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1 | User Manual Part 1 | Users Manual | 5.81 MiB | September 27 2023 / March 25 2024 | delayed release |
User manual Continuous glucose monitoring system 15-Day One-Touch Slim i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea 2023 i-SENS, Inc. All rights reserved. PCGAA-000038 REV A 2023-08 This manual is intended to help you use CareSens Air correctly. Please read this manual carefully before using the product, and follow all instructions. i-SENS, Inc. has carefully prepared the information in this manual to be as accurate as possible. However, i-SENS is not responsible for any errors or omissions contained in the manual. i-SENS may change the product described in this manual or any related software applications without notice in order to enhance the product reliability, features, or design. This document is protected by copyright. It is strictly prohibited to copy or alter this manual without prior consent from i-SENS. Note Make sure to read the user manual before use to ensure correct usage. Failure to use CareSens Air according to the instructions, warnings, and cautions provided may lead to failure to detect severe hypoglycemia or hyperglycemia, or incorrect treatment decisions. 3 Contents Before use ......................................................................................8 Document conventions ..................................................................9 Safety information ........................................................................11 Risks and benefits ........................................................................15 1 Understanding CareSens Air .............................................17 Intended purpose ........................................................................17 Significance of use .......................................................................17 Operating mechanism ..................................................................18 1.1 Product components .................................................................19 Applicator ......................................................................................20 Sensor ...........................................................................................20 Smart device .................................................................................21 1.2 Conditions for use ......................................................................22 Expiration date ..............................................................................22 Conditions for use and storage ...................................................22 Installing the CareSens Air app .........................................23 Recommended smart device specifications ...............................23 Installing the app on an Android smart device ......................24 Installing the app on an iOS smart device ..............................24 3 Using the app .......................................................................25 3.1 Logging in ....................................................................................26 For first-time users .......................................................................26 Previously registered users ..........................................................31 Reset password ............................................................................32 3.2 Connecting to a sensor .............................................................35 2.1 2.2 2 4 Contents Connecting the sensor to Android apps .....................................36 Connecting the sensor to iOS apps ............................................41 Attaching the sensor ....................................................................45 Configuring your alert settings after connecting to the sensor ..49 If the sensor fails to connect ........................................................52 If the connection between the sensor and the smart device is interrupted ....................................................................................52 Disconnecting and removing the sensor .....................................53 3.3 Understanding the home screen .............................................55 Basic information ..........................................................................56 Menu bar .......................................................................................57 Glucose data ................................................................................59 Trend arrows .................................................................................62 Interpreting trends in glucose data ..............................................63 Viewing previous data .................................................................65 Notification history ........................................................................66 3.4 Exploring the app features ........................................................67 Running the widget .....................................................................68 Entering a calibration value ..........................................................69 Editing and checking your profile ................................................70 Viewing the log book ....................................................................72 Recording an event ......................................................................73 Changing your settings ................................................................74 Setting app lockout ......................................................................77 Connecting with a glucose meter ................................................78 Uploading data .............................................................................81 Updating the app .........................................................................82 See how to use .............................................................................83 See Help .......................................................................................84 Making an inquiry .........................................................................85 3.5 Logging out .................................................................................88 5 Contents 4 Calibration ............................................................................89 How to calibrate a sensor ............................................................89 When to calibrate a sensor ..........................................................89 4.1 Measuring a calibration value ..................................................90 4.2 Entering a calibration value ......................................................91 After completing sensor warmup ................................................91 Setting and receiving calibration alerts ........................................92 5 Using events .........................................................................93 5.1 Checking your event information .............................................93 Viewing the log book ....................................................................93 Viewing events on your glucose trends .......................................95 5.2 Recording an event ....................................................................96 5.3 Changing an event .....................................................................99 Editing an event ............................................................................99 Deleting an event ........................................................................101 6 Using alerts ........................................................................102 6.1 Changing your smart device settings ...................................102 6.2 Initial app alert settings ...........................................................103 6.3 Checking your alerts ................................................................106 Signal loss alert ..........................................................................107 Glucose alert Level .....................................................................108 Rapidly changing glucose level alert .........................................109 Calibration alert ...........................................................................110 Low battery alert .........................................................................111 Sensor replacement alert ...........................................................112 Sensor error ................................................................................113 Follower addition notification .....................................................114 6.4 Changing alert settings ...........................................................115 6 Contents 7 Sharing your blood glucose information ........................117 7.1 Adding followers .......................................................................117 7.2 Changing sharing options .......................................................119 7.3 Removing followers .................................................................121 8 Maintenance .......................................................................122 8.1 Taking care of the sensor during use ....................................123 8.2 Storing a sensor .......................................................................123 8.3 Disposing of this product ........................................................123 9 Warranty ..............................................................................124 Warranty period ..........................................................................124 Warranty exclusions ...................................................................124 Warranty obligations...................................................................125 Appendix A Frequently Asked Questions ..............................126 Appendix B Technical information ..........................................129 B.1 Device features and characteristics ......................................129 Electromagneticcompatibility ...................................................129 Safety ..........................................................................................131 Radio regulation compliance .....................................................132 B.2 Product specifications .............................................................134 Sensor specifications .................................................................134 Performance in terms of accuracy (based on YSI): ..................136 B.3 Cybersecurity ............................................................................137 Appendix C Glossary ................................................................138 7 Before use CareSens Air is intended for people aged 18 years or older who are diabetic or need glucose level management. It continuously monitors glucose concentration in intracellular fluid in real-time. Continuous glucose monitoring calculates the concentration of glucose in the blood by measuring the concentration of glucose in the interstitial fluid. However, when the concentration of glucose in the blood changes, the concentration of glucose in the interstitial fluid changes about 5 to 15minutes later. This product only makes use of personal information which the user has agreed to allow to be collected. Contact the manufacturer or visit the website for details of this product. Note was issued. All standards and regulations mentioned are in effect as of the date this manual Some features described in this manual may not be available in some countries. Please consult the local representative for region-specific information. The screenshots and illustrations in this manual are provided for explanatory purposes. They may differ from the actual appearance. 8 Before use Document conventions Notational conventions This manual uses the following notational conventions to aid in understanding its content. Notational conventions Boldface
'Cross-
references'
Visual aids Tables Description Boldface is used to display elements of the graphic user interface, including menus and directories. Single quotation marks are used to indicate pages, portals, and screens from the graphical user interface.
'Cross references' are used to refer to different sections of this document. Visual aids in the form of graphics, illustrations, or screen captures are used to help the reader understand the text. Tables are used to present large amounts of data in an easy-to-read format. Supplementary descriptions and explanations You can refer to these for information about exceptions and limitations. Note This indicates reference situations to note which can provide helpful information or help you avoid danger when using the product. Precautions This manual uses the following types of safety messages to alert the user of situations in which they need to take precautions when using the product:
Warning This marks a potential danger that could result in serious injury or death if not avoided. Caution This marks a situation that could result in minor injury or property damage if not avoided. 9 Definitions of symbols The following table lists graphicalsymbols for electrical equipmentinmedicalpractice set by the IEC(International Electrotechnical Commission). These symbols not only provide additional information on the product and product use, but also on safety. Before use Symbol Description CE Mark Authorized representative in the European Community/European Union Medical device Caution Do not reuse Please refer to the user manual Type BF Applied Part Keep away from sunlight Keep dry Do not discard this product with other household-type waste Temperature limit Humidity limitation Atmospheric pressure limitation Do not use if package is damaged and consult instructions for use Degree of protection against ingress of foreign material or water Sterilized using ethylene oxide Single sterile barrier system with protective packaging outside Manufacturer Batch code Serial number Use-by date date 10 Before use Safety information You must read, understand, and strictly comply with the indications, warnings, and precautions listed in this chapter before using CareSens Air. Contraindications Remove the sensor before an MRI, CT scan, radiofrequency ablation, high-
frequency electrical heat, or high intensity focused ultrasound. Magnetic fields or heat can damage the device, leading to inaccurate glucose level readings or alert errors. This product should not be used by those who are pregnant, nursing, on dialysis, critically ill or under the age of 18. Warnings Severe hypoglycemia or shock may result in abnormal measurements. Do not use this product for patients with severe symptoms, as ketoacidosis or a hyperosmolar hyperglycemic nonketotic state may result in abnormally low measurements. If you use an insulin pump, attach the sensor at least 8 cm away from it. If a sensor sensing part breaks or disconnects in the process of attaching the sensor, you must check whether the sensing part has remained under the skin. If you cannot see the sensing part with the naked eye, seek medical help. If you experience inflammation, redness, swelling, or pain due to an infection at the site where the sensor was attached, seek assistance from a medical professional. If you experience bruising or severe bleeding at the location where the sensor has been attached, stop use and remove the sensor, then consult immediately with a physician or medical professional. In the event of slight bleeding when attaching the sensor, an improperly attached sensor, or abnormal measurements, you must remove the sensor and attach it to a different part of the body. The adhesive tape used to secure the sensor to the skin and the guide needles used to help with sensor insertion may trigger allergic reactions (erythema or edema) or itchiness in some users. If this occurs, remove the adhesive tape and/or sensor immediately and consult a physician or medical professional. Swallowing the sensor could result in choking. Please supervise the children so that they do not touch the sensor. CareSens Air app data may be lost if it is not uploaded to the cloud server. If you delete the smart device app while using the sensor, all the data saved by the app will be lost. If you need to delete the app or switch to a different smart device, upload all important data to the cloud server and save a backup file on a separate storage device. 11 Before use Warnings Wash your hands thoroughly with soap and running water and dry them before attaching the sensor. Wipe the area where the sensor will be attached to the skin with an alcohol swab and dry it completely. Failure to comply may lead to infection. Blood glucose readings obtained using CareSens Air cannot substitute for the care of a medical professional and cannot be used to diagnose diabetes. They are only intended to provide glucose data to patients in order to help them manage their diabetes, and to assist medical professionals with diagnosis and treatment. The user should not make treatment decisions on their own based on the glucose data obtained with this product. Make treatment decisions after consulting with a medical professional. Do not use the product if the sensor package has been damaged or opened. This may lead to infection. Keep the desiccant included in the package out of the reach of infants or children. Do not eat the desiccant included in the package. If the contents of the desiccant get in your eyes, wash them thoroughly with running water right away. You should consult a physician if you experience any problems. Choose a new location to attach each new sensor. Continuing to attach new sensors to a previously used location may cause skin irritation or scarring. The location chosen for insertion must meet the following criteria:
- It must be at least 8 cm away from an insulin pump infusion set or infusion location.
- It must not be close to the waistband, tattoos, bone, scars, or irritated skin.
