Empecs Medical Device Medisign MM1100 BT User Manual

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Manufactured by:

Tianjin Empecs Medical Device Co.,Ltd.

No.35 and 37, Yingcheng Street, Hangu,

Binhai New Area, 300480 Tianjin China

Medisign MM1100 BT

Blood Glucose Monitoring System

User Manual

Read this User Manual carefully before you start the test and do a quality

control test. If you have any questions about the control test consult with your

healthcare professional. Confirm the measuring unit on the display is correct

with ever test result.

Table of Contents

Troubleshooting

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Summary of Contents for Empecs Medical Device Medisign MM1100 BT

Page 1: Blood Glucose Monitoring System
Manufactured by: Read this User Manual carefully before you start the test and do a quality Tianjin Empecs Medical Device Co.,Ltd. control test. If you have any questions about the control test consult with your No.35 and 37, Yingcheng Street, Hangu, healthcare professional.
Page 2 Important Safety Instruction Sign of Trouble Blood glucose meters are at high risk of contamination with blood-borne pathogens If you are experiencing any of the issues below, call customer service at such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human 1-888-885-6677.
Page 3: Table Of Contents
Contents About Your New System Reviewing Test Results ..................Welcome ......................Downloading Test Results to a PC ..............Intended Use ....................Pairing Your Meter Application ..................... How to Pair Your Meter ................... Test Principle ....................Control Test Special Features ..................... Performing a Control Test ................
Page 4: About Your New System Welcome
Medisign MM1100 Blood Glucose Test Strips are for in-vitro diagnostic use and questions, contact Customer Service at 1-888-885-6677, anytime-24 hours a for self testing only. The Medisign MM1100 BT Blood Glucose Meter is not a day. You can also obtain information at www.empecs.com.
Page 5: Special Features
Do not put the monitoring system near any electromagnetic field. (e.g. TV, Accurate result in 5 seconds using only 0.5㎕ blood sample. microwave oven, mobile phone) The Medisign MM1100 BT Glucose Meter identifies the test strip code Handle your monitoring system with care. automatically.
Page 6: Important Information
The meter and test strips should be handled at the same temperature. Before the test you must make sure that the code number displayed on For accurate test results, keep the Medisign MM1100 BT Blood Glucose the meter matches the code number on the test strip vial.
Page 7 Testing under out of the specification range may cause inaccurate results. collecting capillary blood into test tubes. Patients undergoing oxygen therapy may yield false low results. Be sure to clean and disinfect your Medisign MM1100 BT Blood Glucose Lipemic samples (triglycerides) in excess of 1,500 mg/dL may produce Meter regularly.
Page 8 Medisign MM1100 BT Blood Glucose Meter Blood Glucose Monitoring System Serial port Battery Lid The Medisign MM1100 BT Blood Glucose Monitoring System includes the Medisign MM1100 BT Meter, Ten(10) Medisign MM1100 Test Strip, Lancing Display Label Device, Lancets, Carrying Bag, User Manual, Warranty Card, (2) 3.0 Volt CR2032 Lithium Batteries and Logbook.
Page 9 Ready to Test Control Solution Use Medisign MM1100 Blood Glucose Test Strips with the Medisign MM1100 Average Result and Medisign MM1100 BT Blood Glucose Meter. Month / Date Check the expiration date of your test strips before using. Time Write the opening date of the new test strip vial in order to avoid using any Bluetooth (wireless RF on) expired products.
Page 10 4. Insert a test strip to turn on the meter. Make sure it is inserted completely 7. Adjust the puncture depth setting if necessary by turning the lancing device without bending the test strip. cap, number 1 is the shallowest depth while number 5 is the deepest. Slide the ejection/cocking control barrel back until it clicks.
Page 11: Testing Your Blood Glucose
Testing Your Blood Glucose Performing a Blood Glucose Test Disinfect Before Testing 1. Remove your lancing device cap. 2. Install the new lancet into your lancing device. 3. Remove the protective cap from the lancet. Replace the lancing device Before testing, wash your hands with soap and water and dry thoroughly. cap.
Page 12 10. Hold the tip of the test strip to the drop of blood, the test strip will CAUTION: automatically draw the blood into the test strip. When the test strip has Do not drop the blood directly on the end of the test strip. enough blood the meter will beep and count down from five seconds.
Page 13 NOTICE: If the test result is abnormal, please retest with a new test strip. If the test result also has a problem, please refer to the Troubleshooting section in this manual. CAUTION: Do not leave the lancet in the lancing device after use, be sure to dispose of properly.
Page 14: Flagging Test Results
Flagging Test Results 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.
Page 15: Handling The Used Test Strips
Alternate Site Testing Handling Used Test Strips Contact your Healthcare Professional before using any alternative sites to test your blood glucose. Alternative site results may be different from fingertip results when glucose levels are changing rapidly (e.g., after a meal, after taking insulin, or during or after exercise).
Page 16: Lancing And Sampling From An Alternate Site
Lancing and Sampling from an Alternate Site Do not rely on test results at an alternative sampling site, but use samples taken Sampling from your palm or forearm allows you to use your fingertips less often. from the fingertip, if any of the following applies: You may find that obtaining a blood sample from an alternative site is less you think your blood sugar is low.
Page 17: Meter Setup, Memory And Downloading
Meter Setup, Memory and Downloading Setting up Your Meter The Lancing Device Clear Cap is used for forearm and palm sampling only. Replace the lancing device cap to the clear cap and follow the same steps as descried in the chapter titled "Performing Blood Glucose Test". NOTICE: You may need to wait a little longer to get a large enough drop of blood from the forearm or palm.
Page 18 3. Setting the Month : When the month blinks, press and release the 'C' Button 6. Setting the Hour : When the hour blinks, press and release the Button until until the correct month appears, then press the Button to set the correct the correct hour appears, then press the Button to set the correct hour month and move to the date setting.
Page 19 9. Measurement Unit : The glucose measurement unit is defaulted to "mg/dL". Press the 'M' Button to move on to turning the "Beep" sound on or off. NOTICE: This cannot be changed, if you have any questions concerning the 10. Turning the Beep Sound On or Off: The meter is preset to the beep sound Unit Type contact Customer Service at 1-888-885-6677.
Page 20: Reviewing Test Results
Reviewing Test Results 11. Deleting Your Test Result: Select the Button to toggle between YES and " " 1. Begin with the meter off. Press the Button, you will hear a beep sound and the meter will turn on. " NO .
Page 21: Downloading Test Results To A Pc
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.
Page 22: Pairing Your Meter
How to Pair Your Meter Before Pairing Your Meter Pairing must be completed between the Medisign MM1100 BT meter and your Bluetooth mobile device before your meter can communicate with your mobile device. Both devices must be within Ten (10) meter of each other in order to sync properly.
Page 23: Control Test
Control Test Performing a Control Test Performing a control test lets you know that your meter and test strips are working properly. You should perform a control test when: You open a new box of test strips. You left the test strip container open. You want to check the meter and test strips.
Page 24: Performing A Control Solution Test
Performing a Control Solution Test 1. Insert the test strip with the black side and three(3) black lines facing up and 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 pointing towards the test strip port.
Page 25: Understanding Control Solution Test Results
Use Medisign Glucose Control Solution for the Medisign MM1100 and Medisign MM1100 BT System Control Test. 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 Meter.
Page 26: Maintenance And Troubleshooting
Maintenance and Troubleshooting Cleaning and Disinfecting Cleaning Instructions : Use the CaviWipes Towelettes for a cleaner and disinfectant. Whenever your Glucose Meter is dirty, clean the outside of the The meter should be cleaned and disinfected to prevent the transmission of meter with a new CaviWipes Towelette.
Page 27 The life of the device is three (3) years. The Medisign MM1100 BT meter was serial port. Do not wrap the meter in a wipe. Take extreme care not to demonstrated that there was no change in performance or in the external get liquid in the test strip, test strip port and serial port of the meter.
Page 28: Replacing The Batteries
Replacing the Batteries For more information on cleaning and disinfecting, contact Customer Service at (1-888-885-6677). CAUTION: Squeeze the excess liquid from the cloth before you wipe the meter’s surface. The meter must be off when you clean or disinfect the meter. Do not get moisture on the test strip or in the test strip port or serial port.
Page 29: Screen Messages
Screen Messages Messages Descriptions Solutions The meter has detected a Repeat the test with a new problem with the test strip. The test strip. test strip is either used or damaged. The blood sample was Remove and discard the test 2.
Page 30 Messages Descriptions Solutions Messages Descriptions Solutions The temperature is above or The temperature should be 50- There is not enough blood in Repeat the test with a new test below the proper range for ℉ the strip to perform a test. strip and make sure enough 104 .
Page 31: Troubleshooting
Troubleshooting Messages Descriptions Solutions Causes Solutions When the test result is higher Retest with a new test strip. If The meter does Make sure that the test strip is inserted into the test strip than 600mg/dL, the screen will the "Hi" mark appears again, not work after port completely.
Page 32: Technical Information And Warranty
Causes Solutions Make sure the test strip vial has not been opened for Product Name Medisign MM1100 BT Blood Glucose Monitoring System longer than three (3) months. Test Sample Fresh capillary whole blood Make sure the meter code and test strip code match.
Page 33: Warranty
Warranty Tianjin Empecs Medical Device guarantees that the Medisign MM1100 BT Blood Display Glucose Meter shall be free of defects in material and workmanship for a Operating Temp ℉ 50 - 104 period of three years. This guarantee is valid from the date of purchase. This...
Page 34: Disposing Of Your Meter
Disposing of your Meter Blood Glucose Target Range During blood glucose measurement the meter itself may come into contact Normal blood glucose reference value for non-diabetics is as follows: with blood. Used meters therefore carry a risk of infection. Please dispose of Before eating : <...
Page 35: Additional Supplies Available
Additional Supplies Available The following supplies and accessories are available from your supplier, for more information contact Customer Service at 1-888-885-6677. Medisign Link Cable Medisign Link Software Medisign MM1100 Test Strips Medisign Glucose Control Solution...
Page 36 FCC Part 15.19 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC Part 15.21 Any changes or modifications (including the antennas) to this device that are not expressly approved by the manufacturer may void the user's authority to operate the equipment.
Page 37 FCC Part 15.105 (B) Note : 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.