McKesson TRUE METRIX PRO Instruction Manual

INTRODUCTION: McKesson TRUE METRIX® PRO
Professional Monitoring Blood Glucose Meter
McKesson TRUE METRIX® PRO is a simple, accurate way to test whole blood glucose (sugar) level, anytime, anywhere. Our goal is to provide quality healthcare products and dedicated customer service. For questions about McKesson TRUE METRIX® PRO products, call 1-800-777-4908.
McKesson recognizes the importance of practicing safe and reliable testing using the McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Meter. Each patient should have specic blood glucose target ranges that are determined by their Doctor or Diabetes Healthcare Professional. Having most blood glucose results within the patient’s target range shows how well a treatment plan is working to control glucose levels. Keeping results within the patient’s target range helps slow or stop complications from diabetes.
e McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Test Strips are for use with the McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the ngertip or forearm, or venous whole blood collected only in sodium heparin vacutainer tubes. e McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Meter measures current glucose results. It also detects, analyzes and corrects for hematocrit and temperature, and calculates the glucose result.
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IMPORTANT SAFETY INFORMATION:
For the most accurate results using McKesson TRUE METRIX® PRO:
• Read all product instructions for use before testing.
• Use of McKesson TRUE METRIX® PRO in a manner not specied in this Owner's Manual is not recommended and may aect ability to determine true blood glucose levels.
• McKesson TRUE METRIX® PRO is an in vitro (outside the body) quantitative system for multiple patient use testing of human whole blood only.
• Do not use for the diagnosis of or screening for diabetes mellitus or for measuring blood glucose in newborns.
• ONLY use auto-disabling single use lancing devices/ lancets to obtain capillary blood sample.
• 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.
• DO NOT use venous whole blood collected in sodium uoride (grey top), lithium heparin, or EDTA vacutainer tubes for testing, as this may cause inaccurate results.
• Use ONLY McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Test Strips and McKesson TRUE METRIX® Control Solution with the McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Meter.
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• 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 sample 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.
• Perform Control Tests with more than one level of control solution. ree levels of McKesson TRUE METRIX® Control Solution are available for Control Tests. Call 1-800-803-6025 for assistance in obtaining dierent levels of control solution.
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IMPORTANT INFORMATION (cont.): WARNING!
Healthcare Professionals should adhere to standard precautions and disinfection procedures when handling or using this device for testing. ALL parts of the McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Meter are considered potentially infectious, and capable of transmitting blood-borne pathogens between patients and healthcare professionals.
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Only use auto­disabling, single-use lancing devices/lancets to obtain capillary blood. For more information on standard precautions and practices please refer to http://www.cdc. gov/hicpac/ 2007ip/2007isolationprecautions.html.
• Multiple patient use devices such as blood glucose meters should be used on only one patient and not shared. If dedicating blood glucose meters to a single patient is not possible, the meters must be properly cleaned and disinfected aer every use following the guidelines found in Meter Care, Cleaning/Disinfecting.
• Healthcare Professionals should wear gloves when cleaning and disinfecting the meter. Wash hands aer taking o gloves. A new pair of gloves should be worn before testing each patient.
IMPORTANT INFORMATION (cont.):
• If the patient is showing symptoms of low or high blood glucose, check their blood glucose. If any result seems higher or lower than expected, repeat the test with a new test strip. Contact the Doctor or Diabetes Healthcare Professional with any unusual results.
~ Low blood glucose (hypoglycemia) symptoms may
include trembling, sweating, intense hunger, nervousness, weakness or trouble speaking.
~ High blood glucose (hyperglycemia) symptoms may
include intense
thirst, a need to urinate oen, a dry
mouth, vomiting, or headache.
is device has not been validated for use in the
critically ill.
• 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.
• Follow facility protocols to verify blood glucose results with laboratory results for patients who are unresponsive or unable to com municate.
