Sunbeam HTD8216C Manual de usuario
Infrared Body Thermometer
Instruction Manual
Model : HTD8216C
Software version: V10
- 3 -
INDEX
Foreword
Safety Information
Overview
Operation
Troubleshooting
Cleaning, Care and Storage
Replacing the Battery
Disposal
Warranty
EMC Declaration
Body temperature
3
4
10
16
21
22
23
23
24
24
30
FOREWORD
The Infrared Body Thermometer Operating Instructions intend
to provide the necessary information for proper operation of the
HTD8216C Thermometer model.
Only Body Mode was reviewed and certied.
General knowledge of Infrared Thermometer and an understanding of
the features and functions of the HTD8216C Thermometer model are
prerequisites for proper use.
The Infrared Body Thermometer is a medical device, and can be used
repeatedly. The device shelf life is 5 years.
Do not operate HTD8216C Thermometer without completely reading
and understanding these instructions.
PLEASE READ THE MANUAL FIRST BEFORE USING
IT. IF THE USAGE IS NOT FULLY UNDERSTOOD,
PLEASE STOP USING THE THERMOMETER.
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.
- 4 - - 5 -
SAFETY INFORMATIONSAFETY 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 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 SOFTWARE VALIDATION.
• 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 room at a lower temperature
to another room at a higher temperature, allow the
thermometer to remain in a room for 30 minutes
where the temperature is between 59℉ - 95℉
(15℃ - 35℃) before using.
• 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 liquids; when cleaning and
disinfecting, please refer to and follow the "care
and storage" requirements.
• DO NOT touch the sensor of infrared detection with
your ngers.
• If a cold compress is used to cool down, the
temperature reading will be low and will not be
accurate.
• When measuring the forehead select "forehead"
mode. when measuring ear temperature, please
select the "ear" mode.
• This product should only be used in a room with
stable ambient temperature. Fluctuations in ambient
temperature may result in inaccurate readings.
• DO NOT use near strong electrostatic or magnetic
elds to avoid impact on the accuracy of the
measurement data.
• DO NOT mix the old and new batteries to avoid
damage to the product.
- 6 - - 7 -
• Brush aside any hair and make sure the forehead
is clean and free of perspiration, cosmetics, or any
coverings (hats, caps, scarves) that may interfere with
measuring.
• Measurement results are for reference only. Contact
your physician if you have or suspect a medical
condition.
• Ensure the ear canal is clean and dry before using
the "ear" mode as this may interfere with the
measurement.
WARNINGS
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 against
extreme moisture, heat, lint, dust and direct
sunlight. Never place any heavy objects on the
thermometer.
DO NOT throw batteries into re.
DO NOT discard in household trash.
Only use recommended batteries. DO NOT use
rechargeable batteries.
This thermometer is not intended as replacement
for advice from a physician or medical professional.
DO NOT drop, disassemble or modify the device.
DO NOT use this device if you think it is damaged
or notice anything unusual.
SAFETY INFORMATION
- 8 - - 9 -
This device comprises sensitive components
and must be treated with caution. Observe the
storage and operating conditions described in the
’Technical Specications’ section.
DO NOTperform service or maintenance while the
Thermometer is in use.
While in use DO NOT touch the battery and the
person at the same time.
DO NOT use the Thermometer if it is damaged,
degraded or loosened in any way.
Continuous use of a damaged Thermometer may
cause injury, improper results, or serious danger.
Based on the current science and technology,
other potential allergic reactions are unknown.
This devise needs to be used and serviced in
accordance with the information provided in this
INSTRUCTION MANUAL.
WARNINGS INTENDED USE
The Infrared Body Thermometer, Model: HTD8216C, is an
electronic clinical thermometer using an infrared sensor to
detect body temperature from the forehead or auditory canal
in people of all ages for home setting use.
The Sunbeam Thermometer is a hand-held, reusable,
battery operated device, which can measure human body
temperature on the forehead and in the ear. It can also
measure the surface temperature of objects.
