INSTRUCTION MANUALFORDIGITAL EAR THERMOMETER
Model:

CTD504(Antibacterial Model)

EnglishEspañol

1801

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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.

Do not immerse CTD504 in water, or any other liquid.

– Eng 1 –Español English

Accessory:
One +3V CR2032 Lithium Battery

Español English

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.
2.
3.

If not, skip to next step.

4.

Each measurement takes about 1 ~ 3 seconds.

– Eng 2 –

Important Notice before Measuring
Ŗ In sleep, pressure on the ear may cause higher-than-normal temperature. Wait several
minutes, and then measure again.
Ŗ Make your external ear clean before measuring. To secure an accurate result, keep
your ear free from obstructions or excess earwax.
Ŗ The measuring results took from left or right ears differ slightly. We suggest you
measure in the same ear.
Ŗ Before 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.

MEMORY STORAGE

CTD504 can store up to 12 measuring results at once. When full, CTD504 overrides theoldest data with new one. Next time when you start CTD504 up, LCD screen automaticallydisplays last measuring result, with flickering M Symbol.

Once deleted, your data can not be restored.

Small children may choke on battery, or tiny component parts by accident.

NOTE: Please dispose of worn-out device and batteries per local regulations.

TIPS FOR NEW USERS

We already put one CR2032 lithium battery inside CTD504. Open battery cap as the figure.
– Eng 3 –Español English

NOTE: Do not attempt to turn CTD504 off in the process.

Español English

Afterwards, use the same alcohol swab to clean exterior area back and forth for another15 seconds (around 20 times).

Be sure to clean CTD504 up before disinfection. Please wash your hands withsoap and water before disinfection.
Signs of Deterioration
During Cleaning and Disinfection, beware of following signs of deterioration:Ŗ)NQUU[UWTHCEGQH%6&DNWTU
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If any signs listed above occur, please contact your local distributor.

FEVER ALERTThe 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.
– Eng 4 –

Español English

3.

Body Site
Oral
Axillary
RectalEar

Normal Range
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 andinterpreting tympanic thermometers., Advance PA, February 1995.

– Eng 5 –– Eng 6 –Español English

Español English

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)

Temperature limitation
Degrees of protection provided by enclosures– Eng 7 –

Español English

TYPE BF APPLIED PART

Manufacturer:

Authorized Representative in the European Community:
Prinsessegracht 20, 2514 AP The Hague, The Netherlands
Date of Manufacture
Serial Number
Batch code

Factory:
Health & Life (Suzhou) Co., Ltd.
No.1428 Xiang Jiang Road, Suzhou New District,Suzhou City 215129, Jiangsu Province, China– Eng 8 –

Español English

Maximum
Permissible Range
Display

Operating ambientconditions

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
Liquid Crystal Display

Temperature: 10.0 °C ~ 40.0 °C (50.0 °F ~ 104.0 °F)
Humidity: 15 % ~ 95 % R.H.
Atmospheric pressure: 700 hPa ~ 1060 hPa

Storage / Transportation Temperature: -25 °C ~ 55 °C (-13.0 °F ~ 131.0 °F)
Conditions
Humidity: ≦ 95 % R.H.
Type BF applied part
Product Life

5 Years* The contents and specifications in this manual are subject to change for
improvement without notice.

– Eng 9 – Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environments listed below, and should
only be used in such environments:
Emissions test

ComplianceElectromagnetic environment – guidance

RF emissions
CISPR 11

Group 1

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.

RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3Class B
Not Applicable
Not Applicable

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 fordomestic purposes.

 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:
Immunitytest

IEC 60601
test level

Compliance
level

Electromagnetic environment –guidance

Electrostatic
discharge(ESD)
IEC 61000-4-2± 8 kV contact
discharge± 8 kV contact
discharge± 15 kV air
discharge± 15 kV air
discharge

In the case of air discharge testing, theclimatic conditions shall be within thefollowing ranges:
Ambient Temperature:15°C~35°C,
Relative Humidity:30%~60%.

