HoMedics HTD8816C User manual
HTD8816C
TE-350-EU
2 YEAR GUARANTEE
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FOREWORD
The Non-Contact Infrared Body Thermometer operating Instructions intend to provide
the necessary information for proper operation of the 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
thermometer model are prerequisites for proper use. The Non-Contact Infrared Body
Thermometer is a medical device, and can be used repeatedly for the product’s
recommended lifetime of 5 years.
Please read the manual first before using it, if not fully understand the usages, please
stop using the thermometer.
Do not operate the 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:
HoMedics Group Ltd, Somerhill Business Park, Five Oak Green Road,
Tonbridge, Kent TN11 0GP.
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]
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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 SoftwareValidation.
WARNING
Warnings are identified by the WARNING symbol shown above.
• The Non-Contact Infrared Body Thermometer is to be operated by consumers in the
home setting and primary care setting as screening tool. 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 for use 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 15°C to 40°C (59°F- 104°F).
• Remove primary batteries if equipment is not likely to be used for long time.
• This product is not waterproof, do not immerse in water or other liquid; If cleaning
and disinfecting, please follow the “Care and Storage” section requirements.
• Do not touch the sensor of infrared detection with your fingers.
• Avoid using the thermometer to take a body temperature reading while using a cold
compress or other measure to reduce fever.
• If measuring human forehead temperature, please select “body” mode; for measuring
other objects, liquids, food and other temperature please select “surface” mode.
• This product must be operated in a stable environment. If the ambient environment
is unstable, please check whether there is fog on the sensor and remove this before
using in accordance with the “Care and Storage” section.
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• 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 aect 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 device in a dry room and protect it against extreme moisture, heat, lint, dust and
direct sunlight. Never place any heavy objects on the thermometer body.
Do not throw batteries into fire.
Only use recommended batteries.Do not use rechargeable batteries.
This thermometer does not replace a hospital diagnosis.
Do not drop, 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.
OVERVIEW
Intended Use
The HoMedics Non-Contact Infrared Body Thermometers are designed to be used for
intermittent measurement and monitoring of human body temperature by consumers in
the home setting and primary care setting as screening tool.
Description of Non-Contact Infrared Body Thermometer
• Device principle and introduction
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• The HoMedics Non-Contact Infrared Body Thermometer is a hand-held, reusable,
battery operated device, 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 dierent signal when measuring dierent object temperature or in dierent
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
1. IR sensor
2. Liquid crystal display (LCD)
3. MODE button
4. MEMO button
5. ON/scan button
6. Battery cover
7. Surface mode
8. Body mode
9. Data indicator
10. Indicator of measurement results
11. Low Battery indicator
12. Voice on/o indicator
13. Memory number
14. Fahrenheit
15. Celcius
16. Memory indicator
Figure 1: Non-Contact Infrared Thermometer
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THERMOMETER APPLICATIONS
Thermometer
Model Number Thermometer Style Adult Pediatric
Ear Forehead Ear Forehead
HTD8816C
TE-350-EU
Non-Contact Infrared Body
Thermometers ü ü
EQUIPMENT SYMBOLS
Warning Restriction of Hazardous Substances
Non-sterile packaging Batch code
Refer to operating instructions Compliance with WEEE Standard
Operating Temperature DO NOT THROW AWAY
Intended for multiple use
Operating Humidity Operating atmospheric pressure
This device compiles with Part 15
of FCC (Federal Communications
Commission) Rules.
Indicates this device is in compliance
with MDD 93/42/EEC. 0598 is the
Notified Body Number
Manufacturer Authorized Representative in the
European community
Recyclable Serial number
IP22: The first number 2: Protected against solid foreign objects of Ф12.5 mm and
greater. The second number: Protected against vertically falling water drops when
enclosure
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TECHNICAL SPECIFICATIONS
Measurement unit °C/°F
Operating mode Adjusted mode (Body mode)
Direct mode (surface mode)
Reference Body Site Axillary
Rated output range Body mode:
34.0 - 43.0°C / 93.2 - 109.4°F
Surface mode:
0 - 100.0°C / 32 - 212°F
Output range Body mode:
34.0 - 43.0°C / 93.2 - 109.4°F
Surface mode:
0 - 100.0°C / 32 - 212°F
Laboratory Accuracy Body mode:
34.0 - 34.9°C: ± 0.3°C / 93.2 - 94.8°F: ± 0.5°F
35.0 - 42.0°C: ± 0.2°C / 95.0 - 107.6°F: ± 0.4°F
42.1 - 43.0°C: ± 0.3°C / 107.8 - 109.4°F: ± 0.5°F
Surface mode:
± 2°C / ± 3.6°F
Display Resolution 0.1°C/0.1°F
Three-colour Backlight
(Colour Alarm)
35.5 - 37.3°C / 95.9 - 99.1°F: Green (Normal Temperature)
37.4 - 38.0°C (Alarm point) / 99.3 - 100.4°F: Yellow (Slight Fever)
38.1 - 43.0°C / 100.6 - 109.4°F: Red (High Fever)
Note: 1. Surface mode is always with Green backlight
2. In body mode 34.0-35.4°C is with green backlight
Auto Power O Time ≤18s
Measuring Time ≤ 2s
Measuring Distance 1 - 5cm (0.4 - 2 in)
Memories 50
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Power Supply Requirements
Batteries 2 x 1.5V (AAA) Alkaline battery (IEC Type LR03)
Adaptable Range 2.6V - 3.6V
Environmental
Operating Condition Operating Temperature:
15 - 40°C (59 - 104°F)
Relative Humidity:
≤ 85%
Atmospheric pressure:
70-106Kpa
Transport and Storage
Condition
Storage Temperature:
-20 - 55°C (-4 - 131°F)
Relative Humidity:
≤ 93%
Atmospheric pressure:
70-106Kpa
Dimension and Weighting
Weight (without batteries) 80g
Size L:122mm X W:96mm X H:42mm
Compliance
Item Compliant with
Equipment classification Safety Standards:
EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015
Type of protection Internally powered equipment (on battery power)
Degree of protection Non-Applied part
Front panel and case labelling EN ISO15223-1:2016
Temperature EN ISO80601-2-56:2017
Home healthcare environment EN 60601-1-11:2015
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Calculated values of the indicators according to ISO 80601-2-56
Indicators Calculated value
Clinical bias, rcb -0.027
Standard deviation, σj0.14
Limits of agreement, LA 0.26
Clinical repeatability, σr0.07
Note: the above value is calculated from clinical data of HTD8818A.
Safety classification of ME EQUIPMENT
Protection against electric shock Internally powered ME equipment
Applied part Non-Applied part
Protection against harmful ingress of water
or particulate matter
IP22
Mode of operation Continuous operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT.
GB | 10
• 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 15°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.
OPERATION
Battery installation
Caution: The Non-Contact Infrared Body Thermometer does not operate with dead
batteries or external power sources.Install new batteries.
1. Slide the battery door 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.
How to operate
Before applying the Thermometer, be sure to read and understand all warnings listed of
the instructions before use.
• 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, temperature will display immediately,see figure 2.
401cm-5cm
Figure 2: Measuring position and distance
This manual suits for next models
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