EVIE EvieMED Ring Instructions For Use Manual

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Introduction ................................................................................................................................................................................................ 2

Package contents .............................................................................................................. 2

Required, not supplied ...................................................................................................... 2

Also sold separately .......................................................................................................... 2

Intended Use .............................................................................................................................................................................................. 2

Contraindications ....................................................................................................................................................................................... 3

Possible Adverse Events ............................................................................................................................................................................ 3

Warnings .................................................................................................................................................................................................... 3

Precautions ................................................................................................................................................................................................. 5

Information to Get Started ......................................................................................................................................................................... 5

EvieMED Ring ................................................................................................................. 5

EvieMED Ring Charger ................................................................................................... 6

Biometrics Measured ........................................................................................................ 6

Notifications and Visual Indicators .................................................................................. 6

App Icons and Symbols .................................................................................................... 8

Setting up and Using the EvieMED Ring .................................................................................................................................................. 9

Unpacking the EvieMED Ring ......................................................................................... 9

Downloading the EvieMED App...................................................................................... 9

Navigating the App Overview .......................................................................................... 10

EvieMED Pulse Oximeter Setup-App Screenshots ....................................................... 11

Taking a Pulse Oximeter Reading-App Screenshots ..................................................... 15

Understanding Pulse Oximeter Results ............................................................................ 15

Sharing Pulse Oximeter Results ....................................................................................... 15

Evie Wellness-Today-App Screenshots ...................................................................... 19

Evie Wellness-My Body--App Screenshots ................................................................... 20

Evie Wellness-Sleep/Journaling-App Screenshots ...................................................... 21

Cleaning ................................................................................................................................................................................................... 24

Recharging ............................................................................................................................................................................................... 25

Storage and Disposal................................................................................................................................................................................ 25

Specifications ........................................................................................................................................................................................... 25

EvieMED Ring Specifications .......................................................................................... 25

EvieMED Ring Charger Specifications ............................................................................ 26

EvieMED Ring Mobile App Specifications ..................................................................... 26

EvieMED Ring Pulse Oximetry Optical Characteristics .................................................. 26

Information Security ................................................................................................................................................................................ 28

Quality of Service .................................................................................................................................................................................... 29

Maintenance ............................................................................................................................................................................................. 29

Troubleshooting ....................................................................................................................................................................................... 29

Declaration and Manufacturer's Guidance .............................................................................................................................................. 30

Labeling Symbols .................................................................................................................................................................................... 35

Product Details ......................................................................................................................................................................................... 35

Warranty Information .............................................................................................................................................................................. 35

Manufactured for: .................................................................................................................................................................................... 35

320-01349 I

EvieMED Ring

Instructions for Use (IFU)/User Guide

For Prescription Use Only

Page 1 of 35

Table of Contents

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Summary of Contents for EVIE EvieMED Ring

