor use only
Altitude up to 6562 feet (2000 meters)
Temperature range: 64o 90o F (18o 32o C)
Maximum relative humidity 80% for temperatures up to 90o F (32o C)

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Installation Procedures and Special Requirements

Installation
Inventory and Unpacking
Inspect the packaging before unpacking the instrument. Notify the shipper if there
is any damage. An authorized Abbott representative will uncrate, inspect and place
the instrument in the specified location.
Accessories
Ensure that the following accessories have been received:
Table 2.1

Accessories Kit
Item

Diluent Reagent line with cap

Waste Line with cap

Hand-held barcode scanner

Table 2.2

Installation Kit
Item

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Quantity

Quantity

AC Adapter/Transformer

US Power Cord

European Power Cord

Flat Screwdriver (Key)

CELL-DYN Emerald Service Kit

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Section 2

Installation

Table 2.3

Service Kit
Item

Quantity

Tubing L = 1000 mm 1.5 x 3.2 mm

Tubing L = 500 mm 2 x 4 mm

Tubing 9

Tubing 10

Cable Ties

Short Arm Torx T10 Tool

Short Arm Torx T20 Tool

O-ring Dia 13.1 x 1.6 Fluocarbon

O-ring Dia 1.4 x 1.25 Fluocarbon

O-ring Dia 5 x 1 Fluocarbon

Bottle cap filter

EMLD Grease 3 gm

Instrument Preparation
1. Open the box from the top, remove the packing material and the Accessory
kit.
2. Remove the CELL-DYN Emerald from the box and remove the plastic
covering.
3. Perform the following visual checks:

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Section 2

Installation

1. Lift off the left side door (1) covering the

reagent tray and remove the Installation kit.
Remove the key from the kit and open the
right side door.

1. Ensure the counting chambers (1) are

locked in their manifold locations.
2. Ensure the aspiration probes removable
clip (2) is seated in the rocker (3).
3. Ensure that the rocker is moved all the way
to the front position.
4. Remove foam packing material (4), if
present, from below the valves.
5. Remove protective film from LCD display
on the front of the analyzer.

Figure 2.1

Instrument Inspection

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Section 2

Installation

CAUTION: Moving parts inside. Use care when instrument power is ON.
Electrical Connections
1.
2.
3.
4.
5.
6.
7.
8.

USB Port
USB Port
Ethernet Connection (TCP/IP)
External Bar Code Reader (RS232)
LIS Connection (RS232C)
Printer Connection
Power Cord Connection
For ground use

1
2
3
4
5
6
8

Figure 2.2

Electrical Connections

CAUTION: Only the printer, power, USB, and barcode reader

connections can be made without authorization from Abbott.
AC Adapter
The CELL-DYN Emerald must be connected to power with the AC Adapter/
Transformer provided with the instrument. Place the AC Adapter/Transformer in a
well-ventilated location at the rear of the instrument, away from any potential
liquid spills.
1. Connect the appropriate power cord to the AC
Adapter/Transformer.
2. Connect the AC Adapter/Transformer to the
instrument.
NOTE: Do not force connection. Connection is
made when resistance is felt. Connector may not
appear to be flush with instrument rear panel.
3. Connect the power cord and AC Adapter/
Transformer to a grounded power outlet.

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Section 2

Installation

IMPORTANT: To disconnect power to the CELL-DYN Emerald, unplug the

power cord from the power outlet.
CAUTION: If it is necessary to replace the main power cord, the
replacement must comply with local regulations and should be 12.3"
(31.2 cm) cable with a 110V or 220V, 10A plug. The CELL-DYN Emerald
has been certified with the Power Adapter provided. Use of another Power
Adapter is not recommended.
Printer installation
IMPORTANT: The CELL-DYN Emerald System has been configured for and
tested with the specific printer that is shipped with the instrument. For additional
information about specific printer capability with the CELL-DYN Emerald System
contact your local Abbott Customer Service representative. Use of a printer other
than that recommended by Abbott Laboratories may lead to erroneous printer
functionality.
Please refer to the documentation shipped with the printer for set-up instructions.
For a parallel printer connection, use a parallel, shielded cable, maximum length
10 Ft. (3 M). Connect the cable to the printer connector at the rear of the instrument
and to the connector on the printer. For a USB printer connection, use the cable
provided or recommended by the printer manufacturer.

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Section 2

Installation

Reagent installation
CAUTION: Before handling reagents, refer to the information provided
in Section 1: Use or Function, Subsection: Reagent System.
1. Remove the reagent door on the left side
of the instrument.
2. Place the reagent bottles in their
designated locations and remove the
caps.
3. Place the green collar reagent tubing (2)
and cap on the CELL-DYN Emerald
Cleaner Reagent (1) bottle.
4. Place the blue collar reagent tubing (4)
and cap on the CELL-DYN Emerald
CN-free Lyse Reagent (3) bottle.

Figure 2.3

2-10

4
3

Lyse and Cleaner Reagent Connections

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Section 2

Installation

5. Connect the diluent tubing (male connector) to

the diluent port (lower port) (5), insert the tubing
in the CELL-DYN Emerald Diluent Reagent
container and tighten the cap.
6. Place the diluent at the same level as the
CELL-DYN Emerald.
CAUTION: Diluent must be at the same
level as the instrument for proper operation.
7. Connect the waste tubing (female connector) to
the waste port (upper port) (7), insert the tubing
into a properly labeled waste container and
tighten the cap.
CAUTION: Do not modify the type or length
of the diluent and waste tubing.

7
5

NOTE: Waste container or drain must be placed

lower than the instrument.

Figure 2.4

Diluent Reagent and Waste Connections

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Section 2

Installation

Instrument Start Up
CAUTION: Ensure that the reagent and waste lines have been properly
connected before starting this procedure.
1. Power ON the instrument.
Ensure the AC Adapter and power
cord are connected
Press the POWER/ON/OFF key
2. The Cycle LED turns red and
remains red until the initialization
cycle is complete. The Cycle LED
turns green and the LOGIN screen
displays when the instrument is
ready to use.
NOTE: Cycles Left indicates the
number of runs available. This is
automatically updated, using
information from the reagents bar code
label whenever a reagent is changed, or
based on available capacity in the waste
container, whichever is less. At initial
startup all reagent volumes are set to
zero. Resetting of reagent volumes will
be required as part of the installation
process.
Figure 2.5

Power ON

3. Language Selection:
a. Touch the Dropdown menu and touch the
desired language to select it. It may be
necessary to use the scroll bar at the right of
the Language Dropdown menu to view all
available languages.
b. Touch [OK] to continue.

Figure 2.6

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Language Selection

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Section 2

Installation

Instrument Set Up
Operator Log In and Log Out
Each operator should log in to the CELL-DYN Emerald when operating the
instrument. Log In names can be up to ten characters in length. Each operator
should log out when they have finished running specimens.
The CELL-DYN Emerald provides four access levels (three are passwordprotected). All passwords can be up to four characters in length.
a. User (Operator) no password is entered
b. Lab Tech (Supervisor) default password is 1-2-3. The Supervisor should
enter a new password during the initial instrument set up.
c. Service for Abbott Service Personnel Only
d. Factory for Abbott Manufacturing Personnel Only
NOTE: After the instrument is initialized,
the <LOG IN> field displays the last log in
name that was entered.
1. If the Log In name is correct, proceed to
step a. If not, proceed to step 2.
a. Touch the <PASSWORD> field and

then touch [A-Z] or use the

numeric keypad to enter a
password, if required for access.
Touch each letter to enter it in the
<PASSWORD> field.
b. Touch [CONFIRM] from the alpha
keyboard screen, if used.
c. Touch [OK] to enter the password.
NOTE: To Log In, touch [OPER. LOG
IN/OUT] at the MAIN menu and follow the
steps below.
To Log Out, go to the MAIN menu and
touch [OPER. LOG IN/OUT]. For added
security, you may use the DEL key to
delete your personal LOGIN.
NOTE: To Log In with a different access
level, touch [OPER. LOG IN/OUT] at the
MAIN menu and follow the steps above.
2. To enter a different Operator LogIn

name, touch the data entry box to

the right of <LOGIN>.
a. Use the alpha or numeric keypads as
described above to enter your login
name and password.
Figure 2.7

Operator Log In/Out

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Section 2

Installation

System Status
The current status of the CELL-DYN Emerald can be displayed at any time by
touching the Date/Time display in the upper left corner of the display.
The status is displayed as follows in the
Information window that opens when the Date/
Time display is touched:
1. Instrument Serial Number (ID)
2. Operator ID (USER) the current entry
3. Operators access level for the current entry
4. Setup Version
5. Software (SW) Version
6. Loader current version (used to launch the
instrument software)
Touch [EXIT] to return to the previous menu.
NOTE: The information displayed will represent
the current software version(s) installed on your
instrument and may not match the screen
shown in here.
Figure 2.8

System Status

Loading or Replacing Reagents

CAUTION: Ensure that the reagent and waste lines have been properly
connected before starting this procedure.
The first time the CELL-DYN Emerald is powered ON, it is necessary to load all
three reagents and prime the system as described below.
Whenever a new lot of reagent is put into use, the lot number, expiration date,
container serial number, verification key and container volume should be entered
as directed in the following procedures.
After priming a new reagent, run a background cycle and verify that the results are
within specifications. Repeat background, if needed, until all results are within
specifications.

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Installation Procedures and Special Requirements

Replacing the Reagents Diluent, Lyse, Cleaner

Using Reagent Bar Codes
Barcodes used on the CELL-DYN Emerald reagents monitor reagent usage and expiration date.
From the MAIN menu, touch
[REAGENTS], followed by [DILUENT] to
access the Diluent screen.
1. Remove the empty container and
replace it with a full one.
2. Scan the two barcodes on the label of
the new reagent container to
automatically populate all empty fields.
NOTE: Both barcodes must be scanned to
auto-populate the reagent fields.
3. Verify that all fields are complete. If not,
repeat the scan of both barcode labels.
If entry of reagent information is still not
complete, refer to Manual Entry of
Reagent Information in this section.
4. Touch [CONFIRM]
If the information entry is successful the
[PRIME DILUENT] key turns green.
5. Touch [PRIME DILUENT].
6. Touch [ESC] when finished.
7. To replace the Lyse or Cleaner, touch
[ESC] to return to the REAGENTS
menu and repeat the above steps for
the desired reagent.
Figure 2.9

Reagent Bar Codes

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Replacing the Reagents Diluent, Lyse, Cleaner

Section 2

Manual Entry of Reagent Information

From the Main menu, touch
[REAGENTS], followed by [DILUENT] to
access the Diluent screen.
1. Remove the empty container and
replace it with a full one.
2. Touch the box to the right of <LOT>.
3. Using the A-Z keys (touch [A-Z]) and
the numeric keypad, enter the lot
number.
4. Touch the box to the right of
<EXPIRATION> and use the numeric
keypad to enter the expiration date.
NOTE: The default date format is
DDMMYY. To change the format for all
date fields refer to Section 2: Installation
Procedures and Special Requirements,
Subsection: Other Settings.
5. Touch the box to the right of
<CAPACITY> and use the numeric
keypad to enter the reagent volume.
6. Touch the box to the right of <BOTTLE
SERIAL NUMBER> and use the
numeric keypad to enter the information
on the label.
7. Touch the box to the right of
<VERIFICATION KEY> and use the
numeric keypad to enter the information
on the label.
8. Touch [PRIME DILUENT].
9. Touch [CONFIRM] to save the entries.
The entered information is recorded in
the reagent logs.
10.Touch [CONFIRM] to save entries and
return to the REAGENTS screen.
11. To replace the Lyse or Cleaner, repeat
the above steps for the desired
reagent.
Figure 2.10 Manual Entry of Reagent Information

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Section 2

Replacing the Reagents Diluent, Lyse, Cleaner

Replacing or Emptying the Waste Container

Be sure to label and dispose of waste properly.
CAUTION: Ensure that the waste line has been properly connected
before starting this procedure.
The first time the CELL-DYN Emerald is powered ON, it is necessary to reset the
waste volume as described below.
From the MAIN menu, touch
[REAGENTS], followed by [WASTE].
1. Remove the full container and replace
it with an empty one.
NOTE: Waste container or drain must
be lower than the instrument.
2. Touch the box below and to the right of
<CAPACITY> and use the numeric
keypad to enter the volume of the
waste container.
3. Touch [RESET] or [CONFIRM] to enter
the container capacity into the system
memory.
4. The system will prompt, DO YOU

WANT TO SAVE
MODIFICATIONS? Touch [YES] to
save and return to the Reagents
screen or touch [NO] to return to the
Waste screen.
5. Touch the HOME icon to return to the
MAIN menu.
NOTE: If you are disposing of waste
directly to a drain, enter 99999 in the
capacity field, then proceed as described
in Steps 3 through 5, above. The waste
counter will need to be reset when the
system has dispensed 99999 mL of waste.
Figure 2.11 Changing the Waste Container

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Section 2

Replacing the Reagents Diluent, Lyse, Cleaner

Other Reagent Menu functions

The remaining buttons on the REAGENTS menu are:
1. PRIME ALL - This button is used to prime all reagents at the same time.
2. CYCLE COUNTER The CYCLE COUNTER button displays the
information shown in the following figure.
1. RUNS displays the total number of
runs since the last reset.
2. STARTUP displays the number of
Startup cycles run since the last reset.
3. SHUT DOWN displays the number of
Shut Down cycles run since the last
reset.
NOTE: Only authorized Abbott Personnel
can reset the CYCLE COUNTER.

Figure 2.12 CYCLE COUNTER Screen

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Installation Procedures and Special Requirements

Set Up Menu
If necessary, touch the HOME icon to return to the
MAIN menu. From the MAIN menu, touch [SET UP]
to display the screen shown at the right.
1. Date and Time: Touch <TIME> and use the
numeric keypad to enter the time in the desired
(24 hour or AM/PM) format, If using AM/PM time
format, check the box next to PM to select PM or
deselect (uncheck) for AM. Touch <DATE> and
use the numeric keypad to enter the date in the
selected format. For information about selecting
AM/PM time format and selecting date format, refer
to Subsection: Other Settings within this section.
NOTE: The date format must match the format
defined under the ADVANCED setup menu.
IMPORTANT: Changing time setting. It is possible
to change the time ahead for the start of Daylight
Savings Time without effect on data. To reset the
time back one hour at the end of Daylight Savings
Time, perform this step at the beginning of the day,
after Start Up and before any samples are run to
avoid deletion of results.
IMPORTANT: Changing the date setting. The
Emerald system will delete results (from Datalog,
QC, and Calibration files) if the date is reset to a
past date. Before results are deleted, the system
prompts the user with a warning message that must
be acknowledged. Ensure that the system date is set
correctly prior to first use of the analyzer.
2. Language: Touch the Language dropdown menu
arrow to display the available languages and
touch the desired language to select it.
NOTE: Language may be set from either this display
or at the OPER. LOG lN/OUT screen.
3. Printer: Touch the Printer dropdown menu arrow
to display the available printers and touch the
appropriate printer to select it. An option for no
printer may also be selected.
4. Paper size: Touch the Paper Size dropdown
menu to display the available paper sizes for the
selected printer and touch the desired paper size
to select it.
NOTE: Choose the correct paper size for proper
printer functionality.
Figure 2.13 Date/Time Set Up

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Installation Procedures and Special Requirements

Set Up Menu

Section 2

5. AUTO SID: Touch the AUTO SID box to select

automatic incrementing of the SID. This should
only be selected if auto-increment of the SID is
required in your laboratory.
6. Touch <START DAY SID> and use the numeric
keypad to enter the first SID for each day.
7. Touch <CURRENT SID> and use the numeric
keypad to enter a new SID for the current run.
NOTE: The AUTO SID box must be checked in
order to enter Start Day SID and Current SID.
8. ADVANCED: Information about the use of this
button can be found in the next Subsection:
Advanced Set Up.
9. When entries are complete:
Touch [CONFIRM] to save the entries. At the
pop-up prompt DO YOU WANT TO SAVE
MODIFICATIONS?, touch [YES] to save and
exit. Touch [NO] to change the entry. Touch
[ESC] to exit without saving changes.
10.PRINTER 3 UPDATE: For instructions on how to
copy a new printer driver from a USB drive, refer
to subsection: USB Drive (Thumb Drive) in
Section 5: Operating Instructions.

Figure 2.13 Date/Time Set Up (Continued)

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Installation Procedures and Special Requirements

Section 2

Set Up Menu

Advanced Set Up
The Advanced Set Up button is available from Lab Tech access level and higher.
CAUTION: Any changes to these options can affect the quality of results.
Do not modify these settings until you have been properly trained to do so.
1. From the MAIN menu, touch [SET UP],
and then touch [ADVANCED] to
display the screen shown at the right.
2. Each button is described in detail on
the following pages.

Figure 2.14 Advanced Set Up Menu

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Section 2

Set Up Menu

Printer Button
The Printer Button accesses the PRINTER SET UP menu that is used to configure
the printed report.
Touch the corresponding check box to
select from the following options:
1. EXPECTED VALUES prints the
laboratorys reference range (Patient
Limits) on each report.
2. HEADER prints a specified header.
Touch the header entry fields below the
Print Box and then touch [A-Z] and
enter header information, if desired.
3. COMMENTS - provides space for
handwritten comments on the printed
report.
4. UNITS prints the selected units on
the report.
5. INTERP. RPT prints the Interpretive
Report messages based on the Patient
Limits entered in step 1. Refer to the
following sub-section for a description
of the messages.
6. FLAGS prints all flags on the report.
7. GRAPHS prints all histograms on the
report.
8. AUTOPRINT To automatically print
ANALYSIS (Patients Results), QC
(Quality Control Result) or STARTUP
(Startup Results) select the
appropriate box(es).
To deselect an option, touch the check box
again.
When all selections have been made,
touch [CONFIRM] to exit and save the
entries. Touch [ESC] to exit without saving
changes.
Figure 2.15 Printer Set Up

Interpretive Report
Interpretive messages display and are printed when the values entered for Patient
Limits are exceeded. These messages display and print only when the Interpretive
Messages (Interp. Rpt) option on the Printer Set Up screen is selected.
Refer to Section 3: Principles of Operation, Table 3.7, Interpretive Report for a
comprehensive listing of interpretive messages.

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Section 2

Set Up Menu

Communication Button
This button is used to configure the data transmission between the CELL-DYN
Emerald and a host Laboratory Information System (LIS).
Touch the corresponding box to select the
desired option.
1. HOST SERIAL Used to select RS232
communication mode.
2. HOST NET Used to select data TCP/IP
communication mode.
3. NONE Used when no data
transmission is desired.
4. EMERALD NUMBER Used to identify
instruments when more than one
Emerald is connected to the LIS system.
5. DELAY (ms) Lag time for start of
transmission in milliseconds.
6. HANDSHAKE If this box is selected,
data will not be transmitted if there are
any errors in the acknowledgement
process. If not selected, all data will be
transmitted regardless of
acknowledgement errors.
7. SERIAL PARAM Used to access
system configuration parameters for data
transmission via the RS232 port.
8. NET. PARAM. Used to access system
configuration parameters for data
transmission via TCP/IP or UDP/IP using
the Ethernet port.
9. Touch [CONFIRM] to save entries or
touch [ESC] to return to Main Menu.

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Section 2

Set Up Menu

Reporting Options Button

The Reporting Options Button is used to select other options for running the
instrument and for the printed report.
Touch the corresponding check box to select from the
following options:
1. NAME REQUIRED - To run a specimen, operator
must enter the patients name.
2. PID REQUIRED - To run a specimen, operator must
enter the patients ID number.
NOTE: When Name and/or PID is selected, the name
and/or PID must be entered or the probe will not descend.
3. STARTUP ALARMS
When the STARTUP ALARMS box is selected:
a. The message STARTUP FAILED displays and
prints below the results when the Startup cycle
failed.
b. The message STARTUP NOT DONE displays and
prints below the results when a Startup cycle has
not been run.
4. IUO For Abbott service use only.
5. US MODE For Abbott service use only.
6. ABSOLUTE LMG When selected, absolute values
for Lymphocytes, Mid Cells and Granulocytes are
displayed. When deselected, percent values for
Lymphocytes, Mid Cells and Granulocytes are
displayed. Regardless of selection, absolute and
percent Lymphocytes, Mid Cells and Granulocytes are
printed and sent to the LIS.
7. QC ALARMS When the QC ALARMS box is
selected:
a. The message QC ALERT displays and prints below
the patient results when the QC results are out of
tolerance or the lot has expired. The system must be
configured to display these flags. See Section 2:
Installation Procedures and Special
Requirements, Subsection: Reporting Options
Button.
b. The message QC NOT DONE displays and prints
below the results when QC has not been run on the
current date.
8. Units* Three unit systems are available:
a. Standard (USA)
b. SI (International System of Units)
c. SI MOD (Modified International System of Units)
Figure 2.16 Reporting Options Set Up

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Section 2

Set Up Menu

9. Bar Code Reader The bar code is assigned to the

PID, name or SID
10.BOLD DISPLAY Selected options will display and
print in bold face type:
a. +++++ D result exceeds reportable range
b. PANIC HIGH (H) result exceeds entered high limit
c. LIMIT HIGH (h) result exceeds entered high
Patient limit but below Panic High (H) limit
d. DIL result exceeds linearity limit
(not used)
e. PANIC LOW (L) result is below entered low limit
f. LIMIT LOW (l) result is below entered low Patient
limit but above Panic Low (L) limit
g. REJECT (*) count or measurement rejection
h. When all selections have been made, touch
[CONFIRM] to exit and save the entries. Touch
[ESC] to exit without saving changes.
NOTE: Flags are discussed in detail in Section 3:
Principles of Operation.
*Refer to Table 3.2, Report Units, Section 3, Principles
of Operation for examples of each type of units.
Figure 2.16 Reporting Options Set Up (Continued)

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Installation Procedures and Special Requirements

Section 2

Set Up Menu

Lab Preferences Buttons

The options on the Lab Preferences menu allow the laboratory to configure the
limits and calibration adjustments for specimen types other than STANDARD. It
also allows the laboratory to define limits for the STANDARD specimen type.
NOTE: Thresholds and Specimen Cal. Adjustments cannot be edited for the
STANDARD specimen type.
This menu is used to define the
measurands associated with Specimen
Types other than STANDARD.
Descriptions of these options follow. The
options are:
1. TYPE
2. LIMITS
3. THRESHOLDS For Factory use
only.
4. ALARMS For Factory use only.
5. SPECIMEN CAL. ADJUSTMENTS
6. RENAME SPECIMENS
Figure 2.17 Modify Specimen Settings Menu

Type
This menu allows the operator to define up to 19 different types of specimens. For
example, specimen types can be used to establish separate limits for males,
females, neonatal, pediatric and other specimen types. In the Lab Preferences
menu, one can define separate Limits & Calibration Factors for each specimen
type. After defining specimen types in the Lab Preferences menu, the user can
choose a specific specimen type from the Run Sample screen and the
pre-defined limits and calibration factors set here will be applied.
IMPORTANT: When a non-Standard specimen run is completed, be certain to
select Standard from the dropdown menu on the Next Sample set up screen.
The Standard selection re-sets the instrument to the Standard Limits and
Calibration Factors.

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Section 2

Set Up Menu

Limits
This screen allows entry of the
laboratorys Expected (l, h) and Panic
(L, H) limits.
1. Touch each entry field and use the
numeric keypad to type in the values.
2. Touch [ ] to display the remaining
measurands as shown on the
following screen.
3. Touch each entry field and use the
numeric keypad to type in the values.
4. When all entries have been made,
touch [CONFIRM] to exit and save the
entries. Touch [ESC] to exit without
saving changes.
5. Touch [<<] or [PREVIOUS SCREEN]
to return to the previous screen.
NOTE: Limits may be defined for any
specimen type, including STANDARD.

NOTE: Stored Patient Limit Set Flagging can be affected if limits are changed.
NOTE: The CELL-DYN Emerald does not have limits Factory Set. It is the responsibility of each laboratory
to determine limit sets appropriate for its patient population. A list of references for limit sets and limit set
determination may be found in Appendix D: CBC Reference Intervals: Literature Sources.
Figure 2.18 Limits Entry

SPECIMEN CAL. ADJUSTMENTS

This option allows the user to enter a manually calculated calibration factor for
non-standard specimen types. For information about calculation of calibration
factors, please refer to Appendix F.
IMPORTANT: Use care when modifying and using these factors so that results
are not adversely affected.
Thresholds
Thresholds are only accessible to Abbott personnel.
Alarms
Alarms are only accessible to Abbott personnel.

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Section 2

Set Up Menu

1. From the LAB PREFERENCES menu,

touch the Type dropdown menu to
select the specimen type.
2. Touch [Specimen Cal. Adjustments].
NOTE: This option is not available for
the Standard Specimen type.
3. Touch the entry field next to each
measurand to edit, entering new values
using the numeric keypad.
4. When entries are complete, touch
[CONFIRM] to exit and save. Touch
[ESC] to exit without saving changes.
Figure 2.19 Calibration Factor Entry

Rename Specimen Type

This option is used to rename specimen
types 2 through 20.
1. From MAIN menu touch [SET UP].
2. Touch [ADVANCED], then [LAB
PREFERENCES].
3. Touch [RENAME SPECIMENS].
4. Touch Radio Button next to file to be
renamed.
5. Touch [A..Z].
6. Type in the specimen type name.
Touch [CONFIRM] to save the entry.
Touch [ESC] to exit without saving
changes.
7. At the next screen, touch [CONFIRM]
to save the entry.
8. Select [YES] at Pop Up DO YOU

WANT TO SAVE
MODIFICATIONS?
Repeat this procedure to define
additional specimen types.
Figure 2.20 Specimen Types Set Up

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Section 2

Set Up Menu

Calibration Factors
This option allows the operator to assign manually calculated calibration factors to
the standard specimen type.
IMPORTANT: Modifying these factors without performing the calibration
procedure will adversely affect results.
To change values for a selected specimen
type:
1. Touch [CALIBRATION FACTORS].
2. Touch the entry screen next to the
desired measurand.
3. Use the numeric keypad to enter the
value.
4. When entries are complete, touch
[CONFIRM] to exit and save the
entries. Touch [ESC] to exit without
saving changes.

Figure 2.21 Changing Calibration Factors

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Section 2

Set Up Menu

Other Settings
The Other Settings Button displays the following screen.
The Delay Box is used to configure the following
options:
1. SHUT DOWN Sets the time in minutes
between automatic shut down cycles.
a. Touch the entry field and use the numeric
keypad to enter the time in minutes. The default
value is 180 and the range is 30-480 minutes
2. PROBE UP Sets the time in minutes to retract
the probe when the instrument is not in use.
a. Touch the entry field and use the numeric
keypad to enter the time in minutes. The
default value is 5 minutes and the range is 1
to 60 minutes.
3. SET AUTOCLEAN Configures the system to
automatically run an Auto-clean cycle when the
specified number of cycles is reached.
a. Touch the entry field next to
<SET AUTOCLEAN> to select the option.
b. Touch the entry field next to <CLEAN
INTERVAL> and use the numeric keypad to
enter the number of cycles. The default value
is 80 cycles and the range is 10 to 5000 cycles.
NOTE: The maximum number of runs
recommended between Autoclean cycles is 80.
NOTE: Automatic autoclean occurs only when the
number of samples run since Start Up on a single
day exceeds the number entered at
<CLEAN INTERVAL (CYCLES)>.
4. PRESSURE CHECKING For Abbott Service
Personnel only.
5. The LAB TECH PASSWORD field can be used
to change the current password. Touch the
entry field and use either [A-Z] or the numeric
keypad to enter a new password. Make sure to
record the password for future reference.
6. The DATE FORMAT dropdown menu is used to
select the format for the date. Available options
are:
a. DD/MM/YY
b. MM/DD/YY
c. YY/MM/DD
Touch the dropdown menu button and then
touch the desired format to select it.

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Section 2

Set Up Menu

7. When entries are complete, touch

[CONFIRM] to exit and save the entries.
Touch [ESC] to exit without saving
changes.
8. STORAGE
The Storage option allows the operator to
define specific data storage options.
a. DATALOG OPTIONS
There are two options for internal data
storage management on the
CELL-DYN Emerald.
i. If the box next to FIFO MODE is not
selected, the datalog must be
manually managed. When the internal
CELL-DYN Emerald memory is full,
the system prompts the user to delete
results to allow additional results to be
stored.
ii. If FIFO MODE is selected, the system
manages datalog storage
automatically. As the datalog becomes
full, the system automatically deletes
results on a first-in-first-out basis.
IMPORTANT: Because FIFO MODE
automatically deletes results without notifying
the operator, it is important to have a backup
system in place to avoid loss of data. One
example of a backup system is autoprinting of
results and storage of the paper record.
b. EXT. STORAGE DEVICE OPTIONS
External storage device options allow the
direct storage of datalog data to a
formatted USB drive.
i. If REAL TIME RUNS SAVE is
selected, the CELL-DYN Emerald will
store the results directly onto the USB
drive inserted into the analyzer.
ii. If REAL TIME RUNS SAVE is
deselected, all datalog storage is in
the systems internal memory.
This sub-menu allows you to format the USB
drive before use on the Emerald system by
using the FORMAT EXT. STORAGE DEVICE
key. Refer to Section 5: Operating
Instructions, and Subsection: USB Flash
Drive (Thumb Drive) for additional
information.
Figure 2.22 Other Settings Set Up
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Section 2

Set Up Menu

Version Release
The VERSION RELEASE button allows the operator to perform software upgrades
from the USB storage device.
1. Insert the USB key with the software upgrade in a free USB port on the rear
of the instrument.
NOTE: If another USB key is present in the other USB port, it must be removed
before proceeding.
2. Touch the [VERSION RELEASE] button.
3. Select the software version in the table on the right side of the screen by
touching the corresponding number in the left column.
4. The selected software version will display in the text entry field on the left
side of the display, below [VERSION RELEASE]. After confirming the
correct version of software is displayed, touch the [LOAD] button.
5. A pop-up message will display asking you to confirm loading the file. Touch
[YES] to continue with the software upgrade or [NO] to escape without
loading the software.
6. Follow any instructions on the screen during the software upgrade process.
7. When the software is successfully loaded, a confirmation message will
appear on the display.
Setup Configuration Printout
This Option allows the operator to print a copy of their SETUP menu
configuration.
From the MAIN menu
touch [SET UP].
1. Touch the [TOOL]
Icon. Touch [PRINT].
2. This print-out
contains most of the
setup menu
configuration. Save
this document for
future use.

Instrument Quality Checks

When installation and set up are complete, the following procedures are used to
finalize installation and prepare the instrument for running specimens. When all
procedures have been successfully completed, the instrument is ready to run
specimens and report results.
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Section 2

Set Up Menu

Start Up
From the MAIN menu, touch [START UP] to run the Start Up Cycle. The cycle
takes approximately two minutes. The cycle primes and flushes cleaner out of the
system, and checks the mechanical and electronic systems. At the end of the cycle,
a background count is automatically run and printed (if a printer is connected and
configured). When more than one background count is performed during Start Up,
only the final count is printed. If the Start Up cycle is successful, the operator is
returned to the MAIN menu, the Status LED turns green and the instrument is ready
to run specimens. If the Start Up cycle is unsuccessful, the message START UP
FAILED displays. If START UP FAILED displays, touch [START UP] again to
repeat it a second time. If Start Up fails two times, refer to Section 10,
Troubleshooting for guidance.