30 A/m50 or 60 Hz

30 A/m50 or 60 Hz

Powerfrequency
magnetic field
IEC 61000-4-8

Power frequency magnetic fields
should be at levels characteristic of atypical location in a typical commercial
or hospital environment.



Recommended separation distances between portable and mobile RFcommunication 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:
Separation distance according to frequency of transmitter
Rated maximumm
output power
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.7 GHzof transmitter
Not Applicabled = 1.2
d = 2.3
W
0.01
Not Applicable
0.12
0.23
0.1
Not Applicable
0.38
0.73
1
Not Applicable
1.2
2.3
10
Not Applicable
3.8
7.3
100
Not Applicable
1223
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 thetransmitter, 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 affectedby absorption and reflection from structures, objects and people.

 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:
Immunity
test
Conducted RF
IEC 61000-4-6

IEC 60601
test level
3V rms
At 0.15-80 MHz
6V rmsAt ISM & Radio
Amateur Freq

Compliancelevel
Not Applicable

Radiated RF
IEC 61000-4-3

10 V/m at 80-2700
MHz

10 V/m at 80-2700
MHz

Proximity
fields fromRF wirelesscommunications
equipment
IEC 61000-4-3

AM Modulation
And 9-28V/m at
385-6000MHz,
Pulse Mode andother Modulation.
The system shallbe tested as
specified in
IEC60601-1-2
Table 9 forproximity fields
from RF wirelesscommunications
equipment using
the test methods
specified in
IEC 61000-4-3

AM Modulation
And 9-28V/m at
385-6000MHz,
Pulse Mode andother Modulation.
The system shallbe tested as
specified in
IEC60601-1-2
Table 9 forproximity fields
from RF wirelesscommunications
equipment using
the test methods
specified in
IEC 61000-4-3

Electromagnetic
environment – guidancePortable and mobile RFcommunications equipment
should be used no closer to any
part of the device, including
cables, than the recommended
separation distance calculated
from the equation applicable tothe frequency of the transmitter.
Recommended separation
distanced = 1.2
80 MHz to 800 MHz
d = 2.3
800 MHz to 2.7 GHz
where P is the maximum output
power rating of the transmitter inwatts (W) according to thetransmitter manufacturer and dis the recommended separation
distance in metres (m).
Field strengths from fixed RF
transmitters, as determined byan electromagnetic site survey,ashould be less than thecompliance level in eachfrequency range.b
Interference may occur in thevicinity of equipment marked
with the following symbol:

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 isaffected 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 beconsidered. 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.

To prove the accuracy of CTD504, we perform clinical experiments at one hospitalby 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.

Statistic of subjects for Infrared Ear Thermometer
EN12470-5
Statistic of Subjects

Repeatability(≦0.3)

Mean bias(≦±0.2)

SD(≦0.4)

Group A

0.109

-0.0880.232

Group B

0.104

0.017

0.267

Group C

0.104

-0.036

0.215

ISO 80601-2-56 for Infrared Ear Thermometer
CLINICAL
5(3($7$%,/,7< ıU

CLINICAL BIAS
¨FE

LIMITS OF
AGREEMENT (LA)

ALL

0.113

-0.088

0.194

A1

0.121

-0.056

0.222

A2

0.108

-0.1050.180Group B

0.102

0.017

0.185

Group C

0.112

-0.036

0.187

Statistic ofSubjects

Group A

Unit:Û&Unidad de temperatura conmutable. Nuestra unidad predeterminada es el grado
centígrado. Mediante el ajuste de la configuración, el usuario puede disponer de launidad de grados centígrados o Fahrenheit según le parezca. Para obtener detalles,
consulte la página sobre cómo cambiar de a (de a ).

No sumerja la unidad CTD504 en agua ni en ningún otro líquido.

n&TQnEspañol English

Accesorio:
Una pila de litio CR2032 de +3V/PUB$VBMRVJFSDBNCJPBSUJlDJBMFOMPT
BSUÀDVMPTPSJHJOBMFTQPESÀBQSPWPDBSVOFSSPSFOMBNFEJDJÅOEspañol English

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.
2.
3.
Si no, salte al paso siguiente.
4.

