S6 EasySense Disposable CGM System User Guide
©2015, Medtrum Technologies Inc. All rights reserved. 0197 Medtrum Technologies Inc. 7F, Building 8, No. 200, Niudun Road Shanghai 201203, China Tel：+86-‐21-‐50274781 Fax：+86-‐21-‐50274779 www.medtrum.com This p roduct complies with Directive UG883013 EC REP 93/42/EEC (MDD) and Directive 1995/5/EC (R&TTE).
Contents Contents .................................................................... 0 Introduction ............................................................... 0 Before You Begin ................................................... 0 Indications ............................................................ 0 Contraindications .................................................. 1 User Safety ...........................................
Transmitter .......................................................... 17 Insert a New Sensor ............................................. 19 Select an Insertion Site ...................................... 19 Prepare the Insertion Site .................................. 20 Remove the Glucose Sensor from the Package . 21 Remove the Protective Liner from the Sensor Support Mount ...
Event Distribution .............................................. 49 Log Summary ..................................................... 50 Enter the Logs ...................................................... 52 Set Your Reminders .............................................. 59 Customize Your Settings ....................................... 61 CGM System Settings .........................................
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Introduction Before You Begin The S6 EasySense Disposable CGM System is composed of three parts: a Transmitter, a Sensor and Medtrum EasyTouch Mobile App on your smart device. Not all devices or accessories are available in all countries where the CGM system is approved.
Contraindications The S6 EasySense Disposable CGM System is not recommended for people who are unwilling or unable to: Maintain contact with their healthcare provider. Test their blood glucose levels at least twice per day. Recognize and respond to alerts and alarms. (Sufficient vision and/or hearing are required.
performance. If you do not understand something or have questions, ask your healthcare provider, call customer support, or contact your local Medtrum distributor. No modification of this system is allowed.
local waste disposal regulations. Do NOT ignore symptoms of high or low glucose. If you believe your sensor glucose readings are inconsistent with how you feel, manually measure your blood glucose with a blood glucose meter. If the problem continues, discard the old Sensor and insert a new one.
Cleaning Do NOT use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to clean your Transmitter. Small amounts of rubbing alcohol can be used to clean the surface of your Transmitter. Never put your Transmitter in the dishwasher or use very hot water to clean it.
designed to tolerate common electromagnetic and electrostatic fields, including airport security systems and cellular phones. Consumables Glucose Sensor — The Transmitter (MD-‐TY-‐015) is only used with the Medtrum Glucose Sensor (MD-‐JY-‐006). Change your Glucose Sensor every seven days.
Radio Frequency (RF) Communication The S6 EasySense Disposable CGM System complies with Part 15 of the FCC Rules.
• Increase the distance between the S6 EasySense Disposable CGM System and the other device that is emitting/receiving interference. Common consumer electronic devices that transmit in the same frequency band used by the S6 EasySense Disposable CGM System may prevent communication between your Transmitter and smart device.
water at depths greater than 2.5 meters (8 feet) or for more than 1 hour. Check often to make sure the Transmitter and Sensor are securely attached and in place.
Warranty Information Medtrum Technologies Inc. (“Medtrum”) warrants its Transmitter against defects in materials and workmanship for the period of 1 year from the original date of shipment of the Transmitter to the original end use purchaser (the “Warranty Period”).
persons after the date of manufacture; • If damage results from service or repairs performed to any part of the Transmitter by any person or entity other than Medtrum; • If a non-‐Medtrum Glucose Sensor is used with the Transmitter; • If damage results from a Force Majeure or other event beyond the con
MEDTRUM NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT.
Basics of the S6 EasySense System How the S6 EasySense System Works The S6 EasySense Disposable CGM System consists of three parts: a wireless Transmitter, a Glucose Sensor and Medtrum EasyTouch Mobile App on your smart device.
Glucose Sensor (MD-‐JY-‐006) The wireless Transmitter (MD-‐TY-‐015) is a small reusable electronic device that connects to the Sensor and sends your sensor glucose information to your smart device every 2 minutes. The Transmitter contains a built-‐in 3.0 V button cell which can last for 30 days.
