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Diabeloop SA DBLG1 User Manual

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Summary of Contents for Diabeloop SA DBLG1

  • Page 3: Table Of Contents

    1.5.1 – When flying 1.5.2 – Data transfer to YourLoops Part 2: Using your system 2.1 – DBLG1: first-time use 2.1.1 – Installing the battery and charging the DBLG1 2.1.2 – Turning the DBLG1 on 2.1.3 – PIN code 2.1.4 – Initialization procedure...
  • Page 4 2.3.5 – Inserting the infusion set under your skin 2.3.6 – Connecting your pump to the infusion set 2.3.7 – Pairing the Kaleido pump and the DBLG1 2.3.8 – Checking the status of your insulin pump 2.4 – Managing loop mode 2.4.1 –...
  • Page 5 2.6 – Information displayed on the DBLG1 2.6.1 – DBLG1 Home screen 2.6.2 – Lock screen of DBLG1 2.6.3 – Trend arrows of the Dexcom G6 sensor 2.7 – Meals 2.7.1 – Declaring a meal 2.7.2 – Meal bolus recommendations 2.7.3 –...
  • Page 6 4.1 – Warranty 4.1.1 – What is covered and for how long 4.1.2 – What is not covered 4.1.3 – Obligations of Diabeloop SA under this limited warranty 4.2 – Cleaning and storage 4.2.1 – Dexcom G6 4.2.2 – Kaleido insulin pump 4.2.3 –...
  • Page 7 6.3.2 – Electromagnetic immunity and emissions: declaration and guidance 133 6.3.3 – Manufacturer’s declarations and statements 6.4 – DBLG1 6.4.1 – Expected effects of the DBLG1 System 6.4.2 – Technical specifications of the handset 6.4.3 – Frequency bands and maximum radio frequency power 6.4.4 –...

  • Page 9: Part 1: Getting Started

    A continuous glucose monitoring system (CGM). An insulin pump. The DBLG1 software gathers data from the CGM and the insulin pump, transmits alarms and alerts triggered by the CGM and the pump, and issues insulin delivery commands to the pump.

  • Page 10: Intended Purpose

    The DBLG1 software is intended for adult patients with type 1 diabetes who are aged 18 or older. The main function of the DBLG1 software is to adjust the insulin delivery at the correct time in order to maintain the patient's blood glucose in the target range and thus minimize both hypoglycemic events and long-term complications associated with elevated average glycemia.

  • Page 11: Safety Statements

    Without Dexcom G6 sensor readings or alarm/alert notifications, you could be exposed to a severe low or high glucose event. The safety and effectiveness of the DBLG1 System have not been tested or approved for the following categories of people.
  • Page 12 Unique device Date of manufacture Do not re-use identifier (UDI) Use-by date ® Country of MR (magnetic Bluetooth wireless Manufacturer manufacture resonance) unsafe technology Direct current (DC) Keep away from Class II equipment Type BF applied part sunlight Universal serial bus (USB) port/plug Humidity limitation Temperature limit...

  • Page 13: General Safety Statements

    1.2.2 – General safety statements As a patient, you are viewed as an operator and are expected to use the DBLG1 System independently at home after getting trained on its use by a competent healthcare professional and/or local support.
  • Page 14 Dexcom G6 sensor. Modification of this device is strictly forbidden. This medical device is meant for personal use. Make sure you always have a first-aid kit readily available. Despite the use of the DBLG1 System, severe hypoglycemia cannot be ruled out. To be prepared, always have your first-aid kit ready and tell someone you trust what to do in an emergency.

  • Page 15: Safety Statements About The Dexcom G6

    Do not try to modify, alter or disassemble any part of your DBLG1 System. We recommend that you keep your DBLG1 close by when you have the volume set low. 1.2.3 – Safety statements about the Dexcom G6 The Dexcom G6 CGM (sensor and transmitter) is intended to replace fingerstick blood glucose testing for diabetes treatment decisions.
  • Page 16 Use the correct sensor code When you start with a new sensor, you must enter a code into your DBLG1 to use the G6 without fingerstick calibrations. Each sensor has its own code printed on the back of the adhesive patch.
  • Page 17 Use your fingertips Use your fingertip to calibrate from your blood glucose meter. Blood from other areas may provide less accurate results and not be as timely. Be accurate, be quick Enter the exact blood glucose value displayed on your meter within 5 minutes of using your meter.

  • Page 18: Safety Statements About The Kaleido Pump

    Use as directed The transmitter is small and may pose a choking hazard. Do not put it in your mouth or let children hold it without adult supervision. Reuse – do not throw away When ending a session, do not throw away the transmitter. The transmitter is reusable for three months.
  • Page 19 Types of insulin to be used The DBLG1 System is not provided with the U100 insulin you need to use for your pump. For this, you should contact your healthcare professional. Your Kaleido pump and insulin cartridges are only approved for use with Humalog® and NovoRapid®...
  • Page 20 Do not open the packaging of the Kaleido disposables until immediately before use. Sterility of the package contents cannot be ensured when opening the packaging before immediate use. Using non-sterile components may result in infection. Check for damage of the insulin cartridge, infusion set and pump if you notice that your glucose levels are high or when you need more insulin than expected.

