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EMC GUIDANCE

EMC GUIDANCE

EMC Guidance

1)This product needs special precautions regarding EMC and needs to be 
installed and put into service according to the EMC information provided,
and this unit can be affected by portable and mobile RF communications 
equipment.
2)* Do not use a mobile phone or other devices that emit electromagnetic 
fields, near the unit. This may result in incorrect operation of the unit.
3)Caution: This unit has been thoroughly tested and inspected to assure 
proper performance and operation!
4)* Caution: This machine should not be used adjacent to or stacked with 
other equipment and that if adjacent or stacked use is necessary, this 
machine should be observed to verify normal operation in the configuration in 
which it will be used.

Table 1 

Guidance and manufacturer’s declaration – electromagnetic emissions

RF emissions 
CISPR 11

Group 1 

Class B 

Class A

Complies

Compliance

Harmonic emissions 
IEC 61000-3-2

Voltage fluctuations/ 
flicker emissions  
IEC 61000-3-3  

RF emissions 
CISPR 11

Emissions test

Electromagnetic environment - guidance

The 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.

The device uses RF energy only for its internal 
function. Therefore, its RF emissions are very low 
and are not likely to cause any interference in nearby 
electronic equipment.

The device is suitable for use in all establishments,
other than domestic and those directly connected to 
the public low-voltage power supply network that 
supplies buildings used for domestic purposes.

 

Guidance and manufacturer’s declaration – electromagnetic immunity 

Immunity test

 

±8 kV contact
±15 kV air 

±8 kV contact
±15 kV air 

 

±2 kV 

power supply lines: 

line(s) to line(s): ±1 kV  
line(s) to earth: ±2 kV 

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

 ; 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 

Electromagnetic 
environment - guidance

30 A/m
50Hz/60Hz

Power frequency 

(50Hz/60Hz) 
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

input/output lines:
±1 kV

The 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.

IEC 60601 test level

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

±2 kV 

power supply lines: 

100 kHz repetition
frequency

line(s) to line(s): ±1 kV  

100 kHz repetition
frequency

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

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

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

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

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

 ;300 cycle

Summary of Contents for TMB-1776

Page 1: ...Pressure Monitor TMB 1776 Please read the user s manual carefully and thoroughly so as to ensure the safe usage of this product Keep the manual well stored for further reference in case you have probl...

Page 2: ...ds Delete the Records INFORMATION FOR USER 18 Tips for measurement Maintenances Contraindications ABOUT BLOOD PRESSURE 20 What are systolic pressure and diastolic pressure What is the standard blood p...

Page 3: ...igns below might be in the user manual labeling or other component They are the requirement of standard and using Symbol for THE OPERATION GUIDE MUST BE READ Symbol for COMPLIES WITH MDD 93 42 EEC REQ...

Page 4: ...ation When measuring please avoid compression or restriction of the connection tubing CAUTION The device cannot be used with HF surgical equipment at the same time The ACCOMPANYING DOCUMENT shall disc...

Page 5: ...two years of reliable service If you have any problems with this device such as setting up maintaining or using please contact your LOCAL DEALER for SERVICE Don t open or repair the device by yourself...

Page 6: ...he battery cover Installing and Replacing the Batteries CAUTION CAUTION Replace the batteries whenever the below happens The shows The display is dim The display does not light up The Choice of Power...

Page 7: ...re using your blood pressure monitor so that a time stamp can be assigned to each record that is stored in the memory The setting range of the year 2017 2057 time format available 24H 1 When the monit...

Page 8: ...rtably with your tested arm resting on a flat surface Place your elbow on a table so that the cuff is at the same level as your heart Turn your palm upwards Sit upright in a chair and take 5 6 deep br...

Page 9: ...ll finish the whole measurement Take user 1 for example 2 Press the to power off otherwise it will turn off within 1 minute The current No is No 1 The corresponding time is 6 00 24H Format The corresp...

Page 10: ...or 3 seconds when the monitor is in the memory recall mode dEL ALL will flash on the display 2 Press to confirm deleting and dEL donE will be shown on the display then the monitor will turn off 3 If y...

Page 11: ...he device is not suitable for use on patients with implanted electrical devices such as cardiac pacemakers and defibrillators Ask your Doctor before use 3 We suggest above mentioned population to meas...

Page 12: ...arging Systolic relax blood entering Diastolic When ventricles contract and pump blood out of the heart the blood pressure reaches its maximum value in the cycle which is called systolic pressure When...

Page 13: ...ement can affect the measurement Relax for a moment and then measure again Relax for a moment and then measure again The measurement process does not detect the pulse signal Loosen the clothing on the...

Page 14: ...anual General Requirements for Safety Electromagnetic compatibility Performance requirements Clinical investigation Usability Software life cycle processes Bio compatibility ISO 10993 1 2009 Biologica...

Page 15: ...hat supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity Immunity test 8 kV contact 15 kV air 8 kV contact 15 kV air 2 kV power supply lines l...

Page 16: ...ion appropriate for the frequency of the transmitter Recommended separation distances d 0 35 d 1 2 10V m 80 Am at 1kHz 80 MHz to 800 MHz d 1 2 800 MHz to 2 7 GHz d 2 3 where P is the maximum output po...

Page 17: ...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...

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