eZthings HW-F7 User manual

Non-Contact Forehead Thermometer
Model: HW-F7
Heavy Duty Sensor
Compliant to IEC 60601-1, IEC60601-1-11, IEC 60601-1-2, IEC 62304, ISO80601-2-56, ASTM E1965-98 Manual instruction
Please read this manual instruction thoroughly before use.
Version: V2.0 Date: 2020-06-08
Distinguish the positive and negative poles of the battery
1.Take out the thermometer and open the battery
lid to install 2*AAA batteries
1.9-3.1 IN
2. Keep distance at 5cm to 8cm from thermometer
probe to the middle of forehead, please do not
contact forehead directly
Measurement button
The icon for human
body mode”
the icon for object
mode” ”
3. Select measurement mode a nd click the
measurement button to start taking temperature
4. Reading displays on the screen after successful
measurement
1.Introduction & classification
Instruction Manual
This is a Non-Contact Forehead Thermometer applicable to forehead measurement. Th e thermomet er measures body temp erature b y collect ing heat radi ation emitting from forehead. New probe structure is adopted in this ther mometer. It' hygeian, reliable and highly accurate. Users can get precise reading within one second by one touch. This thermometer is cost-effective and is widely used in schools, customs, hospitals and for family use.
Intended Use & Indication for use: The Non-Contact Forehead Thermometer is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
This thermometer is classified as a Class IIa(for CE)/class II(for FDA) Medical Device, sorted as internally- powered equipment and type BF application device. It's prohibited to use this thermometer in flammable anesthetic gas or gas mixture of air and oxygen or nitrous oxide. This is a continuous operation equipment.
2.Working principle
Any object can generate certain proportion of infrared radiant energy
as per its own temperature. The radi ant energy and its wavelength
distribution are subjected to its su rface temperature. Based on t his
principle, this thermometer is designed to detect infrared radi ation
at 5~14um by highly precise infrared sensor. By adopting this high
quality sensor plus special calculation and calibration, this thermometer
is able to take accurate body temperature.
3.Safety precautions
Warning:
Using this thermometer is not intended as a substitute for consultation with your physician.It is dangerous for users to perform a self-evaluation and self-treatment based on the measuring result.please follow doctor’s instruction. Keep the thermometer out of reach of children ,please consult the doctor at once in case of accidental swallow of battery or other component . Don’t throw the battery into fire.
s simply operation al,
Notice:
The device is precision instrument, don’t drop, tramp or impose any vibration or impact on the thermometer.
Do not touch the lens of the probe with your fingers and disassemble the device by yourself.
Please make sure your forehead is clean before measuring forehead temperature.
Please stay still indoors about 30 minutes af ter exercise, eating or bathing before measuring.
Please place the thermometer indoors for about 30 minutes if ambient temperature varies a lot before using.
Please collect the record of Individual temperature under the good condition of body in usual days as a reference for checking fever or not.
Do not measure the sites of scarred tissue or tissue compromised by skin disorders because they will affect the accuracy of measurement.
Do not measure if patient is treated with certain drug therapies because body temperature may rise in the drug within the effort time limit.
Do not immerse the device into water or any other liquid, do not expose to the sun.
Do not use a mobile or cordless phone near the thermometer
Do not use the thermometer near a mobile or
measuring. cordless phone.
Please don’t measure body temperature in strong electromag netic interference environment (such as microwave, high frequency equipment operation environment) to ensure the accuracy of measurement data.
This thermometer only a personal device, please do not share with others.
Please store the thermometer according to the technical specifications.
Keep the sensor and probe cavity clean before use and after use.
-
The materials (ABS) of contact with patient has passed the ISO 10993-5 and ISO 10993-10 standard test, no toxicity, allergy and irritation reaction. They are compliant with the MDD requirements based on the current science and technology, and other potential allergic reactions are unknown.
The patient can measure, read data and replace battery under normal circumstances and maintain the device and its accessories according to the user manual.
The PATIENT is an intended OPERATOP.
Recommendations:
Don’t use this thermometer for other purposes. It is forbidden to leave the product exposed to any chemical
solvent, direct sunshine or high temperature in case of damaging the product or the battery.
Do not measure while talking on the phone. Please report to MANUFACTURER if any unexpected operation
or events occur.
