HeraMED HeraBEAT User Manual Download Page 31

31

Appendices

  17.3.  Electromagnetic Immunity - for all Equipment and Systems that are not Life-supporting

Guidance and manufacture’s declaration – electromagnetic immunity

The HeraBEAT

TM

 US 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

Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Radiated RF

IEC 61000-4-3

10 V/m 

80 MHz – 2,7 GHz 

80 % AM at 1 kHz 

10 V/m

Portable and mobile RF communications equipment should be used no closer to 
any part of the 

HeraBEAT

TM

 

US

  

device, including cables, than the recommended 

separation distance calculated from the equation applicable to the frequency of 

the transmitter.

Recommended separation distance

 

Where  P  is  the  maximum  output  power  rating  of  the  transmitter  in  watts  (W) 

according to the transmitter manufacturer and d is the recommended separation 

distance in metres (m).

Field strengths from fixed RF transmitters, 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 

symbol:

NOTE 1

  At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 

 These guidelines may not apply in all situations. Electromagnetic propagation is

    affected by absorption and reflection from structures, objects and people.

 

a

  Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM

    radio broadcast and 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

TM

 US device is 

    used exceeds the applicable RF compliance level above, the 

HeraBEAT

TM

 US device should be observed to verify normal operation. 

         If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 

HeraBEAT

TM

 US device.

 

b

 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Summary of Contents for HeraBEAT

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

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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