Heska Element COAG Operator's Manual

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Page 1

Heska Element COAG

Veterinary Analyzer

Operator’s Guide

™

November 8, 2017

Page 2

Page 3

Contents

About this Guide vii

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

I. The Heska Element COAG™Veterinary Analyzer 1

1. Introduction 3

1.1. General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.2. Intended Use of the Heska Element COAG™Analyzer . . . . . . . . . . 3

1.3. Basic Operating Principles . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.4. Features of the Heska Element COAG™Analyzer . . . . . . . . . . . . 4

1.4.1. Symbols Used in Labeling . . . . . . . . . . . . . . . . . . . . . 5

1.4.2. Intended Use of the Heska Element COAG™Cartridges . . . . . 5

2. System Description and Setup 7

2.1. User Information and Precautions . . . . . . . . . . . . . . . . . . . . . 7

2.2. Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2.3. Main Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.3.1. The Heska Element COAG™Analyzer . . . . . . . . . . . . . . 9

2.3.2. The Heska Element COAG™Cartridge . . . . . . . . . . . . . . 11

2.4. Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3. Conﬁguring the Heska Element COAG™Analyzer 13

3.1. The Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.2. Conﬁguration of the Heska Element COAG™Analyzer . . . . . . . . . . 14

3.2.1. Clinic Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3.2.2. Software Version/Upgrade . . . . . . . . . . . . . . . . . . . . . 16

3.2.3. Copy Data from the Analyzer . . . . . . . . . . . . . . . . . . . 17

3.2.4. Customize . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

3.2.5. Regional Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3.2.5.1. Set Date . . . . . . . . . . . . . . . . . . . . . . . . . 20

3.2.5.2. Set Time . . . . . . . . . . . . . . . . . . . . . . . . . 22

3.2.5.3. Set the Date Format . . . . . . . . . . . . . . . . . . . 23

3.2.5.4. Set the Language . . . . . . . . . . . . . . . . . . . . 24

3.2.5.5. Set the Keyboard Layout . . . . . . . . . . . . . . . . 25

iii

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Contents

3.2.6. Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

3.2.6.1. Printer . . . . . . . . . . . . . . . . . . . . . . . . . . 28

3.2.6.2. Network . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.2.7. Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . 32

3.2.7.1. Calibration . . . . . . . . . . . . . . . . . . . . . . . . 32

3.2.7.2. Analyzer Self Test . . . . . . . . . . . . . . . . . . . . 34

3.2.8. Screen Saver . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

3.2.8.1. Load Pictures . . . . . . . . . . . . . . . . . . . . . . 35

4. Memory Database 37

4.1. Viewing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

4.2. Performing a Database Search . . . . . . . . . . . . . . . . . . . . . . . 38

4.2.1. Search by Patient ID . . . . . . . . . . . . . . . . . . . . . . . . 39

4.2.2. Search by Sample ID . . . . . . . . . . . . . . . . . . . . . . . . 39

4.2.3. Search by Date . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

4.2.4. Search by Test Type . . . . . . . . . . . . . . . . . . . . . . . . 40

5. Maintenance and Support 41

5.1. Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

5.2. Cleaning the Outer Shell . . . . . . . . . . . . . . . . . . . . . . . . . . 41

5.3. Cleaning the Cartridge Slot and Air Filter . . . . . . . . . . . . . . . . . 41

5.4. Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5.5. Disposal of the Heska Element COAG™Analyzer . . . . . . . . . . . . . 42

6. Troubleshooting 43

6.1. Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

6.2. Problems That Give No Advisory Messages . . . . . . . . . . . . . . . . 43

6.3. List of Advisories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

6.4. Screen Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

II. The Heska Element COAG™Test Portfolio 47

7. PT/aPTT Combination Test 49

7.1. Blood Coagulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

7.2. Test Speciﬁcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

7.3. Test Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

7.3.1. Materials and Equipment . . . . . . . . . . . . . . . . . . . . . . 53

7.3.2. Blood Sample Preparation . . . . . . . . . . . . . . . . . . . . . 53

7.4. Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

7.5. Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

8. Equine Fibrinogen Test 57

8.1. Fibrinogen Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

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Contents

8.2. Test Speciﬁcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

8.3. Test Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

8.3.1. Materials and Equipment . . . . . . . . . . . . . . . . . . . . . . 60

8.3.2. Centrifuge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

8.3.3. Sample Preparation . . . . . . . . . . . . . . . . . . . . . . . . 61

8.4. Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

8.5. Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

9. Canine Fibrinogen Test 67

9.1. Fibrinogen Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

9.2. Test Speciﬁcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

9.3. Test Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

9.3.1. Materials and Equipment . . . . . . . . . . . . . . . . . . . . . . 70

9.3.2. Centrifuge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

9.3.3. Sample Preparation . . . . . . . . . . . . . . . . . . . . . . . . 70

9.4. Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

9.5. Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

10.Canine DEA 1 Blood Typing 77

10.1. Canine Blood Typing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

10.1.1. Blood Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

10.1.2. Blood Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . 78

10.2. Test Speciﬁcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

10.3. Test Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

10.3.1. Materials and Equipment . . . . . . . . . . . . . . . . . . . . . . 80

10.3.2. Blood Sample Preparation . . . . . . . . . . . . . . . . . . . . . 81

10.4. Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

10.5. Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

11.Feline A, B and AB Blood Typing 87

11.1. Feline Blood Typing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

11.1.1. Feline Blood Groups . . . . . . . . . . . . . . . . . . . . . . . . 87

11.1.2. Blood Transfusion Risks . . . . . . . . . . . . . . . . . . . . . . 88

11.1.3. Mating risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

11.2. Test Speciﬁcations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

11.3. Test Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

11.3.1. Materials and Equipment . . . . . . . . . . . . . . . . . . . . . . 90

11.3.2. Blood Sample Preparation . . . . . . . . . . . . . . . . . . . . . 91

11.4. Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

11.5. Test Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Bibliography 95

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About this Guide

This Operator’s Guide is written for Heska Element COAG™Analyzers with software newer than version ing ﬁnding the version of the software currently installed on the analyzer and instructions to upgrade to the newest version.

The following symbols and convention are used in this guide:

Bold Used for menu, command and keyboard selections and screens you will see.

Italics

Used for emphasis.

Helpful information about a particular topic.

Important information to prevent problems and ensure that you are successful

in using the instrument.

Technical Support

For any inquiries about the instrument or use of the test cartridges, contact your Distributor or Heska Corporation Customer Support.

See contact information below:

03102017_0848

. Please refer to

Section 3.2.2

for information regard-

Heska Corporation

3760 Rocky Mountain Avenue Loveland, Colorado 80538 USA

T 800-464-3752

Í www.heska.com

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Part I.

The Heska Element COAG

Veterinary Analyzer

™

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1. Introduction

1.1. General Information

The Heska Element COAG™Analyzer is an innovative specialty Analyzer developed and used exclusively for veterinary diagnostics.

The Heska Element COAG™Analyzer enables veterinarians to perform automated in-clinic specialty testing using disposable cartridges. The Heska Element COAG Analyzer’s operation is based on light absorption.

The Heska Element COAG™Analyzer contains microprocessors and LED optical elements to control all testing and analytical functionalities. The operator controls the Analyzer’s functions through a 7-inch color touch screen. An open slot in the front of the Analyzer allows the insertion of a cartridge, and guides the test cartridge into place for analysis.

The Heska Element COAG™Analyzer test cartridge has two optical detection windows and is preloaded with dry reagents speciﬁc to the tests. All blood clot formations or reactions occur within the test cartridge.

Test results are displayed on screen, and are automatically stored in the instrument’s memory database for later retrieval. The results can be printed to an optional USB printer or exported to a central Laboratory Information System (LIS). An external keyboard can also be connected to USB ports at the back of the instrument, if so desired.

Chapter 1

™

1.2. Intended Use of the Heska Element COAG™Analyzer

The Heska Element COAG™Analyzer provides quantitative in-vitro determination of:

• Fibrinogen

• PT (Prothrombin Time)

• aPTT (activated Partial Thromboplastin Time)

• DEA 1 Canine Blood Typing

• Feline A & B Blood Typing

Page 12

1. Introduction

If the Heska Element COAG™Analyzer is used in any way other than that

described in this manual, the Analyzer may not operate as intended, may produce inaccurate or no results, and may pose a safety hazard. Only use approved Heska Element COAG™cartridges with the Analyzer.

1.3. Basic Operating Principles

The Heska Element COAG™Analyzer’s operation is based on one-time-use test cartridges containing micro channels and test-speciﬁc reagents. Samples added to the Heska Element COAG™cartridges ﬂow through micro channels in the cartridge where it reacts with test-speciﬁc reagents. Light passing through the optical detection window on the cartridge is absorbed by the sample in the channels. The Analyzer measures how much light is absorbed and automatically calculates the test results, which are displayed on screen and stored in the Analyzer’s database. No interaction is needed or required by the user during the analysis.

1.4. Features of the Heska Element COAG™Analyzer

• Large, 7-inch color touchscreen

• Easy-to-use touchscreen controls

• Small sample size (100 µL or less)

• Fast and accurate point-of-care results

• Simple and user-friendly operation

• Continuous internal self-test monitoring during operation

• Small footprint

•

Up to 1000 test results can be stored and retrieved from the instrument’s results database

• Allows Patient and Sample ID input (optional)

• LIS-interface

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1.4. Features of the Heska Element COAG™Analyzer

1.4.1. Symbols Used in Labeling

Caution, risk of danger

(see accompanying warning text)

Caution, risk of electric shock

Alternating Current

Direct Current

USB Connection

1.4.2. Intended Use of the Heska Element COAG™Cartridges

The Heska Element COAG™cartridges are exclusively intended for use with the Heska Element COAG™Analyzer. Utilizing it with other instruments is not advisable.

•

Each Heska Element COAG™cartridge is clearly labeled with test type and individually packed in a sealed pouch with a desiccant bag to protect it from moisture.

•

Once the pouch has been opened, the Heska Element COAG™cartridge must be used within the time limit stated on the package insert.

•

Do not use the cartridge after its expiration date since it is only stable until the date stamped on the pouch. Using it after the duration date can result in inaccurate test results.

•

Do not store the Heska Element COAG™cartridge outside the temperature range stated on the package insert:

– Fibrinogen Test (36 °F to 46 °F) / (2◦C to 8◦C)

Chapter 1

– PT/aPTT Combination Test (36 °F to 46 °F) / (2◦C to 8◦C)

– DEA 1 Canine Blood Typing Test (36 °F to 77 °F) / (2◦C to 25◦C)

– Feline A & B Blood Typing Test (36 °F to 77 °F) / (2◦C to 25◦C)

•

The Heska Element COAG™cartridges should be at room temperature before use, i.e., between temperatures impairs its accuracy.

•

Used cartridges, pipettes and collection tubes are considered potentially infectious. Dispose them oﬀ properly in accordance with the policies and regulations practiced at the place of operation.

59 °Fto86 °F(15◦Cto30◦C

). Exposing the cartridge to extreme

Page 14

1. Introduction

•

When using the Heska Element COAG™cartridges, all biohazard safety guidelines pertaining to handling and disposal of animal blood samples must be strictly followed.

Do not reuse cartridges. All Heska Element COAG™cartridges are for single

use only. Once used, the cartridge should be disposed of in accordance with the safety guidelines at the place of operation.

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2. System Description and Setup

2.1. User Information and Precautions

Please read the instructions in this Operator’s Guide carefully before using the Heska Element COAG™Analyzer, and follow all instructions and warnings and keep it handy for future references.

The Heska Element COAG™Analyzer and its cartridges are exclusively intended for veterinary use. If the Heska Element COAG™Analyzer is used in a manner not speciﬁed by the manufacturer, the protection provided by the instrument may be impaired.

Observe the following:

•

Attempting to open or dismantle the instrument can cause electric shock and will void the warranty.

•

Protect the instrument from being wet, whether it is exposure to wet locations or to rain or snow.

•

Use only the power supply that is provided together with the instrument. Use of any other power supply will damage the instrument, thus, voiding the warranty.

•

It is highly recommended that the power supply be disconnected or the instrument turned oﬀ when not in use.

•

The power supply must be connected to a main power outlet that is grounded and of a quality normally found in hospitals, domestic and commercial environments.

•

Do not expose the Heska Element COAG™Analyzer to extreme temperatures: below

59 °F(15◦C

COAG™Analyzer near a heat source nor expose it to direct sunlight.

) and above

86 °F(30◦C

). Never expose the Heska Element

Chapter 2

•

It is strongly recommended to inspect the Heska Element COAG™Analyzer regularly for damages. If damaged, disconnect instantly and contact Technical Support for assistance.

•

If the Heska Element COAG™Analyzer is accidentally dropped, immediately contact Technical Support. In this case, no test should be performed until it has been serviced by authorized personnel.

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2. System Description and Setup

•

Do not use non-Heska Element COAG™cartridges with the Heska Element COAG Analyzer. A non-Heska Element COAG™cartridge will not operate in the instrument and will only generate an error message when used.

•

Before inserting the cartridge, make sure that there are no foreign objects in the cartridge slot. Test cartridges should slide in easily into the cartridge slot. No force is needed in the insertion.

•

Do not use excessive force or sharp objects on the Analyzer’s sensitive touch screen. A light tap is suﬃcient.

•

The detachable power supply cord set and appliance inlet of the external power supply are considered as the disconnecting device.

•

The USB interface connector of the Heska Element COAG™Analyzer must only be connected to SELV circuits.

•

The LAN connector must only be connected to 10Base-T/100Base-TX circuits. External computing devices connected to the USB and LAN interface connectors have to comply with the standard UL60950 for US and Canada, and IEC60950 for other countries.

•

Network/USB cables connected to Heska Element COAG™Analyzer should not be more than 3 meters long.

2.2. Unpacking

When unpacking the instrument, be sure that the following guidelines are followed:

• Remove the Heska Element COAG™Analyzer from the shipping carton.

•

Place the Analyzer on a leveled surface relatively free of animal hair, dust and other contaminants.

• Do not place near a window or a heat source.

™

Make sure that you received the following components:

• Heska Element COAG™Analyzer

• Sealing Cartridge

• Power supply with cord

• Power cord

• Heska Element COAG™Diagnostic System Operator’s Guide.

•

Quick Guide for each of the tests in the Heska Element COAG™test portfolio, see Part II.

Page 17

2.3. Main Components

2.3.1. The Heska Element COAG™Analyzer

2.3. Main Components

The main components of the Heska Element COAG™Analyzer are shown in and an overview of the Analyzer’s technical speciﬁcations is given in Table 2.1.

The Heska Element COAG™Analyzer has a 7-inch touch screen which serves as the main interaction point between the operator and the instrument itself. The instrument has a cartridge slot located on the front where the Heska Element COAG™test cartridges are inserted. The power supply connector is located at the back of the instrument together with the LAN port and two USB 2.0 ports. An on/oﬀ button is located at the rear of the instrument as well.

Touch

Screen

Figure 2.1: Front (left) and back (right) view of the Heska Element COAG™Analyzer.

Cartridge

Slot

On/Oﬀ Button

USB 2.0

Ports

LAN Port

Figure 2.1

Power

Supply

Connector

Chapter 2

Page 18

2. System Description and Setup

Table 2.1: Technical Speciﬁcations for the Heska Element COAG™Analyzer.

Operating Environment Indoor use only Temperature 59 °F to 86 °F (15◦C to 30◦C) Max. Relative Humidity 80 % Max. Altitude 9843 ft (3000 m) Pollution Degree 2

Others Mode of Operation Continuous Instrument’s placement minimum distance from the nearest object

Power Supply Input 100 V AC to 240 V AC

Output 12 V DC

Instrument Input 12 V DC

Power Consumption 32.4 W Transient Overvoltage Category II of IEC 60364-4-443 Instrument Input Connections 12 V DC Power Supply Instrument Input and Output Connections

15 cm/6 in

(ﬂuctuations < 10 % of nominal voltage)

1.5 A 50 Hz to 60 Hz

6.67 A

2.7 A

LAN and USB 2.0

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2.3.2. The Heska Element COAG™Cartridge

2.4. Setup

Figure 2.2

COAG™cartridge has a label that indicates the kind of test the cartridge performs. It has a sample well where the sample is being added or placed.

