Avita ADTEMP 429 User manual

PLEASE NOTE:
THIS MEDICAL INSTRUMENT MUST BE
USED ACCORDING TO INSTRUCTIONS TO
ENSURE ACCURATE READINGS.
Questions?
Call ADC toll free at 1-800-232-2670
AdtempTM
Non-Contact
Thermometer
Model 429
User’s Manual
®
IB p/n 93-429-00 rev7 (7/2/20)
Printed in China
AViTA Corporation
9F, No.78, Sec.1, Kwang-Fu Rd.,
San-Chung District,
24158 New Taipei City,
Taiwan
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
EC REP
Distributed by:
American Diagnostic Corporation
55 Commerce Drive,
Hauppauge, New York 11788
Inspected in the U.S.A.
Made in China
tel: [phone]
fax: [phone]
www.adctoday.com
email: [email protected]
0598
93-429-00 Small IFU rev 6.qxp_Layout 1 4/1/20 12:06 PM Page 1
Contract Manufacturer : AViTA (WuJiang) Co.Ltd
Tel: [phone]
Address: No. 858, Jiao Tong Rd., Wujiang Economic Development Zone,
Suzhou City, Jiangsu Province, P.R.C.
Model: NT16, REF :429
China Medical Production License No.: 苏食药监械生产许20040018号
China Product Registration Number: 苏械注准20182200808
Standard: GB/T 21417.1-2008

2 19
A Special
Thank You...
Thank you for choosing an ADC®AdtempTM Non-Contact thermometer.
We're proud of the care and quality that goes into the manufacture of each
and every item that bears our name. Only the finest materials are used to
assure you of a timeless instrument designed for optimum performance.
You'll quickly appreciate the results, for you now own one of the finest
non-contact thermometers that money can buy.
With proper care and maintenance, your ADC Adtemp thermometer is
sure to provide you with many years of dependable service. Please read
the following instructions and general information which will prove helpful
in allowing you to enjoy your ADC product.
Read this booklet thoroughly before attempting to use your new
ADC Adtemp thermometer.
Thank you for your patronage. It is indeed our pleasure to serve you.
Sincerely,
American Diagnostic Corp.
©2020 AMERICAN DIAGNOSTIC CORP.
15. Contact Information
To register your product visit us at
www.adctoday.com/register
This manual is available online in a
variety of languages,
follow the links for language options.
www.adctoday.com/care
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The 429 IR Thermometer is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the 429
IR Thermometer can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment
(transmitters) and the 429 IR Thermometer as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum
output power of
transmitter W 150 kHz to 80 MHz
d=1.2 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
150 kHz to 80 MHz
d=1.2 P
150 kHz to 80 MHz
d=2.3 P
Recommended separation distances between portable and mobile RF
communications equipment and the 429 IR Thermometer
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
14. Warranty
This thermometer is guaranteed for a period of 24 months from date of
purchase. This warranty does not cover batteries, or damage resulting
from improper handling or use. Specific legal rights stipulated in your state
may guide this warranty. If you have a legitimate claim under this
warranty, send item(s) postage paid to Service Center, Attn: Repair Dept.,
55 Commerce Dr., Hauppauge, NY 11788. Please include your name and
address, phone no., proof of purchase, and a brief note explaining the
problem.
Adtemp 429 - Instruction Manual
Table of Contents
1. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
2. Introduction / Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . .5
3. General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . . .5-7
4. Using the Thermometer . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9
4a. Controls and Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
4b. LED Screen/Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
4c. Selecting a Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9
4d. Changing the Temperature Scale . . . . . . . . . . . . . . . . . . . . .9
5. Taking a Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10
6. Memory Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
7. Troubleshooting / Error Messages . . . . . . . . . . . . . . . . . . . . .12
8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-14
8a. Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . . . .12-13
8b. Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . .13-14
9. Calibration Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
10. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
11. Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
12. Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
13. Guidance and Manufacturer’s Declaration . . . . . . . . . . . .16-18
14. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
15. Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
18 3
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WARNING: The warning statements in this manual identify conditions or practices that
could lead to illness, injury, or death.
CAUTION: The caution statements in this manual identify conditions or practices that
could result in damage to the equipment or other property, or loss of data.
Instructions for use (IFU).
