Table of Contents
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Professional Monitoring
Blood Glucose System
(using TRUE METRIX
PRO Test Strips with GDH-FAD Enzyme)
®
Comprehensive Resource Guide
for Healthcare Professionals
(Policies, Processes, and Procedures)
Information in this guide is specific
for healthcare professionals using the
TRUE METRIX
PRO Professional
®
Monitoring Blood Glucose System*
in a multiple-patient clinical setting.
© 2015 Nipro Diagnostics, Inc. TRUE METRIX, TRUEmanager and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics, Inc. MKT0523 Rev. 2
*TRUE METRIX is intended for self-monitoring blood glucose only and not for multiple patient use. Only TRUE METRIX PRO is intended for multiple-patient use.
For assistance please call:
Customer Care 1-800-803-6025
www.niprodiagnostics.com
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Table of Contents
Troubleshooting
Related Manuals for NIPRO Diagnostics True Metrix Pro
Summary of Contents for NIPRO Diagnostics True Metrix Pro
- Page 1 © 2015 Nipro Diagnostics, Inc. TRUE METRIX, TRUEmanager and the Nipro Diagnostics logo are trademarks of Nipro Diagnostics, Inc. MKT0523 Rev. 2 *TRUE METRIX is intended for self-monitoring blood glucose only and not for multiple patient use. Only TRUE METRIX PRO is intended for multiple-patient use.
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Page 2: Table Of Contents
Table of Contents Introduction ........1-5 • Introduction • Intended Use Statement • Safety • System Specifications • CLIA Requirements System Components ......6-11 • System Components • Meter Key Features • Meter Design • Meter Display Screen • Test Strip Design •... -
Page 3: Introduction
Introduction... -
Page 4: Introduction
Introduction The purpose of this document is to provide you with specific manufacturer’s information on using the TRUE METRIX PRO System in a multiple-patient, ® clinical use setting. The information includes manufacturer’s processes and procedures for: • Understanding system intended use, safety information and testing method. -
Page 5: Intended Use Statement
Intended Use Statement The TRUE METRIX PRO Blood Glucose ® Monitoring System is intended for the quantitative determination of glucose in human whole blood taken from the fingertip or forearm (capillary) or from the vein (venous). The system is not to be used for neonates. -
Page 6: Safety
Safety no. 9480-4), rub the entire outside of the meter using Healthcare professionals should adhere to standard 3 circular wiping motions with moderate pressure on precautions and disinfection procedures when the front, back, left side, right side, top and bottom handling or using this device. -
Page 7: System Specifications
System Specifications Meter Specifications Chemical Composition Result Range: 20-600 mg/dL TRUE METRIX PRO Test Strips: Glucose ® dehydrogenase-Flavin adenine dinucleotide Sample Size: Minimum 0.5 microliter (0.5 μL) (GDH-FAD) (Aspergillus sp.), mediators, buffers and stabilizers. Sample Type: Fresh capillary whole blood from the finger or forearm, venous whole blood collected TRUE METRIX Control Solution: Water, d-glucose,... -
Page 8: Clia Requirements
CLIA Requirements Self-testing and point-of-care testing of blood glucose has been classified by the Clinical Laboratory Improvement Amendments (CLIA) as a waived test. CLIA requires all entities that perform even one test, including waived tests, [on materials derived for the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings] to meet... -
Page 9: System Components
System Components... - Page 10 System Components Meter Test Strip Vial Test Strips Control Solution TRUE METRIX PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) System Components 6 ®...
