Nipro True2go Owner's Manual

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Fort Lauderdale, FL 33309 EE. UU.

Fabricado por:

Owner’s

Booklet

Use only with TRUEtest Blood Glucose Test Strips

Manufactured by:

24/7 Customer Consultation

English or Spanish

1-800-803-6025 1-954-677-4599

www.niprodiagnostics.com

™

Scan this code with your smart phone

for additional TRUE2go information. Always refer to the Owner’s Booklet

for detailed product information.

Fast Test Guide

Two

1 2

INSERT TEST STRIP

simple steps

APPLY BLOOD SAMPLE

For quick reference only, not intended as a substitute for

complete instructions. Please read entire Owner’s

Booklet and product Instructions for Use before testing.

Expected Results for people without diabetes: Plasma Blood Glucose Result1 Before eating < 100 mg/dL

INTRODUCTION:

TRUE2go™ Blood Glucose Monitoring System

TRUE2go is a simple, accurate way to test whole blood glucose (sugar) level, anytime, anywhere. Our goal is to provide quality healthcare products and dedicated customer service. For questions about TRUE2go products, visit our web site at: www.niprodiagnostics.com.

Caution! Please read complete Owner’s Booklet and all product Instructions for Use.

Additional instructions for use of the System in a professional multi-patient setting are included in the Quality Assurance/Quality Control Manual. The QA/QC Manual is available on our website www.niprodiagnostics.com, or call 1-800-803-6025 or 1-954-677-4599.

Importance of Blood Glucose Monitoring

The more you know about diabetes, the better you will be able to care for yourself. A Doctor or Diabetes Healthcare Professional will determine how often you should test and what your target ranges are for blood glucose results. Having most results within your target ranges shows how well a treatment plan is working to control glucose levels. Keeping results within your target ranges helps slow or stop complications from diabetes.

NEVER change your treatment plan without consulting a Doctor or Diabetes Healthcare Professional.

Use of TRUE2go in a manner not specified in this Owner’s Booklet is not recommended and may affect the ability to determine true blood glucose levels.

FOR PATIENTS IMPORTANT HEALTH and SAFETY INFORMATION: WARNING!

NEVER reuse Test Strips. NEVER wipe Test Strips with

water, alcohol or any cleaner. DO NOT attempt to remove blood or control sample from Test Strips or clean Test Strips and re-use. Reuse of Test Strips will cause inaccurate results.

• NEVER add a second drop of sample to Strip. Adding more sample gives an error message.

The TRUE2go Blood Glucose Monitoring System is for one person use ONLY. DO NOT share your Meter or your Lancing Device with anyone, including family members. DO NOT use on more than one person. ALL parts of your Blood Glucose Monitoring System could carry blood-borne diseases after use, even after cleaning and disinfection.

2,3

For cleaning and disinfecting your Meter see Meter Care, Cleaning/Disinfection. For cleaning and disinfecting your Lancing Device see the Instructions for Use.

Caution!

We suggest cleaning the Meter when visibly dirty. Wash your hands thoroughly with soap and warm water after handling the Meter, Lancing Device, or Test Strips as contact with blood presents an infection risk.

FOR PATIENTS IMPORTANT HEALTH and SAFETY INFORMATION:

•

DO NOT use the TRUE2go System to test your blood

glucose if you are undergoing peritoneal dialysis (dialysis through the abdomen/stomach area).

• DO NOT use the TRUE2go System to test

your blood glucose if you are receiving medical treatment that contains sugars such as maltose or xylose (Extraneal®, Icodial®, immunoglobulins such as Octagam®, or Orencia®).

The treatments listed above may cause false high glucose results when testing with the TRUE2go System.4

Before using the TRUE2go System, check with your Doctor or Healthcare Professional if you think you may be receiving any of these treatments.

If you have symptoms of low or high blood glucose, check your blood glucose immediately. If your result does not match the way you feel, repeat the test. If your results still do not match the way you feel, call your Doctor or Healthcare Professional.

• Low blood glucose (hypoglycemia) symptoms may be trembling, sweating, intense hunger, nervousness, weakness, and trouble speaking.

• High blood glucose (hyperglycemia) symptoms may be intense thirst, a need to urinate often, a dry mouth, vomiting, and headache.

