AgaMatrix Jazz Wireless 2 User manual

Welcome to Your New AgaMatrix Jazz™ Wireless 2
Blood Glucose Monitoring System
The AgaMatrix Jazz Wireless 2 Blood Glucose Meter is
designed to work with the AgaMatrix Diabetes Manager, an
iOS or AndroidTM application (app) installed on a supported
device. Data is transmitted between the AgaMatrix Jazz
Wireless 2 Meter and the AgaMatrix Diabetes Manager App
via Bluetooth® wireless technology.
Key Features in the AgaMatrix Jazz Wireless 2 Meter
Convenient Connection – The AgaMatrix Jazz Wireless 2
Meter uses Bluetooth® wireless technology–for an easy to use,
wireless connection to supported devices.
Seamlessly Sync Results to App – Use the AgaMatrix
Jazz Wireless 2 Meter with the AgaMatrix Diabetes Manager
App to sync glucose results directly to your iOS or Android de-
vice. The App can be used to conveniently store and manage
your diabetes information, review trends, or share with your
healthcare team. It can be downloaded from the App StoreSM
or on Google PlayTM.
Small size – The AgaMatrix Jazz Wireless 2 Meter is small and
portable, for easy testing on the go.
System Requirements (Meter and App)
A compatible iOS or Android device. Visit our website for
more information: www.myagamatrix.com

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Toll-Free, 24 Hour Customer Service: 1 [phone]
In case of emergency, contact your healthcare professional or
emergency medical response.
By using the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
(Meter) with the AgaMatrix Diabetes Manager (the App).
You agree that the use of this software together with an iPod, iPhone or iPad
(“Apple Product”) shall only be as a personal organization or supplemental
data display tool and not as a source of medical advice. You agree that this
software will never be used to replace the advice of a doctor, or your own
common sense and independent judgment, and that you will not at any time
rely on any information presented on your Apple Product as the basis for
health care, medical or other decisions that may result in injury or other ill
effects. You agree to take sole responsibility for your health care decisions,
including contacting a physician or other health care professional regarding
all medical conditions, tests, diagnoses and treatment options and agree that
Apple shall have no liability for any action you or anyone using the software
may take, regardless of the information received, displayed, calculated or
transmitted by your Apple Product. Apple assumes no risk for your use of the
software and makes no warranties whatsoever, express or implied, regarding
the accuracy, completeness or usefulness of any information presented on
your Apple Product as a result of using the software.

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8100-10155 Rev B
©2016 AgaMatrix, Inc. Meter Firmware ©2014-2016 AgaMatrix, Inc.
US and International Patents Pending. All rights reserved.
All trademarks and copyrights are the property of their respective owners.
For patent information, see www.agamatrix.com/patents
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG,
Inc. and any use of such marks by AgaMatrix, Inc. is under license. Other trademarks and
trade names are those of their respective owners.
Apple, the Apple logo, iPhone 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.
Android is a trademark of Google Inc. Google Play is a trademark of Google Inc.
Manufacturer:
AgaMatrix, Inc.
7C Raymond Avenue
Salem, NH 03079 USA

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Contents
CHAPTER PAGETITLE
1
2
3
4
5
6
7
8
9
10
Important Information About Your AgaMatrix
Jazz Wireless 2 System
Important Safety Instructions
The AgaMatrix Jazz Wireless 2 System Kit
About the Meter, Test Strips, and Lancing Device
Pairing and Syncing Your Meter with the App
Important Information about Performing
Control Solution Tests
How to Perform a Control Solution Test
Before you Test your Blood – Important
Health-related Information
How to Test Your Blood Glucose Level
Viewing Past Test Results on Your Meter
5
10
11
11
16
23
26
30
33
42

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CHAPTER PAGETITLE
11
12
13
14
15
16
17
Important Cleaning and Disinfection Procedures
Batteries
Error Messages
Troubleshooting
AgaMatrix Jazz Wireless 2 System Specifications
Electrical Safety and Standards
Warranty
43
48
50
55
60
61
64

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AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring
System Intended Use:
The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
is intended for quantitative measurement of blood glucose
(sugar) levels in fresh capillary whole blood samples drawn
from the fingertip. It is intended to be used by a single patient
and should not be shared.
The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring
System 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 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring
System is not intended for use in diagnosis of, or screening for
diabetes and not intended for use in neonates.
For use with AgaMatrix Jazz Test Strips and AgaMatrix Control
Solution only. Do not use other brands of test strips and con-
trol solution with this meter as this may produce inaccurate
results.
IMPORTANT: The AgaMatrix Jazz Wireless 2 Meter is intended
to be carried in the carrying case provided with the meter and
not directly in a pocket. If the meter is carried in a pocket it
could be damaged.
Important Information About Your
AgaMatrix Jazz Wireless 2 System
1
CHAPTER

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Limitations
· Not for diagnosis of or screening of diabetes mellitus
· Not to be used for patients who are dehydrated, hypoten-
sive, in shock, critically ill, or in a hyperosmolar state
· Not for persons undergoing Oxygen therapy
· Not for testing the glucose levels in neonates (children
under 4 weeks)
· Not for testing glucose levels in arterial or venous blood
samples
· Not for testing glucose from sites other than samples
drawn from the fingertip
Getting Started
This Owner’s Guide is intended to instruct the user on how to
use the meter.
Your meter is ready to use right out of the box. Unpack your
system. Check that all system kit contents are included–there
is a list of kit contents in this Owner’s Guide. Ensure that the
retail carton has not been damaged.
You should sync your meter to the AgaMatrix Diabetes Man-
ager App (the App) to set your meter’s time and date before
testing. This will ensure that results from meter are sent wire-
lessly to the App. See Chapter 5 for more information.

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CAUTION: Please read all the instructions provided in this
Owner’s Guide and practice the testing procedures before
using the AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring
System. Blood glucose monitoring should be done under the
guidance of a healthcare professional (HCP).
Important Safety Instructions:
The meter, lancing device and lancets should be used by one
person. Never share meter, lancing devices, or lancets. Used
meter, test strips, lancets, and lancing devices may be con-
sidered biohazardous or medical waste in your city or town.
Follow your healthcare professional’s instructions for disposal.
In case of emergency, contact your healthcare professional or
emergency medical response.
Keep the meter and testing supplies away from young children.
Small items such as test strips, lancets, protective covers on
the lancets, and control solution vial cap are choking hazards.
Do not ingest or swallow any items.
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring
System Test Principle:
The AgaMatrix Jazz Wireless 2 blood glucose monitoring
system measures a glucose concentration in a sample of fresh
capillary whole blood drawn from the fingertip.
WaveSense™ is the technology used in AgaMatrix Meters.
After insertion of a test strip into the AgaMatrix Jazz Wireless 2

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Meter, a sample of blood obtained by fingerstick is applied
to the test strip. The blood sample size for the meter is a
minimum of 0.5 µL.
The blood reacts with a reagent on the test strip that contains
glucose oxidase, an electron mediator, and other materials.
The chemical reaction with glucose that takes place on the
strip generates an electrical signal that is measured and pro-
cessed by the meter.
The meter computes a glucose concentration and displays
the result. The measurement range of the system is 20 to
600 mg/dL glucose. Capillary whole blood samples with a
hematocrit range of 20% to 60% can be measured.
The AgaMatrix Jazz Wireless 2 Meter is calibrated to provide
a glucose concentration for a capillary whole blood sample
that is equivalent to the plasma glucose concentration of that
sample.
AgaMatrix Jazz Test Strips
AgaMatrix Jazz Test Strips are for use with the AgaMatrix Jazz
Wireless 2 Blood Glucose Meter to quantitatively measure
glucose of fresh capillary whole blood drawn from the the
fingertip.
AgaMatrix Control Solutions
AgaMatrix Control Solutions Levels 2 and 4 are for use with the
AgaMatrix Jazz Wireless 2 Blood Glucose Meter and AgaMatrix
Jazz Test Strips to check that the meter and test strips are

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working together properly and that the test is performing
correctly. To order either Level 2 or Level 4 Control Solution,
please contact Customer Service.
Bluetooth®
Bluetooth® is a type of wireless RF (Radio Frequency) com-
munication. Cell phones use Bluetooth® wireless technology
as do many other devices. Your meter uses Bluetooth® to pair
with compatible iOS and Android devices to send results to
the AgaMatrix Diabetes Manager (the App).
Note: You should sync your meter to the App to set your meter’s
time and date before testing. This will ensure that results from
meter are sent wirelessly to the App. See Chapter 5 for more
information.
Supported Devices
The AgaMatrix Diabetes Manager, “the App”, is an application
that allows users to add, modify, and view health data, includ-
ing glucose, insulin, carbs, and weight. The App works on a
variety of iOS and Android devices. To see an updated list,
visit your meter manufacturer’s website.
When the App is paired with your meter, the data from your
meter will automatically sync with your App whenever the
two devices are in range and the meter is turned on.

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1. http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm224025.htm
2. http://www.cdc.gov/injectionsafety/fingerstickdevicesbgm.html
3. http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
The meter and lancing device are for single patient use. Do not
share them with anyone including other family members! Do not
use on multiple patients!
All parts of the kit are considered biohazardous and can poten-
tially transmit infectious diseases, even after you have performed
cleaning and disinfection.
For important instructions for disinfecting your meter and lanc-
ing device, please read Chapter 11.
The Food and Drug Administration (FDA) and the Center for
Disease Control (CDC) have issued warning and notications
regarding the risk of bloodborne pathogen transmission
when blood glucose monitoring systems have been used
by more than one individual. Please read the following
references for more information:
·“FDA Public Health Notification: Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting Blood-
borne Pathogens: Initial Communication” (2010)1
·“CDC Clinical Reminder: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens” (2010) 2
Important Safety Instructions
2
CHAPTER

11
·“Infection Prevention during Blood Glucose Monitoring and
Insulin Administration” (2012) 3
The AgaMatrix Jazz Wireless 2 System Kit
3
CHAPTER
• AgaMatrix Jazz Wireless 2 Blood Glucose Meter
• Two Pre-installed CR2032, 3 Volt, Lithium Batteries
• Lancing Device with Cap
• 10 Sterile Lancets
• Compact Carrying Case
• 1 Vial of 10 AgaMatrix Jazz Test Strips
• AgaMatrix Jazz Test Strip Insert
• AgaMatrix Jazz Wireless 2 Owner’s Guide
• Getting Started–Meter Pairing & Syncing Guide
• Registration Card
The System Kit Contains:
About the AgaMatrix Jazz Wireless 2 Meter
Please note the correct orientation of the device in the sample
image below.
About the Meter, Test Strips,
and Lancing Device
4
CHAPTER
2
1
3

12
(1) Display Area: Glucose test results, symbols, and messages
appear here.
Inspect the display for damage by viewing the Intro
Animation. You will see the Intro Animation every time
you insert a test strip or press the meter button. If you
see a significant portion of the display not lighting up
appropriately, do not use the meter and call Customer Service.
(2) Meter Button: The button is the circle on the front of the
meter. It is on the opposite side of the meter’s strip port. It is
used to turn on the meter and view past glucose test results.
(3) Test Strip Port: Insert the AgaMatrix Jazz Test Strip, with
the contact bars facing up, into the test strip port.
Note: The batteries are pre-installed in the meter.
About the AgaMatrix Jazz Test Strips
With your system, you can test your blood glucose on your
fingertips. Testing with the system requires a small sample
size, 0.5µL of blood, about the size of a pinhead.
4
3
12
5

13
(1) Front of the Test Strip: The front of the test strip is black
in color. Ensure that the front (black-colored) side of the test
strip is facing towards you when inserting a test strip into the
meter’s test strip port.
(2) Back of the Test Strip: The back of the test strip is white
in color. Ensure that the back (white-colored) side of the test
strip is facing away from you when inserting a test strip into
the meter’s test strip port.
(3) Contact Bars: This end is inserted, front of the test strip
facing towards you, into the meter’s test strip port.
(4) Sample Area: Blood or control solution should be applied
to the tip of the test strip here.
(5) Visual Fill Window: This window will turn red when
enough blood has been applied or blue when enough control
solution has been applied.
Important Test Strip Information:
• Store the AgaMatrix Jazz Blood Glucose Test Strip vial in a
cool, dry place at 46°F to 86°F (8°C to 30°C) and at a rela-
tive humidity of 10% to 90%.
• Keep away from direct sunlight and heat.
• Store your AgaMatrix Jazz Blood Glucose Test Strips in
their original vial only; never store them in another vial,
any other container or outside the vial.

