Roche ACCU-CHECK User Manual

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Page 1

User’s Manual

Blood Glucose Meter

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Contents

Introduction ............................................................................................................................3

Chapter 1: Your New System ..................................................................................................5

Chapter 2: Blood Glucose Tests .............................................................................................13

Chapter 3: Control Tests ........................................................................................................25

Chapter 4: Meter Settings .....................................................................................................31

Chapter 5: Review Your Data.................................................................................................53

Chapter 6: Wireless Communication and Meter Pairing .........................................................71

Chapter 7: Meter Maintenance and Troubleshooting .............................................................85

Chapter 8: Technical Information ..........................................................................................97

Chapter 9: Guarantee .......................................................................................................... 103

Index ..................................................................................................................................105

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Introduction

The Accu-Chek Guide System

The Accu-Chek Guide test strips with the Accu-Chek Guide meter are intended to quantitatively measure glucose in fresh capillary whole blood from the ﬁnger, palm, forearm, and upper arm as an aid in monitoring the eectiveness of glucose control.

The Accu-Chek Guide test strips with the Accu-Chek Guide meter are intended for in vitro diagnostic self-testing by people with diabetes.

The Accu-Chek Guide test strips with the Accu-Chek Guide meter are intended for in vitro diagnostic use by healthcare professionals in clinical settings. Venous, arterial, and neonatal blood testing is limited to healthcare professional use.

This system is not for use in diagnosis of diabetes mellitus, nor for testing neonate cord blood samples.

Suitable for self-testing

The system includes:

Accu-Chek Guide meter with batteries, Accu-Chek Guide test strips,* and Accu-Chek Guide control solutions*.

*Some items may not be included in the kit. They are a separate purchase.

wWARNING

• Choking hazard. Small parts. Keep away from children under the age of 3years.

• Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Third Edition; CLSI document M29-A3, 2005).

Introduction

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Introduction

Why Regular Blood Glucose Testing Is Important

Testing your blood glucose regularly can make a big dierence in how you manage your diabetes every day. We have made it as simple as possible.

Important Information About Your New Meter

• The meter may prompt you to choose a language and the time format (12-hour or 24-hour clock) the ﬁrst time you turn it on.

• Check the time and date on the meter before you begin testing. Adjust the time and date if necessary.

• Sample data screens are shown throughout the manual. Your data will dier.

• If you follow the steps in this manual but still have symptoms that do not seem to match your test results, or if you have questions, talk to your healthcare professional.

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Your New System

1. Display

Shows results, messages, and test results stored in memory.

2. Back Button

Returns to a previous display or ﬁeld.

3. Up Arrow and Down Arrow Buttons

Press to move between menu options or to increase or decrease numbers.

4. Power/Set/OK Button

Turns meter on or o and sets options.

5. Test Strip Slot with Light

Insert test strip here.

6. Battery Door

Flip open to replace batteries.

7. Micro USB Port

Transfers data from the meter to a computer (PC).

8. Test Strip Ejector

Press to remove test strip.

The Accu-Chek Guide Meter

Front View

Chapter 1: Your New System

Back View

Side View

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Your New System

9. Test Strip Container*

10. Metallic End

Insert this end into meter.

11. Yellow Edge

Touch blood drop or control solution here.

12. Control Solution Bottle*

13. Batteries

14. USB Cable*

Connects the meter to a PC.

* Some items may not be included in the kit.

They are a separate purchase.

(for example)

Test Strip

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Your New System

Button Functions

Here are the functions of the back, arrow, and Power/Set/OK buttons on the meter. These functions are used throughout this manual. See the chapter Meter Settings for speciﬁc instructions on setting up the meter.

Button Function

Back Button

Return to the previous display.

Return to the previous ﬁeld.

Up Arrow and Down

Arrow Buttons

Navigate up and down in a menu.

Increase or decrease a number.

Power/Set/OK Button

Press brieﬂy to turn the meter on.

Press and hold to turn the meter o.

Press to select an option.

Press to move to the next ﬁeld or display.

Press to save an option.

With the meter o, press and hold to check the meter display.

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Your New System

Meter Menus

1 Title of display or menu 2 Menu options 3 Scroll down 4 Scroll up

Display Description

There are more menu options listed beneath the last option. Press on the meter to view the options.

There are more menu options listed above the ﬁrst option. Press on the meter to view the options.

There are more menu options listed above and below the options. Press or on the meter to view the options.

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Your New System

Display Description

Highlighted option (Test)

Press

to enter the Test menu.

Highlighted ﬁeld (Hour)

Press

or to increase or decrease the hour. Press to set

the hour and move to the minutes ﬁeld.

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Your New System

Symbols

Here is a list of the symbols on the meter display.

Symbols Description

Above target range

After meal

Bedtime

Before meal

Below target range

Blood glucose test

Checkmark / Control test OK / Selected option or setting

Control bottle

Control test not OK

Edit

Error

Fasting

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Your New System

Symbols Description

Flight mode

Help

Low battery

My data

No comment

Other

Overall

Settings

Test reminder

Warning

Within target range

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Your New System

Setting the Language and Time Format

The meter may prompt you to choose a language and time format (12-hour or 24-hour clock) the ﬁrst time you turn it on.

Turn the meter on by briefly pressing . Language appears.

Press or to highlight the language. Press to set the desired language and return to

Main Menu.

If the meter prompts you to set the time format:

Time Format appears. Press or to highlight 12 hour (am/pm) or 24 hour.

Press

to set the option and

return to Main Menu.

2 3

NOTE

If you select the wrong language and cannot correct it, contact Roche.

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Blood Glucose Tests

wWARNING

Blood glucose results can be displayed in either mg/dL or mmol/L. The back label of the meter shows the unit of measurement. If the meter shows the wrong unit, contact Roche. If you do not know which unit of measurement is correct for you, contact your healthcare professional. Using the wrong unit of measurement may cause misinterpretation of your actual blood glucose level and may lead to improper therapy.

mg/dL or mmol/L is printed here

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Blood Glucose Tests

Using the Accu-Chek Guide System

• Use only Accu-Chek Guide test strips.

