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RF emissions CISPR 11

Class B

The model Portable ECG monitor is suitable for use in
all establishments, including domestic establishments
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.

Harmonic emissions IEC

61000-3-2

Class A

Voltage fluctuations/

flicker emissions IEC

61000-3-3

Complies

Recommended separation distances between RF wireless communications equipment

The device is intended for use in an electromagnetic environment in which radiated RF disturbances

are controlled. The customer or the user of the device can help prevent electromagnetic

interference by maintaining a minimum distance between RF wireless communications equipment

and the device as recommended below, according to the maximum output power of the

communications equipment.

Frequenc

y MHz

Maximum

Power

W

Distance

IEC 60601

Test Level

Complia

nce

Level

Electromagnetic Environment -

Guidance

385

1.8

0.3

27

27

RF wireless communications

equipment should be used no closer

to any part of the device, including

cables, than the recommended

separation distance calculated from

the equation applicable to the

450

2

0.3

28

28

710

0.2

0.3

9

9

745

780

Recommended separation distances between portable and mobile RF communications equipment

and the A&D unit

The model Portable ECG monitor is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of The model Portable ECG
monitor can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and The model Portable ECG
monitor as recommended below, according to the maximum output power of the communications
equipment.

Rated maximum output

power of transmitter (W)

Separation distance according to frequency of transmitter (m)

150kHz to 80MHz

P

V

d

]

5

.

3

[

1

80MHz to 800MHz

P

E

d

]

5

.

3

[

1

800MHz to 2.7GHz

P

E

d

]

7

[

1

0.01

0.12

0.04

0.07

0.1

0.37

0.12

0.23

1

1.17

0.35

0.70

10

3.70

1.11

2.22

100

11.70

3.50

7.00

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where p is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.

Summary of Contents for PB-20

Page 1: ... 3 2 ECG Recorder 8 About ECG Recorder 8 Measuring with Cable 9 4 Settings 9 4 1 Opening Settings Menu 9 4 2 Turning On Off Bluetooth 10 4 3 Setting ECG Length 10 4 4 Changing User Mode 10 4 5 Changing Brightness 10 4 6 Turn on off voice 11 4 7 Setting Date Time 11 4 8 Erase Data 11 4 9 Factory Reset 11 4 10 Identify Software Version 11 5 Review ECG Recorder 11 6 Maintenance 12 6 1 Warranty 12 6 2...

Page 2: ...not drop this device or subject it to strong impact Do not place this device in pressure vessels or gas sterilization device Do not dismantle the device as this could cause damage or malfunctions or impede the operation of the device This device is not intended for use by people including children with restricted physical sensory or mental skills or a lack of experience and or a lack of knowledge ...

Page 3: ...RF restricted areas For further information on potential restrictions refer to documentation on the Bluetooth usage by the FCC DO NOT use this product with other medical electrical ME equipment simultaneously This may result in incorrect operation of the product and or cause an inaccurate blood pressure readings and or EKG recording Sources of electromagnetic disturbance may affect this product e ...

Page 4: ...f Green the monitor is turned on and working normally or when the battery is fully charged Blue the battery is being charged Red and flash the battery is low 3 Multi functional micro D connector It connects with external ECG cable or charging cable 4 Home Power On Off When the monitor is off press this button to power it on When the monitor is on press and hold it for 2 seconds to turn it off Duri...

Page 5: ... Main Screen is shown as below User Mode Single User Mode Dual Tapping a button in the Main Screen will start a measurement activate a function or open corresponding menu 1 5 Result Screen This device provides ECG Recorder For each measurement a Result report will be provided after the measurement is finished An example is shown below 1 Measured parameters and readings 2 Buttons ...

Page 6: ... is intact open the package and remove the equipment and accessories carefully Check all materials against the packing list and check for any mechanical damage Contact us in case of any problem Warnings Save the packing case and packaging material as they can be used if the device must be reshipped Keep the warranty card which is useful within the period of warranty When disposing of the packaging...

Page 7: ...ectly against the skin If your skin or hands are dry moisten them using a damp cloth before taking the measurement If the ECG electrodes are dirty remove the dirt using a soft cloth or cotton bud dampened with disinfectant alcohol During the measurement do not touch your body with the hand with which you are taking the measurement Please note that there must be no skin contact between your right a...

Page 8: ...fore using this function please read the Section 3 1 Different methods of taking the ECG measurement are available on Portable ECG monitor The ECG recorder offers four different methods to measuring ECG Tap the External icon to switch between two pages As shown above from left to right there are Method A Lead II right hand to left leg or right hand to left abdomen Method B Chest Lead right hand to...

Page 9: ...in order to achieve an accurate ECG reading If the device does not detect good contact between the electrodes and the skin the warning Touch electrodes properly will be displayed Do not press the device too firmly against your skin which may result in EMG electromyograph interference After you finish the above steps hold the device stably and stay calm 4 Once the device detects stable waveform it ...

Page 10: ...ensure communication compatibility worldwide The pairing and transmitting distance of wireless function is 1 5 meters in the normal If the wireless communication is delay or failure between the phone and the product you will try to narrow the distance between the phone and the product The product can pair and transmit with the phone under the wireless coexistence environment e g microwaves cell ph...

Page 11: ...et 1 In the Settings menu tap the Factory Reset 2 Tap Yes to load default settings tap NO to cancel option 4 10 Identify Software Version Choose About in the Settings menu to identify the software version of your device Telling the version information when reporting a problem may help to identify and solve your problem 5 Review ECG Recorder Tap the History icon to review measurement result and wav...

Page 12: ...e the product covered by the warranty Repair or replacement is our only responsibility and your only remedy under the warranty 6 2 Battery The product is designed to operate on rechargeable Lithium ion battery The battery is charged automatically when the monitor is connected to an adapter which can output electronic power and is approved by IEC 60601 1 On screen battery symbols indicate the batte...

Page 13: ...device or not meet the claimed specifications Problem Possible Cause Solution The device does not turn on 1 The battery may be low 2 The device might be damaged 1 Charge the battery and try again 2 Please contact with your local distributor Low battery indicator is blinking The battery is low Charge the battery and try again The ECG waveform amplitude is small The lead you choose is not suitable f...

Page 14: ...een color backlit Wireless connectivity Built in Bluetooth dual mode support 4 0 BLE Power Supply Battery type Rechargeable lithium polymer battery 580 mAh Charge time Less than 2 hours to 90 ECG Lead type Integrated ECG electrodes External ECG cable and electrodes Lead set Lead I lead II Chest Lead Sampling rate 500 Hz Sampling accuracy 16 bit Display Gain 1 25 mm mV 2 5 mm mV 5 mm mV 10 mm mV 20...

Page 15: ...he equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help The device has been evaluated to meet general RF exposure requirement The device can be used in portable exposure condition without restriction 9 1Reference to Standards 10 Electromagnetic Compatibility The device meets the requirements o...

Page 16: ... separation distances between portable and mobile RF communications equipment and the A D unit The model Portable ECG monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of The model Portable ECG monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF c...

Page 17: ...sed in such an environment Immunity test IEC 60601 test level Complian ce level Electromagnetic environment guidance Conducted RF IEC61000 4 6 Radiated RF IEC61000 4 3 3Vrms 150kHz to 80MHz 10V m 80MHz to 2 7GHz N A 10V m Portable and mobile RF communications equipment should be used no closer to any part of The model Portable ECG monitor including cables than the recommended separation distance c...

Page 18: ...ing or relocating The model Portable ECG monitor d Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Shenzhen Viatom Technology Co Ltd Hereinafter called Viatom owns the intellectual property rights to this Viatom product and this manual This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights...

Page 19: ...mation contained in this manual is believed to be correct Viatom shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this manual PN 255 01761 00 Version A Sep 2019 Shenzhen Viatom Technology Co Ltd 4E Building 3 Tingwei Industrial Park No 6 Liufang Road Block 67 Xin an Street Baoan District Shenzhen Gua...

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