zoetis AlphaTrak 3 Glucose Monitoring System for Dogs User Guide

June 12, 2024
zoetis

AlphaTrak 3 Glucose Monitoring System for Dogs

User Guide – AlphaTrak3 Meter

1.0 How It Works

The AlphaTrak3 Meter is designed for in vitro diagnostic use in
animals. It measures the blood glucose levels in animals to assist
in diabetes management. The meter uses test strips and a lancing
device to obtain blood samples and provides accurate glucose
readings within seconds.

2.0 Components

Starter Kit

The starter kit includes the following components:

  • AlphaTrak3 Meter
  • Test strips
  • Lancing device
  • Lancets
  • User guide (this manual)

3.0 Important Information

Before using the AlphaTrak3 Meter, please read and understand
all the instructions provided in this user guide. It is important
to follow the instructions carefully to ensure accurate and
reliable results. If you have any questions or concerns, consult
your veterinarian.

4.0 AlphaTrak3 Meter Usage

To use the AlphaTrak3 Meter, follow these steps:

  1. Insert a test strip into the meter.

  2. Turn on the meter.

  3. Use the lancing device to obtain a small blood sample from your
    animal’s ear or paw.

  4. Apply the blood sample to the test strip.

  5. Wait for the meter to analyze the blood sample and display the
    glucose reading.

  6. Record the glucose reading for future reference.

  7. Dispose of the used test strip and lancet properly.

7.0 Obtaining Blood Samples

How to Lance

To obtain a blood sample using the lancing device, follow these
steps:

  1. Select an appropriate site on your animal’s ear or paw.
  2. Hold the lancing device against the selected site.
  3. Press the release button to activate the lancet and obtain a
    blood sample.

8.0 Blood Glucose Testing

After obtaining a blood sample, apply it to the test strip as
instructed in section 4.0. The meter will analyze the sample and
display the blood glucose reading on the screen. Refer to section
9.0 to understand the blood glucose results.

9.0 Understanding Blood Glucose Results

The AlphaTrak3 Meter provides accurate blood glucose readings.
Low and high blood glucose results may indicate potential health
issues in your animal. Consult your veterinarian for further
guidance if you encounter abnormal readings.

11.0 Using Meter Memory

The meter has a memory function that allows you to store glucose
readings for future reference. Refer to this section to learn how
to access and manage the meter’s memory.

12.0 Reminder Alarms

The AlphaTrak3 Meter is equipped with reminder alarms to help
you remember when to perform blood glucose testing. This section
explains how to set and manage the reminder alarms.

14.0 Error Codes

In case the meter displays an error code, refer to this section
to understand the meaning of the code and possible solutions.

15.0 Troubleshooting

If you encounter any issues or difficulties while using the
AlphaTrak3 Meter, refer to this section for troubleshooting tips
and solutions.

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User Guide

For In Vitro Diagnostic Use In Animals

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Table of Contents
1.0 How It Works …………………………………………………………………………………………………………………………………………………………………………………… 3
2.0 Components…………………………………………………………………………………………………………………………………………………………………………………….. 4 Starter Kit………………………………………………………………………………………………………………………………………………………………………………………………………………..4
3.0 Important Information …………………………………………………………………………………………………………………………………………………………………… 5
4.0 AlphaTrak3 Meter Usage……………………………………………………………………………………………………………………………………………………………….. 6
5.0 Bluetooth® Wireless Technology …………………………………………………………………………………………………………………………………………………. 7
6.0 Meter Set Up ……………………………………………………………………………………………………………………………………………………………………………………. 8 Setting the Meter Sound…………………………………………………………………………………………………………………………………………………………………………………….8 Sound Volume ……………………………………………………………………………………………………………………………………………………………………………………………………….8 Blood Glucose Unit………………………………………………………………………………………………………………………………………………………………………………………………9 Date Format……………………………………………………………………………………………………………………………………………………………………………………………………………9 Time Format …………………………………………………………………………………………………………………………………………………………………………………………………………..10 Bluetooth® Connection……………………………………………………………………………………………………………………………………………………………………………………….10 Glucose Warnings ……………………………………………………………………………………………………………………………………………………………………………………………….. 11
7.0 Obtaining Blood Samples …………………………………………………………………………………………………………………………………………………………….. 12 How to Lance …………………………………………………………………………………………………………………………………………………………………………………………………………12
8.0 Blood Glucose Testing …………………………………………………………………………………………………………………………………………………………………… 14
9.0 Understanding Blood Glucose Results ………………………………………………………………………………………………………………………………………. 18 Low and High Blood Glucose Results……………………………………………………………………………………………………………………………………………………………18
10.0 Control Solution ……………………………………………………………………………………………………………………………………………………………………………… 20 Control Solution Information ……………………………………………………………………………………………………………………………………………………………………………20 Out of Range Control Solution Results …………………………………………………………………………………………………………………………………………………………20 How to Perform an AlphaTrak 3 Control Solution Test……………………………………………………………………………………………………………………………21

