Nipro TrueResult Owner's Manual

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Page 1

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Owner’s

propietario

Booklet

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Use only with TRUEtest Blood Glucose Test Strips

24/7 Customer Consultation English or Spanish

1-800-803-6025 1-954-677-9201

www.niprodiagnostics.com

Manufactured by:

™

Fort Lauderdale, FL 33309 U.S.A.

Scan this code with your smart phone

for additional TRUEresult information.

Always refer to the Owner’s Booklet

for detailed product information.

Page 2

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

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INTRODUCTION: TRUEresult® Blood Glucose Monitoring System

TRUEresult 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 TRUEresult 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. e QA/QC Manual is available on our website www.niprodiagnostics.com, or call 1-800-803-6049 or 1-954-677-4599.

Importance of Blood Glucose Monitoring

e more you know about diabetes, the better you will be able to care for yourself. A Doctor or Diabetes Healthcare Professional will determine how oen you should test and what your target ranges are for blood glucose results.

Having most blood glucose results within your target range shows how well a treatment plan is working to control glucose levels. Keeping results within your target range helps slow or stop complications from diabetes.

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

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

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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.

e TRUEresult 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 aer use, even aer 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 aer handling the Meter, Lancing Device, or Test Strips as contact with blood presents an infection risk.

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FOR PATIENTS IMPORTANT HEALTH and SAFETY INFORMATION:

•

DO NOT use the TRUEresult System to test your

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

• DO NOT use the TRUEresult 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®).

e treatments listed above may cause false high glucose results when testing with the TRUEresult System.

Before using the TRUEresult 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 oen, a dry mouth, vomiting, and headache.

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FOR HEALTHCARE PROFESSIONALS IMPORTANT HEALTH and SAFETY INFORMATION:

DO NOT use the TRUEresult 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 TRUEresult System when receiving the above treatments may cause false high glucose results. 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.

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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.

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Other Important Information for Healthcare Professionals:

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

Health Related Information DO NOT perform capillary blood glucose testing on critically ill patients. Capillary blood glucose levels in critically ill

patients with reduced peripheral blood ow may not reect the true physiological state. Reduced peripheral blood ow may result from the following conditions (for example):

• shock

• severe hypotension

• severe dehydration

• hyperglycemia with hyperosmolarity, with or

without ketosis.

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IMPORTANT INFORMATION:

For the most accurate results using TRUEresult:

• Read all instructions before testing.

• TRUEresult 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 TRUEresult 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: ree 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.

• Remove only one Strip at a time from vial when

testing. Recap vial immediately aer removing Strip.

• When using the meter for the ﬁrst time, check

the unit of measure in the meter Display aer 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.

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

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

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

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

Know Your System

Meter ...................................................................................... 9-10

Meter Display ............................................................................11

Test Strip ..................................................................................12

Test Strip Vial Label ................................................................13

Glucose Control Bottle Label .................................................14

Getting Started

Quality Control .................................................................. 15-16

Control Test ........................................................................ 17-20

Testing your Blood

Obtaining a Blood Sample ................................................ 21-22

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

System Out of Range Warning Messages ............................. 25

Meter Set Up

Time and Date .................................................................... 26-27

Alert and Reminders .......................................................... 28-30

Meter Memory

Viewing Averages (7, 14 and 30-day) ...................................31

Viewing Results ........................................................................32

Care, Cleaning/Disinfection and Troubleshooting

Caring for TRUEresult ...................................................... 33-34

Changing Battery ......................................................................35

Troubleshooting ........................................................................... 36

Display Messages ............................................................ 37-38

System Speciﬁcations/Chemical Composition ........................39

Meter Warranty ............................................................................40

References ......................................................................................40

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Know Your System

Meter

① “ + ” Button

Increase numbers in Meter Set Up; add ALT

Symbol; move forward by date/time when viewing results in Memory.

② “ S ” Button

Turn Meter on to view Average values, to view

results in Memory, and to access Meter Set Up.

③ “ - ” Button Decrease numbers in Meter Set Up; remove ALT

Symbol; move backward by date/time when viewing results in Memory.

Top of Meter

1 32

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① Display Screen

Shows results, messages, user prompts, information.

② Test Port Insert TRUEtest Test Strip here.

