One Drop One Drop User manual

Welcome to Your One Drop Blood Glucose Monitor-
ing System
The One Drop Meter works with the One Drop for Diabetes
App for iOS, or Android™ (the “One Drop App” or “App”)
installed on a supported device. Data is transmitted between
the One Drop Meter and the One Drop App via Bluetooth®
wireless technology.
Key Features in the One Drop Meter
Convenient Connection – The One Drop Meter uses Blue-
tooth® wireless technology for an easy to use wireless connec-
tion to supported devices.
Seamlessly Sync Results to App – Use the One Drop Meter
with the One Drop App to sync glucose results directly to your
iOS or Android™ device. The One Drop 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 One Drop Meter is small and portable, for
easy testing on the go.
System Requirements (One Drop Meter and One
Drop App)
The One Drop Meter is compatible with devices running iOS
8.3 and above or Android™ 5.1 and above.

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Customer Service 1 [phone]
[e-mail]
In case of emergency, contact your healthcare professional or
emergency medical response.
By using the One Drop Blood Glucose Monitoring System (Meter) with the
One Drop App (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.
Blood Glucose Monitoring System

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8100-10216 Rev B
©2016 One Drop & Informed Data Systems, 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 One Drop & Informed Data Systems, 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.
The One Drop Meter is compatible with devices running iOS 8.3 and above or Android™ 5.1
and above.
Designed by One Drop in USA
Manufactured exclusively for One Drop & Informed Data Systems, Inc. by 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 One Drop
System
Important Safety Instructions
The One Drop Blood Glucose Monitoring System
About the One Drop Meter, One Drop Test Strips,
and One Drop Lancing Device
Pairing and Syncing Your One Drop Meter with
the One Drop App
Before You Test Your Blood — Important Health-
related Information
How to Test Your Blood Glucose Level
Viewing Past Test Results on Your One Drop Meter
Important Cleaning and Disinfection Procedures
Important Cleaning and Disinfection Procedures
Batteries
5
10
11
12
16
21
24
33
34
39

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CHAPTER PAGETITLE
11
12
13
14
15
Error Messages
Troubleshooting
One Drop System Specifications
Electrical Safety and Standards
Warranty
44
46
53
54
56

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One Drop Blood Glucose Monitoring System Intended
Use:
The One Drop 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 One Drop 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 effec-
tiveness of diabetes control.
The One Drop 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 One Drop Test Strips only. Do not use other
brands of test strips with the One Drop Meter as this may
produce inaccurate results.
IMPORTANT The One Drop Meter should be carried in the
carrying case provided with the meter and not directly in a
pocket. If the One Drop Meter is carried in a pocket, it could be
damaged.
Important Information About Your
One Drop System
1
CHAPTER

6
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 One Drop Meter.
Your meter is ready to use right out of the box. Unpack your
system. Check that all system contents are included–there is
a list of contents in this Owner’s Guide. Ensure that the retail
carton has not been damaged.
See Chapter 5, Page 16, for more information.
CAUTION: Please read all the instructions provided in this

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Owner’s Guide and practice the testing procedures before
using the One Drop Blood Glucose Monitoring System. Blood
glucose monitoring should be done under the guidance of a
healthcare professional (HCP).
Important Safety Instructions:
Only one person should use the One Drop Meter, One Drop
Lancing Device, and lancets. Never share One Drop Meter,
One Drop Lancing Device, or lancets. Used One Drop Meter,
One Drop Lancing Device, One Drop Test Strips, and lancets
may be considered biohazardous or medical waste in your
city or town. Follow your healthcare professional’s instruc-
tions for disposal.
In case of emergency, contact your healthcare professional or
emergency medical response.
Keep the One Drop Meter and testing supplies away from
young children. Small items such as One Drop Test Strips, lan-
cets, protective covers on the lancets, and control solution vial
cap are choking hazards. Do not ingest or swallow any items.
One Drop Blood Glucose Monitoring System
Test Principle:
The One Drop Glucose Monitoring System measures a glucose
concentration in a sample of fresh capillary whole blood
drawn from the fingertip.
After insertion of a One Drop Test Strip into the One Drop Meter,