FOR HEALTHCARE PROFESSIONALS IMPORTANT HEALTH AND SAFETY INFORMATION:

DO NOT use the TRUE2go System for patients

receiving the following treatments:

•

Peritoneal dialysis using solutions containing icodextrin (Extraneal®, Icodial®) that is metabolized to maltose,

•

Injections or infusions of solutions containing galactose or maltose, including some human immunoglobulin preparations (Octagam

, WinRho®,

SDF Liquid, HepaGam B™),

•

Xylose absorption testing,

•

Intravenous solutions containing maltose,

•

Any drugs that contain or metabolize to maltose, galactose, or xylose (Orencia®, Adept®, Bexxar®).

Using the TRUE2go System when receiving the above treatments may cause false high glucose results.4 False high results may lead to inappropriate therapy, which may result in coma or death. For more information see www.fda.gov/BiologicsBloodVaccines/ SafetyAvailability/ucm154213.htm .

Safe Practices Recommendations for Healthcare Professionals:

•

At patient admission/presentation and periodically throughout the patient’s stay at the facility, assess the presence and use of therapies containing interfering drugs (see previous page).

•

Use only laboratory methods for monitoring blood glucose levels in patients receiving interfering drugs.

•

If there are pre-print order sets for patients receiving interfering drugs, include a prescription to test blood glucose using only laboratory methods.

•

Establish facility protocols to verify point-of-care (bedside) blood glucose results with laboratory results for patients who are unresponsive or unable to communicate.

Other Important Information for Healthcare Professionals

The most accurate results come from using fresh, capillary whole blood from the fingertip or forearm. Venous whole blood drawn into EDTA (purple top tube) or heparin (green top tube) may be used. Mix tube contents gently before using.

When comparing results between TRUE2go and a laboratory system, perform a TRUE2go blood test within 30 minutes of laboratory test. Results from TRUE2go are considered accurate if within 20% of laboratory results.5 If patient has recently eaten, fingerstick results from TRUE2go can be up to 70 mg/dL higher than venous laboratory results.

DO NOT perform capillary blood glucose testing on critically ill patients. 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.

IMPORTANT INFORMATION:

For the most accurate results using TRUE2go:

• Read all instructions before testing.

• TRUE2go is an in vitro (outside body) quantitative system

that is used for self-testing and point-of-care testing of human whole blood only.

• Meter displays results as plasma values.

• Use only TRUEtest™ Test Strips and TRUEtest Glucose

Control with TRUE2go Meter.

• Do not use for diagnosis of diabetes or for testing blood

glucose in newborns.

• Perform Control Tests before performing a blood glucose

test for the first time (see Getting Started).

Note: Three levels of TRUEtest Glucose Control Solution are

available for Quality Control Testing. It is important to perform Control Tests with more than one level of Control to assure your System is working properly and your testing technique is good. Contact place of purchase or call for assistance to obtain Control.

• When carrying your TRUE2go System with you, do not

leave it where the storage temperature printed on vial label may be exceeded (car, trunk, briefcase, etc).

• Remove only one Strip at a time from vial when testing.

Recap vial immediately after removing Strip.

• When using the meter for the first time, check the unit of

measure in the meter Display after performing a control or blood test. Result must display in the correct unit of measure (mg/dL).

• If the result does not display in the correct unit of measure,

DO NOT use the meter and DO NOT use the meter result to determine treatment.

Phone Number, Fast Test Guide, Expected Results ....................

............................................................................................see covers

Introduction and Important Information .............................. 1-7

Table of Contents ..........................................................................8

Know Your System

Meter ............................................................................................ 9

Test Strip ..................................................................................10

Test Strip Vial Label ................................................................11

Glucose Control Bottle Label .................................................12

Attach/Remove TRUE2go Meter to Test Strip Vial ...........13

Getting Started

Quality Control .................................................................. 14-15

Control Test ........................................................................ 16-19

Testing your Blood

Obtaining a Blood Sample ................................................ 20-21

Testing Blood Glucose ....................................................... 22-23

System Out of Range Warning Messages ............................. 24

Meter Memory

Viewing Results in Memory ...................................................25

Care, Cleaning/Disinfection and Troubleshooting

Caring for TRUE2go .......................................................... 26-27

Changing Battery ................................................................ 28-29

Troubleshooting ....................................................................... 30

Display Messages ............................................................ 31-32

System Specifications/Chemical Composition ........................33

Meter Warranty ............................................................................34

References ......................................................................................35

Know Your System Meter

① Set Button - Turn Meter on for Memory, view/

scroll results in Memory, mark result as Alternate Site.