Sample added to the Heska Element COAG™cartridge is drawn by capillary force into the cartridge where it is mixed with reagents. The microﬂuidic based design makes it possible to have two independent detection windows on the cartridge with a sample volume below ing through the two optical detection windows is absorbed by the sample. Test results are determined by using the measurement technology of light absorbance.

The cartridge contains the reagents necessary to perform the tests. The user only needs to insert the cartridge in the instrument’s cartridge slot and follow the on-screen instructions. A small sample volume is enough to carry out the tests. Just add an adequate amount of sample and see the results after a few minutes.

shows a typical Heska Element COAG™test cartridge. The Heska Element

Optical detection windows

Sample

well

100 µL

Cartridge

label

. Light pass-

Figure 2.2: Heska Element COAG™cartridge.

2.4. Setup

Chapter 2

Before setting up the Heska Element COAG™Analyzer:

• Make sure that the room temperature is between 59 °F to 86 °F (15◦C to 30◦C).

•

If the instrument has been stored outside the aforementioned temperature range, let the instrument reach room temperature prior to use.

•

When the abovementioned factors have been met, place the Heska Element COAG™Analyzer on a clean, ﬂat, and stable vibration free surface at least (6 in) from the nearest object.

• Plug the Heska Element COAG™Analyzer into the power supply.

•

Turn on the instrument by touching the power button at the back of the instrument.

15 cm

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2. System Description and Setup

The Heska Element COAG™Analyzer is now ready for conﬁguration. See a detailed description of the Analyzer software and conﬁguration options.

Chapter 3

for

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3. Conﬁguring the Heska Element COAG Analyzer

3.1. The Home Screen

™

The Home Screen is the instrument’s main menu screen, see the ﬁrst screen visible after the instrument has been turned on and serves as the main access point for operating the Analyzer and modifying the settings of the instrument.

Make sure that the date and time shown on the screen are correct; otherwise, refer to Change the Date/Time under ready for use at this point. The following features are available at the Home Screen:

Turn Oﬀ

Start Test

History

an on-screen touch button situated at the upper left corner of the screen, used to turn the instrument oﬀ. It is also possible to turn oﬀ the instrument using the power button located at the back of the instrument.

on-screen touch buttons used to initiate the tests. Currently, canine and feline PT/aPTT coagulation tests, canine and feline blood typing, and canine and equine ﬁbrinogen testing are available. See the speciﬁc tests.

on-screen touch button for search and retrieval of measurement data gathered

from previous testing. The results database is described in Chapter 4.

Section 3.2.5

for resetting directions. The instrument is

Chapter 7toChapter 10

Figure 3.1

. This screen is

Figure 3.1:

Screen. The main screen holds buttons for starting a new analysis, review the results history, and modify the instruments settings as well as turning oﬀ the instrument.

for instructions about

Home

Chapter 3

Page 22

3. Conﬁguring the Heska Element COAG™Analyzer

Setup

on-screen touch button for instrument conﬁguration. This opens the Settings

Menu for conﬁguration. The instrument conﬁguration is described in Section 3.2.

3.2. Conﬁguration of the Heska Element COAG™Analyzer

Conﬁguration of the Heska Element COAG™Analyzer is performed from the Settings Menu which is accessed by touching the Menu can be seen in Figure 3.2.

Setup

button at the Home Screen. The Settings

Figure 3.2:

Menu. From the Settings Menu it is possible to change and review the Analyzer conﬁguration. The conﬁguration options are organized in categories which can be accessed by touching the purple arrow button to the right of the category title.

The conﬁguration options are divided into categories. The settings for a category can be accessed by touching the purple arrow button to the right of the category title. The categories are:

Clinic Info

Software V.

Copy data

Setttings

Edit yourclinic information (name, contact information, etc.), see The information is not required, but if present it will appear on the result printouts and blood typing certiﬁcates.

View and update software version. The currently installed software version is printed in the text ﬁeld next to the category title. Touch the to install a diﬀerent software version, see Section 3.2.2 for detailed instructions.

Copy test data and results to a USB stick or an external hard drive, see

Section 3.2.3

case of unexpected results or problems with the Analyzer.

. The exported data can be sent to Customer Support for analysis in

Section 3.2.1

Customize Modify the Analyzer’s default settings, see Section 3.2.4.

Regional Setup

time and date are always displayed on the Analyzer’s Home Screen and will be printed on the results printouts and logged in the results database.

Change time, date and time format, see

Section 3.2.5

. The current

Page 23

3.2. Conﬁguration of the Heska Element COAG™Analyzer

Connections

Laboratory Information System (LIS), see of the connectivity options.

Quality assurance

Fibrinogen Test, see

Section 3.2.7.2.

Screen saver

when the screen saver is running, see Section 3.2.8.

When the instrument is conﬁgured, touch Screen.

Use this menu to install an external printer or connect the instrument to a

Section 3.2.6

From this menu, it is possible to calibrate the instrument for the

Section 3.2.7.1

Turn the screen saver on/oﬀ and change the images shown on the screen

The

Service

internal system functions and requires a password.

button is only used by Authorized Service Personnel to access

, or to perform a self test of the Analyzer, see

Done

to return to the Analyzer’s Home

for a detailed discussion

3.2.1. Clinic Info

The Clinic Info screen is shown in clinic’s contact information. To enter the Clinic Info screen touch the the Analyzer’s Home Screen and touch the to the right of the Clinic Info category in the Settings Menu.

All information in the Clinic Info screen is optional but will, if present, appear on the result printouts. Further, when connecting to a data exchange or computer network, the clinic information will also be transferred to any connected Laboratory Information System (LIS). Refer to LIS.

Section 3.2.6.2

Figure 3.3

for details regarding how to setup the Analyzer with a

. The menu has data ﬁelds for entering the

Setup

button on

Chapter 3

To enter your clinic information:

Figure 3.3:

In the Clinic Info menu the user can optionally supply name and contact information for the clinic. If entered, the information will be printed on result printouts and be exported if the Analyzer is connected to a LIS.

Clinic Info.

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3. Conﬁguring the Heska Element COAG™Analyzer

Touch the purple arrow button across the Clinic Info ﬁeld on the Settings Menu. This opens the Clinic Info screen shown in Figure 3.3.

2. Edit each ﬁeld by touching across each ﬁeld.

3. Use the on-screen keyboard to type in relevant information.

When ﬁnished, touch touch Cancel.

5. Repeat item 2 to 4 for each ﬁeld that needs changing.

6. When all changes are applied, touch Done to return to the Settings Menu.

Touching the change(s).

Cancel

Done

. To clear any undesired changes and to start anew,

clears any undesired change(s) and touching

Done

3.2.2. Software Version/Upgrade

conﬁrms

The Software screen is shown in

Setup

button on the Analyzer’s Home Screen and touch the to the right of the Software v. category in the Settings Menu. The current version of the software installed on the instrument is indicated on the Settings Menu screen and is also printed in the Current software version text ﬁeld on the Software screen.

Figure 3.4:

Version Screen. The currently installed software version is printed in the Current software version text ﬁeld. A software upgrade can be applied by touching the Upgrade button.

To upgrade the Analyzer software:

Software

Unplug any device that may be plugged into the USB port at the back of the Analyzer.

Insert the installer USB memory stick into the USB port at the back of the instrument and wait 10 seconds for the Analyzer to register the memory stick.

Touch

Upgrade

on the lower right hand side of the screen of the Software screen.

Figure 3.4

. To enter the Software screen touch the

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3.2. Conﬁguration of the Heska Element COAG™Analyzer

Touch

Yes

in the dialog box when asked to conﬁrm that you want to upgrade,

otherwise, touch No.

Wait for the Analyzer to apply the upgrade and reboot. When the instrument starts up anew, the upgrade has been applied and the new software version will be printed in the Current Software version text ﬁeld.

Software upgrade requires that you obtain a USB memory stick containing an

installer for the new software from Heska Corporation or from your Distributor.

3.2.3. Copy Data from the Analyzer

All test data and results stored in the Analyzer can be copied to a USB memory stick by touching the to the right of the Copy data category in the Settings Menu, see

Figure 3.5.

Chapter 3

Figure 3.5:

data can be copied from the instrument by touching to the right of the Copy data category in the Settings Menu. When the data transfer is complete, Data copied will be printed in the text ﬁeld next to the Copy data category.

To copy data from the Analyzer to a USB stick:

Unplug any device that may be plugged into the USB port at the back of the Analyzer.

Insert a USB memory stick into the USB port and wait 10 seconds for the Analyzer to register the memory stick.

From the Settings Menu touch the purple to the right of the Copy data category. The data transfer will begin and Copying data. . . will appear in the status text ﬁeld.

When the data transfer is complete Data copied will appear in the status text ﬁeld.

5. Remove the USB stick and reconnect any device that was unplugged.

If a USB error message appears, check if the USB memory stick is properly

inserted into the USB port and assure that the USB stick is not defective.

Measurement

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3. Conﬁguring the Heska Element COAG™Analyzer

3.2.4. Customize

The Customize screen is shown in the

Setup

button on the Analyzer’s Home Screen and touch the to the right of the

Customize category in the Settings Menu.

Figure 3.6:

From the Customize screen it is possible to customize whether or not Patient and Sample ID must be supplied during the test sequence, the unit for test results and frequency between notiﬁcations.

In the Customize menu, you can change the defaults for the following settings in the Heska Element COAG™Analyzer:

Patient ID Required

Sample ID Required

Calibration Reminder

Fibrinogen Unit

Customize.

By default, this feature is deactivated but should be activated when used together with LIS as this ﬁeld is used by many LIS systems to identify the test result for a particular patient. When Patient ID required is set to Yes, it is not possible to continue a test sequence without supplying information about the Patient ID.

Requiring Patient ID is highly recommended when using Heska Element

COAG™with a LIS, since editing the Patient ID is no longer possible after testing. For LIS users, please note that the Patient ID ﬁeld is used as a unique identiﬁer denoted as Practice Assigned ID (See

By default, this feature is deactivated but can be activated if the clinic wishes to have information in the Sample ID ﬁeld in the results history (can be used to search for a particular result). When Sample ID required is set to Yes it is not possible to continue a test sequence without supplying information about the Sample ID.

By default is set to no, and does not remind you when the next Fibrinogen calibration is due. Should an analyzer require ﬁbrinogen calibration, please contact Heska Technical Services.

Includes a selection of available units that is used for the Fibrinogen

Test results. Possible choices are: grams per liter (g/L), milligrams per deciliter

Figure 3.6

. To enter the Customize screen touch

Section 3.2.6.2

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3.2. Conﬁguration of the Heska Element COAG™Analyzer

(mg/dL) and grams per deciliter (g/dL). By default, the ﬁbrinogen results are reported in grams per liter.

Add-sample notiﬁcation

sample. Possible choices are: once, every 10 seconds, every 30 seconds and every minute. By default, the user is notiﬁed only once when the test is ready for the sample.

To customize the above settings:

Toggle between the available options by touching the purple arrow button to the right of the relevant menu point.

When ﬁnished, touch tions, touch Cancel.

Touching

the change(s).

Change the frequency of beeps when a test is ready for the

Done

to conﬁrm the new settings. To cancel any modiﬁca-

Cancel

clears any undesired change(s) and touching

Done

3.2.5. Regional Setup

conﬁrms

Chapter 3

The Regional Setup screen is shown in touch the the Regional Setup category in the Settings Menu.

From the Regional Setup screen it is possible to adjust the settings listed below:

Date Use this menu to set the current date, see Section 3.2.5.1.

Time Use this menu to set the current time, see Section 3.2.5.2.

US/Europe

Setup

button on the Analyzer’s Home Screen and touch the to the right of

Use this menu to set the desired date and time format, see

Figure 3.7

. To enter the Regional Setup screen

Figure 3.7:

Setup. In the Regional Setup menu, it is possible to adjust the date and time, modify the date/time format and change the language and keyboard layout used by the Analyzer.

Regional

Section 3.2.5.3

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3. Conﬁguring the Heska Element COAG™Analyzer

Language

Use this menu to select the language used by the instrument, see

Section 3.2.5.4

Keyboard layout Use this menu to change the keyboard layout, see Section 3.2.5.5.

To change any of the above settings, touch the to the right of the relevant settings ﬁeld. When done modifying the regional settings, touch the

Done

button to return to the

Settings Menu.

3.2.5.1. Set Date

The screen for setting or displaying the current date is shown in Figure 3.8.

Figure 3.8: Date menu. The current date is displayed in the text ﬁeld at the top of the page. To change the current date use the on-screen keyboard. The date must be speciﬁed using mm/dd/yyyy format.

When the complete

entry complies with this format, Correct Format is displayed above the text ﬁeld. Otherwise,

Incorrect Format is

displayed.

To set the current date:

1. From the Home Screen, touch Setup (this opens the Settings Menu).

From the Settings Menu, touch to the right of the Regional Setup category (this opens the Regional Setup Menu).

From the Regional Setup page, touch to the right of the Date entry ﬁeld. shows the Set Date screen.

4. Use the on-screen keyboard to enter the date.

5. Conﬁrm by touching Done.

Figure 3.8

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3.2. Conﬁguration of the Heska Element COAG™Analyzer

The Date Format is shown below the Entry Box. Incorrect Format message is

displayed above the entry box until the complete entry has been made. When the entry has been completed with the correct format, Correct Format message is displayed.

Touching the change(s).

Cancel

clears any undesired change(s) and touching

Done

conﬁrms

Chapter 3

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3. Conﬁguring the Heska Element COAG™Analyzer

3.2.5.2. Set Time

The screen for setting or displaying the current time is shown in Figure 3.9.

Figure 3.9: Time menu. The current time is displayed in the text ﬁeld at the top of the page. To change the current time use the on-screen keyboard. The time must be speciﬁed using the format shown below the entry ﬁeld.

When the complete

entry complies with this format, Correct Format is displayed above the text ﬁeld. Otherwise,

Incorrect Format is

displayed.

To set the current time:

1. From the Home Screen, touch Setup (this opens the Settings Menu).

From the Settings Menu, touch to the right of the Regional Setup category (this opens the Regional Setup Menu).

From the Regional Setup page, touch to the right of the Time entry ﬁeld.

Figure 3.9 shows the Set Time screen.

4. Use the on-screen keyboard to enter the time.

5. Conﬁrm by touching Done.

The Time Format is shown below the Entry Box. Incorrect Format message is

displayed above the entry box until the complete entry has been made. When the entry has been completed with the correct format, Correct Format message is displayed. The time and date format can be changed in the US/Europe Menu, see Section 3.2.5.3.

Touching the change(s).

Cancel

clears any undesired change(s) and touching

Done

conﬁrms

Page 31

3.2. Conﬁguration of the Heska Element COAG™Analyzer

3.2.5.3. Set the Date Format

The screen for setting or displaying the current date and time format is shown in

Figure 3.10. Two formats are available:

USA

When this date/time format is active, the date is shown as mm/dd/yy and the time is displayed using the 12-hour system followed by AM or PM.

Europe

When this date/time format is active, the date is shown as dd/mm/yy and the

time is displayed using the 24-hour system.

Figure 3.10:

mat. The currently active date and time format is indicated with a dark purple arrow button to the right. To select a diﬀerent format, touch the to the right of the desired format.

To set the current time and date format:

1. From the Home Screen, touch Setup (this opens the Settings Menu).

From the Settings Menu, touch to the right of the Regional Setup category (this opens the Regional Setup Menu).

From the Regional Setup page, touch to the right of the US/Europe entry ﬁeld.

Figure 3.10 shows the Date Format screen.

Activate the desired date and time format by touching to the right of the preferred menu item. The active format is indicated by a dark purple button.

5. Touch Done to conﬁrm the change.

Touching the change(s).

