User's Manual

ManualsBrandsGrektek ManualsMedical Supplies & EquipmentWatch with medical ECG

Copyright Grektek Holdings, Inc. 2020   V2.4 July 22, 2020 
1 
Everbeat User Manual 
Version 2.4 
22 July 2020 
 
Table of Contents 
Purpose of the everbeat System ..................................................................................................... 2 
Everbeat Watch Description ........................................................................................................... 2 
The everbeat Watch Key Components ........................................................................................... 3 
Contraindications ............................................................................................................................ 4 
Cautions .......................................................................................................................................... 4 
Directions for Use ........................................................................................................................... 6 
Step 1. Downloading the everbeat App and Setting Up Your Account ...................................... 6 
Step 2. Charging the everbeat watch ......................................................................................... 8 
Step 3. Wearing the everbeat watch .......................................................................................... 9 
Step 4. Connecting your everbeat watch to the everbeat App .................................................. 9 
Step 5. Daily Use ....................................................................................................................... 10 
Recording your ECG .............................................................................................................. 10 
ECG Recording Tips ............................................................................................................... 11 
Step 6. ECG Results Messages .................................................................................................. 12 
Cleaning Instructions .................................................................................................................... 13 
Troubleshooting ............................................................................................................................ 13 
Warranty ....................................................................................................................................... 14 
Specifications ................................................................................................................................ 14 
Appendix I EMC Tables ................................................................................................................. 15 
FCC Compliance ........................................................................................................................ 15 

Summary of content (16 pages)

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Everbeat User Manual Version 2.4 22 July 2020 Table of Contents Purpose of the everbeat System..................................................................................................... 2 Everbeat Watch Description ........................................................................................................... 2 The everbeat Watch Key Components ........................................................................................... 3 Contraindications ..............................
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Purpose of the everbeat System Indications for Use (as reflected in FDA clearance application) The everbeat system is intended to record, store, display and transfer single-channel electrocardiogram (ECG) rhythms, when prescribed or used under the care of a physician. Intended Use The everbeat system is intended for use by patients who would like to monitor and record their heart rhythms using a single-channel electrocardiogram (ECG).
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The everbeat Watch Key Components Figure 2: Back of the everbeat watch 7. band screws 1. charging leads (2) 6. adjustment holes 2. PPG sensor 5. Band Loop 4. Band Button 3. ECG contacts rear 1. Battery Charger Leads – The two gold colored pickups on the far left of the bottom of the everbeat watch line up with corresponding pickups on the charging station. 2. PPG sensor - The green light is a photoplethysmogram, or PPG, sensor.
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Procedures associated with the everbeat system 1. Follow instructions to install and set up the everbeat App from the Apple App Store. 2. Put the watch on your wrist, again following our simple instructions and videos. 3. You will be able to take an ECG reading that can be shared with your doctor for medical instructions. Contraindications • • • DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices.
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• • • • • • • • • • • • • • The everbeat watch and charging stand is designed for use only with UL listed chargers with 5 volts DC, and between .5 and 1.0 amps output through a standard USB connection. The everbeat system has been tested satisfactorily for biocompatibility and electrical safety. Maintain a distance of at least 3 feet from other wireless devices to avoid potential interference. The everbeat device will still operate properly without access to a WiFi network.
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Directions for Use Step 1. Downloading the everbeat App and Setting Up Your Account You must have the following in order to download the everbeat app • Apple iPhone 5 or later • iOS 10.3 or greater • iTunes ID and password • Existing email account 1 Confirm that your phone will be able to run the everbeat app On your iPhone, open SETTINGS Next, Select GENERAL and then ABOUT which will identify your operating system version which must be 10.
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3 Creating an everbeat Account Your physician may register you with everbeat and if so, you will receive an email walking you through the account creation process. If not, create a new account by launching the everbeat App on your phone and select New Account. Follow these instructions for setting up your account. Figure 3: everbeat Login Screen Touch here to create a new account You will be prompted to read/accept the terms of use and enter your full name, and email address, twice.
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1. Check your email account, and open the “Invitation to use everbeat” email 2. Touch on the first “here” to set up your password 3. Type in your password identically twice. Figure 5 Registration email from everbeat system Touch here to set password Your account is now ready to use! If you forget your password later on, you can touch on the “forgot password” link and you will receive an email to reset your password. Now return to your everbeat App and login using your email and password that you set.
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Step 3. Wearing the everbeat watch Note: Click on this LINK to watch a video showing how to put on the everbeat watch. Fitting the watch for good contact is very important to ensure a good ECG reading. Note: A successful recording may be difficult with very dry skin. If you experience such difficulty, try moistening your skin. 1.Strap your everbeat on your wrist with the metal contact close to your body on your thumb side 2. Thread the button side of the band through the loop side of the band. 3.
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Step 5. Daily Use Note: Click on this LINK to watch a video showing how to use the everbeat system each day. 1. Open the everbeat App on your iPhone and login, if necessary. Note: Try, Try, Try Again! Using the everbeat watch can take some practice. If it doesn’t work the first time, just return to the main screen to start over, and try again. The everbeat watch requires time to configure itself to your body.
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5. Rest your watch hand on a table or on your lap. Figure 10: Recording an ECG 6. Without touching your hands together, place the index finger of your opposite hand on the metal contact and hold until the reading is complete. A successful reading will look like this: Figure 11: A successfully recorded everbeat ECG ECG Recording Tips - - If the reading is “unable to determine” or you receive a “Contact Separation” message, you can reset the reading and try again.
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Step 6. ECG Results Messages Caution: The everbeat system is not a diagnostic device, but can help your physician detect possible heart conditions. If you have any symptoms you should contact your doctor and follow their instructions. 1. A successful recording is achieved when the iPhone App displays “Recording Complete” with a value for heart rate after it. You may review this ECG from the main App screen. You may review this with your physician as agreed with them at time of prescription.
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Cleaning Instructions Your everbeat watch will perform best if cleaned periodically. Use a soft, clean cloth or paper towel moistened with isopropyl alcohol (at least 70% by volume). Moisten and clean every surface of the watch especially the underside of the watch body and anywhere it contacts your skin. You may need to use a cotton swab or Q-tip to effectively clean the screws on the bottom of the watch. DO NOT use soaps, hand sanitizers or other household cleaners which could cause skin irritation.
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Operating Information: Storage: You may store your everbeat watch either on its charging stand, in its original package, or securely by itself. It should always be stored at normal room temperature and humidity. Travel or international use: The everbeat system can be used internationally as long as proper use and instructions are followed.
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Appendix I EMC Tables FCC Compliance FCC ID: 2AW2WEVBT1 See the FCC database for our certification information. Note: 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.
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Appendix I EMC Tables (continued) Guidance and manufacturer’s declaration – electromagnetic immunity The everbeat system is intended for use in an environment in which electrostatic and electromagnetic disturbances are controlled. The customer or the user of everbeat can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and everbeat as recommended below.