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Set Up Menu

Section 2

Background Count
A background count is automatically run at the end of the Start Up cycle.
Background counts can be run at any time by touching the Start Switch located
behind the Aspiration Probe. Results must be within specifications before
proceeding.
Startup Specifications can be found in Section 4: Performance Characteristics
and Specifications:
If startup background counts exceed limits refer to Section 10: Troubleshooting.
NOTE: The system must be configured to print the Start Up background count.
Carryover
Check the carryover as described in Section 4: Performance Characteristics and
Specifications.
Calibration
Complete the Pre-Calibration procedures and then verify calibration as described
in Section 6: Calibration.
Quality Control
When calibration has been verified, run three levels of control material as
described in Section 11: Quality Control.

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Section 3 Principles of Operation

Section 3

Principles of Operation

Overview
The CELL-DYN Emerald is designed to automatically perform the following
functions:
Aspirate and dilute whole blood
Count, size and classify cells present in a whole blood specimen
Measure the hemoglobin concentration of a whole blood specimen
Analyze the raw data that is collected
Output results to the display, printer and laboratory information system
Two types of measurements and several innovative techniques are used to count,
size and classify blood cells and to measure hemoglobin. The two types of
measurements are:
Electrical Impedance Counting used for WBC, RBC and PLT
measurements
Absorption Spectrophotometry used for HGB measurement
Hemoglobin measurement is carried out in the WBC Counting Chamber using
absorption spectrophotometry. The reagent used for Hemoglobin measurement is
cyanide-free. Each measurement is discussed in detail as it relates to each
measurand.
This section also discusses Instrument Alarms and Data Flags.

Sample Analysis Cycle Overview

NOTE: Sample and reagent volumes given in this section are stated as the
nominal values. Slight differences between instruments may cause these
volumes to vary.
The CELL-DYN Emerald aspirates 9.8L of whole blood from a well-mixed, open
collection tube held under the Aspiration Probe. After the outside of the probe is
rinsed, the Diluent Syringe dispenses 2mL of diluent to deliver the blood to the
WBC Counting Chamber. The dilution is bubble mixed. The Aspiration Probe is
rinsed and then aspirates 20L of this dilution and delivers it to the RBC Counting
Chamber where 1.5mL of diluent is added for the RBC/PLT dilution. Then,
0.38mL of lyse is added to the WBC Counting Chamber and the dilution is bubble
mixed again for the WBC/HGB dilution. Final dilution ratios are:
WBC/HGB = 1:244
RBC/PLT = 1:15,000

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Overview

Measurement Principles
Impedance Counting
Electrical Impedance counting is used to count and size WBCs, RBCs and
platelets. This method is based on the measurement changes in an electrical current
produced by particles (cells), suspended in a conductive liquid, as they pass
through an aperture of known dimensions. An electrode is submerged in the liquid
on either side of the aperture to create an electrical pathway through it.
As each cell passes through the aperture, a transitory change in the resistance
between the electrodes is produced. This change produces a measurable electrical
pulse. The number of pulses indicates the number of cells that traversed the
aperture. The amplitude of each pulse is essentially proportional to the volume of
the cell that produced it.
Each pulse is amplified and compared to internal reference voltage channels. These
channels are delineated by calibrated size-discriminators to accept only pulses of
certain amplitude. Thus, pulses are sorted into various size channels according to
their amplitude.
WBC Analysis
The instrument aspirates 9.8L from the whole blood specimen. The blood is
mixed with 2mL of diluent and 0.38mL of Lyse in the WBC counting chamber. The
lyse reagent destroys the RBC and resultant stroma and perforates the WBC
cytoplasmic membrane allowing the cytoplasm to escape. The WBCs are counted
directly by impedance and the Differential measurands are obtained from the
graph:
WBC

White Blood Count

LYM%

Lymphocyte Percent

LYM#

Lymphocyte Absolute Number

MID%

Mid Cell Percent

MID#

Mid Cell Number

GRA%

Granulocyte Percent

GRA#

Granulocyte Absolute Number

The Mid Cell fraction includes monocytes, eosinophils and basophils.

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Overview

Figure 3.1

WBC Graph

The preceding figure shows the WBC Graph. The lymphocytes are located
between the beginning of the curve and the M1 line. Mid Cells are located between
M1 and M2. Granulocytes are located between the M2 line and the end of the
curve. When the WBC result is outside the pre-set specification, the WBC
differential measurands and the graph are suppressed.
The WBC measurands are expressed as follows:
WBC

# K/L

LYM

# K/L and %

MID

# K/L and %

GRA

# K/L and %

RBC Analysis
The instrument aspirates 20L of the dilution from the WBC Counting chamber
and adds 1.5mL of diluent to the RBC Counting Chamber for the RBC/PLT
dilution. The RBCs are counted directly by impedance and four measurands are
obtained:

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RBC

Red Blood Count

HCT

Hematocrit

MCV

Mean Cell Volume

RDW

Red Blood Cell Distribution Width

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Overview

Figure 3.2

RBC Graph

The Hematocrit (HCT) is the ratio of red blood cells to plasma and is expressed as
a percentage of the whole blood volume. It is derived from the volume of the RBCs
that are counted during the measurement cycle.
The mean cell volume (MCV) is the average volume of individual RBCs.
MCV =

HCT x 10
RBC

The Red Cell Distribution Width (RDW) is a measurement of the heterogeneity of

the RBC population. It is derived from the distribution of the RBC graph.
The RBC measurands are expressed as follows:
RBC

# M/L

HCT

MCV

femtoliters (fL)

RDW

% CV (coefficient of variation)

Platelet Analysis
Platelets are counted directly by impedance in the RBC Counting Chamber
at the same time as RBCs.
PLT

Platelet Count

MPV

Mean Platelet Volume

Figure 3.3

Platelet Graph

The MPV is derived from the platelet graph after the platelet count has been
determined.
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The PLT measurands are expressed as follows:

PLT

# K/L

MPV

femtoliters (fL)

Absorption Spectrophotometry and Hemoglobin Measurement

Hemoglobin is measured using a methemoglobin chromagen formed using the
cyanide-free lytic reagent. The methemoglobin is measured by means of
absorption spectrophotometry using a 555 nm LED as the light source. The LED
shines through the WBC counting chamber after the WBC count is completed. The
Hemoglobin concentration is directly proportional to the absorbency of the sample.
A blank reading is made during the rinse. The blank and sample readings are
compared to determine the hemoglobin concentration of the sample. Three
measurands are obtained:

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HGB

Hemoglobin concentration

MCH

Mean Cell Hemoglobin

MCHC

Mean Cell Hemoglobin Concentration

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Overview

The Hemoglobin value is used to calculate the MCH and MCHC as follows:
The MCH is the average amount of HGB contained in the RBC. It is calculated as
follows:
MCH = HGB x 10
RBC
The MCHC is the ratio of the weight of HGB to the volume of the average RBC.
It is calculated as follows:
MCHC = HGB x 100
HCT
The HGB measurands are expressed as follows:
HGB

g/dL

MCH

picograms (pg)

MCHC

g/dL

Measurand Reporting Conventions

Results can be expressed in different units of measurement as selected by using the
Reporting Options button on the ADVANCED SET UP menu. For instructions for
selecting units, refer to Section 2: Installation Procedures and Special
Requirements, Subsection: Instrument Set Up.
Some units are reported as exponential units. For example, 10e9/L, meaning 109/L
and 10e3/L, meaning 103/L.
The following exponents are also used for reporting numerical results. These may
be used for number of cells, cell volumes, or grams of material per quantity of
whole blood.
Table 3.1

3-6

Exponents Values
Exponents Value

Prefix

Symbol

1012

tera

109

giga

106

mega

103

kilo

10-6

micro

10-12

pico

10-15

femto

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Overview

Examples of the same specimen run with each of the available unit selections are
shown in the following table.
Table 3.2

Report Units
USA

Measurand

SI

SI MOD

Value

Units

Value

Units

Value

Units

WBC*

5.32

K/L

5.32

G/L

5.32

10e9/L

RBC

5.15

M/L

5.15

T/L

5.15

10e12/L

HGB

16.2

g/dL

162

g/L

10.1

mmol/L

HCT

47.6

0.476

L/L

0.476

L/L

MCV

92.3

fL

92.3

fL

92.3

fL

MCH

31.5

pg

31.5

pg

1.96

fmol

MCHC

34.1

g/dL

341

g/L

21.2

mmol/L

RDW

12.5

12.5

%CV

12.5

%CV

PLT

323

K/L

323

G/L

323

10e9/L

MPV

8.26

fL

8.26

f/L

8.26

fL

LYM#, MID# and GRA# are reported in the same units as WBC

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Overview

NOTES

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Principles of Operation

Instrument Alarms, Operational Alerts, and Measurand

Data Flags
The alarm messages and data flags on the CELL-DYN Emerald may be instrument
or measurement-related. Flags display to the right of the result field on the instrument
display and Alarm messages display in the Flags box, located below the results.

Instrument Alarms
There are two instrument alarm messages:
INS_T Indicates that the ambient temperature is lower than 63 F (17 C)
or higher than 91 F (33 C). Verify that the instrument is installed in an
environment that is within the installation environment listed in Section 2:
Installation Procedures and Special Requirements.
All results are invalidated (flagged with *) when this alarm appears.
INS_H Indicates that the hemoglobin channel is saturated. All results are
invalidated. Perform a start up cycle.

Operational Alerts
There are four operational alerts:
STARTUP NOT DONE
STARTUP FAILED
QC NOT DONE
QC ALERT
STARTUP NOT DONE A Start Up cycle has not been performed on the current date.
Action: Perform a Start Up cycle. Do not perform QC or patient testing until the
issue is resolved.
STARTUP FAILED Indicates that the last Start Up cycle did not meet specifications.
Action: Perform a Start Up cycle.
WARNING: Do not perform QC or patient testing until the Start Up passes.
If the Start Up cycle has been repeated twice without resolution refer to Section 10:
Troubleshooting, for additional information.
QC NOT DONE Indicates that a QC run has not been performed on the current date.
Action: Run QC according to your laboratorys requirements.
QC ALERT Indicates QC failed for one or more measurands on one or more levels

of control material. The system must be configured to display these flags.

See Section 2: Installation Procedures and Special Requirements,
Subsection: Reporting Options Button.
Action: Refer to Section 10: Troubleshooting, to resolve the out of range QC and
repeat the QC test(s).
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Instrument Alarms, Operational Alerts, and Measurand Data Flags

Measurand Data Flags

The CELL-DYN Emerald displays a measurand flagging message when a sample
exhibits any reportable abnormalities as detected by the analyzer. The messages are
created when one of the following sample abnormalities is present:
Dispersional Data Alerts (H, h, L, l, ++++, D, ----)
Suspect Measurand Flags
Count Invalidation Flags (*)
Dispersional Data Alerts
There are five levels of values for the CELL-DYN Emerald:
Patient Limits are established closest to the normal or typical patient results
and are set according to the type of patient samples to be run. The operator
can define Patient Limits. Refer to Section 2: Installation Procedures and
Special Requirements.
Panic Limits are set outside the Patient Limits but inside the Display Range.
Panic limits serve to alert the Operator that results deviate from the Patient
Limits by a significant degree. The Operator can define panic limits. Refer to
Section 2: Installation Procedures and Special Requirements.
Analytical Measurement Range (AMR or Linearity) represents the range
over which the system will yield accurate results. Consult Section 4:
Performance Characteristics and Specifications, for additional information
on AMR.
Display Range is set by the system software and reflects the defined limits
of the screen display and printer output. The Operator cannot change these
limits.
The Low Events Count is defined by the system software. The Low Events
Count limits applies only to WBC, RBC, and PLT are as follows:
WBC < 1.0 K/L
RBC < 0.5 M/L
PLT < 10.0 K/L
Histograms are not displayed or printed for low event count results. WBC
differential results are not displayed or printed for WBC low event count results.
HCT, MCV, MCH, MCHC and RDW are not displayed or printed for RBC low
event count results. MPV is not displayed or printed for PLT low event count
results.

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Instrument Alarms, Operational Alerts, and Measurand Data Flags

It is suggested that one Patient Limits set or the Panic Limits set be used to enter
instrument-specific laboratory action limits. A result that falls outside a laboratory
action limit can also indicate the need for the operator to follow a laboratory
protocol, such as repeating the sample, performing a smear review or notifying the
physician. In cases where a cellular abnormality is present that alters cellular
morphology to the extent that the cells do not fit the criteria used by the instrument
to generate a flag, dispersional data alerts may be the only flag(s) that will alert the
operator to a potentially erroneous result.
Action: When a result is flagged with a Patient or Panic Limits alert, it is
recommended that you follow your laboratorys review criteria, which may include
review of a stained smear to verify the result and to check for the presence of any
additional abnormality.
If results for a measurand exceed the upper end of the Display Range, a numeric
result does not appear on the screen or printout. Instead, plus symbols (++++)
appear in the results area and the letter D appears and prints to the right of the
++++.

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Instrument Alarms, Operational Alerts, and Measurand Data Flags

Table 3.3

Dispersional Data Alerts

Flag Result* Interpretation

D

++++

Applicable
Measurands

Trigger

Other Affected
Measurands

Affected
Measurand
result

Result is above WBC

the upper
Display Range

>100K/L

LYM
GRA
MID

----------

RBC

>8.0M/L

HCT
MCV
MCH
MCHC
RDW

----------------

MCV

>150fL

HCT
RBC
MCH
MCHC
RDW

----------------

HGB

>25g/dL

MCH
MCHC

-------

HCT

>80%

MCV
RBC
MCH
MCHC
RDW

----------------

PLT

>1500K/L MPV

----

Result
Flag Color on
Color on
Display
Display
Magenta

White

XXXX

Result is above All

the upper
Patient Limits,
but below the
upper Panic
Limits.

Based on
limit
definition

N/A

N/A

Magenta

Magenta

XXXX

Result is below All

the lower
Patient Limits,
but above the
lower Panic
Limits.

Based on
limit
definition

N/A

N/A

Yellow

Yellow

XXXX

Result is above All

the upper Panic
Limits.

Based on
limit
definition

N/A

N/A

White text on Magenta

a red
background

XXXX

Result is below All

the lower Panic
Limits.

Based on
limit
definition

N/A

N/A

White text on Magenta

a red
background

*Where XXXX represents a numeric value.

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Instrument Alarms, Operational Alerts, and Measurand Data Flags

WBC Flags
L1
CL1

CL1-2

L2

CL2-2

Figure 3.4

L3
CL2

CL2-3

L4

L5

CL4

CL5

WBC Flags and Possible Causes

L1

Platelet Aggregates
NRBCs
Giant Platelets
Cryoglobulins
Incomplete Lysis of RBC
Small Lymphocytes
Fibrin Clots
Shift in WBC cell distribution due to EDTA anticoagulant equilibration

L2
Myelocytes
Lymphoblasts
Basophils
L3
Eosinophils
Myelocytes
L4
Granulocyte volume is too low
L5
Large size cells present
The WBC Flagging Regions are shown in the previous figure. All WBC flags are
shown in white text in the Flags box at the bottom of the result screen.
WBC Suspect Measurand Flags
These flags are generated after the instrument evaluates the measured data for a
particular measurand or group of measurands. The result may be suspect due to
interfering substances or the inability of the instrument to measure a particular
measurand due to a sample abnormality. The name of each flag, how it is displayed,
the cause of the flag, and the action to be taken are given in the following
explanations.

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Principles of Operation
Section 3

Instrument Alarms, Operational Alerts, and Measurand Data Flags

Table 3.4

WBC Flags
Result
Flag

Measurand

Text in
Flags Box

Result
Displayed

Cause

Action

WBC and
Differential

L1 (white
text)

XXXXX

May be due to platelet

aggregates, NRBCs,
giant platelets,
cryoglobulins,
incomplete lysis of
RBC, small
lymphocytes, fibrin
clots, shift in WBC cell
distribution due to EDTA
anticoagulant
equilibration.

Check the specimen for

clots or agglutination.
Follow your laboratorys
review criteria or review a
stained smear to confirm
the differential results
and verify the WBC
count. Redraw and retest
the specimen as
required.

Differential

L2 (white
text)

XXXXX

May indicate the

presence of
myelocytes,
lymphoblasts, or
basophils.

Check the specimen for

clots or agglutination.
Follow your laboratorys
review criteria or review a
stained smear to confirm
the differential results.
Redraw and retest the
specimen as required.

Differential

L3 (white
text)

XXXXX

May indicate the

presence of eosinophils
or myelocytes.

Check the specimen for

clots or agglutination.
Follow your laboratorys
review criteria or review a
stained smear to confirm
the differential results.
Redraw and retest the
specimen as required.

Differential

L4 (white
text)

XXXXX

Granulocyte volume is
too low.

Check the specimen for

clots or agglutination.
Follow your laboratorys
review criteria or review a
stained smear to confirm
the differential results.
Redraw and retest the
specimen as required.

Differential

L5 (white
text)

XXXXX

Large-size cells
present.

Check the specimen for

clots or agglutination.
Follow your laboratorys
review criteria or review a
stained smear to confirm
the differential results
and verify the WBC
count. Redraw and retest
the specimen as
required.

3-14

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Principles of Operation
Section 3

Instrument Alarms, Operational Alerts, and Measurand Data Flags

Platelet (PLT) Flags

P1

P2

CP1

Figure 3.5

CP2

CP3-2
P3

P CP3

PLT Flags

The PLT Flagging Regions are shown in the previous figure. All PLT flags are
shown in yellow text in the Flags box at the bottom of the result screen.
PLT Suspect Measurand Flags
These flags are generated after the instrument evaluates the measured data for a
particular measurand or group of measurands. The result may be suspect due to
interfering substances or the inability of the instrument to measure a particular
measurand due to a sample abnormality. The name of each flag, how it is displayed,
the cause of the flag, and the action to be taken are given in the following
explanations.
PLT Suspect Measurand Flags invalidate the PLT count and all measurands
calculated from the PLT count (MPV).

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Principles of Operation
Section 3

Instrument Alarms, Operational Alerts, and Measurand Data Flags

Table 3.5

Platelet Flags
Result
Flag

Measurand

Text in
Flags Box

Result
Displayed

Cause

Action

PLT, MPV

P1 (yellow
text)

XXXXX

May indicate the

presence of an
abnormal quantity of
debris, contaminated
reagent, electronic
noise, microbubbles,
or small cells.

Check the background

count. Refer to Section 5:
Operating Instructions. If
the background count is
within the limits, perform
another run on the same
specimen. If the flag
persists, review a stained
smear to determine the
cause of the interference
and verify the PLT count by
a different method.

PLT, MPV

P2 (yellow
text)

XXXXX

May indicate the

presence of
schistocytes.

Review a stained smear to

determine the cause and
confirm the PLT count.

PLT, MPV

P3 (yellow
text)

XXXXX

May indicate the

presence of
microcytic RBCs,
schistocytes, giant
platelets, sickle cells,
platelet clumps.

Review a stained smear to

determine the cause and
confirm the PLT count.

3-16

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Principles of Operation
Section 3

Instrument Alarms, Operational Alerts, and Measurand Data Flags

Count Invalidating Flags

These flags are generated by the instrument when the measurement fails internal
check criteria and appear in the Flags box below the displayed or printed results.
R_CL
W_CL
R_CLW_CL
HGB COUNT INVALID
Table 3.6
Flag

Count Invalidating Flags

Result

Interpretation

Applicable
measurands

Flag
Color on
Display

Flag color in
Flags box

Other affected
results

R_CL

---- *

Measurement
rejected/
invalidated,
possible RBC/
PLT aperture
clog.

RBC, PLT

white

red

All results are

invalidated.

W_CL

---- *

Measurement
rejected/
invalidated,
possible WBC
aperture clog.

WBC

white

white

All results are

invalidated.

R_CLW_
CL

---- *

Measurement
rejected/
invalidated,
possible RBC/
PLT and WBC
aperture clogs.

RBC, PLT,
WBC

white

red

All results are

invalidated.

HGB
COUNT
INVALID

---- *

HGB blank
reading failed.

HGB

white

white

All results are

invalidated.

Warning, Information, and Input Error Pop-Ups

Under certain circumstances the CELL-DYN Emerald will prompt the Operator
with a Warning, Information, or Input Error Pop-Up message. These Pop-Ups
display a message that requires a response from the Operator. In some cases, the
message will display until the Operator acknowledges the message. Some of the
circumstances, where Pop-Ups occur are as follows1:
1. This table is not inclusive of all Warning, Information, or Input Errors displayed by the CELL-DYN Emerald.

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Principles of Operation
Instrument Alarms, Operational Alerts, and Measurand Data Flags

Section 3

Operator exits a data input screen,

by touching or pressing [ESC] key,
without saving changes.

Operator exits a data input screen

by touching [CONFIRM].

Registration of a new reagent fails.

Figure 3.6

3-18

Warning, Information and Input Error Pop-Ups

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Principles of Operation
Section 3

Instrument Alarms, Operational Alerts, and Measurand Data Flags

INPUT ERROR. The Operator has

entered a value outside of a
pre-defined range.

INPUT ERROR. The Operator has

entered an invalid value.

Figure 3.6

Warning, Information and Input Error Pop-Ups

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Principles of Operation
Section 3

Instrument Alarms, Operational Alerts, and Measurand Data Flags

Interfering Substances
It is important to note there are commonly occurring interfering substances that can
affect the results reported by hematology analyzers. While the CELL-DYN Emerald
has been designed to detect and flag many of these substances, it may not always
be possible to do so. Appendix B: Potential Causes of Spurious Results lists some
of the substances that may interfere with specific measurands.
Interpretive Messages (Interpretive Report)
Interpretive messages display and are printed when the values entered for Expected
Values (l and h) are exceeded. These messages display and print only when the
Interpretive Messages (Interp. Rpt) option on the Printer Set Up screen is selected.
Refer to Section 2: Installation Procedures and Special Requirements,
Subsection: Advanced Set Up for instructions for entering Expected Values.
Table 3.7

Interpretive Report
Messages

3-20

Measurand

Result Below Low Expected

Value

Result Above Expected Value

WBC

Leukopenia

Leukocytosis

LYM%

Lymphopenia

Lymphocytosis

LYM#

Lymphopenia

Lymphocytosis

MID%

no message

no message

MID#

no message

no message

GRA

Granulocytopenia

Granulocytosis

GRA#

Granulocytopenia

Granulocytosis

RBC

no message

Erythrocytosis

HGB

Anemia

no message

MCV

Microcytosis

Macrocytosis

MCH

no message

no message

MCHC

Hypochromia

Cold Agglutinin

RDW

no message

Anisocytosis

PLT

Thrombocytopenia

Thrombocytosis

MPV

no message

Giant Platelets

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Section 4 Performance Characteristics and Specifications

Section 4

Performance Characteristics and Specifications

Overview
This section describes the specification and performance characteristics of the
CELL-DYN Emerald. The following is included in this section:
Physical Specifications
Power Specifications
Environmental Specifications
Operational Specifications
Bar Code Specifications
Performance Specifications

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Performance Characteristics and Specifications

Section 4

Overview

NOTES

4-2

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Section 4

Performance Characteristics and Specifications

Specifications

Physical Specifications
Physical specifications for the CELL-DYN Emerald are listed in the following
tables.
Table 4.1

Dimensions

Dimension

Instrument

Height

13.8 in. (35 cm.)

Width

9.8 in. (25 cm.)

Depth

13.8 in (35 cm.)

Weight

19.8 lbs. (9 kg.)

Table 4.2

Dimensions in Shipping Carton

Dimension

Instrument

Height

18.3 in. (46.4 cm.)

Width

18.1 in. (46 cm.)

Depth

15.4 in (39 cm.)

Weight

25.8 lbs. (11.7 kg.)

NOTE: Refer to the Printer Manual for physical specifications for the printer.
Physical Specifications for the AC Adapter are as follows:
Table 4.3

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9140848DDecember 2009

Dimensions for the AC Adapter

Dimension

AC Adapter

Height

1.2 in. (3.1 cm.)

Width

2.3 in. (5.85 cm.)

Depth

5.2 in (13.2 cm.)

Weight

0.8 lbs. (0.35 kg.)

4-3

Performance Characteristics and Specifications

Section 4

Specifications

Power Specifications
Power requirements are as follows:
The instrument requires a constant, non-fluctuating power source. Use of an
AC line with dimmer switches can cause electrical current fluctuations that
could affect proper instrument function and therefore, is not recommended.
A circuit dedicated to the system is recommended but not required.
Table 4.4

Instrument Power Source Requirements

Nominal Line Voltage

Operating Range

Operating Cycles

120

99 132 VAC

50/60 HZ

220 240

198 264 VAC

50/60 HZ

The AC Adapter input is as follows:

100 240 VAC, 4.1 A, 50 60 HZ
Power consumption is as follows:
In cycle 30 VA (-30% +10%)
On, but not in cycle 20 VA (-30% +10%)
Maximum 50 VA (-30% +10%)

Environmental Specifications
Operating Temperature from 64 90 F (18 32 C)
Storage Temperature from 14 122 F (-10 50 C)
CAUTION: If the CELL-DYN Emerald has been stored at a temperature
of less than 50 F (10 C), it must remain at room temperature for 24 hours
before switching on.
Relative Humidity 80% maximum at 88 F (31 C)

4-4

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Performance Characteristics and Specifications

Section 4

Specifications

Operational Specifications
Throughput

60 samples/hour (approximate)

Storage capacity

1500 records, including demographics, results,

and histograms. Additional storage capacity is
possible with use of a removable storage device.
6 QC files, 100 records per file

Sample volume

9.8 L (approximate)

Measurement Principles Electrical impedance for WBC, RBC, and platelet

Absorption Spectrophotometry for hemoglobin
Reagent consumption is shown in the following table:
Table 4.5

Reagent Consumption (in mL)

CYCLE

DILUENT

LYSE

CLEANER

12.6

0.38

0.55

Drain All

Refill

Back flush

0.55

Initialization**

10

28.2

10

Lyse

10

Diluent

30

Cleaner

10

Clean cycle

2.2

Bleach clean

32.5

0.38

0.55

Shut Down

16

Auto Rinse

13

Run sample*

All
Reagent
Prime

Start Up

* A QC cycle uses the same amount of reagent as Run Sample.

** The initialization cycle is the cycle required after an emergency stop.

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9140848DDecember 2009

Based on one background run. The amount of reagent will increase if two or three
background cycles are run during the Start Up.

4-5

Performance Characteristics and Specifications

Section 4

Specifications

Bar Code Specifications

Quality and clarity in printed bar code labels is critical. High contrast (very dark
bars and clean white spaces) is essential for the bar code reader to measure the
difference in light reflection between the bars and spaces. The bars of the code must
be printed with precise edges. The dimensional accuracy of the bars must be
consistent throughout the label and consistent from label to label.
The Bar Code Reader reads the following bar codes: Chinese post, Codabar,
Code39, Code39 Full ASCII, Code 93, Code128, EAN8, EAN13, EAN128, IATA,
Industrial 2of5, Interleaved 2of5, Italian Pharmaceutical, Matrix 2of5, MSI/
Plessey, UK/Plessey, Telepen, TriOptic, S-Code, UPC A, UPC E.

4-6

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Section 4

Performance Characteristics and Specifications

Performance Specifications

Background Counts
Background values must be within the following specifications before testing
patient samples, running QC, or performing calibration:
Table 4.6

Background Specifications
Measurand

Background Concentration Limits

WBC

< 0.5 K/L

RBC

< 0.1 M/L

HGB

< 0.2 g/dL

PLT

< 10.0 K/L

NOTE: The Background Specification applies only to WBC, RBC, HGB, and
PLT. There are no background specifications for other measurands, so if
results are displayed they should be disregarded.

Carryover
The following table shows carryover percent for WBC, RBC, HGB and PLT.
Carryover was determined by running whole blood specimens with high target
values of WBC, RBC, HGB and PLT. Each specimen was run in triplicate followed
by three aspirations of whole blood specimens with low target values. Carryover is
calculated and expressed as a percentage using the following formula:
Percent Carryover =

CELL-DYN Emerald Operators Manual

9140848DDecember 2009

(Low Target Value1-Low Target Value3)

x 100
(High Target Value3-Low Target Value3)

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Performance Characteristics and Specifications

Section 4

Performance Specifications

Table 4.7

Carryover Specifications
Target Values

Measurand*
(units)

% Carryover (95%
Confidence Limit)

Low Target
Values

High Target
Value

WBC
K/L

>0 and <3

>90

<1%

RBC
M/L

>0 and <1.5

>6.20

<1%

HGB
g/dL

>0 and <5.0

>22.0

<1%

PLT
K/L

>0 and <100

>900

<2.2%

* Results are expressed in Standard (US) units.

To prevent carryover effects verify background after abnormally elevated platelet

results.
Display Range
The Display Ranges are the defined limits of the screen display and printer output.
If a result exceeds the upper limit of the Display Range, plus symbols (++++)
appear on the screen and printout instead of a numeric result1 and the D flag
appears.
Linearity/Analytical Measurement Range (AMR)
The Analytical Measurement Range (AMR) is the range of analyte values that a
method can directly measure on the specimen without any dilution, concentration,
or other pretreatment not part of the usual assay process.
The analytical measurement range (AMR) specifications in the following table
were determined by analyzing dilutions and concentrations of fresh human whole
blood, supplemented with commercial linearity materials. Because the Display
Ranges are wider than the AMR, values can be displayed/printed that are beyond
the limits of the AMR. In order to report patient results beyond the AMR, your
laboratory must perform validation studies of this expanded range (often called the
Clinically Reportable Range). For example, your laboratory may choose to
report patient results as greater than or less than the specific AMR upper or lower
limit, respectively, as determined by the Laboratory Director.

1.

4-8

The number of plus symbols that display or print may vary.

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Performance Characteristics and Specifications

Section 4

Performance Specifications

Table 4.8

Display Range and Analytical Measurement Range

Measurand

Units*

Display Range

AMR

WBC

K/L

0 100

0.4 96.1

RBC

M/L

08

0.22 7.61

HGB

g/dL

0 25

3.3 24.6

HCT

0 80

5.3 75.6

MCV

fL

0 150

48.8 115

PLT

K/L

0 1500

9 1375

* Results are expressed in Standard (US) units.

NOTE: Results displayed with * indicate suspect results that should not be
reported. For additional information about flagged results, refer to
Section 3: Principles of Operation, Subsection: Instrument Alarms,
Operational Alerts, and Measurand Data Flags.

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Performance Characteristics and Specifications

Section 4

Performance Specifications

Imprecision (Reproducibility)
Imprecision is expressed as the standard deviation (SD) or coefficient of variation
(CV) of analytic results in a set of replicate or duplicate measurements. Fresh
whole blood specimens used to verify imprecision specifications should have mean
values that fall within the range tested in the following table.
The table below represents the results of imprecision specifications for the
hemogram parameters. The stated CV% in the table represents instrument
imprecision from N=31 runs.
Table 4.9

Fresh Blood Imprecision Specifications

Measurand
(units)

Ranges Tested

Observed %CV
Range

%CV (95%
Confidence
Limit)

WBC (K/L)

4.7 10.2

1.5 3.4

3.5

RBC (M/L)

4.2 5.4

0.7 1.9

2.0

HGB (g/dL)

12.2 16.1

0.4 1.8

2.1

HCT (%)

35.7 50.7

0.9 1.6

1.7

MCV (fL)

73.4 96.0

0.3 0.8

0.8

RDW (%)

11.8 17.0

2.1 3.4

3.3

PLT (K/L)

185.2 387

2.8 5.8

6.1

MPV (fL)

7.6 9.0

1.3 2.6

2.7

LYM %

13.1 50.1

1.7 5.0

5.4

MID %

6.3 11.0

3.4 7.3

8.1

GRA %

43.1 75.8

1.1 3.0

2.9

NOTE: Laboratories should confirm this imprecision performance using fresh

whole blood specimens within the ranges shown above. Specimens with
values outside these ranges may have higher or lower %CV.

