iHealth PT3 Forehead Thermometer User Manual

iHealth PT3
Infrared No-Touch Forehead Thermometer
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User's Manual
Version 4.5
Table of content
Indications for use 1
Product introduction 1
Safety Precautions 1
Caution 1
Overall Description
Product performance
Expected use and scope of applications
Contraindications
Instruction For Use
Product errors and troubleshooting
Body temperature
Cleaning and Care
Care the probe
Maintenance
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Disposal
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Operating, shipping, and storage conditions ------------
Accessories
Standard icons
Calibration
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Storage
OTHER STANDARDS AND COMPLIANCES --------------- 9
ELECTROMAGNETIC COMPATIBILITY INFORMATION ------ 10
WARRANTY 11
Indications for use
The Infrared No-Touch Forehead Thermometer is intended for
the intermittent measurement of body temperature from the
forehead on people of all ages. It can be used by consumers in
the household environment and by healthcare providers.
Product introduction
Thank you for choosing our product.
This product is a high-tech infra-red (IR) thermometer
designed to take human body temperature by measuring the
energy of IR emitted from the forehead. The product will help
you to assess you and your family members’ health
conditions easily and quickly.
Product Name: Infrared No-Touch Forehead Thermometer
Product Model: PT3
Safety Precautions
A Warning
@ Use of this thermometer is not intended as a substitute for
consultation with your physician. Please consult your doctor
if you have any doubt about the temperature reading.
@ Keep the thermometer out of reach of children. For
accidental swallowing of the battery or other components,
please contact emergency services immediately.
O Batteries must not be thrown into an open fire or short
circuited.
A Caution
(1) Measurements
1. Thermometer readings should be regarded as a reference.
Do not attempt self-diagnostics or self-treatment using the
temperature readings. Please seek professional medical
advice when necessary.
2. There is no absolute standard for human body temperature.
Knowing your own normal body temperature range is
important to accurately determine if you have a fever.
3. Make sure that the forehead of the subject is free from
sweat, cosmetics, dirt, or grease before measuring.
4. Patients should not drink, eat, or be physically active
before/while taking a reading. Wait 30 minutes before
taking a measurement. Temperature readings taken when a
body is in a state of stable equilibrium is more accurate and
useful as a reference.
5. Do not take temperature measurement over scar tissue,
open sores or abrasions.
6. Do not measure body temperature from scar tissues on the
forehead as such tissues will affect temperature conduction
of the body.
7. lf there is a temperature difference between the
thermometer storage area and the new ambient
environment around the subject, please let the
thermometer sit within the new environment for 30 minutes
before taking the measurement.
8. Do not measure body temperature immediately after
consuming a drug that raises body temperature.
Temperature readings taken at this time will not be accurate.
1
9. It is normal for readings taken from continuous
measurements to fluctuate within a small range. During
continuous measurements, the subject’s body
temperature may be transmitted to the thermometer,
affecting measurement accuracy. We recommend taking
only up to 3 continuous readings within a short period.
10. Do not directly face the sun or an air outlet of an air
conditioning or radiator device during the measurement
as this will cause changes to the forehead temperature.
Measurements should be taken in a stable environment
where possible.
. Do not measure body temperature in an environment with
strong EM interference (examples include places close to a
working microwave, induction cooker, or cellphone in-use)
as EM interference may cause errors in the reading or even
device failure.
12. This product should be considered a personal device.
Clean and sanitize the product properly to prevent cross
contamination.
13. To clean a dirty thermometer probe, gently swipe the
probe using a cotton swab dipped in 70% Isopropyl. Let
the cleaned thermometer sit for at least 15 minutes before
taking more measurements.
14. This infrared thermometer meets requirements established
in ISO 80601-2-56: 2017/AC: 2018. It displays subject’s
temperature over a range of 89.6 °F ~109.2 °F (32°C-42.9°C).
