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ENGLISH Continuous Glucose Monitoring System USER GUIDE...
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TABLE OF CONTENTS TABLE OF CONTENTS LEGAL DISCLAIMER IMPORTANT SAFETY INFORMATION Getting started with iCan Continuous Glucose Monitoring System (CGM) Resources Section 1: System Overview System Description 1.2 Intended Purpose 1.3 User Safety Section 2: Start Your Sensor 2.1 Prepare the Sensor 2.2 Choose a Site 2.3 Pair Your Sensor with the Transmitter 2.4 Apply Your Sensor...
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Section 4: Treatment Decisions 4.1 Talk with your Healthcare Professionals (HCPs) 4.2 When to Use Your Blood Glucose Meter 4.3 Using Your CGM to Help for Your Treatment Decisions Section 5: End a Session 5.1 End Your Sensor Session 5.2 Remove Sensor 5.3 Start New Sensor Session Attachment A: Troubleshooting Attachment B: Security and Air Travel...
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Seek medical attention when appropriate. Any serious incident that has occurred in relation to the iCan CGM should be reported to A.Menarini Diagnostics and the competent authority of the Member State in which you are established or Swissmedic.
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Continuous ® Glucose Monitoring System (CGM) GlucoMen iCan Continuous Glucose Monitoring System (Model: o3, hereafter referred as iCan CGM) gives you a more complete picture of your glucose control than blood glucose (BG) monitoring alone. Using a sensor allows you to receive up to 480 sensor glucose (SG) readings every 24 hours, filling the gaps between your BG checks.
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Resources Tutorial: Our tutorial walks you through your first sensor session, including picking a display device, inserting the sensor, and using alerts. The tutorial is available at: www.glucomen.com In-App Videos: There are In-App Videos to 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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1.1 System Description Thank you for choosing the GlucoMen iCan Continuous Glucose Monitoring ® System (Model: o3, hereafter referred as iCan CGM). The iCan CGM System consists of three main components: a Sensor Pack, a Bluetooth Low Energy (BLE) Transmitter Pack, and a Mobile Application (APP). The iCan 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 you see What it’s called What it does This is a sterile package where Sensor Pack the Sensor is stored. The Sensor Pack is designed for single use. The Sensor-Applicator helps Button Safety Switch you insert the Sensor under your skin.
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1.1.2 The iCan CGM APP The iCan CGM APP serves as the display for the iCan 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 of compatible mobile devices, visit www.glucomen.com WARNING: Missing alerts from the iCan CGM APP may result in undetected low and high glucose levels.
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1.3 User Safety This section includes important safety information such as indications, contraindications, safety warnings, potential adverse reactions, and how to protect the system from radiation exposure damage. 1.3.1 Contraindications • Do not use the iCan CGM if you are pregnant, on dialysis, implanted with a pacemakers or critically ill.
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MR UNSAFE • Do not use iCan CGM, if you are suffering from coagulation disorders or taking anticoagulant drugs. 1.3.2 Safety Warnings 1.3.2.1 General Warnings WARNINGS: • Do not Ignore Low/High Symptoms Do not ignore symptoms that may be due to low or high blood glucose. Keep your blood glucose meter close to you.
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• The patient is an intended operator. No modification of this equipment is allowed. • Do not use the iCan CGM if you are pregnant, on dialysis, implanted with a pacemaker or critically ill. It is not known how different conditions or medications common to these populations may affect performance of the system.
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1.3.2.3 Transmitter • Do not use the device if you see any cracking, flaking, or damage to the transmitter. A damaged transmitter could cause injuries from electrical shocks and may make the iCan CGM not work correctly. • Do not allow children or pets to put small parts in their mouth. This product poses a choking hazard for young children and pets.
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• Do not use sensor if its sterile package has been damaged or opened, because it might cause an infection. • Do not open the sterile package until you are ready to insert the sensor because an exposed sensor can become contaminated. •...
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1.3.3 Precautions 1.3.3.1 General Precautions • Avoid exposing your iCan CGM to insect repellent and sunscreen. Contact with these skin care products may cause damage to your CGM. • Do not wear the iCan CGM in a hot tub. • If you notice significant skin irritation around or under your sensor, remove the sensor and stop using the CGM.