Monitor CGM System CAL 90% 2D 22H 40M left 90 NORMAL mg/dL 19:00 Today 24h Medtrum EasyTouch Mobile App Key Features of the S6 EasySense System 7-‐day Sensor The 7-‐day Sensor 14 combines excellent
performance with features designed to provide exceptional comfort and ease of use. The ultra-‐sensitive and flexible Sensor goes just under your skin to read glucose levels. The Transmitter snaps into the Sensor to form a small and discreet patch.
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How to Change the Sensor Remove the Current Sensor and Disconnect the Transmitter Your Sensor gives glucose readings for up to seven days. After your Sensor expires, your Sensor session will be shut off automatically, and glucose readings won’t be displayed on your smart device.
2. Pinch the center of the ribbed release tabs on the sides of the sensor support mount, and gently pull the Transmitter away from the sensor support mount. 3. Discard the sensor support mount and reuse the Transmitter.
use. A Transmitter can be used for up to four sensor sessions. Insert a New Sensor Select an Insertion Site When inserting the senor, choose an area with adequate subcutaneous fat. This area should stay flat during normal daily activities without bending or creasing. The sensor site should be at least 7.
Have a rotation schedule for choosing a new site. Using the same site too often might not allow the skin to heal, and can possibly cause scarring or skin irritation. Select a new insertion site at least 5 cm (2 inches) from the previous site. Prepare the Insertion Site 1.
Warning: If the Sensor dislodges due to the sensor support adhesive failing to adhere to the skin, you may get unreliable or no results. Improper site selection and improper site preparation may cause poor adherence to the skin.
Remove the Protective Liner from the Sensor Support Mount Bend the two-‐piece protective liner slightly so you can see the seam between the two pieces. Remove the liner from the sensor support mount one half at a time, using the white tabs on the backing.
Remove the Safety Lock Hold the Glucose Sensor with one hand. Firmly squeeze the two release tabs of the safety lock with your thumb and index finger of the other hand, as you lift the safety lock away from the inserter. Save the safety lock, you will need it later.
Insert Sensor Hold the inserter as shown and press the two buttons at the same time. You might feel a slight pinch as the Sensor is placed just under your skin.
Remove Inserter Twist the inserter about a 40° turn in the direction shown, and lift the inserter away from the mount. Only the sensor support mount will be left on your body.
Check the Sensor Support Mount Confirm the sensor support mount remains tightly adhered to your skin by sliding your finger along the edges of the adhesive pad and examine for any gaps in adhesion. Warning: If bleeding occurs at the insertion site, do not attach the Transmitter to the Sensor.
waste disposal regulations when discarding the inserter. We recommend discarding the sensor inserter into a sharps container or a puncture-‐proof container with a tight lid. Attach Your Transmitter After the Sensor is inserted, follow these steps to attach your Transmitter: 1.
Tape the Sensor Support Mount (Optional) The sensor support mount should stay on your skin using its own adhesive. But, if you find that the sensor support mount is not adhering well during daily activities, you can use medical tape for extra support.
adhesive patch on all sides for even support. Do NOT tape over the Transmitter or any of the plastic parts of the sensor support mount.
How to Use Medtrum EasyTouch Mobile App Install the App Compatible smart devices: iPhone 4S, iPhone 5, iPhone 5C, iPhone 5S, iPhone 6, iPhone 6 Plus, iPhone 6S, iPhone 6S Plus, iPod touch 5th Gen, iPad 3, iPad 4, iPad Air, iPad Air 2, iPad Mini, iPad Mini 2, iPad Mini 3 Supported operating systems: IO
smart device’s user guide. Medtrum EasyTouch Mobile App cannot override your smart device settings. To receive sensor status and alerts you must: 1. Make sure your smart device’s Bluetooth is available and turned on. 2. Make sure Silent and Do Not Disturb are off. 3.
Login/Register Make sure your smart device is connected to the Internet. Open the Medtrum EasyTouch Mobile App and enter the Login screen. If you have a Medtrum account, login with your account and password. If you don’t have a Medtrum account, tap Register to set your username and password.
Connect Transmitter With App Every time you change to a new Transmitter, you need to add the Transmitter SN to your App. After that your App and Transmitter will connect automatically for each sensor session. Tap at the top-‐left corner of the screen to view the Main Menu.
Settings CGM System Insulin Pump General Account Security About Us Tap CGM System to enter the CGM System settings screen. Turn the CGM feature On.