Cancel

clears any undesired change(s) and touching

Done

Date for-

Chapter 3

conﬁrms

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3. Conﬁguring the Heska Element COAG™Analyzer

3.2.5.4. Set the Language

The screen for selecting or displaying the language used by the graphical user interface is shown in arrow button to the right of the language name. Currently, English (the default language) and Spanish, are supported.

Figure 3.11

. The currently active language is indicated by a dark purple

Figure 3.11:

Menu. The currently active language is indicated by a dark purple arrow button to the right of the language name. Touch the purple to the right of another language option to change the language of the user interface.

To select a diﬀerent language for the graphical user interface:

1. From the Home Screen, touch Setup (this opens the Settings Menu).

5. Touch Done to accept the change and return to the Regional Setup screen.

Language

From the Settings Menu, touch to the right of the Regional Setup category (this opens the Regional Setup Menu).

From the Regional Setup page, touch to the right of the Language entry ﬁeld.

Figure 3.11 shows the Language screen.

To change the language, touch the to the right of the desired language so that it changes from purple to dark purple.

The purple arrow button to the right of the language options turns dark purple

when the designated language is selected.

Touching the change(s).

Cancel

clears any undesired change(s) and touching

Done

conﬁrms

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3.2. Conﬁguration of the Heska Element COAG™Analyzer

3.2.5.5. Set the Keyboard Layout

The screen for selecting or displaying the keyboard layout used by the graphical user interface is shown in dark purple arrow button to the right of the keyboard layout name.

The keyboard layout refers to the visual and functional arrangement of the keys and legends associated with the arrangement of buttons on the on-screen keyboards. Currently, ﬁve commonly used keyboard layouts are available:

QWERTY

AZERTY

QWERTZ

Dvorak

Blickensderfer

This keyboard layout is the most widespread layout in use and is the default layout used by the Heska Element COAG™Analyzer. In this layout Q-W-E-R-T-Y are the ﬁrst six letters in the upper row of letters on the keyboard.

This keyboard layout is commonly used in French speaking countries. In this layout A-Z-E-R-T-Y are the ﬁrst six letters in the upper row of letters on the keyboard.

This keyboard layout is commonly used in Germany. In this layout Q-W-E-R-

T-Z are the ﬁrst six letters in the upper row of letters on the keyboard.

This keyboard layout is frequently used as an alternative for the QWERTY keyboard layout. In this keyboard layout most of the English characters are concentrated in the middle row of letters.

The bottom row of characters in this layout is D-H-I-A-T-E-N-S-O-R.

Figure 3.12

This keyboard layout, for some people, provides better typing eﬃciency.

. The currently active keyboard layout is indicated by a

Chapter 3

Figure 3.12:

Layout. The currently selected keyboard layout is indicated by a dark purple arrow button to the right of the keyboard layout name. Touch the purple to the right of another layout option to change the layout of the graphical user interface.

By default, the Heska Element COAG™Analyzer displays the QWERTY Keyboard Layout. To change to a diﬀerent layout:

Keyboard

Page 34

3. Conﬁguring the Heska Element COAG™Analyzer

1. From the Home Screen, touch Setup (this opens the Settings Menu).

From the Settings Menu, touch to the right of the Regional Setup category (this opens the Regional Setup Menu).

3. From the Regional Setup, touch to the right of the Keyboard Layout entry ﬁeld.

To change to a diﬀerent keyboard layout, touch the button to the right of the desired layout. A dark purple button indicates the layout chosen. shows the Keyboard Layout screen.

5. To apply the new setting, touch Done.

Touching the change(s).

Cancel

clears any undesired change(s) and touching

Figure 3.12

Done

conﬁrms

3.2.6. Connections

The Connections screen is shown in

Setup

on the Analyzer’s Home Screen and the across the Connections category in

the Settings Menu.

Figure 3.13:

Menu. The currently selected printer and the status for the LIS system is shown in the text ﬁelds in the connection menu.

Two external connections are available from the Connections screen:

Printer

Network

Connections

The name of the currently selected printer is shown in the text ﬁeld to the right of the Printer category. Refer to to a diﬀerent printer.

The network text ﬁeld shows the status of the build in Laboratory Information System (LIS). By default, data export to a LIS is disabled. Refer to for details regarding how to conﬁgure the Heska Element COAG™Analyzer for use with a LIS.

Figure 3.13

Section 3.2.6.1

. To enter the Connections menu, touch

for details regarding how to change

Section 3.2.6.2

Page 35

3.2. Conﬁguration of the Heska Element COAG™Analyzer

To conﬁgure the Heska Element COAG™Analyzer’s connections to an external printer or an external network, touch the to the right of the preferred category.

Touching Done returns to the Settings Menu.

Chapter 3

Page 36

3. Conﬁguring the Heska Element COAG™Analyzer

3.2.6.1. Printer

The Heska Element COAG™Analyzer is programmed to run with speciﬁc printer models that are currently available in the market. This section covers the necessary information regarding printer compatibility and suggestions regarding other options, if these printers are not available at your convenience.

The Heska Element COAG™Analyzer only functions properly if connected to a printer approved by the manufacturer and compatible with the Heska Element COAG™Analyzer.

Figure 3.14:

Selection Menu. The Printer Menu shows a list of printers that are compatible with the Heska Element COAG The currently selected printer is indicated by a dark purple arrow button to the right of the printer name.

To change the printer or to view a list of printer models compatible with the Heska Element COAG™Analyzer, follow these steps:

1. From the Home Screen, touch Setup (this opens the Settings Menu).

Printer

™

Analyzer.

From the Settings Menu, touch to the right of the Connections category (this opens the Connections Menu).

From the Connections screen, touch to the right of the Printer entry ﬁeld. This will display a list of printers compatible with the Heska Element COAG™Analyzer.

Connected printers are indicated with black text, oﬄine printers with red.

The currently selected printer is indicated by a dark purple arrow button to the right of the name of the printer.

To select a diﬀerent printer for use with the Heska Element COAG™Analyzer, set the printer up according to the manufacturer’s instructions and connect it to the Heska Element COAG™Analyzer using a USB cable. The USB port is located on the back of the instrument, see Figure 2.1.

Select your connected printer by touching the corresponding arrow key on the right-hand side of the screen.

Page 37

3.2. Conﬁguration of the Heska Element COAG™Analyzer

6. Touch Done to conﬁrm and return to the Settings Menu.

Touching

the change(s).

As the instrument uses an embedded operating system, it has no physical

means of adding new custom printers. If the available printers do not match your preference, it is recommended to use Heska Element COAG™Auto-printer instead. Heska Element COAG™Auto-printer is a free, standalone network based utility program, supplied by Heska Corporation that enables the Analyzer to print to any printer, connected directly or indirectly to a local network. Contact your Distributor regarding Auto-printer.

3.2.6.2. Network

This section discusses prerequisites and guidelines relevant to LIS technicians and the options that are available regarding data transmission from the Heska Element COAG Analyzer to a media within your data exchange network.

If your laboratory does not have a Laboratory Information System setup, leave

the Data Export setting at oﬀ (the default) and disregard the remainder of this section.

Cancel

clears any undesired change(s) and touching

Done

conﬁrms

Figure 3.15:

Screen. From the Network Screen it is possible to conﬁgure the Heska Element COAG™Analyzer for use with a LIS.

Network

Chapter 3

™

Prerequisites

an IP address and port number of your LIS are required in order to set up the data export.

The Heska Element COAG™Analyzer should be connected to the network where a connection to your LIS can be achieved through an Ethernet port located at the back of your Heska Element COAG™Analyzer.

The Heska Element COAG™Analyzer transmits data via TCP/IP, hence

Page 38

3. Conﬁguring the Heska Element COAG™Analyzer

Note that the information is transmitted in the language chosen on the Heska Element COAG™Analyzer.

Contact Heska Corporation for an updated list of applied LIS tags, enabling your LIS operator to set a viable connection up to your Heska Element COAG™Analyzer. With regard to any LIS system, Heska Corporation does not deliver any speciﬁcation ﬁles, drivers or middleware applications.

Industrial standard NCCLS LIS protocols, NCCLS LIS01-A2, Vol. 28, No. 13

and NCCLS LIS02-A2, Vol. 24, No. 33, have been implemented.

Guidelines

must be provided by the user.

Edit each ﬁeld in the Network Screen (see button to the right of the corresponding entry box.

Server The following ﬁelds apply to the identiﬁcation of your LIS server:

Data Export

To conﬁgure your Heska Element COAG™Analyzer with a LIS, information

Figure 3.15

Enables/disables data export to a LIS on the Analyzer. With data export

activated the following ﬁelds become editable.

Note that when enabling data export from the Heska Element COAG™Analyzer it will still function as a stand-alone instrument saving all measurements on disk, but will additionally transfer measurement results to your LIS.

Results measured when the connection to the LIS is oﬄine are queued and transmitted when a connection has been established. This queue does not survive a power cycle (switching the instrument oﬀ/on).

With data export enabled a test results of the Heska Element COAG™Analyzer. This enables the operator to retransmit all or individually selected measurements stored on the Heska Element COAG™Analyzer. Touching will queue the measurement results for retransmission upon a reconnection. This queue does not survive a power cycle (switching the instrument oﬀ/on).

With data export enabled, the LIS can query the Heska Element COAG™Analyzer to resend individual or all results. If communication is lost in the process, the Heska Element COAG™Analyzer will queue the intended measurements for retransmission upon reconnection. This queue does not survive a power cycle (switching the instrument oﬀ/on).

On the Home Screen of the Heska Element COAG™Analyzer, LIS connection problems are indicated, notifying the user to check connectivity.

Resend

button appears on the history pages for the

when the connection to the server is oﬄine

) by touching the purple arrow

Page 39

3.2. Conﬁguration of the Heska Element COAG™Analyzer

•

A small ‘N’ ﬂashes on the lower right-hand corner, when no LIS connection can be established.

•

A small ‘T’ ﬂashes on the lower right-hand corner, when the LIS is not responding.

If the connection is lost or oﬄine, reconnection is attempted at pre-deﬁned time intervals.

IP Address

IP Port Type your LIS server application’s IP port number. This ﬁeld is forced editable,

Instrument

address automatically from the network or to specify one manually.

IP Origin

Type your LIS server application’s IP Address here. This ﬁeld is forced

editable, if data export has been enabled.

if data export has been enabled.

The instrument section in the screen speciﬁes whether to obtain an IP

By default the IP origin is set to Obtain automatically. It is strongly recom-

mended to leave this setting at the default value. As the Heska Element COAG

Analyzer is equipped with Automatic Private IP Addressing (APIPA), it is not neces-

sary to alter the remaining settings in the Instrument section (the Heska Element COAG™Analyzer will work on networks without a DNS server).

Note that setting a ﬁxed IP address as IP Origin will produce error mes-

sages if the instrument cannot connect to the network. If you set the IP Origin to a ﬁxed value, you must contact you local IT administrator to obtain the values for the IP Address, Subnet mask and Default gateway.

If you have a strict IT setup at your facility, and need to white-list your Heska Element COAG™Analyzer, the DNS or APIPA automatically obtained IP address for the Heska Element COAG™Analyzer will be listed in the ﬁeld Instrument IP

Address. The MAC address of your Heska Element COAG™Analyzer can be

found on the Service page.

Chapter 3

™

An important note on Practice Assigned ID: The LIS ﬁeld, Practice Assigned

ID, is a unique identiﬁer (key) for any LIS to handle exported data. For this ﬁeld, the Heska Element COAG™Analyzer uses the Patient ID the operator entered. Therefore, when using the Analyzer in a data export setup, it is highly recommended to apply the user option to require Patient ID (See

Section 3.2.4

Page 40

3. Conﬁguring the Heska Element COAG™Analyzer

A Note on the Communications Log: In the service page of the Heska Element

COAG™Analyzer, a log of the data export communication can be found (the last 1000 messages are shown). The log page is intended for LIS service technicians to ﬁnd transmission problems when integrating the Heska Element COAG™Analyzer into their LIS system. The transmitted data is shown at protocol layer with a primary column indicating direction to and from the instrument. In addition to the transmitted data, the Heska Element COAG™Analyzer will log messages when the communication with the server is established or lost. Also, miscellaneous error messages will appear here.

3.2.7. Quality Assurance

Figure 3.16:

assurance menu.

3.2.7.1. Calibration

The Calibration menu is shown in over date(s) and time(s) for when calibration for the Fibrinogen Test has been performed. The currently active calibration is indicated with a dark purple button to the right of the row with the calibration information.

Quality

Figure 3.18

. The Calibration menu gives an overview

Page 41

3.2. Conﬁguration of the Heska Element COAG™Analyzer

Figure 3.17:

Overview. The Calibration overview shows details regarding date(s) and time(s) for when calibration for the Fibrinogen Test has been performed.

To access the Calibration overview, touch the then touch the to the right of the Calibration category in the Settings Menu.

The Calibration page has three buttons:

Done

Touching the

to the Fibrinogen Calibration settings.

Save

If more than one calibration has been carried out, you can choose which calibration the Analyzer should use when performing a Fibrinogen Test. If the calibration is changed, you must touch Menu.

Done

button returns to the Settings Menu without making changes

Save

to store the new selection and return the Settings

Setup

button on the Home Screen and

Calibration

Chapter 3

Calibrate

To perform a new calibration of the Heska Element COAG™Analyzer for use

with the Fibrinogen Test, touch the

sequence.

Note that performing a calibration of the Heska Element COAG™Analyzer

requires an Fibrinogen Calibration Kit. Please contact Technical Support Services for details regarding this procedure.

Calibrate

button. This will start a calibration

Page 42

3. Conﬁguring the Heska Element COAG™Analyzer

3.2.7.2. Analyzer Self Test

Figure 3.18:

self test results. This menu provides an overview of the details regarding date(s) and time(s) for when an Analyzer self test has been performed.

Analyzer

3.2.8. Screen Saver

The Screen Saver Settings screen is shown in Settings screen, touch right of the Screen Saver category in the Settings Menu. The Heska Element COAG Analyzer’s screen saver consists of user-selected pictures shuﬄed randomly.

Figure 3.19:

saver settings. From the screen saver settings menu, it is possible to enable/disable the screen saver. If the screen saver is enabled, the delay for starting the screen saver and the interval between the exchanging the displayed images can be conﬁgured.

Screen

Setup

on the Analyzer’s Home Screen and touch the to the

Figure 3.19

. To enter the Screen Saver

™

Five options are available to conﬁgure the Heska Element COAG™Analyzer’s screen saver:

Enable

Touch the to the right to turn the screen saver on/oﬀ. If the screen saver is

turned oﬀ, the remaining settings have no eﬀect.

Page 43

3.2. Conﬁguration of the Heska Element COAG™Analyzer

Delay

Touch the to the right to change the delay before the screen saver is started.

Possible choices are 1 minute, 5 minutes, 10 minutes, and 30 minutes.

Interval

Load pictures

Start now

3.2.8.1. Load Pictures

Pictures for display when the Heska Element COAG™Analyzer’s screen saver is running can be loaded from the Screen Saver Pictures menu, see pictures can be loaded and displayed at random when the screen saver is running.

Touch the to the right to change the interval between exchanging the displayed images when the screen saver is running. Possible choices are every 10 seconds, every minute, and every 5 minutes.

To select pictures to be displayed when the screen saver is running, touch the to the right. See formats and how to load the pictures.

Touch the to the right to test the screen saver. Touch anywhere on the

screen to return to the Screen Saver Settings menu after testing.

Touching

Done

in the Screen Saver Settings menu returns to the Settings Menu.

Section 3.2.8.1

for details regarding supported image

Figure 3.20

Figure 3.20: Load Pictures. Up to eight screen saver pictures can be loaded at a time for use by the Heska Element COAG screen saver. To load a picture, touch the

desired picture number and select the image ﬁle. To delete a picture touch the purple cross next to the image.

. Up to eight

™

to the right of the

Analyzer’s

Chapter 3

To add a new picture for use by the screen saver:

1. From the Home Screen, touch Setup (this opens the Settings Menu).

From the Settings Menu, touch to the right of the Screen Saver category (this opens the Screen Saver Settings page).