- It must be a location which will not be bumped, pushed, or pressed during sleep. After you separate the safety cap from the applicator, be careful not to print it Do not press the release button on the applicator until you are ready to attach the toward any person. sensor. Do not calibrate if your blood glucose level is changing rapidly (by 2 mg/dL (0.1 mmol/L) or more per minute). This may affect the accuracy of the sensor. Do not use a damaged or defective sensor. This may lead to infection. The sensor must be used according to the guidelines in the user manual and must be attached to the part of the body as indicated in the user manual. Attach the sensor to the back of your upper arm. There is insufficient evidence that the sensor operates correctly when attached to another part of the body. The sensor should be attached immediately after opening the applicator package to avoid airborne contamination. Calibration must be conducted immediately upon the occurrence of the calibration alert. Otherwise, the accuracy of readings may decrease. 12 Before use Warnings Do not use a measurement taken from any part of the body (palm, forearm, etc.) other than your fingertip for calibration. The result may be different from one taken by pricking a finger, and this can affect the accuracy of the sensor glucose readings. If the result of the finger prick reading is lower than 10 mg/dL (0.6 mmol/L) or higher than 600mg/dL (33.3 mmol/L), it cannot be used as a calibration value. If a blood glucose level alert occurs, check your glucose level using a glucose meter. If the result is the same, consult with a physician or medical professional. Do not remove the safety cap of the applicator until you are ready to attach the sensor. Failure to comply may lead to infection caused by exposure to bacteria. 13 Before use Precautions The applicator and the sensor are intended for single-use only and cannot be reused. If a skin care product such as sunscreen or insect repellent gets on the sensor, wipe it immediately with a clean cloth. These products may affect the operation of CareSens Air. The dedicated sensor, applicator, and user app must be used together to obtain accurate measurements. of 530 C. Do not store the sensor in a freezer. It is recommended to store it at a temperature The sensor has been sterilized with EO after packaging. Do not clean the product with water or any other solution before use. Do not use an expired sensor. Do not repair this product without the authorization of the manufacturer. Do not repair, disassemble, and assemble the product on your own. Do not use a damaged device. The product may not function normally. Do not disinfect the product. CareSens Air has already been sterilized. Failure to follow this instruction may affect product performance. This product is composed of highly sensitive electronic components and thus can be easily damaged by improper use. User precautions must be taken when using the device to avoid damage. The product is waterproof for up to 24 hours at a depth of 1 meter. Please do not submerge the product deeper than 1 m or longer than 24 hours. You can go through Advanced Imaging Technology (AIT) body scanners or metal detectors while wearing the CareSense Air. If you cannot temporarily use your smart device in the security checkpoint area, please measure and manage your blood glucose levels using a blood glucose meter. Please check the latest status of security checkpoints at the airport prior to travel. Do not expose the product to direct sunlight. This may affect product life and performance. Do not wash the sensor. Using an unsuitable solution could damage the device. When using iOS, never close the app after connecting the sensor. It will be disconnected from the sensor. 14 Before use Risks and benefits Risks The Risks of Using CareSens Air are:
Missing your alerts Adhesion reactions Retained sensing part Missing your alerts In order not to miss the alerts from the CareSens Air, your smart device must follow the settings recommended by i-SENS. For detailed information, please refer to settings >
tutorials > using alerts > changing your smart device settings in the CareSens Air app. See the recommended smart device specifications, using alerts, and frequently asked questions in the user manual for more information. Adhesion reactions The skin adhesive tapes and sensor tapes used in the CareSens Air have passed the biological stability test. Adhesion reactions are mild or do not occur at all in most cases. Some people who took part in the clinical study experienced some redness and swelling and did not pose a major medical risk. Retained sensing part The sensing part of the CareSens Air sensor is unlikely to break or disconnect to remain under the skin as it never did in clinical trials. Sterilized sensing parts that are left under the skin do not usually pose a significant medical risk. If the sensing part breaks or disconnects and remains under the skin, showing signs of infection or inflammation, please contact your healthcare provider or the nearest authorized distributor. 15 Before use Benefits Benefits of Using Your CareSens Air are:
Preventing hyperglycemia and hypoglycemia with high and low glucose level alerts Tracking glucose trends and patterns for better diabetes management Tracking trends and patterns CareSens Air helps to detect hyperglycemia and hypoglycemia by providing continuous blood glucose information, manage changes in blood glucose levels through analyzing trends and patterns, encourage you to make better decisions on food and exercise habits, and assist in diagnosis and treatment when consulting with medical staff. Keeping informed If you have diabetes, it is extremely important to manage your glucose levels in real time. The CareSens Air uses alerts to notify you when your glucose level is too high or too low, or rapidly changing. With the alerts, you can better manage your diabetes. 16 1 Understanding CareSens Air Intended purpose The CareSens Air Continuous Glucose Monitoring System (CGMS) is indicated for continuous monitoring of blood glucose levels via measurement of glucose in the interstitial fluid in patients with diabetes mellitus aged 18 years and older. CareSens Air CGMS is indicated for use as an adjunctive device to complement blood glucose information obtained from standard home glucose monitoring devices and does not replace it. CareSens Air CGMS helps to detect trends such as hyperglycemia and hypoglycemia by providing continuous blood glucose information, to manage changes in blood glucose levels through trend detection and pattern tracking, and to assist in diagnosis and treatment when consulting with medical staff. CareSens Air CGMS results should not be used to diagnose diabetes nor provide any medical decisions. CareSens Air CGMS is intended for use by patients at home and in healthcare facilities. Warning Glucose readings obtained from CareSens Air cannot substitute for professional medical care. They are only intended to provide the patient with data on glucose level changes in order to help with diagnosis and treatment through consultation with a medical professional. Significance of use Conventional glucose meters measure blood glucose levels at specific times, and do not show how the level is changing or give an overview of glucose level changes over time. However, CareSens Air helps manage diabetes by continuously measuring glucose levels in intracellular fluids and providing the user with data on trends in glucose level changes. Continuous glucose monitoring calculates the concentration of glucose in the blood by measuring the concentration of glucose in the interstitial fluid. However, when the concentration of glucose in the blood changes, the concentration of glucose in the interstitial fluid changes about 5 to 15 minutes later. 17 Operating mechanism Understanding CareSens Air Sensor User app The user attaches the sensor to their body by pressing the Release button of the applicator. The sensor attached to the rear of your upper arm measures glucose levels in intracellular fluid and sends the measurements to a smart device. All the data on your smart device can be backed up on a cloud server to prevent loss of data. Healthcare professionals can refer to the blood glucose values and trends taken by the CareSens Air sensor to help with diabetes management. The user can monitor the blood glucose level data received from the sensor in the CareSens Air app on a smart device. You can also use the app to record information on life events and to input calibration values taken with a glucose meter, which can lead to more effective diabetes management. 18 Understanding CareSens Air 1.1 Product components CareSens Air is only designed for single-use. Once it has been attached, a sensor cannot be re-used. The contents of the package are as follows. Make sure that all of the contents are present before opening the package. Warning may lead to infection. Do not use the product if the sensor package has been damaged or opened. This Keep the desiccant included in the package out of the reach of infants or children. Do not eat the desiccant included in the package. If the contents of the desiccant get in your eyes, wash them thoroughly with running water right away. You should consult a physician if you experience any problems. User manual Continuous glucose monitoring system 15-Day One-Touch Slim Applicator Quick Reference Guide User manual Note The sensor is inside the applicator. 19 Understanding CareSens Air Applicator The applicator is used to protect the sensor and attach the sensor to the skin. Note The applicator is intended for single-use only and cannot be re-used. Do not press the Release button until you have removed the safety cap of the applicator and are ready to attach the sensor. Release button Safety cap The following names are used for the parts of the applicator:
Name Safety cap Release button Function This prevents the sensor from being released unintentionally. When this button is pressed, the sensor is released and attaches to the user's body. Sensor The sensor measures glucose levels and sends the readings to a smart device. Note to 24 hours. The sensor is water resistant. It can be submerged in up to 1 meter of water for up Solid foreign substances measuring 1.0 mm or larger cannot enter the sensor. The smart device and the sensor must be kept within 6 meters of each other. The transfer range of the sensor decreases when it comes into contact with water. The battery of the sensor has a life of 15 days. An alert will occur when the battery begins to run out. 20 Understanding CareSens Air Power button Sensing part Transmitting part Skin adhesive tape The table below shows the names and functions of the sensor's various parts. Name Power button Transmitting part Function Turns on power to the sensor. It has a built-in battery and transmits the glucose concentration value measured through the sensing part to the user app. Attaches the sensor to the user's skin. Measures the user's glucose levels. Skin adhesive tape Sensing part Smart device You can use the CareSens Air application to monitor your glucose levels. Note Scan the barcode on the sensor package label to connect the sensor to your smart device. For more information, please refer to 'Connecting the sensor to Android apps' or 'Connecting the sensor to iOS apps'. 21 Understanding CareSens Air 1.2 Conditions for use Expiration date The sensor's product shelf life is 12 months after its date of manufacture. The expiration date is indicated on the sensor package label. Check the sensor expiration date before using the product. The sensor can be used for 15 days, and it cannot be re-used. The sensor must be disposed of once it is expired. Different countries may have different regulations on how to dispose of a medical device that has been in contact with bodily fluids. Follow your country's regulations for disposing of medical waste. Refer to '7.3 Disposing of this product' for more information on sensor disposal. Caution Do not use an expired sensor. Conditions for use and storage The following table explains the necessary environmental conditions for storing, transporting, and using CareSens Air. Category Temperature Humidity Altitude Pressure While in use 10 C 42 C 10 %-95 %
-382 m 3,011 m 700 hPa-1,060 hPa While storing or transporting 5 C 30 C 15 %-85 %
-382 m 3,011 m 700 hPa-1,060 hPa 22 2 Installing the CareSens Air app You can use the CareSens Air app to monitor glucose readings from the sensor in real time. The following smart device specifications are required to install the app. Recommended smart device specifications Your smart device must meet the following specifications for you to be able to install the app. The following smart device operating systems have been verified as compatible with the CareSens Air app by their manufacturers. Note Make sure that you connect your sensor to a smart device that meets the recommended requirements. Smart devices with operating systems which have not been verified as compatible by the manufacturer are not guaranteed to operate normally. You must check the OS version of your smart device before installing the app. The app may not function properly if you update the OS of your smart device after installing the app. You can set the date and time automatically from the Settings menu of your smart device. If the date and time are not set automatically, you must set them manually if you travel to a different time zone. Operating System Android iOS VERSION Android 7.0 or higher iOS 13.2 or higher Manufacturer Samsung, Google Apple 23 Installing the CareSens Air app 2.1 Installing the app on an Android smart device 1 Tap to launch the Play Store app on your Android smart device. 2 Type "CareSens Air" into the search bar of the Play Store, then tap 3 Select the CareSens Air app from the list of apps and tap Install. 4 Wait for installation to be completed, then tap Open. The CareSens Air app will 2.2 Installing the app on an iOS launch. smart device Note to launch the App Store on your iOS smart device. Do not install the app on an iOS smart device that has been jailbroken or an Android smart device that has been rooted. The app may not function properly. 1 Tap 2 In the App Store, tap 3 Select the CareSens Air app from the list of apps and tap Install. 4 Enter your Apple ID and password. 5 Wait for installation to be completed, then tap Open. The CareSens Air app will and enter "CareSens Air" into the search bar. launch. 24 3 Using the app The CareSens Air app allows users to monitor the glucose readings taken by the sensor on their smart devices. You must be registered in order to log in to the CareSens app. Any data stored in the CareSens Air app can be uploaded to the cloud server and stored in encrypted form. In the event that your data is lost, it can be retrieved from the backup data stored on the cloud server. The glucose change arrows, glucose trends, events, and calibration values available on the app allow you to manage your diabetes more effectively. This section will help you to:
1. Register for and log in to the app 2. Connect the app with the sensor to allow stable operation 3. Use the app to configure your glucose monitoring environment 4. Learn to interpret your glucose levels and the glucose trends shown in the app 5. Learn about and use the features provided by the app Caution If you delete the smart device app while using the sensor, all the data saved by the app will be lost. If you need to delete the app or switch to a different smart device, upload all important data to the cloud server and save a backup file on a separate storage device. 25 3.1 Logging in Using the app To use the CareSens Air app, you need to register an account and log in to it. When registering an account you will enter your user information, and then your email address will be verified. The app only provides data on the user currently logged in. Note iOS: Storage, Phone, Alerting, Camera The CareSens app requires permission to use the following features of your smart device:
Android: Location, Storage, Phone, Alerting, Camera For first-time users If you sign up for an integrated i-SENS account, you can use all i-SENS apps with one account. Follow the steps below to sign up for an integrated i-SENS account. 1 Run the CareSens Air user app on your smart device. 2 Tap Log In on the start screen. 26 Using the app 3 Move to the integrated i-SENS login screen. Tap Create an account. 4 Tap Sign up by E-mail. 27 5 Select your country of residence and language, then tap Confirm. Using the app 6 Enter the email you want to sign up with and tap Send verification code. A verification code will be sent to the email address you provided. 28 Using the app 7 Enter the six-digit code from the verification email and tap Verify. Note You should enter the code within 5 minutes after the email has been sent. Tap Resend the verification code to issue a new code if you fail to enter the code within the time limit. You cannot create an account without completing the verification. 8 After accepting the required terms and conditions, tap Confirm. 29 9 Enter the user information and tap Confirm. Using the app 10 On the integrated i-SENS login screen, enter your email address and password, then tap Log In. 30 Using the app Previously registered users If you are already a registered user, take the following steps to log in to the CareSens Air user app. 1 Find the CareSens Air user app on your smart device and tap 2 Tap Log In on the start screen. 3 On the integrated i-SENS login screen, enter your email address and password, then 4 If you enter a correct email address and password, you will be logged in as a tap Log In. registered user. 31 Using the app Reset password Take the following steps if you have forgotten your integrated i-SENS login password. 1 Find the CareSens Air user app on your smart device and tap 2 Tap Log In on the start screen. 3 Move to the integrated i-SENS login screen. Tap Forgot your password?