Table of Contents (continued)

11.0 Using Meter Memory………………………………………………………………………………………………………………………………………………………………………. 23

12.0 Reminder Alarms…………………………………………………………………………………………………………………………………………………………………………….. 24

13.0 Maintenance & Care ……………………………………………………………………………………………………………………………………………………………………….. 25 Replacing the Batteries………………………………………………………………………………………………………………………………………………………………………………………26 Cleaning & Care …………………………………………………………………………………………………………………………………………………………………………………………………….26

14.0 Error Codes………………………………………………………………………………………………………………………………………………………………………………………. 27

15.0 Troubleshooting ……………………………………………………………………………………………………………………………………………………………………………… 31

16.0

Specifications………………………………………………………………………………………………………………………………………………………………….. 32 Meter ………………………………………………………………………………………………………………………………………………………………………………………………………………………… 32 Test Strips………………………………………………………………………………………………………………………………………………………………………………………………………………..33 Control Solution…………………………………………………………………………………………………………………………………………………………………………………………………….33

17.0 Regulatory……………………………………………………………………………………………………………………………………………………………………….. 34 USA …………………………………………………………………………………………………………………………………………………………………………………………………………………………… 34 Canada…………………………………………………………………………………………………………………………………………………………………………………………………………………….. 35 European Union…………………………………………………………………………………………………………………………………………………………………………………………………….36

18.0 Definition of Symbols……………………………………………………………………………………………………………………………………………………… 37

19.0 References……………………………………………………………………………………………………………………………………………………………………….. 39

How It Works
AlphaTrak 3 is an easy-to-use veterinary canine and feline blood glucose monitoring system.

1 System Check Screen This display always appears when the meter is turned on. You should check that the meter matches the example exactly every time the meter turns on. Do not use the meter if the display check screen does not exactly match the example. If the screen does not match, the meter may show an incorrect result. Please contact Customer Care
2 Display Screen Displays test results and other important information
3 Test Strip Port Insert the top end of a new AlphaTrak 3 strip here. The meter powers on when you insert the test strip
4 AlphaTrak 3 Test Strip Insert strip into the meter printed side up and following the purple arrow

5 Sample Area Sample area is the dark-colored rectangle on the test strip
Apply blood or control solution to the front edge of the sample area only (not on top of it)
6 m (Mode) Button · Turns meter on/off · Access primary settings · Access record log · Scroll backwards · Silences alarm
7 c (Configure) Button · Scrolls forward · Silences alarm · Access secondary settings · Marks a control solution test
Press m and c at the same time after glucose test or when viewing record log to turn on Bluetooth

Hold c and press m to change species code after inserting the test strip and waiting on sample

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For more information www.alphatrak.com
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Components
Starter Kit 1 AlphaTrak 3 Meter
2 50 AlphaTrak 3 Test Strips
3 Lancing Device and 30 Lancets

4 AlphaTrak 3 Control Solution (4 mL) 5 Carrying Case 6 Code Strip

7 Diabetes Diary 8 Quick User’s Guide 9 Two Batteries (3V, CR2032)

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9 For more information www.alphatrak.com
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Important Information
Important health-related information The AlphaTrak 3 meter is intended for testing outside the body only (in vitro diagnostic use). The AlphaTrak 3 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from cats and dogs. Glucose values are affected by stress, meals, exercise, health, and medication use. Severe dehydration and excessive water loss may cause false low results.
CAUTION The AlphaTrak 3 test strips are not intended for human blood glucose testing. If the AlphaTrak 3 meter is used in any way other than described in this manual, the meter may not operate as intended, may produce inaccurate or no results, and may pose a safety hazard. WARNING This system contains small parts that may be dangerous if swallowed. U.S. CUSTOMER CARE 1-888-963-8471 5

AlphaTrak 3 meter usage

DO use the AlphaTrak 3 meter for:

Testing blood glucose in dogs and cats Testing fresh whole blood samples
Testing fresh whole capillary samples Testing fresh whole venous samples Testing whole blood collected in a syringe or tube with EDTA or heparin anticoagulant if testing is carried out within 10 minutes of sample collection Testing whole blood collected in a syringe or tube without anticoagulant, if testing is performed immediately after sample collection

DO NOT use the AlphaTrak 3 meter for:

Testing arterial blood Testing serum

Testing plasma Diagnosis of diabetes

I M P O R TA N T Use only AlphaTrak 3 test strips and AlphaTrak 3 control solution with this meter. Using older version AlphaTrak test strips or off- brand test strips and control solution can yield inaccurate results. CAUTION Read all instructions before and practice the testing procedure before using the AlphaTrak 3 meter. Blood glucose monitoring should be done with the guidance of a veterinarian/veterinary surgeon.
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Bluetooth® Wireless Technology

The AlphaTrak 3 meter uses Bluetooth® wireless technology to pair and send glucose results to compatible mobile devices.