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Page 11: Meter Key Features
Meter Key Features Front of Meter Display Screen Shows test results, messages, user prompts, information Strip Release Button Releases test strip after testing for disposal Test Port Insert TRUE METRIX PRO Test Strip here, ® contact blocks facing up “ ” Button Increase numbers in Meter Set Up;... -
Page 12: Meter Design
Meter Design Alternating time/date for convenient Event Tagging tracking and trending helps identify trends of data associated with blood glucose results Large display and digits for easy legibility High quality bezel for exclusive look; Elegant black scratch resistant soft touch surround material/coating for easy grip of meter Strip Release Button... -
Page 13: Meter Display Screen
Meter Display Screen Full Display Screen Time, Date Time is AM/PM Result is from Memory Result is from 7-, 14-, or 30- Day Average Test Result Event Tag Symbols Units of Measure (factory set; Control Symbol cannot be changed by user) Battery Symbol Ketone Test Alert Symbol... -
Page 14: Test Strip Design
Test Strip Design TRUE METRIX PRO Test Strips – DETECT ® Featuring TRIPLE SENSE TECHNOLOGY ™ Sample Environment • An electrode pair on the test strip detects hematocrit • An internal unit in the meter detects temperature Sample Size • System triggers proper fill detection eliminating errors due to improper sample size Control... -
Page 15: Control Solution
Control Solution/Solución de Control Level/Nivel 1 3 mL Manufactured for/Fabricado para: Fort Lauderdale FL 33309 USA For in vitro diagnostic use only. Store at temperature between 36-86°F (2-30°C). DO NOT FREEZE. R5NPD01 Rev. 3 Control Solution K 7461(50%) Control Solution/Solución de Control 1.953 x 1.109 Level/Nivel 1 3 mL... -
Page 16: Clinical Information
Clinical Information... -
Page 17: Performance Characteristics
Performance Characteristics for Healthcare Professionals Introduction The International Organization for Standardization (ISO) Fingertip Capillary Blood ≥ 75 mg/dL (HCP finger vs. YSI) develops standards in response to an identified need ±5% 122 / 266 = 45.9% in the community that will eventually be suitable for ±10% 220 / 266 = 82.7% implementation on as broad a basis as possible. - Page 18 Performance Characteristics for Healthcare Professionals cont. Precision (Repeatability): The TRUE METRIX PRO System was also tested by ® Precision describes the variation between results. healthcare professionals at a research center. The data Precision results were performed in a laboratory. was compared to parallel results obtained on a Yellow Springs Instrument (YSI).
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Page 19: Limitations Of Use
Limitations of Use • Please read all product Instructions for Use • Alternate site (forearm) testing should not be used carefully before referencing or using this guide. for insulin dose calculations. • Use only TRUE METRIX PRO Blood Glucose Test •... -
Page 20: Interference Testing
Interference Testing Interference testing was performed using the concentrations recommended by Clinical and Laboratory Standards Institute (CLSI) procedure EP7-A2; Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition. Potential interferents were added to whole blood samples at 10 to 50-fold concentrations depending on solubility characteristics. -
Page 21: Meter Setup
Meter Setup & Quality Control Testing... -
Page 22: Meter Setup
Meter Setup Meter Setup is to be used if changes need to be made to the time and date, Event Tags, 1. Press and hold “•” Button until the full display is Ketone Test Alert, or if settings need to be shown and a tone sounds (around 10 seconds). - Page 23 Meter Setup cont. Set Event Tags, Ketone Alert and When a Ketone Test Alert is shown in Test Reminders the meter display, it does not mean that ketones have been detected Meter comes with Event Tags, Ketone Test in the patient’s blood. Perform a Alert and all Test Reminders turned off.
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Page 24: Quality Control Testing
Quality Control Testing Quality Control Testing is used to detect errors that may occur due to test system errors, product defects, adverse environmental conditions and variance in operator performance. Ongoing Quality Control Testing is also used to detect any performance issues of the system over time. - Page 25 Quality Control Testing cont. Automatic Self-Test Control Test An Automatic Self-Test is performed Use ONLY TRUE METRIX Control ® by the meter each time a test strip is Solution to check the performance inserted correctly into the Test Port. of the system. It is important to perform Control Tests with more than one level of control solution Insert a test strip into Test Port.
- Page 26 Quality Control Testing cont. How to Perform a Control Test 6. Wait until Drop Symbol appears in Use the Quality Control Record Form located Display. Keep test strip in meter until in the Appendix D, or the form provided by your testing is finished.
- Page 27 Quality Control Testing cont. 11. Compare result to Control Test range printed on test strip vial label for level of control solution you are using. If result is in range, system can be used for testing blood. If result does not fall Control Bottle within range, repeat test using a new test strip.
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Page 28: Quality Control Testing Data Form
Quality Control Testing Data Form (located in Appendix) TRUE METRIX PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Quality Control Testing Data Form 22 ®... -
Page 29: Blood Glucose Testing
Blood Glucose Testing... - Page 30 Blood Glucose Testing Type of Blood Sample Information Fresh, capillary whole blood from the fingertip or forearm is the recommended sample to be used for testing blood glucose. Capillary forearm sampling must not be used when the blood glucose levels are rapidly changing (see Obtaining a Capillary Forearm Blood Sample below).
