Cherub Baby FDIR-V16 User manual

4 in 1 Ear & Forehead
Infrared thermometer
User's Manual
1. Summary of Non-Contact Infrared Thermometer
The FDIR-V16 is a high technologymedical thermometer for measuring eardrum and forehead
temperature of human body via in frared rays emitted from the eardrum and skin surface.
Following the correct way to measure is very important to obtain a precise temperature.
To ensure proper use, please be sure to read this user manual carefully.
In order to properly use this product, please carefully read the full text of this manual before using,
in particular the“safety precautions”section.
Please keep these instructions handy ina safe placefor reference.
2. Safety precautions
All the materials used in the FDIR-V16 have passed the non toxicity testing of the
international regulations.
Warning
Use of 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. Be
sure to follow doctor’s instruction.
Keep the thermometer out of reach of children. If thebattery or other component is swallowed
nent, please consult a doctor immediately.
Don’t throw the battery into fire.
Notice
The device is a precision instrument, don’t drop, tramp or impose any vibration or impact on the ther-
mometer.
Do not touch the lens of the probe with your fingers, and do not dissemble the device by yourself.
Before measuring the temperature, make sure there is no hair or sweat in the way.
After you do some exercise, eating and bathing, you should stay still indoors about 30 minutes before
measurement.
To make the measurement data reliable and stable, when ambient temperature varies a lot, the ther-
mometer should be placed indoors for about 30 minutes before using.
When we measure somebody continuously, the temperature should be measured every minute, if
you need to measure yourself continuously for a short time, there are some slight errors when you
read the temperature ,which is a normal phenomenon. At this time, we should choose the average.
There is no absolute standard about the temperature of the human, so please try to collect the re
-
cording of individual temperature in normal conditions, as a reference for having a fever or not.
Do not measure the sites of scarred tissue or tissue compromised by skin disorders, because sensing
body temperature from sites of scarred tissue or tissue compromised by skin disorders.
Do not measure the forehead temperature if the patient has trauma on forehead.
Do not measure when the measuring site (forehead) is exposed to direct sunlight, fireplace heat,
cold compress therapies, direct air conditioner flow. If you are in these environments please leave
and wait for 30 minutes to measure.
Do not immerse the device into water or any other liquid, and don’t expose directlytosunlight.
In order to ensure the accuracy of measurement data, please don’t take measurement of body tem
perature in strong electromagnetic interference environment (such as microwave, high frequency
equipment operation environment).
3. Intended use
Onlyuse this product for the temperature measurement of ear and forehead. It can be used for anybody, The measuring probe tip is the mode delicate componentof the thermometer and itmust
be cleanand undamagedto ensure accurate readings. To clean the probe tip please follow
these instructions:
1. Very gently wipe the surface of the probe tip withacotton swap or soft cloth
moistended with alcohol or an alcohol wipe.
2. After cleaning, inspect the probe tip to ensure that is itclean and undamaged.
3. If you nd the probe tip is damaged do not use the thermometer and contact
customer service.
4. Use asoftdry cloth toclean the thermometerLCD screen and surface of the body.
Donotuse abrasive cleaners and never immerse the product in water.
e.g. for new-born, for children and adults.
For safety reasons, measurement of children or baby’s temperature must be measured by adults.
Children and babies should not operate the thermometer.
4. Temperature Measurement Modes and Range Description:
The infrared thermometer has the following measurement modes:
1) Forehead temperature measurement mode -- measures the skin surface of human forehead’s
temperature accurately.
2) Eardrum temperature measurement mode—measures the skin surface of a humans eardrum
temperature accurately.
Normal temperature range for di erent measuring position:
Measuring position Normal temperature (°C) Normal temperature (°F)
Anus 36.6-38.0 97.9-100.4
Oral 35.5-37.5 95.9-99.5
Armpit 34.7-37.3 94.5-99.1
Forehead 35.8-38.0 96.4-100.4
ear 35.5-37.8 95.9-100
Normal Forehead Temperature Range Based on Dierent Ages:
Ages Normal temperature (°C) Normal temperature (°F)
0-2 years old 36.4-38.0 97.5-100.4
3-10 years old 36.1-37.8 97.0-100.0
11-65 years old 35.9-37.6 96.6-99.7
＞65 years old 35.8-37.5 96.4-99.5
NOTE: The normal temperature and di erence between the di erent body parts can vary between
individuals.
To dene your average temperature, measure your temperature for a least 2 weeks
in the same ear canal and forehead position.
NOTE: When consulting your physician, communicate the temperature that the thermometer
recorded and in what positionand roomenvironment as well as your normalbody
temperature range as additional reference.
NOTE: Because the forehead temperature is a ected by the external environment (eg:
environment, air conditoning and color, etc),we advise that you take the forehead
temperature only as reference. When you have a doubt about the measurement
result, please use the ear temperature to con rm it.
5. Features
6. Care and Cleaning
Two user design
The product has a two user mode, each user's test data is stored separately
.
High reliability
This product has passed the life and reliability test of the manufacturer, the time to failure
is≥1000h of use.
High accuracy
This product has passed the European Union infrared thermometer performance standards
for measuring clinical requirements, measuring clinical repeatability is no more than ±0.5°F
(0.3°C).
LED display
When the temperature exceeds the range, LCD will display the Lo or Hi prompt.
When the operating environment exceeds the design speci cations, the LCD will display the Err
prompt. When the thermometer battery power is insucient, it has low voltage icon.
Has the hardware self-test function, when hardware malfunction is detected, the Err will display
prompts.
Power saving function
When the thermometer is not in use afterapproximately30 seconds it willautomatically enter standby
mode and the screen will display the time and environmental temperature alternately.
Memory storage function
The thermometer is able to record the previous 32 temperature recordings for yourreference.
Backlight indication function
With the backlight indication function, it is easy for people to identify the temperature in a dark
environment.
Two-color LED indication function
In the forehead temperature measure mode:
If the body temperature is within 89.6°F -99.5°F (32°C -37.5°C), the Green LED will light up indicating
a safe body temperature.
If the body temperature is within 99.6°F -109.2°F (37.6°C -42.9°C), the Red LED will light up indicating
potential feversymptoms.
Flashlight function
The product is equipped with a ashlight, so you can take babies temperature at night time whilst
baby is sleeping.
7. Overall description
Power/Scan Switch
Measuring probe
(Sensor)
Flashlight
Rating label
Memory/User Switch
Flashlight Switch
8. Operation Instruction
1) Replace the batteries to ensure e cient power supply if there is a low battery icon showing.
2) Ensure the sensor is clean. Refer to the sectionabove, Care and Cleaning for details.
3) When you press the [Power/Scan] button, the system self tests the software and hardware.
If there are problems, th e LCD will display “Err” symbol. Check if the sensor laser is dirty or
damaged.
4) To ensure anaccurate measuring result, put the thermometer in the measurement
environment for 30 minutesso the thermometer is acclimatized.
5) Accuracy of unexpected uctuations in ambient temperature may decrease the measurement
results. When the thermometer displays di erent ambient temperaturesin the same position it
may not be able to provide an accurate result. Be sure to take the temperature in an
environment where the room termpature is stable (ie not in front of an air conditioner).
6) Clean forehead and move hair aside. The forehead should be unobstructed and clean, in order
to ensure the accuracy of the measurement.
7) The probe tip is required to be cleaned after each use so it can be re-used. See chapter 6
above “Care and Cleaning”. After ensuring the thermometer is clean you should always
store the thermomter in accordance with Chapter 9 ”Storage”.
【Instruction for use】
1) Before measurement begins.
Power on
For the rst use, put the battery inside the battery compartment. The product into the o state, press
the [Power /Scan] button to turn on. Itwillthen boot as follows:
- Red backlight on, then Green backlight on, then boot LCD 2 seconds.
