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BIOCORP smartdot, Instructions For Use Manual

The BIOCORP smartdot Instructions For Use Manual is a comprehensive and user-friendly guide to help you make the most of your smartdot device. This manual is readily available for download, absolutely free of charge, from our website, ensuring easy access to the essential information you need for seamless operation.

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Biocorp Production

ZI de Lavaur La Bechade

63500 Issoire – France

IFU_v6.1_28022022

Summary of Contents for smartdot

Page 1: ...smartdot transmitter for aluetta pen injectors 6 12 and 20 Instructions for Use ...

Page 2: ...ology Your healthcare provider has access to those data The smartdot transmitter is reusable and has a rechargeable battery Do not share your transmitter with any other person smartdot is intended for use at home by one aluetta pen user only The smartdot transmitter does not change the aluetta pen injection process Please read your aluetta pen injector instructions before starting to use the trans...

Page 3: ...e presence of children due to the risk of serious injury swallowing or choking or damage to the device Do not use smartdot while it is charging Do not use smartdot in the case of visible damage Contact your healthcare professional for further assistance Do not attempt to modify or repair smartdot It may damage the transmitter or cause you harm Please note smartdot does not require any special main...

Page 4: ...smartdot Compliance information Quick Start Guide USB cable Part 2 What s in the box 4 ...

Page 5: ...Light signal Dial wheel Injection button Micro USB port charging Part 3 Your smartdot transmitter 5 ...

Page 6: ...battery is empty You can check the status of smartdot by pressing the injection button See Part 9 Troubleshooting guide no light for more details No signal The white light shows that smartdot is ready to use White The orange light appears when the battery is low See Part 9 Troubleshooting guide orange light Orange The purple light appears when activation or deactivation is in progress See Part 5 P...

Page 7: ...arged the blinking blue light will disappear and no light is shown 5 Remove the charging cable smartdot is now ready to be paired You must charge your transmitter before using it for the first time smartdot will automatically switch on when you plug in the USB cable After initial charging your smartdot will need to be recharged approximately every 2 weeks Do not use smartdot while it is charging 2...

Page 8: ...omplete the registration you will receive a second email to activate your account and a link to download the growlink app You can also download the app by scanning the QR code below You can also find this QR code in the Quick Start Guide Install the growlink app on your smartphone and log in with your details Downloading the growlink app PLACEHOLDER Part 5 Preparing B 8 ...

Page 9: ...er near your smartphone You can do this while the transmitter is charging 3 Open the growlink app and follow the onscreen instructions to pair it with your smartdot 4 After successful pairing smartdot will display a white light Your growlink app will also confirm that the pairing was successful Part 5 Preparing C 9 ...

Page 10: ...transmitter by the dial wheel 3 Place the transmitter onto the aluetta dose knob and push the dial wheel down until the aluetta knob is completely covered by smartdot and you cannot push anymore Do not hold or push the injection button when placing it onto the aluetta pen smartdotTM transmitter should cover the pen button entirely Part 5 Preparing D 10 ...

Page 11: ...elease the button smartdot will display a white light When the white light turns off smartdot has been successfully activated Note You need to activate smartdot to use it This will allow your transmitter to record injection data when you perform your injection Middle of the button Purple Light Step 2b White Light Part 5 Preparing E 11 ...

Page 12: ...skin 5 Release the button The white light will stay for few seconds Note Your smartdot transmitter does not change the injection process for your aluetta pen Please follow the aluetta instructions for use to prepare and perform your injection The steps below only cover the use of smartdot Note If the smartdot battery is low the white light will turn orange for few seconds after the button is relea...

Page 13: ...tep 2c Hold while slowly counting to 10 Step 2b Press and hold the button all the way down Middle of the button Step 3a Make sure the number 0 0 appears in thedose window to ensure you injected the full dose Part 6 Injecting 13 ...

Page 14: ...Place your pen and attached smartdot transmitter in the aluetta storage case Store it according to the Saizen patient information leaflet Part 7 Storing 14 ...

Page 15: ...before removing it from the aluetta pen See Part 8 Frequently Asked Questions C How do I deactivate and remove the smartdot transmitter Do not clean smartdot while it s connected to external power source Unplug the transmitterbefore cleaning it Do not immerse smartdot in water It is not waterproof and you may damage the transmitter Do not leave your smartdot or its accessories in a dusty location ...

Page 16: ...smitter from the aluetta pen To reactivate smartdot see Part 5 Preparing E Activating your smartdot transmitter Cleaning smartdot or your aluetta pen Charging smartdot when the room temperature is above 25 C Moving smartdot to a new aluetta pen smartdot must be deactivated before you can remove it from the aluetta pen This will prevent data being recorded in error You need to deactivate the transm...

Page 17: ...rowlink app if your Once paired with growlink you can perform 100 injections with smartdot without opening the app The data will synchronize at least once a month when there is an established connection with the app as specified above If you want to pair your transmitter with a new smartphone 1 Open the growlink app and ensure all your injection data is synchronized You can manually synchronize yo...

Page 18: ...ith local regulations Before disposing your smartdot transmitter perform a factory reset to delete your personal medical data Part 9 Troubleshooting guide A Reset your smartdot transmitter It displays a red light You want to pair it with a new smartphone You want to delete smartdot injection data You need to reset your smartdot if To reset your transmitter see Part 9 Troubleshooting guide A Reset ...

Page 19: ...nd ensure that all your data has been synchronized You can manually synchronize your data through the smartdot settings in the app 2 Open smartdot settings in your app and select Reset smartdot The transmitter will display a blinking red light during the reset 3 Switch smartdot on by plugging in and unplugging the USB cable Then see steps C E in Part 5 Preparing Continued on the next page What do ...

Page 20: ...this action three times You will see a blinking red light 4 Switch smartdot on by plugging and unplugging it once See steps C E in Part 5 Preparing x3 If the red light remains your smartdot is still defective Remove it from your pen and contact your healthcare professional for further assistance Note You can still perform your injections without using your transmitter Part 9 Troubleshooting guide ...

Page 21: ... light signal appear What does it mean Orange light B Charge your smartdotTM transmitter 1 Connect it to the supplied USB cable 2 Connect the cable to a powered USB wall charger 3 During charging smartdot will display a blinking blue light A complete charge can take up to 2 hours 4 When the transmitter is fully charged the blinking blue light will disappear and you can remove the charging cable Co...

Page 22: ...rature is above 25o C you must deactivate Smartdot and remove it from your pen See Part 8 Frequently Asked Questions C How do I deactivate and remove the smartdot transmitter 1 Switch on the smartdot transmitter by plugging and unplugging it once with the charging cable when connected to an external power supply 2 See steps C E in Part 5 Preparing 3 Activate your transmitter See Part 5 Preparing E...

Page 23: ...e Note You can still perform your injections without using your transmitter 1 Charge your smartdot transmitter See above for details 2 Pair smartdot with the growlink app See Part 5 Preparing C Pairing smartdot with the growlink app See Part 5 Preparing E Activating your smartdot transmitter Part 9 Troubleshooting guide If there is problem with your aluetta pen please refer to the aluetta Instruct...

Page 24: ... specified or provided by the manufacturer of this equipment may result in increased electromagnetic emissions or decreased immunity of this equipment and may result in improper operation Portable RF communications devices including peripherals such as antenna cables and externalantennas should not be operated closer than 30 cm 12 inches to any part of the EM DEVICE or SYSTEM including cables spec...

Page 25: ...to landfill Public authorities shall adopt appropriate measures for users distributors and manufacturers to contribute to the collection of electrical and electronic equipment by establishing legal requirements for the reuse recovery or recycling of such equipment Dispose of the smartdot transmitter according to local recommendations Declaration of conformity 2012 19 UE and 2011 65 UE Regulatory i...

Page 26: ...eceive Transmit Radio module specifications Bluetooth LE type Frequency band Number of channels Channel spacing Bandwidth Max EIRP Effective Isotropic Radiated Power BLE 2400 2483 5 MHz 40 2MHz 1MHz 5 5dBm Specification Value Technical specifications Part 12 A 26 ...

Page 27: ...Fully charge after 2 hours 2 weeks 2A min 500 mA USB Characteristics Use an IEC UL 60950 1 or IEC UL 62368 1 certified USB charger with CE or UL mark to charge the battery via the supplied USB cable Please connect the supplied USB cable to the USB port of an AC adapter suitable for your region with the following specifications Battery Characteristics Part 12 Technical specifications B 27 ...

Page 28: ...nal module with automatic voltage adaptation no selection required Input voltage range Frequency range Category Output voltage Output current 90 264 V 47 63 Hz II double isolation 5V DC 500mA 2A USB Charger not included Part 12 Technical specifications Electronical information 2 of 2 C 28 ...

Page 29: ...essary to consult instructions for use web site Direct current Manufacturer Serial number Product reference Distributor reference Date of manufacture European Conformity marking Symbol Description and information Symbols and information on the packaging Part 13 29 ...

Page 30: ...number Unique Device Identification Temperature limits to which the device can be safely exposed 2 C to 40 C The pressure limits to which the device can be safely exposed 700 hPa to 1060 hPa MODEL Humidity limits to which the device can be safely exposed 15 to 90 Humidity sensitive device Do not expose the device to moisture Symbol Description and information IP32 Part 13 Symbols and information o...

Page 31: ...as to be returned to a local authorized collection system By following this procedure you will contribute to the protection of the environment and human health The recycling of the materials will help to conserve natural resources Valid in the EU member states and in any countries with corresponding legislation Symbol Description and information Part 13 Symbols and information on the packaging 31 ...

Page 32: ...Biocorp Production ZI de Lavaur La Bechade 63500 Issoire France IFU_v6 1_28022022 ...

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