CGM System CGM System Add Transmitter ALERT SETTINGS GLUCOSE ALERTS High Glucose Low Glucose Glucose Alert Limits 00:15 High Predicted 00:15 Low Predicted Rapid Rise 4.0 mg/dL/min Rapid Fall 4.0 mg/dL/min STATISTICS SETTINGS Glucose Limits for Statistics Time Segments Connect your Transmitter to a Sensor.
to add this Transmitter to your Medtrum account and to start communication between your Transmitter and smart device. You can use your smart device to search for your Transmitter, or you can enter the SN printed on your Transmitter manually.
Calibration Button Transmitter Signal Transmitter Battery Life Monitor CGM System CAL 90% 2D 22H 40M left 90 NORMAL mg/dL Remaining Sensor Life Real-time Sensor Status 19:00 Today 24h Sensor Trend Graph 1. The Calibration Button is explained in the next section Calibrate Your Sensor. 2.
remaining Transmitter battery life. 4. The Remaining Sensor Life shows the operating sensor life left in a total of 7 days. 5. The Real-‐time Sensor Status area shows your current sensor status. l Sensor Warmup After you connect the Transmitter to a new Sensor, it takes 2 hours for the Sensor to warm up.
Sensor Condition Trend Arrow 90 Most Recent Sensor Reading mg/dL NORMAL 19:00 Today Time of the Reading After Sensor warmup is completed, you can calibrate your Sensor and monitor the real-‐time sensor status. The trend arrow shows the speed and direction of your sensor glucose readings.
6. The Sensor Trend Graph shows your glucose level and trend. See Sensor Trend Graph in this chapter for more information.
Calibrate Your Sensor After Sensor warm-‐up, tap CAL on the Monitor screen to enter the Calibration screen. Select Fingerstick and enter the current fingertip blood glucose level, or select Lab Calibration and enter a venous blood glucose level.
CAL Note: The button will disappear under the following circumstances: Smart device Bluetooth off Sensor warmup Sensor error Within 1 hour after the alert Sensor Calibration Error 1 Sensor glucose rises/falls too quickly No Sensor signal Sensor Trend Graph The Sensor Trend Graph on the Monitor screen
Tap the Sensor Trend Graph from the Monitor screen to enter the Sensor screen and view detailed CGM information. You can view the sensor data of 1 day, 7 days, 14 days, 30 days, or 90 days before the end date. The default end date is today. Tap the date to change.
percentage of target SG (target range set by user), the percentage of high SG (above the high limit of SG target range), the percentage of low SG (below the low limit of SG target range) and the percentage of hypoglycemia (below the hypoglycemic threshold).
Understand the Statistics Tap at the top-‐left corner of the screen to view the Main Menu. Tap Statistics on the Main Menu to enter Sensor Overlay screen.
successively. Swipe right to return to the previous screen. Double tap a graph or hold your smart device horizontally to view the graph in full-‐screen mode.
Trend Analysis Here shows the sensor reading histogram within a given number of days before a selected date. The default end date is today. Tap the date to change if needed. You can view the data of 7 days, 14 days, 30 days, or 90 days before the end date.
SG Distribution Here shows the SG distribution within different time segments, each pie chart demonstrating the proportions of low, target and high glucose. Red represents low, green represents target, and yellow represents high. You can set the time range of each segment.
Event Distribution Note: This screen appears only when your smart device is connected to a sensor and a Medtrum insulin pump at the same time.
cause high/low glucose. The default end date is today. Tap the date to change if needed. You can view the data of 7 days, 14 days, 30 days, or 90 days before the end date, or you can change the number of days by selecting More and entering a number.
The table includes the times of BG tests and the mean BG, the times of food intake and the grams of carb, the total amount of insulin injected, and the times and duration of exercise.
Enter the Logs Tap at the top-‐left corner of the screen to view the Main Menu. Tap Logs on the Main Menu to enter the Logs screen. Tap to add new logs. Add Log Screen Select a category in Add Log screen to record data or events. Tap to return to the Log screen. 1.
2. Add Injection The default date and time are the current date and time. Tap the date and time to change if needed. Tap Before Meal or After Meal to select the period. Enter a name for this insulin injection record. Select from Rapid-‐acting, Short-‐acting, Intermediate-‐acting, Long-‐acting, and Pre-‐mixed.