Full responsibility for the conformance of this product to
the standard is assumed by (manufacturer: ANDON
HEALTH CO., LTD. Add: No. 3 Jinping Street, Ya An Road,
Nankai District, Tianjin 300190, China).
—i
_
(2) About the product
1. This product is a precision device. Return the product to its
original packaging for proper storage after use. To ensure
accurate measurements, avoid the device or probe
contacting any liquid or droplets. Avoid tiny particles (such
as dust or powder) falling into the probe.
2. Avoid dropping or subjecting the product to external forces.
Do not disassemble or re-assemble the product on your own.
3. Do not directly touch the probe with your fingers or blow
on it. Measurements taken using a damaged or dirty IR
probe may be inaccurate.
4. Keep the product at a place inaccessible to children to
prevent children from swallowing the batteries or small parts.
5. Do not throw the thermometer or batteries into fire to
prevent explosions.
6. Remove the batteries from the thermometer if the device
will not be used for more than one month.
7. If you are allergic to plastic/rubber, please don’t use this
device.
8. The materials (ABS, TPU, metal) of expect contact with
patient had passed the ISO 10993-5 and ISO 10993-10
standards test, no toxicity, allergy and irritation reaction.
They are in compliance with the MDD requirements. Based
on the current science and technology, other potential
allergic reactions are unknown.
9. This device complies with part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
2
(2) This device must accept any interference received,
including interference that may cause undesired operation.
Overall Description
The thermometer is mainly comprised of a plastic casing, IR
temperature sensor, MCU, vibration motor, LED display screen
and batteries.
NON O ___ Thermometer
<< robe
soley LANE. )| *
LED display 100 © Distance
area probe
Measurement ——
button
—T Battery cover
LED screen instructions
Temperature _| 44% °C 4— Celsius
display area | | | [К | [К |
| Г г | г | oF ——— Fahrenheit
i о о
ow power
reminder | O
Device dimensions: 5.39 in x 1.34 in x 1.54 in
Screen dimensions: 1.01 in x 0.75 in
Product weight: 90 y
Product performance
1. Measurement position: Centre of the forehead surface
2. Measurement distance: <1.18in(3 cm)
3. Power source: 2 x 1.5V ==SIZE AAA batteries
4. Measurement range: 89.6°F-109.2°F (32°C-42.9°C)
5. Measurement precision: +0.4°F/0.2°C within 95°F-107.6°F
(35°C-42°C), and+0.5°F/0.3°C for other temperature ranges.
6. Resolution: 0.1°F/0.1°C
7. Clinical reproducibility: Within £0.5°F/0.3°C
8. Operating conditions:
Temperature: 59°F-104°F(15°C-40°C)
Humidity: 15-95%RH, non-condensing
Atmospheric Pressure: 70~106kPa
9. Operation mode:
Adjusted mode: forehead
10. Expected lifetime of the product: 5 years
11. Reference Body Site: Oral
12. Software version: V1.0
Expected use and scope of applications
This product mainly uses infrared sensors to measure the
temperature of the human forehead. It can be used for babies,
children, and adults. Infants and children cannot operate the
thermometer; it is recommended that adults take the
measurement.
Reminder: Temperature readings may differ according to skin
tone and measurement distance.
Contraindications
It is not recommended for people whose measuring part has
local lesions, such as inflammation, trauma, postoperative, etc.
Instruction For Use
The patient is an intended operator. The patient can measure,
transmit data and change battery.
(1) Installing the product
Insert two batteries into the battery compartment on the
back of the device. The product will initiate a self-check and
then enter the standby mode (if the device indicates low
battery power, then replace the batteries to ensure ample
power supply).
(2) Measurement process
© Aim the thermometer probe at the center ofthe forehead
and keep the probe 1.18in (3cm) away from the forehead
(the optimal distance is about the width of an adult’s
index finger). Do not touch the forehead with the probe.
