Exigo Vet User Manual

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 Section 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 Section Overview ............................................................................................................. 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 Section Overview ............................................................................................................. 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
SECTION 6: QUALITY CONTROL (QC) AND BLOOD CONTROL MEMORY ..................................46 Section Overview ............................................................................................................. 46 6.1 Quality Control (QC) ................................................................................................ 46 6.2 Levey-Jennings Plots................................................................................................. 48 SECTION 7: CALIBRATION ........................................................................................................50 Section Overview ............................................................................................................. 50 7.1 Preparations before calibration ............................................................................... 50 7.2 Calibration ................................................................................................................. 51 SECTION 8: CLEANING, MAINTENANCE & TRANSPORT ..........................................................54 Section Overview ............................................................................................................. 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 Transport (< 12h) ................................................................................. 56 8.6 Re-packaging and Long Term Transport (>12h)................................................... 57 8.7 Permanent Shut-Down and Storage ........................................................................ 57 8.8 Disposal Information................................................................................................. 58 SECTION 9: PARAMETER & SYSTEM INFORMATION MESSAGES.............................................59 Section Overview ............................................................................................................. 59 9.1 Low & High Abnormal Results Information.......................................................... 59 9.2 Sample Pathology ...................................................................................................... 60 9.3 System Information................................................................................................... 69 SECTION 10: TECHNOLOGY ......................................................................................................72 Section Overview ............................................................................................................. 72 10.1 Measuring Principles .............................................................................................. 72 10.2 Counting Time RBC & WBC................................................................................. 73 10.3 WBC Differentials ................................................................................................... 74 SECTION 11: SPECIFICATIONS ..................................................................................................76 Section Overview ............................................................................................................. 76 11.1 General ..................................................................................................................... 76 11.2 Short List of Specifications..................................................................................... 77 11.3 Parameter Ranges ................................................................................................... 78 11.4 Reagents and Reagent Consumption..................................................................... 78 SECTION 12: TROUBLESHOOTING ............................................................................................79 Section Overview ............................................................................................................. 79 12.1 Aspiration Issues...................................................................................................... 79 12.2 Communication Issues ............................................................................................ 80 12.3 General Information Displays................................................................................ 82 12.4 System Information Displays ................................................................................. 87 12.5 Troubleshooting Other Issues ................................................................................ 92 INDEX ........................................................................................................................................93 APPENDIX A ..............................................................................................................................94
Preface
Introduction
Analyzer description
The Exigo Veterinary Hematology Analyzer is a 17 parameter, 3-part leukocyte 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. The serial number is located on the rear of the analyzer as indicated.
Serial number
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 1.2
Additional Documentation
Additional documentation available from your authorized distributor includes: Quick Reference Guide Service Manual Veterinary Case Book Basic Hematology User Definable Settings Product Data Sheets The following operator requirements must be fulfilled before operating the Exigo Veterinary hematology system. Basic skills in a laboratory environment. Basic skills in hematology. It is highly recommended that the operator read and understand this manual.
Operator requirements
Optional accessories and consumables
Accessories and consumable lists are available from your local distributor.
Manufacturers details
Boule Medical AB P.O. Box 42056 SE-126 13 Stockholm Sweden Telephone number: +46 8 744 77 00 Fax number: +46 8 744 77 20 Email: info@bm.boule.se
Distributor details
Distributors are listed on http://www.boule.se
International standards and regulations
EN591:2001 SSEN 61010-2-101 (Low Voltage Directive 2006/95/EC) EN 61326 (2006) (EMC 2004/108/EC) 2002/95/EC RoHS 2002/96/EC WEEE Standards harmonized with FDA Nov 2010 Article no: 1504301
Date of Issue
Section 1: Safety Instructions

Section Overview
Introduction
This section describes the safety features and warnings associated with the Exigo analyzer. This section contains the following topics: Topic Intended Use Safety Instructions Biohazards Emergency Procedures Warning Signs in Manual Signs on Equipment See Page 5 6 6 7 7 9
Contents
1.1 Intended Use

Description
The Exigo is a fully automatic hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions. Operator must have basic laboratory skills and be aware of good laboratory practice. Service must be performed by Boule Medical AB (hereafter referred to as 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. Each Boule system is tested using recommended reagents, blood controls, 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 patients hematological status. The clinician uses this data in conjunction with other diagnostic information and clinical findings to establish a patients diagnosis and recommended course of treatment.
Operator Requirements
Warranty limitations
Warranty stipulations
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. 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 personal injury. If a reagent comes in contact with eyes, rinse with running water for several 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.
Restrictions
Important
Handling of reagents
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. Protection of Laboratory Workers From Infectious Disease Transmitted by 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.
Support documentation
1.3 Biohazards
Handling of biohazardous material
(continued)
Always wear protective gloves and goggles. Follow local regulations. Handle samples with great care. Report incident according to local regulations. Do not touch the waste liquid when discarding waste.
If blood comes in contact with eyes or open cut, wash affected area with plenty of water. If the waste liquid is inadvertently touched, wash affected area with Mandatory Action disinfectant solution first and follow with soap.
1.4 Emergency Procedure

In case of emergency
If there are any obvious signs of malfunction such as smoke or liquid leaking out of the analyzer proceed as follows: Step 1 2 Action Disconnect the main power supply immediately by pulling out the cord from the main supply. 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 operators attention to this condition.
Sign Function
Indicates operation procedures that could result in personal injury or loss of life if not correctly followed.
Warning
Caution
Indicates operation procedures that could result in damage or destruction of equipment if not strictly observed. 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
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
GB DE ES IT FR DK GR SE PO PL NO EST CZ CN
Caution,consult instruction for use Achtung, Gebrauchsanweisung beachten Atencin,ver instrucciones de uso Attenzione, vedere le istruzioni per l'uso Attention voir notice d'instructions Forsigtig se brugsanvisning , Varsamhet, se bruksanvisning Ateno, ler as instrues de utilizao Ostrzeenie skonsultowa z instrukcj obsugi Forsiktig! Sjekk instruks nye fr bruk Hoiatus, vt. infot kasutusjuhendist Upozornn, pette si nvod k pouit
Biological risk Biologissche Risiken Riesgo biolgico Rischio biologico Risques biologiques Biologisk fare Biologisk risk Risco biolgico Ryzyko wystpienia skaenia biologcznego Biologisk risiko Bioloogiline risk Biologick riziko
Consult Instructions for UseGebrauchsanweisung beachten Consulte las instrucciones de uso Consultare le istruzioni per l'uso Consulter les instructions d'utilisation Se brugsanvisning Se bruksanvisning Consultar as instrues de utilizao Skonsultowa z instrukcj obsugi Sjekk instruks fr bruk Tutvu kasutusjuhendiga Pette si nvod k pouit
Use by Verwendbar bis Fecha de caducidad Utilizzare entro Utiliser jusque Holdbar til Anvnd fre Data de validade Uzyc przed Holdbarhet Kasutada enne Datum expirace
EC REP
2
LOT
Authorized representative in the EC Bevollmchtigter in der Europischen Gemeinschaft Representante autorizado en la Comunidad Europea Mandatario nella Comunit Europea Mandataire dans la Communaut europenne Reprsentant i det Europiske Fllesskab Auktoriserad representant inom Europeiska Gemenskapen Representante autorizado na Comunidade Europeia Autoryzowany Przedstawiciel w Unii Europejskiej Autorisert representant i EC Autoriseeritud esindaja EU-s Autorizovan zstupce vrobce pro EU
Temperature limitation Zulssiger Temperaturbereich Limite de temperatura Limiti di temperatura Limites de temprature Temperaturbegrnsning Temperaturbegrnsning Limites de temperatura Zakres temeratury przechowywania Temperaturbegrensning Temperatuuri piirang Limitujc teploty
Manufacturer Hersteller Fabricante Fabbricante Fabricant Producent Tillverkare Fabricante Producent Produsent Tootja Vrobce
Lot number Chargenbezeichnung Cdigo de lote Codice del lotto Code du lot Lotnummer Lotnummer Nmero de lote Numer serii Lot nummer Lot number slo are
EC
IVD
CONTROL H 16
High control, 16 parameters Hoch Kontrolle, 16 Parameter Control alto, 16 parmetros Controllo alto. 16 parametri Contrle haut, 16 paramtres Hj Kontrol, 16 parametrer , 16 Hg kontroll, 16 parametrar Controlo alto, 16 parmetros Poziomie wysokim kontrolny, 16-parametrowy Kontroll; 16 parametere, hy Krge kontroll, 16 parameetrit Vysok kontrola, 16 parametr
CONT
CONTROL
In Vitro Diagnostic Medical Device In Vitro Diagnostikum Producto sanitario para diagnstico in vitro Dispositivo medico-diagnostico in vitro Dispositif mdical de diagnostic in vitro Medicinsk udstyr til in vitro-diagnostik In Vitro In vitro diagnostik Dispositivo mdico para diagnstico in vitro Produkt medyczny do diagnostistyki in vitro In vitro bruk In Vitro Diagnostika Meditsiini seade Diagnostick inidlo In Vitro
Content Inhalt Contenido Contenudo Contenu Indhold Innehll Contedo Zawarto opalpwania Innehold Sisu Obsah
Control Kontrolle Control Controllo Contrle Kontrol Kontroll Controlo Materia kontrolny Kontroll Kontroll Kontrola
16
CONTROL N 16
GB DE ES IT FR DK GR SE PO PL NO EST CZ CN Normal control, 16 parameters Normal Kontrolle, 16 Parameter Control normal, 16 parmetros Controllo normale, 16 parametri Contrle normale, 16 paramtres Normal Kontrol, 16 parametrer , 16 Normal kontroll, 16 parametrar Controlo normal, 16 parmetros Poziomie normalnym kontrolny, 16-parametrowy Kontroll; 16 parametere, normal Normaalne kontroll, 16 parameetrit Normln kontrola, 16 parametr
CONTROL L 16
Low control, 16 parameters Nierig Kontrolle, 16 Parameter Control bajo, 16 parmetros Controllo basso, 16 parametri Contrle bas, 16 paramtres Lav Kontrol, 16 parametrer , 16 Lg kontroll, 16 parametrar Controlo baixo, 16 parmetros Poziomie niskim kontrolny, 16-parametrowy Kontroll; 16 parametere, lav Madal kontroll, 16 parameetrit Nzk kontrola, 16 parametr
REF
CAL
Catalogue number Bestellnummer Nmero de catlogo Numero di catalogo Rfrence du catalogue Katalognummer Katalognummer Referncia de catlogo Numer Katalogowy Katalog-/referansenr. Kataloogi number Katalogov slo
Calibrator Kalibrator Calibrador Calibratore Calibrateur Kalibrator Kalibrator Calibrador Kalibrator Kalibrator Kalibraator Kalibrtor
16
16
Figure 1.5 IVD Symbol Table
Section 2: Installation
Section Overview
Introduction Contents
This section describes how to unpack and install the Exigo analyzer. This section contains the following topics: Topic Unpacking / Operating Placement and Environment Installation Checklist and Menu Analyzer Cable, Interface, and Reagent Tube Connections Reagent Installation Changing Reagents Power Supply See Page 10 12 14 15 18 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 Material
Analyzer 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 Material
Printer 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/ Operating Placement
The analyzer should be placed in a laboratory environment according to the guidelines below: 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/ Operating Environment
Indoor Use Temperature +18 to +32 C (64 to 90 F) Humidity < 80% Relative Grounded main supply
Operating the analyzer in an environment over +32 C (90F) 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 1 Menus Installation Menu.
Action
Press Step 1 [SET DATE & TIME], set date and time, and press [EXIT] to return to
Figure 2.2
Figure 2.3
12
2.2 Installation Checklist and Menu