Page 44

3. Conﬁguring the Heska Element COAG™Analyzer

From the Screen Saver Settings page, touch to the right of the Load pictures entry (this opens the Screen Saver Pictures page, see Figure 3.20).

Insert a USB stick with the desired pictures in the USB port on the back of the Analyzer, see Figure 2.1 for the location of the USB port.

The pictures must be in JPEG format with extension “.jpg” and be smaller

than 1 MB.

Touch the to the right of the desired picture number. This will open a list of JPEG images located at the root of the USB stick. If no images are found an error message will be displayed.

6. Select the image to load and touch Done.

Repeat

item 5

and

item 6

for all pictures you want to appear when the screen saver

is running.

When all images are loaded, touch menu, see Section 3.2.8 for options in this menu.

Touching Settings menu.

Done

in the Screen Saver Pictures menu returns to the Screen Saver

Done

to return to the Screen Saver Settings

Page 45

4. Memory Database

Up to a 1000 test results are automatically stored in the Heska Element COAG™Analyzer’s memory database. The ﬁles in the database are sorted by date, with the most recent ﬁrst. Each ﬁle is stored with Patient ID, Sample ID, Test Date and Time, and test results. There is a built-in search function to retrieve test results by Test Type, Patient or Sample ID or by Date. Test results can be printed if a printer is connected to the Analyzer.

4.1. Viewing Test Results

To view the results database, touch the This will open the results database view shown in 1000 results obtained on the Analyzer sorted by date (newest ﬁrst).

For each result the following are listed: Date and time of test, Test Type, Patient ID and Sample ID. Patient and Sample ID are supplied by the operator when running the test. The test date/time and test type are automatically logged by the Analyzer when running a test.

Results can be retrieved from the database by performing a search based on the above meta-data. To access the Search Menu, touch the screen and follow the directions given in Section 4.2.

History

button on the Analyzer’s Home Screen.

Figure 4.1

. This view shows the last

button at the buttom of the

Figure 4.1:

history. Up to 1000 test results are stored in the internal results database on the Heska Element COAG Analyzer.

Results

Chapter 4

™

Page 46

4. Memory Database

The

Resend

button to syncronize the results in the LIS if you have changed the Analyzer conﬁguration (language, time format, etc.) or if the connection to the LIS has been corrupted. All test results will remain in the Analyzer’s database and only a copy will be transmitted to the LIS.

Touch the Done button to return to the Analyzer’s Home Screen.

To view details for a particular test, follow the steps below:

1. From the Home Screen, touch History (this opens the Memory database).

2. Touch the H and N buttons to scroll through the ﬁles in the database.

button is only visible if the Analyzer is connected to a LIS. Use the

Touch the on the right hand side of the screen corresponding to each ﬁle or the result line to review the detailed test results. The test result is retrieved in the same format as it was originally obtained.

If a printer is connected to the Analyzer, the test result can be printed by

touching the on-screen Print button.

Resend

4.2. Performing a Database Search

It is possible to search the results database for a particular result based on a number of search criteria. To access the Search menu, touch the screen, see Figure 4.1. Figure 4.2 shows the results history search interface.

button on the Memory

Figure 4.2:

Search. A search for a particular result can be carried out using the Patient ID, Sample ID or test date and type as search criteria.

The available ﬁlters for a database search are listed below. It is possible to combine one or more search criteria when performing a database search.

Patient ID

Results

Supply a text string for ﬁltering the results based on the user-supplied Patient

IDs. See Section 4.2.1 for details.

Page 47

4.2. Performing a Database Search

Sample ID

From date & To date

Test type

Supply a text string for ﬁltering the results based on the user-supplied Sample

IDs. See Section 4.2.2 for details.

Supply dates for ﬁltering the results based on the test dates when

the analyses were performed. See Section 4.2.3 for details.

Use the to the right of the text ﬁeld to toggle which test types to show in a

results search. See Section 4.2.4 for details.

4.2.1. Search by Patient ID

Touch

History

hand side of the Memory screen to access the Search Menu.

2. On the Search Menu, touch the purple arrow button across the Patient ID ﬁeld to access the on-screen keyboard to type in the designated information required to retrieve the corresponding measurement data for a speciﬁc patient.

3. Touch Done when ﬁnished registering the search entry.

To begin the search, touch restart the search process touch Clear All.

5. If the Search-button was previously touched, the results gathered will be shown.

6. To start anew, touch Back.

Writing the whole Patient ID info is not necessary. You can write the word or

just part of the word as the search phrase.

on the Home screen, and then touch

on the lower right hand side of the screen. To

on the lower right

Chapter 4

4.2.2. Search by Sample ID

Touch

History

hand side of the Memory screen to access the Search Menu.

On the Search Menu, touch the purple arrow button across the Sample ID ﬁeld to access the on-screen keyboard to type in the designated information required to retrieve the corresponding measurement data for a speciﬁc patient.

3. Touch Done when ﬁnished registering the search entry.

To begin the search, touch restart the search process touch Clear All.

5. If the Search-button was previously touched, the results gathered will be shown.

6. To start anew, touch Back.

on the Home Screen, and then touch

on the lower right hand side of the screen. To

on the lower right

Page 48

4. Memory Database

Writing the whole Sample ID info is not necessary. You can write the word or

just part of the word as the search phrase.

4.2.3. Search by Date

Touch

History

on the Home Screen, and then touch

hand side of the Memory screen to access the Search Menu.

On the Search Menu, touch the across the From Date ﬁeld to access the onscreen keyboard to type in the start date wherein the test took place or touch the

across To Date ﬁeld, if the end date is desired.

Touch Done when ﬁnished registering the search entry, or touch the entry and return to the Search menu.

To begin the search, touch restart the search process touch Clear All.

5. If the Search-button was previously touched, the results gathered will be shown.

6. To start anew, touch Back.

on the lower right hand side of the screen. To

on the lower right

Cancel

4.2.4. Search by Test Type

Touch

History

on the Home Screen, and then touch

hand side of the Memory screen to access the Search menu.

2. On the Search Menu, touch the across the Test Type ﬁeld until the desired test type is accessed. These test types are as follows:

• DEA 1 Canine Blood Typing

• PT/aPTT Combo

• Equine Fibrinogen

• Feline A & B Blood Typing

• Canine Fibrinogen

Touch

Done

when ﬁnished registering the search entry, or touch

the entry and return to the Search Menu.

To begin the search, touch restart the search process touch Clear All.

5. If the Search-button was previously touched, the results gathered will be shown.

6. To start anew, touch Back.

on the lower right hand side of the screen. To

on the lower right

Cancel

to clear

Page 49

5. Maintenance and Support

5.1. Routine Maintenance

The Heska Element COAG™Analyzer only requires cleaning on a regular basis as maintenance. A visual inspection of the instrument for damage and a regular cleaning of the surface are strongly recommended.

Do not use the Heska Element COAG™Analyzer if it appears to be damaged.

Disconnect the power, and contact your Distributor for technical support.

5.2. Cleaning the Outer Shell

Visually inspect the instrument and clean if necessary. Pay special attention to the cartridge slot opening. Removal of dried blood, dirt or other foreign matters is done by using a water-moistened cotton swab or a damp cloth. Make sure to remove residual water with a dry cotton swab or a dry cloth. If a disinfectant is needed, use Virkon ( solution). After disinfection of the instrument, wipe it with a damp water-moistened cloth or cotton swab to remove any residual disinfectant.

•

Use of solvents or strong cleaning agents is inadvisable, as they may damage the instrument’s surface and the LCD touch screen.

•

Use of aerosols or pouring detergents, solutions or any other liquid directly onto the instrument is likewise not recommended.

1 %

Chapter 5

We strongly suggest that you follow the instructions to avoid damaging the

instrument. Damages incurred due to improper maintenance are not covered by the warranty.

5.3. Cleaning the Cartridge Slot and Air Filter

Cleaning of the cartridge slot and air ﬁlter should be done by lightly vacuuming their openings. The air ﬁlter is located on the right side (as seen from the front) of the instrument and the cartridge slot in front.

Page 50

5. Maintenance and Support

Do not vacuum the fan opening as this may cause damage to the fan. The

fan opening is located on the left-hand side (as seen from the front) of the instrument. Damage caused by non-recommended cleaning methods is not covered by the product warranty.

5.4. Service

The instrument monitors its internal hardware and software and reports problems to the display screen (see Troubleshooting Section). If the instrument, for some reason, does not work properly and needs to be serviced, please contact your Distributor or Heska Corporation Customer Support for technical assistance at 1-800-464-3752.

• The Heska Element COAG™Analyzer has no user-serviceable parts.

•

There is a battery on the computer board inside the instrument. Replacement of this battery must be carried out by an authorized service provider.

•

The Heska Element COAG™Analyzer has an anti-tampering device. The warranty is voided if the instrument is opened by a non-authorized service provider.

5.5. Disposal of the Heska Element COAG™Analyzer

The Heska Element COAG™Analyzer contains electronic circuits and battery, therefore, local regulations for electric equipment disposal should be followed in disposing of the instrument.

Page 51

6. Troubleshooting

6.1. Technical Support

Contact Heska’s Technical Support Services for assistance at 1-800-464-3752.

6.2. Problems That Give No Advisory Messages

Problems that may occur but will not give an error message on the screen are tabulated in Table 6.1.

Problem Corrective Action

Nothing happens when the instrument is turned on

The Heska Element COAG™cartridge cannot be inserted in the cartridge slot of the Heska Element COAG™Analyzer

The message

tridge

after the cartridge has been inserted.

Nothing happens when a button is touched or there is a misalignment between the point of touch and the action carried out by the Analyzer.

Table 6.1: List of problems that give no error messages.

Make sure that the instrument is connected to the power supply and that the power supply is connected to a power outlet. Check that the LED on the power supply is lit.

Make sure that there are no foreign objects in the cartridge slot.

Please insert new car-

is still shown on the screen even

Make sure that the cartridge is fully inserted in the cartridge slot.

Make sure that the Analyzer’s touch screen is properly calibrated. See Section 6.4 for information regarding how to perform a screen calibration.

Chapter 6

6.3. List of Advisories

In case a problem occurs during a test, the Heska Element COAG™Analyzer will in most instances report an Advisory Number. For a list of possible advisories and corresponding corrective actions, please refer to Table 6.2.

Page 52

6. Troubleshooting

If the problem persists after trying the corrective action listed for the relevant advisory number in Table 6.2, please contact technical support.

Table 6.2: List of Advisories.

No. Cause Corrective Action

7 Flow too fast in the cartridge Repeat the test with a new cartridge. Be

8 Flow too slow in the cartridge Repeat the test with a new cartridge. Be

9 Sample added too early

12 Ambient temperature too low

13 Ambient temperature too high

14–19 Light detection issue

20 No cartridge detected

22–23 Light detection issue

24 LIS is not responding Check LIS and Ethernet cable

Blood sample not detected due to inadequate amount of blood used

No clot detected. Can be due to a very sick animal or the tube not ﬁlled correctly

Malfunction of instrument components

On-going test terminated by the user

Continued on next page

Repeat the test with a new cartridge. Be sure to follow the on-screen instructions

sure to follow the on-screen instructions

Wait for the message Add sample and

wait before adding sample to the cartridge.

Be sure to follow the on-screen instructions

Turn oﬀ and restart the instrument

Repeat the test with a new cartridge

Restore recommended ambient conditions for the instrument

Repeat the test with a new cartridge and ensure that no foreign objects are in the cartridge slot

Make sure that the cartridge is fully inserted in the cartridge slot

Repeat the test with a new cartridge and ensure that no foreign objects are in the cartridge slot

Page 53

6.4. Screen Calibration

No. Cause Corrective Action

25 Test error Repeat the test with a new cartridge. Be

sure to follow the on-screen instructions

26 Autoaggulatination detected

27 Flow too slow in cartridge

29 Wrong calibration code

30–33 Incorrect cartridge code Retype code from pouch

34 Incorrect cartridge code

35 Incorrect cartridge code Check expiry date from pouch

36 Internal error Contact technical service

37–38 Signal distortion Repeat the test with a new cartridge. Be

Poor sample quality due to hemolysis, RBCs or lipemia

Please check the sample quality and repeat the test with a new cartridge

Please ensure proper dilution of the sample and repeat test

Ensure that the 11-digit code is correct and that the calbration kit has not expired

Check date setting on instrument and retype code from pouch

sure to follow the on-screen instructions

Check sample quality and if needed take new sample

6.4. Screen Calibration

A screen calibration can be initiated by touching the touch screen (anywhere) during startup of the Heska Element COAG™Analyzer. initiation.

Figure 6.1

shows the Screen Calibration

Figure 6.1:

Calibration. A screen calibration can be initiated by touching the Heska Element COAG touch screen during start-up.

™

Screen

Analyzer’s

Chapter 6

Page 54

6. Troubleshooting

Once the screen calibration has been initiated, a progress-bar will appear. Upon progress bar time-out, the screen calibration program will start automatically. Otherwise, touch

Start Now

screen calibration, touch the the calibration. You will need a small and pointy – but not sharp – piece of plastic to perform the screen calibration.

on the touch screen to initialize the program immediately. To cancel the

Cancel

button. Follow the on-screen instructions to perform

Page 55

Part II.

The Heska Element COAG™Test

Portfolio

Page 56

Page 57

7. PT/aPTT Combination Test

The PT/aPTT Coag Combo cartridge used with the Heska Element COAG Analyzer is designed to detect and diagnose abnormalities in Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT).

Each PT/aPTT Coag Combo cartridge contains dual optical detection windows ﬁlled with micro-channels: one for detecting PT clotting time, another for aPTT clot detection.

The PT/aPTT Coag Combo test cartridge can simultaneously measure PT and aPTT from a single drop of citrated whole blood with nominal test duration of 10 minutes including warm-up time.

™

Figure 7.1:

The Heska Element COAG PT/aPTT COAG Combo test kit.

7.1. Blood Coagulation

Blood coagulation is the process by which blood forms clots [1–4]. Disorders in the coagulation process can lead to an increased risk of bleeding and/or clotting. Events that lead to the formation of a blood clot are simpliﬁed in coagulation theory into two coagulation cascades that are referred to as the intrinsic pathway and the extrinsic pathway, both leading to the common pathway and the formation of a stable ﬁbrin clot. The analysis of blood coagulation can be a guide in determining a large number of existing or potential disorders that can seriously aﬀect the health of the patient, see

Figure 7.2 and [4].

™

Chapter 7

The extrinsic pathway is initiated through the interaction of tissue factor with factor VII. Tissue factor is released from or exposed on the damaged tissue, disrupted cells, or cells such as macrophages, monocytes, or activated endothelial cells. In-vivo platelets, the essential cofactors in this reaction, provide the platelet phospholipid surface on which the

Page 58

7. PT/aPTT Combination Test

Prolonged Normal

PT PT

aPTT

Prolonged Normal Prolonged Normal

Common path-

way disorder

± combined intrinsic and

extrinsic pathway disorder

DIC

Over-heparinization

Common pathway factor deﬁciency

Vitamin K deﬁciency

Rodenticide toxicity

Intrinsic path-

way disorder

Hemophilia A (VIII)

Hemophilia B (IX)

Hemophilia C (XI)

Factor XII deﬁciency with no associated bleeding disorder

Extrinsic path-

way disorder

Factor VII deﬁciency

Early rodenticide deﬁciency

Vitamin K deﬁciency/antagonist

No coagula-

tion disorder

Consider primary bleeding disorder

- platelets

- von Willebrand factor

- vascular disorder

Figure 7.2: Guide to possible diagnosis based on PT and aPTT clot time.

coagulation occurs. The test reagents include phospholipid, therefore thrombocytopenia does not aﬀect this test.

The intrinsic pathway is started through contact activation of factor XII. The pathway goes through several reactions that result in the formation of activated factor X. The common pathway uses factor X, factor V, and free calcium to create enzymatic conversion of prothrombin to thrombin, which is then used in creating ﬁbrin from ﬁbrinogen. Activated Partial Thromboplastin Time (aPTT) and Prothrombin Time (PT) tests are general coagulation tests used for screening and measuring the functionality of the blood coagulation cascade. PT is used to assess the extrinsic and common pathway and aPTT to assess the intrinsic and common pathway.

