TRUE METRIX RE4NPD03r5 Owner's Manual

INTRODUCTION: TRUE METRIX™
Self Monitoring Blood Glucose System
TRUE METRIX is a simple, accurate way to test your whole blood glucose (sugar) level, anytime, anywhere. Our goal is to provide quality healthcare products and dedicated customer service. For questions about TRUE METRIX products, visit our web site at:
www.niprodiagnostics.com.
e TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the ngertip or forearm. e TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not to be shared.
e TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the eectiveness of diabetes control.
e TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
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e TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the ngertip or forearm. e TRUE METRIX Self Monitoring Meter measures the current, detects, analyzes and corrects for hematocrit and temperature and calculates the glucose result.
e TRUE METRIX Control Solution is for use with the TRUE METRIX Self Monitoring Meter and TRUE METRIX Self Monitoring Test Strips to check that the meter and the test strip are working together properly and the test is performing correctly.
Importance of Blood Glucose Monitoring
e more you know about diabetes, the better you will be able to care for yourself. A Doctor or Healthcare Professional determines how oen you should test and what your target ranges are for blood glucose results.
Having most blood glucose results within your target range shows how well your treatment plan is working to control glucose levels. Keeping results within your target range helps slow or stop complications from diabetes.
NEVER change your treatment plan without consulting a Doctor or Healthcare Professional.
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IMPORTANT INFORMATION:
For the most accurate results using TRUE METRIX:
• Read all product instructions for use before testing.
• Use of TRUE METRIX in a manner not specied in this Owner’s Booklet is not recommended and may aect ability to determine true blood glucose levels.
• TRUE METRIX is an in vitro (outside body) quantitative system that is used for self-testing of human whole blood only.
• Alternative site (forearm) testing should not be used to calibrate continuous glucose monitors (CGMs).
• Alternative site (forearm) testing should not be used for insulin dose calculations.
• Use only TRUE METRIX Self Monitoring Test Strips and TRUE METRIX Control Solution with the TRUE METRIX Self Monitoring Meter.
• Remove only one test strip at a time from test strip vial. Recap vial immediately.
• NEVER reuse test strips. NEVER wipe test strips with water, alcohol or any cleaner. DO NOT attempt to remove blood or control solution from test strips or clean test strips and re-use. Reuse of test strips will cause inaccurate results.
• NEVER add a second drop of sample to test strip. Adding more sample gives an error message.
• Perform Control Tests before performing a blood glucose test for the rst time.
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IMPORTANT INFORMATION (cont.):
• Perform Control Tests with more than one level of control solution. ree levels of TRUE METRIX Control Solution are available for Control Tests. Call 1-800-803-6025 for assistance in obtaining control solution.
• e TRUE METRIX Self Monitoring Blood Glucose System is for one person use ONLY. DO NOT share your meter or lancing device with anyone, including family members. Do not use on multiple patients!!
• ALL parts of your blood glucose monitoring system could carry blood-borne pathogens aer use, even aer cleaning and disinfecting.
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• Cleaning and disinfecting the lancing device and the meter destroys most, but not necessarily all, blood­borne pathogens.
• Wash your hands thoroughly with soap and warm water before and aer handling the meter, lancing device, lancets, or test strips as contact with blood presents an infection risk.
• If the meter is being operated by a second person who provides testing assistance, the meter and lancing device should be disinfected prior to use by the second person.
• It is important to keep the meter and the lancing device clean and disinfected. For instructions on how to clean and disinfect the meter and lancing device, see
Meter Cleaning and Disinfecting and Lancing Device Cleaning and Disinfecting.
IMPORTANT INFORMATION (cont.):
• If you have symptoms of low or high blood glucose, check your blood glucose immediately. If your result does not match the way you feel, repeat the test. If your results still do not match the way you feel, call your Doctor or Healthcare Professional.
~ Low blood glucose (hypoglycemia) symptoms may
be trembling, sweating, intense hunger, nervousness, weakness, and trouble speaking.
~ High blood glucose (hyperglycemia) symptoms may
be intense thirst, a need to urinate oen, dry mouth, vomiting, and headache.
• Do not use for diagnosis of or screening of diabetes or for neonatal use.
• Inaccurate results may occur in severely hypotensive individuals or in dehydrated patients or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
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Phone Number, Fast Test Guide, Expected Results ............Cover
Introduction and Important Information ................................ 1
Know Your System
Meter ............................................................................................. 7
Test Strip .................................................................................... 10
Control Solution ........................................................................ 12
Getting Started
Quality Control Solution .......................................................... 15
Automatic Self Test ....................................................................15
Control Test ................................................................................16
How to Test Control Solution .................................................. 17
Testing your Blood
Obtaining a Blood Sample........................................................ 21
How to Test Blood ..................................................................... 25
TRUE METRIX System and Laboratory Testing ..................29
System Out of Range Warning Messages ...............................30
Meter Set Up
Set Time and Date ...................................................................... 31
Set Event Tags, Ketone Test Alert and Test Reminders .........33
Meter Memory
View Averages (7-, 14-, and 30-day) ........................................ 36
View Results ................................................................................ 37
Care, Cleaning/Disinfecting and Troubleshooting
Caring for TRUE METRIX ......................................................38
Changing Battery .......................................................................44
Troubleshooting ......................................................................... 45
Display Messages ....................................................................... 46
System Specications/Chemical Composition .......................... 49
Meter Warranty..............................................................................50
References .......................................................................................51
Notes ............................................................................................... 52
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Know Your System Meter
“ ▶ ” Button
Increase numbers in Meter Set Up; add ALT Symbol;
move forward by date/time when viewing results and Averages in Memory; scroll through Event Tags to mark results (if feature on).
