User Manual for Mendor SMART Blood Glucose Meter Model Name: GM01CAB Manufacturer i-SENS, Inc. www.i-sens.
FOR THE USER OF MENDOR SMART BLOOD GLUCOSE METER TABLE OF CONTENTS Thank you for selecting Mendor SMART Blood Glucose Monitoring System. The system provides you with safe, convenient and painless blood glucose in vitro (i.e., outside the body) diagnostic monitoring. You can obtain accurate results in just 5 seconds with a small (0.5 μl) blood sample. Information Table of Contents............................................................................................3 Information: Read This First!....
INFORMATION: READ THIS FIRST! IMPORTANT INFORMATION To receive safe and optimum system benefits, please read the entire manual contents before using the system. Please note: • Do not use the system for the diagnosis of diabetes without the guidance of a healthcare professional or for testing newborns. • Use only fresh capillary whole blood samples for testing. • Wash your hands before each measurement. If water is not available, use disinfectant wipes with 70 % IPA only, dry your hands carefully.
IMPORTANT INFORMATION Caution: • Do not expose the meter to direct sunlight or heat for an extended period of time. • Prevent the entry of dirt, dust, blood, or water at the meter’s test strip port. • Do not drop the meter or submit it to strong shocks. • Do not try to fix or alter the meter in any way. • Keep the meter in a cool and airy place. • Keep the meter away from strong electromagnetic fields such as cell phones and microwave ovens.
MENDOR SMART BLOOD GLUCOSE MONITORING SYSTEM COMPONENTS WARNINGS Components (provided by the manufacturer): Read through the warnings before using the device. Basic safety precautions should be taken before using the device including those listed in the Warnings. The Mendor SMART Blood Glucose Meter Test Strips shall be used only with fresh capillary whole blood samples. Do not use venous or arterial blood samples.
MENDOR SMART BLOOD GLUCOSE METER TEST STRIP MENDOR SMART BLOOD GLUCOSE METER The Mendor SMART Blood Glucose Meter Test Strip supports the accurate measurement of blood glucose levels in a capillary whole blood sample. Contact bars Gently push the test strip, with its contact bars facing up, into the test strip port of the meter. Confirmation window Check here to see whether sufficient blood sample has been applied. Edge to apply blood sample Apply blood sample here for testing.
METER DISPLAY MAIN MENU Main Menu History The main menu is composed of symbols as shown in the picture below. Using “ ”, “ ”, and “ ” button, you can enter into each menu. When you select History menu, the screen is displayed as shown in the picture below. You can then check measured test results on the screen by using the “ “ button. Scroll down to see old test results. Sound On/Off Displays the status of the sound function. PP2 Alarm Appears when the alarm has been set remotely using Mendor Balance.
MAIN MENU MAIN MENU Test Wizard Settings When you select Test Wizard menu, the meter gives stepwise instructions for the blood glucose measurement with pictures. In Setting mode, you can set Date/Time, Sound, Alarm, Network, Synchronize and Security Token. Before testing please see section “Testing your blood glucose” Insertion stage Insert the test strip with contact bars facing upwards. Sound Set up Audio Function and adjust volume. Date/Time Set up current date and time.
OPERATING MENDOR SMART BLOOD GLUCOSE METER BASIC SETTINGS Turn on Mendor SMART Blood Glucose Meter When using the Mendor SMART Blood Glucose Meter for the first time, please, check and update the meter’s settings prior to using the meter. You can start Mendor SMART Blood Glucose Meter by pressing the “ “ button for 3 seconds and the display will turn on. When the progress bar animation completes loading, you are ready to use Mendor SMART Blood Glucose Meter.
BASIC SETTINGS BASIC SETTINGS Step 3a: Auto Set mode Step 5: Setting the Time Format In Auto set mode, by pressing “Agree” button, the meter sets automatically to the local timezone. This includes daylight saving. The meter provides two options for your convenience. You can choose from “12-Hour” or “24-Hour” option. 12 Hour format is displayed as “HH:MM AM/PM” while 24 Hour format is displayed as “HH:MM”.
BASIC SETTINGS BASIC SETTINGS Setting up the Audio function Setting up the Alarm Step 1: Setting the Sound (Beep) Step 1: Entering the Alarm settings Enter the Sound mode. The meter provides 2 different sound options: On and Off. If the Sound is turned “On” the meter makes the “beep” sound at certain steps when measuring the blood glucose level.
BASIC SETTINGS BASIC SETTINGS Step 4: Checking the Alarm Network In this mode, you can see current alarm setting. Check marks indicates that “This alarm is activated.“ Mendor SMART Blood Glucose Meter provides up to 3 regular alarms. If you set up 3 normal alarms, “+Add” is deactivated (greyed) as shown on the right. Step 1: Enter the Network Settings Enter the Network settings by moving the cursor to “Network” and pressing the “ “ button.