Page 1: Table Of Contents
Biometrics Measured ......................6 Notifications and Visual Indicators .................. 6 App Icons and Symbols ....................8 Setting up and Using the EvieMED Ring ..............................9 Unpacking the EvieMED Ring ..................9 Downloading the EvieMED App..................9 Navigating the App Overview ..................10 EvieMED Pulse Oximeter Setup—App Screenshots ............
Page 2: Introduction
The device may need to be recharged every 4+ days. The EvieMED Ring is connected to an iPhone 8 or later, running iOS 16 or later (copyright Apple, Inc., Cupertino, CA) via Bluetooth Low Energy (copyright SIG, Kirkland, Washington), which in turn is connected to external cloud storage via Wi-Fi or cellular service for data processing, calculations, trending, and storage.
Page 3: Contraindications
EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only Contraindications • Magnetic field: Do not use if you have a pacemaker, ICD, or any other device that is magnetically susceptible as this could cause injury or death. •...
Page 4 • Non-medical or wellness data (Evie) o None of the functions in Evie Wellness (activity, workout, steps, pulse rate graph, menstrual cycle tracking, sleep and sleep measurements) provide medical data for clinical decision-making. Only the EvieMED Pulse Oximeter provides medical data for clinical decision-making.
Page 5: Precautions
The Ring must be connected to view historical data and sleep data. • o Use the Ring sizer provided to size your finger: ring fit is important, and the EvieMED Ring should always be comfortable. o If the Ring is too loose or too tight or not worn with the arrow in the up position, the device may be uncomfortable and/or data loss may occur.
Page 6: Eviemed Ring Charger
EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only EVIEMED RING CHARGER • The Charger can charge the Ring when not connected to a USB AC Adapter, allowing you to take it anywhere and recharge your Ring. The LED light on the outside of the Charger in the front will indicate how much battery the Charger has left.
Page 7 If there is a new firmware update available, a local notification will be sent once a day to inform user about it until the firmware has been updated. • Visual Indicators on the EvieMED Ring When worn, the LED lights on the Ring will turn on to indicate when data is being collected. LED lights can be green as shown on the right or the LED lights can be red.
Page 8: App Icons And Symbols
This is the toggle at the top of the Evie Today opening screen of the app. Evie will have a light background and EvieMED will have a dark background when on the wellness side of the app.
Page 9: Setting Up And Using The Eviemed Ring
Before moving forward with setting up the EvieMED Ring, make sure it is fully charged by plugging in the Charger to an outlet for two hours. Keep the EvieMED Ring inside the Charger. A USB-C cable is provided, but you will need an AC adapter (also called a wall Charger or power brick) to plug the Charger into a wall. The light on the Charger will turn green when fully charged.
Page 10: Navigating The App Overview
Daily Summary (Evie Wellness) o The main screen of the Evie (wellness) feature of the app will always be set to the Today screen which provides a summary of your day, including everything related to activity and recovery. Filling the entire Daily Summary circle is achieved through meeting your combined daily goals for steps, activity, and sleep (all customizable within your profile settings).
Page 11: Eviemed Pulse Oximeter Setup-App Screenshots
EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only EVIEMED PULSE OXIMETER SETUP—APP SCREENSHOTS To register after downloading the App for the first time, or when opening the App after registration, the app will open to the EvieMED splash screen, which will open the welcome screen.
Page 12 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only If you indicate that you forgot your password, this screen will appear. A reset link will be sent to your email account. You’ve created an account (or logged-in). Next you need to pair your Ring.
Page 13 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only Pairing progress screen appears when pairing is initiated. The pairing may time out. If it does, ensure that your phone and the ring are charged, the ring is in the charger, and the charger/ring and phone are close together.
Page 14 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only When the ring is paired to the App, this screen will appear. The App will ask permission to send you notifications. If a firmware update is needed, initially or during subsequent use, a notice will be displayed.
Page 15: Taking A Pulse Oximeter Reading-App Screenshots
EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only TAKING A PULSE OXIMETER READING—APP SCREENSHOTS Understanding Pulse Oximeter Results Always follow your healthcare provider’s instructions when taking and evaluating your SpO and pulse results. Your healthcare provider will tell you: •...
Page 16 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only The EvieMED medical device pulse oximeter and Evie wellness measurements are defined immediately following setup. Selecting “Let’s do this!” will take you to the opening screen following registration. You can get a pulse rate and a SpO2 reading by selecting the bar, “Take your pulse and SpO...
Page 17 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only Once trending data is available, the date and time and pulse oximeter data of historical readings are displayed. All readings are provided for trending, including the readings that failed for pulse, SpO2, or both.
Page 18 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only If you lose the connection between your Ring and the App, you’ll see one of these pop-ups. Ensure Wi-Fi and Bluetooth are on using your phone settings and that you are connected to a network.
Page 19: Evie Wellness-Today-App Screenshots
The warning disappears after a few seconds (right). Across the very top of the Evie wellness Today screen are phone icons: time, WiFi, and battery. App icons include the Ring battery level, Evie and...
Page 20: Evie Wellness-My Body--App Screenshots
EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only EVIE WELLNESS—MY BODY--APP SCREENSHOTS The top of the “My body” screen provides tabs for steps, active minutes, and calories burned screens. These are not medical data for clinical decision- making.
Page 21: Evie Wellness-Sleep/Journaling-App Screenshots
EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only EVIE WELLNESS—SLEEP/JOURNALING—APP SCREENSHOTS Sleep zones data are available for the day (shown left) and the week. Sleep data is captured during your sleep hours. Wellness information about your average resting...
Page 22 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only Then go into the My body tab and scroll to the bottom. Select go to journal and select Start tracking your period. If you elect to start tracking your period, the app will need some additonal information to calculate the start of your next estimated period start.
Page 23 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only The app will estimate the dates of your period based on the length and duration between each cycle. The period estimation and period confirmed dates will be marked on a calendar. Period data can be edited.
Page 24: Cleaning
Rinse the Ring with mild soap such as dish soap (e.g., Dawn) and warm tap water (about 100 °F or 38 °C, comfortably warm like a slightly hot bath) weekly or when soiled to clean all surfaces of the EvieMED Ring. Dry thoroughly with a soft cloth.
Page 25: Recharging
• Store the EvieMED Ring and Ring Charger in a location which is at a temperature within the Storage Temperature specifications below. If the Ring is left in a cold or hot environment, allow the Ring to come to room temperature before using.
Page 26: Eviemed Ring Charger Specifications
Pulse oximeter accuracy was tested in accordance with ISO 80601-2-61 by calculating the root mean square error (RMSE) between the EvieMED Ring and arterial blood gas data at room air and then at different and stable levels of oxyhemoglobin saturation. The IRB-approved clinical study was performed using four rings each in eleven healthy subjects, aged 23-27, with Fitzpatrick skin tones from 1 to 6.
Page 27 EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only Accuracy for Male Subjects, n=3 Range (%) 70-100% 70-80% 80-90% 90-100% # Data Pairs Mean Bias -0.76 0.02 -0.72 -1.39 Arms 2.74 2.51 2.48 3.08 Accuracy for Female Subjects, n=8...
Page 28: Information Security
Understanding cybersecurity risks The EvieMED Ring is a device that utilizes software to connect with a network and can become vulnerable to cybersecurity threats. A secure Wi-Fi or Cellular connection is not required for a secure connection from the EvieMED Mobile Application (App) to the EvieMED Cloud (Cloud).
Page 29: Quality Of Service
Pulse Rate. • The EvieMED Ring uses Bluetooth Low Energy (BLE) radio protocols to transmit the sensor data to the Mobile Application and will fulfil Essential Performance with BLE data rates as low as 1.5kb/s, with power levels at the mobile device as low as -81dBm, and within the 1.5 meter (about 5 feet) range as stated in this User Guide.
Page 30: Declaration And Manufacturer's Guidance
Resize or take off and clean frequently beneath the ring Declaration and Manufacturer’s Guidance The EvieMED Ring requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in these accompanying documents. WARNINGS •...
Page 31 For Prescription Use Only Guidance and manufacturer’s declaration – electromagnetic immunity The EvieMED Ring is intended for use in the electromagnetic environment specified below. The customer or the user of the EvieMED Ring should assure that it is used in such an environment.
Page 32 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EvieMED Ring is used exceeds the applicable RF compliance level above, the EvieMED Ring should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the EvieMED Ring.
Page 33 For Prescription Use Only Guidance and manufacturer’s declaration – electromagnetic immunity The EvieMED Ring is intended for use in the electromagnetic environment specified below. The customer or the user of the EvieMED Ring should assure that it is used in such an environment.
Page 34 EvieMED Ring. The EvieMED Ring is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EvieMED Ring can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EvieMED Ring as recommended below, according to the maximum output power of the communications equipment.
Page 35: Labeling Symbols
EvieMED Ring Instructions for Use (IFU)/User Guide For Prescription Use Only Labeling Symbols For the safe and effective use of this device, the operator must consult the For prescription use only instructions prior to use. Manufacturer Does not contain latex...