Meets essential requirements of European Medical Device Directive 93/42/EEC.
0598
1. Symbols
Documentation Symbols
Shipping, Storing, and Environment Symbols
Temperature Limits: -13°F/-25°C - 131°F/55°C
Keep dry
Electronic Waste: Dispose of this device in accordance with local or national
regulations
Fragile
Humidity Limitation: Up to 85%
Protected against solid foreign objects of 12.5mm diameter or greater. Protected against
vertically falling water drops when the device is titled up to 15°.
IP22
-13°F
-25°C
131°F
55°C
15%
85%
Miscellaneous Symbols
Manufacturer
Product identifier
European authorized representative
Global trade identification number
Serial number
REF
SN
EC REP
GTIN
4 17
Guidance and Manufacturer's Declaration Electromagnetic emissions
The 429 IR Thermometer is intended for use in the electromagnetic environment specified below. The
customer or the user of the 429 IR thermometer must make sure it is used in such an environment.
a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited
to patient rooms and respiratory treatment facilities in hospitals or clinics. The more restrictive acceptance limits of
Group 1 Class B (CISPR 11) have been considered and applied. The equipment is suitable for use in the mentioned
environments when directly connected to the Public Mains Network.
b) The test is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEM used will be connected
to the PUBLIC MAINS NETWORK and the power input is otherwise within the scope of the Basic EMC standard.
Guidance and manufacturer’s declaration - Electromagnetic immunity - Enclosure port
a) The equipment is suitable for use in Home Health Environments and Professional Health Care Environments limited
to patient rooms and respiratory treatment facilities in hospital or clinics. The more restrictive IMMUNITY acceptance
limits have been considered and applied.
b) Before modulation is applied.
c) This test level assumes a minimum distance of at least 15 cm between the ME EQUIPMENT or ME SYSTEM and
source of power frequency magnetic fields.
Professional healthcare facility
environment a)
Home Healthcare environment a)
Guidance and manufacturer’s declaration - Electromagnetic emissions
Phenomenon
Phenomenon Immunity test levelsBasic EMC standard
or test method
Conducted and radiated RF EMISSIONS
Harmonic distortion
Voltage fluctuations and flickering
Not applicable
Not applicable
CISPR 11 Group 1 Class Ba)
ELECTROSTATIC
DISCHARGE
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8 30 A/m c)
50 Hz or 60 Hz
a) 10 V/m b) 80MHz - 2.7
GHz 80% AM at 1kHz
IEC 61000-4-2 ± 8 kV contact
± 2 kV, ±4 kV ±, ±8 kV, ±15 kV air
Professional healthcare
facility environment
HOME HEALTHCARE
ENVIRONMENT
Radiated RF EM fields
Proximity fields
from RF wireless
communications
equipment
RATED power frequency
magnetic fields
COMPLIANT NOTE: Further information about
distances to be maintained between portable and
mobile RF communications equipment (transmitters)
and the 429 IR can be requested from ADC using the
contact information provided in this manual. However,
it is advisable to keep the electromechanical aerosol
equipment at an adequate distance of, at least 0.5 m
from mobile phones or other RF communications
transmitters to minimize possible interference.
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12. Standards
ASTM E1965-98
EN 12470-5
MDD (93/42/EEC) Annex II
13. Guidance and Manufacturer's Declaration
The 429 IR Thermometer is intended for use in the electromagnetic environment specified
below. The customer or the user of the 429 Thermometer should assure that it is used in such
an environment.
Emissions Test Compliance Electronic environment guidance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic Emissions
IEC 61000-3-2 N/A
Voltage
Fluxuations/flicker
emissions
IEC 61000-3-3
N/A
The 429 IR Thermometer uses RF energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
The 429 IR Thermometer is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic
purposes.
The 429 IR Thermometer is intended for use in the electromagnetic environment specified
below. The customer or the user of the 429 IR Thermometer should assure that it is used in
such an environment.
Immunity Test IEC 60601 Test level Compliance Electronic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±6kV contact
±8kV air
Power Frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
3A/m 3A/m
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
Guidance and Manufacturer's Declaration Electromagnetic emissions
16 5
2. Introduction / Intended Use
Intended use
The Adtemp Non-Contact thermometer is a clinical-grade device intended for
the intermittent measurement of human body temperature in patients of all
ages. It can also be used to measure the temperature of objects.
3. General Warnings and Cautions
Warning and caution statements may appear on the thermometer,
its packaging, shipping container, or in this instruction manual.
This thermometer is safe for patients and clinicians when used in accor-
dance with the instructions and with the warning and caution statements in-
cluded in this manual. Before using the thermometer, users must familiarize
themselves with the general safety information included below. Specific
warnings and cautions are also found throughout this manual.
•Failure to understand and observe any warning statement in this
manual could lead to patient illness, injury, or death.
•Failure to understand and observe any caution statement in this
manual could lead to damage to the thermometer or other property,
damage to the surrounding environment, or loss of patient data.
•High, prolonged fever requires immediate medical attention,
especially for young children.
Warning: Failure to review and adhere to the recommendations presented
in this manual could result in personal injury or could affect the accuracy of
the thermometer itself.
Miscellaneous Symbols
Type BF applied part
Battery Level Indications
Low battery - thermometer can still be used
Low battery - the batteries must be replaced before further operation
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Warning: If the accuracy of any measurement is in question or the use of
this thermometer is not appropriate due to patient condition, check the pa-
tient's temperature with an alternate method and then check to verify the
device is functioning properly by comparing it against a calibrated reference
device.
Warning: Keep this thermometer and its batteries out of the reach of
children. Do not allow children to take their temperature with this
thermometer unattended.
Warning: Dispose of this thermometer and its batteries in accordance with
local or national regulations for electronic waste.
Caution: When replacing the batteries, always replace both batteries and
ensure that they are of the type and specification indicated in this manual.
Observe correct polarity when inserting new batteries.
Caution: Do not use rechargeable batteries. The use of rechargeable
batteries may compromise the performance of this device.
Caution: Remove the batteries whenever the device is not expected to be
used for an extended period of time.
Caution: If battery leakage occurs, fully clean the battery compartment
using personal protective equipment prior to re-use.
Caution: Observe proper measurement distance, starting between 4 and 6
cm from the patient's forehead. This is essential to the accuracy of the
measurement.
Caution: Do not modify or disassemble this device in any way without prior
authorization.
Caution: To avoid accuracy concerns, make sure that the thermometer’s
lens is clean and intact prior to use and after measurement is complete.
Caution: Avoid touching the lens directly with your fingers.
Caution: Do not expose the thermometer to extreme temperatures or
humidity levels.
Caution: Do not expose to direct sunlight.
Caution: The thermometer is not waterproof; do not immerse in water or any
other liquid.
6 15
11. Technical Specifications
Type Non-Contact infrared thermometer
Model no. 429
Measuring Range:
Human Mode: 50.0°F ~ 122.0°F
(10°C ~ 50°C)
Object Mode: 32.0°F ~ 212.0°F
(0°C ~ 100°C)
Calibration Accuracy:
Human Mode: 71.6°F ~ 104.0°F: ±0.5°F
(22°C ~ 40°C): ±0.3°C
Object Mode: ≤ 68°F: ± 1°F (≤ 20°C: ± 1°C)
> 68°F: ± 5% (> 20°C: ± 5%)
Display Resolution: 0.1°F (0.1°C)
Operating Environment: 60.8°F ~ 104°F
(16°C ~ 40°C)
with relative humidity up to 95%
(non condensing)
Storage/Transportation
Environment: -4°F ~ 122°F
(-20°C ~ 50°C)
with relative humidity up to 95%
(non condensing)
Power Supply: 2x 1.5V AAA size alkaline batteries
Weight: Approximately 3 oz / 87 g (with batteries)
Dimensions: Approximately 2.06” x 1.75” x 5”
52.4 mm x 44.5 mm x 129.9 mm (LxWxH)
Operation Distance: Starting approximately 1.57” - 2.36”
4 ~ 6 cm (±1 cm)
Auto Off: After 30 seconds of inactivity
Battery Life: 2,000-2,500 measurements
50° F
10° C
122.0° F
50° C
32.0° F
0° C
212.0° F
100° C
71.6° F
22° C
104.0° F
40° C
60.8° F
16° C
104.0° F
40° C
-4° F
-20° C
122° F
50° C
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Caution: Avoid dropping the device or exposing it to heavy shock or vibration.