The infrared thermometer measurement window should
be held perpendicular to the forehead and the subject
should remain steady.
-<1.18in(3cm)
© Gently press the
measurement button
[ @ ] to start the
measurement.
13) The device will vibrate once a NN
reading is obtained. Once the
measurement is successful, the ONE -
reading will be displayed on $ |
the screen. The whole time is
about 1s. If the measurement is
failed, the device will not
vibrate the screen but display
[---*] instead.
Possible reasons for measurement errors include:
A. Measurement distance is greater than
1.18in (3cm);
B. Environment temperature does not
meet measurement requirements or
there is an excessively large temperature
difference;
C. Target temperature exceeds measurement range.
(3) Power off
If no more measuring is required, simply let the device sit idle
for 8 seconds to power off automatically.
(4) Unit switching
—
. When the device is powered OFF, press and hold the
measurement button for 8 seconds to enter unit switching
mode. Under this mode, both °C and °F should flash at the
same time.
2. Under this mode, press the measurement button to switch
to Fahrenheit or Celsius. The corresponding symbol of the
selected unit after switching will flash.
3. After selecting the unit, press and hold the measurement
button for 8 seconds to leave the unit switching mode.
Reminder: If you do not press and hold the measurement
button for 8 seconds to confirm the unit selected before the
screen switches off, the system will consider the switch as a
failure and retain the original unit for temperature
measurements.
(5) Installing and replacing batteries
Each time the thermometer is started, the battery will be
automatically detected. If battery capacity is low but
adequate for measurements, the low power symbol [O3] will
be displayed with the measurement results. However, if the
battery capacity is too low for measurements, the screen will
display a single, flashing [ ©] icon and automatically switch
OFF after 8 seconds. To continue using the device, old
batteries must be replaced.
(6) Replacing batteries
1. Press down and hold the battery cover with the finger and
apply some force to slide the cover backwards to open the
battery compartment.
2. Remove the old batteries and install the new batteries.
3. Refer to the battery polarity symbols to orient the batteries
properly during installation. Make sure that the new
batteries are tightly inserted into the battery compartment
and make sure that the polarity is not reversed during
installation.
4. Return the battery cover to close the battery compartment.
@ Comply with relevant national laws and regulations when
disposing of the used batteries.
@ Do not dispose of batteries directly into the trash bag.
@ Remove the batteries if the device will not be used more
than one month.
@ When using, shall not touch battery and the patient
simultaneously.
® Do not throw batteries into fire.
O The typical service life of the new and unused batteries is
3000 measurements for the operation time is 60s.
Product errors and troubleshooting
Problem Item to detect Solution
Replace old
- Battery depleted batteries with
new ones
- Batteries have been Take out the
installed with the batteries and
wrong polarity re-install them
correctly.
- Batteries are not
installed properly
- Unable to carry out Replace the
measurement as batteries
current battery
capacity is too low.
- Measurement Follow the
distance too long instruction
. manual and
. Target temperature is
repeat the
"7 beyond range of measurements
measurements 89.6°F-
109.2°F(32°C-42.9°C)
- Environment temperature
either exceeds the design
range 59°F-104°F(15°C-
40°C) or is unstable
nc : Current state: All Please contact
ni. oF symbols are flashing customer
u u on the screen. The services.
o product is not usable.
CIÓN | * Current battery Replace the
1 0) [К F capacity is too low. battery as soon
o as possible.
Body temperature
O Body temperature varies from person to person and
fluctuates during the course of the day. For this reason, it is
suggested to know one's normal, healthy forehead
temperature to correctly determine the temperature.
O Body temperature runs approximately from 95.9°F to100°F
(35.5°C-37.8°C). To determine if one has a fever, compare the
temperature detected with the person's normal temperature.
A rise over the reference body temperature of 1.8°F/1°C or
more is generally an indication of fever.
O Different measurement sites(rectal, axillary, oral, frontal,
auricular) will give different readings. Therefore it is wrong to
compare the measurement taken from different sites.
