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Appendices

EMC Information-Guidance and Manufacture’s Declaration

HeraBEAT

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. Please

follow the guidelines from tables 17.1-17.5 to avoid unnecessary risks.

Please note that in some cases where the above essential elements are degraded due to EM disturbances, the device

wireless communication may turn off with the result that the device may stop communicating with the smartphone

application. In this case the device reset itself and resume communication. If it happens during a measurement, please

start a new measurement by pressing the START key.

Содержание HeraBEAT

Страница 1: ...Your Personal Ultrasound Fetal Doppler By HeraMED Your Personal Ultrasound Fetal Doppler HeraBEAT US User Manual...

Страница 2: ......

Страница 3: ...9 6 HeraBEATTM US Configuration LED Indicators 9 7 Charging HeraBEATTM US 11 8 First Time Use 12 9 Measurement of the Fetal Heart Rate 13 10 Care and Maintenance 18 11 Troubleshooting 20 12 Smartphone...

Страница 4: ...control All these enable and ensure measurement accuracy HeraBEATTM US will assist and guide you to locate the optimal position for acquiring Fetal Heart Rate FHR measure the Fetal Heart Rate FHR and...

Страница 5: ...mission Gel 4 Power Supply 5 Carry Case 6 User Manual fig 1 HeraBEATTM US device fig 2 HeraBEATTM application fig 3 2 Ultrasound Transmission Gel Check that the box includes all items Do not use the d...

Страница 6: ...an supply interpretation of measurement results Do not use the HeraBEATTM US device on or near the eyes The device must be charged only with the supplied power supply fig 4 Do not charge the device un...

Страница 7: ...ipment adjacent to or stacked with other equipment should be avoided because it could result in Use the device and its accessories only on intact skin Do not leave the HeraBEATTM US device unattended...

Страница 8: ...improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Use of accessories transducers and cables other than th...

Страница 9: ...y to the HeraBEATTM US smartphone application the HeraBEATTM App using BLE communication channel The HeraBEATTM App receives the digital information and displays the data to the user The HeraBEATTM Ap...

Страница 10: ...pregnancy week App Settings Menu App Settings Menu Tutorial Support About Change Language Advanced Settings Measurement History Tap on the Home Screen to access the in app settings menu Tap to access...

Страница 11: ...er Supply from the electrical outlet and then disconnect its cord from the HeraBEATTM US device Before you turn ON and start using the device fully charge it When the HeraBEATTM US device lights flash...

Страница 12: ...a little shake or by unplugging it from the power supply fig 4 A White light will quickly turn on Note The device will turn itself off automatically 2 minutes after it is not in use and disconnected...

Страница 13: ...th is turned ON Bluetooth ON Before begining a search please make sure you have available with you HeraBEATTM US fig 1 your smartphone fig 2 the supplied ultrasound transmission gel tube fig 3 and a c...

Страница 14: ...Manual Search In Guided search the app will guide you through several positions on your abdomen based on the your pregnancy week while it is searching for the Fetal Heart Rate After placing the devic...

Страница 15: ...the measurement Abdominal activity or fetal movements detected may prolong the search duration you may be requested to wait in your current position to allow the device to locate the fetal heart rate...

Страница 16: ...mind you to add more gel if necessary every 5 search positions the screen and a Fetal Heart Rate sound is played Results are presented in Beats Per Minute BPM A timer displays the measuring duration a...

Страница 17: ...ments History All recorded measurements are kept and organized in accordance with your pregnancy week in the history screen Tap any week to see its measurements as shown below Tap a specific measureme...

Страница 18: ...leaning and disinfection solutions stated in the instructions Use of any other solutions may result in damage to the device WARNING Never submerge the device in liquids Do not allow any liquid to ente...

Страница 19: ...ely following the end of each use to remove all ultrasound gel and any other soil from all device surfaces Delay in cleaning may result in the ultrasound gel drying on the device and being more diffic...

Страница 20: ...p the measurement and try again once fetal movements have stopped 3 Detection of Fetal Heart Rate in early weeks of pregnancy can be challenging in some cases The size of the fetus heart can be very s...

Страница 21: ...contact service support hera med com Problem Charge light is flashing both orange and green lights Details An error with the charge circuit has occurred This may be due to a depleted battery Solution...

Страница 22: ...mended Use official antitheft services Backup smartphone data Log out of any website that you conduct financial transactions on Special care should be taken when using smartphones in public places and...

Страница 23: ...F Input 10 dBm Typical Receive Sensitivity 94 dBm Maximum RF Tx 4 dBm Output Power HeraBEAT US Specification Safety Complies with IEC EN 60601 1 60601 1 2 60601 1 11 60601 2 37 Classification Anti ele...

Страница 24: ...interference received including interference that may cause undesired operation HeraBEAT US Device Label 2 7 9 7 Manufacturer Date of Manufacture Serial Number Ingress Protection Caution Consult Accom...

Страница 25: ...assume all risk of loss or damage to the Product while in transit back to the Distributor The time to credit your account may vary depending on processing time 2 LIMITED WARRANTY The Product will mate...

Страница 26: ...rging not in accordance with the Product s user manual viii Any of the seals on the Product s battery enclosure is broken or tampered ix The Product has been subjected to any other misuse abuse neglec...

Страница 27: ...HE PRODUCT OPERATES THE LIMITATIONS SET FORTH HEREUNDER ARE INTENDED TO LIMIT THE LIABILITY OF THE COMPANY AND THE DISTRIBUTOR AND SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY L...

Страница 28: ...ition make sure other wireless devices in the vicinity are turned off or are kept at least 1 5 feet away from the HeraBEATTM US Device and smartphone during operation and make sure the smartphone is w...

Страница 29: ...rmation Guidance and Manufacture s Declaration could lead to degradation in device accuracy and potential risk to you or the fetus Please follow the guidelines from tables 17 1 17 5 to avoid unnecessa...

Страница 30: ...30 A m 50 or 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Emission Test Compliance Electromagnetic en...

Страница 31: ...s as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbo...

Страница 32: ...uency of transmitter m 150 kHz to 80 MHz outside ISM bands 150 kHz to 80 MHz in ISM bands 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 2 0 4 1 0 1 0 37 0 64 1 3 2 6 1 1 17 2 4 8 10 3 7 6 4 13 26 1...

Страница 33: ...AN 802 11b g n RFID 2450 LTE Band 7 Pulse 217 Hz 2 0 3 28 28 5 240 5 500 5 785 5100 5800 WLAN 802 11a n Pulse 217 Hz 0 2 0 3 9 9 17 5 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless com...

Страница 34: ...2 Global Maximum Value 0 02 21 14 Associated Acoustic Parameter pr 3 MPa 0 03 Wo mW 70 70 fc mW 2 1 2 1 Zsp cm 4 1 4 1 Beam Dimensions x 6 cm 2 0 y 6 cm 1 3 PD cm n a n a FRP cm n a n a EBD Az cm 2 5...

Страница 35: ...ges without prior written consent of HeraMED The materials are protected by the copyright law including but not limited to confidential information such as technical information contained in this Inst...

Страница 36: ...al Doppler 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 HeraBEAT US User Manual 01 07290111520020 20 05 91 US HERA CM...

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