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MANUFACTURER’S DECLARATION – ELECTROMAGNETIC 

The Romed Infrared Forehead Thermometer  is intended for use in the electromagnetic environment 

specified below. The customer or the user of The Romed Infrared Forehead 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

3 Vrms 150kHz to 

80MHz 

6 Vrms in

 

ISM bands 

3V/m 80MHz to

 

2.5GHz

 

385MHz-5786MHz 

Test specification

 

for ENCLOSURE 

PORT IMMUNITY

 

to RF wireless 

communication

 

equipment(refer

 

to table 9 IEC

 

60601-1-2:2

 

014)

 

Not applicable 

Not applicable 

3V/m

 

80MHz to 2.5GHz

 

385MHz-5786MHz

 

Test specification 

for ENCLOSURE 

PORT IMMUNITY 

to RF

 

wireless

 

communication 

equipment(refer to 

table 9 IEC

 

60601-1-2:2014)

 

Portable and mobile RF communications 

equipment should be used no closer to any 

part of The Romed Infrared Forehead 

Thermometer , including cables, than the 

recommended

 

separation distance calculated from the 

equation application to the frequency of the 

transmitter.

 

Recommended separation distance

 

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 form fixed RF transmitters, as 

determined by an electromagnetic site survey, 

a 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:

 

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

 

NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and 

reflection from structures, objects and people.

 

a  Field strengths from transmitters, such as base stations for radio (cellular/cordless) telephones and land 

mobile radios, amateur radio, AM and FM radio broadcast 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 

Romed Infrared Forehead Thermometer  is used exceeds the applicable RF compliance level above, The 

Romed Infrared Forehead Thermometer  should be observed to verify normal operation. If abnormal 

performance is observed, additional measures may be necessary, such as reorienting or relocating The 

Romed Infrared Forehead Thermometer .

 

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

 

11

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Summary of Contents for THERM-IR

Page 1: ...read this Instruction Manual before using the unit in order to use it safely it safely and correctly The instruction manual should be well kept for your reference at any time H O L L A N D H O L L A N D USER MANUAL INFRARED FOREHEAD THERMOMETER THERM IR w w w b i o m a r k l v ...

Page 2: ... the device This device can be applied to all people No special training is needed but the user shoul read the manual carefully before use 1 Foreword 2 Device Description 3 Instructions for Use 4 Specifications 5 Cleaning and Disinfection 6 Maintenance 7 Trouble Shooting 8 Disposal 9 Electromagnetic Compatibility INDEX 1 2 4 7 8 8 8 9 9 w w w b i o m a r k l v ...

Page 3: ...ying the device Please do not clean or perform maintenance on the device while in use Please wait for 30 minutes before use if the environment has a sudden change e g from under sunlight to an air conditioned room or the accuracy may be influenced Degraded sensors and electrodes or loosened electrodes can degrade performance or cause other problems DO NOT open the battery cover around any source o...

Page 4: ...ing the body temperature by measuring the heat radiation from the forehead Probe Type BF Applied part Serial number Batch code Catalogue number CE Mark Date of manufacture Manufacturer Keep dry Keep away from sunlight Temperature limit Collect separately from other household waste IP classification Refer to user manual Consult instructions for use Caution 2 w w w b i o m a r k l v ...

Page 5: ...Button 4 Thermosensor 5 Distance Sensor 6 Battery Cover 7 Body Mode Indicator 8 Object Mode Indicator 9 Temperature reading distance indicator 10 C F CM 11 Memory Indicator 12 Memory Times Remaining time 13 Battery Charge 14 Measure Distance 15 Batteries 3 w w w b i o m a r k l v ...

Page 6: ...r leave the device for 30 minutes before operation if it is moved from different environment and make sure the device always works in the correct range temperature 3 Position thermometer up to 3 cm away from the centre of the forehead just between the eyebrows If the eyebrow area is covered with hair sweat or dirt please clean the area beforehand to improve the reading accuracy It is important to ...

Page 7: ...p 3 FEVER GUIDANCE FEATURE Fever guidance helps you to better understand the meaning of the temperature with the colour indicated on the display The screen displays green is normal yellow when the temperature is low fever and a red alert for a possibly high fever 10 audible beeps indicate temperatures above 38 5 C 101 3 F to alert the user that the patient may have a fever Backlight Colour Tempera...

Page 8: ...f In the memory view interface press and hold the measurement button for approx 5 seconds to display CLR and delete the all memories CHANGING MEASUREMENT MODE In the ON status press the power button to switch between the object mode and the body temperature mode Object mode is able to measure the surrounding environment or object temperature To ensure the accuracy of measurement please do not cond...

Page 9: ... 0 1 C 0 1 F Measurement Accuracy 0 2 C for range 35 0 C 42 0 C 0 3 C outside this temperature range at standard room temperature of 25 C 77 0 F Memory 30 recorded measurements Button 3 buttons Power Model Button Measurement Memory Button C F Button Alarm Sound when peak temperature reached Calibration No need for calibration before use To ensure the measurement accuracy please use and store the d...

Page 10: ... The continuous use of a damaged unit may cause injury improper results or serious danger Store and use the device at a cool dry and ventilated environment Avoid approaching fire and heat sources or it will cause the battery to explode If you have any problems with this device such as setting up maintaining or using or in the case of an unexpected operation or event please contact Van Oostveen Med...

Page 11: ...ns section 8 DISPOSAL DO NOT dispose the batteries in domestic waste Dispose of the batteries according to the local regulations dealing with the disposal of these special materials e g to the collecting points The device is made of a combination of plastic and stainless steel Be sure to dispose of it in accordance with local regulations as unsorted municipal waste You may recycle it at your local...

Page 12: ...rehead Thermometer is intended for use in the electromagnetic environment specified below The customer or the user of The Romed Infrared Forehead 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 8 kV contact 2 kV 4 kV 8 kV 15 kV air 8 kV contact 2 kV 4 ...

Page 13: ... the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths form fixed RF transmitters as determined by an electromagnetic site survey a 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 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE...

Page 14: ...ximum output of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 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 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the freq...

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