Citizen CTD 504 User manual

INSTRUCTION MANUAL
FOR
DIGITAL EAR THERMOMETER
Model: CTD504
(Antibacterial Model)
English
Español
1801

– Eng 1 –
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Accessory:
One +3V CR2032 Lithium Battery
Do not immerse CTD504 in water, or any other liquid.
Español English
Commutable Temperature Unit. Our default unit is Celsius. By adjust
settings, user can have Celsius or Fahrenheit unit as they see fit. See
how to switch from to (from to )page for details.

– Eng 2 –
Do not modify this equipment without authorization of the manufacturer.
The patient is an intended operator.
CTD504 is an adjusted mode (ear mode) clinical thermometer.
1. Follow steps in “Cleaning and Disinfection” section to clean CTD504 up.
Each measurement takes about 1 ~ 3 seconds.
If not, skip to next step.
2.
3.
4.
Español English

– Eng 3 –
NOTE: Do not attempt to turn CTD504 off in the process.
NOTE: Please dispose of worn-out device and batteries per local regulations.
Important Notice before Measuring
Once deleted, your data can not be restored.
ŖIn sleep, pressure on the ear may cause higher-than-normal temperature. Wait several
minutes, and then measure again.
ŖMake your external ear clean before measuring. To secure an accurate result, keep
your ear free from obstructions or excess earwax.
ŖThe measuring results took from left or right ears differ slightly. We suggest you
measure in the same ear.
ŖBefore measuring, users and CTD504 should be in a steady room for at least 30
minutes. User should also take a 30-minutes-rest after exercising beforehand.
CTD504 can store up to 12 measuring results at once. When full, CTD504 overrides the
oldest data with new one. Next time when you start CTD504 up, LCD screen automatically
displays last measuring result, with flickering
M Symbol.
Small children may choke on battery, or tiny component parts by accident.
MEMORY STORAGE
We already put one CR2032 lithium battery inside CTD504. Open battery cap as the figure.
TIPS FOR NEW USERS
Español English

– Eng 4 –
Afterwards, use the same alcohol swab to clean exterior area back and forth for another
15 seconds (around 20 times).
Be sure to clean CTD504 up before disinfection. Please wash your hands with
soap and water before disinfection.
During Cleaning and Disinfection, beware of following signs of deterioration:
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If any signs listed above occur, please contact your local distributor.
Signs of Deterioration
Español English
The CTD504 has a built-in "Fever Alert" feature.
If you have a fever between 37.5 °C - 43.0 °C (99.5 °F - 109.4 °F), the "Fever Alert"
function will inform you by a flashing result, and a series of beeps.
NOTE:
Do not use the CTD504 as a replacement for medical advice. Consult your doctor if
you have any concerns.
FEVER ALERT

– Eng 5 –
Body Site Normal Range
Oral
Axillary
Rectal
Ear
35.5 ~ 37.5 °C
95.9 ~ 99.5 °F
34.7 ~ 37.3 °C
94.5 ~ 99.1 °F
36.8 ~ 38.0 °C
98.2 ~ 100.4 °F
35.8 ~ 37.7 °C
96.4 ~ 99.9 °F
Chamberlain, J.M.,Terndrup,T.E., The ears have it. Using and
interpreting tympanic thermometers., Advance PA, February 1995.
Español English
3.

– Eng 6 –
Español English

– Eng 7 –
Español English
Temperature limitation
Degrees of protection provided by enclosures
Safety standard:
EN 60601-1 Medical electrical equipment Part 1: General requirements for basic
safety and essential performance
EMC standard:
EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
Performance standards:
EN 12470-5 Clinical thermometers - Part 5: Performance of infra-red ear
thermometers (with maximum device)

– Eng 8 –
Español English
Date of Manufacture
Manufacturer:
Prinsessegracht 20, 2514 AP The Hague, The Netherlands
Authorized Representative in the European Community:
Factory:
Health & Life (Suzhou) Co., Ltd.
No.1428 Xiang Jiang Road, Suzhou New District,
Suzhou City 215129, Jiangsu Province, China
Serial Number
Batch code
TYPE BF APPLIED PART