4-10

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Performance Characteristics and Specifications

Section 4

Performance Specifications

Repeatability and Within-Device Imprecision (Long-Term Precision)

The following Tables provide simplified within-device mean imprecision for 6
CELL-DYN Emerald analyzers, using two lots of a commercial tri-level control.
For each measurand, at each control level, on each of 6 CELL-DYN Emerald
analyzers, within-device imprecision estimate was calculated per section 10.8.2 in
CLSI EP5-A2. By weighting each %CV value by the number of data points
creating that particular %CV, an average %CV was calculated for all 6 analyzers
and both lot numbers.
Table 4.10

Long-Term Commercial Control Imprecision: CBC

Average %CV*

Control
Level

CD-16
WBC X 109/L

Low

5.4

Normal

3.0

High

2.4
RBC X 1012/L

Low

2.0

Normal

1.8

High

1.7
Hb g/dL

Low

3.0

Normal

1.8

High

1.6
HCT %

Low

2.2

Normal

1.9

High

1.8

* Values are the sample count-weighted averages of the individual instrument and
individual lot %CV.

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Performance Characteristics and Specifications

Section 4

Performance Specifications

Table 4.10

Long-Term Commercial Control Imprecision: CBC (Continued)

MCV fL

Low

1.0

Normal

0.9

High

0.8
MCH pg

Low

2.9

Normal

1.6

High

1.4
MCHC g/dL

Low

2.9

Normal

1.6

High

1.4
RDW %

Low

3.4

Normal

3.0

High

2.8
PLT X 109/L

Low

10.4

Normal

4.9

High

4.0
MPV fL

Low

3.5

Normal

1.8

High

1.6

* Values are the sample count-weighted averages of the individual instrument and
individual lot %CV.

4-12

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Performance Characteristics and Specifications

Section 4

Performance Specifications

Table 4.11

Long-Term Commercial Control Imprecision: WBC Differential

Average %CV*

Control
Level

CD-16 Control
Lymphocytes %

Low

5.6

Normal

1.5

High

1.9
Mid %

Low

9.7

Normal

5.1

High

2.9
Granulocytes %

Low

2.9

Normal

1.5

High

2.4
Lymphocytes - absolute

Low

10.5

Normal

3.2

High

3.6
Mid - absolute

Low

19.1

Normal

6.5

High

4.2
Granulocytes - absolute

Low

5.2

Normal

3.6

High

2.7

* Values are the sample count-weighted averages of the individual instrument and
individual lot %CV.

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Performance Characteristics and Specifications

Section 4

Performance Specifications

Comparability (Correlation)
Evaluation of the correlation of the CELL-DYN Emerald is shown in the tables
below. This data was computed from Passing-Bablock regression analysis of data
obtained from studies performed on whole blood analyzed against a comparative
instrument using similar technology. The results in individual laboratories may
differ from these data.
The internal Abbott site obtained the following results on 330 blood samples.
Table 4.12

Comparability (Correlation) to CELL-DYN 1800 Internal Site

Data Range

Measurand*

r-value

Min

Max

Intercept

Slope

WBC (K/L)

0.994

0.4

42.3

0.578

0.905

RBC (M/L)

0.993

1.31

7.38

-0.147

1.032

HGB (g/dL)

0.997

4.8

24.4

0.222

1.004

HCT (%)

0.993

14.7

66.9

-0.158

1.036

MCV (fL)

0.921

63.6

119.6

-12.170

1.175

RDW (%)

0.758

11.8

20.9

6.320

0.558

PLT (K/L)

0.990

2.0

1039.0

1.212

1.044

MPV (fL)

0.912

6.8

11.5

2.641

0.580

LYM (%)

0.970

4.0

75.6

1.240

1.011

MID (%)

0.761

1.6

17.8

1.560

0.895

GRA (%)

0.972

21.9

94.4

-1.782

0.990

* Results are expressed in Standard (US) units. Correlation coefficient, established by

Passing-Bablock regression analysis.

4-14

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Performance Characteristics and Specifications

Section 4

Performance Specifications

The external laboratory GA-Atlanta obtained the following results on 569 blood
samples.
Table 4.13

Comparability (Correlation) to CELL-DYN 1800 External Site

Data Range

Measurand*

r-value

Min

Max

Intercept

Slope

WBC (K/L)

0.997

0.4

82.5

0.602

0.895

RBC (M/L)

0.992

1.36

6.81

-0.270

1.074

HGB (g/dL)

0.994

4.3

19.6

-0.230

1.038

HCT (%)

0.988

12.9

57.5

-0.810

1.032

MCV (fL)

0.943

60.7

110.1

-8.067

1.097

RDW (%)

0.750

10.9

26.4

4.467

0.690

PLT (K/L)

0.982

4.0

958.0

5.554

0.995

MPV (fL)

0.916

6.0

10.9

2.582

0.561

LYM (%)

0.986

2.5

76.9

1.057

1.034

MID (%)

0.819

1.7

19.8

2.005

0.979

GRA (%)

0.982

12.6

95.7

-7.150

1.048

* Results are expressed in Standard (US) units. Correlation coefficient, established by

Passing-Bablock regression analysis.

Table 4.14

Comparability (Correlation) of WBC Differential to Microscopy

Measurand

Range Tested*

Replicates

r-value

Slope

Y-intercept

GRA%

23.15 95.70%

180

0.932

0.943

1.302

MID%

1.800 19.25%

180

0.874

0.612

3.350

LYM%

2.500 62.10%

180

0.943

0.989

3.317

* Results are expressed in traditional US units. These values do not represent the
analytical measurement range, which is provided in another table.
Correlation coefficient, established by Passing-Bablock regression analysis.

Interfering Substances
A wide variety of interfering substances have been shown to impact the results
from automated hematology analyzers. A list of substances that can potentially
interfere with CELL-DYN Emerald results is included in Appendix B: Potential
Causes of Spurious Results.
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Performance Characteristics and Specifications

Section 4

Performance Specifications

Reference Intervals
Table 4.15

Reference Intervals

Measurand
(units)*

Sex

Range

WBC (K/L)

M/F

270

4.70 - 10.30

RBC (M/L)

M/F

270

4.03 - 5.46

HGB (g/dL)

M/F

270

12.40 - 16.90

HCT (%)

M/F

270

36.60 - 48.30

MCV (fL)

M/F

270

81.50 - 96.80

MCH (pg)

M/F

270

27.50 - 33.10

MCHC (g/dL)

M/F

270

32.40 - 35.70

RDW (%)

M/F

270

11.80 - 14.90

PLT (K/L)

M/F

270

165 - 385

MPV (fL)

M/F

270

7.20 - 10.20

LYM %

M/F

270

12.70 - 47.80

MID %

M/F

270

6.30 - 14.00

GRA %

M/F

270

43.50 - 78.90

* Results are expressed in Standard (US) units.

These ranges do not represent globally applicable reference intervals, but reflect
combined reference ranges tested in the validation study. Each laboratory should
establish/verify its own reference intervals.

4-16

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Performance Characteristics and Specifications

References
1. Clinical and Laboratory Standards Institute. Preliminary Evaluation of
Quantitative Clinical Laboratory Methods; Approved Guideline Third
Edition. CLSI document EP10-A3 [ISBN 1-56238-622-0] Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
PA, 19087-1898 USA, 2006.
2. Clinical and Laboratory Standards Institute. Evaluation of the Linearity of
Quantitative Measurement Procedures; A Statistical Approach; Approved
Guideline. CLSI document EP6-A [ISBN 1-56238-498-8] Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
PA, 19087-1898 USA, 2003.
3. Clinical and Laboratory Standards Institute. Evaluation of Precision
Performance of Quantitative Measurement Methods; Approved Guideline
Second Edition. CLSI document EP5-A2 [ISBN 1-56238-542-9] Clinical
and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, PA, 19087-1898 USA, 2004.

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Performance Characteristics and Specifications

Section 4

References

NOTES

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Section 5 Operating Instructions

Section 5

Operating Instructions

Overview
This section discusses the operation of the CELL-DYN Emerald System. The
following topics are included:
Software Menu
Instrument Start Up
Specimen Analysis
Routine Operation
DATALOG
USB Flash Drive
Bar Code Scanner
Additional information for operating the CELL-DYN Emerald is discussed in the
following sections:
Calibration

Section 6: Calibration

Maintenance

Section 9: Service and Maintenance

Troubleshooting Section 10: Troubleshooting

Quality Control

Section 11: Quality Control

Instructions for configuring the instrument are provided in Section 2: Installation

Procedures and Special Requirements, Subsection: Instrument Set Up and
Advanced Set Up.

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Operating Instructions
Section 5

Overview

NOTES

5-2

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Section 5

Operating Instructions

Instrument Logbook
It is suggested a logbook be created for the instrument. This logbook should
contain all necessary calibration documentation and other information that is
pertinent to the instrument. Suggested sections that you may want to include are:
Installation documentation
Your laboratorys operating procedure
Quality Control
Calibration
Maintenance
Reagent Lot Number Changes
Troubleshooting and Problem resolution
Service calls and problem resolution/service performed documentation
Software upgrade information
Store the logbook near the instrument so that it is accessible to operators and
Abbott Service Personnel. Sample log sheets may be found in Appendix E:
Sample Logs and Worksheets.

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Operating Instructions
Section 5

Instrument Logbook

Software Menu
The software menu is shown in this section. All sub-menus are accessed from the
MAIN menu, which displays when HOME is touched. The sub-menus used for
setting up the instrument are described in Section 2: Installation Procedures and
Special Requirements, Subsection: Instrument Set Up and Advanced Set Up.
Remaining sub-menus are discussed in appropriate sections. For example, the
Calibration menu is discussed in Section 6: Calibration and Quality Control is
discussed in Section 11: Quality Control.
MAIN MENU*

START UP

OPER. LOG
IN/OUT

EVENT LOG

REAGENTS

DILUENT

LYSE

CLEANER

WASTE

PRIME
DILUENT

PRIME
LYSE

PRIME
CLEANER

RESET

SHUT DOWN

PRIME ALL

DATE

REPORTING
OPTIONS

SET UP

MAINTENANCE

RUN SAMPLE

NEXT
SAMPLE

VIEW

RUN AND
RESULTS

RUN AND
RESULTS

EDIT

COMMUNICATION

DATALOG

CYCLE
COUNTER

EDIT

PRINTER

QUALITY
CONTROL

CALIBRATION

LAB
PREFERENCES

LAB ID
INFORMATION

RESTORE

ADVANCED

PRINTER3
UPDATE

CALIBRATION
FACTORS

OTHER
SETTINGS

VERSION
RELEASE

STORAGE

TYPE

FORMAT EXT.
STORAGE DEVICE

DRAIN
ALL

REFILL

LIMITS

THRESHOLDS

INITIALIZE
SYSTEM

MOTOR INIT

CLEAN

BACKFLUSH

SPECIMEN CAL.
ADJUSTMENTS

ALARMS

FLUDICS

BLEACH

MECHANICAL
CHECKS

INIT
PRESS

RENAME
SPECIMENS

SPECIAL
MODES

SYS CLEAN

PRECISION

LINEARITY

ERROR LOG

ABBOTT
SERVICE

SOFTWARE ACCESS LEVELS

GREEN = ACCESS FOR ALL USERS

CHECK
VALVES

CHECK
PROBE

CHECK
ROCKER

CHECK
SYRINGE

CHECK
SENSORS

HGB LED
OFF

REMOVE
PROBE

LUBRICATION
POS.

BLUE = ACCESS FOR SUPERVISOR

GREY = ACCESS FOR ABBOTT
PERSONNEL ONLY

Figure 5.1

5-4

Software Tree

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Operating Instructions
Section 5

Instrument Logbook

Instrument Power On
Check the reagent and waste levels before starting the days run. If reagents need
to be replaced or waste needs to be emptied, refer to instructions given in
Section 2: Installation Procedures and Special Requirements, Subsection:
Replacing the Reagents Diluent, Lyse, Cleaner. Check that there is sufficient
paper in the printer.
If the printer has been powered OFF, press the power button to turn it ON. If the
instrument has been turned off, the display is black and the LED light is off. Press
the Power button to turn the instrument on.
1. The instrument initializes and checks the motors.
2. The cycle LED turns red. The instrument cannot be cycled until initialization
is complete and the LED turns green.
3. When initialization is complete, the OPER. LOG IN/OUT screen displays.

Operator Log In

If the instrument is ON, touch [OPER. LOG IN/OUT] and log in as described in
Section 2: Installation Procedures and Special Requirements, Subsection:
Operator Log In.

Specimen Analysis
Specimen Collection and Handling
WARNING: Potential Biohazard. Consider all clinical specimens,
reagents, controls, surfaces or components that contain or have contacted
blood, serum, or other bodily fluid as potentially infectious. Wear gloves,
lab coats, and safety glasses, and follow other biosafety practices as
specified in the OSHA Bloodborne Pathogen Rule (29CFR Part 1910.1030)
or other equivalent biosafety procedures.
NOTE: For additional information on collecting venous specimens, refer to CLSI
Standards H3-A51.

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Operating Instructions
Section 5

Instrument Logbook

All performance statements given in this manual were generated using

venipuncture specimens collected in K2EDTA anticoagulant.
Specimens must be mixed well before analysis. It is recommended that specimens be
mixed for 10 minutes on a rotary mixer or rocker that rotates 20 30 times/minute.
Specimen Stability
Well-mixed fresh5 whole blood specimens, collected in K2EDTA anticoagulant
and analyzed within 1 to 4 hours after collection, provide the most accurate results
for hemogram measurands. White blood cell size distribution can shift if specimens
are tested prior to the optimal time frame indicated. In particular, specimens may
be associated with false Suspect Population Flags due to WBC population shifts. If
flagging does occur, follow corrective action(s) listed in Section 10 before
reporting results.
Small shifts may be observed for MCV and MPV within a 30-minute post
collection interval. Please note that published studies indicate that MPV results can
be affected by EDTA for up to 2 hours after collection. Most accurate MPV results
are obtained between 2 and 8 hours after collection.3,4
The stability of capillary specimens collected in microcollection2 tubes can vary
depending on the tube manufacturer. Refer to the tube manufacturers package
insert for stability claims.
Interfering Substances
It is important to note that there are commonly occurring interfering substances that
can affect the results reported by hematology analyzers. While the
CELL-DYN Emerald has been designed to detect and flag many of these
substances, it may not always be possible to do so.
For additional information on interfering substances, refer to the table provided in
Appendix B: Potential Causes of Spurious Results.
Specimen Identification
Each specimen can be identified as follows:
Name 20 characters can be entered in the name field.
Patient ID (PID) this field can be used to enter a unique patient ID number,
such as a medical record number. 16 characters can be entered in the PID
field. If Name and/or PID Required option has been selected, this information
must be entered for each sample before the sample can be run.
Specimen ID (SID) This field is used to enter a specimen ID. The
instrument will automatically increment the SID if AUTO SID is selected on
the SET UP SCREEN. When AUTO SID is selected, the SID can be set to
start at one (or whatever number is desired) at the start of each days run. 16
characters can be entered in the SID field. If AUTO SID is not selected and no
SID is entered at the Run Sample screen, the SID field will be auto populated
with NO ID Entered.

5-6

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Section 5

Instrument Logbook

Identification is entered by touching [NEXT SAMPLE] on the RUN SAMPLE

screen as shown in the following figure.
1. Touch the <Name> field and use the
alphabetic buttons to type the name.
2. Press the ENTER key on the keypad to
enter the name and advance the cursor
to the PID field.
3. Use the alphabetic buttons and/or the
numeric keypad to enter the PID.
4. Press the ENTER key on the keypad to
enter the PID and advance the cursor to
the SID field.
5. If AUTO SID is selected, it is not
necessary to type an entry in this field. If
AUTO SID is not selected, use the
numeric keypad to enter the SID.
6. Press the ENTER key on the keypad to
enter the SID and advance the cursor to
the Type Dropdown menu.
7. If the type is correct, touch [CONFIRM]
to save the entries and return to the
RUN SAMPLE SCREEN.
8. Touch [ESC] to exit the screen without
saving the entries.
9. When the entries are confirmed, run the
specimen as directed later in this
section.
Figure 5.2

Entering Specimen Identification

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Operating Instructions
Section 5

Instrument Logbook

NOTES

5-8

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Section 5

Operating Instructions

Routine Operation
Daily Start Up Procedures
The Daily Start Up procedures include:
Running the Start Up Cycle and confirming that Background Counts are
within acceptable limits
Performing daily Quality Control checks
From the MAIN menu, touch [START UP] to run the Start Up Cycle. The cycle
takes approximately two minutes. It primes and cleans the system, and checks the
mechanical and electronic systems. At the end of the cycle, a background count is
automatically run and printed if a printer has been connected and configured. Up
to three (3) background counts may be automatically performed as part of the Start
Up Cycle. The final background will be automatically printed, if a printer is
configured. If the Start Up cycle is successful, the operator is returned to the MAIN
menu, the Status LED turns green, and the instrument is ready to run specimens. If
the Start Up cycle is unsuccessful, the message START UP FAILED displays. If
START UP FAILED displays, touch [START UP] again to repeat it a second time.
If Start Up fails two times, refer to Section 10: Troubleshooting for guidance.
1. If a Start Up Cycle failed the message START UP FAILED is displayed and
printed with every result when the user is logged in as an Operator or
Supervisor. The system must be configured to display these flags. See
Section 2: Installation Procedures and Special Requirements, Subsection:
Reporting Options Button.
2. Background counts must be within acceptable limits before running controls
or patient specimens.
When the Start Up Cycle is successfully completed, perform daily Quality Control
checks according to the regulations governing your laboratory before running
patient specimens. Refer to Section 11: Quality Control.
NOTE: The message QC ALERT displays and prints below the patient results
when the QC results are out of tolerance or the lot has expired. The system
must be configured to display these flags. See Section 2: Installation
Procedures and Special Requirements, Subsection: Reporting Options
Button. The message QC NOT DONE displays and prints below the
results when QC has not been run for the day.

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Operating Instructions
Section 5

Routine Operation

NOTES

5-10

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Operating Instructions

Running Specimens
Ensure Background Counts are within acceptable limits and Quality Control results
are acceptable according to your laboratorys Quality Control program. Ensure
specimens have been properly mixed.
WARNING: Potential Biohazard. Consider all clinical specimens,
reagents, controls, surfaces or components that contain or have contacted
blood, serum, or other bodily fluid as potentially infectious. Wear gloves,
lab coats, and safety glasses, and follow other biosafety practices as specified in the OSHA Bloodborne Pathogen Rule (29CFR Part 1910.1030) or
other equivalent biosafety procedures.
From the MAIN menu, touch [RUN SAMPLE]. To enter NAME, PID, or/and SID
press the [NEXT SAMPLE] at the bottom of screen. Enter the desired information
and press confirmation. To enter all of the identification, including the Name, PID,
SID, and select the type, refer to the instructions provided in Subsection:
Specimen Identification, earlier in this section.
NOTE: Do not run linearity material in the patient mode. Run linearity material
in the LINEARITY mode. Refer to Section 9: Service and Maintenance.

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Operating Instructions
Running Specimens

Section 5

1. If the Aspiration Probe is not visible,

press the Start Switch (located directly
behind the probe) and wait for it to
descend. If more than one hour has
elapsed since the last cycle, the
instrument will initiate an auto rinse
cycle before the probe is presented for
aspiration. Refer to Subsection: Auto
Rinse Cycle within this Section for
additional information.
NOTE: If the system has been configured
to require Name and/or PID (SET UPADVANCED- REPORTING OPTIONS),
then the probe will not descend until that
patient information has been entered
under RUN NEXT SPECIMEN.
2. Remove the cap from the specimen
tube.
3. Immerse the probe in the well-mixed
specimen and press the Start Switch.
NOTE: Visually verify that the probe is
well immersed into the sample. This is
required to avoid short sampling.
4. The Cycle LED (located directly above
the Aspiration Probe) turns Red and
flashes.
5. Hold the tube under the probe until the
Cycle LED turns Green.
6. Remove the tube and re-cap it.
7. Results will print automatically, if the
printer has been configured, when the
analysis is complete.
8. Enter the identification for the next
specimen and run it as directed in steps
1-6 above.
It is not necessary to wait for the results to
print before running the next specimen.
Information displayed to the right of
each measurand identifies results out
of the range for patient and panic limits.
Graphs are displayed on the right side
of the screen.
The Flags region (located below the
results) displays analytical alarms and
flags.
Figure 5.3

5-12

Results Screen

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Operating Instructions
Section 5

Running Specimens

Results are automatically printed and sent

to the LIS (if one is connected) at the end
of each analysis cycle. Refer to Section 2:
Installation Procedures and Special
Requirements, Subsection: Advanced
Set Up for instructions for configuring the
printed report.
Touch the TOOLS icon to make additional
printouts, send or save results. When the
tools icon is touched, the window shown at
right displays.
Touch [PRINT] to print the displayed
result.
Touch [SEND] to send the displayed
result to the LIS.
Touch [EXIT] to close the window.
Figure 5.4

Printing Results

DATALOG
The CELL-DYN Emerald Datalog stores 1500 records, including demographics,
results and graphs. Records are archived with a Sequence Number (SEQ), assigned
by the instrument software. Sequence numbers begin at 0001 for the first sample
of each day. Start Up Cycles, QC, and Precision runs are all assigned sequence
numbers, but are not stored in the Datalog. From the MAIN menu, touch
[DATALOG] to access the Datalog screen shown in the following figure. Follow the
instructions provided to access the Datalog information.
NOTE: When the Datalog is first opened from the MAIN menu, the display shows
the most current runs. If no results are stored in the internal memory and
a USB flash drive is connected, the system will display results from the
most current date stored on the drive.

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Operating Instructions
Running Specimens

Section 5

The Datalog screen displays the following

information:
1. The first column lists the measurands and the
header row lists the sequence number.
NOTE: Sequence numbers are reset to 0001 for the
first sample of each day. Start Up backgrounds are
typically the first cycle run daily and are not stored in
the Datalog. Therefore, sequence number 0001 will
not usually be seen in the Datalog.
2. Touch [ ] and [ ] to scroll to the previous or
next page, respectively.
3. Results are selected by touching the SEQ
number of the result at the top of the result
column. This highlights the results for that record.
4. The Name, PID, SID, date and time for the
selected specimen are displayed on the bottom
of the screen.
5. Touch [VIEW] to display the highlighted record,
including graphs and flags. (See Figures 5.6 and
5.7) Touch [PREVIOUS RESULT] or [NEXT
RESULT] to view the previous or next record,
respectively. Touch the RETURN icon to return to
the Datalog screen.
Results may also be accessed by date.
1. Touch DATE.
2. Select the location of the stored files you wish to
access. The default setting is the system
INTERNAL MEMORY. If the desired results are
stored on an external USB drive, insert the drive
into one of the ports on the rear of the instrument,
then use the dropdown menu to select MASS
STORAGE.
3. Select the desired YEAR and MONTH from the
left column by touching the year on the left side
of the row where the desired month is shown.
Selecting the date in the month column will not
select a file; the year to the left of the desired
month must be selected.
4. Select the desired day by touching the
appropriate date in the DAY column. The column
to the right of DAY shows the number of samples
tested on that day.
NOTE: The day cannot be selected by touching any
field below the NUM. column.
5. Touch VIEW to display the results for the
selected date.
6. Touch the SEQ for the desired result and touch
VIEW to display an individual result.
Figure 5.5
5-14

Datalog Screens
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Operating Instructions
Section 5

Running Specimens

Figure 5.6

View Record Screen

To print, send, delete or save results from the

Datalog, follow these steps:
1. Touch the TOOLS icon to print, send, delete
or save the record. From the selection box,
touch:
a. <ALL> for all stored records within the
selected date. The total number of pages
to be printed is shown to the right of this
field.
NOTE: The selection ALL refers to all
results selected within a selected date. It does
not refer to the entire datalog.
b. <SEQ> and use the numeric keypad to
enter the number(s) of the records.
2. Touch [PRINT] to print the selection(s).
3. Touch [SEND] to send the selection(s) to
the LIS.
4. Touch [DELETE] to delete the selected
results from datalog.
5. Touch [SAVE] to save the selected results
on a USB drive.
NOTE: For instructions on how to save the
results on a USB drive, refer to Subsection:
USB Flash Drive (Thumb Drive) within this
section.
6. Touch [EXIT] to return to the record.
7. Touch the HOME icon to return to the MAIN
menu.
Figure 5.7

DATALOG Options

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Operating Instructions
Section 5

Running Specimens

Daily Shut Down

The CELL-DYN Emerald must be put through a Shut Down cycle once during
every 24 hours of operation. Auto Shut Down after a specified idle interval can be
configured in the Other Settings menu under [ADVANCED] in setup, refer to
Section 2: Installation Procedures and Special Requirements. To shut down
manually, follow the instructions below:
From the MAIN menu, touch [SHUT DOWN] to initiate the Shut Down Cycle.
All of the fluidics are rinsed and cleaned with Cleaning Reagent.
The cycle stops automatically when it is complete.
To resume operation, press the ON/OFF; a Start Up Cycle will be
automatically performed as described earlier in this section.
NOTE: If a Start Up Cycle is not successfully completed, the message START UP
FAILED is printed with every result.
Auto Rinse Cycle
The CELL-DYN Emerald performs an automatic rinse of the fluidics pathway
when a cycle is initiated following system idle time of one hour or more. Even
when the instrument is off, the elapsed time count for the auto rinse remains active.
While the rinse cycle is running, a pop-up message is displayed to notify the user.
At completion of the cycle the instrument is ready to use.
While in the RUN SAMPLE mode the operator may enter ID information for the
next sample while the auto rinse cycle is running. At the end of the cycle, the LED
turns green and the sample probe descends.

Figure 5.8

5-16

Autorinse

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Operating Instructions

USB Flash Drive (Thumb Drive)

Overview
The CELL-DYN Emerald is capable of using either of the two USB ports on the
rear of the instrument in conjunction with a USB flash drive. Use of an optional
USB flash drive allows the operator to move data from the USB drive to the
CELL-DYN Emerald (upload) or from the CELL-DYN Emerald to the USB drive
(download). The different functions associated with use of a USB drive are
described in the following sections.
A USB drive is a flash memory data storage device integrated with a USB interface
(connector). The amount of data that can be stored on any USB drive is directly
related to the memory capacity of that drive. USB drives up to two gigabytes may
be used on the CELL-DYN Emerald. Do not use USB drives larger than 2 GB.
For current information about USB drives that have been validated for use on the
CELL-DYN Emerald, USA customers please contact Abbott Diagnostics
Customer Service. The following information applies only to USB drives
formatted on the CELL-DYN Emerald.
Characteristics of CELL-DYN Emerald USB Drives
Any USB drive to be used with the CELL-DYN Emerald must be properly
formatted. Instructions for formatting a drive can be found later in this Section.
More than one USB drive can be in use with a single CELL-DYN Emerald
instrument. In addition, one USB drive can store data for one or more
CELL-DYN Emerald instruments. Instrument-specific information is stored on the
USB drive in files identified by the instrument serial number and cannot be
accessed by other instruments. However, any CELL-DYN Emerald System can
access data that is not instrument-specific.
USB Storage Information
Average size of result file is approximately 5 kb.
A 128 MB USB drive stores approximately 14,000 result files.
A 256 MB USB drive stores approximately 28,000 result files.
A 512 MB to 2 GB USB drive stores approximately 60,000 result files.
NOTE: 512 MB to 2 GB USB drives store the same number of results.
If USB drives are present in both USB ports, the CELL-DYN Emerald will only
recognize/utilize the first drive listed.
IMPORTANT: When saving or reviewing Emerald files on a computer, do not
change any files name. Changing file names may prevent proper restoration of
saved files or may lead to duplicate file names on the CELL-DYN Emerald.

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Operating Instructions
Section 5

USB Flash Drive (Thumb Drive)

Error messages associated with USB drives on the CELL-DYN Emerald

If a USB drive is recognized by the CELL-DYN Emerald, but contains an
unsupported file structure, a pop-up message will display under these conditions,
THE USB THUMB DRIVE FILE SYSTEM IS NOT COMPATIBLE WITH
THE EMERALD. EITHER REMOVE IT OR FORMAT IT.
If an unsupported USB device is inserted into one of the USB ports, a pop-up
message will appear, THE USB DEVICE PLUGGED IN PORT _ IS NOT
COMPATIBLE WITH THE EMERALD. PLEASE REMOVE IT FROM
PORT _ .
Formatting the USB drive for use on the CELL-DYN Emerald.
NOTE: USB drives can be formatted only under the Supervisor password.
WARNING: Formatting the USB drive will erase all data currently stored
on the drive. Make sure to transfer data from the USB drive to another
storage media before proceeding.
1. Insert a USB drive into either of the USB ports (1 or 2) on the back panel of
the CELL-DYN Emerald.
2. From the MAIN menu, touch [SET UP], then [ADVANCED].
3. Touch [OTHER SETTINGS].
4. Touch the [STORAGE] button.
5. In the box titled EXT. STORAGE DEVICE OPTIONS, touch [FORMAT EXT.
STORAGE DEVICE].
6. A pop up box will appear with the prompt, ALL THE DATA ON THE
EXTERNAL STORAGE DEVICE WILL BE DELETED. DO YOU
CONFIRM?

Figure 5.9

5-18

Delete Data from External Device

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Section 5

USB Flash Drive (Thumb Drive)

7. Select the [YES] button to proceed or select the [NO] button to exit without
formatting the USB drive.
8. If [YES] was selected, the CELL-DYN Emerald will proceed to format the
USB drive. Once the formatting is completed, an AB18 folder is created in
the USB drive. When the formatting process is complete you will be returned
to the EXT. STORAGE DEVICE screen.
9. Touch the HOME icon to return to the MAIN menu. The USB drive may now
be removed. Your USB drive is ready to be used with the
CELL-DYN Emerald.
USB File Folder Structure
Information is stored on the USB drive in the following folder structure:
Root Folder
(Emerald
analyzers only)

AB18
LOT
SETTINGS

Common Folders
(can be shared between
Emeralds)

UPDATE
PRTDRV
VERSION
XXXXXX
YYYYYY
CALI
EQC
LOG

Analyzer Serial
Number Folders
(cannot be
shared
with another
Emerald)

QC
RESULTS
2008-04
17

Result Folders
(The analyzer
results are
archived in
folders in a
YYYY-MM then
sub-folder DAY
format)

18
SETTINGS
REAGENTS

Figure 5.10 USB File Folder Structure

NOTE: Datalog files are saved to the USB drive in a format read by the
CELL-DYN Emerald. To easily view the contents of the files, open the
file from your CELL-DYN Emerald rather than on a PC.
From the MAIN menu, touch [DATALOG], touch [DATE], touch the dropdown
menu at the upper right, select MASS STORAGE and review the desired date.

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USB Flash Drive (Thumb Drive)

Available Functions for the USB Drive

USB drive functionality is not supported in the following selections from the MAIN
menu: START UP, OPER. LOG IN/OUT, and SHUT DOWN.
Use of the USB drive in the EVENT LOG menu.
The information stored in the instrument EVENT LOG can be saved to the USB
drive.
1. Touch [EVENT LOG] from the MAIN menu.
2. Touch the [TOOLS] button on the left side of the screen.

Figure 5.11 Save EVENT LOG to USB

3. Select ALL to save all data to the USB drive or select DAY and enter the
sequence numbers corresponding to the date range you want to save.
4. Touch the [SAVE] button to save the selected data to the USB drive.
5. Touch the [EXIT] button to exit the menu.
Use of the USB drive in the REAGENT menu.
Use of the USB drive in the REAGENT menu is restricted to Abbott personnel.
Installing a Printer Driver
NOTE: Follow Abbotts specific instructions provided with the printer driver to
copy a new printer driver onto the USB drive.
1. Insert the USB drive into either USB port on the rear panel of the
CELL-DYN Emerald.
2. From the MAIN menu, touch the [SET UP] button.
3. Touch [PRINTER 3 UPDATE] at the bottom of the SET UP screen.