32 Using the app 4 Enter your email address on the 'Forgot your password?' screen and tap Send verification code. The verification code is sent to the user's email address. and tap Verify. 5 Enter the six-digit code from the verification email You should enter the code within 5 minutes after the email has been sent. Tap Resend the verification code to issue a new code if you fail to enter the code within the time limit. You cannot reset your password without completing the verification. 33 6 Enter your new password and confirmation password, then tap Confirm. Your password has been reset. Using the app 34 Using the app 3.2 Connecting to a sensor Make sure that the sensor has been attached to the skin and that the power has been turned on. Connect the sensor with the app. Once it is successfully connected, the sensor will be warm up. The smart device and the sensor communicate via Bluetooth. You must maintain the connection between the sensor and the smart device when in use. Follow these steps to connect the sensor to the app. 1 Connect the sensor with the app. Configure the alert settings in the app. 2 Sensor warmup will occur. 3 Enter an initial calibration value. If sensor warmup is not completed successfully, check whether the sensor or smart device is malfunctioning and try again. The sensor and the device must always remain connected. Note Once a sensor has been connected, it cannot be connected with another device unless:
When the sensor has not yet expired The same account is used, and Keep the sensor and the smart device within 6 meters of each other, without any obstacles such as walls or metal objects in between. The distance from the sensor to the smart device must be closer if there is any solid object between them. Otherwise, the connection may fail. 35 Using the app Connecting the sensor to Android apps Connect the sensor to the app. Scan the barcode shown on the sensor package label, or manually enter the sensor PIN code. Follow the steps below to connect the sensor to the app:
1 Turn on Bluetooth on your smart device. 2 Tap your smart device and log in. 3 Tap Safety information on the 'Product description' screen. 4 Read the information on the 'Safety information'
screen, then tap Enter sensor information. 36 Using the app 5 On the 'Enter sensor information' screen, scan the barcode on the package label. 6 Tap OK when the sensor information appears. 7 You can manually enter the barcode instead. Tap Manual input. 37 8 Enter the 6-digit PIN code and the last 4 digits of the serial number written on the sensor package label, then tap OK. Using the app Note When entering the sensor information manually, please make sure to enter the numbers accurately. The sensor will fail to connect if you enter the wrong serial number or PIN code. 38 Using the app 9 Once the barcode is successfully recognized or the PIN code and the serial number are successfully entered, you will see the 'Attaching the sensor' screen. Check how to attach the sensor and then tap Start sensor connection. 39 Using the app On the 'Connect to sensor' screen, attach the sensor to the rear of your upper arm and press the power button until it clicks. The button is then recessed inward. 10 Wait until the sensor connection is completed. It may take up to 15 minutes for the sensor to connect, depending on the network environment. 40 Using the app Connecting the sensor to iOS apps Connect the sensor to the app. Scan the barcode shown on the sensor package label, or manually enter the sensor PIN code. Follow the steps below to connect the sensor to the app:
1 Turn on Bluetooth on your smart device. 2 Tap on your smart device and log in. 3 Tap Safety information on the 'Product description' screen. 4 Read the information on the 'Safety information'
screen, then tap Enter sensor information. 41 5 On the 'Enter sensor information' screen, scan the barcode on the package label. Using the app 6 You can manually enter the barcode instead. Tap Manual input. 7 Enter the last 4 digits of the serial number written on the sensor package label, then tap OK. 42 Using the app 8 Once the barcode is successfully recognized or the information is manually entered, you will see the 'Attaching the sensor' screen. Follow the steps below to attach the sensor on the rear of your upper arm, and tap Start sensor connection. On the 'Connect to sensor' screen, attach the sensor to the rear of your upper arm and press the power button until it clicks. The button is then recessed inward. 9 Wait until the sensor connection is completed. Once the barcode is successfully recognized, the serial number and PIN code are displayed on the screen. If manually entered, only the serial number is displayed. It may take up to 15 minutes for the sensor to connect, depending on the network environment. 43 10 When a Bluetooth connection request appears on the screen, enter your PIN code and tap Pair. Using the app Warning When using iOS, never close the app after connecting the sensor. It will be disconnected from the sensor. 44 Using the app Attaching the sensor Follow the steps below to attach the sensor to the rear of your upper arm:
1 Open the CareSens Air sensor package. 2 Take the applicator out of the package and set it on a flat, stable surface. 3 Check the expiration date on the sensor package label. 4 Wash your hands well with soap and running water, and dry them with a clean cloth. 5 Wipe the area where the sensor will be attached to the skin with an alcohol swab and wait for it to dry completely. Caution Choose a new location to attach each new sensor. Continuing to attach new sensors to a previously used location may cause skin irritation or scarring. The sensor should be attached immediately after opening the applicator package to avoid airborne contamination. The location chosen for insertion must meet the following criteria:
It must be at least 8 cm away from an insulin pump infusion set or infusion location. It must not be close to the waistband, tattoos, bone, scars, or irritated skin. It must be a location which will not be bumped, pushed, or pressed during sleep. After you separate the safety cap from the applicator, be careful not to point it toward any person. 45
1 | User Manual Part 2 | Users Manual | 5.14 MiB | September 27 2023 / March 25 2024 | delayed release |
Using the app 6 Hold the safety cap and remove the applicator. When the safety cap is removed, the backing paper covering the skin adhesive is removed at the same time. Note Make sure that the backing paper has been completely removed from the skin adhesive and is on top of the safety cap. 1 2 Backing paper Caution The applicator and the sensor cannot be re-used. Warning Do not press the release button on the applicator until you are ready to attach the sensor. 46 Using the app 7 Remove the safety cap, and place the applicator horizontally on the rear of your upper arm where the sensor will be attached. The sensor may not attach properly if the applicator is positioned vertically. Note Place the applicator horizontally on the area of attachment and then press the Release button. Do not press the applicator on the area of the attachment too hard. Do not leave any space between the area and the applicator. Do not tilt the applicator onto the area. 8 Press the Release button on the applicator. The sensor is then released from the applicator and can be attached to the rear of your upper arm. 47 Using the app 9 Remove the applicator and make sure that the sensor has been properly attached. After attaching the sensor, sensor tape can be attached as shown in the picture below to prevent the sensor from being easily removed from the attachment area. For example, 7 days after attaching the sensor, the tape can be used to prevent it from being removed from the attachment area. 1 2 Remove the middle back side of the sensor tape. Attach the sensor in the center of the sensor tape. 3 4 Remove both back sides of the sensor tape. To affix the sensor to the area, press the sensor tape. 10 The applicator is intended for a single use only. Discard it after use. 48 Using the app Configuring your alert settings after connecting to the sensor After the sensor is connected successfully, enter threshold values for very low, low, and high and proceed with setting up your alerts. It is recommended to consult a medical professional to choose the appropriate threshold values for very low, low, and high. Take the following steps to configure your alert settings after connecting with the sensor. 1 Make sure that the sensor is attached and that the power is on. Refer to 'Attaching 2 Tap Alert settings on the 'Connect to sensor'
the sensor' for more information on attaching sensors. screen if you would like to receive app alerts while using the sensor. 49 Using the app 3 On the 'Alert settings' screen, enter threshold values for very low, low, high, rapidly changing blood glucose levels and alert types, then tap Finished. 4 Sensor warmup will start automatically. If you need to make a treatment decision during the 2 hours needed for sensor warmup, use a glucose meter. Note 50 Using the app The home screen shows the status of sensor warmup, which takes about 2 hours. If the sensor fails to warm up, contact your place of purchase or customer service. changes its color from grey to red. Tap the red 5 Once warmup is completed, 6 On the 'Calibration value input' screen, enter two glucose measurements within 5 minutes taken with a personal glucose meter by pricking a finger and tap Apply. 7 Once the values are entered successfully, the home screen will appear. Note If you do not input initial calibration values, no measurements will be displayed on the chart. 51 Using the app If the sensor fails to connect If the sensor fails to connect, a pop-up window explaining the cause of the failure will appear. Depending on the cause of the failure, follow these steps to try connecting the sensor again:
If a sensor is malfunctioning: The sensor is defective and cannot be used. Disconnect the sensor if necessary. Then, attach and connect with a new sensor. Read 'Disconnecting and removing the sensor' for more information on how to disconnect the sensor. For more information on connecting the sensor, please refer to 'Connecting the sensor to Android apps' or 'Connecting the sensor to iOS apps'. If the connection is not secure: The sensor cannot be connected due to unstable connection with your mobile device. Take the following steps and try connecting again:
If the sensor is already in use: You have tried to connect to a sensor that is already being used by another user. Check whether the sensor information on the package has been entered correctly. Enter the serial number and PIN code accurately and connect again. Keep the sensor and the smart device close to each other. In the settings of your smart device, turn Bluetooth off and then back on. If the connection between the sensor and the smart device is interrupted A communication error between the sensor and the smart device may occur in the following cases:
If Bluetooth is turned off on your smart device If the sensor is not within connection range of the smart device If the sensor is out of battery If the sensor is broken If the smart device has insufficient storage space If a communication error occurs, a normally operating sensor will store the data it collects and transfer it to the smart device when the connection is reestablished. The sensor can save data for 12 hours. After 12 hours, any additional data may be lost. If a connection error occurs, follow these steps and try connecting again:
Keep the sensor and the smart device close to each other. Exit the app, then restart it. Turn off and restart Bluetooth on your smart device. Turn the power of the smart device off and then back on. 52 Using the app Disconnecting and removing the sensor The sensor is automatically disconnected when it expires. You can manually disconnect from a sensor while it is still in use. You can disconnect from a sensor if it malfunctions due to damage or low battery. You may lose any data that hasn't been transferred when you disconnect the sensor. Check that all recent data has been received before you disconnect it. Follow these steps to disconnect from the sensor:
1 Run the app and tap 2 Tap Disconnect on the right of Connection at the bottom of the home screen. management. The sensor disconnection pop-up window will appear. 3 Enter the 4-digit code in the sensor disconnection popup window and then tap Disconnect. Once the sensor is successfully disconnected, the connection status will change to Not connected. 53 Using the app 4 Remove the sensor attached to the rear of your upper arm. Remove it slowly, starting from the edge of the skin adhesive tape. 54 Using the app 3.3 Understanding the home screen If the sensor is operating stably, a real-time graph of changes in glucose level will be displayed on the home screen of the app. The CareSens Air app home screen contains the following:
Basic information: user profile, user name Menu bar: links to the home screen, the log book, and Settings Glucose data: sensor connection status, current glucose level, glucose level change arrow, glucose trends, and calibration values The glucose level and glucose change arrow on the home screen can help you understand your glucose status. You can check the changes in the sensor's glucose levels in the glucose trends. Understanding the content and features of the app will help you use CareSens Air to manage your diabetes more effectively. This section will help you to:
Understand what is displayed on the Home screen. Learn what the icons on the Home screen do. Learn how to check past glucose trends. Check glucose levels. See your low and high alert levels in the glucose trends. Check whether a sensor has been calibrated Check the event logs and the details of events 55 Basic information The table below explains the basic information which the CareSens Air app displays at the top of the home screen. Using the app No. 1 2 Icon Name Profile picture Nickname Description The image uploaded to your profile is shown. You can change this image on the 'User information' screen by tapping your nickname. The nickname you entered when you registered is be displayed. It can be changed on the 'User information' screen by tapping it. 56 Using the app Menu bar The following table explains the icons and features available on the Home screen menu. No. 1 2 Icon Name Home Log book Description Tap this to go back to the app home screen. When you tap this icon, a list of events registered by the user will be displayed. You can add, edit, or delete events. Refer to '5 Using events' for detailed information on events. 57 Using the app Description When you tap this icon, you will see a display telling you about the sensor connection status, whether or not the battery is low, the calibration status, alert type, and your glucose alert levels. All data saved on the app can be uploaded and saved to the cloud server. You can change your settings to automatically upload data, or you can instantly upload data whenever you want. You can connect to a new sensor, or disconnect from a currently connected sensor. You can check the user manual, help center, and app info. Refer to 'Changing Settings' for more information on changing your settings. Refer to 'Updating the app' for more information on updating to the latest version of the app. You can check the personal glucose meter that is connected to your smart device, or register a new one. Refer to 'Connecting with a glucose meter' for more information on connecting with your personal glucose meter. No. Icon Name 3 Configuration 58 Using the app Glucose data The CareSens Air app displays your current glucose level and the glucose change arrow as shown below. You can choose whether to display them vertically or horizontally on your smart device screen. The table below explains how the home screen displays glucose level data:
No. Icon Name 1 Connection status Description The status of the connection between the smart device and the sensor is displayed in the following colors:
