NIPRO Diagnostics True Metrix Pro User Manual

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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

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

• Control Solution

Clinical Information .........................12-15

• Performance Characteristics

• Limitations of Use

• Interference Testing

Meter Setup &

Quality Control Testing ....................16-22

• Meter Setup

• Quality Control Testing

• Quality Control Testing Data Form

Blood Glucose Testing .....................23-24

• Blood Glucose Testing

Diabetes Data Management

Capabilities ......................................25-28

• Memory

• Diabetes Management Software

System Maintenance ........................29-33

• Troubleshooting

• Troubleshooting Display Messages

• Battery Replacement

• Cleaning and Disinfection

• System Storage

Training Program .............................34-42

• Training Program

• Training Checklist

• Training Post Test

References ............................................43

Appendix

• Appendix A – Clinical Studies

• Appendix B – Product Labeling

• Appendix C – Safety Data Sheets

• Appendix D – Forms

• Appendix E – Proficiency Testing Information

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Table of Contents

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Introduction

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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.

• Reviewing System components and key design features.

• Examining clinical white papers on proven product performance.

• Reviewing limitations of use including physiological and pharmacological interfering substances.

• Performing the blood glucose testing process using various specimens.

• Reviewing processes for Quality Control Testing, product maintenance, system operating temperature and storage ranges.

• Selecting diabetes data management options for data retrieval and management.

• Training program for your staff focused on safe use of the product in a clinical setting.

Most clinical sites already have clearly deﬁned policies and procedures that address bedside blood glucose testing, safety, quality control, clinical evaluations and other processes. This document is intended to be an adjunct to already established policies and procedures within a facility and not as a replacement for the policies and procedures.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Introduction 1

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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. The system is intended

for multiple-patient use in professional

healthcare settings.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Intended Use Statement 2

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Safety

Healthcare professionals should adhere to standard precautions and disinfection procedures when handling or using this device. ALL parts of the TRUE METRIX® PRO Blood Glucose Monitoring System are considered potentially infectious and capable of transmitting blood-borne pathogens. Only use auto-disabling, single-use lancing devices with this product.

• NEVER re-use test strips. NEVER wipe test strips with water, alcohol, or any cleaner.

• DO NOT attempt to remove blood or control solution 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 the test strip. Adding more sample gives an error message.

A point-of-care blood testing device, such as a blood glucose meter, should be used only on one patient and not shared. If dedicating one blood glucose meter to a single patient is not possible, the meter must be properly cleaned and disinfected after every use following the guidelines found in System Maintenance and Cleaning and Disinfection sections of this Resource Guide.

Clean and disinfect the meter after each use to prevent the transmission of blood-borne pathogens. Healthcare professionals should wear gloves when cleaning and disinfecting the meter. Wash hands after taking off gloves. Contact with blood presents a potential infection risk. A new pair of gloves should be worn before testing each patient.

Note: Clean to remove blood or soil from the surface of

your meter and disinfect. Disinfecting removes most but not all possible infectious agents (bacteria or virus) from the meter, including blood-borne pathogens.

1,2

To Clean and Disinfect the Meter

1. Wash hands thoroughly with soap and water. Wear a clean pair of gloves.

2. Make sure meter is off and a test strip is not inserted. With ONLY PDI Super Sani Cloth Wipes (or any disinfectant product with EPA* reg.

no. 9480-4), rub the entire outside of the meter using 3 circular wiping motions with moderate pressure on the front, back, left side, right side, top and bottom of the meter. Repeat as needed until all surfaces are visibly clean. Discard used wipes. (*Environmental Protection Agency.)

3. Using fresh wipes, make sure that all outside surfaces of the meter remain wet for 2 minutes. Make sure no liquids to enter the Test Port or any other opening in the meter.

Super Sani-Cloths may be purchased at the following places:

• Amazon.com

• Ofﬁcedepot.com or visit your local Ofﬁce Depot

store for other options

• Walmart.com

4. Let meter air dry thoroughly before using to test.

5. Verify that the system is working properly by performing an Automatic Self-Test.

Note: Other disinfectants have not been tested. The

effect of other disinfectants used interchangeably has not been tested with the meter. Use of disinfectants other than Super Sani Cloth Wipes may damage meter.

Note: Super Sani Cloth Wipes have been tested on

the meter for a total of 10,950 cleaning and disinfecting cycles, which is equal to cleaning and disinfecting the meter 10 times per day for a 3 year period. The use life of the meter is 3

years.

EMC Safety Information

This meter meets the electromagnetic immunity requirements as per ISO 15197 Annex A3. It meets the electromagnetic emissions requirements as per EN 61326 series. Interference from the meter to other electronically driven equipment is not anticipated. The electromagnetic environment should be evaluated prior to operation of the device.

Do not use the meter in a very dry environment, especially one in which synthetic materials are present. Do not use the meter close to sources of strong electromagnetic radiation, as these may interfere with the proper operation.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Safety 3

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System Speciﬁcations

Meter Speciﬁcations

Result Range: 20-600 mg/dL

Sample Size: Minimum 0.5 microliter (0.5 μL)

Sample Type: Fresh capillary whole blood from the

ﬁnger or forearm, venous whole blood collected in sodium heparin blood collection tubes only, or control solution

Test Time: Results in as little as 4 seconds

Result Value: Plasma equivalent values

Assay Method: Amperometric

Reference Method: Yellow Springs Instrument

Glucose oxidase reagent

Power Supply: One 3V lithium battery #CR2032 (non-rechargeable).

Battery Life: Approximately 1,000 tests or 1 year

Automatic Shut-Off: After two minutes of non-use

Weight: 1.66 ounces

Chemical Composition

TRUE METRIX® PRO Test Strips: Glucose

dehydrogenase-Flavin adenine dinucleotide (GDH-FAD) (Aspergillus sp.), mediators, buffers and stabilizers.

TRUE METRIX® Control Solution: Water, d-glucose, buffers, viscosity enhancing agent, salts, dye and preservatives.

Note: Material Safety Data Sheets can be found in

the Appendix.

Size: 3.44" x 2.16" x 0.69"

Memory Size: 500 glucose and control results

Operating Conditions

System Operating Range (meter & test strips):

Relative Humidity: 10-90% (Non-condensing)

Temperature: 41°F-104°F

Hematocrit: 20-70%

Altitude: Up to and including 10,200 feet

Note: Use within speciﬁed environmental

conditions only.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) System Speciﬁcations 4

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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 certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

Waived laboratories must meet the following requirements:

• Complete the Clinical Laboratory Improvement

Amendments of 1988 (CLIA) Application for Certiﬁcation. Form CMS-116. The form and instructions on completing and mailing the form are found on http://www.cms.hhs.gov/CLIA/06 How_to_Apply_for_a_CLIA_Certiﬁcate_Including_ Foreign_Laboratories.asp#TopOfPage.

• Pay applicable certiﬁcate fees biennially.

• Follow manufacturer’s test instructions, including

instructions for Quality Control, maintenance, and storage instructions.

Upon approval of Form CMS-116, a Certiﬁcate of Waiver is forwarded to the laboratory.

For more information on the CLIA program, see http://www.cms.hhs.gov/CLIA/.