7.2. Test Speciﬁcations

An overview of the PT/aPTT COAG Combo test speciﬁcations is given in test has been validated for use with feline (cat) and canine (dog) citrate-stabilized whole blood. Under normal operating conditions, test results have a Coeﬃcient of Variation (CV) of 7 % or better.

A PT/aPTT COAG Combo test takes less than 15 minutes to perform. The actual time depends on the blood sample and test environment. At room temperature, it takes about

Table 7.1

. The

Page 59

7.2. Test Speciﬁcations

90 seconds for the instrument to warm up the test cartridge to the operating temperature of

99 °F/37◦C procedure of the assay begins, the result is reported as soon as a clot is identiﬁed in either of the measuring channels. Typically, this occurs within approximately 10 minutes.

Each test cartridge is individually packed in a sealed pouch with a desiccant bag and a disposable pipette. The pouch should be stored at refrigerated temperatures ( 46 °F/2◦Cto8◦C reach room temperature prior to running the test. The pouch should not be exposed to direct sunlight. Once the pouch has been opened, the cartridge should be used within 10 minutes. A cartridge must be used within that day. Do not return a warmed cartridge to the refrigerator. If stored in accordance with these guidelines, the test cartridges are stable until the expiration date printed on the pouch label.

The test cartridge can be used only once and only in combination with the Heska Element COAG™Analyzer. Once used, the cartridge, pipette and sample collection tube should be considered as potentially infectious. Dispose of them properly in accordance with the policies and regulations at the place of operation.

. Lower and higher temperatures may change the warm up time. Once the

36 °F

). Remove the pouch from the refrigerator and allow the cartridge to

Always strictly adhere to all biohazard safety guidelines pertaining to handling and disposing of animal blood samples.

Chapter 7

Page 60

7. PT/aPTT Combination Test

Table 7.1: Speciﬁcations for the PT/aPTT COAG Combo Test.

Measurement Technology Clot time, light absorbance

Result Units Second

Reference Ranges Species PT aPTT

Feline (Cat) 15 s to 21 s 90 s to 130 s Canine (Dog) 14 s to 19 s 75 s to 105 s

Dynamic Range PT aPTT

11 s to 35 s 30 s to 200 s

Sample Type Whole blood

Sample Volume 60 µL

Sample Collection 3.2 % concentration sodium citrate tube

Sample Stability

Cartridge Stability

Storage Refrigerate at 36 °F to 46 °F/2◦C to 8◦C

Shelf Life The expiration date is printed on the pouch label

Time to results Approximately 10 minutes

2 hours of room temperature ( 30◦C

). Invert the tube back and forth 10 times every 10

minutes

Do not expose cartridges in the foil pouch to direct sunlight. Once warmed to room temperature, cartridge must be used within that day. Do not return warmed cartridges to the refrigerator. Use cartridges taken from the foil pouch within 10 minutes

59 °Fto86 °F/15◦C

Page 61

7.3. Test Requirements

7.3.1. Materials and Equipment

The following materials and equipment are required in order to perform a Heska Element COAG™PT/aPTT COAG Combo Test on the Heska Element COAG™Analyzer:

• Heska Element COAG™Analyzer

• PT/aPTT COAG Combo Test Cartridge

• Pipette (included in the sealed pouch with the test cartridge)

• Syringes with a 22-gauge needle or larger

• Sample tubes containing 3.2 % sodium citrate as an anticoagulant

• Package insert for the PT/aPTT COAG Combo Test

7.3.2. Blood Sample Preparation

Use a syringe with a 22-gauge needle or larger when drawing the blood to avoid hemolysis. Collect the blood directly into the tube containing citrate as the anticoagulant. The result of a coagulation analysis is very much dependent on the quality of the blood sample and the correct concentration of anticoagulant in the sample. Follow standard blood-drawing procedures at all times and pay special attention to the following:

•

Blood samples, if possible, should be collected about 5 minutes before testing to stabilize the mixture of the blood and the citrate.

•

The sample collection tube must not be over- or under-ﬁlled. Even though the assay requires only tube has been ﬁlled to the correct ﬁlling line.

•

Slowly invert the tube containing the blood sample 10 times every 10 minutes as an alternative if a blood rocker is not available.

•

The blood sample should be kept at room temperature, in case the testing is delayed. Blood may be tested up to two hours after it has been collected without aﬀecting the test result.

•

Contamination from thromboplastin, alcohol and intravenous solutions will interfere with the coagulation assay.

•

Hemolysis and foaming of the blood sample are potential sources of inaccurate and imprecise test results.

60 µL

of whole blood, it is very important that the sample collection

Chapter 7

Page 62

7. PT/aPTT Combination Test

•

When collecting the blood sample, it is important that exhilaration of the patient be minimized. Exhilaration or excitement increases the amount of blood cells in the blood. This can increase platelet count and/or aggregation, levels of Von Willebrand factors, ﬁbrinogen and factors V and VIII, which have signiﬁcant inﬂuence on the coagulation cascade.

• Sedatives and analgesics can also inﬂuence blood coagulation.

The accuracy of the PT/aPTT COAG Combo Test is mainly dependent on the

quality of the blood sample. The way the blood is collected and has been handled can greatly aﬀect the blood quality.

7.4. Limitations

The veterinarian is always the ﬁnal arbiter of test result interpretation and impact on diagnosis. Therefore it is highly recommended that Heska Element COAG™test results should be scrutinized in the light of a speciﬁc patient’s condition and medical history, as well as current or potential therapy.

Any test result exhibiting inconsistency with a patient’s status should be repeated and/or supplemented with additional diagnostic tests.

The accuracy of Heska Element COAG™Analyzer test results is largely dependent on the quality of the blood specimen which in turn is dependent on:

• The blood sample collection

• The proper volume of blood/citrate

• The proper mixing of the citrated blood

• The proper introduction of the blood sample into the cartridge well.

Blood samples with a hematocrit of less than mended for use with the Heska Element COAG™Analyzer. Blood samples outside this range may result in an instrument error or inaccurate test result.

Please observe all precautions cited in this guide and use good blood sampling

technique at all times.

15 %

or greater than

65 %

are not recom-

7.5. Test Procedure

Verify that you have the necessary materials and equipment for performing a PT/aPTT COAG Combo test, see Section 7.3.

Afterward, follow these simple test procedures:

Page 63

7.5. Test Procedure

Step 1:

Step 2:

Step 3:

Step 4:

Step 5:

Remove a pouch with a test cartridge from the refrigerator and let the pouch and cartridge reach room temperature starting the test.

Draw blood from the patient into a sample tube containing as an anticoagulant.

From the Home Screen, touch either the

nine PT/aPTT

to start the test.

When the message Please insert new cartridge

is shown on the screen, insert the test cartridge completely into the cartridge slot on the front of the Analyzer.

The cartridge must have the label facing upward and the sample well sticking out of the Analyzer.

On the on-screen keyboard, enter the cartridge code (printed on the cartridge pouch label) in the entry ﬁeld and touch Done.

or the

Feline PT/aPTT

59 °Fto86 °F/15◦Cto30◦C

3.2 %

sodium citrate

Ca-

button

before

Step 6:

Step 7:

Touch

Conﬁrm

has been obtained in a citrate test tube and that the tube was appropriately ﬁlled.

Touch

Patient ID

formation using the on-screen keyboard.

Touch Done to conﬁrm.

Entering Sample ID is optional but recommended to aid in ﬁnding the result in the Analyzer’s database.

to acknowledge that the blood

and enter the necessary in-

Chapter 7

Page 64

7. PT/aPTT Combination Test

Step 8:

Step 9:

Step 10:

Touch

to continue. The

ing Up screen opens.

It takes approximately 90 seconds for the Analyzer to warm up the test cartridge to 37◦C

depending on the environment’s temperature. Lower and higher room temperatures may change the warm up time.

Do not add blood samples while the cartridge is warming up. Wait

until a prompt appears on the screen instructing you to add the sample. By default, a message and a single beeping sound can be heard which signals that the blood sample can now be added to the cartridge.

Gently invert the test tube back and forth 10 times to obtain a uniform mixture of blood cells and plasma.

When the message disposable one-time-use pipette supplied with the cartridge to add a droplet of blood sample to the cartridge’s sample well.

Be sure to ﬁll the sample well with at least 60 µL blood.

The measurement starts automatically as soon as the sample is detected. The test progress is shown on the screen. Measurement takes approximately 10 minutes. If the Analyzer alerts you that an insuﬃcient amount of sample was placed into the sample well, repeat the measurement with a new cartridge. Touch Cancel to terminate the ongoing test.

The test result is displayed on the screen when the test is ﬁnished.

Cartridge Warm-

99 °F

Add blood and wait

ﬂashes on the screen

appears on the screen, use the

If a printer is connected to the instrument, touch Print to print the test result.

Touch

Done

to return to the Home screen. Remove the used test cartridge and dispose of it properly.

Page 65

8. Equine Fibrinogen Test

The Heska Element COAG™Fibrinogen cartridge used with the Heska Element COAG™Analyzer is designed to measure the concentration of clottable ﬁbrinogen in an equine (horse) plasma sample using the Ellis–Stransky method.

Each Fibrinogen cartridge contains dual optical detection windows ﬁlled with microchannels.

The Heska Element COAG™test cartridge measures the ﬁbrinogen concentration from nominal test duration of approximately 10 minutes including warm-up time.

100 µL

diluted plasma with

8.1. Fibrinogen Testing

Fibrinogen is an acute phase protein (APP), used as a clinical indicator of acute or chronic systemic inﬂammation. APPs are quickly released into the bloodstream as a reaction to injury or infection. APPs are proteins in which plasma concentration either increase or decrease by at least an inﬂammatory stimulus [5, 6].

Early detection of systemic inﬂammation is particularly signiﬁcant in formulating and initiating an eﬀective treatment plan [7]. Inﬂammation that is undiagnosed or unrecognized can impair growth and performance. Fibrinogen plasma concentration normally increases within 24 to 48 hours in response to inﬂammation. Elevated levels of ﬁbrinogen indicate a degree of systemic inﬂammatory response. Increase in ﬁbrinogen concentration is related to the magnitude of inﬂammation and often occurs before clinical evidence of disease [8–

]. Low levels of ﬁbrinogen may indicate a potential bleeding and/or liver problem. Quick

and accurate diagnosis is essential for successful outcome of treatment.

When measured in citrated plasma, a level above the normal range of indicates a systemic inﬂammatory response. Age and breed have to be taken into

Figure 8.1:

The Heska Element COAG Fibrinogen test kit.

25 %

after

2.0 g/Lto4.0 g/L

™

Chapter 8

Page 66

8. Equine Fibrinogen Test

consideration when evaluating the ﬁbrinogen level [14]. Newborn foals normally have 40 %

less plasma ﬁbrinogen reaching normal level 4 to 7 days after birth meaning that normal ﬁbrinogen range in newborn foals is expected to be lower compared to older foals and adult horses [15–17].

Detection of low levels of ﬁbrinogen can indicate a systemic activation of the clotting system, with consumption of clotting factors faster than synthesis. Excessive clotting factor consumption is known as Disseminated Intravascular Coagulation (DIC). In the context of acute critical illness such as sepsis or trauma, DIC can be diﬃcult to diagnose, but a strong clue is detection of low ﬁbrinogen and concomitant observation of prolonged clotting time (PT and aPTT). Liver problems can also result in decreased levels of ﬁbrinogen.

8.2. Test Speciﬁcations

An overview of the Heska Element COAG™Fibrinogen test speciﬁcations is given in

Table 8.1

extracted from citrate-stabilized whole blood. Under normal operating conditions, test results have a precision of 0.3 g/L or better.

A Fibrinogen test takes approximately 10 minutes to perform. The actual time depends on the blood sample and test environment. At room temperature, it takes about 5 minutes for the Analyzer to warm up the test cartridge to temperatures may change the warm up time. Once the procedure of the assay begins, the result is reported within approximately 10 minutes.

Each test cartridge is individually packed in a sealed pouch with a desiccant bag and a disposable pipette tip. The pouch should be kept at refrigerated temperatures ( 46 °F/2◦Cto8◦C reach room temperature prior to running the test. Once the pouch has been warmed to room temperature, the cartridge should be used within the same day. After opening the foil package, the cartridge must be used within 10 minutes. Do not return the cartridge to the refrigerator once warmed to room temperature. If stored in accordance with these guidelines, the test cartridges are stable until the expiration date printed on the pouch label. One pre-ﬁlled tube with diluent should be used with each test. Dispose of the diluent tube after running a test.

The test cartridge can be used only once and only in combination with the Heska Element COAG™Analyzer. Once used, the cartridge, pipette tip, diluent tube, and sample collection tube should be considered as potentially infectious. Dispose of them properly in accordance with the policies and regulations at the place of operation.

. The test has been validated for use with diluted equine (horse) plasma

99 °F(37◦C

). Remove the pouch from the refrigerator and allow the cartridge to

Always strictly adhere to all biohazard safety guidelines pertaining to handling

and disposing of animal blood samples.

). Lower and higher ambient

36 °F

Page 67

8.2. Test Speciﬁcations

Table 8.1: Speciﬁcations for the Heska Element COAG™Fibrinogen Test.

Measurement Technology Light absorbance, turbidity-based plasma assay

Result Units mg/dL, g/L or g/dL

Reference Range Species mg/dL g/L

Horse (equine) 150 to 400 1.5 to 4.0

Dynamic Range mg/dL g/L

0 to 2000 0.0 to 20.0

Sample Type Platelet poor plasma

Sample Volume 100 µL

Sample Collection 3.2 % or 3.8 % concentration sodium citrate tube

Sample Stability

Cartridge Stability

Storage Refrigerate at 36 °F to 46 °F or 2◦C to 8◦C

Shelf Life The expiration date is printed on the pouch label.

Time to results Approximately 10 minutes

12 hours at room temperature ( 30◦C) for whole blood sodium citrate samples.

3 hours at room temperature ( 30◦C) for plasma extracted.

30 days at freezing temperature ( plasma samples extracted from a citrate tube and placed in a red-top tube.

Do not expose cartridges in the foil pouch to direct sunlight or leave at room temperature for more than one day. Use cartridges taken from the foil pouch within 10 minutes

59 °Fto86 °For15◦C

14 °For−10◦C

) for

Chapter 8

Page 68

8. Equine Fibrinogen Test

8.3. Test Requirements

The Heska Element COAG™Analyzer must be calibrated to run the Fibrinogen Test cartridge. the Analyzer will be pre-calibrated from the factory.

8.3.1. Materials and Equipment

The following materials and equipment are required in order to perform an Equine Fibrinogen Test on the Heska Element COAG™Analyzer:

• Heska Element COAG™Analyzer

• Fibrinogen Test Cartridge

• Pipette tip (included in the sealed pouch with the test cartridge)

• 100 µL ﬁxed-volume pipette

• Pre-ﬁlled diluent tube (included in each box of cartridges)

• Syringes with a 22-gauge needle or larger

• Sample tubes containing 3.2 % or 3.8 % sodium citrate as an anticoagulant

• Package insert for Heska Element COAG™Fibrinogen Test cartridge

• Centrifuge minimum 7000 g × minutes.

8.3.2. Centrifuge

Table 8.2

revolutions per minute to obtain platelet-poor plasma as needed by the Heska Element COAG™Fibrinogen Test.

Some centrifuges do not display theg-loading of the sample, but instead show the revolutions per minute (RPM) of the centrifuge. In that case, use the table to ﬁnd the required centrifugation time for a given RPM and centrifuge radius1.

lists the required centrifugation time as a function of centrifuge radius and

The centrifuge radius is the distance between the axis of rotation and the center of the test-tube when placed in the

centrifuge.

Page 69

8.3. Test Requirements

Table 8.2:

Centrifugation time for various combinations of centrifugation speeds and

centrifuge radius.

