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EMC GUIDANCE

EMC GUIDANCE

25

24

Table 2

Table 3

Guidance and manufacturer’s declaration – electromagnetic Immunity

Immunity Test

IEC 60601-1-2  Test level

Compliance level

Electrostatic

discharge 

(ESD)

IEC 61000-4-2

±8 kV contact

±2 kV, ±4kV, ±8 kV, ±15 kV air

±8 kV contact

±2 kV, ±4kV, ±8 kV,

±15 kV air

Electrical fast

transient/

burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV signal input/output

100 kHz repetition frequency

±2 kV for power supply lines

±1 kV signal input/output

100 kHz repetition frequency

Surge

IEC61000-4-5

±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV,±2 kV common mode

±0.5 kV, ±1 kV differential mode

±0.5 kV, ±1 kV,±2 kV common mode

Voltage dips, 

short

interruptions 

and voltage 

variations on 

power  supply 

input lines 

IEC 61000-4-11

0 % U

T

; 0,5 cycle. At 0°, 45°, 90°, 135°,

180°, 225°, 270° and 315°.0 % U

T

;

1 cycle and 70 % U

T

; 25/30 cycles;

Single phase: at 0°.0 % U

T

; 250/300 

cycle

0 % U

T

; 0,5 cycle. At 0°, 45°, 90°, 135°,

180°, 225°, 270° and 315°. 0 % U

T

1 cycle and 70 % U

T

; 25/30 cycles; 

Single phase: at 0°. 0 % U

T

; 250/300 

cycle

Power 

frequency

magnetic field

IEC 61000-4-8

30 A/m

50Hz/60Hz

30 A/m

50Hz/60Hz

Conduced RF

IEC61000-4-6

3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands

between 0,15 MHz and 80 MHz

80 % AM at 1 kHz

3 V

0,15 MHz – 80 MHz

6 V in ISM and amateur radio bands

between 0,15 MHz and 80 MHz

80 % AM at 1 kHz

Radiated RF

IEC61000-4-3

10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

NOTE U

T

 is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration - electromagnetic Immunity

Radiated RF

IEC61000-4-3

(Test

specifications

for 

ENCLOSURE

PORT

IMMUNITY to

RF wireless

commu-

nications 

equipment)

Test 

Frequency

(MHz)

Band

(MHz)

Service

Modulation

Modulation

(W)

Distance (m)

IMMUNITY

TEST

LEVEL

(V/m)

385

380-

390

TETRA

400

Pulse

modulation 

b) 18Hz

1.8

0.3

27

450

430-

470

GMRS 460,

FRS 460

FM c) ± 

5kHz

deviation 

1kHz sine

2

0.3

28

710

704-

787

LTE Band

13, 17

Pulse

modulation 

b) 217Hz

0.2

0.3

9

745

780

810

800-

960

GSM

800/900,

TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

Pulse

modulation 

b) 18Hz

2

0.3

28

870

930

1720

1700-

1990

GSM 1800;

CDMA 

1900;

GSM 1900;

DECT;

LTE 

Band 1,

3, 4,25; 

UMTS

Pulse

modulation 

b) 217Hz

2

0.3

28

1845

1970

2450

2400-

2570

Bluetooth,

WLAN,

802.11

b/g/n, 

RFID

2450, LTE

Band 7

Pulse

modulation

217 Hz

2

0.3

28

5240

5100-

5800

WLAN

802.11

a/n

Pulse

modulation

217 Hz

0.2

0.3

9

5500

5785

Summary of Contents for PY-802-LTE

Page 1: ...LTE Blood Pressure Monitor PY 802 LTE Thank you for choosing Pylo Health This manual outlines how to use your Pylo blood pressure monitor safely and correctly Please be sure to read it thoroughly and...

Page 2: ...Principle Safety Information LCD Display Signal Components of the Device Included Parts List What are systolic pressure and diastolic pressure What is the standard blood pressure classification Irreg...

Page 3: ...on and provides step by step instructions for using the product Please read this manual thoroughly before using the product This product uses the Oscillometric Measuring Method to detect blood pressur...

Page 4: ...eck that operation of the device does not result in prolonged impairment of patient blood circulation When measurement please avoid compression or restriction of the connection tubing The device canno...

Page 5: ...he device doesn t need to be calibrated within two years of reliable service If you have any problems with this device such as setting up maintaining or using please contact the SERVICE PERSONNEL of P...

Page 6: ...d special power adapter which complies with local safety standard Do not use new and used batteries together Do not use different types of batteries together Do not dispose the batteries in fire Batte...

Page 7: ...in place Don t make it too tight allow a finger to fit between the cuff and your arm 10 If possible relax and rest for at least 5 minutes before taking a measurement 11 Lay your arm on a table with y...

Page 8: ...urn on the monitor The cuff will begin to inflate and the measurement will be taken and saved 2 Once measurement is taken the device will connect to the network and start transmission The symbol will...

Page 9: ...e device In a very cold environment When cleaning device use a lightly moist cloth without soap or detergent After drinking tea coffee or using tobacco products Keep away from water If splashed immedi...

Page 10: ...he person takes medicine the pressure may vary even more 3 Wait at least 3 minutes between measurements What you need to pay attention to when you measure your blood pressure at home If the cuff is ti...

Page 11: ...1 Problem SYMPTOM CHECK THIS REMEDY No power or Low batteries Display will not light up or show Batteries are exhausted Replace with new batteries Batteries are inserted incorrectly Insert the batteri...

Page 12: ...to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential ins...

Page 13: ...rer of medical devices General Requirements for Safety EN 60601 1 2006 A1 2013 IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General requirements for basic safety and essential performa...

Page 14: ...z Conduced RF IEC61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz 80 MHz 6 V in ISM and amateur radio bands between 0 15 MHz and...

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