Goodlife Cloudia User manual

User Guide
Blood Glucose
Monitoring System (Cloudia)

Contents
About GoodLife 4
About the System 5
Important Information 6
Important Safety Instruction 8
Blood Glucose Meter 10
Meter LCD Window 12
Blood Glucose Test Strip 14
Glucose Control Solution 17
Check Strip 20
Setting Meter Parameters 22
Performing Blood Test 26
Understanding Your Test Result 31
Data Transmission 33
Memory Recall 35
Replacing the battery 36
How to Clean and Disinfect 38
Storage and Handling 46
Display Messages and Problem-Solving Guide 47
Performance Evaluations
System Specication
54
FCC Regulations 66
Warranty 70
How to view transmitted reading 58
52
iglucose Diabets Management 5456
Please read this User Guide before using your GoodLife
Blood Glucose Meter (Cloudia). If you have any questions
or enquiries, please contact customer support at 1-855-
692-3511 for assistance.

4 5
About GoodLife™ About the System
Intended Use
Principle of the Test
GoodLife Blood Glucose Monitoring System(Cloudia)
is intended to be used for the quantitative measure-
ment of glucose (sugar) in fresh capillary whole
blood sample drawn from the ngertips only. It is
intended to be used for single patient and should not
be shared. It is not indicated for the diagnosis or
screening of diabetes or for neonatal use.
The GoodLife System is an electrochemical biosensor
system that measures the amount of electric current
produced and displays the result as a blood glucose
level.
The GoodLife Blood Glucose Monitoring System
(Cloudia) (GoodLife System) is designed to provide
blood glucose measurements with easy and comfort-
able testing. The system requires 0.5μL of blood
sample and 5 seconds for the test to complete.
The GoodLife System consists of:
GoodLife Blood Glucose Meter (Cloudia), GoodLife
Blood Glucose Test Strips (Cloudia), Check Strip,
GoodLife Glucose Control Solution(Level I & II), Safety
Lancet (optional for purchase).
These products are intended to be used together to
get accurate blood glucose test results. Do not use
other test strips or control solutions with your meter.
NOTE:
Not for use on patients who are dehydrated, hypo-
tensive, in shock, or in a hyperosmolar state.ÿ

The GoodLife System is intended for in vitro diagnos-
tic use with capillary whole blood. The system should
not be used for diagnosis and screening of diabetes
or for testing newborn infant (neonatal testing).
CAUTION
The test result does not suggest any medical
indication. The user should consult his or her
clinician for further diagnostic and treatment.
Call your doctor immediately if you experience
symptoms that are not consistent with your
blood glucose test results.
Severe dehydration or excessive water loss may
cause false, high results. Call your doctor right
away if you suspect you are suering from dehy-
dration.
A sample with large amount of reducing
substances such as triglycerides(>1000mg/dL),
ascorbic acid (>2.25mg/dL), uric acid (>15mg/dL)
and xylose (> 50mg/dL).
1.
2.
3.
4.
A red blood cell count (hematocrit) that is either
very high (over 55%) or very low (under 30%) can
cause false result.
High altitudes above than 8,800 feet (2,750
meter) may aect the test results.
Temperatures outside the range of 50°F to104°F
(10°C to 40°C), 20%-80% RH may aect the test
results.
Do not use GoodLife system to test on critically ill
patient.
Not for use on patients who are dehydrated,
hypotensive,in shock, or in a hyperosmolar state.
5.
6.
7.
8.
9.
67
Important Information
Triglyserides
Ascorbic acid
Substance Highest c oncentration
without interference
( mg/dL)
Toxic
Concertration
( mg/dL)
Theraprutic
Physiological
Levels
N/A
N/A
N/A
N/A
0.40 - 2.00
150 - 500
2.52 - 8.00
57
Uric acid
Xylose
2.25
1000
15
50
Theraprutic/

8 9
Important Safety Instruction
The meter and lancing device are for single
patient use. Do not share them with anyone
including other family members. Do not use on
multiple patients.
Because all parts of the kit may come in contact
with your blood, all parts of the kit are considered
biohazardous and can potentially transmit infec-
tious diseases. Please refer to "How to Clean and
Disinfect" section to help mitigate biohazard.
Users should wash hands thoroughly with soap
and water and dry thoroughly after handling the
meter, test strips and any lancing device.
For customer support contact at 1-855-692-3511.
(Mon-Fri 9:00 am~4:30 pm Pacic Time)
NOTE:Please make sure that all products listed on the
"contents" of the box are contained in the package before
using this system. If you nd any imperfection in our products,
please contact customer support at 1-855-692-3511.
(Mon~Fri 9:00am~4:30pm Pacic Time)
1.
2.
3.
“FDA Public Health Notication: Use of Fingerstick
Devices on More than one Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial Com-
munication” (2010)
http://www.fda.gov/MedicalDevice/
Safety/AlertsandNotices/ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick
Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-
DeviceBGM.html
References
1.
2.

