User Manual Exigo

User Manual
CONTENTS
PREFACE ................................................................................................................ 3
Introduction ....................................................................................................................................................................... 3
SECTION 1: SAFETY INSTRUCTIONS ...................................................................... 5
Section Overview .............................................................................................................................................................. 5
1.1 Intended Use ................................................................................................................................................................ 5
1.2 Safety Instruction ......................................................................................................................................................... 6
1.3 Biohazards ................................................................................................................................................................... 6
1.4 Emergency Procedure .................................................................................................................................................. 7
1.5 Warning Signs in Manual ............................................................................................................................................ 7
1.6 Signs on Equipment ..................................................................................................................................................... 8
SECTION 2: INSTALLATION.................................................................................. 10
Section Overview ............................................................................................................................................................ 10
2.1 Unpacking / Operating Placement & Environment.................................................................................................... 10
2.2 Installation Checklist and Menu ............................................................................................................................... 12
2.3 Analyzer Cable, Interface, & Reagent Tube Connections ........................................................................................ 14
2.4 Reagent Installation ................................................................................................................................................... 15
2.5 Changing Reagents .................................................................................................................................................... 18
2.6 Power Supply............................................................................................................................................................. 19
SECTION 3: GENERAL OVERVIEW ...................................................................... 20
3.1 General Analyzer Overview ...................................................................................................................................... 20
3.2 Menu Structure .......................................................................................................................................................... 21
3.3 System Flow .............................................................................................................................................................. 23
3.4 Sample Volume, Throughput, and Parameters........................................................................................................... 24
SECTION 4: ANALYZER SETUP ............................................................................ 25
4.1 Menu Selection .......................................................................................................................................................... 25
4.2 Initial Setup ............................................................................................................................................................... 26
4.3 Advanced Setup ......................................................................................................................................................... 27
4.4 Reagent Setup ............................................................................................................................................................ 31
4.5 User Interface ............................................................................................................................................................ 33
SECTION 5: SAMPLE ANALYSIS ........................................................................... 36
5.1 Preparations before Analysis ..................................................................................................................................... 36
5.2 Startup Sequence ....................................................................................................................................................... 37
5.3 Background Count ..................................................................................................................................................... 38
5.4 Sample Identification ................................................................................................................................................. 39
5.5 Analyzing the Sample (Open Tube)........................................................................................................................... 40
5.6 Analyzing the Sample (Micro Pipette Adapter, MPA) .............................................................................................. 42
5.7 Results ....................................................................................................................................................................... 44
5.7 Results (continued) .................................................................................................................................................... 45
SECTION 6: QUALITY CONTROL (QC) AND BLOOD CONTROL MEMORY ........ 46
6.1 Quality Control (QC) ................................................................................................................................................. 46
6.2 Levey-Jennings Plots ................................................................................................................................................. 48
SECTION 7: CALIBRATION ................................................................................... 50
7.1 Preparations before calibration .................................................................................................................................. 50
7.2 Calibration ................................................................................................................................................................. 51
SECTION 8: CLEANING, MAINTENANCE & TRANSPORT ..................................... 54
8.1 Daily Cleaning ........................................................................................................................................................... 54
8.2 Annual Cleaning ........................................................................................................................................................ 55
8.3 Analyzer Maintenance ............................................................................................................................................... 55
8.4 Re-location of analyzer (within the laboratory) ......................................................................................................... 56
8.5 Short Term Shutdown (< 12h) ................................................................................................................................... 56
8.6 Re-packaging and Long Term Transport (>12h) ....................................................................................................... 57
8.7 Permanent Shut-Down and Storage ........................................................................................................................... 58
8.8 Disposal Information ................................................................................................................................................. 58
1
SECTION 9: PARAMETER & SYSTEM INFORMATION MESSAGES ....................... 59
9.1 Low & High Abnormal Results Information ............................................................................................................. 59
9.2 Sample Pathology ...................................................................................................................................................... 60
9.3 System Information ................................................................................................................................................... 69
SECTION 10: TECHNOLOGY................................................................................. 72
10.1 Measuring Principles ............................................................................................................................................... 72
10.2 Counting Time RBC & WBC .................................................................................................................................. 73
10.3 WBC Differentials ................................................................................................................................................... 74
10.4 Photometric Method – HGB Hemoglobin ............................................................................................................... 74
10.5 Measurement of Eosinophils ................................................................................................................................... 75
10.6 Parameter Definitions .............................................................................................................................................. 76
SECTION 11: SPECIFICATIONS ............................................................................. 78
11.1 General .................................................................................................................................................................... 78
11.2 Short List of Specifications...................................................................................................................................... 79
11.3 Parameter Ranges .................................................................................................................................................... 80
SECTION 12: TROUBLESHOOTING ....................................................................... 81
12.1 Aspiration Issues...................................................................................................................................................... 81
12.2 Communication Issues ............................................................................................................................................. 82
12.3 General Information Displays .................................................................................................................................. 84
12.4 System Information Displays................................................................................................................................... 89
12.5 Troubleshooting Other Issues .................................................................................................................................. 94
INDEX ................................................................................................................... 95
APPENDIX A ......................................................................................................... 96
APPENDIX B ....................................................................................................... 102
2
Preface
Introduction
Analyzer The Exigo Veterinary Hematology Analyzer is a 17 parameter, 3-part leukocyte

description differential hematology analyzer produced by Boule Medical for multi-species
veterinary applications. Exigo EOS gives an additional measurement of
Eosinophil Granulocytes, 19 parameters and 4-part leukocyte differential.
Serial number The serial number is located on the rear of the analyzer as indicated.
Serial Number
Figure 1.1
Software version The software version, along with serial number, is displayed on the screen
when starting up the analyzer.
Software version
Figure 1.2p
Instrument List of models

Product code Product name
1400061 Exigo Veterinary Hematology A
1400076 Exigo EOS Hematology Analyzer
3
Additional Additional documentation is available from your authorized distributor.
Documentation Current additional documentation is listed below:
 Service Manual
 Veterinary Case Book
 Basic Hematology
 User Definable Settings
 Product Data Sheets
Operator requirements The following operator requirements must be fulfilled before operating
the Exigo Veterinary hematology system.
 Basic skills in a laboratory environment.
 Basic skills in hematology.
 The operator must read and understand this manual.
Optional accessories Accessories and consumable lists are available from your local
and consumables distributor.
Manufacturer’s details Boule Medical AB

Domnarvsgatan 4
SE–163 53 Spånga, Sweden
Telephone number: +46 8 744 77 00
Fax number: +46 8 744 77 20
Email: info@boule.se
Distributor details Please contact Boule for information.
International SS-EN ISO 18113-3:2011

standards and SSEN 61010-2-101 (Low Voltage Directive 2006/95/EC)
regulations EN 61326 (2006) (EMC 2004/108/EC)
2012/19/EU WEEE
Standards harmonized with FDA
Date of Issue April 2014 Article no: 1504423
Software version Firmware 2.9.2
Third-party Software For information see Appendix B.
4
Section 1: Safety Instructions
Section Overview
Introduction This section describes the safety features and warnings associated with the
Exigo analyzer.
Contents This section contains the following topics:
Topic See Page

Intended Use 5
Safety Instructions 6
Biohazards 6
Emergency Procedures 7
Warning Signs in Manual 7
Signs on Equipment 9
1.1 Intended Use
Description The Exigo is a fully automatic hematology analyzer intended for in vitro
diagnostic testing of veterinary blood specimens under laboratory conditions.
Operator Operator must have basic laboratory skills and be aware of good laboratory
Requirements practice.
Warranty  Service must be performed by Boule Medical AB (hereafter referred to as

limitations Boule) or by service personnel authorized by Boule.
 Use only original parts and Boule authorized reagents, blood controls,
calibrators and cleaners. (If these products are substituted it may void your
warranty and makes customer support difficult.)
 The appropriate supervisor(s) are responsible that Boule products are
operated and maintained according to the procedures described in manuals,
product & control inserts, and technical bulletins.
Warranty  Each Boule system is tested using recommended reagents, blood controls,
stipulations calibrators and cleaners. All performance claims are generated as part of this
complete system.
 Boule products do NOT make diagnoses on patients. Boule intends its
diagnostic products (systems, software and hardware) to be used to collect
data reflecting the patient’s hematological status. The clinician uses this data
in conjunction with other diagnostic information and clinical findings to
establish a patient’s diagnosis and recommended course of treatment.
5
1.2 Safety Instruction
Description Boule incorporates safety features within the analyzer in order to protect the
operator from injury, the analyzer from damage and the test results from
inaccuracies.
Restrictions In order to insure the safety of the operator and analyzer, follow the instruction
below:
 Do not use the analyzer outdoors.
 Do no modify the analyzer.
 Do not remove the cover. (Authorized personnel only)
 Do not use the analyzer for other purposes than described in this manual or by
Boule technical bulletin covering an application.
 Do not spill blood or other fluids on the analyzer in such a way that it can
leak through the analyzer casing. (This might result in electrical malfunction
and/or personal injury)
 Unauthorized modification of the analyzer might result in erroneous results or

risk for electrical shock.
 Spilling fluids into the analyzer might cause electrical malfunction and/or
Important personal injury.
Handling of  If a reagent comes in contact with eyes, rinse with running water for several
reagents minutes. If symptoms occur seek medical attention.
 If the reagent comes into contact with skin, wash affected area with water.
 If swallowed, rinse out mouth. If persistent symptoms occur seek medical
attention.
1.3 Biohazards
Description As there are no assurances of the absence of HIV, Hepatitis B or C viruses or

other infectious agents in blood samples, blood controls, calibrators and waste
these products should be handled as potentially biohazardous.
Support  Protection of Laboratory Workers From Infectious Disease Transmitted by

documentation occupationally acquired infections – 2nd Edition, Approved Guidelines (2001)
Document M29-T2 promulgated by the Clinical and Laboratory Standards
Institute, CLSI (NCCLS).
 Follow local regulatory documentation.
Handling of  Use universal precautions when handling samples and discarding waste.
biohazardous  Handle any exposure according to established laboratory protocol regulations.
material
6
1.4 Emergency Procedure
In case of If there are any obvious signs of malfunction such as smoke or liquid leaking
emergency out of the analyzer proceed as follows:
Step Action
Disconnect the main power supply immediately by pulling out the
1
cord from the main supply.
2 Contact your authorized distributor.
1.5 Warning Signs in Manual
Warning Signs The following warning signs in the manual are used to identify possible hazards
and to call on the operator’s attention to this condition.
Sign Function
Indicates operation procedures that could result in

personal injury or loss of life if not correctly followed.
Warning
Indicates operation procedures that could result in

damage or destruction of equipment if not strictly
observed.
Caution
Emphasizes operating procedures that must be followed

to avoid erroneous results.
Important
Indicates that protective clothing, gloves or goggles must

be used when performing described procedures.
Mandatory Action
7
1.6 Signs on Equipment
Description Signs placed on the analyzer define areas that need special attention or areas
that contain danger. See IVD Symbol Table on page 9.
Signs on equipment
Figure 1.3 Figure 1.4
8
Batch code Serial number Catalogue number Manufacturer
Authorised*
Fragile, handle with
Representative in the Biological Risks Use by
care
European Community
In vitro diagnostic Lower limit of Upper limit of Temperature

medical device temperature temperature limitation
Consult instructions Normal control, 8

Control Calibrator
for use parameters
Content Recycling
Figure 1.5 IVD Symbol Table
9
Section 2: Installation
Section Overview
Introduction This section describes how to unpack and install the Exigo analyzer.
Topic See Page

Unpacking / Operating Placement and Environment 10
Installation Checklist and Menu 12
Analyzer Cable, Interface, and Reagent Tube Connections 14
Reagent Installation 15
Changing Reagents 18
Power Supply 19
2.1 Unpacking / Operating Placement & Environment
Description The analyzer is packed in a specifically designed protective box.
Visual Checking Check the box for physical damage. If damaged notify your carrier
immediately.
Included  Analyzer
Material  User Manual
 Quick Steps Guide
 Waste line
 Reagent tube assembly for the Diluent (Red)
 Reagent tube assembly for the Lyse (Yellow)
 Reagent tube assembly for the Cleaner (Blue)
 Reagent tube assembly for the EOS Reagent (Green)*
 Reagent bottle tray
 Power adapter and cord
 Installation form
 Declaration of Conformity
 Barcode reader
 MPA kit
* Exigo EOS only
Optional  Printer
Material  Printer paper
 External Keyboard
 Boule reagents, blood controls, calibrators and cleaning kit
10
2.1 Unpacking / Operating Placement & Environment (continued)
The following procedures must be followed exactly. Boule has no

responsibility in case of faulty or erroneous installation.
Important
Installation/ The analyzer should be placed in a laboratory environment according to the

Operating guidelines below:
Placement  Place the analyzer on a clean horizontal surface.
 Avoid lifting the analyzer from the front cover
 Avoid exposure to sunlight.
 Make sure the analyzer has access to proper ventilation. The analyzer should
have at least 5 cm (2 inches) of air above it.
 Place the rear of the analyzer so it has at least 10 cm (4 inches) of free space
behind it.
5 cm (2 in)
10 cm (4 in)
Figure 2.1
Installation/  Indoor Use

Operating  Temperature +18 to +32 ºC (64 to 90 ºF)
Environment
 Humidity < 80% Relative
 Grounded main supply
Operating the analyzer in an environment over +32 °C (90°F) may increase

service needs and may contribute to more rapid blood sample degradation.
Important
11
2.2 Installation Checklist and Menu
Description Follow the quick Installation Checklist and Installation Menu step by step for best
installation results. For more detail on each step refer to Sections 2.3 – 2.6.
Installation Checklist
Complete Unpacking / Operating Placement and Environment instructions in Section 2.1.
Connect the power adapter to the back of the analyzer, but do not plug it into an electrical socket.
Connect the printer. (If not using Boule provided printer see Section 4.3.)
Connect the barcode reader to the back of the analyzer.
Connect the PC (optional).
Install the reagent bottle tray. Remove foam from tray.
Connect the waste line to the analyzer and plumb to waste container or drain.
Remove clear plastic covers from reagent tube assemblies.
Connect the Diluent reagent tube assembly (red) and electronic sensor to the analyzer.
Connect the Lyse reagent tube assembly (yellow) and electronic sensor to the analyzer.
Connect the Cleaner reagent tube assembly (blue) and electronic sensor to the analyzer.
If Exigo EOS connect the EOS reagent tube assembly (green) and electronic sensor to the analyzer.
Plug the power cord into the power adapter and the electrical socket and power up the analyzer by turning the
On/Off switch to ON.
After system initialization follow Installation Menu instructions below.
Installation Menu The following Installation Menu instructions were created to make installation as
quick and easy as possible. After completing the following five steps on the
Installation Menu, the system will be ready for the first sample analysis.
The following Installation Menu Steps must be followed in sequential order.

Important
Step Action
Press Step 1 [SET DATE & TIME], set date and time, and press [EXIT] to return to
1
Installation Menu.
Menus
12
2.2 Installation Checklist and Menu (continued)
Step Action
Press Step 2 [ENTER REAGENT BARCODES].
 Scan barcode 1 and then barcode 2 on the Diluent bottle. (Press and hold the
ACTIVE or ON button each time a barcode is scanned.)
 Press [ENTER ANOTHER BARCODE] and scan barcode 1 and then barcode 2
on the Lyse bottle.
2  Press [ENTER ANOTHER BARCODE] and scan barcode 1 and then barcode 2
on the Cleaner bottle.
 If Exigo EOS press [ENTER ANOTHER BARCODE] and scan barcode 1 and
then barcode 2 on the EOS Reagent bottle.
 Press [EXIT] to return to Reagent Barcode Input screen and then press [EXIT]
again to return to the Installation Menu.
After reagents are scanned, place bottles in reagent tray. Loosen reagent bottle caps,
3 remove factory seals, and connect the reagent tube assembly to respective bottles
based on color-coding.

Press Step 3 [ENTER CONTROL BARCODES] to enter assay value ranges into the
system for the lot of Control being used.
4  Scan barcodes 1-9, in that order.
 Once accepted press [EXIT] to return to Installation Menu.
Press Step 4 [PERFORM FILL SYSTEM] to fill system with reagents. This cycle will
5 last for approximately 3 minutes.

Press Step 5 [GO TO STARTUP]. See Section 5.2 for details on guided startup
Optional sequence.
13
2.3 Analyzer Cable, Interface, & Reagent Tube Connections
Description All connections are located on the rear panel of the analyzer. The connections
available are as stated below:
2
3
4
6
5
Figure 2.8
Number Part Function

1 USB host ports Connects analyzer to USB devices
2 Electronic Sensors Connects Reagent level sensors to analyzer.
3 Power Supply port Connects Main power outlet to analyzer.
4 Power switch Switches power On and Off.
5 Ground Connector Connects Ground connector to analyzer.
6 USB Device Port Connects analyzer to USB host
Printer The printer is connected to the rear of the analyzer with USB printer cable.
Installation (Printer is not manufactured by Boule.) See Figure 2.8.
Supported DPU 411/2 and DPU 414 (Supplied by Boule as an optional accessory). Follow
Printers the instructions in the printer user’s manual to install.
Compatible HP-PCL compatible, IBM Proprinter compatible, or supported USB printers.

Printers If using one of these printers see Section 4.3 for setup instructions.
14
2.4 Reagent Installation
Description The reagents for the analyzer are contained in plastic bottles with plastic color-
coded caps.
Supported Isotonic Diluent, Hemolyzing reagent, Enzymatic Cleaner and EOS Reagent
Reagents hereafter referred to as Diluent, Lyse, Cleaner and EOS. (Specifically designed
for the Exigo system.)
Location of This section describes placement of reagent bottles.

