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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 Emissions

Emissions Test

Compliance

RF emissions

EN 60601-‐1-‐2:2007+AC:2010, IEC

60601-‐1-‐2:2007

and

CISPR

11:2009+A1:2010

Group 1

RF emissions

EN 60601-‐1-‐2:2007+AC:2010, IEC

60601-‐1-‐2:2007

and

CISPR

11:2009+A1:2010

Class B

Содержание S6 EasySense

Страница 1: ...S6 EasySense Disposable CGM System User Guide...

Страница 2: ...China Tel 86 21 50274781 Fax 86 21 50274779 www medtrum com Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany 49 40 2513175 REP EC This product complies with Direc...

Страница 3: ......

Страница 4: ...rays MRIs and CT Scans 4 Consumables 5 Radio Frequency RF Communication 5 Water 7 Storage 8 Warranty Information 9 Basics of the S6 EasySense System 12 How the S6 EasySense System Works 12 Key Feature...

Страница 5: ...ty Lock 23 Insert Sensor 24 Remove Inserter 25 Check the Sensor Support Mount 26 Discard the Sensor Inserter Safely 26 Attach Your Transmitter 27 Tape the Sensor Support Mount Optional 28 How to Use M...

Страница 6: ...ewing 67 Remote View Other Accounts 67 Allow Others to Remote View Your Account 69 Safety System and Alerts 72 List of Alerts 72 Manufacturer s Declaration 78 Electromagnetic Emissions 78 Electromagne...

Страница 7: ...3...

Страница 8: ...tives Indications The S6 EasySense Disposable CGM System is indicated for use in persons ages 2 and older with diabetes for continuously recording interstitial fluid glucose levels You can upload the...

Страница 9: ...their blood glucose levels at least twice per day Recognize and respond to alerts and alarms Sufficient vision and or hearing are required User Safety Warnings and Precautions General Make sure that y...

Страница 10: ...thing other than the accessories specified in this User Guide which could permanently damage your system and voids its warranty Do not allow young children to hold the Transmitter or Sensor without ad...

Страница 11: ...ical conditions or medications Please discuss these conditions and medications with your healthcare professional before using the Sensor If you suspect your Sensor is broken during usage do NOT attemp...

Страница 12: ...ryer microwave oven or conventional oven to dry your Transmitter Use a soft towel Do NOT clean any part of the system while it is in use X rays MRIs and CT Scans The S6 EasySense Disposable CGM System...

Страница 13: ...to confirm appropriate operation when used with Glucose Sensors manufactured or distributed by Medtrum We recommend using Medtrum Glucose Sensors as we cannot guarantee appropriate operation if the C...

Страница 14: ...rovide reasonable protection against harmful interference in a residential installation The S6 EasySense Disposable CGM System can generate use and radiate radio frequency energy and may cause harmful...

Страница 15: ...ever does not cause any incorrect data to be sent and does not cause any harm to your device RF communication between your Transmitter and smart device works up to a distance of 10 meters 33 feet Wate...

Страница 16: ...C 86 F the Sensor will require cooled storage at temperatures no lower than 2 C 36 F You may store the Sensor in the refrigerator if it is within this temperature range The Sensor should not be store...

Страница 17: ...either repair or replace with a new or recertified Transmitter at Medtrum s discretion any defective Transmitter subject to the conditions and exclusions stated herein This Warranty applies only to n...

Страница 18: ...e including but not limited to improper storage or physical abuse such as dropping or otherwise This warranty shall be personal to the original end use purchaser Any sale rental or other transfer or u...

Страница 19: ...E FOR ANY INCIDENTAL CONSEQUENTIAL OR SPECIAL DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT ALL OTHER WARRANTIES EXPRESS OR IMPLIED ARE EXCLUDED INCLUDING THE WARRAN...

Страница 20: ...and the glucose reading is updated every 2 minutes You can upload the Sensor data to your smart device after a period of use or you can keep the Sensor connected to your smart device and enjoy real t...

Страница 21: ...very 2 minutes The Transmitter contains a built in 3 0 V button cell which can last for 30 days Medtrum EasyTouch Mobile App downloaded to your smart device works as a receiver It displays all your se...

Страница 22: ...14 Medtrum EasyTouch Mobile App Key Features of the S6 EasySense System 7 day Sensor The 7 day Sensor combines excellent Monitor CGM System NORMAL CAL 90 2D 22H 40M left 90mg dL 19 00 Today 24h...

Страница 23: ...m EasyTouch Mobile App not only will you always know where your glucose level is you ll know which way it is heading how fast it s moving there and as you approach your glucose limits you ll be warned...

Страница 24: ...16...

Страница 25: ...ngs 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 You must remove your Sensor after it...

Страница 26: ...bed 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 Note Do NOT di...

Страница 27: ...site or manual injection site The insulin might affect Sensor performance and you might miss a low or high blood glucose value Avoid inserting the Sensor into areas of skin with scarring tattoos or i...

Страница 28: ...ew insertion site at least 5 cm 2 inches from the previous site Prepare the Insertion Site 1 Wash your hands thoroughly with soap and water and let them dry 2 Wipe the selected insertion area with rub...