The operation principle is based on Infrared Sensor
technology. The IR sensor can output different signals when
measuring different object temperatures or in different
ambient temperatures, and the ASIC can turn the signal from
IR Sensor to a digital value and display it on the LCD.
CONTRAINDICATIONS:
1. DO NOT measure areas on the forehead with scar tissue
or tissue compromised by skin disorders as this can affect
the measurement accuracy.
2. DO NOT measure temperature of persons in trauma.
3. DO NOT use if being treated with drug therapies that can
increase the body temperature.
4. DO NOT measure temperature on sites of the skin exposed
to external sources of heat or cold such as direct sunlight,
replace heat, cold compress, air conditioner ow, etc.
- 10 - - 11 -
INFRARED BODY THERMOMETER
COMPONENTS
INFRARED BODY THERMOMETER
COMPONENTS
1
1
2
2
4
3
3
5
4
6
5
7
9
6
8
Cap
Ear mode
Measuring status indicator
Liquid crystal display (LCD)
Data indicator
Battery cover
Low battery indicator
Volume on/off indicator
Mode button (inside cover)
Indicator of measurement result
Memory indicator
Passive infrared probe
Forehead mode
START button
Measurement unit
3
6
4
5
1 2
Figure 1 Model : HTD8216C Figure 2 Model : HTD8216C
1
7 8
2 3 4
5
6
9
- 12 - - 13 -
Thermometer
Model #
Thermometer
Style
Adult Pediatric
Ear Forehead Ear Forehead
HTD8216C Infrared Body
Thermometer √ √ √ √
Warning Operating atmospheric
pressure
Non sterile Packaging Type BF (Body Floating)
Consult instructions for use Compliance with WEEE
Standard
Operating Temperature DO NOT THROW AWAY
Intended for multiple use
Operating Humidity Serial number
Manufacturer Restriction of Hazardous
Substances
Recyclable Batch code
This device compiles
with Part 15 of FCC
( Federal Communications
Commission) Rules
IP22: The rst number 2:
Protected against solid
foreign objects of
12.5mm Ø and greater.
The second number:
Protected against vertically
falling water drops when
enclosure titled up to 15º.
LOT
Measurement Unit ºF / ºC
Operating mode Forehead mode / Ear mode
Measuring site Forehead / Ear
Reference Body
Site Axillary
Output Range Body mode: 93.2°F - 109.2°F / 34.0ºC - 42.9ºC
Surface mode: 32°F - 212°F / 0ºC - 1 00.0ºC
Laboratory
Accuracy
Forehead mode/Ear mode:
93.2°F - 94.8°F: ±0.5°F / 34.0ºC - 34.9ºC: ±0.3ºC;
95.0°F - 107.6°F: ±0.4°F / 35.0 - 42.0ºC:±0.2ºC;
107.8°F - 109.2°F: ±0.5°F / 42.1 - 42.9ºC:±0.3ºC;
Display Resolution 0.1°F / 0.1ºC
Three-color
Backlight
(Color Alarm)
93.2°F - 99.1°F / 34°C - 37.3°C Green (Normal Temperature);
99.3°F - 100.4°F / 37.4°C - 38.0°C (Alarm point)
Yellow (Slight Fever)
100.6°F - 109.2°F / 38.1°C - 42.9°C Red (High Fever)
Note: Color Alarm is only for Body mode
Auto Power Off
Time ≤35s
Measuring Time ≤5s (under ear mode); ≤2s (under Forehead mode)
Memories 1
Power Supply Requirements
Batteries DC 3V (2 x 1.5V AAA batteries)
Environmental Conditions
Operating
Condition
Operating Temperature: 59°F - 95°F (15°C - 35°C),
Relative Humility≤85%, atmospheric pressure: 70 - 106Kpa
Transport and
Storage Condition
Storage Temperature: -4°F - 131°F / -20°C - 55°C
Relative Humility≤93%, atmospheric pressure: 70 - 106Kpa
THERMOMETER APPLICATIONS TECHNICAL SPECIFICATIONS
EQUIPMENT SYMBOLS
Note: not all symbols may appear in this instruction manual
- 14 - - 15 -
Weight
(without batteries) 2.3oz (65g)
Size 6.1" x 1.3" x 2" (154mm x 33mm x 51mm)
Item Compliant with
Equipment classication 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
labeling EN ISO15223 -1:2012
Temperature EN ISO80601 - 2 - 56:2012
Home healthcare
