VivaChek Ino Plus User Manual

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Blood Glucose Monitoring System

Dear VivaChek™ Ino Plus System User,

Thank you for choosing the VivaChek™ Ino Plus Blood Glucose Monitoring
System! VivaChek™ Ino Plus Blood Glucose Monitoring System is desig ned for
easy test of blood glucose and helps you keep blood glucose under control.

Read this Us er’s Manu al ca refully befo r e you use your mete r s yst em . T his m a nual
will help you to get comfortable using the VivaChek™ Ino Plus Blood Glucose
Monitoring System and get reliable test results. Please keep your User’s Manual in
a safe place; you may want to refer it in the future.

Thank you again for choosing the VivaChek™ Ino Plus System.

Intended Use and Principle

VivaChek™ Ino Plus Blood Glucose Monitoring System is comprised of the
VivaChek™ Ino Plus Bl ood Glucose Mete r and the VivaChek™ Ino Blood Gluco se
Test Strips. The VivaChek™ Ino Plus Blood Glucose Monitoring System (Meter

Model: VGM22) is designed to quantitatively measure the glucose concentration in

fresh capillary whole blood. It is used at home as a way to monitor the
effectiveness of dia betes cont rol pr ogram s. Thi s sys tem is i nte nded t o be us ed b y
a single patient and should not be shared.

The VivaChek™ Ino Plus Blood Glucose Monitoring System is not used for the
diagnosis of or screening of diabetes or for neonatal use.

The VivaChek™ Ino Blood Glucose Control Solution is for use with the VivaChek™
Ino Plus Blood Glucose Meter and VivaChek™ Ino Strips as a quality control check
to verify th at the meter and test strip are working together properly, and th at the
test is performing correctly.

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TABLE OF CONTENTS

1. Understanding Your Testing Tools…………………………………..

1

Your Meter System Overview………………………………………….. 1
Your Meter Displa y………………………………………………………. 2
Important Safety Information……………………………………………… 4
Limitations…………………………………………………………………... 5

2. Setting Up Your System………………………………………………..

6

Set the Time and Date…………………………………………………......

6

Pairing your meter with the Smartphone……………………………….

7

Syncing to send results wirelessly to the app……………………………

7

3. Taking a Test…………………………………………………………….....

8

Preparing the Test Strip…………………………………………………. 8
Getting a Blood Drop and Testing………………………………………… 9
Discard the Used Test Strip…..…………………………………………... 10

Testing with Control Solution…………………………….……………...... 11

Using the Meter Memory……………… ………… ……… ……… ……… .. 14

4. Maintenance and Troubleshooting………………………………......

15

Replace Batteries…………………………………………………………. 15

Caring for Your Glucose Monitoring System…………………………….

15

Cleaning and Disinfection………………………………………………….

15

Troubleshooting Guide…………………………… ……… ……… ……… .. 17

Symptoms of High or Low Blood Glucose……………………………….

19

5. Technical Information…………………………………………………….

20

System Specifications……………………………………………………... 20
Warranty…………………………………………………………………….. 21

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CHARPTER 1: UNDERSTANDING YOUR TES TING TOOLS

Your Meter System Overview

The VivaChek™ Ino Plus B lo od G luc ose Meter and Strip

2

Your Meter Display

The picture below shows all the symbols that appear on your meter display.
Please make sure the display is working properly before testing. When the meter is
off, press and hold to see the complete display. All display segments will
appear. If you need more time to check the display, repeat the abo ve op era t io n .
All of the segments should be clear and exactly like the picture below. If not,
contact VivaChek Customer Support at 800-951-8430 (7 days a week. 9 a.m.-5
p.m. Easter n Time) for help. Please contact your health care professional if you
need help.

Icon What it Means

The top left area on the screen indicates the date.

The top right area on the screen indicates the time.

Date, month.

Indicates average memory

Indicates the alarms have been set.

Indicates a low battery or it needs to be replaced.

3

Center area on the display that shows test results or error
codes.

Indicates the system is ready to test.

Control test result.

Pre-meal marker.

Post-meal marker.

Test results are displayed as mg/dL or mmol/L according to
local governm ent re gul ati o n.

Indicates the temperature is not suitable for testing.

Ketone warning.

Indicates that a low test result may cause hypoglycaemia.

Bluetooth

Sound on or off

Notes:

Your VivaChek™ Ino Plus meter is pre-set with beep sound function, the meter will
beep when:

• turn on the meter.

• the test strip is inserted and ready to apply blood or control solution.