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USB Flash Drive (Thumb Drive)

Figure 5.12 Printer Driver Upload

4. The CELL-DYN Emerald will display a list of the printer drivers that are
available to be loaded.

Figure 5.13 Printer Driver Selection

NOTE: Available printers may not appear as shown in example.

NOTE: In the pull-down box, printer drivers 1 and 2 are defaults and printer 3
allows the addition of a third approved printer driver. Loading a printer
driver will automatically overwrite any existing driver for PRINTER 3.
5. Touch to select the desired printer driver from the table on the right side of
the screen.
NOTE: Be sure to select the printer with the correct port type for your installation:
USB for a USB connection between the instrument and the printer, LPT
for a 25-pin printer cable.
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USB Flash Drive (Thumb Drive)

6. Confirm the correct printer and port type appear in the upper left of the screen
and touch [LOAD].
7. A pop-up box will appear with the message: DO YOU CONFIRM TO LOAD
THE FILE selected printer name will appear here? Touch [YES] to load
the file and [NO] to exit without changes.
8. A pop-up box will appear with the message, THE PRINTER DRIVER XXX
HAS BEEN SUCCESSFULLY LOADED. Touch [OK].
Use of the USB drive in the CALIBRATION menu.
Saving current calibration data.
Data for the current calibration factors may be saved to the USB drive as a
Calibration Report. The Calibration Report contains the following information for
the current calibration stored on the instrument: Calibration date, operator ID for
the calibration, calibration factors for all calibrated parameters, lot number of
calibration material, expiration date of calibration material, assay values and limits
for all calibrated parameters.
1. From the MAIN menu, touch the [CALIBRATION] button.
The instrument will display a screen showing the current calibration factors
(FCTR column) as well as the assay values used in that calibration. Lot
number and expiration date are displayed at the top of the screen. All of this
information may be saved to the USB drive.
2. Insert the USB drive into either USB port on the rear panel of the
CELL-DYN Emerald.
3. Touch the [TOOLS] button.

Figure 5.14 Save Calibration Data to USB

4. Touch the [SAVE] button.

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USB Flash Drive (Thumb Drive)

5. When the pop-up box appears prompting: YOU ARE ABOUT TO SAVE
THE CALIBRATION REPORT. DO YOU CONFIRM? Touch [YES] to
save the report or [NO] to exit without saving the report.

Figure 5.15 Confirm Save of Calibration Report

Use of the USB drive in the QC menu.

Using the USB drive, an operator can upload QC material information (lot,
expiration date, assay values and ranges), save QC, download QC data for peer
group review, or restore QC data backed up previously.
Uploading commercial Quality Control material information.
An operator can upload QC material information (lot, expiration date, assay values
and ranges) from a USB drive to the CELL-DYN Emerald.
1. Insert a USB drive into either of the USB ports (1 or 2) on the back panel of
the CELL-DYN Emerald.
2. From the MAIN menu, touch the [QUALITY CONTROL] key.
3. Select the radio button corresponding to the file desired.

Figure 5.16 Selection of QC File for Upload

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USB Flash Drive (Thumb Drive)

Section 5

NOTE: If QC information is loaded to a file that has already been used, all
existing information, including QC results, will be erased.
4. Select [EDIT].

Figure 5.17 Display of Current QC Lot Information

5. Touch [LOAD].

Figure 5.18 Select QC Lot and Level for Upload

6. Identify the desired lot number and level corresponding to the QC material
you will be using in the table on the right side of the display and touch it to
select.
The selected lot will display in the box in the upper left side of the display,
the level selected will be to the right of the lot number.
7. After verifying that this is the desired lot number and level, touch the [LOAD]
button.
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USB Flash Drive (Thumb Drive)

8. In the pop-up box DO YOU CONFIRM TO LOAD THE FILE < >?,
select [YES] to load the file or [NO] to exit without loading the file.

Figure 5.19 Confirmation of QC Upload

9. Confirm all information on the next screen against the product labeling
provided with the Control material. Correct any information as necessary.
Once the correct information is displayed, touch [CONFIRM] or touch [ESC]
to exit without saving.

Figure 5.20 Upload QC Information

10. When prompted DO YOU WANT TO SAVE MODIFICATIONS?, touch

[YES] to save the modifications or touch [NO] to exit without saving.
11. A pop-up box will appear, YOU ARE GOING TO DELETE ALL
ASSOCIATED RESULTS. DO YOU WANT TO CONTINUE?
touch [YES] to continue or [NO] to exit without saving.

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USB Flash Drive (Thumb Drive)

Saving Current QC Data

QC data may be saved to the USB drive to back up, archive, or view on a personal
computer.
1. From the MAIN menu, touch the [QUALITY CONTROL] key.
2. Touch the TOOLS icon.
3. Select one or more lot numbers using the radio buttons and touch the [SAVE]
button.
4. To save the QC files, touch the [BACKUP] button.
5. You will see an information Pop-up box: PROCESSINGPLEASE WAIT.
6. After the message disappears it is safe to remove the USB drive.
Save QC data for eQC.
QC data may be saved to the USB drive to submit to eQC. For information about
the eQC program, contact your local Abbott representative.
To submit QC data to the eQC program, LAB ID INFORMATION must be entered
from the QUALITY CONTROL screen.
ENTERING LAB ID INFORMATION:

1. From the MAIN menu, touch the [QUALITY CONTROL] key.

2. Touch the [LAB ID INFORMATION] button.

Figure 5.21 Enter Lab ID Information

NOTE: The instruments Serial Number is not part of LAB ID INFORMATION

but will be copied from the software with the eQC Identification file
(ID.DAT).
3. Enter the desired information in the <NAME>, <STREET 1>, <STREET 2>,
<CITY>, <STATE>, <COUNTRY>, <ZIP>, <PHONE>, and <ATTENTION>
fields. Use the numeric keypad and/or the [A-Z] button to access the alpha
keypad.

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USB Flash Drive (Thumb Drive)

4. When using the alpha keypad to enter information, touch [CONFIRM] to

enter the information and return to the LAB ID INFORMATION screen.

Figure 5.22 Alpha keypad for Lab ID Entry

5. When all information has been correctly entered, touch [CONFIRM] to save
the information or touch [ESC] to exit without saving.
6. At the WARNING Pop-up: DO YOU WANT TO SAVE
MODIFICATIONS?, touch [YES] to save or touch [NO] to exit without
saving.
NOTE: Information must be entered into each field to successfully submit
information to the eQC program.
Saving QC data to the USB key for eQC
1. Insert a USB drive into either of the USB ports (1 or 2) on the back panel of
the CELL-DYN Emerald.
2. From the MAIN menu, touch the [QUALITY CONTROL] key.
3. Touch the TOOLS icon.
4. Select one or more lot numbers using the radio buttons and touch the [SAVE]
button.

Figure 5.23 Selection of QC file(s) for eQC

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USB Flash Drive (Thumb Drive)

5. To save the QC files, touch the [eQC] button.

6. You will see an INFORMATION Pop-up box: PROCESSINGPLEASE
WAIT.
After the message disappears it is safe to remove the USB drive.
Restore previously saved QC data.
1. From the MAIN menu, touch the [QUALITY CONTROL] key.
2. Using the radio buttons, select the desired file.
3. Touch the [RESTORE] button.

Figure 5.24 Restore Saved QC Data

NOTE: If a QC file containing data is selected you will see the WARNING Popup: YOU ARE GOING TO DELETE ALL ASSOCIATED RESULTS.
DO YOU WANT TO CONTINUE? Touch [YES] to continue, or touch
[NO] to exit without deleting data.
4. Select the lot and level to be restored from the list on the right side of the
display by touching the desired row.

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USB Flash Drive (Thumb Drive)

Figure 5.25 Selection of QC Lot and Level to Restore

The selected lot will appear in the box on the upper left side of the display with the
level displayed to the right.
5. After verifying that the information is correct, touch the [RESTORE] button.
6. At the WARNING Pop-up: DO YOU CONFIRM TO RESTORE THE
FILE, touch [YES] to restore the file or [NO] to exit without restoring.
Use of the USB drive in the DATALOG menu.
The information stored in the instrument DATALOG can be copied to the USB
drive.
1. From the MAIN menu, touch the [DATALOG] key.

Figure 5.26 DATALOG

2. Touch the TOOLS icon.

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USB Flash Drive (Thumb Drive)

Figure 5.27 DATALOG Tools

3. Select the data to be saved by selecting the radio button for ALL or SEQ. If
using SEQ for the selection, enter the SEQ numbers in FROM and TO fields
corresponding to the data range desired.
4. Touch the [SAVE] button. At the WARNING Pop-up: YOU ARE ABOUT
TO COPY RESULTS FROM DATALOG TO THE EXTERNAL STORAGE
DEVICE. DO YOU CONFIRM? touch [YES] to save the data or [NO] to
exit without saving.
If YES is selected a pop-up box will briefly appear showing the progress of the save
operation. When the data has been saved this pop-up box disappears and it is safe
to remove the drive.
Use of the USB drive in the SET UP menu.
The information stored in instrument SET UP can be copied to the USB drive.
1. From the MAIN menu, touch the [SET UP] button.
2. Touch the TOOLS icon.

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USB Flash Drive (Thumb Drive)

Figure 5.28 Saving to USB Drive Settings

3. Touch the [SAVE] button to save the current set up to the USB drive. At the
WARNING Pop-up: YOU ARE ABOUT TO SAVE THE USER
SETTINGS. DO YOU CONFIRM?, touch [YES] to save or [NO] to exit
without saving.
NOTE: This function can be used to save SET UP information prior to service and
restore the information afterwards.
Restoring SETUP information from the USB drive.
1. From the MAIN menu, touch the [SET UP] button.
2. Touch the TOOLS icon.

Figure 5.29 Restoring Settings

3. Touch the [LOAD] button.

4. You will see a pop-up WARNING message: YOU ARE ABOUT TO LOAD
THE USER SETTINGS. DO YOU CONFIRM?
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Section 5

5. Touch [YES] to load the stored settings from the USB drive. This will
overwrite all settings currently stored on the system. Touch [NO] to exit
without loading the stored settings.
Use of the USB drive in the MAINTENANCE and RUN SAMPLE menus.
There are no USB functions available to operators in the MAINTENANCE or RUN
SAMPLE menus.
Bar Code Scanner
Overview
The CELL-DYN Emerald is shipped with a bar code scanner that may be used for
information entry in the RUN SAMPLE menu. The instrument software can be
configured to input scanned information into either the PID, name, or SID fields.
Please refer to Section 2: Installation Procedures and Special Requirements
Subsection: Set Up Menu, for configuration instructions.
The barcode scanner is also used to input reagent information. Please refer to
Section 2: Installation Procedures and Special Requirements, Subsection:
Using Reagent Bar Codes for instructions on scanning reagent bar codes.
For additional information about the bar code scanner, such as instructions for use
and troubleshooting, please consult the manufacturers instructions packaged with
the bar code scanner.

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Operating Instructions

References
1. Clinical and Laboratory Standards Institute/NCCLS. Procedures for the
Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard Sixth edition. CLSI/NCCLS document H3-A6 (ISBN 1-56238650-6) CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898,
2007.
2. Clinical and Laboratory Standards Institute (CLSI). Procedures and Devices
for the Collection of Diagnostic Capillary Blood Specimens; Approved
StandardSixth Edition. CLSI document H04-A6 [ISBN 1-56238-677-8].
Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite
1400, Wayne, Pennsylvania 19087-1898 USA, 2008.
3. Thompson CB, Diaz DD, Quinn PG, Lapins M, Kurtz SR, Valeri CR. The role
of anticoagulation in the measurement of platelet volumes. Am J Clin Pathol
1983 Sep;80(3):327-32.
4. McShine RL, Sibinga S, Brozovic B. Differences between the effects of
EDTA and citrate anticoagulants on platelet count and mean platelet volume.
Clin Lab Haematol 1990;12(3):277-85.
5. International Council for Standardization in Haematology (ICSH). Protocol
for Evaluation of Automated Blood Cell Counters. Clinical and Laboratory
Hematology 1984; 6:69-84.

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References

NOTES

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Section 6 Calibration

Section 6

Calibration

Overview
Calibration is a procedure that confirms the accuracy of the CELL-DYN Emerald.
The instrument is initially calibrated at the factory. During installation, an Abbott
representative will assist the laboratory in verifying the factory calibration.
The CELL-DYN Emerald is designed to remain stable without frequent calibration
when it is operated and maintained according to the recommendations provided in
this manual.
The following measurands can be calibrated by CELL-DYN Emerald operators:
WBC
RBC
HGB
MCV
PLT
The following measurands can be calibrated by Abbott service personnel or in the
factory:
MPV
RDW
The following information is discussed in the section:
When to Calibrate
Calibration Guidelines
Pre-Calibration Procedures
Calibration Procedures
Calibration Verification Procedure

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Calibration
Section 6

Overview

NOTES

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Section 6

Calibration

When to Calibrate
Scheduled calibration of the CELL-DYN Emerald must conform to the guidelines
established by the regulatory agencies governing the laboratory.
Calibration should be confirmed on a regular basis according to your laboratorys
protocols. The Quality Control program on the CELL-DYN Emerald provides
confirmation of instrument calibration. The decision to re-calibrate can be based on
Quality Control results. For information on Quality Control, refer to Section 11:
Quality Control.
Criteria should also be established for calibration verification. Calibration
verification criteria include:
When indicated by Quality Control data
After major maintenance and service procedures
At least every six months
As directed by the regulatory agencies governing the laboratory
A common method for calibration verification is to process a commercial
calibrator and compare the results with the assay values provided by the
manufacturer. If instrument results exceed verification criteria, the instrument
should be re-calibrated.
If needed, calibration is the last step in a troubleshooting sequence. Frequent,
unnecessary, recalibrations can mask underlying instrument problems and should
be avoided.
NOTE: If there are questions about when to re-calibrate, contact Abbott
Diagnostics Customer Service.

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Section 6

When to Calibrate

NOTES

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Section 6

Calibration

Calibration Guidelines
Calibration Materials
The CELL-DYN Emerald can be calibrated with commercial calibrator, such as
CELL-DYN Calibrator, or with assayed whole blood specimens. Commercial
calibrator is the method of choice.
Commercial calibrator must be used before its expiration date and should be
used according to the manufacturers instructions.

Pre-Calibration Procedures
It is advisable to perform calibration when it can be completed without
interruption. Pre-Calibration Procedures ensure proper instrument performance
and a successful calibration. These steps should be completed just before starting
the CELL-DYN Emerald calibration process. If problems are detected during these
checks, do not attempt to calibrate the instrument. After the problems have been
resolved, repeat the Pre-Calibration Procedures to verify proper instrument
performance.
A Pre-Calibration Procedures Checklist is provided in Appendix E: Sample Logs
and Worksheets. The checklist outlines the procedures and is used to document the
results. It can be duplicated as needed.

Calibration Menu
From the MAIN menu, touch [CALIBRATION] to display the Calibration screen
shown in the following figure.

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Calibration Guidelines

Section 6

The Calibration screen displays the

following information from the last
calibration that was performed:
1. LOT Lot number of the last calibrator
used.
2. EXPIRATION Expiration date of the
calibrator
3. CAL ON Date the calibration was
performed
NOTE: If one or more calibration
factors have been manually entered,
the letter M appears after the CAL.
ON date on this screen.
4. BY Operator name entered when the
calibration was performed
5. ASSAY - Assay values entered for the
last calibration
6. FCTR Current Calibration Factors
Touch the TOOLS icon to print the
displayed information, send the
information to the LIS, or save the
information to a removable storage
device.
Touch [EDIT] to enter new information as
shown in the following figure.
Figure 6.1

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Calibration Screen

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Section 6

Calibration Guidelines

Automated Calibration Procedure

Entering Calibrator Information
NOTE: Before editing any information in the
Calibration screen, touch the [TOOLS] icon then
[PRINT] to print the current calibration factors.
This screen is used to enter new Calibration
information as follows:
1. Touch the <Lot> entry field and use [A-Z] and
the numeric keypad to type in the lot number of
the calibrator.
2. Touch the <Expiration> entry field and use the
numeric keypad to type in the calibrators
expiration date. Press the Enter key after each
entry to advance the cursor to the next input field.
NOTE: Expiration dates prior to the current date
will not be accepted by the system.
NOTE: Be sure to observe the date convention
established by your laboratory when entering the
expiration date.
3. Touch the <Assays> and <Limits> entry fields
and use the numeric keypad to type in the assay
value and limits from the calibrators assay
sheet.
4. Touch [CONFIRM] to save the information and
return to the previous screen, which shows the
newly entered information. You will be prompted:
DO YOU WANT TO SAVE MODIFICATIONS?
Respond [YES] to save or [NO] to return to the
Calibration Entry Screen. Touch [ESC] to exit the
screen without saving modifications. You will be
prompted: DO YOU WANT TO CANCEL
MODIFICATIONS? Respond [YES] to exit or
[NO] to return to the Calibration Entry Screen.
NOTE: If a previous calibration has been
performed, a warning window will display, when
you touch the [EDIT] or [RUN AND RESULTS]
indicating: YOU ARE GOING DELETE ALL
ASSOCIATED RESULTS. DO YOU WANT TO
CONTINUE? Touch [YES] to delete all results.
5. Touch [RUN AND RESULTS] to display the
screen shown in the following figure.
IMPORTANT: Be certain that the calibrator is at
room temperature and has been mixed according to
the instructions in the package insert before
proceeding with the Automated Calibration
Procedure.
Figure 6.2

Calibration Entry Screen

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Section 6

Calibration Guidelines

Automated Calibration Procedure

1. Immerse the Aspiration Probe in a well mixed
calibrator and press the Start switch.
2. The Cycle LED flashes during aspiration. The probe
retracts when aspiration is complete.
3. Re-cap the calibrator vial and gently mix until the
Cycle LED turns green and the probe extends.
4. Repeat the previous three steps to run the calibrator
a minimum of five times. (maximum 10 runs.)
Results are stored in the calibration table shown at the
right.
Statistical calculations are done automatically with
each run.
Statistics and new Calibration Factors are shown at
the bottom of the screen.
NOTE: The calibration factors displayed on this
screen (FCTR) are rounded to one decimal place
due to display size constraints and are intended to
provide a gross estimate of the calibration factors as
obtained during the calibration process.
Actual calibration factors are three decimal places
as shown in Figure 6.1. Apparent discrepancies
between the two values are due to rounding.
The SEL column is used to select or deselect
individual runs from the calculations.
Use of the SEL column:
By default, all results in the calibration table are
indicated by a in the column labeled SEL.
All results with in the SEL column are included in
the calculation table at the bottom of the calibration
screen.
To deselect one or more calibration runs from the
Factor, Mean, SD, and CV% calculations, touch the
to the left of the set of results you wish to
exclude.
NOTE: You cannot delete a run from the calibration
run but you may deselect runs to remove that runs
data from the calculations of the factor, mean, SD
and CV%.
Deselect any run with an error (short sample) or
incomplete mixing.
To select or deselect all runs touch [SEL] at the top
of the column.
Values displayed in bold text are outside of the
defined target range.
NOTE: The Numbers display or print in bold only if
PANIC HIGH and PANIC LOW, in SETUPADVANCED-REPORTING OPTION has been
configured.
Figure 6.3
6-8

Calibration Result Table

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Section 6

Calibration Guidelines

5. If any of the results are excluded, ensure the

calibrator is properly mixed, and run additional
samples until the total number of runs equals five.
Invalidated results should be excluded from
calculations. When a minimum of five successful
runs are completed, review the data again and if
result are still unacceptable, refer to Section 10:
Troubleshooting.
6. Using the Calibration Verification Worksheet
from Appendix E, enter the assay value into the
first column and the mean from the result file into
the second column. If the difference between the
two columns for any measurands exceeds the +/limit shown on the Calibrator Assay Sheet,
calibration is required; proceed as follows. If all +/limits are within tolerance, calibration is not needed.
7. Make a copy of the completed Calibration
Worksheet and save for your records. (The
Calibration Worksheet can also be found in
Appendix E, Sample Logs and Worksheets.)
8. If calibration is not needed, touch [EXIT] to return to
calibration run screen. Touch [HOME] to return to
the MAIN menu.
9. If calibration is needed, touch [CALIBRATION] to
display the Result window shown at right.
10.In the CALIBRATION section of the window,
deselect the box next to the measurand(s) that do
not need to be calibrated.
NOTE: By default all the measurands are selected,
which means all the measurands will be calibrated.
If you do not wish to calibrate one or more
measurands, deselect the appropriate measurand.
11. When selections are complete, touch
[CALIBRATION] to calibrate the selected
measurands.
12.A warning prompt displays: YOU ARE GOING TO
REPLACE CALIBRATION FACTOR(S). ARE YOU
SURE?, touch [YES].
13.The selected measurands are now calibrated.
14.Touch [EXIT] to return to calibration screen.
15.Touch [HOME] to return to MAIN menu.
16.Touch [CALIBRATION] to display the calibration
factors.
17.Touch the [TOOL] icon then touch [PRINT] to print
the new calibration factor(s).
18.Verify Calibration as directed in the Calibration
Verification procedure below.
Figure 6.3

Calibration Result Table (Continued)

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Calibration Guidelines

Section 6

Calibration Verification Procedure

Calibration Verification is done to verify the accuracy of the calibration. It is
accomplished by running the second tube of calibrator in the same manner as the
first and comparing the results to the Assay Values.
1. When calibration is complete and all required information has been printed,
touch [HOME] followed by [MAINTENANCE], touch [SPECIAL MODES],
touch [PRECISION].
2. Ensure that the second tube of calibrator is at room temperature and mixed
according to the instructions given in the package insert.
3. Run the calibrator two times in the precision file.
4. Using the Calibration Verification Worksheet from Appendix E: Sample
Logs and Worksheets, enter the assay value from the assay sheet into the first
column and the mean of the two runs from the result file into the second
column. Verify the difference between the two columns is within the +/tolerance limits as shown on the Calibrator Assay Sheet; if not, troubleshoot;
if it is within the limits, complete the Calibration Verification Worksheet and
make a copy for your records.

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Section 6

Calibration

References
1. International Council for Standardization in Haematology (ICSH). Protocol
for Evaluation of Automated Blood Cell Counters. Clinical and Laboratory
Hematology 1984; 6:69-84.
2. Clinical and Laboratory Standards Institute/CLSI. Procedure for
Determining Packed Cell Volume by the Microhematocrit Method; Approved
Guideline Third edition. CLSI document H7-A3 (ISBN 1-56238-413-9)
CLSI, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA
2000.

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Section 6

References

NOTES

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Section 7 Operational Precautions and Limitations

Section 7

Operational Precautions and Limitations

Overview
This section addresses operational requirements, precautions, and limitations to
ensure operator safety and accurate test results. Failure to follow these
requirements or take these precautions may cause damage to the system, impact
system performance, or adversely affect results, or present a hazard to the operator.
Operational precautions and limitations topics include:
General requirements
Precautions and requirements for System Operation
Requirements for handling consumables
Requirements for handling specimens
Requirements for collecting, preparing and storing specimens
Interfering substances and conditions
Limitations of result interpretation
Other factors you should consider when interpreting patient test results

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Section 7

Overview

NOTES

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General Requirements
The following general CELL-DYN Emerald system requirements should be
followed to help ensure proper system performance:
Ensure the system is located out of direct sunlight, heat and drafts, and away
from any heat-generating device. Exposure to heat and drafts can interfere
with the ability of the system to maintain an operating temperature that is
within the acceptable range.
Place the instrument on a hard, level surface. Maintain the required space on
all sides of the system. For more information about space requirements, refer
to Section 2: Installation Procedures and Special Requirements. This
clearance is essential for:
Adequate ventilation and cooling of electrical components
Easy access for maintenance
Easy access for disconnecting the power cord when required
Place the instrument away from centrifuges, x-ray equipment and copiers.
CAUTION: Do not use mobile telephones, wireless telephones, mobile
radios, or any other radio frequency (RF) transmitting devices in the same
room as the instrument.
NOTE: The CELL-DYN Emerald has been evaluated to EN 55011 and EN 61000
for electromagnetic emissions and immunity, respectively.
Leave the system power on continuously unless instructed otherwise in a
maintenance or troubleshooting procedure, or unless an emergency situation
occurs.
Ensure the waste line is connected to the appropriate outlet and is routed to a
suitable waste container or drain. Dispose of all waste materials in
accordance with local, state and federal regulations.
If an external waste container is used, ensure the top of the waste container is
placed below the bottom of the analyzer.
If a drain is used for waste, ensure the waste outlet tube is secured in the drain
hole. Ensure system components are located away from potential waste
overflow.
Perform maintenance procedures as recommended in Section 9: Service and
Maintenance.
Do not attempt any maintenance or repairs that are not specified in
documentation provided by Abbott Laboratories. An Abbott-authorized
representative should perform all major service work.

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Section 7

General Requirements

CELL-DYN components are designed specifically for use with the

CELL-DYN Emerald System. Substitution of unauthorized components may
adversely affect system performance.

Precautions and Requirements for System Operation

These precautions should be taken and requirements followed when operating the
CELL-DYN Emerald System. Failure to do so may cause damage to the system
and may adversely affect test results.
Precautions Before Operation
Before operating the system:
Read this manual thoroughly to understand the full functionality of the
system and associated hazards.
Read reagent labels and package inserts provided with calibrator and control
material to understand:
warnings and precautions
safety precautions
handling precautions
Requirements Before Operation
Before operating the system:
Ensure specimens are premixed according to your laboratorys procedure.
Specimens collected in micro-collection tubes should be premixed according
to the manufacturers recommendations.
Ensure background counts are within specifications before running controls
or patient specimens. Background counts are performed automatically as part
of Start Up.
Precautions During Operation
While operating the system:
Keep all instrument covers in place unless instructed otherwise in a
maintenance or troubleshooting procedure.
Do not disconnect any electrical connection while the power is ON.

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Section 7

General Requirements

The following information is applicable to European Economic Area countries:

Battery Disposal Information

Hg

The European Battery Directive requires separate collection of spent

batteries, aiming to facilitate recycling and to protect the environment.
This device contains batteries that are not intended to be serviced or removed
by the user. The batteries in this product should be removed at the end of the
life of the device by an Abbott Service technician or a qualified individual,
and disposed in accordance with local regulations for separate collection of
spent batteries.
Your local Abbott product support office may be contacted for additional
information.
Requirements for Handling Consumables
These requirements should be followed when handling reagents, calibrators and
controls to help ensure operator safety and accurate results. Refer to the
manufacturers documentation, such as a product label, package insert, or Material
Safety Data Sheet (MSDS) for detailed information. For a detailed description of
the hazard symbols, refer to Section 8: Hazards.
Requirements for Storage
Follow these requirements for storing reagents, calibrators and controls:
Store reagents, calibrators and controls according to the directions provided
on the label or in the package insert.
Contact Abbott Customer Service if you receive CELL-DYN reagents,
calibrators or controls that are in a condition contrary to the products label
or package insert, or are damaged.
Requirements for Use
Follow these requirements for using reagents, calibrators and controls:
Do not substitute. Substitution of materials may affect CELL-DYN Emerald
System performance, results, safety, and equipment life.
Keep the diluent container at the same level as the instrument.
Keep reagents away from direct sunlight and protect them from evaporation.
The cap attached to each inlet tube minimizes evaporation and
contamination.
Use caution when handling reagents, calibrators and controls to prevent
contamination and operator exposure.

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General Requirements

Prior to using the product, refer to the manufacturers instructions for

reagent, calibrator, and control temperature requirements and handling
instructions.
Wear clean gloves to avoid contamination and exposure when removing and
replacing the reagent inlet lines.
Do not smoke, eat, drink, apply cosmetics, or handle contact lenses in areas
where specimens, reagents, calibrators and controls are handled.
Do not use reagents, calibrators and controls after their expiration dates.
Do not mix reagents, calibrators and controls within a lot or between lots.
Requirements for Handling Specimens
WARNING: Consider all clinical specimens, reagents, calibrators and
controls that contain human-sourced materials as potentially infections.
Consider all system surfaces or components that have come in contact with
human-sourced materials as potentially infectious. Refer to Section 8:
Hazards for additional information.
Collect all specimens according to your laboratorys procedures, following the
recommendations of the collection tube manufacturer. Follow all usual precautions
when collecting blood by venipuncture to avoid clotting and/or specimen
hemolysis.
Requirements for Collecting, Preparing and Storing Specimens
Follow these requirements for collecting, preparing and storing specimens:
Use fresh whole blood specimens to achieve the most reliable result data. The
International Committee for Standardization in Haematology (ICSH) defines
a fresh blood specimen as one processed within four hours after collection.1
Maximum suggested elapsed time and storage temperatures after collection
of venous whole blood:
Four hours at room temperature.
For information on maximum suggested elapsed time for specimens
collected using micro collection devices, refer to the manufacturers
package insert.
Any refrigerated specimens should be brought to room temperature
before mixing and processing.
Interfering Substances and Conditions
Any substance or condition that can interfere with the CELL-DYN Emerald
Systems principles of operation should be considered an interfering substance or
condition. Refer to Section 3: Principles of Operation, Subsection: Instrument
Alarms, Operational Alerts, and Measurand Data Flags for a list of interfering
substances. For additional information on interfering substances, refer to the table
provided in Appendix B: Potential Causes of Spurious Results.
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General Requirements

Limitations of Result Interpretation

The CELL-DYN Emerald has been validated for its intended use. However, error
can occur due to potential operator errors and system technology limitations.
Results obtained from the system should be used with other clinical data, for
example, patient symptoms, other test results, patient history, clinical impressions,
information available from clinical evaluation, and other diagnostic procedures.
All data should be considered for patient care management. If the results are
inconsistent with clinical evidence, additional testing is suggested to confirm the
result.

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NOTES

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Operational Precautions and Limitations

Reference
International Council for Standardization in Haematology (ICSH). Protocol
for Evaluation of Automated Blood Cell Counters. Clin Lab Haemat. 1984;
6:69-84.

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Section 7

Reference

NOTES

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Section 8 Hazards

Section 8

Hazards

Overview

This section provides information on potential hazards to personnel and potential

damage to the laboratory environment.
Hazard and safety topics include:
Safety icons
Provides an illustration of each safety icon and sample text associated with the
icon.
Biological and chemical hazards
Provides an overview of the biological and chemical hazards and precautions to
minimize exposure to these hazards.
Electrical hazards
Provides an overview of precautions to avoid personal injury or damage to the
system from its electrical components.
Mechanical hazards
Provides an overview of the precautions to avoid personal injury or damage to the
system from the systems mechanical components.
Physical hazards
Provides an overview of the precautions to avoid physical injury when operating
or moving the system.

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Section 8

Overview

NOTES

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Hazards

Operator Responsibility
Operators are responsible for using the CELL-DYN Emerald system only as
designed. Operators should be trained before being allowed to operate the system.
Failure to follow instructions for safe use of the system could cause personal injury,
damage to the system, or could adversely affect results. See also Section 7:
Operational Precautions and Limitations.
Safety Icons
Safety icons in this manual and on the CELL-DYN Emerald System identify
potentially dangerous conditions. Learn the icons and understand the type and
degree of potential hazard they represent.
The following icons may be used with text or in lieu of text. If text accompanies
the icons, it describes the nature of the hazard and is labeled with WARNING or
CAUTION.
WARNING: is defined as a physical, mechanical, or procedural condition that
could result in moderate to serious personal injury.
CAUTION: is defined as a condition that could result in minor injury or interfere
with proper functioning of the system.
Table 8.1

Safety Icons

Icon

NOTE:

Hazard

Description

WARNING: Potential Biohazard.

Identifies an activity or area where operators may be

exposed to potentially infectious material.

WARNING: Electrical Hazard.