For a comprehensive look at waived testing, see http://www.cdc.gov/mmwr/preview/mmwrhtml/ rr541a1.htm.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) CLIA Requirements 5

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System Components

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System Components

Meter

Test Strips

Test Strip Vial

Control Solution

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) System Components 6

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Front of Meter

Top of Meter

Meter Key Features

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; 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); turn on Event Tags, Ketone Test Alert and Test Reminders during Meter Set Up

Back of Meter

“ • ” 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

Battery Door

Use one non-rechargeable 3V lithium battery (#CR2032), positive (“+”) side up

Meter Label

Contains serial number of meter

Data Contacts

Connects meter with computer via docking station for data upload

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Meter Key Features 7

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Event Tagging

helps identify trends associated with blood glucose results

High quality bezel

for exclusive look; scratch resistant

Strip Release Button

safely releases test strip without user coming in contact with contaminated test strip

Meter Design

Alternating time/date

for convenient tracking and trending of data

Large display

and digits for easy legibility

Elegant black

soft touch surround material/coating for easy grip of meter

Test strip guide

for easy test strip insertion

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Meter Design 8

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Result is from Memory

Meter Display Screen

Full Display Screen

Time, Date

Time is AM/PM

Result is from

7-, 14-, or 30-

Day Average

Test Result

Control Symbol

Battery Symbol

Alternate Site (ALT)

Symbol

Drop Symbol – Apply blood or

Event Tag Symbols

Units of Measure

(factory set;

cannot be

changed by user)

Ketone Test Alert

Symbol

Test Reminder

Symbol

Temperature Symbol

control solution

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Meter Display Screen 9

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Test Strip Design

TRUE METRIX® PRO Test Strips – Featuring TRIPLE SENSE TECHNOLOGY

No Coding Technology eliminates the need for coding of the meter.

• Code is assigned during manufacturing process

• Code is printed onto contacts on end of test strip

• Meter reads code on insertion

Advanced technologies – the meter, a complex algorithm, chemistry and electrodes – on the test strip work together as part of the TRUE METRIX® PRO system to produce accurate results.

Featuring TRIPLE SENSE TECHNOLOGY™, the system provides proven accuracy and conﬁdence in results.

™

DETECT

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

• Detects control solution and automatically identiﬁes results in memory for accurate data trending

ANALYZE

Environmental and Physiological Factors

• Every system analyzes the testing environment for hematocrit and temperature, which could impact or inﬂuence the accuracy of results

• Testing outside of speciﬁed operating temperature range is marked by an error code – eliminating incorrect results

CORRECT

Hematocrit/Temperature Variables

• Employs a Proprietary Dynamic Adaptive Algorithm, which incorporates:

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Test Strip Design 10

– Active hematocrit correction

– Temperature compensation

• Combined, this algorithm corrects results based on the testing environment

• Ensures proven accuracy and conﬁdence in results

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Control Solution

Control Solution/Solución de Control

Level/Nivel 1 3 mL

Manufactured for/Fabricado para:

Control Solution/Solución de Control

Level/Nivel 1 3 mL

K 7461(50%)

1.953 x 1.109

R5NPD01 Rev. 3

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.

Control Solution/Solución de Control

Level/Nivel 2 3 mL

Manufactured for/Fabricado para:

No coating areaNo coating areaNo coating area

K 729(50)%

1.953 x 1.109

Control Solution/Solución de Control

Level/Nivel 1 3 mL

K 7461(50%)

1.953 x 1.109

R5NPD01 Rev. 3

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.

Control Solution/Solución de Control

Level/Nivel 2 3 mL

R5NPD02 Rev. 3

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.

Control Solution/Solución de Control

Level/Nivel 3 3 mL

Manufactured for/Fabricado para:

No coating areaNo coating areaNo coating area

What Is Control Solution?

Control solution is a red liquid containing a known amount of glucose.

Test Principle:

Use control solution instead of blood to make sure your system is working.

Storage and Handling:

Control solution must be stored upright, tightly sealed, at 36°F-86°F, room temperature.

DO NOT REFRIGERATE OR FREEZE

3 Levels of Control Solution

Control Test

Use ONLY TRUE METRIX® Control Solution to check the performance of the system. It is important to perform control tests with more than one level of control solution to assure that the system is working properly and testing technique is good. Three levels of TRUE METRIX® Control Solution (Levels 1-3) are available. Call 1-800-803-6025 for assistance in obtaining different levels of control solution.

Control Test(s) should be performed:

• Before using the system for the ﬁrst time.

• For practice to ensure that testing technique is good.

• When opening a new vial of test strips.

• If results seem unusually high or low based on the patient’s condition.

• If test strip vial has been left open or exposed to extreme heat, cold or humidity.

• Use ONLY TRUE METRIX® Control Solution to

perform Control Tests.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Control Solution 11

• Whenever a check on the performance of the system is needed.

• If meter damage is suspected (meter was dropped, crushed, wet, etc.).

Ranges printed on the 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.

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Clinical Information

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Introduction

Performance Characteristics4 for Healthcare Professionals

The International Organization for Standardization (ISO) develops standards in response to an identiﬁed need in the community that will eventually be suitable for implementation on as broad a basis as possible. ISO developed the standard for blood glucose monitoring performance – 15197:2003 – based on a consensus of professionals around the world.3 It is recognized as the standard in many countries.

Standard Reference Results ISO Bias Limit Criteria for Accuracy

Less than 75 mg/dL

Greater than or equal to 75 mg/dL

± 15 mg/dL from laboratory

reference result

± 20% from laboratory

reference result

95% of all results

Clinical data obtained by healthcare professionals on the TRUE METRIX® PRO Blood Glucose Monitoring System exceeded the minimum accuracy criteria for ISO 15197:2003.

Accuracy: TRUE METRIX® PRO accuracy was assessed against the Yellow Springs Instrument. Studies were conducted at 3 clinical sites by healthcare professionals;

100% of healthcare professionals (HCP) TRUE METRIX® PRO ﬁngertip values fell within 15 mg/dL of the YSI results at glucose level <75 mg/dL and within 20% at glucose levels ≥ 75 mg/dL.

Fingertip Capillary Blood ≥ 75 mg/dL (HCP ﬁnger vs. YSI)

±5% 122 / 266 = 45.9%

±10% 220 / 266 = 82.7%

±15% 260 / 266 = 97.7%

±20% 266 / 266 = 100%

100% of TRUE METRIX® PRO forearm values fell within 15 mg/dL of the YSI results at glucose levels <75 mg/dL and within 20% at glucose levels ≥ 75 mg/dL

Forearm Capillary Blood < 75 mg/dL

(HCP forearm vs. HCP ﬁnger)

±5 mg/dL 2/4 = 50%

±10 mg/dL 3/4 = 75%

±15 mg/dL 4/4 = 100%

Forearm Capillary Blood ≥ 75 mg/dL

(HCP forearm vs. HCP ﬁnger)

±5% 24/96 = 25%

±10% 58/96 = 60.4%

±15% 88/96 = 91.7%

±20% 96/96 = 100%

Fingertip Capillary Blood < 75 mg/dL (HCP ﬁnger vs. YSI)

±5 mg/dL 26/34 = 76.5%

±10 mg/dL 32/34 = 94.1%

±15 mg/dL 34/34 = 100%

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Performance Characteristics 12

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Performance Characteristics4 for Healthcare Professionals cont.

The TRUE METRIX® PRO System was also tested by healthcare professionals at a research center. The data was compared to parallel results obtained on a Yellow Springs Instrument (YSI). The table below shows how often TRUE METRIX® PRO Blood Glucose System venous values obtained by healthcare professionals achieve the accuracy goals.

Venous samples drawn into sodium heparin anticoagulant tubes.

Venous Blood < 75 mg/dL

Within ±5 mg/dL 5/6 = 83.3%

Within ±10 mg/dL 6/6 = 100%

Within ±15 mg/dL 6/6 = 100%

Venous Blood ≥ 75 mg/dL

Within ±5% 20/106 = 18.9%

Within ±10% 60/106 = 56.6%

Within ±15% 101/106 = 95.3%

Within ± 20% 106/106 = 100%

Precision (Repeatability): Precision describes the variation between results. Precision results were performed in a laboratory.