Reagent  It is recommended that all reagent bottles are placed in the reagent bottle
tray in the correct order corresponding with the color/label on the bottle and
the color/label on the reagent bottle tray.
 If Exigo; all reagent bottles shall be placed in the reagent bottle tray.
 If Exigo EOS; a separate diluent box should be placed at the same level or
maximum 1 meter below the instrument.
 Not placing the reagent bottles in the correct order or in the reagent bottle
tray could cause system flow issues, analyzer malfunction, and/or erroneous
parameter results.
Caution
Connecting Reagent
This section describes how to connect the reagent bottle tray to the analyzer.
Bottle Tray
Step Action
1 Carefully lift up right-hand side of analyzer about 1 inch off of the countertop.
Slide metal plate of reagent bottle tray underneath the analyzer so that the feet
2 align with corresponding holes in the metal plate. (The Diluent port should be
facing the front of the analyzer.)
Figure 2.9
3 Carefully set analyzer down. Reagent bottle tray is now in place.
15
2.4 Reagent Installation (continued)
Reagent Bottle This section describes how to connect the reagent tube assemblies to the
Placement analyzer and where to place the reagent bottles for use.
Step Connect
1 The Diluent reagent tube assembly (red) and electronic sensor to the analyzer.
2 The Lyse reagent tube assembly (yellow) and electronic sensor to the analyzer.
3 The Cleaner reagent tube assembly (blue) and electronic sensor to the analyzer.
If Exigo EOS; the EOS Reagent tube assembly (green) and electronic sensor to
4
the analyzer.
2 4
3
1
4
2
Figure 2.10
Place reagent bottles, in the correct order, into reagent bottle tray.
If Exigo (Fig 2.11a): 1 = Diluent bottle, 2 = Lyse bottle, 3 = Cleaner
5
If Exigo EOS (Fig 2.11b): 1 = Diluent box, 2 = Lyse bottle, 3 = Cleaner bottle
and 4 = EOS bottle
1 2 3 2 3 4 1
Figure 2.11b
Figure 2.11a
Insert the reagent tube assembly assemblies into the corresponding reagent
6
bottles.
16
Waste Connect the waste line to the analyzer. Place the other end of the waste line
directly into the drainage system or into a waste container, following local
regulations. See Section 8.9 for Disposal information.
The end of the waste line must be at a lower level than the analyzer itself. Not
following this may lead to improper analyzer functions and/or waste liquid
flowing backwards into the analyzer.
Caution
Always use protective gloves when working with the waste container and the
waste line.
Mandatory Action
Fill System  For initial fill of analyzer, plug in analyzer and turn On/Off switch to ON.
 Press [EXIT] button upon display of Fill prompt, and follow the instructions
below to fill analyzer.
Step Action
1 Select MENU tab.
2 Press [REAGENT SETUP] and then press [ENTER NEW REAGENTS].
Scan in barcodes on side of reagent bottles, when all barcodes are entered a
screen will display that reagent barcodes have been accepted.

4 Return to MAIN Menu and press [ADVANCED].
5 Press [MAINTENANCE] and then [FILL SYSTEM].
17
Step Action
Menus
Figure 2.14 Figure 2.15 Figure 2.16

6 The system is now filling up with reagents. This cycle will last for approximately 3 minutes.
Print All After initial setup, it is recommended to print all analyzer settings and keep for
Settings personal records. Select [ADVANCED] from Main Menu, then [SETUP], and then
[PRINT ALL SETTINGS].
Factory Both sample analysis modes (Open Tube and MPA) are factory calibrated. However,
Calibration calibration should always be checked upon installation. See Section 7 for more details.
2.5 Changing Reagents
Description The interlocked reagent system displays indicator and warning messages to alert the
operator when reagents are running low and need to be changed. When this occurs
perform the following:
Step Action
1 Select [MENU] to access the Main menu and then select [REAGENT SETUP].
2 Select [ENTER NEW REAGENT].
Scan Barcode 1 and then Barcode 2 from the side of the reagent container. Press and hold the ON
3
button on the barcode reader each time a barcode is scanned.
4 When all barcodes are entered a screen will display that reagent barcodes have been accepted.
5 Select [EXIT] to return to the Main menu.
6 Remove the used reagent container from the reagent tray.
7 Place the new reagent bottle in the proper reagent tray position.
8 Remove the cap and seal on the new reagent container.
9 Transfer the reagent tube assembly from the used container to the new reagent container.
The analyzer is now ready to resume operation or analyze samples. No priming or fill cycle is
10
necessary when putting on a new reagent bottle, if indicator and warning messages are followed.
A reagent alarm will display when at least one of the reagent containers is running
low, empty, or expired. Once alarm is displayed it will continue to display after each
Important sample run until the indicated container is changed.
18
2.6 Power Supply
Main supply The power supply is an external all voltage/frequency power supply and
environment designed to be operated indoors. Only a Certified external mains power supply
can to be used with the Exigo system, see Section 11.2 for more detail.
Electrical shock hazard.

 The analyzer must only be connected to a grounded mains supply. Violating
this might result in injuries and/or loss of life and/or erroneous parameter
Warning
results.
Power In case of an abrupt power loss there will be no damage done to the analyzer.
interruptions Calibration constants and other parameters necessary for operation are
protected against main supply loss.
Connecting Insert power adapter into the analyzer’s main power inlet and connect it to the
Power Adapter main power supply. (This should only be performed after connecting the
reagent bottle tray and the reagent tube assemblies to the analyzer.)
When cycling the power switch from power on – power off – power on, it is
recommended to have a delay of 3 seconds after power off. If the power
switch is cycled back to power on too quickly, sensitive components in the
Important instrument electronics may get damaged.
19
Section 3: General Overview
Section Overview
Introduction This section contains general information about the analyzer and optional
accessories.
Topic See Page

General Analyzer Overview 20
System Menu 21
System Flow 23
Sample Volume, Throughput, and Parameters 24
3.1 General Analyzer Overview

Analyzer
Overview
1
5
4
2
7
Figure 3.1
Part Function
TFT-LCD Touch screen with incorporated keyboard and numerical
1. Display
pad.
2. Blood tube mixer Uniformly mixes samples before analysis.
3. Whole blood sample probe Aspirates whole blood for analysis.
4. MPA Micro Pipette Adapter enables analysis using 20 µl of blood.
Barcode reader enables user to quickly enter patient, control, and
5. Barcode reader
reagent pack identifications, and utilize the QC program.
6. Printer Prints sample results. (Not shown.)
7. Reagent bottle tray Attaches to analyzer to hold reagent bottles in place.
20
3.2 Menu Structure
Flowchart 3.1 Main Menu Structure

Select Analysis Profile
New Sample 11 possibilities of Analysis profiles
Next
ID_______
Prev
Main Menu 1,2,3..CE..
Ok
Set Profile >
New Sample > Next Profile
Sample > Prev Profile
Run Con/Cal Sample
List > Run Con/Cal >
Operator ID > 12 possibilities of Con/Cal Assay Values
Menu Next
A,B,C.. 1(4) >
Prime System Prev
ÅåÖö...1 (4) (optional) >
Power Down Cancel
Ok ¤
Advanced >
Cancel <
Reagent Setup >
Standby
1/4 ABC
Q/C >
2/4 abc
Sample 3/4 123...!?/...CE
New Sample > 4/4 ÅåÖö… (optional)
[GRAPH WBC] Ok
[GRAPH RBC] Cancel
[GRAPH PLT]
[PARAMETER RESULT]
!
Prev ¤
Next ¤
1(3) >
List
Menu <
Print Select Sample Criteria
ID __________________
Seq (fr-to) ____________
List Date (fr-to)____________
Profile
New Sample > Today
Sample Select All
Search > Selected __/__
[SEQ. x-y LISTED] Exit
Previous ¤ Sample Report
Next ¤ Delete
1(6) (param. listed) > Send
Menu < Print
Print Stats
Reagent Setup Menu Reagent Barcode Input

Enter New Reagent > Input manually >
View Reagents > Exit >
Inactivate Reagent >
Diluent: xx more cycles.

Lyse: xx more cycles.
View Reagent Statistics
Current Diluent/Lyse/Cleaner
Cycles Left
Lot No./Pack No.
Exp. Date
Q/C Menu Open Date/Last Date
View Con/Cal > Print
Enter Con/Cal > Exit
View Assays >
Exit <
Inactivate Reagent
Do you want to inactivate the current
reagent bottles?
Yes >
No >
21
3.2 Menu Structure (continued)
Flowchart 3.2 Advanced Menu Structure
Calibration
Whole Blood >
Capillary Device >
Calibration Log >
Exit <
Maintenance Cleaning Menu

Prime System Read the cleaning kit instructions
Clean Orifice before proceeding further!
Fill System ¤
Cleaning Menu > Clean Cycle Empty >
Empty System Clean Cycle Fill >
Probe Flush ¤ Exit <
Exit <
Service Menu Service Menu 2

Serial no
Serial no
Firmware
Firmware
Clot Removal >
Blood Detector >
Noise test >
Level Detectors >
Configuration >
Beaker Detector >
Pump & Valve >
Advanced Reagent Detector >
Instrument Log >
Calibration > HGB >
Flush Shear Valve >
Maintenance > Shear Valve >
Ptest (if applicable) >
Service > CVP (if applicable) >
Service Setup 2 >
Setup > Exit <
Exit <
Exit <
Setup Menu 1 Setup Menu 2

Setup Menu 3
Print Setup > Barcode Setup >
Color setup >
Serial Setup > Memory Setup >
Mixer Setup >
Print All Settings > Blood Det. Setup >
PLT offset Setup >
Send All Settings > Standby Setup >
High Alt. Setup >
SEQ No. Setup > Date/Time Setup >
Instrument ID >
Setup Menu 2 > Regional Setup >
Setup Menu 3 > Exit <
Analysis Profile >
Exit < Exit <
Analysis Profile Setup

Activate
[X] >
Default >
Name >
Block parameters >
Normal Ranges >
WBC setup >
RBC/PLT Setup >
Misc. Setup >
Next / Prev
Exit <
22
3.3 System Flow
Description This section contains the system flow concerning standby and cleaning cycles.
Flowchart 3.3 System Flow
After 15 minutes*
Screen Saver
Mode×
Before 8 hours* After 8 hours*
Press anywhere on
In Standby Mode ◊
screen to view screen
Press [EXIT] Press anywhere on

screen to view screen
Press [Exit Standby]

Returns user to
and OPID to exit
last displayed page
standby mode □
* This time amount is user adjustable.

× Possible to start directly if in View Sample, List
Sample, or Main Menu screens.
◊ Default automatically runs background count. If

default is inactivated by user, background count
run recommended.
□ In standby mode the system is automatically

filled with cleaner.
23
3.4 Sample Volume, Throughput, and Parameters
Description The Exigo is a fully automated cell counter reporting up to 19 parameters.
Sample volume < 125 µl (Open Tube), 20 µl (MPA)
Throughput  Analysis time (open tube, whole blood) is ~1 minute.

 Analysis time including EOS is ~ 3 minutes
19 Parameters See list of parameters below:
Leukocyte parameters
WBC Total White Blood Cell Count
LYM% Lymphocyte percentage
LYM# Lymphocytes (absolute)
MONO% Monocyte percentage
MONO# Monocyte (absolute)
GRAN% Granulocyte percentage
GRAN# Granulocyte (absolute)
NEUT% Neutrophile percentage *
NEUT# Neutrophile (absolute) *
EOS% Eosinophile percentage*
EOS# Eosinophile (absolute)*
* If EOS parameter is activated, NEUT and EOS will be displayed instead of GRAN.
Erythrocyte parameters
RBC Total Red Blood Cell Count
HGB Hemoglobin Concentration
HCT Hematocrit
MCV Mean Cell Volume of RBCs
MCH Mean Cell Hemoglobin
Mean Cell Hemoglobin
MCHC
Concentration
Red Blood Cells distribution
RDW%
width percentage
Red Blood Cells distribution
RDWa
width (absolute)
Platelet parameters
PLT Total Platelet Count
MPV Mean Platelet Volume
24
Section 4: Analyzer Setup
Section Overview
Introduction This section covers the initial configuration needed to customize the analyzer
settings.
Topic See Page

Menu Selection 25
Initial Setup 26
Advanced Setup 27
Reagent Setup 31
User Interface 33
4.1 Menu Selection
Main Menu upon  The List Menu will be displayed upon initialization.
initialization  From this main screen all other menus can be accessed for setup.
 By selecting the MENU tab and then pressing [ADVANCED] the
Advanced Menus will be displayed.
List and System
Menu
25
4.2 Initial Setup
Initial Setup Initial setup of the analyzer, except date and time, has been factory set to
default values for veterinary users. However, other user definable formats may
be preferred, details are provided below.
Setting up The date/time function is shown on all samples and printouts and should always
date/time be setup correctly. To set date/time follow the instruction below:
Step Action
1 Start by pressing [ADVANCED] from the MENU tab.
2 Press [SETUP], then press [SETUP MENU 2].
3 Press [DATE/TIME SETUP] to enter the set date/time menu.
4 Press [DATE FORMAT] to select date specific setting.
1 = DD/MM/YY; 2 = YY/MM/DD, 3 = YY/DD/MM, 4 = MM/DD/YY
Press on the item that you want to change and enter the changes on
5
the numerical pad. See Menus below.
Menus
Setting up
Change of display language is performed by following the instructions below:
language
Step Action
2 Press [SETUP], then press [SETUP MENU 2].
3 Press [REGIONAL SETUP], a list of local settings will be displayed.
4 Press [MORE] until language button is displayed.
5 Press [LANGUAGE] to enter language screen.
Choose the number that corresponds with the language desired and
6
press OK to save.
26
4.3 Advanced Setup
Description Initial advanced setup of the analyzer, has been factory set to default values for
veterinary users. However, other user definable formats may be preferred,
details on how to install and configure external components such as barcode
readers, printers, data communication, etc. are provided below.
Default Printer The analyzer has been automatically set to USB printer provided by Boule.
(Printer Type 4)
USB Printer  Contact local distributor for current list of available USB printers
 If using USB printer other than that specified by distributor, the printer
must be HP PCL 5 or IBM proprinter compatible.
Select Printer Follow the instruction below for interfacing analyzer to different printer types.
Type (To connect printer see Section 2.3)
Step Action
Press [SETUP] and then [PRINT SETUP] to enter the Print Setup
2
menu.
Press [MORE] to view Printer type. Printer types are as follows:
4 = USB printer
3 5 = Seiko DPU 411/12 and 414 (default setting)
6 = IBM proprinter / Epson compatible format
7 = HP PCL 3 and 5 protocol compatible
To change printer type press [PRINTER TYPE], enter the correct
4
number and press [OK] to save.
Print modes To select options for printing results:
Step Action
2 Press [SETUP].
3 Press [PRINT SETUP] to enter the printer setup menu.
To set Manual Print Mode function select from the following:
4
0 = None, 1 = Without Histograms, or 2 = With Histograms (default).
To select Auto Print Mode function select from the following:
5
0 = None, 1 = Without Histograms, or 2 = With Histograms (default).
Extended printer format settings and user definable print layouts are
Note also available. Please contact local distributor for further detailed
information on how to setup user definable formats.
27
4.3 Advanced Setup (continued)
Barcode Setup To setup the barcode reader follow the instructions below. (Note that the
default barcode setting is 9600N81). See barcode reader insert to determine
types of barcodes that can be scanned, if using barcodes for patient Ids.
Step Action
2 Press [SETUP] and then [SETUP MENU 2].
3 Press [BARCODE SETUP] to enter the barcode setup menu.
For serial barcode readers, set Barcode Reader Type = 1. If not, set it = 0.
To use another USB barcode reader, other than the one delivered by Boule, together
with the instrument, perform the following:
 Leave the barcode reader unconnected.
 Press the button to the right of [Set USB barcode reader].
 The display shows [Connect a USB barcode reader to enable it].
4
 Connect the USB barcode reader to one of the USB host connectors.
 The instrument returns to [Barcode Reader Setup].
 Check that you can input barcodes with the barcode reader.
Note: If you want to go back to using the USB barcode reader delivered by Boule
together with the instrument, follow the procedure above. The instrument can only
handle one kind of USB barcode reader at a time.
Keyboard Setup To setup the keyboard follow manufacturer instruction for setup and plug
(optional) into analyzer keyboard port. See Section 2.3 for details.
Step Action
3 Press [REGIONAL SETUP] and then [MORE].
4 Press [KEYBOARD LAYOUT], and select keyboard type.
5 Press [EXIT] until Main Menu is reached.
6 Turn analyzer OFF, and then turn ON again for changes to take effect.
High Altitude Setup This function only needs to be activated if various HF, HH, HL, or HN
Indicators repeatedly appear (see Section 9.2 in User Manual), then mode
may need to be changed to Moderate or Maximum compensation in higher
elevations.
Step Action
2 Press [SETUP], then [SETUP MENU 2] and then [SETUP MENU 3].
3 Press [HIGH ALT. SETUP], and then [HIGH ALTITUDE COMPENSATION].
Choose the setting that is appropriate for your location:
0 = No Compensation (default)
4
1 = Moderate Compensation
2 = Maximum Compensation
By choosing 1 or 2, the software incorporates some minor timing sequences for the
Note
wash cycles, no other functions are affected.
28
Activate Mixer To activate mixer follow the instruction below:
Step Action
3 Press [SETUP MENU 3] and then [MIXER].
If the mixer is activated the button will have brackets [X]. To deactivate
4
press button and select ( [ ] ).
Menus

Upon sample aspiration mixer will discontinue rotation until sample
Note
analysis is complete.
Prior to analysis, the tube should be placed in the mixer for a minimum
of one minute.
Important
Serial modes To select options for sending results:
Step Action
2 Press [SETUP].
3 Press [SERIAL SETUP] to enter the serial setup menu.
To set Manual Send Mode function select from the following:
4
0 = None (default), 1 = Without Histograms, or 2 = With Histograms.
To select Auto Send Mode function select from the following:
5
0 = None (default), 1 = Without Histograms, or 2 = With Histograms.
HW handshake is automatically activated to check serial port connection. To
6
inactivate change [X] to ([ ]), and then [OK] to save.
Send with Ack. is automatically activated to send an acknowledgement
7 message with each sample being transmitted to computer. To inactivate change
[X] to ([ ]), and then [OK] to save.
Baud Rate sets the transfer speed on the serial port. The default is 1
8 (19200N81). To change to slower baud rate, select 2 (9600N81), and then [OK]
to save.
29
Select Serial port sets the output port for sample data, select from the
following:
9
2 = USB device port, 3 = USB memory stick, or 4 = USB RS232 serial port
adapter
Select USB vendor and product ID sets the USB identity for the analyzer.
 Select 2 (Boule USB Vendor ID) if your PC application supports the Boule
USB Vendor ID.
10
 If not, select 1 (Gadget Serial USB Vendor ID).
 If unsure, please check the documentation for your PC application, or contact
the company that developed it.
Data The analyzer is equipped with three different outputs for connection to a
Communication computer (network).
1. USB output with USB device port connector.
2. USB memory stick
3. USB RS232 serial port adapter
USB connection To connect to a PC computer using a USB connector, simply plug in USB
connectors between analyzer and computer, and follow below instructions:
Step Action
2 Press [SETUP], then [SERIAL SETUP], and then [MORE].
Menus