Step
(continued)
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. 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, remove factory seals, and connect the reagent tube assembly to respective bottles based on color-coding.
Figure 2.4
Figure 2.5
4 5
Press Step 3 [ENTER CONTROL BARCODES] to enter assay value ranges into the system for the lot of Control being used. 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 last for approximately 3 minutes.
Figure 2.6
Figure 2.7
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:
1 6 7 8 9
Figure 2.8
3 4 5
Number 1 2 3 4 5 6 7 8 9
Printer Installation Supported Printers Compatible Printers
Part Parallel port Keyboard port Serial (male) port Serial (female) port USB ports Power Adapter port Power switch Electronic Sensors Ground Connector
Function Connects printer to analyzer. Connects external keyboard to analyzer. Connects computer to analyzer. Connects barcode reader to analyzer. Connects USB cable to analyzer. Connects Main power outlet to analyzer. Switches power On and Off. Connects Reagent tube assemblies to analyzer. Connects Ground connector to analyzer.
The printer is connected to the rear of the analyzer with printer cable. (Printer is not manufactured by Boule.) See Figure 2.8. DPU 411/2 and DPU 414 (Supplied by Boule as an optional accessory). Follow the instructions in the printer users manual to install. HP-PCL, IBM Proprinter or USB compatible 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 colorcoded caps. Isotonic Diluent, Hemolyzing reagent, Enzymatic Cleaner and EOS Reagent hereafter referred to as Diluent, Lyse, Cleaner and EOS. (Specifically designed for the Exigo system.) This section describes placement of reagent bottles. 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.
Supported Reagents
Location of Reagent
Important
Connecting Reagent This section describes how to connect the reagent bottle tray to the analyzer. Bottle Tray
Step 1 2
Action 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 align with corresponding holes in the metal plate. (The Diluent port should be facing the front of the analyzer.)
Figure 2.9
Carefully set analyzer down. Reagent bottle tray is now in place.
15
2.4 Reagent Installation

Reagent Bottle Placement Step 1 2 3 4
(continued)
This section describes how to connect the reagent tube assemblies to the analyzer and where to place the reagent bottles for use.
Connect
The Diluent reagent tube assembly (red) and electronic sensor to the analyzer. The Lyse reagent tube assembly (yellow) and electronic sensor to the analyzer. 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 the analyzer.
1
4 2 3 4
1
2 3
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 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 2.11a
Figure 2.11b
Insert the reagent tube assembly assemblies into the corresponding reagent bottles.
16
2.4 Reagent Installation (continued)

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.
Caution
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.
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. Action Select MENU tab. 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.
Step 1 2
Figure 2.12
Figure 2.13
4 5
Return to MAIN Menu and press [ADVANCED]. Press [MAINTENANCE] and then [FILL SYSTEM].
17
2.4 Reagent Installation (continued)

Step Menus Action
Figure 2.14
Figure 2.15
Figure 2.16
6 Print All Settings
The system is now filling up with reagents. This cycle will last for approximately 3 minutes.
After initial setup, it is recommended to print all analyzer settings and keep for personal records. Select [ADVANCED] from Main Menu, then [SETUP], and then [PRINT ALL SETTINGS]. Both sample analysis modes (Open Tube and MPA) are factory calibrated. However, calibration should always be checked upon installation. See Section 7 for more details.
Factory Calibration
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 1 2 3 4 5 6 7 8 9 10
Action Select [MENU] to access the Main menu and then select [REAGENT SETUP]. Select [ENTER NEW REAGENT]. Scan Barcode 1 and then Barcode 2 from the side of the reagent container. Press and hold the ON button on the barcode reader each time a barcode is scanned. When all barcodes are entered a screen will display that reagent barcodes have been accepted. Select [EXIT] to return to the Main menu. Remove the used reagent container from the reagent tray. Place the new reagent bottle in the proper reagent tray position. Remove the cap and seal on the new reagent container. 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 necessary when putting on a new reagent bottle, if indicator and warning messages are followed.
Important
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 sample run until the indicated container is changed.
18
2.6 Power Supply

Main supply environment
The power supply is an external all voltage/frequency power supply and 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 results. In case of an abrupt power loss there will be no damage done to the analyzer. Calibration constants and other parameters necessary for operation are protected against main supply loss. Connect the external power adapter to the analyzers power adapter port and connect it to the main power supply. (This should only be performed after connecting the reagent bottle tray and the reagent tube assemblies to the analyzer.)
Warning
Power interruptions
Connecting Power Cable
19
Section 3: General Overview

Section Overview
Introduction
This section contains general information about the analyzer and optional accessories. This section contains the following topics: Topic General Analyzer Overview System Menu System Flow Sample Volume, Throughput, and Parameters See Page 20 21 23 24
Contents
3.1 General Analyzer Overview

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

New Sample Sample List Menu Prime System Power Down Advanced Reagent Setup Standby Q/C > > >
ID_______ 1,2,3..CE.. Set Profile Next Profile Prev Profile Run Con/Cal Operator ID A,B,C.. 1(4) ...1 (4) (optional) >
11 possibilities of Analysis profiles Next Prev
Ok Run Con/Cal Sample

12 possibilities of Con/Cal Assay Values Next Prev
> > > >
> > >
Ok Cancel
<
Cancel
Sample
New Sample >
[GRAPH WBC] [GRAPH RBC] [GRAPH PLT] [PARAMETER RESULT]
1/4 2/4 3/4 4/4
ABC abc 123...!?/...CE (optional)
Ok Cancel
! Prev Next 1(3) List Menu Print
> <
Select Sample Criteria

ID __________________ Seq (fr-to) ____________ Date (fr-to)____________ Profile Today Select All Selected __/__
List
New Sample > Sample Search > [SEQ. x-y LISTED] Previous Next 1(6) (param. listed) > Menu < Print
Exit Sample Report Delete Send Print Stats
Reagent Setup Menu

Enter New Reagent View Reagents Inactivate Reagent
Diluent: xx more cycles. Lyse: xx more cycles.
> > >
Reagent Barcode Input

Input manually Exit > >
View Reagent Statistics

Current Diluent/Lyse/Cleaner Cycles Left Lot No./Pack No. Exp. Date Open Date/Last Date
Q/C Menu
View Con/Cal Enter Con/Cal View Assays Exit > > > <
Print 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
Prime System Clean Orifice Fill System Cleaning Menu Empty System Probe Flush >
Cleaning Menu
Read the cleaning kit instructions before proceeding further! Clean Cycle Empty Clean Cycle Fill > >
Exit
<
Exit
<
Service Menu
Serial no Firmware
Service Menu 2
> > > > > > > >
Serial no Firmware
Advanced
Calibration Maintenance Service Setup > > > > <
Clot Removal Noise test Configuration Pump & Valve Instrument Log Flush Shear Valve Ptest (if applicable) Service Setup 2
Blood Detector Level Detectors Beaker Detector Reagent Detector HGB Shear Valve CVP (if applicable)
> > > > > > >
Exit
Exit
<
Exit
<
Setup Menu 1
Print Setup Serial Setup Print All Settings Send All Settings SEQ No. Setup Setup Menu 2 Analysis Profile > > > > > > > <
Setup Menu 2
Barcode Setup Memory Setup Blood Det. Setup Standby Setup Date/Time Setup Regional Setup Setup Menu 3 > > > > > > > <
Setup Menu 3
Color setup Mixer Setup PLT offset Setup High Alt. Setup Instrument ID > > > > > <
Exit
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 screen to view screen
In Standby Mode
Press [EXIT]
Press anywhere on screen to view screen
Returns user to last displayed page

* 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.
Press [Exit Standby] and OPID to exit standby mode
23
3.4 Sample Volume, Throughput, and Parameters

Description
The Exigo is a fully automated cell counter reporting up to 19 parameters. < 125 l (Open Tube), 20 l (MPA) Analysis time (open tube, whole blood) is ~1 minute. Analyse time including EOS is ~ 3 minutes
Sample volume
Throughput
19 Parameters
See list of parameters below: WBC LYM% LYM# MONO% MONO# GRAN% GRAN# NEUT% NEUT# EOS% EOS# Leukocyte parameters Total White Blood Cell Count Lymphocyte percentage Lymphocytes (absolute) Monocyte percentage Monocyte (absolute) Granulocyte percentage Granulocyte (absolute) Neutrophile percentage * Neutrophile (absolute) * Eosinophile percentage* 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 Total Platelet Count Mean Platelet Volume
PLT MPV
24
Section 4: Analyzer Setup

Section Overview
Introduction
This section covers the initial configuration needed to customize the analyzer settings. This section contains the following topics: Topic Menu Selection Initial Setup Advanced Setup Reagent Setup User Interface See Page 25 26 27 31 33
Contents
4.1 Menu Selection

