biovotion Everion Instructions For Use Manual
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biovotion Everion Instructions For Use Manual

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92200.0002 Rev 4 Status: RELEASED
printed 11/09/2018 15:33:43 by Charlene Lim
EN
Everion
Instructions for Use

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  • Page 1 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Everion Instructions for Use...
  • Page 2 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Non-invasive physiological monitoring...

  • Page 3: Table Of Contents

    Alternative method ......................20 How to take off your Everion ..................22 Operation ..........................23 Explanation of the windows and LED lights on your Everion ....23 Explanation of the LED lights on the Charger..........24 How to turn on your Everion ...................25 How to charge your Everion ..................26 How to turn off your Everion ..................29...
  • Page 4 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim How to perform a self-test ..................31 6. Errors and Error Messages ....................32 Everion ..........................32 Charger ..........................33 Connectivity .........................34 Cleaning ..........................34 Storage ............................35 Maintenance and Calibration ..................36 Re-use ............................36 Disposal ..........................37 Explanation of Symbols ....................38...
  • Page 5 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Undesirable Side effects ....................53 Customer Service ......................54 Warranty ..........................54 Technical Information ......................57 Frequency band(s) in which the radio equipment operates .....62 Maximum radio-frequency power transmitted in the frequency band(s) in which the radio equipment operates ..........62 Regulatory Information....................63 Declaration of conformity ..................63 FCC Warning note: ......................64...

  • Page 6: General Comments

    This Instruction for Use belongs to the Everion. It contains important Informa- tion about use and maintenance. Please read the Instructions for Use before using your Everion. Disregard of the Instructions for use may lead to serious injury or to damages to the Everion.

  • Page 7: Everion Overview

    11/09/2018 15:33:43 by Charlene Lim Everion Overview Everion is a monitor that tracks your heart rate, heart rate variability, blood oxygen saturation, blood pulse wave, respiration rate under rest, skin blood per- fusion, activity, steps, skin temperature, barometric pressure and electrodermal activity.
  • Page 8 Activity tracks the general activity level of the user and yields a classification such as walking, running, cycling and resting. • Skin temperature measures the temperature of the skin under the Everion. This value cannot be used as a substitute for a core temperature measure- ment.
  • Page 9 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim This monitor is intended for fitness and general wellness only. The monitor is not intended for medical applications.

  • Page 10: Everion Components

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Everion Components Everion The Everion is a wearable device with multiple sensors for conti- nuous vital sign monitoring. LEDs GSR electrode photo sensor reset window...
  • Page 11 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Armband with fasteners This is an elastic band used to attach the Everion to the upper arm. It consists of: elastic band fastener Measurement Band This measurement band is used to...
  • Page 12 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Charger The charger is used to charge the Everion. It consists of: red LED power connector blue standby LED Power Cord The power cord is used to power the charger...

  • Page 13: Initial Operation

    Before you put on your Everion, please make sure it is fully charged (see chapter “Operation”). Then put your Everion on your upper arm with the armband as can be seen in the following images. An alternative method for putting on your Everion is described at the end of this...
  • Page 14 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Please take the measurement  band out of the box. It is already assembled correctly  The measurement band is threa- ded through both narrow slits The reading in the middle window determines the size of ...
  • Page 15 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim  Choose the correct length for the armband by measuring the circumference of your upper arm with the provided measurement band as shown in the picture. On the next page, you find a ...
  • Page 16 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Bent arm circumference (cm) Armband size 19.0 – 21.5 22.0 – 24.5 25.0 – 27.5 28.0 – 30.5 31.0 – 33.5 34.0 – 36.5 37.0 – 39.5 40.0 – 42.5 XXXL...
  • Page 17 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Now hold your Everion in one  hand with the sensors facing downwards Place the fi rst fastener on your  Everion Now snap the fastener onto your ...
  • Page 18 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim  Create a loop with the armband. Attach the second fastener to  your Everion.
  • Page 19 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Slip your Everion with the now  already attached armband over your hand and up to your upper arm: on the outside of your upper arm   directly on the skin ...

  • Page 20: Alternative Method

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Alternative method Position your Everion with the  attached armband: on the outside of your upper arm  directly on the skin  about two fi ngers above your ...
  • Page 21 This way, you can attach your Everion with one hand and over an infusion line if necessary. Please replace your armband with a new one if it is becoming looser and...

  • Page 22: How To Take Off Your Everion

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim How to take off your Everion Either slip it back down your arm   Or detach the fi rst fastener and take it off...

  • Page 23: Operation

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Operation Explanation of the windows and LED lights on your Everion No function Reset-window  Blue: Bluetooth connection. Blinking indicates readiness to connect, constant light indicates connection. Green: Constant light indicates ...

  • Page 24: Explanation Of The Led Lights On The Charger

    11/09/2018 15:33:43 by Charlene Lim Explanation of the LED lights on the Charger Red: Indicates incorrect position  of your Everion on the Char- ger or interrupted charging. See chapter “Errors and Error messages” Blue: Standby LED indicates if ...