Indicates the possibility of electrical shock if

procedural or engineering controls are not observed.

CAUTION:

Identifies an activity that may present a safety related

hazard and advises you to consult the associated
caution or warning instructions provided.

Important Information:

Indicates important additional information.

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Operator Responsibility

Biological and Chemical Hazards

You may be exposed to biological materials and hazardous chemicals while using
the CELL-DYN Emerald system. The following information is presented to help
you minimize the likelihood and degree of impact of any such exposure.
Biological and chemical hazard topics include:
Biological hazards
Chemical hazards
Spill clean-up
Waste handling and disposal
Decontamination procedure requirements
Biological Hazards
The following activities may involve the presence of biological materials:
Handling patient specimens, reagents, calibrators, and controls
Cleaning spills
Handling and disposing of waste
Moving the system
Performing maintenance procedures
Performing decontamination procedures
Performing component replacement procedures
Precautions
You should consider all clinical samples, reagents, calibrators, and controls that
contain human-sourced material as potentially infectious. You should consider all
system surfaces or components that have come in contact with human-sourced
material potentially infectious. No known test method can offer complete
assurance that products derived from human-sourced material will not transmit
infection. Therefore, all products derived from human-sourced materials and
system components exposed to human-sourced materials should be considered
potentially infectious.
It is recommended that you handle all potentially infectious materials in
accordance with the Standard on Bloodborne Pathogens1. You should use
Biosafety Level 22 or appropriate biosafety practices3,4 for materials that contain or
are suspected of containing infectious agents. Precautions include, but are not
limited to, the following:
Wear gloves, lab coats, and protective eye wear when handling humansourced material or contaminated system components.
Do not pipette by mouth.

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Operator Responsibility

Do not eat, drink, smoke, apply cosmetics, or handle contact lenses when
handling human-sourced material or contaminated system components.
WARNING: Potential Biohazard. Identifies an activity or area where
you may be exposed to potentially infectious material.
Clean spills of potentially infectious materials and contaminated system
components with an appropriate disinfectant, such as 0.5% sodium
hypochlorite or another suitable disinfectant. Refer to Appendix C:
Preparation of diluted sodium hypochlorite solutions, Subsection:
Decontamination Procedure, for instructions for preparing the sodium
hypochlorite solution.
Decontaminate and dispose of all specimens, reagents, calibrators, controls,
and other potentially contaminated materials in accordance with local, state,
and federal regulations.
If you are exposed to biohazardous or potentially infectious materials, seek
medical attention immediately and take steps to clean the affected area.
The following label is affixed to the CELL-DYN Emerald System:

Figure 8.1

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Biohazard label

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Section 8

Operator Responsibility

The Biohazard label is affixed to the Start Switch below the Aspiration Probe as
shown in the following figure:

Figure 8.2

Biohazard Label location

The Biohazard label is also affixed to the rear of the instrument next to the waste
outlet as shown in the following figure:

Figure 8.3

8-6

Waste Outlet Biohazard Label

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Hazards
Section 8

Operator Responsibility

Chemical Hazards
Operators and others may be exposed to hazardous chemicals when handling
reagents, calibrators, and controls.
Exposure to hazardous chemicals is minimized by following instructions provided
in the manufacturers documentation, such as product labels, package inserts or
Material Safety Data Sheets (MSDS).
Precautions
In general, observe the following precautions when handling chemicals:
Consult MSDS for safe-use instructions and precautions.
Avoid contact with skin and eyes. If contact with material is anticipated, wear
impervious gloves, protective eye wear and clothing.
Maintain good housekeeping. Do not eat, drink, or store food and beverages
in areas where chemicals are used.
Seek medical attention if irritation or signs of toxicity occur after exposure.
Hazard symbols that appear on CELL-DYN Emerald System product labeling may
be accompanied by risk (R) and safety (S) numbers and represent risk and safety
phrases defined by European Community Directives. The risk and safety phrases
describe precautions to be used when working with a particular chemical or
chemical mixture.
Spill Clean-Up
Clean spills in accordance with established biosafety practices and follow
instructions provided in the MSDS. In general, use these safe work practices for
cleaning spills:
1. Wear appropriate personal protective equipment, such as a lab coat,
protective eyewear and gloves.
2. Absorb the spill with absorbent material.
3. Wipe the spill area with detergent solution.
4. Wipe the area clean with an appropriate disinfectant such as 0.5% sodium
hypochlorite or another suitable disinfectant. Refer to Section 9: Service and
Maintenance, Subsection: Decontamination Procedure, for instructions for
preparing the sodium hypochlorite solution.
5. Dispose of spilled and contaminated material in accordance with local, state,
and federal regulations.
Waste Handling and Disposal
Dispose of all waste materials in accordance with local, state, and federal
regulations.
It is the responsibility of each facility to label all waste containers and to
characterize its waste stream to ensure the waste is disposed in accordance with the
appropriate waste disposal regulations.
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Decontamination Procedure Requirements

The CELL-DYN Emerald system must be decontaminated before servicing,
shipment, and relocation. Always wear appropriate personal protective equipment
while performing decontamination activities. Refer to Section 9: Service and
Maintenance, Subsection: Decontamination Procedure for instructions.

Electrical Hazards
The CELL-DYN Emerald System does not pose uncommon electrical hazards to
operators if it is installed and operated without alteration, and is connected to a
power source that meets required specifications. Refer to Section 4: Performance
Characteristics and Specifications for power requirements and specifications.
The electrical circuit spacing of the CELL-DYN Emerald system is based on
pollution degree 2 and altitude [up to 2000 M (6562 ft)] as per IEC 61010-15.
Pollution degree 2 is defined as an environment where normally only nonconductive pollution occurs. Occasionally, however, a temporary conductivity
caused by condensation should be expected.
Electrical Safety
WARNING: Electrical Hazard. Indicates the possibility of electrical
shock if operating or servicing instructions are not followed.
Basic electrical hazard awareness is essential to the safe operation of any system.
Only qualified personnel should perform electrical servicing. If the instrument is
used or modified in a manner not specified by the manufacturer, the protection
provided by the instrument may be impaired.
Elements of electrical safety include, but are not limited to, the following:
Inspect electrical cabling into and on the CELL-DYN Emerald system for
signs of wear and damage.
Use only approved power cords and electrical accessories, such as those
supplied with the system, to protect against electric shock.
Use a properly grounded electrical outlet of correct voltage- and currenthandling capability.
Do not disconnect any electrical connection or service any electrical or
internal components while the power is ON.
Keep liquids away from all electrical or communication component
connectors.
Do not touch with wet hands any switches or outlets.
Keep the floor under and around the CELL-DYN Emerald system dry and
clean.
Clean spilled fluids immediately. Always unplug the instrument before
cleaning up major liquid spills.
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Section 8

Operator Responsibility

Mechanical Hazards
The CELL-DYN Emerald system is an automated system that operates under
computer control. As with most automated equipment, there is potential for injury
and bodily harm from moving mechanical components whenever the system is in
operation.
The CELL-DYN Emerald System minimizes mechanical hazards by providing
protective covers and locking mechanisms to protect against accidental contact
with mechanical and moving components.
During operation of the CELL-DYN Emerald system, the operator is potentially
exposed to the moving Aspiration Probe Assembly.
Basic elements of mechanical safety include, but are not limited to the following:
Never bypass or override a safety device.
Keep all protective covers in place.
Never allow any part of the body to enter the region of movement of any
mechanical component when the system is operating.
Never perform manual tasks on the surface of the system.
Open or remove covers only as directed during routine and as-needed
maintenance, component troubleshooting, or reagent removal and
replacement procedures described in Section 9: Service and Maintenance,
Section 10: Troubleshooting and Section 2: Installation Procedures and
Special Requirements, Subsection: Replacing the Reagents Diluent,
Lyse, Cleaner.
Use caution and wear a lab coat, protective eyewear and powder-free gloves
when operating the instrument, cleaning the instrument, reagent handling,
and when performing maintenance or service procedures. Always use
protective equipment when specified.
Do not wear long hair loose or articles of clothing or accessories that could
catch on the system.
Keep pockets free of items that could fall into the system.

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Operator Responsibility

Section 8

Physical Hazards
Safe practices should be observed to avoid physical injury in the following
situations:
Aspiration Probes
WARNING: Aspiration probes are potentially contaminated with
infectious material. Avoid contact with the tip of the probe. Although the
CELL-DYN Emerald system presents and lowers the probe for sample
aspiration, never reach into the access area until the probe is in place.
Place the aspiration probe in an appropriately labeled, puncture-resistant, and
leakproof container before treatment and disposal.
Heavy Objects
CAUTION: Identifies an activity where you may be required to lift or
move a heavy object. Use proper lifting techniques.
The CELL-DYN Emerald Diluent and waste containers are heavy when full. Use
proper lifting techniques to reduce the risk of injury when handling the containers.
The CELL-DYN Emerald System is heavy. Ensure there is adequate help before
attempting to move the system.
Tripping Hazard
The CELL-DYN Emerald System is equipped with power cords. To avoid a
tripping hazard, ensure that cords avoid high traffic areas or are properly stowed.

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Hazards

References
1. US Department of Labor, Occupational Safety and Health Administration, 29
CFR Part 1910.1030, Occupational Exposure to Bloodborne Pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological
and Biomedical Laboratories. Fourth Edition. Washington, DC: US
Government Printing Office, May 1999.
3. World Health Organization. Laboratory Biosafety Manual. Geneva: World
Health Organization, 1993.
4. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
Third Edition. CLSI document M29-A3 (ISBN 1-56238-567-4). Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA, 2005.
5. IEC 61010-1, International Electrotechnical Commission - World Standards
for Electrical and Electronic Engineering, 61010: - Safety Requirements for
Electrical Equipment for Measurement, Control, and Laboratory Use,
61010-1 (2001) Part 1: General Requirements.

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Section 8

References

NOTES

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Section 9 Service and Maintenance

Section 9

Service and Maintenance

Overview
The CELL-DYN Emerald System has been designed to require minimal routine
maintenance. To ensure optimum performance, the operator is encouraged to
routinely perform the scheduled maintenance procedures described in this section.
Failure to perform recommended maintenance can result in inaccurate or imprecise
results.
This section describes the recommended preventative maintenance procedures and
provides instructions for storing, relocating or shipping the instrument.
The maintenance schedule outlined in this section minimizes operational problems
with the CELL-DYN Emerald. The recommended intervals are based on
instruments operating in laboratories analyzing up to 50 specimens per day from a
general patient population. If more than 50 specimens per day are typically
analyzed, adjust the maintenance frequency proportionally. These intervals are
affected by several factors, including:
Number of specimens processed
Work load schedule
Operating environment
Patient population being analyzed
Each laboratory must assess its own situation and modify these recommended
intervals as necessary.
NOTE: Overdue maintenance is usually indicated by an increase in imprecision
of one or more of the directly measured measurands. This increase may
be due to carryover or dilution/sampling inconsistencies. If this occurs on
more than a random basis, the appropriate maintenance should be
performed more frequently.
WARNING: Potential Biohazard. Consider all clinical specimens,
reagents, calibrators, controls or other materials and all system surfaces or
components that contain or come in contact with human-sourced material
as potentially infectious. Wear a lab coat, gloves and safety glasses when
performing service or maintenance. Follow biosafety practices as specified
in the OSHA Bloodborne Pathogen rule (29 CFR Part 1910.1030)1 or other
equivalent biosafety practices.2, 3
Gloves should be powder-free; powder can cause instrument problems.
Maintenance procedures should not be performed without adequate training.

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Section 9

Overview

NOTES

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Section 9

Service and Maintenance

Event Log
The instrument provides an Event Log. This log maintains a record of certain
activities by date and holds 365 records, one for each day that the instrument is run.
Access the log from the MAIN menu by touching [EVENT LOG]. The Event Log is
shown in the following figure.
The days of operation are displayed in the
first row with day 001 being the first day of
the instrument operation - installation.
When a specific day is selected, the date,
day number, and the number of runs for
the selected day are displayed to the right
of the log. The abbreviations used in the
log are as follows:
SPR: Supervisor log in
SVC: Service log in
FCT: Factory log in
INT: Service Operation(s) performed
SUP: Start Up Cycle passed
SUF: Start Up Cycle failed
SDN: Shut Down Cycle
DIL: Diluent Reagent changed
LYS: Lyse Reagent changed
CLN: Cleaner changed
ACN: Cleaning Cycle (either automatic
or manual)
BLH: Bleach Cleaning
CAL: Calibration performed
QC: QC performed
DEL: Results deleted from Datalog
When the Event Log approaches capacity
the operator will be alerted to print the
Event Log. When the Event Log has 365
entries it will begin to delete entries on a
first-in first-out basis or the operator can
manually delete selected entries. The last
100 entries are maintained, even though
other entries are deleted.
An x will appear in the day column if the
specific event has occurred once or more
in that day.
Figure 9.1

EVENT LOG Screen

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Section 9

Event Log

Saving and Printing the Event Log

The EVENT LOG may be saved to a USB drive (see Section 5: Operating
Instructions) or printed to provide a permanent record.
1. From the MAIN menu, touch [EVENT LOG].
2. Touch the TOOLS icon.
To print the EVENT LOG:
1. Select the range of records by touching either
the [ALL] radio button or the [DAY] radio
button. If using the DAY method, enter the
number(s) representing the desired day(s) to
print in the fields to the right.
NOTE: To see the date associated with a particular
day in the EVENT LOG, touch the day on the
display and the date will appear in the gray area on
the right side of the display. To view a day not
shown on the display, use the scroll bar to move
right and left.
2. Touch [PRINT].
To save the EVENT LOG:
1. Insert a formatted USB drive into either USB
port on the rear panel of the
CELL-DYN Emerald.
2. Select the range of records by touching either
the [ALL] radio button or the [DAY] radio
button. If using the DAY method, enter the
number(s) representing the desired day(s) to
print in the fields to the right.
NOTE: To see the date associated with a particular
day in the EVENT LOG, touch the day on the
display and the date will appear in the gray area on
the right side of the display. To view a day not
shown on the display, use the scroll bar to move
right and left.
3. Touch [SAVE].
Figure 9.2

Saving and Printing the Event Log

Abbott recommends that CELL-DYN Emerald Operators keep a record of

scheduled and unscheduled maintenance in an instrument logbook. (Refer to
Section 5: Operating Instructions, Subsection: Instrument Logbook.)
For your convenience, a blank Maintenance Log is included in Appendix E:
Sample Logs and Worksheets. This page can be photocopied as necessary.
Enter the month and year at the top of each page and initial each task when it is
completed.

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Event Log

Maintenance Menu
The MAINTENANCE Button is found on the MAIN menu. The options accessible
from the MAINTENANCE Button are described, below.
1. Initialize System. This button is used to
initialize the Emerald following an
Emergency Stop or as directed during
instrument troubleshooting.
2. Motor Init. Used for troubleshooting as
directed by an Abbott Representative.
3. Fluidics. Refer to Subsection: Fluidics
Menu Options, found later in this section.
4. Mechanical Cycles. Used for
troubleshooting as directed by an Abbott
Representative.
5. Special Modes. Used to access the
Precision and Linearity buttons,
described later in this section.
6. Sys Clean. Used as described in
Subsection: Preparing for Storage,
Relocation or Shipping, found later in
this section.
7. Error Log. An automatic log of all system
errors generated by the
CELL-DYN Emerald. For use in
troubleshooting as directed by an Abbott
Representative.

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Event Log

Special Modes Button

The SPECIAL MODES Button is accessed from the MAIN menu by touching the
MAINTENANCE button.
Precision. The Precision Button allows
an operator to perform a precision test
consisting of up to 33 runs. The mean
(+/-), SD (Standard Deviation) and CV%
are calculated automatically for each
parameter.
1. Touch [MAINTENANCE], [SPECIAL
MODES], then [PRECISION].
If data is already present in the file from
a previous precision test, the software
prompts the user to delete the previous
results. Touch [YES] to erase previous
results, or [NO] to view or print previous
results.
NOTE: If prior results are not deleted, the
sample probe will not descend.
2. When the sample probe descends,
present a well-mixed sample and touch
the start switch. Repeat until the
number of desired precision replicates
is reached. The mean, SD, and CV%
will update with each run.
3. Select or deselect individual runs by
touching the (<>) to the left of the run.
The mean, SD, and CV% will update as
runs are selected and deselected.
Individual run reports are not printed for
samples tested in Precision. To print a
summary of the precision test results,
touch the Tools icon, and touch [PRINT].
Precision test results are not stored in the
DATALOG and are accessible only
through the PRECISION Button.

9-6

Figure 9.3

The Precision Button

Figure 9.4

Precision Data

Figure 9.5

The Precision Run Screen (shown with an empty file)

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Section 9

Linearity. The Linearity Button allows an

operator to test linearity material or other
samples that consist of only one blood cell
type. All samples tested in the Linearity
mode will have LINEARITY in the NAME
field.
1. Touch [MAINTENANCE], [SPECIAL
MODES], then [LINEARITY].
2. Enter additional information about the
sample in the <NEXT SID> field, if
desired. To utilize the alpha touch
screen, or to enter information into the
PID field, touch the [NEXT SAMPLE]
button at the lower left of the display.
Use the numeric keypad on the
Emerald and/or the alpha keypad on
the display to enter the desired
information. Touch [CONFIRM] to save
entries or [ESC] to exit without saving.
3. At the Linearity Run screen, aspirate
the sample. All results of linearity
testing are stored in the Datalog.

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Event Log

Figure 9.6

The Linearity Button

Figure 9.7

The Linearity Run Screen

9-7

Service and Maintenance

Section 9

Event Log

NOTES

9-8

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Section 9

Service and Maintenance

Fluidics Menu Options

The following options are available on the FLUIDICS menu. To access FLUIDICS
from the MAIN menu, touch [MAINTENANCE], then [FLUIDICS].
These options are described for as-needed use during troubleshooting.
DRAIN ALL Drains the counting
chambers and the Waste/Vacuum
Syringes.
REFILL Refills the counting chambers.
CLEAN Cleans the Apertures and
Counting Chambers with Cleaner
Reagent.
BACKFLUSH Applies backpressure to
the apertures.
BLEACH Initiates the Bleach Cleaning
cycle.
INIT PRESS For Abbott Service use
only.
Figure 9.8

Fluidics Menu

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Service and Maintenance

Section 9

Fluidics Menu Options

NOTES

9-10

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Section 9

Service and Maintenance

Preventive Maintenance Schedule

The CELL-DYN Emerald does not require routine daily or weekly maintenance.

Monthly Maintenance
Bleach Cleaning
Cleaning the system with a bleach solution is performed monthly or as needed
when a measurand is repeatedly rejected.
Materials Required
Powder-free gloves, lab coat, safety glasses
Sodium hypochlorite (undiluted, unscented purchased bleach)
Plastic transfer pipette or other disposable pipette with 2 mL capacity
Flat screwdriver
Prepare a 3.6% sodium hypochlorite (bleach) solution according to the formula in
Appendix C. Transfer the prepared solution to the squirt bottle.

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Section 9

Procedure
Access the bleaching function as follows:
1. From the MAIN menu, touch
[MAINTENANCE] to display the
MAINTENANCE menu.
2. From the MAINTENANCE, touch
[FLUIDICS] to display the FLUIDICS menu.
(shown at the right)
3. From the FLUIDICS menu, touch [BLEACH]
to start the bleaching process and drain the
counting chambers.

When the warning window displays, proceed as

follows:
4. Open the instruments right side door using
the flat screwdriver/key.
5. Measure 2mL of the prepared bleach solution
into each counting chamber as shown, touch
[OK].
6. When the information box indicates PLEASE
CLOSE FLUIDICS DOOR, close the right side
door using the flat screwdriver/key, and touch
[OK].
7. The instrument automatically draws the
bleach through the apertures and then goes
into a Stand-By mode for two minutes.
8. At the end of the Stand-By mode, the
instrument automatically rinses the bleach
out of the system.
9. When the status LED turns green the cycle is
complete. Perform a Start Up and verify that
all measurands are within specifications
before running patient or other samples.
10.Run QC and verify that results are within
specifications.
11. The instrument is now ready to run
specimens.
12.Document the maintenance on the
Maintenance log.
Figure 9.9

9-12

Bleach Cleaning

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Section 9

Preventive Maintenance Schedule

Semi-Annual Maintenance
Lubricating the Pistons
For optimal operation, the Syringe Pistons should be lubricated every six months
as described below.
Short arm T20 torx tool
NOTE: This procedure is used only for the 4 white teflon syringe pistons. The
metal sample syringe piston should not be lubricated.
Materials Required
Powder-free gloves, lab coat, safety glasses
Silicone Grease supplied in the Installation Kit
Short Arm Torx T20
Flat screwdriver / key
Procedure
Move the syringe pistons to the lubrication
position as follows:
1. From the MAIN menu, touch
[MAINTENANCE] to display the
MAINTENANCE menu.
2. From the MAINTENANCE menu, touch
[MECHANICAL CHECKS], then touch
[LUBRICATION POS.] to move the
syringe pistons to the lubrication
position.

Figure 9.10 Mechanical Checks Menu

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Preventive Maintenance Schedule

When the warning window displays, CONTINUE, proceed

as follows:
3. Open the instruments right side door using the flat
screwdriver / key.
4. Put a small amount of lubricant on your fingertip.
5. Apply a thin film of lubricant around the white teflon
pistons as shown. Small pistons (lyse (1) and diluent
(3)) can be turned with your fingertips. The large pistons
(Waste Syringes (2)) can be turned with the Short Arm
Torx T20 Tool provided in the Service Kit. Insert the Torx
Tool into the socket at the bottom of the syringes to turn
the Waste Syringes.
6. When all pistons are lubricated, close the right side door
using the key.
7. Touch [OK] on warning window to return the pistons to
their operational position.
8. Run a background count and QC, verify that results are
within specifications before processing any samples.
9. Document the maintenance on the Maintenance Log.
10.Touch HOME icon to go back to the MAIN menu.

Figure 9.11 Lubricating the Syringe Pistons

As Needed Maintenance
Emergency Stop
If there is a mechanical or fluidic problem, press the ON/OFF button to
immediately stop the instrument. Under certain conditions, the system may halt
due to an internally detected fault condition. In either situation, when the problem
is corrected, it is necessary to initialize the system. Before initializing the system,
respond to any pop-up messages displayed. This function is accessible from the
MAINTENANCE menu as shown in the following Figure.
Initialize System
To initialize the system after an Emergency
Stop:
1. From the MAIN menu touch
[MAINTENANCE].
2. Touch [INITIALIZE SYSTEM].
3. When initialization is complete, perform
the Daily Start Up Procedures as
described in Section 5: Operating
Instructions, Subsection: Daily Start
Up Procedures.
Figure 9.12 Maintenance Menu
9-14

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Service and Maintenance

Section 9

Preventive Maintenance Schedule

Cleaning the cover

Material Required
0.5% Sodium Hypochlorite Solution
Cotton gauze pads
Wipe the outside surfaces with a non-abrasive detergent cleaning solution to
remove any soil. Then, wipe the surfaces with a tuberculocidal disinfectant, such
as a 0.5% sodium hypochlorite solution. Instructions for preparing the hypochlorite
solution are provided in Appendix C.
Preparing for Storage, Relocation or Shipping
Salt deposits and reagent residue can damage the fluidics if they are not removed
before the CELL-DYN Emerald is stored (idle for two weeks or longer) or shipped.
The System should be decontaminated prior to shipment or relocation.
The OSHA Bloodborne Pathogen Rule (29 CFR Part 1910.10301) requires the
decontamination of laboratory equipment prior to servicing or shipment. Wipe the
surfaces of the System with a non-abrasive detergent cleaning solution to remove
any soil. Then, wipe the surfaces with a tuberculocidal disinfectant such as a 0.5%
sodium hypochlorite solution.
WARNING: Potential Biohazard. Consider all clinical specimens,
reagents, calibrators, controls, or other materials and surfaces or
components that contain or have contacted human-sourced material as
potentially infectious. Wear gloves, lab coat, and safety glasses. Follow
biosafety practices as specified in the OSHA Bloodborne Pathogen Rule
(29 CFR Part 1910.1030)1 or other equivalent biosafety practices.2, 3
Materials Required
Cotton gauze pads
Three beakers, each filled with about 150 mL of deionized water (one for
each reagent line)
0.5% sodium hypochlorite (bleach) cleaning solution (Refer to Appendix C)
3.6% sodium hypochlorite (bleach), for Clean Out cycle (Refer to
Appendix C)
Warm tap water
Plastic bags one each for diluent and waste tubing
Packaging or cellophane tape
Clean paper towels

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Preventive Maintenance Schedule

Section 9

Decontamination Procedure
1. Place 1 mL of the 0.5% sodium hypochlorite solution in a clean test tube,
immerse the tip of the aspiration probe in the bleach solution, and touch [RUN
SAMPLE] to decontaminate the fluidics.
2. When the instrument is ready for the next cycle, dampen a gauze pad with the
0.5% sodium hypochlorite solution and wipe the outside of the Aspiration
Probe.
3. Initiate a CLEAN OUT cycle as follows:
NOTE: Use the 3.6% sodium hypochlorite (bleach) for these steps.

4.
5.
6.
7.
8.

9.

10.
11.
12.

13.
14.
15.

9-16

a. From the MAIN menu touch [MAINTENANCE]

b. Touch [SYS CLEAN] and follow the instructions step-by-step as
displayed
When the cleaning procedure is completed, power off the instrument by
pressing and holding the Power On/Off button until the display turns dark.
Remove the power cord from the rear of the instrument and then disconnect
it from the power outlet.
Disconnect the AC Adapter from the power cord.
Disconnect the printer according to manufacturer's directions.
Disconnect the Diluent line from the rear of the instrument and allow any
reagent in the line to drain into the container. Remove the cap from the
container and remove the tubing. If necessary, wipe the outside of the tubing
with a clean paper towel and then place the tubing in a plastic bag and close it.
Disconnect the waste line from the rear of the instrument and allow any waste
in the line to drain into the container. Dispense 0.5% sodium hypochlorite
solution into the tubing and allow it to drain into the waste container. Remove
the cap from the container and remove the tubing. Rinse the tubing inside and
out with warm running tap water. Wipe the outside with a clean paper towel,
place the tubing in a plastic bag and close the bag.
Wipe the outside of the Cleaner and Lyse tubing with gauze dampened with
deionized water.
Dispose of reagents, waste and containers according to your laboratorys
protocol.
Wipe the outside surfaces with a gauze pad dampened with 0.5% sodium
hypochlorite, followed by a wipe with deionized water and drying with a
paper towel.
Place the bags of tubing, power cord, AC Adapter and any other accessories
in the accessory kit or a suitable container.
Store the instrument at temperatures within the range: 14F to 122F (-10C
to 50C).
If the instrument is to be shipped, contact Abbott Diagnostics Customer
Service for instructions.

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Section 9

Preventive Maintenance Schedule

Clean
The Clean procedure may be used for troubleshooting, as described in Section 10:
Troubleshooting. This is an automated process.
1.
2.
3.
4.

From the MAIN menu, touch [MAINTENANCE].

Touch [FLUIDICS].
Touch [CLEAN].
When the Clean cycle is complete, the LED will turn green. Perform a Start
Up to ensure backgrounds are within specifications before testing patient or
control samples.

Backflush
The Backflush procedure may be used for troubleshooting, as described in
Section 10: Troubleshooting. This is an automated process.
1.
2.
3.
4.

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From the MAIN menu, touch [MAINTENANCE].

Touch [FLUIDICS].
Touch [BACKFLUSH].
When the Clean cycle is complete, the LED will turn green. Perform a Start
Up to ensure backgrounds are within specifications before testing patient or
control samples.

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Service and Maintenance

Section 9

Preventive Maintenance Schedule

Sample Probe Removal and Replacement

Materials Required
Powder free gloves, lab coat and safety glasses.
Flat screwdriver / key
Sampling Probe
WARNING: Potential Biohazard. The probe is sharp and potentially
contaminated with infectious materials. Avoid contact with the tip of the
probe.
Sample Probe Removal
1. From the MAIN menu, touch
[MAINTENANCE], [MECHANICAL
CHECKS] then [REMOVE PROBE].

Figure 9.13 Sample Probe Removal

9-18

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Section 9

Preventive Maintenance Schedule

2. The rocker moves the sample probe to the

disassembling position. When the warning
pop-up displays [CONTINUE], use the flat
screwdriver to open the right side door to
have access to the flow panel.
IMPORTANT: Do not touch OK until
replacement of the probe is complete.
Turn the instrument so that the flow panel is
facing you.

3. The sample probe (1) is in front of the

counting chambers.

Figure 9.13 Sample Probe Removal (Continued)

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Section 9

Preventive Maintenance Schedule

4. To remove the sample probe, gently press

down on the white plastic rinse head (1)
and pull the rinse head and probe toward
you until they disengage from the rocker.

Figure 9.13 Sample Probe Removal (Continued)

9-20

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Section 9

Preventive Maintenance Schedule

5. Disconnect the tubing from the top of the

sample probe.

6. While holding the white rinse head with one

hand, gently pull up on the sample probe
until it is free from the rinse head.
7. Dispose of the sample probe according to
your laboratorys procedure.
Figure 9.13 Sample Probe Removal (Continued)

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Service and Maintenance

Preventive Maintenance Schedule

Section 9

Sample Probe Replacement

1. Holding the rinse head with the black
fitting up, gently insert the probe from the
top.
2. Connect the tubing to the top of the
sample probe.

NOTE: If the tubing does not fit tightly at

the probe connection disconnect
the tubing from the probe, cut off
up to 3mm of tubing and
reconnect.

3. Insert the rinse head into the rocker and

press gently to make sure it is fully seated.
Gently press the wide part of the sample
probe above the rinse head to ensure that it
is clipped into the rocker.

4. Close and latch the right side door.

Touch [OK] on the display.
5. Run a background count and QC, verify
that results are within specifications before
processing any samples.
Figure 9.14 Sample Probe Replacement

9-22

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Section 9

Service and Maintenance

References
1. US Department of Labor, Occupational Safety and Health Administration.
29CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens.
2. World Health Organization. Laboratory Biosafety Manual. Geneva: World
Health Organization, 1993.
3. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
Third Edition. CLSI document M29-A2 (ISBN 1-56238-567-4). Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898, USA, 2005.

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Service and Maintenance

Section 9

References

NOTES

9-24

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Section 10 Troubleshooting

Section 10

Troubleshooting

Overview
This section provides information for use in troubleshooting instrument problems.
The CELL-DYN Emerald continuously monitors system status and provides
instrument alarms and warnings when problems are detected.

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Troubleshooting
Section 10

Overview

NOTES

10-2

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Section 10

Troubleshooting

General Information
Conditions that are instrument-or reagent-related will usually be seen on all
specimens, including controls. When patient results are suspect, it is important to
confirm instrument performance by running controls. If control results are also
suspect, troubleshoot as directed in this section.
WARNING: Potential Biohazard. Follow established biosafety practices
when performing maintenance, service, or troubleshooting procedures.
Refer to Section 8: Hazards for additional information.
Troubleshooting Guide
Understanding normal instrument operation is essential for identifying and
resolving operational problems. Effective troubleshooting requires a logical, stepby-step approach to problem solving. Logical troubleshooting can be divided into
three steps:
1. Problem Identification requires the Operator to investigate not only what
is wrong but to note what is right. The investigation should identify the
problem area and eliminate areas that are working correctly. When this step
is done, move to the next step.
2. Problem Isolation further classifies an instrument problem. Problems are
generally divided into three categories:
Measurement-related to sample analysis
Software-related
Hardware component-related
Hardware and software problems may or may not be operator-correctable with
technical assistance. Measurement problems are generally operator-correctable.
They are further divided into problems related to sample handling, maintenance or
calibration.
3. Corrective Action involves taking appropriate steps to correct the
problem. If the operator can correct the problem, with or without technical
assistance, normal operation can quickly resume.

