Roche Accu-Chek Mobile User manual

User’s Manual
for Single Patient Use Only
Blood Glucose Meter
Instrucciones de uso
únicamente para uso de un
paciente individual
Medidor de glucemia
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Roche USA – 81265
V1/1 – 08500142002 – Black
Blood Glucose Monitoring System
Sistema de monitorización de glucemia
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CVR_81265_08500142002.indb 2 10/28/2019 1:23:38 PM

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 – 81265
V2/1 – 08500142002 – Black
Roche USA – 81265
V2/2 – 08500142002 – PMS 307
Contents
Important Safety Information ..................................................................................................3
Chapter 1: Your New System ..................................................................................................7
Chapter 2: The Accu-Chek FastClix Lancing Device ..............................................................13
Chapter 3: Blood Glucose Tests.............................................................................................17
Chapter 4: Control Tests........................................................................................................25
Chapter 5: Review Your Data.................................................................................................31
Chapter 6: Wireless Communication, Meter Pairing, and Data Transfer .................................35
Chapter 7: Meter and Lancing Device Cleaning and Disinfecting...........................................41
Chapter 8: Meter Maintenance and Troubleshooting .............................................................47
Chapter 9: Technical Information ..........................................................................................55
Chapter 10: License and Warranty ........................................................................................63
Index ....................................................................................................................................67
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3
Important Safety Information
The Accu-Chek Guide Me System
The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me
meter and Accu-Chek Guide test strips.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose
in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the
eectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic
single-patient use by people with diabetes.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and
should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing
rapidly).
Accu-Chek Guide control solutions are for use with the Accu-Chek Guide Me Blood Glucose Monitoring
System to check that the meters and test strips are working together properly and that the test is
performing correctly.
The system includes:
Accu-Chek Guide Me meter with batteries, Accu-Chek Guide test strips,* Accu-Chek Guide control
solutions,* Accu-Chek FastClix lancing device, Accu-Chek FastClix lancet drums.*
*Some items may not be included in the kit. They are a separate purchase.
WARNING
• Choking hazard. Small parts. Keep away from children under the age of 3years.
• Keep new and used batteries away from children. Ingestion or insertion into the
body may cause chemical burns, perforation of soft tissues, and death. Severe
burns may occur within 2 hours of swallowing. If you think a battery might have
been swallowed or placed inside any part of the body, seek medical attention
immediately.
• If the battery compartment does not close securely, stop using the product and
keep it away from children. Contact the Accu-Chek Customer Care Service Center
at 1-800-858-8072.
Important Safety Information
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4
Important Safety Information
NOTE
• The term “blood glucose” is used when referring to blood sugar.
• Sample data screens are shown throughout the manual. Your data will dier.
Limitations
• Do not use the meter at high hematocrit levels above 65 % or low hematocrit levels below 10 %.
• Not for use in diagnosis or screening of diabetes mellitus.
• Not for neonatal use.
• Abnormally high concentrations of ascorbic acid (vitamin C) resulting in blood concentrations in excess
of 5 mg/dL may cause inaccurate results. If you are not sure please check with your doctor.
•Do not use the meter system to measure blood glucose in people who are experiencing cardiovascular
collapse (severe shock) or decreased peripheral blood flow.
• Do not use this system during xylose absorption test.
• Not for use on critically ill patients, patients in shock, dehydrated patients, or hyperosmolar patients.
• This system has not been tested at altitudes higher than 10,150 feet.
Need Help?
For questions, contact the Accu-Chek Customer Care Service Center toll-free at 1-800-858-8072. Hours
of operation are Monday through Friday between 8:00 am and 8:00 pm eastern standard time (EST). We
oer assistance in many languages. You can also visit accu-chek.com for diabetes management tools and
product demonstrations.
Please register your meter online at accu-chek.com/register so you receive the best customer service
possible, in addition to product updates.
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5
Important Safety Information
About Testing Yourself or Others
WARNING
• DO NOT CHANGE YOUR THERAPY BASED ON A TEST RESULT THAT DOES NOT MATCH HOW
YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.