  • Page 21: Safety Statements About The Dblg1

    Recharge your battery at temperatures between –10°C and +50°C. Keep the battery out of reach of children. The maximum autonomy of the DBLG1 is 35 hours. If the battery of the DBLG1 does not last a full day, contact your local support for a battery replacement.
  • Page 22 Do not expose your DBLG1 to mechanical vibrations or impacts. Do not place your DBLG1 close to a source of heat such as a radiator or a stove. Do not expose the DBLG1 to excessive amounts of smoke, dust or high relative humidity conditions.

  • Page 23: Safety Statements About The Insulin

    Hospitals Always make sure that your DBLG1 is switched off in hospitals when so instructed by warning signs or medical staff. Systematically disconnect the charger from the plug socket when the battery is completely charged to ensure that it does not consume energy needlessly.

  • Page 24: System Components

    You can find all these numbers on their respective boxes. Your DBLG1 System kit contains all the equipment listed below. Contact your local support to find out how to obtain more supplies. Handset with pre-installed DBLG1 software...

  • Page 25: Dexcom G6

    G6 readings can be viewed on the DBLG1 and are refreshed every 5 minutes, without having to take samples from your fingertips. Your readings are carried out in the interstitial fluid by a disposable sensor inserted under the skin.
  • Page 26 When the pump is paired with the DBLG1 with loop mode ON, the decision-making process about the insulin doses to be injected is automated. However, the system also allows you to manually adjust the recommended insulin dose in certain situations, for instance following a meal declaration.
  • Page 27 Name Description Illustration Kaleido insulin pumps Insulin pump 1: Holder for your insulin cartridge (x2) 2: Groove for insulin cartridge tubing Reusable inserter to insert your Kaleido infusion set. Inserter Ensure you keep it handy with (x1) your Kaleido disposables. 1: Activation button Connection cable USB–...
  • Page 28 Top-up kit Name Description Illustration Insulin cartridge, which can be filled with 200 U of U100 insulin Tubing: 5 cm or 30 cm Insulin cartridge 1: Hole 1 2: Hole 2 (x10) 3: Insulin cartridge connector 4: Plastic tab 5: Filling cradle catch 6: Insulin cartridge tubing 7: Filling cradle 2.5 mL syringes to fill insulin...

  • Page 29: Dblg1

    Your DBLG1 also recommends that you take rescue carbs if you are at risk of hypoglycemia. If loop mode is OFF, you can still view the G6 readings and trend arrows on the DBLG1 screen and use them to control the pump.

  • Page 30: Composition Of Your First-Aid Kit

    YourLoops account when you first initialize your DBLG1. Refer to Initialization procedure on page 33. The use of YourLoops is not mandatory for the proper functioning of the system. 1.4 – Composition of your first-aid kit Always have a first-aid kit readily available.

  • Page 31: When Flying

    1.5.2 – Data transfer to YourLoops When you travel to some countries, the SIM card in your DBLG1 will not be able to transmit data to YourLoops. The data will be transmitted to YourLoops on the first day of the month following the return to a covered country.

  • Page 32: Part 2: Using Your System

    The DBLG1 can take up to 5 minutes to start when it has been switched off. If no action has been taken on the DBLG1 for more than a few seconds, the screen switches to sleep mode. Briefly press the ON/OFF button to turn the screen back on.

  • Page 33: Pin Code

    You can change it but for security reasons you cannot deactivate it. The code required for the first launch of the DBLG1 is 0000. You will be required to enter a new PIN during the initialization phase of the device. For security reasons if the device is stolen, you should avoid using four identical digits.
  • Page 34 Your DBLG1 suggests checking for software updates. NEXT and then follow the instructions on the screen to check for updates and install them right away. Otherwise tap SKIP. If you choose to skip the update at this stage, refer to...
  • Page 35 Select the time format. Check the units for the G6 readings and for the weight. These units are set by default. Tap CONTINUE. Fill in your personal information. This step is used to create your profile on YourLoops. Tap CONTINUE. Part 2: Using your system...
  • Page 36 If you do not already have a YourLoops account, tap on SIGN UP. If you already have an account, tap on LOG IN enter your login (email) and password. Create your account with a unique email address. If a professional account already exists, use another email address for the patient account.
  • Page 37 Tap CONTINUE. Enter your basal safety profile (based on the prescription): start time, end time and desired rate for each time slot. If loop mode switches off, the DBLG1 System will deliver this basal safety treatment. Tap ADD between each entry.
  • Page 38 Set your target glucose level and your hypoglycemia and hyperglycemia thresholds. By default these are set to 110, 70 and 180 mg/dL respectively. Adjust them as necessary. Tap CONTINUE. Enter a new PIN code and tap CHANGE. For security reasons if the device is stolen, you should avoid using four identical digits.

  • Page 39: Main Menu

    Access your personal profile. Check for system updates. Help Obtain help on the various components of your DBLG1 System. Test the sounds for alarms, alerts and notifications. View release notes, information on the product and manufacturer, software version installed, and terms of use and privacy policies.

  • Page 40: Setting Up The Glucose Sensor

    IGNORE if you want to use your G6 with manual calibration (calibration once a day). Put your DBLG1 down and set up your G6 as described below before pairing the transmitter and launching the sensor. Part 2: Using your system...

  • Page 41: Using The Applicator To Insert The Built-In Sensor

    2.2.2 – Using the applicator to insert the built-in sensor Where to insert: things to check Keep the safety guard on until you put the G6 applicator against your skin. If you remove the safety guard first, you may hurt yourself by accidentally pushing the button that inserts the sensor before you mean to.

