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The FDIR-V16 is a high technology medical 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 in a safe place for reference.
All the materials used in the FDIR-V16 have passed the non toxicity testing of the international regulations.
Notice
Only use this product for the temperature measurement of ear and forehead. It can be used for anybody, 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.
The infrared thermometer has the following measurement modes:
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 Di erent 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 |
35.8-37.5 | 96.4-99.5 |
NOTE: The normal temperature and difference between the different body parts can vary between individuals. To define 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 position and room environment as well as your normal body temperature range as additional reference.
NOTE: Because the forehead temperature is affected 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 confirm it.
Two user design
The product has a two user mode, each user's test data is stored separ.ately
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 specifcations, the LCD will display the Err prompt. When the thermometer battery power is insuffcient, 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 after approximately 30 seconds it will automatically 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 your reference.
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 fever symptoms.
Flashlight function
The product is equipped with a flashlight, so you can take babies temperature at night time whilst baby is sleeping.
The measuring probe tip is the mode delicate component of the thermometer and it must be clean and undamaged to ensure accurate readings. To clean the probe tip please follow these instructions:
Do not use abrasive cleaners and never immerse the product in water.
TEMPERATURE TAKING HINTS
In these cases, remove the individual from the situation and wait 30 minutes prior to taking a temperature.
TEMPERATURE TAKING HINTS
Store the thermometer in a clean and dry location that's free from dust and contamination. Ensure the therometer is stored out of direct sunlight.
Do not expose the thermometer to temperature 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).
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 a
s:
When the battery voltage is lower than d.c. 2.5V it displays "" and "Lo" sign, "
" icon flash, after 3 times it will be automatically power off, you should be replace the new batteries.
Battery replacement:
Notice:
No modification of this equipment is allowed!
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 information see last page.
Only use original accessories. Check that the contents of the delivery are complete.
Quantity | Parts |
1pc | Thermometer |
1pc | Quickstart Guide |
1pc | User Manual |
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 | ||
The thermometer show the symbol "Hi" | Temperature hampered by an air flux. | 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 other object, such as the sunlight, the air from the fireplace. 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) | ||
![]() | 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 first, 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. |
Device name | Infrared Thermometer |
Model | Cherub Baby Code: CHTH001/A Factory Code: FDIR-V16 |
Measurement site | Forehead and ear temperature |
Measure time | About 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 of display | 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(With batteries) |
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 specifications 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 per ASTM standards E 667-86 is ±0.2°F/0.1°C.
Cherub Baby declares that the thermometer complies with following applicable standards:
EN 1041 | Information supplied by the manufacturer with medical devices |
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/IEC 60601-1 | Medical electrical equipment Part 1: General requirements for basic safety 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 in the 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 12470-5 | Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with maximum device) |
ASTME 1965 | Standard Specification for Infrared Thermometer for Intermittent Determination of Patient Temperature |
EN/IEC 62304 | Medical device software - Software life-cycle processes |
EN/IEC 62366 | Medical 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 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
![]() | 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), Notified 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 finger); the grade of waterproof is dripping (15° tilted). |
![]() | Batch code |
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 yields d = 3.3 m at an IMMUNITY LEVEL of 3 V/m
Cherub Baby
Phone: +61(03)90051734 or mail@cherubbaby.com.au
This product conforms to the provisions of the EC directive 93/42/EEC (Medical Device Directive).
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC.
Portable and mobile RF communications equipment can affect 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, mail@cherubbaby.com.au, +61390051734 Manufacturer: Famidoc Technology Co., Ltd. Add.: No. 212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town, Donguang 523853, Guangdong Province, P.R. China.
Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.
Download Cherub Baby FDIR-V16 - 4 In 1 Ear & Forehead Infrared Thermometer Manual
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