General Information Contact Information Aventusoft, LLC. 3651 FAU Blvd. Boca Raton, FL 33431 Phone: 954.399.3335 Hours: 9am - 5pm EST General email: info@hemotag.com Service email: service@hemotag.com Website: www.hemotag.
Contraindications • Apply the HEMOTAG Device only to intact and clean skin. Do not apply over open wounds, lesions, infected or inflamed areas. • Do not use lotions, oils or sprays on skin location where you will place the HEMOTAG Device. • Do not dispose of the HEMOTAG Device. Return the Device to your health care provider, or mail to Aventusoft. • Do not disassemble the Device. • Keep away from other electronic devices as they may interfere with the wireless connectivity of the Device.
Conventions & Notations in this Manual Conventions Bold text indicates a button or key that you touch or press. Notations Warning icons idenfity conditions or practices that could result in injury to patients or users. Caution icons identify conditions of practices that could result in damage to equipment or other property. Note icons provide additional information about a feature or process. Tip icons convey helpful information about how to use the HEMOTAG device.
The HEMOTAG Kit If for any reason you are missing one of the components listed below, contact Aventusoft at 954.399.3335.
HEMOTAG Device Lights The color and pattern of lights on the HEMOTAG Device indicate the status of the device.
Using the HEMOTAG System 1. Setting Up Charge the HEMOTAG Device using the Charging Cable. All lights will go off when the HEMOTAG Device is fully charged. (The battery light will display flashing yellow when low on power). NOTE: Do not attempt to utilize the HEMOTAG Device while charging. The HEMOTAG Device will not transmit or operate while charging. While your HEMOTAG Device is charging, take this time to set up the HEMOTAG App on your smartphone.
2. Launch the HEMOTAG App Use your smartphone to launch the HEMOTAG App. Sign in to the app, using your email, password, and the HEMOTAG ID, located on the HEMOTAG, or located on the box. Stay within 3 feet of your smartphone in order for the HEMOTAG App to properly receive your heart data. For Healthcare professionals only: Enter your patients medical record number in the “Patient ID”. 3.
Using the HEMOTAG System 4. Turn on the HEMOTAG Device Turn on the HEMOTAG Device by long pressing the center power button. The Device will begin broadcasting, waiting to connect to the HEMOTAG App, and the right green LED will start flashing. 5. Attach the HEMOTAG Device to your chest. Prep your skin! Remove any and all hair in the placement location, and thoroughly clean the area with soap and water. Do not apply lotions, oils, or other topical ointments. Peel away the adhesive backing on the electrode.
Sternal notch Place HEMOTAG Sternal angle If you have skin allergies, consult your doctor for different electrodes. 6. Lie Down With the HEMOTAG Device ready, lie down on a comfortable surface, such as a bed. You want to be as still as possible in order for the HEMOTAG Device to record an accurate reading.
Using the HEMOTAG System Try to keep your smartphone within 3 feet of the HEMOTAG Device. If something occurs that disrupts the data stream (no battery charge, no connection), the HEMOTAG App will show the necessary indications visually. See Appendix D. Keep the HEMOTAG Device charged. If your smartphone’s Bluetooth is off, it won’t be able to connect to the HEMOTAG Device. Make sure Bluetooth is on while using the HEMOTAG Device. 7.
8. Turn off the HEMOTAG Your HEMOTAG Device will automatically turn off after each session. To manually turn off the HEMOTAG Device, press and hold the center power button for at least 5 seconds. 5 sec. 9. Remove the Electrodes from the HEMOTAG Device Hold the electrodes against your skin and lift the arms of the HEMOTAG Device until the electrodes snap off one at a time. Discard the used electrodes.
Appendix A: Specifications HEMOTAG specifications Shelf life 24-months Battery Capacity 110mAh typical Battery Charger Power Requirement 100-240 VAC, 50-60Hz Battery Type Rechargeable Li-polymer Battery Voltage 3.
Warnings This product is prescription-use only. Aventusoft should not be contacted in the case of medical emergencies. If you experience anything not outlined in this manual, contact your doctor immediately. If you are having a medical emergency, call 911. If you require assistance with usage, application, or technical issues, contact Aventusoft at 954.399.3335. Remove the HEMOTAG Device before swimming, bathing, or performing similar activities, and re-attach the HEMOTAG Device afterwards.
Warnings • Use only Ag/AgCl-type ECG electrodes with the HEMOTAG Sensors. Other types of electrodes might result in misleading results and incomplete HEMOTAG Device or ECG reports. • There are no serviceable parts in the HEMOTAG Device. Do not open the Device to change the Battery or modify the Device. Use only the included Charging Cable to recharge the internal Battery. • Do not use the tip of a pen to touch the HEMOTAG power button because it can damage the switch. Use only your fingers.
Symbols The following symbols may appear on the HEMOTAG Device as well as the included accessories. ECG electrode Part number/ catalog item Contains no latex Serial number Sensor pouch Lot number Sensor box Prescription-use only 4 Temperature limitation (operating) Manufacturer 85% Date of Manufacture Not defib-proof type of CS equipment Type BF applied part Consult accompanying documents FCC ID: 2AQS4-HT17999999 This device complies with Part 15 of FCC Rules.
Appendix B: Electromagnetic environment The HEMOTAG Device is suitable for use in the specified electromagnetic environment. The purchaser or user of the HEMOTAG Device should assure that it is used in an electromagnetic environment as described below: Emissions RF emissions CISPR 11 Group 1 The monitor or HEMOTAG uses RF energy only for its internal function. Therefore, the RF emission is very low and not likely to cause any interference in nearby electronic equipment.
Immunity Standard IEC 61000-4-3 Test Description Test Level/Limits Radio Frequency Electromagnetic Field Amplitude Modulated 80 MHz to 2.7 GHz 3V/m 80% AM 1kHz Spot frequency tests 385 MHz (18 Hz Pulse mod) 27 V/m, 450 MHz (1 kHz sine FM +/-5 kHz dec) 28 V/m, 710, 745 & 780 MHz (217 Hz Pulse mod) 9 V/m, 810, 870 & 930 MHz (18 Hz Pulse mod) 28 V/m, 1.720, 1.845, 1.970 & 2450 GHz (217 Hz Pulse mod) 28 V/m, 5.240, 5.500 & 5.785 GHz (217 Hz Pulse mod) 9 V/m IEC 61000-4-4 Electrical Fast Transients ±2.
Appendix C: LED Light Table LED Displays What do the HEMOTAG lights mean? HEMOTAG is off. Power-on sequence, attempting to connect with smartphone. Stay within 3 feet of smartphone. HEMOTAG connected to HEMOTAG App on smartphone. HEMOTAG capturing cardiac data. HEMOTAG transmitting cardiac data. Electrodes do not have good contact with skin. Check if plastic lining has been removed. Press firmly on the skin. Try replacing all three electrodes with new ones. Battery charging. Low battery.
Appendix D: HEMOTAG App Guide There are a total of three screens on the HEMOTAG App: the splash screen, login screen, and main screen. A B C D E Figure 1: Splash Screen Figure 2: Login Screen The user will first be greeted with the splash screen. After the app loads, the user can review the introduction screens. Press the Login button at anytime. This is where the user must provide identification information as well as the Devices information to access the HEMOTAG Device’s service. A.
Appendix D: HEMOTAG App Guide B C A D E F G H J I Figure 3: Main Screen 21
A. Exit Button: Stop the current activity and exit the app. B. Welcome Indicator: Shows the username. C. Device Battery Level Status Bar: Indicates the device battery level informaton when the device is powered on and connected. D. EKG Status Indicator: Indicate whether device is connected and EKG is detected on or not. E. Top Status Indicator. F. Main Button: Press to start data collection. After the data collection process is finished, press to exit the app.
A Simplified Approach to Patient Care A Simplified Approach to Remote Patient Care Remote Patient Patient Cardiopulmonary Assessment Assessment Cardiopulmonary Remote Cardiopulmonary Assessment Cardiopulmonary Assessment Event Capture initiated by Patient Secure wireless Transmission of Data Secure wireless Transmission of Data HEMOTAG Cloud Secure HIPAA-compliant cloud platform High Availability Cloud Environment Secure HIPAA-Compliant Data Storage Automated Analysis of Heart Sounds and ECG for Cardiopu
The HEMOTAG System can be operated by either a healthcare professional or the patient. How the HEMOTAG System Works The complete HEMOTAG Cardiopulmonary Assessment System (CPAS), as shown on page 5, consists of components to record and collect your Heart Sounds and ECG data. The Device includes software that communicates over an encrypted Bluetooth link with a smartphone App to transmit data over an SSL link to a secure HIPAA compliant webdashboard for storage analysis and reporting.
Storing the Device & Charging Cable Store the Device in its box when not in use or for long-term storage or during travel. Wait approximately @ ambient temperature 20°C for 1 hour to warm up/ cool down to the appropriate operating temp of 10°C to 45°C per spec page 13, to enable the device. For charging the HEMOTAG device, connect the provided charging cable as shown.
Frequently Asked Questions Why does the smartphone HEMOTAG App show a number pad and ask for a HEMOTAG ID? Enter the alphanumberic HEMOTAG ID from your HEMOTAG Device. The HEMOTAG ID is also available on the HEMOTAG Box Sleeve. Why does the smartphone HEMOTAG App fail to log in? Verify you are entering the full email address (e.g. you@company.com). Verify you are entering your correct password. Verify you are entering the alphanumberic HEMOTAG ID from the back of your HEMOTAG Device.
Why does the smartphone vibrate and display ‘ECG not detected’ message on the screen and the ECG icon is not green? The Device is unable to get reliable skin contact. Ensure all three ECG electrodes are snapped to the Device and the clear adhesive backing on each electrode is removed. Verify the Device adheres securely to the skin. Verify the Device positioning on the chest. If the message continues to display, you may need to replace the ECG electrodes. If this problem persists, contact 954.399.3335.
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