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Table 4 Guidance and MANUFACTURER’s declaration – electromagnetic IMMUNITY –

for ME 

EQUIP

MENT and ME SYSTEMS that are not LIFE-SUPPORTING 

Guidance and manufacturer’s declaration – electromagnetic immunity

IMMUNITY test

3 Vrms

3 V/m 

Compliance 

level

IEC 60601 

TEST LEVEL

Conducted RF

IEC 61000-4-6 

Radiated RF 

IEC 61000-4-3

3 V/m

80 MHz to

2.5 GHz 

3 Vrms

150 kHz to

80 MHz 

Electromagnetic environment - 

guidance

Portable and mobile RF 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 frequency of 

the transmitter.

Recommended separation distance

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.

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 metres (m).

Field strengths from fixed RF 

transmitters, as determined by an 

electromagnetic site survey,   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:

P

=

d

P

=

d

 80 MHz to 800 MH

P

=

d

2.3

  800 MHz to 2,5 G

1.2 

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 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 broad-

cast and TV broadcast cannot be predicted theoretically with accuracy. To assess 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 

the device is used exceeds the applicable RF compliance level above, the device 

should be observed to verify normal operation. If abnormal performance is observed, 

additional measures may be necessary, such as re-orienting or relocating the device.

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

b

1.2 

 

150 kHz to 80 MHz 

80 MHz to 800 MHz 

800 MHz to 2.5 GHz 

Table 6 Recommended separation distances between portable and mobile 

RF communications equipment and the ME E

Q

UIPMENT or ME SYSTEM –

for ME 

EQUI

PMENT and ME SYSTEMS that are not LIFE-SUPPORTING 

Recommended separation distances 

between  portable and mobile RF communications equipment and the device.

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 portable and mobile RF communications equipment (transmittters) and the 

device 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)

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 80MHz and 800MHz, 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.

0.01

0.1

1

10

100

0.12

0.12
0.38
1.2
3.8
12

0.23
0.73
2.3
7.3
23

P

=

d

P

=

d

1.2

2.3

P

=

d

0.38
1.2
3.8
12

1.2

26

27

EMC GUIDANCE

EMC GUIDANCE

Содержание TMB-995-BT

Страница 1: ...Monitor TMB 995 BT 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 Guangdong Transtek Medical Electronics Co Ltd Zone A No 105 Dongli Road Torch Development District Zhongshan 528437 Guangdong China ...

Страница 2: ...th Your Device Data Transmission INFORMATION FOR USER 15 Tips for measurement Maintenances ABOUT BLOOD PRESSURE 17 What are systolic pressure and diastolic pressure What is the standard blood pressure classification Why does my blood pressure fluctuate throughout the day Why do I get a different blood pressure at home compared to the hospital Is the result the same if measuring on the right arm TR...

Страница 3: ... the cuff and stethoscope auscultation method This manual contains important safety and care information and provides step by step instructions for using the product Read the manual thoroughly before using the product The Transtek Blood Pressure Monitor is digital monitors intended for use in measuring blood pressure and heartbeat rate with arm circumference ranging from 22cm to 42cm about 8 16 It...

Страница 4: ...ecome anaesthetic swollen and even purple due to a lack of blood When not in use store the device with the adapter in a dry room and protect it against extreme moisture heat lint dust and direct sunlight Never place any heavy objects on the storage case This device may be used only for the purpose described in this booklet The manufacturer cannot be held liable for damage caused by incorrect appli...

Страница 5: ...luer lock connectors are used in the construction of tubing there is a possibility that they might be inadvertently connected to intravascular fluid systems allowing air to be pumped into a blood vessel Please use the device under the environment which was provided in the user manual Otherwise the performance and lifetime of the device will be impacted and reduced 6 7 INTRODUCTION LCD display sign...

Страница 6: ...uff Type BF applied part 22cm 42cm 3 4 AA batteries Please use TRANSTEK authorized cuff The size of the actual cuff please refer to the label on the attached cuff Component list of pressure measuring system 1 Cuff 2 Air pipe 3 PCBA 4 Pump 5 Valve AIR HOSE AIR CONNECTOR PLUG LCD DISPLAY START STOP 5 AC Adaptor KH0601000UW CUFF The Choice of Power Supply 1 Battery powered mode 6VDC 4 AA batteries 2 ...

Страница 7: ...and take 5 6 deep breaths Rest for 5 minutes before first measuring Wait at least 3 minutes between measurements This allows your blood circulation to recover The patient must relax as much as possible and do not move and talk during the measurement procedure For a meaningful comparison try to measure under similar conditions For example take daily measurements at approximately the same time on th...

Страница 8: ...cord 1 is shown first Each new measurement is assigned to the first 1 record All other records are pushed one digit e g 2 becomes 3 and so on and the last record 60 CAUTION Pair up the Blood Pressure Monitor with Your Device 1 Turn on Bluetooth and the app Make sure both are on when pair up is proceeding 2 When the monitor is off press and hold the START STOP button to start pair up The symbol and...

Страница 9: ... 20 centimeters away from the human body especially the head when the data transmission is proceeding after measurement To enable the data transmission function this product should be paired to Bluetooth end at 2 4 GHz How to mitigate possible interference The range between the device and BT end should be reasonably close from 1 meter to 10 meters Please ensure no obstacles between the device and ...

Страница 10: ...ac examination but serves to detect pulse irregularities at an early stage Only a physician can tell your normal BP range Please contact a physician if your measuring result falls out of the range Please note that only a physician can tell whether your blood pressure value has reached a dangerous point The chart on the right is the standard blood pressure classification published by American Heart...

Страница 11: ...ed questions for problems you may encounter with your blood pressure monitor If the products not operating as you think it should check here before arranging for servicing TROUBLESHOOTING PROBLEM SYMPTOM CHECK THIS REMEDY No power Low batteries Error message Display will not light up Batteries are exhausted Replace with new batteries Insert the batteries correctly Replace with new batteries Batter...

Страница 12: ...ly Powered ME Equipment AC Adaptor Powered Mode Class II ME Equipment IP21 It means the device could protected against solid foreign objects of 12 5mm and greater and protect against vertically falling water drops Pressure 5 40 within 3mmHg 0 4kPa pulse value 5 A temperature range of 5 C to 40 C A relative humidity range of 15 to 90 non condensing but not requiring a water vapour partial pressure ...

Страница 13: ... 1 General requirements IEC 80601 2 30 2013 Medical electrical equipment Part 2 30 Particular requirements for the basic safety and essential performance of automated non invasive sphygmomanometers ISO 81060 2 2013 Non invasive sphygmomanometers Part 2 Clinical validation of automated measurement type EN 60601 1 2 2007 IEC 60601 1 2 2007 Medical electrical equipment Part 1 2 General requirements f...

Страница 14: ...will be used Guidance and manufacturer s declaration electromagnetic immunity IMMUNITY test 6 kV contact 8 kV air 6 kV contact 8 kV air 2 kV for power supply lines 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 3A m NOTE UT is the a c mains voltage prior to application of the test level Table 2 Guidance and MANUFACTURER ...

Страница 15: ... RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device Over the frequency range 150 kH...

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