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a sample of blood obtained by fingerstick is applied to the
One Drop Test Strip. The blood sample size for the One Drop
Meter is a minimum of 0.5 µL.
The blood reacts with a reagent on the One Drop 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 mea-
sured and processed by the One Drop 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 One Drop Meter is calibrated to provide a glucose con-
centration for a capillary whole blood sample that is equiva-
lent to the plasma glucose concentration of that sample.
One Drop Test Strips
Use the One Drop Test Strips only with the One Drop Meter
to quantitatively measure the glucose in fresh capillary whole
blood drawn from your fingertip.
AgaMatrix Control Solutions
If you feel your meter is not working correctly, use AgaMatrix
Control Solutions Levels 2 and 4, the One Drop Meter, and One
Drop Test Strips to ensure that the One Drop Meter and One
Drop Test Strips are working together properly and that the

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test is performing correctly. To order either Level 2 or Level 4
Control Solution, please contact Customer Service at 1 (800)
437-1474.
Bluetooth® Wireless Technology
Bluetooth® wireless technology is a type of wireless RF (Radio
Frequency) communication. Cell phones use Bluetooth®
wireless technology as do many other devices. Your One
Drop Meter uses Bluetooth® wireless technology to pair with
compatible iOS and Android™ devices to send results to the
One Drop App.
Minimum operating system requirements for compatible
devices are iOS 8.3 and above or Android™ 5.1 and above.
Note: You should sync your One Drop Meter to the One Drop App
to set your One Drop Meter’s time and date before testing. This
will ensure that results from One Drop Meter are sent wirelessly to
the One Drop App. See Chapter 5, Page 16, for more information.
Supported Devices
The One Drop App, is an application that allows users to add,
modify, and view health data, including glucose, insulin,
carbs, and weight. The One Drop App works on a variety
of iOS and Android™ devices. Minimum operating system
requirements for compatible devices are iOS 8.3 and above or
Android™ 5.1 and above.

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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 One Drop Meter and One Drop Lancing Device are for single
patient use. Do not share them with anyone including other fam-
ily 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 9, Page 34.
The Food and Drug Administration (FDA) and the Center for
Disease Control (CDC) have issued warnings 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:
Important Safety Instructions
2
CHAPTER
When the One Drop App is paired with your One Drop Meter,
the data from your One Drop Meter will automatically sync
with the One Drop App whenever the two devices are in
range and the One Drop Meter is turned on.

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·“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
·“Infection Prevention during Blood Glucose Monitoring and
Insulin Administration” (2012)3
The One Drop Blood Glucose Monitoring
System
3
CHAPTER
The One Drop Blood Glucose Monitoring System
Contains:
• One Drop Blood Glucose Meter
• One Drop Lancing Device with Cap
• One Drop Test Strips — 2 Vials (100 Strips)
• One Drop Compact Carrying Case
• One Drop Owner’s Guide
• Lancets — 10 Sterile
• Two Pre-installed CR2032, 3-Volt, Lithium Batteries

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About the One Drop Meter
Please note the correct orientation of the device in the sample
image below.
(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 One Drop Test Strip or press the meter button.
If you see a significant portion of the display not lighting
up appropriately, do not use the One Drop Meter and call
Customer Service.
(2) Meter Button: The button is the circle on the front of the
One Drop Meter. It is on the opposite side of the One Drop
Meter’s strip port. It is used to turn on the One Drop Meter
and view past glucose test results.
(3) Test Strip Port: Insert the One Drop Test Strip, with the
contact bars facing up, into the One Drop Test Strip port.
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1
2
About the One Drop Meter, One Drop Test
Strips, and One Drop Lancing Device
4
CHAPTER