4.Features
Measurement mode for human body and object available,one button to switch measurement mode;
Beeper for high temperature;
℃/℉ reading available;
Automatic shut off;
Storage of last 10 readings;
3 Colors Backlight LCD for easy reading.
5.Technical parameters
Measurement distance
Measurement
5cm~8cm
Human body
Object
34.0℃~43.0(93.2℉~109.4℉) <34.0/93.2℉, “LO”displays >43.0/109.4℉,“HI”displays
0℃~93℃ (32.0℉~199.4℉) <0℃/32℉,“LO”displays >93℃/199.4℉, “HI”displays
Measuring accuracy(at laboratory conditions)
Resolution
Working condition
Storage condition
Power supply
Power consumption
Memory Storage of last 10 readings
Display 3 Colors Backlight LCD (red, green, orange) Reading scale
Automatic shut off In 30 seconds
Dimensions Net weight 75g
for forehead temperature: ±0.2℃/0.4℉ during 34.0℃-42.0℃; ±0.3℃/0.5℉ during 42.1℃-43.0℃.
0.1℃/0.1℉
15℃~40℃(59.0℉~104℉) RH≤95%Non-condensing
“ERR”displays when it’s not used under
working condition
-25℃~55℃ (-13℉~131℉) RH≤95%Non-condensing
d.c. 3V 2*AAA Batteries When off≤10uW When measurement≤30mW
Celsius or Fahrenheit
5.4 IN×3 IN×1.5 IN
Shelf life 5 Year
6.Illustration
LCD display
Battery lid
3 IN
Probe
Measurement button
Handle
Product label
Lot label
1.5 IN
5.4 IN
Setting buttons
7.Display & icons
DetailsIconFunction definition
The battery is in low level, but the thermometer is still
When it is
functional properly.Please
visible
replace battery asap The battery is exhausted
and thermometer can not
Battery level
Measurement mode
Reading scale
Reading display
Memory
8.Function definition of buttons
To switch measurement mode between
Mode
human body and object To track last 10 readings MEM
To switch unit of temperature readingC/F
9.Setting
User can change reading scale between Celsius and Fahrenheit, and change measurement mode between human body mode and object mode .
Measurement mode setting:
When thermometer is on, it displays current measurement mode ( fig.9.1). Press the “Mode” button to change measurement mode( fig.9.2).
Reading scale setting:
When thermometer is on, it displays current Reading scale. Press the C/F”button to select reading scale.
When it flashes
When it is visible
Human Body mode
Object mode
Celsius reading
Fahrenheit reading
Temperature value
Temperature value of previous measurement
DescriptionButtons
function properly. Please replace battery immediately
Battery power is sufficient. and it functions properly.
( fig.9.1) ( fig.9.2)
Notice:
1.Temperature under human body mode is obtained from dynamic compensation of environmental temp and forehead surface temp.
2. Object temperature mode is to test surface temperature of an object. The temperature get from forehead under this mode is merely temperature of forehead surface but not body temperature.
10.Measurement
10.1 Body temperature
Press measurement button to turn on thermometer and it displays boot screen (fig.10.1). After POST and two beeps, it will display value of last reading and be ready for measurement (fig.10.2). Make sure the thermometer is under body mode. Keep distance at 5cm to 8cm from thermometer probe to the middle of forehead (fig.10.3). Press measurement button and then it gives a beep to indicate measurement is finished and value will be displayed (fig.10.4). If
measurement value exceeds alarm value(Defaulted value is 38℃),it gives
beep. beep. beep as a indication. After measurement, if the thermometer is idle for 30 seconds, it will display OFF (fig.10.5) and gives a beep and shut off automatically.
1.9-3.1 IN
(fig.10.1) (fig.10.2) (fig.10.4) (fig.10.3)(fig.10.5)
10.2 Object temperature
Press measurement button to turn on thermometer (fig.10.6). Make sure the thermometer is under object mode. Keep vertical distance at 5cm to 8cm from object to measurement probe. Press measurement button and then it gives a“beep”to indicate measurement is finished and value will be displayed (fig.10. After measurement, if the thermometer is idle for 30 seconds, it will display
“OFF”
(fig.10.8) and gives a “beep” and shut off automatically.
7).
Notice:
1.
The value under this mode is object surface temperature instead of core temperature.
