OneTouch VERIO SYNC Owner's Manual

Blood Glucose Monitoring System
Owner’s Booklet Instructions for use
For use with the
App on iPhone®, iPod touch® and iPad®
Owner’s Booklet
Blood Glucose Monitoring System
2
Owner’s Booklet
Thanks for choosing OneTouch®!
The OneTouch® Verio®Sync Blood Glucose Monitoring System is made specifically to work with the OneTouch® Reveal™ app (application)* on the iPhone, iPad or iPod touch. One of the latest product innovations from LifeScan, the OneTouch® Verio®Sync Meter sends results wirelessly to the app using Bluetooth® (wireless RF). The app lets you review and graph your results, and helps identify patterns.
This Owner’s Booklet offers a complete explanation of how to use your new meter and testing supplies. It reviews the do’s and don’ts of testing your blood glucose. Please keep your Owner’s Booklet in a safe place. You may want to refer to it in the future.
We hope OneTouch® products and services will continue to be a part of your life.
*In this booklet, OneTouch® Reveal™ app will be referred to as the “app.” For details on the app, please see the app Owner's Booklet or More > Help in the app.
3
System Requirements
The OneTouch® Verio®Sync System requires:
The OneTouch® Reveal™ app. You can download the app to your iPhone, iPod touch or iPad from the App Store℠ for free.
A compatible Apple® device with iOS 4.3 and 5.1.1
Made for iPod touch (3rd and 4th generation), iPhone 4S, iPhone 4, iPhone 3GS, iPad (3rd generation), iPad 2 and iPad.
Visit www.OneTouch.com for updates on compatible Apple devices and operating systems.
For information on the app, see the OneTouch® Reveal™ App Owner’s Booklet at www.OneTouch.com.
iPhone, iPod touch and iPad not included.
4
Symbols
Cautions and Warnings. Refer to the Owner’s
Booklet and inserts that came with your system for safety-related information.
Direct current
Consult instructions for use
Low battery
Empty battery
Low battery charging
Empty battery charging
Last blood glucose result
Apply blood
Do not apply blood/Do not test
Bluetooth® (wireless RF on)
Airplane mode (wireless RF not on)
Syncing with the OneTouch® Reveal™ app
Control solution test result
5
Table of Contents
1
Setting up your system
- Turning your meter on 16
- Turning your meter o 17
- Pairing your meter with the
Apple device 18
- Initial syncing of the meter and app 23
- Syncing to send results wirelessly
to the app 26
2
Taking a test
- Testing your blood glucose 30
- Testing with control solution 55
3
Viewing your results 64
4
Care and maintenance 66
5
Battery (recharging) 72
6
Troubleshooting 80
7
Detailed information
about your system 96
8
Index 107
6
Before you begin
Before using this product to test your blood glucose, carefully read this Owner’s Booklet. Also read the inserts that come with the OneTouch® Verio® Test Strips and OneTouch® Verio® Control Solutions.
NOTE: It is best to fully charge the battery before using the OneTouch® Verio®Sync Meter. See pages 72-79 for instructions.
Apple Legal Notice
“Made for iPod touch”, “Made for iPhone” and “Made for iPad” mean that an electronic accessory has been designed to connect specifically to iPod touch, iPhone or iPad, respectively, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. Please note that the use of this accessory with iPod touch, iPhone or iPad may affect wireless performance.
Apple, iPad, iPhone, iPod, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.
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Important safety instructions
• This meter and lancing device are for single patient use
only. Do Not share them with anyone else, including family members! Do Not use on multiple patients!
• After use and exposure to blood, all parts of this kit
are considered biohazardous. A used kit may transmit infectious diseases even after you have performed cleaning and disinfection. For more information, see:
FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm224025.htm.
CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick­DevicesBGM.html.
8
Intended use
The OneTouch® Verio®Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single person and should not be shared. The OneTouch® Verio®Sync BGMS is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio®Sync BGMS is not to be used for the diagnosis of or screening of diabetes or for neonatal use. The OneTouch® Verio®Sync BGMS is also not for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar patients.
The OneTouch® Verio®Sync Meter is intended for use with the OneTouch® Verio® Control Solutions and OneTouch® Verio® Test Strips. The OneTouch® Verio® Control Solution is used to check that the meter and test strips are working together properly and that the test is performed correctly. The OneTouch® Verio®Sync BGMS communicates wirelessly with the OneTouch® Reveal™ app on commercially available mobile devices and via USB cable with LifeScan diabetes PC-based applications.
9
Test principle
Glucose in the blood sample mixes with the enzyme FAD-GDH (refer to page 98) in the test strip and a small electric current is produced. The strength of this current changes with the amount of glucose in the blood sample. Your meter measures the current and calculates your blood glucose level. It then displays the blood glucose result and stores it in the meter memory.
About Bluetooth®
Bluetooth® is a type of wireless (RF) communication. Cell phones use Bluetooth® technology as do many other devices. Your OneTouch® Verio®Sync Meter uses Bluetooth® to pair with the Apple device and to send results to the app.
m CAUTION
Before testing, you must first pair your meter with the Apple device and initially sync with the app. This will
ensure that results from your meter are sent wirelessly to the app on your Apple device. See pages 18-25.
10
Your meter is subject to and complies with U.S. federal guidelines, Part 15 of the FCC rules for devices with RF capability. These rules state two conditions specific to the operation of the device. They are:
• This device may not cause harmful interference.
• This device must accept any interference received,
including interference that may cause undesirable operation.
These guidelines help ensure that your meter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of your meter.
With the exception of your iPhone, other electronic wireless devices that are in use nearby, such as a cell phone or a wireless network, may prevent or delay the transmission of data from your meter to the app. Moving away from or turning off these electronic devices may allow communication.
The meter has been tested and found to be appropriate for use at home. In most cases, it should not interfere with other home electronic devices if used as instructed. However, this meter gives off RF energy when Bluetooth® is on. If not used correctly, your meter may interfere with your TV, radio, or other electronic devices that receive or transmit RF signals.
11
If you experience meter interference problems, try moving your meter away from the source of the interference. You can also move the electronic device or its antenna to another location to solve the problem.
If you continue to experience interference, contact Customer Service at 1 888 567-3003 (available 7 days a week, 8 a.m. – 10 p.m. Eastern Time), or visit www.OneTouch.com. Or, contact support service for the manufacturer of the electronic device causing the interference.
In locations where cell phone use is not permitted, such as hospitals, some healthcare professional offices, and airplanes, you should set the meter to “Airplane” mode (Bluetooth® off). See Step 1 on page 20 for more information.
m WARNING
The Bluetooth® feature on your meter sends test results to your Apple device. To prevent other people’s results from being sent to the Apple device, Do Not let anyone else use your meter to test their blood glucose. This meter is for single patient use only.
Bluetooth® Trademark
The Bluetooth® word mark and logos are owned by the Bluetooth® SIG, Inc. and any use of such marks by LifeScan, Inc. is under license. Other trademarks and trade names are those of their respective owners.
12
The OneTouch® Verio®Sync
Blood Glucose Monitoring System
Included with your kit:
The following item is sold separately.
A
B
HG
D
E
C
F
I
13
A
OneTouch® Verio®Sync Meter
(with internal rechargeable battery)
B
Carrying case
C
AC adapter
D
OneTouch® Delica® Sterile Lancets
E
Mini USB cable
F
OneTouch® Delica® Lancing Device
G
OneTouch® Verio® Level 3 Control Solution
H
OneTouch® Verio® Test Strips
The following item is sold separately.
I
OneTouch® Verio® Level 4 Control Solution*
You can use either OneTouch® Verio® Level 3 Control Solution or OneTouch® Verio® Level 4 Control Solution with your OneTouch® Verio®Sync Meter.
*For availability of test strips and control solutions, ask your pharmacist or healthcare professional.
m WARNING
Keep the meter and testing supplies away from young children. Small items such as the test strips, lancets, protective covers on the lancets, and control solution vial cap are choking hazards. Do Not ingest or swallow any items.
14
Getting to know your OneTouch® Verio®Sync
Blood Glucose Monitoring System
1
Setting up your system
Meter
Test strip port
Insert test strip here to turn meter on
Data/Battery charging port
• Connect to recharge
meter battery
• For downloading results to computer
Display
Meter button
• Turns meter on/off
• Dims backlight and
turns test strip port light on/off
• Turns Bluetooth®
(wireless RF) on/off
Battery symbol
Battery power indicator (appears if low)
mg/dL is the pre-set unit of measure and cannot be changed
15
1
Setting up your system
Test strip
Channel to apply sample
(either side)
Silver prongs
Insert into test strip port
16
Setting up your system
1
Turning your meter on
1. Press and hold the meter button until the meter comes on
m CAUTION
If you see any missing segments within the start-up screen, there may be a problem with the meter. Contact Customer Service at 1 888 567-3003 (available 7 days a week, 8 a.m.– 10 p.m. Eastern Time).
Next, the Last Result screen appears. The arrow ( ) indicates that this is the Last Result screen. The three dashes (---) mean that no results are currently stored in the meter. The airplane symbol ( ) indicates that Bluetooth® is not on. When Bluetooth® is on ( ), your meter will automatically attempt to sync ( ) any unsent blood glucose readings.
17
Setting up your system
1
Using the display backlight and test strip port light
The backlight and test strip port light come on automatically when the meter is turned on or a test strip is inserted. The backlight will dim and the test strip port light will turn off when you press and release the meter button once, or after about 30 seconds of no activity. Pressing the meter button or inserting a test strip will turn them both back on. The test strip port light provides additional light that may help you complete a test. Five seconds after applying blood (or control solution), the test strip port light will turn off.
Turning your meter o
There are three ways to turn your meter off:
• Press and hold meter button for several seconds until the meter turns off. Or,
• Your meter will turn off by itself within 10 seconds after
sending results to the Apple device. Or,
• In all other instances, the meter will turn off by itself if
left alone for 2 minutes.
Using the meter button to turn the meter off will save battery power.
18
Setting up your system
1
Figure 1
Multiple meters
Single Apple
device
Pairing your meter with the Apple device
Pairing prepares your OneTouch® Verio®Sync Meter and Apple device to communicate with each other. The devices must be within 10 feet of each other to pair and sync. Download the OneTouch® Reveal™ app from the App Store before pairing your meter and Apple device.
Multiple OneTouch® Verio®Sync Meters can be paired with your Apple device. For example, your Apple device can be paired with a meter at home and another at work (see Figure 1). To pair multiple meters, simply repeat the pairing instructions on pages 20-23 for each meter.
19
Setting up your system
1
However, your OneTouch® Verio®Sync Meter can only be paired with one Apple device at a time. For example, you can pair your meter with an iPod touch, iPhone or iPad, but not more than one at the same time (see Figure 2).
m WARNING
Do Not pair another person’s meter with your Apple device.
Figure 2
Single meter
Multiple Apple
devices
20
Setting up your system
1
To pair the Apple device with your meter, start with your meter on and follow these steps:
1. To turn on Bluetooth®, press the meter button twice
The ( ) symbol will appear to indicate Bluetooth® is on. The ( ) symbol indicates that Bluetooth® is turned off. To switch between ( ) and ( ) modes, press the meter button twice quickly.
2. To turn on Bluetooth® on your Apple device tap the Settings icon on the home screen
3. Then select General
NOTE: Test result data sent to the app from multiple meters will be combined, just as though the data came from a single meter. If you do not want test data from multiple meters displayed together, Do Not pair any additional OneTouch® Verio®Sync Meters with the Apple device. See pages 18-19 and 28-29 for important information on pairing and syncing multiple meters.