  • Page 25: How To Turn On Your Everion

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim How to turn on your Everion Place your Everion on the Char-  ger or perform a reset. Your Everion turns on automati-  cally when you place it on the...

  • Page 26: How To Charge Your Everion

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim How to charge your Everion  I f your Everion emits a short double beep followed by two short vibrations, the battery is almost empty.  P lug the charger in with the provided power cord.
  • Page 27 Place your Everion in the  charger with the sensors facing upwards. A constant green LED light indi-  cates that your Everion is being charged. Once the green LED goes out  your Everion is fully charged. No Vital Signs are measured ...
  • Page 28 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Whenever you take your Everion  off the charger, it runs through a self-test. If the self-test passes, there are two short beeps. You do not need to do anything.

  • Page 29: How To Turn Off Your Everion

    Place the finger on the re-  set-window on the back of your Everion. A LED lights up. After 3 seconds, your Everion  vibrates. Now remove your finger, your Everion turns off and the light of blue LEDs go off.

  • Page 30: How To Perform A Reset

    How to perform a reset Place a finger on the re-  set-window and keep it there. LED lights up.  After 3 seconds, your Everion  will vibrate and after about 10 seconds the LED goes off.  Your Everion is reset.

  • Page 31: How To Perform A Self-Test

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim How to perform a self-test Place your Everion on the char-  ger for at least five seconds. The green LED lights up Take it off the Charger. If the ...

  • Page 32: Errors And Error Messages

    The battery of your Everi- Please charge your with two short vibrations on is running low Everion One long beep together The Everion has no valid Please reposition your with a long vibration signal Everion and verify the new placement.

  • Page 33: Charger

    Alarms What it means What to do LED blinks The placement of the Reposition your Everion Everion is not optimal to find a better placement. LED is constantly on Charging has stopped Remove your Everion, either due to timeout or...

  • Page 34: Connectivity

    The Everion transmits the Vital Sign Data over Bluetooth smart connection to an authorized gateway like your mobile phone. With the Biovotion X App on your mobile phone, you can receive the vital signs of your Everion and they are visualized.

  • Page 35: Storage

    Please store your Everion at room temperature in a dry place. Protect it from direct sunlight and other heat sources. If you do not use your Everion, place it on the charger or switch it off. This way, no unintended measure- ments are possible.

  • Page 36: Maintenance And Calibration

    The expected service life of your Everion, Charger and Power Cord is two years. Please replace your armband with a new one if your Everion is not properly held in place any longer.

  • Page 37: Disposal

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim 12. Disposal This symbol points out that the Everion shall not be disposed in household refuse. Please return this product to an authori- zed collection point for electrical appliances. You may access...

  • Page 38: Explanation Of Symbols

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim 13. Explanation of Symbols Symbol Meaning Symbol Meaning Device emits electromag- Part number netic radiation Temperature range spe- Serial number cifications for storage (on package) or use (on device) Relative humidity range for Lot number storage (on package) or use...
  • Page 39 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim European conformity mark Manufacturing date (conformité européenne) Name and address of Federal Communications manufacturer Commission conformity mark Do not throw away (cont- Ingress protection class ains battery) Follow Instructions for Use General warning sign Consult Instructions for Indicates the Reset-window...

  • Page 40: Safety

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Protection against electri- cal shock, class II Indicates the charging LED For indoor use only Indicates the connection LED 14. Safety Warnings...
  • Page 41 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Danger to the User or others: Consult your doctor before you start an exercise regime if you have kidney disease and/or diabetes mellitus type 1 or 2 or heart disease. Consult your doctor and do not start or continue exercising if you experience any of the following signs or symptoms: •...
  • Page 42 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim • Having a known heart murmur. • Having swollen ankles. Exercising while experiencing any of these symptoms might increase the risk of heart problems. It is important to always listen to your body first, instead of only relying upon measurements that the device provides.
  • Page 43 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Exercising with a too high heart rate could cause health problems, like tempo- rary chest pain, heart overload or exhaustion. Do not modify this equipment. This may result in hazardous situations. Make sure the device is in proper working condition before use.
  • Page 44 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim • Do not wear the armband too tight, to ensure it is still comfortable to wear. • Avoid using skin care products (e.g. oils and lotions) in the area you wear the device if they lead to skin irritation.
  • Page 45 Danger of Explosion: Do not use your Everion in a flammable atmosphere, for example close to flammable anesthetics, they could catch fire. Danger of light burn. Your Everion may attain 43°C during charging. Allow it to cool down for 5 minutes before placing it on the arm.
  • Page 46 Risk of spreading infection: Your Everion may get contaminated and spread infection if used for multiple users. Please clean your Everion regularly as descri- bed in chapter “Cleaning”. Especially before giving it to another person.

  • Page 47: Precautions

    Danger of damage to the Everion (including Charger, Armband and Power Cord): Do not try to perform maintenance or repair your Everion yourself. Do not open the housing. Please contact Biovotion AG for repair or warranty issues. Do not connect your Everion to other equipment not described in the instruc- tions for use.
  • Page 48 Keep your Everion away from aggressive chemicals or flammable substances. Keep your Everion away from heat sources like radiant heaters or fireplaces. Do not use your Everion while bathing, swimming, surfing, in a hot tub or sauna. Avoid contact with soap, detergent, chlorinated water, salt water, lotion and sunscreen Avoid contact with bug spray.
  • Page 49 Danger of electromagnetic interference: Do not use your Everion close to MRI or CT facilities. Do not use your Everion less than 1 m distance from a short wave or Microwave or high frequency surgery device. Do not stack or store the Everion close to other equipment.
  • Page 50 Avoid direct light and direct sunlight. Intensive ambient light may impair the measuring function. Make sure the Everion is worn in the defined anatomical area and with the correct armband size. Intensive motion might lead to values not being displayed momentarily.
  • Page 51 App. However, a skin type according to the Fitzpatrick scale of 4 and above might restrict the full operational appli- cation of the Everion. Skin types according to the Fitzpatrick scale of 6 might further significantly restrict the operational application. In this case, please consult our customer support portal for further information.

  • Page 52: Contra-Indications

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Contra-indications Do not wear your Everion over an area with a tattoo, skin disease or other skin problems including wounds, sores and burns as this can result in prolongation or aggravation of symptoms.

  • Page 53: Undesirable Side Effects

    Do not use your Everion in cold environment of under 0°C. Undesirable Side effects Please avoid wearing your Everion for more than approximately 12 hours on the exact same location. This might lead to itching due to accumulated humidity. You can move it to your other arm or reposition it on the same arm.

  • Page 54: Customer Service

    Please have the Model Number ready. You will find it on the backside of your Everion. 16. Warranty Warranty period: Biovotion grants the usual minimal legal warranty period for the Everion and the Charger...
  • Page 55 Damage occurring during shipment is not covered by this warranty. NOTE: No other warranty, written or oral is authorized by Biovotion AG. This warranty gives you specific legal rights, and you may also have other rights which vary from state to state.
  • Page 56 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim The warranty does not apply in cases of: Accident or unforeseen events (e.g. lightning, water, fire, etc.). Improper use or transport Disregard of Safety- and Maintenance instructions Other improper use or modification Misuse and abuse Lack of reasonable care The affixing of any attachment not provided with the product or loss of...

  • Page 57: Technical Information

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim 17. Technical Information Technical data Everion Charger Electrical power supply: Lithium Ion Cell, 3.7V, 720 100-240 VAC, 0.13A 50/60 Hz Classification: Internally powered Safety Class: IP67 IP 21 Weight: approx.
  • Page 58 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim  The Everion is IP Class 67 which means which means it is protected from dust and from immersion in liquids between 15 centimeters and 1 meter in depths.
  • Page 59 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Vital Signs Parameter Measurement Range Measurement Accuracy Heart Rate: 30 – 240 beats per minute ±4bpm MAD***, ±5% MARD**** (at rest) ±4bpm MAD, ±4% MARD (under motion*) Oxygenation**: 65 – 100% (at rest) ±3% - in the range >...
  • Page 60 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Skin Temperature: 0 °C – 60 °C ± 1°C (standalone sensor) Respiration Rate 6-30 breaths per minute Less accurate under motion Energy Expenditure 0-65’535 kCal per day Heartrate Variability 0-255 ms (RMSSD*****) Blood pulse wave 0-5.1 (without unit)
  • Page 61 15% – 93% RH 10% – 93% RH Barometric Pressure: 860 – 1060 mbar 700 – 1060 mbar Height: - 390 – 3012 m - 390 – 5574 m * Temperature limits do not apply while the Everion is worn on the body...

  • Page 62: Frequency Band(S) In Which The Radio Equipment Operates

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim Frequency band(s) in which the radio equipment operates Bluetooth BLE smart: 2402 MHz – 2480 MHz Maximum radio-frequency power transmitted in the frequency band(s) in which the radio equipment operates 4 dBm (2.5 mW)

  • Page 63: Regulatory Information

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim 18. Regulatory Information Declaration of conformity Biovotion AG hereby declares that the Everion is conform to the Essential Requirements of the following Directives: RED 2014/53/EU RoHS 2011/65/EU 2014/30/EC (EMC Directive)

  • Page 64: Fcc Warning Note

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim This device complies with applicable standards and regulations of the FCC Ru- les. The FCC-ID is available on the device label. FCC Warning note: Contains FCC ID 2AAQS-ISP130301 Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
  • Page 65 92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 66: Ic Warning Statement

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim - Consult the dealer or an experienced radio/TV technician for help. IC Warning Statement Contains IC ID 11306A-ISP130301 This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

  • Page 67: Rf Radiation Exposure Statement

    Changes or modifications made to this equipment not express- ly approved by Biovotion AG may void the FCC authorization to operate this equipment. Trademarks App Store and iPhone are trademarks of Apple Inc., registered in the U.S.

  • Page 68: Manufacturer Information

    92200.0002 Rev 4 Status: RELEASED printed 11/09/2018 15:33:43 by Charlene Lim 19. Manufacturer Information Biovotion AG Kreuzstrasse 2 8008 Zurich Switzerland www.biovotion.com 92200.0002 / 4...

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