2.The default value of edinfrared emissivity is 0.95. The reading will deviate from the real temperature because of different emissivity. For example, the reading on stainless steel is obviously lower than real temperature. BE CAUTIOUS FOR SCALDING.
(fig.10.8)(fig.10.7)(fig.10.6)
10.3 Exceeding measurement range Body mode:
When measurement value is lower than 34.0ºC(93.2℉), it displays Lo (fig.10.9) and gives“beep. beep.beep.beep”, with the color of backlight turning red.
When measurement value is higher than 43.0 ºC(109.4℉), it displays Hi (fig.10.10) and gives“beep. beep.beep.beep”, with the color of backlight turning red.
Object mode:
When measurement value is lower than 0ºC(32℉), it displays Lo (fig.10.11) and gives “beep. beep.beep.beep”,with the color of backlight turning red. When measurement value is higher than 93ºC(199.4℉), it displays Hi (fig.10.12)
and givesbeep. beep.beep.beep”,with the color of backlight turning red.
Notice: When surrounding temperature is lower than 15.0ºC(59℉) or higher than 40.0ºC(104℉), it displays Err(fig.10.13) and gives “beep.beep.beep.beep”, with the color of backlight turning red. Under this condition, it’s not allowed to use this thermometer or accuracy is not assured.
(
fig.10.13
fig.10.9
) (
fig.10.10
) (
fig.10.11
) (
fig.10.12
11. Battery replacement
Open the battery lid and take out exhausted battery. Put into 2 AAA batteries and close up battery lid. After new battery is installed, the color of backlight turns in the order of green , orange and re flashing one time respectively, with a “beep” heard. If no beep is heard, please check if the positive and negative pole is correct (see fig.11.1).
)
d , each of them
)(
Notice:
1.Take out battery in case the thermometer is not used for a long time. Don't put the battery to fire.
2.Dispose battery according to local regulations.
12. Maintenance & tips
Make sure the sensor and probe cavity is clean otherwise it will affect accuracy. Cleaning method for probe:
1.Use the cotton stick or soft cloth with water or alcohol to wipe the casing.
2.Use the cotton stick or soft cloth with alcohol to wipe the sensor surface or probe cavity gently. Don't use thermometer before alcohol is vaporized. Read this manual book thoroughly before use. Make sure battery is well installed. It is not allowed to put the thermometer in any liquid or expose to strong sunlight or extremely low temperature.
(
fig.11.1
)
Strong crash or hit to the product will cause its damage. Do not dismantle this thermometer by yourself.
Keep the thermometer from children's reach. Do not use the thermometer under circumstance of strong electromagnetic interfere. The measurement results are probably fluctuating due to improper measurement ways. Please practice adequate measurements in order to improve your skill. The measurement results can not supersede a doctor's diagnosis. Special maintenance is unnecessary for this thermometer. Please contact distributor or manufacturer in case of malfunction.
13. Trouble shooting
Description Solutions
LCD display“LO”
or“HI”
No response when pressing measurement button No display or improper display
Shut off right after switching on
Standard list
IEC 15223-1
EN 1041
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11
ASTM E1965-98
1.Breeze, water, sweating, cosmetic on forehead may affect measurement.
2.While if the testing environmental temp changes so enormously or if the thermometer is used directly from high -temp object to very low-temp one, the measurement difference will happen.The thermometer should be kept in a relatively stable environment for 10 minutes to get heat balance before starting a new measurement.
3.Ensure measurement distance is 5cm to 8cm.
1.Take out and reassemble battery.
1.Take out battery and install battery again.
1.Check battery level or take out the battery and install the battery again.
Symbols for use in the labeling of medical devices
Information supplied by the manufacturer with medical devices
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Medical electrical equipment – Part1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environment
Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature
Medical electrical equipment part 2-56: particular
ISO 80601-2-56
IEC 62304 Medical device software - Software life-cycle processes
IEC 62366
ISO 10993-1
Disposal
NOTES:
Please act according to the native law to proceed to handle the battery and wastes. Take out the battery if you are not going to use the unit for a long time.
Normalized symbols
requirements for basic safety and essential performance of clinical thermometer for body temperature measurement
Medical devices – Application of usability engineering to medical devices
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Dispose of the device in accordance with the regulation applicable at the place of operation. Dispose of at public collection point in the EU countries – 2012/19/EU WEEE Directive. If you have any queries, please refer to the local authorities responsible for waste disposal.
Dispose of empty battery at your retail store or at appropriate collection sites according to national or local regulations to protect environment. Dispose of at public collection point in the EU countries – 2006/66/EC Directive.
Read instruction manual before use
Type BF applied part
LOT
Batch
Serial number
SN
Manufacturer information
Complies with the European Medical Device Directive(93/42/EEC
1639
and amended Directive 2007/47/EC.Notified Body is SGS
Complies with RoHS directive 2011/65/EU of the European
RoH S
COMPL IANT
parliament and of the council of 8 June 2011
Disposal in accordance with Directive 2012/19/EU (WEEE)
Follow operating instructions
IP code of the device: this device’s grade of against ingress of solid foreign objects --12.5mm diameter (and the against access to
IP22
hazardous parts with finger); the grade of waterproof is dripping (15° tilted)
14. EMC Declaration
1) Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
2) Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this the Infrared Thermometer could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
3) Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Infrared Thermometer, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic emission
The infrared thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of infrared thermometer should assure that it is used in such an environment..
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations flicker emissions IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Emissions test
Group 1
Class B
N/A
N/A
Electromagnetic environment - guidance
The Infrared Thermometer uses RF energy only for its internal function. There for, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The Infrared Thermometer suitable for use in all establishments, including domestic establishments 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 emission
The infrared thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of infrared thermometer should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrostatic transient / burst
IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50/60 Hz) magnetic field
IEC 61000-4-8
IEC 60601
Compliance level
test level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
± 2 kV for
± 1 kV for
± 1 kV differential mode ± 2 kV common mode
0 % UT; 0,5 cycle g) At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0°
0 % UT; 250/300 cycle
30 A/m 30 A/m
power
supply lines
input/output
lines
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
N/A
N/A
N/A
Electromagnetic
environment-guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
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. If the user of the Infrared thermometer requires continued operation during power mains interruptions, it is recommended that the Infrared thermometer be powered from an uninterruptible power supply or a battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE
Guidance and manufacturer´s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS
UT is the a. c. mains voltage prior to application of the test level.
Guidance and manufacturer´s declaration – electromagnetic immunity
The infrared thermometer is intended for use in the electromagnetic environment specified below. The customer or the user of infrared thermometer should assure that it is used in such an environment.
Immunity test Compliance level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
NOTE 1 At 80 MHz and 800 MHz, the higher frequency ra nge applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people.
IEC 60601 test level
3 Vrms
150 kHz to 80 MHz
6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz
10 V/m
80 MHz to 2.7 GHz
385MHz-5785M Hz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-2:2014)
N/A
10 V/m
80 MHz to 2.7 GHz
385MHz-5785MHz Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-2:2014)
Electromagnetic
environment-guidance
Portable and mobile RF communications equipment should be used no closer to any part of the Infrared thermometer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
3.5
d=[ ] p
1
V
12
d=[ ] p
2
V
3.5
d=[ ] p
80 MHz to 800 MHz
1
E
7
d=[ ] p
800 MHz to 2.7 GHz
1
E
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. Interference may occur in the vicinity of equipment marked with the following symbol:
b
b
a
a. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz. b. 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 Infrared thermometer is used exceeds the applicable RF compliance level above, the 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 Infrared thermometer. c. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM -for EQUIPMENT and SYSTEMS
portable and mobile RF communications equipment and the Infrared thermometer
The Infrared thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Infrared thermometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Infrared thermometer as recommended below, according to the maximum output power of the communications equipment
maximum
transmitter
Recommended separation distances between
Separation distance according to frequency of transmitter
Rated
output of
W
0.01
0.1
1
10
100
150 kHz to 80 MHz
outside ISM and
amateur radio bands
3.5
d=[ ] p
1
V
0.12
0.38
1.2
3.8
12
150 kHz to 80 MHz in ISM and amateur
radio bands
12
d=[ ] p
2
V
0.20
0.63
2.00
6.32
20.00
m
180 MHz to 800
0.035
MHz
0.11
0.35
1.10
35
800 MHz to 2.7 GHz
0.07
0.22
0.70
2.21
70
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.
15. Quality commitment
Company name: REED Add:1601 WEST LAFAYETTE DETROIT, Michigan 48216 USA Email: Natimazor@yahoo.com Tel:917-719-5114
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