Bluetooth® wireless technology is used by some smartphones and other devices. The AlphaTrak 3 meter uses Bluetooth® wireless technology to pair and send glucose results to compatible mobile devices. The meter is designed to work with the AlphaTrak Mobile App available for pet owners and veterinary professionals. By connecting the meter with the App, it allows to review and graph glucose results, record pets’ daily activities such as water intake, feeding, exercise, set up notifications and reminders. The Mobile App helps pet owners to connect with their veterinarians to strengthen their relationship, share their pet’s glucose results and send reports. It also allows veterinary professionals to easily keep track of their patient’s diabetes management and create Blood Glucose Curves to better understand their patients. Visit www.alphatrak.com for more information.

WARNING In locations where cell phone use is not permitted, such as hospitals, some healthcare professional offices and airplanes, the Bluetooth® feature should be turned off.

Meter Set Up

Setting the Meter Sound

With the meter off (no test strip inserted), press and hold “m” for 3 seconds until SET appears on the screen.

Use “c” and “m” buttons to progress through the steps of the initial meter set up.

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Press “m” to bypass the 4 optional reminder alarms setting. You may choose to

set these later (see `Reminder Alarms’ section).

Sound Volume 2

Note: With the sound volume on, the meter will beep when: The test strip is full of blood The test result appears on the display An error occurs
You may also choose to silence the meter.

If you prefer No sound A low beep A louder beep

Press “c” until you see:

Then
Press “m” to save your preference

U.S. CUSTOMER CARE 1-888-963-8471 7

U.S. CUSTOMER CARE 1-888-963-8471 8

Meter Set Up (continued)
Blood Glucose Unit
Note: Blood glucose results are generally reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L). Please be aware of which unit your device is displaying as normal results can appear abnormal, and vice versa if the results are ascribed to the wrong units. Please check with your veterinarian regarding the preferred units. The glucose unit is preset to mg/dL. 3 Press “c” to change the unit to mmol/L then press “m” to save.

Date Format 4

Year The year will blink first. Press “m” to accept the displayed year or press “c” to change. Press “m” to save.
Date format Note: The date format depends on the blood glucose unit you chose before. Press “c” to change the format to day-month or month-day then press “m” to save.
Month The month will blink first. Press “c” to set the correct month then press “m” to save.
Day Press “c” to set the correct day then press “m” to save.

Meter Set Up (continued)

Time Format 5

Note: The meter can display time in 12-hour (e.g., 1:24P) and 24-hour (e.g., 13:24) time formats. “A” is displayed for AM and “P” is for PM. It is set to 12-hour format by default.
Press “c” to change to 24-hour format then press “m” to save.
Hour Press “c” to set the hour then press “m” to save.
Minutes Press “c” to set the minutes then press “m” to save.
Press and hold “m” for 3 seconds until the meter turns off. Initial set up is now complete.

Bluetooth® Connection

Note: The Bluetooth® is “ON” by default, so the meter will automatically turn on the Bluetooth® when the strip measurement is complete. This will enable automatic data transfer to the AlphaTrak App.

If you want to change the Bluetooth settings, press and hold “c” for more than 3 seconds to enter the Bluetooth® and Glucose Warning setting mode.

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Press “c” again to turn OFF the automatic Bluetooth® connection mode then press “m” to save your

preference.

U.S. CUSTOMER CARE 1-888-963-8471 9

U.S. CUSTOMER CARE 1-888-963-8471 10

Meter Set Up (continued)

Glucose Warnings 7

Note: Glucose warnings can help you easily evaluate a pet’s glucose readings, whether they are too high or too low. Glucose warning setting will apply for all species. Hematocrit warning is “OFF” by default.
High Glucose values can be set between 140 mg/dL (7.5 mmol/L) and 400 mg/dL (22.5 mmol/L). You can change the value in steps of 10 mg/dL (0.5 mmol/L).
1. Press “c” to turn the High Glucose warning “ON” or “OFF” then press “m” to save.
2. Press “c” to set the High Glucose value, then press “m” to save.
Note: The Hyperglycemia (High Glucose) warning is “OFF” by default and preset to 250 mg/dL (14.0 mmol/L).
Low Glucose values can be set between 45 mg/dL (2.4 mmol/L) and 95 mg/dL (5.4mmol/L). You can change the value in steps of 5 mg/dL (0.2 mmol/L).
1. Press “c” to turn the Low Glucose warning “ON” or “OFF” then press “m” to save.
2. Press “c” to set the Low Glucose value then press “m” to save.
Note: The Hypoglycemia (Low Glucose) warning is “ON” by default and preset to 65 mg/dL (3.6 mmol/L).
Note: Hematocrit (Hct) warning is “OFF” by default. Press “c” to turn the Hct warning “ON” or “OFF” then press “m” to save. Press and hold “m” for 3 seconds until the meter turns off. Bluetooth® and Glucose Warning set up is now complete.

