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: [phone]
Monday through Friday from 8am to 5pm EST
E-mail: [email protected]
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 notication and standard practice guideline are:
• “FDA Public Health Notication: 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.