2.3 Pair Your Sensor with the Transmitter ...........30 2.4 Apply Your Sensor .................33 2.5 Sensor Warmup ................38 Section 3: Understand Your iCan i3 CGM Results ......39 3.1 Home Screen Overview..............40 3.2 Glucose Information ..............40 3.3 Navigation and Status Bar .............46 3.4 Events....................49...
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3.5 Alerts....................51 3.6 Access ...................57 Section 4: Treatment Decisions ............60 4.1 Talk with your Healthcare Professionals (HCPs) ......61 4.2 When to Use Your Blood Glucose Meter ........61 4.3 Using Your CGM to Help for Your Treatment Decisions ....61 Section 5: End a Session ..............63 5.1 End Your Sensor Session ..............64 5.2 Remove Sensor ................66 5.3 Start New Sensor Session.............66...
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(low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and result from the iCan i3 CGM do not (BG) value from your blood glucose meter to make diabetes treatment decisions.
Getting started with iCan Continuous Glucose Monitoring System (CGM) Continuous Glucose Monitoring System (hereafter referred as CGM) gives you a more complete picture of your glucose control than blood glucose (BG) monitoring alone. Using a sensor allows you to receive gaps between your BG checks.
Resources Tutorial: picking a display device, inserting the sensor, and using alerts. The tutorial is available at: iCan-cgm.com In-App Videos: There is an in-App Videos can help you learn: • Overview: See how your CGM shows where your sensor glucose is now, where it is going, and where it has been •...
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Sinocare provides Customer Care email for assistance. If you experience problems, report the issue to support@icancgm.com. When you send the request, please make sure the serial number of your device is included in your email. The serial number is listed on your sensor kit package.
Sensor Pack, a Bluetooth Low Energy (BLE) Transmitter Pack, and a mobile application (APP). The iCan i3 CGM provides real-time glucose levels and allows you to continuously view your sensor glucose values on your selected mobile device.
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1.1.1 Device Components What it’s What you see What it does called This is a sterile package where Sens or Pack the Sensor is stored. The Sensor Pack is designed for single use. The Sensor-Applicator helps you Button insert the Sensor under your Safety Switch skin.
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1.1.2 The iCan CGM APP The iCan CGM APP serves as the display for the iCan i3 CGM and supports Android and iOS devices (mobile devices). The APP is available on Google Play (Android) and the APP Store (iOS). To see a list...
1.3.1 Contraindications • Do not use the iCan i3 CGM if you are pregnant, on dialysis, implanted with a pacemakers or critically ill. It is not known how inaccurate in these populations.
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(CT) scan, or high-frequency electrical heat (diathermy) treatment. The iCan i3 CGM has not been tested in those situations. The i3 CGM, which may cause it to display inaccurate sensor glucose results or may prevent alerts. Without iCan i3 CGM results or alert To get the most...
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• No Treatment Decision if…. If your iCan i3 CGM does not show a number or arrow, or your results do not match your symptoms, use your Blood Glucose Meter to make diabetes treatment decisions.
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1.3.2.3 Transmitter to the transmitter. A damaged transmitter could cause injuries from electrical shocks and may make the iCan i3 CGM not work correctly. • Do not allow children or pets to put small parts in their mouth. This • Do not use the transmitter adjacent to other electrical equipment that may cause interference with the normal system operation.
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Seek for professional medical help or contact our Customer Care Email. • Store your iCan i3 CGM between 2°C and 30°C. Do not store • Do not use a sensor past its expiration date because it may give incorrect results.
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7 cm (3 inches) from the bleeding site. 1.3.3 Precautions 1.3.3.1 General Precautions • Avoid exposing your iCan i3 CGM to insect repellent and sunscreen. Contact with these skin care products may cause damage to your CGM. • Do not wear the iCan i3 CGM in a hot tub.
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• Monitoring results of the product can only be used as a reference for the auxiliary diagnosis of diabetes, not as the basis for clinical diagnosis. • If there is a burning sensation, or any discomfort, please remove the CGMS immediately 1.3.3.2 Testing Your Blood Glucose glucose is changing quickly;...
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1.3.3.4 Potential Risks Related to Sensor Use • Going Through Security Check Point When wearing your iCan i3 CGM, ask the Transportation Security Administration (TSA) for a full-body pat-down with a visual inspection of your sensor and transmitter. Don’t put your iCan i3 AIT body scanner and x-ray machine have not been evaluated or know the damage they may cause the iCan i3 CGM.
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• Hyperglycemia or hypoglycaemia Failure to use the iCan i3 CGM according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence.
Section 2: Start Your Sensor • Prepare the Sensor • Choose a Site • Pair Your Sensor with the Transmitter • Apply Your Sensor • Sensor Warmup CGM User Guide Section 2 Start Your Sensor...
Whether you're new to CGM or experienced, you must review the Quick Start Guide and complete the In-APP tutorials before using. User Requirement: Adult diabetes user who can read, understand and follow the iCan i3 CGM Instruction of Use and Quick Start Guide could use the device safely. CGM User Guide...
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2.1.2 APP Installation and Set up Step 1: APP Setup Tap CGM APP to open the APP. Tap “Allow” to enable Bluetooth, Location access, and allow being denied of Bluetooth service. CGM User Guide Section 2 Start Your Sensor...
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Recommended Mobile Device Settings See your mobile device instructions to learn how to change its settings. Use the following with your CGM system: • Bluetooth on: Your transmitter and APP communicate via Bluetooth. If it is not on, you will not get alerts and CGM results. locked screen.
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destination to let your smart phone switch the time automatically. Note that CGM APP displays all the glucose readings of the on-going Step 3: Login Enter existing Username and Password. CGM User Guide Section 2 Start Your Sensor...
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Or, if you need to create a new iCan account, follow the onscreen instructions below. CGM User Guide Section 2 Start Your Sensor...
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Step 4: Review Tutorials Next, the App will prompt you to review safety instruction including a tutorial video that guides you on using your iCan system. Note: This in-APP overview of iCan system does not replace this Instruction for Use. Read all of the information in this Instruction for Use before using CGM APP.
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2.1.3 System Settings The “System Settings” option under “Settings” button is where you Changing the glucose unit of measurement used throughout the APP (mg/dL or mmol/L) Tap the “System Settings” button, select “Unit of Measurement”. measurement has been changed. CGM User Guide Section 2 Start Your Sensor...
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Changing your email Your email address is used to log in to your account, as well as for important communications about your CGM. In the APP, tap the “System Settings” button, select “Change Email Address”. Enter the new email address you want to use, and press “Next”.
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Data Consents Please Review and revise data consents. In the APP, tap the “System Settings” button, select “Data Consents” CGM User Guide Section 2 Start Your Sensor...
2.2 Choose a Site Discuss ideal sensor insertion sites with your Healthcare Professionals (HCP). WARNING: Do not choose other sites. As the other sites have not been clinically evaluated, your sensor glucose results could be inaccurate. TIPS: • Place the sensor at least 7 cm (3 inches) from your insulin pump infusion set or injection site.
Clean the insertion site with alcohol. Let the area air dry. 2.3 Pair Your Sensor with the Transmitter The iCan i3 CGM transmitters communicate with the APP via Bluetooth, so it must be connected with the APP before using the system. This process is also called “Pairing”.
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Transmitter, make sure you enter the correct code. If you enter the wrong code or code from another Sensor Pack, you will not be able to use the iCan i3 CGM or your glucose result could be incorrect. CGM User Guide...
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Step 4: Pairing After clicking the "Next", the APP will instruct you how to attach Sensor to the Transmitter. You can follow the in-APP instructions below to apply your CGM. The Paring will start automatically. CGM User Guide Section 2 Start Your Sensor...
2.4 Apply Your Sensor The sensor probe is inside the Sensor-Applicator. Before applying the sensor, get familiar with the Sensor-Applicator. Button Insert sensor under your skin Sensor Sensor probe inserts through this hole Transmitter Send your glucose information from the sensor to the APP Adhesive Tape Keeps the sensor and transmitter on skin...
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Step 2: Apply the Sensor • Line up the blue arrow mark on the Sensor-Applicator with the matching blue arrow mark on the Transmitter Tray. On a hard • Gently turn the safety switch from the "Locked icon" to the "Unlocked icon"...
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CAUTION: Do not press the white button in the middle once the Safety Switch is fully released to prevent unintended results or injury • Lift the Sensor-Applicator out of the Transmitter Tray • Now it’s ready to apply the sensor. CGM User Guide Section 2 Start Your Sensor...
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Step 3: Apply the sensor • Place the Sensor Applicator over the prepared site and push down • Press down the button in the middle to apply the CGM Sensor. You will hear a click sound, that means the insertion is completed. •...
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CAUTION: Discard the used Applicator according to local regulations. sensor stays on the body for the entire duration of wear. CAUTION: Once inserted, the sensor is waterproof up to 2.5 meters, but the smart phone may not. If you're in or near water, the display device may need to be kept closer (less than 6 meters) to get sensor readings.
2.5 Sensor Warmup After inserting your sensor, the transmitter will automatically pair with your iCan CGM APP. You need to press “Start Sensor” to initiate the 2-hour sensor warmup period. During the warmup period, you will not receive alerts or CGM results. During sensor warmup, use your blood glucose meter if need.
Section 3: Understand Your iCan i3 CGM Results • Home Screen Overview • Glucose Information • Navigation and Status Bar • Events • Alerts CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
Graph Change from last glucose reading Current Landscape View Glucose High Glucose Alert Level Glucose Graph Low Glucose Alert Level Insulin Note Sport Note Add Note 3.2 Glucose Information CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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Glucose is changing but less than 3 mg/dL (0.16mmol/L) per 3 minutes. Trend Arrow: Rising or Falling slowly Glucose is changing slowly, more than 3 mg/dL (0.16mmol/L) or up to 6 mg/dL (0.33mmol/L) per 3 minutes. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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The numbers on the left show glucose levels in mg/dL (mmol/L). The numbers on the bottom show the time. CAUTION: displays all the glucose readings of the on-going session with their CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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• In your target range (between your high and low alert settings) when in the green area • Low when in the red area. When the transmitter reconnects with the display device after a Signal on the graph. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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CGM results from other times. To switch between view menu. The white hollow dot indicates a selected result in 1 of the days, the glucose result shows up on the top left panel. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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E. Time below Range (TBR) is the percentage of time that your glucose levels are low, below target ranges. CGM APP default low range is below 70 mg/dL(3.9 mmol/L). CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
• In the APP, tap the “Events” button on the status bar at the bottom. • Tap “History Report” and select the date range for which you want to view. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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• Tap “Event History” and you can review all Alerts information. • Tap the “SHARE” button to email the report to whom you want to share with. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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3.3.2 Help Guide The “Help” section provides a digital version of the iCan i3 CGM System user’s instructions including the “Quick Start Guide”, “Product Tutorials”, “Instruction for Use” and other device information. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
3.4 Events the iCan i3 CGM System you can track your daily events so you can APP, events can be viewed in the home screen as well as in the reports. trends. You can review the reports with your healthcare professional (HCP) and create a plan to manage your diabetes.
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For your convenience, there is no need to stop everything and enter your events as they are happening. When you have a moment, you can enter past events. Events are meant to be entered as individual occurrences. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
Urgent Low. What you hear, feel, and see • Initial alert: Vibrates 4 times and beeps 4 times Otherwise, as long as your mobile device is getting CGM results and CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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When your CGM result is below the target glucose range you set, you get your Low Alert. What you hear, feel, and see: High Alert range. What you hear, feel, and see: CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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Wait 10 minutes, if this still does not work, restart the mobile device and reopen the CGM APP. During signal loss, use your BG meter to check your glucose and make any treatment decisions. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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To change the default glucose alert levels: a. Tap “Settings” at the bottom of the Sensor Warmup screen or the home screen. b. Select “Personal Settings.” c. Tap the alert level to be changed. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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55 mg/dL (3.1 mmol/L) and 99 mg/dL (5.5 mmol/L). Choose the sound and message for this alert. Volume and vibration will match your mobile device settings. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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117 mg/dL (6.5 mmol/L) and 450 mg/dL (25.0 mmol/L). Choose the sound and message for this alert. Volume and vibration will match your mobile device settings. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
Settings > iCan ACCESS. Then follow the instructions on the APP screens. You can invite them by entering their name and email. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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“ ” to enable or disable an item, then tap “Send Invitation” CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
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3.6.2 Edit Status The Access screen shows the status of your “Care Partner” and lets you invite new ones. CGM User Guide Section 3 Understand Your iCan i3 CGM Results...
Section 4: Treatment Decisions • Talk with your Health Care Professionals (HCPs) • When to Use Your Blood Glucose Meter • Using Your CGM for Treatment Decisions CGM User Guide Section 4 Treatment Decisions...
Always follow their instructions in treatment decision. You should keep using your BG meter until you're comfortable with iCan i3 CGM. Trend arrows show the speed and direction of your CGM results so you can see where you are heading. Talk to your healthcare provider about using the trend arrows to determine how much insulin to take.
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Steady Arrow Actions to consider: • Low: Eat • High: Watch and wait if you took insulin recently. Otherwise, adjust insulin dose up • In target range: No action needed Arrows Going Up Actions to consider: • Low: Watch and wait •...
5.1 End Your Sensor Session Your iCan i3 CGM is intended to last for 15 days. The Sensor will automatically stop when the 15-day session is over. You can also end the sensor session early by manually stopping it. Before it ends, you will you start a new sensor session, you must...
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5.1.2 Manually stopping a session If you choose to stop a session before the end of the 15 days, you will need to stop it manually. In the CGM APP, tap the “Setting” button and choose “End the Monitoring”, hold the button for 3 seconds to end the current session. CGM User Guide Section 5 End a Session...
5.2 Remove Sensor Pull up the edge of the adhesive tape that keeps your Sensor attached to your skin. Slowly peel away from your skin in one motion. CAUTION: Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol. Discard the used Sensor.
Attachment A: Troubleshooting component. The solutions here are meant to be brief and not all- preventative measures there. Are you still not sure what to do after reading this Section? If your issue, contact Customer Care Email: support@icancgm.com Web: iCan-cgm.com A.1.
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Things to Examine / Solutions Questions to Ask try to remove it. Contact your HCP. Also seek professional medical help Broken sensor swelling, or pain at the insertion site). Prior to insertion, make sure the site is properly cleaned and dried. Sensor adhesive tape will See Section 2 for cleaning instructions.
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A.2. Transmitter Issues Things to Examine/ Solutions Questions to Ask Check the following: -The QR code on the Transmitter matches the one on the Sensor Pack (see Section 2 for details) - The transmitter and the mobile device are within 6 meters of each other and Bluetooth is on Transmitter did not pair -If the transmitter was previously connected to your mobile device but...
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Home screen shows Low treat your high or low blood glucose. When your result is between 36 or High instead of CGM and 450 mg/dL your iCan i3 CGM will display your result instead of Low result or High. CGM User Guide...
Attachment B: Security and Air Travel For help with your iCan i3 CGM System, contact Customer Care Email: support@icancgm.com. WARNING: In case of emergency, contact your HCP or emergency medical response. B.1. Security Check You can use any of the following methods to go through security when...
Attachment C: Take Care of Your CGM C.1. Maintenance Components What you shall do……. Sensor-Applicator • Keep it in the sterile package until ready for use • Do not use if it has expired Transmitter • Keep it in kit box until ready for use. Check transmitter and do not use if damaged •...
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Here is the recommended mobile device setting for your iPhone and Android mobile device. Screen Time's Downtime and APP Limits can temporarily disable apps. Screen Time You can: Add CGM APP to the Always Allowed APP list Do Not Disturb silences all alerts except for the Urgent Low alert. Do Not Disturb For iOS, you can You must...
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to Scheduled Summary. Permission You can: Background APP Refresh allows the CGM APP to continue running in Background APP alerts may be delayed. App Refresh You can: On iOS 15 and above, the Focus feature will silence alerts and mode, your iCan APP alerts may be delayed. You can: •...
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logging in, creating a new account, pairing the transmitter require your display devices online, or you cannot use the CGM, which may cause Make sure your display a treatment delay. devices is online Sharing your glucose data to others also requires your display devices online, or you cannot share, which may cause inconvenience.
18 years and older. Accuracy The accuracy of the iCan i3 CGM is shown in the table below. on average how far away the glucose sensor reading is from a blood glucose reading The iCan i3 CGM MARD is 8.71%, meaning it may read 8.71% lower or higher than your blood glucose.
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Performance Metrics* Result Notes Clinical Accuracy 100% % of readings in Consensus Error Grid Zone A (% CEG Zone A+B) to be clinically acceptable, whereas results outside of Higher numbers are better. *Reference is venous plasma glucose value measured on YSI glucose •...
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• Potential for improved quality of life monitoring Decreased manual record keeping Increased ability to identify and treat hypoglycemia; Increased reassurance for those fearful of hypoglycemia during sleep, sports, driving etc monitoring include: inconvenience; physical intrusiveness of "poking" multiple times daily; limited single “point-in-time” glucose measurement;...
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Operating humidity 10% - 90% Relative humidity Applied part Type BF applied part Transmitter 1 non-serviceable, non-rechargeable button cell inside Transmitter battery type the transmitter, DC 1.5 V Applied part Type BF applied part Operation Mode Continuous operation TX Frequency Bandwidth Maximum Output Power 1+1 dBm...
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3-minute intervals. If connection is lost between the transmitter and display device, upon re-connection any missed packets (up to 360 hours) will be transmitted from the transmitter to the display device. The iCan i3 CGM System is designed to only accept radio devices. D.4. Security Measures The iCan i3 CGM System is designed to transmit data between the...
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In addition to the security provided by the BLE connection, communication between the iCan transmitter and mobile applications is protected by additional levels of security and safety mitigations using an encrypted and proprietary data format. This format embeds various methods to verify data integrity and to detect potential instances of data tampering.
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CGM to help manage your diabetes. Your healthcare professional can help you decide how you should best use this device.
Attachment E: Label Symbols Symbol Description Manufacturer UK Responsible Person Date of manufacture Use-by date Serial number Batch code IP28 Type BF Applied Part User Guide CGM Attachment E Label Symbols...
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Single sterile barrier system Temperature limit Humidity limitation MR Unsafe Do not re-use Do not use if package is damaged This product must not be disposed of via municipal waste collection. Separate collection for electrical and electronic equipment waste per Directive 2012/19/EC in the European Union is required.
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Keep Away from sunlight Keep Dry Bluetooth This symbol suggests that the CGM has acquired European technical conformity in accordance with (EU) 2017/745 Medical device other persons within the MR environment Follow instructions for use Indicates the entity importing the medical device into the locale User Guide CGM Attachment E Label Symbols...
Attachment F: Alerts Vibrations and Sounds F.1 Glucose Alerts Screen Description Notify when the result is below the default low glucose level (default is 55 mg/dL) Rise rate alert. Notify when the glucose result is above the High Alert level and rising quickly.
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Notify when the glucose result is above the High Alert level Notify when the glucose result is below the Low Alert level. Notify when the glucose result is above result range (default is 450 mg/dL) Notify when the glucose result is below result range (default is 36 mg/dL) User Guide CGM Attachment F Alerts Vibrations and Sounds...
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F.2 System Alerts Screen Description Notify when the transmitter and mobile device Bluetooth Notify when user cannot connect to network, unable to connect to server. User Guide CGM Attachment F Alerts Vibrations and Sounds...
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Notify when an incorrect QR code is scanned. After the QR code scanning is completed, it will automatically connect between smartphone and transmitter. Notify if it has not been connected for 3 minutes. Notify when binding a device that has already been bound and the monitoring session has ended.
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Notify when the equipment status is already at the end of detection, User repeatedly click the "End Monitoring" button. Notify when there is no data within the query time period User Guide CGM Attachment F Alerts Vibrations and Sounds...
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F.3 Abnormal Alert Screen Description Notify when there is no sensor reading or glucose reading for a while. Replace it with a new device. Or use your BG meter during the transition period. If needed, please contact your Healthcare professional Notify when the sensor produces abnormal electrical signal for a while.
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Notify when the sensor produces abnormal electrical signal for a while. Notify when the sensor produces abnormal low value. Notify when the sensor produces abnormal high value. User Guide CGM Attachment F Alerts Vibrations and Sounds...
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Sensor start anomaly warning Low operating temperature alert High operating temperature alert User Guide CGM Attachment F Alerts Vibrations and Sounds...
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Notify when unable to connect to server during uploading data (automatically or manually) User Guide CGM Attachment F Alerts Vibrations and Sounds...
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Notify when unable to connect to server while viewing personal details. User Guide CGM Attachment F Alerts Vibrations and Sounds...
Glossary Blood glucose meter A device used to measure the levels of glucose in the blood. Blood glucose result The concentration of glucose in the blood, measured as either milligrams of glucose per deciliter of blood (mg/dL) or millimoles of glucose per liter of blood (mmol/L).
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Insulin A hormone produced by the pancreas that regulates the metabolism of glucose and other nutrients. Insulin injections may be prescribed by a healthcare professional to help people with diabetes process glucose (sugar), if their pancreas is damaged and does not produce insulin. Limitations CGM should not be used because it may be harmful to you or damage the system.
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age d'utilisation du CGM ican i3
The Sinocare iCan i3 CGM is intended for use by adults aged 18 years and older.
This answer is automatically generated