U.S. CUSTOMER CARE 1-888-963-8471 11

Obtaining Blood Samples
How to Lance

1 Select a test site There are many sites to obtain capillary blood samples. See illustrations below.

Use the AlphaTrak 3 lancet to obtain blood samples
Consult a veterinarian/veterinary surgeon for recommended sampling methods and instructions

Marginal ear vein (cats and dogs)

Paw pad (cats and dogs)

Leg callus (usually dogs)

Inner lip (dogs only)

Warming the area will help increase blood flow. Gently rub or apply a warm (not hot) cloth to the test site. If using a wet cloth, place the cloth inside a plastic bag to avoid diluting the blood sample.
2 Wash your hands and the test site with soap and warm water to ensure accurate results. Thoroughly dry your hands and the test site.

CAUTION Animal blood is a potential source of zoonotic diseases. We recommend wearing personal protective equipment when handling animal blood. Be sure to follow local occupational health and safety regulations.
U.S. CUSTOMER CARE 1-888-963-8471 12

Obtaining Blood Samples (continued)
3 Prepare the lancing device and puncture the test site Optional: a thin layer of petroleum jelly may be applied to the test site prior to lancing. This can help the blood form a droplet without getting into the hair. The AlphaTrak 3 lancing device may be used to help obtaining a blood sample. For more information on the lancing device follow the instructions included in your AlphaTrak 3 Starter Kit (Quick Start Guide).
4 Perform a glucose test See `Blood Glucose Testing’ section of this user guide.
5 Gently apply pressure to the test site Use a sterile gauze or cotton pad to help stop the bleeding.
CAUTION If you accidentally stab or scratch yourself with the lancet, follow basic first aid procedures. If bleeding persists, contact your local healthcare professional.
U.S. CUSTOMER CARE 1-888-963-8471 13

Blood Glucose Testing
DO: Use the test strips within the meter’s operating temperature range: 39 – 104 °F (4 – 40 °C) Store test strips in a dry place between 36 – 90 °F (2 – 32 °C) Store test strips away from direct sunlight and heat

Store test strips in their original vial only
Clean and dry your hands before removing a strip from the vial
Close the vial cap tightly immediately after removing a test strip

DO NOT: Use the test strips beyond the expiration date printed on the side of the test strip vial since this may cause inaccurate results (Test strips expire at 12 months after opening) Transfer test strips to another container Store test strips outside the vial Bend, cut, or alter test strips
Read the AlphaTrak 3 test strip package insert for more information.

Press the test strip against the test site Scrape the blood onto the test strip Apply blood to the flat side of the test strip Apply blood to the test strip when the test strip is out of the meter Put blood or foreign objects into the meter

I M P O R TA N T Use only AlphaTrak 3 test strips. Other test strips can give inaccurate results. The test strips are single use only. WARNING Drying agents in the test strip vial may be harmful if inhaled or swallowed and may irritate skin and eyes.
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Blood Glucose Testing (continued)

Testing 1

Check test strip expiration date (printed on the vial) Do not use expired test strips or the results may be inaccurate.

Remove a test strip from the vial 2

Insert test strip into the meter to turn it on Note: The meter turns off automatically after 2 minutes of inactivity. Remove and re-insert the unused test strip to restart the meter. If the meter does not turn on, refer to `Troubleshooting’ section. Note: If you are using the AlphaTrak 3 meter or a new strip vial for the first time, it will ask to confirm the Lot Code (for dog or cat). To do so, insert the Code Strip attached to the test strip vial.
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Blood Glucose Testing (continued)

Set Lot Code (using the Code Strip)

· Insert Code Strip

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· Press “c” to set the correct code (match the code on the strip vial)

· Press “m” to save

Set Species

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· Change the species on the meter after inserting the test strip

· Press and hold “c” and at the same time press “m” to switch between the species

Obtain a Blood Sample

When the blood droplet and strip icons appear on the display, use the lancing device to obtain a drop of blood.

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See `Obtaining Blood Sample’ section of this user guide.

Apply and hold blood to the front edge of the sample area of the test strip (dark-colored rectangle on the test strip) until you hear a beep, and a vertical line appears on the screen.
The meter will start to count down (3, 2, 1) which indicates the test strip has enough blood and the meter is checking the glucose level. 7 If a vertical line does not appear after 5 seconds, the sample may be too small.
If the test does not start after applying the blood drop, go to `Troubleshooting’.

U.S. CUSTOMER CARE 1-888-963-8471

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Blood Glucose Testing (continued)

View result

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The result will appear on the display when the test is complete.

Add feeding information (optional)

If you like to add information about whether the glucose test has

been taken before or after feeding your pet, press “c” until the desired

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setting appears (full, empty, or no food bowl).

The selected setting will automatically be captured after the meter turns off.

Turn on Bluetooth®

Note: If the Bluetooth® mode is set to turn on automatically, you will see the blinking Bluetooth® icon once the result is ready. This indicates that Bluetooth® is on and ready to pair with the AlphaTrak App.