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Troubleshooting
Section 10

General Information

If additional information or assistance is needed, technical assistance can be

obtained by contacting Abbott Customer Service as described in the Foreword of
this manual. This is always facilitated by providing sufficient information and a
clear and detailed description of the problem. When assistance is needed, please be
prepared to provide the following information:
Instrument model name
Instrument serial number
Software version in use
Description of the problem
Any alarms or error messages that are displayed
Lot numbers and expiration dates of reagents, calibrators and controls
currently in use
Instrument maintenance history
Examples of data to facilitate the discussion, such as, data from quality
control runs, patient data, data from the last calibration, etc.
Troubleshooting Tables
The following tables are included in this section:
Table 10.1: Measurand-related problems
Table 10.2: Instrument-related problems
Table 10.3: Alarm messages
Each table lists the problem and suggested corrective action.

10-4

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Troubleshooting
Section 10

General Information

Troubleshooting Log
An example of a Troubleshooting Log is provided in Appendix E: Sample Logs
and Worksheets. This log can be used to keep a record of troubleshooting
observations and problem resolution and can be photocopied as needed. This
record can be useful for providing troubleshooting guidance.
Table 10.1

Measurand-Related Problems

NOTE: This table can be used for troubleshooting of patient results or QC.
Measurand

Problem
No WBC and HGB results
WBC Clog Error (W-CL)

1. Check the lyse reagent to be sure it is not

empty or expired.
2. Check the lyse tubing connection to the
WBC counting chamber.
3. Check the wires attached to the WBC
counting chamber to be sure they are
connected.

No WBC result, HGB is OK

WBC Clog Error (W-CL)

1.
2.
3.
4.
5.

Imprecise, Inaccurate results or

false Suspect Population Flags

1. Verify all samples are well-mixed prior to

analysis.
2. Verify that Cleaner & Lyse connections
are correct.
3. Perform a Shut Down and then a Start Up.
4. Perform Back Flush.
5. Perform Clean.
6. Perform Bleach Cleaning.
7. Look for evidence of leakage (liquid or
dried reagent or blood) below the syringe
block.

WBC

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Corrective Action

Perform Back Flush.

Perform Clean.
Perform Bleach Cleaning.
Perform a Shut Down and then a Start Up.
Check the wires attached to the WBC
counting chamber to be sure they are
connected.

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Troubleshooting
Section 10

General Information

Table 10.1

Measurand-Related Problems (Continued)

NOTE: This table can be used for troubleshooting of patient results or QC.
Measurand
RBC

HGB

PLT

10-6

Problem

Corrective Action

No RBC, HCT or PLT results

RBC Clog Error (R-CL)

1.
2.
3.
4.

Perform Back Flush.

Perform Clean.
Perform a Shut Down and then a Start Up.
Check the wires attached to the RBC
counting chamber to be sure they are
connected.
5. Perform Bleach Clean.

Imprecise or inaccurate RBC,

HCT and PLT results

1. Verify samples are well-mixed prior to

analysis.
2. Perform Back Flush.
3. Perform Clean.
4. Perform a Shut Down and then a Start Up.
5. Perform Bleach Cleaning.
6. Look for evidence of leakage (liquid or
dried reagent or blood) below the syringe
block.

No results

1. Run a Start Up Cycle.

Imprecise results

1. Check that there are no bubbles in the

lyse tubing.
2. Perform Bleach Cleaning.

Rejected results ---- *

1. Be sure the right side door is closed.

2. Run a Start Up cycle.

Imprecise or Inaccurate results

1.
2.
3.
4.

Elevated background

1. Prime diluent.

Perform Back Flush.

Perform Clean.
Perform Bleach Clean.
Verify reagent connections.

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Troubleshooting
Section 10

Table 10.2

General Information

Instrument-Related Problems
Source

Problem

Corrective Action

Diluent leaks around the

Aspiration Probe during the Run
cycle.

Contact Abbott Customer Service.

No power

Check the connections of the power

cord to the instrument and AC
Adapter. Check the connection of the
AC Adapter to the power outlet.

All results appear erroneous

Check the Diluent level and be sure

the tubing is not pinched.

No display

1. Press the Standby Button.

2. Call Abbott Customer Service.

Unable to enter ID and/or PID

1. Check the settings. Touch

[SET UP], followed by
[ADVANCED], followed by
[REPORTING OPTIONS].

CELL-DYN Emerald

Note that a supervisor password

is required to access the
ADVANCED SET UP menu.
Touch screen is unresponsive

Calibrate touch screen

1. Invoke Touch Screen Calibration
by simultaneously pressing the .
key and the
DEL key on
the numerical keyboard.
2. Touch the center of the cross
shown on the screen.
3. Repeat Step 2 for two more
screen locations. When
complete, the Touch Screen
Calibration returns to the original
menu.

Printer does not print

1. Check the paper and then check

the electrical connection.
2. Verify that the correct printer is
configured in Setup.

Print quality is bad

1. Check and/or replace the printer

ribbon or cartridge.

Printer

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Troubleshooting
Section 10

General Information

Table 10.3

Alarm Messages
Message

Corrective Action

BACKUP: NO MEMORY AVAILABLE FOR

STORAGE

Print and/or save results, then delete stored results.

BACKUP: PRECISION HISTORY IS FULL

Print and/or save Precision results and report, then

delete stored results.

BACKUP:INCORRECT FOLDER DUPLICATION

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

BACKUP:CALIBRATION HISTORY IS FULL

Print and/or save calibration results and report, then

delete stored results.

BACKUP:ERROR HISTORY IS FULL

Contact the Abbott Customer Support Center.

BACKUP:FILE SYSTEM FAILED

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

BACKUP:FOLDER NOT FOUND

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

BACKUP:LAST QC RESTORED

Indicates that QC has been restored.

BACKUP:LAST RESULTS RESTORED

Indicates that results have been restored.

BACKUP:LAST SETUP RESTORED

Indicates that SETUP values have been restored. No

action required.

BACKUP:MEMORY ALMOST FULL. PLEASE

DELETE RESULTS

Print and/or save results, then delete stored results.

BACKUP:QC HISTORY IS FULL

Print and/or save QC results and report, then delete

stored results.

BACKUP:SECTOR FAILED

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

BACKUP:SETUP UPDATED WITH DEFAULT

VALUES

Indicates that SETUP values have been restored to

the default values.

BACKUP:SYSTEM ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

CLEAN NOT DONE

Perform a Clean cycle.

CLEANER REAGENT : REMAINING CAPACITY IS

EQUAL OR LOWER TO 10%.

Replace the bottle and Prime Cleaner.

10-8

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Troubleshooting
Section 10

Table 10.3

General Information

Alarm Messages (Continued)

CLEANER REAGENT IS EXPIRED. PLEASE

REGISTER A NEW CONTAINER OF CLEANER
REAGENT.

Replace the bottle and prime cleaner.

CLEANER REAGENT IS EMPTY. PLEASE

REGISTER A NEW CONTAINER OF CLEANER
REAGENT.

Replace the bottle and prime cleaner.

COM:CHECKSUM ERROR

Contact the Abbott Customer Support Center.

COM:CRC CONTROL ERROR

Retry sending results. If not resolved, contact the

Abbott Customer Support Center.

CONTROL CYCLE NOT DONE

Run an Initialization cycle.

CYCLE BUSY

Wait until LED is green before initiating the cycle.

CYCLE STOPPED BY USER

Initialize the system.

CYCLE: FLUIDIC DOOR OPENED

Close door and latch using the screwdriver. Initialize

system.

CYCLE: EMERGENCY STOP

Initialize the system.

CYCLE: INIT NOT DONE

Initialize the system.

CYCLE:CMD FAILED

Contact the Abbott Customer Support Center.

CYCLE:PRESSURE DEFAULT

Check for empty reagents and replace if necessary.

Check for disconnected tubing and reconnect, if
needed. If not resolved, contact the Abbott Customer
Support Center.

CYCLE:VALVE 1 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 2 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 3 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 4 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 5 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

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Section 10

General Information

Table 10.3

Alarm Messages (Continued)

CYCLE:VALVE 6 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 7 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 8 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 9 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 10 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

CYCLE:VALVE 11 FAILED

Restart the Emerald. If not resolved call Abbott

Customer Support Center.

DILUENT REAGENT IS EMPTY. PLEASE

REGISTER A NEW CONTAINER OF DILUENT
REAGENT.

Replace the container and prime Diluent.

DILUENT REAGENT : REMAINING CAPACITY IS

EQUAL OR LOWER TO 10%

Replace the container and prime Diluent.

DILUENT REAGENT IS EXPIRED. PLEASE

REGISTER A NEW CONTAINER OF DILUENT
REAGENT

Replace the container and prime Diluent.

HGB CHANNEL SATURATION. PLEASE RUN A

START UP.

Run a Start Up. If not resolved, call Abbott Customer

Support Center.

HARDWARE:SYSTEM ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

HOST: TIME OUT

Re-start the Emerald.

NAME AND/OR PID MANDATORY

Enter an ID and/or PID.

INIT PRINTER

Verify that printer power is on, verify connections are

correct, verify settings in Set Up. If not resolved,
contact the Abbott Customer Support Center.

INITIALIZATION NOT DONE

Initialize the system.

INTERN: COUNT ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

INTERN: RESULT AREA IS LOCKED

Wait until LED is green before initiating the cycle.

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Troubleshooting
Section 10

Table 10.3

General Information

Alarm Messages (Continued)

INTERN:MEMORY CORRUPTED

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

INTERN:NO MEMORY AVAILABLE

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

LYSE REAGENT IS EMPTY. PLEASE REGISTER A

NEW CONTAINER OF LYSE REAGENT.

Replace the bottle and Prime Lyse.

LYSE REAGENT : REMAINING CAPACITY IS

EQUAL OR LOWER TO 10%

Replace the bottle and prime Lyse.

LYSE REAGENT IS EXPIRED PLEASE REGISTER

A NEW CONTAINER OF LYSE REAGENT

Replace the bottle and Prime Lyse.

LAST RESULT SAVED

Print and/or save results, then delete saved results.

MECH: HOME NEEDLE NOT FOUND

Initialize the system.

MECH: MOTOR ROCKER GAP

Initialize the system, if not resolved, Contact the

Abbott Customer Support Center.

MECH: MOTOR SYRINGE GAP

Initialize the system, if not resolved, Contact the

Abbott Customer Support Center.

MECH: MOTOR NEEDLE GAP

Initialize the system, if not resolved, Contact the

Abbott Customer Support Center.

MECH: PROBE NOT IN TOP POSITION

Initialize the system, if not resolved, Contact the

Abbott Customer Support Center.

MECH:HOME ROCKER NOT FOUND

Initialize the system, if not resolved, Contact the

Abbott Customer Support Center.

MECH:HOME SYRINGE NOT FOUND

Initialize the system, if not resolved, Contact the

Abbott Customer Support Center.

MECH:MOTOR NEEDLE BUSY

Restart the Emerald and perform a Start Up cycle. If

not resolved, contact the Abbott Customer Support
Center.

MECH:MOTOR SYRINGE BUSY

Restart the Emerald and perform a Start Up cycle. If

not resolved, contact the Abbott Customer Support
Center.

NO PRINTER RESPONSE

Verify that printer power is on, verify connections are

correct, verify settings in Set Up. If not resolved,
contact the Abbott Customer Support Center.

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Troubleshooting
Section 10

General Information

Table 10.3

Alarm Messages (Continued)

NO PRINTER SELECTED

Verify printer settings in Set Up, check for correct

printer driver. If not resolved, contact the Abbott
Customer Support Center.

OUT OF RANGE

Check the value and re-enter.

PRINTER ERROR

This error will occur if the system is configured for a

printer, but no printer is connected to the analyzer.
Verify that printer power is on, verify connections are
correct, verify settings in Set Up. If not resolved,
contact the Abbott Customer Support Center.

PRINTER IS BUSY

Wait until current print job is complete then repeat

Print request.

PRINTER:NO DRIVER ON

Contact the Abbott Customer Support Center.

PRINTER:NO PAPER

Add paper to printer.

PRINTER IS OFF

Turn the printer On.

REFILL NOT DONE

Perform a Refill cycle.

HOST:ACK ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

COM:INTERNAL ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

HOST:SYNCRO ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

RUNNING AUTO CLEANING

Wait until LED is green before initiating the cycle.

START UP CYCLE FAILED

Perform another Start Up cycle, up to two times. If not

resolved, contact the Abbott Customer Support
Center.

START UP CYCLE NOT DONE

Run a Start Up cycle.

SYSTEM:BUSY

Wait until LED is green before initiating the cycle.

SYSTEM:EEPROM COM ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

SYSTEM:FATAL ERROR

Restart the Emerald and perform a Start Up cycle. If

not resolved, contact the Abbott Customer Support
Center.

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Troubleshooting
Section 10

Table 10.3

General Information

Alarm Messages (Continued)

SYSTEM:INTERNAL TIME OUT

Contact the Abbott Customer Support Center.

THE DILUENT REAGENT LOG IS FULL.

Reagent log must be deleted. Contact Abbott

Customer service.

THE LYSE REAGENT LOG IS FULL.

Reagent log must be deleted. Contact Abbott

Customer service.

THE CLEANER REAGENT LOG IS FULL.

Reagent log must be deleted. Contact Abbott

Customer service.

SYSTEM:UNKNOWN ERROR

Restart the Emerald. If not resolved, contact the

Abbott Customer Support Center.

THE PRINTER IS OFF

Turn printer power on.

UNKNOWN COMMAND

Contact the Abbott Customer Support Center.

USB:UNABLE TO OPEN FILE

Read error. Try again. Format flash drive or replace

it.

USB: EXTERNAL STORAGE DEVICE IS FULL

Delete files or replace flash drive.

USB:EMPTY FILE

Check the USB storage device.

USB:EXTERNAL STORAGE DEVICE IS NOT

PRESENT

Connect flash drive.

USB:WRITE PROTECTED FILE

Check the USB storage device.

USB:DIRECTORY DOES NOT EXIST

Check the USB storage device.

USB: EXTERNAL STORAGE DEVICE I/O ERROR

Check the USB storage device.

FAILED TO LOAD THE REAGENTS LOG FILE. THE

FILE IS NOT PRESENT OR UNVALID.

Check the USB storage device.

FAILED TO SAVE THE RESULT ONTO THE

EXTERNAL STORAGE DEVICE. THE INTERNAL
MEMORY IS USED INSTEAD.

Verify Storage device is present.

INVALID FORMAT

Reformat the USB storage device

THE LOT ALREADY EXISTS, ACTION IS

ABORTED

Select another Lot.

MAXIMUM NUMBER OF FILES PER FOLDER IS

REACHED. TO SAVE NEW FILES, OLDER FILES
HAVE TO BE DELETED.

Delete some files on USB storage device.

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Troubleshooting
Section 10

General Information

Table 10.3

Alarm Messages (Continued)

VERSION RELEASE FAILED. THE CHOSEN

RELEASE IS NOT COMPATIBLE WITH THE
EMERALD SYSTEM.

Select correct version.

PRINTER DRIVER UPDATE FAILED. THE

CHOSEN DRIVER IS NOT COMPATIBLE WITH
THE EMERALD SYSTEM.

Select correct version.

NETWARE: SERVER INIT. FAILED

Check your analyzer configuration.

NETWARE: CLIENT INIT. FAILED

Check your analyzer configuration.

A USB THUMB DRIVE IS ALREADY MOUNTED ON

PORT 2. PLEASE REMOVE THE THUMB DRIVE
FROM THE PORT 1.

Remove extra flash drive.

A USB THUMB DRIVE IS ALREADY MOUNTED ON

PORT 1. PLEASE REMOVE THE THUMB DRIVE
FROM THE PORT 2.

Remove extra flash drive.

THE USB THUMB DRIVE FILE SYSTEM IS NOT

COMPATIBLE WITH THE EMERALD. EITHER
REMOVE IT OR FORMAT IT.

Format or replace flash drive.

THE USB DEVICE PLUGGED IN PORT 1 IS NOT

COMPATIBLE WITH THE EMERALD. PLEASE
REMOVE IT FROM PORT 1.

Format or replace flash drive.

THE USB DEVICE PLUGGED IN PORT 2 IS NOT

COMPATIBLE WITH THE EMERALD. PLEASE
REMOVE IT FROM PORT 2.

Format or replace flash drive.

A USB PRINTER IS ALREADY PLUGGED IN PORT

2. PLEASE REMOVE THE PRINTER FROM THE
PORT 1.

Remove the unused printer cable.

A USB PRINTER IS ALREADY PLUGGED IN PORT

1. PLEASE REMOVE THE PRINTER FROM THE
PORT 2.

Remove the unused printer cable.

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Section 10

Troubleshooting

References
1. US Department of Labor, Occupational Safety and Health Administration.
29CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens.
2. World Health Organization. Laboratory Biosafety Manual. World Health
Organization, Geneva 2003.
3. Clinical and Laboratory Standards Institute. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline
Third Edition. CLSI document M29-A3 (ISBN 1-56238-567-4). CLSI, 940
West Valley Road, Suite 1400, Wayne, PA 19087-1898, 2005.

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Troubleshooting
Section 10

References

NOTES

10-16

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Section 11 Quality Control

Section 11

Quality Control

Overview
Quality Control (QC) procedures are performed at a frequency needed to monitor
System results trueness. Quality Control procedures, both internal and external,
allow the operator to verify the performance of the analytical system. Evaluation
of results from commercial and patient controls facilitates the interpretation of
laboratory data to determine the acceptability of patient results. This section
discusses:
When to Run QC
Quality Control Methods and Materials
QC File Set Up
QC Guidelines
Running Controls
Levey-Jennings Graphs

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Section 11

Overview

NOTES

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Section 11

Quality Control

When to Run QC
Each laboratory should determine the frequency of performing quality control runs
with commercial controls and/or retained patient specimens. This may be specified
by the regulatory agencies governing the laboratory. Quality Control specimens
must be run and results confirmed to be within acceptable limits before reporting
patient results. Abbott recommends you, run controls:
After daily Start Up procedures are completed and background counts are
within specifications
After a reagent lot number change
After calibration (confirmatory step)
When there is an unusual shift or trend in patient results
After performing maintenance, a service call or component replacement
After a software change or upgrade
According to your laboratorys quality control protocol
According to regulatory requirements

Quality Control Methods and Materials

Internal QC Methods consist of running commercial control material or retained
patient specimens.
Commercial controls contain fixed cells and are assayed by the manufacturer
to determine expected recovery ranges. Abbott recommends CELL-DYN
Control Materials for use on the CELL-DYN Emerald System. A tri-level
control is available that provides three levels of monitoring for each
measurand; the number of controls used is determined by each laboratory.
Refer to Appendix A: Accessories for information on CELL-DYN Controls
used with the CELL-DYN Emerald System.
Patient controls are retained patient specimens with results that fall within the
laboratorys defined ranges. They are tested by the laboratory to establish
recovery against defined target ranges. They provide an accurate and costeffective means of evaluating system performance.
External QC methods use resources available outside the laboratory to assess
system performance. These programs use a peer-review process to allow a
laboratory to compare its performance with that of other laboratories. For example,
in the USA, laboratories are required to participate in proficiency testing programs.
Proficiency testing provides independent validation of a laboratorys internal QC
program.

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Quality Control
Section 11

When to Run QC

QC File Setup
Six QC files are available on the CELL-DYN Emerald. Each file stores 100 results
and the instrument automatically calculates the Mean, Standard Deviation and
Coefficient of Variation % for those results. Levey-Jennings graphs are
automatically plotted for each file. QC files are accessed from the MAIN menu by
touching [QUALITY CONTROL].
Overview of the QC window.
The LOTS window, shown at the right,
shows the lot number for each file.
1. The last file that was used is identified
with a dot in the circle to the left of the
lot number.
NOTE: If files have not been set up, touch
the file location (space next to the circle) to
choose a file.
NOTE: The level of control (L=low,
N=normal, H=high) material associated
with each file is displayed to the right of the
lot number. When the file is selected, a box
appears surrounding the radio button and
lot number. The selected level designation
is not within the box.
2. Touch the lot number to select a file.
3. Touch [EDIT] to enter new Assay
Values and Limits.
4. Touch [RUN AND RESULTS] to view
file data.
5. Touch the TOOLS icon to print:
Assays (and Limits), Results or
Graphics (Levey-Jennings Graphs)
6. Touch [SEND] to send results to the
LIS.
7. Touch [EXIT] to return to the previous
screen.
NOTE: If using the instrument keypad
arrows to navigate on this screen, it is
necessary to press the ENTER key to
complete the file selection.
Figure 11.1 QC Window

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Quality Control
Section 11

When to Run QC

The LAB ID INFORMATION button is used

to input information used for eQC. For
information about eQC, contact you local
Abbott Customer Service.
1. Touch [LAB ID INFORMATION].
2. Using the numeric keypad on the
Emerald and/or the A-Z key to access
the alphabetical screen keyboard,
enter information in each displayed
field. The NAME field is for the name of
your facility. The ATTENTION field is
used for the name of the person
responsible for your laboratorys QC
program.

NOTE: For proper eQC functionality, an

entry must be made in each named field on
the display. If a named field has two lines it
is not necessary to enter information on
both lines. If any named field is not
applicable for your laboratory, enter a
period, ., in that field.
3. To save your entry, touch [CONFIRM].
At the Warning Pop-up: DO YOU

WANT TO SAVE
MODIFICATIONS? Touch [YES] to
save or [NO] to return to the entry
screen. To exit without saving, touch
[ESC].
The [RESTORE] button is used to load QC
files that were backed up to an external
storage device. Files can only be restored
to the CELL-DYN Emerald on which they
were created.
Figure 11.2 Lab ID Information

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Quality Control
When to Run QC

Section 11

1. Touch the file to be used for the

restored results. Note that if you select
a file that has been previously used,
restoring data will overwrite the current
contents of that file. Thus, print, send or
save the current results before
proceeding.
2. Touch [RESTORE]. If the selected file
contains data, you will see the Warning
Pop-up: YOU ARE GOING TO

DELETE ALL ASSOCIATED

RESULTS.DO YOU WANT TO
CONTINUE? If you have not already
saved the current file data, touch [NO]
and print the file before proceeding. If
you are ready to delete results and
proceed with restoring the file, touch
[YES].
3. Identify the file to be restored in the
displayed table. Note that files are
identified by lot number (LOT) and level
(LEVEL) and each has a file sequence
number listed to the left of the LOT.

4. To select a file, touch the

corresponding file sequence number.
The selected file will be highlighted and
will also appear in the <LOT> field at
the upper left of the display.
5. After verifying the selection, touch
[RESTORE] to restore the file contents
to the Emerald.

Figure 11.3 Restoring a QC file

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Quality Control
Section 11

When to Run QC

6. At the Warning Pop-up: DO YOU

CONFIRM TO RESTORE THE

FILE ...?, touch [YES] to restore
or [NO] to return to the restore
selection screen.
7. When you return to the QC screen, the
restored file name will appear in the
LOTS area of the display at the
selected file location.

Figure 11.3 Restoring a QC file (Continued)

Entering QC Assay Values and Limits

QC Assay values and limits are entered as described below.
Files may be arranged in any order but it is suggested that the first three files be
configured for the low, normal and high levels, respectively. The remaining three
files can be used at the laboratorys discretion.
NOTE: Before entering information for a new lot number, ensure that all results
have been printed for the current lot number. Results will be deleted when
new information is entered. Only the assay and limit values may be edited
without deleting all results from the QC file.

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Quality Control
When to Run QC

Section 11

1. Touch the file location followed by [EDIT] to display the entry

screen.
2. Touch the <LOT> entry field and use the numeric keypad to
enter the lot number. If the lot number contains an alpha
character, touch [A-Z] and use the alphabet and numeric
keypad to enter the lot number. Press the ENTER key on the
keypad to advance the cursor to the next entry field, or touch
each field to enter information.
3. The cursor moves to the <EXPIRATION> entry fields. Use
the numeric keypad to enter the expiration date and press
the ENTER key on the keypad after each entry to save it and
advance the cursor.
NOTE: Be sure to enter the date in the format selected when
the instrument was installed.
4. Select the radio button (L for low, N for normal, or H for high)
corresponding to the level of control for this QC file.
NOTE: Backup, restore & eQC (For information about eQC,
please contact Abbott Diagnostics Customer Service.)
functions will not operate as expected unless the radio
button is selected.
5. After selecting the QC level, touch the <WBC> entry field.
Use the numeric keypad to enter the ASSAYS (Target or
Assay Values) and LIMITS (+/- Mean Range or your
calculated range), then press the ENTER key to save each
entry and advance the cursor to the next field. Alternatively,
you may touch [LOAD] to upload control assay values from a
removable storage device.
NOTE: For instructions on how to load assay values from a
removable storage device, refer to Section 5: Operating
Instructions, Subsection: Uploading commercial
Quality Control material information.
NOTE: The values entered for ASSAYS must be greater
than those entered for LIMITS.
6. When all entries are complete, touch the TOOLS icon, then
[PRINT] to generate a permanent record of your settings.
7. When entries have been verified to be correct, touch
[CONFIRM].
8. A window displays asking if you want to save the
modifications. Touch [YES] to save the entries or [NO] to
return to the entry screen.
9. When [YES] is touched, a second window displays.
a. If the selected file already contains data, the window
notifies that all results will be deleted for the previous lot.
Touch [YES] to continue or [NO] to return to the entry
screen.
b. If the file is empty, a processing pop-up window appears.
10.Set up additional files as directed above.
Figure 11.4 Targets and Limits Screen

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Section 11

Quality Control

QC Guidelines
General Information
Quality Control procedures must be performed in accordance with your
laboratorys protocols, good laboratory practice, and according to regulatory
requirements according to the following general guidelines:
Before running patient specimens, run a minimum of two levels of control.
Confirm that results are within acceptable limits and monitor the data for
shifts and trends.
If results fall outside acceptable limits, try another vial from the same lot. If
results are still outside acceptable limits, refer to Section 10:
Troubleshooting.
Always run controls in the same manner as patient specimens.
Control Material Guidelines
Always mix and handle commercial controls according to the directions
provided in the package insert. Proper handling and mixing are essential for
accurate results.
Pay particular attention to the following:
Check the condition of incoming control material. Be sure that vials are at the
proper temperature and are not leaking. Check for hemolysis.
If controls are stored inside a refrigerator, place them in a central location
away from the door.
Check the expiration date and open-vial Stability dating. Do not use products
longer than recommended by the manufacturer or results can be
compromised.
Normal Specimen Guideline: The Rule of Three
Because normal erythrocytes (RBC) are biconcave discs with a uniform quantity
of hemoglobin (HGB) in each cell, there is a fairly constant numeric relationship
involving RBC, HGB, and hematocrit (HCT)5 that is informally known as the rule
of 3:
HCT = HGB X 3
HGB = RBC X 3
If there is no RBC pathology (i.e., normal cell size, normal RBC hemoglobin
concentration and no abnormal forms), a discrepancy in these numeric ratios
suggests analytic error in one or more of the measurands. For example, a lipemic
(fatty plasma) specimen may produce a falsely high HGB result due to turbidity
interference; in this case the HCT:HGB ratio will be less than 3, while the
HGB:RBC ratio will be greater than 3.

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Quality Control
QC Guidelines

Section 11

This rule of 3 applies only to fresh normal human specimens, and not to
commercial control materials.
Over the years, clinicians and technologists have used a quick mathematical check
to ensure that HGB and HCT values are consistent. The HCT is roughly three times
the HGB. This simple formula works only on specimens that are normochromic,
normocytic (specimens with MCV and MCHC values within typical reference
ranges). Typically, results from CELL-DYN instruments correlate within the
narrow range of 3% on normal specimens. If the calculated HCT (HGB x 3) does
not agree with the instrument value with an increasing frequency (>5%) of outliers,
the system could be miscalibrated, malfunctioning or the specimen has pathology
requiring further investigation.1
Running Controls
Before running controls, be sure the vials have been properly warmed and mixed
according to the directions given in the manufacturers package insert.
NOTE: If a Start Up cycle has not been done, an error message will display
indicating one must be run before running controls. It is not possible to
run controls until the Start Up cycle is run.

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Quality Control
Section 11

QC Guidelines

From the MAIN menu, touch [QUALITY

CONTROL], access the QC file by touching the
appropriate lot number and then touch [RUN/
RESULTS].
1. Remove the cap from the control vial.
2. Immerse the aspiration probe in the control
vial and press the start switch.
3. When the cycle LED turns red, the probe
retracts.
4. Results are displayed in the upper part of the
screen. The results are displayed with the
most current run in the last row of the table.
Numbers displayed in bold text are outside of
the defined range for that measurand.
Statistics are automatically calculated and
shown at the bottom of the screen.
NOTE: The Numbers display or print in bold only
if PANIC HIGH and PANIC LOW, in
SETUP-ADVANCED-REPORTING
OPTION has been configured.
5. Unacceptable results (for example, a short
sample) can be removed from the calculation
by touching the <SEL> entry field by the result.
6. Touch the [QC LOT] dropdown menu to
select another file. Run the control as
described above.
Comments:
1. Touch the scroll bar or the right [>] and left [<]
arrow buttons below the results to display
more data points. Touch [<<] or [>>] below
measurands to display the remaining
measurand results.
2. Touch [LJ] to display the Levey-Jennings
graphs. Refer to Subsection: LeveyJennings Graphs later in this Section for
additional information.
3. Touch the TOOLS icon to print, send, save or
delete results. Refer to the following
Subsection: Use of Tools in the QC Menu
for additional information.
NOTE: Due to space limitations on the display,
the MEAN, SD, and/or CV% are rounded. To
view all digits used in the calculated values,
touch the TOOLS icon and print the file. The
MEAN, SD, and/or CV% on the printout are
correct and, if there is an apparent discrepancy
between the printed and displayed values, it is
due to rounding only and the printed values
should be used.
Figure 11.5 QC Results Screen
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Quality Control
Section 11

QC Guidelines

Use of Tools in the QC Menu

Printing QC Results
It is recommended to utilize the auto print feature so that the results of QC testing
are printed for each run. Because results of QC testing are not stored in the Datalog,
individual control results can only be printed at the time of testing or before another
sample (QC, patient, or other). Summary reports may be printed at any time.
To print a QC result that has not been automatically printed, exit the QUALITY
CONTROL menu by touching the HOME icon. Touch [RUN SAMPLE]. If no other
tests have been performed since the QC run, the display will show the last QC
results. Touch the TOOLS icon to print the result. Note that if another sample has
been run since the last QC run, only a summary report can be printed.
To print a summary report of the contents of a QC file, touch the TOOLS icon and
select PRINT. Note that use of this option does not print individual QC results.
For a Levey-Jennings report, touch the [LJ] button from the QC file, select
[TOOLS], then [PRINT].

Sending QC Results
To send the contents of a QC file to the LIS, if configured, touch the TOOLS icon
followed by the [SEND] button.
NOTE: If an empty file is selected when the PRINT command is made, a blank
report will be printed.
Deleting QC Results
Each of the six control files stores up to 100 results.
The contents of a QC file are automatically deleted when certain fields of the file
(expiration date, lot number, or limits) are edited.
Changing any field within a QC file by using the [EDIT] button will cause the
system to prompt the user, DO YOU WANT TO SAVE MODIFICATIONS? If a
modification has been made to the expiration date, lot number, or limits a second
prompt will appear if the user has responded to DO YOU WANT TO SAVE
MODIFICATIONS? with [YES]. The second prompt is a warning message, YOU
ARE GOING TO DELETE ALL ASSOCIATED RESULTS. DO YOU WANT
TO CONTINUE? Responding [YES] to this prompt will delete all results within
this QC file.