Settings icon
21
Setting up your system
1
4. Next select
Bluetooth and set Bluetooth to ON
Your devices are now searching for each other.
5. Look for a device
named OneTouch, followed by the beginning of the Serial Number on the back of your meter
This is your meter.
6. Tap on the entry
that represents your OneTouch meter
22
Setting up your system
1
7. Enter your meter PIN number using the keypad
The PIN number can be found on the back of your meter in the box.
PIN:
xxxxxx
SN: V3CHP01
PIN
Number
8. Tap Pair
23
Setting up your system
1
9. Wait for the
device status to say “Connected”
Congratulations! Your meter and Apple device are now paired. Before testing, you must now initially sync the meter with the app.
NOTE: The Sync symbol ( ) on the meter will continue to blink after successful pairing.
Initial syncing of the meter and app
You must initially sync the meter and app before you start testing your blood glucose. The first time you sync, the Apple device will set the clock in the meter. However, you will not see the date and time on the meter display until after your first test.
The Apple device checks and updates the date and time in your meter each time you sync. Check the date and time on your Apple device often to be sure they are correct. For instructions on setting the date and time on your iPhone, iPad or iPod touch, see the user manual for your Apple device.
24
Setting up your system
1
1. Open the OneTouch® app on the Apple device
2. Turn your meter on
3. The Sync symbol ( ) blinks on the meter display
4. “Syncing Data” will appear on the app to notify you that the meter is communicating with the app
NOTE: It is important to sync the meter and app before testing for the first time. This will ensure that the correct
date and time are attached to your test results. Any glucose results from tests taken before your initial Sync will not be assigned a date or time, and will never be sent to the app.
Syncing Data
25
Setting up your system
1
Meter Time Difference
Your meter time is out of sync with
your device. Would you like to set
your meter time to match your
device?
No
No
Yes
Yes
NOTE: The first time you sync, the app will display a Meter Time Difference message.
Tap Yes to set the clock in your meter. The date and time will appear on your meter after your first test.
NOTE: If you tap No or do not act on the message, the clock in the meter will not be set. Any glucose results from tests taken before the meter clock is set will not be assigned a date or time, and will never be sent to the app. With your meter off, repeat steps 2-4 on page 24 to initially sync and set the meter clock.
When complete, the date and time of the initial Sync will appear under Last Sync on the app Summary screen. When you begin testing, the date and time of your test will appear on the meter.
NOTE: We recommend personalizing the app in your Apple device after initial syncing and before you begin testing your blood glucose. Refer to the OneTouch® Reveal™ App Owner’s Booklet or the Help file in the app.
26
Setting up your system
1
Syncing to send results wirelessly to the app
After pairing the meter with your Apple device and initially syncing with the app, you are ready to begin testing (see pages 30-54). Sync often to send test results wirelessly to the app.
1. Open the app on your Apple device
2. Turn your meter on and make sure the Bluetooth® symbol ( ) is displayed
If needed, press the meter button twice quickly to turn Bluetooth® on.
3. The Sync symbol ( ) blinks on the meter display
27
Setting up your system
1
4. “Syncing Data” will
appear on the Apple device to let you know the meter is sending results to the app
5. After the Sync, the
app will display a list of any new blood glucose results sent from the meter
Example
Syncing Data
28
Setting up your system
1
Using your meter without the app
The meter can be used without an Apple device or the app. You can still test your blood glucose and review your last result on the meter screen. To review additional results in the meter memory, you can download to a computer (see page 64). However, no date and time will appear with
results unless you have downloaded the app, paired your meter with your Apple device and initially synced your meter with the app (see pages 18-25).
IMPORTANT NOTE
If you plan to sync more than one meter with the app
When sending test results to the app from more than one meter, it is recommended that the meters are synced one at a time. Each meter has a unique serial number that will appear on your Apple device when pairing. (The serial number will be shortened when you view it on your Apple device.)
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