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1.3.3.3 Get Ready Before Start • Clean and dry your hands and your insertion site before inserting your sensor. Wash your hands with soap and water, not gel cleaners, and then dry them before opening the Sensor Pack. If your hands are dirty when you insert the sensor, you may get germs on the insertion site and get an infection.
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1.3.3.4 Potential Risks Related to Sensor Use • Going Through Security Check Point ■ When wearing your iCan 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 CGM System components through x-ray machines.
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SECTION 2: START YOUR SENSOR •Prepare the Sensor •Choose a Site •Pair Your Sensor with the Transmitter •Apply Your Sensor •Sensor Warmup GlucoMen iCan CGM ®...
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2.1 Prepare the Sensor 2.1.1 Before starting, make sure you have everything you need. iCan CGM System: • Sensor Pack. ■ Check expiration date on Sensor Pack. Do not use if expired. ■ Do not open the sensor sterile package until you are ready to insert the sensor.
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2.1.2 APP Installation and Set up Step 1: APP Setup The APP is available on Google Play (Android) and the App Store (iOS). Tap CGM APP to open the APP. Step 2: Enable notification and location access Tap “Allow” to enable Bluetooth, Location access, and allow notifications on your mobile device, so you will not miss the alerts or being denied of Bluetooth service.
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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. •...
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• Time: If you are crossing various time zones, DO NOT change your smart device time manually, wait until you have arrived at your final destination to let your smart phone switch the time automatically. Note that CGM APP displays all the glucose readings of the on-going session with their testing time in the current time zone.
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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”. You will receive a confirmation code through your new Email address, type it in and press “Confirm”.
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2.2 Choose a Site The iCan CGM is intended for the use on the abdomen only. Choosing a comfortable, effective place for your sensor is important. 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.
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• Do not use sites that have muscles or areas constrained by clothing or accessories, areas with rough skin or scar tissue, sites subjected to rigorous movement during exercise, or in sites under a belt or on the waistline for best sensor performance and to avoid accidental sensor removal.
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Step 3: Scan the SN Code Please scan the 2D barcode on the Sensor Pack Or enter the SN on the Sensor Pack manually 59004E3B00001 Next Following Step 4 from Sec 2.1.2, scan the SN 2D barcode located on the Sensor Pack label or enter the full SN Code on Sensor Pack by typing manually.
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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 surface, press down firmly until it comes to a stop and hear a click. •...
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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 injuries. • Lift the Sensor-Applicator out of the Transmitter Tray. • Now it’s ready to apply the sensor. USER GUIDE...
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Step 3: Insert the Sensor Applicator • Place the Sensor Applicator over the prepared site and push down firmly. • Press down the button in the middle to apply the CGM Sensor. You will hear a click sound, that means the insertion is completed. GlucoMen iCan CGM ®...
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• Gently pull the Applicator away from your body. CAUTION: Discard the used Applicator according to local regulations. • Smooth down the sensor adhesive tape with a finger to ensure the 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 be.
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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. Your first results begin after the 2-hour sensor warmup has passed.
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SECTION 3: UNDERSTAND YOUR iCan CGM RESULTS •Home Screen Overview •Glucose Information •Navigation and Status Bar •Events •Alerts USER GUIDE...
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3.1 Home Screen Overview The home screen below is from the iOS APP, the Android APP looks similar. Glucose Graph Bluetooth Connected Connection Graph of your current and stored glucose readings 02/22/2021 09:20 AM 8D 1h 10.1 Trend Arrow Current Glucose Change from last 0 mmol/L...
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When your most recent CGM result is above 25.0 mmol/L or below 2.0 mmol/L, you will not get a number. Instead, your display device will display LO (Low) or HI (High). If you do not have a number, use your blood glucose meter to measure your glucose.
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Trend Graph The graph below shows where your CGM results have been for the past few hours. It plots your CGM results every 3 minutes. The most recent CGM result is the black dot on the right. The white hollow dot in the middle is your glucose level on the selected time (for example in the picture below, 7.9 mmol/L is the glucose result at 2:00 PM).