3. Add Carbs The default date and time are the current date and time. Tap the date and time to change if needed. Enter a name for this carbs record. Enter the grams of carbs. Tap Note to add a note if needed.
4. Add Exercise The default date and time are the current date and time. Tap the date and time to change if needed. Enter the type of exercise. Select the intensity and duration of exercise. Enter the calories burned. Tap Note to add a note if needed.
5. Others The default date and time are the current date and time. Tap the date and time to change if needed. Tap Note to add a note about other health information like medication and menstruation.
Logs Screen Here show all the logs before the end date. Tap the end date to change if needed. Tap a log to view its details or to edit.
Edit Log Screen You can tap a log to edit it on the Edit Log screen. After editing, tap Done to save the changes. You can also tap Delete to delete the log.
Set Your Reminders Tap at the top-‐left corner of the screen to view the Main Menu. Tap Reminder on the Main Menu to enter the Reminder screen. Tap at the top-‐right corner to add new reminders. Tap Done to save changes.
needed. Tap Done to save the changes. Reminder Screen 1. Here shows a list of saved reminders, each reminder with an ON/OFF switch. Tap a switch to turn on/off the reminder. 2. To edit a reminder, tap it to enter the Reminder Settings screen. To delete a reminder, swipe left and tap Delete.
Customize Your Settings Tap at the top-‐left corner of the screen to view the Main Menu. Tap Settings on the Main Menu to enter the Settings screen.
CGM System Settings Make sure the CGM feature is turned on. Alert Settings Glucose Alerts: The default setting is off. After you turn it on, you can view the following list of alert settings. CGM System CGM System Add Transmitter ALERT SETTINGS GLUCOSE ALERTS High Glucose Low Glucose Glucose Alert Limits High Predicted 00:15 Low Predicted 00:15 Rapid Rise 4.
1. High/Low: The default setting of High Glucose and Low Glucose are both off. After you turn High Glucose on, you can set up to eight High Limits throughout a day and receive alerts when your glucose is above the set High Limit.
3. Low Predicted: The default setting is off. After you turn it on and set a time period, you can receive alerts when your glucose is predicted to reach the set low limit in the set period of time. 4. Rapid Rise: The default setting is off.
Glucose Limits for Statistics High Limit Low Limit (mmol/L) Before Breakfast After Breakfast Before Lunch After Lunch Before Dinner After Dinner 7.8 4.4 13.3 4.4 7.8 4.4 13.3 4.4 7.8 4.4 13.3 4.4 Time Segments: 1. Meal Start Time Settings: Set the periods within which Breakfast, Lunch, and Dinner starts. Each period cannot exceed 1 hour. 2.
Time Segments MEAL START SETTINGS Breakfast 07:00 to 08:00 Lunch 11:30 to 12:00 Dinner 18:00 to 19:00 The period before meal is fixed to 1h.
miss an alert/alarm. General Language English AUDIO OPTIONS Audio Vibrate Snooze 00:20 UNIT SETTINGS Glucose mg/dL Weight lb Height cm mmol/L kg st feet Remote Viewing Remote View Other Accounts Tap at the top-‐left corner of the screen to view the Main Menu. Tap Remote View on the Main Menu to enter the Account Management screen.
Tap the switch to turn on Remote View. Tap Add account you want to view to enter the Add Account screen. Enter an account name and apply to connect. If permitted by the user, you will have access to their Monitor screen and view their real-‐time sensor status.
Allow Others to Remote View Your Account If your App receives an application from another user for remote viewing your account, you can choose to allow or deny their access. If you want to stop a user’s access to your account, go to Account Security under Settings and tap Remote View Permission.
Remote View Permission Edit Family1 Delete Family 3 70
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Safety System and Alerts To make you aware of a condition that is outside normal CGM system activity or potentially serious condition, your smart device with the Medtrum EasyTouch Mobile App vibrates or emits a tone on an alert and displays a on-‐screen message.