If it is not set to turn on automatically, but you would like to send the result to your AlphaTrak App, press and hold “m” and then press “c” within 3 seconds to turn on Bluetooth®.

Note: If you are pairing an AlphaTrak 3 meter to the AlphaTrak App for the first time, press on “Device” on the left side

of the bottom menu in the App. Then click on “Add a Meter”. Select the meter you want to pair from the list and confirm.

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Next, a 6-digit pairing key will be displayed on your AlphaTrak 3 meter. Please enter these 6 digits to your AlphaTrak App

on your phone (pop up window) and confirm. This will complete the pairing process. Next, click on “Get Results” on the

Dashboard screen to sync the meter results to the App.

Note: When the meter is connected to the AlphaTrak App, the Bluetooth® icon will stop blinking.

Note: 2 blinking arrows will indicate that the result is being transmitted.

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Blood Glucose Testing (continued)
Remove test strip to turn meter off (meter turns off automatically after 1 minute) 11
Discard used lancet and test strip as directed below

Understanding Blood Glucose Results

Low and High Blood Glucose Results1,2,3

Result
Lower than 65 mg/dL (3.6 mmol/) for adult cats & dogs

What It Means
Low blood glucose (Hypoglycemia)

Clinical Signs1
Dogs and Cats · Lethargy or abnormal
drowsiness · Weakness · Disorientation · Visual disturbances · Incoordination · Tremors/shaky movements · Seizures · Coma

What To Do
· Repeat the test with a new test strip if the result is not consistent with the clinical signs.
· If the blood glucose result is not consistent with the clinical signs, perform a control solution test with a new test strip.
· If the test results are within the range printed on the test strip vial, retest using fresh blood and a new test strip.
· If the blood glucose result is still not consistent with the clinical signs, contact a veterinarian/ veterinary surgeon.

NOTE: Consult a veterinarian if your pet is displaying any abnormal signs or behavior, to know more about your pet’s normal glucose ranges, or for assistance with any further questions you may have about your pet´s glucose results.
I M P O R TA N T Low or high blood glucose readings can indicate a potentially serious medical condition. Consult a veterinarian regarding low and high blood glucose levels.
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Understanding Blood Glucose Results (continued)

Higher than 250 mg/dL (13.9 mmol/L) for adult cats & dogs2, 3

High blood glucose (Hyperglycemia)

Lo Result Display (LOW)

Result
Lower than 20 mg/dL or 1.1 mmol/L (outside the system range)

What It Means
Severe low blood glucose (Hypoglycemia)

HI Result Display (HIGH)

Result
Higher than 750 mg/dL or 41.6 mmol/L (outside the system range)

What It Means
Severe high blood glucose (Hyperglycemia)

Dogs and Cats · Excessive thirst · Frequent urination · Weight loss · Excessive appetite · With chronically elevated
levels can see vomiting, dehydration, depression, acetone (`fruity’) breath, coma

· Repeat the test with a new test strip if the result is not consistent with the clinical signs.
· If the blood glucose result is not consistent with the clinical signs, perform a control solution test with a new test strip.
· If the test results are within the range printed on the test strip vial, retest using fresh blood and a new test strip.
· If the blood glucose result is still not consistent with the clinical signs, contact a veterinarian/ veterinary surgeon.

What To Do
· Follow a veterinarian/veterinary surgeon’s advice to treat low blood glucose · If the blood glucose result does not match the clinical signs, perform a control
solution test to confirm that the meter and strips are working properly

What To Do
· Follow a veterinarian/veterinary surgeon’s treatment advice to treat high blood glucose
· If the blood glucose result does not match the clinical signs, perform a control solution test to confirm that the meter and strips are working properly

I M P O R TA N T Low or high blood glucose readings can indicate a potentially serious medical condition. Consult a veterinarian regarding low and high blood glucose levels.
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Control Solution
AlphaTrak 3 control solution is a red liquid that contains a fixed amount of glucose. The purpose of a control solution test is: · To practice testing without using animal blood · To confirm that the meter and test strips work together properly · To use when you are unsure of the blood glucose test results

Control solution information
· Use only AlphaTrak 3 control solution with the AlphaTrak 3 meter
· Replace the bottle cap and tighten it securely immediately after use

· Control solution results are only accurate between 39 ­ 104 °F (4 ­ 40 °C)
· Store control solution at a dry place between 39 – 86 °F (4 – 30 °C)
· Do not add water or other liquid to the control solution

For information on how to obtain control solution, contact Zoetis Customer Care.