• Use the test strip immediately after removing it from the test strip container.

• Do not apply blood or control solution to the test strip before inserting it into the meter.

• Close the test strip container tightly immediately after removing a test strip to protect the test strips from humidity.

• Store the unused test strips in their original test strip container with the cap closed.

• Check the use by date on the test strip container. Do not use the test strips after that date.

• Store the test strip container and meter in a cool, dry place such as a bedroom.

• Refer to the test strip package insert for test strip storage and system operating conditions.

wWARNING

Do not store test strips in high heat and moisture areas (bathroom or kitchen)! Heat and moisture can damage test strips.

Performing a Blood Glucose Test with Blood from Your Fingertip

NOTE

• Before you perform your ﬁrst blood glucose test, set up the meter correctly.

• You need the meter, a test strip, and a lancing device with a lancet inserted to perform a blood glucose test.

• A blood glucose test cannot be performed while the meter is connected to a PC with a USB cable.

• There are 2ways to start a blood glucose test.

• Insert a test strip into the meter.

• Turn the meter on by brieﬂy pressing

. Select Test > .

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Blood Glucose Tests

Wash your hands with warm soapy water and dry thoroughly.

Prepare the lancing device.

Check the use by date on the test strip container.

Do not use test strips past the use by date.

Remove a test strip from the test strip container.

Close the cap tightly.

2 3

Insert the metallic end of the test strip into the meter.

The meter turns on. Preparing

to test appears.

When Apply drop appears, perform a fingerstick with the lancing device.

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Blood Glucose Tests

Gently squeeze your finger to assist the blood flow. This helps you get a blood drop.

Touch the yellow edge of the test strip to the blood drop. Do not put blood on top of the test strip.

Analyzing appears when there is enough blood in the test strip.

The test result appears on the display.

You have the option of adding a comment to the test result by pressing

OR proceed to Step11 to complete the test.

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Blood Glucose Tests

Add Comment appears. Press to highlight a comment. Press to set the comment for the test result. See the Adding Comments to Blood Glucose Results section of this chapter for details.

The final result appears. Press or to set the comment and return to Main Menu. Or to change the comment, press to select the comment.

Press

to return to Add Comment.

9 10

Remove and discard the used test strip by pulling the test strip out of the meter or by pushing the test strip ejector on the side of the meter.

or or

Press here to eject test strip

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Blood Glucose Tests

Blood glucose may be lower than the measurement range of the system. See the Unusual Blood Glucose Results section of this chapter.

Blood glucose may be higher than the measurement range of the system. See the Unusual Blood Glucose Results section of this chapter.

Blood Glucose Warnings

If your blood glucose result is outside the measurement range of the meter, a warning is displayed. Press

to acknowledge the LO or HI warning, OR the meter automatically moves to the LO or HI result display.

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Blood Glucose Tests

Adding Comments to Blood Glucose Results

NOTE

Analyzing your blood glucose results stored in the meter is an eective way for you and your healthcare professional to determine how well you are controlling your diabetes. This analysis is a valuable tool for making improvements to your diabetes management. Use care when adding comments to blood glucose results. Incorrect comments can cause inaccurate patterns to be detected by the meter when Patterns is On.

Overview

It is very important to have the correct time and date set in the meter. Having the correct time and date setting helps ensure accurate interpretation of information by you and your healthcare professional.

• You may add comments to blood glucose results to help you and your healthcare professional analyze patterns detected by the meter (see the Patterns section in the chapter Meter Settings for details).

• If Patterns is set to On, once a pattern is detected you may NOT change the comment attached to a blood glucose result (see the Patterns section in the chapter Meter Settings for details).

• Adding a comment saves the comment and the symbol with the blood glucose results.

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Blood Glucose Tests

Here is a list of comment symbols that can be added to a blood glucose result.

Symbols Name Description

Before meal If Patterns is On, select Before breakfast, lunch, dinner, or snack (see the

following page for adding comments with Patterns On).

After meal If Patterns is On, select After breakfast, lunch, dinner, or snack (see the

following page for adding comments with Patterns On).

Fasting Select Fasting for no caloric intake for at least 8 hours.*

Bedtime

Other comment

You can use this comment to mark an event such as an AST result or exercise.

No entry 1. You do not want to add a comment.

2. You want to remove a comment for the current blood glucose result.

* American Diabetes Association: Standards of Medical Care in Diabetes-2013.

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Blood Glucose Tests

The ﬁnal result appears with the comment symbol. Press

or to set the comment and return to Main Menu.

To change the comment, press

to select the comment.

Press

to return to Add Comment.

After performing a blood glucose test, the test result is displayed on the screen with Add Comment highlighted. Press to add a comment.

The Add Comment menu appears. Press to highlight the desired comment (the example here is Before meal). Press to select the comment.

1 2

If Patterns is On:

If Patterns is on and you select Before meal or After meal, press

to select a speciﬁc meal (Breakfast, Lunch, Dinner, or Snack). Press to set the selected meal for the test result.

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Blood Glucose Tests

Performing a Blood Glucose Test with Blood from Your Palm, Forearm, or Upper Arm (Alternative Site Testing)

You have the option of obtaining a blood sample from other sites on your body besides the ﬁngertip. Alternative sites include the palm, forearm, and upper arm.

Blood obtained from the ﬁngertip and palm can be used at any time to perform a blood glucose test.

If blood from the forearm or upper arm is used, there are certain times when testing is not appropriate. This is because your blood glucose level changes faster in your ﬁngertip and palm than in the forearm and upper arm. These dierences may cause you to misinterpret your actual blood glucose level, leading to improper therapy and potential adverse health eects.

Read the next section before you try testing from the forearm or upper arm.

You may perform a forearm or upper arm test

• immediately before a meal.

• while fasting.

You may NOT perform a forearm or upper arm test

• up to 2hours following a meal, when blood glucose values can rise quickly.

• after injecting bolus insulin, when blood glucose values can decrease rapidly.

• after exercise.

• if you are sick.

• if you think your blood glucose is low (hypoglycemia).

