CALIBRATION
The thermometer is initially calibrated at the time of manufacture. If the
thermometer is used according to the use instruction, periodic readjustment is
not required. However, we recommend checking calibration every two years or
whenever clinical accuracy of the thermometer is in question. Turn on the
thermometer and insert into the water bath and then check the laboratory
accuracy. Please send the complete device to the dealers or manufacturer.
ASTM laboratory accuracy requirements in the display range of 98.6 to 102.2°F
(37.0 to 39.0°C) for electronic thermometers is ±0.2°F(±0.1°C).
The above recommendations do not supersede the legal requirements. The
user must always comply with legal requirements for the control of the
measurement, functionality, and accuracy of the device which are required by
the scope of relevant laws, directives or ordinances where the device is used.
FCC INFORMATION
Caution: Changes or modifications to this unit not expressly approved by the
party responsible for compliance could void the user authority to operate the
equipment.
*Note:
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and can radiate radio
frequency energy. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try and correct the interference by one or more of
the following measures:
• Reorient or relocate the receiving antenna.
• Increase the distance between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Disposal of this product and used batteries should be carried out
in accordance with the national regulations for the disposal of
electronic products.
BATTERY REPLACEMENT
1. Replace battery when “ ” appears in the lower right corner of LCD display.
2. Pull battery cover off as shown in Figure 3.
3. Gently pull out plastic circuit board with battery chamber approximately 1
cm (slightly less than1/2 in.) (See Figure 4)
4. Use pointed object such as a pen to remove old battery. Discard battery
lawfully. Replace with new 1.5V DC button type LR41 or SR41,UCC392, or
equivalent. Be sure battery is installed with “+” polarity facing up. (See
Figure 5)
5. Slide battery chamber back into place and attach cover.
WARNING
• Read instructions thoroughly before using digital thermometer.
• Choking Hazard: Thermometer cap and battery may be fatal if swallowed. Do
not allow children to use this device without parental supervision.
• Do not use thermometer in ear. Designed use is for oral, rectal, and armpit
(axilla) readings only.
• Do not place thermometer battery near extreme heat as it may explode.
• Note: Use of the probe cover may result in a 0.2ºF(0.1ºC) discrepancy from
actual temperature.
• The use of temperature readings for self-diagnosis is dangerous. Consult
your doctor for the interpretation of results. Self-diagnosis may lead to the
worsening of existing disease conditions.
• Do not attempt measurements when the thermometer is wet as inaccurate
readings may result.
• Do not bite the thermometer. Doing so may lead to breakage and/or injury.
• Do not attempt to disassemble or repair the thermometer. Doing so may
result in inaccurate readings.
• After each use, disinfect the thermometer especially in case the device is
used by more than one person.
• Do not force the thermometer into the rectum. Stop insertion and abort the
measurement when pain is present. Failure to do so may lead to injury.
• For children who are two years old or younger, please do not use the devices
orally.
• If the unit has been stored at temperatures over 104ºF (40ºC), leave it in
41ºF~104ºF (5ºC~40ºC) ambient temperature for about 15 minutes before
using it.
PLEASE READ CAREFULLY BEFORE USING
This digital thermometer provides a quick and highly accurate reading of an
individual's body temperature. The digital thermometer is intended to measure
the human body’s temperature in regular mode orally, rectally or under the
arm, and the device is reusable for clinical or home use on people of all ages.
To better understand its functions and to provide years of dependable results,
please read all instructions first.
This appliance conforms to the following standards:
ASTM E1112 Standard Specification for Electronic Thermometer for
Intermittent Determination of Patient Temperature,
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,
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 and complies with the requirements
of IEC 60601-1-2(EMC), AAMI/ANSI ES60601-1(Safety) standards. And the
manufacturer is ISO 13485 certified.
CONTENTS
MFR #s 16-412GM-00, 16-413BGM-00, 16-413RGM-00, 16-413BGM,
16-413RGM, 16-415GMHT, and 16-415GMST come with 1 thermometer, 1
owner’s manual, 1 storage case, and 5 probe sheaths.
MFR #s 16-413BKGM and 16-413RKGM come with 1 thermometer, 1 owner’s
manual, 1 storage case, and 20 probe sheaths.
PRODUCT ILLUSTRATION
PRECAUTION
*The performance of the device may be degraded should one or more of the
following occur:
• Operation outside the manufacturer’s stated temperature and humidity
range.
• Storage outside the manufacturer’s stated temperature and humidity range.
• Mechanical shock (for example, drop test) or degraded sensor.