- Page 31 Blood Glucose Testing cont. 2. Check dates on test strip vial 7. With test strip still in meter, touch Sample being used. Do not use test Tip of test strip to top of blood drop from strips 4 months past written sample obtained in Step 1 and allow blood opened date or after date printed to be drawn into test strip.
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Page 32: Diabetes Data Management Capabilities
Diabetes Data Management Capabilities... -
Page 33: Memory
Memory View Results Note: The use of Memory features (Averages, test results) may not be suitable for Memory stores 500 results. When the Memory is full, the multiple-patient use of the system. oldest result is replaced with the newest result. Check with the facility procedures/ policy before use. -
Page 34: Diabetes Management Software
Diabetes Management Software TRUEmanager Diabetes ® Management Software TRUEmanager Diabetes Management Software ® TRUEmanager Diabetes Management Software (DMS) ® provides an easy way for patients with diabetes and is a stand-alone software program for a single user or healthcare providers to understand and manage blood multiple user/multiple patient setting. - Page 35 Diabetes Management Software cont. TRUEmanager Diabetes Management Software lets HL7 Interface Overview ® you establish and maintain valuable testing records that • The HL7 interoperability module is installed after include demographics, health insurance information, TRUEmanager PRO Diabetes Management Software ® medications, testing regimen recommendations, and and provides the ability to send information stored in the results history.
- Page 36 Diabetes Management Software cont. Server • IBM Compatible PC with one of the following operating systems installed: - Windows 2003 Server (Service Pack 2 or later) - Windows 2008 Server (Service Pack 2 or later) • Pentium 4 Processor minimum 2GHz or faster (unless using a multi-core processor) •...
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Page 37: System Maintenance
System Maintenance... -
Page 38: Troubleshooting
Troubleshooting Troubleshooting 2. After applying the sample to the test strip, test does not start/meter does not begin testing. The following is a brief guide for Troubleshooting the most common errors when using TRUE METRIX PRO. ® Sample drop too small. If any problems arise that cannot be resolved by using the guide or the Display Messages, please call for - Repeat test with a new test strip and a larger... -
Page 39: Troubleshooting Display Messages
Troubleshooting Display Messages Display Messages Display Reason Action Repeat with new test strip, using capillary whole blood from the finger or forearm or venous whole blood collected with Invalid Hematocrit sodium heparin blood collection tube. If error persists, call for assistance. -
Page 40: Battery Replacement
Battery Replacement Battery Replacement A low battery displays Battery Symbol while continuing to function. A dead battery displays Battery Symbol, beeps, and then turns off. To replace battery: 1. Lift tab on Battery Door. 2. Turn meter over, while holding meter in one hand with Battery Door facing down, tap gently on the palm of your other hand to loosen and remove battery. -
Page 41: Cleaning And Disinfection
Cleaning and Disinfection Using fresh wipes, make sure that If system is to be used on multiple all outside surfaces of the meter patients, cleaning and disinfection of the remain wet for 2 minutes. meter should be done between patients. NEVER put meter in liquids or allow any liquids to enter the test port. -
Page 42: System Storage
System Storage TRUE METRIX PRO System TRUE METRIX Control Solution ® ® • Store the system (meter, control solution, • Write the date first opened on control test strips) in carrying case to protect from solution bottle label. Discard if either 3 liquids, dust and dirt. -
Page 43: Training Program
Training Program... - Page 44 Fort Lauderdale, FL 33309 and competent in each test they will perform before reporting patient results. In addition, training should Nipro Diagnostics, Inc. will return a Trainer’s Certificate include aspects of safety (including Infection Control upon satisfactory completion of the Post Test (100% Policies) and Quality Control.
- Page 45 Training Program cont. TRUE METRIX PRO Blood Glucose System ® Training Program Information During the training of facility personnel on the The training program provided in this section of this TRUE METRIX PRO Blood Glucose Monitoring System, ® Resource Guide is recommended to supplement we also recommend including a review of the following already established facility policies and procedures.