10 11
Blood Glucose Meter
DISPLAY: The large, easy
to read display shows
the test results, mes-
sages, blood glucose re-
sults stored in memory,
time and date.
Mem Button: Press Mem but-
ton to enter memory mode to
recall the information stored in
meter’s memory.
Set Button: Press Set button to
enter date and time setting.
STRIP SLOT: Holds a Blood Glucose Test Strip or Check
Strip in place when you perform blood glucose test
or perform check test.
: Holds
-
Button: For data transmission
3L-02-XXXXXX V1.0
Blood Glucose
Monitoring System
Cloudia
For Self-testing
Battery:AAA,6V
HMD BioMedical Inc.
Hsinchu , Taiwan
serial no.: XXXXX-0000001
SIM:
8901204043780370392
For In Vitro Diagnostic Use Only FCC ID: AYY0000001
3L-02-XXXXXX V1
SIM
AAA
AAA
AAA
AAA
S
SISI
M
M
M
AA
AA
A
A
A
A
AA
A
AA
A
A
A
A
AA
AA
AA
AA
AA
A
A
A
AA
A
A
A
AA
AA
AA
AA
A
A
AA
A
AA
3L-02-810035 V1.0
Blood Glucose
Monitoring System
Cloudia
For Self-testing Battery:AAA,6V
serial no.: 65534-XXXXXXX
For In Vitro Diagnostic Use Only
FCC ID: AYY0000002
Distrubutor:
Kannact Inc. / KRemedy
10260 SW. Greenburg Road Suite 525,
Portland OR 97223
Battery Compartment
four AAA batteries. Before us
ing the meter, please install
Meter SN Label: The label shows the
meter serial number.
STRIP EJECTOR:
For easy ejection
of the test strip.

12 13
Meter LCD Window
DATE: Month/Year/Day
and the temperature at
the moment of the test.
THERMOMETER SYMBOL:
Appears when ambient
temperature is above or be-
low the acceptable range
needed for testing.
CODE: A code number
should appear before me-
ter is used to test sample.
Ř
Meter is at a Mem-
ory mode. Prior analysis
results can be read.
Symbol:The test
can be adjusted and
stored into 3 types of test
modes - Before Meal Test
(), After Meal Test(
) and Control Solution
Test( ).
Alarm Symbol:
Appears when
alarm is set. Symbol: Appears
when data transmission.
Test Result
Time: 12 and 24 hour period format.
mg/dL: The units of measurement in the U.S. are mg/dL.
Ř
Memory capacity is 999 entries. The display shows to
ensure that all digits are working properly.
Strip Symbol: Appears when the strip is inserted and meter is
ready for blood testing. Replace vial cap after removing test strips.
Battery Symbol: Appears when battery is low.

14 15
(correct) (incorrect )
Blood Glucose Test Strip
Aperture: apply
the blood to the
front of the strip.
Black Electrode End:
Insert this end of test
strip into meter.
Blood Reaction
Zone: It must be
lled with blood
entirely.
GoodLife System measures the amount of
glucose in capillary whole blood. Blood can be
applied to the front of the test strip and is auto-
matically drawn to the test strip through capillary
action.
GoodLife Blood Glucose Test Strips (Cloudia) are
intend ed for in vitro diagnostic use with capillary
whole blood or GoodLife Glucose Control
1.
2.
Solution.
Results will not be accurate if used with plasma or
serum samples.
Do not use test strips beyond the expiration date
indicated on the strip vial label.
The discard date for test strips is 90 days after rst
opening the vial. Record the discard date on the
vial when you open a new vial of test strips.
Blood Glucose Test Strip can be damaged by heat
and light. Keep them sealed in the original vial.
Store the vial in a cool, dry place between
104°F(40°C) and 50°F (10°C). Do not refrigerate.
Do not use damaged test strips in any way. Use
test strip immediately after taking it out from the
vial or foil packet; replace the vial cap and close it
tightly.
3.
4.
5.
6.
7.

16 17
Glucose Control Solution
IMPORTANT INFORMATION
Do not transfer test strips to a new vial. Always
carry test strips in their original vial.
Do not place in direct heat or sunlight.
Do not carry loose test strips in your carrying
case.
Test strips are for single use only.
8.
9.
10.
11.
GoodLife Glucose Control Solution is
used to check if the GoodLife Blood
Glucose Monitoring System(Cloudia)
and Test Strip are working correctly as
a system.
Users should perform a control
solution test when:
a new vial of test strip is opened.
a meter is dropped
whenever results are not consis-
tent with patient’s symptoms.
1.
2.
3.
Do not use control solution beyond the expira-
tion date indicated on the bottle label.
The discard date for control solution is 90 days
after rst opening. Record the discard date on the
bottle when you open a new bottle of control
solution.
1.
2.

18 19
Test result will show up in 5 seconds. The result
should correspond to the range printed on the
label of strip vial used.
NOTE: Repeat test if the result falls outside the control
range. If you continue to get the result falling outside the
control range, the potential causes are
1. the test strip is damaged or get moist
2. the test strip is expired.
3. the meter and strip may not be working properly.
Do not use the system to test your blood until you get a
test result falls within the control range.
Contact customer support at 1-855-692-3511 or your
healthcare provider for help.
5.Store the control solution closed at temperatures
between 50ºF (10ºC) and 86ºF (30ºC).
Please carefully read the label before use.
For purchase of control solution, please contact
your local distributor or customer support at
1-855-692-3511 for more information.
3.
4.
5.
Perform Control Test
Insert a new test strip into the strip slot, the
meter will activate.
The code number will appear on the screen.
Compare the code number shown on the screen
against the code number on the test strip vial. If
the two numbers match, you may begin test,
otherwise contact customer support at 1-855-
692-3511 or your healthcare provider for help.
When shows up, press Set button and choose
control solution test.
Gently shake the control solution and apply a
drop to the aperture of strip. Make sure that the
control solution has saturated the blood reaction
zone.
1.
2.
3.
4.

20 21
Check Strip
CHECK
CH
How to check meter by check strip
How to delete memory
The Check Strip can be used in 2
ways:
1.
2.
To test only the function of
the meter and not complete
BGM test system. Please
check the complete test
system with Control Solution
To delete all test memories.
Insert the check strip into strip slot with label side
up as above.
You should obtain an “OK“ reading within 10
seconds, which means your meter is working
properly.
Remove the check strip to exit. Meter will auto-
matically turn o.
NOTE:If you do not get "OK" reading but appear other
error message, turn o the meter by remove check strip
from the meter. Then check the battery and repeat the
test. If the second result persists, contact customer
support at 1-855-692-3511 or your healthcare provider.
1.
2.
Insert check strip into strip slot with label side up.
After “OK” displayed, press and hold the Set
button until ashing “dEL” shows up with a beep
sound.
Press and hold the Mem button until you hear a
beep sound, Meter will display “OK” before
turning o and all the memory has been deleted
successfully.
Remove the check strip from the meter.
1.
2.
3.
4.

22 23
Setting Meter Parameters
Setting Time & Date
Setting Temperature Unit/ 12h,24h period/ Alarm
Press the Mem button, the meter will enter to the
setting of “year”. Press Set button to select the
desired year.
Press the Mem button to conrm and shift to the
next setting.
Repeat above steps to set the month, day, hour
and minute by Set and Mem buttons.
After minute is set, the meter will display “OK”
before turning o.
Note: While setting the time and date, you can exit the
setting mode anytime by pressing Mem button for 3
seconds.
1.
2.
Press the Set and Mem buttons at same time for
2 seconds to turn on the meter.
1.
When you begin to use the meter or replace a new
battery, please follow the steps below to set the
date and time manually.
Celsius and Fahrenheit can be set according to your
preference.
Then press the Set button to choose between “C”
(for Celsius) and “F” (for Fahrenheit).
When Temperature Unit preference is set, press
the Mem button to enter the 12h/24h period set
ting.
Press the Set button to choose your preference of
12h/24h period.
When 12h/24h period is set, press the Mem
button to enter the alarm setting.
Press the Set button to turn on or turn o the
alarm. The GoodLife has 5 alarms to keep your
blood glucose monitoring on time.
2.
3.
4.
5.
6.
When “ON“ is choosen, press the Mem button
to congure the alarm hour. Press the Set
button to change hour. When alarm hour is
set, Press the Mem button to congure the
alarm minutes. Press the Set button to change
minutes and press the Mem button to enter
next setting.
When “OFF“ is chosen, press the Mem button
to enter next setting.
t
t

24 25
Setting Auto Data Transmission
To congure the other 4 alarms, please repeat
step 6.
After setting, the meter will display “OK“ before
turning o.
7.
8.
Press and hold the Set button for 2 seconds to
turn on the meter when “ON“ show up, it means
auto transmission.
Press the Set button to choose between
“ON“(auto) and “OFF“ (manual).
1.
2.
When the preference is set, press the Mem button,
the meter will display “OK“ before turning o.

26 27
Performing Blood Test
1. Wash your hands in warm,
soap water. Rinse and dry
completely.
!!
2.
Set
Mem
3.
9
Set
Mem
4. When the
you are ready to perform a test.
5. If the test is done within 2
hours of a meal, press the
Set button to change the
setting from to . If the
test is a control solution test,
press the Set button again to
change the setting from to
.
6. Use safety lancet or lancing device to obtain the
required blood volume. To perform the test, you
need 0.5 uL of blood sample.
Remove new test strip from
vial. Be sure to tightly replace
vial cap after removing test
strips. Insert test strip immedi-
ately into strip slot as
illustrated. The meter turns on
automatically.
Check if the code number on
the meter matches the code
on the vial. If the 2 numbers
match, you may begin blood
testing. Otherwise insert
another new one. If the code
number still doesn’t match,
please contact customer
support at 1-855-692-3511 for
help.
Caution: To avoid the blood borne pathogen transmis-
sion, the lancing device is for single patient use. Do not
share with anyone else including other family members.
Do not use on multiple patients.
NOTE: Please refer to safety lancet or lancing device user
manual for further instructions on use and handling.

28 29
7.
Mem
8. Test result will show up in 5
seconds.
9. Before removing the strip from the
meter, you can press Set button to
set the test as BEFORE MEALS TEST
, or AFTER MEALS TEST , or a
CONTROL SOLUTION TEST
.
Set
Mem
10. After setting complete, remove
the strip from meter. Please
follow the healthcare provider’s
recommendations for disposal of
used lancets and strips.
Set
Mem
11.
Set Mem
WARNING: Inaccurate results may occur in severely hy -
potensive individuals or patients in shock, inaccurate low
results may occur in individuals experiencing a hyperglyce-
mic/hyperosmolar state, with or without ketosis, and criti-
cally ill patients should not be tested with the meter.
Important Safety Information
* The meter is for single patient use. Do not share them
with anyone including other family member.
Apply the blood sample to the
front aperture of test strip in a
way that comfortab.e for you.
Make sure that the blood drop
has saturated the blood
reaction zone.
After removing the strip, the
result will be transmitted to data-
base through GSM system auto-
matically. It will diaplay “OK” if
the transmission succeeds.
Press the “Mem” button to turn
the meter o. If “Err” appears,
please refer to “Display Messages
and Problem-Solving Guide.

30 31
Understanding Your Test Result
Expected range for people without diabetes :
Time of Day Expected Range, Non-Diabetes
Before Meals Less than 100 mg/dL
After Meals Less than 140 mg/dL
Source: American Diabetes, Association Position Statement,
Diabetes Care Vol.37 (Suppl.1) p.s16 (2014).
Consult your healthcare professional to nd out
your target blood glucose value.
If your blood glucose result seems unusually high
or low, or inconsistent with your previous results,
check the following:
1. Does the code number on the test strip vial
match the code number on the meter?
2. pirtstsetehtotdeilppaelpmasdoolbehtsaW
immediately after the strip was removed from
Was the size of the blood sample sucient?
the vial?
3.
* All parts of the kit are considered biohazardous
and canpotentially transmit infectious disease.
Please refer to “How to Clean and Disinfect“
section to help mitigate biohazards.
* Safety Lancet is for single use only.

32 33
4. Was the test strip vial cap tightly sealed?
5. Was the test strip used before the expiration
date?
6. Were the test strips stored away from extreme
temperatures or from areas of high humidity?
Data Transmission
Then run a quality control check with your
Glucose Control Solution and a new test strip. If
the control test result is within the acceptable
range, review testing procedure and repeat your
blood glucose test with a new test strip. If your
blood glucose value is still inconsistent with your
previous results, contact your doctor immediately
for help.
When the meter is set as “auto transmission”
(refer to the section “Setting Auto Data Transmis-
sion”), the test result will be transmitted to the
database through GSM system after every time
you test.
When the meter is set as “manual transmission”,
press es and holds the button for 2 seconds to
turn the meter on.
The test result could be transmitted to a secure web
database for further management.
NOTE:
1. It is recommended to transmit in good reception areas.
1.
2.
When the meter displays “Err”, please refer to the
section “Display Messages and Problem-Solving
Guide“.
3.
If there is no record in the meter, it will display “M0”,
and then “OK“ before turning o.
If there are records in the meter that haven’t been
transmitted, it will display “OnL“ and transmit the
data. After that, it will display “OK“. Press the Mem
button to turn o or allow the system to auto turn o
after 3 minutes of inactivity.
t
t

34 35
Memory Recall
To recall Results Stored in Memory
2. By pressing Mem button, you will see your
test record from the latest to the earliest.
3. Press and hold the Mem button for 2 seconds
to turn the system o or allow the system to
auto turn o after 30 seconds of inactivity.
For example:
Pacemaker (Keep a safe distance more than 15cm),
Medical telemetry or telemetry equipment (Telemetry),
Physiological signal sensing or monitoring device (such
as ECG, EMG, EEG, ERG, ENG, MEG, Holter, asphyxia
monitors, etc.),
NMR diagnosis photography devices,
Electronic microscope,
Life-sustaining devices with micro-processor control
(such as infusion pumps, hemodialysis machines, breath-
ing assistor, anesthesia machines, infant incubators, etc.)
t
t
t
t
t
t
The test records in the meter will not be removed
after transmission. Please refer to the section
“Check Strip” for removing records.
3.
The GoodLife Blood Glucose Meter automatically
store a maximum of 999 test results including the
result done before a meal or after a meal, or for a
control solution test.
When recalling the results, each single result appears
from the latest to the earliest with time and date.
Turn meter on by pressing Mem
button till you hear a beep sound. The
rst result displayed on the screen is
your latest test result. 12 represents
the 12 th recorded of the overall results
on this meter.
1.

36 37
Replacing the battery
To Replace the Batteries
1. Make sure the meter is turned o.
Set
Mem
2. Place the meter face down on a
at surface.
3. Slide battery compartment door
open.
NOTE: Every time when the batteries are replaced, the
meter will turn on. Please follow the section “Setting
Meter Parameters“ to set the time and date.
The GoodLife Blood Glucose Meter comes with four
AAA batteries. Please install your batteries before
starting.
When the battery symbol appears on the meter
display, batteries level is getting low. You will still be
able to test with low battery, but you should replace
them as soon as possible. When battery symbol
appears ashing on the display, the meter will no
longer give results and you must replace the batter-
ies immediately.
Remove the old batteries and
insert 4 new AAA batteries into
the battery compartment. Be sure
to align the plus (+) and minus (-)
signs correctly.
4.
Close the battery compartment
door. Check to see that your
meter is working. If it fails to turn
on, the batteries may have been
inserted incorrectly. Remove the
batteries and reinsert them
correctly.
5.
3L-02-810035V1.0
BloodGlucose
MonitoringSystem
Cloudia
ForSelf-testing Battery:AAA,6V
serialno.:65534-XXXXXXX
ForInVitroDiagnosticUse Only
FCCID:AYY0000001
Distrubutor:
KannactInc./KRemedy
10260SW.GreenburgRoadSuite 525,
PortlandOR97223
ForSelf-testing
Battery:AAA,6V
HMDBioMedicalInc.
Hsinchu,Taiwan
3L-02-XXXXXXV1.0
IG1-0000001
8901204043780370392
BloodGlucose
MonitoringSystem
ForSelf-testing
Battery:AAA,6V
HMDBioMedicalInc.
Hsinchu,Taiwan
3L-02-XXXXXXV1.0
IG1-0000001
8901204043780370392
BloodGlucose
MonitoringSystem

38 39
How to Clean and Disinfect
1. www.cloroxprofessional.com
2. www.amazon.com
3. or call the Clorox service number at 1-800-
234-7700
Dierences between Cleaning and Disinfection
tClean: to remove visible signs of dirt or
pollution.
tDisinfect: to free from infection especially by
destroying harmful microorganisms.
NOTE: If the meter is operated by the care giver rather
than the primary user, the meter should be disinfected by
the meter operator rather than by the user.
To mitigate the risk of bloodborne pathogen trans-
mission (eg. viral hepatitis), the meter must be prop-
erly cleaned and disinfected.
The life of the meter is 5 years for 18,250 cleaning and
disinfection cycles. The meter, for single patient
home use, should be cleaned and disinfected at least
once per week as recommended.
The following disinfactant product with sodium
hypochlorite 0.55% as the active ingredient have
been shown to be safe for use with GoodLife meter,
but any disinfectant product with the EPA registra-
tion number of 67619-12 may be used on this device.
It should be cleaned and disinfected once per week.
The Clorox Germicidal Wipes can be purchased on