Main Menu upon initialization
The List Menu will be displayed upon 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
Figure 4.1
Figure 4.2
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. The date/time function is shown on all samples and printouts and should always be setup correctly. To set date/time follow the instruction below: Step 1 2 3 4 5 Menus Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP], then press [SETUP MENU 2]. Press [DATE/TIME SETUP] to enter the set date/time menu. Press [DATE FORMAT] to select date specific setting.
1 = DD/MM/YY; 2 = YY/MM/DD, 3 = YY/DD/MM, 4 = MM/DD/YY
Setting up date/time
Press on the item that you want to change and enter the changes on the numerical pad. See Menus below.
Figure 4.3
Figure 4.4
Setting up language
Change of display language is performed by following the instructions below: Step 1 2 3 4 5 6 Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP], then press [SETUP MENU 2]. Press [REGIONAL SETUP], a list of local settings will be displayed. Press [MORE] until language button is displayed. Press [LANGUAGE] to enter language screen. Choose the number that corresponds with the language desired and 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. The analyzer has been automatically set to the DPU 411/2 and DPU 414 printer provided by Boule. (Printer Type 1) 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 compatible.
Default Printer
USB Printer
Select Printer Type
Follow the instruction below for interfacing analyzer to different printer types. (To connect printer see Section 2.3) Step 1 2 Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP] and then [PRINT SETUP] to enter the Print Setup menu. Press [MORE] to view Printer type. Printer types are as follows: 1 = Seiko DPU 411/12 and 414 (default setting) 2 = IBM proprinter / Epson compatible format 3 = HP PCL 3 and 5 protocol compatible 4 = USB printer To change printer type press [PRINTER TYPE], enter the correct number and press [OK] to save.
Print modes
To select options for printing results: Step 1 2 3 4 5 Note Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP]. Press [PRINT SETUP] to enter the printer setup menu. To set Manual Print Mode function select from the following: 0 = None, 1 = Without Histograms, or 2 = With Histograms (default). To select Auto Print Mode function select from the following: 0 = None, 1 = Without Histograms, or 2 = With Histograms (default). Extended printer format settings and user definable print layouts are 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. Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP] and then [SETUP MENU 2]. Press [BARCODE SETUP] to enter the barcode setup menu. Choose the format that is appropriate for the barcode reader being installed. (The generic driver is most common and is compatible with most readers). 0 1 2 No barcode reader Generic barcode reader (9600N81) Panasonic ZE-84RMSM (9600O72)
Step 1 2 3
Keyboard Setup (optional)
To setup the keyboard follow manufacturer instruction for setup and plug into analyzer keyboard port. See Section 2.3 for details. Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP] and then [SETUP MENU 2]. Press [REGIONAL SETUP] and then [MORE]. Press [KEYBOARD LAYOUT], and select keyboard type. Press [EXIT] until Main Menu is reached. Turn analyzer OFF, and then turn ON again for changes to take effect.
Step 1 2 3 4 5 6
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 1 2 3
4
Note
Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP], then [SETUP MENU 2] and then [SETUP MENU 3]. Press [HIGH ALT. SETUP], and then [HIGH ALTITUDE COMPENSATION]. Choose the setting that is appropriate for your location: 0 = No Compensation (default) 1 = Moderate Compensation 2 = Maximum Compensation By choosing 1 or 2, the software incorporates some minor timing sequences for the wash cycles, no other functions are affected.
28

Activate Mixer
To activate mixer follow the instruction below: Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP] and then [SETUP MENU 2]. Press [SETUP MENU 3] and then [MIXER]. If the mixer is activated the button will have brackets [X]. To deactivate press button and select ( [ ] ).
Step 1 2 3 4
Menus
Figure 4.5
Figure 4.6
Note
Upon sample aspiration mixer will discontinue rotation until sample 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 1 2 3 4 5 Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP]. Press [SERIAL SETUP] to enter the serial setup menu. To set Manual Send Mode function select from the following: 0 = None (default), 1 = Without Histograms, or 2 = With Histograms. To select Auto Send Mode function select from the following: 0 = None (default), 1 = Without Histograms, or 2 = With Histograms.
29

Data The analyzer is equipped with three different outputs for connection to a Communication computer (network).
1. USB output with USB port connector. 2. Serial output with a male 9 pin DSUB (RS232 specification)
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 1 Start by pressing [ADVANCED] from the MENU tab. 2 Press [SETUP], then [SERIAL SETUP], and then [MORE]. Menus
Figure 4.7
Figure 4.8
3 4
To activate the USB connection to a PC computer, press [SELECT SEND PORT] button, then type in [ 2 ], and then [OK] to save. To activate the USB connection to a memory stick, press [SELECT SEND PORT] button, then type in [ 3 ], and then [OK] to save.
Figure 4.9
Note
For Select Send Port activation to function correctly user must have a PC application that can receive and process reports.
30

To connect to a PC computer using a 9 pin RS232 see instructions below: Cable end analyzer (9pin) 2 3 5 7 8 Cable end pc (9pin) 2 3 5 7 8
To connect to a PC computer that uses a 25 pin RS232 see instructions below: Cable end analyzer (9 pin) 2 3 5 7 8 Cable end PC (25 pin) 3 2 7 4 5
The pinning of the male 9-PIN-DSUB is as follows: (analyzer end) 1 Not used 2 TX-OUTPUT 3 RX-INPUT 4 Not used 5 GND 6 Not used 7 CTS-INPUT 8 RTS-OUTPUT 9 Not Used
4.4 Reagent Setup

Description
This section describes the functions of the reagent setup menu and how to access reagent statistics. The Exigo system is interlocked with specified Boule reagents for optimal performance. The reagent bottles must be identified by the analyzer before analysis of samples can begin. To identify reagents scan in or manually enter the barcodes on the reagent bottles. See section 2.4.
Reagent Input (Enter New Reagents)
31
4.4 Reagent Setup

View Reagent
(continued)
The system monitors reagent consumption and computes remaining cycles. This information may be viewed at any time, in one of two ways:
Method 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 Diluent, Lyse, Cleaner and EOS are displayed. (It is important to remember that cycles include analyses, wash cycles, background counts, primes, exit standbys, etc.)
Step 1 2
Menus
Figure 4.10
Figure 4.11
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. 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.
Figure 4.12
Figure 4.13
32
4.4 Reagent Setup

Inactivate Reagent
(continued)
It is possible for the operator to inactivate the current reagent bottle by pressing 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.) The interlocked reagent system displays indicator and warning messages to alert the operator when reagents are running low and need to be changed. See Section 12.2 and 12.3.
Reagent Indicators
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. 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:
Analysis Profile
Step 1 2
Action Start by pressing [ADVANCED] from the MENU tab. Press [SETUP], then [ANALYSIS PROFILE] to enter the Analysis Profile Setup menu.
Figure 4.14
Figure 4.15
Note 5
To set profile name press [NAME]. Press [PREV] or [NEXT] to choose an open profile on list (e.g. AP8, AP9, etc). 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 analysis. To set new profile as default press [DEFAULT] and select [X].
33
4.5 User Interface

Step
6
(continued) Action
7 8 9
Note
10
Note
To block certain parameters press [BLOCK PARAMETERS] to see list and then [MORE] to 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 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 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 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 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 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 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 1
Action
To view recent previous analyses present in a sequential list, press [PREV] or [NEXT] buttons 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.
Figure 4.16
Figure 4.17
Note
To return to previous selection criteria press [SEARCH], then [SELECT ALL], and then [EXIT].
34
4.5 User Interface

Step 3 4 5 6 7 Note
(continued)
Action To view Sample Statistics, select sample or group of samples to view, and press [STATS] to enter the Statistical Results menu. 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 display a prompt to verify deletions, press [YES]. To print a summary report of every sample run press [SAMPLE REPORT] and then [PRINT ALL SUMMARY REPORT]. To print a summary report of a selected group of samples, select desired criteria (See #2 above), then press [SAMPLE REPORT] and then [PRINT PATIENT SUMMARY REPORT]. These summary reports will print on a horizontal sheet of paper. 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]. From Menu tab press [ADVANCED] and then [SETUP] to enter Setup Menu. To change sequence number press [SEQ NUMBER SETUP], press [NEXT SEQ NUMBER], enter in new sequence number and press OK to save. More detailed Setup Menu descriptions can also be found in the User Definable Settings document, which can be located at www.exigo-vet.com > Support > Downloads > Documents.
Change Sequence Number
User Definable Settings Document
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. This section contains the following topics: Topic Preparations before Analysis Startup Sequence Background Count Sample Identification Analyzing the Sample (Open Tube) Analyzing the Sample (Micro Pipette Adapter, MPA) Results See Page 36 37 38 39 40 42 44
Contents
5.1 Preparations before Analysis

EDTA K3 (Ethylene Diamine Tetracetic Acid, Tri-potassium) liquid and EDTA K2 Anticoagulant recommendation (Ethylene Diamine Tetracetic Acid, Di-potassium) spray-dried solution. Recommended by ICSH and NCCLS. Sample collection Obtain the sample by means of a clean venipuncture to minimize platelet 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 guage. 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 of samples
Immediately mix the EDTA tube by gentle inversion 6-8 times to adequately mix 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. See Section 5.7 for details of handling of capillary blood samples using the Micro Pipette Adapter (MPA). 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 4 hours. Excessive cold or heat could cause erroneous results.
Handling of capillary blood samples
Important
36
5.2 Startup Sequence

Startup Sequence
The following sequence walks the operator through the beginning of the day startup 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. 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.
Default setup
Step 1
2 3
Action Touch display or switch on power to the analyzer. Press [EXIT STANDBY] or [PWRUP], depending on how the analyzer was shutdown previously, to wake up the analyzer. When wake up cycle is complete, press start plate to begin the first step of the startup sequence.
Menus
Figure 5.1
Figure 5.2
Note Menus
When complete the background count results are displayed. If the results are acceptable, 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 screen instructions to analyze background count again.
Figure 5.3
Figure 5.4
37
5.2 Startup Sequence

Step
5
(continued)
Note Menus
Action When complete the control results are displayed. If control results are acceptable, the startup sequence is complete. Press [ANALYZE SAMPLES] 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] to analyze control sample again.
Figure 5.5
Figure 5.6
5.3 Background Count

Background Check
The following sequence is performed to check that the background count is low 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 1
2 3
Action From the main screen press [NEW SAMPLE]. Press [NEXT PROFILE] or [PREV PROFILE] to scroll to BACKGROUND and press OK to save. Press the whole blood start plate, which is located behind whole blood 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

Accepted Background values
(continued)
The background count should not be higher than the figures shown below. Rerun sample if values are not acceptable.
Parameters RBC WBC HGB PLT Values accepted 0.03 (1012/ L) 0.2 (109/ L) 0.2 (g/ dL) 10 (109/ L)
5.4 Sample Identification

Description
This section describes the different methods of inputting Sample IDs (Identification). The ID can be entered with the following methods: Manually (touch screen or external keyboard) Barcode (See section 4.3)
ID Input Methods
Character Input 15 Characters Limitations
Step
1 2 3 4 Menus
Action From the main screen press [NEW SAMPLE] or begin sample aspiration, which automatically opens NEW SAMPLE menu. Press numerical keys to enter sample ID or scan in the ID barcode from the sample tube. Press [NEXT PROFILE] or [PREV PROFILE] to scroll to desired profile. Press OK to save profile and sample ID or begin sample aspiration.
Figure 5.8
Figure 5.9
Aspirate sample following selected procedures in sections 5.4 5.5.
39
5.4 Sample Identification