  • Page 42: Attaching The Transmitter

    Clean the sensor site with an alcohol wipe and let it dry. Remove both adhesive backings; do not touch the adhesive. Place the applicator on the skin. Fold and break off the safety guard. Press the button to insert the sensor. Remove the applicator from the skin leaving the patch and holder on.

  • Page 43: Pairing The Transmitter And Starting The Sensor Session

    Clean the transmitter with an alcohol wipe. Insert the transmitter, tab first, into the holder. Snap the transmitter onto the sensor. Snap the transmitter firmly into place (listen for the click). Make sure it is flat and snug in its holder. Rub around the patch three times.

  • Page 44: Calibrating Your Dexcom G6 (Optional)

    Searching. Wait up to 30 minutes during this search phase. During this time, you will not receive any readings or alarms/alerts from your G6. If this phase fails, you are notified through the DBLG1. Refer to the List of alarms and alerts on page 108 for actions to be taken.
  • Page 45 Another calibration will be required after 12 hours, and again 12 hours after that. Then one calibration every 24 hours will be necessary. Reminder: your G6 readings are updated every 5 minutes on your DBLG1. Be accurate, be quick Enter the exact blood glucose value displayed on your meter within 5 minutes of using your meter.

  • Page 46: Checking The Status Of The Sensor

    > System status. Status Meaning No sensor registered There is no sensor paired with your DBLG1. Searching Your DBLG1 is attempting to pair with your transmitter. Initializing Your sensor is in its 2-hour warmup period. Part 2: Using your system...

  • Page 47: Stopping The Sensor Session

    The sensor session is stopped when the 10-day period comes to an end. You may also have to end the session prematurely at your own initiative or on infrequent occasions when the DBLG1 detects issues related to the sensor and requests that you end the session.

  • Page 48: Removing The Sensor

    41 to install a new sensor. The transmitter's serial number is recorded in the memory of the DBLG1. You do not need to enter this number when you change sensors. Make sure you wait 15 to 20 minutes before attaching the transmitter to the new sensor, otherwise the system will not recognize the sensor as a new one and will display an error message.

  • Page 49: Changing The Transmitter

    Before removing a used cartridge and/or changing the pump, always stop your pump using the DBLG1. Remove and discard the insulin cartridge appropriately. Put your pump to charge. These steps are important because your DBLG1 cannot pair with a new pump if it is still paired with the previous one.
  • Page 50 Do not fill an insulin cartridge with cold insulin. Only fill the insulin cartridge using room temperature insulin. Filling the insulin cartridge with cold insulin may cause air bubbles to form inside your insulin cartridge. Always follow the insulin manufacturer’s instructions regarding storage and use of insulin.
  • Page 51 Without moving the plunger, push the tip of the syringe firmly into Hole 1 so that it fits securely into the filling cradle. Holding the syringe in place with one hand, use the other hand to carefully pull the plunger all the way up to the top of the syringe.
  • Page 52 Remove the needle cap from the needle. Draw the plunger down to fill the syringe with 2.5 mL of air. Place the vial on a flat surface in front of you. Carefully push the needle through the rubber stopper of the insulin vial.
  • Page 53 Check the syringe for air bubbles. If there are air bubbles, repeat Steps 13 and 14 as often as needed to get rid of the air bubbles in the syringe. This will help make sure that there are no air bubbles in the syringe that can be pushed into your insulin cartridge during the filling process.

  • Page 54: Inserting The Cartridge Into The Pump

    You will need to prime and then remove your insulin cartridge from the filling cradle. Hold the top of your insulin cartridge with your fingers on both of the round edges and squeeze it further into the filling cradle. This will unhook the plastic tab on the insulin cartridge from the filling cradle so that the insulin cartridge pops back up.

  • Page 55: Choosing Your Infusion Site

    DBLG1. Your DBLG1 will only be able to respond if it is turned on and within range of your pump. As well as confirming that your pump and DBLG1 are ready to connect, the beeps let you know that your pump and DBLG1 alarm systems are working properly.

  • Page 56: Inserting The Infusion Set Under Your Skin

    Strictly adhere to the infusion sites shown in green on the following diagram. Avoid wearing your infusion set in the following areas or locations. Highly sensitive areas, Under a waistband or tight clothing, Areas exposed to rubbing or bumping, Over a bone, Bruised skin or areas with burns or cuts, Blood vessels, 5 cm around the belly button,...
  • Page 57 Do not reuse infusion sets. Doing so may contaminate your insulin and lead to infection and possible under or no delivery of insulin. Do not let the infusion set come in contact with water within the first hour of applying. Making the infusion set wet within the first hour of application may cause decreased adhesion properties.
  • Page 58 Remove the protective circle of plastic that is sitting on top of your infusion set. Do not touch the cannula before use. The cannula is sterile. Touching the cannula before using it may lead to infection. With your infusion set still in its packaging, place it on a flat surface.
  • Page 59 If possible, use one hand to hold your skin taut. Be careful not to touch the actual spot that you will insert the cannula into. Then use your other hand to position your inserter on your skin. Remember, you can use the gap in the base of your inserter as a guide for where your insulin cartridge will connect to your infusion set.