③ Strip Release Button Releases Strip aer testing.

④ Battery Door

Use one non-rechargeable 3V lithium battery

(#CR2032), positive (“+”) side up (see Changing Battery).

⑤ Meter Label

Contains serial number of Meter and phone

number to call for assistance.

Back of Meter

Front of Meter

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Full Display Screen

1. Result is from Memory

2. Time, Date

3. Time is AM/PM

Result is from 7, 14, or 30 day Average

5. Day of Week

6. Test Result

7. Units of Measure (Note: Factory set, cannot be

changed by user.)

8. Ketone Test Alert

Testing Reminder

10. Temperature Symbol

11. Drop Symbol - Apply blood or Glucose Control

12. Alternate Site (ALT) Symbol

13. Battery Symbol

14. Control Symbol

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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

(Meter beeps and dashes move across Display)

• Do not smear or scrape drop with Strip.

• Do not apply more sample to the Strip aer

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

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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 aer 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 results must fall to assure the System is working properly.

Test Strip Vial Label

May 30, 2014

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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 aer opening or date printed next to EXP on bottle label has passed, whichever comes ﬁrst.

③ Control Level (1, 2, or 3) - ree 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 dierent levels of Control.

Glucose Control

May 30, 2014

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Getting Started

e Meter turns on when a Test Strip is inserted into the Test Port or when “ S ” Button is pressed (see Memory and Meter Set Up). Meter turns o when the Strip is released from the Meter or aer 2 minutes of non-use.

Meter comes with pre-set time, date and all testing Alerts and Reminders o. Before using the Meter for the ﬁrst time or aer a battery change, check the time, date, Alerts and Reminders, and update as needed (see Meter Set Up).

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Full Display

Quality Control Testing

To assure you are getting accurate and reliable results, TRUEresult oers two kinds of quality control tests. ese tests let you know that your TRUEresult 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. e Meter is working properly if:

- the full Display appears, then

- the time appears in the upper part of the Display, and then,

- the Drop Symbol begins to blink. If an error message appears in the

Display, the Meter will not perform a test. See Troubleshooting or call for assistance (see 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.

Contacts Facing Up

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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 le opened or exposed to extreme

heat or cold, or humidity,

• If Meter damage is suspected (Meter was dropped,

crushed, wet, etc.)

Note:

ree 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.

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Contacts

face up

How to Test Glucose Control

Use ONLY TRUEtest Glucose Control Solution with the TRUEresult Meter.

Allow Control, vial of Strips and Meter to adjust to

68°-77°F (room temperature). Write date ﬁrst opened

on both 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 aer opening or date next to EXP

on label, whichever comes ﬁrst; Strips - 4

months aer opening or date next to EXP

on labels, whichever comes ﬁrst.) Discard

expired products and use new products.

3. Swirl or invert bottle gently to mix Control.

DO NOT SHAKE!

4. Remove one Strip from vial. Close Strip vial

immediately.

Note: Use Strip quickly aer 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

Page 21

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 o bottle tip.

Gently squeeze a Control drop onto

a small piece of unused aluminum

foil or clear plastic wrap. Dispose

aer use.

With Strip still in Meter, touch edge

of Sample Tip to drop of Control.

Allow drop to be drawn into Strip.

Remove Strip from drop when

Meter beeps.

10.

Dashes appear across the Display to

show Meter is testing.

Note: If Meter does not beep and begin

testing soon aer drawing up sample, release and discard Strip. Repeat test with new Strip. If problem persists, see Troubleshooting.

LB0010

Drop Symbol

Meter testing

Page 22

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: Control Test result shows

the Control Symbol in the Display.

Note:

When using the meter for the ﬁrst time, check the unit of measure in the meter Display aer 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. Aer result is shown, Strip Release Button

ashes. Hold Meter with Test Strip pointing

down. Press Strip Release Button to release

and discard Strip in appropriate container.

Meter turns o.

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.

Control Symbol

Test Strip

Vial Label

Glucose Control

Bottle Label

Page 23

Obtaining a Blood Sample

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

Caution!

e 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 aer 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.

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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 ow.

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 oen uctuating,

- 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.

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How to Test Blood Glucose

1. Check dates on Test Strip vial being used. Do

not use if either 4 months aer opening or aer 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 aer removal from vial.

