ApexBio MultiSure GK Link MTM309 User Manual Download

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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

E-mail: [email protected]

Website: www.apexbio.com

Manufactured by

Glu

mg /dL

Link

Model : MTM309

Summary of Contents for MultiSure GK Link MTM309

Page 1: ...ser 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 E mail info apexbio com Web...

Page 2: ...ad 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 contro...

Page 3: ...nostic 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 i...

Page 4: ...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...

Page 5: ...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...

Page 6: ...ly 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...

Page 7: ...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...

Page 8: ...orming 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 r...

Page 9: ...anging 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 Specificatio...

Page 10: ...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 informati...

Page 11: ...here 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 w...

Page 12: ...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 B...

Page 13: ...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...

Page 14: ...hold 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 abo...

Page 15: ...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 measure...

Page 16: ...hing rapidly and meter s BLE is on and waiting for pairing Used to indicate the icon is flashing slowly and meter s BLE is transmitting data after pairing Again used to indicate the icon is shown with...

Page 17: ...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 st...

Page 18: ...ithin the specified 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 tight...

Page 19: ...een 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 t...

Page 20: ...d 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 confirm Set Year Step 3 The current year will...

Page 21: ...nce to set the day Set Day Step 5 The current day will flash Press or to select the correct day Press to confirm your choice and advance to set the 12 hour or 24 hour time format Set 12 hour or 24 hou...

Page 22: ...ng a MultiSure GK Blood Glucose Test Strip see Testing Your Blood Glucose on page 34 MultiSure GK Blood Ketone Test Strip see Testing Your Blood Ketone on page 48 or press and hold to turn off the met...

Page 23: ...he alarm Materials you need Your MultiSure GK Link Blood Glucose and Ketone Meter CAUTION Before setting the alarms please check that the time is properly set Step 1 Select Alarm clock and Press to co...

Page 24: ...is OFF You can turn it on by pressing or Press to confirm the selection and move on to the next step Step 4 Press or to select the hour Press to confirm the selection and move on to the next step Step...

Page 25: ...g during testing Alarm will follow the time format 12 hour or 24 hour you choose when setting up the clock Alarm settings will not be erased when changing the batteries Begin testing by inserting a Te...

Page 26: ...ON You can adjust the beeper feature as follows Step 1 Select BEEP and Press to enter beeper setup Step 2 Press or to turn on off the tone Step 3 Press to confirm and return to the setting menus once...

Page 27: ...e screen will show hypo or hyper depending on whether your blood glucose test result is below your low glucose or above your high glucose threshold values Please consult your physician or healthcare p...

Page 28: ...t the Hyper and Hypo threshold values Material you will need Your MultiSure GK Link Blood Glucose and Ketone Meter Set hypo Step 1 Press or until the meter display screen shows hypo and Press to enter...

Page 29: ...d Press to enter hyper setup Step 5 Press or to turn the hyper alarm ON OFF Step 6 Press to set the hyper alarm value if ON Press or to select the desired value Press and hold either or to accelerate...

Page 30: ...l start blinking and an intermittent beep will sound reminding the user that a blood ketone test would be recommended IMPORTANT Consult your doctor or healthcare provider when setting the ketone test...

Page 31: ...OFF Step 3 Press to set the blood glucose threshold value if Ketone test warning is ON Press or to select the desired value Press and hold either or to accelerate the numbering Press to confirm the se...

Page 32: ...Glucose test Temperature 41 F to 113 F Relative Humidity 20 to 90 RH Ketone test Temperature 50 F to 104 F Relative Humidity 85 RH Do not store or use the meter where there are sharp temperature fluct...

Page 33: ...your meter with anyone else to avoid the risk of infection The meter complies with applicable electromagnetic emission requirements EMC However do not perform measurements with this meter near mobile...

Page 34: ...ure 41 F to 113 F Relative Humidity 20 to 90 RH Ketone test Temperature 50 F to 104 F Relative Humidity 85 RH After first opening the vial do not use the test strips beyond the time limit indicated on...

Page 35: ...Lancing Device CAUTION The lancets are for single use only Always use a new sterile lancet each time you perform the test DO NOT share your lancing device or lancets with other people Sharing or reus...

Page 36: ...to 15 seconds massaging through the wrist palm and then finger This can stimulate the blood flow to the finger more quickly Step 3 Hold the lancing device or lancet against the side of the finger and...

Page 37: ...lthcare professional before testing blood from the palm or forearm DO AST ONLY in the following intervals In a pre meal or fasting state more than 2 hours since last meal 2 hours or more after taking...

Page 38: ...You are testing for hyperglycemia Your routine glucose results are often fluctuating Consult with your healthcare professional to decide if AST is right for you NOTE Rubbing forearm until warm before...

Page 39: ...bottom left hand corner of the display Make sure the test strip contact points are inserted all the way into the meter The meter will turn on automatically If nothing appears on the screen remove the...

Page 40: ...3 Read your test result You will hear a beep when the test result appears on the screen together with the glucose icon GLU CAUTION If LO or HI appears on the screen If you see HI or LO displayed your...

Page 41: ...n from a fingertip do not use an alternative site If the test result still does not match how you feel contact your doctor or healthcare professional Do not ignore test results Do not alter your blood...

Page 42: ...and disinfect the meter and lancing device after the test When ejecting the used test strip point your meter downwards and away from others Disposal of biohazard waste Used lancets and test strips ar...

Page 43: ...ntil the markers icons start blinking Press or to scroll through the icons backwards or forwards according to the following sequence Before meal marker After meal marker Exercise marker Check marker G...

Page 44: ...s damaged You leave the test strip bottle cap open for a while your blood glucose test results do not reflect how you feel You want to check the performance of the meter and MultiSure GK blood glucose...

Page 45: ...tes before running the control test Temperature 41 to 113 F Relative Humidity 20 to 90 RH DO NOT FREEZE Store the control solutions at 39 F 86 F Do not drink the control solution It is not intended fo...

Page 46: ...ing appears on the screen remove the test strip insert it into the test strip port again and wait for the drop icon to start blinking Step 2 Enable the CTL mode WARNING If the CTL mode has not been en...

Page 47: ...ap on the control solution bottle immediately after use Step 4 Hold the meter and touch the control solution to the edge of the sampling end of the test strip The control solution will be automaticall...

Page 48: ...ge stop using the system and contact the Apex Biotechnology Corp customer service Step 6 Press the release button to remove the test strip or by pulling it out with your hand and throw it into a prope...

Page 49: ...use CAUTION Wash the puncture site with soap and water and dry the site thoroughly before sampling blood The lancets are for single use only Always use a new sterile lancet each time you perform the...

Page 50: ...drop icon starts blinking on the screen and the ketone icon Ket will be shown at the bottom left hand corner of the display Make sure the test strip contact points are inserted all the way into the m...

Page 51: ...beep when the test result appears on the screen together with the ketone icon Ket The test result will blink until meter switches off CAUTION If HI appears on the screen HI appears if your test resul...

Page 52: ...it into a proper wastebasket and the meter will turn off automatically The meter will also time out after 1 5 minutes of inactivity Step 5 Remove the used lancet from your lancing device according to...

Page 53: ...MultiSure GK Link Blood Glucose and Ketone Monitoring System 52 disease Please follow your local healthcare provider s recommendation regarding proper disposal of used lancets and test strips...

Page 54: ...working properly the meter has been dropped the meter is damaged You want to practice the testing procedure your ketone test results do not match with how you feel you want to check the performance o...

Page 55: ...at least 30 minutes before running the control test Temperature 50 to 104 F Relative Humidity 85 RH DO NOT FREEZE or REFRIGERATE Store the control solutions at 39 F 86 F Do not drink the control solu...

Page 56: ...lly If nothing appears on the screen remove the test strip insert it into the test strip port again and wait for the drop icon to start blinking Step 2 Enable the CTL mode IMPORTANT If the CTL mode ha...

Page 57: ...trol solution bottle immediately after use Step 4 Hold the meter and touch the control solution to the edge of the sampling end of the test strip The control solution will be automatically pulled into...

Page 58: ...were made and then repeat the control solution test CAUTION If you still have test results that fall outside the acceptable range stop using the system and contact the Apex Biotechnology Corp custome...

Page 59: ...d date Reviewing glucose past results You can review past results stored in the memory Your meter stores up to 730 glucose test results with dates times and markers The meter also provides 1 7 14 30 6...

Page 60: ...4 Press or to scroll through all the stored data Step5 Press for 3 seconds to switch the meter off NOTE If there are no results in the memory the screen displays ooo At the end of reviewing the indivi...

Page 61: ...erage press to return to the memory recall mode Step9 Hold for 3 seconds to switch the meter off NOTE If there are less than 2 results in the memory for the averaged period the screen displays ooo If...

Page 62: ...switches off Step 2 Press for 2 seconds to turn the meter on and enter the memory recall mode the mem icon appears on the screen and the Ket icon will blink Step 3 Press or on time to shift to ketone...

Page 63: ...oll through all the stored data Step 6 Press for 3 seconds to switch the meter off NOTE If there are no results in the memory the screen displays ooo At the end of reviewing the individual test result...

Page 64: ...terial you will need Your MultiSure GK Link Blood Glucose and Ketone Meter A micro USB cable Step 1 Insert a micro USB cable into the data port to transmit stored readings to Personal Computer Follow...

Page 65: ...their DMS The Data Management System DMS is not included in the meter If you need this data management function please contact Apex Biotechnology Corp customer service The Data Management System DMS...

Page 66: ...application on your mobile device that can accept the meter s data You can use this application to wirelessly and selective synchronies your test information between the meter and the mobile device Ma...

Page 67: ...instructions to pairing the meter The screen will show Ent and the BLE icon shall be flashing in the meter Step 3 Press to pair with your Mobile Device Step 4 As pairing is ok the BLE icon stop flashi...

Page 68: ...olve problems Step 6 After the data transfer is completed turn off the meter or the meter switches off automatically For Memory recall Mode Glucose Ketone Step 1 Follow the step of Viewing Stored Read...

Page 69: ...g Then the screen of meter will show Ent and BLE icon As pairing fails Er6 is displayed on the screen of the meter To see page 78 to solve problems BLE transmission Step 5 Press to confirm Data transm...

Page 70: ...n the meter is in transfer mode testing is not possible The distance between the meter and the mobile device can be transmitted within a range of 10 m m MultiSure GK Link Blood Glucose and Ketone Mete...

Page 71: ...try to clean the test strip holder Do not contaminate the strip holder with blood or control solution Handle the meter with care severe shock such as dropping the meter could damage the electronics Cl...

Page 72: ...s is available through major retailers online please refer to page 74 for purchase information We recommend the frequency for cleaning and disinfection is once per week 1 Wash hands with soap and wate...

Page 73: ...er or any other liquids Do not use glass household cleaners or ammonia on the meter or lancing device Use only Clorox HealthCare Bleach Germicidal Wipes The cleaning step should be performed prior to...

Page 74: ...cted prior to use by the second person Keep Clorox Healthcare Bleach Germicidal Wipes out of reach of children and stored according to its instruction Do not flush towels down toilet IMPORTANT If you...

Page 75: ...sentative https www cloroxpro com products clorox healthcare bleach germicidal disinfectants To find a local distributor in your area call Customer Service at 800 234 7700 Mon Fri 8 30am 5 00pm EST Yo...

Page 76: ...aterials you will need Two CR 2032 3V Lithium coin cell batteries Your MultiSure GK Link Blood Glucose and Ketone Meter Step 1 Turn meter off Remove the battery cover on the back of the meter by pushi...

Page 77: ...the batteries are being changed If batteries replacement takes longer than 2 minutes and you do not reset time and date all subsequent test results will be stored with the incorrect date and time Dis...

Page 78: ...Do not store or use the meter or test strips where they may be exposed to high humidity levels such as in a bathroom or kitchen Do not take the meter apart Doing so will void the warranty Do not use t...

Page 79: ...tone test strips Message What It Means What You Should Do Damaged meter electronic or test strip Used or contaminated test strip Replace the batteries and turn on the meter again Remove the test strip...

Page 80: ...test strip and repeat the test with a new test strip See Testing Your Blood Glucose on page 34 Remove the test strip and repeat the test with a new test strip See Testing Your Blood Ketone on page 48...

Page 81: ...hat You Should Do BLE pairing is fail Data transmission via BLE is fail Low battery Check Blutooth device is working well and repeat confirm to pairing Remove USB cable from Data transmission port Cha...

Page 82: ...s within recommended range and allow 30 minutes for it to reach the new temperature Wash and dry your hands and repeat the test on your fingertip with a new glucose test strip If the result is still H...

Page 83: ...ult is lower than 0 1 mmol L Wash and dry your hands and repeat the test on your fingertip with a new ketone test strip If the result is still HI contact your physician or healthcare professional imme...

Page 84: ...No memorized results in the meter Check if the date and time on your meter is set up See Setting Up Your New System on page 18 Start testing your blood glucose see Testing Your Blood Glucose on page 3...

Page 85: ...ealthcare professional to determine an appropriate target range for you What to Do If You Get a High or Low Reading If the meter displays results that are HI or LO or you get a result that is more tha...

Page 86: ...als 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...

Page 87: ...or that you are getting sick 1 If your blood glucose is higher than 250 mg dL 13 9 mmol L and your blood ketone result is 2 Below 0 6 mmol L a normal blood ketone level 0 6 to 1 5 mmol L a moderate l...

Page 88: ...Testing on page 54 Test again with a new test strip If you still get a high reading contact your healthcare professional immediately IMPORTANT Inaccurate results may occur for individuals experiencing...

Page 89: ...y Corporation is limited to repair or replacement and in no event shall Apex Biotechnology Corporation be liable for any collateral or consequential damages or loss Instruments subjected to misuse abu...

Page 90: ...5 L for glucose test 0 8 L for ketone test Hematocrit Range 10 70 for glucose test 20 60 for ketone test Display Type LCD screen with back lighting Alarms 3 for glucose test 3 for ketone test Data ma...

Page 91: ...wer off After 90 seconds of inactivity before the test sensor strip inserted into the meter drop icon flashing After 60 seconds of inactivity after the test and Error messages Err2 Err3 Err4 HI and LO...

Page 92: ...MultiSure GK Link Blood Glucose and Ketone Monitoring System 91 For additional information refer to the MultiSure GK blood Glucose Test Strip insert and MultiSure GK blood Ketone Test Strip insert...

Page 93: ...with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause h...

Page 94: ...of this device could void the user s authority to operate the equipment This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not ca...

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ApexBio MultiSure GK Link MTM309, User Manual

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Summary of Contents for MultiSure GK Link MTM309

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