• if you sometimes do not notice when your blood glucose is low.

wWARNING

Do not use alternative site testing to calibrate a continuous glucose monitoring system or to make insulin dosing calculations.

If you are interested in AST, talk to your healthcare professional ﬁrst.

To obtain an AST cap and detailed AST instructions, contact Roche.

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Blood Glucose Tests

Unusual Blood Glucose Results

If your blood glucose result does not match how you feel, check this list to help solve the problem.

Troubleshooting Checks Action

Were the test strips expired? Discard the test strips if they are past the use by

date. Repeat the blood glucose test with an unexpired test strip.

Was the cap on the test strip container always closed tightly?

Replace the test strips if you think the test strip container was uncapped for some time. Repeat the blood glucose test.

Was the test strip used immediately after it was removed from the test strip container?

Repeat the blood glucose test with a new test strip.

Were the test strips stored in a cool, dry place? Repeat the blood glucose test with a properly

stored test strip.

Did you follow the directions? See the chapter Blood Glucose Tests and repeat

the blood glucose test. Contact Roche if you still have problems.

Are the meter and test strips working properly? Perform a control test. See the chapter Control

Tests for instructions.

Are you still unsure of the problem? Contact Roche.

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Blood Glucose Tests

Symptoms of Low or High Blood Glucose

Being aware of the symptoms of low or high blood glucose can help you understand your test results and decide what to do if they seem unusual.

Low blood glucose (hypoglycemia): Symptoms of hypoglycemia may include, but are not limited to, anxiety, shakiness, sweating, headache, increased hunger, dizziness, pale skin color, sudden change in mood or irritability, fatigue, diculty concentrating, clumsiness, palpitations, and/or confusion.

High blood glucose (hyperglycemia): Symptoms of hyperglycemia may include, but are not limited to, increased thirst, frequent urination, blurred vision, drowsiness, and/or unexplained weight loss.

wWARNING

If you are experiencing any of these symptoms, or other unusual symptoms, test your blood glucose from the ﬁngertip or palm. If your blood glucose result is displayed as LO or HI, contact your healthcare professional immediately.

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Control Tests

When to Perform a Control Test

Performing a control test lets you know the meter and test strips are working properly. You should perform a control test when:

• you open a new test strip box.

• you left the test strip container open.

• you think the test strips are damaged.

• you want to check the meter and test strips.

• the test strips were stored in extreme temperatures, humidity, or both.

• you dropped the meter.

• your test result does not match how you feel.

• you want to check if you are performing the test correctly.

About the Control Solutions

• Use only Accu-Chek Guide control solutions.

• Close the control solution bottle tightly after use.

• Write the date you open the control solution bottle on the bottle label. The control solution must be discarded 3months from the date the control solution bottle was opened (discard date) or on the use by date on the bottle label, whichever comes ﬁrst.

• Do not use control solution that is past the use by or discard date.

• Refer to the control solution package insert for control solution storage conditions.

• The meter automatically recognizes the dierence between the control solution and blood.

• The control results are not displayed in memory.

• The control solution can stain fabric. Remove stains by washing with soap and water.

Chapter 3: Control Tests

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Control Tests

Performing a Control Test

You need the meter, a test strip, and control solution Level 1 or Level 2.

Check the use by date on the test strip container. Do not use test strips past the use by date.

Remove a test strip from the test strip container.

Close the cap tightly.

1 2

Insert the metallic end of the test strip into the meter. Place the meter on a flat surface.

The meter turns on. Preparing

to test appears.

Apply drop appears.

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Control Tests

Select the control solution to test. You will enter the level later in the test.

Remove the bottle cap. Wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip.

Touch the drop to the yellow edge of the test strip. Do not

put control solution on top of the test strip.

Analyzing appears when there is enough control solution in the test strip.

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Control Tests

Control Result and the control bottle symbol appear. Press or to select the control level you tested. If you do not select a level, the control result is saved without a control level. Press .

Within range and appear if the control result

is within range.

Out of range and

appear if the control result

is out of range.

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Control Tests

Wipe the tip of the bottle with a tissue. Cap the bottle tightly.

Remove and discard the used test strip.

NOTE

The meter turns o 90seconds after a successful test or 15seconds after the test strip is removed, provided no other action is taken.

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Control Tests

Understanding Out-of-Range Control Results

wWARNING

The control ranges are printed on the test strip container label. If the control result is out of range, check this list to help solve the problem.

Troubleshooting Checks Action

Were the test strips or control solutions expired? Discard the test strips or control solution if either is

past the use by date. If the control solution was opened more than 3months ago, discard it. Repeat the control test with an unexpired test strip and an unexpired control solution.

Did you wipe the tip of the control solution bottle before use?

Wipe the tip of the bottle with a tissue. Repeat the control test with a new test strip and a fresh drop of control solution.

Were the caps on the test strip container and the control solution bottle always closed tightly?

Replace the test strips or control solution if you think either was uncapped for some time. Repeat the control test.

Was the test strip used immediately after it was removed from the test strip container?

Repeat the control test with a new test strip and a fresh drop of control solution.

Were the test strips and control solutions stored in a cool, dry place?

Repeat the control test with a properly stored test strip or control solution.

Did you follow the directions? Read the chapter Control Tests and repeat the

control test.

Did you choose the correct control solution level, either 1 or 2, when you performed the control test?

If you chose the wrong control solution level, you can still compare the control result to the range printed on the test strip container.

Are you still unsure of the problem? Contact Roche.

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Meter Settings

Overview

You can adjust the following settings in the meter for your personal preferences. Refer to the sections later in this chapter for details and how to set the options.

Setting Options Function

Time/Date Time / Date Set the time and date.

Beeper On / O Select On or O.

Wireless Select wireless communication settings. See the chapter Wireless Communication

and Meter Pairing.

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Meter Settings

Setting Options Function

Target Ranges O / Single Range / 2 Ranges Select the blood glucose target range

appropriate for you.

NOTE

Consult your healthcare professional for the appropriate target range for you.

O – no target range arrow symbols appear with blood glucose result. Patterns is O (see the Patterns section of this chapter for details).