Out of range control solution results Possible causes: · Expired or defective control solution · Expired or defective test strip · Testing error

· Watered-down control solution · Meter malfunction · Test strip deterioration · Control solution test done outside of 39 ­ 104 °F (4 ­ 40 °C) · Correct code is not set in the meter

What to do: · Repeat the test if control solution results are out of range
(printed on the test strip vial)

· Stop using the meter if control solution results are consistently out of range (printed on the test strip vial)
· Contact Zoetis Customer Care

I M P O R TA N T Control solution results should fall within the control solution range printed on the test strip vial. Do not use this range when testing blood glucose.
CAUTION Control solution range is not a range for animals’ blood glucose level.
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Control Solution (continued)
How to Perform an AlphaTrak 3 control solution test Check the expiration date of the control solution (printed on the bottle)
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Remove a test strip from vial 2
Insert test strip into the meter to turn it on Note: The meter turns off automatically after 2 minutes of inactivity. Remove and re-insert the unused test strip to restart the meter. If the meter does not turn on, refer to `Troubleshooting’ section. 3

Confirm system check screen

· This display appears when you turn on the meter. Do not use the meter if the display check screen

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does not exactly match this example. Contact Zoetis Customer Care.

· See the `How it works’ section for more information

· If the system check screen does not appear, go to `Troubleshooting’

I M P O R TA N T Do not use expired control solution. Discard control solution 3 months after opening or on the day of expiration printed on the bottle, whichever comes first. (Example: opened on April 15, discard on July 15; write the discard date on the side of the bottle.)
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Control Solution (continued)
How to Perform an AlphaTrak 3 control solution test (continued) Set the correct species code See steps in `Blood Glucose Testing’ section
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Start control solution testing Press and hold “c” for 3 seconds until you see the control solution bottle icon on the display 6

Apply control solution to the sample area of the test strip until you hear a beep, and a vertical line

appears on the screen. The meter will start to count down (3, 2, 1) which indicates the test strip has

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enough sample and the meter is running the control solution test. If a vertical line does not appear

after 5 seconds, the sample volume may be too small.

If the test does not start after applying the control solution, go to `Troubleshooting’.

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Review result

Compare the control solution result to the test range printed on the test strip vial. The result should

fall within this range.

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Note: The control solution test results correlate with the species code. Choosing different species will

result in different readings.

Remove the test strip to turn off the meter (meter turns off automatically after 1 minute)

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Using Meter Memory
Turn meter on Press the “m” button for less than 3 seconds 1

View result history

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Press “m” again for less than 3 seconds

Press “c” to scroll to the Control Solution test result 3

Press “m” to scroll to the earliest test results 4
Note: The latest control reading is at the end of the list.
Transfer stored test results to the AlphaTrak App Press and hold “m” then press “c” within 3 seconds to turn on Bluetooth® Note: Two blinking arrows will indicate that results are being transmitted Press and hold “m” to exit meter memory 5

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Reminder Alarms
Press and hold “m” for more than 3 seconds to enter system settings
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Press “c” to select which alarm you would like to set (1, 2, 3, or 4) 2

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Press “m” to save

Set hour

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· Press “c” to select correct hour

· Press “m” to save

Set minute

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· Press “c” to select correct minute

· Press “m” to save

Set sound

· Press “c” to select your preferred sound setting for this alarm (low beep, loud beep, no sound).

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Note: If you select “no sound”, the reminder will be suspended.

· Press “m” to save

Press and hold “m” for 3 seconds to turn off the meter

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Maintenance & Care
Replacing the batteries The meter comes with two CR 2032 3 V lithium batteries already installed. Pull the plastic tab up to release the batteries, if you are using the meter for the first time.
icon on the screen indicates low battery
· When the icon appears, the meter may fail to turn on
· When you are ready to install new batteries, remove the old batteries and install the new ones one after the other to avoid losing your settings
· If time and date settings are lost, time and date will flash until reset
· Even if the time and date settings are lost, you may still perform accurate blood glucose test
· Memory log and certain previously stored user settings, such as date and time format, are not affected by removing the batteries
Note: The battery in this product should be removed and disposed in accordance with local regulations for separate collection of electronic waste and spent batteries.

Open the battery door 1

Remove the old batteries 2

Insert 2 new batteries (+) facing up
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Slide the battery door in until it snaps into place to close
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Maintenance & Care (continued)
Cleaning & care Handle the meter with care and avoid getting dirt, dust, blood, control solution or any type of liquid on the meter test strip area and in data ports.
Clean the outside of the meter using a damp cloth and:

Mild detergent/soap and water

or 70% isopropyl alcohol (available in the USA)

or A mixture of 1 part household bleach, 9 parts water

I M P O R TA N T Do not immerse the meter in water or other liquids.

