Ypsomed mylife Unio Neva User manual

mmol/L
More freedom. More condence. With mylife™.
10132357-en-cs/V01 // 101-3GM722-090 // Rev. Date: 2018-02
User guide
Blood glucose monitoring system
Uživatelská příručka
Systém pro měření glykémie

Thank you for choosing the mylife™Unio™ Neva blood glucose monitoring system.
Please read this user guide thoroughly before testing your blood glucose. It provides all
information you need to use the product. The mylife™Unio™ Neva blood glucose meter
must only be used with mylife™Unio™test strips and mylife™ControlGDH control solution.
The use of other test strips or control solutions may lead to incorrect test results.
It is recommended that the blood glucose level should be monitored regularly. The mylife™
Unio™ Neva blood glucose monitoring system is accurate and easy-to-use, and is therefore
your reliable diabetes management assistant.
Preface
2

The mylife™ AutoLance™lancing device and mylife™ Lancets are intended for patient
self-monitoring by an individual. They must not be used on more than one person due to
the risk of cross-contamination.
The mylife™ Unio™ Neva blood glucose monitoring system is manufactured by Bionime
Corporation and distributed by Ypsomed Distribution AG.
If you have any questions or concerns, please contact your local Ypsomed customer service
(see page 91).
3

Table of contents
First steps
Intended use 6
mylife™ Unio™ Neva package contents 7
Bluetooth®wireless technology 8
mylife™ Unio™ Neva blood glucose meter 10
Initial start-up with Bluetooth® and mylife™App 12
Initial start-up without Bluetooth®15
How to perform a blood glucose measurement 20
– while Bluetooth®is in use 25
– while ight mode is in use 27
– when Bluetooth® is not congured 29
How to work with Bluetooth®31
mylife™Unio™ Neva blood glucose meter
Editable markers 33
How to add/change markers for your results 34
Menu guidance 35
Records: recall test results 37
Averages: recall average test results 38
Alarm: how to set an alarm 41
Settings: wireless/device management 43
Settings: set volume 47
Settings: set date/time 48
Settings: set blood glucose target range 51
Settings: set language 53
Quality control test with
mylife™ControlGDH control solution 54
Data management 62
Battery change 64
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Further information
Precautions 78
Limitations of the mylife™ Unio™ Neva meter 80
Maintenance and cleaning of the meter 81
Error messages and troubleshooting 82
Technical specications 87
Disposing of mylife™Unio™Neva meter, mylife™Unio™
test strips, mylife™AutoLance™and mylife™Lancets 89
Warranty 90
Customer service 91
Description of symbols used 94
Manufacturer 95
mylife™AutoLance™lancing device
Overview 68
Handling 69
Alternative site testing (AST) 71
mylife™Unio™ test strips 74
5

The mylife™ Unio™ Neva blood glucose monitoring system is intended for in-vitro (outside the
body) diagnostic use for self-testing. The coding of the test strips is automatically detected.
The test result is plasma equivalent and achieved by using (a) fresh capillary whole blood that
may be drawn from the ngertip, palm or forearm, (b) venous whole blood samples and (c)
arterial whole blood samples.
You may consult your healthcare professional for instructions on how to use the system
correctly. Our customer support staff are available to assist you.
Healthcare professionals may use the mylife™ Unio™ Neva blood glucose monitoring system
for surveillance of the blood glucose levels of patients in medical facilities.
For a better understanding of this user guide, the mylife™ Unio™ Neva blood glucose monitoring
system will be referred to as BGMS; the mylife™ Unio™ Neva blood glucose meter as
meter; the mylife™ SoftCase as SoftCase; the mylife™ Unio™test strips as test strips; the mylife™
AutoLance™ lancing device as lancing device; the mylife™ Lancets as lancets; the mylife™
ControlGDH control solution as control solution; the mylife™App/mylife™Software as app
and the smartphone or personal computer as mobile device.
Intended use
6

mylife™ Unio™ Neva package contents
➊mylife™ SoftCase
➋mylife™ Unio™ Neva blood glucose meter
(with 2 CR2032, 3 volt batteries installed)
➌Vial with mylife™ Unio™ test strips (10 pcs.)
➍mylife™ AutoLance™lancing device
➎Disposable mylife™ Lancets (10 pcs.)
➏mylife™ Unio™ Neva user guide
➐mylife™ Unio™ Neva quick start guide
➑Diabetes diary
7
➊
➎ ➏ ➐ ➑
➋ ➌ ➍

Bluetooth®wireless technology is used by most smartphones and many other devices.
Your mylife™Unio™ Neva meter uses Bluetooth®wireless technology to pair and to transmit
your glucose results to compatible wireless devices (such as PCs and smartphones).
The mylife™Unio™ Neva meter is designed to work with the mylife™App.
Visit www.mylife-diabetescare.com for information on which wireless devices are compatible
with your mylife™Unio™ Neva meter, and where/how to download the mylife™App and mylife™
Software on your compatible device.
Bluetooth®wireless technology
8