To activate the USB connection to a PC computer, press [SELECT
3
SEND PORT] button, then type in [ 2 ], and then [OK] to save.
To activate the USB connection to a memory stick, press [SELECT
4
SEND PORT] button, then type in [ 3 ], and then [OK] to save.
To activate the USB connection to the RS232 serial port adapter,
5 press [SELECT SEND PORT] button, then type in [ 4 ], and then
[OK] to save.
30
Figure 4.9
For Select Send Port activation to function correctly user must have a
Note
PC application that can receive and process reports.
To connect to a PC computer using a 9 pin RS232 see instructions below:
Cable end converter (9pin) Cable end pc (9pin)

2 3
3 2
5 5
7 8
8 7
4.4 Reagent Setup
Description This section describes the functions of the reagent setup menu and how to access
reagent statistics.
Reagent Input The Exigo system is interlocked with specified Boule reagents for optimal
(Enter New performance. The reagent bottles must be identified by the analyzer before
Reagents) analysis of samples can begin. To identify reagents scan in or manually enter the
barcodes on the reagent bottles. See section 2.4.
31
4.4 Reagent Setup (continued)
View Reagent The system monitors reagent consumption and computes remaining cycles. This
information may be viewed at any time, in one of two ways:
Step Method 1
1 Start by pressing [REAGENT SETUP] from the MENU tab.
On the lower left-hand side of the Reagent Setup Menu, both the remaining cycles for
2 Diluent, Lyse, Cleaner and EOS are displayed. (It is important to remember that cycles
include analyses, wash cycles, background counts, primes, exit standbys, etc.)
Menus

Step Method 2
The second method of viewing reagent statistics is by pressing [VIEW REAGENTS]
from the Reagent Setup Menu. There are two screens that are divided into the last four
lots of Lyse- Diluent- Cleaner- and EOS Reagent Statistics. For each, the operator can
view the following:
 [X] indicates which reagent is currently activated.
1  The number of cycles left for specific reagent bottle.
 The Lot and Pack Numbers
 The expiration date of the specific reagent bottle.
 The Open Date, when the reagent bottle was first used on the system.
 The Last Date, when the last time that reagent bottle was used to run a cycle.
32
4.4 Reagent Setup (continued)
Inactivate It is possible for the operator to inactivate the current reagent bottle by pressing
Reagent the [INACTIVATE REAGENT] button and then [YES]. Once deactivated the
operator must scan in or manually enter another reagent bottle before analysis
of samples can begin. (An inactive reagent can be re-activated by simply
scanning the barcode on the reagent bottle again.)
Reagent The interlocked reagent system displays indicator and warning messages to
Indicators alert the operator when reagents are running low and need to be changed. See
Section 12.2 and 12.3.
4.5 User Interface
Description This section describes the functions of available menus in the analyzer that
have not been described in any other section of this manual.
Analysis Profile It shall be possible for authorized operators to customize analysis profiles.
Animal/species analysis profiles have been pre-defined in Exigo analyzer.
Some of analysis profiles are inactivated at delivery. Each analysis profile has
many different formatting options, including profile name, default settings,
normal ranges, analysis constants, blocking parameters, etc. To add or change
analysis profile settings see the following menu options:
Step Action
2 Press [SETUP], then [ANALYSIS PROFILE] to enter the Analysis Profile Setup menu.

To set profile name press [NAME].
 Press [PREV] or [NEXT] to choose an open profile on list (e.g. AP8, AP9, etc).
4  Press [NAME ON DISPLAY] to enter new profile name and press OK when complete.
 Press [NAME ON PRINTOUT] to enter new profile name to be displayed on printout
and press OK when complete.
Remember to [ACTIVATE] the new profile in order to view it as a selection for sample
Note
analysis.
5 To set new profile as default press [DEFAULT] and select [X].
33
4.5 User Interface (continued)
Step Action
To block certain parameters press [BLOCK PARAMETERS] to see list and then [MORE] to
6
view specific parameters. Press any parameter and select [X] to block parameter.
To change RBC/PLT discriminators press [RBC/PLT SETUP] to see list and then [MORE] to
7 view specific discriminators. Press specific discriminator button to change value and then OK to
save.
To change WBC discriminators press [WBC SETUP] to see list and then [MORE] to view
8 specific discriminators. Press specific discriminator button to change value and then OK to
save.
To change normal ranges press [NORMAL RANGES] to see list and then [MORE] to view
9 specific parameter range. Press specific parameter range button to change value and then OK to
save.
Indicative normal ranges are provided in this instrument. It is recommended to establish local
reference ranges (normal ranges) for your laboratory. (For guidance on how to establish these
Note ranges and examples of normal ranges for other species go to: www.exigo-vet.com >
Distributors > Profiles.)
To change background mode setting of the profile press [MISC. SETUP], choose
[BACKGROUND MODE PROFILE] button, choose [X] or [ ] to activate or deactivate, and
10 then [OK] to save. By enabling this setting, the current profile will behave like the factory
default BACKGROUND profile (i.e. disable AF flagging, disable pathology messages, etc.).
The operator will be prompted to enter a 4-digit Operator ID (Operator ID is recommended for
in-house records but not required) and Authorization Code (REQUIRED) before a change or
Note update to an analysis profile can be made. To update or change analysis profiles input the
Authorization Code [2576].
Sample Memory The following procedures explain how to search for previous sample analyses and
statistics, and print, send, and delete sample results that are stored in memory.
Step Action
To view recent previous analyses present in a sequential list, press [PREV] or [NEXT] buttons
1 to scroll through samples in either Sample or List menus.
To view a specific sample or a group of samples press [SEARCH] in List Menu. In this menu
samples can be selected by Sample ID, SEQ, Date, and Sample profile. Press corresponding
button to select, and then [EXIT] to return to List menu and view newly selected samples.

To return to previous selection criteria press [SEARCH], then [SELECT ALL], and then
Note [EXIT].
34
4.5 User Interface (continued)
Step Action
To view Sample Statistics, select sample or group of samples to view, and press
3 [STATS] to enter the Statistical Results menu.
4 To print or send selected sample or sample statistics press [PRINT] or [SEND].
To delete selected sample or group of samples press [DELETE]. The analyzer will
5 display a prompt to verify deletions, press [YES].
To print a summary report of every sample run press [SAMPLE REPORT] and then
6 [PRINT ALL SUMMARY REPORT].
To print a summary report of a selected group of samples, select desired criteria
7 (See #2 above), then press [SAMPLE REPORT] and then [PRINT PATIENT
SUMMARY REPORT].
 These summary reports will print on a horizontal sheet of paper.
Note  To print summary reports you can only use HP PCL 3 and 5 protocol
compatible and USB printers.
Menu
Figure 4.18
All Settings From Menu tab press [ADVANCED] and then [SETUP] to enter Setup Menu.
 To print all analyzer settings, verify analyzer is connected to a printer and
press [PRINT ALL SETTINGS].
 To send all analyzer settings, verify analyzer is connected to a computer and
press [SEND ALL SETTINGS].
Change Sequence From Menu tab press [ADVANCED] and then [SETUP] to enter Setup Menu.
Number To change sequence number press [SEQ NUMBER SETUP], press [NEXT
SEQ NUMBER], enter in new sequence number and press OK to save.
User Definable More detailed Setup Menu descriptions can also be found in the User
Settings Document Definable Settings document, which can be located at www.exigo-vet.com >
Support > Downloads > Documents.
35
Section 5: Sample Analysis
Section Overview
Introduction This section covers the sample analysis routine, including how to analyze a sample in
the two different modes offered in the Exigo system.
Topic See Page

Preparations before Analysis 36
Startup Sequence 37
Background Count 38
Sample Identification 39
Analyzing the Sample (Open Tube) 40
Analyzing the Sample (Micro Pipette Adapter, MPA) 42
Results 44
5.1 Preparations before Analysis

Anticoagulant EDTA K3 (Ethylene Diamine Tetracetic Acid, Tri-potassium) liquid and EDTA K2
recommendation (Ethylene Diamine Tetracetic Acid, Di-potassium) spray-dried solution.
Recommended by ICSH and NCCLS.
Sample  Obtain the sample by means of a clean venipuncture to minimize platelet

collection aggregation.
 Collect the appropriate volume as specified by the EDTA tube being used.
 If collecting blood for hematology and chemistry, fill the EDTA tube first and any
other tubes next.
 Avoid use of needles smaller than 22 gauge. If a smaller needle is used, the blood
should be transferred to the EDTA tube with no tube top and needle removed.
 Avoid transfer of blood to the tubes by turbulent force. The vacuum should be
allowed to fill the tubes.
Handling venous  Immediately mix the EDTA tube by gentle inversion 6-8 times to adequately mix
blood samples with the anticoagulant.
 It is recommended that samples are placed on mixer as soon as possible after
collection. If sample is placed in mixer within 5 minutes of collection only a
minimum of one minute is required for mixing.
 If samples are not placed on mixer within five minutes of collection (i.e. tube is
placed in tube rack or on counter) then an increased mixing time is advised, a
minimum of 3 minutes in the mixer.
Handling of  The sample in the micropipette can be analyzed directly after collection and for
capillary blood optimal results not longer than 10 minutes from collection.
samples  For capillary samples collected in Microtainer tubes follow the “Handling of venous
blood samples” section above.
 The sample should be kept at room temperature and analyzed within 6 hours.
 Excessive cold or heat could cause erroneous results.
Important
36
5.2 Startup Sequence
Startup The following sequence guides the operator through the beginning of the day startup
Sequence routine for the analyzer. There are 2 simple steps to follow which takes the user
through a background and control analysis sequence with detailed guidance at each
step.
Default setup The startup sequence is set as a default in the Exigo system but can be bypassed if a
different startup routine is desired. It is recommended by Boule to use this guided
startup sequence.
Step Action
1 Touch display or switch on power to the analyzer.
Press [EXIT STANDBY] or [PWRUP], depending on how the analyzer was
2
shutdown previously, to “wake up” the analyzer.
Enter operator ID and press [OK] or press [CANCEL] to exit Standby. The analyzer will
3
now run a “wake up” sequence.
When “wake up” cycle is complete, press start plate to begin the first step of the
4
startup sequence.
Menus

When complete the background count results are displayed. If the results are acceptable,
5 scan in the barcode on control vial and follow directions on the display to begin the
second step of the startup sequence.
If the background count results have a H (high) indicator press [RERUN] and follow the
Note screen instructions to analyze background count again.
Menus
37
5.2 Startup Sequence (continued)
Step Action
When complete the control results are displayed. If control results are
acceptable, the startup sequence is complete. Press [ANALYZE SAMPLES]
6
to go the main screen, and follow instructions in the following sections to
analyze samples.
If control sample results have a H (high) or L (low) indicator press [RERUN]
Note
to analyze control sample again.
Menus
5.3 Background Count
Background The following sequence is performed to check that the background count is low
Check enough to run a sample. It is recommended to run a background check at the
beginning of each day and when switching between different analysis modes.
Step Action
1 From the main screen press [NEW SAMPLE].
2 Press [NEXT PROFILE] or [PREV PROFILE] to scroll to BACKGROUND.
Press the whole blood start plate, which is located behind whole blood
3
sample probe. (See Figure 5.7 below)
Start plate
Figure 5.7
The aspiration time is approximately 10 seconds. After ~ 10 seconds the
analyzer will time out due to no detection of blood, and continue its cycle.
38
5.3 Background Count (continued)
Accepted Back- The background count should not be higher than the figures shown
ground values below. Rerun sample if values are not acceptable.
Parameters Values accepted

RBC ≤ 0.03 (1012/ L)
WBC ≤ 0.2 (109/ L)
HGB ≤ 0.2 (g/ dL)
PLT ≤ 10 (109/ L)
The micropipette inlet is acceptable at  0.3 (109/L) on WBC due to potential pre-analytical contributions
5.4 Sample Identification
Description This section describes the different methods of inputting Sample Ids
(Identification). There are two (2) ID Fields available.
.
ID Input The ID can be entered with the following methods:
Methods  Manually (touch screen or external keyboard)
 Barcode (Barcode entry is limited to ID 1 only)
Character Input A maximum of 16 Characters (alpha and numeric) are allowed in both ID 1 and
Limitations ID 2 fields.
Step Action
From the main screen press [NEW SAMPLE] or begin sample aspiration, which
1
automatically opens NEW SAMPLE menu.
Press numerical keys to enter sample ID or scan in the ID barcode from the sample
2
tube. Press sample ID2 if a second ID is needed.
3 Press [NEXT PROFILE] or [PREV PROFILE] to scroll to desired profile.
4 Press OK to save profile and sample ID or begin sample aspiration.
Menus

5 Aspirate sample following selected procedures in sections 5.4 – 5.5.
39
5.4 Sample Identification (continued)
Operator ID The Operator ID is an optional feature which can be entered prior to analyzing
a sample or when exiting Standby Mode. To enter an Operator ID press the
specified button and enter up to a 4-digit numerical or alphabetic ID. The
Operator ID will stay the same until Operator ID button is pressed again and
changed, or when the analyzer goes into Standby Mode.
5.5 Analyzing the Sample (Open Tube)
Description This section describes how to aspirate and analyze a sample with the “Open
Tube” procedure. The system aspirates blood sample through the sample probe.
Starting Refer to Section 5.1 for blood sample preparation and then follow the procedure
procedure below:
Step Action
Choose List, Sample, or Main menu to begin sample analysis.
1
Analyzer must be in one of these operation modes to aspirate.
Aspirate the sample through the sample probe by gently inserting
2 sample probe into the sample tube and then press the whole blood start
plate behind the sample probe. (See Figure 5.10)
Follow the instruction on the menu when to remove the sample tube.
3 A beep is also an audible indication the sample should be removed
from the sample probe.
 Make sure that the blood sample tube is not touching the upper part of the
sample probe.
 Not removing the sample tube could result in incorrect washing sequence of
the sample probe.
 Do not remove sample prior to instruction, incomplete aspiration could
Important
occur, causing erroneous results.
Sample Aspiration
Figure 5.10
40
5.5 Analyzing the Sample (Open Tube) (continued)
Sample Aspiration Display

The analyzer now switches to the sample analysis screen.

Results will be displayed on List or Sample menu. For more information
7
of results refer to Section 5.7.
When NEW SAMPLE button returns to green, operator can begin analysis
8
of next sample.
If needed, wipe the sample probe with a clean, dry, lint-free, absorbent
Note
cloth to remove possible traces of blood.
41
5.6 Analyzing the Sample (Micro Pipette Adapter, MPA)
Description This section describes how to analyze capillary whole blood samples with the use
of the Micro Pipette Adapter (MPA).
Micropipettes ONLY Boule supplied, plastic, high precision EDTA micropipettes should be used
when running MPA. Glass micropipettes can cause damage to analyzer if inserted
incorrectly.
Starting procedure Follow the procedure below to operate MPA:
Step Action
Choose List, Sample, or Main menu to begin sample analysis. Analyzer
1
must be in one of these operation modes to aspirate.
Pull out the MPA adapter. (The analyzer will give an instruction to put
2
back the loaded MPA adapter to start the analysis cycle).
3 Remove the previous sample micropipette. (If applicable)
4 Place the adapter on the table.
Note The EOS parameter is not available through MPA mode.
Drawing blood and sample preparation:
Step Action
Aspirate the sample as shown below.
Figure 5.15
 Fill the micropipette completely with fresh whole blood and wipe off excessive
blood on the outside surface.
 Be careful not to wick blood from open ends of the micropipette.
Important  Ignoring these instructions might cause incorrect and non-reproducible results.
Figure 5.16
42
5.6 Analyzing the Sample (Micro Pipette Adapter, MPA) (continued)
Step Action
Insert the micropipette into the MPA device as shown below:
Figure 5.17
Insert the MPA into its holder and the analyzer will automatically
start the analyzing sequence.
Figure 5.18
Do not remove MPA during sample aspiration or analysis. Removal prior to
completion of analysis may cause erroneous results.
Important 5 Refer to Section 5.5 Steps 6 - 10 for remainder of analysis sequence.
43
5.7 Results
Description This section describes the information that can be obtained from the sample
analysis results.
After sample After a sample has been analyzed the result information can be viewed in the
analyze following three screen displays:
Sample View 1
Analysis mode and
Sample ID analysis profile
Primary Diagnostic
Parameters Operator ID
Displays aspiration time

for sample analysis, and
WBC and RBC counting
times. Press on to view
different views of
the same sample.
Use these buttons to scroll to
previous or next samples.
Figure 5.19
Sample View 2
Sample results Normal Range display

with sample results.
Information Indicator - When Red bar = Results

flashing user can press button Out-of-Range
to display system information
and/or sample pathology.
Green bar = Results
within Range
Press to manually print
current sample analysis.
Figure 5.20
44
5.7 Results (continued)
Sample View 3
Total WBC count and WBC histogram

differential values
HGB parameter RBC histogram
HCT and RBC parameters PLT histogram
PLT count and PLT parameters
Figure 5.21
Sample View 4
Total WBC count
EOS count in absolute EOS histogram

and % values
EOS counting time
Figure 5.22
Note If EOS parameter is inactivated, GRAN will be displayed instead of NEUT and EOS.
45
Section 6: Quality Control (QC) and Blood
Control Memory
Section Overview
Introduction The Exigo system is equipped with a QC memory capable of displaying and
printing Levey Jennings plots.
Topic See Page

Quality Control (QC) 46
Levey-Jennings Plots 48
6.1 Quality Control (QC)
Introduction This section describes the procedures to be performed for running control
samples.
QC Menu and CON/CAL Follow the instruction below to access the QC menu and to input
Assay Values input Control/Calibrator Assay Values from the Assay sheet.
Step Action
1 Enter the QC menu by pressing [QC] from the menu tab.
2 Press [ENTER CON/CAL].
Refer to the Assay sheet for instructions on how to input control assay
values. (These pages are delivered with authorized Boule controls).