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Phone Number and Expected Results ................................................... Cover
Introduction and Important Information ..................................................1
Description of System
Meter ..............................................................................................................7
Test Strips ....................................................................................................10
Control Solution .........................................................................................12
Quality Control Testing
Automatic Self-Test ....................................................................................13
Control Test .................................................................................................14
How to Test Control ...................................................................................15
Blood Glucose Testing
Obtaining a Blood Sample .........................................................................19
How to Test Blood ......................................................................................22
TRUE METRIX® PRO Meter and Laboratory Testing ...........................25
System Out of Range Warning Messages .................................................26
Meter Set Up
Set Time and Date .......................................................................................27
Set Event Tags, Ketone Test Alert and Test Reminders ..........................29
Meter Memory
View Averages (7-, 14-, and 30-day) .........................................................33
View Memory ...............................................................................................34
Care, Cleaning/Disinfecting and Troubleshooting
Caring for TRUE METRIX® PRO .............................................................35
Changing Battery ........................................................................................39
Troubleshooting ...............................................................................................40
Display Messages ........................................................................................41
System Specifications/Chemical Composition ............................................44
Warranty ...........................................................................................................45
References .........................................................................................................46
Notes .................................................................................................................47
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Description of 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, and turn on Event Tags in Meter Memory.
“ ◀ ” Button Decrease numbers in Meter Set Up; remove ALT
Symbol; move backward by date/time when viewing results and Averages in Memory; turn on Event Tags in Meter Set Up.
Top of Meter
1 32
Display Screen
Shows results, messages, user prompts, information.
Test Port Insert 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.
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1
Front of Meter
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5
Back of Meter
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9
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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2
1
7
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5
8
9
10
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Contact End -
Insert into Test Port with contact
blocks facing up
.
Sample Tip -
Touch Tip to top of drop of sample (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 Sample Tip aer testing begins.
• Do not apply blood or control 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 identification
when calling for assistance.
Expiration Dates (EXP) - Write date first opened
on vial label. Discard vial and unused test strips 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.
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Test Strip Vial Label
1
2
2
3
May 30, 2015
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Control Bottle Label
Lot Number (LOT) - Used for identification
when calling for assistance.
Expiration Dates (EXP) - Write date first opened
on bottle label. Discard bottle 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. Call 1-800-803-6025 for assistance in obtaining dierent levels of control solution.
• For use only with McKesson TRUE METRIX ® and TRUE METRIX
®
PRO Blood Glucose Test Strips
• Not intended for human consumption
• For in vitro diagnostic use only Store at temperature range of 36-86°F (2-30°C).
DO NOT FREEZE.
Distributed By McKesson Medical-Surgical Inc. Richmond, VA 23228 Rev. 00 03/15 Made in USA R5SUN01 rev 1
Control Solu tion LEV EL 1
MFR # 06-R5051-1
NET CONTENTS
3 mL
LOT
8LOA18
EXP
2015/10/31
1
2
3
May 30, 2015
Control Solution (Control)
Contact Blocks
Face Up
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Quality Control Testing
To assure accurate and reliable results, McKesson TRUE METRIX® PRO oers two kinds of Quality Control Tests. ese tests ensure that McKesson TRUE METRIX® PRO is working properly and 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 for assistance (see Booklet cover for phone number).
Caution! If any segments are missing in the Display
when meter is first turned on, do not use the meter for testing. Call for assistance.
Full Display
Drop Symbol
Error Message
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Control Test
We recommend performing Control Tests to check the performance of the system.
Control Tests should be performed:
• Before using the System for the rst time,
• For practice to ensure testing technique is good,
• When opening a new vial of test strips,
• If results seem unusually high or low, based on patient's condition,
• If a vial has been le opened or exposed to extreme heat or cold, or humidity,
• Whenever a check on the performance of the system is needed,
• If meter damage is suspected (meter was dropped, crushed, wet, etc.)
Note: It is important to perform Control Tests with more
than one level of control solution. ree levels of McKesson TRUE METRIX® Control Solution are available for Control Tests. Call 1-800-803-6025 for assistance in obtaining dierent levels of control solution.
Caution! Ranges printed on test strip vial label are for
Control Test results only and are not to be used for management of patient’s blood glucose. Do not drink control solution.
How to Test Control Solution
Use ONLY McKesson TRUE METRIX® Control Solution with the McKesson TRUE METRIX® PRO Professional Monitoring Blood Glucose Meter and Test Strips.
1. Check dates on control solution label
and test strip vial label. Do not use control solution or test strips if Expiration Dates have passed. (Control solution - 3 months aer rst opening or date next to EXP on label; test strips - 4 months aer rst opening or date next to EXP on labels.) Discard expired products and use new products.
2. Allow control solution, vial of test strips and
meter to adjust to room temperature. Write date first opened on both control solution bottle label and test strip vial label.
3. Gently swirl or invert control solution bottle to mix. DO NOT SHAKE!
4. Remove one test strip from vial. Close strip vial immediately. Use test strip quickly aer removal from vial.
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