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Section 11

QC Guidelines

To manually delete results from a QC file:

1. From the MAIN menu, touch the
[QUALITY CONTROL] button.
2. Touch the radio button to the left of the QC
file you want to delete.

3. Touch [RUN AND RESULTS]. Note that

the SEL column in the display indicates
that all results are selected. Before
proceeding to the next step, touch the row
in the SEL column corresponding to any
QC results that you wish to delete. If you
wish to select or deselect all results at
once, touch the SEL box at the top of the
column.

4. Touch the TOOLS icon.

Figure 11.6 Manually Deleting QC Results

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Quality Control
Section 11

QC Guidelines

5. Touch the [DEL NOT SELECT] button to

delete all not selected results, and touch
[YES] to confirm deletion. Touch [NO],
followed by [EXIT] to exit without deleting
results.

Figure 11.6 Manually Deleting QC Results (Continued)

Saving QC Results
QC Results can be saved to a USB drive. For additional information, refer to
Section 5: Operating Instructions, Subsection: Saving Current QC Data.
Viewing Results in the QC Menu
QC runs are added to the display in the RUN and RESULT screen at the bottom of
the table. It is only possible to view a report with histograms for a QC run
immediately after it has been tested and before any other samples have been tested.
Due to the size of the display, it is necessary to utilize scroll bars to view all
measurands and results.
NOTE: To view date/time (hour) of QC runs, use the right/left scroll bar to scroll
to the far right.
Viewing all QC Runs Within a File
The scroll bar at the right side of the display allows the operator to scroll up and
down through multiple QC runs, with the oldest runs at the top of the table and the
newest results at the bottom.
Viewing all Measurands Within the QC File
The scroll bar at the bottom of the result table is used to scroll right and left to view
results for all measurands.
Viewing QC Statistics
Statistics associated with the data in a QC file are displayed at the bottom of the
QC file screen.

11-14

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Quality Control
Section 11

QC Guidelines

Figure 11.7 QC Statistics

The statistics displayed represent calculations based on the selected QC runs only.
Thus, if no QC runs are selected, all values will be 0. The mean (MEAN), standard
deviation (SD), and coefficient of variation percentage (CV%) may be rounded in
this table due to available display space.

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Quality Control
Section 11

QC Guidelines

Levey-Jennings Graphs
Results are automatically plotted on Levey-Jennings graphs as shown in the
following figure.
The Levey-Jennings (LJ) graphs are
displayed by touching [LJ] on the Control
Results screen.
The left column shows each
measurand with the target values and
limits shown on the right side next to
the plots.
The upper and lower dashed lines
represent the LIMITS entered during
QC FILE Setup. The solid lines
represent two times the LIMITS
entered during QC FILE Setup.
The number displayed directly under
each measurand is the result for the
run selected by the vertical line on the
graphs. To move the line to another
sample, use the [<] and [>] buttons to
the left of the time displayed at the
bottom of the screen.
The scroll bar on the bottom of the
screen moves the cursor to display
select additional measurands.
The arrow keys displayed under the
scroll bar can also be used to move the
cursor to a specific measurand.
The number of the result at the cursor
position and the date and time it was
run are shown in the box on the bottom
of the screen.
Touch [>>] or [<<] to scroll through all
results.
The date and time displayed at the
bottom of the screen correspond to the
sample indicated by the vertical line on
the graph. To move the line to another
sample, use the [<] and [>] buttons to
the left of the time displayed at the
bottom of the screen.
Only results that have been selected in
the RUN/RESULTS screen are plotted
on the L-J Graphs.
Figure 11.8 Levey-Jennings Screen

11-16

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Section 11

Quality Control

References

1. Stine-Martin, Ph.D., EA et. Al. 1998. Clinical Hematology 2nd Edition.

Philadelphia and New York: Lippincott-Raven. pp. 112-113.
2. Cembrowski GS and Carey RN. 1989. Laboratory Quality Management.
Chicago: ASCP Press. p. 189
3. College of American Pathologists. Hematology-coagulation checklist.
Northfield, IL: Cap, 2006: HEM.2660, HEM.27330, HEM.25870.
4. Westgard JO. QC the calculations. http://www.westgard.com/
lesson14.htm.
5. Abbott Laboratories. Hematology quality control primer.
6. Westgard JO, Quam E. Barry T. Basic QC practices. Training in statistical
quality control for healthcare laboratories. Madison, WI: Westgard Quality
Corporation, 1998.
7. Steine-Martin EA, Lotspeich-Steininger CA, Kopke JA. Clinical
hematology. Principles, procedures, correlations. 2nd edition. Philadelphia,
PA: Lippincott-Raven, 1998: 112-113.
8. Cembrowski GS, Carey RN. Laboratory quality management. QC ? QA.
Chicago: American Society of Clinical Pathology Press, 1989:189.

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Quality Control
Section 11

References

NOTES

11-18

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Appendix A Accessories

Appendix A

Accessories
This section provides the list numbers for components, accessories, reagents,
controls, and consumables used with the CELL-DYN Emerald System.
To place an order for the products listed or to obtain technical assistance, USA
customers contact Abbott Diagnostics Customer Service at:
1-877-4ABBOTT (1-877-422-2688)
For customer support in Canada, call:
1-800-387-8378
For customer support outside the USA and Canada, call your local Hematology
Customer Support representative.

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Accessories
Appendix A

NOTES

A-2

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Appendix A

Accessories

Accessories
List numbers are unique identifiers used when ordering products. List numbers and
quantities provided in this section are intended for guidance only and are subject to
change. USA customers, contact Abbott Diagnostics Customer Service at
1-877-4ABBOTT (1-877-422-2688) for the most current information regarding
list numbers. Customers outside the USA, contact your local Abbott Customer
Service Representative for assistance.
Table A.1

Accessories

List Number

Quantity

Name

09H40-01

CELL-DYN Emerald
Operators Manual, printed

09H52-01

Bar Code Scanner

25860-01

Label Dispenser, Bar Code

09H58-01

Emerald Grease

09H54-06

USA Power Cord

09H54-02

European Power Cord

09H54-04

Flat Screwdriver/Key

09H50-01

Diluent Reagent line with

cap

09H51-01

Waste line with cap

Table A.2

Comments

Dispenser for Bar Code Label rolls

Consumables

List Number

Quantity

Name

Comments

03B96-02

500/pkg

Printer paper

8.5 x 11 sheets

99650-01

1 roll

Bar Code Labels, Tube ID

1000 labels per roll

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Accessories
Appendix A

Accessories

Table A.3

Reagents

List Number

Quantity

Name

09H48-02

CELL-DYN Emerald Diluent Reagent

10L cubitainer

09H47-02

CELL-DYN Emerald CN-Free Lyse

Reagent

960 mL Bottle

09H46-02

CELL-DYN Emerald Cleaner

Reagent

960 mL Bottle

Table A.4

Comments

Calibrator and Controls

List Number

Quantity

Name

Comments

09H70-01

2 x 2.5 mL tubes

CELL-DYN 18 Plus Calibrator

09H69-01

12 x 2.5 mL tubes

CELL-DYN 18 Plus Control

Tri-level

09H69-02

6 x 2.5 mL tubes

CELL-DYN 18 Plus Control

Tri-level, half pack

A-4

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Appendix B Potential Causes of Spurious Results

Appendix B

Potential Causes of Spurious Results

Potential Causes of Spurious Results

This table provides a detailed list of interfering substances. Note that some of the
substances listed may not interfere with CELL-DYN Emerald results. Not all
interferents were tested as part of the Emerald Medical-Clinical Validation Study
performed by Abbott.
Table B.1

Potential Causes of Spurious Results with Automated Cell Counters

Measurand

Causes of Spurious Increase

Causes of Spurious Decrease

White Cell Count

(WBC)

Cryoglobulin, cryofibrinogen
Heparin
Monoclonal proteins
Nucleated red cells
Platelet clumping
Unlysed red cells

Clotting
Smudge cells
Uremia plus immunosuppressants

Red Cell Count

(RBC)

Cryoglobulin, cryofibrinogen
Giant platelets
High white cell count (>50,000 K/L)

Autoagglutination
Clotting
Hemolysis (in vitro)
Microcytic red cells

Hemoglobin (HGB)

Carboxyhemoglobin (>10%)
Cryoglobulin, cryofibrinogen
Hemolysis (in vivo)
Heparin
High white cell count (>50,000 K/L)
Hyperbilirubinemia
Lipemia
Monoclonal proteins

Clotting

Hematocrit
(Automated) (HCT)

Cryoglobulin, cryofibrinogen
Giant platelets
High white cell count (>50,000 K/L)
Hyperglycemia (>600 mg/dL)

Autoagglutination
Clotting
Hemolysis (in vitro)
Microcytic red cells

Hematocrit (HCT)
(Microhematocrit)

Hyponatremia
Plasma trapping

Excess EDTA
Hemolysis (in vitro)
Hypernatremia

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Potential Causes of Spurious Results

Appendix B

Potential Causes of Spurious Results

Table B.1

Potential Causes of Spurious Results with Automated Cell Counters (Continued)

Measurand

Causes of Spurious Increase

Causes of Spurious Decrease

Mean Cell Volume

(MCV)

Autoagglutination
High white cell count (>50,000 K/L)
Hyperglycemia
Reduced red cell deformability
Swollen red cells

Cryoglobulin, cryofibrinogen
Giant platelets
Hemolysis (in vitro)
Microcytic red cells

Mean Cell
Hemoglobin (MCH)

High white cell count (>50,000 K/L)

Spuriously high hemoglobin
Spuriously low red cell count

Spuriously low hemoglobin

Spuriously high red cell count

Mean Cell
Hemoglobin
Concentration
(MCHC)

Autoagglutination
Clotting
Hemolysis (in vivo and in vitro)
Spuriously high hemoglobin
Spuriously low hematocrit

High white cell count (>50,000 K/L)

Spuriously low hemoglobin
Spuriously high hematocrit

Platelets (PLT)

Cryoglobulin, cryofibrinogen
Hemolysis (in vivo and in vitro)
Microcytic red cells
Red cell inclusions
White cell fragments

Clotting
Giant platelets
Heparin
Platelet clumping
Platelet satellitosis

SOURCE: Cornbleet, J. Spurious Results from Automated Hematology Cell

Counters. Laboratory Medicine, 1983. 14: 509-514.

B-2

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Appendix C Preparation of diluted sodium hypochlorite solutions

Appendix C

Preparation of diluted sodium hypochlorite solutions

Preparation of diluted sodium hypochlorite solutions

Use the following formula to calculate the percent (%) sodium hypochlorite
concentration desired.
A = desired % sodium hypochlorite solution
B = % of purchased sodium hypochlorite (bleach) solution
X = parts water to be mixed with one part of the purchased sodium
hypochlorite solution
X= BA
A
Example:
If you need a 3.6% sodium hypochlorite solution and the label on the bleach bottle
states that it is 5.25% sodium hypochlorite, then:
X = 5.25 3.6
3.6

X = 0.46

Add 0.46 parts deionized water to one part bleach to obtain the 3.6% sodium
hypochlorite solution. For example, add 0.46 mL of deionized water to 1.0 mL of
the 5.25% sodium hypochlorite solution (bleach) to obtain the 3.6% solution. Final
volume in this example is 1.46 mL.
NOTE: In the US, commercially available sodium hypochlorite is often
approximately 5% to 5.25%. Read the container labeling to verify the
concentration.

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Preparation of diluted sodium hypochlorite solutions

Preparation of diluted sodium hypochlorite solutions

Appendix C

NOTES

C-2

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Appendix D Reference Intervals

Appendix D

Reference Intervals

CBC Reference Intervals: Literature Sources

1. Jones JD. Factors that affect clinical laboratory values. J Occup Med. 1980;22:316-320.
2. Costongs GMPJ, et al. Short-term and long-term intra-individual variations and critical differences of
haematological laboratory parameters. J Clin Chem Clin Biochem. 1985;23:69-76.
3. Dufer J. Hematology: erythrocytes, hemoglobin, mean corpuscular volume and hematocrit, In
Interpretation of clinical laboratory tests, G Siest et al, eds. Reference values and their biological variation.
Foster City, CA: Biomedical Publications, 1985:270-289.
4. Tarallo P. Leukocytes: total and differential counts, In Interpretation of clinical laboratory tests, G Siest et
al, eds. Reference values and their biological variation. Foster City, CA: Biomedical Publications,
1985:315-338.
5. Tarallo P. Platelets, In Interpretation of clinical laboratory tests, G Siest et al, eds. Reference values and
their biological variation. Foster City, CA: Biomedical Publications, 1985:379-391.
6. Lubin BH. Reference values in infancy and childhood, In Hematology of Infancy and Childhood, 3rd
edition, DG Nathan and FA Oski, eds. Philadelphia: WB Saunders, 1987:1677-1697.
7. Perry DA. Changes in laboratory values in patients receiving total parenteral nutrition. Lab Med.
1990;21:97-102.
8. Saxena S, Wong ET. Heterogeneity of common hematologic parameters among racial, ethnic, and gender
subgroups. Arch Pathol Lab Med. 1990;114:715-719.
9. Kjeldsberg C. Normal blood and bone marrow values in man, In Wintrobes Clinical Hematology, 9th
edition, GR Lee et al, eds. Philadephia: Lea & Febiger, 1993:2298-2309.
10. Whitehead TP, et al. The effects of cigarette smoking and alcohol consumption on blood haemoglobin,
erythrocytes, and leucocytes: a dose related study on male subjects. Clin Lab Haem. 1995;17:131-138.
11. Walters MC, Abelson HT. Interpretation of the complete blood count. Pediatr Clin North Amer.
1996;43:599-622.
12. Tsang CW, et al. Hematological indices in an older population sample: derivation of healthy reference
values. Clin Chem. 1998;44:96-101.
13. Millward M, Dix D. Determining reference ranges by linear analysis. Lab Med. 1992;23:815-818.
14. Young DS. Determination and validation of reference intervals. Arch Pathol Lab Med. 1992;116:704-709.
15. Lott JA. Estimation of reference ranges: how many subjects are needed? Clin Chem. 1992;38:648-650.
16. Nilsson-Ehle, et al. Blood haemoglobin declines in the elderly: implications for reference intervals from
age 70 to 88. Eur J Haematol. 2000;65:297-305.
17. Clinical and Laboratory Standards Institute/NCCLS. How to define and determine reference intervals in
the clinical laboratory; Approved guideline Second edition. CLSI/NCCLS document C28-A2 [ISBN 156238-406-6]. Clinical and Laboratory Standards Institute/NCCLS, 940 West Valley Road, Suite 1400,
Wayne, PA, 2000.
18. Van den Bossche J, et al. Reference intervals for a complete blood count determined on different
automated haematology analysers: Abx Pentra 120 Retic, Coulter Gen-S, Sysmex SE 9500, Abbott Cell
Dyn 4000 and Bayer Advia 120. Clin Chem Lab Med. 2002;40:69-73.
19. Trost DC, et al. Probability-based construction of reference ranges for ratios of log-Gaussian analyses. An
example from automated leukocyte counts. Am J Clin Pathol. 2002;117:851-856.

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Reference Intervals
CBC Reference Intervals: Literature Sources

Appendix D

20. Kratz A, et al. Effect of marathon running on hematologic and biochemical laboratory parameters,
including cardiac markers. Am J Clin Pathol. 2002;118:856-863.
21. Pfaeffli J. Reference limits for the automated haematology analyser Sysmex XE-2100. Sysmex J Intl.
2002;12:18-23.
22. Hanson CA. Peripheral blood and bone marrow: morphology, counts and differentials, and reactive
disorders, In Clinical Laboratory Medicine, 2nd ed, KD McClatchey, ed. New York: Lippincott Williams
& Wilkins, 2002:807-815.
23. Bock BJ, et al. The data warehouse as a foundation for population-based reference intervals. Am J Clin
Pathol. 2003;120:662-670.
24. Nordin G, et al. A multicentre study of reference intervals for haemoglobin, basic blood cell counts and
erythrocyte indices in the adult population of the Nordic countries. Scand J Clin Lab Invest.
2004;64:385-398.
25. Bertholf RL. Statistical methods for establishing and validation reference intervals. Lab Med.
2006;37:306-310.
26. Mandisodza AR, et al. Haematological reference ranges for adults in Zimbabwe. Sysmex J Intl.
2006;16(suppl 1):38-41.

D-2

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Appendix E Sample Logs and Worksheets

Appendix E

Sample Logs and Worksheets

Sample Logs and Worksheets

This section contains samples of logs and worksheets referenced in other Sections
of this manual. All pages can be duplicated as needed.
The following worksheets are provided:
Pre-Calibration Procedures Checklist
Maintenance Log
Troubleshooting Log
Calibration Verification Worksheet
Training Checklist
Manual Calibration Factory Entry Worksheet

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Sample Logs and Worksheets

Appendix E

Sample Logs and Worksheets

Worksheet E.1
Pre-Calibration Procedure Checklist
If problems are detected during these checks, DO NOT attempt to calibrate the instrument. Consult Section 10:
Troubleshooting, for assistance in resolving the issue. When problems are resolved, repeat these procedures to
verify proper instrument performance.
Date: _____________________________ Operator: _____________________________
Initial each item after it is completed.
1. _____Ensure all maintenance is complete before calibrating the instrument. Refer to
Section 9: Service and Maintenance for further information.
2. _____Confirm reagent containers are at least half full --- replace them as necessary.
3. _____Confirm the waste container is at least half empty --- replace it as necessary.
4. _____Verify all reagents have not expired. Record the lot numbers and expiration dates:
Diluent Reagent:
Lot # _____________ Exp. Date ______________
CN-Free Lyse Reagent: Lot # _____________ Exp. Date ______________
Cleaner Reagent:
Lot # _____________ Exp. Date ______________
5. _____Verify the calibrator is not expired. Record the lot number and expiration date:
Lot # ____________
Exp. Date _____________
6. _____Confirm the Background Counts are within acceptable limits. Refer to Section 4: Performance
Characteristics and Specifications for Background Count specifications. Record results below or
attach a printout to this document.
WBC
RBC
HGB
PLT

< 0.5 K/L

< 0.1 M/L
< 0.2 g/dL
< 10.0 K/L

7. _____Verify instrument precision by running a fresh, normal whole blood specimen ten times into the
PRECISION file. Refer to Section 9: Service and Maintenance, Subsection: Precision for
information on using QC files. Ensure that CV% results are within the limits as provided in Section
4: Performance Characteristics and Specifications. Record the results below or attach a printout to
this document.
NOTE: You may also use the PRECISION function within the MAINTENANCE menu to run precision. N=10.
Parameter
WBC
RBC
HGB
MCV
PLT

%CV Limit
3.5%
2.0%
2.1%
0.8%
6.1%

%CV

8. _____If any problems are detected during these checks, document the problem and corrective action below:
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
E-2

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9140861CDecember 2009

Lubricate
the Pistons

SemiAnnually

CELL-DYN Emerald Operators Manual

As Needed

Day

Preparation
for Storage,
Relocation
or Shipping

Un-scheduled Bleach
Cleaning

Bleach
Cleaning

Day

Month:

Maintenance Log

Monthly

Table E.1

10

10

11

11

12

12

13

13

14

14

15

15

16

16

17

17

18

18

19

19

20

20

21

21

22

22

23

23

24

24

25

25

26

26

27

27

28

28

29

29

30

30

31

31

Appendix E

WARNING: Potential Biohazard. Consider all clinical specimens, reagents, calibrators, controls or other
materials and all system surfaces or components that contain or come in contact with human-sourced material
as potentially infectious. Wear a lab coat, gloves and safety glasses when performing service or maintenance.
Follow biosafety practices as specified in the OSHA Bloodborne Pathogen rule (29 CFR Part 1910.1030)1 or
other equivalent biosafety practices.2, 3 Refer to Section 8: Hazards for additional information.

Year:

________________________________________________________________

Sample Logs and Worksheets

Sample Logs and Worksheets

E-3

E-4

Date

Operator
Name

Control
Lot No.

Troubleshooting Log

Instrument Serial No:

Table E.2

Diluent
Lot No.

Lyse Lot
No.

Cleaner
Lot No.

Troubleshooting Log

Observation

Resolution

Sample Logs and Worksheets

Sample Logs and Worksheets

Appendix E

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Sample Logs and Worksheets

Appendix E

Table E-3

Sample Logs and Worksheets

CELL-DYN Emerald Diluent Log

Instrument Serial Number _________________________

Lot Number

Open Date

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Expiration Date

Operator ID

E-5

Sample Logs and Worksheets

Appendix E

Sample Logs and Worksheets

Table E-4

CELL-DYN Emerald Cleaner Log

Instrument Serial Number _________________________

Lot Number

E-6

Open Date

Expiration Date

Operator ID

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Sample Logs and Worksheets

Appendix E

Table E-5

Sample Logs and Worksheets

CELL-DYN Emerald CN-Free Lyse Reagent Log

Instrument Serial Number _________________________

Lot Number

Open Date

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Expiration Date

Operator ID

E-7

Sample Logs and Worksheets

Appendix E

Sample Logs and Worksheets

Worksheet E.2
Calibration Verification Worksheet
Date: _____________________________
Operator: _____________________________
Calibrator Lot # ____________________
Exp. Date: _____________________________
Calibrator
Assay
Value

Mean
Value

Difference

+/- Limit

Calibration
Needed (Y/N)

WBC
RBC
HGB
MCV
PLT

Retain all calibration documentation in the instrument logbook.

E-8

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Sample Logs and Worksheets

Appendix E

Sample Logs and Worksheets

Worksheet E.3

Training Checklist
TOPIC
Component and Features
Analyzer
Display and Numeric Keypads
Printer
Reagent
Barcode Reader
AC Adaptor/Transformer
Analyzers Software
Main Menu
Software Navigation
Basic Operation
Instrument Overview
Power On
Operators Login
Operators Passwords
Loading/Replacing Reagents
Replacing Waste Containers
Start-up
Running Background
Running Controls
Specimen Identification
Running Specimens
Shutdown
Daily Shutdown

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TOPIC
Setup
Header
Date and Time
Languages
Printer
Paper Size
Date Format
Auto Clean Interval
Auto Shutdown
Patient Limits
Reagent Log
Start-Up Alarms
QC Alarms
QC Setup
Data Interpretation
QC Results Interpretation
Accuracy and Precision
QC Statistics
Patient Result Interpretation
Patient Report Overview
Datalog

TOPIC
Calibration
When to Calibrate
Calibration Materials
Pre-calibration Checklist
Calibration
Post Calibration Procedure
Maintenance
Monthly
Semi-Annual
As-Needed
Component replacement
Quality Control
Review QC Data
QC Log Editing
Printing QC Log and
LEVEY-JENNINGS
External QC Program (eQC)
Troubleshooting
Basic
Abnormal/erratic RBC, WBC,
HGB, MCV and PLT
Background data
unacceptable
Erratic Results/Multiple
Parameters
Interfering substances
Abbott Customer Service
1-877-4ABBOTT

E-9

E-10
2008 Abbott Laboratories

CELL-DYN is a registered trademark of Abbott Laboratories.

ABBOTT EXTEND and Education for Tomorrows Success are trademarks of Abbott Laboratories.
P.A.C.E. is a registered trademark of the American Society for Clinical Laboratory Science

Upon completion of training:

1. Completely fill out information requested on both sides of the checklist. PLEASE PRINT.
2. The checklist trainer or Abbott facilitator must sign and date the certification statement below and as appropriate on the checklist side of
this document.
3. If you wish to have P.A.C.E. continuing education credits, the Checklist Trainer or Abbott Facilitator must affix the P.A.C.E. seal to this
document to validate your training.
4. Whether you are obtaining P.A.C.E. credits or not, make a copy of the checklist side of this document and return the copy to the Abbott
address given below, preferably within two weeks of training.
5. Keep original for your records. If you need additional checklists, photocopy any unused checklist form or contact your Abbott Support
Specialist.

NOTE: Completion of this checklist indicates the trainee has successfully completed training
on the listed topics. This document can be used for regulatory review and as
documentation of continuing education.

Supervisor ____________________________________________ Date __________________

Trainer ____________________________________________ Date __________________

REFERENCES: CELL-DYN Emerald Operators Manual

Trainee Phone Number ___________________

Trainee ____________________________________________ Date __________________

Trainee Signature ____________________________________________

Trainee License Number (if applicable) ___________________

ABBOTT CELL-DYN Emerald Training Checklist

Address ______________________________ City/State _____________ Zip _________

Account Name ____________________________________________ SN ___________________

PLEASE PRINT

Sample Logs and Worksheets

Sample Logs and Worksheets

Appendix E

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Sample Logs and Worksheets

Appendix E

Sample Logs and Worksheets

Worksheet E.4

Manual Calibration Factor Entry Worksheet

Date:__________________________________
Name:_________________________________
Calculate all calibration factors to three decimal places.
New Calibration Factors

Reference Mean
x Current Calibration Factor = New Calibration Factor
CELL-DYN Emerald Mean
For example, if the Reference Mean Value for WBC is 6.6, the
CELL-DYN Emerald Mean is 7.1, and the current Calibration Factor is 0.98, then:

6.6 x 0.98 = 0.91

7.1
and 0.91 is the new Calibration Factor.
CELL-DYN
Emerald
Mean

Reference
Mean

Current
Calibration
Factor

New
Calibration
Factor

Range*

WBC

0.50-2.0

RBC

0.50-2.0

HGB

0.50-2.0

MCV

0.50-2.0

PLT

0.50-2.0

* If factor exceeds limits, do not calibrate. Check all calculations and, if

necessary, contact Abbott Diagnostics Customer Service for assistance.

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Sample Logs and Worksheets

Appendix E

Sample Logs and Worksheets

NOTES

E-12

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Appendix F Manual Calibration Procedure

Appendix F

Manual Calibration Procedure

Manual Calibration Procedure

Calibration with fresh whole blood is accomplished by performing multiple
analyses of each specimen using accepted reference methods or a reliably
calibrated hematology analyzer. The mean value is calculated for each measurand
and used to calibrate the CELL-DYN Emerald.
Requirements for Whole Blood Specimens
Following are the requirements for whole blood specimens used for calibration:
The ICSH (International Committee for Standardization in Haematology)
recommends that fresh specimens be less than four hours old. Specimen
age should not exceed six hours at the conclusion of the calibration
procedure.
All measurand values should be within the laboratorys reference range.
All cellular morphology should be normal.
No known interfering substances should be present. Refer to the list of
interfering substances provided in Appendix B: Potential Causes of
Spurious Results.
All specimens should be collected in K2EDTA according to the instructions
provided by the tube manufacturer.

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Manual Calibration Procedure

Manual Calibration Procedure

Appendix F

Requirements for Whole Blood Calibration

Minimum requirements for a whole blood calibration are provided in this section.
Specimens should all meet the requirements for fresh whole blood specimens
outlined in the previous section. Additional specimens and/or more replicates can
be used to achieve accuracy beyond these recommendations.
1. Five different specimens assayed in duplicate by reference methodology and
on the CELL-DYN Emerald.
2. No more than two hours should elapse between the assay by reference
methods and the CELL-DYN Emerald run.
NOTE: If specimens are run on the CELL-DYN Emerald first, the assay by
reference methods should be completed within one hour. Certain
reference methods are sensitive to RBC swelling caused by in vitro
deoxygenation.
3. Mean values should be calculated for each measurand, for each sample, from
the reference assay results. Average the values to obtain the cumulative mean
value for each measurand. (A worksheet, provided in Appendix E: Sample
Logs and Worksheets, can be used to assist in calculating the cumulative
mean values and can be duplicated as needed.) These cumulative measurand
values can then be entered into the Calibration screen on the CELL-DYN
Emerald as target values. Alternatively, calibration factors may be calculated
and manually entered, as described within this section.
Reference Methods
Values for Whole Blood Calibration should be determined according to the
following ICSH recommendations.
WBC, RBC and PLT
Values for these measurands can be determined using multiple counts from a
certified hemocytometer, from a cell counter that meters a fixed, calibrated sample
volume or from a reliably-calibrated hematology analyzer.
HGB
Values for hemoglobin can be determined either using the reference
cyanmethemoglobin method or a reliably-calibrated hematology analyzer.
NOTE: Do not use hemoglobin standards designed for the calibration of
cyanmethemoglobin methods on the CELL-DYN Emerald. The
instrument uses a different method, which is not designed to analyze these
standards directly.
MCV
Values for MCV can be determined by calculation from the reference
microhematocrit and the RBC results from a reliably-calibrated hematology
analyzer.

F-2

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Appendix F

Manual Calibration Procedure

NOTE: Reference microhematocrit values can be determined using the CLSI method
for Packed Cell Volume (PCV). Use only plain, non-anticoagulated capillary
tubes. Be certain to verify proper operation of the microhematocrit centrifuge
and the timer as recommended by CLSI.

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Manual Calibration Procedure

Manual Calibration Procedure

Appendix F

Manual Calibration Factor Entry

The Manual Calibration Factor Entry method is used to enter a predetermined
factor to adjust calibration when a consistent bias exists between the
CELL-DYN Emerald and a comparison instrument. A percent Bias Factor can be
determined and entered through the SET UP menu to change calibration for the
following measurands WBC, RBC, HGB, MCV, PLT. (NOTE: MPV and RDW
calibration factors, also accessible through the SET UP menu, are for Abbott
service use only.) Calibrator or fresh whole blood may be used to calibrate the
instrument with the Manual Calibration Factor Entry method. A set of worksheets
is provided in Appendix E: Sample Logs and Worksheets that can be used for
Manual Calibration Factor Entry.
Manual Calibration Factor Entry Procedure Fresh Whole Blood
To perform a Manual Calibration Factor Entry with fresh whole blood, proceed as
follows:
NOTE: No more than two hours should elapse between determining the
Reference Mean Values and performing the calibration.
NOTE: Once testing has begun to determine the Reference Mean Values on an
instrument, testing should not be interrupted.
Obtain five different fresh whole blood specimens that meet the requirements in Subsection: Requirements
for Whole Blood Calibration.
Using your reference method, test each of the five fresh blood specimens in duplicate. Print results, calculate
the mean values for the calibratable measurands (RBC, WBC, HGB, MCV, and PLT) and set aside to use as
the Reference Mean Values for the calibration factor calculation.

F-4

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Appendix F

Manual Calibration Procedure

Manual Calibration Procedure

1. From the MAIN menu, touch [MAINTENANCE]
followed by [PRECISION].
2. At the WARNING Pop-up message,
DELETE RESULTS? touch [YES].
NOTE: The probe will not descend for sampling
until the previous results are deleted.
3. Take the first fresh whole blood specimen and mix well by gently inverting the tube 10 to 15 times. Do not
shake the tube.
4. Remove the cap from the specimen tube and place the tube under the probe. Raise the tube so that the
end of the probe is deeply immersed in the specimen.
5. Press the Start Switch to aspirate the sample. Test each of the five samples in duplicate. If any run has
invalid results, deselect that run by touching the symbol to the left of the results to deselect it. Repeat
any invalid runs so that there are two valid runs for each of the five samples.
6. Touch [TOOLS] and [PRINT] to print the
results. The mean values for each measurand
are the Reference Mean Values used later in
this procedure.
7. Touch [HOME] to return to the MAIN menu and
touch [CALIBRATION].
8. Touch [TOOLS] and [PRINT] to print the
current calibration factors. Retain this printout
for your records.

9. To determine the new calibration factor(s):

Use the Reference Mean Values determined
above. Enter this information in the Manual
Calibration Factor Entry Worksheet provided in
Appendix E: Sample Logs and Worksheets
to calculate the new calibration factor for each
measurand.
Figure F.1

Manual Calibration Procedure

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Manual Calibration Procedure

Manual Calibration Procedure

Appendix F

10.Touch [HOME] to return to the MAIN menu and

touch [SET UP].
11. Touch [ADVANCED] then [CALIBRATION
FACTORS].
12.Touch the entry field to the right of each
measurand to enter the new calibration factor.
When finished, touch [CONFIRM], and answer
[YES] when prompted to save the changes.
13.Touch the HOME icon to return to the MAIN
menu.
14.Touch [CALIBRATION].