Assay values for 12 different lots can be stored simultaneously.
When renewing the assay values, the previously scanned CON/CAL assay
Note values will be removed in a chronological order starting with the assay
values that were entered first.
46
6.1 Quality Control (QC) (continued)
Control Analysis Good laboratory practice indicates that the performance of the Exigo system is
checked daily with certified blood controls authorized by Boule. For good
laboratory practice controls may also be used for troubleshooting purposes and
when changing to a new lot of reagents, to check for damage during transport or
storage. Comparing the analyzer results to the known values on the Boule control
assay sheet is a good assurance that the system is functioning properly.
 Please refer to the Blood Control Product Insert for complete instructions for
handling and use of blood control materials.
 Never use an open vial longer than recommended by the manufacturer or
subject any vial to excessive heat or agitation.
Important  Wipe the sample probe with a clean, dry lint free absorbent cloth before each
control run. Not following this technique will impact control accuracy.
Step Action
1 Follow directions on Assay Sheet to scan in values of the Lot of control material in use.
2 Choose either List, Sample, or Main Menu to begin control analysis.
Using installed barcode reader, scan the Control ID from the blood control vial label or
3
manually enter in barcode.
Aspirate the blood control and wait for the results. The Exigo analyzer will identify this
4
ID and match the results with the previously defined assay values.
5 Compare Control results to assay values on results screen.
Search Function Each blood control lot can be found by Lot number, date or sequence number.
Step Action
1 Enter the QC menu and press [VIEW CON/CAL].
2 Input the search criteria to be used.
Pressing on the SEQ bar will display Figure 6.4, in which one particular lot or level can
3
be selected.
Menus

4 Press the [SAMPLE] or [LIST] buttons to display the selected samples.
47
6.1 Quality Control (QC) (continued)
Step Action
Once samples are displayed they can also be printed out in a Monthly QC
summary report.
 After the control lot (profile) has been selected the Monthly QC
button will become active.
5
 Press [MONTHLY QC] button, use the [PREV] and [NEXT] buttons
to scroll to desired month, and press [EXIT].
 The Monthly QC button will turn green when lot and month have
been chosen. Press [REPORT] button to print out report.
Menus

To exclude a sample from the Monthly QC or LJ Diagram summary
reports perform the following steps prior to Step 5 above:
 Scroll to the control sample to be excluded using the [PREV] and
[NEXT] buttons in the Con/Cal Sample or List tabs.
6
 Then press [EXCLUDE/INCLUDE] button. An “X” will be placed
next to excluded sample.
 To include the sample press the [EXCLUDE/INCLUDE] button
again.
6.2 Levey-Jennings Plots
Procedure
instruction
This section describes selecting, viewing, and printing Levey-Jennings Plots.
L-J Plots Levey-Jennings (L-J) plots are used to monitor the long term stability of the
analyzer using Boule blood controls.
Blood controls To be able to use L-J plots, the Control/Calibrator Assay values for the blood
controls must be scanned with the installed barcode reader or manually entered
in. Follow direction to scan in values of CON/CAL Assay values.
48
6.2 Levey-Jennings Plots
Displaying and
To display and print the L-J plots, follow the instructions below:
printing L-J Plots
Step Action
1 Enter the QC menu and press [VIEW CON/CAL].
Scan the barcode label on the blood control tube, with the barcode reader,
2
select control from Select Con/Cal Sample Menu, or manually enter in value.
3 Press [L-J VIEW] to display the Levey - Jennings plots.
L-J plot Image 6.7 below is constructed from several samples and will not be shown
diagrams as below until a sufficient amount of samples have been analyzed.

4 Scroll through parameters by choosing [MORE].
5 Print diagrams by choosing [PRINT].
6 A Monthly QC L-J Diagram report can also be viewed and printed:
 Follow Steps 5 -6 in Section 6.1 to select control lot and month.
 Press [L-J VIEW] to view the monthly diagrams. The Monthly L-J
diagrams will differ from the normal L-J plots as the x-axis uses the
expected range for its out-of-bounds criteria and on the y-axis the points
can be visibly traced to which day of the month it was analyzed on.
 To print the diagrams on the displayed page, press [PRINT] or to print
all diagrams, scroll to the last display page without plots and press
[PRINT].
Parameters displayed The L-J plots are displayed for all parameters defined in the CON/CAL
on L-J Plots ASSAY VALUES page except the WBC differential parameter “MONO”.
Note If a control shows a system information indicator, the parameter values of

such a control will not be included in the L-J plots.
49
Section 7: Calibration
Section Overview
Introduction This section describes the step-by-step procedure for calibration of the Exigo
analyzer. Boule has calibrated the analyzer prior to shipment. Good laboratory
practice, however, requires regular checks and calibration of the directly
measured parameters.
Topic See Page

Preparations before calibration 50
Calibration 51
7.1 Preparations before calibration
Before  It is advisable that the performance of the Exigo system is checked daily with
Calibration a certified blood control authorized by Boule.
 Analyze control blood once in the open tube mode and compare results with
the assigned values prior to calibration.
 Before recalibration of the instrument check that calibrator and reagents are
not outdated and exclude instrument failure.
 Verify that instrument maintenance/cleaning is current. (See Sections 8.1 –
8.3)
 Prior to calibration print Calibration Log. Select [ADVANCED] from Main
Menu, then [CALIBRATION], then [CALIBRATION LOG], and then
[PRINT].
 The user should be thoroughly familiar with the analyzer system and the
calibration procedure before performing calibration.
 Please refer to the Calibrator Product Insert for complete instructions for
handling and use of blood calibration materials.
 Handle and prepare the calibrator in accordance to the control package insert.
Important  Never use an open vial longer than recommended by the product insert or
subject any vial to excessive heat or agitation.
 Wipe the sample probe with a clean, lint free absorbent cloth before each
calibrator run. Not following this technique will impact control accuracy.
Input calibrator Follow the instruction in Section 6.1 Quality Control to access the QC menu
definitions and to input Control/Calibrator Assay Values from the Assay sheet.
50
7.2 Calibration
Whole Blood The following instructions are used to calibrate the Open Tube mode. Follow
Calibration the instructions below to calibrate:
Step Action
1 Follow directions on Assay Sheet to scan in calibrator assay values.
2 Choose either List, Sample, or Main menu to begin calibrator analysis.
3 Using installed barcode reader, scan the Calibrator ID from the
calibrator vial label.
4 To perform calibration, it is recommended that five calibration
analyses be performed in consecutive order through the open tube
mode.
Important 5 When analyses are complete press [ADVANCED] from the MENU
tab.
Press [CALIBRATION] and then choose [WHOLE BLOOD].

Calibration analysis must be last analysis performed on analyzer for
parameter values to be shown in calibration menus. (e.g. no values
Note
will show if in the middle of calibration a patient sample analysis was
performed)
Scroll through parameter screens by using the [NEXT] button and
verify that the CVs for the following parameters are within the stated
limits:
Parameter OT CV% MPA CV%
RBC < 2.2 < 3.2
7
MCV < 1.8 < 1.8
PLT < 5.8 < 6.2
HGB < 1.8 < 2.9
WBC < 4.2 < 4.8
*CV limits are wider on the MPA calibration due to differences
in pipetting and blood collection techniques at the operator level.
51
7.2 Calibration (continued)
If CV values are not within range the operator will be unable to perform
calibration. (Analyses with system information indicators will
automatically inactivate that analysis from the CV calculation and
8 depending on flag may not be stored on list at all.) If a known sample
handling error or erroneous result is present, then that sample can be
inactivated by pressing the button to the left of that particular analysis,
resulting in empty brackets [ ].
If all parameters have acceptable CVs proceed to next step, if not rerun
9
calibration following steps above.
The new calibration factor can be entered in two ways.
 The recommended method is to select the [USE CAL] button which
will automatically calculate the new calibration factor using the target
range from CON/CAL assay value sheet.
10  The second method, if no calibrator is available, is to perform Steps 4-9
using a sample with target values from an assay value sheet or
determining target values using a reference analyzer or a microscope
method with an in-house sample. The target values can be entered
selecting the [SET TV] button and manually entering in the values.
In both methods the calibration factor is automatically calculated once
11
either the [USE CAL] button is pressed or target value is entered.
Once calibration factor has been entered using one of the methods above,
operator will be prompted to enter a 4-digit Operator ID (Operator ID is
12 recommended for in-house records of calibration operator but not required)
and Authorization Code (REQUIRED) before the new value can be
changed or updated.
Authorization Code prompt is displayed only once per calibration
Note sequence when [USE CAL], [TARGET VALUE], or [NEW CAL
FACTOR] buttons are pressed.
Authorized operator can update or change calibration factor by inputting
the Authorization Code [2576].
13
Figure 7.3
52
7.2 Calibration (continued)
Perform steps 10-11 for RBC, MCV, PLT, HGB, and WBC parameters.
14
To move to the next parameter press [NEXT].
It is recommended to not change preset calibration factors for RDW%,
15 RDWa and MPV. If necessary, please contact local distributor or Boule
service technician for procedure.
Once parameters are calibrated, press [EXIT] and a screen will be
displayed asking operator if a calibration report is wanted, [SEND],
[PRINT], or [EXIT] can be selected. It is recommended that calibration
reports be printed and archived in case it may be needed for future
reference.
16
Figure 7.4
It is recommended to run controls after calibration to verify that all
17 parameters have been calibrated correctly and that calibration is
synchronized with the control program. See section 6.1 to perform QC.
Capillary Device To calibrate MPA follow Steps 1-17 above except select
Calibration [CALIBRATION] and then choose [CAPILLARY DEVICE] instead of
Whole Blood calibration in Step 6 and use MPA mode for analysis.
(See Section 5.6 for details on capillary device sample analysis.)
53
Section 8: Cleaning, Maintenance & Transport
Section Overview
Introduction This section contains information that is crucial for maintaining, transporting
and storing the Exigo system.
Topic See Page

Daily Cleaning 54
Annual Cleaning 55
Analyzer Maintenance 55
Re-location of analyzer (within the laboratory) 56
Short Term Shutdown (<12h) 56
Re-packaging and Long Term Transport 57
Permanent Shut-Down and Storage 57
Disposal Information 58
8.1 Daily Cleaning
Description The majority of the analyzers cleaning procedures are automated to keep the
user maintenance to an absolute minimum.
External
Cleaning The Daily Cleaning takes only a few minutes, the instructions are as follows:
Procedure
Step Action
Clean the sample probe using a paper tissue moistened with a 70%
1
alcohol solution.
Remove possible traces of salt crystals or blood at the top of the
2 sample probe and probe rinse cup using a paper tissue moistened
with the alcohol solution.
Automatic The Exigo system has been designed to clean internal components on a daily
Cleaning Mode basis. The system uses the enzymatic cleaner to flush and clean all components
that come into contact with blood when in standby or power-off mode. The
analyzer remains filled with the cleaner until it is powered back on or taken out
of standby. This automatic daily cleaning increase the longevity of the analyzer
and decreases maintenance procedures.
54
8.2 Annual Cleaning
Description To increase the life of the analyzer’s internal tubing, the following cleaning
procedure is strongly recommended.
Cleaning  Press [ADVANCED] from Main menu, then press [MAINTENANCE], and then
Procedure press [CLEANING MENU] to enter the Cleaning Menu.
 Follow the instruction for the Boule Cleaning kit to clean the analyzer.
(Instructions for use are supplied with the Boule Cleaning kit solutions).
 The Annual Cleaning procedure takes approximately one hour and 15 minutes to
complete.
Figure 8.1 Figure 8.2 Figure 8.3
Boule Cleaning The Boule Cleaning Kit contains the following items:
Kit  Hypochlorite (2%)
 Enzymatic cleaner
 Detergent cleaner
LCD Display When necessary, gently clean the display with a soft cloth, slightly moistened
with water and a mild soap. Dry carefully.
8.3 Analyzer Maintenance
Description This section describes the maintenance that is required to maintain and increase
the life of the analyzer. Contact distributor for warranty requirements.
Maintenance The preventive maintenance should be performed annually by local distributor

or an authorized service technician.
55
8.4 Re-location of analyzer (within the laboratory)
Description This section describes the procedure performed to move the analyzer over very
short distances. (From table to table).
Before the re- If the analyzer is in “standby” mode do not unplug analyzer. Make sure that the
location analyzer is in Sample or List menu before turning off.
Step Action
Detach the reagent tray from analyzer but DO NOT detach the reagent tube assemblies or
1
the electronic sensors. Move these components together after analyzer has been re-located.
2 Remove the waste line from waste container or drain, but do not detach tube from analyzer.
3 Disconnect all electrical connections.
Re-location Make sure that the analyzer is lifted from beneath to avoid unnecessary stress on
the front cover.
After re-location
Step Action
1 Place the waste line in waste container or drain.
2 Re-attach the reagent bottle tray.
3 Reconnect the electrical connections.
4 Power on unit.
5 Perform Prime.
6 Verify Background.
It is recommended that the performance of the Exigo system is checked with certified blood
7
controls authorized by Boule.
8.5 Short Term Shutdown (< 12h)
Description This section describes the procedure performed before transporting the analyzer
over short distances outside the usual facility. This procedure only describes the
preparations performed before transporting the analyzer for less than 12 hours.
Step Action
Begin by emptying the system. Remove the reagent tube assemblies from the reagent
1 bottles. (System will not perform empty cycle if reagent tube assemblies are not removed
from the bottles.)
2 Remove reagent bottles from reagent bottle tray.
3 Press [ADVANCED] button on MENU tab.
4 Press [MAINTENANCE] and then [EMPTY SYSTEM].
When empty procedure is complete, the following statement will appear on screen: ‘System
5
is empty and ready for fill or power off.’
6 Switch off power and then unplug analyzer.
Before the re- After analyzer is powered off, detach reagent tube assemblies, waste line, reagent
location bottle tray, electronic sensors and all electrical connections. Package all
components carefully for transport.
56
8.5 Short Term Shutdown (<12h) (continued)
Guidelines for  The analyzer should be transported in temperature conditions between 5 to 32 ºC

transport (41 to 90 ºF)
 Humidity should be less than 80%.
8.6 Re-packaging and Long Term Transport (>12h)
Description This section describes the procedure when transporting or shutting down the
analyzer for a longer period of time (>12 hours).
 It is very important to follow the below instructions for preparing the

analyzer for long term transport or re-packaging, to avoid erroneous results
upon re-installation.
Important  The main difference between Section 8.5 and 8.6 is the importance of
cleaning the instrument with the Boule cleaning kit and distilled water, prior
to re-packaging to avoid contaminates.
Long term Shut-Down
Step Action
Select [CLEANING MENU] from MAINTENANCE Menu, and then select
1
[CLEAN CYCLE EMPTY].
Follow the instructions for the Boule cleaning kit. (Instruction is supplied with the
2
Boule cleaning kit solutions).
After completing the cleaning of the analyzer, insert the reagent tube assemblies into
3
distilled water. Select [CLEAN CYCLE FILL] from CLEANING Menu.
When the analyzer has been filled with distilled water, select [PROBE FLUSH]
4
from MAINTENANCE Menu. Repeat.
After the two Probe Flushes are complete, remove reagent tube assemblies and
5
select [CLEAN CYCLE EMPTY] from CLEANING Menu.
When system is emptied, disconnect the main supply cable and all other connections
6
such as reagent tube assemblies, reagent bottle tray, and waste line.
7 If transporting instrument, pack securely using the original shipping container.
8 Mark the container with DELICATE ANALYZER, FRAGILE and THIS SIDE UP.
9 Follow Guidelines for transport below.
Guidelines for The analyzer in its export package should fulfill the following transport/storage
transport conditions:
 Does not exceed - 40°C for ≥ 24 hours.
 Does not exceed a Dry heat of + 70°C for ≥ 24 hours.
 Dramatic change of temperature between - 40°C and + 30°C.
 Does not exceed a Damp heat steady state of 90% RH and + 40°C during
48 hours.
 Does not exceed a Damp heat cyclic of 90-100% RH and + 25°/+40°C
12+12 hours.
57
8.7 Permanent Shut-Down and Storage
Permanent Shut- Prepare the analyzer using the same procedures as Section 8.6, Long Term
Down and Storing Transport.
8.8 Disposal Information
Description Customers are advised to be knowledgeable of applicable local, state and

federal requirements, and the content of effluent streams, before disposing of
waste in public sewer systems or recycling decontaminated equipment.
Disposal  Used reagents

Materials  Reagents mixed with potentially biohazardous material
 Instrument and instrument components
 Controls and calibration material
Manufacturer  Place the instrument close to a waste container or drain suitable for disposal
Guidelines for of used reagents.
waste products  Check that the drainage is suitable for disposal of chemical and biological
waste.
 Check that the waste line is securely fastened in the drain.
Always use protective gloves when working with the waste container, waste
line and when in contact with potentially biohazardous materials.
Mandatory Action
Instrument decontamination and disposal
The European Directive 2012/19/EU on Waste Electric and Electronic

Equipment (WEEE) aims to minimize the impact on the environment by
prevention of waste. The Exigo veterinary hematology analyzer has been
labeled with the WEEE symbol (as given in the margin) and there is a
procedure to allow waste collection and recycling of the equipment at the end
of it's life cycle.
 The instructions for decontamination can be found on the Exigo home page
www.exigo-vet.com under User Support.
 If there are any question on how to follow this procedure, contact your local
Important distributor for more information.
The analyzer should be considered as infected and the end user must follow a
decontamination procedure before it is safe to hand over to a recycler.
Warning
58
Section 9: Parameter & System Information
Messages
Section Overview
Introduction As samples are analyzed, the system software may produce three types of
intelligent information. The information is designed to guide and aid the user
in the practice of complete hematology. The three categories of information
are:
 Low & High Abnormal Results - message of abnormal patient results or
out-of range control results with an L or H notation.
 Sample Pathology – messages for additional diagnostic or hematologic
procedures involving the sample.
 System Information – messages for checking some aspect of the analyzer
system.
Note As granulocytes include neutrophils and eosinophils all parameter and system
information messages use the common word granulocyte (GRAN).
Topic See Page

Low & High Abnormal Results Information 59
Sample Pathology 60
System Information 68
Description of Information is indicated on the touch screen with the results and is printed on
Information the patient report. For Sample Pathology and System Information messages,
Indicators the touch screen’s i-button becomes active when a message is present. The
information is automatically included in the printed report. The user has the
preference to access this information detail by either touching the i-button on
the touch screen or reviewing the printed hemogram report. Further detail and
background information may also be obtained by referring to this section of
the user manual. The three categories of intelligent information are outlined
in detail below.
9.1 Low & High Abnormal Results Information
Description Reference ranges may be stored in the system software for each species
configuration. When a patient sample in analyzed, the system software will
compare each parameter value to its corresponding reference range stored in
the system software. Any value that is outside the reference range will result
in display of an L for Low or H for High next to the value. This information
is included on the printed patient report. The printed report also shows the
reference range for all values.
59
9.1 Low & High Abnormal Results Information (continued)
Estimation of Reference ranges are inherently probabilistic estimates of normalcy in a given

