background image

EMC GUIDANCE

Guidance and manufacturer’s declaration – electromagnetic Immunity 

Immunity Test

±8 kV contact

±2 kV, ±4kV, ±8 kV,  ±15 kV air 

±8 kV contact

±2 kV for power supply lines

±0.5 kV, ±1 kV differential mode   

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

30 A/m
50Hz/60Hz

NOTE      U

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

Table 2 

Compliance level

Electrostatic 

discharge (ESD) 

IEC 61000-4-2 

30 A/m
50Hz/60Hz

 Power frequency 
magnetic field
IEC 61000-4-8

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

Electrical fast 

transient/burst 

IEC 61000-4-4 

Surge

IEC61000-4-5

±1 kV signal input/output 
100 kHz repetition frequency

IEC 60601-1-2 
Test level

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 

±2 kV, ±4kV, ±8 kV,  
±15 kV air 

±2 kV for power supply lines

±1 kV signal input/output 
100 kHz repetition frequency

±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 

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

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

Radiated RF
IEC61000-4-3

Table 3

Guidance and manufacturer’s declaration - electromagnetic Immunity

Test 
Frequency
 (MHz)

385

0.3

27

Radiated RF 
IEC61000-4-3 
(Test 
specifications 
for 
ENCLOSURE 
PORT 
IMMUNITY to 
RF wireless 
communica-
tions 
equipment) 

Band 
(MHz)

Service 

Modulation 

Modulation 
(W)

Distance (m)

IMMUNITY 
TEST 
LEVEL 
(V/m)

380-390

TETRA 
400

Pulse 
modulation b) 
18Hz

1.8

450

430-470

GMRS 460

FRS 460

FM c) ± 5kHz
deviation 1kHz
sine

2

0.3

28

710

704-787

745

780

LTE Band
13,
17

Pulse 
modulation b)
217Hz

0.2

0.3

9

810

870

930

800-960

GSM 
800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5

Pulse 
modulation b)
18Hz

2

0.3

28

1720

1845

1970

1700-
1990

GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,
4,25; UMTS

Pulse 
modulation b)
217Hz

2

0.3

28

2

0.3

28

2450

2400-
2570

Bluetooth,
WLAN,
802.11 
b/g/n, RFID
2450, LTE
Band 7

Pulse 
modulation 
217 Hz

5240

5500

5785

5100-
5800

WLAN
802.11
a/n

Pulse
modulation 
217 Hz

0.2

0.3

9

EMC GUIDANCE

34

35

Summary of Contents for TMB-2079

Page 1: ...079 Please do read the user manual carefully and thoroughtly so as to ensure the safe usage of this product and keep the manual well for further reference in case you have problems version 1 0 Guangdo...

Page 2: ...ENT 20 Recall the Records Delete the Records INFORMATION FOR USER 24 Tips for measurement Maintenances ABOUT BLOOD PRESSURE 26 What are systolic pressure and diastolic pressure What is the standard bl...

Page 3: ...e user manual labeling or other component They are the requirement of standard and using Symbol for THE OPERATION GUIDE MUST BE READ Symbol for MANUFACTURER Symbol for SERIAL NUMBER Symbol for TYPE BF...

Page 4: ...t in prolonged impairment of patient blood circulation When measurement please avoid compression or restriction of the connection tubing CAUTION The device cannot be used with HF surgical equipment at...

Page 5: ...ce in accordance with the information provided in the ACCOMPANYING DOCUMENTS Wireless communications equipment such as wireless home network devices mobile phones cordless telephones and their base st...

Page 6: ...T 5V 1A Do not use new and used batteries together Do not use different types of batteries together Do not dispose the batteries in fire Batteries may explode or leak Remove batteries if the device is...

Page 7: ...p can be assigned to each record that is stored in the memory The setting range of the year 2020 2099 time format 24H 1 When the monitor is off Long press MEM button it will display the time Then pres...

Page 8: ...USER button will decrease time 3 After the trends start time and end time are set the LCD will disply do nE and then it will turn off Select the User ID Before you start the measurement please select...

Page 9: ...our test information Search your test information BEFORE YOU START BEFORE YOU START Install the App and Pair Up Download the MedM Health app from APP Store or Google Play Install the APP and register...

Page 10: ...time on the same arm or as directed by a physician 6 Take the measurement in a silent room The cuff should maintain at the same level as the right atrium of the heart Please sit comfortably Do not cro...

Page 11: ...data for the desired user Take User 1 for example Install the APP and register an account Then set your personal information Gender Birthday Height Weight Name and so on N 5 Press the START STOP butto...

Page 12: ...ecall the Records 3 Then show the latest measurement records you can press the MEM or SET button to get the record you want The current No is No 2 The corresponding time is A M 06 00 The corresponding...

Page 13: ...h dE LE YES the display will show dE LE YES User ID 3 Press START STOP button to confrim deleting the LCD will display do nE and then turn off If you did not get the correct measurement you can delete...

Page 14: ...he reusable cuff with water and never immerse the cuff in water Tips for Measurement Within 1 hour after dinner or drinking Within 20 minutes after taking a bath In a very cold environment Immediate m...

Page 15: ...andard blood pressure classification Irregular Heartbeat Detector CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heart beat was detected during...

Page 16: ...en measure again Warning message Relax for a moment Refasten the cuff and then measure again If the problem persists contact your physician OUT shows Out of measurement range TROUBLE SHOOTING SPECIFIC...

Page 17: ...d found 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 residen...

Page 18: ...edical devices Part 10 Tests for irritation and skin sensitization EN ISO 15223 1 2016 ISO 15223 1 2016 Medical devices Symbols to be used with medical device labels labelling and information to be su...

Page 19: ...differential mode 0 5 kV 1 kV 2 kV common mode 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...

Reviews: