Roche Accu-Chek Performa operation manual

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User’s Manual

Blood Glucose Meter

Gebrauchsanweisung

Blutzuckermessgerät

Roche USA – 51820 V4/1 – 07054190001_01 – Black

Roche USA – 51820 V4/2 – 07054190001_01 – Cyan

Roche USA – 51820 V4/3 – 07054190001_01 – Magenta

Roche USA – 51820 V4/4 – 07054190001_01 – Yellow

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Contents

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

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

Chapter 2: Blood Glucose Tests ........................................................................................... 9

Chapter 3: Meter Memory, Setup, and Data Transfer ......................................................... 17

Chapter 4: Control Tests ....................................................................................................27

Chapter 5: Maintenance and Troubleshooting ...................................................................31

Chapter 6: Technical Information ...................................................................................... 37

Index ................................................................................................................................43

This ﬁle may not print or view at 100%. Die lines and color breaks do not print. “Holding Area” text, box and rules do not print.

Roche USA – 51820 V2/1 – 07054190001_01Black

Roche USA – 51820 V2/2 – 07054190001_01PMS 287 CVC 30%

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Introduction

The Accu-Chek Performa System

The Accu-Chek Performa meter is designed to be used with the Accu-Chek Performa test strip to quantitatively measure glucose in fresh venous, arterial, neonatal, and capillary whole blood as an aid in monitoring the eectiveness of glucose control. Capillary whole blood for testing of blood glucose can be obtained from ﬁngertip and approved alternative sites (for example, forearm). Refer to the Alternative Site Testing (AST) section of this manual for approved alternative sites and associated limitations. The Accu-Chek Performa meter with the Accu-Chek Performa test strips provide a complete test system that is meant for in vitro diagnostic use by healthcare professionals in clinical settings and by people with diabetes at home. The system is not for use in diagnosis or screening of diabetes mellitus. Healthcare professional blood sample collection and preparation is described in the test strip package insert. For use only with the Accu-Chek Performa test strips and control solutions Suitable for self-testing The system includes:

• Accu-Chek Performa meter with battery

• Accu-Chek Performa test strips*

• Accu-Chek Performa control solutions* *Some items may not be included in the kit. They are a separate purchase.

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Introduction

wWARNING

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).

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 comes with a preset time and date. You may need to change the time to your time zone.

• 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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Chapter 1: Your New System

The Accu-Chek Performa Meter

1. Power/Set Button

Turns meter on or o and sets options.

2. Display

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

3. Right Arrow and Left Arrow Buttons

Press to enter memory, adjust settings, and scroll through test results.

4. Test Strip Slot

Insert test strip here.

5. Battery Door

6. Infrared (IR) Window

Transfers data from meter to computer.

Your New System

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Your New System

(for example)

7. Test Strip Container*

8. Insert this end into meter.

9. Yellow Window

Touch blood drop or control solution here.

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

10. Control Solution Bottle*

11. Battery

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Your New System

Using the Accu-Chek Performa System

• Use only Accu-Chek Performa 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.

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Your New System

Button Functions

Here are the functions of the power/set and arrow buttons on the meter. These functions are used throughout this manual. For more information on using these buttons during meter setup, see Chapter 3, Meter Memory, Setup, and Data Transfer.

Button Function Action

(power/set

button)

Turn the meter on or o.

Enter the set-up mode.

Set the chosen feature.

Press and release

Turn the meter on. Press and hold appears on the display.

Press and release

until set-up

(right arrow

and left

arrow

buttons)

Exit the set-up mode at any time.

Check the display segments.

Adjust settings for time and date, beeper, test reminders, and hypoglycemic alert.

Enter memory. Press and release

Mark a blood glucose result. Press and release

Press and hold symbol appears on the display.

Turn the meter o. Press and hold complete display.

If one of the segments is missing or looks dierent from the picture, do not use the meter. Contact Roche.

Press and release

Press and hold or to scroll faster.

until the ﬂashing test strip

to see the

or .

