ApexBio MultiSure GK Link MTM309 User manual
Blood Glucose and Ketone
Monitoring System
P/N 650700XXX
Rev.3/20
User's Guide
For single-patient use
APEX BIOTECHNOLOGY CORP.
No7, Li Hsin Rd. V, Hsinchu Science Park
Hsinchu, Taiwan
TEL: 1-877-979-5454
Monday through Friday from 8am to 5pm EST
Website: www.apexbio.com
Manufactured by
Glu
mg /dL
PM
Link
Model : MTM309
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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Dear MultiSure GK Link Owner
Thank you for choosing the MultiSure GK Link Blood Glucose and Ketone Monitoring
System to help you easily monitoring your blood glucose and Ketone. We hope it
will be of great help in the management of your diabetes. This manual explains how
to use your new meter. Before testing, carefully read through this manual and the
package inserts that come with: MultiSure GK blood glucose test strip, MultiSure GK
blood ketone test strip, Contrex Plus 4 glucose control solution, and KET-1 ketone
control solution. Pay particular attention to listed warnings and cautions. Please keep
this manual at hand for future reference.
Please call us at 1-877-979-5454 between 8:00 am and 5:00 pm US Central
Standard Time, Monday through Friday for questions and inquiries. If you have any
questions or need assistance outside the operational days and times, please contact
your health care provider.
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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Intended Use
Your MultiSure GK Link Blood Glucose and Ketone Meter, MultiSure GK blood
glucose test strip, and MultiSure GK blood ketone test strip are in vitro diagnostic
medical devices to quantitatively measure blood glucose in fresh capillary whole
blood drawn from
ngertips, palm, or forearm, and blood ketone in venous whole blood or capillary
whole blood from ngertips. Alternative site testing for glucose test should be
performed only during steady-state (when glucose is not changing rapidly). They
are intended for self-testing outside the body (in vitro diagnostic use) by people
with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes
control and should only be used by a single patient and it should not be shared. They
are not intended for diagnosis or screening of diabetes and DKA or for neonatal use.
Do not alter your treatment on the basis of test results of this meter without previously
consulting your doctor or healthcare professional.
IMPORTANT:
• Dehydration – Severe dehydration may lead to inaccurate blood glucose test result.
If you suspect you are severely dehydrated, contact your healthcare professional
immediately.
• Hematocrit range – A hematocrit range that is higher than 70% or lower than 10%
can cause inaccurate blood glucose test results; A hematocrit range that is higher
than 60% or lower than 20% can cause inaccurate blood ketone test results.
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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• Not intended for use on neonates.
• Testing is done outside the body (In Vitro diagnostic use).
• Do not use test strips if expiration date has passed.
• Use MultiSure GK blood glucose test strip within 12 months of opening test strip
vial. Use MultiSure GK blood ketone test strip within 3 months of opening test strip
vial.
Important Safety Instructions
• 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!
• All parts of the kit are considered biohazardous and can potentially transmit
infectious diseases, even after you have performed cleaning and disinfection.
• Users should wash hands thoroughly with soap and water after handling the meter,
lancing device, or test strips.
The link of public health notication and standard practice guideline are:
• “FDA Public Health Notication: 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
• “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person
Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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injectionsafety/Fingerstick-DevicesBGM.html
Limitations
• Inaccurate results may occur in severely hypotensive individuals or patients in
shock.
• Inaccurate low results may occur for individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis.
• Critically ill patients should not be tested with this device.
• No for use on neonates.
• Altitude higher than 10,335 feet may cause inaccurate results.
• A hematocrit range that is higher than 70% or lower than 10% can cause inaccurate
blood glucose test results; A hematocrit range that is higher than 60% or lower than
20% can cause inaccurate blood ketone test results.
• Severe dehydration may lead to inaccurate blood glucose/ ketone test result.
• For In vitro diagnostic only.
• For over the counter use.
• Alternative site testing should be performed only during steady-state (when glucose
is not changing rapidly).
• For single-patient use only.
• Alternative site measurements should never be used to calibrate continuous
glucose monitors (CGMs).
• Alternative site measurements should never be used for insulin dosing calculations.
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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• The following drugs do not generally interfere with the MultiSure GK Link system
at normal or therapeutic levels However, higher concentrations (listed below) were
found to interfere with glucose measurements.
• Acetaminophen levels above 10 mg/dL may give falsely high test results.
• Tolbutamide levels above 15 mg/dL may cause falsely low test results.
• Ibuprofen levels above 40 mg/dL may cause falsely low test results.
• Acetylsalicylic acid levels above 40 mg/dL may give falsely low testresults.
• Tolazamide levels above 23 mg/dL may cause falsely high test results.
• Paralidoxime Iodide (PAM) levels above 50 mg/dL may cause falsely high test
results.
• Uric acid levels above 15 mg/dL may give falsely low test results.
• Cholesterol levels above 500 mg/dL may give falsely low test results.
• Triglyceride levels above 1500 mg/dL may give falsely high test results.
• Glutathione levels above 46 mg/dL may give falsely high test results.
