Users Manual 1

FCC ID: OH27781

Users Manual

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FCCID_4342191

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 -


Africa:                                       Bulgaria:
  Medtronic Africa (Pty) Ltd.                   RSR EOOD
  Tel: +27 (0) 11 677 4800                      Tel: +359 888993083
Albania:                                        Helpline: +359 884504344
  Net Electronics Albania                     Canada:
  Tel: +355 697070121                           Medtronic of Canada Ltd.
Argentina:                                      Tel: 1-800-284-4416 (toll free/sans frais)
  Corpomedica S.A.                            Chile:
  Tel: +(11) 4 814 1333                         Medtronic Chile
  Medtronic Directo 24/7:+0800 333 0752         Tel: +(9) 66 29 7126
Armenia:                                        Medtronic Directo 24/7: +1 230 020 9750
  Exiol LLC                                     Medtronic Directo 24/7 (From Santiago):
  Tel: +374 98 92 00 11 or +374 94 38 38 52        +(2) 595 2942
Australia:                                    China:
  Medtronic Australasia Pty. Ltd.               Medtronic (Shanghai) Ltd.
  Tel: 1800 668 670                             24 Hour Help (Cell): +86 400-820-1981
                                                24 Hour Help (Land): +86 800-820-1981
Azerbaijan:
  Isomed                                      Colombia:
  Tel: +994 (12) 464 11 30                      Medtronic Latin America Inc. Sucursal
                                                   Colombia
Bangladesh:
                                                Tel: +(1) 742 7300
  Sonargaon Healthcare Pvt Ltd.
                                                Medtronic Directo 24/7 (Landline):
  Mobile: (+91)-9903995417
                                                   +01 800 710 2170
  or (+880)-1714217131
                                                Medtronic Directo 24/7
Belarus:                                           (Cellular): +1 381 4902
  Zarga Medica
                                              Croatia:
  Tel: +375 29 625 07 77 or:
                                                Mediligo d.o.o.
      +375 44 733 30 99
                                                Tel: +385 1 6454 295
  Helpline: +74995830400
                                                Helpline: +385 1 4881144
België/Belgique:
  N.V. Medtronic Belgium S.A.                   Medtronic Adriatic d.o.o.
  Tel: 0800-90805                               Helpline: +385 1 4881120
Bosnia and Herzegovina:                       Česká republika:
  Novopharm d.o.o. Sarajevo                     Medtronic Czechia s.r.o.
  Tel: +387 33 476 444                          Tel: +420 233 059 111
  Helpline: 0800 222 33                         Non-Stop Helpline (24/7): +420 233 059 059
                                                Zákaznický servis (8:00 - 17:00):
  Epsilon Research Intern. d.o.o.                  +420 233 059 950
  Tel: +387 51 251 037
                                              Danmark:
  Helpline: 0800 222 33
                                                Medtronic Danmark A/S
Brasil:                                         Tel: +45 32 48 18 00
  Medtronic Comercial Ltda.
                                              Deutschland:
  Tel: +(11) 2182-9200
                                                Medtronic GmbH
  Medtronic Directo 24/7:
                                                Geschäftsbereich Diabetes
     +0800 773 9200
                                                Telefon: +49 2159 8149-370
                                                24-Stdn-Hotline: 0800 6464633


Eire:                                          Italia:
   Accu-Science Ltd.                              Medtronic Italia S.p.A.
   Tel: +353 45 433000                            Tel: +39 02 24137 261
España:                                           Servizio assistenza tecnica:
   Medtronic Ibérica S.A.                         N° verde: 800 60 11 22
   Tel: +34 91 625 05 42                       Japan:
   24 horas: +34 900 120 330                      Medtronic Japan Co. Ltd.
Estonia:                                          Tel: +81-3-6776-0019
   AB Medical Group Eesti OU                      24 Hr. Support Line: 0120-56-32-56
   Tel: +372 6552310                           Kazakhstan:
   Helpline: +372 5140694                         Medtronic BV in Kazakhstan
Europe:                                           Tel: +7 727 311 05 80 (Almaty)
   Medtronic Europe S.A. Europe, Middle East           +7 717 224 48 11 (Astana)
      and Africa HQ                               Круглосуточная линия поддержки:
   Tel: +41 (0) 21-802-7000                          8 800 080 5001
France:                                        Kosovo:
   Medtronic France S.A.S.                        Yess Pharma
   Tel: +33 (0) 1 55 38 17 00                     Tel: +377 44 999 900
                                                  Helpline: +37745888388
Hellas:
   Medtronic Hellas S.A.                       Latin America:
   Tel: +30 210677-9099                           Medtronic, Inc.
                                                  Tel: 1(305) 500-9328
Hong Kong:
   Medtronic International Ltd.                Latvija:
   Tel: +852 2919-1300                            RAL SIA
   To order supplies: +852 2919-1322              Tel: +371 67316372
   24-hour helpline: +852 2919-6441               Helpline (9am to 6pm): +371 29611419
India:                                         Lithuania:
   India Medtronic Pvt. Ltd.                      Monameda UAB
   Tel: (+91)-80-22112245 / 32972359              Tel: +370 68405322
   Mobile: (+91)-9611633007                       Helpline: +370 68494254
   Patient Care Helpline: 1800 209 6777        Macedonia:
Indonesia:                                        Alkaloid Kons Dooel
   Medtronic International Ltd.                   Tel: +389 23204438
   Tel: +65 6436 5090 or +65 6436 5000         Magyarország:
Israel:                                           Medtronic Hungária Kft.
   Medtronic                                      Tel: +36 1 889 0688
   Tel (orders): +9729972440, option 3 +       Malaysia:
      option 1                                    Medtronic International Ltd.
   Tel (product support): +9729972440,            Tel: +603 7946 9000
      option 2
   Helpline: (17:00 – 08:00 daily/weekends –
      Israel time): 1-800-611-888


México:                                      Romania:
  Medtronic Servicios S. de R. L. de C.V.      Medtronic Romania S.R.L
  Tel (México DF): +(11) 029 058               Tel: +40372188017
  Tel (Interior): +01 800 000 7867             Helpline: +40 726677171
  Medtronic Directo 24/7 (from México DF):   Schweiz:
      +(55) 36 869 787                         Medtronic (Schweiz) AG
  Medtronic Directo 24/7:                      Tel: + 41 (0) 31 868 0160
      +01 800 681 1845                         24-Stunden-Hotline: 0800 633333
Middle East and North Africa:                Serbia:
  Regional Office                              Epsilon Research International d.o.o.
  Tel: +961-1-370 670                          Tel: +381 113115554
Montenegro:                                    Medtronic Serbia D.o.o.
  Glosarij d.o.o.                              Helpline: +381 112095900
  Tel: +382 20642495
                                             Singapore:
Nederland, Luxembourg:                         Medtronic International Ltd.
  Medtronic B.V.                               Tel: +65 6436 5090 or +65 6436 5000
  Tel: +31 (0) 45-566-8291
  Gratis: 0800-3422338                       Slovenija:
                                               Zaloker & Zaloker d.o.o.
New Zealand:                                   Tel.: +386 1 542 51 11
  Medica Pacifica                              24-urna tehnična pomoč:
  Phone: 64 9 414 0318                         +386 51316560
  Free Phone: 0800 106 100
                                             Slovenská republika:
Norge:                                         Medtronic Slovakia, s.r.o.
  Medtronic Norge A/S                          Tel: +421 26820 6942
  Tel: +47 67 10 32 00                         HelpLine: +421 26820 6986
Philippines:                                 Sri Lanka:
  Medtronic International Ltd.                 Swiss Biogenics Ltd.
  Tel: +65 6436 5090 or +65 6436 5000          Mobile: (+91)-9003077499
Россия:                                           or (+94)-777256760
  ООО «Медтроник»                            Suomi:
  Tel: +7 495 580 73 77                        Medtronic Finland Oy
  Круглосуточная линия поддержки:              Tel: +358 20 7281 200
      8 800 200 76 36                          Help line: +358 400 100 313
Polska:                                      Sverige:
  Medtronic Poland Sp. z o.o.                  Medtronic AB
  Tel: +48 22 465 6934                         Tel: +46 8 568 585 20
Portugal:                                    Taiwan:
  Medtronic Portugal Lda                       Medtronic (Taiwan) Ltd.
  Tel: +351 21 7245100                         Tel: 02-21836000
Puerto Rico:                                   Toll Free: +886-800-005285
  Medtronic Puerto Rico                      Thailand:
  Tel: 787-753-5270                            Medtronic (Thailand) Ltd.
Republic of Korea:                             Tel: +662 232 7400
  Medtronic Korea, Co., Ltd.
  Tel: +82.2.3404.3600


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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