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Chapter 2: Blood Glucose Tests

Blood Glucose Tests

Performing a Blood Glucose Test with Blood from Your Fingertip

NOTE

Blood samples taken from the palm are equivalent to blood samples taken from the ﬁngertip. To receive Alternative Site Testing (AST) instructions and an AST cap for obtaining blood from the palm, contact Roche.

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

Before you perform your ﬁrst blood glucose test, set up the meter correctly. You need the meter, a test strip, a lancing device, and a lancet.

Wash and dry your hands.

When the blood drop symbol flashes, perform a fingerstick with the lancing device.

Prepare the lancing device.

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

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

Insert the test strip into the meter in the direction of the arrows. The meter turns on and beeps.

Touch the blood drop to the front edge of the yellow window of the test strip. Do not put blood on top of the test strip. The meter beeps and blood in the test strip.

ﬂashes when there is enough

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The test result appears on the display. To assign a marker to the test result, leave the test strip in the meter. See Chapter2, Marking Blood Glucose Results and Setting the Post-Meal Test Reminder. Otherwise, remove and discard the used test strip. After a successful test, the meter turns itself o 5seconds after the test strip is removed.

Blood Glucose Tests

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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.

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Blood Glucose Tests

You may perform a forearm or upper arm test

You may NOT perform a forearm or upper arm test

If you are interested in AST, talk to your healthcare professional ﬁrst. To obtain an AST cap and detailed AST instructions, contact Roche.

• immediately before a meal.

• while fasting.

• 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.

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Blood Glucose Tests

Marking Blood Glucose Results and Setting the Post-Meal Test Reminder

You can mark a blood glucose result to indicate a special event. If you select a test result marker, it is automatically stored in memory. When you review the test results in memory, these markers can help you remember what was dierent about the test result.

Symbol Function

Pre-Meal Marker

Marking blood glucose results with a pre-meal marker provides more information about your test results to help you and your healthcare professional in the management of your diabetes.

Pre-Meal Marker with Post-Meal Test Reminder

When a pre-meal result is marked with a post-meal test reminder, the meter beeps 1 or 2hours after you test to remind you to do a post-meal test.

Post-Meal Marker

Marking blood glucose results with a post-meal marker provides more information about your test results to help you and your healthcare professional in the management of your diabetes. The post-meal marker automatically appears with the test result if a test is performed 15minutes before or after the post-meal test reminder is programmed to beep. Set the post-meal test reminder time to 1 or 2hours in the set-up mode. The meter will beep 1 or 2hours after the pre-meal test to remind you to do a post-meal test.

General Marker

You might want to use the general marker to mark an event such as an AST result or exercise.

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Blood Glucose Tests

Here is how to mark a test result and initiate a post-meal test reminder:

1. Perform a blood glucose test. The blood glucose result appears on the display.

2. Leave the test strip in the meter. Press and release

post-meal test reminder.

3. When the marker or test reminder that you wish to select appears on the display, remove the test strip

from the meter.

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

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

2. Was the cap on the test strip container closed tightly?

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

4. Were the test strips stored in a cool, dry place?

5. Did you follow the directions? See Chapter 2, Blood Glucose Tests, and repeat the

6. Are the meter and test strips working properly?

7. Are you still unsure of the problem? Contact Roche.

or to toggle through the test result markers and

Repeat the blood glucose test with an unexpired test strip.

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

Repeat the blood glucose test with a new test strip.

Repeat the blood glucose test with a properly stored test strip.

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

Perform a control test. See Chapter 4, Performing a Control Test, for instructions.

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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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Chapter 3: Meter Memory, Setup, and Data Transfer

Meter Memory, Setup, and Data Transfer

Memory

Storing Blood Glucose and Control Results

The meter automatically stores up to 500blood glucose results and up to 20 control results with the time and date of the result and any test result marker which you can review at any time. Test results are stored from the newest to the oldest, so set the time and date correctly in the meter. Having the correct time and date setting helps ensure appropriate interpretation of stored blood glucose results by you and your healthcare team.