Caution: Do not autoclave. Follow only the cleaning procedures described in
this manual.
Caution: Stop using this device if it operates erratically or if the display
malfunctions.
Caution: Contact ADC or your local ADC representative for any assistance
with this device. Refer to the warranty section of this manual for contact details.
Caution: Allow 30 minutes for both patient and thermometer to become
accustomed to existing environmental conditions prior to measurement.
Caution: Wherever possible, measurements should be taken by pointing the
infrared sensor at the same area of the forehead. Temperatures measured at
different measurement sites on the temples, on opposite sides of the head,
or on different body parts can vary considerably.
Caution: Avoid taking temperature measurements for at least 30 minutes
after physical activity, bathing, swimming, consuming food or beverages,
or spending time outdoors.
Caution: Wait at least 1 minute between temperature measurements.
Repeating measurements more often may compromise the accuracy of
the readings.
Caution: When taking patient temperature, avoid pointing the infrared
sensor at any heat source other than the patient. When using in object mode,
be sure to point sensor directly at the object being measured.
Caution: Holding the thermometer for an excessive period of time or exposing
the device to external heat sources may result in distorted temperature readings.
14 7
10. Disposal
The thermometer contains no hazardous materials. Discard in accordance
with national or local regulations. Remove the batteries before disposal.
Battery:
Dispose of empty batteries in accordance with national or local
regulations.
9. Calibration Testing
This thermometer is calibrated at the time of manufacture. If the thermome-
ter is operated in accordance with these instructions, periodic readjustment
is not required. ADC recommends checking calibration on an annual basis or
whenever clinical accuracy of the thermometer is in question.
Recommendations for calibration do not supersede any legal obligations that
you may have in relation to this equipment. Please consult applicable local
or national laws in the place of use to ensure that the requirements for the
control of the measurement, functionality, and accuracy of the device are
maintained for your specific uses.
Note that ADC is not responsible for validating the cleaning or disinfection
protocols used on this device outside of ADC’s manufacturing site. You
should determine the requirements for personnel, equipment, and materials
necessary to achieve your desired disinfection levels and may need to em-
ploy routine monitoring of your disinfection protocols within your facility.
After cleaning or disinfecting, wait at least 10 minutes prior to taking an-
other measurement.
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8 13
4. Using the Thermometer
4a. Controls and Features
4b. LED Screen/Display
4c.Selecting a Scan Mode
With the power on, press the Human/Object button to switch between scan
modes. There are 4 modes available, including Human, Object,
Human/Night, and Object/Night mode (in order). The thermometer’s volume
will be muted in both Human/Night mode as well as Object/Night mode, and
the Moon symbol will appear on the LCD in both Night modes.
Cleaning the lenses
Never use water to wash the thermometer lens directly.
Slightly moisten a cotton swab or cloth with isopropyl
or ethyl alcohol and gently wipe the surface of the lens.
Wipe from side to side rather than in a circular motion
to avoid getting debris on the center of the sensor.
Avoid touching the lens except when cleaning
is required.
8b. Cleaning and Disinfecting
The thermometer can be cleaned and an intermediate-level of disinfection can be
achieved using the following method.
CAUTION: Never submerge the thermometer in water or any other liquid
CAUTION: Never use abrasive cleaning agents, thinners or benzene for cleaning
and never immerse the instrument in water or other cleaning liquids.
CAUTION: Never insert a sharp object into the scanner area or any other open
surface on the thermometer.
CAUTION: Do not use unapproved cleaning or disinfection agents. Use of these
agents may cause damage to components.
CAUTION: Do not use chemicals other than isopropyl or ethyl alcohol on the lens.
If the batteries are completely depleted, “Lo” will be displayed
along with the low battery symbol.
1. Use a Phillips head screwdriver to loosen battery
cover screw. Remove cover.
2. Remove the batteries.
3. Insert two AAA (or equivalent) batteries, correctly
positioned with positive “+” and negative “-”
as shown in illustration.
4. Place the battery cover on the thermometer
and tighten the screw to secure it in place.
Note: Remove the batteries before storing the
thermometer for an extended period of time.
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Note: Each press of the Human/Object button is accompanied by a beep
sound to confirm that the setting is activated (excluding Night modes).