• It is always a good idea to have a back-up testing method available. Failure to test could
cause a delay in therapy decisions and lead to a serious medical condition. Examples of
back-up testing methods include a back-up meter or testing by a laboratory. Ask your
healthcare professional or pharmacist about other possible back-up methods.
• If your blood glucose result does not match how you feel and you have followed the
instructions in this User’s Manual, follow your healthcare professional’s instructions, or
contact your healthcare professional.
WARNING
• During normal testing, any blood glucose meter or lancing device may come in contact
with blood. All parts of the kit are considered biohazardous and can potentially transmit
infectious diseases from bloodborne pathogens, even after you have performed cleaning
and disinfecting.
1,2
• The meter and lancing device should never be used by more than one person. Do not share
the meter and lancing device with anyone, including family members, due to the risk of
infection from bloodborne pathogens.
1,2
Do not use on multiple patients!
• Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily
all, bloodborne pathogens.
3
• If the meter is being operated by a second person who is providing testing assistance to
the user, the meter and lancing device should be cleaned and disinfected prior to use by
the second person.
• Disinfect the meter and lancing device before allowing anyone else to handle them. Do not
allow anyone else to test with the meter or lancing device.
• It is important to keep the meter and lancing device clean and disinfected. For instructions
on how to clean and disinfect the meter and lancing device, see the chapter Meter and
Lancing Device Cleaning and Disinfecting.
• Wash hands and dry thoroughly before and after handling the meter, lancing device, or test
strips.
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6
Important Safety Information
NOTE
• Perform a control test when you open a new test strip box or if you think that a test result is
incorrect. Performing a control test lets you know that the meter and test strips are working
properly.
• Refer to the test strip and control solution package inserts for additional health-related
information.
• Blood glucose and BG are interchangeable and mean the same thing.
Special Information for Caregivers
• Consult your healthcare professional to determine if it is appropriate for your child to be taught how to
use the meter system or any other medical products.
• Some people with diabetes do not experience symptoms of low blood glucose (hypoglycemia). Others,
such as children or people who are unconscious or have certain disabilities, may not be able to
communicate their symptoms to caregivers. For these reasons, do not change any therapy without first
talking to a healthcare professional.
Before You Start Testing
WARNING
• Carefully read and follow the instructions in the User’s Manual and package inserts for the
test strips and control solutions. It is very important to follow the instructions in order to
avoid an incorrect test result that leads to improper therapy.
• Inspect the test strip container before using the test strips for the first time. If you see any
damage to the container cap or if anything prevents the cap from closing properly, do not
use the test strips. Contact the Accu-Chek Customer Care Service Center. Damaged test
strips can cause inaccurate results, which could lead to improper therapy.
• The meter, test strips, and control solution are only for use outside the body (in vitro). Do
not eat the test strips. Do not swallow or inject the control solution or use the control
solution for any purpose other than testing the Accu-Chek Guide Me system.
NOTE
Set the time and date on the meter before you begin testing.
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7
Your New System 1
1. Power/Set Button
Turns the meter on or o and sets
options.
2. Display
Shows results, messages, and test
results stored in memory.
3. Left Arrow Button
Press to enter memory, adjust settings,
and scroll through test results.
4. Right Arrow Button
Press to enter memory, adjust settings,
and scroll through averages.
5. Test Strip Slot
Insert test strip here.
6. Battery Door
Open to replace batteries.
7. Micro USB Port
Transfers data from meter to a computer (PC).
The Accu-Chek Guide Me Meter
Chapter 1: Your New System
Front View Back View Side View
1
2
3
5
4
6
7
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8
Your New System
1
8. Test Strip Container*
9. Test Strip* – Metallic End
Insert this end into the meter.
10. Test Strip* – Yellow Edge
Touch blood drop or control solution here.
11. Control Solution Bottle*
12. Batteries
13. USB Cable*
Connects the meter to a PC.
*Some items may not be included in the kit.
They are a separate purchase.
8
9
13
12
11
10
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9
Your New System 1
The Accu-Chek FastClix Lancing Device
1. Cap
For fingertip testing.
2. Comfort Dial with Depth Selection
Select penetration depth.