Radius RPM Acc. Time Radius RPM Acc. Time

[cm] [1/min] [g] [min] [cm] [1/min] [g] [min]

2.5 5000 698 11 7.5 7000 4104 2

2.5 6000 1005 7 7.5 8000 5360 2

2.5 7000 1368 6 7.5 9000 6784 2

2.5 8000 1787 4 7.5 10 000 8375 1

2.5 9000 2261 4 10.0 2000 447 16

2.5 10 000 2792 3 10.0 3000 1005 7

5.0 5000 1396 6 10.0 4000 1787 4

5.0 6000 2010 4 10.0 5000 2792 3

5.0 7000 2736 3 10.0 6000 4020 2

5.0 8000 3574 2 10.0 7000 5472 2

5.0 9000 4523 2 10.0 8000 7147 1

5.0 10 000 5584 2 10.0 9000 9045 1

7.5 5000 2094 4 10.0 10 000 11 167 1

7.5 6000 3015 3

8.3.3. Sample Preparation

Use a syringe with a 22-gauge needle or larger when drawing the blood to avoid hemolysis. Collect the blood directly into the blue top tube containing citrate as the anticoagulant. The result of a Fibrinogen analysis is dependent on the quality of the blood sample and the extracted plasma.

To extract platelet-poor plasma from the whole blood sample, centrifuge the blood for a minimum The rotation speed and necessary spin time is dependent on the centrifuge size. Please refer to

7000 g × minutes

Table 8.2

for mini-

Figure 8.2:

blood sample after centrifugation.

mum centrifuge requirements.

Make sure to collect plasma for the Fibrinogen Test from the upper part of the plasma in the tube to avoid contaminating the plasma with RBCs.

As part of the test procedure, the extracted platelet-poor plasma must be diluted in accordance with the on-screen instruction on the Heska Element COAG™Analyzer.

Follow standard blood-drawing procedures at all times and pay special attention to the following:

Plasma

Buﬀy coat

Red blood cells

Whole

Chapter 8

Page 70

8. Equine Fibrinogen Test

•

Contamination from thromboplastin, alcohol and intravenous solutions will interfere

with the ﬁbrinogen assay. Hemolysis and foaming of the blood sample are potential

sources of erroneous test results.

•

Do not use blood that has been stabilized in any other way than using

3.8 % citrate collection tubes.

• Do not use blood from over-ﬁlled or under-ﬁlled citrate tubes.

•

Do not use plasma from samples that have been centrifuged at less than

• Do not use blood samples with visible clotting or debris accumulation.

•

Do not use plasma exhibiting signs of hemolysis, lipemia or other conditions that may aﬀect turbidity. A general guideline is that the sample should be clear and more yellow than red in color.

•

To avoid mechanical hemolysis, the needle used should have a 22-gauge or larger.

•

The vein puncture site should be cleaned with alcohol and allowed to air-dry completely.

•

When diluting the platelet poor plasma, ensure that no diluent is caught in the cap of the pre-ﬁlled micro tube by tapping the cap prior to opening the tube.

•

Use only the supplied Heska Element COAG™Fibrinogen pre-ﬁlled micro tube

with diluent. The Fibrinogen test will not work correctly if other diluents are used.

•

To avoid contaminating the plasma with red and white blood cells, please extract the required volume from the upper half of the plasma.

•

Do not touch the part of the pipette tip that will come in contact with the plasma

when removing the pipette tip from the pouch.

•

Test results may be impaired if sample is older than 12 hours or the extracted plasma is older than 3 hours.

3.2 %

7000 g × minutes

The accuracy of the Heska Element COAG™Fibrinogen Test is mainly depen-

dent on the quality of the blood sample and the extracted plasma. The way the blood is collected and has been handled can greatly aﬀect the blood and plasma quality.

8.4. Limitations

The veterinarian is always the ﬁnal arbiter of test result interpretation and impact on diagnosis. Therefore, it is highly recommended that Heska Element COAG™test results should be scrutinized in the light of a speciﬁc patient’s condition and medical history, as well as current or potential therapy.

Page 71

8.5. Test Procedure

Any test result exhibiting inconsistency with a patient’s status should be repeated and/or supplemented with additional diagnostic tests.

The accuracy of Heska Element COAG™Analyzer test results is largely dependent on the quality of the sample specimen which in turn is dependent on:

• The blood sample collection

• The proper volume of blood/citrate

• The proper mixing of the citrated blood

• The proper extraction of platelet-poor plasma

• The proper introduction of the sample into the cartridge well.

Please observe all precautions cited in this guide and use good blood sampling

technique at all times.

8.5. Test Procedure

Verify that you have the necessary materials and equipment for performing a Fibrinogen test, see Section 8.3.

Afterward, follow these simple test procedures:

Step 1:

Step 2:

Step 3:

Remove a pouch with a test cartridge from the refrigerator and let the pouch and cartridge reach room temperature starting the test.

Draw blood from the patient into a sample tube containing sodium citrate as an anticoagulant. The Fibrinogen assay requires only platelet poor plasma but the tube should be full to ensure the correct concentration of sodium citrate.

Separate the whole blood by centrifuging the blood sample in the collection tube into platelet poor plasma. To achieve suﬃciently platelet poor plasma, the blood sample must be centrifuged at minimum

Table 8.2 for a list of required centrifugation time.

The plasma should be extracted as soon as possible after collecting the blood sample. The whole blood sample can be kept for maximum 12 hours provided that the temperature does not exceed the sample at room temperature until testing. Do not expose to direct sunlight.

59 °Fto86 °For15◦Cto30◦C

3.2 %or3.8 %

7000 g × minutes

86 °F/30◦C

. It is recommended to store

before

100 µL

, see the

Chapter 8

Page 72

8. Equine Fibrinogen Test

Step 4:

Step 5:

Step 6:

Step 7:

From the Home Screen, touch the rinogen button to start the test.

When the message Please insert new cartridge ﬂashes on the screen, insert the Heska Element COAG™test cartridge completely into the cartridge slot on the front of the Analyzer.

The cartridge must have the label facing upward and the sample well sticking out of the Analyzer.

On the on-screen keyboard, enter the cartridge code (printed on the cartridge pouch label) in the entry ﬁeld and touch Done.

Touch

Conﬁrm

has been obtained in a citrate test tube, that the tube was appropriately ﬁlled, and that whole blood sample was spun to platelet poor plasma at minimum 7000 g × minutes.

to acknowledge that the blood

Equine Fib-

Step 8:

Step 9:

Touch

Patient ID

mation using the on-screen keyboard. Touch Done to conﬁrm.

Entering Sample ID is optional but recommended to aid in ﬁnding the result in the Analyzer’s database.

Touch

ing Up screen opens.

It takes approximately 5 minutes for the Analyzer to warm up the test cartridge to 37◦C

depending on the environment’s temperature. Lower and higher room temperatures may change the warm up time.

and enter the necessary infor-

to continue. The

Cartridge Warm-

99 °F

Page 73

Step 10:

Step 11:

Step 12:

8.5. Test Procedure

Do not add sample while the cartridge is warming up. Wait until a

prompt appears on the screen instructing you to add the sample. By default, a message and a single beeping sound can be heard which signals that the diluted plasma sample can now be added to the cartridge.

Ensure that no diluent is caught at the top of the diluent tube by tapping the tube on a hard surface. Using the supplied pipette tip, puncture the foil on the diluent tube. Extract the

100 µL

ﬁxed volume pipette and supplied pipette tip. Dilute the platelet poor plasma by aspirating into the supplied diluent tube and ensure proper mixing by aspirating a minimum of 5 times.

Make sure that no diluent is caught in the lid of the diluent tube.

When the message use a

100 µL

diluted plasma to the cartridge’s sample well.

Be sure to ﬁll the sample well with

The test result is displayed on the screen when the test is ﬁnished.

100 µL

Add 100 µL sample and wait

ﬁxed-volume pipette and the supplied pipette tip to add

Add sample and wait

platelet poor plasma from the collection tube using

100 µL

ﬂashes on the screen

appears on the screen,

100 µL

diluted platelet poor plasma.

If a printer is connected to the instrument, touch Print to print the test result.

Touch Done to return to the Home screen.

Step 13: Remove the used test cartridge and dispose of it properly.

Chapter 8

Page 74

Page 75

9. Canine Fibrinogen Test

The Heska Element COAG™Canine Fibrinogen cartridge used with the Heska Element COAG™Analyzer is designed to measure the concentration of clottable ﬁbrinogen in a canine (dog) plasma sample using the Ellis–Stransky method.

Each Canine Fibrinogen cartridge contains dual optical detection windows ﬁlled with micro-channels.

The Canine Fibrinogen test cartridge measures the ﬁbrinogen concentration from 100 µL

diluted plasma with nominal test duration of approximately 10 minutes including warm-up time.

9.1. Fibrinogen Testing

Fibrinogen (clotting factor I) is a coagulation protein produced by the liver and present in plasma of all vertebrates [18,19]. It plays an important role in blood coagulation, cellular interactions, inﬂammation and wound healing. Fibrinogen is also known as an acute phase protein (APP) and has been widely used as a clinical indicator of acute or chronic inﬂammation or tissue damage in mammals [18, 20–22].

The canine normal range of plasma circulated ﬁbrinogen is evaluating canine ﬁbrinogen level, age has to be taken into consideration: younger dogs show slight but statistically signiﬁcant higher ﬁbrinogen level [23].

In response to ongoing inﬂammation, ﬁbrinogen plasma concentration changes within 24 to 48 hours [24]. The function and quantity of plasma ﬁbrinogen can be altered by both inherited and acquired disorders [25]. Fibrinogen is an essential component of the hemostatic process and its level may be increased in response to inﬂammation, or reduced due to consumption [26]. Low plasma ﬁbrinogen concentration can indicate a systemic activation of the clotting system, where consumption of clotting factors is faster than synthesis, with increased risk of bleeding as a consequence.

Figure 9.1:

Heska Element COAG™Canine Fibrinogen Test kit.

1.2 g/Lto3.0 g/L

. When

Chapter 9

Page 76

9. Canine Fibrinogen Test

In dogs, during active acute or chronic hepatitis, hyperﬁbrinolysis is observed frequently in association with liver cell necrosis or apoptosis [27–29]. Therefore, the main purpose of measuring ﬁbrinogen level in canine medicine is to indicate blood coagulation disorders in which the concentration of ﬁbrinogen falls [30]. Moreover, measurement of ﬁbrinogen level, together with determination of other APPs, provides accurate information of the course of the disease and allows better monitoring of treatment.

9.2. Test Speciﬁcations

An overview of the Canine Fibrinogen test speciﬁcations are given in test has been validated for use with diluted canine (dog) plasma extracted from citratestabilized whole blood. Under normal operating conditions, test results have a precision of 0.3 g/L or better.

A Fibrinogen test takes up to 10 minutes to perform. The actual time depends on the blood sample and test environment. At room temperature, it takes about 5 minutes for the Analyzer to warm up the test cartridge to temperatures may change the warm up time. Once the procedure of the assay begins, the result is reported within approximately 10 minutes.

Each test cartridge is individually packed in a sealed pouch with a desiccant bag and a disposable pipette tip. The pouch should be kept at refrigerated temperatures ( 46 °F/2◦Cto8◦C reach room temperature prior to running the test. The pouch should not be exposed to direct sunlight and should be used within the same day it is warmed to room temperature. Once the pouch has been opened, the cartridge should be used within the 10 minutes. If stored in accordance with these guidelines, the test cartridges are stable until the expiration date printed on the pouch label. One pre-ﬁlled tube with diluent should be used with each test. Dispose of the diluent tube after running a test.

Always strictly adhere to all biohazard safety guidelines pertaining to handling

and disposing of animal blood samples.

). Remove the pouch from the refrigerator and allow the cartridge to

99 °F(37◦C

). Lower and higher ambient

Table 9.1

. The

36 °F

Page 77

9.2. Test Speciﬁcations

Table 9.1: Speciﬁcations for the Heska Element COAG™Canine Fibrinogen Test.

Measurement Technology Light absorbance, turbidity-based plasma assay

Result Units mg/dL, g/L or g/dL

Reference Range Species mg/dL g/L

Dog (canine) 120 to 300 1.2 to 3.0

Dynamic Range mg/dL g/L

0 to 2000 0.0 to 20.0

Sample Type Platelet poor plasma

Sample Volume 100 µL

Sample Collection 3.2 % or 3.8 % concentration sodium citrate tube

Sample Stability

Cartridge Stability

Storage Refrigerate at 36 °F to 46 °F or 2◦C to 8◦C

Shelf Life The expiration date is printed on the pouch label.

Time to results Approximately 10 minutes

12 hours at room temperature ( 30◦C) for whole blood sodium citrate samples.

3 hours at room temperature ( 30◦C) for plasma extracted.

30 days at freezing temperature ( plasma samples extracted from a citrate tube and placed in a red-top tube.

Do not expose cartridges in the foil pouch to direct sunlight or leave at room temperature for more than one day. Use cartridges taken from the foil pouch within 10 minutes

59 °Fto86 °For15◦C

14 °For−10◦C

) for

Chapter 9

Page 78

9. Canine Fibrinogen Test

9.3. Test Requirements

9.3.1. Materials and Equipment

The following materials and equipment are required in order to perform a Canine Fibrinogen Test on the Heska Element COAG™Analyzer:

• Heska Element COAG™Analyzer

• Canine Fibrinogen Test Cartridge

• Pipette tip (included in the sealed pouch with the test cartridge)

• 100 µL ﬁxed-volume pipette

• Pre-ﬁlled diluent tube (included in each box of cartridges)

• Syringes with a 22-gauge needle or larger

• Sample tubes containing 3.2 % or 3.8 % sodium citrate as an anticoagulant

• Package insert for Canine Fibrinogen Test cartridge

• Quick Guide for Canine Fibrinogen Test

• Centrifuge minimum 7000 g × minutes.

9.3.2. Centrifuge

Table 9.2

revolutions per minute to obtain platelet-poor plasma as needed by the Canine Fibrinogen Test.

lists the required centrifugation time as a function of centrifuge radius and

9.3.3. Sample Preparation

Use a syringe with a 22-gauge needle or larger when drawing the blood to avoid hemolysis. Collect the blood directly into the test tube containing citrate as the anticoagulant. The result of a Fibrinogen analysis is dependent on the quality of the blood sample and the extracted plasma.

The centrifuge radius is the distance between the axis of rotation and the center of the test-tube when placed in the

centrifuge.

Page 79

9.3. Test Requirements

Table 9.2:

Centrifugation time for combinations of centrifugation speed and centrifuge radius.

Radius RPM Acc. Time Radius RPM Acc. Time

[cm] [1/min] [g ] [min] [cm] [1/min] [g] [min]

2.5 5000 698 11 7.5 7000 4104 2

2.5 6000 1005 7 7.5 8000 5360 2

2.5 7000 1368 6 7.5 9000 6784 2

2.5 8000 1787 4 7.5 10 000 8375 1

2.5 9000 2261 4 10.0 2000 447 16

2.5 10 000 2792 3 10.0 3000 1005 7

5.0 5000 1396 6 10.0 4000 1787 4

5.0 6000 2010 4 10.0 5000 2792 3

5.0 7000 2736 3 10.0 6000 4020 2

5.0 8000 3574 2 10.0 7000 5472 2

5.0 9000 4523 2 10.0 8000 7147 1

5.0 10 000 5584 2 10.0 9000 9045 1

7.5 5000 2094 4 10.0 10 000 11 167 1

7.5 6000 3015 3

To extract platelet-poor plasma from the whole blood sample, centrifuge the whole blood in a centrifuge for minimum 7000 g × minutes time is dependent on the centrifuge size. Please refer to

Table 9.2 for minimum centrifuge requirements.

. The rotation speed and necessary spin

Plasma

Buﬀy coat

Red blood cells

Centrifugation will separate the Red Blood Cells (RBC) from the plasma, see tation of a sample tube after centrifugation. Make sure to collect plasma for the Canine Fibrinogen Test from the

Figure 9.2

for a schematic represen-

Figure 9.2:

Whole blood

sample after centrifugation. upper part of the plasma in the tube to avoid contaminating the plasma with RBCs.