O The following are typical temperatures for adults, based on
different measurement sites:
Rectal 97.9°F-99.1°F 36.6°C to 38°C
Axillary 94.5°F-99.1°F 34.7°C to 37. 3°C
Oral 95.9°F-99.5°F 35.5°C to 37.5°C
Auricular 96.4°F-100.4°F 35.8°C to 38°C
Cleaning and Care
The thermometer is mainly for home use, if use for multiple
patients, please clean the device in between uses with the
following steps:
@ Use an alcohol swab or cotton tissue moistened with
alcohol (70% Isopropyl) to clean the thermometer casing
thoroughly,The wiping process preferably lasts 15 seconds.
O Allow at least 5 minutes drying time before taking a
temperature.
© After cleaning, if the device is not visually clean when
observed with magnification and adequate lighting, please
repeat the clean steps above.
Note 1. The cleaning steps above has been validated according
to the FDA Guidance, “Reprocessing Medical Devices in Health
Care Settings: Validation Methods and Labeling”.
Note 2. Ensure that no liquid enters the interior of the device.
Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the device in water or other
cleaning liquids.
Care the probe
—
. The probe (comprising a temperature sensor and a distance
sensor) is the most intricate part of the thermometer, and
should be kept clean and intact to acquire accurate readings.
Use the following method to clean the probe: Gently swab
the surface of the probe using a cotton bud soaked in 70%
Isopropyl.
2. If the probe (sensor) is broken, please contact customer
services.
3. The product is not waterproof. Do not clean the device with
detergents. Do not soak the thermometer in water or other
liquids.
Maintenance
=
. This company has not authorized any agency or individual
to carry out product repairs or maintenance. Do not
attempt to disassemble or modify the thermometer if you
suspect functional issues with the device.
2. The IR thermometer is an extremely precise instrument. Any
improper maintenance, disassembly, or modification may
lead to inaccuracies of the product measurements.
3. If you suspect any product issues during the warranty
period, please contact customer services for subsequent
handling.
Disposal
Dispose of the battery in accordance with the
Я regulation applicable at the place of operation.
Dispose of at public collection point in the EU
— countries - 2002/96/EC WEEE Directive.
If you have any queries, please refer to the local
authorities responsible for waste disposal.
Notes
+ Please act according to local laws for disposal of used batteries.
» Take out the battery if you are not going to use the unit for a
long time.
To protect the environment, dispose of empty
batteries at appropriate collection sites according
to national or local regulations.
Dispose of at public collection point in the EU
countries - 2006/66/EC Directive.
Operating, shipping, and storage conditions
(1) Operating conditions
Range of operating environments
Temperature: 59°F-104°F(15°C- 40°C)
Humidity: 15-95%RH, non-condensing
Atmospheric Pressure: 70kPa-106kPa
(2) Transportation / storage conditions
Temperature: -4°F-131°F(-20°C- 55°C)
Humidity: 15-95%RH, non-condensing
Atmospheric Pressure: 70kPa~106kPa
Accessories
Use only accessories provided by the original manufacturer,
and check for any missing accessories.
1 IR Thermometer 2 AAA batteries
1 Instruction manual 1 Quick user guide
Standard icons
© Symbol for “THE OPERATION GUIDE MUST BE READ”
The sign background color: blue.
The sign graphical symbol: white.
E The batteries and electronic instruments must
be disposed of in accordance
— with the locally applicable regulation, not with
domestic waste.
all Symbol for “MANUFACTURER”
Symbol for "WARNING"
Symbol for "Type BF Applied Parts"
Symbol for “SERIAL NUMBER”
Symbol for “EUROPEAN REPRESENTATIVE”
SEL
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).
Calibration
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
is on the last page.
Storage
1) Do not put the thermometer under direct
Я sunlight, high temperature, ог moist
a environments. Do not allow it to come into
contact with fire or harsh vibrations.
