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EMC Tables 

 

Table 2 For all ME EQUIPMENT and ME SYSTEMS

 

Guidance and manufacturer’s declaration-electromagnetic immunity 

The 

NT16B TOUCH FREE Infrared Thermometer

 is intended for use in the 

electromagnetic environment specified below. The customer or the user of 
the 

NT16B TOUCH FREE Infrared Thermometer

 should assure that it is 

used in such an environment. 

Immunity 

test 

IEC 60601   

Test level 

Compliance 

Level 

Electromagnetic 

environment-guidance 

Electrostatic 

discharge (ESD) 

IEC 61000-4-2 

±6kV contact 

±8kV air 

 

±6kV 

contact 

±8kV air

 

Floor should be wood, 

concrete or ceramic tile. If 

floors are covered with 

shythetic material, the 

relative humidity should 

be at least 30%.   

Electrical fast 

transient/burst 

IEC 61000-4-4

 

±2 kV for power 

supply lines 

±1 kV air for 

input/output 

lines

 

Not 

applicable 

Mains power quality 

should be that of a typical 

commercial or hospital 

environment. 

Surge 

IEC 61000-4-5 

±1kV differential 

mode 

±2kV common 

mode 

Not 

applicable 

Mains power quality 

should be that of a typical 

commercial or hospital 

environment. 

Voltage dips, 

short 

interruptions and 

voltage 

variations on 

power supply 

input lines 

IEC 61000-4-11 

<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 

 

Not 

applicable 

Mains power quality 

should be that of a typical 

commercial or hospital 

environment. If the use of 

the TS41 

Ear/Forehead/Object 

Thermometer requires 

continued operation 

during power mains 

interruptions, it is 

recommended that the 

TS41 

Ear/Forehead/Object 

Thermometer be powered 

from an uninterruptible 

power supply or a battery. 

Power 

frequency 

(50/60 Hz) 

magnetic field   

IEC 61000-4-8 

3 A/m 

3A/m 

Power frequency 

magnetic fields should be 

at levels characteristic of 

a typical location in a 

typical commercial or 

hospital environment. 

NOTE 

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

17 

 

 

EMC Tables 

 

Table 3 For EQUIPMETN and SYSTEMS that are not 

LIFE-SUPPORTING 

Guidance and manufacturer’s declaration-electromagnetic immunity 

The 

NT16B TOUCH FREE Infrared Thermometer

 is intended for use in the 

electromagnetic environment specified below. The customer or the user of 

the 

NT16B TOUCH FREE Infrared Thermometer

 should assure that it is 

used in such an environment.

 

Immunity 

test 

IEC 60601 

Test level 

Compliance 

Level 

Electromagnetic 

environment-guidance 

Conducted RF 

IEC 61000-4-6 

 

 

Radiated RF   

IEC 61000-4-3 

3Vrms 

150kHz to 80 

MHz 

 

3V/m 

80MHz to 2.5 

GHz 

3 Vrms 

 

 

 

3 V/m 

 

Portable and mobile RF 

communications equipment 

should be used no closer to 

any part of the 

NT16B 

TOUCH FREE Infrared 

Thermometer,

 including 

cables, than the 

recommended separation 

distance calculated from the 

equation applicable to the 

frequency of the transmitter. 

Recommended separation 

distance. 

d=1.2

P  

d=1.2

P 80 MHz to 800 MHz 

d=2.3

P 800 MHz to 2.5 GHz 

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 meters (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.” Interference 

may occur in the vicinity of 

equipment marked with the 

following symbol:   

 

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. 

Field strengths from fixed transmitters, such as base stations from radio 

(cellular/cordless) telephones and land mobile radios, amateur radio, AM 

and FM radio broadcast and TV broadcast can not be predicted theoretic 

call 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 

NT16B TOUCH FREE 

Infrared Thermometer

 is used exceeds the applicable RF compliance level 

above, the 

NT16B TOUCH FREE Infrared Thermometer

 should be 

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

additional measures may be necessary, such as reorienting or relocating the 

NT16B TOUCH FREE Infrared Thermometer

Over the frequency range 150kHz to 80MHz, field strengths should be less 

than [V1] V/m. 

 

18 

 

 

Summary of Contents for NT16B

Page 1: ...attery Installation 5 Switching Between Fahrenheit or Celsius 6 Switching between 4 Kinds of Scan Mode 6 Tips for Measuring Human Temperature 7 Measuring Human Temperature 7 Measuring Object Liquid Temperature 9 Memory Function 10 Cleaning and Disinfecting 11 Applied Standards 12 FCC Important Information 12 Error Codes 13 Operating the Bluetooth function 14 Technical Specification 15 EMC Tables 1...

Page 2: ...rmometer 2 Be sure to clean the thermometer lens each time after usage 3 Avoid direct finger contact with the lens 4 No modification of this equipment is allowed 5 It is recommended that user may take 3 temperatures If they are different use the highest reading 6 Do not expose the thermometer to extreme temperature very high humidity or direct sunlight 7 Avoid extreme shock or dropping the device ...

Page 3: ...Product Identification 3 Description of LCD Display 4 ...

Page 4: ...s must be disposed of in accordance with local environmental and institutional policies 5 Dispose of used batteries in accordance with the applicable legal regulations Never dispose of batteries in the normal household waste 5 Switching Between Fahrenheit or Celsius Your thermometer can display results in either degrees Celsius C or degrees Fahrenheit F To switch between Celsius and Fahrenheit whi...

Page 5: ...ymbol will appear on the display If the patient s skin is covered with hair sweat or dirt clean the area and wait 10 minutes before taking a measurement Ensure that the thermometer is held firmly during measurement and that the patient does not move until the measurement is complete Movement can impact the measurement 7 Measuring Human Temperature 3 Position the thermometer under 3cm around 1 inch...

Page 6: ...memory to share with your physician or trained healthcare professional 1 When the device is on press once briefly on the MEM button then pass it again to show the last measurement accompanied by symbol 2 The symbol or symbol will appear with each measurement stored in memory to indicate whether a person or object temperature was taken 3 Each press of the same button recalls a previous measurement ...

Page 7: ...rt 2 56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement IEC EN 60601 1 Medical electrical equipment Part 1 General requirement for safety IEC EN 60601 1 2 Medical electrical equipment Part 2 Collateral standard Electromagnetic compatibility Requirements and tests FCC Important Information a FCC Caution To assure continued...

Page 8: ...perating the Bluetooth function What You Need NT16BB Bluetooth IR Ear Thermometer An Android device with Android version 4 3 or above and hardware support for Bluetooth 4 0 An iOS device with iOS version 5 or above and hardware support for Bluetooth 4 0 All devices Apple released since the iPhone 4S including the 4S do the older ones don t Note Please refer to the instruction manual of your smart ...

Page 9: ...equency Interference EMC RFI Readings may be affected if the unit is operated within a radio frequency electromagnetic fi eld strength of approximately 3 volts per meter but the performance of the instrument will not be permanently affected Care should be taken to keep the NT16B at least 6 inches away from R C transmitters to avoid radio frequency interference 2 Avoid keeping the NT16B too close t...

Page 10: ...hermometer is intended for use in the electromagnetic environment specified below The customer or the user of the NT16B TOUCH FREE Infrared Thermometer should assure that it is used in such an environment Immunity test IEC 60601 Test level Compliance Level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3Vrms 150kHz to 80 MHz 3V m 80MHz to 2 5 GHz 3 Vrms 3...

Page 11: ...r W 150kHz to 80MHz d 1 2 P 80kHz to 800MHz d 1 2 P 800kHz to 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 19 Explanation of Symbols The CE marking with the Registration Number of the Notified Body This denotes the compliance of European Medical Device Directive 93 42 EEC Follow instructions for use Disposal information Should you wish to dispose ...

Page 12: ...72 N16BMN AV1 2017 03 27 ...

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