Other than centrifugation, no special sample preparation is needed before initiating the Canine Fibrinogen Test. As part of the test procedure, the extracted platelet-poor plasma must be diluted in accordance with the on-screen instruction on the Heska Element COAG™Analyzer.

Follow standard blood-drawing procedures at all times and pay special attention to the following:

•

Contamination from thromboplastin, alcohol and intravenous solutions will interfere with the ﬁbrinogen assay. Hemolysis and foaming of the blood sample are potential

Chapter 9

Page 80

9. Canine Fibrinogen Test

sources of erroneous test results.

•

Do not use blood that has been stabilized in any other way than using

3.8 % citrate collection tubes.

• Do not use blood from over-ﬁlled or under-ﬁlled citrate tubes.

•

Do not use plasma from samples that have been centrifuged at less than

• Do not use blood samples with visible clotting or debris accumulation.

•

Do not use plasma exhibiting signs of hemolysis, lipemia or other conditions that may aﬀect turbidity. A general guideline is that the sample should be clear and more yellow than red in color.

•

To avoid mechanical hemolysis, the needle used should have a 22-gauge or larger.

•

The vein puncture site should be cleaned with alcohol and allowed to air-dry completely.

•

When diluting the platelet poor plasma, ensure that no diluent is caught in the cap of the pre-ﬁlled micro tube by tapping the cap prior to opening the tube.

•

Use only the supplied Heska Element COAG™Fibrinogen pre-ﬁlled micro tube

with diluent. The Fibrinogen test will not work correctly if other diluents are used.

•

To avoid contaminating the plasma with red and white blood cells, please extract the required volume from the upper half of the plasma.

•

Do not touch the part of the pipette tip that will come in contact with the plasma

when removing the pipette tip from the pouch.

•

Test results may be impaired if the sample is older than 12 hours or the extracted plasma is older than 3 hours.

3.2 %

7000 g × minutes

The accuracy of the Canine Fibrinogen Test is mainly dependent on the quality

of the blood sample and the extracted plasma. The way the blood is collected and has been handled can greatly aﬀect the blood and plasma quality.

9.4. Limitations

Any test result exhibiting inconsistency with a patient’s status should be repeated and/or supplemented with additional diagnostic tests.

Page 81

9.5. Test Procedure

The accuracy of Heska Element COAG™Analyzer test results is largely dependent on the quality of the sample specimen which in turn is dependent on:

• The blood sample collection

• The proper volume of blood/citrate

• The proper mixing of the citrated blood

• The proper extraction of platelet-poor plasma

• The proper introduction of the sample into the cartridge well.

Please observe all precautions cited in this guide and use good blood sampling

technique at all times.

9.5. Test Procedure

Before performing any tests, be sure that the Heska Element COAG™Analyzer has been installed properly in accordance with the instructions in this guide. See details regarding how to set the Analyzer up correctly.

Verify that you have the necessary materials and equipment for performing a Heska Element COAG™Canine Fibrinogen test, see Section 9.3.

Afterward, follow these simple test procedures:

Step 1:

Step 2:

Step 3:

Step 4:

Remove a pouch with a test cartridge from the refrigerator and let the pouch and cartridge reach room temperature starting the test.

Fractionate the whole blood by centrifuging the blood sample in the collection tube into platelet poor plasma. To achieve suﬃciently platelet poor plasma, the blood sample must be centrifuged at minimum

Table 9.2 for a list of required centrifugation time.

Remove the cartridge and pipette tip from the pouch and the pre-ﬁlled tube with diluent from the kit box.

59 °Fto86 °For15◦Cto30◦C

7000 g × minutes

86 °F/30◦C

. It is recommended to store

Chapter 3

3.2 %or3.8 %

for

before

100 µL

, see the

Chapter 9

Page 82

9. Canine Fibrinogen Test

Step 5:

Step 6:

Step 7:

Step 8:

From the Home Screen, touch the rinogen button to start the test.

When the message Please insert new cartridge ﬂashes on the screen, insert the Heska Element COAG™test cartridge completely into the cartridge slot on the front of the Analyzer.

The cartridge must have the label facing upward and the sample well sticking out of the Analyzer.

On the on-screen keyboard, enter the cartridge code (printed on the cartridge pouch label) in the entry ﬁeld and touch done.

Touch

Conﬁrm

has been obtained in a citrate test tube, that the tube was appropriately ﬁlled, and that whole blood sample was spun to platelet poor plasma at minimum 7000 g × minutes.

to acknowledge that the blood

Canine Fib-

Step 9:

Step 10:

Touch

Patient ID/Sample ID

essary information using the on-screen keyboard. Touch Done to conﬁrm.

Entering Sample ID is optional but recommended to aid in ﬁnding the result in the Analyzer’s database.

Touch

to continue. The

ing Up screen opens.

It takes approximately 5 minutes for the Analyzer to warm up the test cartridge to 37◦C

depending on the environment’s temperature. Lower and higher room temperatures may change the warm up time.

and enter the nec-

Cartridge Warm-

99 °F

Page 83

Step 11:

Step 12:

Step 13:

9.5. Test Procedure

Do not add sample while the cartridge is warming up. Wait until a

Ensure that no diluent is caught at the top of the diluent tube by tapping the tube on a hard surface. Using the supplied pipette tip, puncture the foil on the diluent tube. Extract the

100 µL

ﬁxed volume pipette and supplied pipette tip. Dilute the platelet poor plasma by aspirating into the supplied diluent tube and ensure proper mixing by aspirating a minimum of 5 times.

Make sure that no diluent is caught in the lid of the diluent tube.

When the message use a

100 µL

diluted plasma to the cartridge’s sample well.

Be sure to ﬁll the sample well with at least

poor plasma. The measurement starts automatically as soon as the sample is detected. The test progress is shown on the screen. Measurement takes approximately 10 minutes. If the Analyzer alerts you that an insuﬃcient amount of sample was placed into the sample well, repeat the measurement with a new cartridge. Touch Cancel to terminate the ongoing test.

The test result is displayed on the screen when the test is ﬁnished. If a printer is connected to the instrument, touch result.

100 µL

Add 100 µL sample and wait

ﬁxed-volume pipette and the supplied pipette tip to add

Add sample and wait

platelet poor plasma from the collection tube using

to print the test

ﬂashes on the screen

appears on the screen,

100 µL

diluted platelet

100 µL

Touch Done to return to the Home screen.

Step 14: Remove the used test cartridge and dispose of it properly.

Chapter 9

Page 84

Page 85

10. Canine DEA 1 Blood Typing

Chapter 10

The Canine DEA 1 Test Cartridge is used in conjunction with the Heska Element COAG Analyzer for in vitro blood group determination testing. The Canine DEA 1 cartridge is intended for use in performing a rapid blood group determination for Canine DEA 1 from a drop of diluted EDTA-stabilized canine whole blood.

10.1. Canine Blood Typing

While it is broadly true that dogs do not possess alloantibodies to incompatible blood groups and, thus, will generally tolerate well an initial incompatible transfusion, sound practice of veterinary medicine dictates that such transfusions be avoided. The half life of the transfused incompatible cells will be quite short and, thus, the intended therapeutic result may not even be attained. Also, the potential future needs of the canine patient must be considered. Antibodies resulting from a transfusion of incompatible blood may form in only 5 to 7 days and will have longterm viability [31–35]. This eliminates the option of using incompatible blood in a future emergency situation.

Figure 10.1: The Canine DEA 1 test kit.

™

In addition, antibodies developed in bitches by sensitization resulting from transfusion of incompatible blood groups must be of special concern to breeders. Since antibodies are present in the colostrum, bitches with alloantibodies to a given blood type should not be bred to a sire possessing that blood group if they are expected to nurse the resulting puppies [32]. The nursing puppies will develop isoerythrolysis and may be susceptible to disease or even die due to hemolytic anemia [32, 36–38].

Page 86

10. Canine DEA 1 Blood Typing

10.1.1. Blood Groups

Eight speciﬁc antigens have been identiﬁed on the surface of the canine erythrocytes [31,

]. The internationally accepted canine blood group system, the Dog Erythrocyte Antigen (DEA), is based on these antigens. It currently characterizes eight common blood groups, the antigens DEA 1, 1.2, 3, 4, 5, 6, 7, and 8.

As occurred in human medicine, new antigens are now being discovered on the red cells of dogs. One, DAL, has been reported and is the subject of journal articles. These are often breed speciﬁc and, thus, can be considered rare.

The DEA 1 blood group is the most signiﬁcant blood factor in the dog. The DEA 1 blood group is highly antigenic and is the primary lytic factor in canine transfusion medicine [32,39–47]. Although all of the blood group antigens are capable of stimulating formation of alloantibodies, DEA 1 has the greatest stimulation potential. Thus, most reactions resulting from the transfusion of incompatible cells occur when DEA 1 positive blood is given to a DEA 1 negative recipient [32]. Clinically signiﬁcant reactions to DEA 1.2 may occur but are less severe. DEA 7 may be a factor in transfusion reactions, but since it is a cold agglutinin and a naturally occurring isoantibody, it is considered to have very low clinical signiﬁcance. The remaining antigens are considered to cause clinically insigniﬁcant transfusion problems [32].

10.1.2. Blood Transfusion

Ideally, all transfused blood would be DEA 1 negative. However, until the concept of using blood rapidly available from commercial sources is more widely accepted, transfusion from dogs that are present in the area at the time of need will remain the norm.

It is estimated that auto-agglutinate and because a very anemic dog may give equivocal results, typing prior to an urgent need for the information is indicated. Identifying a particular dog as DEA 1 positive or negative at birth greatly simpliﬁes future decision making. A DEA 1 positive dog can receive both DEA 1 positive and negative blood. A dog that is DEA 1 negative should not receive DEA 1 positive blood.

The Canine DEA 1 test cartridge used with the Heska Element COAG™Analyzer is intended for use to classify dogs as DEA 1 positive, negative or inconclusive.

40 %

of all dogs are DEA 1 positive [31]. Because a number of dogs

10.2. Test Speciﬁcations

Test results obtained under normal operating conditions have an accuracy of better. A small percentage of blood samples is not possible to type deﬁnitely using the Heska Element COAG™Analyzer. The results for these samples will be reported as

95 %

Page 87

10.2. Test Speciﬁcations

Inconclusive. A minimum of

the Canine DEA 1 Blood Typing Test.

All components of the test kit are stable at refrigerated temperatures ( 46 degree For2◦Cto8◦C warmed do not return cartridge to the refrigerator and use within the same day. After opening the pouch and cartridge must be used within 10 minutes. Kits and components should not be exposed to direct sunlight. Once warmed do not return cartridge to the refrigerator and use within the same day. After opening the pouch and cartridge must be used within 10 minutes. The time it takes to perform a blood type determination with the Heska Element COAG™Analyzer depends on factors such as type of test and test environment. At room temperature, it takes about 90 seconds for the instrument to warm up the test cartridge to change the warm up time. Once the procedure of the assay begins, an answer should be available within 5 minutes.

Table 10.1: Speciﬁcations for the Canine DEA 1 Blood Typing Test.

Measurement Technology Agglutination detection using light absorbance

Species Canine (Dog)

Possible results Positive, Negative and Inconclusive

Sample Type Diluted whole blood

Sample Volume 100 µL of whole blood

Sample Collection EDTA collection tube

Sample Stability Use the blood within the day of collection. Do not dilute

Cartridge Stability Do not expose the cartridges in the foil pouch to direct

Storage Store at 36 °F to 77 °F/2◦C to 25◦C

Shelf Life The expiration date is printed on the pouch label.

Warm-up time

Time to results Approximately 5 minutes from adding the sample to the

95 %

of correctly collected blood samples are typable using

36 degree F

) until the expiration date printed on the pouch label.Once

99 °For37◦C

the sample until prompted to do so on-screen.

sunlight or leave them at room temperature for more than one day. Use cartridges taken from the foil pouch within 10 minutes

Approximately 90 seconds. The actual time depends on the blood sample and test environment. Very low or high ambient temperatures may change the warm-up time.

cartridge

. Lower and higher room temperatures may

Chapter 10

Page 88

10. Canine DEA 1 Blood Typing

Each Canine DEA 1 Blood Typing Test cartridge contains a monoclonal antibody speciﬁc to the DEA 1 antigen on a red blood cell. Each cartridge is individually packed with a disposable plastic pipette tip in a sealed pouch containing a desiccant bag to keep it moisture free. A torn or otherwise damaged pouch may allow moisture to reach the test cartridge and adversely aﬀect performance. Do not use a test cartridge from a damaged pouch. Open the pouch just prior to use.

Always strictly adhere to all biohazard safety guidelines pertaining to handling

and disposing of animal blood samples.

10.3. Test Requirements

10.3.1. Materials and Equipment

In order to perform a Canine DEA 1 Blood Typing Test with the Heska Element COAG Analyzer, the following materials and equipment are required.

The following materials are required but not provided with the Canine DEA 1 Blood Typing Test:

• Heska Element COAG™Analyzer

• Syringes with a 22-gauge needle or larger

• Sample collection tube with EDTA as the anticoagulant

• 100 µL ﬁxed volume pipette

The following materials are required and supplied with the Canine DEA 1 Blood Typing Test:

• Canine DEA 1 Blood Typing cartridge

•

Dropper bottle pre-ﬁlled with diluent. The plastic bottle contains phosphate buﬀered saline (PBS) at pH 7.4. The dropper tip dispenses approximately

The bottle contains enough ﬂuid to perform all the tests in the kit

• Tube for sample preparation (one for each cartridge)

• Plastic pipette tip (one for each cartridge)

The following materials are optional:

40 µL

of ﬂuid.

™

Page 89

10.4. Limitations

•

Package insert for the Canine DEA 1 Blood Typing Test (shipped with each box of cartridges)

•

Quick Guide for the Canine DEA 1 Blood Typing Test (shipped with the software update for the Canine DEA 1 Blood Typing Test)

10.3.2. Blood Sample Preparation

Use a syringe with a 22-gauge needle or larger to avoid hemolysis. Collect blood directly into the EDTA test tube. The result of any blood analysis is dependent on the quality of the blood sample. Follow standard blood-drawing procedures at all times and pay special attention to the following:

•

Blood samples, if possible, should be collected within the day of testing. Ensure proper mixing of the anticoagulant into the blood sample.

•

If a blood rocker is not available, slowly invert the tube containing the blood sample 10 times every 10 minutes.

•

The blood sample should be kept at room temperature, in case the testing is delayed.

•

Inspect the blood sample for hemolysis when measuring the hematocrit. As a general rule, the plasma must be clear and more yellow than red in order for the sample to be suitable for testing with the Canine DEA 1 Blood Typing Test.

Chapter 10

The accuracy of the Canine DEA 1 Blood Typing Test is mainly dependent on

the quality of the blood sample. The way the blood is collected and has been handled can greatly aﬀect the blood quality.

10.4. Limitations

Any test result exhibiting inconsistency with a patient’s status should be repeated and/or supplemented with additional diagnostic tests.

The accuracy of Heska Element COAG™Analyzer test results is largely dependent on the quality of the blood specimen.

Page 90

10. Canine DEA 1 Blood Typing

•

The accuracy of the test results is dependent on the quality of the blood sample.

The quality of the blood sample is dependent upon the blood sample collection, the

proper blood to EDTA ratio, and the proper introduction of the sample and diluent into the sample well. Please observe all precautions cited in this manual and use good blood sample collection techniques at all times.

•

A very limited number of canine patients exhibit auto-agglutination of varying degrees due to serum factors that cause agglutination of the patient’s own red cells. The Canine DEA 1 cartridge has two channels – a reference channel and a test channel. If auto-agglutination occurs in the reference channel, this will be indicated on the results screen. If auto-agglutination occurs the blood should not be used for transfusion and the dog should only be transfused with blood from a DEA 1 negative donor. This occurs in only a very small percentage of patients.