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Table of Contents
Understanding Your New Blood Glucose and Ketone Monitoring System
The MultiSure GK Link Blood Glucose and Ketone Meter..................... 10
The MultiSure GK Link Blood Glucose and Ketone Meter Display Screen ........ 12
The MultiSure GK Link Blood Glucose Test Strip ........................... 16
The MultiSure GK Link Blood Ketone Test Strip ............................ 17
Setting Up Your New System
The Setup Screen ................................................... 18
Setting the Clock .................................................... 19
Alarm Setup ........................................................ 22
Beeper Setup ....................................................... 25
Setting up hypo/hyper warning value..................................... 26
Ketone test warning setup ............................................. 29
Before Testing
Caution when using the meter .......................................... 31
Caution when using the test strips ....................................... 32
Testing Your Blood Glucose
Preparing Your Lancing Device ......................................... 34
Important Information on Alternative Site Testing (AST) ...................... 36
Performing a Blood Glucose Test ....................................... 38
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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Marking Test Results ................................................. 42
Glucose control Solution Testing
Performing a Glucose Control Solution Test ............................... 44
Testing Your Blood Ketone
Preparing Your Lancing Device ......................................... 48
Performing a Blood Ketone Test ........................................ 49
Ketone Control Solution Testing
Performing a Ketone Control Solution Test ................................ 54
Viewing Stored Readings from Memory
Reviewing glucose past results ......................................... 58
Reviewing ketone past results .......................................... 61
Data transmission
Upload data via USB ................................................. 63
Upload data via Bluetooth ............................................. 65
Caring for the Meter
Cleaning and Disinfecting Your Meter and Lancing Device.................... 70
Purchase Information for Clorox Healthcare Bleach Germicidal Wipes........... 74
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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Changing the Batteries ................................................. 75
Storage and Precautions ............................................... 77
Solving Problems ..................................................... 78
Understanding Your Blood Glucose Test Results ........................... 84
Understanding Your Blood Ketone Test Results ............................ 86
Product Warranty ..................................................... 88
Specications ........................................................ 89
FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT .... 92
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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Understanding Your New Blood Glucose and Ketone Monitoring System
Each MultiSure GK Link Blood Glucose and Ketone system may include the following items:
Note:
• Contents may change without notice.
• Lancets and Lancing Device are optional components.
• MultiSure GK Blood Glucose Test Strip MultiSure GK Blood Ketone Test Strip ,
Contrex Plus 4 glucose control solution and KET-1 ketone control solution are
necessary but sold separately.
Please contact us at 1-877-979-5454 Monday through Friday from 8am to 5pm US
Central Standard Time for purchasing information.
Lancing Device
User Guide
Contrex Plus 4
Level 3 Glucose
Control Solution
KET-1
Level 1 Ketone
Control Solution
KET-1
Level 2 Ketone
Control Solution
Contrex Plus 4
Level 2 Glucose
Control Solution
Contrex Plus 4
Level 1 Glucose
Control Solution
Lancets
The MultiSure GK Link Blood
Glucose and Ketone Meter
The MultiSure GK Blood
Glucose Test Strip
The MultiSure GK Blood
Ketone Test Strip
(vial or foil-wrapped)
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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The MultiSure GK Link Blood Glucose and Ketone Meter
TEST STRIP PORT
This is where you insert the test strip and the meter will turn on automatically.
ENTER ( ) BUTTON
Press and hold for 2 seconds to access meter memory or simultaneously press and
▲ for 2 seconds to enter setup mode while not testing.
UP/DOWN (▲/▼) BUTTONS
Press or hold to scroll through different options and/or values.
TEST STRIP PORT
UP/DOWN (▲/▼) BUTTONS
ENTER ( ) BUTTON
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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RELEASE BUTTON
Press this button to remove used test strip.
BATTERY HOLDER
Houses two CR2032 3V lithium coin cell batteries.
DATA TRANSFER PORT
Connection port for PC data cable and Bluetooth device from Apex Biotechnology
Corp.
PUSH
RELEASE BUTTON
BATTERY HOLDER
DATA TRANSFER PORT
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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The MultiSure GK Link Blood Glucose and Ketone Meter Display Screen
hyper
mem
Glu
Ket
mmgl/dL
AM
PM
DAY
AVG
LOW BATTERY
MEMORY
BLOOD DROP
ALARM / CLOCK
WRONG
TEMPERATURE
MAIN DISPLAY
AREA
HYPO / HYPER
UNIT OF
MEASUREMENT
DAY AVERAGE
TIME
BLE
KETONE
GLUCOSE
DATE
CONTROL SOLUTION
MODE (CTRL)
MARKERS ICONS
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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MEMORY ........................Indicates that you are using the memory
CLOCK/ALARM...............“clock” appears while setting the time (see page 19); “alarm”
appears while setting the acoustic reminder(s), and will be
displayed if any alarm is on (see page 22).