NOTE

• The memory is not lost when the battery is replaced; however, conﬁrm that the time and date are still correct. See Chapter3, Setting the Time and Date.

• Once 500blood glucose results are in memory, adding a new test result causes the oldest one to be deleted.

• If more than 500blood glucose tests are performed within a 90-day period, only the most recent 500test results are included in the 90-day average.

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

• Control results are not included in the 7-, 14-, 30-, and 90-day averages.

• Only test results that have been assigned a pre-meal or post-meal marker are included in pre-meal and post-meal averages. All blood glucose results are included in the general 7-, 14-, 30-, and 90-day averages.

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Meter Memory, Setup, and Data Transfer

Memory

Viewing Test Results in Memory

With the meter on or o, press and release or to enter memory. The most recent test result appears on the display.

Button Function Action

Previous test results

(left arrow

button)

General averages

(right arrow

button)

Press

to view previous test results from newest to oldest.

Press

to view 7-, 14-, 30-, and 90-day averages.

n = number of test results in the average

(right arrow

button)

Pre-meal averages Post-meal averages

Continue to press and post-meal averages.

to view 7-, 14-, 30-, and 90-day pre-meal

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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Meter Memory, Setup, and Data Transfer

Setup

Using the Set-Up Mode

The following features can be customized as required.

Symbol Function Action Factory Pre-set

Time and date Set the time and date.

Beeper Select On or OFF. Setting the beeper to OFF

Post-meal test reminder

Test reminders Select On or OFF. You can set up to 4test

Hypoglycemic alert

does not aect test results. The beeper must be On to use the test reminders feature.

Select 1hour or 2hours. The meter will beep 1 or 2 hours after the pre-meal test to remind you to do a post-meal test.

reminders per day.

Select On or OFF. The hypoglycemic alert can be set to a level between 50 and 90mg/dL or 2.8 and 5.0mmol/L to let you know when your blood glucose is possibly too low.

A-1 8:00 A-2 12:00 A-3 18:00 A-4 22:00

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Meter Memory, Setup, and Data Transfer

Setup

Setting the Time and Date

Press and release (power/set button) to turn the meter on. The ﬂashing test strip symbol appears on the display.

Press and hold until set-up appears on the

display. The hour ﬂashes.

3 4

Press and release

or to decrease or increase the hour. Press and release set the hour. The minutes ﬂash.

Repeat step3 to set minutes, day, month, and year. To set up more options,

press and release To exit, press and hold until the ﬂashing test strip symbol appears on the display.

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Meter Memory, Setup, and Data Transfer

Setup

Setting the Beeper On or OFF

NOTE

The beeper prompts you:

• 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 a button is pressed.

• when it is time to perform a test (if you set the test reminders or post-meal test reminder).

• if an error occurred while performing a blood glucose or control test (even if the beeper is o, it still beeps for an error).

Press and release to turn the meter on. The ﬂashing test strip symbol appears on the display. Press and hold set-up appears on the display.

until

Press and release repeatedly until the flashing beeper symbol and On or OFF appear on the display.

Press and release

between On and OFF. To set up more options, press and release To exit, press and hold until the ﬂashing test strip symbol appears on the display.

or to switch

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Meter Memory, Setup, and Data Transfer

Setup

Setting the Post-Meal Test Reminder

NOTE

The post-meal test reminder:

• beeps 1 or 2hours after the blood glucose test to remind you to do a post-meal test.

• beeps every 2minutes up to 3times.

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

• If a test was performed within 15minutes of a test reminder, the test reminder does not beep.

• If the meter is on at the test reminder time, the test reminder does not beep.

• Exposure to cold conditions may disable test reminders until the meter is turned on.

Press and release to turn the meter on. The ﬂashing test strip symbol appears on the display. Press and hold set-up appears on the display.

until

Press and release repeatedly until set-up and the flashing 1Hr or 2Hr appear on the display.

Press and release

or to select 1Hr or 2Hr. Press and release set the option. To set up more options, press and release To exit, press and hold until the ﬂashing test strip symbol appears on the display.

This display appears when a post-meal test reminder occurs.

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Meter Memory, Setup, and Data Transfer

Setup

Setting the Test Reminders

NOTE

Test reminders:

• beep at the same time each day.

• beep every 2minutes up to 3times.

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

• If a test was performed within 15minutes of a test reminder, the test reminder does not beep.

• If the meter is on at the test reminder time, the test reminder does not beep.

• Exposure to cold conditions may disable test reminders until the meter is turned on.

• If a test reminder is o in set-up mode, any subsequent test reminders are also o. For example, if you set A-1 but turn o A-2, then A-3 and A-4 will automatically be o.

1 2

Press and release to turn the meter on. The ﬂashing test strip symbol appears on the display. Press and hold set-up appears on the display.

until

Press and release repeatedly until the bell symbol, OFF, set-up, and the flashing A-1 appear on the display.

Press and release

between On and OFF. Press and release set your choice. If On is selected, the hour ﬂashes.

or to switch

Press and release

hour. Press and release

set the hour. The minutes ﬂash.

or to adjust the

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Meter Memory, Setup, and Data Transfer

Press and release

or to select 00, 15, 30, or 45. These are the only choices. Press and release set the minutes. The bell symbol, OFF, and the ﬂashing A-2 appear on the display.

Either set the A-2 test reminder or press and release to set up more options. To exit, press and hold until the flashing test strip symbol appears on the display.

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Meter Memory, Setup, and Data Transfer

Setup

Setting the Hypoglycemic Alert

wWARNING

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

• Consumer: Before you set the hypoglycemic alert, talk to your healthcare professional to help you decide what blood glucose level is your hypoglycemic level.

• Healthcare professionals: The hypoglycemic level may vary from person to person. It is recommended to turn the hypoglycemic alert OFF when using the meter in a professional setting.

Press and release to turn the meter on. The ﬂashing test strip symbol appears on the display. Press and hold set-up appears on the display.

until

Press and release repeatedly until set-up, OFF, and the flashing appear on the display.

Press and release

or to switch between On and OFF. Press and release set your choice. If you select On, set-up appears and

ﬂashes.

Press and release

level. Press and release set the level. To exit, press and hold until the ﬂashing test strip symbol appears on the display. The set-up mode is complete.

or to adjust the

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Meter Memory, Setup, and Data Transfer

Data Transfer

Transferring Results to a Computer

We oer a variety of software to help you transfer your results. For information on Accu-Chek software, contact Roche. You can transfer your stored results to a computer to track, identify patterns, and print.

wWARNING

Transferring data to a computer from meters used for multiple-patient testing is NOT recommended since individual patient results cannot be identiﬁed.

Transferring Data Directly to a Computer Using Specialized Software and an Infrared Cable

1. Install the software according to the instructions.

2. To transfer the results to a computer, connect the infrared cable according to the instructions.

3. Run the software program and follow the instructions for data transfer. Make sure the software is ready to accept data from the meter.

4. With the meter o, press and hold both

5. Locate the infrared (IR) window on the top of the meter.

6. Locate the IR window on the infrared cable.

7. Place the meter on a ﬂat surface. Point the 2IR windows toward each other. They should be 3–10cm apart.

8. Do not move the infrared cable or meter during the data transfer.

9. Follow the prompts on the software.

10. The software program may shut o the meter automatically when the data transfer is complete. Should this occur, follow the prompts on the computer screen.

and until 2arrows on the display alternately ﬂash.

NOTE

• If the data did not transfer successfully, try again. Contact Roche if you still have problems.

• To make the most of the transfer feature, make sure the meter is set to the correct time and date.

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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 Solution

• Use only Accu-Chek Performa control solution.

• 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.

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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.

Touch the drop to the front edge of the yellow window of the test strip until you see flash.

Do not put control solution on top of the test strip.

Insert the test strip into the meter in the direction of the arrows. Place the meter on a ﬂat surface.

When you see ﬂash, there is enough control solution in the test strip.

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

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

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

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