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Page 46: System Maintenance
Training Program cont. Product Training Agenda (example) Training Topic Estimated Time Source of Information to Complete Purpose of Training Overview 5 minutes Technical Overview located in Appendix E of this Resource Guide Overview of System 5-10 minutes Technical Overview located in Appendix E of this Resource Guide and Components the System Components section of this Resource Guide Performing Quality Control Testing... -
Page 47: Training Checklist
Training Checklist TRUE METRIX PRO Blood Glucose System Training Checklist (Please print) ® Name ______________________________________________________ Date ____/____/____ Title __________________________________________________________________________ Facility _______________________________________________________________________ 1. The Facility Personnel has completed the following: ____ Read the Owner’s Booklet ____ Read the Test Strip Instructions for Use ____ Read the Control Solution Instructions for Use ____ Read the sections in the Comprehensive Resource Guide located prior to the Training Program section... - Page 48 Training Checklist cont. Name ___________________________________________________ 4. Quality Control Tests ____ Understands manufacturer’s instructions for quality control testing ____ Understands the purpose of the automatic self-check of the meter upon insertion of test strip into Test Port ____ Understands the purpose of control tests, the frequency of testing, and the number of control solution levels to be tested ____ Understands the testing temperature range and what may result if testing temperature is out of range...
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Page 49: Training Post Test
Training Post Test TRUE METRIX PRO Blood Glucose System Training Written Test (Please print) ® Name __________________________________________________ Date _____/_____/_____ Title _______________________________________________________________________ Facility Name _______________________________________________________________ Address____________________________________________________________________ Phone/Fax _________________________________________________________________ True or False 1. It is recommended that healthcare personnel complete the training program prior to using the TRUE METRIX PRO Blood Glucose Monitoring System for the first time in a facility. - Page 50 Training Post Test cont. TRUE METRIX PRO Blood Glucose System Training Written Test (Please print) ® Name __________________________________________________ Multiple Choice (choose only one answer for each question) 1. Training on the use of the TRUE METRIX PRO System consists of reviewing the following: ®...
- Page 51 Training Post Test cont. TRUE METRIX PRO Blood Glucose System Certified Training Written Test (Please print) ® Name __________________________________________________ 6. The Control solution use by date (expiration date) is: a) One week after opening b) 120 days after opening c) 3 months after opening d) The date pre-printed on the bottle next to the EXP e) c and d 7.
- Page 52 Training Post Test Answer Key TRUE METRIX PRO Blood Glucose System Training Written Test Answer Key ® True or False Q 1. True Q 2. False Q 3. True Q 4. False Q 5. False Q 6. True Q 7. False Multiple Choice Q 1.
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Page 53: References
References... - Page 54 References 1. FDA Public Health Notification: Use of Fingerstick CLSI POCT12-A3 Point of Care blood glucose Devices on More than One Person Poses Risk testing in acute and chronic care facilities; for Transmitting Blood Borne Pathogens: Initial Approved Guideline – Third Edition, Communication Update 11/29/2010 [Electronic January 2013.
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Page 55: Appendix A Clinical Studies
Appendix A Clinical Studies Note: Available for download at www.niprodiagnostics.com... -
Page 56: Appendix B Product Labeling
Appendix B Product Labeling Note: Your Distributor will provide copies of product labeling. (Owner’s Booklet, Test Strip Instructions for Use and Control Solution Instructions for Use) -
Page 57: Appendix C Safety Data Sheets
Appendix C Safety Data Sheets... - Page 58 Test Strip – Safety Data Sheet Other Protective Equipment/Clothing: None Section 1: Product Information Product Name: TRUE METRIX PRO Blood Glucose ® Section 9: Physical Data Test Strips Appearance and odor: Vial - vial with desiccant liner, Section 2: Composition / Information on Ingredients test strips - Plastic strip with reaction area.
- Page 59 Control Solution – Safety Data Sheet Section 9 : Physical Data Section 1: Product Information Appearance and odor: Bottle - plastic bottle with cap, Product Name: TRUE METRIX Control Solution – ® control solution - Red liquid. Levels 1, 2, and 3 pH: N/A Section 2: Composition / Information on Ingredients Specific Gravity: N/A...
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Page 60: Appendix D Forms
Appendix D Forms... - Page 61 Quality Control Testing Data Form TRUE METRIX PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Quality Control Testing Data Form ®...
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Page 62: Appendix E Proficiency Testing Information
Appendix E Proficiency Testing Information... - Page 63 Proficiency Testing Information TRUE METRIX PRO Professional Blood ® Glucose Monitoring System Proficiency Testing Information Resources to learn about and obtain proficiency samples: The objective of proficiency testing is to qualitatively determine the skill of the user of a specific product •...