Blood (Within Lot): N=100

Mean (mg/dL) 44 89 150 199 329

SD (mg/dL) 1.8 3.6 4.9 7.3 9.6

CV% 4.1 4.0 3.3 3.7 2.9

Control Solution: N=100

Mean (mg/dL) 33 105 306

SD (mg/dL) 1.6 3.8 10.3

CV% 4.8 3.6 3.4

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Performance Characteristics 13

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Limitations of Use

• Please read all product Instructions for Use carefully before referencing or using this guide.

• Use only TRUE METRIX® PRO Blood Glucose Test Strips and TRUE METRIX® Control Solution with the TRUE METRIX® PRO Meter.

• Do not leave test strips or control solution where the storage temperature printed on vial label may be exceeded.

• Perform control tests before performing a blood glucose test for the ﬁrst time (See the Quality Control Testing section of this Resource Guide).

• Perform control tests with more than one level of control solution. Three levels of TRUE METRIX® Control Solution are available for control tests. Contact place of purchase or call for assistance to obtain control procedure/policy.

• TRUE METRIX® PRO is an in vitro (outside the body) quantitative system that is used for multiplepatient use testing of human whole blood only.

• The most accurate results are obtained using fresh, capillary whole blood from the ﬁngertip or forearm. Venous whole blood drawn using only sodium heparin tubes may be used. Mix well before use.

• Do not use venous whole blood collected in sodium ﬂuoride (grey top) vacutainer tubes for testing, as this may cause false low results.

• Capillary blood from the forearm may be used. Check with the doctor or healthcare professional to see if forearm testing may be used for glucose testing on the patient. Results from the forearm are not always the same as results from the ﬁngertip. Use ﬁngertip instead of forearm:

- Within 2 hours of eating, exercise, or taking insulin;

- If the patient’s blood glucose may be rising or falling rapidly or their results often ﬂuctuate;

- If the patient is ill or under stress;

- If the glucose result may be low or high;

- If symptoms of low or high glucose levels are not evident.

• Alternate site (forearm) testing should not be used to calibrate continuous glucose monitors (CGMs).

• Alternate site (forearm) testing should not be used for insulin dose calculations.

• Do not use for the diagnosis of or screening for diabetes mellitus or for measuring blood glucose in newborns.

• When comparing results between TRUE METRIX® PRO and a laboratory system, TRUE METRIX® PRO blood tests should be performed within 30 minutes of laboratory test. If a patient has recently eaten, ﬁngerstick results from the TRUE METRIX® PRO System can be up to 70 mg/dL higher than venous laboratory results.5 Diabetes experts have suggested that glucose meters should agree within 15 mg/dL of a laboratory system when the glucose concentration is less than 75 mg/dL, and within 20% of a laboratory system when the glucose concentration is 75 mg/dL or higher.

• The device has not been validated for use in the critically ill. Capillary blood glucose levels in critically ill patients with reduced peripheral blood ﬂow may not reﬂect the true physiological state. Reduced peripheral blood ﬂow may result from the following conditions (for example):

- shock,

- severe hypotension,

- severe dehydration,

- hyperglycemia with hyperosmolarity, with or without ketosis.

• Testing at altitudes up to and including 10,200 feet will not affect accurate results.

• Hematocrit levels between 20% and 70% will not affect accurate results.

• Do not use the TRUE METRIX® PRO System during a xylose absorption test. This may falsely raise glucose results. Please check with patients doctor before using the TRUE METRIX® PRO System.

• Do not use the TRUE METRIX® PRO System if

blood concentrations of ascorbic acid are > 2 mg/dL

• Do not use the TRUE METRIX® PRO System if blood

concentrations of uric acid > 5 mg/dL

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Limitations of Use 14

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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.8 Potential interferents were added to whole blood samples at 10 to 50-fold concentrations depending on solubility characteristics. Where no recommendation was given, the potential interferents were added at concentrations higher than normal or therapeutic ranges. Blood samples containing each of the potential interferents were tested concurrently with control blood samples containing no added potential interferents. All blood samples originated from normal healthy donors. The highlighted interferents below are listed as interferents in the Owner’s Booklet and Test Strip Instructions For Use.

Potential Interferent Normal/Therapeutic

Concentrations

Acetaminophen 2.0 mg/dL 30 mg/dL -------

Acetone 2.0 mg/dL 20 mg/dL -------

Ascorbic Acid 1.5 mg/dL 6.0 mg/dL 2 mg/dL

Bilirubin 1.0 mg/dL 15 mg/dL -------

Caffeine 1.25 mg/dL 6.0 mg/dL -------

Cholesterol 150 mg/dL 250 mg/dL -------

Creatinine 1.5 mg/dL 5.0 mg/dL -------

Dopamine 0.03 mg/dL 0.1 mg/dL -------

EDTA 0.1 mg/dL 360 mg/dL -------

Ethanol 150 mg/dL 400 mg/dL -------

Fluoride, Sodium 0.05 mg/dL 429 mg/dL 108 mg/dL

Galactose 5.0 mg/dL 15 mg/dL -------

Gentistic acid 0.4 mg/dL 1.8 mg/dL -------

Glipizide 0.1 mg/dL 0.2 mg/dL -------

Glutathione 0.15 mg/dL 10 mg/dL -------

Hemoglobin 150 mg/dL 1400 mg/dL -------

Heparin, Lithium 0.675 U/mL 31.7 U/mL -------

Heparin, Sodium 0.675 U/mL 31.7 U/mL -------

Ibuprofen 4 mg/dL 50 mg/dL -------

Icodextrin ------- 20 mg/dL -------

L-Dopa 1.3 mg/dL 4.0 mg/dL -------

Maltose 125 mg/dL 250 mg/dL -------

Maltotetraose 30 mg/dL 70 mg/dL -------

Maltotriose 90 mg/dL 180 mg/dL -------

Metformin 0.4 mg/dL 4.0 mg/dL -------

Methyl-Dopa 0.42 mg/dL 1.5 mg/dL -------

Naproxen Sodium 7.5 mg/dL 50 mg/dL -------

PAM 1.0 mg/dL 21 mg/dL -------

Salicylic acid 2.0 mg/dL 70 mg/dL -------

Tetracycline 0.35 mg/dL 1.5 mg/dL -------

Tolazamide 2.5 mg/dL 5.0 mg/dL -------

Tolbutamide 8.1 mg/dL 64 mg/dL -------

Triglyceride 150 mg/dL 1000 mg/dL -------

Uric acid 3 mg/dL 9.0 mg/dL 5 mg/dL

Xylose 5.0 mg/dL 58 mg/dL 7 mg/dL

High/Toxic Concentrations

Concentrations Determined That Will Affect Meter Glucose Results

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Interference Testing 15

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Meter Setup &

Quality Control Testing

Page 22

Meter Setup is to be used if changes need to be made to the time and date, Event Tags, Ketone Test Alert, or if settings need to be reset because of battery change.

Meter Setup

1. Press and hold “•” Button until the full display is

shown and a tone sounds (around 10 seconds). Release “•” Button. Meter goes into Set Up.

Note: Setting up the time, date, Event Tags,

Ketone Test Alert and Test Reminders may not be suitable for a multiplepatient use of the system. Check with the facility procedures and policies before performing Set Up.

Note: If the meter turns off at any time during

Set Up, go back to Step #1 under Meter Set Up and begin again.

Set Up of Time and Date

2. The hour ﬂashes. To change, press “ ” or “ ”

Button on top of the meter to select the hour. Like many alarm clocks, to set “AM” or “PM”, scroll through the hours until “AM” or “PM” appears in the Display. Press “ • ” Button to set.

