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Declaration of Conformity 

This Device Complies With Part 15 Of The FCC Rules.

 

 

Operation is subject to the following two conditions; 

this device may not 

cause harmful interference, and 

this device must accept any interference 

received, including interference that may cause undesired operation. 
 
 

This equipment has been tested and found to comply with the limits for a 
Class B digital device, pursuant to Part 15 of the FCC Rules. These limits 
are designed to provide reasonable protection against harmful interference in 
a residential installation. This equipment generates uses and can radiate 
radio frequency energy and, if not installed and used in accordance 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 harmful interference to radio or 
television reception, which can be determined by turning the equipment off 
and on, the user is encouraged to try to correct the interference by one or 
more of the following measures: 
• Reorient or relocate the receiving antenna. 
• Increase the separation between the equipment and receiver. 
• Connect the equipment into an outlet on a circuit different from that to 

which the receiver is connected. 

• Consult the dealer or an experienced radio/TV technician for help. 

 

 
 
 
 
 
 

Caution: Changes or modifications not expressly approved by the party responsible
for compliance could void the user's authority to operate the equipment.

To comply with RF exposure compliance requirements, the antenna used for this
transmitter must not be colocated or operating in conjunction with any other antenna
or transmitter.

Summary of Contents for GluNEO Lite Smart

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Page 3: ...sional before making any changes to your diabetes management The GluNEO Lite Smart Blood Glucose Monitoring System is for in vitro diagnostic use only Customer Service is available 24 hours a day 7 da...

Page 4: ...ose Monitoring System 5 Do not change your medication based on the GluNEO Lite Smart meter test results without contacting your physician or healthcare professional first 6 Do not assemble or disassem...

Page 5: ...sugar 27 Reviewing your averages 27 Reviewing your results with activated user ID 28 Deleting test results 28 5 Alternate Site Test Lancing and sampling from an alternate site area 29 31 Lancing devi...

Page 6: ...rin does not interfere with GluNEO Lite Smart test strips Do not use during or soon after xylose absorption testing Xylose in the blood will cause interference Before using any product please read all...

Page 7: ...strip 3 Reusable Lancing Device 4 Lancets 5 Instructions for use 6 Warranty Registration Card 7 Carrying Case 8 Patient Logbook 9 3V Coin 1EA Battery CR2032 Your GluNEO Lite Smart Blood Glucose Monit...

Page 8: ...eases and discards test strip Serial Number Battery Cover CAUTION 1 Do not use GluNEO Lite Smart glucose test meter in a dry environment especially If synthetic materials are present Synthetic clothes...

Page 9: ...ooting Symbol DATE Delete Results Average Test Result System Before Having a Meal After Having a Meal After Taking Medication After Sport Activity Control Solution Symbol Blood Drop Symbol for Test Us...

Page 10: ...t strips Throw GluNEO Lite Smart test strips and vial away after the expiry date 5 Do not use the test strips after the expiration date printed on the package or vial since it may cause inaccurate res...

Page 11: ...glucose test strip 3 Practice using the lancing device and become accustomed with its use 4 Lancets and blood glucose test strips should be single use only 5 Wash your hands in warm clean running wat...

Page 12: ...ing either or buttons to set the year push button User Activity Option After pressing and releasing either or buttons to turn the User Activity Option on off push button Date Time After pressing and r...

Page 13: ...programming the number of desired alarms 5 alarms possible push button CAUTION 1 VERY IMPORTANT Set the right test unit Your GluNEO Lite Smart Meter is pre set to mg dL as test unit A wrong test unit...

Page 14: ...code number on the glucose test meter every time Check the code on the vial to see if the codes match each other CAUTION 1 Do not bend the glucose test strip to prevent the automatic code recognition...

Page 15: ...se test meter or blood glucose test strip is not functioning properly If your blood glucose test results are not consistent with your symptoms or if you think results are not accurate If you have drop...

Page 16: ...range CAUTION 1 Control solution is for in vitro diagnostic use only This means that it is only used for testing outside the body 2 Control solution is exclusively made for the GluNEO Lite Smart Bloo...

Page 17: ...Do not use beyond expiration date Once opened the control solution expires after 3 months If your control solution test falls out of range please follow the next steps before contacting customer suppo...

Page 18: ...ls out of range do not perform a glucose test and please contact your local representative 2 The glucose control solution s measurement range has nothing to do with individual s blood glucose level as...

Page 19: ...us this also comes with a transparent tip for AST Alternative Site Testing CAUTION 1 Never use a lancet that has been used by someone else Sharing lancet could lead to contamination 2 If the lancing d...

Page 20: ...ot enough blood gently massage the area until a sufficient sample is collected STORAGE Products must be stored at room temperature protected from sunlight or moisture CLEANING AND DISINFECTION Clean a...

Page 21: ...test strip code number and adjusts the meter accordingly A blinking test strip will appear at the top of the screen which indicates that the meter is ready for testing CAUTION 1 If you do not see the...

Page 22: ...nsmit infectious disease even after you have conducted cleaning and disinfection measures 2 Avoid getting hand lotion oil dirt or debris in or on the lancets single use only and the lancing device 3 W...

Page 23: ...thick or calloused skin 6 Pull the end of the lancet device back 7 To prick your finger push the center button CAUTION 1 If the blood smears or runs do not use such blood sample Dry the area and gentl...

Page 24: ...f your finger until you get the beep sound The test will automatically start Please respect recommended quantity of blood sample Too much blood may cause malfunction of your meter by contaminating it...

Page 25: ...your result then press and release the power button If you do not select to use User Activity option during set up press the power button If you selected to use the User ID option during set up press...

Page 26: ...ous waste in your area Be sure to contact your local representative for proper disposal 1 Push the needle into the protective cover 2 Pull the lancet out and discard accordingly CAUTION 1 Pushing the...

Page 27: ...er to calculate ReviewingYour blood sugar Press and release button The most recent result appears first Note the time and day of your blood sugar result Press and release the button and your previous...

Page 28: ...results of the selected user ID are displayed DATE DeletingTest Results Deleting individual test result To delete any individual test result in the memory press or button for 3 seconds Then displayed...

Page 29: ...used when sugars are stable before meals and before bedtime However when sugars are changing blood from the fingertip may show these changes sooner than blood from other body areas LIMITATION 1 Alter...

Page 30: ...a of the forearm or upper arm away from bone visible veins and thick hairs of the arm Sometimes there is less blood flow to these areas than to the fingertip To help you get enough drops of blood you...

Page 31: ...vice with anyone The lancing device clear tip is used for alternate site testing Lance the test site with the lancing device 1 Remove the lancing tip by twisting off 2 Insert lancet and replace with t...

Page 32: ...ure site each time you test Repeated punctures in the same spot may cause soreness and calluses 3 If bruising occurs at an alternate site or you have difficulty getting a sample consider sampling from...

Page 33: ...r in 1 bleach 9 water ratio Dampen a cloth with this solution and wipe the lancing device thoroughly Soak only the tip for at least 30 minutes in the disinfectant solution Do not soak the lancing devi...

Page 34: ...rect sunlight and heat Do not freeze After removing a test strip from the vial immediately close it tightly Record the discard date date vial opened plus 6 months on the test strip label Do not use if...

Page 35: ...from the date you first open a new vial of test strips Throw GluNEO Lite Smart test strips and vial away after the discard date 5 Do not use the test strips after the expiration date printed on the p...

Page 36: ...at the same time as buzzer sound the LCD window will display the P and the operating time count by one second units The meter will begin to transfer Bluetooth signal to your mobile phone and to count...

Page 37: ...est results from the GluNEO Lite Smart meter to a computer You will need to download the software from the following web site http www osanghc com and purchase the computer cable from your local repre...

Page 38: ...ium battery should be used Follow up Action 1 Check your meter with the glucose control solution 2 Perform your test again 3 If you are experiencing symptoms that are not consistent with your blood gl...

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Page 40: ...lp you identify certain problems but may not solve all the problems that could occur Contact your authorized representative or customer support center of OSANG Healthcare Co Ltd if the problem continu...

Page 41: ...t a new glucose test strip and perform your test again If Sun is blinking avoid direct sunlight and re test Contact your local representative or customer support at OSANG Healthcare Co Ltd if the prob...

Page 42: ...Change the batterry and if the problem persists contact your local represen tative or customer support at OSANG Healthcare Co Ltd...

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Page 44: ...connecting device Once the app is ready to receive your measuring value following message is appeared Turn off the power of the device by clicking power button push Bluetooth button according to the m...

Page 45: ...th GluNEO Lite Smart device If the connection status between app and GluNEO Lite Smart is not set the display of product number registration will be appeared Register product serial number into your A...

Page 46: ...Display of product number registration In case that registered product number is different from the device product number...

Page 47: ...ely transferred below display will be appeared Select Select Save button or Save all button and store measuring value into your App If several people use one GluNEO Lite Smart device together select S...

Page 48: ...Healthcare Co Ltd has no knowledge of the performance of the instrument when the test strip is altered or modified in any manner Purchaser must contact the customer service department of OSANG Health...

Page 49: ...ever there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by t...

Page 50: ...20 60 Bluetooth Bluetooth Smart Bluetooth Low Energy...

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Page 52: ...MEMO...

Page 53: ...132 Anyangcheondong ro Dongan gu Anyang si Gyeonggi do Korea 14040 www osanghc com INFM001LS IMC01538...

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