Normalcy patient. The reference range is calculated as the median 95% of values from a
population of apparently healthy animals. Therefore normally 5% of healthy animals
may have values slightly H, with 2.5% being distributed at each limit. Laboratory
value normalcy for an individual is best determined by samples analyzed at the time
of a routine adult health examination. Samples slightly out of range should prompt
consideration of pathology while also considering that the value may be normal for
that animal. Conclusive, meaningful pathology is not certain until values are
considerably outside the normal range.
Unusual Species Reference ranges are not required for proper sample analysis by the system software.
Reference Ranges Therefore an unusual species not configured in the system may be analyzed using a
species configuration with a similar MCV range. An example is that a new world
monkey could be analyzed as a dog. The values generated by the system are reliable,
but the results flagging against the dog reference ranges should be ignored.
Differentials for unusual species should be verified by microscopy.
Specific Assay The L and H messages are also applied to results of control samples compared with
Value Ranges lot specific assay value ranges. The barcode reader enters assay value ranges into the
system memory for each lot of control material. The barcode reader is used to
identify the control lot by scanning the tube each time a control is analyzed. The
assay value ranges are designed to demonstrate that the system is both calibrated to a
reference standard and operating to specification. Control sample results are
expected to be within these ranges 99% of the time. A sporadic value slightly
outside the limits may occur normally. Troubleshooting action should be taken when
control values are either consistently out of range or when values are markedly out of
range.
9.2 Sample Pathology
Description The sample analysis software is capable of displaying intelligent information

messages related to pathology that may be present in the sample.
Triggering The Sample Pathology information includes a short message defining the sample
mechanisms abnormality followed by recommendation(s) for that sample. The information may
be triggered by the following mechanisms:
 Histogram shape abnormalities detected by system software calculations.
 Selected values that exceed defined limits outside the reference range. These
messages occur when selected values are moderately to markedly abnormal.
Values slightly outside the reference range are typically treated as cautionary by
the clinician, as described above.
60
9.2 Sample Pathology (continued)
Evaluating This information brings attention to results that are likely to have additional pathology
Sample or clarifying findings that may be detected in either a blood film review or other
Pathology procedures involving the sample. These are standard techniques used by laboratories in
conjunction with all hematology analyzers. Recommendations for evaluating the
sample for additional pathology may be accessed in the form of messages. The
message(s) may be accessed either by touching the i-button on the touch screen or
reviewing the printed report. These recommendations are patterned after procedures
used in conjunction with analyzers by reference laboratories. The techniques and
procedures are regarded as integral to the practice of complete hematology by any
competent laboratory. Users are referred to standard textbooks of veterinary
hematology for more in-depth information on hematologic procedures and pathology.
Sample Pathology Information Messages
Total WBC
Criteria Information Message Recommended Action
< 3000 WBC: Leukopenia; slide The total WBC and differential are reliable. Pathology of WBC
review advised often associated with leukopenia may be detected on a slide review.
Review the blood film for the presence of neutrophil toxic change
and/or left shift. This is useful to differentiate severe inflammatory
consumption from bone marrow injury.
> 15% above WBC: Leukocytosis; slide The total WBC and differential are reliable unless there is pathology
upper limit review advised that may be detected as a distribution abnormality by histogram
analysis. The slide should be examined with low power to confirm
that the differential appears reasonable and that there are no
surprises in the form of abnormal WBC types. See WBC
Differential distribution abnormalities for additional detail.
WBC Differential
WBC Histogram WBC DIFF: Lymphocyte  Scan the blood film with low magnification to verify that the
Mode < 90 fl with predominance; slide majority cell is lymphoid.
single population review advised  Use high magnification to determine if there is abnormal
present lymphocyte morphology when lymphocytosis is present.
 Use high magnification to determine the presence of left shift
and toxic change if the pattern is due to neutropenia.
WBC Histogram WBC DIFF: Abnormal  Scan the blood film with low magnification to get a sense of the
Mode < 190 fl WBC distribution; slide predominant cell population. Possibilities for this pattern
with single review advised. include the following:
population present o Unusually high percentage of monocytes; this may occur
with a relatively low total WBC concentration in which
monocytes are predominant
o Occasionally the granulocyte population may collapse into
this middle region. This occurs in occasional dogs for an
unknown reason.
o Predominance blast cells that may occupy this middle
region
o an unusually high percentage of metarubricytes and
rubricytes; typically >50% NRBC. This is rare.
o Inappropriate sample handling. Granulocyte collapse may
occur if the sample has aged and is analyzed greater than
12 hours post collection.
 Using criteria established for your laboratory, use high
magnification to perform a microscopy differential to clarify
the distribution of leukocytes present.
61
WBC Differential
Grans ≥ 90% WBC DIFF: Granulocyte  Scan the blood film with low magnification to verify that there are
and WBC predominance; slide review no surprises such as:
Histogram advised o Blast cells that may mimic granulocytes
Mode > 190 fl o An unusual percentage of eosinophils
o Other abnormal cells in low numbers such as NRBC
 Examine the granulocytes at higher magnification to determine if
there is additional pathology. This includes left shift cells (bands
and metamyelocytes) and neutrophil toxic change.
 Using criteria established for your laboratory, perform a
microscopy differential if any of the above abnormalities are
present. This is typically done in laboratories when any of the
above abnormalities are prominent on scanning.
EOS% > 10% EOS%: Evaluate histogram See description of EOS% in this section.
above upper & WBC morphology on slide
limit
RDWa
> 10% above RDW: Evaluate histogram & See description of RDW in this section.
upper limit RBC morphology on slide
MCV
> 10% below MCV: Evaluate histogram & As described for RDWa, a low MCV will be associated with an RBC
lower limit RBC morphology on slide histogram that has widened to the left. Evaluate the blood film for
RBC features of iron deficiency.
> 10% above MCV: Evaluate histogram & As described for RDWa, a high MCV will be associated with an RBC
upper limit RBC morphology on slide histogram that has widened to the right. Evaluate the blood film for
RBC features of regeneration or dysplastic production (cats) and
other morphologic features that may be related to a specific cause of
anemia.
HCT
> 10% below HCT: Anemia; evaluate RBC See description of HCT in this section.
lower limit on slide
> 10 % above HCT: Evaluate patient for  Evaluate physical hydration status and serum or plasma protein
upper limit causes of polycythemia concentration and other laboratory values for signs of
hemoconcentration.
 If hemoconcentration is ruled out, check for signs of a
cardiopulmonary blood oxygenation problem or primary
polycythemia.
MCHC
> 10% below MCHC: In the following  Examine the data and blood film for any features above that may
lower limit order: explain a mildly decreased MCHC value.
 Evaluate for extreme RBC  If erythrocyte abnormalities on the blood film are ruled out,
regeneration analyze the sample a second time.
 Run Control  If the results are consistent on re-analysis, check the system with
a blood control sample. If the control exhibits the same result,
contact Technical Support.
62
MCHC
> 10% above MCHC: In the following  This value is not physiologic. It is usually due to interference with
upper limit order: the hemoglobin measurement because of sample turbidity or sample
 Evaluate for turbidity, hemolysis. Check the sample for the known sample-related causes
lipemia, and extreme of a disproportionately high hemoglobin or false low HCT.
hemolysis Potential causes of sample-related high hemoglobin relative to HCT
 Heinz bodies – cat include:
 Evaluate for o Lipemia – the most common cause
agglutination /spin crit o Marked sample hemolysis
 Run Control o Marked agglutination in immune-mediated hemolytic anemia.
In this instance the hemoglobin measurement is accurate, but
the HCT is false low because large aggregates of RBC are not
included in the derivation of HCT. Agglutination may be seen
on the slide or in a saline wet mount of a small amount of
blood.
o Marked Heinz body formation in cats – this may be seen on the
slide
 If sample-related causes are ruled out, re-analyze the sample. If the
results of re-analysis are consistent, check the system with a blood
control. If the control exhibits the same problem, contact Technical
Support.
PLT
> 25% below PLT: Evaluate platelets on  The stained blood film should be examined to verify the decreased
lower limit slide platelets.
o Platelet clumping is the most common cause of a decreased
platelet concentration measurement, especially in cats. This
examination should start with low power examination of the
feathered edge for platelet clumping. Large platelet clumps will
be observed on the feathered edge, while numerous small
platelet clumps may be evenly distributed on the slide. If
prominent platelet clumping is present, it may be assumed that
the platelets are likely adequate. If there is further concern, the
sample should be recollected with a clean venipuncture and
analyzed again.
o If clumping is ruled out, the platelet density should be examined
by high magnification in the monolayer or counting area of the
slide. Using criteria established for your microscope, verify that
the decreased measurement corresponds to a decrease in platelet
density in the counting area. Prominently decreased platelets to
a degree associated with bleeding is associated with nearly a
complete absence of platelets on the slide.
> 50% above PLT: Evaluate histogram  High platelet concentration is not very important for clinical
upper limit for extreme RBC interpretation or diagnostic purposes. Thrombocytosis has been
microcytosis associated with iron deficiency anemia, but may also occur
uncommonly in association with a variety of inflammatory states.
This is presumably resulting in cytokine responses that enhance
platelet production. The following two steps are used to confirm the
marked thrombocytosis.
o Evaluate PLT / RBC histogram to make sure that extreme RBC
microcytosis has not contributed to the PLT measurement by
exceeding the floating threshold limits.
o Scan a blood film to confirm that platelets are prominently
increased in the counting area or monolayer.
63
WBC Differential Background on WBC histograms: The analyzer system will provide information on
Distribution pathologic distribution of the differential data. This is based on analysis of the WBC
Abnormalities histogram shape and associated channel data. In most WBC distributions, the
floating threshold software acts on the presence of two modes separated by a valley,
as shown in the following WBC histogram.
Floating thresholds in valley region
Gran Mode
Lymph
Mode
Figure 9.1
Common pathologic leukocyte responses may often result in the presence of a
predominant single leukocyte population. When the predominant population is
greater than 85-90% of the cells, the histogram may have only one mode and
inherently no valley. When this occurs, the system software will utilize fixed
thresholds placed on the histogram in average position for that species. The most
common cause of a single mode is granulocyte predominance. This occurs in steroid
responses, marked inflammatory responses, and the combination of these responses.
Examples of granulocyte predominance with fixed thresholds are shown in the
following WBC histograms.

 The histogram and data in Figure 9.2 are representative of a typical steroid
response.
 The histogram and data in Figure 9.3 are representative of a chronic
inflammatory response. In both cases the granulocytes make up greater than
90% of the WBC population.
WBC analyses with single modes and fixed thresholds are placed into one of three
categories. When this occurs, the i-button becomes active. Additional information
may be obtained by either touching the i-button on the touch screen or reviewing the
printed hemogram report. Three categories of abnormal unimodal histogram are
outlined below.
64
WBC Mode < 90 fl This pattern is usually due to either lymphocytosis or neutropenia. If it is due to
(Lymphocyte neutropenia, the total WBC will be decreased. If there is lymphocytosis, the
Predominance) total WBC will be increased. Lymphocytosis should be characterized by
examination of the lymphocyte morphology on the stained blood film. Rarely,
metarubricytosis may mimic lymphocytosis. An example of this type of
histogram from a case of lymphocytic leukemia is shown below in Figure 9.4.
WBC Mode < 190 fl This is a relatively uncommon pathologic leukocyte response. Several highly
(Abnormal WBC abnormal WBC responses may cause this pattern. The pathology is best
Distribution) characterized by review of the blood film. An example of this type of
histogram is shown above in Figure 9.5 and possible causes are detailed under
recommended actions.
WBC Mode > 190 fl Examples are shown above in Figures 9.2 and 9.3 in WBC Differential
(Granulocyte Predominance) Distribution Abnormalities. This is due to the most common pathologic
leukocyte responses, steroid and/or inflammatory. When the granulocyte
population has a mode of >190 fl, the differential analysis is highly reliable.
Normal lymphocytes will not move into the granulocyte region. On rare
occasions, blast cells in a leukemia may occur in the granulocyte region
because they are highly unpredictable in all analytical systems.
Background on During the cell analysis interval, a very large number of erythrocytes are
Erythrocyte Sizing evaluated by individual cell analysis to determine the volume of each cell.
Each cell volume value is assigned to a narrow, discrete volume bin on the x
axis of a volume scale. The high number of cells analyzed results in
construction of a highly reproducible erythrocyte volume distribution
histogram. The shape and width of the histogram is very constant in the normal
animal and these features are uniformly characteristic for each species. A
typical histogram is shown in Figure 9.6.
65
Erythrocyte Sizing The mean cell volume, MCV, is calculated from the total number of erythrocyte
Calculations volumes measured. The RDW value is a measure of erythrocyte volume dispersion
or heterogeneity. After application of a technique to exclude the histogram tails,
the RDW value is calculated by two methods. The RDWa is the standard deviation
(SD) of erythrocyte volumes included in the calculation. The conventional RDW is
more complex. It is calculated as a coefficient of variation (CV) by dividing the SD
by the mean or MCV. For veterinary applications, the RDWa value is
recommended.
RDW
RDWa = SD o
Relative SD
Number RDW = CV X 100
MCV
MCV
Cell Volume (fl)
Figure 9.6
An increased RDWa value indicates that there is a disturbance in the volume
homogeneity of the erythrocyte population. Almost all disturbances are due to
altered production by the marrow and other tissues with hemopoietic potential.
These disturbances are associated with production of cells having abnormal volume
and result in increased volume heterogeneity.
RDWa > 10% Recommended actions for additional evaluation:
Above Upper Limit  First, examine the RBC histogram in conjunction with the MCV value to
determine if the size disturbance is moving in either the microcytic or
macrocytic direction.
 Examine the blood film for RBC morphologic defects associated with either
microcytosis or macrocytosis. Some common pathology patterns are:
o Increased RDWa as a result of production of microcytes is seen as widening
of the RBC histogram on the left side. With time there is progressive
reduction in MCV. Iron deficiency, indicating chronic external blood loss,
is the cause. An example of a histogram with an increased RDWa and
decreased MCV from a cat with iron deficiency is shown below. The dashed
curve indicates a normal histogram, while the solid curve indicates the
patient histogram.
33 45
Relative
Number
RDW
24 300
Cell Volume (fl)
Figure 9.7
66
o Increased RDWa as a result of macrocyte production is seen as a widening of the

RBC histogram on the right side. This is typical of regenerative anemia. This may
also occur in myelodysplastic disease, especially in cats, in which there is a chronic
poorly regenerative anemia. An example of an increased RDW due to macrocytic
cell production in a dog with regenerative anemia is shown below. The response
has resulted in a mildly increased MCV. The dashed curve indicates a normal
histogram, while the solid curve indicates the patient histogram.
74
Relative
Number
24 300
Cell Volume (fl)
Figure 9.8
Note There is no pathologic response that results in a decreased RDWa value.
Decrease in Recommended actions for additional evaluation:

HCT  Determine if the anemia is non-regenerative or regenerative by evaluating the
following. Examine the RBC size information. This includes the RDW, RBC
histogram, and MCV.
o When a regenerative response occurs due to acute blood loss or hemolysis,
there is accumulation of macrocytic erythrocytes in blood. This will result in
progressive changes in the form of increased RDW and widening of the RBC
histogram on the right side. After a number of days of prominent regeneration,
the MCV may become increased above the upper limit of the reference range.
o With non-regenerative anemia the RDW, MCV, and RBC histogram remain
normal.
o Iron deficiency is associated with the production of microcytic erythrocytes.
This is seen as widening of the RBC histogram to on the left side, increased
RDW, and low normal or decreased MCV. In very chronic situations,
homogeneously microcytic cells replace the whole RBC normocyte population.
This results in a markedly low MCV and RBC histogram that is moved to the
left.
 Examine the RBC’s in the blood film monolayer to determine either absence or
evidence of erythrocyte regeneration. This is indicated by increased
polychromatophilic erythrocytes on the Wright’s stained slide. The most reliable
method for quantitation of the regenerative response is to evaluate a stained slide
for reticulocytes using new methylene blue or brilliant cresyl blue. The presence of
regeneration indicates that the anemia is due to either hemorrhage or hemolysis.
The absence of regeneration present of for several days or longer indicates the
anemia is due to one of several causes of bone marrow suppression of erythrocyte
production.
67
 Examine the blood film for RBC morphologic defects that provide additional
clues to the cause of the anemia.
o For hemolytic disease this includes specific RBC changes such as spherocytes
and hemotropic parasites. In most cases hemolytic disease will have a normal
to high normal total protein concentration whereas with hemorrhage the total
protein is expected to be low normal or decreased.
o For chronic external blood loss leading to iron deficiency changes may
include hypochromic erythrocytes (increased zone of central pallor),
keratocyte injury, and fragments.
o Non-regenerative anemia is typically associated with normal RBC
morphology.
o If there is prominent agglutination present, as in many cases of
immunohemolytic anemia, the hematocrit should be verified by
microhematocrit centrifugation. A false low HCT in this situation is
also suggested by an abnormally high MCHC value (see below).
Background on Background on MCHC. The MCHC value has little clinical utility. Its value is
MCHC regarded as a form of intra-sample quality control because of the constant relationship
between HCT and HGB and their independent measurement in the system. The
MCHC value is calculated from the HCT and the hemoglobin concentration. HCT is
derived from RBC concentration measurement and individual RBC sizing in one
dilution and operational subsystem. The hemoglobin concentration is measured in a
completely separate dilution and subsystem in which the RBC’s are lysed liberating
hemoglobin into the dilution. See Figure 9.9.
RBC / PLT Dilution WBC / HGB Dilution
Subsystem Subsystem
Measure RBC and MCV through Lyse RBC, liberating free HGB
aperature (arrow)
Measure HGB by photometry
then,
HCT = RBC x MCV Also count WBC
HGB
MCHC (g/dl) = x 100
HCT
MCHC physiologic reference range for most species = 32 - 38 g/dl
Figure 9.9
68
MCHC as a Within animal blood, the MCHC value is a physiologic constant that may be used to
Physiologic monitor the relationship between hemoglobin concentration and HCT. Therefore, for
Constant each sample, the HGB value corroborates the HCT value and vice versa. An MCHC
value that exceeds certain limits of either low or high indicate either a sample problem or
an analysis problem in one of the measurement subsystems. This is a great tool for
monitoring individual samples for such problems. If there is malfunction in one of the
subsystems, then all values in that subsystem are suspect. For example, if there has been
a dilution error in the hemoglobin subsystem, the total WBC value will be subject to the
same dilution error.
Decrease in Values < 30 g/dl are not physiologic and values < 25 g/dl are nonsensical. Some possible
MCHC causes of minor decrease in MCHC are the following. Following are some scenarios and
guidelines for reviewing samples with non-physiologic MCHC values.
 Historically, iron deficiency was associated with MCHC values in the range of 26-32
g/dl range. However, this is exceedingly rare in results from automated hematology
systems. In addition, iron deficiency should be accompanied by microcytosis (low
MCV) and morphologic changes of hypochromia and fragmentation on the blood
film.
 Extreme regeneration (typically reticulocytes >25%) may be associated with mildly
decreased MCHC (29-32 g/dl). This occurs because the immature erythrocytes are
still synthesizing hemoglobin. Erythrocytes produced under conditions of maximal
regeneration are macrocytic and may eventually result in an increased MCV.
 Hereditary stomatocytosis is a rare erythrocyte defect in selected breeds. This defect
may be associated with very high MCV values (mid 90’s) and MCHC values in the
mid 20’s as a result of pathologic cell swelling as the cell matures in the circulation.
This situation is identified by stomatocytes on the blood film.
 Analysis of blood >24 hours post collection may also slightly reduce the MCHC
because of artifactual RBC swelling reflected in measurement of MCV and
calculation of HCT. Values for MCHC in this situation are typically in the low 30’s.
 A decreased MCHC in the absence of any of the above findings or an MCHC value
outside this limit indicates there is a mismatch in measurements on the system from
this specific cycle. That is, something has happened to one of the subsystem dilutions
or subsequent measurements.
Increase in
See Sample Pathology Information Messages table.
MCHC
Note Sample pathology information messages may be blocked by a serious system information
indicator, even if the parameter values may seem ok. It is recommended to always re-
analyze the sample if the instrument reports any system information indicator.
9.3 System Information
Description The system software monitors a number of analytical and system functions and will
display information that indicates the possible attention of the operator. This information
will alert the operator to check the system or institute selected troubleshooting
procedures. This information is presented on the touch screen as a code next to one or
more parameters. Additional detail and recommendations may be accessed by either
pressing the i-button on the touch screen or reviewing the printed report.
69
9.3 System Information (continued)
Note #### indicates an out of measurement range parameter, the count is too high or too low to
measure. If it is expected that the parameter is too high, the sample can be diluted and rerun,
and then the dilution factor can be multiplied with the result to calculate the correct value.
System Information Indicators
Aspiration Indicators (Sample Probe)