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• With clean, dry hands you may gently handle the AgaMatrix
Jazz Blood Glucose Test Strip when removing it from the
vial or inserting it into the meter.
• After removing an AgaMatrix Jazz Blood Glucose Test Strip
from the vial, immediately close the vial cap tightly.
• Do not use AgaMatrix Jazz Blood Glucose Test Strips
beyond the expiration date or 180 days after first open-
ing the vial. This may cause inaccurate results. Write the
discard date (180 days from the first opening) on the test
strip vial.
• Do not bend, cut or alter AgaMatrix Jazz Blood Glucose
Test Strips.
• Apply only fresh capillary blood or control solution to the
sample area of the AgaMatrix Jazz Blood Glucose Test Strip.
• Use AgaMatrix Jazz Blood Glucose Test Strips only once.
• Only use AgaMatrix Jazz Blood Glucose Test Strips with
the AgaMatrix Jazz Wireless 2 Meter.
• Dispose of used test strips properly.

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About the AgaMatrix Lancing Device
(1) Cocking Handle: Cocks the device so it is ready to lance.
(2) Depth Adjustment Dial: Adjusts how deep the lancet will
lance the skin.
(3) Depth Indicator Window: Displays the depth setting of
the lancing device.
(4) Release Button: Fires the lancet.
(5) Lancet Holder Cup: Holds the lancet into place inside the
lancing device.
(6) Lancing Device Cap: Covers the lancet when in lancing
device.
(7) Lancet: Lances the skin to produce a drop of blood.
(8) Lancet Cover: Covers the lancet for safety. Remove after
inserting into the lancet holder cup.

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The AgaMatrix Diabetes Manager (“the App”) is an
application that allows users to add, modify, and view health
data, including glucose, insulin, carbs, and weight.
If you want to sync readings from your meter to the App and
set your meter’s time and date, you must pair your meter with
the App.
When the App is paired with your meter, the data from your
meter will automatically sync with your app every time it is
within close proximity (10 feet) of your paired device, and the
meter screen is activated.
Compatibility
The app works on a variety of iOS and Android devices. To
see an updated list, visit your meter manufacturer’s website.
The App can be downloaded for free from the App StoreSM
on your iPhone® or iPod touch® or on Google Play™ on your
Android™ device.
IMPORTANT: Please note that the App stores sensitive
health-related information on your supported device. We
recommend keeping your supported device up-to-date
with the latest security software. For more information on
keeping your supported device and information safe, please
contact the manufacturer of your supported device.
Pairing and Syncing Your Meter
with the App
5
CHAPTER

17
Pair Versus Sync
All devices that communicate via Bluetooth® wireless
technology need to first “pair” with each other so they can
establish a connection and get authorized to communicate
with each other. You will only have to pair your meter to
another device one time.
After your meter is paired with your device, it will “sync”, or
transfer data, every time it is within close proximity (10 feet) of
your paired device, and the meter screen is activated.
Pairing for the First Time
Before pairing your meter with the App for the first time, the
App must be installed on your supported device. Ensure that
the date and time on your supported device is correct.
Note: Test results without a set time and date will be saved to
the meter in chronological order, but will not sync to the App
when paired. Test results without a set time and date will be
displayed on your meter with “--:--“ and “--/--“ in place of the
time and date.
[1] Launch the App: Tap on the App icon on your supported
device.

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[2] Navigate to the Menu: Tap on the icon made of three lines.
[3] Tap on “Meters”
[4] Tap “Add a new meter”
[5] On your meter, press and hold the Meter Button.
[6] Tap on your meter’s serial number when it appears in the
App. You can find this label under the meter battery door.
[7] Enter the passkey: A 6-digit passkey will appear on the
meter. Type the number into the App.
Example image
of a passkey:
[8] Confirm pairing is successful: Both the meter and the App
will indicate that pairing was successful. The meter will have
a check symbol and the App will show a message.
Example image of
a check symbol:
The meter and the App must be within 10 feet of each other
in order to pair and transfer data.