Gmate SMART User manual

Customer Care (Toll-Free)
xxxxxx / Rev. Date 2014-05 / Printed in Korea
www.Gmate.com
24 hours a day, 7 days a week
Tel [phone]
Fax [phone]
E-mail [email protected]
philosys Co., Ltd.
827-3, Sangpyeong-ri, Okgu-eup,
Gunsan-si, Jeollabuk-do, Korea
MANUFACTURED BY:
Tel 855-GO-GMATE
(855-464-6283)
Fax [phone]
E-mail [email protected]
DISTRIBUTED BY:
philosys, Inc.
New York, NY 10010
855-GO-GMATE (855-464-6283)

Small, Fast, Diabetes Monitoring System for your Smart Phone.
Owner’s Manual
Thank you for choosing the Gmate® SMART Blood Glucose Monitoring System.
Gmate® SMART is the smallest meter in the world. Please read the Owner’s
Manual carefully before use.
For use with the Gmate™SMART App on your iPhone®, iPad®and iPod touch®.
iOS 5.0 or higher is required.
Please keep this Owner’s Manual in a safe place for reference.

Customer Service Toll-Free: 1-855-GO-GMATE (1-855-464-6283). Available 24 hours
a day, 7 days a week.
01
GMATE® SMART BLOOD GLUCOSE MONITORING SYSTEM
In case of an emergency, contact your doctor or dial 911 for the emergency service in
your area.
By using the Gmate® SMART Blood Glucose Monitoring System (Meter) with the
Gmate™SMART App, you agree that the use of this Gmate™SMART App together
with the iPhone, iPad or iPod touch shall only be used for personal organization or as a
supplemental data display tool and NOT as a source of medical advice. You agree that
the Gmate™SMART App will never be used to replace the advice of your doctor, or
your common sense, and that you will not at any time rely on any information
presented on your iPhone, iPad or iPod touch 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 your doctor or healthcare provider regarding all medical conditions, tests,
diagnoses, and treatment options, and agree that Apple shall have no liability for any
action taken by you or anyone using the Gmate™SMART App, regardless of the
information received, displayed, calculated or transmitted by your iPhone, iPad or iPod
touch.
Apple assumes no risk for your use of the Gmate™SMART App and makes no
warranties whatsoever, expressed or implied, regarding the accuracy, completeness or
usefulness of any information presented on your iPhone, iPad or iPod touch as a result
of using the Gmate™ SMART App.
02
GMATE® SMART BLOOD GLUCOSE MONITORING SYSTEM
© 2013 philosys, Inc.
Gmate® is a registered trademark of philosys, Inc. All rights reserved. Patents Pending.
Apple, the Apple logo, iPhone, iPad 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.

03
TABLE OF CONTENTS
Intended Use 04
Core Features of the Gmate® SMART 06
Important Safety Instructions 08
About the Gmate® SMART 13
System Functions 16
Installing the Gmate™SMART App 19
Testing your Blood Glucose 27
Collecting a Blood Sample 30
Testing with a Fingertip Sample 34
Alternate Site Testing 46
Reviewing Results 51
Control Solution Testing 60
Caring for the Gmate® SMART 72
Error Messages 82
Troubleshooting 84
Gmate® SMART Meter Specifications 88

INTENDED USE
The Gmate® SMART Blood Glucose Monitoring System is intended for the quantita-
tive measurement of glucose (sugar) in fresh capillary whole blood samples drawn
from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® SMART Blood
Glucose Monitoring System is intended to be used by a single person and should not
be shared with any other person.
The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing
outside the body (in vitro diagnostic use only) by people with diabetes at home to
monitor the effectiveness of diabetes control. The Gmate® SMART should not be
used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site
testing should be done only during steady state times (when glucose is not changing
rapidly).
04

INTENDED USE
05
The Gmate® Blood Glucose Test Strips are for use with the GMATE® SMART Meter to
quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn
from the fingertips, forearm, upper arm, palm, thigh or calf.
The Gmate
™ SMART App is a component of the Gmate® SMART Blood Glucose
Monitoring System and is intended to be used by people with diabetes at home as an aid
to monitor and track the effectiveness of their diabetes management. The Gmate
™
SMART App allows the user to view their glucose test results and stores a lifetime of
results. The user may e-mail their glucose test results to their healthcare provider to help
them review, analyze, and evaluate their glucose test results to support an effective
diabetes management program. The user can also graph and trend their glucose test
results to provide an outlook of their diabetes management.