Indicator Message Description Action
Possible reasons for AF flag include a short
sample, clogging or air bubbles in sample tube.
Aspiration failed, check Check profile type is correct
AF Note: This flag is also displayed when running
sample and then re-analyze sample.
a background count (blank) without selecting
the background analysis profile.
HGB Indicators (HGB)
The instrument detected a problem during the
HGB Measuring Problem
HF filling of liquid in WBC counting chamber
– run prime cycle
during HGB blank.
Run a “Prime cycle”, before
HGB Measuring Problem The HGB blank or sample readings reported a
HH re-analyzing the sample.
– run prime cycle too high light level.
HGB Measuring Problem The HGB blank or sample readings reported a
HL
– run prime cycle light level that was too low.
HGB Measuring Problem The HGB sample reading reported more light
Wait one minute, and then re-
HN – wait one minute then than the blank reading. This gives a negative
analyze sample.
re-analyze HGB value.
Switch off the analyzer and
HGB Measuring Problem The HGB dark (offset) reading reported a light switch it back on after 3
HO
– restart system level that was too high or too low. seconds, and then re-analyze
sample.
HGB Measuring Problem Run a “Prime cycle”, before
HS Individual HGB readings vary too much.
– run prime cycle re-analyzing the sample.
Ensure instrument is in
Temperature reading If HT-flag; the instrument temperature reading
ambient temperature of about
HT error” (HGB) is outside the limits (10-50 ºC) or the
18-32ºC. If still HT flag,
temperature sensor is nonfunctional.
contact a service engineer
Note: If various HF, HH, HL or HN Indicators repeatedly appear check High Altitude Compensation, mode may need to be changed to
Moderate or Maximum compensation in higher elevations. A more detailed description can also be found in the User Definable Settings
document, which can be located at www.exigo-vet.com > Support > Downloads > Public > Documents.
Measuring Chamber Indicators (RBC, PLT, WBC)
The cell pulses arrived faster than the analyzer
could process them. Possible reasons might be
air bubbles, electrical disturbances or
Measurement warning – incomplete lysing.
OR Re-analyze sample
re-analyze Note: Filtered away cell pulses might raise the
OR flag, so it might not be possible to see them
in the histograms or the result parameters. This
is a hard limit determined by the software.
The rate of cell pulses per time unit varies too
much. Possible reasons might be clogging, air
bubbles, electrical disturbances or difficult to
Measurement Statistics
SE lyse cells. Re-analyze sample
Warning; re-analyze
Note: Filtered away cells might raise the SE
flag, so it might not be possible to see them in
the histograms or the result parameters.
Slide review advised. If
control blood is analyzed,
LW Measurement Warning The sample may contain lyse resistant WBC.
make sure control profile is
used.
70
9.3 System Information (continued)
Mixing Beaker Indicators (RBC, PLT, WBC)

The analyzer detected an abnormality during
Run a “Prime cycle”,
Liquid System Problem – the emptying of the first dilution from the
TE before re-analyzing the
run prime cycle mixing beaker. Reasons for flagging might be
sample.
timeout, or too short of a transfer time.
Reagent and Control Indicators (RBC, PLT, WBC, LYM/MONO/GRAN)
EC Expired control A control blood was used past its expiry date. Use a fresh blood control
The reagent was used past its expiry date.
ER Expired Reagent Use a new lot of reagents
Change to a non-expired lot of reagent.
The analyzer’s capacity counter has gone
below zero and no reagent is detected. Reason
Not enough reagent left,
NR for no reagent may include empty reagent Check reagent levels
check reagent levels
bottle or reagent tube assembly not inserted
correctly into reagent bottle.
Reagent Pipette Indicators (RBC, PLT, WBC)
Diluent system problem one of the fill cycles of the diluent pipette.
DF
– run prime cycle Reasons for flagging might be timeout, short
time or bubbles at the upper detector.
one of the empty cycles of the diluent pipette.
Diluent system problem
DP Reasons for flagging might be timeout, short
– run prime cycle
time or liquid not detected at the lower Verify analyzer is filled,
detector. run a “Prime cycle” and
The analyzer detected an abnormality during then re-analyze sample.
Lyse system problem – the fill cycle of the lyse pipette. Reasons for
LF
run prime cycle flagging might be timeout, short time or
bubbles at the upper detector.
Lyse system problem – the empty cycle of the lyse pipette. Reasons
LP
run prime cycle for flagging might be timeout, short time or
liquid not detected at the lower detector.
The time for the liquid meniscus to pass from
Air bubbles – run prime
ST the lower to the upper detector is
cycle
unreasonably short.
Air bubbles – run prime Air bubbles were detected by the start detector
TB Run a “Prime cycle”,
cycle in the diluent column.
before re-analyzing the
Possible orifice
The liquid meniscus in the measuring tube sample.
TL blockage: Run prime
never passed the lower detector.
cycle and then re-analyze
Possible orifice The liquid meniscus in the measuring tube
TU blockage: Run prime passed the lower detector but never passed the
cycle and then re-analyze upper one.
EOS reagent pipette Fill the fill cycle of the EOS reagent pipette.
EF
error (EOSa) Reasons for flagging might be timeout, short
time or bubbles at the upper detector. Verify analyzer is filled,
The analyzer detected an abnormality during run a “Prime cycle” and
the empty cycle of the EOS reagent pipette. then re-analyze sample.
EOS reagent Pipette
Reasons for flagging might be timeout, short
EP emptying error (EOSa)
time or liquid not detected at the lower
detector.
71
Section 10: Technology
Section Overview
Introduction This section describes the different methods and principles of measurement and
calculations.
Topic See Page

Measuring Principles 72
Counting Time RBC & WBC 73
WBC Differentials 74
Photometric Method – HGB Hemoglobin 74
Measurement of Eosinophils 75
Parameter definitions 76
10.1 Measuring Principles
Description This section describes the measuring principles of the Exigo system.
General
The measuring principles of the Exigo analyzer are based on impedance and
Measuring
Principles
spectrophotometer principles.
Whole Blood The RBC and WBC concentration values are determined by counting cells in
Dilution whole blood dilutions of 1:40,000 for the RBC and 1:400 for the WBC.
Theoretical If a sample contains 5 million red blood cells per µl, a dilution of 1:40 000 will
Principles give a final concentration of 5 million divided by 40,000 = 125 cells per µl.
(RBC Example) Each µl containing 125 cells, drawn through the aperture, will generate 125
pulses.
72
10.1 Measuring Principles (continued)
Measured The measured volume drawn through the aperture is 270 µl (Manufacturer
Volumes calibrated). Based on the assumption made above, the system will count
(Example) 270*125 = 33,750 pulses, which is equivalent to 5.0x106 cells/µl in the
concentrated blood.
Stop sensor
Flow
Measured
Volume =
270 µl
Start sensor
Figure 10.1
Theoretical The calculation principle for white blood cells is the same but with a difference
Principles in dilution ratio and cell quantity. An example of this could be as follows:
(WBC Example) 5,000 cells/ µl diluted 1:400 =12.5.
10.2 Counting Time RBC & WBC
Description The counting time is defined as being the time needed for the sample to fill the
metering unit from the start to the stop detector.
Counting Time The normal counting time limits for the RBC and WBC metering units are
Limits between 21 – 30 seconds* and 10 – 13 seconds respectively. If the counting
time is below or exceeds the above mentioned limits, the flag ST,TL and TU
will be displayed.
* refers to 60 µm orifice instruments, 80 µm orifice instruments have a normal

counting time of 13 – 18 seconds.
Note The ´counting time´ is not related to the actual result. Atmospheric pressure
variations, protein built up within the orifice (aperture) and other secondary
effects that might cause pressure changes will NOT affect the counted
parameters RBC, PLT and WBC.
73
10.3 WBC Differentials
Description The Exigo system uses a floating discriminator technology which performs a
mathematical calculation to estimate the best separation between 3 populations
of white blood cells (lymphocytes, granulocytes and mono-cell fractions).
Floating After the analyzing process, the analyzer finds two main modes (Granulocyte
Discriminator Peak and Lymphocyte Peak) within the total distribution. By extrapolating the
technology in two main population peaks value a third population can be mathematically
general calculated. This third population is classified as the mono-cell area, which
mainly consists of monocytes. See Figure 10.2 below:
n
MONO
LYM GRAN
Volume (fl)
Figure 10.2
10.4 Photometric Method – HGB Hemoglobin
HGB The hemoglobin is determined from the same dilution as the WBC. For each sample a
(Hemoglobin blank is measured as a reference, this means that any drift in reagent-, cuvette-
Concentration) absorption, or diode is eliminated. The photometer system consists of a photodiode, a
cuvette with a length of 15 mm and a filter at a wavelength of 535 nm (bandwidth 20
nm). The HGB readings are slightly corrected for turbidity in case of extreme WBC
counts. The diode is switched off if the instrument is in standby mode, giving it an
extended lifetime.
Figure 10.4
74
10.5 Measurement of Eosinophils
Description Each analyze profile can be settable to measure the Eosinophil (EOS) in two
different methods adapted to specific species, either as a conventional 3 part
WBC differential or as a 4 part WBC differential impedance based analyzer.
EOS Method #1: 4 part  The method is included the conventional 3 part differential analysis
WBC differential together with an added EOS measurement with a total analyzing
impedance based analyzer time of about 3 minutes.
 After the 3 part differential analysis the instrument continues with
an additional WBC dilution but instead of lyse, EOS reagent is
used to achieve the final 1:400 dilution.
 After an incubation time (20 seconds) all cells are lysed except the
eosinophils.
 The EOS population is displayed as a separate size-distribution
curve,
see fig 10.3.
 A settable discriminator is used to separate the EOS population
from debris and to count the total number and percentage in
relation to the total WBC count.
Figure 10.3
EOS Method #2: 3 part  This method is only based on the conventional 3 part differential
WBC differential and will not use any EOS reagents and has an analyzing time of 1
impedance based analyzer minute.
 A settable discriminator is used to separate the EOS population
from the conventional 3 part differential size distribution and count
the total number and percentage in relation to the total WBC count.
 Fig 10.4 below displays this method which is currently
recommended when running cat species where the neutrophils are
difficult to lyse and separate from the eosinophils.
Figure 10.4
75
10.6 Parameter Definitions
Description This section describes the parameter definitions that have not been defined yet in
other sections.
MCV ( Mean  The MCV parameter is derived from the RBC distribution curve. As the
Cell Volume distribution curve has a maximum volume range of 250fl, the maximum channel
RBCs) also contains clumps of cells that are larger than this volume. Therefore this
channel is excluded from the MCV calculation. The MCV is calculated from the
volume position of the discriminator to 249 fl. Be aware that the discriminator
might be 'floating' or fixed by the user in the 'Discriminator set-up program'
 In general, RBC counts that are lower than 0.60 (displayed value) do not give a
MCV/HCT value due to low statistical significance.
 If the MCV is calibrated by using the 'calibration' procedure, in the user manual,
the whole curve is recalculated and moved in a correct way that reflects the new
calibration setting. The printed curve will therefore always be correct in respect to
the actual MCV value.
RDW (Red Cell The RDW parameter is calculated from the RBC distribution curve. The CV of the
Distribution curve is calculated. However, the CV is only calculated on a portion of the curve.
Width) This avoids that other populations might interfere. The RDW value is therefore only
measured on a portion of the RBC size distribution curve. I.e. not all particles are
included in the RDW calculation. The RDW parameter is only valid if the MCV value
is not zero.
HCT The HCT is defined as being the packed volume of red cells in whole blood and is
(Hematocrit) calculated through MCV * RBC. If no MCV is derived from a sample due to too low
a number of RBC cells, no HCT is calculated.
MPV (Mean  The mean cell volume of the platelets is determined from the PLT size distribution
Platelet Volume) curve.
 The MPV is defined as being the mean value of the PLT size distribution curve
from the lower discriminator (2.5 fl) to the position of the upper discriminator
which can be programmed as 'floating' or fixed.
 MPV is not displayed in case of extreme low PLT counts due to high statistical
inaccuracy of such a population.
MCH (Mean Cell The MCH is a calculated value and is defined as HGB/RBC giving the mean HGB
Hemoglobin) concentration in the red cells.
MCHC (Mean  The MCHC is a calculated value and is defined as HGB/HCT.

Cell Hemoglobin  The MCHC is calculated from 3 measured parameters and therefore an excellent
Concentration) instrument stability check. MCHC=HGB/HCT=HGB/(MCVxRBC).
 In general it could be stated that if a daily mean value is found outside the range
32-36 g/dl, the instrument has been incorrectly calibrated. The daily mean value of
the MCHC parameter should always be 34.5 +/- 1.5 g/dl.
76
10.6 Parameter Definitions (continued)
PLT (Platelets)  Platelets are defined (for the purpose of discrimination) as cells in a range from
2.5fl to the discriminator level that is either set on a fixed volume or 'floating' and
determined by the software on each sample. The setting of the upper discriminator
is done in the setup menu.
 The platelets are determined from the same dilution as the RBC, in fact, the system
is counting just 'cells' during the RBC/PLT counting process. The determination of
which cell is a PLT or RBC is done at the end of the counting procedure and fully
determined by the setting of the user defined discriminator behavior (‘floating’ or
fixed)
 Example: Let us suppose that a sample contains 200,000 platelets/µl in whole
blood. After a dilution of 1:40,000 the sample contains 200,000 divided by 40,000
= 5 cells/µl. So, each µl drawn through the aperture gives 5 pulses. As the counting
volume (the volume of the metering glass tube) is 270 µl, the total number of cells
that are analyzed will be 5*270=1350 cells.
 In other words, the total number passing through the orifice when determining the
PLT is the value shown on the display screen without decimals multiplied by the
division factor 6.75.
 The reproducibility is directly dependent on the total number of cells entering the
orifice.
 Measuring PLT from the same dilution as RBC, the CV will be less than 3.5% for
most of the samples within normal range. A 'mean' CV of about 3.2 % is expected
for well-treated fresh EDTA whole blood samples within the range of 250-350
10e3/uL.
 As the system uses an orifice size of 80 µm diameter, coincidence losses will take
place with extreme sample RBC/PLT counts. The system has a well-balanced
mathematical correction algorithm for these effects within the software.
 Please note that if a floating discriminator is used and no well-defined minimum is
found between the RBC and PLTs the reproducibility of mainly the PLT is
affected. To check the reproducibility of the low PLTs, it might be wise to put the
analyzer in a fixed discriminator mode to exclude any error introduced by a not
well-defined RBC-PLT population.
77
Section 11: Specifications
Section Overview
Introduction This section describes the specifications for the Exigo analyzer and its
parameters.
Topic See Page

General 78
Short List of Specifications 79
Parameter Ranges 80
Reagent and Reagent Consumption 80
11.1 General
Description This section describes the Exigo analyzer and its parts in general.
User The operator works with a menu from which the desired program is chosen,
Environment e.g. discriminator settings.
Reagents Three external reagent reservoirs are used:

 Isotonic diluent (Diluent)
 Hemolyzing reagent (Lyse)
 Enzymatic Cleaner (Cleaner)
 EOS Reagent (EOS)
Technology The Exigo system is a fully automatic hematology analyzer designed to

measure 17 parameters using whole blood from an open inlet and 20µl micro
pipettes. Exigo EOS measure 19 parameters using whole blood.
WBC The analyzer performs a 3-/ 4-part WBC differential by means of a cyanide free
differential hemolyzing reagent.
Protected A sample memory is available and protected against main power failures. The
Sample Memory sample memory also contains a search function with selective printing and QC
Options.
78
11.2 Short List of Specifications
Specifications (Short)
Measuring principle
Impedance
RBC, WBC, PLT
Measuring principle HGB Photometer, Cyanide free method 535nm ±5nm
Programmable WBC Discriminator Yes
Sampling system Closed shear valve
17-parameters:
RBC, MCV, HCT, PLT, MPV, HGB, MCH, MCHC, WBC,
RDW%, RDW abs, LYM abs, MONO abs, GRAN abs,
LYM%, MONO%, GRAN
Parameters reported
19-parameter (Exigo EOS):
RBC, MCV, HCT, PLT, MPV, HGB, MCH, MCHC, WBC,
RDW%, RDW abs, LYM abs, MONO abs, NEUT abs, EOS
abs, LYM%, MONO%, NEUT%, EOS%
Size distributions printed for RBC, PLT , WBC and EOS diff.
Aspirated blood volume
< 125 µl
(Open Tube)
Blood volume using the Micro Pipette
20 µl
Adapter (MPA)
TFT-LCD display Graphical color touch screen, 240 columns x 320 rows
Keyboard Virtual incorporated keyboard (External keyboard possible)
Analysis time ~ 1 minute ; ~3 minutes including EOS
QC capabilities Mean, SD, CV, Levey-Jennings
Control sample memory capacity > 1000 control samples
Sample memory capacity > 1000 samples
HGB correction on high WBC counts Yes
System information indicators on
Yes
parameter abnormalities
Floating discriminator RBC/PLT Yes (position printed)
Automatic HGB blank on each sample Yes
Carry over HGB, WBC ≤ 1%; RBC, PLT ≤ 2%
Barcode reader input Yes
Serial output Yes (Conformed to standard EN 60950)
Power consumption (operational) Max 100VA
Power consumption (standby) Max 20VA
Mains Frequency 50 – 60 HZ
Mains Voltage 100-240V
Effective mains current Max 2 A
Certified external mains power supply AML150PS24>2556 or FDF1503-A-24-C14 (51441).
Built-in test / adjustment programs Yes
Temperature 18 – 32°C (64 – 90°F)
Humidity (noncondensing) Up to 80%
Dimensions (HxWxD) 410 x 290 x 460 mm (16.1 x 11.4 x 18.1 in)
Weight ≤ 18 kg (Standard Version) (≤ 40 lb)
Diluent Consumption Approximately 22 ml per analysis cycle
Approximately 50 ml per analysis cycle including EOS
Lyse Consumption Approximately 4.8 ml per analysis cycle.
Cleaner Consumption Variable depending on the usage per day. 32 ml per day can
be estimated for the average user.
EOS Reagent Consumption Approximately 3.6 ml per analysis cycle.
79
11.3 Parameter Ranges
Displayed Range Total range where results are reported, also outside of linearity range.
Parameter Displayed Range

WBC 0.0 - 119.9 x 109/ L
RBC 0.00 – 14.00 x 1012/ L
MCV 15.0 – 250.0 fL
PLT 0 - 1999 x 109/ L
HGB 0.0 – 35.0 g/dL
Correlation Correlation was performed, using a Bayer/Advia 120 as reference, resulting

in the following correlation coefficients (R): WBC > 0.97, RBC > 0.98,
MCV > 0.98, PLT > 0.95, and HGB > 0.98. Note that the range for each
parameter was limited by the types of samples available for the study.
Precision (typical) Typical value from QC testing (n=10), using Boule Con Vet.
Parameter CV (%)
WBC  1.9
RBC 1.1
MCV 0.3
PLT 3.5
HGB 1.0
80
Section 12: Troubleshooting
Section Overview
Introduction This section contains information needed to troubleshoot the Exigo analyzer.
Contents This Section contains the following topics:
Topic See Page

Aspiration Issues 81
Communication Issues 82
General Information Displays 84
System Information Displays 89
Troubleshooting Other Issues 94
12.1 Aspiration Issues
Description This section contains information regarding errors associated with aspiration
and the sample probe.
If Then Possible cause

No aspiration of 1. Suggest performing clot removal 1. Blockage of tubing or leak causes
sample is taking place. procedure below. sample to not be pulled correctly
2. Verify that there are no leaks and through shear valve.
tubing is connected properly and 2. Valve malfunction.
not kinked. 3. Clot in sample caused by incorrect
3. Perform valve check in Service sample handling or pathologic sample.
Menu
No cleaning of 1. Suggest cleaning upper area of 1. Sample tube is touching the upper part
aspiration probe sample probe. of the sample probe when analyzing.
2. Verify that there are no leaks and 2. Diluent is not flowing correctly
tubing is connected properly and through tubing to sample probe.
not kinked
81
12.1 Aspiration Issues (continued)
Clot Removal This process will help operator to remove a clot from the system. This should
Procedure only be used when the OT sample probe is blocked.
Step Action
1 From Main Menu press [ADVANCED] and then press [MAINTENANCE].
Press [PROBE FLUSH] to begin procedure. Diluent will be flushed through the shear
valve and the sample probe, while the waste pump simultaneously turns on and
removes excess liquid and clotted matter through the probe rinse cup.

When menu screen returns to Maintenance Menu probe flush is complete. Run
3 background count to confirm background values are within correct range and continue
with next sample analysis.
If the sample probe is unable to be flushed, an AF system information indicator will be
displayed when background count is analyzed. This indicates that the clot was unable
Note to be removed using the automatic procedure. Contact distributor Technical service for
Manual Clot Removal procedure.
12.2 Communication Issues
Description This section contains information regarding errors associated with printers,
barcode readers and serial data communication.
Printer Issues See Section 4.3 Printer Modes for further detail.

The printout has unusual layout 1.Verify that printer type matches 1. New printer was connected but
or strange characters. the printer being used. not matched with analyzer
2.Verify that the correct paper setup.
format has been selected for the 2. Printer may need maintenance
printer paper. or to be reset.
Results are not printing out after 1. Verify that Auto Print Mode is 1. Auto Print Mode was turned
sample or control analysis. NOT set to ‘0’. off and not reset.
82
12.2 Communication Issues (continued)
1. Printer Alarm message is 1. The printer is not connected to

displayed. the analyzer or the printer setup
2. Printer is not ready to print, wait is incorrect.
unit printer has finished with 2. The printer has not completed
previous printout. last printout.
3. Verify that printer is connected
the analyzer.
4. Verify that the setup of the
analyzer is correct for the printer
in use.
1. The Printer is connected to the 1. The printer has timed out.

analyzer and on, but not activated. 2. Printer paper may need to be
2. Verify that printer is not in refilled.
standby or offline. 3. Incorrect setup for information
3. Verify that printer is set to print transmission.
and not serial port only setup.
Serial Data Issues See Section 4.3 Data Communication for further detail.

The data sent does not seem 1. Make sure that the correct HW 1. Serial setup in analyzer is
correct handshake and Auto Send Mode incorrect.
has been selected.
Results are not being sent to 1. Verify that Auto Send Mode is 1. Auto Print Mode was turned off
computer after sample NOT set to ‘0’. and not reset.
analysis
1. Serial Output in not ready to 1. The analyzer has not completed
transmit. transmission of last sample.
2. Wait until previous sample has
finished transmitting.
3. Then resend selected sample.
4. If sending to USB memory,
check that a USB memory with
enough free space is inserted in
the instrument.
83
12.2 Communication Issues (continued)
1. Verify that analyzer is connected 1. The serial output has timed out.
to computer. 2. The computer is not connected
2. Verify that computer is turned on. to the analyzer or the serial
3. Verify that a receiving program output setup is incorrect.
runs on the computer.
4. Or switch off the HW handshake.
option if the computer’s receiving
program does not support HW
handshake
1. Verify that computer is turned on 1. Serial output protocol problem.

and connected to the analyzer.
2. Verify that computer’s receiving
program is active.
3. Or switch off the Send with Ack.
option if the computer’s receiving
program does not support Ack.
12.3 General Information Displays
Description This section contains information regarding general information displays.
General General information displays are informative screen displays that appear after a
Information function has been completed. Instruction is then displayed for the operator on
Displays next step or function to be performed.
84
12.3 General Information Displays (continued)
Standby, Power Down, and Power Up Informational Displays
The system is empty from all liquid The system is filled with liquid and is The system has not been used during
and prepared to be filled with other prepared for power off. Press [PWR the preset display saver time. Press
liquid or be stored away. Press UP] if you want to return the system [RESUME] to activate the analyzer.
[FILL] if you want to refill system or to active status or [EXIT] if you want Once activated, the analyzer is ready
[EXIT] if you want to return to to return to analyzer menu. It is to perform an analysis.
analyzer menu. No analyze can be recommended to use [ENTER
performed before the analyzer is STANDBY] and that power is left on,
refilled with reagents. instead of using this feature.
Analyzer will enter Standby mode in The analyzer is in the process of going The system is in Standby. Press
2 minutes. Press [CANCEL] to return into Standby. Please wait. [EXIT STANDBY] to activate the
to analyzer menu. analyzer. Once activated, the analyzer
is ready to perform an analysis.
85
Standby, Power Down, and Power Up Informational Displays
The system is preparing the analyzer The analyzer is in process of powering The analyzer is in process of powering
for analysis mode. If the background down. Please wait. up. Please wait.
check is activated, background result
will be displayed. Once activated, the
analyzer is ready to perform an
analysis.
Cycle In Progress Informational Display
The analyzer is priming the system. The analyzer is filling the system. The analyzer is emptying the system.
Please wait. Please wait. Please wait.
86
The analyzer is cleaning the Open Every 24 hours the analyzer performs The system has finished the count of
Tube sample probe. Please wait. a wash of the system. During wash cells and displays the results. The
cycle the analyzer can not be used for analysis cycle in not yet completed, as
performing an analysis. the system still needs to perform wash
cycle for an accurate next sample
result. Please wait until the [NEW
SAMPLE] button is activated. If
sample probe was submerged in next
sample by mistake, perform a
background count before continuing
with the next analysis.
The printer is in the process of The analyzer is in the process of Analyzer displays this notice to
printing. Please wait. transmitting serial output data. Please inform operator that Diluent reagent
wait. will soon need to be changed.
87
Reagent and Control Informational Displays
Analyzer displays this notice to Analyzer displays this notice to Analyzer displays this notice to
inform operator that Lyse reagent will inform operator that Cleaner reagent inform operator that EOS reagent will
soon need to be changed. will soon need to be changed. soon need to be changed.
Analyzer displays this notice when The reagent barcodes were scanned in The Con/Cal Assay Values were
reagent bottle or bottles need to be correctly using the barcode reader and scanned in correctly using the barcode
changed. Not changing reagents at the analyzer has accepted the values. reader and the analyzer has accepted
this time could cause erroneous the values.
results or possible damage the
analyzer.
88
12.4 System Information Displays
System System information displays appear after a function has been performed incorrectly or
Information to inform the operator that further action is needed to complete the desired task. The
Displays system information display describes the situation and instructs the operator on next
step or function to resolve issue.
System Power Down Information Displays
The system has been switched off for The system was switched off The system was manually switched
a long time period. The analyzer has incorrectly. Perform a prime to off with system emptied of reagents.
been powered down with all valves prepare the system for analysis. Check Fill the analyzer with reagents to
open and filled with liquid. Empty method for correct analyzer power prepare for analysis or exit if only a
and refill the system with reagents, down procedure. search of analyzer menus is needed.
and perform a background count.
The system was powered down with The regular 24 hour wash has failed.
The analyzer has been switched off
liquid in system and has been unused Make sure that reagent bottles are
with power down function before
for long period of time. Perform the filled and the reagent tube assemblies
power was switched off. Perform a
cleaning procedure according to are inserted correctly.
power up to prepare the reagent
cleaning kit instruction. Perform a
system for analysis.
background check.
89
12.4 System Information Displays (continued)
Reagent System Information Displays
The regular 24 hour wash has not The reagent bottle or bottles are This message is displayed if reagent
been performed. Check if reagent empty. Check if the bottles are empty bottle or bottles are empty when
bottles are empty and if the reagent and if the reagent tube assemblies and coming out of Standby. Check if the
tube assemblies are in contact with electronic sensors are inserted bottles are empty and if reagent tube
reagent. correctly. assemblies and electronic sensors are
inserted correctly.
Reagent tube assemblies must be Analyzer has detected liquid in the

removed from the reagent bottles system. The empty cycle must be run
when emptying the system. Verify prior to a fill cycle. Run the Empty
that all tubes have been removed. function to remove any extra liquid
remaining in the system then fill the
analyzer with reagents.
90
Diluent bottle need to be changed. Lyse bottle needs to be changed. Not Cleaner bottle needs to be changed.
Not changing reagents at this time changing reagents at this time could Not changing reagents at this time
could cause erroneous results or cause erroneous results or possible could cause erroneous results or
possible damage the analyzer. damage the analyzer. Connect new possible damage the analyzer.
Connect new reagent bottle and scan reagent bottle and scan in barcode on Connect new reagent bottle and scan
in barcode on bottle. bottle. in barcode on bottle.
EOS bottle needs to be changed. Not No more space is available to scan in

changing reagents at this time could new Con/Cal assay values. Follow the
cause erroneous results or possible recommendation or manually delete
damage the analyzer. Connect new all the controls with same ID, to free
reagent bottle and scan in barcode on space for scanning the new assay
bottle. values.
91
Barcode System Information Displays
Con/Cal assay value barcode Reagent barcode scanning failed. The analyzer was unable to wash the
scanning failed. The assay values or Barcode printing or order of scanning Open Tube sample probe. Verify that
order of scanning in the barcodes in the barcodes may have been tube is removed and wash rinse cup is
may have been incorrect. Verify that incorrect. Verify that setups on the in correct position, then perform OT
setups on the analyzer match the analyzer match the required setup for Wash.
required setup for the barcode reader. the barcode reader.
Open Tube System Information Displays
The analyzer was unable to wash the The analyzer is unable to wash the The MPA was opened during an
Open Tube sample probe. Verify that Open Tube sample probe. Verify that inappropriate time. It is recommended
tube is removed and wash rinse cup is tube is removed and wash rinse cup is to perform a prime cycle before next
in correct position. It is recommended in correct position. It is recommended analysis.
that background count is performed that background count is performed
before next sample analysis. before next sample analysis.
92
Capillary Device System Information Displays
The MPA was opened during a cycle The MPA holder was opened during Assay Value Input failed. The Assay
or analysis. Re-insert holder, and an inappropriate menu. The MPA sheet or order of scanning in the
follow suggested recommendation. holder should only be opened in List, barcodes may have been incorrect.
Sample or Main menu. Verify that setups on the instrument
match the required setup for the
barcode reader. (See Section 4.3 and
6.1 for more detail.)
Authorization Code and Control Entry Displays
The barcode scanned in is not Incorrect authorization code was No authorization code was entered. See
recognized as a control sample in the entered. See calibration section in calibration section in User Manual for
system. Verify that control sample is User’s Manual. entry of correct authorization code for
being scanned in. ( See Section 6.1 calibration, or contact local distributor
for more detail.) or authorized service technician.for
service related authorization codes.
93
12.5 Troubleshooting Other Issues
Description See Troubleshooting Flowchart in Appendix A for other possible issues that may arise.
Areas on Flowcharts highlighted in dark grey should only be performed by service
technician or authorized personnel.
Indication Indications error codes are specific instrument situations that in most cases need the
Error Codes attention of the operator or might need service action.
 The first indication display is the most important as it describes the issue and how to
solve the problem. The 300 indication series displayed after a two digit indication is
added information for the user.
 In most cases, the instrument is stopped and the operator has to confirm with [OK] to
continue. Once [OK] is pressed and instrument returns to display menus, user should
repeat previous actions again (e.g. re-analyze sample, printing results, etc.)
 If indication error appears again or a three digit indication was displayed as the first
indication message, contact local distributor or authorized service technician.
Indication Series Description