4. With Meter o, 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 old Strip. Use new Strip for testing.

Note:

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

5. Wait until Drop Symbol appears in

Display.

6. Lance ﬁngertip or forearm. Allow

drop to form (see Obtaining a Blood

Sample).

Drop Symbol

Page 26

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 aer the Meter beeps and dashes appear across the Meter Display.

Note: If Meter does not begin testing

soon aer 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.

9. Aer the test is ﬁnished, result is displayed. e

Strip Release Button ashes. Record result in log book.

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

the unit of measure in the meter Display aer 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.

10. Hold Meter with Strip pointing down. Press Strip

Release Button to discard Strip in the appropriate container. Meter turns o. Result is stored in Memory with day, date and time.

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.

Page 27

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.

If blood glucose test result is greater than 240 mg/dL, and Ketone Testing Alert is turned on, “Ketone” appears in Display with glucose result (see Ketone Testing Alert).

Note: Ketone Testing Alert can be

turned on or o during Meter Set-up.

Ketone Alert

Page 28

Meter Set Up

Note: If the Meter turns o at any

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

1. Press and hold “ S ” until the

full Display is shown and a tone sounds (around 30 seconds). Release “ S ”. Meter goes into Set Up.

Set Time/Date

2. e hour ashes. To change, press

“ + ” or “ - ” 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 “ S ” to set.

Note: “AM” or “PM” does not display if Meter is

factory set to 24-hour clock.

3. e minutes ash. To change, press

“ + ” or “ - ” to select the minutes. Press “ S ” to set.

Page 29

4. e month (number) ashes.

To change, press “ + ” or “ - ” to select the month. Press “ S ” to set.

5. e day (number) ashes. To

change, press “ + ” or “ - ” to select the day. Press “ S ” to set.

6. e year ashes. To change,

press “ + ” or “ - ” to select the year. Press “ S ” to set.

Note: Day of the week (Mon, Tue,

Wed, u, Fri, Sat, Sun) selfadjusts when month, day or year are changed.

Note: Meter beeps every time a setting

is conﬁrmed (“ S ” is pressed).

Page 30

Setting Alert

Ketone Testing Alert

Note: If the Meter turns o at any time during Set

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

When a blood glucose result is over 240 mg/dL, the Ketone Testing Alert is a reminder to check your ketones per your treatment plan.

1. Aer setting year, press “ + ” or

“ - ” to turn Alert on or o. Press “ S ” to set.

Caution! When a Ketone Testing Alert sounds,

it does not mean that ketones have been detected in your blood. Perform a ketone test per your health plan, as prescribed by your Doctor or Healthcare Professional.

Page 31

Testing Reminder

Up to four Testing Reminders per day may be set. Reminder sounds at set time for 10 seconds.

To set the Testing Reminders:

1. Aer pressing “ S ” to set Ketone

Testing Alert, Display shows ﬁrst Reminder setting (A-1). Press “ + ” (on) or “ - ” (o) to turn Reminder on or o.

2. If “on” is chosen, press “ S ” . e

hour ashes. Press “ + ” or “ - ” to set the hour. To set AM/PM, scroll (press “ + ” or “ - ”) until “AM” or “PM” is next to correct time. Press “ S “ to set.

Note: “AM” or “PM” will not display if the Meter

is factory set to 24-hour time format.

If “o” is chosen and the “ S ” is pressed,

the Meter goes to the next Testing Reminder.

3. Press “ + ” (on) or “ - ” (o) to turn

Reminder on or o.

4. e minutes ash. Press “ + ” or

“ - ” to set the minutes. Press “ S ” to set.

Ketone Testing

Alert

Page 32

5. Turn Reminders on and repeat

setting the time for next 3 Reminders (if needed).

6. Press and hold “ S ” when ﬁnished

to turn o Meter. Meter turns o aer 2 minutes of non-use.

Note: If Alert or Testing Reminders are

set, the Alert Symbol appears in all Displays.

Note: If battery dies or is replaced,

Alert and Testing Reminders may have to be reset.

Exit Set-Up

Press and hold “ S ” until Meter turns o. Set-up choices are saved.