The Gmate® SMART is easy to use.
Its small size, simple portability and sleek design allow you to take it everywhere and
anywhere.
No coding required. Insert a Gmate® Test Strip and you are ready to test.
No batteries required.
No settings required.
Stores a lifetime of test results. It also displays information in various useful formats.
You do not need to carry a log book.
It requires a very small blood sample (0.5µL). Displays the result in 5 seconds.
The Gmate™SMART App is designed solely for the use of the Gmate® SMART
Blood Glucose Monitoring System.
06
CORE FEATURES OF THE GMATE® SMART:

The Gmate® SMART is intended for alternate site testing (AST), providing less painful
testing options.
The Gmate® SMART Meter uses the smartphone technology, currently Apple’s iOS
(with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod touch 4th
generation, iPad and iPad 2), to view glucose test results, store a lifetime of test results,
manage your diabetes information, graph and review trends and share your diabetes
management with your healthcare provider. The Gmate™SMART App can be
downloaded from the App StoreSM.
07
CORE FEATURES OF THE GMATE® SMART:
The Gmate ™ SMART App has been specifically designed to work with your iPhone, iPad, iPod touch and
has been certified by the developer to meet Apple’s performance standards. Apple is not responsible for
the operation of this device or its compliance with safety and regulatory standards. Please note that
when the Gmate
™ SMART App is in use, it may affect the device’s wireless performance.

08
The Gmate® SMART Blood Glucose Monitoring System is for use outside the body
(in vitro diagnostic use only).
Use the Gmate® SMART Blood Glucose Monitoring System to test your blood
glucose level with fresh capillary whole blood. Do NOT use the Gmate® SMART for
any other purpose.
Read all the instructions in this Manual before using the Gmate® SMART System.
The meter and lancing device are for single patient use. Do not share them with
anyone, including family members! Do not use on multiple patients!
Check with your doctor or healthcare provider for correct use of this meter.
Only use the Gmate® SMART Meter with the Gmate® Test Strips and Gmate®
Control Solution.
Keep the Gmate® SMART Meter away from and out of reach from children. Do NOT
swallow. If any parts are swallowed, contact your healthcare provider immediately or
dial 911 for emergency help.
IMPORTANT SAFETY INSTRUCTIONS

Practice good hygiene before and after using the Gmate® SMART Blood Glucose Monitoring
System.
Properly dispose of system components, including lancets and test strips. If you are a
caregiver or helper to the owner of this blood glucose monitoring system, please refer to
page 81 for a special message to avoid the transmission of diseases.
Keep your Gmate® SMART Meter and iPhone, iPad or iPod touch clean. Clean and disinfect
your Gmate® SMART Meter and iPhone, iPad or iPod touch at least once per week by
following the instructions on page 73 of this manual. Wash hands thoroughly with soap and
water after handling the meter, lancing device, or test strips.
It is important to clean and disinfect your Gmate® SMART Meter and iPhone, iPad or iPod
touch
. Cleaning and disinfecting your Gmate® SMART and iPhone, iPad or iPod touch
should be completed in two steps:
Step 1 – Clean the surfaces of the Gmate® SMART Meter, lancing device, and iPhone,
iPad or iPod touch with CaviWipes
TM
towelettes if there is any blood, dirt or residue.
09
IMPORTANT SAFETY INSTRUCTIONS

10
IMPORTANT SAFETY INSTRUCTIONS
Step 2 – Disinfect the surfaces of the Gmate® SMART Meter, lancing device, and
iPhone, iPad or iPod touch to kill bloodborne pathogens such as hepatitis B, hepatitis C,
or HIV.
All parts of the kit are considered biohazardous and can potentially transmit infectious
diseases, even after you have performed cleaning and disinfection.
If you are interested in additional information on the importance of disinfection, please
use the following references:
1. “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
2. “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses
Risk or Transmitting Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