•

Being an absorption assay, the test accuracy is dependent on proper dilution of the whole blood before adding the sample to the cartridge. Always measure the hematocrit of the sample prior to testing and follow the on-screen dilution procedure.

•

Hemolyzed blood samples may cause false DEA 1 negative results because the

Analyzer is unable to distinguish RBC agglutinates from the plasma containing

hemoglobin. Always verify that the sample is not hemolyzed when measuring the hematocrit. As a general guideline, the plasma must be clear and more yellow than red. If the sample is severely hemolyzed, a new blood sample should be drawn.

•

Blood samples with a hematocrit of less than recommended for use with the Heska Element COAG™Analyzer. Blood samples outside this range may result in an instrument error or inaccurate test result.

10 %

or greater than

70 %

are not

10.5. Test Procedure

Verify that you have the necessary materials and equipment for performing a Canine DEA 1 Blood Typing test, see Section 10.3.

Step 1:

Step 2:

Step 3: Determine the hematocrit of the sample.

Remove a pouch with a test cartridge from the refrigerator and let the pouch and cartridge reach room temperature 30◦C before starting the test.

Draw blood from the patient into a tube coated with or containing EDTA as an anticoagulant. The assay requires only 100uL of whole blood but the syringe or tube should be full to ensure the correct concentration of EDTA. If the blood type is not to be determined immediately, nutrients such as CPDA should not be added.

59 /degree Fto86 /degree F/15◦C

Page 91

10.5. Test Procedure

Step 4:

Step 5:

Step 6:

Step 7:

Step 8:

Remove the cartridge and pipette tip from the pouch and the pre-ﬁlled tube with diluent from the kit box.

From the Home Screen, touch the Blood Typing button to start the test.

When the message Please insert new cartridge

ﬂashes on the screen, insert the test cartridge completely into the cartridge slot on the front of the Analyzer.

The cartridge must have the label facing upward and the sample well sticking out of the Analyzer.

On the on-screen keyboard, enter the cartridge code (printed on the cartridge pouch label) in the entry ﬁeld and touch Done

Touch

Conﬁrm

has been obtained in a EDTA test tube and that the tube was appropriately ﬁlled.

to acknowledge that the blood

Canine

Chapter 10

Step 9:

Step 10:

Touch

Patient ID

mation using the on-screen keyboard. Touch

Done

to conﬁrm. Entering Sample ID is optional but recommended to aid in ﬁnding the result in the Analyzer’s database.

Enter the previously measured hematocrit value in percent using the on-screen keyboard. Based on the speciﬁed hematocrit the Heska Element COAG™Analyzer will calculate the number of diluent drops needed for correct dilution of the sample.

Touch Next to continue.

and enter the necessary infor-

Page 92

10. Canine DEA 1 Blood Typing

Step 11:

Step 12:

Step 13:

Step 14:

Dilute the sample following the on-screen instructions. First, dispense the number of drops of diluent stated on the screen into one of the supplied sample tubes. Then mix blood into the diluent using the ﬁxed volume pipette and supplied pipette tip. Ensure proper mixing by aspirating a couple of times using the pipette.

Touch

to continue. The

ing Up screen opens.

It takes approximately 90 seconds for the Analyzer to warm up the test cartridge to or

37◦C

depending on the environment’s temperature. Lower and higher temperatures may change the warm up time.

Do not add the sample while the cartridge is warming up. Wait until

a prompt appears on the screen instructing you to add the sample. By default, a message screen and a single beeping sound can be heard which signals that the blood sample can now be added to the cartridge.

Gently invert the test tube back and forth 10 times to obtain a uniform mixture of blood cells and diluent.

When the message use the ﬁxed volume pipette and the pipette tip supplied with the cartridge to add 100 µL of diluted blood to the cartridge’s sample well.

Be sure to ﬁll the sample well with at least 100 µL blood.

The measurement starts automatically as soon as the sample is detected. The test progress is shown on the screen. Measurement takes approximately 5 minutes. If the Analyzer alerts you that an insuﬃcient amount of sample was placed into the sample well, repeat the measurement with a new cartridge. Touch the ongoing test.

The test result is displayed on the screen when the test is ﬁnished.

Add 100 µL sample and wait

100 µL

Cartridge Warm-

99 °F

Add 100 µL sample and wait

appears on the screen,

Cancel

ﬂashes on the

to terminate

If a printer is connected to the instrument, touch Print to print the test result.

Touch Done to return to the Home screen.

Page 93

10.5. Test Procedure

DEA 1 Blood Typing Certicate

Patient Information Clinic Information

Blood Typing in Dogs

Dog blood groups are classied using the Dog Erythrocyte Antigen (DEA) system. The DEA system denes six blood types based on the presence of specic inherited antigens on the surface of the red blood cells.

In the context of transfusion DEA 1 is the most important blood type because transfusion with DEA 1 positive blood to a negative recipient can cause sensitization or severe heamolytic reactions.

The Element COAG™ DEA 1 Blood Typing Test uses antibodies specic to the DEA 1 antigens to determine the amount of DEA 1 antigens on the blood cells in a sample.

Blood Typing Result

The result of the Element COAG™ DEA 1 blood typing test is shown below

DEA 1 Negative

Safe Blood Donation

Dogs that have been tested positive for DEA 1 can be transfused with blood from any donor without risk of sensitization or hemolytic reactions. Blood from DEA 1 positive donors can only be donated to DEA 1 positive recipient dogs.

Dogs that are dicult to type due to antigen properties should only be transfused with blood from DEA 1 negative donors. Blood from dogs in this group should only be donated to DEA 1 positive recipient dogs.

To avoid sensitization or hemolytic transfusion reactions DEA 1 negative dogs should only be transfused with blood from DEA 1 negative donors. Dogs that have been tested negative for DEA 1 are suitable donors for any other dog.

The Element COAG™ DEA 1 Blood Typing Test is a joint development of dmslaboratories, inc. and Heska and is manufactured by Zoetis Denmark ApS. Element COAG™ is a trademark of Heska.

DEA 1 Positive

dmslaboratories

If the printer supports printing on A4-paper, it is possible to print the result on a pre-formatted Heska Element COAG™Blood Typing Certiﬁcate.

The user-supplied clinic information and Patient and Sample ID will appear on the printed certiﬁcate.

Step 15: Remove the used test cartridge and dispose of it properly.

Chapter 10

Page 94

Page 95

11. Feline A, B and AB Blood Typing

The Feline A & B Blood Typing Test Cartridge is used with the Heska Element COAG Analyzer for in vitro blood group determination. The Feline A & B Blood Typing cartridge is intended for use in performing a rapid blood group determination for cats from a drop of diluted EDTA-stabilized whole blood.

11.1. Feline Blood Typing

11.1.1. Feline Blood Groups

The AB system is the major blood group system in domestic cats. The common blood types are A and B. Cats with blood type A have naturally occurring anti-B antibodies at a low titer and cats with blood type B have naturally occurring anti-A antibodies at a high titer. A third rare type AB is also known. Cats with the rare AB type do not have anti-A or anti-B antibodies. There are however no null phenotype and as a consequence, there is no universal donor [48].

The A and B blood groups are genetically determined and blood type A is the most common among cats but the frequency varies signiﬁcantly by breed and geographic location. Breeds that do not have the B type are Siamese, Burmese, American Shorthair, Oriental Shorthair and Tonkinese. Breeds with high incidence of the B blood type are Abyssinian, Japanese Bobtail, Birman, Persian, Scottish Fold, British Shorthair, Cornish Rex, Exotic Shorthail, Somali, Sphynx, Turkish Van, Turkish Angora and Devon Rex [49].

The inheritance of the rare AB group is not well understood and the incidence of the AB type is reported to be less than 1 %. Breeds that have the very rare type AB blood

Figure 11.1:

The Feline A & B Blood Typing test kit.

™

Chapter 11

Page 96

11. Feline A, B and AB Blood Typing

include Birman, British Shorthair, Scottish Fold, Somali, and Sphynx. Somalis are more likely than average to have the rare type AB blood [49].

11.1.2. Blood Transfusion Risks

Cats that are transfused, even once, with an incompatible blood type, are at risk for a transfusion reaction. Cats with Type B blood exhibit an immediate and catastrophic systemic anaphylactic reaction and a Hemolytic Transfusion Reaction (HTR) when transfused with Type A blood, because of their natural high-titered anti-A antibody. As an outcome death of the patient is extremely likely.

Cats with type A blood exhibit a natural low-titered anti-B antibody response when transfused with type B blood. In this case, the reaction is mild but the transfused cells will have a shortened life span. The recipient will develop moderate titers of anti-B antibody that will result in a serious reaction if a subsequent incompatible transfusion is administered [48].

11.1.3. Mating risks

Serious problems can also result from accidental or mismatched mating. A mating of a type B queen with a type A tom will result in their type A kittens being at risk for neonatal isoerythrolysis (“NI”), commonly known as “fading kitten syndrome”. The maternal naturally occurring highly titered anti-A antibody occurs in the colostrum where from it can be absorbed by the newborn kittens. The absorbed antibody attacks the kittens’ type A erythrocytes. Although the kittens can seem normal at birth, they develop signs after nursing, fade and die within the ﬁrst days of life. Determining the blood type of the queen and the tom prior to mating, coupled with appropriate genetic counseling, can minimize the risk of NI. Furthermore, immediate blood type determination of the newborn kittens will alert the client to remove the kittens and to begin surrogate nursing where necessary [48].

11.2. Test Speciﬁcations

The Feline Blood Typing test cartridge used with the Heska Element COAG™Analyzer is intended for use to classify cats as A positive, B positive, or A and B positive. Test results obtained under normal operating conditions have an accuracy of 99.31 %.

All components of the test kit are stable at refrigerated temperatures ( 2◦Cto25◦C warmed to room temperature, the cartridge must be used within that day and should not be returned to the refrigerator.

). Kits and components should not be exposed to direct sunlight. Once

36 °Fto77 °F

Page 97

11.2. Test Speciﬁcations

The time it takes to perform a blood type determination with the Heska Element COAG Analyzer depends on factors such as type of test and test environment. At room temperature, it takes about 90 seconds for the instrument to warm up the test cartridge to or

37◦C

. Lower and higher room temperatures may change the warm up time. Once

the procedure of the assay begins, an answer should be available within 5 minutes.

Each Heska Element COAG™/RapidVet®Test cartridge contains a monoclonal antibody or a lectin speciﬁc to the A antigen on a red blood cell or to the B antigen. Each cartridge is individually packed with a sealed pouch containing a desiccant bag to keep it moisture free. A torn or otherwise damaged pouch may allow moisture to reach the test cartridge and adversely aﬀect performance. Do not use a test cartridge from a damaged pouch. Open the pouch just prior to use. Once the pouch has been opened, the test cartridge should be used within 10 minutes.

Table 11.1:

Measurement Technology Agglutination detection using light absorbance

Species Feline (Cat)

Possible results A, B or AB

Sample Type Diluted whole blood

Sample Volume 100 µL of whole blood (in cases with low hematocrit of

Sample Collection EDTA collection tube

Sample Stability Use the blood within the day of collection. Do not dilute

Cartridge Stability Do not expose the cartridges in the foil pouch to direct

Storage Store at 36 °F to 77 °F/2◦C to 25◦C

Shelf Life The expiration date is printed on the pouch label.

Warm-up time

Time to results Approximately 5 minutes from adding the sample to the

Speciﬁcations for the Heska Element COAG™/RapidVet®Feline Blood Typing Test.

the blood (below 29 %), more volume will be needed.)

the sample until prompted to do so on-screen.

sunlight, or leave at room temperature for more than one day. Use cartridges taken from the foil pouch within 10 minutes

Approximately 90 seconds. The actual time depends on the blood sample and test environment. Very low or high ambient temperatures may change the warm-up time.

cartridge

™

99 °F

Chapter 11

Page 98

11. Feline A, B and AB Blood Typing

The expiration date of each cartridge is printed on the pouch label. Do not use the cartridge after the expiration date.

The test cartridge can be used only once and only in combination with the Heska Element COAG™Analyzer. Once used, the cartridge, pipette tip and diluent tube should be considered as potentially infectious. Dispose of them properly in accordance with the policies and regulations at the place of operation.

Always strictly adhere to all bio-hazard safety guidelines pertaining to handling

and disposing of animal blood samples.

11.3. Test Requirements

11.3.1. Materials and Equipment

In order to perform a Feline Blood Typing Test with the Heska Element COAG™Analyzer, the following materials and equipment are required.

The following materials are required but not provided with the Feline Blood Typing Test:

• Heska Element COAG™Analyzer

• Syringes with a 22 gauge or larger needle

• Sample collection tube with EDTA as the anticoagulant

• 100 µL ﬁxed volume pipette.

The following materials are required and supplied with the Feline Blood Typing Test:

• Feline A & B Blood Typing cartridge

•

Tube pre-ﬁlled with diluent (one for each cartridge). Each tube contains phosphate buﬀered saline (PBS) at pH 7.4 and contains enough ﬂuid to perform one test on a cartridge.

• Pipette tips.

•

Package insert for the Feline Blood Typing Test (shipped with each box of cartridges)

Page 99

11.4. Limitations

11.3.2. Blood Sample Preparation

Use a syringe with a 22 gauge or larger needle to avoid hemolysis. Collect blood directly into the EDTA test tube. The result of any blood analysis is dependent on the quality of the blood sample. Follow standard blood-drawing procedures at all times and pay special attention to the following:

•

Blood samples, if possible, should be collected within the day of testing. Ensure proper mixing of the anticoagulant into the blood sample.

•

If a blood rocker is not available, slowly invert the tube containing the blood sample 10 times every 10 minutes.

•

The blood sample should be kept at room temperature, in case the testing is delayed.

The accuracy of the Feline A & B Blood Typing Test is mainly dependent on

the quality of the blood sample. The way the blood is collected and has been handled can greatly aﬀect the blood quality.

11.4. Limitations

Any test result exhibiting inconsistency with a patient’s status should be repeated and/or supplemented with additional diagnostic tests.

The accuracy of Heska Element COAG™Analyzer test results is largely dependent on the quality of the blood specimen.

•

The quality of the blood sample is dependent upon the blood sample collection, the proper blood to EDTA ratio, and the proper introduction of the sample and diluent into the sample well. Please observe all precautions cited in this manual and use good blood sample collection techniques at all times.

•

Auto-agglutinated or hemolyzed blood samples may cause false results. The Analyzer is unable to distinguish RBC agglutinates from plasma containing hemoglobin. Always verify that the sample is not hemolyzed when measuring the hematocrit. As a general guideline, the plasma must be clear and more yellow than red. If the sample is severely hemolyzed a new blood sample should be drawn.

Chapter 11

Page 100

11. Feline A, B and AB Blood Typing

•

Blood samples with a hematocrit of less than recommended for use with the Heska Element COAG™Analyzer. Blood samples outside this range may result in an instrument error or inaccurate test result.

4 %

or greater than

60 %

are not

11.5. Test Procedure

Verify that you have the necessary materials and equipment for performing a Feline A & B Blood Typing test, see Section 11.3.

Chapter 3

for

Step 1:

Step 2:

Step 3: Determine the hematocrit of the sample.

Step 4:

Step 5:

Step 6:

Remove a pouch with a test cartridge from the refrigerator and let the pouch and cartridge reach room temperature starting the test.

Draw blood from the patient into a tube coated with or containing EDTA as an anticoagulant. The assay requires only 100uL of whole blood but the syring or tube should be full to ensure the correct concentration of EDTA. If the blood type is not to be determined immediately, nutrients such as CPDA should not be added.

Remove the cartridge and pipette tip from the pouch and the pre-ﬁlled tube with diluent from the kit box.

From the Home Screen, touch the Blood Typing button to start the test.

When the message Please insert new cartridge ﬂashes on the screen, insert the Feline A & B Blood Typing test cartridge completely into the cartridge slot on the front of the Analyzer. The cartridge must have the label facing upward and the sample well sticking out of the Analyzer.

59 °Fto86 °F/15◦Cto30◦C

Feline

before