1 - 19 Indication series for auxiliary errors like battery faults or similar.
20 - 29 Indication series for ‘Liquid’ errors.
30 - 39 Indication series for Communication errors between the PCBs (CAN bus).
40 - 49 Indication series for Printer and serial output errors.
50 - 59 Indication series for General Memory errors.
60 - 69 Indication series for EEPROM/HPC errors.
70 - 79 Indication series for Shear Valve problems.
80 - 89 Indication series for Cap Piercer errors (Closed Tube Adaptor)
90 - 99 Indication series for Sampling device errors.
Indication series for internal hardware and software problems, and messages during
100-255
subboard firmware upgrades.
300 -399 Indication series for cycle aborted indication numbers.
94
Index
A O
Abnormal Results Information................................................................ 59, 60 Open Tube .............................................................................18, 24, 40, 51, 79
Advanced menu ........ 17, 18, 25, 26, 27, 28, 29, 30, 33, 35, 50, 51, 55, 56, 82 Operator ID........................................................................................ 34, 40, 52
Analysis profile ....................................................................................... 33, 34
P
Aspiration issues ............................................................................... 70, 81, 82
Parameter Ranges .................................................................................... 78, 80
Assay values ............................................46, 47, 48, 49, 51, 52, 60, 88, 91, 92
PCT ................................................................................................................ 79
Assay Values ........................................................................................... 46, 93
PDW .............................................................................................................. 53
Authorization code ............................................................................ 34, 52, 93
PLT ............................................................ 24, 34,39,51,53,63,70,71,73,79,80
B PLT ................................................................................................................ 51
Background count .............................32, 34, 37, 38, 39, 70, 82, 86, 87, 89, 92 Power adapter ..............................................................................10, 12, 19, 79
Barcode.......................................................................................................... 39 Power Down ...................................................................................... 85, 86, 89
Barcode reader...................... 10, 12, 18, 20, 28, 47, 48, 51, 60, 79, 82, 92, 93 Power supply ................................................................................................. 14
Blood film ........................................................... 61, 62, 63, 65, 66, 67, 68, 69 Power Up .....................................................................................37, 85, 86, 89
Prime................................................................................32, 70, 71, 86, 89, 92
C
Printer ..................................................... 10, 12, 14, 20, 27, 35, 82, 83, 87, 94
Calibration ................................................................. 18, 50, 51, 52, 53, 57, 93
Probe flush ............................................................................................... 57, 82
Calibrators ..................................................................... 5, 6, 10, 50, 51, 52, 58
Cleaning ...................................................................................... 50, 54, 55, 57 Q
Cleaning kit ................................................................................. 10, 55, 57, 89 QC....................................................................... 20, 46, 47, 49, 50, 53, 78, 79
Clot Removal................................................................................................. 82
R
Control barcodes ....................................................... 13, 37, 47, 49, 88, 92, 93
RBC .............. 24, 34, 39, 51, 53, 62, 63, 66, 67, 68, 69, 70, 71, 72, 73, 79, 80
Controls 5, 6, 10, 13, 37, 38, 46, 47, 48, 50, 53, 58, 60, 62, 63, 71, 79, 88, 91,
RDW ................................................................................24, 53, 62, 66, 67, 79
93
Reagent barcodes .............................................................13, 17, 18, 33, 88, 91
CV.. ............................................................................................. 51, 52, 79, 80
Reagent bottle10, 12, 13, 15, 16, 17, 18, 20, 31, 32, 33, 56, 71, 88, 89, 90, 91
D Reagent bottle tray.............................................. 12, 13, 15, 16, 18, 20, 56, 57
Date/time function ................................................................................... 12, 26 Reagent consumption .............................................................................. 78, 79
DF.. ................................................................................................................ 71 Reagent level sensors .................................................................................... 14
Disposal ............................................................................................. 17, 54, 58 Reagent setup ..............................................................................17, 18, 31, 32
Distributor ......................................................... 4, 7, 27, 53, 55, 58, 82, 93, 94 Reagent tube assemblies................... 10, 12, 13, 16, 18, 19, 56, 57, 71, 89, 90
DP.. ................................................................................................................ 71 Reagents ................................... 5, 6, 13, 15, 18, 58, 71, 78, 85, 87, 88, 89, 91
Results .................................................... 20, 34, 37, 38, 41, 44, 45, 60, 82, 83
E
EDTA ...................................................................................................... 36, 42 S
Emergency Procedure ..................................................................................... 7 Safety features .............................................................................5, 6, 7, 17, 58
Empty .............................................................................. 56, 57, 71, 86, 89, 90 Sample analysis ........ 12, 29, 33, 36, 38, 40, 41, 42, 44, 51, 53, 60, 82, 83, 92
Erroneous results ............................................... 6, 7, 36, 40, 42, 43, 57, 88, 91 Sample collection .......................................................................................... 36
Sample ID ................................................................................................ 34, 39
F
Sample memory ................................................................................. 34, 78, 79
Fill 13, 17, 56, 57, 71, 85, 86, 89, 90
Sample menu ................................................ 34, 40, 41, 42, 47, 48, 51, 56, 93
Floating discriminator ............................................................................. 74, 79
Sample Pathology ................................... 59, 60, 61, 62, 64, 65, 66, 67, 68, 69
G Sample Pathology Messages ................................................................... 61, 63
General Information Displays ............................................... 84, 85, 86, 87, 88 Sample probe .......................................... 20, 38, 40, 47, 50, 54, 81, 82, 87, 92
GRAN................................................................................................ 24, 71, 79 Sample statistics ..........................................................................31, 32, 34, 35
Sample View ........................................................................................... 44, 45
H
Send Mode ............................................................................................... 29, 83
HCT ........................................................................... 24, 62, 63, 67, 68, 69, 79
Sequence number .............................................................................. 34, 35, 47
Hemolysis ................................................................................................ 63, 67
Serial number .................................................................................................. 3
HGB ................................................................................ 24,39,51,53,70,79,80
Serial output ......................................................................3, 29, 79, 83, 84, 87
I Service .................................................................................4, 5, 11, 81, 93, 94
i-button ........................................................................................ 59, 61, 64, 69 Service technician........................................................................53, 55, 93, 94
Indications error codes .................................................................................. 94 Setup ..................................... 14, 18, 25, 26, 27, 28, 29, 30, 82, 83, 84, 92, 93
Installation ...............................................10, 11, 12, 13, 14, 15, 16, 17, 18, 57 Setup menu ......................................................... 18, 26, 27, 28, 29, 30, 33, 35
Instrument settings .................................................................................. 25, 35 Specifications .......................................................................................... 78, 79
Standby ..................................................................................32, 37, 40, 85, 86
K
Startup................................................................................................ 13, 37, 38
Keyboard ........................................................................................... 10, 28, 79
Storage ............................................................................................... 47, 57, 58
L Summary report ....................................................................................... 35, 48
Language ....................................................................................................... 26 System Information Displays ......................................................89, 90, 92, 93
Levey-Jennings plots ................................................................................ 48,49 System Information Messages ..............................................52, 59, 70, 71, 79
Lipemia.......................................................................................................... 63
T
List menu .................................................25, 34, 40, 41, 42, 47, 48, 51, 56, 93
Target values ................................................................................................. 52
LYM ........................................................................................................ 24, 71
TL… .............................................................................................................. 71
M Transport .....................................................................................47, 54, 56, 57
Main menu...................................18, 21, 25, 28, 40, 42, 47, 50, 51, 55, 82, 93 Troubleshooting.....................................................................47, 60, 69, 81, 94
Maintenance ...................................................................................... 50, 54, 55 TU.. ................................................................................................................ 71
Maintenance menu ................................................................ 17, 55, 56, 57, 82
U
MCH ........................................................................................................ 24, 79
USB .............................................................................................14, 27, 30, 35
MCHC ............................................................................. 24, 62, 63, 68, 69, 79
User Definable Settings ............................................................................. 4, 35
MCV ........................................................24, 51, 53, 60, 62, 66, 67, 69, 79, 80
Measuring principles ..................................................................................... 72 W
Menu Structure .................................................................................. 21, 22, 23 Warning signs ............................................................................5, 7, 17, 19, 58
Micropipette ............................................................................................ 42, 43 Warranty .................................................................................................... 5, 55
MID ................................................................................................... 24, 49, 71 Wash cycle ............................................................................28, 32, 40, 87, 92
Mixer ................................................................................................. 20, 29, 36 Waste ................................................................................................... 6, 17, 58
Monthly QC............................................................................................. 48, 49 Waste container ...........................................................................12, 17, 56, 58
MPA ..................................................10, 18, 20, 24, 42, 43, 51, 53, 79, 92, 93 Waste line ........................................................................10, 12, 17, 56, 57, 58
MPV ........................................................................................................ 24, 53 WBC ....... 24, 34, 39, 49, 51, 53, 61, 62, 64, 65, 69, 70, 71, 72, 73, 78, 79, 80
WBC Mode.................................................................................................... 65
N
NEW SAMPLE ........................................................................... 38, 39, 41, 87
Normal ranges ......................................................................................... 33, 34
95
Appendix A
DF or DP ERRORS
Check for the following:

1. Reagent tube assemblies to back of analyzer are tight.
2. Leakage under instrument.
3. Reagent tube assemblies inserted correctly into bottles.
4. No pinch or kink in reagent tubing.
5. Check Diluent bottle levels.
6. Check that waste tube is not pinched or kinked.
Perform a Prime, then a

background count DONE
NO
NO Re-analyze
DF/DP flag? DF/DP flag?
sample
All highlighted areas of flowchart YES YES

are to be performed by trained in-
house technician ONLY.
Perform [Level
Detector Test] in
Service Menu.
Were all
YES
Run a background
values 2 (2 =
count
liquid)?
NO
Check that lower and upper YES NO

Remove right-
tubing is tightly fitted to DF/DP flag? DONE
side cover.
measuring units
Rotate the units so that no zeros

are displayed in Level Detector
Test in Service Menu
Run a background Did liquid YES Did liquid stop at

count move up and down
upper detector?
YES in unit?
NO YES NO
DF/DP flag?
Is there YES Contact Technical
any liquid in buffer
Service Representative
NO chamber (CH1)?
DONE NO
1. Perform Valve Check

2. Contact Technical Service and
give Valve Check results
96
Discordant Results
Verify that sample is
mixed correctly and tube
has correct ratio of blood Questions to ask:
to anticoagulant. 1. Was sample collected and handled properly?
2. Was the same sample used for both in-house and outside lab analysis?
YES 3. Different blood draw and/or different tube?
4. Could the sample have been switched with another patient?
5. Could discordance be due to age changes during shipping or time periods
NO Is HCT low
between blood draw and analysis (RBC swelling, platelet clumping,
compared to
deterioration of WBC for differential)?
spun PCV? YES
NO Is HCT
Go to ’Are both RBC out-of-range? NO Go to control out of
Are controls Repeat using correct
and HGB low’ below. range Troubleshooting
within range? procedure
protocol
YES NO
YES NO
NO
Is RBC Is MCV
out-of-range? out-of-range?
NO YES Was calibration YES Was calibration
Are all parameters
YES recently protocol followed
discordant?
performed? correctly?
Check that sample is YES

mixed correctly and no Is MCHC NO YES
hemolysis or lipemia is out-of-range?
present.
Change out NO Are reagent
NO Were all
NO reagent and re-
levels ok? parameters low?
analyze sample.
Wait 2 minutes YES Is HGB
and then run a YES Perform
out-of-range? YES
background count Maintenance
Review differences that can be

Go to High Background NO YES
expected when comparing Is Annual
Troubleshooting protocol results from same system, from Maintenance due?
YES Is PLT different systems, etc.
NO
out-of-range?
Run a
background NO
count. Values
NO
Examine blood film Perform Probe Flush
OK?
procedure and
YES Are re-analyze sample.
RBC & PLT both
1. Verify by looking at high or both
blood film. low?
2. Check sample for clots. YES
3. Review PLT histogram. NO Is sample Are results still
(verify bell-shaped curve) YES pathological? discordant?
Are
1. Check reagent level. WBC & HGB both NO NO
2. Run Orifice Clean cycle from high or both
Service Menu (possible YES
low?
blockage of aperture) DONE
3. Check if Annual Maintenance NO
is due.
YES Are
Contact Technical
RBC and HGB
both low?
Contact Technical
NO Service Representative
Re-analyze and/or
redraw sample. 1. Verify by looking at blood film.
Is WBC YES 2. Check sample for clots.
out-of-range? 3. Remix and check correct
sample handling followed.
97
Display Issues
Usual Cause:
1. Keypad flex-cable loose
2. Static electricity
3. Power Outage/Lightening
Verify/determine
with clinic if power
surge was noted
Turn off analyzer with

On/Off switch and then
turn back on.
Is green power
NO Contact Technical
light on front of
analyzer lit?
YES
Contact Technical Touch screen and

Service Representative wait one minute.
NO
Is beep NO YES
Is display
heard when screen DONE
visible?
is touched?
YES
Turn off analyzer with
On/Off switch.
Remove front
cover
YES
Check that keypad flex-

cable, behind top of Turn on analyzer with Is display NO Contact Technical
screen, is firmly pressed On/Off switch. visible? Service Representative
into connector.
98
HIGH BACKGROUND COUNTS
Initial Procedure:
1. Check Diluent Lot Number and expiration date.
2. Check age of Diluent (i.e. when was it opened?)
3. Check that reagent tube assemblies are placed correctly on the reagent bottles and firmly tightened on back of analyzer.
4. Check that reagent tube assemblies are in correct reagent bottles (red=diluent, yellow = lyse, blue = cleaner)
5. Check reagent level.
6. Check environmental condition (i.e. extreme temperature fluctuations?)
Run total of 3
backgrounds to Perform [Probe Flush]
verify procedure from
Maintenance Menu
YES
YES Did all Did

NO Are clots NO Perform Orifice Clean NO
DONE backgrounds background
visible ? in Maintenance menu
pass? pass?
YES
Did YES
background DONE
YES pass?
Repeat procedure NO Was procedure
using correct protocol followed correctly?
NO
YES Was Annual YES Check Noise Test

Were all
Maintenance just under Service
values '0'?
performed? Menu
Run 2 Prime cycles
followed by a NO
background count.
See Noise Issue
NO Flowchart
YES Did
DONE background Is maintenance YES Perform scheduled
pass? procedure scheduled to maintenance and re-
be performed? analyze background.
NO
Run 3 NO
backgrounds. Did
Try another bottle NO
background
of diluent.
pass?
Did NO YES
YES
DONE background Did YES
pass? background DONE
pass?
NO
Put the instrument in Run 2 Prime cycles
standby. Wait 20 followed by a
YES minutes. background count
Did NO Did YES

Contact Technical NO background
Perform Annual
background
Service Representative Cleaning.
pass? pass?
99
Noise Issues
Usual Cause:
1. Bad electrical outlet in clinic
2. Power Outage/Lightening
3. Instrument not plugged into
line conditioner provided
YES Go to user manual

Is SE flag
for SE message
present?
explanation
NO
Perform Noise
Test, under Connect cables
Service Menu
YES
Are the values for the

Are any
Noise Test: YES
cables loose on back
RBC Ampl = 0
of analyzer?
WBC Ampl = 0
NO
NO
Try plugging
analyzer into
different outlet
Are noise NO
values above
limits?
YES
Try moving
analyzer to
another room.
Is Noise test NO
Done
positive?
YES
Contact Technical
100
TU or TL ERRORS
Re-analyze sample (system cleans and rinses the

orifice automatically when error is generated)
All highlighted areas of flowchart NO

TU/TL flag? DONE
are to be performed by trained in-
house technician ONLY.
YES
Perform a Prime, then a
DONE
background count
NO
Re-analyze
TU/TL flag? TU/TL flag?
sample
NO
YES
YES
Perform Orifice Clean

in Maintenance menu
Perform
background count
Check tubing to YES NO

Remove right-side
measuring chambers, TU/TL flag? DONE
cover.
re-attach if necessary.
Check tubing to air

membrane pump (SP1 &
SP2), re-attach if
necessary.
Is YES NO
Check tubing to Run a Prime cycles
liquid level above
metering units, followed by a TU/TL flag? DONE
orifice in measuring
re-attach if necessary. background count
chambers?
YES
NO
1. Perform Valve Check

2. Contact Technical Service
and give Valve Check results
101
Appendix B
This page will not be translated from English.
This product uses some software which are distributed under the GPL and/or the LGPL licences.
Accordingly, Boule Medical AB makes the source code (including changes made by Boule Medical AB)
for the following GPL and/or LGPL licensed software available: U-boot, Linux Kernel, Busybox,
Liblockfile, Lockfile-progs, Udev, (Linux) Kbd, Mtdutils, Ghostscript, Ghostscript-Fonts, Gutenprint,
Glibc. In addition, it uses the Chinese Ghostscript font gpsn00lp.ttf which is under the Arphic Public
License. Contact info@boule.se using the Subject line “BM800 GPL source code request” for
information about access to the source codes. Please refer to http://en.wikipedia.org/wiki/Gpl,
http://www.gnu.org/licenses/old-licenses/gpl-2.0.html and
http://www.gnu.org/licenses/old-licenses/lgpl-2.1.html for further info.
“This software is based in part on the work of the Independent JPEG Group.”
This product also uses fonts with the following copyrights:
Copyright 1984-1989, 1994 Adobe Systems Incorporated.

Copyright 1988, 1994 Digital Equipment Corporation.
Adobe is a trademark of Adobe Systems Incorporated which may be registered in certain jurisdictions.
Permission to use these trademarks is hereby granted only in association with the images described in this
file.
Permission to use, copy, modify, distribute and sell this software and its documentation for any purpose
and without fee is hereby granted, provided that the above copyright notices appear in all copies and that
both those copyright notices and this permission notice appear in supporting documentation, and that the
names of Adobe Systems and Digital Equipment Corporation not be used in advertising or publicity
pertaining to distribution of the software without specific, written prior permission. Adobe Systems and
Digital Equipment Corporation make no representations about the suitability of this software for any
purpose. It is provided "as is" without express or implied warranty.
Cyrillic, Euro and line drawing glyphs copyright 2000 Dmitry Yu. Bolkhovityanov, bolkhov@inp.nsk.su
HR-Net fonts (c) 1995 A. Protopapas and A. Haritsis
Copyright (C) 1988 The Institute of Software, Academia Sinica.

Correspondence Address: P.O.Box 8718, Beijing, China 100080.
Permission to use, copy, modify, and distribute this software and its documentation for any purpose and
without fee is hereby granted, provided that the above copyright notices appear in all copies and that both
those copyright notices and this permission notice appear in supporting documentation, and that the name
of "the Institute of Software, Academia Sinica" not be used in advertising or publicity pertaining to
distribution of the software without specific, written prior permission. The Institute of Software,
Academia Sinica, makes no representations about the suitability of this software for any purpose. It is
provided "as is" without express or implied warranty.
THE INSTITUTE OF SOFTWARE, ACADEMIA SINICA, DISCLAIMS ALL WARRANTIES WITH
REGARD TO THIS SOFTWARE, INCLUDING ALL IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS, IN NO EVENT SHALL THE INSTITUTE OF SOFTWARE,
ACADEMIA SINICA, BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL
DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR
PROFITS, WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE OR OTHER TORTIOUS
ACTION, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS
SOFTWARE.
102
Exigo is a product brand produced by Boule Medical AB
Boule Medical AB
Distributor:
Domnarvsgatan 4, SE-163 53 Spånga, Sweden
Telephone: +46 8 744 77 00
Telefax: +46 8 744 77 20
E-mail: info@exigo-vet.com
www.exigo-vet.com
Art no 1504423 September 2014

User Manual Exigo

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User Manual Exigo

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User Manual

Analyzer The Exigo Veterinary Hematology Analyzer is a 17 parameter, 3-part leukocyte

Instrument List of models

Manufacturer’s details Boule Medical AB

Distributor details Please contact Boule for information.

International SS-EN ISO 18113-3:2011

Date of Issue April 2014 Article no: 1504423

Software version Firmware 2.9.2

Third-party Software For information see Appendix B.

Contents This section contains the following topics:

Topic See Page

1.1 Intended Use

Warranty  Service must be performed by Boule Medical AB (hereafter referred to as

 Unauthorized modification of the analyzer might result in erroneous results or

Description As there are no assurances of the absence of HIV, Hepatitis B or C viruses or

Support  Protection of Laboratory Workers From Infectious Disease Transmitted by

1.5 Warning Signs in Manual

Indicates operation procedures that could result in

Indicates operation procedures that could result in

Emphasizes operating procedures that must be followed

Indicates that protective clothing, gloves or goggles must

Figure 1.3 Figure 1.4

In vitro diagnostic Lower limit of Upper limit of Temperature

Consult instructions Normal control, 8

Figure 1.5 IVD Symbol Table

Contents This section contains the following topics:

Topic See Page

2.1 Unpacking / Operating Placement & Environment

Description The analyzer is packed in a specifically designed protective box.

The following procedures must be followed exactly. Boule has no

Installation/ The analyzer should be placed in a laboratory environment according to the

Installation/  Indoor Use

Operating the analyzer in an environment over +32 °C (90°F) may increase

The following Installation Menu Steps must be followed in sequential order.

Figure 2.2 Figure 2.3

Figure 2.4 Figure 2.5

Figure 2.6 Figure 2.7

Number Part Function

Compatible HP-PCL compatible, IBM Proprinter compatible, or supported USB printers.

Location of This section describes placement of reagent bottles.

Figure 2.12 Figure 2.13

Figure 2.14 Figure 2.15 Figure 2.16

2.5 Changing Reagents

Electrical shock hazard.

Contents This section contains the following topics:

Topic See Page

3.1 General Analyzer Overview

Flowchart 3.1 Main Menu Structure

Reagent Setup Menu Reagent Barcode Input

Diluent: xx more cycles.

Flowchart 3.2 Advanced Menu Structure

Maintenance Cleaning Menu

Service Menu Service Menu 2

Setup Menu 1 Setup Menu 2

Analysis Profile Setup

Flowchart 3.3 System Flow

Before 8 hours* After 8 hours*

Press [EXIT] Press anywhere on

Press [Exit Standby]

* This time amount is user adjustable.

◊ Default automatically runs background count. If

□ In standby mode the system is automatically

Description The Exigo is a fully automated cell counter reporting up to 19 parameters.

Sample volume < 125 µl (Open Tube), 20 µl (MPA)