Related Manuals for HeraMED HeraBEAT
Summary of Contents for HeraMED HeraBEAT
- Page 1 HeraBEAT ™ User Manual Your Personal Ultrasound Fetal Doppler By HeraMED Your Personal Ultrasound Fetal Doppler...
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Page 3: Table Of Contents
Table of Contents 1. About HeraBEAT US Ultrasound Fetal Doppler 2. Who should USE (Indications) or NOT USE (Contraindications) HeraBEAT 3. HeraBEAT US kit includes 4. Safety Instructions 5. Ultrasound Transmission Gel 6. HeraBEAT US Configuration & LED Indicators 7. Charging HeraBEAT 8. -
Page 4: About Herabeat Us Ultrasound Fetal Doppler
US Ultrasound Fetal Doppler ™ (Contraindications) HeraBEAT ™ US Indications for Use Congratulations on purchasing HeraBEAT US, your personal Ultrasound Fetal Doppler. For the first time ever, a safe, effective and easy-to-use Fetal Doppler that delivers HeraBEAT US is intended to detect fetal heart professional results within the comfort of your home. -
Page 5: Herabeat Us Kit Includes
HeraBEAT kit includes ™ 1. HeraBEAT US device 2. HeraBEAT US 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... -
Page 6: Safety Instructions
This device may only be used for the purposes described in Assume there may be measurement errors, and do not rely this User Manual. HeraMED cannot be held liable for damage exclusively on measurement results. or injury caused by incorrect use. Always follow the operating Recorded FHR segments of only a few seconds may be less procedures described in this User Manual. - Page 7 Use device only with the supplied gel (fig. 3). Using ultrasound no closer than 30 cm (12 inches) to any part of the HeraBEAT transmission gel that is not approved by HeraMED may reduce US.
- Page 8 US Device and smartphone during operation, and reposition the HeraBEAT US device. The irregularity might make sure the smartphone is within 10 feet of the HeraBEAT be caused by fetal or maternal movement. US Device. There are several physiological conditions that may impair the...
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Page 9: Ultrasound Transmission Gel
Use device only with the supplied gel (fig. 3). Using ultrasound The HeraBEAT US measures the Fetal Heart Rate, transmission gel that is not approved by HeraMED may processes the data and transmits the information reduce signal quality and can lead to absence of Fetal Heart... - Page 10 Tap to access the Tutorial. measurements history from the App. Device Unpairing will separate the connection between the HeraBEAT US device and the app Support and will allow to connect a new device to the app. Your information and all measurements Tap to end the Fetal Heart history is kept within the App.
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Page 11: Charging Herabeat Us
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 US device. Before you turn ON and start using the device, fully charge it. -
Page 12: First Time Use
US prior to first use. information accurately! Install the HeraBEAT App on your smartphone: Go to AppStore / Google-Play on your smartphone. Search for ‘HeraBEAT Turn HeraBEAT US ON by giving it a in the AppStore/Google-Play and install it on your smartphone. -
Page 13: Measurement Of The Fetal Heart Rate
ON). 2. HeraBEAT US Measurement preparations 2.3 HeraBEAT US APP preparation 2.1 HeraBEAT US preparation Start the HeraBEAT App. Wait for HeraBEAT US to connect. Turn the HeraBEAT US device ON by The App will automatically create giving it a little shake, or by unplugging a Bluetooth connection which will it from the power supply (fig. - Page 14 US bottom side on your abdomen area and position over the bellybutton. 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 US and the skin.
- Page 15 Apply a small amount of pressure pattern” as below, it may be a fetal heart rate. Wait in this position to on HeraBEAT US against your allow for the signal level to rise until skin. Verify full contact during the the fetal heart rate is located: entire measurement.
- Page 16 If the Fetal Heart Rate is not detected at a certain position, you will be asked audibly to move HeraBEAT US to the The longer and more continuous the measurement, next position (the new position will be displayed on the the more reliable and accurate it is.
- Page 17 Tap a specific measurement to see its results screen. An average Fetal Heart Rate. Note: All Measurement history data saved within the Measurement duration (total time from search start to HeraBEAT App. will be deleted should you uninstall the measurement end). app or upgrade to a new smartphone.
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Page 18: Care And Maintenance
CAUTION Do not use paper or abrasive wipes or brushes when cleaning or the HeraBEAT US device. The HeraBEAT US device must always disinfecting the bottom transducer plate as these may damage be thoroughly cleaned at the point of care following each use and the transducer lens window. - Page 19 Report and locate it with its accessories in a safe cool and dry place, any damage to HeraMED and discontinue use of the device. away from direct sunlight. 7. If any ultrasound gel or other soil remains on the device, repeat the cleaning steps 3 through 6 above as necessary.
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Page 20: Troubleshooting
(fig. 4). b. Apply a small amount of pressure on HeraBEAT The white light ring on the top part of the device will against your skin. Verify full contact during the quickly turn on. - Page 21 Troubleshooting Problem: App crashes. Problem: The device does not turn ON Details: A general error may have occurred. or the device’s battery is low. Solution: Details: The ‘low battery’ message is displayed. 1. Close and restart the app. Solution: 2. If error persists, restart the smartphone. 1.
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Page 22: 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 23: Herabeat Us Specification
HeraBEAT™ US Specification Safety Recommended Ultrasound Water soluble hypoallergenic Complies with IEC/EN 60601-1, 60601-1-2, Transmission Gel ultrasonic gel 60601-1-11, 60601-2-37 Power consumption < 2 W Classification Anti-electric Shock Type Class II electrical device when AC/DC Rechargeable Li-ion Battery adapter connected. Otherwise Nominal Capacity 3.7VDC, 1250 mAh... -
Page 24: Herabeat Us Device Label
HeraBEAT™ US Device Label Below are the HeraBEAT US label and symbols used on the device and packaging. When contacting Service, have readily available the Manufacturer device Serial Number colored pink. Date of Manufacture Serial Number IP22 Ingress Protection Caution - Consult Accompanying Documents... -
Page 25: Warranty And Service
Warranty and Service Congratulations on your purchase of the “HeraBEAT US” 2. LIMITED WARRANTY medical grade Ultrasound Fetal Doppler (the “Product”), which is The Product will materially conform to its published specifications and shall be materially free from defects in materials and workmanship manufactured by HeraMed Ltd. - Page 26 Warranty and Service B. EXCEPTIONS TO WARRANTY COVERAGE ix. The Product has been subjected to any other misuse, abuse, The limited warranty does not cover cosmetic damage or normal neglect, accident or external forces. wear and tear and does not apply to any mobile device or the cellular C.
- Page 27 Warranty and Service 5. SERVICE & CUSTOMER SUPPORT TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, When reporting to local service center, please have the device serial NEITHER THE COMPANY NOR THE DISTRIBUTOR (I) ASSUMES number ready. The serial number can be found on the device. ANY LIABILITY FOR ANY INDIRECT, CONSEQUENTIAL SPECIAL OR Customer satisfaction is our top priority.
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Page 28: Wireless Rf Communication
HeraBEAT™ US device and transmission of ultrasound signal within 10 feet of the HeraBEAT US Device. data, i.e., the Fetal Heart Rate, from the HeraBEAT™ US device to the smartphone app. Do not move the smartphone away from the room where the HeraBEAT US Device is in use. -
Page 29: Appendices
US device was tested to comply with EMC standard for medical devices. Accuracy of the fetal heart rate measurement, ultrasound output power and the device temperature are all essential for safe use of the HeraBEAT US device. The presence of electromagnetic disturbances beyond the levels specified in tables of EMC Information-Guidance and Manufacture’s Declaration, could lead to degradation in device accuracy and potential risk to you or the fetus. - Page 30 17.1. Electromagnetic Emissions - for all Equipment and Systems Guidance and manufacture’s declaration – electromagnetic emission The HeraBEAT US 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 31 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 32 Recommended separation distances between portable and mobile RF communications equipment and the HeraBEAT US device The HeraBEAT US device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile...
- Page 33 Appendices 17.5. 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 34 Appendices 4. Tested Acoustic Output Acoustic Output SPTA3 SATA (mW/cm (mW/cm Global Maximum Value 0.02 pr.3 (MPa) 0.03 (mW) (mW) (cm) x-6 (cm) Associated Acoustic Beam Dimensions Parameter (cm) (cm) (cm) Az. (cm) Ele. (cm)
- Page 35 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. HeraMED owns the copyrights of this Instructions for Use. Any materials contained in this document shall not be photocopied, reproduced or translated to other languages without prior written consent of HeraMED.
- Page 36 HeraBEAT ™ User Manual HeraMED Ltd. 6 Meir Ariel St., 4250364 Netanya, POB 8576, Israel Tel: +972 (0) 9 880 3010, Fax: +972 (0) 9 880 3014 mail: support@hera-med.com HERA-CMP-534US Rev: 5, May 2020 (01) 07290111520020 (20) 05 2797 (91) US...
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