AlphaTrak 3 User Guide Draft 0.
Table of Contents AlphaTrak 3 Meter and How It Works .................................................................................................................................................................................................... 3 ................................................................................................................................................................................................................................................................
Understanding Blood Glucose Results ................................................................................................................................................................................................. 18 Low and High Blood Glucose Results1,2 ............................................................................................................................................................................................ 18 GLU-H Result Display (HIGH) .....................
AlphaTrak 3 Meter and How It Works (Placeholder) 3
AlphaTrak 3 Blood Glucose Monitoring System Components Starter Kit AlphaTrak 3 Meter (SKU placeholder) Two Batteries (3V, CR2032) (SKU placeholder) Blood Glucose Test Strips (SKU placeholder) Control Solution (SKU placeholder) Lancing Device (SKU placeholder) Lancets (SKU placeholder) Carry Case (SKU placeholder) (Placeholder) 4
Important Information About AlphaTrak Blood Glucose Monitoring System Important Health Related Information The AlphaTrak 3 meter is intended for use outside the body only (in vitro diagnostic use). The AlphaTrak 3 Blood Glucose Monitoring System is intended for use in monitoring glucose samples taken from dogs or cats. Glucose values are affected by stress, meals, exercise, health and medication intake. Severe dehydration and excessive water loss may cause false low results.
Caution: Read all the instructions provided in this user guide and practice the testing procedures before using the AlphaTrak 3 meter. Blood glucose monitoring should be done with the guidance of a veterinarian/veterinary surgeon. Setting Up the AlphaTrak 3 Meter The purpose of this section is to set the meter sound volume, time, date, units and Bluetooth connection. 1. With the meter off (no test strip inserted), press and hold m for 3 seconds until SET appears. 2.
Low volume Press m to save your preferred volume setting High volume No sound 7
Set Unit Note: The glucose unit is preset to mg/dL. 4. Set unit: Press c to change the unit to mmol/L Press m to save your preferred unit Set Date The year will flash first. 5. Set year: • Press m to accept year or • Press c to change • Press m to save Note: The date is preset to month-date format. 6.
The month will flash first. 7. Set month: • Press c to display correct month • Press m to save 8. Set day: • Press c to display correct day • Press m to save Set Time Note: The meter can display either the 12-hour (1:24P) or the 24-hour (13:24) time formats. The time is preset to 12-hour format. An “A” will be displayed for AM and a “P” will be displayed for PM. 9. Set time format: Press c to change to 24-hour format Press m to save your preferred time format 10.
. Set minutes: • Press c to display correct minutes • Press m to save 12. Press and hold m for 3 seconds until meter turns off. General meter set up is complete. Set Bluetooth Note: This Bluetooth setting is to set whether to automatically turn on the Bluetooth function after the strip measurement is completed. This can help you to automatically capture your pet´s Glucose readings in your AlphaTrak 3 mobile Application. The Bluetooth mode is preset to “OFF”. 13.
Set Glucose Warning Note: This Glucose warning setting can help you to easily evaluate your pet´s Glucose readings. Hematocrit warning setting is default OFF. Glucose warning setting will apply for all species. 14. Set High Glucose Warning (Hyperglycemia): Press c to turn ON/OFF the High Glucose warning Press m to save your preferred setting Note: The Hyperglycemia warning is default OFF and preset to 250 mg/dL (14.0 mmol/L). High Glucose values max. is 400 mg/dL (22.5 mmol/L) and min. is 140 mg/dL (7.
Press c to turn OFF/ON the Low Glucose warning Press m to save your preferred setting Press c to display correct value Press m to save your preferred setting Note: Hematocrit warning is OFF by default. 16. Set Hematocrit warning: Press c to turn OFF/ON the Hct warning Press m to save your preferred setting 17. Press and hold m for 3 seconds until meter turns off. Bluetooth and Glucose Warning set up is complete.
Obtaining a Blood Sample The purpose of this section is to obtain a capillary blood sample from your pet. Caution: Animal blood is a potential source of zoonotic diseases. We recommend wearing personal protective equipment when handling animal blood. Please note local occupational health and safety regulations. How to Lance • Use the AlphaTrak 3 lancet to obtain a blood sample from your pet. • Consult a veterinarian/veterinary surgeon for a recommended sampling method and instructions. (Picture) 1.
the blood flow. If you accidentally prick yourself with a lancet, follow normal first aid procedures. If bleeding persists, contact your local healthcare professional. AlphaTrak 3 Blood Glucose Testing The purpose of this section is to produce an accurate blood glucose test result. Perform a Blood Glucose Test (Picture) 1. Check test strip expiry date. Do not use expired test strips; they may produce inaccurate results. IMPORTANT: Use only AlphaTrak 3 test strips.
• Do not apply blood to the flat side of the test strip. • Do not apply blood to the test strip when the test strip is out of the meter. • Do not put blood or foreign objects into the meter. Warning: Drying agents in the test strip vial may be harmful if inhaled or swallowed and may irritate skin and eyes. 2. Remove test strip from vial. 3. Insert test strip to turn meter on. Press m to turn meter on if it does not turn on upon insertion of test strip.
• Press c to display correct species (matching the code on the strip vial) • Press m to save 6. Set Species After you have inserted the test strip again, you can change the species code on the meter: Press and hold m and at the same time press c to switch between the species codes 7. Obtain a blood drop When the droplet and strip appear on the display, use the lancing device to obtain a blood drop. See Obtaining a Blood Sample section of user guide.