• sufficient blood or control solution is pulled into the test strip.

• the test is complete.

• it is time to perform a test if you set the test alarms.

• if any error occurs during operation.

Meter Use and Precautions

• The meter i s pres et to di splay bl ood gl ucose c oncentrati on in either millim oles
per liter (mmol/L) or milligrams per deciliter (mg/dL). This depends on your
country’s standard unit of measurement. This unit of measure cannot be
adjusted. The meter will be set to mg/dL by default when sold in the United
States.

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• Meter will shut off by itself after 2 minutes of inactivity.

• Do not get water or other liqui ds insi d e the me ter.

• Keep the strip port area clean.

• Keep your meter dry. Avoid exposing it to extreme temperatures or humidity. Do

not leave it in your car.

• Do not drop the meter or get it wet. If you do, check the meter by running a
quality control test. Refer to Quality Control Test for instructions.

• Do not take the meter apart. This will void the warranty.

• Refer to the Caring for Your Meter section for details on cleaning the meter.

• Keep the meter and all associated parts out of reach of children.

Note: Follow proper precautions and all local regulations when disposing of the
meter and used batteries.

Important Safety Information

• The meter is single patient use. Do n ot share them with anyone includi ng

other family members! Do not use on multiple patients!

• Always keep the test strips in the original vial. Tightly close the vial

immediately after you have removed the test strip.

• Do not use the meter if it is dropping into water or splashing water on to it.

• Wash and dry your hands well before and after testing.

• Test strips and Safety lancets are for single use only.

• Do not drop blood directly on the flat surface of the test strip.

• Check the expiration d ates and discard dat es on your te st strips vi al label

(or on the foil pouch) and control solution bottle label.

• Use only Viv aCh ek™ Ino test strip with your VivaChek™ Ino Plus meter.

• Use only VivaChek™ Ino control solution with your VivaChek™ Ino Plus

meter and VivaChek ™ Ino strip.

• For self -teste rs, co nsult your physici an or di abetes he alth car e prof essio nal

before making any adjustments to your medication, diet or activity routines.

• If the system is used in a manner not specified by the manufacturer,

the protection provided by the system can be impaired.

Potential Biohazard

All parts of the kit are considered biohazardous and can potentially transmit

infectious diseases.

Note:

1. The meter an d safety l anc et are for s in gl e patient use. Do not share them with

anyone!

2. All parts of the k it ar e consi dered biohazardo us. The y can po tentiall y transm it

infectious diseases from blood borne pathogens, even after you have
performed cleaning and disinfection. Please follow proper precautions when
handling your meter and lancing device.

3. Cross-use of meter and lancing device may cause Bloodborne Pathogens

Transmission. For more information, please refer to the FDA Public Health

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Notification: “Use of Fingerstick Devices on More than One Person Poses Risk
for Transmitting Bloodborne Pathogens: Initial Communication” (2010) at
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
You ma y als o r efe r to the CDC Clinical Reminder: “Us e of Finge rstick Device s
on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”
(2010) at

http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.

Limitations

• Very high (above 70%) and very low (below 20%) hematocrit levels can

cause false results. Talk to your health care professional to find out your
hematocrit level.

• If you are taking vitamin C (ascorbic acid > 3 mg/dL) then your glucose

results using this meter may not be reliable.

• The system is tested to accurately read the measurement of glucose in

whole blood within the range of 45 to 600 mg/dL.

• The VivaChek™ Ino Plus Blood Glucose Monitoring System has been

tested and shown to work properly up to 13123ft.

• Critically ill patients should not be tested with this system.

• Patient wh o is taking oxygen th erapy is not recom mended for testi ng with

VivaChek™ Ino Plus Blood Glucose Monitoring System.

• Blood sampl es from patients in shock, or with severe deh ydration or from

patients in a hyperosmolar state (with or without ketosis) have not been
tested and are not recommended for testing with VivaChek™ Ino Plus Blood
Glucose Monitoring System.

• The VivaC hek™ Ino Plus Blood Gluc ose Monit oring Sys tem should no t be

used followin g xyl ose ab s or ptio n pro c e dur es.

• Not for neonatal us e .

• Not for screening or diagnosis of diabetes mellitus.

Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause
undesired operation.

Please note that changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.

Note: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in accordance with
the instructions, may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of
the following measures:

 Reorient or relocate the receiving antenna.
 Increase the separation between the equipment and receiver.
 Connect the equipment into an outlet on a circuit different from that to which the receiver

is connected.

 Consult the dealer or an experienced radio/TV technician for help.