iGlucose GM291 User manual

Version 2 Date: 3.17.2016
iGlucose™ Blood Glucose Monitoring System
GM291 User Manual

Version 2 Date: 3.17.2016
iGlucose™ Blood Glucose Monitoring System User Manual
iGlucose™ is a trademark of Smart Meter Corporation
iGlucose Blood Glucose Monitoring System is manufactured by Bionime Corporation, No. 100, Sec. 2,
Daqing St., South Dist., Taichung City 40242, Taiwan (R.O.C)
Preface
Thank you for selecting the iGlucose Blood Glucose Monitoring System. This manual provides all the
information you need to operate this product for accurate test results. Please read this entire
manual before you start any testing.
For people living with diabetes, it is important to regularly monitor blood glucose levels to effectively
reduce complications from the disease. The easy-to-use iGlucose Blood Glucose Monitoring System
provides accurate, reliable test results. It can be connected to web portals by GSM technology to
help you better manage your diabetes.
The iGlucose Blood Glucose Monitoring System is intended to be used for the quantitative
measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The iGlucose Blood Glucose Monitoring System is intended to be used by a single person and should
not be shared.
The iGlucose 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 iGlucose Blood Glucose Monitoring System should not be used for the diagnosis of, or
screening for diabetes or for neonatal use.
The iGlucose Blood Glucose Test Strips are for use with the iGlucose Blood Glucose Meter to
quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the
fingertips.
The iGlucose Blood Glucose Monitoring System is manufactured and supported by Bionime
Corporation. If you have any questions or concerns, please contact the iGlucose Diabetes Customer
Support Center toll free at 1-555-555-5555 (Monday through Friday 8:00 AM to 5:00 PM PST).. We
will make every effort to assist you.
The iGlucose Blood Glucose Monitoring System is a personal blood glucose monitoring system to be
used for self-testing only. The glucose meter and lancing device are for single patient use. Do not use
on multiple patients. Do not share meter or lancing device with anyone including other family
members.
A healthcare professional should be contacted when Customer Service is not available. Please
forward your warranty card to iGlucose Diabetes Customer Support Center.
iGlucose Diabetes Customer Support Center
12345 Main Street
Any town AA, 12345

Caution
- Before
all of th
e
- Please
- The iG
l
strips s
h
results.
- The iG
l
Blood G
to be e
q
- The iG
l
screen f
- If the i
G
temper
a
- Follow
- The iG
l
meter d
Support
- The iG
l
in the c
r
- The mi
0.75µL:
Blood s
a
Blood s
a
Er4 rea
d
test stri
p
Import
a
- The iG
l
share t
h
- All par
t
even af
t
and Disi
using the i
G
e
instructio
n
perform th
e
l
ucose Bloo
d
h
ould not be
l
ucose Bloo
d
lucose test
r
q
uivalent to
t
l
ucose Bloo
d
or or diagn
o
G
lucose Blo
o
a
ture, pleas
e
all environ
m
l
ucose Bloo
d
isplay show
s
Center. Us
e
l
ucose Bloo
d
r
itically ill.
i
nimum blo
o
a
mple size a
b
a
mple size b
e
d
ing will be
d
p
.
a
nt Safety N
o
l
ucose Bloo
d
h
em with an
y
t
s of the kit
a
t
er followin
g
nfecting Pro
G
lucose Bloo
d
n
s and cond
u
e
quality con
d
Glucose M
e
used under
d
Glucose M
o
r
esults using
t
hat of plas
m
d
Glucose M
o
o
se diabetes
o
d Glucose
m
e
wait 45 mi
n
m
ental prote
d
Glucose m
e
s
“mmol/L”
d
e
of the wro
n
d
Glucose M
o
o
d sample si
z
b
ove 3.0µL
m
e
low 0.75µL
d
isplayed if t
h
o
tes:
d
Glucose m
e
y
one includi
n
a
re consider
g
the cleanin
g
cedures" on
d
Glucose
M
u
ct all of the
t
rol test reg
u
e
ter can be
u
any circums
t
o
nitoring Sy
s
fresh capill
a
m
a samples..
o
nitoring Sy
s
mellitus.
m
eter and T
e
n
utes befor
e
ction regula
t
e
ter will be s
d
uring settin
n
g unit of m
e
o
nitoring Sy
s
z
e to test usi
m
ight conta
m
may cause
a
h
e sample si
e
ter and iGl
u
n
g other fa
m
ed biohazar
d
g
and disinf
e
page XX.
M
onitoring S
y
tests includ
i
u
larly to ma
k
u
sed with iG
tances. The
s
tem is inte
n
a
ry whole bl
o
s
tem is inte
n
e
st Strips ar
e
e
measurem
e
t
ions when
d
s
et as mg/dL
g or test, pl
e
e
asurement
s
tem is not f
o
ng the iGluc
o
m
inate the t
e
a
n inaccurat
e
i
ze is too sm
u
cose Lancin
g
m
ily member
s
d
ous and ca
n
e
cting proce
d
y
stem to tes
t
i
ng the quali
k
e sure the
t
l
ucose Bloo
d
use of othe
r
n
ded for in v
i
o
od samples
n
ded for self
-
e
exposed to
e
nt.
d
isposing of
by default
w
e
ase contact
may cause i
n
o
r use on n
e
o
se Blood G
l
e
st strip por
t
e
result or
m
a
ll. In this c
a
g
Device are
s
.
n
potentiall
y
d
ures. Pleas
e
t
your blood
t
y control t
e
est results a
d
Glucose Te
s
test strips
m
tro diagnos
t
from the fi
n
-
testing. It s
h
a substanti
a
batteries.
w
hen sold in
iGlucose Di
a
n
correct tre
a
onates and
s
l
ucose Moni
t
t
and the me
m
ay prevent
a
se, repeat t
h
for single p
a
y
transmit in
f
e
refer to th
e
glucose, ple
e
st (Refer to
a
re accurate.
st Strips. Ot
h
m
ay give ina
c
t
ic use only.
T
n
gertip are c
a
h
ould not b
e
a
l change in
United Stat
e
a
betes Cust
o
a
tment.
should not
b
toring Syste
m
e
ter.
a
meter rea
d
h
e test with
a
tient use.
D
f
ectious dis
e
e
section "Cl
ase read
page XX).
h
er test
c
curate
T
he
a
librated
used to
e
s. If
o
mer
b
e used
m
is
d
ing. An
a new
D
o not
ases,
e
aning

- Users should wash their hands thoroughly with soap and water before and after handling the
meter, lancing device, or test strips.
Please see the following references for further information.
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
Limitations
- Blood glucose meter readings may be significantly lower than "true glucose levels" in a
hyperglycemic- hyperosmolar state, with or without ketosis.
- Caution is advised when glucose values are below 50 mg/dL or above 250 mg/dL. Consult a
Physician as soon as possible, if values in this range are obtained.
- Healthcare professionals should evaluate their patients' technique regarding the use of the
iGlucose Blood Glucose Monitoring System regularly. To accomplish this, it is recommended that
blood glucose monitoring results be compared with a concurrently obtained laboratory
measurement on the same blood sample. A proven clinical laboratory method employing hexokinase
or glucose oxidase should be used as the comparative method.
- Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated
results.
- The results of blood glucose measurements are different for measurements with whole blood and
plasma.
- Storage of strips near bleach as well as bleach containing products will affect the results of the
iGlucose Blood Glucose Test Strips.
- Inaccurate test results may be obtained at altitudes greater than 10,000 feet (3,048 meters) above
sea level.
- Hematocrits below 20% may cause higher results. Hematocrits above 60% may cause lower results.
- High concentrations of Uric acid ≥10 mg/dL, Cholesterol ≥600 mg/dL, and Ascorbic acid (Vitamin C)
≥5 mg/dL may interfere with the glucose test causing inaccurate test results.
- Do not perform the blood glucose test at temperatures below 10°C (50°F) or above 40°C (104°F),
nor below 10% or above 90% relative humidity.
- iGlucose Blood Glucose Test Strips are designed for use with capillary whole blood samples. Do not
use serum or plasma samples.
- Not for screening or diagnosis of diabetes mellitus.

- Not for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar
patients.
- Not for neonatal use.

Table of Contents
PAGE
About the Blood Glucose Monitoring System 2
The iGlucose Blood Glucose System 7
The iGlucose Blood Glucose Meter 8
The iGlucose Test strip 9
Meter Activation and Battery Charging 9
Setting Up Your Meter - Setting the Date, Time 10
Turning On/Off the meter 11
Handling the Blood Glucose Test Strip 11
Getting Ready for Testing 12
Performing a Blood Glucose Test 14
View Appearance of Blood on the Test Strip 16
Understanding Test Results and Messages 16
Setting Meal Markers 17
About Quality Control 18
Performing a quality Control Test 19
Understanding Control Test Results 21
Recalling Test Results 21
Obtaining readings Averages 22
Obtaining Readings History 22
Caring for Your Meter 23
Cleaning and Disinfecting Procedures 23
Error Messages and Troubleshooting 25
FEDERAL COMMUNICATIONS COMMISION (FCC) STATEMENT 27
Specifications 28
Warranty 29
Customer Service 30
Expected Blood Glucose Values Without Diabetes 30
Component Manufacturer Information 30
Log Book 31
Warranty Card 32
Emergency Card 33

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g adapter a
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t Strip
t
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se Test Stri
p
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p
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o
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r 3 months
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p
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to direct s
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trips are ex
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s
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n
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ips and
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10-90%
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ease
ert.
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u
lly
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e. Press

Insert the battery
1. Take the battery out of the plastic bag.
2. Open the back cover of the device by inserting your thumbnail into the small groove
on the right-hand side near the bottom of the back cover and lifting up the cover.
3. Remove the old battery
4. Install a new battery inside the battery compartment so that the small metal
contacts on the bottom of the battery touch the small metal pins in the battery
compartment.
5. Replace the back cover of the device.
Charge the battery
1. Connect the Meter Charger to its adapter cable
2. Plug the pin into the port at the bottom of unit
3. Plug the Charger into a power outlet. When the unit begins charging, the charging
light illuminates and a charging battery icon flashes on the screen for a short while.
Charging takes between 2-3 hours to complete.
4. When charging is complete, the battery icon on the device screen appears solid
green.
5. Unplug the adapter from the socket.
CAUTION
- Please follow the local regulation to properly recycle rechargeable battery.
- Risk of explosion if battery is replaced by an incorrect type.
Setting Up Your Meter - Setting the Date, Time.
Synchronizing the date and time
To synchronize the date and time manually:
1. Press the “up” (Menu) button on the device. The Menu appears.
2. Select the “Date and Time” option. The “Date and Time” menu appears.
3. Select the “Synch Time” option. A confirmation message appears after a few seconds.
Setting the Time and Date Manually
To set the time and date manually:
1. Press the “up” (Menu) button on the device. The Menu appears.
2. Select the “Date and time” option. The “Date and time” menu appears.
3. Select the “Set Date” option. The year appears. Use the up or down buttons to change
the year as needed. Press the “home” button to move on to the month.
4. Press the up or down buttons to change the month as needed. Press the “home”
button to move to the day.
5. Press the up or down buttons to change the day as needed. Press the “home” button
finish and return to the “Date and time” menu.
6. To exit the menu, press the up or down button to scroll to the “Back” option. Select
the “Back” option to exit the menu.

Set
t
To sele
c
Tur
n
Handlin
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Insertin
g
1.
2.
3.
t
ing the Dat
e
c
t your form
a
1. Press
2. Selec
t
3. Selec
t
dat
e
4. Selec
t
tim
e
5. To ex
the
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ing On / O
f
1. How
t
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2. Man
u
To pow
e
sec
o
3. Auto
The iGl
u
but
t
g the iGluc
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g
the iGluco
s
Hold the Bl
o
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Put your fo
r
Insert the i
G
e
or Time fo
r
a
t for date o
the “up” (
M
t
the “Date
a
t
the “Date
F
e
format. Pr
e
t
the “Time
F
e
format. Pr
e
it the menu,
“Back” opti
o
f
f the Meter
t
o turn on t
h
e Main butt
o
u
al Power of
f
e
r off the iGl
o
nds.
Power off
u
cose Blood
G
t
ons are pre
s
o
se Blood Gl
u
s
e Blood Glu
o
od Glucose
facing up.
r
efinger on t
h
G
lucose Bloo
d
r
mat
r
time:
M
enu) button
a
nd Time” o
p
F
ormat” opti
e
ss the hom
e
F
ormat” opt
i
e
ss the hom
e
press the u
p
o
n to exit th
e
h
e iGlucose
B
o
n or Insert
a
f
ucose Blood
G
lucose Me
t
s
sed or no s
t
u
cose Test S
t
cose Test St
r
Test Strip b
e
h
e side of th
d
Glucose T
e
n
on the devi
p
tion. The “
D
on. Press th
e
e
button to
s
i
on. Press th
e
button to
s
p
or down b
u
e
menu.
B
lood Gluco
s
a test strip.
d
Glucose M
e
t
er will pow
e
t
rip is insert
e
trip
rip
e
tween your
e strip as sh
o
e
st Strip int
o
ce. The Me
n
D
ate and Ti
m
e
up or dow
n
s
elect. A con
f
e up or dow
s
elect. A con
u
tton to scr
o
s
e Meter
e
ter, press a
n
e
r off autom
e
d.
thumb and
o
wn.
o
test strip p
o
u appears.
m
e” menu ap
n
button to
s
f
irmation m
e
n button to
s
f
irmation m
e
o
ll to the “B
a
n
d hold the
M
a
tically afte
r
middle fing
e
o
rt until it cli
p
pears.
s
croll to the
e
ssage appe
scroll to the
e
ssage appe
a
ck” option.
S
M
ain butto
n
r
2 minutes i
f
e
r with the v
i
cks and fir
m
desired
ars.
desired
ars.
S
elect
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r
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G
C550 Pack
a
p
immediate
h
e colored
v
lated into a
v
e
rforming a
c
cap. Place t
h
.
The
a
ge
ly.
iew
v
erages.
c
ontrol
h
e cap

6. Place
7. Gentl
y
8. The s
c
9. Tightl
10. The
Solutio
n
CAUTIO
- Your C
o
can still
control
s
- The C
o
10-90%
- Before
The iGl
u
the sam
- Do no
t
strip mi
g
solution
a drop of c
o
y
touch the
s
c
reen will di
s
y replace th
e
control solu
t
n
Range prin
t
N
o
ntrol Solut
i
can be recal
s
olution ico
n
o
ntrol Soluti
o
RH.
"Apply a dr
o
u
cose Blood
G
ple port bef
o
t
drip the co
n
g
ht leak into
. This could
o
ntrol soluti
o
s
ample port
s
play the co
u
e
cap on the
t
ion result
w
t
ed on the B
i
on Test res
u
led and vie
w
n
on the scr
e
o
n Test shou
o
p of blood
"
G
lucose me
t
o
re prompt
e
n
trol solutio
n
the bottle
o
contaminat
e
o
n onto the
t
of the strip
w
u
nt time sta
r
Rightest® C
o
w
ill appear. C
l
ood Glucos
e
u
lts will not
b
w
ed. The Co
n
e
en.
ld be condu
c
"
, do not to
u
t
er is perfor
m
e
d will result
n
on to the s
o
f control sol
e
the meter
v
t
op of the ca
w
ith the co
n
r
ting from 5
.
ontrol Solut
i
C
ompare yo
u
e
Test Strip
v
b
e included i
n
trol Solutio
n
c
ted betwe
e
u
ch the cont
r
m
ing an inte
r
in an error
m
s
ample port
o
l
ution and
m
v
ia the test
s
p.
n
trol solutio
n
.
i
on GC550 b
o
u
r Quality Co
v
ial label.
n the avera
g
n
Test result
e
n 59-104°F
(
r
ol solution
t
r
nal check.
T
m
essage.
o
f the test s
t
m
ay cause th
e
s
trip port.
n
from the t
o
o
ttle.
ntrol Test re
g
e calculatio
n
will be sho
w
15-40°C) an
d
t
o the sampl
T
ouching the
t
rip directly.
e
degenerati
o
p of the ca
p
e
sult to the
C
ns, however
w
n with the
d in a locati
o
e port on th
control sol
u
The reagen
t
i
on of the c
o
p
.
C
ontrol
,
they
o
n with
e strip.
u
tion to
t
on the
ntrol