– Eng 9 –
Español English
Storage / Transportation
Conditions
Temperature: -25 °C ~ 55 °C (-13.0 °F ~ 131.0 °F)
Humidity: ≦95 % R.H.
Product Life 5 Years
Maximum
Permissible Range
* The contents and specifications in this manual are subject to change for
improvement without notice.
35.5 °C ~ 42.0 °C (95.9 °F ~ 107.6 °F)：± 0.2 °C / ± 0.4 °F
Other Range：± 0.3 °C / ± 0.5 °F
Temperature: 10.0 °C ~ 40.0 °C (50.0 °F ~ 104.0 °F)
Humidity: 15 % ~ 95 % R.H.
Atmospheric pressure: 700 hPa ~ 1060 hPa
Operating ambient
conditions
Display
Liquid Crystal Display
Type BF applied part

Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Not Applicable
Not Applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity
test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
discharge
± 15 kV air
discharge
± 8 kV contact
discharge
± 15 kV air
discharge
Power
frequency
magnetic field
IEC 61000-4-8
30 A/m
50 or 60 Hz 30 A/m 50 or 60 Hz
The device is intended for use in the electromagnetic environments listed below, and should
only be used in such environments:
The device is intended for use in the electromagnetic environments listed below, and should
only be used in such environments:
RF energy is used only to maintain device’s operation.
Therefore, its RF emissions are so low that it’s not likely
to cause any interference in nearby electronic equipment.
The device 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.
In the case of air discharge testing, the
climatic conditions shall be within the
following ranges:
Ambient Temperature:15°C~35°C,
Relative Humidity:30%~60%.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
Rated maximum
output power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
Not Applicable 80 MHz to 800 MHz d = 1.2 800 MHz to 2.7 GHz d = 2.3
0.01
0.1
1
10
100
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
Recommended separation distances between portable and mobile RF
communication equipment and the device.
The device is intended for use in an electromagnetic environment where radiated RF
disturbances are under control. User can help prevent electromagnetic interference by keeping
the device at a minimum distance from portable and mobile RF communications equipment
(transmitters). Below table details the maximum output power of transmitter:
For transmitters rated at a maximum output power not listed above, the recommended separation
distance din metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where Pis 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.

Immunity
test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity
fields from
RF wireless
communications
equipment
IEC 61000-4-3
3V rms
At 0.15-80 MHz
6V rms
At ISM & Radio
Amateur Freq
10 V/m at 80-2700
MHz
AM Modulation
And 9-28V/m at
385-6000MHz,
Pulse Mode and
other Modulation.
The system shall
be tested as
specified in
IEC60601-1-2
Table 9 for
proximity fields
from RF wireless
communications
equipment using
the test methods
specified in
IEC 61000-4-3
Not Applicable
10 V/m at 80-2700
MHz
AM Modulation
And 9-28V/m at
385-6000MHz,
Pulse Mode and
other Modulation.
The system shall
be tested as
specified in
IEC60601-1-2
Table 9 for
proximity fields
from RF wireless
communications
equipment using
the test methods
specified in
IEC 61000-4-3
Recommended separation
distance
d= 1.2 80 MHz to 800 MHz
d= 2.3 800 MHz to 2.7 GHz
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and should
only be used in such environments:
Portable and mobile RF
communications equipment
should be used no closer to any
part of the device, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
NOTE 1 At 80 MHz and 800 MHz, 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.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the device is used exceeds
the applicable RF compliance level above, the device should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
where Pis the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the
compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:

Statistic of subjects for Infrared Ear Thermometer
Unit:Û&
EN12470-5
Statistic of Subjects
Group A
Group B
Group C
Repeatability(≦0.3)
0.109
0.104
0.104
Mean bias(≦±0.2)
-0.088
0.017
-0.036
SD(≦0.4)
0.232
0.267
0.215
ISO 80601-2-56 for Infrared Ear Thermometer
Statistic of
Subjects
Group A
Group B
Group C
ALL
A1
A2
CLINICAL
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0.113
0.121
0.108
0.102
0.112
CLINICAL BIAS
¨FE
-0.088
-0.056
-0.105
0.017
-0.036
LIMITS OF
AGREEMENT (LA)
0.194
0.222
0.180
0.185
0.187
To prove the accuracy of CTD504, we perform clinical experiments at one hospital
by professionals on 3 groups of test subjects: new born to 1-year-old for Group A,
1-year-old to 5-year-old for Group B, and 5-year-old or above for Group C.
Each group consists of 50 effective test subjects, and at least 30 % of them are
febrile, with the exception for those who are under 3-month-old.
All clinical test procedures are performed in compliance with EN 12470-5 and ISO
80601-2-56.