Blue: The communication status is good. Red: The smart device has not received any signal for 25 minutes. Grey: The smart device's Bluetooth is turned off. 59 No. Icon Name Using the app Description When you tap this icon, statistics of your glucose levels over the past 24 hours will be displayed:
average level, standard deviation, and how much time your level spent within the target glucose level, and the low and high ranges When you tap the bar on the left of the screen, your previous glucose trends will appear in sections. When you select a section, a detailed screen will be displayed in the same format as the home screen. Changes to your glucose level while the sensor is in use are displayed as a graph. If you tap this icon, the calibration input screen will be displayed. Enter a glucose reading taken with a personal glucose meter by pricking a finger. The icon will be red if an first calibration value has not been entered. Once an first calibration value is entered successfully it turns blue. See '4 Calibration' for more information on calibration. Glucose statistics Viewing previous data Glucose trends Calibration button Date The date when the data was received from the currently connected sensor is displayed. Tap another date to see the glucose trends for that date. Tap to switch between landscape and portrait screen orientation. Screen mode Alert history Move to the alert history screen. 2 3 4 5 6 7 8 60 Using the app No. Icon 9 0 Name Glucose trend arrows Glucose level Description The current rate of change in your glucose level compared with the previous measurement is displayed. Each point indicates a glucose reading taken every 5 minutes. See 'Change arrows' for more information on the glucose level change arrow. The most recently measured glucose reading is displayed, either as a number or as one of the following:
- : No data has been received within the last 25 minutes Lo: Lower than 40 mg/dL (2.2 mmol/L) Hi: Higher than 500 mg/dL
(27.8 mmol/L) 61 Using the app Trend arrows The glucose trend arrow shows the direction and velocity of change between the most recent glucose reading and the second most recent reading. It is shown as an arrow on the right of the most recent glucose reading on the home screen. Velocity arrow Change in glucose level Description The glucose level is increasing or decreasing by less than 1 mg/dL (0.1 mmol/L) per minute, or by less than 5 mg/dL (0.3 mmol/L) every 5 minutes. The glucose level is increasing by 1 mg/dL
(0.1 mmol/L) or higher per minute, or by 5mg/dL (0.3 mmol/L) every 5 minutes. The glucose level is increasing by 2 mg/dL
(0.1 mmol/L) or higher per minute, or by 10mg/dL (0.6 mmol/L) every 5 minutes. The glucose level is increasing by 3 mg/dL
(0.2 mmol/L) or higher per minute, or by 15mg/dL (0.8 mmol/L) every 5 minutes. The glucose level is decreasing by 1 mg/dL
(0.1 mmol/L) or higher per minute, or by 5mg/dL (0.3 mmol/L) every 5 minutes. The glucose level is decreasing by 2 mg/dL
(0.1 mmol/L) or higher per minute, or by 10 mg/dL (0.6 mmol/L) every 5 minutes. The glucose level is decreasing by 3 mg/dL
(0.2 mmol/L) or higher per minute, or by 15 mg/dL (0.8 mmol/L) every 5 minutes. The volume of data is insufficient to calculate the direction and speed of changes in glucose levels. Stable Increasing slowly Increasing Increasing rapidly Decreasing slowly Decreasing Decreasing rapidly Unknown 62 Using the app Interpreting trends in glucose data Interpreting trends in glucose data shown on the home screen can help you manage your diabetes more effectively. The most recent glucose reading is displayed, and the pace and direction of change in comparison with the last measurement is indicated with an arrow. See 'Change arrows' for more information on the glucose level change arrow. Interpreting trends in glucose data will allow you to choose appropriate ways based on the glucose level intervals and the pace and direction of change to manage your diabetes in advance. This will help you keep your glucose level within the target range. No. 1 Description You can use the statistics based on your glucose trends to check your glucose level management status. If the amount of time your blood glucose level remains within the target range is high, but the standard deviation is also high, this indicates large changes in blood glucose level. If the sensor was functioning normally within the given period, you can check your events and use this information to make lifestyle improvements which will help you maintain a stable level. 2 This shows that the sensor attached to your body is operating normally. An alert will occur if the sensor goes out of its range. 63 Using the app Description The most recent glucose reading is 103 mg/dL (5.7 mmol/L), which is within the target range. It has increased in comparison to the previous value, but is still within the target range. However, even if the glucose reading value is 103 mg/dL (5.7 mmol/L), it may increase to 160 mg/dL (8.9 mmol/L) or higher after 30 minutes when you see the change arrow.
means that the glucose level is increasing by 2 mg/dL (0.1 mmol/L) or more per minute, or up to 10 mg/dL (0.6 mmol/L) every 5 minutes. Refer to
'Change arrows' for more information. In this case, the CareSens Air user and those who use personal glucometers may take different actions. With CareSens Air: Interpreting glucose trends allows you to predict a rapid increase in the glucose level to 160 mg/dL (8.9 mmol/L) or higher after 30minutes by looking at the change arrow. This means that observing the graph can help you know that you should take actions to prevent a serious incident occurring due to hyperglycemia. Only using a personal glucose meter: If your glucose level is increasing rapidly, it could reach 160 mg/dL (8.9 mmol/L) in 30 minutes. But you cannot see the change in level unless you take another finger prick measurement. This may make it difficult to take action before a hyperglycemia event occurs. By checking the events displayed in the glucose trends, you can check the change in your glucose level according to your lifestyle. For example, you may see that jogging for 30 minutes every day brings down your high value to the target level and helps you maintain it. The glucose alert levels have been set to 70 mg/dL (3.9 mmol/L) for low and 200 mg/dL (11.1 mmol/L) for high. Check whether your glucose level is staying within the target range. No. 3 4 5 6 You can check calibration values which have been applied normally on your glucose trends. 64 Using the app Viewing previous data You can click the vertical bar on the left of the app home screen to view earlier data. You can not only view readings from the sensor you are currently using but all the data delivered from any sensor used on your account. The glucose trend screen appears when you tap on the date list. Take the following steps to view earlier glucose trends:
1 Tap the vertical bar on the home screen. 2 Tap the date list on the 'View previous data' screen. A detail screen will appear. Tap to go back to the home screen. 65 Using the app on the upper right corner of the home screen to see the notification history. Notification history Tap You can check the history of blood glucose alarms (very low, low blood sugar, high blood sugar, sudden fluctuations), sensor notifications, and follow-related notifications. Follow the steps below to check the notification history. 1 Tap in the top right of the home screen. The notification history screen will be displayed. 2 Tap to go back to the home screen. 66 Using the app 3.4 Exploring the app features You can use various features of the CareSens Air app to manage your diabetes in your daily life. All the glucose readings collected by the sensor appear together on the glucose trends display. You can record your food intake, physical activity, insulin intake, and other items as events. Observing changes in your glucose level and comparing them with these events can help you make lifestyle improvements or make effective treatment decisions. All the data measured by the CareSens Air system can be uploaded and saved on the cloud server. Reading this section will allow you to:
Record events and check past events Configure your alert settings Update the app to the newest version Check help or the tutorial as needed Register a personal glucose meter 67 Using the app Running the widget CareSens Air can display important information and features as a widget so that you can view them on the main screen of your smart device. You can use the CareSens Air widget to check your sensor connection status, sensor glucose readings, and trend arrows, or to enter a calibration value. You can choose from three different widget layouts for Android. You can check the widget layout for iOS. No. Name 1 Glucose data 2 Calibration value input 3 Entering an event Description This display shows your sensor connection status, most recent glucose reading, and a trend arrow. It appears on the home screen when you tap the widget. This display shows whether a calibration value needs to be entered. If a calibration value is required, the icon will turn red. Tapping causes the 'Calibration value input'
screen to appear. Tapping displayed. causes the 'Enter event' screen to be 68 Using the app Entering a calibration value When you need to enter a calibration value, you should use a personal glucose meter to make a blood glucose reading by pricking a finger. Enter this reading as a calibration value for CareSens Air. Refer to '4 Calibration' for more information on glucose level calibration. Follow these steps to enter a calibration value in the app. 1 Tap at the bottom of the home screen. The 'Calibration value input' screen will be 2 Use your personal glucose meter to measure your blood glucose level with a finger 3 Enter the finger prick reading within 5 minutes and tap Apply. The calibration value is displayed. prick. reflected by CareSens Air. 4 Check your glucose trends on the home screen to see whether the calibration value The calibration value is shown as a grey dot on the glucose trends at the date and time of entry. has been applied. 69 Using the app Editing and checking your profile You can view or edit the information in your user profile. Follow these steps to enter profile information. 1 Tap 2 Tap at the top of the home screen. The 'User Information' screen is displayed. on the 'User Information' screen to change your profile photo. The 'Change Profile Photo' screen will be displayed. 3 In the 'Change Profile Photo' pop-up window, tap Take a Picture or Select from the Gallery. 4 To change user information, tap at the top right of the 'User Information' screen. 70 Using the app 5 Tap Change Account Information. 6 On the 'Change account information' screen, change your information and tap Save. 71 Using the app Viewing the log book The log book displays all the events registered by the user, beginning with the most recent. Follow these steps to check event details in the log book. 1 Tap registered by the user are displayed. at the bottom of the home screen. Events The table below explains the icons used on the logbook screen. Icon Name Glucose level Ketone level Insulin Oral medication
: If the entered value indicates a glucose level
: If the entered value indicates a calibration value Description The value entered by the user or measured using the blood glucose meter is displayed as follows at the time the event occurred. The value entered by the user or the ketone value measured by the ketone meter is displayed at the time the event occurred. The name of the insulin and the dosage taken at the time the event occurred are displayed. You can enter up to 2 insulin administration records. The name of the oral medication and the dosage taken at the time the event occurred are displayed. You can enter up to 5 doses of oral medication. 72 Using the app Icon Name Meal Exercise Description The amount of carbohydrates and protein consumed at the time the event occurred are displayed in grams (g). The number of minutes spent exercising is displayed, along with the time. Recording an event Activities or situations that may affect your glucose level can be registered as events. Refer to '5 Using events' for more information on how to use events to manage your diabetes. Follow these steps to register an event. 1 Tap tap screen will be displayed. at the bottom of the home screen and then on the logbook screen. The 'Enter Event'
2 Tap the event icon you want to enter. 3 Enter the event details, including the date and time, on the 'Enter Event' screen, then tap Save. A maximum of 2 types of insulin can be entered. A maximum of 2 doses of oral medication can be entered. If necessary, you can enter notes or attach files such as photos and audio. 73 Using the app Changing your settings The following table explains the icons and features available on the home screen menu:
Your settings are displayed when you tap Icon at the bottom of the home screen. Description If a sensor is connected, In use is displayed. If a sensor is not connected, Not connected is displayed. Name Connection status Serial number This is a unique number assigned to the sensor. Insertion Time Remaining battery life Battery Connection Management Interval The date and time when the sensor was first connected are displayed. The remaining life of the sensor is displayed. in use. The sensor battery status is displayed as Good, Low, or Very low. Tap Disconnect to disconnect the sensor currently If a sensor is not connected, New connection is displayed. Refer to 3.2 Connecting the sensor' for more information on how to connect the sensor. The first two calibrations are made at 12-hour intervals, and the third calibration are made at 24-hour intervals. Last calibration The time of the last calibration is displayed. Very low Low High Enter the threshold value for Very low to receive alerts and select the alert method. Enter the threshold value for Low to receive alerts and select the alert method. Enter the threshold value for High to receive alerts and select the alert method. 74 Using the app Icon Name Rapidly changing System Voice Security Glucose Meter Follower management Last upload Upload now Unit Maximum y-axis value on chart Tutorial Help Description Enter the threshold value for Rapid changes to receive alerts and select the alert method. You can set the notifications for calibration, signal loss, sensor expiration, sensor battery, and error notification. You can choose to have your glucose level and alerts read aloud. You can set the app lock feature. Register and connect a personal glucose meter with your smart device. You can share your data to the follower app. Refer to
'Sharing your blood glucose information' for detailed information on how to share data. The last time data was uploaded to the app is displayed. Tap Upload to save data stored in the app on the cloud server. Choose either mg/dL or mmol/L as a measurement unit. Set the maximum value for the Y axis indicated on the chart. You will be directed to the 'Tutorial' screen. You will be directed to the 'Help' screen. 75 Icon Name App info Using the app Description The current version of the app is displayed. If a new version of the app is available for installation, it will be shown to the right of the current version. Refer to 'Updating the app' for detailed information on how to update the app to the newest version. Follow the steps below to change your alert settings:
1 Tap 2 Make changes on the Settings screen and tap Apply. at the bottom of the home screen. The settings screen offers the following options:
Alert type: Choose from Sound, Vibration, Sound and Vibration, or Mute. Voice: Choose whether you would like to have your Glucose level and Alerts read aloud. Glucose alert level: Enter your very low, low and high alert levels. Rapidly changing: Choose between 2 mg/dL/min (0.1 mmol/L/min) or higher and 3 mg/dL/min (0.2 mmol/L/min) or higher. System: Set whether to receive alerts for calibration, signal loss, sensor expiration, sensor battery, and error notifications. Unit: Select mg/dL or mmol/L as a measurement unit. Maximum y-axis value on chart: Choose among Auto, 300 mg/dL
(16.7 mmol/L), 400 mg/dL (22.2 mmol/L), and 500 mg/dL (27.8 mmol/L) for the max value of the Y axis. 76 Using the app Setting app lockout You can set the app lock feature to protect your personal data. Follow the steps below to set up the app lock feature:
1 Tap 2 Tap at the bottom of the home screen. The Settings screen will be displayed. of App Lock. 3 Tap
. 4 Enter the 4-digit password. 5 Enter the password again to confirm. Note Once the lock setting is complete, you need to enter your password to access the app. If you have forgotten the password, you can reset it after following the on-screen instructions to go through the verification process. 77 Using the app Connecting with a glucose meter You can connect a personal glucose meter to the CareSens Air app and download your glucose meter data. Follow these steps to connect a glucose meter:
Note For your personal glucose meter, use a Bluetooth glucose meter from the manufacturer of CareSens Air. 1 Tap 2 Tap at the bottom of the home screen. The Settings screen will be displayed. next to Glucose Meter. 3 Tap to connect with a new glucose meter. Turn on your personal glucose meter on and connect using Bluetooth. The method for connecting with Bluetooth may differ depending on the type of glucose meter you use. 4 Check the glucose meter registration procedure and then tap Next. 78 Using the app 5 Tap Search to start searching for a glucose meter. for more information on the Tap connection process. 6 From the list of connectable devices, tap the glucose meter you want to connect to. 79 7 Enter the PIN code displayed on the glucose meter screen and tap OK. Using the app 8 When the process is completed, the download will proceed. When the download is completed, you will be directed to the 'Download Data' screen, and the downloaded glucose level will be displayed. Tap Save to complete the process. Note Uncheck My Data to exclude it from the statistics. 80 Using the app Uploading data All the data saved on your smart device by the CareSens Air app can be saved and used on the cloud server. Follow the steps below to upload your app data:
1 Tap 2 Tap Upload to instantly save your app data at the bottom of the home screen. The Settings screen will be displayed. on the cloud server. 81 Using the app Updating the app If a new version of the CareSens Air app is available and has not be downloaded, it will be shown on the Settings screen. Go to the App Store to download and install the most recent version. Follow these steps to update the CareSens Air app to the most recent version. 1 Tap 2 On the Settings screen, tap next to App info. 3 Tap Update in the 'App info' screen. Update is enabled only when a new version of the app is available. at the bottom of the home screen. 4 Tap Update in the popup window. You will be taken to the app store. 5 Download and install the newest version of the app from the app store. Your existing data will not be affected as the app is updated to the most recent version. 82 Using the app See how to use Follow these steps to view the CareSens Air app user guide. 1 Tap 2 On the Settings screen, tap at the bottom of the home screen. next to Tutorial. 3 Tap to check if you have any questions about how to use the device. 83 Using the app See Help 1 Tap next to help Help to read frequently asked questions and answers. You will be taken to the 'Help' screen. 2 Tap categories. on the 'Help' screen to check the 3 Tap a help category to see a list of topics. 84 Using the app Making an inquiry You can use the app to ask questions about CareSens Air. The manufacturer's customer service representatives will check your inquiry and reply by email. To view My inquiries, or Inquiry, follow these steps:
1 Tap 2 On the Settings screen, tap at the bottom of the home screen. next to help. You will be taken to the 'Help' screen and the FAQ list will be displayed. 3 On the 'Help' screen, tap see the list of your inquiries. My inquiries. You can 85 4 Tap Inquiry on the 'My Inquiries' screen to make a new inquiry. Using the app 5 On the 'Make an inquiry' screen, tap Finished after making an inquiry. Email address: The email address associated with the account is entered automatically and cannot be changed. Model number: The model of the smart device using the app is entered automatically and cannot be changed. OS version: The version of the CareSens Air app installed on the smart device is automatically entered and cannot be changed by the user. App version: The version of the CareSens Air app is automatically entered. Title: Enter the title of the inquiry. Content: Enter the details of your inquiry. to attach a product image or screenshot of the app Attachments: Tap screen related to your inquiry. Personal Information Collectionand UsageAgreement: In order to add an inquiry, you must agree to the collection of your personal information. 86 Using the app 6 Tap Close on the pop-up window which confirms receipt of the inquiry. 87 Using the app 3.5 Logging out Follow these steps to log out of the app:
1 Tap 2 Tap Log Out on the 'User Information' screen to log out. at the top of the home screen. The 'User Information' screen is displayed. 3 Tap Log Out on the 'Log Out' pop-up window. Note You cannot view your account information while you are logged out. You need to log in to view your existing account information. 88 4 Calibration The sensor measures glucose levels in intracellular fluid and transfers the data to the CareSens Air app. Continuous glucose monitoring calculates the concentration of glucose in the blood by measuring the concentration of glucose in the interstitial fluid. However, when the concentration of glucose in the blood changes, the concentration of glucose in the interstitial fluid changes about 5 to 15 minutes later. CareSens Air uses readings taken by a glucose meter by pricking a finger and entered by the user within 5 minutes to calibrate the sensor. The calibration is used to match sensor glucose readings as accurately as possible to the actual glucose level in the intracellular fluid, optimizing the performance of the CareSens Air. Caution Do not calibrate if your blood glucose level is changing rapidly (by 2 mg/dL (0.1 mmol/L) or more per minute). This may affect the accuracy of the sensor. Note If a CareSens Air calibration alert occurs, you must calibrate immediately. Otherwise, the accuracy of readings may decrease. How to calibrate a sensor If a calibration alert occurs, you can use a glucose meter to measure your glucose level by pricking a finger and enter it within 5 minutes into the CareSens Air app. This calibration value will be immediately reflected by the app. When to calibrate a sensor Following the sensor warmup, the initial two calibrations should be made at intervals of 12 hours each. Subsequently, calibrations should be made every 24 hours for the remaining of sensors useful life. Refer to '4.2 Calibration value input' for more information on your calibration interval and how to input calibration values. 89 4.1 Measuring a calibration value Calibration Calibration requires a reading taken by pricking a finger. A personal glucose meter is used to measure your glucose level. Refer to 'Connecting to a glucose meter' for more information on how to connect a glucose meter to a smart device. Caution Do not use a measurement taken from any part of the body (palm, forearm, etc.) other than your fingertip for calibration. The result may be different from one taken by pricking a finger, and this can affect the accuracy of sensor glucose readings. If the result of the finger prick reading is lower than 10 mg/dL (0.6 mmol/L) or higher than 600 mg/dL (33.3 mmol/L), it cannot be used as a calibration value. Note If the calibration value is inaccurate, CareSens Air may fail to provide accurate glucose readings. It is recommended that you use the same glucose meter for every measurement. The accuracy of glucose meters differs between models. If you switch to a different glucose meter while using a sensor, this may result in inaccurate glucose readings. Before starting the calibration, make sure that the glucose meter is operating correctly according to manufacturer specifications, and that the date and time on the glucose meter and smart device match. Follow these steps to measure your glucose level from a finger prick using a glucose meter:
1 Before the finger prick test, wash your hands (including the area you will prick) with warm water and soap, and dry them thoroughly. Do not apply any moisturizer or skin care product to the area you will prick. 2 Follow the instructions on the glucose meter when you prick your fingertip. Make sure to use a fingertip. Measurements made using other parts of the body may be inaccurate. 3 Enter the glucose measurement within 5 minutes as the calibration value. Refer to
'4.2 Calibration value input' for more information on how to input calibration values. 90 Calibration 4.2 Entering a calibration value CareSens Air calibrates the sensor using glucose readings taken within 5 minutes by pricking a finger to ensure that its readings are accurate. The user must enter a calibration value in the following situations:
After completing sensor warmup Once the sensor is connected with a smart device, the sensor will warm up for the next two hours. Enter two glucose measurements taken with a glucose meter by pricking a finger. For more information on how to input calibration values after warm up the sensor connection, please refer to 'Connecting the sensor to Android apps' or 'Connecting the sensor to iOS apps'. You can check the calibration interval of the sensor in use on the Settings screen. Refer to
'Changing settings' for more information. 91 Calibration Setting and receiving calibration alerts If you do not enter a calibration value at the end of the calibration interval, a calibration alert will occur and a pop-up window will be displayed. When a calibration alert occurs, follow these steps to enter a calibration value:
on home screen and enter a calibration Tap value then tap Apply. Tap Snooze on the right side of the calibration alert screen to snooze the alert for 10 minutes. The alert will repeat every 3 hours if a calibration value is not entered. 92 5 Using events You can use events to record activities and situations which may affect your glucose levels. You can manage events you have recorded on the CareSens Air app using the log book. You can also view them on your glucose trends, allowing you to manage your glucose levels more effectively. Managing your events allows you to track specific activities or situations that affect your glucose levels, allowing you to manage your diabetes more effectively with the help of a medical professional. You have the option of uploading and saving the events you record on the cloud server. This section will help you to:
Record, edit, or delete an event. Check the event icon on the CareSens Air app. See the effect of events on your glucose levels. 5.1 Checking your event information Viewing the log book Using the log book, you can record appropriate types of events for a variety of situations, and check your glucose levels before and after they occurred. Events are displayed by the CareSens Air user app as shown below. Tap view a list of events you have recorded. on the bottom of the home screen to 93 Using events Index Name 1 Date 2 Time 3 Event value 4 Memo 5 Event filter 6 Attachments Description The year, month, and day that the event occurred are displayed. This displays the time that the event occurred. The event value entered by the user and additional information are displayed. The memo entered with the event is displayed. The results are filtered by the selected item. Displays the picture, audio and files attached to Events. 94 Using events Viewing events on your glucose trends When the screen is oriented horizontally, event details are displayed using the icons above your glucose trends at each specific time. The app displays events from the last 24 hours by default, and you can zoom in or out to view events from the past 6 hours, 12 hours, or 24 hours. When multiple categories are recorded as a single event, the number of items entered is expressed as a number, not as an icon. Tap under the number to display the event category icons. You can view the event details by tapping the event icon. 95 5.2 Recording an event Using events You can record glucose levels, ketones, insulin, oral medication, diet, and exercise that may affect your diabetes management to register them as events Take the following steps to register an event using the CareSens Air user app. 1 Tap 2 Tap 3 Tap the event icon you want to enter. on the menu bar of the home screen. A list of events you have recorded is displayed in chronological order, beginning with most recent. at the bottom right of the event list. 4 On the 'Enter event' screen, select the date and time of the event. 96 Using events 5 On the 'Enter event' screen, enter desired information such as blood glucose level, ketone level, insulin, oral medication, meal, and exercise, and then tap Save. Glucose level: Enter your blood glucose value and diet information. The unit selected in the Unit section of the Settings menu is displayed. Ketone value: Enter the ketone value. Insulin: Enter the type and the dose of insulin administered. You can enter up to 2 items. Oral medication: Enter the name and the dose of oral medication administered. You can enter up to 5 items. Meal: Enter the amount of carbohydrates and proteins in grams. Exercise: Enter the type and duration of the exercise. 6 If necessary, additional information about the event can be recorded in notes and attachments. Memo: Record any significant information at the time of the event. Attachments: You can attach files such as photos and audio. Caution Depending on the size of the attached file, there may be limitations on the attachment function. 97 7 Tap Save when you finish entering information. Using events 98 Using events 5.3 Changing an event You can also change or delete any event details you have recorded. Editing an event You can edit the event information you have recorded. If the event includes a blood glucose reading taken with a personal glucose meter or a calibration value entered by you, the date, time, and glucose level of the event cannot be changed. When you edit an event, any category which cannot be edited is disabled. Calibration values and glucose readings entered by a user or taken with a connected glucose meter as part of an event are displayed as shown below. Glucose level icon in Events ITEM Calibration value (inactive) Blood glucose reading taken with a glucose meter (inactive) Blood glucose reading entered by the user Ketone values entered by the user 99 Using events Follow these steps to edit an event you have recorded. 1 Tap on the menu bar of the home screen. 2 Select the event you want to edit from the event list and tap Edit. 3 Edit the category you want to edit and tap Save. 100 Using events Deleting an event Follow these steps to delete an event you have recorded. 1 Tap 2 Select the event you want to delete and tap Delete. on the menu bar of the home screen. 3 Tap Delete to delete an event on the pop-up window. The event data has been deleted. Note Calibration values entered by you and glucose levels measured with a personal glucose meter cannot be deleted. 101 6 Using alerts If you have diabetes, it is extremely important to manage your glucose levels in real time. The CareSens Air app uses alerts to update you with your glucose levels even when it is not running. With the alerts, you can manage your glucose levels as well as your use of CareSens Air in real-time. This chapter will help you to:
Configure your initial alert settings Understand the differences between various alerts Select appropriate alert settings based on the sound mode of your smart device Change the alert settings to suite you 6.1 Changing your smart device settings To receive alerts from the app, you must enable app notifications in your smart device's settings. Note Make sure that the volume of your smart device is turned on. You will not be able to hear alerts if the volume is turned off. If your smart device is connected to other devices, you can only hear alerts on one device. If you connect your smart device to another device, check the settings and make sure that you can receive alerts Follow these steps to enable the CareSens Air app to send alerts on your smart device:
