Related Manuals for HeraMED HeraBEAT
Summary of Contents for HeraMED HeraBEAT
- Page 1 HeraBEAT ™ The beat of life User Manual Ultrasound Fetal Heart Rate Monitor By HeraMED Ultrasound Fetal Heart Rate Monitor...
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Page 3: Table Of Contents
Table of Contents 1. About HeraBEAT Fetal Heart Rate Monitor 2. Who should USE (Indications) or NOT USE (Contraindications) HeraBEAT 3. HeraBEAT kit includes 4. Safety Instructions 5. Ultrasound Transmission Gel 6. HeraBEAT Configuration & LED Indicators 7. Charging HeraBEAT 8. -
Page 4: About Herabeat Fetal Heart Rate Monitor
Who should USE (Indications) or NOT USE About HeraBEAT™ Fetal Heart Rate Monitor (Contraindications) HeraBEAT™ Intended Use Congratulations on purchasing HeraBEAT , your personal Fetal Heart Rate Monitor. For the first time ever, a safe, effective and easy-to-use Fetal Heart Rate monitor that... -
Page 5: Herabeat Kit Includes
HeraBEAT™ kit includes 1. HeraBEAT device 2. HeraBEAT application (Free to download from the AppStore / Google Play.) 3. 2 Ultrasound Transmission Gel 4. Power Supply 5. Carry Case 6. User Manual (fig. 1) (fig. 4) HeraBEAT device Power Supply (fig. -
Page 6: Safety Instructions
For any Doppler examination, it is essential that an adequate especially by children. supply of Ultrasound Transmission Gel is used to transmit Do not allow water or any liquids to enter the HeraBEAT the ultrasound energy from HeraBEAT to the surface of device or its charging connector. - Page 7 Safety Instructions Do not operate this device in temperatures lower than +5°C Notes (41°F) or higher than +40°C (104°F), nor where humidity is lower than 5% or higher than 95% (non-condensing), or the Notes are intended to draw your attention and aid with the use device may fail or produce inaccurate measurement results.
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Page 8: Ultrasound Transmission Gel
Use device only with the supplied gel (fig. 3). Using ultrasound The HeraBEAT measures the Fetal Heart Rate, processes transmission gel that is not approved by HeraMED may reduce the data and transmits the information wirelessly to the signal quality and can lead to absence of Fetal Heart Rate... - Page 9 Tap to access the Tutorial. Device Unpairing will separate the connection between the HeraBEAT device and the app and will allow to connect a new device to the app. Support Reset will permanently erase your personal...
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Page 10: Charging Herabeat
Plug the Power Supply into an electrical outlet. During charging orange light illuminates. Once fully charged, the orange light turns green. Unplug the Power Supply from the electrical outlet and then disconnect its cord from the HeraBEAT device. Before you turn ON and start using the device, fully charge it. -
Page 11: First Time Use
HeraBEAT device. Make sure you fully charge your HeraBEAT prior to first use. When a device is found, the app will ask if the HeraBEAT Install HeraBEAT App on your smartphone: device is flashing a white light for verification. -
Page 12: Measurement Of The Fetal Heart Rate
2.1 HeraBEAT preparation The HeraBEAT device communicates with your smartphone via Bluetooth Turn the HeraBEAT device ON by Low Energy, therefore please ensure giving it a little shake, or by unplugging that your smartphone’s Bluetooth is it from the power supply (fig. 4). - Page 13 3.3 Hold the device in the palm of your hand and press it gently against your abdomen. Perform a circular motion to ensure a thin and even layer of gel between HeraBEAT and the skin.
- Page 14 Next to the graph, a level bar displays the signal level. If the Fetal Heart Rate is not detected at a certain position, you will be asked to move HeraBEAT Apply a small amount of pressure the next position (the new position will be displayed on HeraBEAT against your skin.
- Page 15 The HeraBEAT app will inform you when the Fetal Heart Rate is detected. The app will then move to the measuring screen. Hold steady while HeraBEAT is measuring the Fetal Heart Rate. The App will present and record the measurement.
- Page 16 Measurement of the Fetal Heart Rate 7. Measurement Results 8. Measurements History Once the measurement has finished, the measurement All recorded measurements are kept and organized by results screen is shown. pregnancy weeks in the history screen. The measurement results screen includes: Tap any week to see its measurements shown below.
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Page 17: Care And Maintenance
1. Before cleaning or disinfection, ensure that it is unplugged Solution: from the power supply. 2. Use a soft cloth, mildly moistured with soap 1. Verify that HeraBEAT is located within 3 meters or detergent solution, to clean the device from your smartphone. - Page 18 Problem: Device is flashing a white light 3 times and turns OFF. b. Apply a small amount of pressure on HeraBEAT Details: Device may require charging against your skin. Verify full contact during the Solution: entire measurement.