  • Page 60: Connecting Your Pump To The Infusion Set

    Make sure you dispose of the needle appropriately. Last but not least, keep your inserter safe, ready for next time. Do not throw it away, it will be useful for future infusion set changes. You should establish a routine for rotation and visual examination of your infusion set insertion sites to ensure that the sites remain healthy and free of redness, irritation, swelling, pain or infection.
  • Page 61 Take your pump patch (1) and peel off the paper backing that covers the back of the patch. This reveals the patch’s adhesive. 1: Pump patch 2: Body patch Stick the pump patch to the bottom of your pump so that it covers the insulin cartridge and the fuzzy hexagon shape is facing outwards.
  • Page 62 Being careful to support the weight of your pump, clip the connector at the end of your insulin cartridge tubing into your infusion set. You will know it is secure when you hear the two distinct clicks as the right- and left-hand sides connect.

  • Page 63: Pairing The Kaleido Pump And The Dblg1

    2.3.7 – Pairing the Kaleido pump and the DBLG1 For the insulin pump to be visible by the DBLG1, you must fix the full cartridge into the location provided for this purpose in the pump body. The Kaleido pump can be identified from its color and its 12-digit identification number (ID).
  • Page 64 The DBLG1 then starts the initialization with the detected pump. Wait during this process. The paired pump beeps four times. Confirm on the DBLG1 that you have heard the pump beep. Then tap OK. If you did not hear the pump beep, tap BEEP AGAIN.
  • Page 65 Ensure your cartridge is new and fully filled, and tap YES. Ensure the infusion set is new and fixed to your body, and tap YES. Part 2: Using your system...
  • Page 66 Select your cannula size: 6 MM Before starting the pump, the system must prime the cannula. Tap PRIME. During the priming process, the DBLG1 displays the message "In progress. Please wait". Part 2: Using your system...

  • Page 67: Checking The Status Of Your Insulin Pump

    2.3.8 – Checking the status of your insulin pump Once your pump starts, it dispenses insulin according to your basal safety profile, which was set during the initialization phase of the DBLG1. Part 2: Using your system...
  • Page 68 Important: at this stage, automatic adjustment of your insulin delivery is not yet operational since loop mode has not been started. Your DBLG1 System cannot yet send orders to the pump to adjust your insulin intake. Refer to Starting loop mode on the facing page to start loop mode on your DBLG1.

  • Page 69: Managing Loop Mode

    2.4.1 – Starting loop mode Do not start loop mode if you have injected a meal bolus or correction bolus without the DBLG1 and the Kaleido insulin pump. Make sure you add this insulin dose to the bolus history on your DBLG1 ( >...

  • Page 70: Checking The Status Of Loop Mode

    System status screen. Sometimes, the pump or the sensor may be temporarily disconnected from the DBLG1. If this happens, the loop mode icon on the Home screen switches to . The pump then delivers the basal safety profile. The pump's status changes...
  • Page 71 Enter the number of units for the bolus and tap CONFIRM then OK. The DBLG1 informs you that the bolus request has been sent successfully. Tap again. You can enter a bolus dose of between 0.05 U and 10.00 U. If you enter a value less or greater than these two values, you will not be able to confirm the delivery of your bolus.

  • Page 72: Stopping And Restarting Insulin Delivery

    If the pump stops because of an alarm-triggering condition, an alarm sounds and a message is displayed on your DBLG1. 2.5.3 – Removing the pump to switch to another pump Always pause or stop your pump prior to removing the pump. Otherwise, insulin may be spilled.
  • Page 73 Remove the old insulin cartridge from the pump you were just using before connecting your DBLG1 to your new pump. In this way, you ensure that your DBLG1 is not connected to your used pump, and you can connect your new pump right away.

  • Page 74: Removing The Pump Temporarily

    This could force you to use a new cartridge and pair a pump again with the DBLG1. As long as the cartridge remains in place in your insulin pump, you can stop and restart the pump with the same insulin cartridge.

  • Page 75: Charging Your Pump

    Stop the pump. Wash your hands thoroughly. Gently squeeze the tabs on the side of your insulin cartridge connector to unclip it from your infusion set – your pump and infusion set are now separated. Close the protective cover on your infusion set. Lift the pump away from your body patch.

  • Page 76: Declaring An External Bolus On The Dblg1

    2.5.6 – Declaring an external bolus on the DBLG1 The system can only calculate active insulin (that is, the amount of insulin delivered by way of a bolus that is still circulating in your body) based on the insulin that it knows has been delivered.

  • Page 77: Unpairing The Pump

    2.6 – Information displayed on the DBLG1 2.6.1 – DBLG1 Home screen The Home screen of the DBLG1 is composed of the following elements. Status bar (black bar at the top of the screen)
  • Page 78 Understanding your Home screen Main menu Trend arrow indicating how your interstitial glucose concentration varies. Displays the G6 readings measured within the last 5 minutes. Displays the amount of active insulin. Green: normoglycemia Your G6 reading is between your hypoglycemia and hyperglycemia thresholds.

  • Page 79: Lock Screen Of Dblg1

    2.6.2 – Lock screen of DBLG1 The lock screen of your DBLG1 contains some of the same information as the Home screen, in particular the latest G6 reading along with the associated trend arrow. 2.6.3 – Trend arrows of the Dexcom G6 sensor...