11
Do NOT use the Gmate® SMART Blood Glucose Monitoring System on patients
who are critically ill, in shock, dehydrated or hyperosmolar.
Severe dehydration may cause inaccurate test results. Check with your doctor or
healthcare provider if you think you may be severely dehydrated.
Repeat the test if your test results are below 50 mg/dL or greater than 250 mg/dL.
If you continue to have the same test results, follow the treatment advice of your
healthcare provider.
Check with your doctor if you experience symptoms inconsistent with your test
results.
Do NOT disassemble or change the Gmate® SMART Meter.
Do NOT drop, step on, or subject the Gmate® SMART Meter to severe shock.
Caution
IMPORTANT SAFETY INSTRUCTIONS

12
Caution
IMPORTANT SAFETY INSTRUCTIONS
The Gmate® SMART Meter is NOT waterproof. Do NOT wash or touch with wet
hands.
Do NOT wipe the Gmate® SMART Meter with paint thinner or abrasive cleaners.
Do NOT expose the Gmate® SMART Meter to rain, or high temperatures over 90°F
(32°C), or under direct sunlight.
Do NOT directly store the Gmate® SMART Meter in the refrigerator. Do NOT freeze.
Keep the Gmate® SMART Meter at room temperature for best use.

ABOUT THE GMATE® SMART
Before you begin
Carefully read this manual and the inserts that come with the Gmate® Test Strips and the
Gmate® Control Solution before using the Gmate® SMART Blood Glucose Monitoring System.
Take note of the “Important” and “Caution” areas throughout the Owner’s Manual.
Note: It may be helpful to practice the test with the control solution before testing with
blood for the first time. See Control Solution Testing and the Control Solution Insert.
Test Principle
The Gmate® SMART Blood Glucose Monitoring System uses small electric currents to
measure the reaction of glucose (sugar) in the blood with the reagents in the strip. The electric
current changes with the amount of glucose in the blood sample. The Gmate® SMART Meter
measures the current and calculates your blood glucose level. Combined with the Gmate
™
SMART App, it displays the test results and stores them on your iPhone, iPad or iPod touch.
13

14
The Owner’s Manual is also included with your Gmate® SMART Meter. If any items
are missing, please contact Gmate® Customer Service at 1-855-GO-GMATE
(1-855-464-6283).
iPhone, iPad or iPod touch is not included and must be purchased separately.
The Gmate® SMART Meter supports iPhone 5, iPhone 4S, iPhone 4, iPhone 3GS, iPad,
iPad 2 and iPod touch 4th generation (iOS 5.0 or higher required).
1. Gmate® SMART Meter
2. Gmate® Blood Glucose Test Strips
3. Gmate® Control Solution
4. Lancets
5. Lancing Device
6. Carrying Case
Gmate® SMART System Contents:
ABOUT THE GMATE® SMART

15
• Minimum of 30MB of available space
• iOS 5.0 or higher installed
• The Gmate
™ SMART App
The Gmate
™ SMART App is not included with the Gmate® SMART Meter. It can be
downloaded from the App Store. To install the app, follow the simple instructions on
page 19, Installing the Gmate
™ SMART App.
To use the Gmate® SMART Meter with your iPhone, iPad or iPod touch, you will need:
System Requirements
ABOUT THE GMATE® SMART

SYSTEM FUNCTIONS
16
Phone Plug
Insert into headphone jack of iPhone, iPad or
iPod touch.
Power Indicator
When this lights up, the meter is powered on
and ready to test.
Test Strip Port
Insert the end of a Gmate® Test Strip into the
test strip port to begin a blood glucose test.
Gmate® SMART Meter

17
Sample Tip
Electrodes
Insert this end of the test strip into the test
strip port of the meter with the electrodes
facing up.
Apply blood sample here.
Gmate® Test Strip
SYSTEM FUNCTIONS

18
SYSTEM FUNCTIONS
Sliding Barrel
Lancing Device
*Clear AST cap is an optional accessory. Please contact
Gmate® Customer Service at 1-855-GO-GMATE
(1-855-464-6283).
Lancet Carrier
Lancet Ejector
Adjustable Cap
Clear AST Cap*
Lancet Holder