n&TQn
Español English
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Accesorio:
Una pila de litio CR2032 de +3V
No sumerja la unidad CTD504 en agua ni en ningún otro líquido.
Unidad de temperatura conmutable. Nuestra unidad predeterminada es el grado
centígrado. Mediante el ajuste de la configuración, el usuario puede disponer de la
unidad de grados centígrados o Fahrenheit según le parezca. Para obtener detalles,
consulte la página sobre cómo cambiar de a (de a ).

n&TQn
No modifique este equipo sin la autorización del fabricante.
La unidad está pensada para que la utilice el paciente.
La unidad CTD504 es un termómetro clínico de modo ajustado (modo auditivo).
1. Siga los pasos de la sección “Limpieza y desinfección” para limpiar la unidad CTD504.
Cada medición tarda entre 1 y 3 segundos.
Si no, salte al paso siguiente.
2.
3.
4.
Español English

n&TQn
NOTA: Deshágase del dispositivo y las pilas utilizados según las normativas locales.
Su CTD504 ya incluye una pila de litio CR2032. Abra la tapa de la pila según se muestra en la figura.
SUGERENCIAS PARA NUEVOS USUARIOS
Los niños pequeños pueden ahogarse con la pila o con componentes pequeños por accidente.
Una vez eliminados, los datos no se pueden restaurar.
NOTA: No apague su CTD504 durante el proceso.
Aviso importante antes de realizar la medición
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Espere varios minutos y, a continuación, vuelva a realizar la medición.
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mantenga el oído despejado y sin cerumen.
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Le recomendamos realizar la medición en el mismo oído.
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una sala estable durante al menos 30 minutos. El usuario también debe descansar previamente
durante 30 minutos después de hacer ejercicio.
La unidad CTD504 puede almacenar hasta 12 resultados de medición simultáneamente.
Cuando se llena, la unidad CTD504 sobrescribe los datos más antiguos con los nuevos.
La próxima vez que encienda su CTD504, la pantalla LCD mostrará automáticamente el
resultado de la última medición, con el símbolo Mparpadeando.
ALMACENAMIENTO EN MEMORIA
Español English

n&TQn
Después, utilice un bastoncillo humedecido en alcohol para limpiar el área exterior hacia
atrás y hacia delante durante otros 15 segundos (unas 20 veces).
Asegúrese de limpiar la unidad CTD504 antes de realizar la desinfección.
Lávese las manos con jabón y agua antes de realizar la desinfección.
Durante la limpieza y desinfección, sea consciente de los siguientes síntomas de deterioro:
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Ŗ0QUGRWGFGOGFKT
Si se produce alguno de los síntomas enumerados anteriormente, póngase en contacto con
su distribuidor local.
Síntomas de deterioro
Español English
El CTD504 cuenta con una función integrada de "Aviso de fiebre".
Si su temperatura se encuentra entre 37,5 °C - 43,0 °C (99,5 °F - 109,4 °F), la función
"Aviso de fiebre" le informará mediante un resultado parpadeante, y varios pitidos.
AVISO DE FIEBRE

n&TQn
Intervalo normalZona del cuerpo
Boca
Axila
Recto
Oído
35.5 ~ 37.5 °C
95.9 ~ 99.5 °F
34.7 ~ 37.3 °C
94.5 ~ 99.1 °F
36.8 ~ 38.0 °C
98.2 ~ 100.4 °F
35.8 ~ 37.7 °C
96.4 ~ 99.9 °F
Chamberlain, J.M.,Terndrup,T.E., Los oídos los tienen.
Uso e interpretación de los termómetros timpánicos.,
Advance PA. Febrero de 1995.
Español English
3.

n&TQn
Español English