3. The minutes ﬂash. To change, press “ ” or “ ”

Button to select the minutes. Press “ • ” Button to set.

4. The month (number) ﬂashes. To change, press

“ ” or “ ” Button to select the month. Press “ • ” Button to set.

5. The day (number) ﬂashes. To change, press “ ”

or “ ” Button to select the day. Press “ • ” Button to set.

6. The year ﬂashes. To change, press “ ” or “ ”

Button to select the year. Press “ • ” Button to set.

▼

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Meter Setup 16

Note: Meter beeps every time a setting is conﬁrmed

(“ • ” Button is pressed).

Page 23

Meter Setup cont.

Set Event Tags, Ketone Alert and Test Reminders

Meter comes with Event Tags, Ketone Test Alert and all Test Reminders turned off.

Note: If the meter turned off at any time

during Set Up, go back to Step #1 under Meter Set Up and begin again.

Event Tags

Event Tags are used to mark a test result that was taken during a speciﬁc event.

1. After setting the year, press “ ” or “ ” Button to turn Event Tags on or off. Press “ • ” Button to set. The meter goes to set Ketone Test Alert.

Event Tags may be used after each blood glucose result. Event Tags are as follows:

Before meal –test was taken just before a meal,

After meal – test was taken 2 hours after the start of a meal,

Exercise – test was taken during or after exercise,

Medications – medication taken may have affected test result,

▼

When a Ketone Test Alert is shown in the meter display, it does not mean that ketones have been detected in the patient’s blood. Perform a ketone test per the treatment plan, as prescribed by their Doctor or Diabetes Healthcare Professional.

Test Reminder

Up to four Test Reminders per day may be set. Reminder sounds at set time for 10 seconds. Meter comes with all Test Reminders off. To set the Test Reminders:

1. After pressing “ • ” Button to set Ketone Test Alert, Display shows ﬁrst Reminder setting (A-1). To turn Reminder on, press “ ” Button. Press “ ” Button to turn

▼

Reminder back to off. Press “ • ” Button to set. Meter goes to next Test Reminder.

2. When “on” is chosen, press “ • ” Button. The hour ﬂashes. Press “ ” or “ ” Button to set the hour. To set AM/PM, scroll (press “ ” or “ ” Button) until “AM” or “PM” is next to correct time. Press “ • ” Button to set.

3. The minutes ﬂash. Press “ ” or “ ” Button to set the minutes. Press “ • ” Button to set. Meter goes to the next Test Reminder.

▼

Test Reminder

Sick – test was taken when sick,

Other – any other reason that the test is unique or different in some way (example: stress, drinking alcohol).

Ketone Test Alert

When a blood glucose result is over 240 mg/dL, the Ketone Test Alert is a reminder to check the patient’s ketones per the treatment plan prescribed by the doctor or diabetes healthcare professional.

2. Press “ ” or “ ” Button to turn Alert on or off. Press “ • ” Button to set. Meter goes to set Test Reminder.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Meter Setup 17

▼

4. Turn Reminders on and repeat setting the time for next 3 Reminders (if needed).

Exit Setup

Press and hold “ • ” Button until meter turns off. Meter also turns off after 2 minutes of non use. Set-up choices are saved.

Note: If Test Reminders are set, the Alert

Symbol appears in all Displays. If battery dies or is replaced, Ketone Test Alert and Test Reminders may have to be reset.

Page 24

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. Facility Quality Control Testing Policy and Procedure should adhere to the manufacturer’s instructions for use and regulatory guidelines.

TRUE METRIX® PRO is a no-coding system, which means the meter does not have to be coded to each lot of test strips. To assure accurate and reliable results, TRUE METRIX® PRO offers two kinds of Quality Control Tests. These tests ensure that the TRUE METRIX® PRO System is working properly and the user’s testing technique is good.

3 Levels of Control Solution

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Quality Control Testing 18

• Use ONLY TRUE METRIX® Control Solution to

perform Control Tests.

• Write date opened on control solution label. Discard if either 3 months after ﬁrst opening or after the date printed next to the EXP on the bottle label has passed, whichever comes ﬁrst.

May 30, 2017

• Control Test ranges are printed on the

TRUE METRIX® PRO Test Strip vial label.

Page 25

Quality Control Testing cont.

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 Test Port. The 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.

If any segments are missing

in the Display when meter is ﬁrst turned on, do not use the meter for testing.

Contact Blocks

Face Up

Full Display

Drop Symbol

Error Message

Control Test

Use ONLY TRUE METRIX® Control Solution to check the performance of the system. It is important to perform Control Tests with more than one level of control solution to assure that the system is working properly and testing technique is good. Three levels of TRUE METRIX® Control Solution (Levels 1-3) containing known amounts of glucose are available.

Control Test(s) should be performed:

• Before using the system for the ﬁrst time.

• For practice to ensure that testing technique is good.

• When opening a new vial of test strips.

• If results seem unusually high or low based on the patient’s condition.

• If strip vial has been left open or exposed to extreme heat, cold or humidity.

• Whenever a check on the performance of the system is needed.

• If meter damage is suspected (meter dropped, crushed, wet, etc.).

Ranges printed on the test strip vial label are for Control Test results only and are not to be used for management of patients’ blood glucose. DO NOT drink control solution.

May 30, 2017May 30, 2017 May 30, 2017

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Quality Control Testing 19

Page 26

How to Perform a Control Test

Use the Quality Control Record Form located in the Appendix D, or the form provided by your facility, to record Control Test results.

Quality Control Testing cont.

6. Wait until Drop Symbol appears in Display. Keep test strip in meter until testing is ﬁnished.

1. Allow control solution, vial of test strips and meter to adjust to room temperature .

2. Check dates on control solution label and test strip vial label.

• Write date ﬁrst opened on control solution bottle.

• Do not use control solution if 3 months past written opened date or after EXP date printed on control solution bottle label, whichever comes ﬁrst.

• Do not use test strips 4 months past written opened date or after EXP date printed on test strip vial label, whichever comes ﬁrst.

• Discard out-of-date products and use new products.

3. Gently swirl or invert control solution

to mix. DO NOT SHAKE!

4. Remove one test strip from vial. Close

test strip vial immediately. Use test strip quickly after removal from vial.

5. Insert test strip into Test Port. Meter

turns on.

May 30, 2017

Note: If test strip is removed before testing

is ﬁnished, an error message appears. Release and discard old test strip.

Drop Symbol

Use new test strip for testing.

7. With cap removed, turn control solution bottle upside down. Gently squeeze one drop of control solution onto a clean tissue. Wipe off bottle tip with the tissue.

8. Gently squeeze a drop of control solution onto a small piece of unused aluminum foil or clear plastic wrap. Dispose after use.

9. With test strip still in meter, touch edge of Sample Tip to top of control solution. Allow drop to be drawn into test strip. Remove test strip from drop when meter beeps.

10. Dashes appear across the Display

to show meter is testing.

Note: If meter does not beep or begin testing

soon after drawing up sample, release and discard test strip. Repeat test with new test strip. If problem persists, see the Troubleshooting section of this Resource Guide.

Meter

Testing

Note: If test strip has been out of the vial

too long before testing, an error message appears upon insertion of the test strip into the meter. Release and discard old test strip. Use new test strip for testing.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Quality Control Testing 20

Contact Blocks

Face Up

Page 27

Control Bottle

Label

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 within range, repeat test using a new test strip.

Note: Control Test result shows the Control Symbol in

the Display.

Test Strip Vial Label

Control Symbol

If Control Test result is outside range, test again. If result is still outside range, the system should not be used for testing blood. Call for assistance.

12. After result is shown, Strip Release Button ﬂashes. Hold meter with test strip pointing down. Press Strip Release Button to release and discard test strip in appropriate container. Meter turns off.

Note: Removing test strip before result displays

cancels the test. An error message appears and the result is not stored in Memory. Retest with a new test strip and do not remove before result is displayed.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Quality Control Testing 21

Page 28

Sample

Initials

Result

Range

Printed

Acceptable

Date

Opened

PRO

TRUE

EXP

Range

Acceptable

Date

Opened

EXP

METRIX

Printed

PRO

TRUE

METRIX

Control Solution - Level __________

test

vial

label

strips

either 3 months

Discard bottle if

Control Solution

bottle label, write

date bottle opened.

test

vial

label

strips

either 3 months

Discard bottle if

Control Solution

bottle label, write

date bottle opened.

used.

being

printed on the

after EXP date

bottle label has

after opening or

being

after opening or

passed, whichever

used.

printed on the

after EXP date

bottle label has

passed, whichever

Quality Control Testing Data Form (located in Appendix)

Initials

comes first.

*Note any problems in Troubleshooting section below.

Result Result

Range

Acceptable

Date

Opened

EXP

Control Solution - Level __________

(see number on Meter label below the bar code)

Date

Opened

QUALITY CONTROL TESTING DATA FORM

EXP

Test Strips Control Solution - Level __________

Date Time

Meter Serial Number _________________

vial

Printed

PRO

TRUE

METRIX

Control Solution

PRO

On TRUE

METRIX

Test Strip vial label,

test

label

bottle label, write

date bottle opened.

write date vial

opened. Discard

used.

strips

being

after EXP date

either 3 months

Discard bottle if

after opening or

opening or

vial if either

4 months after

EXP date printed

comes first.

printed on the

bottle label has

passed, whichever

comes first.

passed, whichever

on the vial label has

Action

Date Problem

*TROUBLESHOOTING

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Quality Control Testing Data Form 22

Page 29

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). Venous blood samples may also be used for testing on the TRUE METRIX® PRO Blood Glucose Monitoring System. If using venous blood for testing, careful consideration must be taken when collecting and handling the venous sample (see Obtaining a Venous Blood Sample below). Follow the facility policy and procedure for obtaining samples for testing blood glucose levels. Always wear clean gloves prior to testing to decrease risk of direct contact with blood.

• Never use arterial or neonatal blood samples.

• Never use clotted blood, plasma or serum as a sample for testing on the meter.

How to Perform a Blood Glucose Test

The TRUE METRIX® PRO is a no-coding system, which means the meter does not have to be coded to each lot of test strips.

Use test strips quickly after removal from test strip vial. Test strips that have been left out of the vial too long will give an error message. If error message displays, release and discard the old test strip and test with a new test strip.

1. To obtain a blood sample for blood glucose testing refer to your facility approved methods and our recommendations listed in the table below. Follow the facility’s established policy and procedure for handling blood and biohazard safety (contaminated biological materials and sharps).

Note: A new pair of gloves should be worn before obtaining a blood sample. Contact with blood presents an infection risk.

Obtaining a Capillary Fingertip Blood Sample

1. Wash hands and put on a new pair of gloves.

2. Select subject’s ﬁngertip. Clean area with soap and warm water, rinse or use an approved disinfectant to clean the area. Dry thoroughly.

Note: Do not squeeze the ﬁngertip

for the blood sample. This will damage the surrounding tissues and the ﬂuid can dilute the blood sample.

3. To help blood drop form, lower the hand to a level below the heart and gently massage the ﬁnger from palm to ﬁngertip.

4. Lance subject’s ﬁngertip.

5. Allow the blood drop to form before attempting to apply the test strip.

6. Discard all biohazard materials into appropriate container.

7. Wash hands after taking off gloves.

Obtaining a Capillary Forearm Blood Sample

Note: Results from the forearm are not

always the same as results from the ﬁngertip. Use ﬁngertip instead of forearm:

• Within 2 hours of eating, exercise, or taking insulin.

• If the subject’s blood glucose may be rising or falling rapidly or their results often ﬂuctuate.

• If the subject is ill or under stress.

• If the glucose result may be low or high.

• If symptoms of low or high glucose levels may not be evident.

1. Wash hands and put on a new pair of gloves.

2. Select subject’s forearm area. Clean area with soap and warm water, rinse or use an approved disinfectant to clean the area. Dry thoroughly.

3. Rub area vigorously or apply a warm, dry compress to increase blood ﬂow.

4. Lance subject’s forearm.

5. Allow the blood drop to form before attempting to apply the test strip.

6. Discard all biohazard materials into appropriate container.

7. Wash hands after taking off gloves.

Obtaining a Venous Blood Sample

Note: Do not collect venous specimens from

the arm that has an active intravenous infusion site. Do not collect samples from an indwelling line that has an intravenous infusion.

1. Clean site for venipuncture with soap, water or cleansing agent. Dry thoroughly.

2. Always collect sample into test tubes containing only sodium heparin.

Note: Do not use, serum, clotted blood, or

plasma for testing on meter.

3. If using venous blood for testing on a laboratory device, it must be used within 30 minutes of laboratory test. Mix well before use.

Note: Do not use sodium ﬂuoride blood collec-

tion tubes. This may cause a false low glucose results.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Blood Glucose Testing 23

Page 31

Blood Glucose Testing cont.

2. Check dates on test strip vial being used. Do not use test strips 4 months past written opened date or after date printed on test strip vial label, whichever comes first.

May 30, 2017

3. Remove one test strip from vial. Close vial immediately. Use test strips quickly after removal from vial.

Note: Test strips that have been left out of the vial too

long before use will give an error message. If error message displays, release and discard the old test strip and test with a new test strip.

4. With meter off, insert test strip Contact End (blocks facing up) into Test Port. Meter turns on. Keep test strip in meter until testing is ﬁnished.

To mark test as alternate site (forearm) result, press “ ” Button. ALT Symbol appears in Display. Press “ ” Button to remove ALT Symbol.

▼

7. With test strip still in meter, touch Sample Tip of test strip to top of blood drop from sample obtained in Step 1 and allow blood to be drawn into test strip. Remove Sample Tip from blood drop immediately after the meter beeps and dashes appear across meter Display.

Note: If meter does not beep and show dashes

in the Display soon after touching the sample to the Sample Tip, release and discard the test strip. Repeat the test with a new test strip and a new sample. If problem persists, see the Troubleshooting section of this Resource Guide.

8. After the test is ﬁnished, result is displayed. The Strip Release Button ﬂashes. Record result as required by your facility.

9. Hold the meter with the test strip pointing down. Press the Strip Release Button to release and discard the test strip into the appropriate container. Meter turns off. Result is stored in Memory with date and time.

Meter Testing

10. Discard all biohazard materials into

Note: Removing the test strip before

the result is displayed cancels the test. An error message appears and result is not stored in memory. Retest with a new test strip and do not remove the test strip from the meter before the result is displayed.

5. Wait until the Drop Symbol appears in the Display.

6. Obtain the blood sample. Allow drop to form (refer to step one).

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Blood Glucose Testing 24

Drop Symbol

appropriate container. Wash hands after taking off gloves.

Used test strips and lancets are considered biohazardous. Dispose used test strips and

lancets in approved biohazard container.

11. Record the result as required by your facility.

Note: If blood glucose test result is greater than 240

mg/dL and the Ketone Test Alert is turned on, the Ketone Test Alert Symbol appears in the Display with the result. Test ketones per the treatment plan. The Ketone Test Alert may be turned on or off during Setup.

When a Ketone Test Alert Symbol appears, it does not mean that ketones have been detected in patient’s blood. The Ketone Test Alert is a reminder to perform a ketone test

as prescribed in the treatment plan.

Page 32

Diabetes Data

Management Capabilities

Page 33

Memory

Note: The use of Memory features (Averages,

test results) may not be suitable for multiple-patient use of the system. Check with the facility procedures/ policy before use.

View Averages (7-, 14-, and 30-Day)

The Averages feature allows viewing of the average of all blood glucose results within a 7-, 14-, and 30-day period. Control Test results are not included in the Averages.

1. Start with meter off. Press and release

“•” Button. Display scrolls through 7-, 14-, and 30-day Average values.

2. Meter turns off after 2 minutes if no

buttons are pressed.

Note: If a Control Test is performed outside

the recommended testing temperature (See the Quality Control Testing section of this Resource Guide), the control solution may read as a blood test and be included in the Averages.

Note: If there are no Average values, three

dashes are displayed for 7-, 14-, and 30-day Averages.

7-Day Average

14-Day Average

30-Day Average

View Results

Memory stores 500 results. When the Memory is full, the oldest result is replaced with the newest result.

1. Press and release “•” Button. Meter displays 7-, 14-, and 30-day Averages.

Memory Symbol

2. Press and release “•” Button again to view most recent Control Test result in Memory. If there are no results in Memory, dashes appear with the Memory Symbol.

Alternate Site

Symbol

3. Press “ ” Button and release to

▼

advance to the most recent blood test. Press “ ” Button to scroll forward

▼

through blood results or “ ” Button to scroll backwards through results.

• Test results marked as alternate site display ALT Symbol.

• Control Test results display the Control Symbol. If no Control Test has been done Display shows dashes and the Control Symbol.

Memory Symbol

Alternate Site

Symbol

Control Symbol

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Memory 25

No Average

• Test results above 240 mg/dL display Ketone Test Alert Symbol, when Ketone Test Alert is turned on during meter Set Up.

Ketone Test

Alert Symbol

Page 34

TRUEmanager® Diabetes Management Software

TRUEmanager® Diabetes Management Software provides an easy way for patients with diabetes and healthcare providers to understand and manage blood glucose results. Results can be downloaded from the TRUE METRIX® PRO Meter or results can be manually entered into the program.

TRUEmanager® Diabetes Management Software gives you the tools to help your patients achieve target blood glucose levels. The design makes it easy and convenient to quickly identify glucose results that are out of target range, so you can consult with your patients to help them understand how various lifestyle and behavior choices may be affecting their blood glucose levels. With this information and your expertise, patients are empowered to make better choices in daily self-management.

Diabetes Management Software

TRUEmanager® Diabetes Management Software (DMS) is a stand-alone software program for a single user or multiple user/multiple patient setting.

• The single user (Home) version is installed from the TRUEmanager® DVD onto a single Windows-based personal computer (PC). It can hold an unlimited number of individual patient records and meter results.

• The multiple user version (TRUEmanager® PRO Diabetes Management Software) easily installs from a TRUEmanager® DVD to a network server and offers a separate Health Level 7 (HL7) interoperability module for data exchange with electronic medical records or other data management systems.

Nipro Meter

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Diabetes Management Software 26

Home

Version

PRO

Version

HL7

• Single PC

• Multiple

• PC

Patient

Clinic with no server

Server

Multiple PC

Page 35

Diabetes Management Software cont.

TRUEmanager® Diabetes Management Software lets you establish and maintain valuable testing records that include demographics, health insurance information, medications, testing regimen recommendations, and results history. It is an all-in-one, easy-to-access diabetes data management system.

TRUEmanager® Diabetes Management Software offers nine comprehensive reports two additional administrative reports are available in the PRO version. Each report interprets test results from varied, valuable perspectives and packages them in easy-to-view, printable reports for evaluation and discussion.

Comprehensive reports include:

• Summary Report

• Glucose Trend Report

• Logbook Report

• Extended Logbook Report

• Conformance Report

• Modal Day Report

• Modal Week Report

• Clinical Indicators Patient Report

• Clinical Indicators Population Report Administrative reports available in the PRO version include:

• Login Audit Report

• Patient Audit Report TRUEmanager® PRO Diabetes Management Software is

available in the following languages that are all available on one DVD (language preference is chosen during installation process):

• English

• Spanish

• French

• Portuguese

• Croatian

• German

• Greek

• Italian

• Russian

• Serbian

HL7 Interface Overview

• The HL7 interoperability module is installed after TRUEmanager® PRO Diabetes Management Software and provides the ability to send information stored in the program to an Electronic Medical Record system using HL7 standard language.

• TRUEmanager® PRO is compatible with Windows 2003 or 2008 Server operating systems.

• An administrative application is included and allows for conﬁguration of HL7 messages and other administrative functionality.

TRUEmanager® PRO Minimum Hardware and Software Requirements

Client

• DVD-ROM

• IBM Compatible PC with one of the following operating systems installed:

- Windows XP 32/64bit (Service Pack 3 or later)

- Windows Vista (Service Pack 2 or later)

- Windows 7 32/64bit

- Windows 8.1 32/64 bit

• 1GB of memory or greater

• 2GB free disk space or greater

• 1 free USB 2.0/3.0 port

• Pentium 4 Processor minimum 2GHz or greater (unless using a multi-core processor)

• Graphics card that supports 1024 x 768 or higher

• Docking station and USB Cable

• Acrobat Reader

• Optional color printer for printing reports

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Diabetes Management Software 27

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)

• 2GB Memory or greater

• 10GB free disk space or more

• Graphics card that supports 1024 x 768 or higher

• Minimum Structured Query Language (SQL) Server 2005 2008 or 2012 Express Edition (Standard or Enterprise Edition recommended for larger facilities)

TRUEmanager® Home Version Minimum Hardware and Software

Requirements

• Pentium IV or higher

• Microsoft Windows operating system XP Professional with Service Pack 3 (SP3), Vista (Service Pack 2 [SP2] or later), Windows 7 (Service Pack 1 [SP1] or later) or Windows 8.1

• USB port

• DVD-ROM drive

• Docking Station and USB cable

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Diabetes Management Software 28

Page 37

System Maintenance

Page 38

Troubleshooting

The following is a brief guide for Troubleshooting the most common errors when using TRUE METRIX® PRO. If any problems arise that cannot be resolved by using the guide or the Display Messages, please call for assistance.

1. After inserting test strip into Test Port, meter does not turn on.

Test strip is inserted upside down or backwards.

- Remove test strip. Re-insert test strip correctly.

Test strip not fully inserted.

- Remove test strip. Re-insert test strip fully into meter.

Test strip error.

- Remove test strip. Repeat with new test strip.

Dead or no battery.

- Replace battery.

Battery in backwards.

2. After applying the sample to the test strip, test does not start/meter does not begin testing.

Sample drop too small.

- Repeat test with a new test strip and a larger sample drop.

Sample applied after two minute automatic shut-off of meter.

- Repeat test with a new test strip and apply sample within 2 minutes of inserting test strip.

Problem with test strip.

- Repeat test with a new test strip.

Problem with meter.

- Call for assistance.

- Check placement of battery. Battery positive (“+”) side must face up.

Meter error.

- Call for assistance.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Troubleshooting 29

Page 39

Troubleshooting

Display Messages

Display Reason Action

Repeat with new test strip, using capillary whole blood from

Invalid Hematocrit

Temperature Error Too Cold/Too Hot

Sample Not Detected or Using Wrong Test Strip

Used Test Strip, Test Strip outside of vial too long, Sample on top of Test Strip.