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Error Codes

Display message What it means
· The sample volume is too small · There may be a problem with the
test strip · Meter error
· Meter error · Internal reference error
(data memory) · Firmware checksum error
(program memory)
· Incorrect test procedure (e.g., applying blood on the test strip before prompted by the meter)
· There may be a problem with the test strip
· Meter error · The test strip is affected by moisture
· There may be a problem with the test strip
· Meter error · Strip Sensing path broken · Strip Type (OEM) error

What to do
· Use a new test strip and try again with proper amount of sample
· Perform a control solution test using a new test strip. If the test results are within the range printed on the test strip vial, retest using a fresh blood sample and a new test strip
· If the control solution result is out of range or the error reappears, contact Zoetis Customer Care
· Perform a control solution test using a new test strip. If the test results are within the range printed on the test strip vial, retest using blood and a new test strip
· If the control solution result is out of range or the error reappears, contact Zoetis Customer Care
· Wait for the drop and strip icons to appear before applying blood or control solution
· Perform a control solution test using a new test strip. If the test results are within the range printed on the test strip vial, retest using blood and a new test strip
· If the control solution result is out of range or the error reappears, contact Zoetis Customer Care
· Perform a control solution test using a new test strip. If the test results are within the range printed on the test strip vial, retest using blood and a new test strip
· If the control solution result is out of range or the error reappears, contact Zoetis Customer Care

27

Error Codes (continued)

Display message What it means

What to do

· There may be a problem with the test strip connection with the meter
· Meter error

· Perform a control solution test using a new test strip. If the test results are within the range printed on the test strip vial, retest using a fresh blood sample and a new test strip
· If the control solution result is out of range or the error reappears, contact Zoetis Customer Care

No calibration code

Use the code strip attached to the test strip vial to set the correct lot code.

Code Strip reading failed Operating temperature too low

· Try to set the lot code again · If the code strip is illegible or broken,
contact Zoetis Customer Care
Try again after warming up the device.

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Error Codes (continued)
Display message What it means Operating temperature too high

What to do Try again after cooling down up the device.

The glucose test result is below the lower limit (outside the system range)

Repeat the test. If the result is still too low, contact your veterinarian for further help.

The glucose test result is higher than the upper limit (outside the system range)

Repeat the test. If the result is still too high, contact your veterinarian for further help.

The hematocrit test result is too low

Repeat the test. If the result is still too low, contact your veterinarian for further help.

The hematocrit test result is too high

Repeat the test. If the result is still too high, contact your veterinarian for further help.

Error Codes (continued)
Display message What it means Dead/flat battery
· Bluetooth® pairing failure
· Wrong pairing key entered

What to do
· Replace battery. Reset date and time, if necessary. · If meter still does not enter test mode, contact Zoetis
Customer Care.
· Ensure Bluetooth® is turned on your mobile device and you
have started the AlphaTrak Application. Press “Get results” on your mobile application to establish the connection. · If you are pairing an AlphaTrak 3 meter to the AlphaTrak mobile app for the first time, press on “Device” on the left side of the bottom menu of the app. Then click on “Add a Meter”. Select the meter you want to pair from the list and confirm. Next, a 6-digit pairing key will be displayed on your AlphaTrak 3 meter. Please enter these 6 digits to your AlphaTrak app on your phone (pop-up window). This will complete the pairing process. · If the error still occurs, contact Zoetis Customer Care.

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30

Troubleshooting
Problem The meter does not enter test mode after inserting a test strip.
The test does not start after applying the blood sample.

Possible cause Test strip is inserted upside down, or bottom end in, or not fully inserted into the meter No battery is installed Battery is installed incorrectly Flat battery
Defective test strip or meter Blood or foreign objects inside the test strip port Blood sample is too small

Easy solution Insert test strip print side up, top end in
Install battery with (+) facing up
· Replace battery. Reset date and time, if necessary
· If meter still does not enter test mode, contact Zoetis Customer Care
Contact Zoetis Customer Care
Repeat the test using a new test strip and a larger blood sample

Defective test strip Sample applied after meter turns off
Defective meter

· Repeat the test using a new test strip. Wait for drop and strip icons to appear before applying blood or control solution
· If problem persists, contact Zoetis Customer Care
Contact Zoetis Customer Care

Specifications
Meter Assay method Calibration Automatic shutoff Hematocrit Measurement units Storage temperature Relative humidity
Operating temperature Altitude
Usage Power source Result range Sample Sample Size Size Weight

Electrochemistry Plasma equivalent 2 minutes of inactivity 15-65% mg/dL or mmol/L ­ 4 to 140 °F (­ 20 to 60 °C) Operation: 5% to 90% (non-condensing) Storage: 5% to 95% (non-condensing) 39 to 104 °F (4 to 40 °C) Operation: 71.7kPA (3048 m) Storage: 54 kPA (5000 m) For indoor use Two CR 2032, 3V lithium battery, replaceable 20 mg/dL (1.1 mmol/L) – 750 mg/dL (41.67 mmol/L) whole blood, capillary, or venous 0.3 microliter (300 nanoliters)
3.56x 2.19 x 0.65
50 g (w/o battery)

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32

Specifications (continued)

Meter (continued) Safety
EMC
Pollution Communication method Operating Frequency Range Operating Output Test strips Storage temperature Storage relative humidity Altitude Strip Open vial Control solution Storage temperature Storage relative humidity Altitude