Alert Symbol

Page 33

Viewing Averages (7, 14 and 30-Day)

e Averages feature allows you to view the average of all your blood glucose results within a 7, 14, or 30 day period. Control Test results are not normally included in the Averages.

Note: If a Control Test is performed

outside the recommended testing temperature (see How to Perform a Control Test), the Control may read as a blood test and be included in the Averages.

You can review the average of your glucose results from the last 7, 14, or 30 days.

1. Start with Meter o. Press and

release “ S ” Button. Display scrolls through 7, 14 and 30-Day Average values.

2. Meter turns o aer 2 minutes

if no buttons are pressed.

Note: If there are no Average values,

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

No Average

30-Day

Average

14-Day

Average

7-Day

Average

Page 34

Viewing Results in Memory

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

Press and release “ S ” Button. Meter displays 7, 14 and 30-day Averages. Press and release “ S ” again to view most recent Control Test result in Memory. If there are no results in Memory, dashes appear with the Memory Symbol.

2. Press “ + ” and release to advance

to the ﬁrst blood test. Press “ + ” to scroll forward through results or “ - ” 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.

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

Ketone Testing

Alert

Control Symbol

Alternate Site

Symbol

Page 35

Caring for TRUEresult

• 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 the 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.

e QA/QC Manual is available on our website www.niprodiagnostics.com, or call 1-800-803-6049 or 1-954-677-4599.

Page 36

TRUEtest Glucose Control Care

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

• Aer 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 aer opening or aer 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 aer removing Strip. Store in a dry place at room temperature below 86°F.

DO NOT REFRIGERATE OR FREEZE.

• Do not reuse Strip.

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

Page 37

Battery

Door

Tab

Changing Battery

A low battery displays Battery Symbol while continuing to function. A dead battery displays Battery Symbol, beeps, and then turns o. To replace battery:

1. Li tab on Battery Door.

2. Turn Meter over, tap gently on

the palm of your other hand to loosen and remove battery.

3. Discard old battery into

appropriate container.

4. Insert new battery, positive (“+”)

facing up. Close Battery Door.

Note: Use non-rechargeable 3V lithium battery

(#CR2032).

Press “ S ” 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 “ S ” . Call for assistance if problem persists.

Low

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.

Page 38

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 aer two minute shut-o

Problem with Strip Problem with Meter

Troubleshooting

1) Aer inserting Test Strip, Meter does not turn on.

2) Aer applying sample, test does not start/

Meter does not beep or begin testing.

For assistance, see cover for phone number.

Page 39

Messages

Display

Reason

Temperature

Error

•

Too Cold/

Too Hot

Sample Not Detected or

Using Wrong

Test Strip

Used Strip,

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

TRUEtest Test 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 symptoms such as fatigue, excess urination,

thirst, or blurry vision, follow your healthcare professional's

advice for high blood glucose.

Page 40

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

Communication

Error

Low or

Dead

Battery

WARNING!!

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 a

new strip. If error persists,

call for assistance.

Call for assistance.

Low: About 50 tests can be

done before battery dies.

Dead: Battery Symbol

appears and beep sounds

before Meter turns o.

WARNING!!

Retest with new Strip.

If result is still

“Hi” (High)

or “Lo” (Low)

contact Doctor

immediately.

Page 41

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 values Assay Method: Electrochemical Power Supply: One 3V lithium battery

#CR2032 (non-rechargeable)

Battery Life: Approximately 2146 tests or 1.5 years Automatic shut-o: Aer two minutes of non-use Weight: 1.66 ounces Size: 3.44” x 2.16” x 0.69” Memory Size: 500 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

TRUEtest Test Strips: Glucose dehydrogenase-PQQ

(Acinetobacter calcoaceticus), mediators, buers and stabilizers. TRUEtest Glucose Control: Contents: Water, d-glucose, buers, viscosity enhancing agent, salts, dye and preservatives.

Page 42

TRUEresult Limited Lifetime Warranty

Nipro Diagnostics, Inc. provides the following Warranty to the original purchaser of the TRUEresult 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) is Warranty does not include the battery supplied with the Meter.

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

4) e 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) is 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/FingerstickDevicesBGM.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. www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm.

5. Data on ﬁle.

6. Larsson-Cohn U: Dierence 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.

E4NPD04 Rev. 25