Operator ID
(continued)
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. Refer to Section 5.1 for blood sample preparation and then follow the procedure below: 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 occur, causing erroneous results. Sample Aspiration Step
Starting procedure
Important
Figure 5.10
40
5.5 Analyzing the Sample (Open Tube)
(continued)
Sample Aspiration Display
Figure 5.11
Figure 5.12
The analyzer now switches to the sample analysis screen.
Figure 5.13
Figure 5.14
7 8 9
In first screen displayed above Sample ID and profile can still be added. Results will be displayed on List or Sample menu. For more information of results refer to Section 5.7. When NEW SAMPLE button returns to green, operator can begin analysis of next sample.
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). ONLY Boule supplied, plastic, high precision EDTA micropipettes should be used when running MPA. Glass micropipettes can cause damage to analyzer if inserted incorrectly. Follow the procedure below to operate MPA: Action Choose List, Sample, or Main menu to begin sample analysis. Analyzer must be in one of these operation modes to aspirate. Pull out the MPA adapter. (The analyzer will give an instruction to put back the loaded MPA adapter to start the analysis cycle). Remove the previous sample micropipette. (If applicable) Place the adapter on the table. The EOS parameter is not available through MPA mode.
Micropipettes
Starting procedure Step 1 2 3 4 Note
Drawing blood and sample preparation: Step Action Aspirate the sample as shown below.
Figure 5.15
Important
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. Ignoring these instructions might cause incorrect and non-reproducible results.
Figure 5.16
42
5.6 Analyzing the Sample (Micro Pipette Adapter, MPA)

Step
(continued)
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
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 a sample has been analyzed the result information can be viewed in the following three screen displays:
After sample analyze
Sample View 1
Sample ID Analysis mode and 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
Normal Range display with sample results.
Sample results
Information Indicator - When flashing user can press button to display system information and/or sample pathology.
Red bar = Results Out-of-Range
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 differential values HGB parameter
WBC histogram
RBC histogram PLT histogram
HCT and RBC parameters
PLT count and PLT parameters
Figure 5.21
Sample View 4
Total WBC count
EOS count in absolute and % values
EOS histogram
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. This section contains the following topics: Topic Quality Control (QC) Levey-Jennings Plots See Page 46 48
Contents
6.1 Quality Control (QC)

Introduction
This section describes the procedures to be performed for running control samples. Follow the instruction below to access the QC menu and to input Control/Calibrator Assay Values from the Assay sheet. Action Enter the QC menu by pressing [QC] from the menu tab. 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).
QC Menu and CON/CAL Assay Values input
Step 1 2
Figure 6.1
Figure 6.2
Note
Assay values for 12 different lots can be stored simultaneously. When renewing the assay values, the previously scanned CON/CAL assay values will be removed in a chronological order starting with the assay values that were entered first.
46

Control Analysis
(continued)
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. Wipe the sample probe with a clean, dry tissue before each control run. Not following this discipline might lead to decreasing parameter values.
Important
Step 1 2
3 4 5
Action
Follow directions on Assay Sheet to scan in values of the Lot of control material in use. 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 manually enter in barcode. Aspirate the blood control and wait for the results. The Exigo analyzer will identify this ID and match the results with the previously defined assay values. 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 1 2
3
Action
Enter the QC menu and press [VIEW CON/CAL]. 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 be selected.
Menus
Figure 6.3
Figure 6.4
Press the [SAMPLE] or [LIST] buttons to display the selected samples.
47

Step
(continued)
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. 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
Figure 6.5
Figure 6.6
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. 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 L-J Plots
This section describes selecting, viewing, and printing Levey-Jennings Plots. Levey-Jennings (L-J) plots are used to monitor the long term stability of the analyzer using Boule 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.
Blood controls
48
6.2 Levey-Jennings Plots

Displaying and printing L-J Plots
To display and print the L-J plots, follow the instructions below:
Action 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.
Step 1
Figure 6.7
Figure 6.8
4 5 6
Scroll through parameters by choosing [MORE]. Print diagrams by choosing [PRINT]. 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. This section contains the following topics: Topic Preparations before calibration Calibration See Page 50 51
Contents
7.1 Preparations before calibration

Before Calibration
It is advisable that the performance of the Exigo system is checked daily with 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. Verify that nothing is erratic with the control blood, the reagents, or the analyzer before calibrating analyzer. 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. 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, dry tissue before each calibrator run. Not following this discipline might lead to decreasing parameter values.
Important
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 Calibration
The following instructions are used to calibrate the Open Tube mode. Follow the instructions below to calibrate: Step 1 2 3 4 Action Follow directions on Assay Sheet to scan in calibrator assay values. Choose either List, Sample, or Main menu to begin calibrator analysis. Using installed barcode reader, scan the Calibrator ID from the calibrator vial label. To perform calibration, it is recommended that five calibration analyses be performed in consecutive order through the open tube mode. When analyses are complete press [ADVANCED] from the MENU tab. Press [CALIBRATION] and then choose [WHOLE BLOOD].
Important
Figure 7.1
Figure 7.2
Note
Calibration analysis must be last analysis performed on analyzer for parameter values to be shown in calibration menus. (e.g. no values 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 meet the limits below: Parameter RBC MCV PLT HGB WBC OT CV% < 2.2 < 1.8 < 5.8 < 1.8 < 4.2 MPA CV% < 3.2 < 1.8 < 6.2 < 2.9 < 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 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 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. 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 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 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 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].
10
11
12
Note
13
Figure 7.3
52
7.2 Calibration
14 15
(continued) Perform steps 10-11 for RBC, MCV, PLT, HGB, and WBC parameters. To move to the next parameter press [NEXT]. It is recommended to not change preset calibration factors for RDW%, 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
17
It is recommended to run controls after calibration to verify that all parameters have been calibrated correctly and that calibration is synchronized with the control program. See section 6.1 to perform QC. To calibrate MPA follow Steps 1-17 above except select [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.)
Capillary Device Calibration
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Section 8: Cleaning, Maintenance & Transport

Section Overview
Introduction
This section contains information that is crucial for maintaining, transporting and storing the Exigo system. This section contains the following topics: Topic Daily Cleaning Annual Cleaning Analyzer Maintenance Re-location of analyzer (within the laboratory) Short Term Transport (<12h) Re-packaging and Long Term Transport Permanent Shut-Down and Storage Disposal Information See Page 54 55 55 56 56 57 57 58
Contents
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 Procedure
The Daily Cleaning takes only a few minutes, the instructions are as follows: Step 1 2 Action Clean the sample probe using a paper tissue moistened with a 70% alcohol solution. Remove possible traces of salt crystals or blood at the top of the sample probe and probe rinse cup using a paper tissue moistened with the alcohol solution.
Automatic Cleaning Mode
The Exigo system has been designed to clean internal components on a daily 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 analyzers internal tubing, the following cleaning procedure is strongly recommended. Press [ADVANCED] from Main menu, then press [MAINTENANCE], and then 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.
Cleaning Procedure
Figure 8.1
Figure 8.2
Figure 8.3
Boule Cleaning Kit
The Boule Cleaning Kit contains the following items: Hypochlorite (2%) Enzymatic cleaner Detergent cleaner When necessary, gently clean the display with a soft cloth, slightly moistened with water and a mild soap. Dry carefully.
LCD Display
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. The preventive maintenance should be performed annually by local distributor or an authorized service technician.
Maintenance
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). If the analyzer is in standby mode do not unplug analyzer. Make sure that the analyzer is in Sample or List menu before turning off.
Before the relocation Step 1 2 3 Re-location
Action Detach the reagent tray from analyzer but DO NOT detach the reagent tube assemblies or the electronic sensors. Move these components together after analyzer has been re-located. Remove the waste line from waste container or drain, but do not detach tube from analyzer. Disconnect all electrical connections.
Make sure that the analyzer is lifted from beneath to avoid unnecessary stress on the front cover.
After re-location Step 1 2 3 Action Place the waste line in waste container or drain. Re-attach the reagent bottle tray. Reconnect the electrical connections.
8.5 Short Term Transport (< 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.
Action Begin by emptying the system. Remove the reagent tube assemblies from the reagent bottles. (System will not perform empty cycle if reagent tube assemblies are not removed from the bottles.) Remove reagent bottles from reagent bottle tray. Press [ADVANCED] button on MENU tab. Press [MAINTENANCE] and then [EMPTY SYSTEM]. When empty procedure is complete, the following statement will appear on screen: System is empty and ready for fill or power off. Switch off power and then unplug analyzer.
Step 1 2 3 4 5 6
Before the relocation
After analyzer is powered off, detach reagent tube assemblies, waste line, reagent bottle tray, electronic sensors and all electrical connections. Package all components carefully for transport. The analyzer should be transported in temperature conditions between 5 to 30 C (41 to 86 F) Humidity should be less than 80%.
Guidelines for transport
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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).
Important
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 reinstallation.
Long term Shut-Down
Step 1 2 3 4 5 6 7 8 9
Action Select [CLEANING MENU] from MAINTENANCE Menu, and then select [CLEAN CYCLE EMPTY]. Follow the instructions for the Boule cleaning kit. (Instruction is supplied with the Boule cleaning kit solutions). After completing the cleaning of the analyzer, insert the reagent tube assemblies into distilled water. Select [CLEAN CYCLE FILL] from CLEANING Menu. When the analyzer has been filled with distilled water, select [PROBE FLUSH] from MAINTENANCE Menu. Repeat. After the two Probe Flushes are complete, remove reagent tube assemblies and select [CLEAN CYCLE EMPTY] from CLEANING Menu. When system is emptied, disconnect the main supply cable and all other connections such as reagent tube assemblies, reagent bottle tray, and waste line. Pack the analyzer using the original shipping container. Mark the container with DELICATE ANALYZER, FRAGILE and THIS SIDE UP. Follow Guidelines for transport below. The analyzer in its export package should fulfill the following transport/storage conditions: Does not exceed - 40C for 24 hours. Does not exceed a Dry heat of + 70C for 24 hours. Dramatic change of temperature between - 40C and + 30C. Does not exceed a Damp heat steady state of 90% RH and + 40C during 48 hours. Does not exceed a Damp heat cyclic of 90-100% RH and + 25/+40C 12+12 hours.
Guidelines for transport
8.7 Permanent Shut-Down and Storage

Permanent Shut-Down and Storing
Prepare the analyzer using the same procedures as Section 8.6, Long Term Transport.
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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. Used reagents Reagents mixed with potentially biohazardous material Instrument and instrument components Controls and calibration material
Disposal Materials
Manufacturer Guidelines for waste products
Place the instrument close to a waste container or drain suitable for disposal of used reagents. 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 2002/96/EC 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.

Important
The instructions for decontamination can be found on the Boule home page www.boule.se under User Support. If there are any question on how to follow this procedure, contact your local 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
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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 outof 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. As granulocytes include neutrophils and eosinophils all parameter and system information messages use the common word granulocyte (GRAN).
Note
Contents
This section contains the following topics: Topic Low & High Abnormal Results Information Sample Pathology System Information See Page 59 60 68
Description of Information Indicators
Information is indicated on the touch screen with the results and is printed on the patient report. For Sample Pathology and System Information messages, the touch screens 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 Normalcy Reference ranges are inherently probabilistic estimates of normalcy in a given 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.
Reference ranges are not required for proper sample analysis by the system software. Unusual Species 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. The L and H messages are also applied to results of control samples compared with 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.
Specific Assay Value Ranges
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. The Sample Pathology information includes a short message defining the sample 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.
Triggering mechanisms
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Evaluating Sample Pathology
(continued)
This information brings attention to results that are likely to have additional pathology or clarifying findings that may be detected in either a blood film review or other 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 < 3000 Information Message WBC: Leukopenia; slide review advised Recommended Action The total WBC and differential are reliable. Pathology of WBC 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. WBC: Leukocytosis; slide The total WBC and differential are reliable unless there is pathology 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.
> 15% above upper limit
WBC Differential
Criteria WBC Histogram Mode < 90 fl with single population present Information Message WBC DIFF: Lymphocyte predominance; slide review advised WBC DIFF: Abnormal WBC Histogram WBC distribution; slide Mode < 190 fl review advised. with single population present Recommended Action Scan the blood film with low magnification to verify that the majority cell is lymphoid. Use high magnification to determine if there is abnormal 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. Scan the blood film with low magnification to get a sense of the predominant cell population. Possibilities for this pattern include the following: 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.
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Criteria Grans 90% and WBC Histogram Mode > 190 fl Information Message WBC DIFF: Granulocyte predominance; slide review advised
(continued)
WBC Differential
Recommended Action Scan the blood film with low magnification to verify that there are no surprises such as: o Blast cells that may mimic granulocytes 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% above upper limit Criteria > 10% above upper limit Criteria > 10% below lower limit > 10% above upper limit
EOS%: Evaluate histogram See description of EOS% in this section. & WBC morphology on slide
RDWa
Information Message Recommended Action RDW: Evaluate histogram & See description of RDW in this section. RBC morphology on slide
MCV
Information Message MCV: Evaluate histogram & RBC morphology on slide MCV: Evaluate histogram & RBC morphology on slide Recommended Action As described for RDWa, a low MCV will be associated with an RBC histogram that has widened to the left. Evaluate the blood film for RBC features of iron deficiency. As described for RDWa, a high MCV will be associated with an RBC 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
Criteria > 10% below lower limit > 10 % above upper limit Information Message Recommended Action HCT: Anemia; evaluate RBC See description of HCT in this section. on slide HCT: Evaluate patient for Evaluate physical hydration status and serum or plasma protein 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
Criteria > 10% below lower limit Information Message MCHC: In the following order: Evaluate for extreme RBC regeneration Run Control Recommended Action Examine the data and blood film for any features above that may explain a mildly decreased MCHC value. If erythrocyte abnormalities on the blood film are ruled out, analyze the sample a second time. 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.
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Criteria > 10% above upper limit Information Message MCHC: In the following order: Evaluate for turbidity, lipemia, and extreme hemolysis Heinz bodies cat Evaluate for agglutination /spin crit Run Control
(continued)
MCHC
Recommended Action This value is not physiologic. It is usually due to interference with the hemoglobin measurement because of sample turbidity or sample hemolysis. Check the sample for the known sample-related causes of a disproportionately high hemoglobin or false low HCT. Potential causes of sample-related high hemoglobin relative to HCT include: o Lipemia the most common cause o Marked sample hemolysis 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
Criteria > 25% below lower limit Information Message Recommended Action PLT: Evaluate platelets on The stained blood film should be examined to verify the decreased 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. PLT: Evaluate histogram High platelet concentration is not very important for clinical 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.
> 50% above upper limit
63
(continued)
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 Lymph Mode Gran 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.
Figure 9.2
Figure 9.3
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.
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WBC Mode < 90 fl
(Lymphocyte Predominance)
(continued)
This pattern is usually due to either lymphocytosis or neutropenia. If it is due to neutropenia, the total WBC will be decreased. If there is lymphocytosis, the 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.
Figure 9.4
Figure 9.5
WBC Mode < 190 fl

(Abnormal WBC Distribution)
This is a relatively uncommon pathologic leukocyte response. Several highly abnormal WBC responses may cause this pattern. The pathology is best 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. Examples are shown above in Figures 9.2 and 9.3 in WBC Differential 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. During the cell analysis interval, a very large number of erythrocytes are 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.
WBC Mode > 190 fl

(Granulocyte Predominance)
Background on Erythrocyte Sizing
65

Erythrocyte Sizing Calculations
(continued)
The mean cell volume, MCV, is calculated from the total number of erythrocyte 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 RDW = CV SD MCV X 100
Relative Number
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. Recommended actions for additional evaluation: RDWa > 10% 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
Cell Volume (fl)
300
Figure 9.7
66
(continued)
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
Cell Volume (fl)
300
Figure 9.8
Note Decrease in HCT
There is no pathologic response that results in a decreased RDWa value. Recommended actions for additional evaluation: 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 RBCs in the blood film monolayer to determine either absence or evidence of erythrocyte regeneration. This is indicated by increased polychromatophilic erythrocytes on the Wrights 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
(continued)
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 MCHC Background on MCHC. The MCHC value has little clinical utility. Its value is 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 RBCs are lysed liberating hemoglobin into the dilution. See Figure 9.9.
RBC / PLT Dilution Subsystem WBC / HGB Dilution Subsystem
Measure RBC and MCV through aperature (arrow) then, HCT = RBC x MCV
Lyse RBC, liberating free HGB Measure HGB by photometry Also count WBC
MCHC (g/dl) =
HGB HCT
x 100
MCHC physiologic reference range for most species = 32 - 38 g/dl
Figure 9.9
68

MCHC as a Physiologic Constant
(continued)
Within animal blood, the MCHC value is a physiologic constant that may be used to monitor the relationship between hemoglobin concentration and HCT. Therefore, for 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.
Values < 30 g/dl are not physiologic and values < 25 g/dl are nonsensical. Some possible 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 90s) and MCHC values in the mid 20s 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 30s. 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.
Decrease in MCHC
Increase in MCHC Note
See Sample Pathology Information Messages table.
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 reanalyze 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

Note
(continued)
#### 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 AF Message Aspiration failed, check sample Description Possible reasons for AF flag include a short sample, clogging or air bubbles in sample tube. Note: This flag is also displayed when running a background count (blank) without selecting the background analysis profile. Action Check profile type is correct and then re-analyze sample.
HGB Indicators (HGB)

Indicator HF HH HL HN Message HGB Measuring Problem run prime cycle HGB Measuring Problem run prime cycle HGB Measuring Problem run prime cycle HGB Measuring Problem wait one minute then re-analyze HGB Measuring Problem restart system Description The instrument detected a problem during the filling of liquid in WBC counting chamber during HGB blank. The HGB blank or sample readings reported a too high light level. The HGB blank or sample readings reported a light level that was too low. The HGB sample reading reported more light than the blank reading. This gives a negative HGB value. The HGB dark (offset) reading reported a light level that was too high or too low. Action Run a Prime cycle, before re-analyzing the sample.
Wait one minute, and then re-analyze sample.
Switch off the analyzer and switch it back on after HO 3 seconds, and then reanalyze sample. Run a Prime cycle, HGB Measuring Problem Individual HGB readings vary too much. before re-analyzing the HS run prime cycle sample. Ensure instrument is in If HT-flag; the instrument temperature reading ambient temperature of Temperature reading about 18-32C. If still HT is outside the limits (10-50 C) or the HT error (HGB) flag, contact a service temperature sensor is nonfunctional. 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.
Measuring Chamber Indicators (RBC, PLT, WBC)

Indicator Message Description The cell pulses arrived faster than the analyzer could process them. Possible reasons might be air bubbles, electrical disturbances or incomplete lysing. 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 lyse cells. 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. Action
OR
Measurement warning re-analyze
Re-analyze sample
SE
Measurement Statistics Warning; re-analyze
Re-analyze sample
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(continued)
Mixing Beaker Indicators (RBC, PLT, WBC)

Indicator TE Message Liquid System Problem run prime cycle Description The analyzer detected an abnormality during the emptying of the first dilution from the mixing beaker. Reasons for flagging might be timeout, or too short of a transfer time. Description A control blood was used past its expiry date. The reagent was used past its expiry date. Change to a non-expired lot of reagent. The analyzers capacity counter has gone below zero and no reagent is detected. Reason for no reagent may include empty reagent bottle or reagent tube assembly not inserted correctly into reagent bottle. Description The analyzer detected an abnormality during one of the fill cycles of the diluent pipette. Reasons for flagging might be timeout, short time or bubbles at the upper detector. The analyzer detected an abnormality during one of the empty cycles of the diluent pipette. Reasons for flagging might be timeout, short time or liquid not detected at the lower detector. The analyzer detected an abnormality during the fill cycle of the lyse pipette. Reasons for flagging might be timeout, short time or bubbles at the upper detector. The analyzer detected an abnormality during the empty cycle of the lyse pipette. Reasons for flagging might be timeout, short time or liquid not detected at the lower detector. The time for the liquid meniscus to pass from the lower to the upper detector is unreasonably short. Air bubbles were detected by the start detector in the diluent column. The liquid meniscus in the measuring tube never passed the lower detector. The liquid meniscus in the measuring tube passed the lower detector but never passed the upper one. The analyzer detected an abnormality during the fill cycle of the EOS reagent pipette. Reasons for flagging might be timeout, short time or bubbles at the upper detector. The analyzer detected an abnormality during the empty cycle of the EOS reagent pipette. Reasons for flagging might be timeout, short time or liquid not detected at the lower detector. Action Run a Prime cycle, before re-analyzing the sample. Action Use a fresh blood control Use a new lot of reagents
Reagent and Control Indicators (RBC, PLT, WBC, LYM/MONO/GRAN)

Indicator EC ER Message Expired control Expired Reagent Not enough reagent left, check reagent levels
NR
Check reagent levels
Reagent Pipette Indicators (RBC, PLT, WBC)

Indicator DF Message Diluent system problem run prime cycle Action
DP
Diluent system problem run prime cycle
Verify analyzer is filled, run a Prime cycle and then re-analyze sample.
LF
Lyse system problem run prime cycle Lyse system problem run prime cycle Air bubbles run prime cycle Air bubbles run prime cycle Possible orifice blockage: Run prime cycle and then re-analyze Possible orifice blockage: Run prime cycle and then re-analyze EOS reagent pipette Fill error (EOSa)
LP
ST TB TL TU
Run a Prime cycle, before re-analyzing the sample.
EF
EP
EOS reagent Pipette emptying error (EOSa)
Verify analyzer is filled, run a Prime cycle and then re-analyze sample.
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Section 10: Technology

Section Overview
Introduction
This section describes the different methods and principles of measurement and calculations. This section contains the following topics: Topic Measuring Principles Counting Time RBC & WBC WBC Differentials Measurement of Eosinophils See Page 72 73 74 74
Contents
10.1 Measuring Principles

Description
This section describes the measuring principles of the Exigo system.
General Measuring Principles
The measuring principles of the Exigo analyzer are based on impedance and spectrophotometer principles.
Whole Blood Dilution
The RBC and WBC concentration values are determined by counting cells in whole blood dilutions of 1:40,000 for the RBC and 1:400 for the WBC. If a sample contains 5 million red blood cells per l, a dilution of 1:40 000 will give a final concentration of 5 million divided by 40,000 = 125 cells per l. Each l containing 125 cells, drawn through the aperture, will generate 125 pulses.
Theoretical Principles (RBC Example)
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10.1 Measuring Principles

Measured Volumes (Example)
(continued)
The measured volume drawn through the aperture is 270 l (Manufacturer calibrated). Based on the assumption made above, the system will count 270*125 = 33,750 pulses. The analyzer uses a fixed division factor of 67.5 calculated as 33,750 / 67.5 = 500 which is the correct value. (Based upon this calculation the analyzer would show RBC = 5.0x106 cells/l).
Stop sensor
Measured Volume = 270 l
Flow
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/ l 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. The normal counting time limits for the RBC and WBC metering units are between 21 30 seconds* and 10 13 seconds respectively. If the counting time is below or exceeds the above mentioned limits, the flag ST or TU will be displayed. * refers to 60 m orifice instruments, 80 m orifice instruments have a normal counting time of 13 18 seconds.
Counting Time Limits
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.
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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). After the analyzing process, the analyzer finds two main modes (Granulocyte Peak and Lymphocyte Peak) within the total distribution. By extrapolating the two main population peaks value a third population can be mathematically calculated. This third population is classified as the mono-cell area, which mainly consists of monocytes. See Figure 10.2 below: n
MONO
Floating Discriminator technology in general
LYMF
GRAN
Figure 10.2
Volume (fl)
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10.4 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. 4 part WBC differential impedance based analyzer The method is included the conventional 3 part differential analysis together with an added EOS measurement with a total analyzing 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.
EOS method #1
Figure 10.3
EOS method #2
3 part WBC differential impedance based analyzer This method is only based on the conventional 3 part differential and will not use any EOS reagents and has an analyzing time of 1 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
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Section 11: Specifications

Section Overview
Introduction
This section describes the specifications for the Exigo analyzer and its parameters. This section contains the following topics: Topic General Short List of Specifications Parameter Ranges Reagent and Reagent Consumption See Page 76 77 78 78
Contents
11.1 General
Description
This section describes the Exigo analyzer and its parts in general. The operator works with a menu from which the desired program is chosen, e.g. discriminator settings. Three external reagent reservoirs are used: Isotonic diluent (Diluent) Hemolyzing reagent (Lyse) Enzymatic Cleaner (Cleaner) EOS Reagent (EOS) The Exigo system is a fully automatic hematology analyzer designed to measure 17 parameters using whole blood from an open inlet and 20l micro pipettes. Exigo EOS measure 19 parameters using whole blood. The analyzer performs a 3-/ 4-part WBC differential by means of a cyanide free hemolyzing reagent.
User Environment
Reagents
Technology
WBC differential
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.
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11.2 Short List of Specifications

Specifications (Short) Measuring principle RBC, WBC, PLT Measuring principle HGB Programmable WBC Discriminator Sampling system Impedance Photometer, Cyanide free method 535nm 5nm Yes 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 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% RBC, PLT , WBC and EOS diff. < 125 l 20 l Graphical color touch screen, 240 columns x 320 rows Virtual incorporated keyboard (External keyboard possible) ~ 1 minute ; ~3 minutes including EOS Mean, SD, CV, Levey-Jennings > 1000 control samples > 1000 samples Yes Yes Yes (position printed) Yes HGB, WBC 1%; RBC, PLT 2% Yes Yes (Conformed to standard EN 60950) Max 100VA Max 20VA 50 60 HZ 100-240V Max 2 A AML150PS24>2556 or FDF1503-A-24-C14 (51441). Yes 18 32C (64 90F) Up to 80% (HxWxD) 410 x 290 x 460 mm (16.1 x 11.4 x 18.1 in) 18 kg (Standard Version) ( 40 lb) Approximately 22 ml per analysis cycle Approximately 50 ml per analysis cycle including EOS Approximately 4.6 ml per analysis cycle. Variable depending on the usage per day. 32 ml per day can be estimated for the average user. Approximately 3.6 ml per analysis cycle.
Parameters reported
Size distributions printed for Aspirated blood volume (Open Tube) Blood volume using the Micro Pipette Adapter (MPA) LCD Keyboard Analysis time QC capabilities Control sample memory capacity Sample memory capacity HGB correction on high WBC counts System information indicators on parameter abnormalities Floating discriminator RBC/PLT Automatic HGB blank on each sample Carry over Barcode reader input Serial output Power consumption (operational) Power consumption (standby) Mains Frequency Mains Voltage Effective mains current Certified external mains power supply Built-in test / adjustment programs Temperature Humidity (noncondensing) Dimensions Weight Diluent Consumption Lyse Consumption Cleaner Consumption EOS Reagent Consumption
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11.3 Parameter Ranges

Displayed Range Parameter WBC RBC MCV PLT HGB Displayed Range 0.0 - 119.9 x 109/ L 0.00 14.00 x 1012/ L 15.0 250.0 fL 0 - 1999 x 109/ L 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. Typical value from QC testing (n=10), using Boule Con Vet.
Parameter WBC RBC MCV PLT HGB CV (%) 1.9 1.1 0.3 3.5 1.0
Precision (typical)
11.4 Reagents and Reagent Consumption

Description
This section describes the reagent consumption for the Exigo analyzer depending on a sample per day calculation. Use only Boule authorized reagents. Erroneous results and damage may occur if other reagents are used. The consumption can be approximately calculated depending on the number of samples per day as shown on the graphs below. The figures, presented in the graphs, assume one background count, one control analysis, and one exit standby are performed per day. The consumption relation between the Diluent and the Lyse is 5:1. NOTE! Consumption example for EOS inactivated For additional information regarding the consumption of cleaning solutions please refer to the Boule Cleaning Kit instruction. (Supplied with the Boule Cleaning Kit).
Supported Reagents
Consumption Calculation
Additional Information
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Section 12: Troubleshooting

Section Overview
Introduction
This section contains information needed to troubleshoot the Exigo analyzer. This Section contains the following topics: Topic Aspiration Issues Communication Issues General Information Displays System Information Displays Troubleshooting Other Issues See Page 80 81 83 88 93
Contents
12.1 Aspiration Issues

Description
This section contains information regarding errors associated with aspiration and the sample probe. Then
1. Suggest performing clot removal procedure below. 2. Verify that there are no leaks and tubing is connected properly and not kinked. 3. Perform valve check in Service Menu 1. Suggest cleaning upper area of sample probe. 2. Verify that there are no leaks and tubing is connected properly and not kinked
If
No aspiration of sample is taking place.
Possible cause
1. Blockage of tubing or leak causes sample to not be pulled correctly through shear valve. 2. Valve malfunction. 3. Clot in sample caused by incorrect sample handling or pathologic sample. 1. Sample tube is touching the upper part of the sample probe when analyzing. 2. Diluent is not flowing correctly through tubing to sample probe.
No cleaning of aspiration probe
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12.1 Aspiration Issues

Clot Removal Procedure
(continued)
This process will help operator to remove a clot from the system. This should only be used when the OT sample probe is blocked. Action
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.
Step 1
Figure 12.1
Figure 12.2
Note
When menu screen returns to Maintenance Menu probe flush is complete. Run 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 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. See Section 4.3 Printer Modes for further detail.
Possible cause 1. New printer was connected but not matched with analyzer setup. 2. Printer may need maintenance or to be reset. 1. Auto Print Mode was turned off and not reset.
Printer Issues
If The printout has unusual layout or strange characters.
Then 1.Verify that printer type matches the printer being used. 2.Verify that the correct paper format has been selected for the printer paper. Results are not printing out after 1. Verify that Auto Print Mode is sample or control analysis. NOT set to 0.
80
(continued)
1. The printer is not connected to the analyzer or the printer setup is incorrect. 2. The printer has not completed last printout.
1. Printer Alarm message is displayed. 2. Printer is not ready to print, wait unit printer has finished with previous 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 has timed out. 1. The Printer is connected to the analyzer and on, but not activated. 2. Printer paper may need to be refilled. 2. Verify that printer is not in 3. Incorrect setup for information standby or offline. transmission. 3. Verify that printer is set to print and not serial port only setup.
Serial Data Issues See Section 4.3 Data Communication for further detail. If The data sent does not seem correct Results are not being sent to computer after sample analysis Then Possible cause 1. Make sure that the correct HW 1. Serial setup in analyzer is handshake and Auto Send Mode incorrect. has been selected. 1. Verify that Auto Send Mode is 1. Auto Print Mode was turned off NOT set to 0. and not reset. 1. Serial Output in not ready to transmit. 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. 1. The analyzer has not completed transmission of last sample.
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(continued)
1. The serial output has timed out. 2. The computer is not connected to the analyzer or the serial output setup is incorrect.
1. Verify that analyzer is connected to computer. 2. Verify that computer is turned on. 3. Verify that a receiving program runs on the computer. 4. Or switch off the HW handshake. option if the computers receiving program does not support HW handshake
1. Verify that computer is turned on and connected to the analyzer. 2. Verify that computers receiving program is active. 3. Or switch off the Send with Ack. option if the computers receiving program does not support Ack.
1. Serial output protocol problem.
12.3 General Information Displays

Description General Information Displays
This section contains information regarding general information displays. General information displays are informative screen displays that appear after a function has been completed. Instruction is then displayed for the operator on next step or function to be performed.
82
(continued)
Standby, Power Down, and Power Up Informational Displays
The system is empty from all liquid and prepared to be filled with other liquid or be stored away. Press [FILL] if you want to refill system or [EXIT] if you want to return to analyzer menu. No analyze can be performed before the analyzer is refilled with reagents.
The system is filled with liquid and is prepared for power off. Press [PWR UP] if you want to return the system to active status or [EXIT] if you want to return to analyzer menu. It is recommended to use [ENTER STANDBY] and that power is left on, instead of using this feature.
The system has not been used during the preset display saver time. Press [RESUME] to activate the analyzer. Once activated, the analyzer is ready to perform an analysis.
Analyzer will enter Standby mode in The analyzer is in the process of going The system is in Standby. Press [EXIT STANDBY] to activate the 2 minutes. Press [CANCEL] to return into Standby. Please wait. analyzer. Once activated, the analyzer to analyzer menu. is ready to perform an analysis.
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(continued)
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. Please wait.
The analyzer is filling the system. Please wait.
The analyzer is emptying the system. Please wait.
84
(continued)
The analyzer is cleaning the Open Tube sample probe. Please wait.
Every 24 hours the analyzer performs a wash of the system. During wash cycle the analyzer can not be used for performing an analysis.
The system has finished the count of cells and displays the results. The analysis cycle in not yet completed, as 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 printing. Please wait.
The analyzer is in the process of transmitting serial output data. Please wait.
Analyzer displays this notice to inform operator that Diluent reagent will soon need to be changed.
85
(continued)
Reagent and Control Informational Displays
Analyzer displays this notice to Analyzer displays this notice to inform operator that Lyse reagent will inform operator that Cleaner reagent will soon need to be changed. soon need to be changed.
Analyzer displays this notice to inform operator that EOS reagent will soon need to be changed.
Analyzer displays this notice when reagent bottle or bottles need to be changed. Not changing reagents at this time could cause erroneous results or possible damage the analyzer.
The reagent barcodes were scanned in The Con/Cal Assay Values were correctly using the barcode reader and scanned in correctly using the barcode the analyzer has accepted the values. reader and the analyzer has accepted the values.
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12.4 System Information Displays

System Information Displays System information displays appear after a function has been performed incorrectly or to inform the operator that further action is needed to complete the desired task. The 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 a long time period. The analyzer has been powered down with all valves open and filled with liquid. Empty and refill the system with reagents, and perform a background count.
The system was switched off incorrectly. Perform a prime to prepare the system for analysis. Check method for correct analyzer power down procedure.
The system was manually switched off with system emptied of reagents. Fill the analyzer with reagents to prepare for analysis or exit if only a search of analyzer menus is needed.
The analyzer has been switched off with power down function before power was switched off. Perform a power up to prepare the reagent system for analysis.
The system was powered down with liquid in system and has been unused for long period of time. Perform the cleaning procedure according to cleaning kit instruction. Perform a background check.
The regular 24 hour wash has failed. Make sure that reagent bottles are filled and the reagent tube assemblies are inserted correctly.
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12.4 System Information Displays
(continued)
Reagent System Information Displays
The regular 24 hour wash has not been performed. Check if reagent bottles are empty and if the reagent tube assemblies are in contact with reagent.
The reagent bottle or bottles are empty. Check if the bottles are empty and if the reagent tube assemblies and electronic sensors are inserted correctly.
This message is displayed if reagent bottle or bottles are empty when coming out of Standby. Check if the bottles are empty and if reagent tube assemblies and electronic sensors are inserted correctly.
Reagent tube assemblies must be removed from the reagent bottles when emptying the system. Verify that all tubes have been removed.
Analyzer has detected liquid in the system. The empty cycle must be run prior to a fill cycle. Run the Empty function to remove any extra liquid remaining in the system then fill the analyzer with reagents.
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12.4 System Information Displays (continued)
Diluent bottle need to be changed. Not changing reagents at this time could cause erroneous results or possible damage the analyzer. Connect new reagent bottle and scan in barcode on bottle.
Lyse bottle needs to be changed. Not changing reagents at this time could cause erroneous results or possible damage the analyzer. Connect new reagent bottle and scan in barcode on bottle.
Cleaner bottle needs to be changed. Not changing reagents at this time could cause erroneous results or possible damage the analyzer. Connect new reagent bottle and scan in barcode on bottle.
EOS bottle needs to be changed. Not changing reagents at this time could cause erroneous results or possible damage the analyzer. Connect new reagent bottle and scan in barcode on bottle.
No more space is available to scan in new Con/Cal assay values. Follow the recommendation or manually delete all the controls with same ID, to free space for scanning the new assay values.
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Barcode System Information Displays
Con/Cal assay value barcode scanning failed. The assay values or order of scanning in the barcodes may have been incorrect. Verify that setups on the analyzer match the required setup for the barcode reader.
Reagent barcode scanning failed. Barcode printing or order of scanning in the barcodes may have been incorrect. Verify that setups on the analyzer match the required setup for the barcode reader.
The analyzer was unable to wash the Open Tube sample probe. Verify that tube is removed and wash rinse cup is in correct position, then perform OT Wash.
Open Tube System Information Displays
The analyzer was unable to wash the Open Tube sample probe. Verify that tube is removed and wash rinse cup is in correct position. It is recommended that background count is performed before next sample analysis.
The analyzer is unable to wash the Open Tube sample probe. Verify that tube is removed and wash rinse cup is in correct position. It is recommended that background count is performed before next sample analysis.
The MPA was opened during an inappropriate time. It is recommended to perform a prime cycle before next analysis.
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Capillary Device System Information Displays
The MPA was opened during a cycle or analysis. Re-insert holder, and follow suggested recommendation.
The MPA holder was opened during an inappropriate menu. The MPA holder should only be opened in List, Sample or Main menu.
Assay Value Input failed. The Assay sheet or order of scanning in the barcodes may have been incorrect. 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 recognized as a control sample in the system. Verify that control sample is being scanned in. ( See Section 6.1 for more detail.)
Incorrect authorization code was entered. See calibration section in Users Manual.
No authorization code was entered. See calibration section in User Manual for entry of correct authorization code for calibration, or contact local distributor or authorized service technician.for service related authorization codes.
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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.
Indications error codes are specific instrument situations that in most cases need the Indication 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. Description Indication series for auxiliary errors like battery faults or similar. Indication series for Liquid errors. Indication series for Communication errors between the PCBs (CAN bus). Indication series for Printer and serial output errors. Indication series for General Memory errors. Indication series for EEPROM/HPC errors. Indication series for Shear Valve problems. Indication series for Cap Piercer errors (Closed Tube Adaptor) Indication series for Sampling device errors. Indication series for internal hardware and software problems, and messages during subboard firmware upgrades. Indication series for cycle aborted indication numbers.
Indication Series 1 - 19 20 - 29 30 - 39 40 - 49 50 - 59 60 - 69 70 - 79 80 - 89 90 - 99
100-255 300 -399
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Index
A Abnormal Results Information ................................................60, 61 Advanced menu..........................................18, 19, 51, 52, 56, 57, 82 Aspiration issues ................................................................71, 81, 82 Assay values............................ 47, 48, 49, 50, 52, 53, 61, 88, 91, 92 Assay Values............................................................................47, 93 Authorization code...................................................................53, 93 B Background count ......................................71, 79, 82, 86, 87, 89, 92 Barcode reader ............ 11, 13, 15, 19, 21, 48, 49, 52, 61, 82, 92, 93 Blood film ............................................62, 63, 64, 66, 67, 68, 69, 70 C Calibration ......................................................19, 51, 52, 53, 54, 93 Calibrators ......................................................6, 7, 11, 51, 52, 53, 59 Cleaning .............................................................................55, 56, 58 Cleaning kit ............................................................11, 56, 58, 79, 89 Clot Removal ................................................................................. 82 Control barcodes ..............................................14, 48, 50, 88, 92, 93 Controls .... 2, 6, 7, 10, 11, 14, 47, 48, 49, 51, 54, 59, 61, 63, 64, 72, 79, 88, 91, 93 CV 52, 53, 79 D Date/time function ......................................................................... 13 DF 72 Disposal..............................................................................18, 55, 59 Distributor ................................................4, 8, 54, 56, 59, 82, 93, 94 DP 72 E Emergency Procedure ...................................................................... 8 Empty ...............................................................57, 58, 72, 86, 89, 90 Erroneous results............................................7, 8, 43, 44, 58, 88, 91 F Fill 14, 18, 57, 58, 72, 85, 86, 89, 90 Floating discriminator.................................................................... 75 G General Information Displays................................84, 85, 86, 87, 88 GRAN ......................................................................................72, 78 H HCT .................................................................63, 64, 68, 69, 70, 78 Hemolysis.................................................................................64, 68 HGB .......................................................................52, 54, 71, 78, 79 I i-button ........................................................................60, 62, 65, 70 Indications error codes................................................................... 94 Installation........................... 1, 11, 12, 13, 14, 15, 16, 17, 18, 19, 58 K Keyboard ..................................................................................11, 15 L Levey-Jennings plots ..................................................................... 50 Levey-Jennings Plots ..................................................................... 49 Lipemia .......................................................................................... 64 List menu................................................................48, 49, 52, 57, 93 LYM .............................................................................................. 72 M Main menu ...........................................19, 22, 48, 51, 52, 56, 82, 93 Maintenance .............................................................................55, 56 Maintenance menu .................................................18, 56, 57, 58, 82 MCH............................................................................................... 78 MCHC ...................................................................63, 64, 69, 70, 78 MCV.............................................. 52, 54, 61, 63, 67, 68, 70, 78, 79 Measuring principles...................................................................... 73 Menu Structure...................................................................22, 23, 24 Micropipette .............................................................................43, 44 MID ..........................................................................................50, 72 Mixer .............................................................................................. 21 Monthly QC .............................................................................49, 50 MPA ........................................ 11, 19, 21, 25, 37, 44, 52, 54, 92, 93 MPV ............................................................................................... 54 N NEW SAMPLE.............................................................................. 87 O Open Tube ........................................................................ 19, 25, 52 Operator ID .................................................................................... 53 P Parameter Ranges .................................................................... 77, 79 PCT ................................................................................................ 78 PDW............................................................................................... 54 PLT ......................................................52, 54, 64, 71, 72, 74, 78, 79 Power adapter .................................................................... 11, 13, 20 Power Down ...................................................................... 85, 86, 89 Power Up ........................................................................... 85, 86, 89 Prime ...................................................................... 71, 72, 86, 89, 92 Printer...................................................11, 13, 15, 21, 82, 83, 87, 94 Probe flush ............................................................................... 58, 82 Q QC 21, 47, 48, 50, 51, 54, 77 R RBC ............ 2, 52, 54, 63, 64, 67, 68, 69, 70, 71, 72, 73, 74, 78, 79 RDW ...................................................................... 54, 63, 67, 68, 78 Reagent barcodes ................................................... 14, 18, 19, 88, 91 Reagent bottle . 11, 13, 14, 16, 17, 18, 19, 21, 57, 72, 88, 89, 90, 91 Reagent bottle tray...............................13, 14, 16, 17, 19, 21, 57, 58 Reagent consumption .............................................................. 77, 79 Reagent setup........................................................................... 18, 19 Reagent tube assemblies....11, 13, 14, 17, 19, 20, 57, 58, 72, 89, 90 Reagents........ 6, 7, 14, 16, 19, 51, 59, 72, 77, 79, 85, 87, 88, 89, 91 Results.............................................................. 21, 45, 46, 61, 82, 83 S Safety features ............................................................. 6, 7, 8, 18, 59 Sample analysis ...................................13, 45, 52, 54, 61, 82, 83, 92 Sample collection............................................................................. 8 Sample memory ............................................................................. 77 Sample menu.......................................................... 48, 49, 52, 57, 93 Sample Pathology ....................60, 61, 62, 63, 65, 66, 67, 68, 69, 70 Sample Pathology Messages ................................................... 62, 64 Sample probe .......................................21, 48, 51, 55, 81, 82, 87, 92 Sample View............................................................................ 45, 46 Send Mode ..................................................................................... 83 Sequence number........................................................................... 48 Serial number............................................................................... 3, 4 Serial output............................................................. 3, 15, 83, 84, 87 Service ................................................................. 4, 6, 12, 81, 93, 94 Service technician........................................................ 54, 56, 93, 94 Setup ..........................................................15, 19, 82, 83, 84, 92, 93 Setup menu .................................................................................... 19 Specifications........................................................................... 77, 78 Standby .............................................................................. 79, 85, 86 Startup ............................................................................................ 14 Storage ..................................................................................... 48, 58 Summary report ............................................................................. 49 System Information Displays ...................................... 89, 90, 92, 93 System Information Messages..................................... 53, 60, 71, 72 T Target values.................................................................................. 53 TL 72 Transport...................................................................... 48, 55, 57, 58 Troubleshooting................................................. 2, 48, 61, 70, 81, 94 TU 72 U USB................................................................................................ 15 User Definable Settings ................................................................... 4 W Warning signs................................................. 1, 6, 8, 10, 18, 20, 59 Warranty .................................................................................... 6, 56 Wash cycle............................................................................... 87, 92 Waste................................................................................ 7, 8, 18, 59 Waste container ........................................................... 13, 18, 57, 59 Waste line ........................................................ 11, 13, 18, 57, 58, 59 WBC ..... 2, 50, 52, 54, 62, 63, 65, 66, 70, 71, 72, 73, 74, 77, 78, 79 WBC Mode .................................................................................... 66
93
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
DF/DP flag?
NO
Re-analyze sample
DF/DP flag?
All highlighted areas of flowchart are to be performed by trained inhouse technician ONLY.
YES
Perform [Level Detector Test] in Service Menu.
YES
Were all values 2 (2 = liquid)?
YES
Run a background count
NO
Check that lower and upper tubing is tightly fitted to measuring units
Remove rightside cover.
YES
DF/DP flag?
NO
DONE
Rotate the units so that no zeros are displayed in Level Detector Test in Service Menu
Run a background count
YES
Did liquid move up and down in unit?
YES
Did liquid stop at upper detector?
NO
DF/DP flag?
YES
NO YES
NO
DONE
Is there any liquid in buffer chamber (CH1)?
Contact Technical Service Representative
NO
1. Perform Valve Check 2. Contact Technical Service and give Valve Check results
94
Discordant Results
Verify that sample is mixed correctly and tube has correct ratio of blood to anticoagulant. Questions to ask: 1. Was sample collected and handled properly? 2. Was the same sample used for both in-house and outside lab analysis? 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 between blood draw and analysis (RBC swelling, platelet clumping, deterioration of WBC for differential)?
YES NO
Is HCT low compared to spun PCV?
YES NO
Go to Are both RBC and HGB low below.
Is HCT out-of-range?
Are controls within range?
NO
Go to control out of range Troubleshooting protocol
Repeat using correct procedure
YES
Is RBC out-of-range?
NO NO
Is MCV out-of-range?
YES YES
NO YES
Was calibration recently performed? Was calibration protocol followed correctly?
YES
Check that sample is mixed correctly and no hemolysis or lipemia is present.
NO
Are all parameters discordant?
YES
Is MCHC out-of-range? Change out reagent and reanalyze sample.
NO
YES
NO
Wait 2 minutes and then run a background count
NO
Are reagent levels ok?
NO
Were all parameters low?
YES
Is HGB out-of-range?
YES
Review differences that can be expected when comparing results from same system, from different systems, etc.
YES
Perform Maintenance
Go to High Background Troubleshooting protocol
NO YES
Is PLT out-of-range?
Is Annual Maintenance due?
YES
NO
Run a background count. Values OK?
NO
NO
Examine blood film Perform Probe Flush procedure and re-analyze sample.
YES
1. Verify by looking at blood film. 2. Check sample for clots. 3. Review PLT histogram. (verify bell-shaped curve) 1. Check reagent level. 2. Run Orifice Clean cycle from Service Menu (possible blockage of aperture) 3. Check if Annual Maintenance is due. Contact Technical Service Representative
Are RBC & PLT both high or both low?
YES
NO
Are WBC & HGB both high or both low?
Is sample pathological?
YES
Are results still discordant?
NO YES
NO
DONE
NO YES
Are RBC and HGB both low?
Re-analyze and/or redraw sample.
NO
Is WBC out-of-range?
YES 2. Check sample for clots.
1. Verify by looking at blood film. 3. Remix and check correct sample handling followed.
95
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 light on front of analyzer lit?
NO
YES
Contact Technical Service Representative Touch screen and wait one minute.
NO
Is beep heard when screen is touched?
NO
Is display visible?
YES
DONE
YES
Turn off analyzer with On/Off switch.
Remove front cover
YES
Check that keypad flexcable, behind top of screen, is firmly pressed into connector. Turn on analyzer with On/Off switch. Is display visible?
NO
96
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 verify
YES
DONE
Perform [Probe Flush] procedure from Maintenance Menu
YES
Did all backgrounds pass?
NO
Are clots visible ?
NO Perform Orifice Clean NO

in Maintenance menu
Did background pass?
YES YES
YES
DONE
Repeat procedure using correct protocol
NO
Was procedure followed correctly?
NO
Was Annual Maintenance just performed?
YES
Run 2 Prime cycles followed by a background count.
YES
Were all values '0'?
Check Noise Test under Service Menu
NO NO
See Noise Issue Flowchart
DONE
YES
Is maintenance procedure scheduled to be performed?
YES
Perform scheduled maintenance and reanalyze background.
NO
Run 3 backgrounds.
NO
Try another bottle of diluent.
NO
DONE
YES
NO
YES YES
DONE
NO
Put the instrument in standby. Wait 20 minutes. Run 2 Prime cycles followed by a background count
YES
NO
Perform Annual Cleaning.
NO
YES
97
Noise Issues
Usual Cause: 1. Bad electrical outlet in clinic 2. Power Outage/Lightening 3. Instrument not plugged into line conditioner provided
Is SE flag present?
YES
Go to user manual for SE message explanation
NO
Perform Noise Test, under Service Menu Connect cables
YES
Are the values for the Noise Test: RBC Ampl = 0 WBC Ampl = 0 Are any cables loose on back of analyzer?
YES
NO
Try plugging analyzer into different outlet
NO
Are noise values above limits?
NO
YES
Try moving analyzer to another room.
Is Noise test positive?
NO
Done
YES
98
TU or TL ERRORS
Re-analyze sample (system cleans and rinses the orifice automatically when error is generated)
All highlighted areas of flowchart are to be performed by trained inhouse technician ONLY.
TU/TL flag?
NO
DONE
YES
Perform a Prime, then a background count DONE
NO
TU/TL flag? Re-analyze sample TU/TL flag?
NO YES
Perform Orifice Clean in Maintenance menu
YES
Perform background count
Check tubing to measuring chambers, re-attach if necessary.
Remove right-side cover.
YES
TU/TL flag?
NO
DONE
Check tubing to air membrane pump (SP1 & SP2), re-attach if necessary.
Is liquid level above orifice in measuring chambers?
YES
Check tubing to metering units, re-attach if necessary.
Run a Prime cycles followed by a background count
NO
TU/TL flag? DONE
NO
YES
1. Perform Valve Check 2. Contact Technical Service and give Valve Check results
99
Exigo is a product brand produced by Boule Medical AB
Distributor:
Boule Medical AB Box 42056, SE-126 13 Stockholm, 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 1504301 November 2010

Exigo Vet User Manual

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Exigo Vet User Manual

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User Manual

when starting up the analyzer.

Optional accessories and consumables

Distributors are listed on http://www.boule.se

International standards and regulations

Section 1: Safety Instructions

1.1 Intended Use

1.2 Safety Instruction

1.4 Emergency Procedure

1.5 Warning Signs in Manual

1.6 Signs on Equipment

Figure 1.5 IVD Symbol Table

2.1 Unpacking / Operating Placement & Environment

The analyzer is packed in a specifically designed protective box.

2.1 Unpacking / Operating Placement & Environment (continued)

Installation/ Operating Placement

Installation/ Operating Environment

2.2 Installation Checklist and Menu

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

Step 1 Menus Installation Menu.

2.2 Installation Checklist and Menu

2.3 Analyzer Cable, Interface, & Reagent Tube Connections

2.4 Reagent Installation

Carefully set analyzer down. Reagent bottle tray is now in place.

2.4 Reagent Installation

2.4 Reagent Installation (continued)

2.4 Reagent Installation (continued)

6 Print All Settings

2.5 Changing Reagents

2.6 Power Supply

Connecting Power Cable

Section 3: General Overview

3.1 General Analyzer Overview

3.2 Menu Structure

New Sample Main Menu

11 possibilities of Analysis profiles Next Prev

Ok Run Con/Cal Sample

> > > >

> > >

1/4 2/4 3/4 4/4

ABC abc 123...!?/...CE (optional)

! Prev Next 1(3) List Menu Print

Select Sample Criteria

Exit Sample Report Delete Send Print Stats

Reagent Setup Menu

> > >

Reagent Barcode Input

View Reagent Statistics

3.2 Menu Structure

Flowchart 3.2 Advanced Menu Structure

> > > > > > >

Analysis Profile Setup

3.3 System Flow

Press anywhere on screen to view screen

Press anywhere on screen to view screen

Returns user to last displayed page

Press [Exit Standby] and OPID to exit standby mode

3.4 Sample Volume, Throughput, and Parameters

Section 4: Analyzer Setup

4.1 Menu Selection

List and System Menu

4.2 Initial Setup

4.3 Advanced Setup

Select Printer Type