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The horizontal lines show your High and Low Alert levels. Your glucose is: • High when your dots are in the yellow area of the graph. • In your target range (between your high and low alert settings) when in the green area.
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Daily Average The APP shows you trends from your CGM data in 1-day segments that summarize the 15 days in view. The white hollow dot indicates the selected daily review you are looking at the top panel. Multiple Days Daily Average Comparison Today 10/01/2023...
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Comparison The CGM APP allows you to select any 2 days from your past monitoring and compare your monitoring results. The color coated line in the graphic indicates the dates you select (on the right of the top panel) and the white hollow dot means the glucose level (on the left of the top panel) on a certain time.
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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. 3.3.2 Help Guide The “Help” section provides a digital version of the iCan CGM System user’s instructions including the “Quick Start Guide”, “Product Tutorials”, “Instructions for Use”...
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3.4.1 Enter Insulin Event Step 1: From the Home screen, tap “+”. Step 2: Then tap “Add Event” next to Insulin. Diet Add Event Exercise Add Event Insulin Add Event Medication Add Event Other Add Event USER GUIDE...
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Step 3: Choose the Insulin Type. You can choose your insulin type – Rapid acting, Rapid-acting inhaled, Regular/short acting, Intermediate acting, Long acting, Ultra-long acting or Premixed here. Step 4: Enter insulin units for each dose, up to 99 units. 3.4.2 Other Events Besides insulin on your APP, you can add other events such as diet, exercise, medication and others.
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3.5 Alerts When your CGM results reaches your pre-set alerts level, your mobile device will advise you by means of visual, vibrational or audible notifications, depending on the kind of alert and on your mobile device notification settings. Until you confirm the glucose-related alert, every 3 minutes you will get the alert screen along with a notification and a vibration.
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3.5.2 Alert An alert is a message telling you your glucose trend levels or CGM system needs attention. You can customize the Alerts in your APP. When you have your mobile device sound on, it vibrates and makes a sound on the alert.
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High Alert This notifies you when your CGM results are above your target glucose range. What you hear, feel, and see: • 6 vibrations and 6 sound alerts when the glucose level reaches the upper target limit; • 2 vibrations and 2 sound alerts every 3 minutes when the glucose level is within the upper target limit and steady;...
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Bluetooth Disconnection Alert This tells you when you are not getting iCan results. Your mobile device may be too far from your transmitter or there may be something, such as a wall or water, between your transmitter and your display device. Unlike other alerts, Bluetooth Disconnected Alert cannot turned off.
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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. Personal Settings Default Settings Do Not Disturb Mode Turn on if you want to silence audible alerts Notify Me Above 11.1 mmol/L...
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Low Glucose Alert The Low Glucose Alert is on by default. Tap the slider to turn the alert off. If the alert is on, you will be notified when your glucose falls below the pre-set level, which is initially set to 3.9 mmol/L. Tap to change this value between 3.3 mmol/L and 5.6 mmol/L.
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High Glucose Alert The High Glucose Alert is on by default. Tap the slider to turn the alert off. If the alert is on, you will be notified when your glucose rises above the pre-set level, which is initially set to 1 1.1 mmol/L. Tap to change this value between 6.5 mmol/L and 25.0 mmol/L.
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3.6 Access Use iCan CGM APP’s “Access” feature to let up to 10 friends, family, or another trusted caregiver view your glucose information. You can give them access to just your Sensor readings and trend arrow, or include the trend graph. You can even set up glucose notifications for them to get when your glucose goes high or low, similar to the alerts you get on your iCan CGM APP.
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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. iCan ACCESS ACCESS To temporarily stop sharing. tum ACCESS off. Care Partners Add a Care Partner Echo Invited Peter USER GUIDE...
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SECTION 4: TREATMENT DECISIONS •Talk with your Health Care Professionals (HCPs) •When to Use Your Blood Glucose Meter •Using Your CGM for Treatment Decisions GlucoMen iCan CGM ®...
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4.1 Talk with your Healthcare Professionals (HCPs) Working with your HCP, define your target glucose range and your alert settings. Discuss how to stay within your target using the iCan CGM System. Let your HCP guide you through the system features, including adjusting your alert settings to match your needs and goals, working with CGM results and trend arrows for treatment decisions, and managing your diabetes with the system.
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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; •...
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SECTION 5: END A SESSION •End Your Sensor Session •Remove a Sensor •Start New Sensor Session USER GUIDE...
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5.1 End Your Sensor Session Your iCan 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 get notifications letting you know your sensor session is ending.
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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.
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Attachment A: Troubleshooting Troubleshooting sections are categorized by function or system component. The solutions here are meant to be brief and not all-inclusive. References to specific Sections for more detailed answers or preventative measures there. Are you still not sure what to do after reading this Section? If your problem is not listed, or the recommended solution here does not fix issue, contact Customer Care.
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Things to Examine / Solutions Questions to Ask Broken sensor If a sensor tip breaks off under your skin and you cannot see it, do not try to remove it. Contact your HCP. Also seek professional medical help if you have symptoms of infection or inflammation (such as redness, swelling, or pain at the insertion site).
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A.2. Transmitter Issues Things to Examine / Solutions Questions to Ask Transmitter did not pair Check the following: with mobile device - 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;...
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Things to Examine / Solutions Questions to Ask Data missing on the If your transmitter and APP lose communication, there may be trend chart on the HOME a gap in the data because results were not sent to the APP. screen Once communication is restored, the gap may be filled in if the transmitter was collecting data during that period.
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Attachment B: Security and Air Travel For help with your iCan CGM System, contact Customer Care. 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 wearing or carrying your iCan CGM without worrying about damaging your CGM components: •...
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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: - Turn off Downtime and APP Limits or - Add CGM APP to the Always Allowed APP list. Do Not Disturb silences all alerts except for the Urgent Low alert.
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Notifications let you get alerts on your phone. If notifications for the CGM APP are off, you will not get any alerts. We recommend turning CGM APP notifications on. On iOS 15 and Notifications above, do not add the APP to Scheduled Summary. Permission 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 Make sure your display CGM, which may cause a treatment to be delay. devices is online Sharing your glucose data to others also requires your display devices online, or you cannot share, which may cause inconvenience.
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Attachment D: Technical Information D.1. Device Performance Characteristics Summary Sinocare assessed iCan CGM performance in a clinical study with 60 adults (18 years and older) participants. The participants all had type 1 or type 2 diabetes. Participants wore devices for up to 15 days on their abdomen. Each participant attended at least one clinical session during the beginning (Day 2), middle (Day 7-9), or end (Day 15) of the 15 days wear period to have their venous blood glucose measured every 15 minutes with a laboratory...
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Performance Metrics* Result Notes Clinical Accuracy 100% % of readings in Consensus Error Grid Zone A (% CEG Zone A+B). Glucose readings in zones A and B are considered to be clinically acceptable, whereas results outside of zones A and B may have a negative clinical outcome.
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• Potential for improved quality of life ■ Decreased fingerstick testing, increased ease of glucose monitoring; ■ Decreased manual record keeping; ■ Increased ability to identify and treat hypoglycemia; ■ Increased reassurance for those fearful of hypoglycemia during sleep, sports, driving etc. •...
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Transmitter Transmitter battery type 1 non-serviceable, non-rechargeable button cell inside the transmitter, DC 1.5 V Applied part Type BF applied part Operation Mode Continuous operation TX Frequency 2.402 GHz - 2.480 GHz Bandwidth 1.06 MHz Maximum Output Power 4.99 dBm Modulation Gaussian Frequency-Shift Keying Data Communication Range...
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Storage capacity No less than 500M Network WLAN (Wireless Local Area Network) or cellular network (4G and above), as well as Bluetooth function Note: Must have secure internet access during setup. Connection to IT- NETWORKS including other equipment could result in previously unidentified RISKS, such as unauthorized access, malware and viruses, data breaches etc.
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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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D.6. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The transmitter is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment. Immunity Test Transmitter Compliance Level Electrostatic Discharge (ESD)
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Attachment E: Symbols Symbol Description Manufacturer Authorized representative in the European Community UK Responsible Person Authorized Representative of Switzerland Date of manufacture Use-by date Serial number Batch code IP28: Protected from touch by fingers and objects greater than 12.5 millimeters. Protected from long term immersion ut to a specified pressure Type BF Applied Part Catalogue number...
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Single sterile barrier system Temperature limitation Humidity limitation Do not reuse 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. Contact the manufacturer for details Caution Consult the electronic instructions for use...
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Keep Dry Bluetooth This symbol suggests that the CGM has acquired European technical conformity in accordance with (EU) 2017/745 Medical device Indicates a carrier that contains unique device identifier information An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment Follow instructions for use Importer...
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Product Item Symbol Description Separate waste collection Recyclable Carton Box Non-corrugated Paper collection fibreboard Instruction for Use Recyclable Paper Paper collection HDPE White seal High density Plastic collection polyethylene (Tyvek ® Sensor Pack Thermoformed transparent Other plastic (PETG) Plastic collection plastic container Follow the local regulations for waste management or for the correct recycling of packaging...
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Attachment F: Alerts Vibrations and Sounds F.1 Glucose Alerts Screen Description Urgent Low Alert Your blood glucose level is currently 2.9 mmol/L, which is below the Set Urgent Low level of 3.1 mmol/L. Your blood glucose has been in the danger Notify when the result is below the default Urgent range.
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Notify when the glucose result is above the High High Glucose Alert Alert level Notify when the glucose result is below the Low Alert Low Glucose Alert level Out Of Range Alert 02/22/2021 09:20 AM 8D 1h Notify when the glucose result is above result range HIGH (default is 25.0 mmol/L) -- mmol/L...
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F.2 System Alerts Screen Description Notify when the transmitter and mobile device Bluetooth connection is off Bluetooth Disconnected Fail to Pair 1. Please make sure device After the QR code scanning is completed, it will assembly is correct. automatically connect between smartphone and 2.
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F.3 Abnormal Alert Screen Description No Sensor Readings You will not receive alerts, alarms or sensor glucose readings until you replace your sensor. Please remove Notify when there is no sensor reading or glucose this sensor and replace with a new reading for a while.
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Sensor abnormal reminder-B Your sensor has encountered an error. Please check to see if your sensor has become detached. You may need to replace this sensor. Notify when the sensor produces abnormal electrical signal for a while after warmup period Contact Customer Service Close Sensor abnormal reminder-C...
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Sensor Start Fail Do not remove the sensor. Try to scan the QR Code again or enter the SN manually. Sensor start anomaly warning Confirm Temperature Alert Your device's operating temperature is below the lower limit. Please use it within the required temperature range of the Low operating temperature alert device.
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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 A safety statement outlining specific situations in which the iCan CGM should not be used because it may be harmful to you or damage the system.
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1030 Brussels, Belgium SUNGO Certification Company Limited floor, 70 Gracechurch Street, London. EC3V 0HR OBELIS SWISS GmbH Ruessenstrasse 12, 6340 Baar/ZG, Switzerland A.Menarini Diagnostics S.r.l. Via Sette Santi 3 50131 Firenze, Italy GlucoMen iCan CGM o3 ® Made in P.R. China P/N: 36301756-A.4...
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UK/REPUBLIC OF IRELAND/ NORTHERN IRELAND MENARINI DIAGNÓSTICOS, LDA A. MENARINI DIAGNOSTICS LTD Quinta da Fonte 405 Wharfedale Road Edifício D. Manuel I, 2o B, Wokingham - Berkshire RG41 5RA 2770-203 Paço de Arcos Tel. +44-1 189-444100 Lisboa - Portugal GlucoMen Careline: Tel.
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MENARINI ΔΙΑΓΝΩΣΤΙΚΑ A. MENARINI DIAGNOSTICS ΙΑΤΡΙΚΑ ΟΡΓΑΝΑ ΑΕΒΕ France SASU 3-5, rue du Jura - BP 70531 Λ. Βουλιαγμένης 575 F-94633 Rungis cedex 16451 Αργυρούπολη - ΕΛΛΑΔΑ Tel. +33 (0)1 56 34 69 10 Τηλ. +30 210 9944950 Φαξ +30 210 9945029 www.glucomen.com Γραμμή...
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