Meter Error

Test Strip Error, Very high blood glucose result - higher than 600mg/dL

the ﬁnger or forearm or venous whole blood collected with sodium heparin blood collection tube. If error persists, call for assistance.

Move meter and test strips to area between 41°F-104°F; wait 10 minutes for System to reach room temperature before testing.

Retest with new TRUE METRIX® PRO Test Strip and larger sample.

Repeat with new test strip. Make sure sample is touched to edge of test strip (not top). If error persists, call for assistance.

Call for assistance.

Retest with new Test Strip. If error persists, call for assistance. If you have symptoms such as fatigue, excess urination, thirst, or blurry vision follow your healthcare professional’s advice for high blood glucose.

Display Messages

Test Strip Removed During Test

Communication Error

Low or Dead Battery

WARNING!! Out of Range - High Results > 600 mg/dL

Out of Range - Low Results < 20 mg/dL

Broken Display

If error message still appears, any other error message appears, or troubleshooting does not solve the problem, call for assistance.

Retest with new test strip. Make sure result is displayed before removing test strip.

Call for assistance.

Low: About 50 tests can be done before battery dies. Dead: Battery Symbol appears and beeps before

meter turns off.

WARNING!!

Retest with new test strip. If result is still “Hi” (High) or “Lo” (Low) contact Doctor immediately.

Do not use meter for testing. Call 1-800-803-6025.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Troubleshooting Display Messages 30

Page 40

Low

Tab

Battery

Door

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.

3. Discard the old battery in an appropriate container.

4. Insert new battery with positive (“+”) side facing up. Close Battery Door.

5. Press “ • ” Button to turn meter on and check time, date, and Testing Alerts and Reminders (see Meter Set Up). If meter does not turn on, check that battery was installed properly. If not, remove and reinsert battery and turn meter on by pressing “ • ” Button. Call for assistance if problem persists.

Battery might explode if mishandled or

incorrectly replaced. Do not dispose of battery in fire. Do not take apart or attempt to recharge battery. Dispose according to local regulations.

Battery is not rechargeable. If you have a

cable or a cradle for downloading results to a computer, DO NOT plug the USB cable end into an electrical outlet. Trying to recharge the battery or power the meter by plugging into an electrical outlet will cause meter to catch on fire or melt.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Battery Replacement 31

Page 41

Cleaning and Disinfection

If system is to be used on multiple

patients, cleaning and disinfection of the meter should be done between patients.

Healthcare professionals should wear gloves when cleaning the meter. Wash hands after taking off gloves as contact with blood presents a risk of infection.

Cleaning removes blood and soil from the meter. Disinfecting removes most, but not all possible infectious agents (bacteria or virus) from the meter, including blood-borne pathogens.

• Clean and disinfect immediately after getting any blood on the meter or if meter is dirty.

• Meter should be cleaned and disinfected between patients.

• Clean and disinfect the meter before allowing anyone else to handle them.

• Do not clean the meter during a test.

To Clean and Disinfect the Meter:

1. Wash hands thoroughly with

soap and water. Wear a clean pair of gloves.

2. Make sure meter is off and a

test strip is not inserted. With ONLY PDI Super Sani Cloth Wipes (or any disinfectant product with the EPA* reg. no. 9480-4), rub the entire outside of the meter using 3 circular wiping motions with moderate pressure on the front, back, left side, right side, top and bottom of the meter. Repeat as needed until all surfaces are visibly clean. Discard used wipes. (*Environmental Protection Agency.)

Using fresh wipes, make sure that all outside surfaces of the meter remain wet for 2 minutes.

NEVER put meter in liquids or allow any liquids to enter the test port.

3. Let meter air dry thoroughly before using to test.

4. Verify that the system is working properly by performing an Automatic Self-Test.

5. Properly dispose of gloves and wipes after cleaning. Wash hands after removing gloves.

Note: Other disinfectants have not been

tested. The effect of other disinfectants used interchangeably has not been tested with the meter. Use of disinfectants other than Super Sani Cloth Wipes may damage meter.

Note: Super Sani Cloth Wipes have been

tested on the meter for a total of 10,950 cleaning and disinfecting cycles, which is equal to cleaning and disinfecting the meter 10 times per day for a 3 year period. The use life of the meter is 3 years.

Stop using the meter and Call Customer Care for assistance at 1-800-803-6025 if:

• Meter display appears cloudy or any display segments

are missing,

• Markings on meter, including back meter label, are

coming off or are missing,

• Buttons are hard to push on the meter or do not work,

• Unable to insert test strip into Test Port,

• Automatic Self-Test gives an error message.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Cleaning and Disinfection 32

Page 42

System Storage

TRUE METRIX® PRO System

• Store the system (meter, control solution, test strips) in carrying case to protect from liquids, dust and dirt.

• Do not keep meter in an area where it may

be crushed (i.e. back pocket, drawer, bottom of bag, etc.).

• Store the system in a dry place

at temperatures between, 40°F-86°F.

DO NOT FREEZE.

• Allow System to sit at room

temperature for 10 minutes before testing

TRUE METRIX® PRO Test Strips

• Store test strips in original vial only. Do not

transfer old test strips into new vial or

store test strips outside of vial.

• Write the date first opened on test strip vial. Discard unused test strips from vial if either 4 months after first opening or after date printed next to EXP on vial label has passed, whichever comes first. Use of test strips past expiration dates may give incorrect results. Discard out of date test strips and use new test strips.

• Close test strip vial immediately

after removing one test strip.

• Store in a dry place at temperatures between, 40°F – 86°F. DO NOT FREEZE.

• Do not reuse test strips.

• Do not bend, cut or alter test strips in any way.

TRUE METRIX® Control Solution

• Write the date first opened on control solution bottle label. Discard if either 3 months after first opening or after date printed next to EXP on vial label has passed, whichever comes first.

• After use, wipe bottle tip using a clean, dry cloth and recap tightly.

• Store at temperatures between, 36°F-86°F.

DO NOT FREEZE.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) System Storage 33

Page 43

Training Program

Page 44

TRUE METRIX® PRO Professional Blood Glucose Monitoring System Training Certiﬁcation Program

Trained and competent testing personnel are essential to good quality testing and patient care. Waived testing sites are subject to a high rate of personnel turnover. Personnel should be trained and competent in each test they will perform before reporting patient results. In addition, training should include aspects of safety (including Infection Control Policies) and Quality Control. The Risk Management and Chief Medical Ofﬁcer, and other persons responsible for overseeing testing should ensure that testing personnel receive adequate training and are competent to perform the procedures for which they are responsible.

Training Program

4. Submit completed Post Test to:

LTC Training Certification Attn.: Customer Care Manager 2400 NW 55th Ct. Fort Lauderdale, FL 33309

Nipro Diagnostics, Inc. will return a Trainer’s Certificate upon satisfactory completion of the Post Test (100% score required). Upon receiving the Trainer’s Certificate, Certified Trainers are qualified to train appropriate personnel at their facility to be Approved Testers. Training Checklists and Certificates must be filed in the employee’s file at the facility.

Certiﬁcate Information

Nipro Diagnostics, Inc. provides a training certiﬁcate for the use of the TRUE METRIX® PRO Professional Monitoring Blood Glucose System for point-of-care multiple patient facilities. The Training Certiﬁcate provides a record that the person listed on the Certiﬁcate has been trained correctly in the use of the TRUE METRIX® PRO System and understands all procedures and limitations concerning the TRUE METRIX® PRO System.

Certiﬁed Trainer

Certified Trainers are personnel from the facility who have received a Trainer’s Certificate from Nipro Diagnostics, Inc. To obtain a Trainer’s Certificate, the person must:

1. Watch and understand the TRUE METRIX® PRO How To Use Video (available online at http://www.niprodiagnostics.com/our_ products/bgm_true_metrix.aspx).