If the test does not start after applying blood drop, go to Troubleshooting section. 9. View result: The result appears on the display when the test is complete. 10. Turn on Bluetooth: Note: If your Bluetooth mode is set to turn on automatically, you will see a flashing Bluetooth icon once the result is ready. This indicates that Bluetooth is activated and ready to pair with mobile the application.
Discard used lancet and test strip properly. Caution: Used lancets and test strips are considered bio-hazardous. Please ensure safe disposal. Professional users should collect and dispose lancets and test strips in a clinical waste container. Consumers can collect them in any strong plastic or metal container with a tight cap or lid. When the container is full, tightly secure the lid and reinforce it with heavy-duty tape before disposing it as household waste.
Higher than 250 mg/dL (13.9 mmol/L) for adult cats & dogs2 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.
GLU-H Result Display (HIGH) Display Appears when result is: higher than 750 mg/dL or 41.7 mmol/L What It Means Severe high blood glucose (Hyperglycemia) What To Do HI reading with clinical signs, follow a veterinarian/veterinary surgeon’s treatment advice. 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.
CAUTION: Control solution range is not a range for the animal’s blood glucose level. Out of Range Control Solution Results • Repeat the test if control solution results are outside the range printed on the test strip vial. • Repeat the test to confirm the results. • The correct test procedures may not have been followed. • Stop using the meter if control solution results are consistently outside the range printed on the test strip vial. Contact Zoetis Customer Care.
of test strip. Note: The meter turns off after 2 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter. If the meter does not turn on go to Troubleshooting section. 4. Confirm System Check Screen: • This display appears when you turn on the meter. Do not use the meter if the display check screen does not exactly match the example. Contact Zoetis Customer Care. • See The AlphaTrak 3 Meter and How It Works section for more information.
If the test does not start after applying blood drop, go to Troubleshooting section. 8. Review Result 9. Compare the control solution result to the range printed on the test strip vial or package insert. The result should fall within the range. Note: The test results of Control Solution are related to species code. When choosing different species, the measured readings are different. 10. Remove the test strip to turn meter off.
Using Meter Memory The purpose of this section is to review your stored test results 1. Turn meter on by pressing the m button for less than 3 sec 2. View result history: Press m again for less than 3 sec 3. Press c to scroll to your oldest result 4. Press m to scroll to your latest results Note: You will find your latest control reading at the end of your records.
To transfer stored results to your AlphaTrak 3 Application, turn on Bluetooth mode: 5. Press m than c in 3 sec Note: you will see 2 flashing arrows while the results are being transmitted To exit meter memory at any time, press and hold m. Setting Reminder Alarms The purpose of this section is to set up to four reminder alarms to prompt you to test throughout the day.
1. Press and hold m for more than 3 sec to enter the system settings 2. Press c to select which alarm you would like to set (1, 2, 3 or 4) 3. Press m to save 4. Set hour: • Press c to display correct hour • Press m to save 5.
6. Set sound: Press c to select your preferred sound setting for this alarm (low beep, louder beep, no sound) Press m to save 7. Press and hold m for 3 sec to turn off the meter. Maintaining the AlphaTrak 3 Meter Replacing the Battery The meter comes with two CR 2032 3 V lithium batteries installed. (Picture) When appears on the display, the battery is low. • When this appears, the meter may fail to turn on.
Cleaning the AlphaTrak 3 Meter Avoid getting dirt, dust, blood, control solution or liquid in the meter test strip and 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) • A mixture of 1 part household bleach, 9 parts water IMPORTANT: Do not immerse the meter in water or other liquid.
• There may be a problem with the test strip • Meter error 1. Internal reference error (data memory) 2. Firmware checksum error (program memory) Incorrect test procedure.
No calibration code Use the code strip attached to the test strip´s vial to set the species code Code Strip read failure Try to set the species code again. If the code strip is illegible or broken, please contact Zoetis Customer Care. Operating temperature too low Try again after warming up the device. Operating temperature too high Try again after cooling down the device.
The glucose test result is below the lower limit. 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 Repeat the test. If the result is still too high, contact your Veterinarian for further help. Replace battery. Reset date and time, if necessary. If meter still does not enter test mode, contact Zoetis Customer Care.
Trouble Shooting 1. The meter does not enter test mode after inserting a test strip. What It Means • 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 Dead battery What To Do 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.
Specifications Meter Assay method Calibration Automatic shutoff Hematocrit Measurement units Storage temperature Relative humidity Operating temperature Altitude 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.
EMC Pollution FCC Part 15 B, IEC 60601-1-2:2014, IEC 61326-1:2012, IEC 61326-2:2012, J55011 (H27):2015 Degree 2 Test Strips Storage temperature Storage relative humidity Altitude Strip Open vial 36 to 90 °F ( 2 to 32 °C) 0% to 90% (non-condensing) Storage: 54 kPA (5000 m) 12 months Control Solution Storage temperature Storage relative humidity Altitude: 39 to 86 °F ( 4 to 30 °C) 0% to 90% (non-condensing) Storage: 54 kPA (5000 m) 34
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.
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.
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 Consult instructions for use or consult electronic instructions for use Indicates the need for the user to consult the instructions for use 37
Caution Indicates that caution is necessary when operating the device in order to avoid undesirable consequences 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.
