Users Manual 1

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Users Manual

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Envision™ Recorder User Guide


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English Introduction The Envision™ recorder is a component of the Envision™ Pro Continuous Glucose Monitoring (CGM) system. It is a retrospective CGM system, therefore data is not available to patients in real time. The recorder is compatible with the Envision™ sensor (MMT-7080). The recorder connects to the sensor, and receives and sends data to the Envision™ Pro application (app) through a Bluetooth™* wireless connection. For detailed information on system components consult the Envision™ Pro Continuous Glucose Monitoring System User Guide for Healthcare Professionals. Indications The recorder is intended for single-patient, single-use in patients with diabetes mellitus. The recorder is a component of the Envision™ Pro CGM system. Contraindications None known. Warnings • Always refer to the Envision™ sensor (MMT-7080) user guide for all contraindications, warnings, precautions, and instructions relating to the sensor. Not referring to the sensor user guide can result in serious injury to the patient or damage to the sensor. • No modification of this equipment is allowed. • This product contains small parts and may pose a choking hazard for young children. • Attempting to send data from the recorder when the recorder is near other medical devices that emit radio frequency should be avoided due to possible interference. If you have communication issues, try moving away from such devices. • Do not expose your recorder to x-ray, ultrasound, or diathermy devices as the performance of the recorder has not been evaluated under those conditions and may be unsafe. If your recorder is exposed to any of these, discontinue use and contact your local country representative for further assistance. • Do not expose your recorder to MRI equipment or other devices that generate strong magnetic fields as the performance of the recorder has not been evaluated under those conditions and may be unsafe. -1-

If your recorder is inadvertently exposed to a strong magnetic field or ionizing radiation, discontinue use and contact your local country representative for further assistance. • Do not expose your recorder to temperatures exceeding those listed in the specifications table for Storage Conditions as this may deplete the battery and result in a non-functional recorder. Precautions Do not reuse recorders. The recorder is designed to be used for one patient, and one evaluation only. Once the recorder is activated for a patient, it cannot be used for another evaluation or patient. The recorder will not function and no data will be gathered. Assistance Please contact your local country representative using the Medtronic Diabetes International Contacts list in this user guide. IEC60601-1-2; Special EMC Precautions for Medical Electrical Equipment 1. Special precautions regarding Electromagnetic Compatibility (EMC): This body worn device is intended to be operated within a reasonable residential, domestic, public or work environment, where common levels of radiated “E” (V/m) or “H” fields (A/m) exist; such as cellular phones, WiFi, Bluetooth™*, electric can openers, microwave and induction ovens. This device generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the provided instructions, may cause harmful interference to radio communications. 2. Portable and mobile RF communications equipment can affect Medical Electrical Equipment as well. If you encounter RF interference from a mobile or stationary RF transmitter, move away from the RF transmitter that is causing the interference. Installing the Envision™ Pro app For information on installing the Envision™ Pro app, consult your Envision™ Pro System User Guide for Healthcare Professionals. Inserting the Envision™ sensor (MMT-7080) and connecting the Envision™ recorder For information about inserting the sensor and connecting the recorder, -2-

consult your Sensor User Guide. For information on pairing the recorder with the app, use the Envision™ Pro app and follow the instructions on your screen. Note: The graphical image, a type of barcode, on the back of the recorder is for manufacturing purposes only. Ending the evaluation and uploading data End the evaluation and upload the data according to the Envision™ Pro System User Guide for Healthcare Professionals. The patient or HCP can upload data either before or after removing the recorder and sensor from the patient. Be sure to upload data before recorder disposal. Removing the sensor and the recorder 1. Put on gloves. 2. Peel the sensor and recorder off of the body as one unit. 3. Separate the sensor and the recorder. 4. Dispose of the sensor in a sharps container. Dispose of the recorder according to local regulations for battery disposal (non-incineration). Note: Do not discard the recorder in a medical waste container or receptacle in which it would be exposed to extreme heat, above 55 °C (131 °F). Bathing and swimming After the recorder and sensor are connected, they form a waterproof seal to a depth of 2.4 meters (8 feet) for up to 30 minutes. Your patient can shower and swim without removing them. No additional tape is required. Help The Envision™ Pro app provides the best source of information for help with the recorder. To access the Help screen, tap Help. The app will walk you through the various Help topics. Storing and transporting the devices Store the recorder in a clean and dry location at room temperature -3-