② Display - Shows results, messages, user prompts,

information.

③ Drop Symbol - Apply blood or Glucose Control. ④ Units of Measure - Note: Factory set, cannot be

changed by user.

⑤ Strip Release Button - Releases Strip after testing. ⑥ Test Port - Insert TRUEtest Test Strip here. ⑦ Meter Label - Contains serial number of Meter and

phone number to call for assistance.

⑧ Battery Cover - Use one non-rechargeable 3V

lithium battery (#CR2032), positive (“+”) side up (

See Changing Battery).

Top of Meter

Bottom of Meter

① Contact End -

Insert into Test Port with blocks

(contacts) facing up

② Sample Tip -

Bring sample (fresh, capillary or

venous blood or Glucose Control) to edge of Tip.

Note: Insert Strip into Meter before touching

Sample Tip to blood or Control drop.

Sample Placement

Correct Placement Incorrect Placement

•

Allow sample (blood or Glucose Control drop)

to be drawn into Sample Tip until testing begins

(Dashes move across Display)

• Do not smear or scrape drop with Strip.

• Do not apply more sample to the Strip after

testing begins.

Note: Do not apply blood or Glucose Control to top

of Test Strip.

Do not insert Sample Tip with sample into

Meter for testing. May damage Meter.

Test Strip

Top of Test Strip

Test Strip Vial Label

① Lot Number (LOT) - Used for identification

when calling for assistance.

②

Expiration Dates (EXP) - Write date first opened

on vial label. Discard vial and unused Strips if either 4 months after opening or date printed next to EXP on vial label has passed, whichever comes first.

Caution!

Use of Test Strips or Glucose Control past the Expiration Dates may give incorrect test results. Discard out-of-date products and test with new products.

③ Control Range - Range of numbers in which

Control Test result must fall to assure System is working properly.

May 30, 2014

Glucose Control Bottle Label

① Lot Number (LOT) - Used for identification

when calling for assistance.

②

Expiration Dates (EXP) - Write date first

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

③ Control Level (1, 2, or 3) - Three levels of

TRUEtest Control are available. We recommend testing at least 2 levels of Control. Use the number on the front cover for information on how to obtain different levels of Control.

May 30, 2014

To Attach / Remove TRUE2go Meter to TRUEtest Test Strip Vial

The TRUE2go Meter is made to attach to the top of the TRUEtest Test Strip vial cap.

To attach:

1. Set Test Strip vial on flat surface with vial lip facing front.

2. With Test Port facing right, place bottom of Meter firmly on vial top. Meter must be seated flat on top of vial cap.

3. Holding the vial, twist the Meter 1/4 turn clockwise. The Test Port area on the Meter should cover the vial lip if attached properly.

4. To open the vial, lift up on the Meter under the Test Port.

To remove:

1. Holding the vial, twist the Meter 1/4 turn counterclockwise.

2. Lift off Meter from vial top.

The Meter may also be used for testing without attaching to the vial.

Lift Up To

Open

Test

Port

Vial Lip

Getting Started

The Meter turns on when a Test Strip is inserted into the Test Port or when Set Button is pressed (see Memory). Meter turns off when the Strip is released or after 2 minutes of non-use.

Quality Control Testing

To assure you are getting accurate and reliable results, TRUE2go offers two kinds of quality control tests. These tests let you know that your TRUE2go System is working properly and your testing technique is good.

Automatic Self-Test

An Automatic Self-Test is performed by the Meter each time a TRUEtest Test Strip is inserted correctly into the Test Port.

Insert a Strip into the Test Port. The Meter is working properly if:

- the full Display appears, then

- the Drop Symbol begins to blink.

If an error message appears in the Display, the Meter will not perform a test. See Troubleshooting or call for assistance (see cover for phone number).

Caution! If any segments are missing in the

Display when Meter is first turned on, do not use the Meter for testing. Call for assistance.

Drop Symbol

Full Display

Control Test

We recommend performing Control Tests for practice before using your Meter for the first time to test your blood.

Control Tests should be performed:

•

For practice to ensure your testing technique is good,

• Occasionally as you use the vial of Strips,

• When opening a new vial of Strips,

• If results seem unusually high or low,

• If a vial has been left opened or exposed to extreme

heat or cold, or humidity,

• If Meter damage is suspected (Meter was dropped,

crushed, wet, etc.)

Note:

Three levels of TRUEtest Glucose Control Solution are available for Quality Control Testing. It is important to perform Control Tests with more than one level of Control to assure your System is working properly and your testing technique is good. Contact place of purchase or call for assistance to obtain Control.

Caution! Ranges printed on Strip vial label are

for Control Test results only and are not suggested levels for your blood glucose. Do not drink Glucose Control.

How to Test Glucose Control

Use ONLY TRUEtest Glucose Control Solution with the TRUE2go.

Allow Control, vial of Strips and Meter to adjust to 68-77ºF (room temperature). Write date first opened on Control bottle label and Strip vial label.

Note:

Running a Control Test at temperatures outside the range listed above may cause Control to read as a blood test.

Check dates on Control label and Strip vial label. Do not use Control or Strips if Expiration Dates have passed (Control - 3 months after opening or date next to EXP on label, whichever comes first; Strips - 4 months after opening or date next to EXP on label, whichever comes first).

Swirl or invert bottle gently to mix Control. DO NOT SHAKE!

Open vial by pushing up under the Test Port of the Meter. Remove one Strip from vial. Close vial immediately by firmly pressing down on the top of the Meter.

Note:

Use Strip quickly after removal from vial.

5. Insert Strip into Test Port. Meter

turns on.

Note:

If Strip has been out of the vial too long before testing, an error message appears upon insertion of the Strip into the Meter. Release and discard old Strip. Use new Strip for testing.

May 30, 2014

Lift Up

To Open

Press Down

To Close

Contacts

face up

6. Wait until Drop Symbol appears in

Display. Keep Strip in Meter until testing is finished.

Note: If Strip is removed before testing

is finished, an error message appears. Release and discard old Strip. Use new Strip for testing.

7. Turn Control bottle upside down.

Squeeze one drop of Control onto a clean tissue. Wipe off bottle tip.

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

With Strip still in Meter, touch edge of Sample Tip to drop of Control. Allow drop to be drawn into Strip.

10. Remove Strip from drop. D

ashes appear across the Display to show Meter is testing.

Note: If Meter does not begin testing

soon after drawing up sample, release and discard Strip. Repeat test with new Strip. If problem persists, see Troubleshooting.

LB0010

Meter Testing

Drop Symbol

11. Compare result to Control Range

printed on Strip vial label for Control Level 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 Strip.

Note: When using the meter for the first

time, check the unit of measure in the meter Display after performing a control or blood test. Result must display in the correct unit of measure (mg/dL). If the result does not display in the correct unit of measure, DO NOT use the meter and DO NOT use the meter result to determine treatment.

Caution! If Control Test result is outside range, test again.

If result is still outside range, System should not be used for testing blood. Call for assistance (see cover for phone number).

12. After result is shown, turn Meter so that

the Strip is pointing down. Press Strip Release button to release and discard Strip in appropriate container. Meter turns off.

Note: Removing Strip before result

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

Test Strip

Vial Label

Glucose Control

Bottle Label

Obtaining a Blood Sample

Refer to Lancing Device “Instructions for Use” for detailed instructions.

Caution!

The Lancing Device is for single patient use ONLY. For cleaning/disinfecting your Lancing Device see Lancing Device Care in the Lancing Device Instructions for Use. Wash your hands thoroughly with soap and warm water after handling the Meter, Lancing Device, or Test Strips. Contact with blood presents an infection risk.

• NEVER share Lancets or Lancing Device.

• Lancets are for single use only. Do not re-use.

From Fingertip

1. Prepare fingertip by washing hands in warm, soapy water.

Rinse well. Dry thoroughly.

2. Place end of Lancing Device

against tip of finger. Lance fingertip.

3. Set Lancing Device aside. To help blood drop form, lower

hand to waist level, gently massaging finger from palm to fingertip. Allow blood drop to form before attempting to apply to Test Strip.

Always recap, remove and discard used Lancet in appropriate container when testing is complete.

Note: Used Strips and lancets are considered biohazardous.

Dispose used Strips and lancets in approved biohazard container.

From Forearm

1. Select area to be lanced. Wash with soap and warm

water, rinse and dry thoroughly.

2. Rub area vigorously or apply a warm compress to

increase blood flow.