“ • ” Button
Turn meter on to view Average values, to view results
in Memory, to access Meter Set Up, to turn on Event Tags in Meter Set Up.
“ ◀ ” Button Decrease numbers in Meter Set Up; remove ALT
Symbol; move backward by date/time when viewing results and view Averages in Memory; scroll through Event Tags to mark results (if feature on).
Top of Meter
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Display Screen
Shows results, messages, user prompts, information.
Test Port Insert TRUE METRIX Test Strip here, contact blocks
facing up.
Strip Release Button Releases test strip aer testing for disposal. Battery Door
Use one non-rechargeable 3V lithium battery
(#CR2032), positive (“+”) side up (see Changing Battery).
Meter Label
Contains serial number of meter.
Data Contacts
Connects meter with computer for data upload.
Feature not available at this time.
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Front of Meter
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Back of Meter
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Full Display Screen
1. Result is from Memory
2. Time, Date
3. Time is AM/PM
4. Event Tag Symbols
5. Result is from 7, 14, or 30 day Average
6. Test Result
7. Control Symbol
8. Battery Symbol
9. Alternate Site (ALT) Symbol
10. Drop Symbol - Apply blood or control solution
11. Temperature Symbol
12. Test Reminder Symbol
13. Ketone Test Alert Symbol
14. Unit of Measure (Note: Factory set to mg/dL,
cannot be changed by user.)
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Contact End -
Insert into Test Port with contact
blocks facing up
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Sample Tip -
Bring Tip of test strip to top of sam­ple drop (blood or control solution) aer Drop Symbol appears in the Display.
Note: Insert test strip into meter before touching Sample
Tip to blood or control solution drop.
Sample Placement
Correct Incorrect
• Allow sample drop to be drawn into Sample Tip until test­ing begins (meter beeps and dashes move across Display).
• Do not smear or scrape drop with test strip.
• Do not apply more sample to test strip aer testing begins.
• Do not apply blood or control solution to top of test strip. Do not insert Sample Tip with sample into Test Port. May damage meter.
Test Strip
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Top of Test Strip
Lot Number (LOT) - Used for identication
when calling for assistance.
Expiration Dates (EXP) - Write date rst opened
on vial label. Discard vial and unused test strips if either 4 months aer rst opening or date printed next to EXP on vial label has passed, whichever comes rst.
Caution! Use of test strips or control solution past the
Expiration Dates may give incorrect test results. Discard out-of-date products and test with new products.
Control Test Range - Range of numbers in
which Control Test result must fall to assure the system is working properly.
Note:
Examples only. Do not represent actual Control Test ranges.
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Test Strip Vial Label
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May 30, 2015
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Control Solution Bottle Label
Lot Number (LOT) - Used for identication
when calling for assistance.
Expiration Dates (EXP) - Write date rst opened
on bottle label. Discard bottle if either 3 months aer rst opening or date printed next to EXP on bottle label has passed, whichever comes rst.
Control Solution Level (1, 2, or 3) - We
recommend testing at least 2 levels of control solution. Contact 1-800-803-6025 for assistance with obtaining dierent levels of control solution.
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May 30, 2015
Control Solution (Control)
Getting Started
Meter comes with pre-set time and date. e Event Tag feature, Ketone Test Alert, and all Test Reminders are o. Before using the meter for the rst time or aer a battery change, check the time, date, Event Tags, Alert and Reminders, and update as needed (see Meter Set Up).
e meter turns on when a test strip is inserted into the Test Port or when “ • ” Button is pressed (see Memory and Meter Set Up).
Meter turns o when the test strip is released or removed from the meter, “ • ” Button is pressed, or aer 2 minutes of non-use.
Turning the Ketone Test Alert on sets a reminder to check your ketones per your treatment plan when a blood glucose result is over 240 mg/dL.
Test Reminders are set like an alarm clock to sound a tone for 10 seconds to remind you to test. Up to four Test Reminders per day may be set.
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Getting Started (cont.)
Event Tags allow you to tag your blood glucose results to link to the following events:
Before meal –test was taken just before a meal, Aer meal –test was taken 2 hours aer the start
of a meal, Exercise – test was taken during or aer exercise, Medications – medication taken may have af-
fected test result, Sick – test was taken when sick, Other – any other reason that the test is unique
or dierent in some way (example: stress, drinking alcohol). In your logbook, note the reason that the test result was tagged. Seeing a result with an Event Tag in the meter Memory reminds you that there is more about this test result in your log book.
Tagging results helps track the eect specic events may have on your blood glucose test results Event Tagging may assist you and your doctor or health­care provider with managing diabetes.
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Quality Control Testing
To assure you are getting accurate and reliable results, TRUE METRIX oers two kinds of quality Control Tests. ese tests let you know that your System is working properly and your testing technique is good.
Automatic Self-Test
An Automatic Self-Test is performed by the meter each time a test strip is inserted correctly into the Test Port.
Insert a test strip into the Test Port. e meter is working properly if:
~ the full Display appears, then ~ the time appears in the upper
part of the Display, and then,
~ the Drop Symbol begins to blink.
If an error message appears in the Display, the meter will not perform a test.
See Troubleshooting or call 1-800-803-6025.
Caution! If any segments are missing in the Display
when meter is first turned on, do not use the meter for testing. Call 1-800-803-6025.
Contact
Blocks
Face Up
Full Display
Drop Symbol
Error Message
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