between 15 °C (59 °F) and 30 °C (86 °F). Do not transport the recorder at temperatures above 55 °C (131 °F) or below -30 °c (-22 °F). Temperatures outside this range can damage components Recorder use life The recorder has a maximum life of 170 hours of glucose recording, plus an additional five days of battery life immediately following the glucose recording to allow for data upload. The life span of the recorder begins when it is connected to the sensor. After 170 hours the recorder will stop recording and no further data will be gathered. When the battery dies, any data not uploaded from the recorder will be lost. Specifications Biocompatibility Recorder: Complies with EN ISO 10993-1 Applied parts Envision™ Sensor (MMT-7080) Operating Temperature: 5 °C to 45 °C (41 °F to 113 °F) conditions Relative humidity: 10% to 95% with no condensation Pressure: 57.6 kPa to 106.0 kPa (8.4 psi to 15.4 psi) Shipping conditions Temperature: -30 °C to 55 °C (-22 °F to 131 °F) Relative humidity: 10% to 95% with no condensation Pressure: 57.6 kPa to 106.0 kPa (8.4 psi to 15.4 psi) Storage conditions Temperature: 15 °C to 30 °C (59 °F to 86 °F) Recorder Bluetooth™* version 4.0 (2.4 GHz band) communication frequency Modulation G1D Maximum output -11.5 dBm effective radiated power (ERP) power Operating range Up to 2.4 meters (8 feet) -4-

Recorder wireless communication Quality of service The recorder and mobile app connect via Bluetooth™* Low Energy (BLE). The recorder sends data and related alerts to the app. The recorder and the app verify the integrity of received data after wireless transmission. Quality of the connection is in accordance with the Bluetooth™* Specification v4.0. Data security The recorder is designed to only accept BLE communications from recognized and linked devices. You must program the app to accept information from a specific recorder. Transmitted sensitive data is encrypted to prevent unauthorized receipt or communication. Guidance and Manufacturer’s declaration Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The recorder is intended for use in the electromagnetic environment specified below. The customer or the user of the recorder should make sure that it is used in such an environment. Emissions Compliance Electromagnetic Environment - Guidance Test RF emissions Group 1 The recorder must emit electromagnetic energy in order CISPR 11 to perform its intended function. Nearby electronic equipment may be affected. RF emissions Class B The recorder is suitable for use in all establishments, CISPR 11 including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. -5-

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The recorder is intended for use in the electromagnetic environment specified below. The customer or the user of the recorder should make sure that it is used in such an environment. Immunity IEC 60601 Compliance Electromagnetic Environment - Test Test Level Level Guidance Electrostatic ±2 kV, ±4 kV, ±2 kV, ±4 kV, For use in a typical domestic, discharge ±8 kV, ±15 kV ±8 kV, commercial, or hospital environment. (ESD) IEC Air ±15 kVAir 61000-4-2 ±2 kV, ±4 kV, ±2 kV, ±4 kV, ±6 kV, ±8 kV ±6 kV, ±8 kV Contact Contact Electrical fast ±2 kV for Not Requirement does not apply to this transient/ power supply applicable battery powered device. burst lines IEC 61000- ±1 kV for input/ 4-4 output lines Surge ±1 kV line(s) to Not Requirement does not apply to this IEC 61000- line(s) applicable battery powered device. 4-5 ±2 kV line(s) to earth Voltage <5% UT (>95% Not Requirement does not apply to this dips, short dip in UT) for applicable battery powered device. interruptions 0.5 cycle and voltage variations on power supply lines IEC 61000- 4-11 Power 3 A/m 400 A/m Power frequency magnetic fields frequency should be at levels characteristic of a (50/60 Hz) typical location in a typical domestic, magnetic commercial, or hospital environment. field IEC 61000-4-8 Note: UT is the a.c. mains voltage prior to application of the test level. -6-

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The recorder is intended for use in the electromagnetic environment specified below. The customer or the user of the recorder should make sure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Environment - Test Level Level Guidance Conducted RF 3 V/m Not Not applicable IEC 61000- 150 kHz applicable 4-6 to 80 MHz Radiated RF 3 V/m 10 V/m Portable and mobile RF communications IEC 61000- 80 MHz 80 MHz to equipment should be used no closer to 4-3 to 2.5 GHz 6 GHz any part of the recorder, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the recorder. Refer to the recommended separation distance table for more information. 80 MHz to 800 MHz 800 MHz to 6 GHz Where P is the maximum output power rating of the recorder in watts (W) according to the recorder manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF recorders, as determined by an electromagnetic site survey3, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: -7-

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The recorder is intended for use in the electromagnetic environment specified below. The customer or the user of the recorder should make sure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Environment - Test Level Level Guidance Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption, and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF recorders, an electromagnetic site survey should be considered. If the measured field strength in the location in which the recorder is used exceeds the applicable RF compliance level above, the recorder should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the recorder. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the recorder The recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. If you have communication issues when attempting to send data from the recorder, try maintaining a separation distance between the recorder and portable or mobile communications equipment as per the following table: Rated maximum Separation distance according to the frequency of recorder (m) output power of recorder (W) 150 kHz to 80 MHz to 800 MHz 800 MHz to 6.0 GHz 80 MHz Not applicable 0.01 Not applicable 0.035 0.07 0.1 Not applicable 0.11 0.22 1 Not applicable 0.35 0.7 10 Not applicable 1.1 2.2 100 Not applicable 3.5 7 For recorders rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the recorder, where p is the maximum output power rating of the recorder in watts (W) according to the recorder manufacturer. -8-

Recommended separation distances between portable and mobile RF communications equipment and the recorder The recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. If you have communication issues when attempting to send data from the recorder, try maintaining a separation distance between the recorder and portable or mobile communications equipment as per the following table: Rated maximum Separation distance according to the frequency of recorder (m) output power of recorder (W) 150 kHz to 80 MHz to 800 MHz 800 MHz to 6.0 GHz 80 MHz Not applicable Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Icon Table Serial number Catalogue or model number One recorder per container/package Five recorders per container/package Manufacturer Refer to instruction manual before every use (appears blue on label) Manufactured in Non-ionizing electromagnetic radiation (RF communication) &21) Configuration or unique version identifier Degree of protection against electric shock: Type BF applied part Recorder: 4 is the level of protection against solid objects with a diameter above 1 mm. 8 is the level of protection against the effects of continuous immersion in water 2.4 meters (8 feet) immersion for 30 minutes -9-

Icon Table Humidity limitation This product conforms to Australia Radio Requirements Signifies European technical conformity Authorized representative in the European community Do not reuse Fragile, handle with care Keep dry Recycle cardboard, paper, plastic packaging supplies and unwanted written material WEEE Initiative: DO NOT THROW IN TRASH. Recycle device according to local disposal requirements Magnetic Resonance (MR) unsafe: keep away from magnetic resonance imaging (MRI) equipment Complies with Industry Canada Radio Communication requirements Use by Date 30°C 86°F Storage temperature 15°C 59°F 55°C 131°F Transit Temperature -20°C -4°F © 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic.™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. - 10 -

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Türkiye: Medtronic Medikal Teknoloji Ticaret Ltd. Sirketi. Tel: +90 216 4694330 Ukraine: Med Ek Service TOV Tel: +380 50 3311898 or: +380 50 4344346 Лінія цілодобової підтримки: 0 800 508 300 USA: Medtronic Diabetes Global Headquarters 24 Hour HelpLine: +1-800-646-4633 To order supplies: +1-800-843-6687 United Kingdom: Medtronic Ltd. Tel: +44 1923-205167 Österreich: Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190


Sanmina Corporation Mexico Carretera Guadalajara-Chapala Km 15.5 No. 29 Tlajomulco de Zuniga Jalisco, Mexico 45640 MMT-7781 M10542489-021_2


Document Created: 2019-03-19 19:56:21
Document Modified: 2019-03-19 19:56:21
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