BIOCORP MERCK smartdot Instructions For Use Manual

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Instructions for Use

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Summary of Contents for BIOCORP MERCK smartdot

Page 1 Instructions for Use...
Page 2: Table Of Contents
SUMMARY Part 1 · Safety information Part 2 · What’s in the box Part 3 · Your smartdot™ transmitter Part 4 · smartdot™ light signals Part 5 · Preparing Part 6 · Injecting Part 7 · Storing Part 8 · Frequently asked questions Part 9 ·...
Page 3: Safety Information
Part 1 Safety information • The purpose of the smartdot transmitter is to store and transfer injection data when administering growth hormone treatment. • The smartdot transmitter can only be used when injecting Saizen ® (somatropin) with the Merck pen injector. •...
Page 4 Part 1: Safety information To preserve the performance and lifespan of the smartdot™ transmitter, please adhere to the following environmental conditions: Do not use in an environment containing flammable substances or oxygen. Do not use smartdot™ transmitter while it is charging. Do not use smartdot™...
Page 5: What's In The Box
Part 2 What’s in the box Compliance Quick Start Guide USB cable smartdot™ information transmitter Note: USB charger is not included.
Page 6: Your Smartdot™ Transmitter
Part 3 Your smartdot™ transmitter Injection button Light signal Micro-USB port (charging) Dial wheel...
Page 7: Smartdot™ Light Signals
Part 4 smartdot™ light signals Blinking blue The blinking blue light shows that smartdot™ transmitter is charging. The smartdot™ transmitter will show no light after it is fully charged and before it is activated. See ‘Part 5: Preparing <A. Charging your smardot™ transmitter.’...
Page 8: Preparing
Part 5 Preparing Charging your smartdot™ transmitter You must charge your transmitter before using it for the first time. The smartdot™ transmitter will automatically switch on when you plug in the USB cable. After initial charging, your transmitter will need to be recharged approximately every 2 weeks.
Page 9 Part 5: Preparing Downloading the App 1. Your healthcare professional will create an account for you in the associated web-based application. You will receive an invitation email with instructions to download the compatible App. 2. Once installed the compatible App on your smartphone, you can log in with the temporary password shared in the invitation email.
Page 10 Part 5: Preparing Pairing your smartdot™ transmitter with the App 1. Activate Bluetooth on your smartphone. ® 2. Place the smartdot™ transmitter near your smartphone. 3. Open the App and follow the onscreen instructions to pair it with your transmitter. 4.
Page 11 Part 5: Preparing Placing smartdot™ transmitter on your pen injector 1. Hold the pen in one hand, so that you can see the dose knob. 2. In your other hand, hold the smartdot™ transmitter by the dial wheel. 3. Place the transmitter onto the dose knob and push the dial wheel down until the dose knob is completely covered by smartdot™...
Page 12 Part 5: Preparing Activating your smartdot™ transmitter Note: You need to activate smartdot™ transmitter to use it. This will allow your transmitter to record injection data when you perform your injection. Learn more about data transmission, see ‘Part 8: Frequently asked questions <F.
Page 13: Injecting
Part 6 Injecting Note: Your smartdot™ transmitter does not change the injection process for your pen injector. Please follow the pen instructions for use to prepare and perform your injection. The steps below only cover the use of smartdot™ transmitter. The green light will show when injection button is pressed, it means that the transmitter is ready to record the injection.
Page 14 Note: If the smartdot™ battery is low, the green light will turn orange for few seconds after the injection button is released. See ‘Part 9: Troubleshooting guide <orange light’ for more details. Step 1 Always set your dose according to your prescription.
Page 15 Part 6: Injecting Step 2c Step 3a Make sure the number “0.0” Hold while appears in the dose window slowly counting to ensure you injected the to 10 full dose. Step 3b Step 3c...
Page 16: Storing
Part 7 Storing Place your pen injector and attached smartdot™ transmitter in the pen storage case. Store it according to the Saizen patient information ® leaflet. Note: Your smartdot transmitter is designed for storage between 2°C to 40°C.
Page 17: Frequently Asked Questions
Part 8 Frequently asked questions How do I check the status of my smartdot™ transmitter? Once smartdot™ transmitter has been connected to the App, you can press the injection button at any time. This will wake up the transmitter and a light will switch on for few seconds.
Page 18 Part 8: Frequently asked questions How do I deactivate and remove the smartdot™ transmitter? The smartdot™ transmitter must be deactivated before you can remove it from the pen injector. This will prevent data being recorded in error. You need to deactivate the transmitter before carrying out the following actions: •...
Page 19 Part 8: Frequently asked questions How do I travel with the smartdot™ transmitter? Place your pen injector and attached smartdot™ transmitter in the pen storage case. Store it according to the Saizen patient information ® leaflet. How do I pair smartdot™ transmitter with a new smartphone? If you want to pair your transmitter with a new smartphone: 1.
Page 20 Part 8: Frequently asked questions When would I reset the smartdot™ transmitter? You need to reset your smartdot™ transmitter if: • It displays a light. • You want to pair it with a new smartphone. • You want to delete smartdot™ injection data. To reset your transmitter, see ‘Part 9: Troubleshooting guide <A.
Page 21: Troubleshooting Guide
Part 9 Troubleshooting guide What do I see? When does this light signal appear? Red light red light can appear when the button is pressed. What does it mean? The smartdot™ transmitter is defective and cannot record your injections. It needs to be reset. What should I do? A.
Page 22 Part 9: Troubleshooting guide Option 2 - Reset with the charging cable 1. Connect the transmitter to a powered USB wall charger through the supplied USB cable. 2. Quickly unplug it from the cable. blinking red light. 3. Repeat this action three times or until you see a 4.
Page 23 Part 9: Troubleshooting guide What do I see? When does this light signal appear? orange light can appear: Orange light • When the button is pressed, and the battery is • When the button is released at the end of an injection and the battery is low What does it mean? The smartdot™...
Page 24 Part 9: Troubleshooting guide When does this light signal What do I see? appear? No signal When the button is pressed, and no light signal appears. What does it mean? What should I do? The smartdot™ transmitter is not 1. Switch on the smartdot™ switched on.
Page 25 Part 9: Troubleshooting guide What does it mean? What should I do? The battery is out of charge. Before you can you use your smartdot™ transmitter again, you will need to perform all the following steps: 1. Charge your smartdot™ transmitter until the blue light stops blinking.
Page 26: Regulatory Information On Radio Communication
Part 10 on radio communication 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/EU (RED). • The full text of the EU Declaration of Conformity is available at the following web address: https://biocorpsys.com/ifu-smartdot/...
Page 27: Regulatory Information On Electronic Waste
Part 11 on electronic waste Declaration of conformity 2012/19/EU and 2011/65/EU • BIOCORP PRODUCTION declares that smartdot™ transmitter radio equipment follows Directive 2012/19/EU (WEEE) and Directive 2011/65/EU (RoHs III) on the restriction of the use of hazardous substances in electrical and electronic equipment going to landfill.
Page 28: Technical Specifications
Technical specifications Part 12 Model number EF36 Radio module specifications The smartdot™ transmitter integrates a Bluetooth module with the ® following features (Receive / Transmit): Specification Value Bluetooth Low Energy type ® Frequency band [2400 - 2483.5] MHz Number of channels Channel spacing 2MHz Bandwidth...
Page 29 Part 12: Technical specifications Electronical information (1 of 2) USB Characteristics Rated voltage 5V DC Rated current 2A (min 500 mA) Model number 0373707 Battery Characteristics Li-ion rechargeable: Battery Li-ion 3,7V-45mAh Battery life with full charge 2 weeks (once a day use) Battery charging time Fully charge after 2 hours Use an IEC/UL 60950-1 or IEC/UL 62368-1 certified USB charger (with...
Page 30 Part 12: Technical specifications Electronical information (2 of 2) Please connect the supplied USB cable to the USB port of an AC adapter suitable for your region with the following specifications: 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.
Page 31 Part 12: Technical specifications You are responsible for properly securing and managing your smartphone. If you suspect an adverse cybersecurity event related to the smartdot transmitter or related App, contact your healthcare professional. Make sure that your smartphone and the smartdot transmitter are kept in a safe place, under your control.
Page 32: Symbols And Information On The Packaging
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 https://biocorpsys.com/ifu-smartdot/ Manufacturer European Conformity marking Serial number Date and country of manufacture Batch number Product reference Distributor reference Direct current...
Page 33 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 IP32 Protection against droplets, if the housing is positioned at an angle of 15 degrees from the vertical or less.
Page 34 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 35 Biocorp Production ZI de Lavaur La Bechade 63500 Issoire – France Saizen, smartdot are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. IFU_smartdot_EN_Ed1.2_Mar2023 Compatible with the firmware 1.3.X...