• Patient temperature is below ambient temperature.
*Portable and mobile RF communications can affect the device. The device
needs special pre-cautions regarding EMC according to the EMC information
provided in the accompany documents.
*Do not use the devices in the MR environment.
SYMBOL EXPLANATION
LOT
MFD
Direct Current
Type BF Applied Part
Consult accompanying documents
Batch code
Manufacture date
SPECIFICATIONS
Type
Measure range
Accuracy
Operating mode
Display
Memory
Battery
Battery life
Expected service life
Ambient
operating range
Storage and
transportation
condition
Ingress
Protection Rating
Classification
Digital Thermometer (Not predictive)
90.0ºF-109.9ºF (32.0ºC-42.9ºC)(ºC/ºF chosen by
manufacturer)
±0.2ºF (±0.1ºC) during 95.9ºF~107.6ºF (35.5ºC~42.0ºC)
at 64.4ºF~82.4ºF (18ºC~28ºC) ambient operating range
±0.4ºF (±0.2ºC) for other measuring and ambient
operating range
Direct Mode
Liquid crystal display, 3⁄ digits
For storing the last measured value
One 1.5V DC button battery
(size LR41 or SR41, UCC 392)
Approximately 200 hours of continuous operation or
1 year with 3 measurements per day
Three years
Temperature: 41ºF~104ºF (5ºC~40ºC)
Relative Humidity: 15%~95%RH
Atmospheric Pressure: 700hPa~1060hPa
Temperature: -4ºF~131ºF (-20ºC~55ºC)
Relative Humidity: 15%~95%RH
Atmospheric Pressure: 700hPa~1060hPa
MFR # 16-412GM-00: IPXO
All remaining MFR #’s: IP27
Type BF
ºF/ºC SWITCHABLE
Temperature readings are available in the Fahrenheit or Celsius scale (ºF/ºC;
located in the upper right corner of LCD.) With the unit off, press and hold the
On/Off Button for approximately 2 seconds to change the current setting.
DIRECTIONS
1. Press the On/Off Button next to LCD display. A tone will sound as the screen
shows , followed by last recorded temperature. After showing the
self-test temperature, the thermometer is now in the testing mode.
2. Position thermometer in desired location (mouth, rectum, or armpit.)
a) Oral Use: Place thermometer under tongue as indicated by“√”
position shown in Figure 2. Close your mouth and breathe
evenly through the nose to prevent the measurement from
being influenced by inhaled/exhaled air. Normal temperature
between 96.3ºF and 99.1ºF (35.7ºC and 37.3ºC).
b) Rectal Use: Lubricate silver probe tip with petroleum jelly for easy
insertion. Gently insert sensor approximately 1cm (less than 1/2 in) into
rectum. Normal temperature between 97.2ºF and 99.9ºF
(36.2ºC and 37.7ºC).
c) Armpit Use: Wipe armpit dry. Place probe in armpit and keep arm
pressed firmly at side.
3. The degree sign flashes throughout the testing process. When flashing stops
an alarm will beep for approximately 10 seconds. The measured reading will
appear on the LCD simultaneously. The minimum measurement time until
the signaling tone (beep) must be maintained without exception. The
measurement continues even after the buzzer notification. So that in order
to achieve better body temperature measurement result, recommend to
keep the probe in mouth and rectum about 2 minutes, or in armpit about 5
minutes regardless of the beep sound and at least 30 seconds measurement
interval should be maintained.
*Note: Normally the buzzes are “Beep-Beep-Beep-Beep-”; Alarm beeps more
rapidly when temperature reaches 100ºF (37.8ºC) or higher, and the buzzes
are“Beep-Beep-Beep-------Beep-Beep-Beep-------Beep-Beep-Beep”
4. To prolong battery life, press the On/Off Button to turn unit off after testing is
complete. If no action is taken, the unit will automatically shut off after
around 10 minutes.
Figure 2
CLEANING AND DISINFECTION
Wipe the thermometer with a soft clean cloth.
For stubborn stains, wipe the thermometer with a cloth that has been
dampened with water or a neutral detergent solution and then wring
thoroughly. Finish by wiping with a soft dry cloth. For disinfection, 75% Ethanol
or Isopropyl alcohol can be used.
Observe the following to prevent damage to the thermometer.
• Do not use benzene, thinner, gasoline or other strong solvents to clean the
thermometer.
• Do not attempt to disinfect the sensing section (tip) of the thermometer by
immersing in alcohol or in hot water (water over 122ºF (50ºC)).
• Do not use ultrasonic washing to clean the thermometer.