15.Touch the TOOLS icon and select [PRINT] to

generate a paper copy of the new calibration
factors. Verify that the calibration factors you
entered in the previous steps match the factors
displayed on the screen.
NOTE: When calibration factors are manually
entered, the calibration date will be followed by the
letter M on the Calibration screen.
Figure F.1

F-6

Manual Calibration Procedure (Continued)

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Appendix G CELL-DYN Emerald Quick Reference Card

CELL-DYN Emerald Quick Reference Card

CELL-DYN Emerald Quick Reference Card

Power on
1. Press the power button to power on the display.
2. Touch the LOGIN field then touch [A-Z] to enter operator ID.
3. Touch the [PASSWORD] field and use the on-screen keyboard or the numeric keypad to enter a password.
Touch [CONFIRM] to continue.
NOTE: No password is required for user access.
4.

Touch [OK].

Daily Start Up
1. From the MAIN menu, touch [START UP].
At the end of the Startup cycle, a background count is automatically displayed.
2. The Background must be within specifications before proceeding to the next step. (See Table A)
NOTE: Refer to the CELL-DYN Emerald Operators Manual Section 2: Installation Procedures and Special
Requirements to set up autoprint of startup background.
3.
4.
5.
6.

Check the reagent levels and replace reagent(s) as needed.

Empty Waste as needed.
Check printer paper supply and add paper, if necessary.
Check the instrument maintenance log and perform any required maintenance.
Table A (Background Specifications)
Parameter

Specification

WBC

< 0.5 K/L

RBC

< 0.1 M/L

HGB

< 0.2 g/dL

PLT

< 10.0 K/L

Manual Daily Shut Down

Daily shutdown is required once every 24 hours, refer to the
CELL-DYN Emerald Operators Manual Section 5: Operating Instructions for detailed information.
1. From the MAIN menu, touch [SHUT DOWN] to manually initiate a Shut Down Cycle.
2. At the end of the Shut Down Cycle the system powers down.
NOTE: Daily Shutdown may be programmed automatically (refer to the CELL-DYN Emerald Operators Manual
Section 2: Installation Procedures and Special Requirements).

Running Quality Control

1. From the MAIN menu, touch [QUALITY CONTROL].
2. Access the QC file by touching the appropriate lot number. Touch [RUN AND RESULTS].
3. Remove the cap from a well-mixed control specimen tube and place the open tube under the Sample Aspiration
Probe. Raise the tube so that the end of the probe is deeply immersed in the specimen. Press the Start Switch.
4. The red LED flashes several times during aspiration. When the Cycle LED turns red, and the probe retracts,
remove the tube.
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CELL-DYN Emerald Quick Reference Card

CELL-DYN Emerald Quick Reference Card
Results are displayed at the top of the QC results table and will print automatically if a printer is connected and
configured. Verify that control results are within the laboratorys acceptable limits.
5.
6.

Touch the QC LOT dropdown menu to select the next file.

Run the other levels of control as described above.

Running a Patient Sample

1. From the MAIN menu, touch [RUN SAMPLE].
2. Touch [NEXT SAMPLE] at the bottom of screen and enter NAME, PID, or/and SID according to your labs
procedures. Press [CONFIRM].
3. Place the well-mixed patient specimen under the Sample Aspiration Probe and raise the tube so that the end of
the probe is deeply immersed in the specimen.
4. Press the Start Switch.
5. Remove the tube when the probe retracts.
6. Results will print automatically, if a printer is connected and configured, when the analysis is complete.
While a sample is running you may enter the demographics for the next specimen using the [NEXT SAMPLE]
key at the bottom of the screen.
Background Count
1. From the MAIN menu, touch [RUN SAMPLE].
2. Press the Start Switch.
3. Results must be within specifications before proceeding. Refer to Table A.
Replacing Reagents-Diluent, Lyse, and Cleaner
1. From the MAIN menu, touch [REAGENTS], followed by [DILUENT] to access the Diluent Screen.
2. Remove the empty container and replace it with a full one.
3. Scan the two barcodes on the label of the new reagent container to automatically populate all empty
fields. Make sure the information on the screen is correct before proceeding.
4. If the information entry is successful the [PRIME DILUENT] button turns green.
a. Proceed to Step 5. If the entry is not successful, enter the reagent information as described in CELL-DYN
Emerald Operators Manual Section 2: Installation Procedures and Special Requirements
Subsection: Manual Entry of Reagent Information.
5. Press [ESC] when finished.
6. To replace the Lyse or Cleaner, touch [ESC] to return to the REAGENTS menu and repeat the above steps for
the desired reagent.
Replacing Waste Container
1. From the MAIN menu, touch [REAGENTS],
2. Touch [WASTE].
3. Remove the full container and replace it with an empty one.
4. Touch the box to the right of [CAPACITY] and use the numeric keypad to enter the volume of the waste
container.
5. Touch [RESET] to enter the container capacity into the system memory.
6. Touch [ESC] to return to the REAGENTS menu.
7. Touch the HOME icon to return to the MAIN menu.
NOTE: If you are disposing of waste directly to a drain, enter 99999 in the capacity field. The waste counter will
need to be reset when the system has dispensed 99999 mL of waste.

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Section 1 Glossary

Glossary

Glossary
NOTE: The references provided in this Glossary, acquired from assorted
reference works, may have been revised to reflect their meanings in
relation to functions and operations of the CELL-DYN Emerald
instrument.
absorption

Uptake of light energy by an atom or a molecule, raising electrons from

their ground state orbitals to orbitals at higher energy levels.

accuracy

The level of agreement between the estimate of a value (the result

generated by the method) and the true value. Accuracy has no
numerical value; it is measured as the amount of (or degree of)
inaccuracy [ICSH].

agglutination

The action of cells or other biological particles clumping or sticking

together because of an antigen-antibody reaction.

agglutinin

An antibody present in the plasma or suspending media that reacts with

an antigen to cause agglutination of blood cells.

aggregation

See agglutination.

algorithm

A step-by-step procedure, typically mathematical in nature, coded into

computer software. On the CELL-DYN Emerald, algorithms are used to
separate cell populations, determine concentrations, and flag selected
results.

aliquot

A fractional part of a solution or specimen.

amplitude of a pulse

The magnitude of variation of an electrical signal from its baseline value.

analyzer

The module of the CELL-DYN Emerald through which the blood sample
passes and where measurements are made.

anticoagulant

A substance that interferes with the normal clot-forming mechanism of

blood.

aperture

An opening of known dimensions that restricts or limits the passage of

energy. In impedance counting, it is the opening at the entrance to the
sensing zone through which the cells are made to pass.

assay

An analysis to determine the presence, absence, or concentration of one

or more components in a solution or specimen.

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Glossary

background

A measurement cycle performed in the absence of a specimen to check

system performance. Often used to determine whether reagents contain
excessive amounts of particulates. On the CELL-DYN Emerald,
background cycles are done at Start Up and may also be done manually.

band

An immature granulocyte in a state of development before segmentation

and maturity. Usually present in circulation in extremely low
concentrations. See also immature granulocyte.

basophil

A granulocytic white blood cell usually present in circulation in

extremely low concentrations. Associated with histamine release,
allergy, and inflammation.

blast

The first stage of a blood cell lineage that can be morphologically

identified on a stained blood film. Normally present in bone marrow but
not in circulation.

blood, whole

A homogenous mixture of blood that has not been separated into cellular
and liquid components.

calibration

The adjustment of a laboratory instrument to correct results to match

truth, defined by standards or reference procedures.

calibration factor

A multiplier obtained during calibration that can be applied to raw data

to obtain accurate results.

calibrator

A material of known characteristics used in conjunction with a

calibration procedure to adjust measurement accuracy. The values must
be traceable to a national or international reference preparation or
method for hematology.

carboxyhemoglobin

A moderately stable union of carbon monoxide with hemoglobin; its

formation prevents the normal transport of carbon dioxide and oxygen
during the circulation of blood; increasing levels result in varying
degrees of asphyxiation, including death.

carryover

Significant interference from a previous specimen with the current

specimen results.

CBC

Acronym for complete blood count. Includes WBC, RBC, HGB, HCT,
MCV, MCH, MCHC, and PLT. On the CELL-DYN Emerald, the CBC
also includes an automated three-part differential.

character self-checking

A Bar Code Symbology Character is considered self-checking if a single

printing defect will not cause a character to be misread as another valid
character in the same symbology. This feature increases the accuracy of
decoding by checking whether each character is read accurately.

Glossary-2

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Glossary

check character/digit

An alphanumeric character that allows the decoder in the bar code reader
to mathematically determine that it has read the bar code characters
correctly. It immediately precedes the stop character in the bar code
symbol.

CLIA

Acronym for the Clinical Laboratory Improvement Amendments.

CLSI

Clinical and Laboratory Standards Institute. Formerly known as NCCLS.

coefficient of variation (CV)

A statistical calculation used to describe population heterogeneity. The

expression of the standard deviation as a percentage of the mean. On the
CELL-DYN Emerald, CVs are automatically calculated by various
quality control programs.

cold agglutinin

A substance in blood that, at low temperatures, aggregates compatible

and incompatible red blood cells. Also called cold hemagglutinin.

cryoglobulin

Any of several proteins similar to gamma globulins that dissolve at 37C

(98.6F).

concentration

The number of a particular type of cell or other biological particle

detected in a known volume of sample.

control

A substance used in routine practice for checking the performance of an

analytical process or instrument. These materials must be similar in
properties to and be analyzed in the same manner as patient specimens.
Control materials can have pre-assigned values [ICSH, NCCLS].

correlation coefficient

A statistic that indicates the degree to which two measurements are

related, expressed as a value from 1.0 to +1.0, with +1.0 indicating that
results are in total agreement and 1.0 indicating that results are exact
opposites (i.e., 4 and 4). A 0.0 value indicates that the two
measurements are unrelated. It is expressed as a value of r, which has
no dimension. Agreement does not mean that the results of the two
measurements are identical. For example, if one method produces a
hemoglobin concentration that is always exactly double that of the other
method, r = 1 but there is important bias. Slope and Y-intercept must
always be stated with an r value.

datalog

On the CELL-DYN Emerald, the repository file that automatically

accepts and stores all result data in chronological order.

diff

Abbreviation for differential white blood cell count.

differential white blood

cell count

The process of classifying white blood cells in a specimen of whole

blood into distinct subpopulations, either automatically or manually,
and outputting a result for each identified subset as a concentration or
percentage. The CELL-DYN Emerald produces a three-part differential.

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Glossary

dilution ratio

A factor by which a sample is diluted before it is analyzed. Samples are

diluted in different ratios to provide cell concentrations that are suitable
for analysis.

drift

A pattern of variation in the accuracy of a system over time.

EDTA

Ethylenediaminetetracetic acid; an anticoagulant commonly used for

hematology cell counting; may be in the form of a liquid or powder as
dipotassium (K2) or tri-potassium (K3) salt.

eosinophil

A mature granulocytic white blood cell normally present in circulation in

low concentrations. Associated with host defense to certain parasites,
allergy, inflammation, and phagocytosis.

error, random

Variation, with no distinct pattern, between successive result data. Often

assumed to be a normal (Gaussian) distribution around a mean.

error, systematic

Directional or patterned variation between values obtained and the

values expected.

erythroblast

See nucleated red blood cell.

erythrocyte

See red blood cell.

false negative

A test result that erroneously excludes an individual from a specific

diagnostic or reference group.

false positive

A test result that erroneously includes an individual in a specific

diagnostic or reference group.

flag

Written or displayed output intended to signal or attract attention. Flags

are output by the CELL-DYN Emerald Data Station to alert the operator
to instrument malfunctions that occurred during sample processing or to
data abnormalities that were detected during data analysis. Operator
review and/or corrective action is usually required.

gain

The amount of change in signal magnitude generated by an amplifier,

presented as a ratio of the output to input signals.

Gaussian

Term used to describe a normal frequency distribution or curve. The

normal distribution is unimodal, bell-shaped and symmetrical about the
mean.

GRA

The identifier for the granulocyte absolute concentration result,

calculated as the number of granulocytes per unit volume of whole
blood.

Glossary-4

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Glossary

G%

The identifier for the granulocyte percentage result, calculated as the

percentage of granulocytes in the white blood cells.

granulocyte

A mature white blood cell that contains prominent cytoplasmic granules.

Possesses nuclei with irregular shapes. Can be physiologically and
morphologically differentiated into neutrophils, eosinophils, and
basophils, but the CELL-DYN Emerald separates the eosinophils and
basophils in MID.

HCT

The identifier for the hematocrit absolute concentration result, which is

calculated as a percentage of red blood cells relative to the total volume
of the sample.

heme

A component of hemoglobin that contains iron and binds oxygen.

hemoglobin

An intraerythrocytic, iron-containing protein that transports oxygen. It is

composed of four globin chains, each containing a heme component.

hemolysis

The destruction of red blood cells resulting in the liberation of

hemoglobin.

heparin

An anticoagulant that combines with and enhances anti-thrombin III to

prevent blood clotting. Not recommended for specimens run on
hematology analyzers.

HGB

The identifier for the hemoglobin result, calculated as the mass of

hemoglobin per unit volume of whole blood. Also abbreviated as Hb.

histogram

Graphical presentation of frequency distribution. Often, an attribute (for

example, cellular volume) is represented on the x-axis, and the relative
frequency of various levels of the attribute is represented on the y-axis.

hyperglycemia

An abnormally high concentration of glucose in the circulating blood,

especially with reference to a fasting level.

ICSH

Acronym for International Council for Standardization in Haematology.

ID

An acronym for identification.

ID, operator

An alphanumeric code that identifies the current operator of the

CELL-DYN Emerald.

ID, specimen

An alphanumeric code that identifies a particular specimen. On the

CELL-DYN Emerald, the specimen ID can be entered automatically by a
bar code reader, from a Work List, or by activating the auto-increment
feature. It also can be entered manually before running the specimen.

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Glossary-5

Glossary

immature granulocyte

One of several cell types that are precursors to mature granulocytes.

They may include (in order of maturity) promyelocytes, myelocytes,
metamyelocytes, and bands.

impedance method

A process that detects and sizes cells suspended in a conductive medium

as they are drawn through an aperture. Each cell creates a resistance to
current flow that is directly proportional to its volume. Voltage pulses
indicate the passage and volume of cells.

imprecision

Variation in the results of a set of replicates or paired (duplicate)

measurements. Expressed as a standard deviation or coefficient of
variation percentage. See Precision.

inaccuracy

The numerical difference between the mean of a set of replicate

measurements and the expected value. The difference (positive or
negative) may be expressed in the units in which the quantity is
measured, or as a percentage of the expected value [ICSH].

indices, RBC

A group of calculated values for red blood cell properties: mean cell
volume (MCV), mean cell hemoglobin (MCH), and mean cell
hemoglobin concentration (MCHC).

interfering
substance/condition

A specimen component or state that affects a measurands measurement.

in vitro

Outside the living body.

in vivo

Within the living body.

leukocyte

See white blood cell.

Levey-Jennings graph

A visual presentation of data points from multiple runs for a single

measurand. Useful for trend analysis. Derived from Shewhart control
charts.

linearity

The ability of an analytical process to provide measurements

proportional to an analyte measured over a defined range of
concentrations or counts [CLSI].

LIS

Acronym for Laboratory Information System.

logarithm

The exponent (power) to which it is necessary to raise a number (the

base) to produce a given value. Abbreviated as log.

LYM

The identifier for the lymphocyte absolute concentration result, which is

calculated as the number of lymphocytes per unit volume of whole
blood.

Glossary-6

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Glossary

lymphocyte

A small, mature mononuclear white blood cell that is present in

circulation in relatively high concentrations. It has a round or slightly
indented nucleus and no granules in the cytoplasm.

lymphocyte, variant

A lymphocyte that has changed in response to a stimulus. Usually seen in

nonmalignant reactive disorders. Also known as atypical or reactive
lymphocyte.

L%

The identifier for the lymphocyte percentage result, calculated as the

percentage of lymphocytes in the white blood cells.

lysis

Alteration or destruction of a cell by action of a chemical agent on the

cell membrane.

macrocytic (giant) platelet

A large platelet in circulation.

macrocytic RBC

A large red blood cell in circulation.

MCH

The identifier for mean cell hemoglobin, the average hemoglobin mass in
the red blood cells.

MCHC

The identifier for mean cell hemoglobin concentration, the average mass
of hemoglobin per unit volume in the red blood cells.

MCV

The identifier for mean cell volume, the average volume of the red blood
cells.

metamyelocyte

A cell present in the bone marrow that gives rise to a granulocyte and is
not normally present in circulation. The maturation phase between
myelocyte and band. See also immature granulocyte.

method, reference

A clearly and exactly described technique for a particular determination.

A competent authority must judge whether the technique provides a
sufficiently accurate and precise determination for it to be used to assess
the validity of other laboratory methods. The accuracy of the reference
method must be established by comparison with a definitive method, if
one exists. The accuracy and degree of imprecision must be stated
[CLSI].

microcytic platelet

A small platelet in circulation.

microcytic RBC

A small red blood cell in circulation.

monocyte

A large, mature mononuclear white blood cell that is normally present in

circulation in low concentrations.

mononuclear

Referring to a subcategory of white blood cells that have unsegmented

nuclei.

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Glossary-7

Glossary

MPV

The identifier for the mean platelet volume result, the average volume of
the platelets.

myelocyte

A cell in bone marrow that gives rise to a granulocyte and is not normally
in circulation. Considered an immature granulocyte. See also immature
granulocyte.

NCCLS

Acronym for the National Committee for Clinical Laboratory Standards.

As of the year 2005, the revised NCCLS organizational name is Clinical
and Laboratory Standards Institute (CLSI).

neutrophil

A mature granulocytic white blood cell present in circulation in high

concentrations. Characterized by a segmented nucleus made up of two to
eight lobes and a cytoplasm containing granules.

NRBC

An acronym for nucleated red blood cell.

nucleated red blood cell

A nucleated cell present in the bone marrow that gives rise to a mature
red blood cell and is not normally present in circulation. Subtypes
include erythroblasts, basophilic normoblasts, polychromatophilic
normoblasts, and orthochromic normoblasts. See also NRBC.

nucleus

A cellular organelle that is essential to cellular functions such as cell

division and protein synthesis.

measurand

A result output by a hematology analyzer. Examples are red blood cell

concentration (RBC) and hemoglobin concentration (HGB).

plasma

The fluid part of whole blood as distinguished from the cells.

platelet

Circulating cytoplasmic fragment of a megakaryocyte present in

moderate concentrations, averaging about 250,000/L of whole blood.
Platelets contain no nuclei, have some granules, and play a key role in
blood clotting. Also called thrombocytes.

PLT

An acronym for platelet. On the CELL-DYN Emerald, PLT is used as the

identifier for the platelet absolute concentration result, calculated as the
number of platelets per unit volume of whole blood.

precision

The degree of agreement in the results of a set of replicate or paired

(duplicated) measurements. Precision has no absolute numerical value. It
is expressed as imprecision, calculated as a standard deviation or
coefficient of variation percentage. See also imprecision.

promyelocyte

A cell present in the bone marrow that gives rise to a granulocyte and is
not normally present in circulation. See also immature granulocyte.

Glossary-8

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Glossary

QC file

On the CELL-DYN Emerald, a repository that stores data automatically

each time a control specimen is run, for review and output in a summary
or Levey-Jennings graph format. The mean, SD, and CV calculations are
automatically updated each time data are received.

quality control (external)

A system of retrospectively and objectively comparing results from

different laboratories by means of surveys organized by an external
agency. The main objective is to establish between-laboratory and
between-instrument comparability, if possible, with a reference standard,
when one exists [ICSH].

quality control (internal)

A set of procedures undertaken by the staff of the laboratory for

continual evaluation of the reliability of its work. The procedures
determine whether the test results are reliable enough to be released to
the requesting clinicians. These procedures should include tests on
control material and statistical analysis of patient data [ICSH].

quiet zone

The quiet zone is the area immediately adjacent to the beginning and end
of the bar code symbol. No writing or other printed material should be
present in the quiet zone.

range

A measure of the dispersion of values. The difference between the largest

and the smallest of a group of measurements.

RBC

An acronym for red blood cell. On the CELL-DYN Emerald, RBC is used
as the identifier for the red blood cell absolute concentration result,
calculated as the number of red blood cells per unit volume of whole blood.

RDW

An acronym for red cell distribution width. On the CELL-DYN Emerald,

the identifier for the red blood cell distribution width result, calculated as
the coefficient of variation percentage of the red cell volume distribution.

reagent

A solution used to dilute, and in some cases, alter the cells in a whole
blood specimen, in preparation for measurement by the Analyzer. May
also refer to a substance used to clean the instrument fluidics.

red blood cell

A biconcave, circular disk approximately 7.5 m in diameter, with no

nuclei. Red blood cells are mature cells present in greater concentrations
than others in circulating blood (averaging 5 million cells per microliter
of whole blood). Primary function is oxygen delivery to the tissues and
carbon dioxide removal. Also called erythrocytes.

reticulocyte

The first non-nucleated red blood cell stage, identified by ribosomal

material in the cytoplasm observed when red blood cells are stained with
supravital dye.

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Glossary-9

Glossary

RNA

Acronym for ribonucleic acid. Any of the various nucleic acids that
contain ribose and uracil as structural components. Associated with the
control of cellular chemical activities, such as protein synthesis.

sample

A part or unit taken at random from a large whole, and so presumed to be

typical of its qualities. On the CELL-DYN Emerald, a representative part
(aliquot) that is obtained from the collected whole blood specimen,
diluted, and analyzed. Not used synonymously with specimen in this
manual.

sample dilution

The mixture of sample and reagent that is analyzed by a hematology

instrument.

sequence number

A cycle identifier that is automatically assigned to result data produced

during that cycle.

shift

An abrupt change in results from specimens thought to be similar.

specimen

Collected whole blood that is presented to the Analyzer for sampling.

Not used synonymously with sample in this manual.

stability

The ability of a specimen, reagent, or control to maintain a constant

concentration of the analyte. May also refer to the ability of an analytical
system to avoid drift.

standard deviation (SD)

A measure of the dispersion of a group of values around a mean. The

square root of the variance expressed in the same units as the
measurements themselves.

standard reference particle

(SRP)

A polystyrene microparticle with measurement properties that can be

traced to a reference standard. Used to verify or set WBC and/or
RBC/PLT gains.

start and stop characters

Bar Code Readers use these characters to determine the order in which to
read the characters in the code and identify the bar code symbology. Start
and stop characters make it possible to scan the label in either direction
and are located at the beginning and end of each bar code symbol.

test

An analysis to detect the presence or measure the concentration of an

analyte.

thrombocyte

See platelet.

throughput

The number of tests an analytical instrument can perform in a given time.

trend

A situation in which results obtained from specimens thought to be

similar move in the same direction for several consecutive runs.

Glossary-10

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Glossary

unit of measure

A determinate quantity adopted as a standard of measurement.

Associated with a numerical result for a measured quantity or property.

verification

A protocol or procedure followed to test the performance of a system or

component to ensure that it meets stated specifications.

WBC

The identifier for the white blood cell absolute concentration result,
which is calculated as the number of white blood cells per unit volume of
whole blood.

Westgard Rules

A multirule system described by Westgard for identifying out-of-control

QC results, based on control procedures described initially by Shewhart
and later by Levey and Jennings. Uses a set of statistical rules to assess
and validate QC data.

white blood cell

A cellular constituent of circulating blood that is present in lower

concentrations than red blood cells or platelets, averaging 7,000/L of
whole blood. Primary function is to guard tissues against invasion by
foreign organisms or chemicals. Also called leukocytes.

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Glossary-11

Glossary

NOTES

Glossary-12

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Glossary

References
1.

2.

3.

4.

CELL-DYN Emerald Operators Manual

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Clinical Laboratory Standards Institute/CLSI. Statistical Quality Control for

Quantitative Measurements: Principles and Definitions; Approved Guideline
Third Edition. CLSI Document C24-A3 (ISBN 1-56238-613-1). CLSI, 940 West
Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA, 2006.
Clinical Laboratory Standards Institute/CLSI. Performance Goals for the
Internal Quality Control of Multichannel Hematology Analyzers; Approved
Standard. CLSI Document H26-A (ISBN 1-56238-312-4). CLSI, 940 West
Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA, 2006.
Clinical Laboratory Standards Institute/CLSI. Reference Leukocyte Differential
Count (Proportional) and Evaluation of Instrumental Methods; Approved
Standard-Second Edition, CLSI Document H20-A2 (ISBN 1-56238-628-X).
CLSI 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA, 2007.
Websters Ninth New Collegiate Dictionary. Springfield, MA: Merriam-Webster
Inc. 1990.

Glossary-13

Glossary

NOTES

Glossary-14

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Index

Index
A

AC Adapter 1-9, 2-8

access levels 2-13
Accessories 2-5
Advanced 2-20
Advanced Set Up 2-21
Alarms 2-27
Analytical Measurement Range 3-10
Auto Rinse Cycle 5-16
Auto SID 2-20
AUTOPRINT 2-22

Data Alerts 3-10, 3-12

Data Flags 3-10
DATALOG 5-13
Date and Time 2-19
DATE FORMAT 2-30
Decontamination 8-8
Spill Clean-Up 8-7
Decontamination Procedure 9-16
Deleting QC Results 11-12
Diluent 1-10
Disclaimer
Instrument x
Display 1-3
Display Range 3-10

B
Background Count 2-34
Bar Code Reader 2-25
Bleach Cleaning 9-11

C
Calibration
Guidelines 6-5
Reference Methods F-2
When to Calibrate 6-3
Whole Blood F-1, G-1
Calibration Factors 2-29
Calibration Menu 6-5
Calibrator 1-12
Calibrator and Controls A-4
Cleaner 1-11
Cleaning the cover 9-15
COMMENTS 2-22
Communication 2-23
Components 1-3
Connections 2-8
Controls 1-12
Count Invalidating Flags 3-17
Counting Chambers 1-8
CURRENT SID 2-20

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E
Emergency Stop 9-14
Entering QC Assay Values and Limits 11-7
Ethernet Connection 2-8
Event Log 9-3
Printing 9-4
Saving 9-4
Expected Values & Patient Limits 2-22
External Bar Code Reader 2-8

F
Flags
Printing 2-22
Fluidics 1-5
Fluidics Menu 9-9

G
GRAPHS 2-22
Ground 2-8

Index-1

Index

H
Hazards 8-1
Biological 8-4
Biological & Chemical 8-4
Chemical 8-7
Electrical 8-8
Icons, Safety 8-3
Mechanical 8-9
Physical 8-10
Safety Icons 8-3
HCT 1-2
HEADER 2-22
Hemoglobin measurands 1-2
Hemoglobin Measurement 3-5
HGB 1-2

I
Icon, Safety 8-3
Impedance 3-2
Initialize System 9-14
Installation 2-5
Installation Environment 2-4
Instrument Alarms 3-9
Instrument Disclaimer x
Instrument Logbook 5-3
Interfering Substances B-1
INTERP. RPT 2-22
Interpretive Messages 3-20
Interpretive Report 2-22

K
Keypad 1-3

L
Lab Preferences 2-26
LAB TECH PASSWORD 2-30
Language 2-19
Language Selection 2-12
Levey-Jennings 11-16
Limits 2-27
Linearity 3-10
Index-2

LIS Connection 2-8

Log In 2-13
Low Events Count 3-10
Lyse 1-11

M
Main Menu 1-4
Maintenance
As Needed 9-14
Cover Cleaning 9-15
Monthly 9-11
Piston Lubrication 9-13
Manual Calibration Factor Entry Procedure F-4
MCH 1-2
MCHC 1-2
MCV 1-2
Measurement Principles 3-2
Monthly Maintenance 9-11
MPV 1-2

O
Other Settings 2-30

P
Panic Limits 3-10
Paper size 2-19
Patient Limits 3-10
Platelet Analysis 3-4
Platelet Flags 3-15
Platelet measurands 1-2
PLT 1-2
power 2-8
Power cord connection 2-8
Power On 5-5
Power Requirements 2-4
Pre-Calibration Procedures 6-5
Precautions and Requirements for System
Operation 7-4
Precautions See Operational Precautions and
Limitations 8-1
Preparation for Shipment 8-8
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Index

Preparation of diluted sodium hypochlorite

solutions for use on the CELL-DYN
Emerald C-1
PRESSURE CHECKING 2-30
Printer 2-19
Setup 2-22
Printer Connection 2-8
Printer Driver Installation 5-20
Printing QC Results 11-12
PROBE UP 2-30

Q
QC
eQC 5-26
Printing 11-12
Saving 5-26
Tools 11-12
QC ALARMS 2-24
QC not done 2-24
QC Send
Results 11-12
Quality Control
Entering Assay Values and Limits 11-7
File Setup 11-4
Levey-Jennings 11-16
Materials 11-9
Running QC 11-10
Selecting Files 11-4
Quality Control Methods and Materials 11-3

R
RBC 1-2
RBC Analysis 3-3
RDW 1-2
Reagent 8-7
installation 2-10
Reagent Bar Codes 2-15
Reagent Menu 2-18
Reagent Storage 1-11
Reagents 1-10, 2-14, 2-15, A-4
Manual Entry 2-16

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Reagents, CELL-DYN Emerald

Hazards 8-7
Red Blood Cell measurands 1-2
Reference Intervals D-1
Relocation 9-15
Relocation of System 8-8
Rename Specimen 2-28
Replacing 2-14
Reporting Options 2-24
Requirements
Waste Disposal 8-7
Requirements for Collecting, Preparing and
Storing Specimens 7-6
Requirements for Handling Specimens 7-6
Requirements for Storage 7-5
Revision Status iii
RUN SAMPLE 5-11
Running Specimens 5-11

S
Safety i
Icons 8-3
Safety Icons 8-3
Sample Analysis Cycle 3-1
Sample Logs E-1
Sample Probe
Removal and Replacement 9-18
Sample Probe Removal and Replacement 9-18
Saving Current QC Data 5-26
Sending QC Results 11-12
SET AUTOCLEAN 2-30
Set Up Menu 2-19
Shipping 9-15
Shut Down 5-16
Shut down
Automatic 2-30
Site Requirements 7-3
Software Menu 5-4
Space Requirements 2-3
Specimen Analysis 5-5
SPECIMEN CAL. ADJUSTMENTS 2-27
Specimen Collection and Handling 5-5
Specimen Identification 5-6
Index-3

Index

Spill Clean-Up 8-7

START DAY SID 2-20
Start Up 2-12, 2-33, 5-9
STORAGE 2-31
Storage Preparation 9-15
Symbols xiv
Syringes 1-7
System Relocation and Shipping Guidelines 8-8
System Status 2-14

USB
Backup 5-30
Restore Settings 5-31
Set Up 5-30
USB drive, Event Log
Event Log 5-20
USB Flash Drive 5-17
USB Port 2-8
Use of the USB drive in the DATALOG 5-29

technical assistance ix
Thresholds 2-27
Thumb Drive 5-17
Tools in the QC Menu 11-12
Trademarks xiii
Troubleshooting 10-3
Results 10-5
Troublshooting
QC 10-5
Type 2-26

Viewing Results 11-14

W
Waste 2-17
Waste Disposal Requirements 2-4, 8-7
Waste Handling and Disposal 8-7
WBC 1-2
WBC Analysis 3-2
WBC Flags 3-13
White Blood Cell measurands 1-2
Worksheets E-1

UNITS 2-22
Units 2-24, 3-7
units of measurement 3-6

Index-4

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