1 Open the settings of your smart device. 2 In 'Settings', tap Notifications. A list of apps which send notifications will appear. 3 Find CareSens Air on the list of apps on the 'Notifications' screen and tap the icon. 4 In app details, tap Notifications and enable Show notifications. 102 Using alerts 6.2 Initial app alert settings The initial alert settings are made when you connect a new sensor to the CareSens Air app. You can change your alert settings in the app settings. For more information, please refer to 'Connecting the sensor to Android apps' or 'Connecting the sensor to iOS apps'. You can set notifications in the CareSens Air app for glucose levels (very low, low, high) and rapid changes (2 mg/dL/min (0.1 mmol/L/min) or higher and 3 mg/dL/min (0.2 mmol/
L/min) or higher). Follow these steps to configure your alert settings on the app. 1 Use the app to finish connecting the sensor and then tap Alert settings on the 'Connect to sensor'
screen. 103 2 On the 'Alert settings' screen, set the threshold alert levels for Very Low, Low and High and tap Next. Using alerts 3 On the 'Alert settings' screen, set the rapidly changing glucose alert level and tap Next. 104 Using alerts 4 Choose an alert type, then tap Finished. 105 6.3 Checking your alerts Using alerts CareSens Air uses various alerts to let you know about changes to your glucose level or the sensor status. If multiple alerts are triggered at the same time, the most important will be delivered, in the following order of priority:
Signal loss alert > Glucose alert Level > Rapidly changing glucose level alert >
Calibration alert > Low battery alert > Sensor replacement alert > Sensor error Note If the system notification settings of your smart device and the notification settings of the CareSens Air App are different, those of the CareSens Air App will take priority. An alert pop-up will always be displayed, even if the smart device is in 'Mute' or
'Do not disturb' mode. It may be difficult to tell the difference between CareSens Air alerts and notifications sent by your smart device or other apps if the app alert type is set to sound or vibration. This chapter will help you to:
Tell the difference between the types of alerts sent by the CareSens Air app Understand how the CareSens Air app delivers alerts to users 106 Using alerts Signal loss alert The Signal loss alert occurs when the connection between the sensor and your smart device is lost for 25 minutes or longer. Measures to take upon signal loss alerts: Refer to 'If the connection between the sensor and the smart device is interrupted'. Refer to '6.4 Changing alert settings' for information on how to change your signal loss alert settings. On the following table, you can see the Signal loss alert settings and the contents of the messages based on what mode the app is running in. Situation Alert type Screen With app running Popup alert If you are using your smart device after closing the app If the smart device screen is locked Notification 107 Using alerts Glucose alert Level These alerts occur if your glucose level falls very low, above the high alert level, or below the low alert level you have set. Refer to '6.4 Changing alert settings' for information on how to change your blood glucose level alert settings. On the following table, you can see the blood glucose level alert settings and the content of messages based on what mode the app is running in. Alert type Situation Screen With app running Popup alert If you are using your smart device after closing the app If the smart device screen is locked Notification 108 Using alerts Rapidly changing glucose level alert Rapidly changing glucose level alert occurs if your glucose level changes more quickly than the set rate. You can select 2 mg/dL/min (0.1 mmol/L/min) or 3 mg/dL/min (0.2mmol/
L/min) as the standard rate for rapidly changing glucose level. Refer to '6.4 Changing alert settings' for more information on how to change your rapid change alert settings. On the following table, you can see the rapid change alert settings and the content of the messages based on what mode the app is running in. Alert type Situation Screen With app running Popup alert If you are using your smart device after closing the app If the smart device screen is locked Notification 109 Using alerts Calibration alert A Calibration alert occurs when a sensor value calibration is required. If you tap Snooze, you'll hear it again after 10 minutes. On the following table, you can check the Calibration alert settings and the content of messages based on what mode the app is running in. Situation Alert type Screen With app running Popup alert If you are using your smart device after closing the app If the smart device screen is locked Notification 110 Using alerts Low battery alert A low battery alert occurs when the sensor battery is low. If the sensor battery is low, replace the sensor with a new one. The 'Low' alert occurs if 2.6V or less of battery power remains. The 'very low' alert occurs if 2.55V or less of battery power remains. On the following table, you can check the low battery alert settings and the content of messages based on what mode the app is running in. Situation Alert type Screen With app running Popup alert If you are using your smart device after closing the app If the smart device screen is locked Notification 111 Using alerts Sensor replacement alert The sensor can be used for a maximum of 15 days. This alert occurs 5 days, 3 days, 1 day, and 1 hour before the sensor expires. The sensor is automatically disconnected when it expires. On the following table, you can check the sensor replacement alert settings and the content of messages based on what mode the app is running in. Situation Alert type Screen With app running Popup alert If you are using your smart device after closing the app If the smart device screen is locked Notification 112 Using alerts Sensor error When an error occurs in the sensor, the following notification occurs:
Depending on whether warmup has been completed, in case of an error, sensor warmup failure appears if it has occurred during warmup, or a sensor error notification occurs if it has occurred during use after warmup has been completed. When this notification occurs, the app disconnects from the sensor and can no longer be used. On the following table, you can check the sensor error alert settings and the content of messages based on what mode the app is running in. Situation Alert type Screen With app running Popup alert If you are using your smart device after closing the app If the smart device screen is locked Notification 113 Using alerts Follower addition notification When a new follower is registered, a notification like the one below occurs. On the table below, you can check the follower addition notification methods and the content of messages based on what mode the app is running in. Situation Alert type Screen With app running Popup alarm If you are using your smart device after closing the app If the smart device screen is locked Notification 114 Using alerts 6.4 Changing alert settings In the 'Alert settings', you can choose whether to receive alerts for the following categories:
Glucose level alert Rapidly changing glucose level alert Alert type Voice alert Note Consult with a medical professional to find the best glucose level alert settings for you. A medical professional can help you find the best settings for managing your diabetes. Follow the steps below to change your alert settings:
1 Tap 2 On the settings screen, change the alert settings as follows. See the table below:
on the home screen. 115 Icon Name Very low Low High Rapidly Changing System Voice Using alerts Description Set the threshold value to very low. The values entered are displayed on the target range of the glucose trends on the home screen. Set the threshold value for low. The values entered are displayed on the target range of the glucose trends on the home screen. Set the threshold value for high. The values entered are displayed on the target range of the glucose trends on the home screen. Choose between above 2 mg/dL/min
(0.1 mmol/L/min) or higher and 3 mg/dL/min (0.2 mmol/L/min) or higher to receive the rapid change alerts. You can set the notifications for calibration, signal loss, sensor expiration, sensor battery, and error notification. You can receive an additional voice alert when a change in glucose concentration is detected or another alert occurs. No. 1 2 3 4 5 6 116 7 Sharing your blood glucose information 7.1 Adding followers 1 After running the CareSens Air user app, tap 2 Tap Manage Followers. 3 On the 'Manage Followers' screen, tap Invite screen. Follower. at the bottom of the home 117 Sharing your blood glucose information 4 On the 'Choose Data For Sharing' screen, select the data and permissions you want to share and tap Generate Sharing Code. Data for sharing include. Glucose and Sensor Alerts Data share 5 Send the generated sharing code to a Sens365 app user (health care manager) who will share your data. The time limit for entering the generated sharing code is 5 minutes. If the code expires, please create a new sharing code. You can share the sharing code to other media by tapping Copy. Health care managers can share the user's blood glucose data by entering the sharing code into the Sens365 app. Refer to the Sens365 app manual for details. 6 When the follower is added, a follower addition completion notification is displayed on the CareSens Air user app. Note For more details on using the Sens365 app, refer to the Sens365 app user guide. 118 Sharing your blood glucose information 7.2 Changing sharing options You can temporarily stop sharing your blood glucose data with your followers or change your options. Follow the steps below to change the sharing options. 1 Tap 2 Tap Manage Followers. 3 On the 'Manage Followers' screen, tap the follower whose options you want to change. at the bottom of the home screen. 119 Sharing your blood glucose information 4 Change your sharing options and tap OK. Data sharing can be enabled/disabled with the enable sharing option. You can cancel sharing by unchecking each item. Note When CareSens Air users change their sharing options, followers are notified of the change in sharing options. 120 Sharing your blood glucose information 7.3 Removing followers at the bottom of the home screen. If you no longer want to share data with your followers, you can turn off data sharing. Follow these steps to turn off data sharing. 1 Tap 2 Tap Manage Followers. 3 On the 'Manage Followers' screen, tap to the right of the Followers you want to stop sharing data with. 4 On the 'Remove follower' pop-up window, tap Remove. It has a built-in battery and transmits the glucose concentration value measured through the sensing part to the user app. 121 8 Maintenance Learning and following these guidelines for how to take care of CareSens Air will allow you to use it more effectively. This section will help you to:
Maintain and take care of the sensor effectively. Safely store the sensor. Safely dispose of CareSens Air. Warning Do not use a damaged or defective sensor. This may lead to infection. Caution The sensor has been sterilized with EO after packaging. Do not clean the product with water or any other solution before use. Note This manual only covers the maintenance of the CareSens Air sensor. For how to maintain your smart device, refer to the manufacturer documentation. 122 Maintenance 8.1 Taking care of the sensor during use Follow these instructions to take care of the sensor during use. Caution Do not wash the sensor. Using an unsuitable solution could damage the device. Method Inspecting the sensor Every day Make sure that the sensor is stably secured to the point where it is attached. Take caution that solid objects smaller than 1.0 mm in diameter do not enter the sensor. Before and after use When needed If a skin care product such as sunscreen or insect repellent gets on the sensor, wipe it immediately with a clean cloth. An alert will occur when the battery begins to run out. Replace the sensor if you receive this alert. 8.2 Storing a sensor Storing sealed sensor packages properly can keep CareSens Air from malfunctioning. Keep sensors sealed (sterilized) until you are ready to attach them. Before and after storing a sensor, check the expiration date on the package label. Store the sensor package at a temperature of 530 C. Store the sensor package at a relative humidity of 1585 %. 8.3 Disposing of this product When disposing of a medical device, you must comply with your countries regulations for handling and managing medical waste. Regulations concerning the disposal of the sensor and of products that have been in contact with bodily fluids may vary by country. 123 9 Warranty i-SENS provides the following limited warranty if problems occur while using this product. i-SENS guarantees quality during the product lifespan labelled on the exterior of the CareSens Air package. However, quality is not guaranteed in the following cases, even during the product lifespan:
If damage is caused by the user not following the instructions and cautions listed in the manual If damage is caused by using an accessory or separate product not approved by the manufacturer If the product is disassembled or assembled by someone not authorized by i-SENS If the surface is scratched or damaged through regular use Lifespan exceeded Warranty period If a material or manufacturing defect is discovered during normal use of the sensor, the following limited warranty is guaranteed for the original purchaser within the warranty period listed below for the period from the shipping date until the corresponding date. CareSens Air sensor: If a replacement is received for the sensor within the warranty period, the remaining warranty period is transferred to the replacement sensor and the warranty of the replacement becomes invalid. Warranty exclusions A warranty is not provided for the following cases in which the user uses the product incorrectly. Accidents, misuse, abuse, negligence, abnormal physical, electrical, or electromechanical stress, alteration of product components, or exterior damage If the barcode on the sensor package label has been removed or cannot be read If there are scratches and damage to the surface or other exposed areas of the product resulting from normal use If there is damage caused by the use of an accessory or separate product that is not provided or approved by CareSens Air If there are flaws or damage resulting from incorrect testing, operation, maintenance, installation, or adjustment If the product is disassembled If damage is caused by exposure to water outside of the acceptable range specified in the manual 124 Warranty Warranty obligations During the warranty period, and at its own discretion, i-SENS will replace a defective CareSens Air sensor without charging the purchaser. The purchaser needs to put the product in an appropriate box and ship it back to the CareSens Air customer service department. When returning the product, a receipt showing the date of purchase, the product serial number, the name and address of the seller, or comparable documentation must be included in the box. To get support regarding the region to which to ship your CareSens Air, contact the nearest authroized distributor. After receiving a defective product, i-SENS will replace it immediately. If i-SENS decides that a warranty exclusion applies to the product, the purchaser must pay for all return shipping costs. 125 Appendix A Frequently Asked Questions This chapter presents situations that may occur while using CareSens Air and how to deal with them. If any situation which is not presented in this chapter occurs, or if you experience an issue that you are unable to resolve on your own, contact the nearest authorized distributor. This section will help you to:
Identify the causes of problems that occur while using CareSens Air. Resolve problems that occur while using CareSens Air. What should I do if I receive a sensor replacement alert?
The sensor's lifespan is 15 days, and the sensor replacement alert will occur 5 days before it expires. Disconnect the sensor within 45 days after receiving the alert and replace it. Read 'Disconnecting and removing the sensor' for more information on how to disconnect the sensor. What should I do if my sensor expires before it is replaced?
A sensor is automatically disconnected when it expires. Remove the sensor from where it is attached. What should I do if the sensor battery is low?
A low battery alert occurs when the sensor battery is low. Disconnect the sensor and replace it with a new one. Read 'Disconnecting and removing the sensor' for more information on how to disconnect the sensor. What should I do if the sensor signal is lost?
Check that your smart device's Bluetooth is turned on. If Bluetooth is turned on, refer to 'If the connection between the sensor and the smart device is interrupted'. 126 Appendix A Frequently Asked Questions My sensor glucose reading does not match a blood glucose reading I took by pricking a finger. A glucose meter measures glucose concentration in blood from the tip of the finger, and the sensor measures glucose concentration in intracellular fluids. It may take time for glucose in the blood to reach the intracellular fluid, resulting in a difference in glucose readings. Enter calibration values regularly to minimize this difference. See '4 Calibration' for more information on the sensor glucose reading calibration feature. What should I do if my sensor glucose reading does not match my physical condition?
Wash your hands thoroughly with water or an alcohol swab, use your personal glucose meter to obtain a reading by pricking a finger, and compare the result with your physical condition. Consult a medical professional if necessary. What should I do if the sensor has been discharged, but it does not separate from the applicator?
The sensor cannot be used if it wasn't separated properly. Hold the adhesive tape on the sensor and gently remove the sensor from the applicator. If it cannot be removed, it is a damaged or a defective product. Do not use the sensor, and contact the nearest authorized distributor or customer service center. What should I do if the place where I attached the sensor is itchy?
Continuously attaching sensors to the same location may cause minor skin irritation. Attach the next sensor to a different location. If the same symptoms persist even after you change the attachment location, stop use and consult a medical professional. What should I do if I can't hear the alert?
If you can't hear the alerts on your smart device, check the following factors:
Check your alert settings on the app. Check the permissions and alert volume settings on your smart device. 127 Appendix A Frequently Asked Questions What should I do if the app can't find a signal when I'm trying to connect with the sensor?
Keep the sensor and the smart device within 6 meters of each other, with no obstacles in between them. Connecting may take up to 15 minutes. If the problem persists after 15 minutes, try the following:
Android: Go to Settings > Applications on your smart device and force restart CareSens Air. iOS: Force restart CareSens Air. How can I terminate a sensor early?
Disconnect the sensor, hold the edge of the adhesive tape, and slowly peel it off. Dispose of the sensor after removing it. Read 'Disconnecting and removing the sensor' for more information on how to disconnect the sensor. Why is there an empty region on my glucose trends?
When the app is unable to receive sensor glucose readings, the status of the signal icon on the home screen will be displayed as Signal loss, and new glucose readings will not be displayed. The sensor takes and sends glucose readings every 5 minutes. Any data that hasn't been sent will be stored for 12 hours. It will be sent automatically when the connection is restored. Can I go in the water with CareSens Air attached?
CareSens Air has been tested as waterproof for 24 hours at a depth of 1 meter. Daily activities within this range will not have an effect on the operation of the sensor. However, the effect on the system of longer periods under water has not been tested. 128 Appendix B Technical information B.1 Device features and characteristics Electromagneticcompatibility This product requires special attention relating to EMC (electromagnetic compatibility) and must be installed and serviced according to the EMC information provided in the manual. Using an accessory, sensor, or cable that is not supported by the manufacturer may increase or decrease the system's burst size. When the sensor is in use, do not put other equipment close to it. If you are using the sensor in such circumstances, check whether it is operating normally. Portable RF communication devices (including peripheral equipment such as antenna cables and external antennas) must be kept at least 30 cm (12 inches) away from all parts of the device. Failure to comply may lead to a decrease in product performance. This device contains licence-exempt transmitter(s)/receiver(s) that comply withInnovation, Science and Economic DevelopmentCanadas licence-exempt RSS(s). Operation is subject to the following two conditions:
1. This device may not cause interference. 2. This device must accept any interference, including interference that may cause undesired operation of the device. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :
1. Lappareil ne doit pas produire de brouillage;
2. Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. 129 The table below includes the manufacturer's declaration and additional information required by IEC 60601-1-2:2014 (Fourth Edition). Appendix B Technical information DC main power voltage Required testing level Note Testing name Radioactivity disturbance Electrostatic discharge immunity test Standard referenced CISPR 11: 2015 +
AMD1:2016 CSV IEC 61000-4-
2:2008 Part tested Enclosure D.C. 3 V Enclosure D.C. 3 V Radiated, RF electromagnetic field IEC 61000-4-3:2006
+ AMD1:2007 +
AMD2:2010 Enclosure D.C. 3 V Group 1, Class B 8 kV/Contact 2, 4, 8, 15 kV/Air 3 V/m 80 MHz ~ 2.7 GHz 80 %, AM at 1 kHz RF wireless communication Power frequency
(50/60 Hz) magnetic field IEC 61000-4-
8:2009 Enclosure D.C. 3 V 30 A/m Proximity magnetic field immunity IEC 61000-4-
39:2017 Enclosure D.C. 3 V 8 A/m 30 kHz CW Modulation 65 A/m 134.2 kHz PM 2.1 kHz 7.5 A/m 13.56 MHz PM 50 kHz 130 Appendix B Technical information Safety IEC 60601-1:2005 + AMD1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Protection against electric shock: Internally powered, Type BF applied part Mode of operation: Continuous operation Not for use in the presence of an oxygen-enriched atmosphere Protection against water and particulate matter: IP48 IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic disturbances Requirements and tests CISPR 11: Group 1, Class B IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability IEC 62366-1:2015+AMD1:2020 Medical equipment Part 1: Application of usability engineering to medical devices IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 131 Appendix B Technical information Radio regulation compliance Radio regulation compliance (FCCID: OELCGM-ST-002) 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. 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. 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. Connect the equipment into an outlet on a circuit different from that to which the Increase the separation between the equipment and receiver. receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Part15.21 statement:
Changes or modifications not expressly approved by the manufacturer (or party responsible) for compliance could void the users authority to operate the equipment. RF exposure statement:
This equipment complies with RF radiation exposure limits set forth for an uncontrolled environment. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. 132 Appendix B Technical information EN 301 489-1 Method of testing common technical EMC for radio equipment EN 301 489-17 Method of testing EMC for radio equipment of low-output wireless data transmission systems IC: 21003-CGMST002 This equipment complies with IC radiation exposure limits set forth for an uncontrolled environment and meets RSS-102 of the IC radio frequency (RF) Exposure rules. CGM-ST-002 a t test et jug conforme aux limites dexposition aux rayonnements nonces pour un environnement non contrl et respecte les rgles dexposition aux frquences radiolectriques (RF) CNR-102 de lISDE. 133 Appendix B Technical information B.2 Product specifications Sensor specifications ITEM Analysis method Enzyme type Measurement range Transmission distance Specifications Electrochemical method GDH-FAD 40500 mg/dL (2.227.7 mmol/L) 6 meters maximum Two calibrations immediately after sensor warmup The first two calibrations are made at 12-hour intervals, and the third calibration are made at 24-hour intervals. Temperature: 1042 C Humidity: 10-95 RH%
Calibration Operating conditions Storage and transport conditions Sterilization Number of uses Dimensions (W x L x H) Weight Color Power supply Power consumption Useful life Shelf life 134 Temperature: 530 C Humidity: 1585 RH%
Ethylene Oxide gas Single-use Transmitting part: 35.2x19.2x5.0 mm Applicator: 49.8x51.8x73.3 mm Transmitting part: 4.5 0.5 g Applicator: 74 5 g Transmitting part: Gray Applicator: White Coin battery (CR1632, 3 V) 1 ea 8 mWh Up to 15 days 12 months Appendix B Technical information ITEM Maximum memory Operating altitude Waterproof protection Data transfer interval Communication method Protection against electrical shock TX/RX frequency Maximum Output Power Modulation Data Rate Specifications 12 hours of glucose data
-3823,011 m IP48: Protected from ingress of dust: Protected from submersion in the water up to depth of 1 m for 24 hours Once every 5 minutes Bluetooth 4.2 Type BF Applied Part 2.4022.480 GHz
-5.6 dBm EIRP GFSK 1 Mbps 135 Appendix B Technical information Performance in terms of accuracy (based on YSI):
FA (Full Analysis) Set: 84 adults aged 19 or older PP (Per-Protocol) Set: 58 adults aged 19 or older 1) Overall accuracy FA Set MARD (%) 10.42 %
PP Set MARD (%) 9.82 %
2) Accuracy according to the number of days worn Category Number of days worn Day 1 Day 3-5 Day 8-10 Day 15 FA Set MARD (%) 10.70 %
9.70 %
9.63 %
11.74 %
3) Accuracy by blood glucose level Category FA Set Reference Glucose Range
(mg/dL)
<54 54-69 70-180 181-250
>250 MAD (mg/dL) or MARD (%) 11.88 mg/dL 12.38 mg/dL 10.53 %
9.40 %
10.42 %
PP Set MARD (%) 10.59 %
8.42 %
9.53 %
10.75 %
PP Set MAD (mg/dL) or MARD (%) 12.25 mg/dL 13.17 mg/dL 9.96 %
8.43 %
10.15 %
*69 mg/dL or less is displayed as MAD (mg/dL) and 70 mg/dL or more is displayed as MARD (%). 136 Appendix B Technical information B.3 Cybersecurity Cybersecurity Install an antivirus software on your smart device to prevent malicious programs from accessing your smart device's information. If the app and sensor are not connected even after scanning the barcode written on the sensor package label or manually entering the 6-digit PIN code and 4 digits of the serial number, check if the 6-digit PIN code and 4 digits of the serial number are entered correctly. If the same problem repeats even if you input it correctly, contact the Customer Service via the product website www.caresens.co.kr. If the app connects to the sensor and cannot find a signal, place the sensor and the smart device within 6 meters of unobstructed distance. This may take up to 15 minutes for the connection. If the same problem persists after 15 minutes, force quit the CareSens Air app in the settings app of the smart device and then restart it. If youre logged out and did not log in from another device, reset your password. If you have failed to enter your password more than 5 times, reset your password. Accounts that have not been logged in for one year will be converted into inactive accounts. If you have switched to an inactive account, email verification is required for log in. In the event of a cybersecurity incident related to a smart device, please contact the nearest authorized distributor or the competent authority. 137 Appendix C Glossary Description A radio wave or electromagnetic wave with a high frequency. This usually refers to waves between 3 and 30MHz in frequency. This means many devices are integrated in one semiconductor chip. A symptom in which glucose concentration in the blood is unusually high. In most cases it is related to diabetes. A display type in which features such as inputs and outputs are displayed in a simple graphical form, making the operation of a device simple and convenient. A machine that is used to locate metal objects or determine whether or not an object is metallic. The property of being resistant to water. A disease which results in a high amount of glucose being mixed with the urine. It occurs when the level of insulin, which is a hormone that controls carbohydrate metabolism, decreases. The frequency and volume of urination increases, water consumption increases due to thirst, and general malaise follows, but appetite improves. The process of acquiring administrator rights on a smart device running the Android operating system. A process which kills bacteria and other microscopic organisms. This can be done using chemicals, or physically using heat. Paper covered with silicone on one or both sides. It is used to protect adhesive surfaces. A symptom in which the skin or mucous membranes swell and become red due to infection. This is caused by enlarging of the capillaries. To generate additional copies of a file on a location such as a disk in case the file is damaged due to a malfunction. Term High frequency Focal Hyperglycemia Graphical user interface Metal detector Water resistance Diabetes Rooting Sterilization Backing paper Redness BACKUP 138 Appendix C Glossary Term Calibration Bluetooth Ethyleneoxide Intracellular fluids Application Applicator Continuous glucose monitoring system Inflammation Widget Insulin Insulin pump Description The process of providing a continuous glucose monitoring device with a glucose measurement taken from a finger prick. This adjusts the accuracy of the sensor's glucose readings. A wireless communication technology that allows data to be transmitted over a short distance between wireless communication devices, for example a personal mobile device and electronic office equipment such as a computer or a printer. One type of cyclic ether. It is oxidized ethylene, a colorless oxide gas. It highly soluble in water, alcohol, and ether, is highly inflammable, and is toxic. It is highly reactive and is used as an ingredient in organic compounds. Its chemical formula is C2H4O. A liquid component that exists in between animal tissue cells and acts as a cell environment. It provides nutrients to cells and removes waste products from them. It may also be referred to as interstitial fluid. A program developed for user convenience to be used on the operating system of a smart device or a tablet PC. A small tool used for application. A system which automatically measures glucose values in a continuous way after a user attaches a sensor to their body. The term can be shortened to CGMS. A defensive response that occurs in the body when tissue is damaged. For example, it appears as a symptom in response to an exterior injury, burn, or microbial invasion, and induces hyperemia, edema, fever, and pain in a part of the body. A collection of features which a user can easily access from the home screen of their smart device, with the most used features in one place. A protein hormone that regulates carbohydrate metabolism. It is secreted by the pancreas. It is used as an allopathic medicine to treat diabetes, as it acts to reduce glucose levels in the body. A device that is used to continuously administer insulin 24 hours a day. It continuously administers small dosages of fast-
acting insulin, and at the same time adjusts insulin dosage administration to account for meals. 139 Appendix C Glossary Description A space in which there is magnetic attraction such as near a magnet or current, or the Earth's surface. A symptom in which glucose concentration in the blood is unusually low. It can be caused by insulin overdose, liver complications, thyroid gland disorders, adrenopathy, pituitary disease, or gastric resection. Symptoms can include hunger, absent-mindedness, and cold sweat. If severe, it could result in holoprosencephaly and coma. The rating of an electrical device or any other device is the specified range the device should be used within. A line segment that connects two points on a circle or sphere while passing through its center. The act of drawing blood for the purpose of diagnosing a disease or performing a transfusion. Refers to blood inside blood vessels or tissues, lymph, and cerebrospinalfluid as a group. A system that saves files and information such as documents, photos, music, etc. on a personal online server. A type of monosaccharide. It forms white crystals that are sweet and highly soluble in water, and is reducible. It is widely distributed in the biological world, and is consumed as energy by living organisms. Its chemical formula is C6H12O6. It is also known as glucose. Sugar which is carried in the blood. In vertebrates, blood sugar consists mainly of glucose, which is the energy source for the brain and the red blood cells. The level in the blood varies with exercise and meals. BG (blood glucose) can also be referred to as plasma glucose. The rear portion of an object A type BF applied part is classified as a type F applied part, meaning that it is electrically isolated from Earth. This requires a higher protection rating than a type B applied part. This protection rating is designed to protect the user from shock if an unexpected surge from an external power source is connected to the patient and is applied to the patient contact location and the ground. Term Magnetic field Hypoglycemia Rating Diameter Finger prick Bodily fluid Cloud Glucose Glucose Back Type BF Applied Part 140 Appendix C Glossary Term CT EMC EU GSM IP rating MRI RF RF communication RFID WEEE Description Computed tomography. A diagnostic tool in which X-rays or ultrasonic waves are measured from different angles and the images of the reflected internal area are processed by a computer to produce a cross-sectional image. It is a technique used to diagnose various illnesses, including tumors. Electro Magnetic Compatibility, testing for immunity to electro magnetic interference from exterior sources. The European Union (an organization formed by 27 countries in the European community under the Maastricht Treaty). The Global System for Mobile Communications. This is the most widely used personal mobile communication system; a communication standard based on TDMA. Ingress protection, a dustproof and waterproof rating regulated by IEC 60529. The first number is a dustproof rating and the second number is a waterproof rating. Magnetic resonance device (a piece of equipment for chemical analysis that uses magnetic resonance phenomena). Radio frequency; the entire field of equipment design and engineering research concerning wireless communication using high frequencies in the electromagnetic frequency band. Wireless communication Radio-Frequency Identification uses electromagnetic waves to uniquely identify an ID, and is often refered to as RFID. RFID technology refers to the technology of using electromagnetic waves to process information over a long distance. Waste Electrical and Electronic Equipment. Regulations regarding obligations for recycling household appliances which have been disposed of. An EU environmental guide which requires consumers to pay recycling fees for disposing of electrical or electronic equipment. 141
1 | Internal Photos | Internal Photos | 213.44 KiB | September 27 2023 / March 25 2024 | delayed release |
1 | External Photos | External Photos | 1.14 MiB | September 27 2023 / March 25 2024 | delayed release |
1 | Label | ID Label/Location Info | 578.12 KiB | September 27 2023 |
LABELLING REQUIREMENTS FCC Certification Labelling Requirements The sample label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time of purchase. But this device is so small that I will put the FCC ID and Part 15.19 related information in the user manual and package label.
[Package]
i-SENS, inc Page 1 of 1 FCC ID : OELCGMST002 PCGCA-000008 REV A CS Air Blister Label CE EN PANTONE 2746 C Printing/Labeling area Dieline size: 62 x 87 mm Continuous Glucose Monitoring System Model: CGM-ST-002 FCC ID: OELCGMST002 UDI imprint area 40X20 mm Serial number Use-by date PIN CODE LOT 30 C 85 %
1060 hPa 5 C 15 %
700 hPa Manufacturer: i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea PCGCA-000026 REV A 2023-07 AL Sheet Desiccant TYVEK LID PET CASE Label Location 1Step Packaging:
TYVEK LID Adhesion 2Step Packaging:
AL Sheet Adhesion
(w/ Desiccant)
1 | Agent Authorization Letter | Cover Letter(s) | 43.78 KiB | September 27 2023 |
9/11/2023 Nemko North America, Inc. 303 River Road Ottawa, Ontario, Canada K1V 1H2 AUTHORITY TO ACT AS AGENT - FCC On our behalf, I appoint Nemko Korea Co., Ltd (165-51, Yurim-ro, Cheoin-gu, Yongin-si, Gyeonggi-do, 17042, Korea) , to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in FCC regulations will have affixed to it a label identical to that submitted for approval with this application. In signing this letter, Applicant certifies that neither the applicant nor any party to the application is not subject to a denial of Federal benefits, that include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47 CFR 1.2002(b) for the definition of a "party" for these purposes. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko North America Inc., still resides still resides with us. Sincerely, Printed name: Mi Seon Lee
1 | Confidentiality Cover Letter | Cover Letter(s) | 123.97 KiB | September 27 2023 |
COMPANY LETTERHEAD September 11, 2023 Nemko North America, Inc. 303 River Road Ottawa, Ontario, Canada K1V 1H2 REQUEST FOR CONFIDENTIALITY - FCC FCC ID: OELCGM-ST-002 Pursuant to Sections 0.457(d) and 0.459 of the Commissions Rules and FCC Guidance document 726920, we hereby request permanent confidential treatment of exhibits identified as such in the table below and request they are permanently withheld from public review based on the documents containing trade secrets and proprietary information not customarily released to the public. The public disclosure of this information might be harmful to the applicant and provide unjustified benefits to its competitors. We also request short-term confidentiality on certain exhibits until the intended date of marketing as outlined below. We request the exhibits be withheld from public view for a period of 180 days. We attest marketing of the product will only commence after the period of short-term confidentiality expires, or if marketing is to commence before the requested number of days listed above, the grantee will inform Nemko to release the Short-Term Confidentiality information withheld on the FCC equipment authorization website. Exhibit Block Diagrams External Photos Internal Photos Operation Description Parts List & Placement/BOM Tune-Up Procedure Schematic Diagrams Test Setup Photos Users Manual Type of Confidentiality Requested Permanent
Permanent*
Permanent Permanent Permanent Permanent
Permanent*
Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term The asterisked items (*) require further information to be provided in this justification letter before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 D01 found at:
https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=41731 and review section II, 3) regarding specific information that must accompany these requests. Note: any documents held under the Short-Term confidentiality will automatically become public after the requested time if an appropriate extension request has not been received. Any exhibits (i.e., schematic diagrams) that may have already been requested to have Permanent confidentiality as shown above need not be repeated under Short-Term confidentiality request. Sincerely, Signed:
Printed name: Mi Seon Lee Title: Assistant Scientist Company Name: i-SENS, Inc.
1 | Covered Equipment Attestation | Attestation Statements | 67.24 KiB | September 27 2023 |
Covered Equipment Certification Attestation Letter 9/8/2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1H2 Canada ATTN.: Reviewing Engineer FCC ID: OELCGM--ST-002 i-SENS, Inc. (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Note: If the equipment for which the applicant seeks authorization is produced by any of the entities identified on the current Covered List, the applicant should include an explanation on why the equipment is not covered equipment. i-SENS, Inc. (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing covered equipment. Signed:
Printed name: Mi Seon Lee Title: Assistant Scientist Company Name: i-SENS, Inc. Date: 9/8/2023
1 | Test Setup Photos | Test Setup Photos | 961.25 KiB | September 27 2023 / March 25 2024 | delayed release |
1 | US Agent for Service of Process | Attestation Statements | 70.87 KiB | September 27 2023 |
COMPANY LETTERHEAD U.S. Agent Designation for Service of Process -
Certification Attestation Letter September 8, 2023 Nemko North America, Inc. 303 River Road Ottawa K1V 1H2 Canada ATTN.: Reviewing Engineer FCC ID: OELCGM-ST-002 Per section 2.911(d)(7) of the FCC rules, i-SENS, Inc. (the applicant) certifies that the equipment for which authorization is sought is designated to the following U.S. Designated agent* for service of process:
Company Name:
Physical U.S. Company Address:
Agent name:
Agent Email Address:
FRN:
i-SENS, Inc. 3545 Lomita Blvd., Unit D, Torrance, CA 90505, USA i-SENS USA, Inc. i-sens-usa@i-sens.com 0033759184 The above contact person accepts the obligation for service of process. The applicant accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Applicant Signed:
Designated Agent Signed:
(Required, if different to Applicant):
Signed:
Printed name:
Title:
Company Name:
Date:
Mi Seon Lee Assistant Scientist i-SENS, Inc. September 8, 2023 Signed:
Printed name:
Title:
Company Name:
Date:
Jeonghan Ha Secretary and CFO i-SENS USA, Inc. September 8, 2023
* the applicant must designate a contact located in the United States for purposes of acting as the applicants agent for service of process, regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as the agent for service of process.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-09-27 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-09-27
|
||||
1 | Applicant's complete, legal business name |
i-SENS, Inc.
|
||||
1 | FCC Registration Number (FRN) |
0027432988
|
||||
1 | Physical Address |
43, Banpo-daero 28-gil, Seocho-gu, Seoul
|
||||
1 |
SEOUL, N/A
|
|||||
1 |
South Korea
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
v******@nemko.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
OEL
|
||||
1 | Equipment Product Code |
CGM-ST-002
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
M****** L********
|
||||
1 | Telephone Number |
82-2-********
|
||||
1 | Fax Number |
82-2-********
|
||||
1 |
m******@i-sens.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/25/2024 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Glucose Monitoring System | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is the maximum conducted output power. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Nemko Korea Co.,Ltd.
|
||||
1 | Name |
H**** K******
|
||||
1 | Telephone Number |
82-31********
|
||||
1 | Fax Number |
82-31********
|
||||
1 |
h******@nemko.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0004000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC