Related Manuals for BIOCORP smartdot
Summary of Contents for BIOCORP smartdot
- Page 1 Instructions for Use smartdot™ transmitter for aluetta™ pen injectors 6, 12 and 20...
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Page 2: Safety Information
• Keep your transmitter out of the reach of children. Small parts could be inhaled or swallowed and may lead to choking. If smartdot™ is being used by a child, they should be supervised by an adult. Please read all the instructions in this manual before using the... - Page 3 Do not use in an environment containing flammable substances or oxygen. • Store the smartdot™ transmitter in a safe place. Do not leave it unattended in the presence of children due to the risk of serious injury (swallowing or choking), or damage to the device.
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Page 4: What's In The Box
Part 2 What’s in the box ™ Quick Start Guide USB cable Compliance information smartdot... - Page 5 Part 3 Your smartdot™ transmitter Injection button Light signal Micro-USB port (charging) Dial wheel...
- Page 6 The blinking blue light shows that smartdot™ is charging. No signal No light is displayed when smartdot™ is sleeping, or the 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.
- Page 7 Preparing Charging your smartdot™ transmitter 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.
- Page 8 Part 5: Preparing Downloading the growlink™ app 1. Your healthcare provider will create an account for you in the growlink™ app. You will receive an email with instructions to complete the registration process. 2. When you complete the registration, you will receive a second email to activate your account and a link to download the growlink™...
- Page 9 Pairing your smartdot™ with the growlink™ app 1. Activate Bluetooth on your smartphone. 2. Place the smartdot™ transmitter 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™.
- Page 10 1. Hold the aluetta™ pen in one hand, so that you can see the aluetta™ dose knob. 2. In your other hand, hold the smartdot™ transmitter by the dial wheel. 3. Place the transmitter onto the aluetta™ dose knob and push the dial wheel down until the aluetta™...
- Page 11 Part 5: Preparing Activating your smartdot™ transmitter Note: You need to activate smartdot™ to use it. This will allow your transmitter to record injection data when you perform your injection. 1. Press the smartdot™ injection button, until you see a purple light.
- Page 12 1. Prepare your aluetta™ pen, as shown in the aluetta™ Instructions for Use. If stored in the refrigerator, open the storage box and wait five minutes before use. 2. Turn the smartdot™ dial wheel until your intended dose is visible in the dose window.
- Page 13 Part 6: Injecting Step 2a Step 2b Press and hold the button all the way down Middle of the button Step 2c Step 3a Make sure the number “0.0” Hold while slowly appears in thedose window to counting to 10 ensure you injected the full dose.
- Page 14 Part 7 Storing Place your pen and attached smartdot™ transmitter in the aluetta™ storage case. Store it according to the Saizen patient information leaflet. ®...
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Page 15: Frequently Asked Questions
See ‘Part 9: Troubleshooting guide’ if you see a red or orange light, or no light at all. Do not play with your pen or smartdot™. Only dial the pen when you are about to perform an injection. - Page 16 2. Release the button as soon as you see the purple light. 3. The light will turn off. smartdot™ is now deactivated, and injections will no longer be recorded. You can now remove the transmitter from the aluetta™ pen. To reactivate smartdot™, see ‘Part 5: Preparing <E. Activating your smartdot™...
- Page 17 Part 8: Frequently asked questions How do I travel with the smartdot™ transmitter? Place your pen and attached smartdot™ transmitter in the aluetta™ storage case. Store it according to the Saizen patient information leaflet. ® How do I pair smartdot™ with a new smartphone? If you want to pair your transmitter with a new smartphone: 1.
- Page 18 How do I dispose of the smartdot™ transmitter? smartdot™ has been built to last 3 years after first use. The smartdot™ transmitter is an electronic product. Do not throw it away as household waste. Dispose of it in accordance with local regulations.
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Page 19: Troubleshooting Guide
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... - Page 20 2. Quickly unplug it from the cable. 3. Repeat 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’. If the red light remains, your smartdot™ is still defective. Remove it from your pen and contact your healthcare professional for further assistance.
- Page 21 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.
- Page 22 Part 9: Troubleshooting guide Note: If you are charging in a room where the temperature is above 25 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™...
- Page 23 See ‘Part 5: Preparing <E Activating smartdot™ has been deactivated. your smartdot™ transmitter’. If there is still no light, remove smartdot™ from your pen and contact your healthcare professional for further assistance. Note: You can still perform your injections without using your transmitter.
- Page 24 Declaration of conformity 2014/53/EU • BIOCORP PRODUCTION declares that the radio equipment of smartdot™ transmitter type is in conformity with the Directive 2014/53/UE (RED). • The full text of the EU Declaration of Conformity is available at the following web address: xxxxxxx.com...
- Page 25 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.
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Page 26: Technical Specifications
Technical specifications Part 12 Radio module specifications smartdot™ integrates a BLE module with the following features (Receive / Transmit): Specification Value Bluetooth LE type ® Frequency band [2400 - 2483.5] MHz Number of channels Channel spacing 2MHz Bandwidth 1MHz Max EIRP (Effective Isotropic... - Page 27 Part 12: Technical specifications Electronical information (1 of 2) USB Characteristics Rated voltage 5V DC Rated current 2A (min 500 mA) Battery Characteristics Battery Li-ion rechargeable: Li-ion 3,6V-45mAh Model number Autonomy with a fully charged 2 weeks battery Battery charging time Fully charge after 2 hours 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.
- Page 28 Part 12: Technical specifications Electronical information (2 of 2) USB Charger (not included) USB charger certified IEC/UL 60950-1 or IEC/UL 62368-1 (with CE or UL mark) Adapted external module with automatic voltage adaptation: no selection required. Input voltage range 90-264 V Frequency range 47-63 Hz Category...
- Page 29 Symbols and information Part 13 on the packaging Symbol Description and information Operator’s manual; operating instructions It is necessary to consult instructions for use [web site] Manufacturer European Conformity marking Serial number Date of manufacture Batch number Product reference Distributor reference Direct current...
- Page 30 Part 13: Symbols and information on the packaging Symbol Description and information For indoor use only Ingress Protection index IP32 Protection against solid bodies greater than 2. 5 mm IP32 Protection against droplets, if the housing is positioned at an angle of 15 degrees from the vertical or less. Humidity sensitive device Do not expose the device to moisture Temperature limits to which the device can be safely...
- Page 31 Part 13: Symbols and information on the packaging Symbol Description and information Management of electrical and electronic waste. Collection and treatment of electrical and electronic equipment* This symbol indicates that this product should not be disposed with household waste. It has to be returned to a local authorized collection system.
- Page 32 Biocorp Production ZI de Lavaur La Bechade 63500 Issoire – France IFU_v6.1_28022022...
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