70–160mg/dL (pre-set target range)

3.9–8.9mmol/L (pre-set target range)

Single Range – blood glucose results are marked as above, within, or below range based on the single target range set in the meter.

Before Meal Range

70–110mg/dL (pre-set target range)

3.9–6.1mmol/L (pre-set target range)

After Meal Range

70–160mg/dL (pre-set target range)

3.9–8.9mmol/L (pre-set target range)

2 Ranges – set Before Meal and After Meal ranges. Blood glucose results are marked as above, within, or below range based on the 2 target ranges (Before Meal and After Meal) set in the meter.

Patterns On / O On – a pattern is detected when 2

below-target or 3 above-target test results with the same comment are detected within a 7-day period.

Reminders On / O / Edit time On – set up to 4 reminders per day to

remind you to test.

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Meter Settings

Setting Options Function

Post Meal On / O / Edit time On – reminds you to perform an after meal

blood glucose test.

Last Result On / O Select whether the previous blood glucose

result (within the past 24hours) appears with the current blood glucose result.

On – the previous blood glucose result appears with the current blood glucose result.

O – only the current blood glucose result appears.

Language Select the language for the meter.

Time Format 12 hour / 24 hour Select the clock format for the meter.

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Meter Settings

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Time/Date is highlighted.

Press .

Press or to adjust each field. Press to set and move to the next field. Set am or pm if necessary.

Press

to save and return to

the previous menu.

Time/Date

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Meter Settings

The beeper prompts you:

• when a test strip is inserted.

• to apply blood or control solution to the test strip.

• when enough blood or control solution is drawn into the test strip.

• when the blood glucose or control test is complete.

• when the meter is turned on.

• when a button is pressed.

• when it is time to perform a test (if Reminders or Post Meal reminders are On).

• when the batteries are inserted.

• when there are no stored blood glucose results or there is an invalid record in the logbook.

• when there are no errors in the error log.

• if an error occurred (even if the beeper is o, it still beeps for an error).

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Beeper. Press .

Press or to highlight On or Off. Press to move to the option.

Press

to set the option and

return to the previous menu.

Beeper

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Meter Settings

Target Ranges

Your healthcare professional can tell you what blood glucose range is appropriate for you. It is very important to stay within your target range.

Target Ranges can be set from a lower limit of 50–100mg/dL (2.8–5.5mmol/L) to an upper limit of 101–200 mg/dL (5.6–11.1mmol/L).

Options Function

O Arrow symbols for above, within, or below target ranges do not appear with the blood

glucose results.

Single Range Set lower limit and upper limit for the Target Range.

You will be prompted to turn on Patterns if desired (see the Patterns section of this chapter for details).

2 Ranges Set lower limits and upper limits for Before meal and After meal target ranges.

You must mark your blood glucose results with a comment for the meter to detect above, within, or below Before Meal or After Meal test results (see the Adding Comments to Blood Glucose Results section in the chapter Blood Glucose Tests for details).

You will be prompted to turn on Patterns if desired (see the Patterns section of this chapter for details).

When Target Ranges is On, the following symbols appear with blood glucose results.

Symbol Meaning

The blood glucose result is below the target range.

The blood glucose result is within the target range.

The blood glucose result is above the target range.

Target Ranges

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Meter Settings

Target Ranges is highlighted. Press .

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight More Options. Press .

wWARNING

This function is no substitute for hypoglycemia training by your healthcare professional.

Target Ranges

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Meter Settings

The appears next to the option you selected.

Press

to return to the

previous menu.

The meter may prompt you to turn on Patterns.

Press

or to highlight Yes or No.

Press

to set the option and return to the previous menu (see the

Patterns section of this chapter for details).

Target Ranges

Press or to adjust the lower limit of the Before Meal target range. Press to set and move to the next field.

Continue to set the upper limit for the Before Meal range and the upper and lower limits for the After Meal target range. Press

Press or to highlight Off, Single Range, or 2 Ranges. Press to select an option (the example here is 2 Ranges).

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Meter Settings

NOTE

Patterns

A Pattern is detected by the meter when 2below-target (Low Pattern) or 3above-target (High Pattern) test results with the same comment are detected within a 7-day period.

• The meter does NOT detect a pattern for the “other” comment added to blood glucose results.

• It is very important to have the correct time and date set in the meter. Having the correct time and date setting helps ensure accurate interpretation of information by you and your healthcare professional.

• Only blood glucose results marked with comments will be included in Patterns. If LO or HI test results are marked with comments, the results become part of Patterns (see the chapter Blood Glucose Tests for more details).

• Target Ranges must be set in the meter to use Patterns. If Target Ranges is not set, the meter prompts you to set them.

Patterns

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Meter Settings

Press to highlight More Options. Press .

Press to highlight Patterns. Press .

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Patterns

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Meter Settings

Patterns

This message appears if Target Ranges is O:

Press to highlight Yes. Press

(To turn Patterns O, select No. Press

to return to Patterns.)

Target Ranges appears on the display (see the Target Ranges section of this chapter for details on setting target ranges).

Press to highlight On. Press

to move to the option.

Press .

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Meter Settings

If Patterns is On and a new pattern is detected with a blood glucose result, a message appears on the display.

Press

to select Details to view the blood glucose results that make up that pattern.

Press

to highlight View

Later.

Press

to return to the

previous screen.

Patterns

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Meter Settings

Reminders

You can set up to 4general test Reminders per day to remind you to test. A series of beeps sound and is displayed for Reminders set in the meter.

Reminders:

• turn o by inserting a test strip or pressing any button.

• are postponed until the next test reminder if a test was performed within 15minutes of a test reminder.

• do not appear/beep if the meter is on at the test reminder time (including when meter is connected to a USB cable).

• do not appear/beep if the meter is connected and communicating to a Continua Certiﬁed

manager.

• do not beep if the meter’s beeper is set to o.

• do not appear/beep if the batteries need to be replaced.

Set Reminders

• Reminder times are pre-set in the meter for 8:00, 12:00, 18:00, and 22:00. You may change reminder times by following the instructions below.