- Green LCD light turns on at the same time and the LCD shows last temperature
recording
- The thermometer then enters the measurementstate.
(2) User selection
Press memory key for3 seconds to select user 1 or user 2.
(3) Measurement unit selection
Press unit key to set measurement unit (°F or °C).
(4) Measure selected site
Put on the probe cover to switch to forehead mode or leave it o and and the thermometer enters
into the ear measuring mode.
When measuring the ear temperature, insert the probe into the ear first, then press the power
key. One second later you will hear“Beep”, and you can remove the thermometer.
TEMPERATURE TAKING HINTS
The right ear temperature may di er from the left ear. Therefore, always take the
temperature in the same ear.
The ear must be free from obstruction or excess earwax build-up to take an accurate reading.
External factors may in uence ear temperatures, including when an individual has:
- beenlying onone earorthe other
- hadtheirearscovered
- beenexposedtoveryhot orverycoldtemperatures
- beenrecentlyswimming orbathing.
In these cases, remove the individual from the situation and wait 30 minutes prior to taking a tem-
perature.
Use the untreated ear if prescription ear drops or other ear medications have been placed in
the ear canal.
Don’t use the thermometer outdoors.
(2) Forhead temperature measure
Install the forehead cap, and press the scan button directly to measure the forehead temperature.
When measuring the forehead temperature, put the tip of the probe on your forehead and press the
scan button. The display will thenshow the tempreature reading in one second.
TEMPERATURE TAKING HINTS
Before take the temperature, please brush back anyhair to prevent measurement deviation.
The sweat on head or cosmetic can a ect the accuracy of measurement. Please maintain the
cleanness of the forehead when measuring.
It is normal that there may be temperature di erence depending on various skin types and
color, since di erent skin type will re ect di erent voltage of infrared ray.
Don’t use the thermometer outdoors.
(3) Temperature test information
If the temperature range is 89.6°F -99.5°F (32°C -37.5°C), the green backlight will display.
If the temperature is above 99.6°F-109.2°F(37.6°C~42.9°C), the red backlight will display.
If the measured temperature is higher than 109.2°F (42.9°C) , it will display“ Hl”.
If the measured temperature is below 89.6°F (32°C) , it will display“Lo”.
AUSTRALIA
Please read the guide carefully before use and keep it in a safe place.
For American please refer to “°F”, for European please refer to “°C”.
Battery Compartment
The measurement is completed.
If the sensor’s lens is damaged, please stop using itand contact Customer Care.
If the ambient temperature outside the range of 50°F -104°F (10-40°C), the thermometer shows“Err”;
4) Memory query mode
At the measure mode, Press memory key to enter measure memory query mode of the user
In the memory query mode, Press Memory/User key to move through previous measurements,
number will start from 1, 2,... 32 and the screen will show the corresponding number records.
In the memory query mode, without any action in 3s, it will turn othe current mode and return
to measure mode

The ambient temperature is beyond of range
of measurement ( 50°F-104°F or 10°C-40°C )
Keep the thermometer in the room
Whose Temperature is ( 50°F-104°F or
10°C-40°C ) for 30 minutes
The sensor or hardware is damaged
Excluding the possibility of
temperature allowance rst ,then send
the device to yourdealer for repair
Low batter, but you can still use itKeep an eye on power and continue
to use.
Lower battery, however you can’t use it Replace the new battery.
16. Specications
Device name Infrared Thermometer
ModelCherub Baby Code: CHTH001/A Factory Code: FDIR-V16
Measurement site Forehead and ear temperature
Measure timeAbout 1 second
Power supply d.c.3V, 2×1.5V AAA batteries
Measuring range:89.6°F -109.2°F (32.0-42.9°C)
Measuring accuracy:
(At laboratory conditions)
± 0.4°F/0.2°C during 95.0°F-107.6°F (35. 0°C -42.0°C);
± 0.5°F/0.3°C during 89.6°F-94.8°F(32.0°C -34.9°C ) and
107.7°F-109.2°F(42.1°C -42.9°C)
Clinical repeatability: Within ±0.5°F/0.3°C
Resolution ofdisplay 0.1°C/0.1°F
Operation condition 50°F-104°F(10.0°C - 40.0°C), 15%-95%RH
Storage condition 163.0 x 40.5 x 28.5 mm
Weight 69g
Storage condition -13 to +131°F(-25-55°C), ≤95%RH
Size 163*40.5*28.5mm
Weight 80g(Withbatteries)
High body temperature hint ≥99.6°F (≥37.6°C)
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
* The above specications are subject to change without prior notice.
Note: ASTM laboratory accuracy requirements in the display range of 95.9°F to 107.6°F/35.5°C to
42.0°C for this thermometer is ±0.4°F/0.2°C, whereas for mercury-in-glass thermometer, the
requirement perASTM standards E 667-86 is ±0.2°F/0.1°C.
17. Standard list
Cherub Baby declares that the thermometer complies with following applicable standards:
EN 1041 Information supplied by the manufacturer with medical devices
EN/ISO 15223-1Medical device – Symbols to be used with medical device labels, labeling and
information to be supplied – Part 1: General requirements
EN/IEC 60601-1Medical electrical equipment Part 1: General requirements for basicsafety and
essential performance
EN/IEC 60601-
1-11
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 inthe home healthcare
environment
EN/IEC 60601-
1-2
Medical electrical equipment -- Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests
EN 12470-5Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with
maximum device)
ASTME 1965Standard Specication for Infrared Thermometer for Intermittent Determination of
Patient Temperature
EN/IEC 62304 Medical device software - Software life-cycle processes
EN/IEC 62366Medical devices — Application of usability engineering to medical devices IEC
62366:2007
EN/ISO 80601-
2-56
Medical electrical equipment – Part 2-56:Particular requirements for basic safety
and essential performance of clinical thermometers for body temperature
measurement
EN/ISO 10993-1Biological evaluation of medical devices - Part 1: Evaluation and testing within a
risk management process
18. DISPOSAL
Spent batteries should not go in the household waste. Dispose of the battery
according to the current regulations. As a consumer, you have obligation to dispose
of batteries correctly.
Dispose of at public collection point in the EU countries – 2002/96/EC WEEE Directive.
Consult your municipal authority or your dealer for information about disposal.
At the end of the product lifecycle, do not throw this product into the normal
household
garbage, but bring it to a collection point for the recyclingof electronic equipment.
Waste Electrical and Electronic Equipment can have potentially harmful eects on the
environment.
Incorrect disposal can cause harmful toxins to build up in the air, water and soil and
can be harmful to human health.
19. 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.
Disposal in accordance with Directive 2002/96/EC (WEEE)
Complies with the European Medical Device Directive (93/42/EEC ),
Notied Body is SGS United Kingdom Ltd.
Manufacturer information: The manufacturer Famidoc Technology Co., Ltd.
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 nger); the grade of waterproof is dripping (15° tilted).
Batch code
20. Electromagnetic Compatibility (EMC) Tables
1) The Infrared Thermometer needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided in the ACCOMPANYING
DOCUMENTS
2) Wireless communications equipment such as wireless home network devices, mobile phones,
cordless telephones and their base stations, walkie-talkies can aect this equipment and
should be kept at least a distance d = 3,3 m away from the equipment.
Note: As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a
maximum output power of 2 W yieldsd = 3.3 m at an IMMUNITY LEVEL of 3 V/m
21. WARRANTY
1. The warranty period for device is one year from the date of purchase. For
further details on the warranty and to make a warranty claim please
visit www.cherubbaby.com.au
Notice:
tPlease observe the related national laws of disposing the abandoned battery and don’t
litter to the garbage can.
tPlease take out the battery if the device is not used for long periods oftime.
tPlease don’t put the battery in the re.
11. 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.
Warning: No modification of this equipment is allowed!
12. Calibration
The thermometer is initially calibrated at the time of manufacture. If this thermometer is used according
to the use instruction, periodic re-adjustment is not required. If any time your question the accuracy of
measurement, please contact distributor or manufacturer, the contact informationsee last page.
13. Storage
1. Don’t put the thermometer under the sunshine, high temperature and moist
environments or someplace which maybe get in touch with re or is vulnerable to
vibration.
2. Take out the battery if you don’t use the device for a long time.
14. Accessories
Only use original accessories. Check that the contents of the delivery are complete.
Quantity Parts
1pcThermometer
1pcQuickstart Guide
1pcUser Manual
15. Trouble-shooting
Troubles or
error messageChecklists or situation Countermeasures orsolution
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
The
thermometer
show the
symbol“Hi”
Temperature hampered by an air ux.Please leave the status and wait for 30
minutes to measure. Re-measure
In the forehead measurement mode:
--Temperature readings too close together.
-- Measured the otherobject, suchas the
sunlight, the air from the replace.
Hi: Higher than 109.2°F (42.9°C);
Please leave the status and wait for
30 minutes to measure. Re-measure
according to the manual.
The
thermometer
show the
symbol“Lo”
The hair and sweat prevent correct
temperature.
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 89.6°F (32.0°C)
Attention
tBefore taking the temperature, please take othe hat or move forehead hair asied to prevent
incorrect measurement.
tThe sweat on head or cosmetics can aect the accuracy of measurement, please maintain the
cleanliness of the forehead when measuring.
tIt is normal that there may be temperature dierences depending on various skin types and color,
since dierent skin type will reect dierent voltage of infrared ray.
10. Battery installment and replacement
Every time you turn on the thermometer, it will detect the battery voltage. When the battery is lower
than d.c. 2.7V it displays“ ”, indicating that the voltage is on the low side, and please keep attention
and replace battery in time. Figure as:
When the battery voltage is lower than d.c. 2.5V it displays“ ”and “Lo” sign,“ ”icon ash, after 3
times it will be automatically power o, you should be replace the new batteries.
Battery replacement
：
(1) Open the battery cover and take out the old batteries.
(2) Follow the polarity marking in the battery compartment, put the new batteries to the battery
compartment and keep it xed well. Please pay attention to the electrode anddon’t make a mistake,
then cover the case to nishthe battery replacement.
Edition: V1.0
9. Storage& Handling
Store the thermometer ina clean and dry location that’s free from dustandcontamination.
Ensure the therometeris stored out of direct sunlight.
Do not expose the thermometer totemperature extremes (below -4 F/ -20 C or over 122 F / 50 C)
or excessive humidity (>95% RH)
The operating ambient temperature range for this thermometer is 50 - 104 F(10-40 C).
0 0 0 0
000 0
This product conforms to the provisions of the EC directive 93/42/EEC (Medical Device Directive).
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC.
ect MEDICAL ELECTRICAL EQUIPMENT.
Please do not dispose of the product in the household waste at the end of its useful lifecycle.
Sponsor: Cherub Baby, 9/6a Railway ave, Oakleigh VIC 3166, [email protected], [phone]
Manufacturer: Famidoc Technology Co., Ltd. Add.: No. 212 Yilong Road, Hexi Industrial Zone, Jinxia,
Changan Town, Donguang 523853, Guangdong Province, P.R. China.
Portable and mobile RF communications equipment can a
Customer Care
Cherub Baby
Phone: [phone] or [e-mail]
5) Flashlight
Pressing the ashlight key will turn on orothe ashlight function.
(5) Following use of the ashlight, 10±2 seconds, the unit will enter into
measurement mode.
(6) If no further operation after voice broadcast and work out the set up mode 30±10seconds, LCD
will show“o”, the unit will enter into shutdown mode accompany with“beep” voice.