3. Penetration Depth Indicator
Points to depth setting.
4. Lever
Advance to a new lancet.
5. Lancet Counter Window
Shows number of available lancets.
6. Release Button
Press to prime and prick.
7. Lancet Drum
Contains 6lancets.
1
2
7
56
4
3
NOTE
Some items may be sold separately.
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10
Your New System
1
Using the Meter Buttons
When instructed to press a meter button, press it briefly and release it.
When instructed to press and hold a meter button, press and hold it for 3 or more seconds.
Button Functions
Here are the functions of the power/set button and arrow buttons on the meter. These functions are used
throughout this manual.
Button Function Action
[power/set
button]
Turn the meter on or o.
Navigate to an option or set a selection.
Check the meter display.
Press and release.
With the meter o, press and hold to
see the complete meter display. If one
of the segments is missing or looks
dierent from this picture, do not use
the meter. Contact the Accu-Chek
Customer Care Service Center at
1-800-858-8072.
[right arrow and
left arrow
buttons]
Adjust settings for time and date, scroll
through test results in memory.
Press and release or press and hold to
scroll faster.
memory
set-up
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11
Your New System 1
Symbols
Symbol Description
7-day average symbol. This indicates that you are viewing the 7-day average of your blood
glucose results.
14-day average symbol. This indicates that you are viewing the 14-day average of your
blood glucose results.
30-day average symbol. This indicates that you are viewing the 30-day average of your
blood glucose results.
90-day average symbol. This indicates that you are viewing the 90-day average of your
blood glucose results.
Bluetooth symbol
Control bottle symbol
Drop symbol
Hourglass symbol
Low battery symbol
No data to display
Pairing symbol. A flashing symbol indicates the meter is attempting to pair with a device. A
solid symbol indicates the meter pairing was successful.
Temperature warning symbol
Test strip symbol. A flashing symbol indicates the meter is ready for you to insert a test strip.
Wireless symbol. A flashing symbol indicates the meter is attempting to connect to the
paired device. A solid symbol indicates the meter is connected to a paired device.
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12
Your New System
1
Press and hold until set-up
appears on the display. The
hour flashes.
Press or to decrease or
increase the hour.
Press and release to turn
the meter on.
The flashing test strip symbol
appears on the display.
2
set-up
Press to set the hour and
move to the next field.
Repeat steps 2 and 3 to set
minutes, am or pm, month, day,
and year. Press and hold
until the flashing test strip
symbol appears. Insert a test
strip to perform a test.
3
4
1
Setting the Time and Date
NOTE
• The meter prompts you to set the time and date the first time you
turn the meter on or if an error occurs.
• Press and hold at any time until the flashing test strip symbol
appears to perform a test.
• The time and date on the meter synchronizes to the time and
date on the paired device each time the meter sends data to the
paired device.
set-up
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13
The Accu-Chek FastClix Lancing Device 2
Using the Accu-Chek FastClix Lancing Device
• The black cap is for fingertip testing only.
• Remember that the opening where the lancet comes out is not in the center of the cap.
• Remove the cap by pulling it straight o. Do not twist the cap.
• A new lancet drum is dark gray with a white end.
• A used lancet drum has a visible red stripe on the white end.
• You cannot reuse a used lancet drum.
• Do not remove the lancet drum until you have used all 6lancets.
• The penetration depth indicator on the comfort dial shows the current depth setting.
The higher the number, the deeper the penetration. The best depth setting is the
lowest number that lets you get enough blood for a test. Try dierent depth settings to
find the one that is right for you.
• For soft skin, we suggest a depth setting of2. For thick skin, try a higher depth setting.
Chapter 2: The Accu-Chek FastClix Lancing Device
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14
The Accu-Chek FastClix Lancing Device
2
Inserting a Lancet Drum
You must first load the lancet drum into the lancing device to get it ready for use.
Remove the cap.
Insert a new lancet drum, white
end first, until it clicks firmly
into place.
1
Slide the cap on until it stops by
aligning the notch on the cap
with the notch on the lancing
device.
2
You are now ready to use the
first lancet.
The lancet counter shows a
number6, meaning you have
6new lancets remaining.
3
NOTE
Once the lancet drum is inserted into the lancing device, do not remove the lancet drum until
completely used. The lancet drum cannot be reused once it has been removed from the lancing device.
WARNING
You must not insert the lancet drum into the lancing device and simultaneously press the
release button or hold the lancing device with the release button resting on a surface such as a
table top. This could release a lancet and inadvertently cause injury.
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15
The Accu-Chek FastClix Lancing Device 2
Using the Accu-Chek FastClix Lancing Device
Adjust the lancet depth by
turning the comfort dial.
1 2
Advance to the next lancet by
sliding the lever forward and
back all the way.
The number in the lancet
counter decreases by1.
The lancet counter window
shows the number of remaining
lancets.
3
Using the Accu-Chek FastClix Lancing Device
Adjust the lancet depth by
turning the comfort dial.
1
Obtain a blood drop. See the
chapter Blood Glucose Tests.
2
3
NOTE
• ALWAYS use a new, sterile lancet each time you test to avoid infection.
• For safety reasons, once you advance to a new lancet, you cannot go back to a used lancet.
• NEVER reuse a lancet.
• NEVER share your lancing device with anyone.
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16
The Accu-Chek FastClix Lancing Device
2
Remove the cap.
Hold the lancet drum between your thumb and index finger and pull
it straight out.
A red stripe is visible on the white part, indicating that the lancet
drum has been used.
Throw the old lancet drum
away.
Always discard according to
local regulations.
1
2
Insert a new lancet drum, white end first, until it clicks firmly into
place.
Slide the cap back on until it stops by aligning the notch on the cap
with the notch on the lancing device.
3
Changing the Lancet Drum
When you have used the sixth and last lancet, change the lancet drum.
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17
Blood Glucose Tests 3
Chapter 3: Blood Glucose Tests
WARNING
• The meter and lancing device should never be used by more than one person. Do not share the
meter and lancing device with anyone, including family members, due to the risk of infection
from bloodborne pathogens.
1,2
Do not use on multiple patients!
• 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 the Accu-Chek
Customer Care Service Center at 1-800-858-8072. The correct unit of measure in the US is
mg/dL. 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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18
Blood Glucose Tests
3
Using the Accu-Chek Guide Me System
• The Accu-Chek Guide test strips are for testing fresh capillary whole blood.
• 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. If you applied
blood or control solution before inserting the test strip into the meter, retest with a new test strip. If a
result appears before applying blood or control solution, do not act on that result.
• Close the test strip container tightly immediately after removing a test strip. Moisture can damage the
test strips and produce incorrect results.
• Store the unused test strips in their original container with the cap tightly closed.
• Discard the test strips if they are past the Use By date printed on the test strip container. If the Use By
date is missing or cannot be read, do not use the test strips. Contact the Accu-Chek Customer Care
Service Center at 1-800-858-8072.
• Refer to the test strip package insert for test strip storage and system operating conditions.
• Do not reuse test strips. Once control solution or blood has been applied to a test strip, discard it. If a
retest is necessary, use a new test strip.
• Perform a control test every time you open a new test strip box.
WARNING
To prevent inaccurate results:
• If you drop the meter or drop the meter with a test strip inserted, the meter and/or test strip
could be damaged. Discard the test strip and perform a control test with control solution and
a new, unused test strip to ensure the meter and test strips are both working properly. Then
repeat the blood glucose test with a new test strip.
• DO NOT remove test strips from the test strip container and put them into another container,
such as a plastic bag, pocket, purse, wallet, etc. Storing test strips outside of the test strip
container can damage the test strips and lead to inaccurate results. It is important that the
test strips remain in their original container until the time of use.
• DO NOT expose test strips to heat, moisture, or humidity. Temperatures outside the required range,
as well as moisture and humidity, can damage the test strips and lead to inaccurate results.
• DO NOT bend, cut, or alter the test strips.
• DO NOT get dirt, food, or other material on the test strip.
• When performing a blood glucose test, remove your finger from the test strip after the test
strip is dosed and the flashing hourglass symbol appears on the meter. Failure to move your
finger away from the test strip during measurement could give inaccurate results.
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