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19

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

DUO is intended for use in the electromagnetic environment specified below.  The user of the Eko DUO should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment-Guidance

Electrostatic Discharge 
(ESD) IEC 61000-4-2

+/- 8 kV contact

+/- 15 kV air

+/- 8 kV contact

+/- 15 kV air

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at 
least 30%

Electrical Fast Transient/
Burst 
IEC 61000-4-4

+/- 2 kV for supply lines
+/- 1kV for input/output lines

+/- 2 kV for supply lines
+/- 1kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment

Surge 
IEC 61000-4-5

+/- 1 kV line to line
+/- 2 kV line to earth

+/- 1 kV line to line
+/- 2 kV line to earth

Mains power quality should be that of a typical commercial or hospital environment

Voltage dips, short 
interruptions and voltage 
variations on power supply 
input lines 
IEC 61000-4-11

5% U

T

  (95% dip in U

T

) for 0.5 cycles

40% U

T

  (60% dip in U

T

) for 5 cycles

70% U

T

  (30% dip in U

T

) for 25 cycle

<5% U

T

  (>95% dip in U

T

) for 5 sec

5% U

T

  (95% dip in U

T

) for 0.5 cycles

40% U

T

  (60% dip in U

T

) for 5 cycles

70% U

T

  (30% dip in U

T

) for 25 cycle

<5% U

T

  (>95% dip in U

T

) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency (50/60 
Hz) magnetic field 
IEC 61000-4-8

30 A/m

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial magnetic field or 
hospital environment.

Conducted RF
IEC 61000-4-6

3 Vrms
150kHz - 80 Mhz

3 Vrms
150kHz - 80 Mhz

Portable and mobile RF communications equipment should be used no closer to any part of DUO, including cables, than the 
recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:
d = [ 3.5 / V

1

] √P

d = [ 3.5 / E

1

] √P 90 MHz to 800 MHz

d = [ 7 / E

1

] √P 800 Mhz to 2.5 GHz

 

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 meters (m). Field strengths from fixed RF transmitters, as determxined by an 
electromagnetic site survey, 

a

 should be less than the compliance level in each frequency range. 

b

 Interference may occur in the 

vicinity of equipment marked with the following symbol:

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to 2.5 GHz

3 V/m
80 Mhz to 2.5 Ghz

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 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 address 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 DUO is used exceeds the applicable RF 
compliance level above, DUO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating DUO.

b

     Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

8.1

Electrical Safety

Summary of Contents for DUO E5

Page 1: ...User Manual Model E5...

Page 2: ...es Inc directly Please report any injury or adverse event to Eko using any of the contact methods below Eko Devices Inc 2600 10th St Suite 260 Berkeley CA 94710 USA General Assistance and FAQs ekodevi...

Page 3: ...y move DUO away from that device and or turn the Bluetooth feature OFF To reduce the risks associated with environmental contamination follow applicable regulations when disposing of this device DUO c...

Page 4: ...rence and 2 this device must accept any interference received including interference that may cause undesirable operation NO MODIFICATION Modifications to this device shall not be made without the wri...

Page 5: ...but not limited to patient body temperature and clean contact area The device uses a Bluetooth Class 2 wireless data link The Bluetooth range will be reduced when objects walls furniture people etc a...

Page 6: ...isclosure of any electronic patient data through the use of software If the user becomes unable to comply with a law or restriction that applies to use and disclosure of such data the user should not...

Page 7: ...power adapter The LED light ring on DUO will begin to flash to signal the charging status All of the LEDs in the ring will light up when the device is fully charged DUO should be periodically recharge...

Page 8: ...ted on the top face An LED ring illuminates when the device is powered on Power Save Mode DUO will automatically power off after 5 minutes of continuous inactivity To resume DUO press and hold the act...

Page 9: ...ing light up based on volume level The device is ON The filter change is indicated by the active LED in the LED ring rotating to a new position The device is ON and has low battery The red warning LED...

Page 10: ...dio press the device firmly against the skin to ensure good contact ECG Capture ECG by placing and orienting DUO on the chest The optimal position to capture ECG data is at an inward facing 45 angle a...

Page 11: ...e device and may affect battery life Operating Warnings Failure to follow care and maintenance recommendations could result in damage to the internal components of the device Internal damage to the pr...

Page 12: ...4 digit login PIN to simplify the login process on the Eko mobile app To create or edit a login PIN manually select the Menu icon on the top left of the home screen Select Account Settings PIN and fol...

Page 13: ...top right of the home screen Select the desired patient and select a recording to add notes to Scroll to the bottom of the recording screen Select Add Comment and begin typing your note Select the th...

Page 14: ...otes 25mm s and 10mm mV 7 3 Main Recording Screen 89 AT T 1 45 PM Hill Thomas Settings Modify Bluetooth Adjust Volume Change Audio Source iPhone speakers or DUO Earpieces Adjust Account Details Name U...

Page 15: ...PIN is recommended so that users do not have to enter full login information each time the App is opened Finally users may log out of the App from this screen 7 4 Settings Screen My Devices Audio Sett...

Page 16: ...ted with the patient Patients may be added to the list individually through manual input or syncing with compatible EHR services 7 5 Patients Screen Aaberg Mark Anonymous PS01CEP90784 Aortic stenosis...

Page 17: ...ok at 01 57 for me Martin Stemper 4 59pm RRR Murmur heard and Indicated Martin Stemper 4 59pm This is one of the more complicated afib cardiology characteristics Will address tomorrow You 4 59pm NOTES...

Page 18: ...ation in the configuration in which it will be used Guidance and Manufacturer s Declaration Electromagnetic Emission DUO is intended for use in the electromagnetic environment specified below The user...

Page 19: ...z 3 Vrms 150kHz 80 Mhz Portable and mobile RF communications equipment should be used no closer to any part of DUO including cables than the recommended separation distance calculated from the equatio...

Page 20: ...rding to Frequency of Transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For...

Page 21: ...www ekodevices com 2016 Eko Devices Inc All Rights Reserved Eko the Eko logo and DUO are trademarks of Eko Other company and product names may be trademarks of their respective owners LBL 009 B...

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