environment EN 60601 - 1 - 11:2015
Accessory name Number
AAA battery 2
Instruction Manual 1
DIMENSION AND WEIGHTING
CALCULATED VALUES OF THE INDICATORS
ACCORDING TO ISO 80601-2-56-2012 EAR MODE:
FOREHEAD MODE:
SAFETY CLASSIFICATION OF ME EQUIPMENT
Indicators Calculated value
Clinical bias, Δcb 0.009
Standard deviation, ∑j 0.11
Limits of agreement, LA0.19
Clinical repeatability, ∑r 0.06
Indicators Calculated value
Clinical bias, Δcb -0.018
Standard deviation, ∑j 0.13
Limits of agreement, LA0.26
Clinical repeatability, ∑r 0.06
Protection against electric shock Internally powered ME equipment
Degree of protection Type BF - Applied part (the probe)
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
- 16 - - 17 -
OPERATION
INSTALLING BATTERIES
1. Remove the battery access cover.
2. Insert two (2) AAA batteries aligned with the “+” and “-” icons.
3. Close the battery access cover.
• Install new batteries when the battery level indicator is low
• Dispose of/recycle used batteries following local
regulations to avoid environmental pollution.
BEFORE TAKING A TEMPERATURE
To maximize results:
• Choose a room or area with stable surrounding temperature,
away from direct sunlight or strong airow sources such as
fans or air conditioners.
• Allow the thermometer at least 30 minutes to adjust to
surrounding room temperature (if moving the device to or
from a warmer or cooler location) before use.
• Allow the body at least ve minutes to adjust to surrounding
room temperature.
• If a cool compress on the forehead or other measures are
taken to reduce fever, the temperature data will be low. You
may also try measuring behind the ear or in EAR MODE for
comparison.
• Brush aside any hair and make sure the forehead is free of
perspiration or head coverings (hats, caps, scarves) when
using FOREHEAD MODE.
• Make sure the ear canal and probe are clean when using
EAR MODE.
OPERATION
GETTING STARTED
Press the START button
• The thermometer will perform a self-test with all functions
displayed for 2 seconds. (See Figure 2)
• An audio signal (three “beeps”) will conrm the self-test is
complete.
• The display will show the last measured temperature stored
in memory. (See Figure 3)
• When the device is ready, the memory symbol will disappear
and the unit symbol will start ashing.
(See Figure 4)
Figure 2
Figure 4
Figure 3
- 18 - - 19 -
OPERATION
SELECTING FOREHEAD, EAR
To measure human BODY temperature (factory default):
• When the cap is off,the thermometer will measure in EAR MODE.
• When the cap is on, the thermometer will measure in
FOREHEAD MODE.
NOTE
To change back to FORHEAD MODE if the bottle icon
appears , follow the below steps:
• Open the battery access panel.
• With the thermometer ON, press the small MODE button
inside the battery compartment to select FOREHEAD MODE
(head icon appears on the display ).
• Replace the battery access cover.
OPERATION
MEASURING BODYTEMPERATURE IN FOREHEAD MODE
Note: Thermometer Cap should be on.
1. Press START to turn on
• A short beep will indicate ready to measure.
2. Hold the device vertically in front of the forehead.
3. Press START to begin measuring.
• A series of “beeps” will indicate measuring is complete.
4. The LCD display will show the target value of the measured
temperature.
5. The backlit screen will indicate a color alert for body
temperature (FOREHEAD AND EAR MODE) measurements.
Green - Normal Temperature/Ready for Measurement
Yellow - Slight Fever WARNING
Red - High Fever WARNING
Test at least 3 times and select the result that appears most.
Tabla de contenidos