BASIC SETTINGS BASIC SETTINGS Synchronize Security Token Step 1: Synchronizing the meter with Balance Step 1: Retrieving the Security Token When using the meter with Balance, the Synchronize function can be used to upload measurements from the meter’s memory to your Balance account (if you have been using the meter in airplane mode or out of network range), as well as synchronizing alarms and messages when you are doing a glucose profiling program in Balance.
CHECKING THE SYSTEM History Checking with control solution You may check your meter and test strips using Mendor SMART Blood Glucose Meter Control Solution, which contains a known amount of glucose and is used to check that the meter and the test strips are working properly. The test strip vials have Mendor SMART Blood Glucose Meter Control Solution ranges printed on their labels.
CONTROL SOLUTION TESTING CONTROL SOLUTION TESTING Comparing the Control Solution Results Step 4: The test result will appear after the meter counts down from five (5) to one (1) in 5 seconds. You can see the control solution mark “Check” on screen. In this case, the result is stored in the meter memory but not included in the averages. 6.7 mmol/L Step 5 Compare the result with the control solution range printed on the Mendor SMART Blood Glucose Meter Test Strip bag.
TESTING YOUR BLOOD GLUCOSE TESTING YOUR BLOOD GLUCOSE Small children (under the age of 10) and handicapped or invalid persons need to be supervised when they use the equipment. Applying Blood Sample Step 3 Preparing the Meter and Test Strip Step 1 Prepare the usable test strip and lancet. Insert a test strip with contact bars facing up into the strip port. Push the strip gently until the meter beeps. The blood symbol will appear indicating that the meter is ready to test.
TESTING YOUR BLOOD GLUCOSE HIGH AND LOW MESSAGE Step 5 Mendor SMART Blood Glucose Meter displays test results between 1.1 33.3 mmol/L (20 - 600 mg/dL). Please refer to the instructions below, if you receive a High or Low message. The test result (in mmol/L) will appear after the meter counts down from five to one (5-to-1). The result is equivalent to your plasma glucose concentration. 6.2 mmol/L Step 6 After finishing the test, remove the test strip 6.
VIEWING TEST RESULTS IN MENDOR SMART BLOOD GLUCOSE METER’S MEMORY MESSAGES Step 1 Mendor SMART Blood Glucose Meter stores the last 500 glucose test results with time and date. If the memory is full, the oldest test result will be replaced by new test results. Mendor SMART Blood Glucose Meter also calculates averages from last 1/7/14/30/90 days starting from the current time and date shown on the meter. The following gives you instructions to view the test results.
CHARGING MENDOR SMART BLOOD GLUCOSE METER CHARGING MENDOR SMART BLOOD GLUCOSE METER Step 1 Step 2 Connect the end of the micro USB cable to the meter charging port. Then plug the other end of the cable to the USB port on your computer or other powered USB socket. The meter charging port is located on the bottom of the meter. Once the micro USB cable is plugged in, the meter displays USB connection status as below.
CHARGING MENDOR SMART BLOOD GLUCOSE METER ERROR MESSAGES When the meter starts charging, the battery icon and its status will be displayed on the screen as shown on the previous page. If error occurs while using the meter, the error screen is displayed and the meter provides a quick solution for resolving the problem. Caution: • Only use provided Micro USB cable. • Do not charge the meter in high humidity or in a wet area. • Do not use the Micro USB cable if it is damaged, abnormally hot or discolored.
ERROR MESSAGES Error 4 Cause The sample was not large enough or it was too thick. Solution Repeat the test with a new test strip. CARING FOR YOUR SYSTEM Use a soft cloth or tissue to wipe the meter exterior. If necessary, the soft cloth or tissue might be dipped in a small amount of 70% isopropyl alcohol. Do not use organic solvents such as benzene, acetone, or household and industrial cleaners that may cause irreparable damage to the meter.
GENERAL TROUBLE SHOOTING PERFORMANCE CHARACTERISTICS The performance of Mendor SMART Blood Glucose Monitoring System has been evaluated in laboratory and in clinical tests. Problem Troubleshooting The display is blank even after inserting a test strip. Check whether the test strip is inserted with the contact bars facing up. Check if the strip has been inserted completely till the end. The test does not start Check if the confirmation window is filled adequately.
WARRANTY INFORMATION MANUFACTURER INFORMATION Manufacturer’s Warranty Mendor warrants that the meter shall be free of defects in material and workmanship in normal use for a period of two (2) years. The meter must have been subjected to normal use. The warranty does not cover improper handling, tampering use or service of the meter. All claim must be made within the warranty period. Mendor will, at its discretion, repair or replace a defective meter or meter part that is covered by this warranty.
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. FCC Part 15.