2) Take out the battery if the device is not used for
a long period of time.
OTHER STANDARDS AND COMPLIANCES
The Infrared No-Touch Forehead Thermometer corresponds
to the following standards: IEC 60601-1: 2005 +A1:
2012(E)/EN 60601-1: 2006/A1: 2013 (Medical electrical
equipment -- Part 1: General requirements for basic safety
and essential performance), IEC 60601-1-2: 2014 (Medical
electrical equipment — Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and Tests), ISO
80601-2-56: 2017/AC: 2018 ( Medical Electrical Equipment --
Part 2-56: Particular Requirements For The Basic Safety And
Essential Performance Of clinical thermometers for body
temperature measurement), ASTM E1965-98: 2016( Standard
Specification for Infrared Thermometers for Intermittent
Determination of Patient Temperature).
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1 - Emission limits per environment
Phenomenon Compliance Electromagnetic
environment
Conducted and | CISPR11 The device is intended
radiated RF Group 1, Class B to be used in home
emissions healthcare environment.
Harmonic IEC 61000-3-2 The device is
distortion NA powered by battery.
Voltage IEC 61000-3-3 The device is
fluctuations NA powered by battery.
and flicker
Table 2 - Enclosure Port
Basic EMC Immunity test levels
Phenomenon
standard Home Healthcare
Environment
Electrostatic +8 kV contact
Discharge IEC 61000-4-2 | | ky, +4KV, +8kV, +15kV air
10V/m
Radiated RF EM field | IEC 61000-4-3 | 80MHz-2.7GHz
80% AM at 1kHz
Proximity fields from
RF wireless | IEC 61000-4-3 | Refer to table 3
communications
equipment
Rated power 30
frequency IEC 61000-4-8 | m
magnetic fields 50Hz or 60Hz
Table 3 - Proximity fields from RF wireless communications
equipment
Test frequency | Band (MHz) Immunity test levels
(MHz) Professional healthcare facility
environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470 FM, +5kHz deviation, 1kHz sine, 28V/m
710 704-787 Pulse modulation 217Hz, 9V/m
745
780
810 800-960 Pulse modulation 18Hz, 28V/m
870
930
1720 1700-1990 | Pulse modulation 217Hz, 28V/m
1845
1970
2450 2400-2570 | Pulse modulation 217Hz, 28V/m
5240 5100-5800 | Pulse modulation 217Hz, 9V/m
5500
5785
WARRANTY
Please contact your dealer or the device center in case of a
claim under the warranty. If you have to send in the unit,
enclose a copy of your receipt with clear statement of defect
description.
The warranty terms as below:
1. The warranty period for device is one year from date of
delivery. In case of a warranty claim, the date of delivery
has to be proven by means of the sales receipt or invoice.
2. Repairs under warranty do not extend the warranty period.
3. The following cases are excluded under the warranty
@ All damage which has arisen due to improper
treatment, e.g. nonobservance of the user instruction.
@ All damage which is due to repairs or tampering by the
customer or unauthorized third parities.
@ Damage which has arisen during transport from the
manufacturer to the consumer or during transport to the
service centre.
@ Accessories which are subject to normal wear and tear.
4. Liability for direct or indirect consequential losses
caused by the unit is excluded even if the damage to the
unit is accepted as a warranty claim.
Manufactured for iHealth Labs Inc.
120 San Lucar Ct., Sunnyvale, CA 94086, USA
+1-855-816-7705
www.ihealthlabs.com
iHealthLabs Europe SAS www.ihealthlabs.eu
36 rue de Ponthieu, 75008, Paris, France
Andon Health Co., LTD.
No. 3 Jin Ping Street, Ya An Road, Nankai District,
Tianjin 300190, China.
Factory: ANDON MEDICAL CO. LTD.
Address: No.26 HangYu Road, Pilot Free Trade Zone,
Tianjin, China