Non Contact Infrared Body Thermometer: User Manual

Download as pdf or txt
Download as pdf or txt
You are on page 1of 18

File No.

ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer Page 1 / 18
Instructions for use

HeTaiDa

Non Contact Infrared Body


Thermometer
User Manual

Model: HTD8823US

Software version: V10


File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 2 / 18
Page
Instructions for use

Foreword
The non contact Infrared body thermometer operating Instructions intend to provide
the necessary information for proper operation of HTD8823US thermometer model.
Only body mode was reviewed and certified by notified body.
General knowledge of Infrared thermometer and an understanding of the features and
functions of the HTD8823US thermometer model are prerequisites for proper use.
The HTD8823US is a medical device, and can be used repeatedly with using life is 5 years.
And the shelf life of HTD8823US is 5 years too.
Please read the manual first before using it, if not fully understand the usages, please stop
using the thermometer.

Do not operate any of the models HTD8823US thermometer without completely


reading and understanding these instructions.

NOTICE
Purchase or possession of this device does not carry any express or implied license to use
with replacement parts which would, alone or in combination with this device, fall within the
scope of one of the relating patents.

For further information contact:


Hetaida Technology Co., Ltd.
Adds: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town,
DongGuan City, Guangdong, China
Tel: +860769-82658050
Fax: +86 0769-82658050 0598
Contact: Tom. Chen
E-mail: [email protected]

Company Name: Wellkang Ltd


Company Address: 16 Castle St, Dover, CT16 1PW, UK
Tel: +44 (20)30869438, 32876300
Fax: +44(20)76811874
Web: www.CEmark.com, www.CE-marking.com, www.CE-marking.eu,
Email: [email protected]

About this manual edition


Current Updated Edition/Revision: A.1, April,13rd, 2020;

2
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 3 / 18
Page
Instructions for use

Safety Information
This device may only be used for the purposes described in these instructions. The
manufacturer cannot be held liable for damage caused by incorrect application.
The non contact infrared body thermometer is designed to minimize the possibility of hazards
from errors in the software program by following sound and light engineering design
processes, Risk Analysis and Software Validation.
Warning

Warnings are identified by the WARNING symbol shown above.


 The Non Contact Infrared Body Thermometer is to be operated by consumers in the
household environment, nursery school and doctor in clinics. This manual, accessories,
Directions for Use, all precautionary information, and specifications should be read
before use.
 This product is designed to measure human body temperature on the forehead. Do not
use it for any other purpose.
 This product is intended in the home setting and primary care setting as screening tool.
 Do not use the thermometer if it malfunctions or has been damaged in any matter.
 When the ambient temperature of the thermometer changes too much, such as moving
the Thermometer from one place of lower temperature to another place of higher
temperature, Allow the thermometer to remain in a room for 30 minutes where the
temperature is between 5°C to 40°C (41°F - 104°F).
 Remove primary batteries if equipment is not likely to be used for long time.
 This product is not waterproof, do not be immersed in water or other liquid; If cleaning
and disinfection, please follow the "Care and Storage" section requirements.
 Do not touch the sensor of infrared detection with your fingers.
 If a cold compress on the forehead fever patients, or take other measures to cool down
the temperature data will low, should be avoided in this case to measure body
temperature.
 This product must be operated in a stable environment, if the ambient environment was
mutations, please should be note whether there is fog on the sensor, if any, before using
accordance with the "Care and Storage" section to removing the fog.
 Do not near strong electrostatic field or strong magnetic fields, thus avoiding the impact
on the accuracy of the measurement data.
 Do not mix the old and new batteries to avoid damage to the product.
 It may affect the accuracy of measurements when the forehead is covered by hair,
perspiration, cap or scarf.
 The measuring result of this product is only for your reference. If you have any doubt,
please measure the temperature in other methods.

The device should be kept out of the reach of children/pets. When not in use, store the

3
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 4 / 18
Page
Instructions for use

device 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.

Do not throw batteries into fire.

Only use recommended batteries. Do not use rechargeable batteries.

This thermometer will irreplaceable the diagnostic in hospitals.

Do not fall, disassemble or modify the device.

Do not use this device if you think it is damaged or notice anything unusual.

This device comprises sensitive components and must be treated with caution. Observe
the storage and operating conditions described in the ‘Technical Specifications’ section.

Not servicing/maintenance while the thermometer is in use.

When using, shall not touch battery and the patient simultaneously.

Do not use the device if it is damaged/ degraded/loosened in any way. The continuous
use of a damaged unit may cause injury, improper results, or serious danger.

Based on the current science and technology, other potential allergic reactions are
unknown.

This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS.

4
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 5 / 18
Page
Instructions for use

Section 1- Overview
Indication for use:
The Non-contact Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical
thermometer using an infrared sensor to detect body temperature from the forehead in people
of all ages for home setting use.
Description of Non Contact Infrared Body Thermometer
 Device principle and introduction
The HeTaiDa Non contact infrared body thermometer are hand-held, reusable,
battery operated devices, which can measure human body temperature on forehead,
the skin temperature on one's forehead.
The operation principle is based on Infrared Sensor technology. The IR sensor can
output different signal when measuring different object temperature or in different
ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital
value and display it on the LCD.
 Description on Controls, Indicators, and Symbols

Figure 2: LCD description

1.Figure 1: Structure description


IR sensor 1. Memory indicator
2. Position lamp 2. Data indicator
3. Liquid crystal display (LCD) 3. Indicator of measurement result
4. On/Scan button 4.Speaker
5. Battery Cover 5. Battery indicator
6.Unit

5
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 6 / 18
Page
Instructions for use

Thermometer Applications

Thermometer Thermometer Adult Pediatric


Model Number Style Ear Forehead Ear Forehead
Non Contact Infrared Body
HTD8823US √ √
Thermometer

Equipment Symbols

Operating atmospheric
Warning
pressure

Non sterile packaging

Refer to operating Compliance with WEEE


instructions Standard

Operating DO NOT THROW AWAY


Temperature Intended for multiple use

Indicates this device is in


compliance with MDD
Operating Humidity
93/42/EEC. 0598 is the
Notified Body Number
This device compiles
with Part 15 of
Restriction of Hazardous
FCC( Federal
Substances
Communications
Commission) Rules.
Authorized
Manufacturer Representative in the
European community

Recyclable Serial number

IP22: The first number


2: Protected against
solid foreign objects of
IP22 Ф 12.5 mm and greater.
Batch code

The second number:


Protected against

6
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 7 / 18
Page
Instructions for use

vertically falling water


drops when enclosure
titled up to 15º.

Technical Specifications
Measurement Unit °C /°F (HTD8823US)
Operating mode Adjusted mode(Body mode)
Reference Body Site Oral
Rated output range 34.0°C ~ 43.0°C / 93.2°F -109.4°F
Range 34.0°C ~ 43.0°C / 93.2°F -109.4°F
Body mode:
34.0°C ~ 34.9°C : ± 0.3°C / 93.2°F - 94.8°F : ± 0.5°F;
Accuracy
35.0°C ~ 42.0°C : ± 0.2°C / 95.0°F - 107.6°F : ± 0.4°F;
42.1°C ~ 43.0°C : ± 0.3°C 107.8°F - 109.4°F : ± 0.5°F;
Display Resolution 0.1°C /0.1°F (HTD8823US)
34.0°C - 35.7°C / 93.2°F - 96.3°F: no backlight;
Three-color Backlight 35.8°C - 37.4°C /96.2°-99.4°F: Green (Normal Temperature);
(Color Alarm) 37.5°C - 38.5°C / 99.5°F - 101.3°F: Yellow (Slight Fever);
38.6°C - 43.0°C / 101.4 - 109.4°F: Orange(High Fever)
Auto Power Off Time ≤18s
Forehead mode: ≤ 2s
Measuring Time
Forehead scan mode: 3 ~ 10s

Measuring Distance 1 CM -5CM(0.4 in -2in)

Memories 1
Power Supply Requirements
Batteries 1.5V (AAA) Alkaline batteryX2 (IEC Type LR03)
Adaptable Range 2.6V~3.6V
Environmental
Operating Temperature: 5°C ~40°C (41°F ~104°F),
Operating Condition Relative Humidity ≤ 85% (no condensing)
Atmospheric pressure: 70 Kpa -106Kpa
Storage Temperature: - 20°C -55°C / -4 °F - 131°F,
Transport and Storage
Relative Humidity ≤ 95% (no condensing)
Condition
Atmospheric pressure: 70 Kpa -106 Kpa
Dimension and Weighting
Weight (without batteries) 47g
Size L: 122mm X W: 30mm X H: 43mm
Compliance
Item Compliant with

7
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 8 / 18
Page
Instructions for use

Equipment classification Safety Standards:


ANSI AAMI ES60601-1: 2005/(R)2012 and A1:2012
IEC 60601-1-2: 2015
Type of protection Internally powered equipment (on battery power)
Front panel and case
ISO 15223-1 : 2016
labeling
Performance ASTM E1965-98 (2016)
Home healthcare
IEC 60601-1-11 : 2015
environment
Calculated values of the indicators according to ISO 80601-2-56
Indicators Forehead mode Forehead Scan mode
Group I
Group II Group III Group I Group II Group III
(Infants)
(Children) (Adults) (Infants) (Children) (Adults)

Clinical Bias 0.18 0.17 0.17 0.16 0.16 0.15


Uncertainty ± 0.11 ± 0.10 ± 0.10 ± 0.09 ± 0.08 ± 0.08
Clinical repeatability, Sr 0.13 0.12
*Infants except less than or equal to 28 days of age

Safety classification of ME EQUIPMENT


Internally powered ME
Protection against electric shock
equipment
Applied part Non Applied part
Protection against harmful ingress of water or
IP22
particulate matter
Mode of operation Continuous operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT

2- Operation
2.1 Battery installation
Caution: The Non Contact Infrared Body Thermometer does not operate with dead
batteries and does not input outer power. Install new batteries.
1) Pull the battery downward, toward the bottom of the Non Contact Infrared Body
Thermometer, and remove the battery access door;
2) Insert two pieces AAA size batteries according to the “+” and “-”;
3) Close the battery cover.
2.2 How to Operate
Before Applying the Thermometer
Be sure to read and understand all warnings listed of the instructions before use.

8
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 9 / 18
Page
Instructions for use

 Forehead mode: press On/Scan button to open the device, the thermometer is
aligned with the middle of the forehead to measure body temperature (between the
eyebrows above) and keep the vertical distance, press the On/Scan button, the
position lamp indicates measurement site with light spot on the forehead,
temperature display immediately, see figure 3.

Figure 3-Measuring position and distance

 Forehead Scan mode: gently position the probe flush (flat) on the center of the
forehead, midway between the eyebrow and the hairline. Press and hold the
On/Scan button. Lightly slide the thermometer across the fore-head keeping the
sensor flat and in contact with the skin until you reach the hairline, release the
On/Scan button and remove the thermometer from the head, then the temperature
will display on the screen. The whole process takes 3~10 seconds.

 When the ambient temperature of the thermometer changes too much, such as
moving the Thermometer from one place of lower temperature to another place of
higher temperature, Allow the thermometer to remain in a room for 30 minutes where
the temperature is between 5°C to 40°C.
 The ambient temperature around the test person should be stable, should keep away
from the larger flow fan, air-conditioning vents and so on.
 When people moving from one place of lower temperature to another place of
higher temperature, should at least remain in the test environment more than 5
minutes, to be consistent with the ambient temperature after the re-measurement.
 Wait at least 1 second for the next measurement. If the continuous measurement of
five times, it is recommended to wait at least 30 seconds and then continue
measurement.
 You cannot use the thermometer in place where the sun is strong.

9
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 10 / 18
Page
Instructions for use

General Setup and Use


 Start measuring
1. Turn on the thermometer by pressing the On / Scan button. The thermometer
will perform self-test with all segments displayed (Figure 4) for 1 second.

Figure 4- All segments displayed

2. And then show last measurement value (Figure 5), and back to ready display
for measurement displayed ‘- - - -‘. (Figure 6)

Figure 5 – Last memory display Figure 6 – Ready display for measurement

3. Forehead mode: Align staff forehead to keep the distance, and then press the
On/Scan button, the position lamp indicates measurement site with light spot
on the forehead, and start the measurement, read the data.
4. Forehead scan method: position the probe flush (flat) on the center of the
forehead, midway between the eyebrow and the hairline. Press and hold the
On/Scan button. Lightly slide the thermometer across the fore-head keeping
the sensor flat and in contact with the skin until you reach the hairline, release
the On/Scan button and remove the thermometer from the head, then the
temperature will display on the screen. The whole process takes 3~10 seconds.

Note: 1) After full display over, you will hear a rattle or "bibi" four times, which means that
the measurements have been completed, while the target value of the measured
temperature is displayed on the LCD, while backlit display according to the
appropriate setting among the three colors green, yellow, orange one of. And the
Green means ready for next measurement. When 37.5°C ~ 38.5°C, it's yellow,
means slight fever warning. Please pay attention to body temperature. When the

10
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 11 / 18
Page
Instructions for use

body temperature is 38.6°C or above, it's orange, means high fever. Please take
action to cool down or go for a doctor.

2) To ensure the accuracy of the measurement, wait at least 30 seconds after 5


consecutive measurements.

 Unit Set ( Only applicable for HTD8823US)


Turn on the thermometer by pressing the On/Scan button. The thermometer will perform self-test
with all segments displayed for 1 second, and then show last measurement value. During last
measurement show, press and hold on On/Scan button to enter unit switch display. When display unit
what you want, release On/Scan button saving the setting, and back to ready display for measurement
displayed ‘- - - -‘.

3- Troubleshooting
MESSAGE SITUATION SOLUTION

Temperature taken in not within  Make sure the forehead


Typical human temperature range. thermometer is for forehead
(34.0 ~ 43.0°C or 93.2°F ~ measurement, not other
109.4°F). human body site.

 Measured over the distance 1-  Optimum measurement


5 cm ( 0.4 - 2 in); distance is 1cm.
 Subjects forehead hair,  Subjects sit quietly 5-10
Antipyretic stickers, head with minutes before the test.
sweat, etc.
 Some people's body  The main concern fever
temperature is lower than the temperature
general population.
Operating temperature exceeds Move to a room within the
the range of specified operating range wait 30 minutes
temperature. before taking temperature.

The screen flicker, automatic turn Replace battery or the product has
off. been damaged, needs repairs.

11
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 12 / 18
Page
Instructions for use

Battery capacity is too low. Taking Install a new battery


Temperature is not allowed.

Ambient temperature changes too Wait until the ambient temperature


fast is stably.

(1) Power is off. (1) Press On/Scan button again.


(2) Improper battery installation. (2) Check the battery polarity.
(3) The battery is exhausted. (3) Replace with a new battery.
(4) Display remains blank. (4) Contact the retailer or service
center.

4-Replacing the Battery


1). Open and release battery cover following indicator on the surface of shell. Before
changing the battery being sure the system is already power off.
2). Remove the batteries and replace with 2 new one, type AAA, Make sure align properly
as indicated inside the battery compartment
3). Slide the battery cover back in until it snaps in place.
Do not dispose of used batteries in household waste. Take them to special local collection
sites.
5). In case, if system is latched up after changing battery. You may not follow up the
process of rule one. Just take off battery, waiting 30 sec, then load battery again.

Warning

Do not recharge, disassemble or dispose of in fire.

1.The typical service life of the new and unused batteries is 2000 measurements for the
operation time is 18s.
2. Only use the recommended batteries, do not recharge non-rechargeable batteries and
do not burn them.
3. Remove the batteries if the thermometer is not to be used for a long period.

12
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 13 / 18
Page
Instructions for use

5-Cleaning, Care and Storage


The lens is very delicate.
It is very important to protect the lens from dirt and damage.

This thermometer is for single patient reuse, you may use 70% isopropyl alcohol wipes to gently
clean thethermometer after each use.

Rubbing device (including markings) by hand without undue pressure with 70% isopropyl alcohol,
especially skin contact part, such as the probe, shell, LCD for 15s after each measurement, wiping
sensor of thermometer (which is in the center of probe surrounded by ABS case) gently for 3s
using a cotton swab wetted 70% isopropyl alcohol if dirty.

Always keep the thermometer a within the storage temperature and humidity range as
specified.

It is recommended to store the thermometer in a dry location free from dust.

Always keep the thermometer within the storage temperature range (- 20°C to 55°C or – 4°F
to 131°F) and humidity range (≤ 95% non-condensing)

It is recommended to store the thermometer in a dry location free from dust. Do not expose
the thermometer to direct sunlight, high temperature/ humidity or any extreme environment,
otherwise the function will be reduced.

When the ambient temperature of the thermometer changes too much, such as moving the
thermometer from one place of lower temperature to another place of higher temperature,
allow the thermometer to remain in a room for 30 minutes where the temperature is between
5°C to 40°C.

6-Disposal
1) Used batteries should not be disposed of in the household rubbish. Used Batteries
should be deposited at a collection point.
2) At the end of its life, the appliance should not be disposed of in household rubbish.
Enquire about the options for environment-friendly and appropriate disposal. Take local
regulations into account.

13
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 14 / 18
Page
Instructions for use

7-Warranty
Our company warrants Non Contact Infrared Body Thermometer at the time of its original
purchase and for the subsequence time period of one year.
The warranty does not cover the followings:
 The device series number label is torn off or cannot be recognized.
 Damage to the device resulting from misconnection with other devices.
 Damage to the device resulting from accidents.
 Changes performed by users without the prior written authorization of the company.
 Batteries and packaging are not covered under warranty
When asked to provide warranty service, you must have a purchase date and purchase
stamp dealers (including dealers name and address) of the warranty card. Be sure to ask the
dealer to purchase this product signature on the warranty card. When asked to provide
warranty service, please put the product to get our distribution points for repair. Products
outside the warranty expires, will be charged accordingly.
Note:
1. If you have any problems with this device, such as setting up, maintaining or using,
please contact with SERVICE PERSONNEL of HeTaiDa Technology Co., Ltd. Don’t open or
repair the device by yourself.
2. Please report to HeTaiDa Technology Co., Ltd. if any unexpected operation or events
occur.
3. Calibration needed to ensure proper function for every two years or after device impact.
4. The patient is an intended operator. The patient can measure and change battery.
Under normal circumstances and maintain the device and its accessories according to the
user manual.

14
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 15 / 18
Page
Instructions for use

EMC Declaration
1) This equipment needs to be installed and put into service in accordance with the information
provided in the ACCOMPANYING DOCUMENTS;

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)* Caution: 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.

Guidance and manufacture’s declaration – electromagnetic emission


The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specified
below. The customer of the user of the Non Contact Infrared Body Thermometer should assure that it is used
in such an environment.

Emission test Compliance Electromagnetic environment – guidance

The Non Contact Infrared Body Thermometer use


RF energy only for its internal function. Therefore,
RF emissions
Group 1 its RF emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic
equipment.

RF emission The Non Contact Infrared Body Thermometer is


Class B
suitable for use in all establishments, other than
CISPR 11
domestic and those directly connected to the public
Harmonic emissions low-voltage power supply network that supplies
Not applicable
IEC 61000-3-2 buildings used for domestic purposes.

Voltage fluctuations/
flicker emissions Not applicable

IEC 61000-3-3

15
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 16 / 18
Page
Instructions for use

Guidance and manufacture’s declaration – electromagnetic immunity


The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The
customer or the user of Non Contact Infrared Body Thermometer should assure that it is used in such an environment.
Electromagnetic environment -
Immunity test IEC 60601 test level Compliance level
guidance
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or
(ESD) ±15 kV air ±15 kV air ceramic tile. If floor are covered with
IEC 61000-4-2 synthetic material, the relative
humidity should be at least 30%.
Electrical fast ±2 kV for power supply Not applicable Mains power quality should be that of
transient/burst lines a typical commercial or hospital
IEC 61000-4-4 ±1 kV for input/output environment.
lines
Surge ± 1 kV line(s) to line(s) Not applicable Mains power quality should be that of
IEC 61000-4-5 ± 2 kV line(s) to earth a typical commercial or hospital
environment.
Voltage dips, short <5% UT Not applicable Mains power quality should be that of
interruptions and (>95% dip in UT) a typical commercial or hospital
voltage variations on for 0.5 cycle environment. If the user of the Non
power supply input Contact Infrared Body Thermometer
lines 40% UT requires continued operation during
IEC 61000-4-11 (60% dip in UT) power mains interruptions, it is
for 5 cycles recommended that the Non Contact
Infrared Body Thermometer be
70% UT powered from an uninterruptible
(30% dip in UT) power supply or a battery.
for 25 cycles

<5% UT
(>95% dip in UT)
for 5 sec
Power frequency 30A/m 30A/m Power frequency magnetic fields
(50Hz/60Hz) magnetic should be at levels characteristic of a
field IEC 61000-4-8 typical location in a typical
commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

16
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 17 / 18
Page
Instructions for use

Guidance and manufacture’s declaration – electromagnetic immunity


The Non Contact Infrared Body Thermometer is intended for use in the electromagnetic environment
specified below. The customer or the user ofthe Non Contact Infrared Body Thermometer should assure
that it is used in such an environment.

Compliance
Immunity test IEC 60601 test level Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment
should be used no closer to any part of the Non
Contact Infrared Body Thermometer, including cables,
than the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
Conducted RF 3 Vrms Not applicable
Recommended separation distance
IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 10V/m 10 V/m Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
IEC 61000-4-3 80 MHz to 2.5 GHz
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from 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 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 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 Non Contact Infrared Body
Thermometer is used exceeds the applicable RF compliance level above, the Non Contact Infrared Body
Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Non Contact Infrared Body Thermometer.

17
File No. ZHTF-CE-01-015
Technical File Rev. No. A.1
Non Contact Infrared Body Rev. Date 2020-6-8
Thermometer 18 / 18
Page
Instructions for use

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Recommended separation distances between

portable and mobile RF communications equipment and the Non Contact Infrared Body Thermometer.
The Non Contact Infrared Body Thermometer is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Non Contact Infrared Body Thermometer can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Non Contact Infrared Body Thermometer as recommended below,
according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

(m)
Rated maximum output
power of transmitter 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

(W)

0.12 0.12 0.23


0.01
0.38 0.38 0.73
0.1
1.2 1.2 2.3
1
3.8 3.8 7.3
10
12 12 23
100
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 80 MHz and 800 MHz, 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.

18

You might also like