2. Read and be familiar with the entire Comprehensive Resource Guide and all product Instructions for Use (Test Strip, Control Solution, Owner’s Booklet).

3. Complete the Training Checklist and Post Test included in this Comprehensive Resource Guide.

• CERTIFIED TRAINERS MUST BE RE-CERTIFIED EVERY 12 MONTHS.

Approved Testers

Approved Testers must be trained by Certified Trainers before they perform Control Tests or blood glucose testing using the TRUE METRIX® PRO System. To become an Approved Tester:

1. Watch the TRUE METRIX® PRO How To Use

Video (available online at http://www.niprodiagnostics.com/our_products/ bgm_true_metrix.aspx).

2. Successfully complete the Training Checklist

under the instruction of a Certified Trainer.

3. Demonstrate the proper technique for testing

with the TRUE METRIX® PRO System using the appropriate blood and Control samples.

4. Identify the facility’s Quality Control Policy and

Procedures, including documentation of Quality Control.

Upon the person’s satisfactory completion of the above, the Certified Trainer documents the training, signs the Training Checklist and files the completed Checklist in the employee’s file at the facility.

• APPROVED TESTERS MUST BE RE-TRAINED EVERY 12 MONTHS BY A CERTIFIED TRAINER.

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Training Program 34

Page 45

TRUE METRIX® PRO Blood Glucose System Training Program Information

Training Program cont.

The training program provided in this section of this Resource Guide is recommended to supplement already established facility policies and procedures. It is recommended that facility personnel be trained on the TRUE METRIX® PRO Blood Glucose Monitoring System prior to performing quality control testing and testing blood samples collected from patients for the ﬁrst time.

This training program includes the following documents to assist in the setup of a training session for facility personnel

• Product Training Agenda (example)

• Materials Checklist

• Training Checklist

During the training of facility personnel on the TRUE METRIX® PRO Blood Glucose Monitoring System, we also recommend including a review of the following established facility speciﬁc policies and procedures:

• Collection of capillary ﬁngertip, capillary forearm, and venous blood samples

• Quality control testing and documentation

• Blood glucose testing and interpreting patient glucose values

• Medical Device Cleaning and Disinfection Guidelines

• Handling blood and biohazard safety (contaminated biological materials and sharps)

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Training Program 35

Page 46

Product Training Agenda (example)

Training Program cont.

Training Topic Estimated Time

Source of Information

to Complete

1. Purpose of Training Overview 5 minutes Technical Overview located in Appendix E of this Resource Guide

2. Overview of System Components

3. Performing Quality Control Testing 10 minutes Technical Overview located in the Appendix E of this Resource Guide,

4. Documenting and Reviewing Quality Control Results

5. Sample Collection 10 minutes Owner Booklet/Test Strip Instructions for Use located in Appendix

6. Performing Blood Glucose Testing

7. Interpreting Blood Glucose Results 5 minutes Facility Policy and Procedure

8. Interpreting Meter Display Messages/Troubleshooting

9. System Maintenance/Storage 5 minutes Technical Overview located in Appendix E of this Resource Guide,

Total Time to Complete All Sections 55-75 minutes

5-10 minutes Technical Overview located in Appendix E of this Resource Guide and

the System Components section of this Resource Guide

Quality Control Testing section of this Resource Guide, and Facility Policy and Procedure on quality control

5 minutes Meter Setup and Quality Control Testing section of this Resource

Guide, and Facility Policy and Procedure on quality control

B of this Resource Guide, Blood Glucose Testing section of this Resource Guide, and Facility Policy and Procedure for collection and handling of blood samples

5-20 minutes Technical Overview located in Appendix E of this Resource Guide,

Blood Glucose Testing section of this Resource Guide, and Facility Policy and Procedure for blood glucose monitoring

5 minutes Technical Overview located in Appendix E of this Resource Guide and

the System Maintenance section of this Resource Guide

System Maintenance section of this Resource Guide, and Facility Policy and Procedure on Medical Device Cleaning and Disinfection

Materials Checklist

Materials for Blood Glucose/Control Testing Available

TRUE METRIX® PRO system(s)-we recommend one meter for every 2 participants

TRUE METRIX® PRO test strips 1 vial (25 or 50 count) shared between every 1-2 participants

TRUE METRIX® Control Solution (Level 1, Level 2, and Level 3 – one bottle of each level) can be shared between every 2 participants

Auto disabling, single use lancets

Gauze or tissue for performing blood or control testing

Personal Protective Equipment (PPE) gloves, etc.

Biohazard container

Alcohol wipes

Cleaning and disinfecting supplies if desired

Other Training Materials

TRUE METRIX® PRO Owners Booklet

TRUE METRIX® PRO Test Strips Instructions for Use

Copies of Checklist, Post-test and Answer Key (for all participants)

Copies of Quality Control Testing Data Form (located in Appendix D of this Resource Guide or the form provided by your facility)

Facility Policy and Procedure for blood glucose testing and interpreting glucose results

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Training Program 36

Page 47

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

2. The Facility Personnel understands the following:

____ Use of the TRUE METRIX® PRO System in a clinical setting ____ System specifications ____ Limitations and critical safety information, including that the TRUE METRIX® PRO System

must not be used for certain patients (neonate)

3. Familiarization with the components of the system.

a. Meter

____ Location of serial number for the meter ____ Review of meter buttons and functions

b. Test Strips

____ Identifies lot number ____ Writes open date on test strip vial label ____ Understands the use by dates, both printed and written ____ Reviews proper handling of test strips including recapping of the test strip vial

immediately after removing test strip

____ Demonstrates proper insertion of the test strip into the meter

c. Control Solution

____ Identifies lot number ____ Writes open date on control solution bottle label ____ Understands the use by dates, both printed and written ____ Identifies control test level ____ Identifies control test ranges

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Training Checklist 37

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 ____ Identifies correct (unopened vs. opened) use by dates on the control solution bottle ____ Identifies the correct control test range for the control solution level and understands the

troubleshooting if the control test result is not within the acceptable range ____ Demonstrates the procedure using the control solution ____ Records the control test result on the TRUE METRIX® PRO Quality Control Testing Data Form

5. Blood Collection

____

____ Understands when fingertip should be used instead of forearm ____ Demonstrates the ability to obtain a sufficient amount of blood for testing from both

____ ____

6. Demonstration of Blood Glucose Testing

____ Demonstrates proper blood glucose testing procedure for the TRUE METRIX® PRO System ____ Understands the proper blood application to the Sample Tip and the significance of the

7. Patient Blood Glucose Test Results

____ Demonstrates the proper documentation of test results ____ Understands that use of Memory, Averages, and Ketone Test Reminder features may not be

____ Proper disposal of biohazardous materials (contaminated biological materials and sharps)

Understands the proper technique of capillary blood collection for both fingertip and

forearm samples

a fingertip and forearm

Understands facility’s procedure on obtaining blood samples

Understands the importance of the use of the recommended type of blood collection tube

for collecting a venous blood sample for the testing on the

Monitoring System

symbols in the Display

appropriate for multiple-patient facilities

per facility policy and procedures

TRUE METRIX® PRO

Blood Glucose

8. Care, Cleaning and Disinfection, Storage of System

____

____ ____ Demonstrates battery replacement ____ Understands proper storage of meter, test strips, and control solution

TRUE METRIX® PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) Training Checklist 38

Understands recommended procedures for cleaning and disinfecting the

PRO

Meter

Understands facility policy and procedure for Medical Device Cleaning and Disinfection

TRUE METRIX®

Page 49

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.