EN 61010-1:2010; IEC 61010-1:2010/AMD1:2016 COR1:2019; IEC 61010-2-101:2018, EN 610102-101:2017; EN ISO 15197:2015 (Clause 5.9 & 5.10) EMC/RF: EN 61326-1:2013; IEC 613261:2020; EN 61326-1:2021; EN 61326-2-6:2013; IEC 61326-2-6:2020; EN 61326-2-6:2021; EN 60601-1-2:2015; FCC Part 15 B (Class B ANSI C63.4-2014); J55011 (H27):2015 EN 301 489-1 V2.2.3:2019-11; EN 301 489-17 V3.2.4:2020-09; EN 300 328 V2.2.2:2019-07; EN 62479:2010 FCC Part 15 B, IEC 60601-1-2:2014, IEC 61326-1:2012, IEC 61326-2:2012, J55011 (H27):2015 Degree 2 Bluetooth 2402.0 – 2480.0 MHz 0.000234 W
36 to 90 °F (2 to 32 °C) 0% to 90% (non-condensing) Storage: 54 kPA (5000 m) 12 months
39 to 86 °F (4 to 30 °C) 0% to 90% (non-condensing) Storage: 54 kPA (5000 m)

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Regulatory
USA
FCC Class B
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
· Reorient or relocate the receiving antenna · Increase the distance between the equipment and receiver · Connect the equipment into an outlet on a circuit different from that to which the receiver is connected · Consult the dealer or an experienced radio/TV technician for help
FCC Class C
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
FCC ID: 2A3FBALPHATRAK3
To assure continued FCC compliance:
Any changes or modifications not expressly approved by the grantee of this device could void the user’s authority to operate the equipment.
Exposure to Radio Frequency Radiation:
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
34

Regulatory (continued)
Canada
IC warning:
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Exposure to Radio Frequency Radiation:
This equipment complies with IC radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
IC ID: 27797-ALPHATRAK3
IC attention:
Cet appareil est conforme aux normes RSS exempts de licence d’Industrie Canada. Son fonctionnement est soumis aux deux conditions suivantes: (1) cet appareil ne doit pas causer d’interférences et (2) cet appareil doit accepter toute interférence, y compris les interférences pouvant provoquer un fonctionnement indésirable de l’appareil.
Exposure to Radio Frequency Radiation:
Cet équipement est conforme aux limites d’exposition aux rayonnements IC définies pour un environnement non contrôlé. Cet émetteur ne doit pas être situé au même endroit ou fonctionner en conjonction avec une autre antenne ou un autre émetteur.
IC ID: 27797-ALPHATRAK3

Regulatory (continued)
European Union
Declaration of Conformity
Directives covered by this Declaration:
· EU RoHS2 Directive 2011/65/EU including amendments by Directives 2015/863/EU and 2017/2102/EU · EU RED Directive 2014/53/EU
The manufacturer hereby declares under his sole responsibility that the AlphaTrak 3 glucose meter complies with the RoHS2 Directive 2011/65/EU including amendments by Directives 2015/863/EU and 2017/2102/EU, and essential requirements set out in Article 3 of the Radio Equipment Directive 2014/53/EU.

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Definition of Symbols

Symbol

Name/description Manufacturer of the device

Date of manufacturing in Taiwan

Model number
Serial number
Biological risks Indicates that there are potential biological risks associated with the device Indicates the need for the user to consult the instructions for use or the electronic instructions for use
Caution Indicates that caution is necessary when operating the device in order to avoid undesirable consequences Indicates important information about the use of the glucose meter
Do not discard in household waste. Needs to be sent to separate collection facilities for recovery and recycling.
DC current Importer contact (EU)

Definition of Symbols (continued)

Symbol

Name/description Single use

Quantity

Temperature limit

Lot number

Expiry date

To be used within X month after opening

Sterilized using irradiation

Official distributor contact

Indicates that a device should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information
Keep away from sunlight

Keep dry

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References
1. BSAVA Manual of Canine and Feline Endocrinology, Third Edition, British Small Animal Veterinary Association. Edited by Carmel Mooney and Mark E Peterson. 2004
2. Ettinger SJ, Feldman EC. Textbook of Veterinary Internal Medicine. Vol 2. WB Saunders Company. pp 1529 – 1534. 1995
3. Ford RB, Mazzaferro EM. Kirk and Bistner’s Handbook of Veterinary procedures and Emergency Treatment (9th ed). Pp. 176-179. 2012
All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted. Ðu169©2021 Zoetis Services LLC. All Rights Reserved. BLUETOOTH® trademark. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG,Inc. and any use of such marks by Zoetis is under license. Other trademarks and trade names are those of their respective owners.
Zoetis Services LLC, 333 Portage Street, Kalamazoo, MI 49007, USA For Zoetis U.S. Customer Care, call 1-888-963-8471. 39

www.alphatrak.com
U.S. Customer Care 1 888 963 8471 Distributed by Zoetis Inc. Kalamazoo, MI 49007
IVD

51613400 40

References

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