Cada medición tarda entre 1 y 3 segundos.

n&TQn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.
Ŗ#PVGUFGTGCNK\CTNCOGFKEKÎPVCPVQNQUWUWCTKQUEQOQGNFKURQUKVKXQ%6&FGDGPRGTOCPGEGTGP
una sala estable durante al menos 30 minutos. El usuario también debe descansar previamentedurante 30 minutos después de hacer ejercicio.

ALMACENAMIENTO EN MEMORIA

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 M parpadeando.

Una vez eliminados, los datos no se pueden restaurar.

Los niños pequeños pueden ahogarse con la pila o con componentes pequeños por accidente.

NOTA: Deshágase del dispositivo y las pilas utilizados según las normativas locales.

SUGERENCIAS PARA NUEVOS USUARIOSSu CTD504 ya incluye una pila de litio CR2032. Abra la tapa de la pila según se muestra en la figura.
n&TQnEspañol English

NOTA: No apague su CTD504 durante el proceso.

Español English

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.
Síntomas de deterioro
Durante la limpieza y desinfección, sea consciente de los siguientes síntomas de deterioro:Ŗ.CUWRGTHKEKGDTKNNCPVGFGUW%6&UGXWGNXGDQTTQUC
Ŗ#WUGPEKCFGTGCEEKÎPCNCUQRGTCEKQPGUŖ/CPEJCFGCIWCKPFGNGDNGGPNCRCPVCNNC.%&Ŗ0QUGRWGFGOGFKTSi se produce alguno de los síntomas enumerados anteriormente, póngase en contacto con
su distribuidor local.

AVISO DE FIEBREEl 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.
n&TQnEspañol English

3.

Zona del cuerpo
Boca
Axila
Recto
Oído

Intervalo normal
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.
n&TQn

n&TQn

Español English

Español English

Normativa de seguridad:
EN 60601-1 Equipos electromédicos, Parte 1: Requisitos generales para laseguridad básica y funcionamiento esencial
Normativa EMC:
EN 60601-1-2 Equipos electromédicos, Parte 1-2: Requisitos generales para laseguridad básica y características de funcionamiento esencial, Norma colateral:
Perturbaciones electromagnéticas; Requisitos y ensayos
Normativas de rendimiento:
EN 12470-5 Termómetros clínicos. Parte 5: Funcionamiento de los termómetros deoído por infrarrojos (con dispositivo de máxima)

Limitación de temperatura
Grados de protección que ofrecen las carcasasn&TQnEspañol English

PARTE APLICADA DE TIPO BF

Fabricante:

Representante autorizado en la Comunidad
Prinsessegracht 20, 2514 AP The Hague, The Netherlands
Fecha de fabricación
Número de serie
Código de lote

Fábrica:
Health & Life (Suzhou) Co., Ltd.
No.1428 Xiang Jiang Road, Suzhou New District,Suzhou City 215129, Jiangsu Province, Chinan&TQnEspañol English

Intervalo máximo
permisible
Pantalla

35,5 °C ~ 42,0 °C (95,9 °F ~ 107,6 °F): ± 0,2 °C / ± 0,4 °F
Otro intervalo: ± 0,3 °C / ± 0,5 °F
Pantalla de cristal líquido

Condiciones
medioambientales defuncionamiento

Temperatura: 10.0 °C ~ 40.0 °C (50.0 °F ~ 104.0 °F)
Humedad: 15 % ~ 95 % R.H.
Presión atmosférica: 700 hPa ~ 1060 hPa

Condiciones
de transporte/
almacenamiento

Temperatura: -25 °C ~ 55 °C (-13.0 °F ~ 131.0 °F)
Humedad: ≦ 95 % R.H.
Parte aplicada de tipo BF

Vida útil del producto

5 años* El contenido y las especificaciones de este manual están sujetos a cambios parasu mejora sin previo aviso.
n&TQn6-1-12, Tanashi-cho, Nishi-Tokyo-shi,
Tokyo 188-8511, Japan
E-mail: sales-oe@systems.citizen.co.jp
http://www.citizen-systems.co.jp/

VER: 001

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P/N: 323103214

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