3. Place end of Lancing Device firmly

against forearm. Press trigger button. Apply firm pressure on lancing device for 10 seconds.

Note: Some lancing devices include a special end cap

for alternate site testing. Check lancing device Instructions for Use.

Important Notes Regarding Forearm Testing

•

Check with your Doctor or Diabetes Healthcare Professional to see if forearm testing is right for you.

• Results from forearm are not always the same as results from fingertip.

•

Use fingertip instead of forearm for more accurate results:

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

- If your blood sugar may be rising or falling rapidly

or your routine results are often fluctuating,

- If you are ill or under stress,

- If your forearm test results do not match how you feel,

- If your blood sugar may be low or high,

- If you do not notice symptoms when blood sugar is low or high.

Drop Symbol

How to Test Blood Glucose

Check dates on Test Strip vial being used. Do not use if either 4 months after opening or after date printed next to EXP on label, whichever comes first.

2. Wash hands (and forearm for alternate site

testing). Rinse well and dry thoroughly.

3. Remove one Strip from vial.

Close vial immediately.

Note: Use Strips quickly after removal

from vial.

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

Note:

If Strip has been out of the vial too long before testing, an error message appears upon insertion of the Strip into the Meter. Release and discard Strip. Use new Strip for testing.

Note:

To mark test as alternate site result, press Set Button. “ A ” Symbol appears in Display. Press Set Button to remove “ A ” Symbol.

5. Wait until Drop Symbol appears in

Display.

6. Lance fingertip or forearm. Allow

drop to form. (see Obtaining a Blood Sample).

Lift Up

To Open

Press Down

To Close

7. With Test Strip still in Meter, touch edge of Sample

tip to blood drop and allow blood to be drawn into Strip. Remove Test Strip Sample Tip from sample drop immediately after dashes appear across the Meter Display.

Note: If Meter does not begin testing

soon after touching blood drop to Sample Tip, discard Strip. Repeat test with new Strip and new blood drop. If problem persists, see Troubleshooting.

8. Dashes appear across Display to show Meter is

testing. Remove Strip from drop.

Note: When using the meter for the first time, check

the unit of measure in the meter Display after performing a control or blood test. Result must display in the correct unit of measure (mg/ dL). If the result does not display in the correct unit of measure, DO NOT use the meter and DO NOT use the meter result to determine treatment.

9. After the test is finished, result is displayed. Record

result in log book.

10. Hold Meter with Strip pointing down. Press Strip

Release Button to discard Strip in the appropriate container. Meter turns off.

Result is stored in Memory.

Note: Removing Strip before result displays

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

System Out of Range Warning Messages

WARNING!

Meter reads blood glucose levels from 20-600 mg/dL.

If blood test result is less than 20 mg/dL, “Lo” appears in Meter Display.

If blood test result is greater than 600 mg/dL, “HI” appears in Meter Display.

ALWAYS repeat test to confirm Low (“Lo”) and High (“HI”) results. If results still display “Lo” or “HI”, call your Doctor or Diabetes Healthcare Professional immediately.

Note: “Lo” results are included in the Average

as 20 mg/dL. “HI” results are included as 600 mg/dL.

Memory

Memory stores 99 results. When Memory is full, the oldest result is replaced with the newest result.

Press and release the Set Button. Meter turns on to view results in Memory. The last result is shown first. Press and release Set Button again to go to the next result in Memory. Continue to press and release Set Button to scroll through results. Holding the Set Button scrolls through the results quickly.

If there are no results in Memory, dashes appear across the Display.

Blood Test results are shown as “R 1” followed by the result, “R 2” followed by the result, and so on (R3, result; R4, result; …).

Control Test results are shown as “C 1” followed by the result, “C 2” followed by the result, and so on (C3, result; C4, result; …).

Alternate site Blood Test results are shown as “A 1” followed by the result, “A 2” followed by the result, and so on (A3, result; A4, result; …).

Caring for TRUE2go

• Store System (Meter, Glucose Control, Test Strips) in Carrying Case to protect from liquids, dust and dirt.

• Store in a dry place at room temperature (36-86°F).

DO NOT REFRIGERATE OR FREEZE.

Meter Care, Cleaning/Disinfection

Cleaning removes blood and soil, disinfecting removes infectious agents. To Clean the Meter (removing blood or soil):

- W

e suggest cleaning your Meter when visibly dirty. Never put Meter in liquids or allow any liquids to enter the Test Port.

- W

ipe Meter with a clean, lint-free cloth dampened with 70% Isopropyl alcohol.

Let Meter air dry thoroughly before using to test.

Do not use bleach to clean the Meter.

For assistance contact Customer Care using the phone number on the cover of the Owner’s Booklet. For Healthcare Professionals, please refer to the Quality Assurance/Quality Control Manual for instructions on Meter care, cleaning and disinfection.

The QA/QC Manual is available on our website www.niprodiagnostics.com, or call 1-800-803-6025 or 1-954-677-4599.

TRUEtest Glucose Control Care

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

• After use, wipe bottle tip clean and recap tightly.

• Store at room temperature (36-86°F).

DO NOT REFRIGERATE OR FREEZE.

TRUEtest Test Strip Care

• Store Strips in original vial only. Do not transfer old Strips to new vial or store Strips outside of vial.

• Write date opened on Strip vial. Discard unused Strips from vial if either 4 months after opening or after date printed next to EXP on label has passed, whichever comes first. Use of Strips past either date may give incorrect results.

• Close vial immediately after removing Strip. Store in a dry place below 86°F (room temperature).

DO NOT REFRIGERATE OR FREEZE.

• Do not reuse Strip.

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

Changing Battery

If “Lb” or “db” appears in Display, change battery. To replace battery:

1. Remove Meter from vial (see Attach/

Remove TRUE2go Meter to TRUEtest Test Strip Vial).

2. Turn Meter over to see Meter label

and Battery Cover are showing.

3. Place edge of a coin in slot in center

of Battery Cover. Twist coin slightly counterclockwise until Battery Cover is loose. Remove coin.

4. Holding the Meter over your other

hand, turn the Meter over. Battery Cover and battery drops out.

Turn Meter back over. Replace battery with new 3V non-rechargeable lithium battery (#CR2032), positive (“+”) side facing up.

Replace Battery Cover, with slot facing up and metal tips in notches. Firmly push Battery Cover down using edge of coin. Turn coin slightly clockwise to close.

7. Re-attach Meter to vial (see Attach/

Remove TRUE2go Meter to TRUEtest Test Strip Vial).

Slot

8. Discard old battery in appropriate container.

9. Press Set Button to turn Meter on. If Meter

does not turn on, check that battery was installed properly with “ + ” facing up. If not, remove and reinsert battery and try again. Call for assistance if problem persists.

Caution!

Batteries 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/ country specific regulations.

Action

Remove Strip. Re-insert correctly. Remove Strip. Re-insert Strip fully into Meter. Repeat with new Strip. Replace battery. Battery positive (“+”) side must face up. Call for assistance.

Action

Repeat test with new Strip and larger drop. Repeat test with new Strip. Apply sample within 2 minutes of inserting Strip. Repeat with new Strip. Call for assistance.

Reason

Strip inserted upside down or backwards Strip not fully inserted

Strip Error Dead or no battery Battery in backwards

Meter Error

Reason

Sample drop too small

Sample applied after two minute shut-off

Problem with Strip Problem with Meter

Troubleshooting

1) After inserting Test Strip, Meter does not turn on.

2) After applying sample, test does not start/

Meter does not begin testing.

For assistance, see cover for phone number.

Messages

Display

Reason

Temperature

Error

•

Too Cold/

Too Hot

Sample Not Detected or

Using Wrong

Test Strip

Used Strip,

Test Strip Outside

of Vial too Long,

Sample on Top of

Strip

Meter

Error

Test Strip Error,

Very high blood

glucose result

(higher than

600 mg/dL)

Action

Move Meter and Strips

to area between

50-104ºF; wait 10 minutes

for System to reach room

temperature

before testing.

Retest with new or

correct Strip and

larger sample.

Repeat with new Strip.

Make sure sample is

touched to edge of Strip

(not top). If error persists,

call for assistance.

Call for

assistance.

Retest with new Strip. If error

persists, call for assistance. If you have

any symptoms such as fatigue, excess

urination, thirst, or blurry vision,

follow your healthcare professional’s

advice for high blood glucose.

Messages (continued)

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

Display

Reason

Strip

Removed

During Test

Memory

Error

Low

Battery

Dead

Battery

Out of Range-

High Results

>600 mg/dL

Out of Range

Low Results

<20

mg/dL

Action

Retest with new Strip.

Make sure result

is displayed before

removing Strip.

Result was not recorded in

Memory. Retest with new

Strip. If error persists, call

for assistance.

About 50 tests

can be done before

battery dies.

Battery Symbol appears

and alert sounds before

Meter turns off.

WARNING!!

Retest with new Strip.

If result is still

“HI” (High)

or “Lo” (Low)

contact Doctor

immediately.

WARNING!!

System Specifications

Result Range: 20-600 mg/dL Sample Size: Minimum 0.5 microliter (0.5 µL) Sample:

Fresh capillary whole blood, venous blood drawn in

EDTA or heparin tubes, or Glucose Control

Test Time: Results in as little as 4 seconds Result Value: Plasma equivalent values Assay Method: Electrochemical Power Supply: One 3V Lithium Battery

#CR2032 (non-rechargeable)

Battery Life: Approximately 1,500 tests or 2 years Automatic shut-off: After two minutes of non-use Weight: 0.6 ounces Size: 1.70” x 1.46” x 0.89” Memory Size: 99 glucose results

Operating Range (Meter & Test Strips):

Relative Humidity: 10-90% (Non-condensing) Temperature: 50-104ºF Hematocrit: 20-60%

Note: Use within specified environmental conditions only.

Chemical Composition

Test Strips: Glucose dehydrogenase-PQQ (Acinetobacter

calcoaceticus), Mediators, Buffers and Stabilizers.

Glucose Control: Contents: Water, d-glucose, buffers, viscosity enhancing agents, salts, dyes and preservatives.

TRUE2go Limited Lifetime Warranty

Nipro Diagnostics, Inc. provides the following Warranty to the original purchaser of the TRUE2go Blood Glucose Meter:

1) Nipro Diagnostics Inc. warrants this Meter to be free of defects in materials and workmanship at the time of purchase. If the meter is ever inoperative, Nipro Diagnostics, Inc will replace the Meter with an equivalent Meter, at its option, at no cost to the purchaser. Failure of the meter due to abuse or use not in accordance with the instructions for use is not covered by this Warranty.

2) This Warranty does not include the battery supplied with the Meter.

3) Do not take the Meter apart. This action will void the Warranty and cause the Meter to display false results.

4) The duration of any implied Warranty, including any implied Warranty of merchantability or fitness for a particular purpose shall be limited to the lifetime in use with the original user in accordance with any state law to the contrary.

5) Nipro Diagnostics, Inc. disclaims liability for incidental or consequential damages for breach of any expressed or implied Warranty, including any implied Warranty of merchantability or fitness for a particular use with respect to the Meter. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusion may not apply.

6) This Warranty gives the user specific legal rights, and the user may also have other rights which vary state to state.

Your Nipro Diagnostics, Inc. Customer Care Representative will be able to provide detailed information regarding procedures for returning your Meter, if necessary.

References

1. American Diabetes Association. Diagnosis and Classification of Diabetes Mellitus. Diabetes Care, Volume 36, Supplement 1,

January 2013.

2. FDA Public Health Notification: Use of Fingerstick Devices on

More than One Person Poses Risk for Transmitting Blood Borne Pathogens: Initial Communication (2010) http://www.fda.gov/

MedicalDevices/Safety/AlertsandNotices.

3. CDC Clinical Reminder: Use of Fingerstick Devices on More than

one Person Poses Risk for Transmitting Bloodborne Pathogens (2010) http://www.cdc.gov/injectionsafety/Fingerstick-

DevicesBGM.html.

4. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research. Important Safety Information on

Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products. [Electronic Version}. Retrieved June 30, 2009. http://

www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ ucm154213.htm.

5. Data on file.

6. Larsson-Cohn U: Difference between capillary and venous blood glucose during oral glucose tolerance tests. Scand J Clin Lab Invest 36:805-808, 1976.

7. Atkins, S. H., Dasmahapatra, A., Jaker, M.A., Chorost, M. I., Redd, S., Fingerstick Glucose Determination in Shock. Annals of Internal Medicine, 114:1020-1024, 1991.

8. Food and Drug Administration. Blood Glucose Meters, Getting the Most Out ofYour Meter. [Electronic Version]. Retrieved December 22, 2009 from http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109371.html.

Nipro True2go Owner's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual