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Blood glucose meters are at high risk of becoming contaminated with 
blood-borne pathogens such as Hepatitis B Virus (HBV), Hepatitis C Virus 
(HCV), and Human Immunodeficiency Virus (HIV). Transmission of these 
viruses from resident to resident has been documented due to 
contaminated blood glucose devices.  Accordingly, cleaning and 
disinfecting of meters between resident uses can prevent the transmission of 
these viruses through indirect contact. 

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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.

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All parts of the kit are considered bio hazardous and can potentially 
transmit infectious diseases, even after you have performed cleaning and 
disinfection.

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User should wash their hands thoroughly with soap and water after handling 
the meter, lancing device or test strips.

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Please see the section on "Cleaning and Disinfection" to clean and disinfect 
the meter or lancing device.

Flagging Test Results

If you want to flag pre-meal, post-meal or control solution readings press the 

 

Button after your test result is displayed. The icon for post-meal (    ) will be 
displayed on your screen. Press the 

 Button to toggle between pre-meal (    ), 

post-meal (    ) and control solution (    ). After you have identified the activity 
you would like to flag simply remove the test strip. 

(see explanation of display on page 

11)

'M'

'C'

NOTICE:

Control Solution Test results are not included in the 14-day average.

Summary of Contents for Medisign MM1100 BT

Page 1: ...al Confirm the measuring unit on the display is correct with ever test result Call Customer Service Toll Free 24 hours a day 7 days a week 1 888 885 6677 or visit our website Manufactured by Tianjin Empecs Medical Device Co Ltd No 35 and 37 Yingcheng Street Hangu Binhai New Area 300480 Tianjin China www empecs com Medisign MM1100 BT Blood Glucose Monitoring System User Manual ...

Page 2: ... cleaning and disinfecting meters between users can prevent the transmission of these viruses through indirect contact l 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 l All parts of the kit are considered as biohazards The system may transmit infectious diseases even after it has been cleaned or ...

Page 3: ...p Memory and Downloading Setting up Your Meter 01 01 02 02 03 04 05 09 13 14 22 23 24 28 Reviewing Test Results Downloading Test Results to a PC n Pairing Your Meter How to Pair Your Meter n Control Test Performing a Control Test Understanding Control Test Results n Maintenance and Troubleshooting Cleaning and Disinfecting Replacing the Batteries Screen Messages Troubleshooting n Technical Informa...

Page 4: ...betes It is intended for self testing by persons at home for single patient use only and should not be shared It is intended for use outside the body in vitro diagnostic use only and not for the diagnosis of or screening of diabetes or for neonatal use The alternative site testing palm and forearm should be done only during steady state times when glucose in not changing rapidly Application Medisi...

Page 5: ...L Usage and Storage l Before using your monitoring system please place it in the environment of the system s normal operating temperature range of 50 104 for about twenty 20 minutes l Do not allow dirt or dust into the test strip port in order to avoid affecting the monitoring system s accuracy l Do not attempt to repair or alter your monitoring system l Do not put the monitoring system near any e...

Page 6: ...d on the meter matches the code number on the test strip vial l Keep your Medisign MM1100 BT Blood Glucose Meter lancing device lancets and control solutions out of reach of children or pets l Be sure to check the glucose measurement unit on the meter before the test This meter is preset to mg dL mg dL is the unit of measurement used in the US l Make sure you close the test strip vial is closed ti...

Page 7: ...ct results however abnormally high concentrations in blood may cause inaccurate results l The Medisign MM1100 BT Blood Glucose Monitoring System is for testing outside of the body in vitro diagnostic use l l l CAUTION Use only Medisign MM1100 Test Strips with your Medisign MM1100 and Medisign MM1100 BT Blood Glucose Meters l Testing under out of the specification range may cause inaccurate results...

Page 8: ...sign MM1100 Test Strip Lancing Device Lancets Carrying Bag User Manual Warranty Card 2 3 0 Volt CR2032 Lithium Batteries and Logbook Medisign MM1100 test strips and Medisign Glucose Control Solution can be provided by contacting your supplier or for additional information you can contact Customer Support at 1 888 885 6677 Display M Button C Button Test Strip port Serial port Battery Lid Label Test...

Page 9: ...trips before using l Write the opening date of the new test strip vial in order to avoid using any expired products Lot Number Expiration Date Sample Channel Test Strip Vial Medisign MM1100 Blood Glucose Test Strip A B Low Battery Warning Stored Test Results Test Results Unit of Measurement Temperature Error No Beep Pre meal Post meal Mark Ready to Test Control Solution Average Result Month Date T...

Page 10: ...e button 9 Gently squeeze your finger to assist the flow of blood Do not squeeze excessively on the puncture site 7 8 9 4 Insert a test strip to turn on the meter Make sure it is inserted completely without bending the test strip 5 The meter identifies the code number automatically Compare the code number displayed on the LCD with the code number shown on the test strip vial If they do not match t...

Page 11: ...CE Refer to the lancing device instruction for additional detailed information The lancing device instruction depicted in this manual is for most universal lancing devices 1 2 3 Testing Your Blood Glucose Disinfect Before Testing l Before testing wash your hands with soap and water and dry thoroughly l Use an alcohol prep pad to wipe the area before testing l Wait until the alcohol dries completel...

Page 12: ...ll show the message of Er 4 Please refer to error messages in this manual CAUTION l Do not drop the blood directly on the end of the test strip l The sample channel at the end of the test strip should show full When you hear the beep sound you have enough blood in the test strip l Inaccurate results may occur for individuals or patient in shock Inaccurate results may occur for individuals experien...

Page 13: ... retest with a new test strip If the test result also has a problem please refer to the Troubleshooting section in this manual CAUTION l Do not leave the lancet in the lancing device after use be sure to dispose of properly l If you have taken the cap off of the lancet and the lancet has fallen to the ground do not use it Make sure you dispose of it and replace it with a new lancet l Always dispos...

Page 14: ...idered bio hazardous and can potentially transmit infectious diseases even after you have performed cleaning and disinfection l User should wash their hands thoroughly with soap and water after handling the meter lancing device or test strips l Please see the section on Cleaning and Disinfection to clean and disinfect the meter or lancing device Flagging Test Results If you want to flag pre meal p...

Page 15: ...t from fingertip results when glucose levels are changing rapidly e g after a meal after taking insulin or during or after exercise l Use alternative site testing only two hours or more after taking insulin two hours or more after a meal two hours or more after exercise l Do not use alternative site testing if you are aware that your glucose level is not as stable as usual or if you think you may ...

Page 16: ...not match how you feel call your Healthcare Professional Lancing and Sampling from an Alternate Site Sampling from your palm or forearm allows you to use your fingertips less often You may find that obtaining a blood sample from an alternative site is less painful than using a fingertip Getting a blood sample from your forearm or palm is different than getting a sample from your fingertips l Forea...

Page 17: ...te excessively l If the sample drop of blood runs or spreads due to contact with hair or a crease in your palm do not use that sample Try puncturing again in a smoother area l You may have to adjust the lancing device to a deeper setting to get a large enough drop of blood Meter Setup Memory and Downloading Setting up Your Meter 1 Press and hold the button for roughly three seconds you will hear a...

Page 18: ... blinking press the C Button to move between 12 h and 24 h then press the M Button to set and move to the hour setting 5 6 6 Setting the Hour When the hour blinks press and release the Button until the correct hour appears then press the Button to set the correct hour and move to the minute setting C M 7 Setting the Minute When the minute blinks press and release the C Button until the correct min...

Page 19: ...ret your blood glucose level and incorrect treatment l Contact your Healthcare Professional if you have any question about measuring units This meter is preset to mg dL mg dL is the unit of measure used in the U S 10 10 Turning the Beep Sound On or Off NOTICE Turning the Beep sound On or Off does not affect your glucose measurement The meter is preset to the beep sound ON To turn the beep sound of...

Page 20: ...will show as pictured above Press the Button again and the meter will turn off C M M M Reviewing Test Results 1 2 1 Begin with the meter off Press the Button you will hear a beep sound and the meter will turn on 2 M The screen will display the date and time After 2 seconds the last 14 days average result will be displayed with a sign 14 and the number of test results for 14 days on the display For...

Page 21: ...omatic shut off and will turn off in roughly two 2 minutes if no changes are detected Downloading Test Results to PC You can transfer test results from the Medisign MM1100 BT Blood Glucose Meter to a computer where they can be summarized in a report with graphs and tables To use this feature you will need to download the Medisign Link Software and use the Medisign Link USB Cable For more informati...

Page 22: ... connected to your mobile device however one meter cannot connect to multiple mobile devices at the same time Medisign MM1100 BT meter is compatible with Android App OS version 4 3 or higher Mobile devices compatible with Bluetooth 4 0 1 Press the M button to turn on Bluetooth 2 If your mobile device is set to search other devices you can find the Medisign MM1100 BT meter name along with the seria...

Page 23: ...ck the meter and test strips l Your test strips were stored in extreme temperature or humidity l You dropped the meter l Your test result does not agree with how you feel l You want to check if you are testing correctly 4 If the mobile device and meter are successfully connected the will be shown on the meter display 5 If you are prompted to pair your mobile device after connecting you may need to...

Page 24: ...he test strip directly from the vial Replace the lid on the control solution vial immediately after use 3 Gently touch the drop of the control solution to the tip of the test strip 4 When the test strip confirmation window is full the meter will beep The meter will count down from five seconds and then show the reading Make sure the reading on the screen is between the ranges displayed on your tes...

Page 25: ...trol Solution for the Medisign MM1100 and Medisign MM1100 BT System Control Test Understanding Control Solution Test Results Range mg dL Level 2 Level 3 High Normal The Range displayed is for EXAMPLE PURPOSES ONLY l The example label shown above on the test strip vial shows the acceptable ranges for Levels 2 Normal 3 High Control Solution for the Medisign MM1100 and Medisign MM1100 BT Glucose Mete...

Page 26: ...ir website at www medexsupply com This product can also be found through large online retail distribution sites such as www amazon com www ebay com etc Cleaning Instructions Use the CaviWipes Towelettes for a cleaner and disinfectant Whenever your Glucose Meter is dirty clean the outside of the meter with a new CaviWipes Towelette CAUTION Do not use other cleaners or disinfectants as they may dama...

Page 27: ...quid in the test strip test strip port and serial port of the meter Allow to remain wet for two 2 minutes at 68 STEP1 STEP2 STEP3 STEP4 Let the meter dry per the towelette manufacturer s instructions Dispose of the wipe when finished l User should wash their hands thoroughly with soap and water after handling the meter or test strips l The life of the device is three 3 years The Medisign MM1100 BT...

Page 28: ... solution directly onto the meter l Do not put the meter under water or liquid l Immersing the meter in liquid will cause damage Replacing the Batteries 1 When the batteries are low the screen will display and blink the low battery icon in the top left hand corner This indicates that there is only enough power left in the meter for about fifty more tests and the batteries should be replaced When r...

Page 29: ...e screen Repeat the test with a new test strip Remove and discard the test strip and insert a new one Apply blood to the test strip after the blood symbol appears on the screen 2 Open the battery compartment lid on the back of the meter and remove the batteries and replace them with two new CR2032 batteries Make sure to align the side facing up toward you Once the new batteries are in place snap t...

Page 30: ...eached the proper range and retest Do not raise or lower the meter temperature artificially Messages Descriptions Solutions There is not enough blood in the strip to perform a test Repeat the test with a new test strip and make sure enough blood has been applied to the strip The wrong strip has been put into the meter Make sure you are using an Medisign MM1100 test strip and repeat the test There ...

Page 31: ...Lo mark appears again please call your doctor or Healthcare Professional immediately Troubleshooting The meter does not work after the blood is applied l Make sure that the test strip is inserted into the test strip port completely l See if the test strip is covered in debris or lint l Make sure the blood is applied to the test strip correctly l Make sure the test strip is inserted correctly and r...

Page 32: ... strip is inserted l Make sure the test strip is completely inserted into the test strip port l Make sure the batteries are inserted correctly with the sign up and facing the right direction Technical Information and Warranty Specifications Product Name Test Sample Calibration Sample size Test Strip Type Measuring Range Measuring Time Power Battery Life Memory Capacity Data Transport Medisign MM11...

Page 33: ... in material and workmanship for a period of three years This guarantee is valid from the date of purchase This guarantee extends only to the original purchaser and is not transferable The warranty ceases to apply under the following conditions l The meter is damaged as a result of incorrect use l The meter is damaged as a result of natural disasters e g hurricane earthquake etc l The meter is dam...

Page 34: ...cal council and authority The meter falls outside the scope of European Directive 2002 96 EC Directive on waste electrical and electronic equipment WEEE Blood Glucose Target Range Normal blood glucose reference value for non diabetics is as follows l Before eating 100 mg dL l 2 hours after meals 140 mg dL In case results are out of reference range please contact your Healthcare Professional and fo...

Page 35: ... following supplies and accessories are available from your supplier for more information contact Customer Service at 1 888 885 6677 Medisign Link Cable Link Software Test Strips Medisign Glucose Control Solution Medisign Medisign MM1100 ...

Page 36: ...fications including the antennas to this device that are not expressly approved by the manufacturer may void the user s authority to operate the equipment RF Exposure Statement 2 1093 This equipment complies with FCC RF Radiation exposure limits set forth for an uncontrolled environment This device and its antenna must not be co located or operating in conjunction with any other antenna or transmi...

Page 37: ...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...

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