  • Page 80: Meal Bolus Recommendations

    Enter the quantity of carbohydrates or select a predefined quantity: Small/Average/Large. If you intend to have a high-fat meal, select this option. Your system will adjust the insulin doses to compensate for delayed hyperglycemia, which is often observed with this type of meal. Tap CONFIRM.

  • Page 81: Modifying Or Deleting A Meal

    DBLG1) and you then have to supplement the bolus manually, you must take into account the insulin dose already administered when you calculate the dose for the supplement.

  • Page 82: Physical Activities

    MODIFY again to save the new declaration. The meal bolus is calculated using the new information that you just provided to your DBLG1. You can eat while listening carefully for any bolus alerts. You can still change this declaration even after you receive a bolus notification. Cancel the bolus notification and repeat the steps described above for modifying the meal.

  • Page 83: Declaring A Physical Activity

    (shorter or longer session, for example), even if the activity has already taken place. If you do not intend to do your planned sport, delete the activity. These measures will ensure that your DBLG1 continues to make the correct adjustments.

  • Page 84: Stopping An Ongoing Physical Activity

    Tap on > History > Physical activities. Tap on Future activities Past activities. MODIFY and change the relevant information. MODIFY again to save the new information. 2.8.3 – Stopping an ongoing physical activity On the Home screen, tap STOP. Confirm that you want to stop the ongoing physical activity or tap DECLARE NEW if you wish to declare another session.

  • Page 85: Rescue Carb Intake

    2.9 – Rescue carb intake 2.9.1 – Rescue carb recommendations The rescue carb recommendation is automatically implemented by loop mode to prevent the occurrence of hypoglycemia. If your G6 reading is close to the hypoglycemia threshold that you defined, an alarm is triggered and the system recommends that you take some rescue carbs.

  • Page 86: History

    Tap CONFIRM. 2.10 – History Your DBLG1 stores 3 months of data (glycemia, injections, meals, activities, device events, etc.). Consult YourLoops to see all your data. 2.10.1 – History graph Tap on >...

  • Page 87: Detailed History Of The Bolus Doses

    After a power interruption: the glycemia information of the past 3 hours is recovered. if the pump is still paired with the DBLG1, the insulin delivery history of the past 24 hours is recovered. Data related to any actions performed during this interruption will not be visible in the history graph for this period (for example, meals, rescue carb intakes, pen or other external boluses...). This type of information must be declared manually when the...

  • Page 88: Detailed History Of The Calibrations

    The software version associated with your DBLG1 is 1.15.x. When an update is scheduled, a notification is displayed on your DBLG1 informing you of the time for the new installation. At the end of the update, your device may restart. A popup message is displayed which informs you that the update has been completed successfully.

  • Page 89: Part 3: System Settings And Customization

    DBLG1 indicates that the setting can be changed at any time. this logo on your DBLG1 indicates that the setting can be changed only if loop mode is OFF. Once the change is saved, you must restart loop mode.

  • Page 90: Loop Mode Settings

    Hypoglycemia refers to abnormally low glycemia. When your glycemia falls below the hypoglycemia limit that you have defined, the information on your DBLG1 is displayed in RED. If loop mode predicts that your glycemia will fall below your hypoglycemia limit, loop mode can temporarily stop insulin delivery and may also recommend a rescue carb.

  • Page 91: Loop Mode Off Settings

    Aggressiveness factors have no direct effect on the amount of carbs proposed by loop mode as rescue carbs. If necessary, we recommend adjusting all aggressiveness settings in steps of 10%. Aggressiveness during hyperglycemia: enables loop mode to adjust the quantity of insulin delivered by increasing or decreasing the size of the correction boluses.

  • Page 92: Patient Settings

    DBLG1—and is based on your prescription. If loop mode switches off, the DBLG1 System will deliver this basal safety treatment. You can adjust your basal rates over time if you feel that they are no longer suitable for your needs.

  • Page 93: Zen Mode Settings

    This value, however, cannot be changed. 3.2 – DBLG1 settings 3.2.1 – Sound and vibration settings (alerting you to a risk) Your DBLG1 System sends messages to inform you on the status of one of the system components. Part 3: System settings and customization...
  • Page 94 You can configure the sound of alerts and notifications related to your system components: insulin pump, sensor, loop mode and DBLG1. By default, the DBLG1 System beeps twice when it sends an alert and once when it sends a notification.
  • Page 95 Tap on > Settings > DBLG1 > Sound and vibration > Glucose sensor Insulin pump (for example). To configure all the alerts or notifications related to the component: within the section GENERAL SETTINGS, tap All alerts notifications. To configure a specific alert or notification:...

  • Page 96: Credentials

    YourLoops. PIN code Tap on > Settings > DBLG1 > Credentials > code. Enter your current PIN code. Then enter the new PIN code and confirm it. For security reasons if the device is stolen, you should avoid using four identical digits.
  • Page 97 Requesting a password reset forgot your password? on the previous screen and then RECEIVE KEY. A one-time key will be sent to your email address. Once you have received the key, tap CREATE NEW PASSWORD. Enter the alphanumeric key (no spaces, with capital letters) and new password (10 characters, no spaces).

  • Page 98: Data Sharing

    Nevertheless, we advise you to regularly check that the time on your DBLG1 is correct, particularly when you are traveling across multiple time zones. Discuss any necessary adjustments to your settings with your healthcare professional if you plan to travel across multiple time zones.
  • Page 99 Checking for updates Make sure your DBLG1 is charged to at least 25% before proceeding with an update. Updates cannot be installed while you are declaring a meal or a physical activity. Complete any meal declarations or physical activity declarations before proceeding with an update.

