01-2021 Instructions For Use Designed for Solostar® Sanofi Embedded software versions 3.6.
TABLE OF CONTENTS 1. 2. 3. GENERAL INFORMATION ...........................................................................................................3 EMBODY COMPATIBILITIES – MOLECULES AND CONCENTRATIONS ................................3 DEVICE DESCRIPTION AND EXAM ENVIRONMENT ................................................................4 3.1 DEVICE DESCRIPTION ......................................................................................................4 EMBODY CHARACTERISTICS ...........
TABLES LIST TABLE 1 - SYMBOLS USED IN IFU ....................................................................................................................... 2 TABLE 2 - ABBREVIATIONS LIST.......................................................................................................................... 2 TABLE 3 - EMBODY COMPATIBILITIES – MOLECULES AND CONCENTRATIONS ........................................... 3 TABLE 4 - EMBODY PARTS NUMBERS ......................................................
SYMBOLS USED IN THIS MANUAL SYMBOL MEANING EXPLANATION WARNING Improper operation may result in serious injury*1 or death to the user, patient CAUTION Improper operation may result in bodily injury*2 or property damage*3 CAUTION Disconnect the device from power supply before servicing/cleaning NOTE Important information for operation Table 1 - Symbols used in IFU *1 Serious injury means electrical shock or poisoning that causes a subsequent complication or requires hospitalization or long-term o
STATEMENTS (US) EMBODY Model: 0273790-SLST FCC ID: 2AYCW-EZL CAUTION: - This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. - The user that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
Device features The EMBODY device is composed of a base and a button that can be mounted on an insulin pen.
1. GENERAL INFORMATION BIOCORP PRODUCTION ZI LAVAUR LA BECHADE DISTRIBUTOR: 63500 ISSOIRE See list at the end of leaflet CEDEX – FRANCE The user manual must be accessible to you at all times. You must read all instructions carefully before using the device. If you have technical problems with our product, please contact a BIOCORP PRODUCTION authorized dealer.
3. DEVICE DESCRIPTION AND EXAM ENVIRONMENT 3.1 DEVICE DESCRIPTION EMBODY CHARACTERISTICS The EMBODY device is composed of a base and a button: BASE BUTTON LED Micro USB port Button Clear square dose window ESSENTIAL PERFORMANCES OF THE SYSTEM (SIGNIFICANT OPERATING CHARACTERISTICS) The essential performance characteristic for the EMBODY device has been defined as follows: Provide reliable data dosage parameters of a drug to the patient and caregivers.
The following parts are necessary to operate the EMBODY device: USB CABLE RESET KEY PN: 0373707 PN: 0373708 Table 5 - Parts necessary for operation 3.2 WEIGHT AND SIZE OF THE MAIN ELEMENTS ELEMENT WEIGHT INSULIN PEN SIZE EMBODY base 0,016 kg SOLOSTAR® (60.8x26.9x21.3) mm EMBODY button 0,006 kg SOLOSTAR® (24.4 x Ø20) mm EMBODY total weight 0,022 kg - - Table 6 - Weight and size of the main elements 4. SAFETY INFORMATION 4.
SYMBOL LOCATION DEVICE DEVICE DESCRIPTION US - Operation is subject to the following 2 conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
WARNING - If you are not certain that you injected your insulin, do not start or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider. - - - - - Disconnect the USB cable from the USB charging port and disconnect EMBODY from the USB cable before using it. EMBODY is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port. Do not attach or tighten cable to or around the head or neck.
4.
4.6 TRANSPORT AND STORAGE CONDITIONS Atmospheric pressure Relative humidity 500 hPa to 1060 hPa 10% to 90% 800 hPa to 1060 hPa 10% to 90% Temperature Transport –10°C to +40°C (14°F < T° < 104°F) –10°C to +40°C Storage (14°F < T° < 104°F) Table 11 - Transport and storage conditions CAUTION - The device must be transported and stored in its original packaging designed to protect it from damage. - Storage and transport conditions must meet conditions described in the above table. 4.
5. UNPACKING AND INSTALLING EMBODY CALIBRATING / ASSEMBLING / PAIRING) (CHARGING / CAUTION - EMBODY can only be paired with a compatible mobile application. - EMBODY is only compatible with the insulin pens: Solostar® Sanofi (except for TOUJEO® MAX and TOUJEO® DOUBLESTAR) Refer to section 2 – EMBODY compatibilities – Molecules and concentrations 5.
STEP 2 – Remove from the box: the base, the button and the accessories You can get EMBODY free support @ my-EMBODY.com 5.2 CHARGING AND CALIBRATING YOUR EMBODY CHARGING YOUR EMBODY NOTE: EMBODY must be charged before first-time use. - CAUTION EMBODY is supplied with a USB cable. Do not use any other cable. Use the cable supplied with the device to connect it to a USB power port. Never use your EMBODY for an injection while it is connected to a USB power port and charging.
CALIBRATING YOUR EMBODY Disconnect the USB cable from the EMBODY base. Check that the EMBODY LED is flashing orange. Slowly tilt the EMBODY base side to side to CALIBRATE. Continue tilting until: The base beeps and the LED light turns green. Then the light will turn off. NOTE: If the orange LED does not light up after disconnecting the USB cable from the EMBODY base, it means that the calibration was done automatically. You can go directly to the next section: Section 5.3.
5.3 ASSEMBLING YOUR EMBODY TO THE INSULIN PEN CAUTION The EMBODY base and button must be correctly attached onto the pen, otherwise, data will not be transferred. ATTACHING BASE TO PEN Hold the EMBODY base so that the clear square plastic window is facing you Align the EMBODY base clear square plastic window with the pen dose window, then snap the base onto the pen. Make sure the EMBODY base window is perfectly aligned with the pen dose window.
5.4 OPERATING IN AUTONOMOUS MODE OR IN PAIRING MODE EMBODY can: - Either operate in autonomous mode: In this case, data cannot be displayed and cannot be shared with another person. Or - Be paired with a compatible mobile application (an autonomous software installed on a smartphone). In this case, please follow the application manufacturer’s instructions to pair EMBODY and use the application. When EMBODY is paired and correctly attached to the injector pen: the LED is green.
6. OPERATING INSTRUCTIONS NOTE: Once EMBODY is attached to the insulin pen, the pen should be used just like a normal insulin pen. Refer to the manufacturer’s injector pen user manual. 6.1 SECURITY TEST - PRIMING WARNING Always perform a priming (safety test) before each injection to ensure that: Your pen and the needle are working properly, The right dose of insulin will be injected.
6.2 INJECTION WARNING If you are not certain that you injected your insulin, do not start or repeat your injection. Monitor your blood glucose as instructed by your healthcare provider. IN AUTONOMOUS MODE OR PAIRING MODE => follow the steps indicated below: Check the insulin dose to inject according to the prescription and the type of medication. Turn the button to select the number of units to inject. The dose indicator should line up with the dose to inject.
7. AFTER USE INSTRUCTIONS: DISASSEMBLE EMBODY FROM PEN Follow the procedure indicated below to disassemble EMBODY from your pen: 7.1 Remove the EMBODY base from the insulin pen. Use your thumb to press on EMBODY and to remove it from the pen. 7.2 Then, remove the EMBODY button from the pen. 7.3 Follow section 5. on assembling your EMBODY to the new insulin pen. NOTE : It is not necessary to pair your EMBODY again when changing the pen (unless your system has been reset - see section 8.2.
8. TROUBLESHOOTING CAUTION - Never attempt to access the internal hardware of the device. - When a functional testing is not successful and if the given recommendations do not solve the issue, you are prompted to contact a BIOCORP PRODUCTION authorized dealer. 8.
ORANGE LED – TROUBLESHOOTING RECOMMENDATIONS The EMBODY base light indicator (LED) remains orange if: - the clear square plastic window of the EMBODY base and the dose window of the pen are not correctly aligned, or if the base is mounted too low / too high ( the top of the EMBODY base must be aligned with the top of the pen, at the base of the dose button on the pen), or - if the EMBODY button is not pushed on enough.
8.2 RESET INSTRUCTIONS The reset procedure of EMBODY may be necessary: If EMBODY is not working properly (no response, etc…), If you need to pair EMBODY with another mobile phone (smartphone), If you want to delete your personal health data from the device. PROCEDURE: Disassemble EMBODY as indicated section 7. Flip EMBODY over so that you can see the following indications: Take the Reset Key: Insert the Reset Key into the hole shown below and WAIT until 3 beeps are emitted before removing the key.
CAUTION - Do not wipe the surface of EMBODY with chemical products or solvents (e.g. acetone) other than those specified in this cleaning procedure as it could lead to discoloration or deterioration. - Please remember that the EMBODY is not waterproof: Do not immerse the device in water and do not clean it under running water. Do not expose the device to moisture. Do not use the device in the bathroom or in areas with high temperature, humidity, dust or rain.
10. TECHNICAL SPECIFICATIONS & PERFORMANCE 10.1 ELECTRICAL RATINGS CAUTION Make sure you connect the EMBODY USB cable to a power source compliant with the IEC 60601-1. USB CHARACTERISTICS 5V DC 2A 500mA IP 22 BATTERY CHARACTERISTICS Li-ion rechargeable : Battery Li-ion 3,7V-130mAh Model Number GEB401730 / FT401235P Operating time with fully charged battery 2 weeks Charging time for fully charged battery Full charge in 2.
11. ELECTROMAGNETIC COMPATIBILITY 11.1 GENERAL PRECAUTIONS AND WARNINGS Electrical medical devices and systems are subject to special measures concerning electromagnetic compatibility (EMC) and must be installed in accordance with the EMC instructions contained in this enclosed document. Portable and mobile radiofrequency communication systems may interfere with electrical medical devices.
11.3 INTERFERENCE IMMUNITY The device is intended for use in the following electromagnetic environment. You must ensure compliance with this guideline. GUIDANCE AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY The EMBODY is intended for use in the electromagnetic environment specified below. The operator of the EMBODY should ensure that it is used in such an environment.
EMBODY is intended for use in an electromagnetic environment where radiated RF disturbances are under control.
11.4 ELECTROMAGNETIC IMMUNITY The device is intended for use in the following electromagnetic environment. You must ensure compliance with this guideline. GUIDANCE AND MANUFACTURER DECLARATION – ELECTROMAGNETIC IMMUNITY The EMBODY is intended for use in the electromagnetic environment specified below. The operator of the EMBODY must ensure that it is used in such an environment.
12. DISCLAIMER The warranty is valid for twelve months from the date of purchase (unless a more advantageous period has been contractually agreed between the manufacturer and the distributor. Please check with your local distributor for more information). The warranty covers any fault, material damage or manufacturing defect in products used in accordance with the instructions in this leaflet.