• If a general test Reminder is set for the same time as a Post Meal reminder, the Post Meal reminder will appear/beep instead of the general Reminder (see the Post Meal Reminders section of this chapter for details).

Reminders

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Meter Settings

Pre-set reminder times appear on the display. Press to highlight a Reminder time. Press .

Reminders

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press

Press to highlight More Options. Press .

Press or to highlight Reminders. Press .

1 2

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Meter Settings

To change the Reminder time shown:

Press

to highlight Edit time.

Press .

Press

or to adjust each ﬁeld. Press to move to the next ﬁeld. Press to return to the previous menu.

A indicates the Reminder is set for the time shown and automatically set to On. To turn the reminder off, press to highlight Off.

Press

to return to Reminders.

The pre-set reminder time appears. Press or to select On or Off. Press to move to the option.

Reminders

The reminder time appears.

Press

to continue to set additional reminders

or press to return to More Options.

6 7

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Meter Settings

Post Meal Reminders

Post Meal reminders can be set to remind you to test again later when you add a Before Meal comment to a blood glucose result. When a reminder occurs, a series of beeps sound and is displayed.

Post Meal reminders:

• turn o by inserting a test strip or pressing any button.

• are postponed until the next reminder if a test was performed within 15minutes of a test reminder.

• do not appear/beep if the meter is on at the test reminder time (including when meter is connected to a USB cable).

• do not appear/beep if the meter is connected and communicating to a Continua Certiﬁed

manager.

• do not beep if the meter’s beeper is set to o.

• do not appear/beep if the batteries need to be replaced.

Set Post Meal Reminders

• Adding a Before Meal comment to a blood glucose result sets a Post Meal reminder in the meter.

• Marking blood glucose results with a Post Meal comment provides more information about your test results to help you and your healthcare professional in the management of your diabetes.

• Talk with your healthcare professional to determine your Post Meal test time.

• Select 1hour, 1.5hours, or 2hours for Post Meal reminders to occur.

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Meter Settings

Post Meal Reminders

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight More Options. Press .

Press to highlight Post

Meal. Press .

1 2 3

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Meter Settings

Press or to highlight On. Press to move to the option.

Press to highlight Edit time. Press .

Press or to highlight 1hour, 1.5hours, or 2hours after a meal for Post Meal reminders to occur.

Press

to move to the

option.

Press

to set and return to

the previous menu.

4 5 6

Post Meal Reminders

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Meter Settings

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

O – only the current blood glucose result 1 appears.

On – the previous blood glucose result

2 appears with the current

blood glucose result.

Last Result

Select whether the previous blood glucose result appears with the current blood glucose result. Test

results older than 24hours do not appear.

Last Result

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Meter Settings

Press to highlight More Options. Press .

Press to highlight Last Result. Press .

2 3

Press or to highlight On or Off. Press to move to the option.

Press

to set the option and

return to the previous menu.

Last Result

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Meter Settings

Language

Choose the language that appears on the meter.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight More Options. Press .

Press to highlight

Language. Press .

1 2 3

Press or to highlight the desired language. Press to move

to the option.

Press

to set the language and return to the previous menu.

Language

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Meter Settings

Time Format

Choose the time format (12-hour or 24-hour clock) that appears on the meter.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight More Options. Press .

Press to highlight Time

Format. Press .

1 2 3

Press or to highlight 12hour (am/pm) or 24hour. Press to move to the option.

Press

to set the time format and return to the previous menu.

Time Format

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Review Your Data

Overview

• Blood glucose results are stored from the newest to the oldest.

• The meter automatically stores up to 720blood glucose results in memory with the time and date of the test and any test result comments.

• Once 720blood glucose results are in memory, adding a new blood glucose result deletes the oldest blood glucose result.

• Only test results that have been marked with a fasting, before meal, after meal, or bedtime comment are included in the average for that comment.

• All test results are included in the overall 7, 14, 30, and 90-day averages regardless of what comment is added.

• Control results are stored in memory but cannot be reviewed on the meter. To view stored control results, transfer them to a compatible software application.

• Control results are not included in the averages or blood glucose reports.

• Once 32control results are in memory, adding a new control result deletes the oldest control result.

wWARNING

Do not change your therapy based on an individual test result in memory. Talk to your healthcare professional before changing therapy based on test results in memory.

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Review Your Data

Turn the meter on by briefly pressing . From Main Menu, press to highlight My Data. Press .

Logbook is highlighted.

Press .

Press or to scroll through Logbook.

The most recent test result

The 2nd most recent test result

Logbook

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Review Your Data

To view details about a test result, press or to highlight the test result. Press . Test result details shown below only appear if Target Ranges is On or comments were added to a test result.

The most recent test result.

The 2nd most recent test result.

1 2

Logbook

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Review Your Data

Press to highlight a category (the example here is Overall). Press .

Press to highlight a time period (the example here is

90 days). Press .

Turn the meter on by briefly pressing . From Main Menu, press to highlight My Data. Press .

Press to highlight Averages. Press .

Press to return to the previous menu if you want to review a different time period OR press or to move through different averages.

Averages

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Review Your Data

Target Percent (%)

Target Percent (%) allows you to view the percentage of your Overall, Before meal, After meal, Fasting, and Bedtime blood glucose results that are above, within, or below your target ranges.

• Target % results can be viewed for 7, 14, 30, or 90-day time periods.

• Target Ranges must be set in the meter to review Target % results.

Turn the meter on by briefly pressing . From Main Menu, press to highlight My Data. Press .

Press to highlight Target %. Press .

Press to highlight a category (the example here is Before meal). Press to select the option.

Target Percent (%)

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Review Your Data

Press to highlight a time period (the example here is

90 days). Press .

The Target % appears (for the Before meal example). The

number of total tests included in the Target % appears at the bottom of the display.

Press

to return to the

previous menu.

Target Percent (%)

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Review Your Data

NOTE

Low/High Data

Your healthcare professional can tell you what blood glucose range is appropriate for you. It is very important to stay within your target range.