LOST SENSOR TRANSMITTER BATTERY LOW TRANSMITTER ERROR SENSOR ERROR SENSOR CALIBRATION ERROR 0 SENSOR CALIBRATION ERROR 1 Lost sensor. Check communicatio n distance. Transmitter battery low. Transmitter error. Call customer support. Sensor error. Check or change sensor. Sensor calibration error. Enter BG after 15 minutes.
SENSOR FAILURE SENSOR CALIBRATION REMINDER CALIBRATE NOW SENSOR END IN 6 HOURS SENSOR END IN 2 HOURS SENSOR END IN 30 MINUTES SENSOR EXPIRED Sensor failure. Replace sensor now. Calibrate sensor soon. Change Sensor. Calibrate sensor now. Enter a new meter BG for calibration. Change sensor in 6 hours.
RAPID RISE Sensor glucose is rising rapidly. RAPID FALL Sensor glucose is falling rapidly. LOW PREDICTED Sensor glucose approaching Low Limit. 75 Monitor trend and glucose level. Follow instructions from your healthcare professional. Monitor trend and glucose level. Follow instructions from your healthcare professional.
HIGH PREDICTED Sensor glucose approaching High Limit. HIGH GLUCOSE Sensor glucose above High Limit. LOW GLUCOSE Sensor glucose below Low Limit. 76 Check blood glucose and treat as necessary. Continue to monitor blood glucose. Check blood glucose and treat as necessary. Continue to monitor blood glucose.
BELOW mmol/L (BELOW mg/dL) 3.1 56 Sensor glucose below 3.1 mmol/L. Please treat as necessary. (Sensor glucose below 56 mg/dL. Please treat as necessary.) Check blood glucose and treat as necessary. Continue to monitor blood glucose. Note: When Transmitter Error occurs, the indicator light on the Transmitter flashes red.
Manufacturer’s Declaration The S6 EasySense Disposable CGM system (consisting of MD-‐TY-‐015 Transmitter and MD-‐JY-‐006 Glucose Sensor) is intended for use in the electromagnetic environment specified below. The customer or the user of the CGM System should make sure that it is used in such an environment.
Electromagnetic Immunity Immunity Test Electrostatic discharge (ESD) IEC 61000-‐4-‐2 IEC 60601 Test Level ±2.0 kV, ±4.0 kV, ±6.0 kV, ±8.0 kV contact discharge ±2.0 kV, ±4.0 kV, ±8.0 kV, ±15.
Appendix I: Symbols and Icons Product Label Symbols Symbol Meaning LOT Lot number REF Reference number Manufacturer Use by: (yyyy-‐mm-‐dd) 80
Caution: See Instructions for use Storage temperature 2 Do NOT reuse Authorized representative EC REP in the European Community Do NOT use if package is 0197 damaged CE mark by notified body 81
STERILE R IPX8 SN Sterilized using radiation Follow instructions for use Radio communication Waterproof to 2.
Type BF equipment (Protection from electrical shock) 83
Appendix II: Specifications Transmitter Specifications Model: MD-‐TY-‐015 Size: 36.1 mm x 19.4 mm x 12 mm Weight: 4.
Glucose Sensor Specifications Model: MD-‐JY-‐006 Storage Temperature Range: +2°C ~+30°C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa Glucose Range: 2.2~22.
(>=) 75 mg/dL (4.2 mmol/L), or within 20 mg/dL (1.1 mmol/l), 30 mg/dL (1.7 mmol/L) or 40 mg/dL (2.2 mmol/L) of YSI values at glucose values below (<) 75mg/dL (4.2 mmol/L). Table.
Glossary App AUC BG Blood Glucose (BG) Calibration Carb A mobile app is a computer program designed to run on mobile devices such as smartphones and tablet computers. The Medtrum EasyTouch Mobile App is used with the S6 EasySense system for continuous glucose monitoring.
Continuous Glucose Monitoring (CGM) Glucose Limits for Alerts Glucose Limits for Statistics High Limit Hypo Low Limit Note Sensor Glucose or simple carbohydrates, such as sugar. A Sensor is inserted under the skin to check glucose levels in interstitial fluid.
(SG) Sensor Session SG Smart Device Warning and is measured by a glucose sensor. The 7-‐day monitoring period after inserting a new sensor. During this time frame, your glucose is being monitored and reported every two minutes, with data being sent to your display device(s). Abbreviation for sensor glucose.
UG883013 348010 90