12 9
4d.Changing the Temperature Scale
The Adtemp 429 Non Contact Thermometer can display readings
in either Fahrenheit (F) or Celsius (C). The default temperature
scale is Fahrenheit. To change the scale to Celsius, power the
device on, then press and hold the Human/Object and Memory
buttons simultaneously for 1 second. Pressing these buttons
again will change the scale back to Fahrenheit. Note: Removing
the batteries will reset the scale to the default setting.
5.Taking a Measurement
1. Press the Measure button to power on the thermometer. The unit will run
a self-test and the LCD will briefly display all of its symbols during this
time. When the device is ready, ‘00’ will appear on the screen, and the
thermometer will beep twice.
2. Select the desired mode by pressing and releasing the Human/Object
button.
Note: When taking a patient’s temperature, ensure that the thermometer
is in Human mode; the Human symbol will appear on the display. Refer to
Section 4c for instructions on selecting a different scan mode.
3. Position the thermometer
about 2 inches (5 cm)
from the center of
the patient's forehead
with the sensor aimed
between the eyebrows.
8. Maintenance
8a. Replacing the Batteries
The thermometer comes with two 1.5V AAA (LR03) alkaline batteries.
Replace with two new AAA (LR03) batteries when the low-battery symbol
“ ” appears on the display.
The thermometer can continue to be used with the low-battery symbol
displayed but the batteries should be replaced as soon as possible.
7. Troubleshooting/Error Messages
LCD Display Cause Solution
The temperature
measured is higher than:
1. Human Mode:
122°F (50°C)
2. Object Mode:
212°F (100°C)
The temperature
measured is lower than:
1. Human Mode :
50°F (10°C)
2. Object Mode :
32°F (0°C)
Take the measurement
again. Follow the steps
in Section 5.
If necessary, clean the
sensor lens.
In the event of a repeated
error message, contact
your retailer or ADC’s Cus-
tomer Service line at:
1-800-ADC-2670
The operating
temperatureis not in
the range from:
60.8°F to 95°F
(16°C to 35°C)
Operate the thermometer
only between the specified
temperature ranges.
In the event of a repeated
error message, contact
your retailer or ADC’s Cus-
tomer Service line at:
1-800-ADC-2670
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Note: If the patient’s skin is covered with hair, sweat, or dirt, clean the area
and wait 10 minutes before taking a measurement.
Note: Ensure that the thermometer is held firmly during measurement and
that the patient does not move until the measurement is complete. Patient
movement can impact the measurement.
4. Press and release the Measure button making sure not to obstruct your
view of the LED display or the buttons area.
5. Slowly move the device towards the patient’s forehead. The unit will
beep continuously and a series of dash icons forming two circles
will rotate on the display. Once the correct distance is reached
(about 1 inch or 3 cm), an amber light will flash just below the
Mode and Memory buttons. The unit will emit a short beep
(except in night mode), and the backlit display will illuminate
when the measurement is complete.
Note: If the distance of the thermometer is too far from or too close to the
patient’s forehead, the dash icons will continue to rotate and the unit will
beep (except in night mode) UNTIL the correct distance is obtained. Once the
Measure button is pressed and released, you will have 20 seconds to obtain
a temperature reading. After 20 seconds the unit returns to standby mode.
6. To repeat the process, return to step 2.
7. The thermometer automatically turns off (with a single beep) after 30
seconds of inactivity.
Note: The device cannot be turned off manually.
Note: The Human or Object symbols will be displayed to indicate the
measurement mode that was in use for the displayed reading in memory.
3. Each press of the Memory button will display a previous measurement
(up to 30).
10 11
To delete readings from memory:
1. Press the Measure button to power the unit on.
2. Press and hold the Memory Button for at least 3 seconds
to delete all the readings.
3. The LCD displays "--" and the device beeps to confirm
all the memories are cleared.
Note: Once 30 measurements are in memory each new measurement will
overwrite the oldest.
Note: All the readings (Human and Object) will be cleared when deleting
readings from memory.
6.Memory Fucntion
The unit retains the last 30 readings.
To recall previous readings:
1. Press the Measure button to power the unit on.
2. Briefly press and release the Memory button then press again to display
the last measurement accompanied by the symbol.
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