• Target Ranges must be set in the meter to track Low/High Data test results (see the Target Ranges section in the chapter Meter Settings for details).

• Low BG or High BG Data includes only results that fall above or below the target ranges set in the meter.

• Low BG or High BG Data is tracked in the meter for 30 days.

Low/High Data

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Review Your Data

Low/High Data

You can select Low BG and High BG results for Overall, Before meal, After meal, Fasting, or Bedtime blood glucose results.

Symbol Name Description

Overall Includes low and high blood glucose results based on

Target Ranges set in the meter.

Before meal You may view low or high test results marked with a Before

Meal comment for Overall, Before breakfast, Before lunch, Before dinner, and Before snack blood glucose results.*

After meal You may view low or high test results marked with an After

Meal comment for Overall, After breakfast, After lunch, After dinner, and After snack blood glucose results.*

Fasting Includes low or high fasting blood glucose results marked

as Fasting in comments.

Bedtime Includes low or high bedtime blood glucose results marked

as Bedtime in comments.

* Test results for Before and After speciﬁc meals are only available if Patterns is set to On.

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Review Your Data

Low/High Data

Turn the meter on by briefly pressing . From Main Menu, press to highlight My Data. Press .

Press to highlight Low/High Data. Press .

If Target Ranges is set to On:

Press

to select Low or High BG Data (the

example here is High BG Data). Press .

If target ranges have NOT been On within the last 30 days:

This message appears on the meter (to turn on Target Ranges see the Target Ranges section in the chapter Meter Settings for details).

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Review Your Data

Low/High Data

Press to highlight a category (the example here is Before meal). Press .

If results with detailed meal comments are saved in the Logbook:

The meter may prompt you to select detailed categories to view. Press

to highlight a category (the example here is Before breakfast). Press .

The selected data appears (the example here is High BG data). Press to scroll through the test results.

Press

to return to the previous menu.

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Review Your Data

Patterns

NOTE

Patterns

• Patterns displays only active Low Patterns or High Patterns based on comments added to blood glucose results within the last 7days.

• A Pattern is generated when 2below-target or 3above-target test results with the same comment are detected within a 7-day period.

Patterns may be viewed on the meter in 3 ways:

when a Patterns option is displayed at the bottom of Main Menu.

from My Data on Main Menu. if a New pattern detected

message appears on the display when performing a blood glucose test.

or or

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Review Your Data

Patterns

Patterns High and low patterns have been detected Patterns may include the

following blood glucose results marked with comments:

Before breakfast, After breakfast, Before lunch, After lunch, Before dinner, After dinner, Before snack, After snack, Fasting, or Bedtime (see the Adding Comments

to Blood Glucose Results section in the chapter Blood Glucose Tests).

High Pattern(s) One or more high patterns have been detected

Low Pattern(s) One or more low patterns have been detected

No Patterns No active pattern based on results from last 7days

Blank Patterns feature is set to O

Patterns detected by the meter may be displayed on the Main Menu as:

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Review Your Data

Patterns

Press to scroll through test results.

Press

to return to the

previous menu.

Turn the meter on by briefly pressing . From Main Menu, press to highlight the Patterns option at the bottom of the screen (the example here is Patterns). Press .

Press to highlight a category to review (the example here is

Before breakfast). Press .

Press or to highlight Low Patterns or High Patterns (the

example here is Low Patterns). Press to select the option.

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Review Your Data

Data Transfer Using Wireless

Turn the meter on by briefly pressing . From Main Menu, press to highlight My Data. Press .

Press to highlight Data Transfer. Press .

Press to select Wireless. Press .

2 3

Data Transfer Using Wireless

This feature allows you to transfer data wirelessly from your meter to another device.

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Review Your Data

Data Transfer Using Wireless

If a device has not been paired with your meter:

The meter prompts you to pair a device to the meter (see the First-Time Pairing section in the chapter Wireless Communication and Meter

Pairing for details).

If the meter has already been paired with at least one device:

Press

or to choose a wireless device for

data transfer.

The meter transfers the data to the device.

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Review Your Data

Data Transfer Using USB Cable

Start the software for data analysis and initiate a data transfer.

Data Transfer Using USB Cable

This feature allows you to transfer data from your meter to special software for diabetes management on a PC using a USB cable.

Plug the small end of the USB cable into the meter.

Plug the large end of the USB cable into a USB port on the PC.

If the meter is o, it turns on.

2 3

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Review Your Data

The meter transfers the data to the software.

Data Transfer Using USB Cable

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Review Your Data

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Wireless Communication and Meter Pairing

Overview

You can wirelessly and automatically synchronize your diabetes information with a mobile device. The process of creating a connection between the meter and the other device is called pairing. You need an application on your mobile device that can accept the meter’s data.

Setting Options Function

Flight Mode On / O Select whether wireless communication is available.

On – wireless communication is not available.

O – wireless communication is available.

Default Device List of devices paired

with the meter

If more than 1device is paired, select the device with which the Auto-Send and Sync Time features will communicate.

Auto-Send On / O Select whether data is automatically sent to the

default paired device after each test.

On – data is automatically sent to the default paired device.

O – data is not automatically sent to the default paired device.

Chapter 6: Wireless Communication and Meter Pairing

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Wireless Communication and Meter Pairing

Setting Options Function

Sync Time On / O Select whether to synchronize the time and date to

the default paired device.

On – the time and date on the meter synchronize to the time and date on the default paired device.

O – the time and date on the meter do not synchronize to the time and date on the default paired device.

Pairing Pair Device / Delete

Pairing

Select whether to pair a device or to delete a paired device.

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Wireless Communication and Meter Pairing

First-Time Pairing

The steps below are for ﬁrst-time pairing.

Up to 5devices can be paired with the meter at any time.

Each device must be paired with the meter one at a time.

The meter and the device to be paired should be within 1meter of each other.

Prepare the device for pairing. Refer to the device’s instructions for information about pairing.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Wireless. Press .

First Time Pairing

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Wireless Communication and Meter Pairing

Pair Device appears. To pair a device, press to highlight Yes. Press .

The meter displays its code.

The mobile device displays a list of found devices, including the meter. Select the meter from the list. When prompted, enter the code displayed on the meter from Step5 into the device to be paired.

When pairing is complete, and the name of the paired device appear.

Press

to return to the previous menu.

First-Time Pairing

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Wireless Communication and Meter Pairing

Main Menu with meter in Flight Mode.

Flight Mode

Select whether wireless communication is available or not. When Flight Mode is on, appears in the title bar and wireless communication is not available.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Wireless. Press .

Flight Mode is highlighted.

Press .

Press or to highlight On or Off. Press to move to the option.

Press

to set the option and return to the previous menu.

Flight Mode

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Wireless Communication and Meter Pairing

Default Device

If more than 1device is paired, select the default paired device for the Auto-Send and Sync Time features.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Wireless. Press .

Press to highlight Default Device. Press .

A list of paired devices appears. Press to highlight the device you want as the default device.

Press

to move to the option.

Press

to set the option and return to the previous menu.

Default Device

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Wireless Communication and Meter Pairing

Auto-Send

Select whether data is automatically sent to the default paired device after each test.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Wireless. Press .

Press to highlight

Auto-Send. Press .

Press or to highlight On or Off. Press to move to the option.

Press

to set the option and return to the previous menu.

Auto-Send

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Wireless Communication and Meter Pairing

Sync Time

Select whether to synchronize the time and date to the default paired device.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Wireless. Press .

Press to highlight Sync Time. Press .

Press or to highlight On or Off. Press to move to the option.

Press

to set the option and return to the previous menu.

Sync Time

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Wireless Communication and Meter Pairing

Pairing Additional Devices

This procedure is to add another paired device (assumes there is already 1paired device).

You can pair 5devices.

If you have 5paired devices, you must delete a pairing before you can add another device.

The device you choose remains the default until you change it.

Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Wireless. Press .

Press to highlight Pairing. Press .

Pairing Additional Devices

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Wireless Communication and Meter Pairing

Press or to highlight Pair Device. Press .

If there are less than 5paired devices:

Pair Device appears. Proceed

to Step5.

If there are already 5paired devices:

Maximum paired devices

appears. You must delete a paired device before you can proceed to Step5. Press

to select Yes. Press .

Press

or to highlight the device to delete. Press . Proceed to Step5.

Prepare the other device for pairing. Refer to the other device’s instructions for information about pairing.

The meter displays its code.

The mobile device displays a list of found devices, including the meter. Select the meter from the list. When prompted, enter the code displayed on the meter from Step6 into the device to be paired.

Pairing Additional Devices

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Wireless Communication and Meter Pairing

If there is more than 1paired device, the meter asks if you want the new device to be the default device. Press or to highlight No or Yes.

Press

to set the option and return to Pairing.

Press

to return to the previous menu.

When pairing is complete, and the name of the paired device appear. Press .

Pairing Additional Devices

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Wireless Communication and Meter Pairing

Delete Pairing

This procedure is to delete a paired device (assumes there is at least 1paired device).

You can pair 5devices. If you have 5paired devices, you must delete a pairing before you pair to another device.

The device you choose remains the default until you change it.

Turn the meter on by brieﬂy pressing . From Main Menu, press to highlight Settings. Press .

Press to highlight Wireless. Press .

Press to highlight Pairing. Press .

Delete Pairing

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Wireless Communication and Meter Pairing

Press or to highlight

Delete Pairing. Press .

Press or to highlight the device to delete. Press to set the option.

Delete Pairing

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Wireless Communication and Meter Pairing

If the selected device is not the default device:

The pairing is deleted. The name of the deleted device and

appear.

If the selected device is the default device:

The meter prompts you to select a new default device. If there is only 1device remaining, it becomes the default device. The list of paired devices appears.

Highlight the new default device and press

. The name of the deleted device and appear, along with the new default device.

Delete Pairing

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Meter Maintenance and Troubleshooting

Meter Maintenance

The meter automatically tests its own systems every time you turn it on and lets you know if something is wrong. See the Error Messages section of this chapter.

If you drop the meter or think the results are not accurate, contact Roche.

Open the battery door on the back of the meter by pushing the tab in the direction of the arrow and pulling the door up.

Release the old batteries by pressing the button. Remove the old batteries.

Slide the new batteries under the black tabs and button, with the (+)side facing up. Put the battery door back in place and snap it closed.

NOTE

• The meter uses two 3-volt lithium batteries, coin cell typeCR2032. This type of battery can be found in many stores. It is a good idea to have spare batteries available.

• Always replace both batteries at the same time and with the same brand.

• The logbook data is saved when you replace the batteries.

Changing the Batteries

Press

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Meter Maintenance and Troubleshooting

Cleaning the Meter

Keep the meter free of dust. If you need to clean or disinfect it, follow these guidelines carefully to help you get the best performance possible.

wWARNING

• Do not allow liquid to enter any openings in the meter.

• Do not spray a cleaning solution directly onto the meter.

• Do not immerse the meter in liquid.

Make sure the meter is turned o.

Gently wipe the meter’s surface with a soft cloth slightly dampened (wring out any excess liquid) with one of these cleaning solutions:

• 70% isopropyl alcohol

• Mild dishwashing liquid mixed with water

• 10% household bleach solution (1part bleach plus 9parts water) made the same day

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Meter Maintenance and Troubleshooting

The meter is connected to a PC and a test cannot be performed.

EITHER remove the USB cable and perform a test OR remove the test strip and start a data transfer.

The meter will not turn on or the display is blank.

• Batteries are dead. Insert new batteries.

• Display is damaged. / Meter is defective.

Contact Roche.

• Extreme temperatures.

Move the meter to a more temperate area.

The connection between the meter and PC was lost.

Disconnect and reconnect the USB cable and retry the connection. Contact Roche if the connection is lost again.

Error Messages

wWARNING

• Never make therapy decisions based on an error message.

• If you have any concerns or see any other error message, contact Roche.

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Meter Maintenance and Troubleshooting

There is no connection between the meter and PC.

Connect the USB cable and retry the connection.

Blood glucose results were not transferred to a paired device.

Make sure the paired device is within range of the meter and turned on.

Data could not be transferred from the meter to the PC.

Check the PC or USB cable.

Data cannot be sent to a paired device because the meter is in Flight Mode.

Retry the data transfer when the meter is not in Flight Mode.

One or more blood glucose results are excluded from the selected averages because the results are invalid or outside the system measurement range.

One or more blood glucose results are excluded from the selected target % data because the test results are invalid.

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Meter Maintenance and Troubleshooting

One or more blood glucose results are excluded from the selected low/high data because the test results are invalid.

The date entered is not valid. Enter the correct date.

A meter setting was changed while in Flight Mode.

The setting change will not take eect until Flight Mode is turned o.

Pairing to a device cannot be performed while in Flight Mode.

Retry pairing when the meter is not in Flight Mode.

The blood glucose result has not been sent to the default paired device. The transfer is still pending.

Place meter and paired device closer together.

The meter was unable to pair with a device.

Retry the pairing.

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Meter Maintenance and Troubleshooting

A meter or test strip error has occurred. Repeat the blood glucose test. If a second E-3 code appears, perform a control test with the control solution and a new test strip.

• If the control result is within the acceptable range, review the proper testing procedure and repeat the blood glucose test with a new test strip.

• If the control result is not within the acceptable range, see the Understanding Out-of-Range Control Results section in the chapter Control Tests.

In rare cases, an E-3 error code may indicate that your blood glucose is extremely high and above the system’s reading range. If you do not feel like your blood glucose is extremely high, repeat the blood glucose test. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests.If the E-3 code still appears for your blood glucose test, contact your healthcare professional immediately.

The test strip may be damaged, not properly inserted, or was previously used.

Remove and reinsert the test strip or replace it if damaged or previously used.

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Meter Maintenance and Troubleshooting

Not enough blood or control solution was drawn into the test strip for measurement or was applied after the test had started.

Discard the test strip and repeat the blood glucose or control test.

Blood or control solution was applied to the test strip before Apply drop appeared.

Discard the test strip and repeat the blood glucose or control test.

An electronic error occurred. Remove the batteries, press

and hold the Power/Set/OK button for at least 2 seconds, and reinsert the batteries. Perform a blood glucose or control test.

The temperature is above or below the proper range for the system.

Refer to the test strip package insert for system operating conditions. Move to an area with the appropriate conditions and repeat the blood glucose or control test. Do not artiﬁcially heat or cool the meter.

The batteries are out of power. Change the batteries now. If the message

reappears after the batteries have been replaced, remove the batteries, press and hold the Power/ Set/OK button for at least 2 seconds, then reinsert the batteries.

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Meter Maintenance and Troubleshooting

The time and date setting may be incorrect.

Make sure the time and date are correct and adjust, if necessary.

The test strip may be damaged. Retest with a new test strip.

Your blood sample may contain a high level of ascorbate.

Contact your healthcare professional.

Fluid or foreign material may be present in the test strip slot.

Remove and reinsert the test strip or repeat the blood glucose or control test with a new test strip. If the problem persists, contact Roche.

An electronic error has occurred. Contact Roche.

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Meter Maintenance and Troubleshooting

The meter time and date have been changed to match the paired device.

There are no results in the Logbook.

There is an invalid result in the Logbook.

There are no test results in range for the selected data.

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Meter Maintenance and Troubleshooting

Target Ranges is O and there are no results for the Target % data stored in the meter.

Target Ranges is O and there are no results for the low/high data stored in the meter.

There are no results stored in the meter for the selected data.

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Meter Maintenance and Troubleshooting

Patterns is On but there are no active patterns stored in the meter.

Patterns is O.

Blood glucose may be higher than the measurement range of the system.

See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests.

Blood glucose may be lower than the measurement range of the system.

See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests.

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Meter Maintenance and Troubleshooting

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Page 99

Technical Information

Product Limitations

See the literature packaged with the test strips and control solutions for the latest information on product speciﬁcations and limitations.

Speciﬁcations

Blood volume

Sample type

Measuring time

Measurement range

Test strip storage conditions

System operating conditions

Refer to the test strip package insert.

Meter storage conditions Temperature: -25–70°C

Memory capacity 720blood glucose results and 32control results with time

and date

Automatic o 90seconds

Power supply Two3-volt lithium batteries (coin cell type CR2032)

Display LCD

Dimensions 80 × 47 × 20 mm (LWH)

Weight Approx. 40g (with batteries)

Construction Hand-held

Protection class III

Meter type The Accu-Chek Guide meter is suitable for continuous

operation.

Control solution storage conditions Refer to the control solution package insert.

Interfaces

USB: micro-B connector; Continua Certiﬁed® to a Continua Certiﬁed manager.

Chapter 8: Technical Information

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Technical Information

Electromagnetic Compatibility – This meter meets the electromagnetic immunity requirements as per ENISO15197. The chosen basis for electrostatic discharge immunity testing was basic standard IEC61000-4-2. In addition, the meter meets the electromagnetic emissions requirements as per EN61326. The meter’s electromagnetic emission is thus low. Interference from the meter to other electrically-driven equipment is not anticipated.

Performance Analysis – Refer to the test strip package insert.

Test Principle – Refer to the test strip package insert.

Declaration of Conformity – Roche hereby declares that the Accu-Chek Guide blood glucose meter

conforms with the basic requirements and other relevant regulations of the European Directive; 1999/5/EC. The conformity declaration may be found at the following Internet address: http://declarations.accu-chek.com

Communication Protocol –

The Accu-Chek Guide blood glucose meter is Continua Certiﬁed. Continua Certiﬁed signiﬁes that this product complies with applicable IEEE 11073-10417 standards and that it has been tested and certiﬁed against the 2014 Continua Design Guidelines which include the Blood Glucose speciﬁcation for Bluetooth Smart®, Bluetooth SIG, Glucose Proﬁle, Version 1.0 and Bluetooth SIG, Glucose Service, Version 1.0.

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Roche ACCU-CHECK User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual