EN 12470-5
Clinical thermometers – Part 5: Performance of infra-red ear thermometers
(with maximum device)
EN 62304
Medical device software - Software life-cycle processes
EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within
a risk management process
ASTM E 1965
Standard Speci
fi
cation for Infrared Thermometer for Intermittent
Determination of Patient Temperature
16. DISPOSAL
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 – 2002/96/EC WEEE
Directive.
If you have any queries, please refer to the local authorities responsible for waste
disposal.
NOTES:
t
Handing of battery and wastes method, please act according to the native law to proceed to handle.
t
Take out the battery if you are not going to use the unit for a long time.
To protect the environment, dispose of empty battery at your retail store or at appropriate
collection sites according to national or local regulations.
Dispose of at public collection point in the EU countries – 2006/66/EC Directive.
17. NORMALIZED SYMBOLS
Attention: see Instructions for use!
Applied part of type BF
The batteries and electronic instruments must be disposed of in accordance
with the locally applicable regulation, not with domestic waste.
Complies with the European Medical Device Directive (93/42/EEC), Noti
fi
ed
Body is SGS United Kingdom Ltd.
Manufacturer information: The manufacturer Famidoc Technology Co., Ltd.
Authorized representative in the European Community.
IP22
IP code of the device: this device’s grade of against ingress of solid foreign
objects --
≥
12.5mm diameter (and the against access to hazardous parts with
fi
nger); the grade of waterproof is dripping (15° tilted).
Batch code
18. Electromagnetic Compatibility (EMC) Tables
Guidance and manufacturer’s declaration - electromagnetic emissions
The customer or the user of the 4in1 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR11
Group 1
The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
causes any interference in nearby electronic equipment.
RF emissions
CISPR11
Class B
The 4in1 device is suitable for use in all establishments
other than domestic and those directly connected
to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic
emissions
lEC61000-3-2
Not applicable
Voltage
lEC61000-3-3
Not applicable
Guidance and manufacturer’s declaration — electromagnetic immunity
The 4in1 device is intended for use in the electrom
The customer or the user of the 4in1 should assure that it is used in such an environment.
Immunity test
IEC 60601 Test
level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge(ESD)
lEC61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Floors should be wood , concrete
with synthetic material, the relative
humidity should be at least 30%.
Guidance and - manufacturer’s declaration. Electromagnetic immunity
The 4in1
ow.
The customer or the user of the 4in1 V1 should assure that it is used in such an environment.
Immunity test
IEC 60501 Test
level
Compliance lev el Electromagnetic environment -
guidance
C o n d u c t e d R F
l E C 6 1 0 0 0 - 4 - 6
Radiated RF lEC
61000-4-3
3V rms
150 kHzto
80 MHz 3V rms
3V/m 3V/m
80 MHz to
2.5 GHz
±6kV contact
±8k Vair
Portable and mobile RF communications
equipment should be used no closer
to any part of the FDIR-V1 device,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter. Recommended separation
distance.
80 MHz to 800 MHz
800MHz to 2,5MHz
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
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:
NOTEI At 80 MHz end 800 MHz. the higher frequency range applies.
a. Field strengths from
fi
xed 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
fi
xed RF transmitters, an electromagnetic site survey should be
exceeds the applicable RF compliance level above, the should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the FDIR-V1.
b.
Recommended separation distances between portable and mobile RF communications
equipment and the FDIR-V1 device.
FDIR-V1 device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the FDIR-V1 device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment(transmitters) and the FDIR-V1 as recommended below,
according to the maximum output power of the communication sequipment.
Rated maximum
outpu
t power of
transmitter W
Separation distance according to frequency of transmitter m
Electrostatic
discharge(ESD)
lEC61000-4-2
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
7.8
7.8
3.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, recommended separation
distance d in meters(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)
accordable to the transmitter manufacturer.
NOTEI At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies.
19. Software Version
This thermometer’s software version is Ver. 2.0.
20. WARRANTY
1. The warranty period for device is one year from date of delivery. In case of a warranty claim, the
date of delivery has to be proven by means of the sales receipt or invoice.
2. Repairs under warranty do not extend the warranty period.
3. The following cases are excluded under the warranty
t
All damage which has arisen due to improper treatment, e.g. nonobservance of the user
instruction.
t
All damage which is due to repairs or tampering by the customer or unauthorized third parities.
t
Damage which has arisen during transport from the manufacturer to the consumer or during
transport to the service centre.
t
Accessories which are subject to normal wear and tear.
4. Liability for direct or indirect consequential losses caused by the unit is excluded even if the
damage to the unit is accepted as a warranty claim.
The
thermometer
show the
symbol “Hi” or
“Lo”
Temperature hampered by an air
fl
ux.
Please leave the status and wait for
30 minutes to measure. Re-measure
according to the manual.
In the forehead measurement mode:
--Temperature readings too close together.
-- Measured the other object, such as the
sunlight, the air from the
fi
replace.
Hi: Higher than 42.9°C;
In the object measurement mode:
--Temperature readings too close together.
-- The object temperature is higher than
100°C.
Hi: Higher than 100.0°C;
The
thermometer
show the
symbol “Lo”
The hair and sweat prevent the temperature
achievement.
Temperature hampered by an air
fl
ux.
In the forehead measurement mode:
-- The measuring distance is too far.
-- Measured the other object, such as the air
from the air conditioner.
Lo: Less than 32.0°C
In the object measurement mode:
-- The measuring distance is too far.
-- Have water vapor condenses on the lens.
Lo: Less than 0°C
The ambient temperature is beyond of range
of measurement (10°C-40°C or 50°F-104°F)
Keep the thermometer in the room
Whose Temperature is (10°C-40°C or
50°F-104°F) for 30 minutes
The sensor or hardware is damaged
Excluding the possibility of
temperature allowance
fi
rst ,then send
the device to your dealer for repair
Low batter, but you can still use it
Keep an eye on power and continue
to use.
Lower battery, however you can’t use it
Replace the new battery.
14. SPECIFICATIONS
Device name
Infrared Thermometer
Model
Cherub Baby 4 in 1
Measurement mode
Forehead, ear and object temperature measurement modes
Power supply
d.c.3V, CR2032 batteries
Measuring range:
32.0-42.9°C (89.6-109.2°F)
Measuring range:
For human body temperature:
32.0°C-42.9°C (89.6°F-109.2°F)
For object temperature:
0°C-100°C (32°F-212°F)
Measuring accuracy:
(At laboratory conditions)
For human body temperature:
± 0.2°C/0.4°F 35. 5°C -42.0°C(95.9°F-107.6°F)
± 0.3°C/0.5°F for other ranges
For object temperature: ±1.0°C/ 1.8°F within 15-60°C(59.0°F-140.0°F);
for other range , ±2.0°C/ 3.6°F
Clinical repeatability:
Within ±0.3°C
Resolution of display
0.1°C/0.1°F
Operation condition
15.0°C-40.0°C(59.0°F-104°F) Relative humidity: 20% to 95% RH
Transportation and storage
condition
-25-55°C(-13°F-131.0°F), Relative humidity
≤
95%RH,
Size
133.8
×
32.7
×
23mm
Weight
39g
High body temperature hint
≥
38.0°C(100.4°F)
Grade of waterproof
IP22
Electric shock
Internally powered ME equipment
Applied part
Type BF applied part, including the whole unit
Mode of operation
Continuous operation
Note: Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT
*The above speci
fi
cations are subject to change without prior notice.
Note: ASTM laboratory accuracy requirements in the display range of 36 to 39°C (96.8 to 102.2°F)
for this thermometer is ±0.2°C(0.4°F), whereas for mercury-in-glass thermometer, the
requirement per ASTM standards E 667-86 is ±0.1°C(0.2°F).
15. STANDARD LIST
Famidoc Technology Co., Ltd declares that the FDIR-V1 complies with following applicable standards:
EN ISO 15223-1
Medical device – Symbols to be used with medical device labels, labeling and
information to be supplied – Part 1: General requirements
EN 1041
Information supplied by the manufacturer with medical devices
EN 60601-1
Medical electrical equipment Part 1: General requirements for basic safety
and essential performance
EN 60601-1-2
Medical electrical equipment -- Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests
Note:
FDIR-V1 provides both Fahrenheit and Celsius readings in countries where the Fahrenheit units
are adopted, otherwise it provides only the Celsius unit. It isn’t a bad one if your product can’t
change °C or °F.
【
Battery installment and replacement
】
1. When the quantity of electric charge is not su
ffi
cient, the icon of low battery will appear on the
lower part of the screen. Though the battery still can be used, it would be perfect to replace it.(Refer
to the Picture 9.1)
2. When the quantity of electric charge of the battery is lower than
the minimal value, “Lo” symbols will be displayed on the screen, and
battery icon
fl
ashes and the sound of “Beep” is sent out (Refer to the
Picture 9.2).Unless you change a new battery, you can not use the
thermometer to conduct measurement.
3. Operation of changing battery.
4. Take out the old battery: open the battery cap (Refer to the Picture 9.3).
Put a new battery on: put on a CR2032 lithium battery with cathode
downward into the battery seat. (Refer to the Picture 9.4)
Notice:
t
Please observe the related national laws of disposing the abondoned battery and don’t
litter to the garbage can.
t
Please take out the battery if the device is not used for long periods of time.
To protect the environment, dispose of empty battery at your retail store or at appropriate collec-
tion sites according to national or local regulations.
8. CARE AND CLEANING
Probe tip (lens) is a most precise part in the thermometer. Please keep clean and entirety in order to
assure the accuracy of
fi
gure.
The probe tip and lens are the most delicate part of the thermometer. It has to be clean and intact to
ensure accurate readings.
Please use the ways to clean the probe as follows:
t
Very gently wipe the surface with a cotton swab or soft cloth moistened with alcohol. After the
alcohol has completely dried out.
t
If the lens is damaged, contact the distributor.
Clean the unit body:
t
Use a soft, dry cloth to clean the thermometer display and unit body.
t
If very dirty, use a soft with alcohol to cleaning.
NOTES:
t
Don not use abrasive cleaners.
t
Don’t use other non-recommended methods to perform disinfect.
t
Non-waterproof, don’t use the abrasive cleaner to clean the product, don’t drop the thermometer in
the water or the other liquid.
9. MAINTENANCE
1) We do not authorize any institution or individual to maintain and repair of the product. If you
suspect that the products have any questions, please contact the manufacturer or distributor to
handle the case.
2) The user must not attempt any repairs to the device or any of its accessories. Please contact the
retailer for repair.
3) Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to
warranty.
10. CALIBRATION
The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according
to the use instruction, periodic calibration is not required. If any time your question the accuracy of
measurement, please contact distributor or manufacturer, the contact information see last page.
11. STORAGE
1) Don’t put the thermometer under the sunshine, high temperature and moist environment or
someplace which maybe get in touch with
fi
re or is vulnerable to vibration.
2) Take out the battery if don’t use the device in a long time.
12. ACCESSORIES
Only use original accessories. Check that the contents of the delivery are complete.
Quantity
Parts
1pc
Cherub Baby Thermometer
1pc
CR2032 battery(install in the thermometer)
1pc
User Manual
1pc
Base stand
13. TROUBLE-SHOOTING
Troubles or
error message
Checklists or situation
Countermeasures or solution
No response/
Automatically
reset
The batteries are used up?
Replace new batteries.
Battery in wrong polarity or type?
Take out the batteries and replace new
ones.
Take out batteries and reinsert it
correct.
Poor battery contact
Edition:
V2..1
Cherub Baby
9/6a Railway ave, Oakleigh VIC 3166
mail@cherubbaby.com.au
+61390051734
Product Manufactured by:
Famidoc Technology Co., Ltd.
Add.: No. 212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan
Town, Donguang 523853, Guangdong Province, P.R. China.