Страница 29: ...ng off the paper on the back of the package Warning Do NOT use a Sensor if its sterile package has been damaged or opened or the Sensor has expired or the Sensor is damaged in any way Note Wash your h...

Страница 30: ...er from the sensor support mount one half at a time using the white tabs on the backing Hold the Sensor by the inserter and try not to touch the adhesive surface Locate the Sensor Support Mount If you...

Страница 31: ...he 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 sa...

Страница 32: ...24 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...

Страница 33: ...25 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...

Страница 34: ...gauze or clean cloth for up to 3 minutes If bleeding stops attach the Transmitter to the Sensor If bleeding does not stop remove the Sensor treat the site as necessary and insert a new Sensor at a dif...

Страница 35: ...m of the Transmitter with an alcohol wipe and let it dry before every use 2 Snap the Transmitter into the sensor support mount until the two flexible arms fit into the notches on the Transmitter The i...

Страница 36: ...ional 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 e...

Страница 37: ...29 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...

Страница 38: ...ad 3 iPad 4 iPad Air iPad Air 2 iPad Mini iPad Mini 2 iPad Mini 3 Supported operating systems IOS 7 0 and above The smart device you install the App on and the charger for that smart device must compl...

Страница 39: ...rts and reminders 4 Make sure the notifications for the Medtrum EasyTouch Mobile App are turned on in the setting s menu of your smart device 5 Make sure the Medtrum EasyTouch Mobile App is open and r...

Страница 40: ...he 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...

Страница 41: ...ansmitter 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 Mai...

Страница 42: ...34 Tap CGM System to enter the CGM System settings screen Turn the CGM feature On Settings CGM System Insulin Pump General Account Security About Us...

Страница 43: ...smart device is connected to the Internet Tap Add Transmitter CGM System CGM System Add Transmitter GLUCOSE ALERTS High Glucose Low Glucose Glucose Alert Limits 00 15 00 15 Glucose Limits for Statisti...

Страница 44: ...smitter or you can enter the SN printed on your Transmitter manually Monitor Sensor Status Once your Transmitter is connected with the App you can use the App to monitor your real time sensor status T...

Страница 45: ...he Bluetooth signal strength between the Transmitter and your smart device 3 The Transmitter Battery Life icon shows the Monitor CGM System NORMAL CAL 90 2D 22H 40M left 90mg dL 19 00 Today 24h Calibr...

Страница 46: ...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...

Страница 47: ...calibrate your Sensor and monitor the real time sensor status The trend arrow shows the speed and direction of your sensor glucose readings NORMAL 90mg dL 19 00 Today Trend Arrow Most Recent Sensor R...

Страница 48: ...40 6 The Sensor Trend Graph shows your glucose level and trend See Sensor Trend Graph in this chapter for more information...

Страница 49: ...e level or select Lab Calibration and enter a venous blood glucose level The blood sampling time must be 8 minutes to 2 hours before the current time After the initial calibration your sensor data wil...

Страница 50: ...nsor 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 shows the gl...

Страница 51: ...date is today Tap the date to change Touch and hold in the graph area to generate a cursor Move the cursor along x axis to view the sensor glucose SG and event at different time points The cursor wil...

Страница 52: ...t range the percentage of low SG below the low limit of SG target range and the percentage of hypoglycemia below the hypoglycemic threshold The Deviation includes the area under the curve AUC above th...

Страница 53: ...tics 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 Swipe left to go to Trend Analysis SG Distribution Event Distribution...

Страница 54: ...n SG maximum SG minimum SG and times of hypo All daily SG curves are displayed in an overlap graph so that you can easily see the SG level change in a given period The default end date is today Tap th...

Страница 55: ...ws 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 9...

Страница 56: ...represents target and yellow represents high You can set the time range of each segment Select any pie chart and a corresponding histogram will be displayed below The default end date is today Tap th...

Страница 57: ...49 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 Here shows the distribution of events that can...

Страница 58: ...d entering a number Log Summary Here shows the log summary in a given period Event Distribution 14 D 30 D 90 D More 7 D Mon 24 08 15 HIGH GLUCOSE 1 2 3 4 5 of high percentage 1 10 2 20 3 30 4 40 Basal...

Страница 59: ...f carb the total amount of insulin injected and the times and duration of exercise 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 b...

Страница 60: ...g screen to record data or events Tap to return to the Log screen 1 Add BG 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 Me...

Страница 61: ...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 Enter t...

Страница 62: ...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 nee...

Страница 63: ...efault 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...

Страница 64: ...56 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...

Страница 65: ...57 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...

Страница 66: ...58 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...

Страница 67: ...nder on the Main Menu to enter the Reminder screen Tap at the top right corner to add new reminders Tap Done to save changes Reminder Settings Screen You can enter the title of reminder select the rem...

Страница 68: ...minder 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 d...

Страница 69: ...omize 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 Settings CGM System Insulin Pump General Account Security...

Страница 70: ...turn it on you can view the following list of alert settings CGM System CGM System Add Transmitter GLUCOSE ALERTS High Glucose Low Glucose Glucose Alert Limits 00 15 00 15 Glucose Limits for Statistic...

Страница 71: ...up to eight Low Limits throughout a day and receive alerts when your glucose is below the set Low Limit The High and Low Limits are also used in statistics 2 High Predicted The default setting is off...

Страница 72: ...ising faster than the set rate limit 5 Rapid Fall The default setting is off After you turn it on and set a fall rate limit you can receive alerts when your glucose is falling faster than the set rate...

Страница 73: ...cannot exceed 1 hour 2 After Meal Settings Set the after meal segments 3 Night Settings Set the start and end time of night Glucose Limits for Statistics High Limit Low Limit Before Breakfast 7 8 4 4...

Страница 74: ...e Note We recommend that you turn Audio and Vibrate on If you turn them both off you might Time Segments Breakfast 07 00 08 00 Lunch 11 30 12 00 Dinner 18 00 19 00 MEAL START SETTINGS The period befor...

Страница 75: ...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 General Language Audio Vibrate Snooze 00 20 English AUDIO OPTIONS...

Страница 76: ...unt 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 Account Management Remote View Add account you want to view P...

Страница 77: ...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 Swipe left on the sel...

Страница 78: ...70 Remote View Permission Family1 Family 3 Edit Delete...

Страница 79: ...71...

Страница 80: ...foreground an alert message appears with a prompt if the App is running in the background an alert message appears as a notification In the former case when there are multiple messages you need to ac...

Страница 81: ...r soon TRANSMITTER ERROR Transmitter error Call customer support Call customer support SENSOR ERROR Sensor error Check or change sensor Check or change sensor SENSOR CALIBRATION ERROR 0 Sensor calibra...

Страница 82: ...ew meter BG for calibration SENSOR END IN 6 HOURS Sensor will expire in 6 hours Change sensor soon Change sensor in 6 hours SENSOR END IN 2 HOURS Sensor will expire in 2 hours Change sensor soon Chang...

Страница 83: ...ons from your healthcare professional RAPID FALL Sensor glucose is falling rapidly Monitor trend and glucose level Follow instructions from your healthcare professional LOW PREDICTED Sensor glucose ap...

Страница 84: ...s necessary Continue to monitor blood glucose HIGH GLUCOSE Sensor glucose above High Limit Check blood glucose and treat as necessary Continue to monitor blood glucose LOW GLUCOSE Sensor glucose below...

Страница 85: ...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 o...

Страница 86: ...agnetic environment specified below The customer or the user of the CGM System should make sure that it is used in such an environment Electromagnetic Emissions Emissions Test Compliance RF emissions...

Страница 87: ...ESD IEC 61000 4 2 2 0 kV 4 0 kV 6 0 kV 8 0 kV contact discharge 2 0 kV 4 0 kV 8 0 kV 15 0 kV air discharge 2 0 kV 4 0 kV 6 0 kV 8 0 kV 56 RH 2 0 kV 4 0 kV 8 0 kV 15 0 kV air 56 RH RF electromagnetic f...

Страница 88: ...80 Appendix I Symbols and Icons Product Label Symbols Symbol Meaning Lot number Reference number Manufacturer Use by yyyy mm dd LOT REF...

Страница 89: ...81 Caution See Instructions for use Storage temperature Do NOT reuse Authorized representative in the European Community Do NOT use if package is damaged CE mark by notified body 2 REP EC 0197...

Страница 90: ...82 Sterilized using radiation Follow instructions for use Radio communication Waterproof to 2 5 m for 1 hour Device serial number Waste Electrical and Electronic Equipment STERILE R IPX8 SN...

Страница 91: ...83 Type BF equipment Protection from electrical shock...

Страница 92: ...ressure 700 1060 hPa Storage Temperature Range 10 C 55 C Storage Relative Humidity Range 20 90 RH Storage Atmospheric Pressure 700 1060 hPa Battery Built in 3 0 V button cell battery Waterproof Rating...

Страница 93: ...7 days CGM System Accuracy A multi center randomized clinic study is designed to determine the sensor accuracy in persons with Type 1 or Type 2 diabetes In clinic testing consisted of frequent venous...

Страница 94: ...or 40 mg dL 2 2 mmol L of YSI values at glucose values below 75mg dL 4 2 mmol L Table Percentage of CGM Glucose Readings within 20 20 30 30 or 40 40 of the YSI Calibrating every 12 hours Abdomen inser...

Страница 95: ...em for continuous glucose monitoring AUC The area under the curve mathematically known as definite integral in a plot of glucose level against time BG Abbreviation for blood glucose See Blood Glucose...

Страница 96: ...r glucose condition Glucose Limits for Statistics The values you set to distinguish High Low and Target glucose range in the statistics graphs High Limit The value you set to determine when the system...

Страница 97: ...th data being sent to your display device s SG Abbreviation for sensor glucose See Sensor Glucose SG Smart Device A smart device is an electronic device that is cordless unless charging mobile easily...

Страница 98: ...90 UG883013 348010...

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