Bluetooth®trademark
The Bluetooth®word mark and logos are owned by Bluetooth®SIG, Inc. and any use
of such marks by Ypsomed Distribution AG is under license. Other trademarks and trade
names are those of their respective owners.
WARNING: The Bluetooth®feature on your meter transmits test results to your
compatible wireless device. To prevent other people’s results from being sent
to your compatible wireless device, do not let anyone else use your meter to
test their blood glucose. This meter is for single patient use only.
WARNING: In locations where cell phone use is not permitted, such as hospitals,
some healthcare professionals’ ofces and airplanes, you should turn
the Bluetooth® feature off (ight mode). See page 43 for more information.
9

mylife™ Unio™ Neva blood glucose meter
Test strip port
Insert test strips here
until you hear a click.
Display
Shows test results,
messages and all other
relevant information.
Left and right
scroll buttons
For operating the meter,
please consult the
details in the following
sections.
Main/conrm button
Single click: conrm.
Double click: return to home
screen.
0.5-second click: power on.
2-second click: power off.
10

Battery cover
Slide cover
downwards to
change batteries.
For instructions
see page 64.
Micro-USB port
For data transfer to a PC/Mac
(data management).
2 ×
CR2032
batteries
Dot code
with serial
number
11

Meter starts automati-
cally after removal
of the isolation tab.
Press for 0.5 sec-
ond to power on the
device when setting
up later.
Select your language
preferences with
the up and down
buttons and press .
Initial start up with Bluetooth® and mylife™App
Language
........
English
........
........
OK
Before you can use the mylife™Unio™ Neva
BGMS, you rst need to pull out the
battery isolation tab from the battery
cover. Download and install the mylife™
App on your smartphone, activate
Bluetooth®and continue with the following
settings (please follow the instructions
on the app when interacting with the
mobile device). This procedure does not
apply with mylife™Software.
12

Select Pair now and
conrm with the
button. The meter
turns on Bluetooth®
and searches for the
mobile device you
want the meter to pair
with.
Pairing is now in progress. Make
sure that Bluetooth®is turned
on on the mobile device and that
the app is started. If the wireless
device you want to pair the
mylife™Unio™Neva with is not
found within 2 minutes, Error 9
“No connection” appears. Con-
rm the warning and repeat the
procedure.
A six-digit number code appears
on the screen of the mylife™
Unio™Neva. Enter the code
shown on the meter into the app
on your mobile device. This code
must be entered within 30 sec-
onds. If the time is exceeded or
a wrong identication code is
entered, Error 9 “No connection”
appears. Conrm the warning
and repeat the procedure.
Pairing
Pair
now
Pair
later
Enter code on
your device
012345
13

When all settings
(date, time und BG
target range) are
done on your mobile
device, you are
ready to use the
mylife™Unio™ Neva
BGMS.
If no device is found
within 2 minutes
or if the code was not
entered timely within
30 seconds, conrm
with the button
and try again or select
“Pair later” to continue.
If pairing fails, check if
Bluetooth®is turned
on on your mobile device
and keep your mobile
device close to the meter.
When changing batteries,
the start-up procedure
may be repeated. Please
see page 64 for further
instructions to keep
settings when changing
batteries.
Settings
saved
Error 9
No connection
OK
The pairing with your
mobile device was
successful. Set date,
time and blood glu-
cose target range on
the app. These set-
tings will then down-
load and set on your
meter automatically.
Paired with
iPhone ...
14

Before you can use the
mylife™Unio™ Neva
BGMS, you rst need to
pull out the battery
isolation tab from the
battery cover and enter
the following settings:
Meter starts automati-
cally after removal
of the isolation tab.
Press for 0.5 sec-
ond to power on the
device when setting
up later.
Select your language
preferences with
the up and down
buttons and press .
Initial start up without Bluetooth®
Language
........
English
........
........
OK
Select Pair later
and conrm
with the button.
Pairing
Pair
now
Pair
later
15

Set the date format
with the up and
down buttons.
Switch and conrm
with the button.
Set date
dd/mm/yyyy
01.01.2017
OK
Set date
mm/dd/yyyy
01.01.2017
OK
Set the day/month/year. Switch and conrm with the button.
Set date
dd/mm/yyyy
28.01.2017
OK
Set date
dd/mm/yyyy
28.09.2017
OK
Set date
dd/mm/yyyy
28.09.2018
OK
16

Set the hour and minute. Switch and conrm
with the button.
Set the time format
(24/12 hour) with the up
and down buttons and
conrm with the button.
Set time
24-hour-time
12:00
OK
Set time
12-hour-time
12:00 PM
OK
Set time
12-hour-time
11:35 AM
OK
17

Set the lower blood
glucose target
range with the up
and down buttons
and conrm with .
The target range function can
be switched “On” or “Off”.
Scroll up and down until
the desired function is high-
lighted at the bottom of the
display and conrm the
selection with the button.
Set the upper blood
glucose target
range with the up
and down but-
tons and conrm
with .
Target range
10.0 mmol/L
3.9 mmol/L
mmol/L
On
Target range
11.1 mmol/L
3.9 mmol/L
On
Target range
11.1 mmol/L
3.6 mmol/L
On
On Off
You are now ready to use
the mylife™ Unio™ Neva BGMS.
Settings
saved
18

The adjustable target range for the lower and upper limit is the same for
both and lies between 3.3 mmol/L and 16.6 mmol/L. The lower limit can
not be higher than the upper limit and vice versa. Both limits cannot
have the same value. Please discuss the blood glucose target range with
your physician.
When changing batteries, the settings may need to be set again. Please
see page 64 for further instructions about how to keep settings when
changing batteries.
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