HYPO ..............................• Setting up your hypoglycemic threshold value (see page
26)
• Indicates your glucose test result maybe at or below your
hypoglycemic threshold value
• Indicates the memorized result maybe at or below your
hypoglycemic threshold value
HYPER ............................• Setting up your hyperglycemic threshold value (see page
26)
• Indicates your test result maybe at or above your
hyperglycemic threshold value
• Indicates the memorized result maybe at or above your
hyperglycemic threshold value
DROP ..............................This icon will ash to indicate that the meter is ready for
blood or control solution testing
MAIN DISPLAY AREA.....Displays test results, stored test values, result averages
and messages.
UNIT OF MEASUREMENT
..Shows the unit of measurement of your meter (mg/dL for
glucose; mmol/L only for ketone).
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TIME................................Shows time (HH:MM, 12H AM/PM or 24H format).
AVERAGE .......................Shows the period related to the displayed average (1, 7,
14, 30, 60 or 90 days –(see page 59)
DATE...............................shows the date (DD-MM format)
GLUCOSE.......................Appears when the value shown in the Main Display Area
refers to glucose test results.
KETONE..........................Appears when the value shown in the Main Display Area
refers to ketone test results, while setting the ketone test
alert threshold or, if blinking and displayed after a glucose
test, to indicate that a ketone measurement is suggested
(see page 29).
WRONG TEMPERATURE
..Appears while testing and temperature is outside the
allowed temperature range.
LOW BATTERY...............Appears when the battery needs to be replaced (see page
75).
MARKERS ......................Displayed while marking a test result (see page 42) or
reviewing a marked result.
Before meal marker
After meal marker
Exercise marker
Check marker
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BLE ICON........................Indicate Bluetooth (BLE) icon
Used to indicate the icon is ashing rapidly and meter’s
BLE is on and waiting for pairing.
Used to indicate the icon is ashing slowly and meter’s
BLE is transmitting data after pairing
Again, used to indicate the icon is shown without ashing
and meter’s BLE is waiting instruction from cell-phone after
pairing.
CTL..................................Indicates a control solution test (see page 43 & 54)
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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The MultiSure GK Blood Glucose Test Strip
The MultiSure GK Blood Glucose Test Strip is a glucose specic, biosensor-based
test strip that can test glucose in capillary whole blood in as quickly as 5 seconds
and requires very little blood sample. The test result is plasma referenced for easy
comparison to lab results. The test strip has under-ll detection to alert you when
there is not enough blood to perform a test, so you can be assure that every reading
you get is an accurate and meaningful result.
IMPORTANT:
• The MultiSure GK Blood Glucose Test Strip is sensitive to moisture and light. For
vial test strip, it is important to close the vial cap of the test strip bottle tightly after
each use. DO NOT leave any test strips outside the bottle while not in use.
• DO NOT reuse test strips. Test strips are for single use only.
• Carefully discard used test strips and lancets in proper waste containers.
• Be sure to use only the MultiSure GK Blood Glucose Test Strip with the MultiSure
GK Link Blood Glucose and Ketone Meter. Other brands of test strips will not work
with the meter.
Contact Points
Insert this end to the test
strip port on the meter
Sampling End
Apply blood or control solution
here
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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The MultiSure GK Blood Ketone Test Strip
The MultiSure GK Blood Ketone Test Strip is ketone specic, biosensor-based
test strip that can test blood ketone level in capillary whole blood in as quickly as 8
seconds and requires very little blood sample. The test result is plasma referenced for
easy comparison to lab results and has under-ll detection to alert you when there is
not enough blood to perform a test, so you can be assure that each reading you get
is an accurate and meaningful result when the control reading in within the specied
range.
IMPORTANT:
• The MultiSure GK Blood Ketone Test Strip is sensitive to moisture and light. For
vial test strip, it is important to close the vial cap of the test strip bottle tightly after
each use. DO NOT leave any test strips outside the bottle while not in use.For foil-
wrapped test strip, DO NOT open the foil wrapping until performing tests.
• DO NOT reuse test strips. Test strips are for single use only.
• Carefully discard used test strips and lancets in proper waste containers.
• Be sure to use only the MultiSure GK Blood Ketone Test Strip with the MultiSure
GK Link Blood Glucose and Ketone Meter. Other brands of test strips will not work
with the meter.
Contact Points
Insert this end to the test
strip port on the meter
Sampling End
Apply blood or control solution
here
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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Setting Up Your New System
The Setup Screen
1. Make sure the meter is off (to turn the meter off press for 3 seconds until the
screen switches off).
2. Simultaneously press and ▲ for 2 seconds to enter the setup menu.
3. Press ▲ or ▼ to scroll through the setting menus (see pictures below) and press
to enter each single menu.
PM PM
▲
▼
▲
▼
▲
▼
▲
▼
▲
▼▲
▼
Glu PM
hyper
Glu PM
Ket
PM
MultiSure GK Link Blood Glucose and Ketone Monitoring System
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Setting the Clock
Material you will need:
• Your MultiSure GK Link Blood Glucose and Ketone Meter
Begin Set Up
Step 1.
press and ▲ for 2 seconds to turn on the meter.
Step 2.
Select Clock and Press to conrm
Set Year
Step 3.
The current year will ash. Press “▲” or “▼” to select the correct
year.
Press to conrm your choice and advance to set the month.
PM
Table of contents
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