  • Page 100: Part 4: Warranty, Maintenance And Disposal

    4.1 – Warranty 4.1.1 – What is covered and for how long Diabeloop SA provides a limited warranty to the original purchaser, under which the DBLG1 System is free from defects in material and workmanship under normal use for the period starting from the date of reception to the end of the warranty period.

  • Page 101: Cleaning And Storage

    4.2 – Cleaning and storage The system should be cleaned when you are not wearing the components on your body. Never try to clean any of the components of the DBLG1 System while it is connected to a power source.

  • Page 102: Kaleido Insulin Pump

    Rinse: focus on the uneven areas. Swirl in Cavicide for 10 seconds and refill the syringe. Scrub: saturate a clean cloth or wipe with Cavicide and wipe the entire transmitter for at least 3 minutes or until all grime has been removed. Focus on the uneven areas. Disinfection Rinse: as before, focus on the uneven areas and swirl in Cavicide for 10 seconds.

  • Page 103: Dblg1

    4.2.3 – DBLG1 Never try to clean the DBLG1 while it is connected to a power source. The DBLG1 is not waterproof. Do not use too much water during the cleaning process. Part 4: Warranty, maintenance and disposal...

  • Page 104: Disposal And Waste Management

    DBLG1. Do not clean the electrical connections. Storage and transport Use the original packaging whenever shipping or storing the DBLG1. Disconnect the cables from the DBLG1 during shipping. We recommend removing the battery from the DBLG1 for shipping. Minimum Maximum Temperature –25°C...

  • Page 105: Kaleido Insulin Pump

    The abandonment or uncontrolled disposal of waste can cause harm to the environment and to human health. Contact your local support for the disposal of your DBLG1. The DBLG1 will then be returned by your local support to Diabeloop SA for destruction. Any health data stored on the DBLG1 will be erased by Diabeloop SA before the DBLG1 is destroyed.

  • Page 106: Part 5: Alarm System And Troubleshooting

    When the DBLG1 is switched on, it displays the corresponding event on the screen if it is still in the pump's memory. The error code is visible in the Events menu.

  • Page 107: Classification Of The Alarm System

    DBLG1 is operational. 5.1.3 – Symbols associated with the alarm system The symbols associated with the alarm system appear on the DBLG1 as popups on the lock screen and as icons in the status bar of the Home screen.

  • Page 108: List Of Alarms And Alerts

    When an alarm or alert is triggered, it is displayed on your DBLG1 within 1 second. All alarms, alerts and notifications are saved and displayed in the...
  • Page 109 The pump can no pump and the occlusion sensors. You will need longer deliver insulin. to pair your pump again with the DBLG1. 5. If the above steps fail, remove your pump and infusion set completely. Switch to your other pump using a newly-filled insulin cartridge and infusion set.
  • Page 110 2. Pair your pump with the DBLG1 again. was removed running. If you do not see the alarm on the DBLG1, from the The pump stopped and remove the cartridge completely from the pump pump while...
  • Page 111 Name reminder Alarm / Alert / Reminder if problem not resolved 1. Bring the DBLG1 and the insulin pump closer together if they are further away from each The system detected a other than the recommended distance. loss of connection...
  • Page 112 12000 OFF. 2. Check the current insulin delivery. Hypoglycemia 3. Take rescue carbs and declare the rescue carb quantity on the DBLG1. : Every 30 minutes 4. Contact your healthcare professional if if the condition is still necessary. present There is a sensor 1.
  • Page 113 • Check the expiration date of the transmitter. The entered ID is • Check that the ID of the transmitter in the incorrect or the 10100 DBLG1 corresponds to the one currently in transmitter has Incorrect use. expired. transmitter ID •...
  • Page 114 The request to stop Failed to stop the sensor session 2. Try again. the sensor failed. 3. If the problem persists, restart the DBLG1 session and then try again. The sensor will expire within the next 12 hours. IMPORTANT: a...
  • Page 115 3. Wait for 5 minutes to ensure that the needed in 15 The system will need calibration has been saved. minutes to be calibrated in 15 View the calibration history of your DBLG1 if minutes. needed. Part 5: Alarm system and troubleshooting...
  • Page 116 2. Check the current insulin delivery. soon alarm is triggered 3. Take rescue carbs and declare the rescue only if loop mode is carb quantity on the DBLG1. OFF. 4. Contact your healthcare professional if necessary. : Every 30 minutes...
  • Page 117 10114 The symbol (???) is 2. Take a rescue carb if necessary and declare No glucose displayed instead of it on your DBLG1. readings for readings. over 20 3. Check the transmitter. Make sure it is flat minutes IMPORTANT: this and snug in its holder.
  • Page 118 Reminder if problem not resolved Do not calibrate. Communication with the transmitter failed. 1. Check that the DBLG1 and the transmitter The DBLG1 displays are within 2 meters of each other and that the symbol (--) there are no obstacles in between.
  • Page 119 1. Check your glycemia using a blood glucose readings for over 30 meter. minutes. Loop mode is OFF. Loop mode 2. Bring the DBLG1 and the G6 closer together 21000 will restart if they are further away from each other than No glucose automatically once the recommended distance.
  • Page 120 15 was less than 100 2. Bring the DBLG1 and the G6 closer together minutes. mg/dL. if they are further away from each other than Risk of the recommended distance.
  • Page 121 OFF physical activity and 3. Check the Events menu in the DBLG1, and for 2 hours this activity is ongoing then resolve the problem if an error message (since you may have caused the shutdown.
  • Page 122 ALARM SYSTEM OF LOOP MODE Error code + Description and Action to be taken Name reminder Alarm / Alert / Reminder if problem not resolved 20105 Loop mode has A sensor detected that a calibration is calibration is ongoing. ongoing. The The bolus Wait for the bolus recommendation to be bolus...
  • Page 123 61000 very low (5%). Your Charge your DBLG1 as soon as possible. DBLG1 may shut down. handset To be on the safe side, charge your DBLG1 every battery is night. very low : Every 15 minutes The DBLG1 regularly tests all functionalities. If Your DBLG1 may not be one of these tests fails, this alarm is triggered.

  • Page 124: Troubleshooting

    5.2 – Troubleshooting 5.2.1 – Dexcom G6 Accuracy issues G6 readings do not match blood glucose meter values Different body fluids give different numbers. A blood glucose meter measures glucose from the blood (i.e., glycemia). The G6 sensor measures glucose from interstitial fluid. Calibrating may help align your G6 readings with your meter values.
  • Page 125 Issue Solution Once your sensor has been inserted, you can reduce peeling by putting an Overpatch or medical tape (such as Blenderm) over the adhesive patch. Do not cover the transmitter. Avoid open wounds. To order an Overpatch, contact your local support. Adhesive patch peeling off body Overpatch...

  • Page 126: Part 6: Technical Specifications

    - transfer the estimated glycemia measurements to loop mode. The device must trigger low, medium and high priority messages coming from the DBLG1, the sensor and the insulin pump, with appropriate sound levels and tone.

  • Page 127: Potential Risks

    6.1.3 – Potential risks Risks related to sensor use General risks related to sensor use may include: skin rash. infection. allergic reaction. sensor breakage or damage. Risks related to insulin administration and Kaleido pump use Due to the use of insulin, there is a risk related to the infusion of insulin and the potential interruption of insulin delivery.

  • Page 128: Dexcom G6

    art cybersecure principles. Security of use is dependent on the user's compliance with the terms and conditions of use and data privacy policies. General risks related to cybersecurity may include: disclosure of data if the device is stolen. ® interception of the Bluetooth signal while pairing two devices ("man-in-the-middle"...

  • Page 129: Technical Specifications Of The Product

    When HIGHER is better Adults Performance metrics* Clinical accuracy 92% [100%] % of readings that were in the Clarke Error Grid (CEG) [% CEG A+B Zone] *Reference is Yellow Springs Laboratory Instrument (YSI). 6.2.2 – Technical specifications of the product Technical specifications of the sensor Glucose range 40–400 mg/dL...

  • Page 130: Electromagnetic Immunity And Emissions: Declaration And Guidance

    Modulation Gaussian Frequency – Shift Keying Data rate 1 Mbps 6.2.3 – Electromagnetic immunity and emissions: declaration and guidance Electromagnetic immunity and emissions The transmitter is intended for use in the electromagnetic environment specified in the following table. The end user of the transmitter should ensure that it is used in such an environment.

  • Page 131: Radio Regulations Compliance

    Electromagnetic emissions specifications Immunity test Compliance Radio frequency emissions Group 1, Class B CISPR 11 RF emission Meets FAA RTCA / DO-160 edition G Section 21, Aircraft use Category M for in-cabin use 6.2.4 – Radio regulations compliance For radio regulations compliance statements, refer to Dexcom.com. 6.3 –...
  • Page 132 Alarm volume >50 dB ® Bluetooth Low Energy Wireless radio Class 3 transmitter with peak power of 1 mW Wireless frequency 2.4 GHz Delivery accuracy ±5% in all operating conditions Maximum infusion pressure at 1 bar occlusion Occlusion alarm threshold 1 hour at a basal rate of 1 U/h Maximum time to occlusion alarm 20 hours at a basal rate of 0.05 U/h...

  • Page 133: Electromagnetic Immunity And Emissions: Declaration And Guidance

    Minimum basal rate: 0.05 U/h Basal rate functionality Maximum basal rate: 5 U/h Basal rate increments: 0.05 U 1 U/min This means the maximum bolus of 30 U will be delivered at the maximum delivery speed in Maximum delivery speed 30 minutes.
  • Page 134 Use of accessories and cables other than those specified or provided by ViCentra could result in increased electromagnetic emission or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables, external antennas and mobile phone) should be used no closer than 30 cm to any part of the pump, including cables specified by ViCentra.
  • Page 135 Test level Compliance Directives related to the Immunity test IEC 60601 level electromagnetic environment The Kaleido pump is suitable for ±2 kV for ±2 kV for use in all establishments, power supply power supply Electric fast including domestic lines lines transient / establishments and those directly burst...
  • Page 136 Test level IEC Compliance Directives related to the Immunity test 60601-1-2 level electromagnetic environment Portable RF communications RF Common 6 V in ISM and equipment (including peripherals mode/ amateur radio 6 V in ISM and such as antenna cables, external Conducted bands amateur radio...
  • Page 137 Test Max. Immunity Band Distance Service Modulation freq. power test (MHz) (MHz) level GSM 1800, 1720 CDMA 1900, Pulse 1700– GSM 1900, modulation 1845 1990 DECT, 217 Hz LTE Band 1, 3, 4, 25 1970 UMTS ® Bluetooth WLAN, Pulse 2450–...