13
Note: The batteries are pre-installed in the One Drop Meter.
About the One Drop Test Strips
Use your system and your fingertip to test your blood glu-
cose. Testing with the system requires a small sample size,
0.5μL of blood, about the size of a pinhead.
(1) Front of the One Drop Test Strip The front of the One
Drop Test Strip is black in color. Ensure that the front (black-
colored) side of the One Drop Test Strip is facing towards
you, when inserting a One Drop Test Strip into the One Drop
Meter’s test strip port.
(2) Back of the One Drop Test Strip The back of the One
Drop Test Strip is white in color. Ensure that the back (white-
colored) side of the One Drop Test Strip is facing away from
you, when inserting a One Drop Test Strip into the One Drop
Meter’s test strip port.
(3) Contact Bars This end is inserted, front of the One Drop
Test Strip facing towards you, into the One Drop Meter’s test
strip port.
4
3
12
5

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(4) Sample Area Blood should be applied to the tip of the
One Drop Test Strip here.
(5) Visual Fill Window This window will turn red when
enough blood has been applied.
Important Test Strip Information:
• Store the One Drop Test Strip vial in a cool, dry place at
46°F to 86°F (8°C to 30°C) and at a relative humidity of 10%
to 90%.
• Keep away from direct sunlight and heat.
• Store your One Drop Test Strips in their original vial only;
never store them in another vial, any other container, or
outside the vial.
• With clean, dry hands you may gently handle the One Drop
Test Strip when removing it from the vial or inserting it
into the One Drop Meter.
• After removing a One Drop Test Strip from the vial, imme-
diately close the vial cap tightly.
• Do not use One Drop Test Strips beyond the expiration
date or 180 days after first opening the vial. This may
cause inaccurate results. Write the discard date (180 days
from the first opening) on the One Drop Test Strip vial.
• Do not bend, cut, or alter One Drop Test Strips.

15
• Apply only fresh capillary blood to the sample area of the
One Drop Test Strip.
• Use One Drop Test Strips only once.
• Only use One Drop Test Strips with the One Drop Meter.
• Dispose of used One Drop Test Strips properly.
About the One Drop Lancing Device
(1) Cocking Handle Cocks the device so it is ready to lance.
(2) Depth Adjustment Slider Adjusts how deep the lancet
will lance the skin.
(3) Lancet Ejector Ejects the lancet.
(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.
+
-
12
4
8
65
7
3

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(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).
The One Drop 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 One Drop Meter to the
One Drop App and set your One Drop Meter’s time and date,
you must pair your One Drop Meter with the One Drop App.
When the One Drop App is paired with your One Drop
Meter, the data from your One Drop Meter will automatically
sync with your One Drop App every time it is within close
proximity (10 feet) of your paired device, and the One Drop
Meter screen and App are activated.
Compatibility
Minimum operating system requirements for compatible
devices are iOS 8.3 and above or Android™ 5.1 and above.
The One Drop App can be downloaded for free from the App
StoreSM on your iPhone® or iPod touch® or on Google Play™
on your Android™ device.
Pairing and Syncing Your One Drop
Meter with the One Drop App
5
CHAPTER

17
IMPORTANT: Please note that the One Drop 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.
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 One Drop
Meter to another device one time.
After your One Drop 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 One Drop Meter
screen and App are activated.
Pairing for the First Time
Before pairing your One Drop Meter with the One Drop App
for the first time, the One Drop 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 One Drop Meter in chronological order, but will not sync to
the One Drop App when paired. Test results without a set time

18
and date will be displayed on your One Drop Meter with “--:--“
and “--/--“ in place of the time and date.
Go to: http://onedrop.today/setup
This website includes up-to-date instructions on how to get
set up and pair your meter.
The One Drop Meter and the One Drop App must be within
10 feet of each other in order to pair and transfer data.
Note: Test results taken prior to the time and date being set will
not have a time and date associated with them on the One Drop
Meter. You can manually add these readings to the One Drop App
to include them in your statistics. Test results without a set time
and date will be displayed on your One Drop meter with “--:--“ and
“--/--“ in place of the time and date.
Important Pairing Information
The Bluetooth® wireless technology feature on your One Drop
Meter sends test results to your supported device.
To prevent other people’s test results from being sent to your
supported device:
[1] Do not let another person test their blood glucose with
your One Drop Meter. This meter is for single patient use only.
[2] Do not pair or sync a One Drop Meter used by another
person with your supported device. If you pair with another
person’s One Drop Meter, the data from each One Drop Meter
will be combined in the One Drop App and will cause your