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Page 19: Smartphone General Security And Privacy
Smartphone General Security and Privacy The product software installed and the information stored Backup smartphone data. on the smartphone should be protected from unauthorized Log out of any website that you conduct financial transactions access and from external threats. We recommend the following security measures: Special care should be taken when using smartphones in public The physical protection of the device: places and other unprotected areas. -
Page 20: Herabeat Specification
HeraBEAT™ Specification Safety Auto Acquisition stop 5 minutes of successful measurement Complies with IEC/EN 60601-1, 60601-1-2, Recommended Ultrasound 60601-1-11, 60601-2-37 Water soluble hypoallergenic Transmission Gel ultrasonic gel Classification Anti-electric Shock Type Internally powered equipment Power consumption < 2 W Anti-electric Shock Degree Type BF equipment... -
Page 21: Herabeat Device Label
HeraBEAT™ Device Label Manufacturer Below are the HeraBEAT label and symbols used on the device and packaging. When contacting Service, have readily available the device Date of Manufacture Serial Number colored pink. Serial Number IP22 Ingress Protection Caution - Consult Accompanying Documents... -
Page 22: Warranty And Service
Warranty and Service 2. LIMITED WARRANTY Congratulations on your purchase of the “HeraBEAT ” medical The Product will materially conform to its published specifications grade home fetal monitor (the “Product”), which is manufactured by and shall be materially free from defects in materials and HeraMed Ltd. - Page 23 Warranty and Service B. EXCEPTIONS TO WARRANTY COVERAGE THERETO, AND SPECIFICALLY EXCLUDES ALL OTHER WARRANTIES, The limited warranty does not apply to consumable parts, such as WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, STATUTORY, batteries or protective coatings that are designed to diminish over CONTRACTUAL, IN TORT OR OTHERWISE, INCLUDING, WITHOUT time, unless failure has occurred due to a defect in materials or LIMITATION, ANY WARRANTY OF DESIGN, MERCHANTABILITY,...
- Page 24 Warranty and Service YOU ALSO ACKNOWLEDGE THAT THE PRODUCT USES ULTRASOUND NEITHER THE COMPANY NOR THE DISTRIBUTOR SHALL HAVE ANY TECHNOLOGY, THAT YOU ARE AWARE OF THE RISKS WITH RESPECT LIABILITY FOR THE OPERATION, AVAILABILITY COVERAGE, SERVICES THERETO AND THAT NEITHER THE COMPANY NOR THE DISTRIBUTOR OR RANGE OF THE CELLULAR OR OTHER NETWORK OR SYSTEM SHALL HAVE ANY LIABILITY WITH RESPECT THERETO.
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Page 25: Appendices
1. Electromagnetic Emissions - for all Equipment and Systems Guidance and manufacture’s declaration – electromagnetic emission The HeraBEAT device is intended for use in the electromagnetic environment specified below. The user of the device should assure that it is used in such an environment. - Page 26 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HeraBEAT...
- Page 27 4. Recommended Separation Distances Guidance and manufacture’s declaration – electromagnetic immunity The HeraBEAT device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment...
- Page 28 Appendices 5. Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Band Service Modulation Distance Test Text Compliance frequency (MHz) Power Level (V/m) Level (MHz) 380 – 390 TETRA 400 Pulse 18 Hz 430 – 470 GMRS 460, FRS 460 FM ±5 kHz 1 kHz sine 704 –...
- Page 29 Appendices HeraMED Ltd. reserves the right to make changes without notice to its products or specifications to improve performance, reliability, or manufacturability. In case of device modifications, the information contained in this document is subject to change without notice. All information supplied by HeraMED Ltd. is believed to be accurate and reliable. However, HeraMED Ltd. assumes no responsibility for its use.
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Page 30: Doctor Mode
‘Doctor Mode’ can be reached only by a user dedicated period date, maternal date of birth & number of access code provided by HeraMED. previous pregnancies. To start ‘Doctor Mode’: tap the Settings menu key... - Page 31 Doctor Mode is indicated with the text ‘DR. mode’ at the top of the Home Screen and Measurement Screen. Doctor Mode enables measurement duration limited to 30min. For convenience the All Measurement results 110-160 BPM area is are stored per patient and highlighted in green on can be reached from the the measurement graph.
- Page 32 HeraBEAT ™ The beat of life User Manual HeraMED Ltd. 6 Meir Ariel St., 4059300 Netanya, POB 8576, Israel Tel: +972 (0) 9 880 3010, Fax: +972 (0) 9 880 3014 mail: support@hera-med.com Obelis S.A., Boulevard General Wahis 53 1030 Brussels, BELGIUM...
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