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

Monitor that tracks your heart rate, heart rate variability, blood oxygen saturation, blood pulse wave, respiration rate under rest, skin blood perfusion, activity, steps, skin temperature, barometric pressure and electrodermal activity
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Summary of Contents for biovotion Everion

  • Page 1 Everion...
  • Page 2 Instructions for Use...
  • Page 4 Non-invasive physiological monitoring...

  • Page 5: Table Of Contents

    Initial operation ......... 16 How to turn off your Everion .....35 Alternative method ....... 24 How to perform a reset .......36 How to take off your Everion .... 26 How to perform a self-test ....38 Operation ..........28 Errors and Error Messages .....39...
  • Page 6 Connectivity .........41 Undesirable Side effects ..... 64 Cleaning ..........42 15. Customer Service ......65 Storage ..........43 16. Warranty ..........65 10. Maintenance and Calibration ..43 17. Technical Information ..... 68 11. Re-use ............44 18. Regulatory Information ....74 12. Disposal ..........45 Declaration of conformity ....

  • Page 7: General Comments

    This Instruction for Use belongs to the Everion. It contains important Information 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 8: Everion Overview

    2. 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 perfusion, activity, steps, skin temperature, barometric pressure and electrodermal activity. ✓ Sweat-proof and water-resistant design ✓...
  • Page 9 Skin blood perfusion is an indicator of the perfusion of the skin under the • Everion. Activity tracks the general activity level of the wearer of an Everion and yields a • classification like walking, running and resting. Skin temperature measures the temperature of the skin under the Everion. This •...
  • Page 10 Electrodermal activity (EDA) is the property of the human body that causes • continuous variation in the electrical characteristics of the skin, such as due to sweating. This monitor is intended for fitness and general wellness only. The monitor is not intended for medical applications.

  • Page 11: Everion Components

    3. Everion Components Everion The Everion is a wearable device with multiple sensors for continuous vital sign monitoring. ① LEDs ② ① ② GSR electrode ③ photo sensor ③ ④ ④ reset window...
  • Page 14 Armband with fasteners ① This is an elastic band used to attach the Everion to the upper arm. It consists of: ② ① elastic band ② fastener Measurement Band This measurement band is used to determine the correct band size ①...
  • Page 15 Charger The charger is used to charge the ① Everion. It consists of: ① red LED ② ② power connector ③ ③ blue standby LED Power Cord The power cord is used to power the charger...

  • Page 16: 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 17 ✓ Please take the measurement band out of the box. It is already assembled correctly ✓ The measurement band is threaded through both narrow slits ✓ The reading in the middle window determines the size of your armband...
  • Page 18 ✓ Choose the correct length for the armband by measuring the circumference of your upper arm with the provided measurement band as shown in the picturepicture. Choose the correct length for the armband by measuring the circumference your upper arm with the provided measurement band as shown in the picture...
  • Page 19 ✓ On the next page, you find a table with arm circumferences Bend your arm during the and the corresponding armband measurement sizes.On the next page, you find a table with arm circumferences and the corresponding band sizes. ✓ If you feel the band size you initially chose is too tight or too loose, please choose the next bigger or smaller band size until...
  • Page 20 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 21 ✓ Now hold your Everion in one hand with the sensors facing downwards ✓ Place the first fastener on your Everion ✓ Now snap the fastener onto your Everion. ✓ Press the fastener all the way down until it rests in the lower...
  • Page 22 ✓ Create a loop with the armband ✓ Attach the second fastener to your Everion.
  • Page 23 ✓ Slip your Everion with the now already attached armband over your hand and up to your upper arm: ✓ on the outside of your upper ✓ directly on the skin ✓ about two fingers above your elbow-crease. ✓ If you are tall, you may need to position it three to four fingers above your elbow-crease.

  • Page 24: Alternative Method

    Alternative method ✓ Position your Everion with the attached armband: ✓ on the outside of your upper ✓ directly on the skin ✓ about two fingers above your elbow-crease. ✓ If you are tall, you may need to position it three to four fingers...
  • Page 25 ✓ Now snap the second fastener onto your Everion. ✓ Press the second fastener all the way down until it rests in the upper groove. This way, you can attach your Everion with one hand and over an infusion line if necessary.

  • Page 26: How To Take Off Your Everion

    Please replace your armband with a new one if it is becoming looser and Everion is no longer properly held in place. How to take off your Everion ✓ Either slip it back down your...
  • Page 27 ✓ Or detach the first fastener and take it off...

  • Page 28: Operation

    5. Operation Explanation of the windows and LED lights on your Everion ✓ Blue: Bluetooth connection. Reset-window No function Blinking indicates readiness to connect, constant light indicates connection. ✓ Green: Constant light indicates charging. See chapter “How to charge your Everion”...

  • Page 29: Explanation Of The Led Lights On The Charger

    See chapter “How to turn off your Everion” Explanation of the LED lights on the Charger ✓ Red: Indicates incorrect position of your Everion on the Charger or interrupted charging. See chapter “Errors and Error messages” ✓ Blue: Standby LED indicates if...

  • Page 30: How To Turn On Your Everion

    ✓ The green light indicates that it is charging. ✓ To turn on your Everion without a charger, perform a reset. After a reset, your Everion is turned on. Please see in chapter “How to perform a reset”...

  • Page 31: How To Charge Your Everion

    How to charge your Everion ✓ If your Everion emits a short double beep followed by two short vibrations, the battery is almost empty. ✓ Plug the charger in with the provided power cord. ✓ A constant blue LED light next to the power inlet shows that the charger is powered.
  • Page 32 ✓ Detach one or both fasteners from your Everion. ✓ Place your Everion in the charger with the sensors facing upwards. ✓ A constant green LED light indicates that your Everion is being charged. ✓ Once the green LED goes out your Everion is fully charged.
  • Page 33 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. ✓ If the self-test does not pass, there is a long beep. Please read...
  • Page 34 chapter “Errors and Error Messages” on how to proceed.

  • Page 35: How To Turn Off Your Everion

    How to turn off your Everion Take your Everion off the ✓ charger. ✓ Place the finger on the reset- window on the back of your Everion. A LED lights up. ✓ After 3 seconds, your Everion vibrates. Now remove your finger, your...

  • Page 36: How To Perform A Reset

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

  • Page 38: How To Perform A Self-Test

    How to perform a self-test Place your Everion on the ✓ charger for at least five seconds. green LED lights up ✓ Take it off the Charger. If the self-test passes, there are two short beeps. You do not need to do anything.

  • Page 39: Errors And Error Messages

    Errors and Error Messages Everion Alarms What it means What to do Two short beeps The battery of your Everion Please charge your Everion together with two short is running low vibrations One long beep together The Everion has no valid...
  • Page 40 No action required One long beep Self-test failed Contact Biovotion (see chapter “Customer Service”) Charger Alarms What it means What to do LED blinks The placement of the Reposition your Everion to Everion is not optimal find a better placement.

  • Page 41: Connectivity

    Charging has stopped either Remove your Everion, wait due to timeout or over for five minutes and replace temperature the Everion onto the charger Connectivity The Everion transmits the Vital Sign Data over Bluetooth smart connection to an authorized gateway.

  • Page 42: Cleaning

    Cleaning ✓ You can clean your Everion with a damp cloth with clean water. o Gently wipe down the Everion ✓ The armband can be hand-washed with standard hand wash detergents. ✓ Never use compressed air, scouring pads, abrasive cleaning agents or aggressive liquids such as gasoline or acetone to clean the device.

  • Page 43: 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 measurements are possible.

  • Page 44: Re-Use

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

  • Page 45: Disposal

    Disposal This symbol points out that the Everion shall not be disposed in household refuse. Please return this product to an authorized collection point for electrical appliances. You may access information about collection points at your municipality, public waste management organizations, authorized bodies for disposal of waste electrical and electronic equipment.

  • Page 46: Explanation Of Symbols

    Explanation of Symbols Symbo Meaning Symbol Meaning Device emits electromagnetic Part number radiation Temperature range Serial number specifications for storage (on package) or use (on device)
  • Page 47 Relative humidity range for Lot number storage (on package) or use (on device) European conformity mark Manufacturing date (conformité européenne) Name and address of Federal Communications manufacturer Commission conformity mark Do not throw away (contains Ingress protection class battery)
  • Page 48 Follow Instructions for Use General warning sign Consult Instructions for Use Indicates the Reset-window Protection against electrical Indicates the charging LED shock, class II For indoor use only Indicates the connection LED...

  • Page 49: Safety

    Safety Warnings 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: Feeling that your heart is beating too hard or fast •...
  • Page 50 Feeling pain in your chest, neck, jaw or arms, • Feeling unusual fatigue with usual activities • Feeling dizzy, nauseated or about to faint • Having shortness of breath during rest/mild exertion, when lying flat or during • the night Having a known heart murmur •...
  • Page 51 Exercising with a too high heart rate could cause health problems, like temporary chest pain, heart overload or exhaustion. Do not share the device. The Everion is designed for personal use only.
  • Page 52 Do not modify this equipment. This may result in hazardous situations. Make sure the device is in proper working condition before use. Only use the Charger and detachable parts authorized by the manufacturer. The use of unauthorized parts or accessories may cause injury or damage to the device. To reduce the risk of skin irritation please follow these instructions: Clean the device and skin underneath the device regularly and after each sport •...
  • Page 53 Avoid using skin care products (e.g. oils) in the area you wear the device if they • lead to skin irritation Keep the device out of reach of infants, children or pets, since inhalation or swallowing of small parts can be dangerous or even fatal. Do not let children play with the armband or the power cord in order to avoid them to entangle themselves or to strangle themselves.
  • Page 54 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 55 If battery leakage comes in contact with your eyes, get medical assistance. Risk of spreading infection: Your Everion may get contaminated and spread infection if used for multiple users. Please clean your Everion as described in chapter “Cleaning”.
  • Page 56 Please do not adjust any therapy or provide medication based upon the measurements from your Everion. This monitor is intended for fitness and general wellness only. The monitor is not intended for medical applications.

  • Page 57: Precautions

    Do not connect your Everion to other equipment not described in the instructions for use. Take care if you use the alternative method of putting on your Everion. Slipping it over rings, watches or other jewelry might damage the sensors at the bottom of your...
  • Page 58 Protect your Everion from mechanical shock and hard bumps. 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.
  • Page 59 Clean your Everion according to the instructions in the chapter “Cleaning”. Do not use a spray bottle to clean your Everion. Please use the correct length of the armband for your Everion by following the instructions in chapter “Initial operation”.
  • Page 60 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. Please note the tables in the chapter “Technical Information” in this document.
  • Page 61 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. Hypotension, Anemia, Shock, hypothermia or constricted vessels may lead to measurement impairment. Use your Everion only on the defined anatomical area.

  • Page 62: Contra-Indications

    Everion and therefore may currently not be recommended. 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 63 If you experience such reactions, please remove the device and give your skin some rest. If the reactions persist, please consult your doctor. Do not use your Everion in a hot environment of over 40°C. Do not use your Everion in cold environment of under 0°C.

  • Page 64: Undesirable Side Effects

    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 65: Customer Service

    Customer Service Please contact us at https://biovotion.zendesk.com or via email at support@biovotion.zendesk.com. Please have the Model Number ready. You will find it on the backside of your Everion. Warranty Warranty period: The Everion and the Charger 1 year Armband: Expected wear and tear is excluded from warranty...
  • Page 66 Note: Before sending us your Everion, please contact us via Customer Service. This way, we can help you in case of operating errors. In Order to make use of the guarantee, please send us the product with all parts included in the scope of delivery. It is suggested that for your protection you return shipments of product by insured mail, insurance prepaid.
  • Page 67 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 parts or subjecting the product to any but the specified voltage.

  • Page 68: Technical Information

    Technical Information Technical data Everion Charger Electrical power supply: Lithium Ion Cell, 3.7V, 100-240 VAC, 0.13A 720 mAh 50/60 Hz Classification: Internally powered Safety Class: IP67 IP 21 Weight: approx. 40 g approx. 90 g Size: approx. 70 x 50 x 12 mm approx.
  • Page 69 ✓ 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 ✓ The Charger is IP Class 21 which means it is protected from touch by finders and objects greater than 12 millimeters.
  • Page 70 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 > 90% ±4% - in the range <...
  • Page 71 Activity: 0 – 255 (without unit) Steps: 0 - 65’535 per day Skin Temperature: 0 °C – 60 °C ± 1°C (standalone sensor) Respiration Rate 6-30 Bpm Energy Expenditure 0-65’535 kCal per day Heartrate Variability 0-255 ms (RMSSD) Blood pulse wave 0-5.2 Electrodermal activity 0-21.8 kOhm...
  • Page 72 ***:MAD – Mean absolute deviation ****:MARD – Mean absolute relative deviation...
  • Page 73 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 74: Regulatory Information

    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) 2014/35/EC (Low Voltage Directive)

  • Page 75: Trademarks

    You can request the full text of the Declaration of Conformity by contacting us via email (info@biovotion.com). Trademarks App Store and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.

  • Page 76: Manufacturer Information

    Manufacturer Information Biovotion AG Kreuzstrasse 2 8008 Zurich Switzerland www.biovotion.com...
  • Page 77 92200.0002 / 3...

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