  • Page 138: Manufacturer's Declarations And Statements

    Separation distance according to frequency of transmitter in m Rated maximum 150 kHz 80 MHz 800 MHz output power of to 80 MHz to 800 MHz to 2.5 GHz transmitter in W d = 1.17 √P d = 0.35 √P d = 0.7 √P 0.01 0.12...

  • Page 139: Dblg1

    6.4 – DBLG1 6.4.1 – Expected effects of the DBLG1 System The DBLG1 System was compared to sensor-pump therapy in 63 adults with type 1 diabetes in a 12-week real-life study. This study was multi-center, open-label and randomized with a crossover design.

  • Page 140: Frequency Bands And Maximum Radio Frequency Power

    Degree of protection from dust IP22 and water Li-Ion Battery type 3.8 V / 2500 mAH Battery autonomy Approximately 35 hours Service life 4 years Alarm volume 66.8 dB Possible sound levels for alerts 0–64 dB Average active efficiency 78.7% No load power consumption 0.10 W Charger input power...

  • Page 141: Electromagnetic Immunity And Emissions: Declaration And Guidance

    Frequency bands Maximum radio frequency power ® Bluetooth 2.4 GHz 5 dBm Wi-Fi 2.4GHz 18.5 dBm Wi-Fi 5GHz 18 dBm 6.4.4 – Electromagnetic immunity and emissions: declaration and guidance Electromagnetic emissions specifications Immunity test Compliance RF Emission CISPR 11 Group 1, Class B Conducted emissions CISPR 11 Group 1, Class B Voltage fluctuations / flicker emissions...

  • Page 142: Manufacturer's Declarations And Statements

    6.4.5 – Manufacturer’s declarations and statements Specific Absorption Rate (SAR) Your DBLG1 is designed not to exceed the limits for exposure to radio waves recommended by international guidelines and those in force in France. These guidelines, developed by an independent scientific body (ICNIRP), include a significant safety margin to ensure people's safety, regardless of age or level of health.
  • Page 143 planet, this document constitutes a formal declaration that the handset produced by MobiWire SAS is compliant with the directive 2011/65/EC of the European Parliament (Directive RoHS concerning the restriction of the usage of hazardous substances). Declaration of Conformity to Directive 2014/53/EU MobiWire SAS hereby declares that the type of DH22 radio equipment complies with Directive 2014/53/EU.
  • Page 144 Index alarms 106 events menu 39, 108 list of 108 testing sounds 39, 107 alerts configuring alerts and notifications 94 events menu 39, 108 hyperglycemia alert 91 hypoglycemia alert 91 list of 108 sensor signal loss alert 91 testing sounds 39 basal rate 68 basal safety profile 47, 70, 92 temporary basal rate 71...
  • Page 145 101 DBLG1 103 transmitter 101 confidential mode 98 data sharing 29 confidential mode 98 flight mode 98 when traveling 31 YourLoops 98 DBLG1 29 cleaning 104 home screen 77 initialization procedure 33 installing the battery/charging 32 lock screen 79...
  • Page 146 first-aid kit 30 flight mode 98 glucose sensor calibrating 44 disposal 104 insertion site 17, 41 pairing 40 QR code 40, 43 setting up 40 showering or swimming 16 status 46 storage 17, 102 technical specifications 129 trend arrows 79 HbA1c 88 help menu 39 history 39...
  • Page 147 infusion site 55 insulin active insulin 76 total daily insulin dose 92 insulin cartridge filling 49 inserting into pump 54 insulin delivery stopping/restarting 72 insulin pump 25 charging 75 cleaning 102 disposal 105 electromagnetic environment 134 pairing procedure 63 PUMP CONTROL mode 70 removing temporarily 74 removing to switch to another pump 72 setting up 49...
  • Page 148 stopping 70 meal bolus 80 meals 39 declaring 79 modifying or deleting 81 patient profile 39 physical activities 39 declaring 83 modifying or deleting 83 stopping the ongoing 84 PIN code 39 changing/resetting 96 release notes 39, 88 rescue carbs 85 safety electromagnetic environment 130 general 13...
  • Page 149 aggressiveness during normoglycemia 91 average quantity of carbohydrates 92 basal safety profile 92 breakfast aggressiveness 91 credentials 96 dinner aggressiveness 91 hyperglycemia alert 91 hyperglycemia threshold 89 hypoglycemia alert 91 hypoglycemia threshold 90 lunch aggressiveness 91 patient settings 92 signal loss 91 sounds and vibrations 93 target glycemia 90 total daily insulin dose 92...
  • Page 150 updates checking for, defining a time 98 warranty 100 YourLoops 29, 31, 36, 39 changing your login / changing or resetting your password 96 Zen mode 39, 93 status 78...
  • Page 152 Report any serious incident that has occurred in relation to the DBLG1 System to your local support. Report any serious incident that has occurred in relation to the DBLG1 System to the competent authority in the country in which you are established.
  • Page 154 DBLG1Z-RA-IFU-001-mgdl-en-Rev5 Effective date: 2023-10-16...

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