Roche ACCU-CHECK User Manual

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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3
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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4
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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5
Your New System
1
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
2
Chapter 1: Your New System
Back View
Side View
3
1
6
7
84
5
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6
Your New System
1
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
9
10
11
12
14
13
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7
Your New System
1
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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8
Your New System
1
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.
1
2
3
4
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9
Your New System
1
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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10
Your New System
1
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
1
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
1
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.
1
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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13
Blood Glucose Tests
2
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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14
Blood Glucose Tests
2
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
2
Wash your hands with warm soapy water and dry thoroughly.
Prepare the lancing device.
1
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.
4
When Apply drop appears, perform a fingerstick with the lancing device.
5
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Blood Glucose Tests
2
Gently squeeze your finger to assist the blood flow. This helps you get a blood drop.
6
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.
7
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.
8
or
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Blood Glucose Tests
2
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
11
Press here to eject test strip
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Blood Glucose Tests
2
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
2
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
2
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
2
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.
3
or
or
or
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Blood Glucose Tests
2
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
2
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
2
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
3
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
3
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.
3
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Control Tests
3
Select the control solution to test. You will enter the level later in the test.
4
Remove the bottle cap. Wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip.
5
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.
6
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Control Tests
3
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 .
7
Within range and appear if the control result
is within range.
Out of range and
appear if the control result
is out of range.
8
or
or
or
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