INSTRUCTION MANUALFORDIGITAL EAR THERMOMETER
Model:

CTD505(Antibacterial Model)

EnglishEspañol

1801

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Do not immerse CTD505 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.
CTD505 is an adjusted mode (ear mode) clinical thermometer.
1. Follow steps in “Cleaning and Disinfection” section to clean CTD505 up.
2.
3. If the CTD505 has saved past results, the LCD screen
automatically displays the latest result. If not, skip to next step.
4.

Each measurement takes about 1 ~ 3 seconds.

– Eng 2 –

Español English

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.

– Eng 3 –

Español English

Afterwards, use the same alcohol swab to clean exterior area back and forth foranother 15 seconds (around 20 times).

Be sure to clean CTD505 up before disinfection. Please wash your hands with soap
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.

– Eng 4 –

Español English

3.

4.

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 PART0DQXIDFWXUHU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

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.
Operating ambientconditions

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 CTD505, 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
Statistic of

CLINICAL

CLINICAL BIAS

LIMITS OF

Subjects

REPEAT$%,/,7< ıU¨FE

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

Group A

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Accesorio:
Una pila de litio CR2032 de +3V/PUB$VBMRVJFSDBNCJPBSUJlDJBMFOMPT
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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.

n&TQn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).

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Zona del cuerpo
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Español English

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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)DEULFDQWH

Representante autorizado en la Comunidad
Prinsessegracht 20, 2514 AP The Hague, The Netherlands)HFKDGHIDEULFDFLyQ
1~PHURGHVHULH
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,QWHUYDORPi[LPR
SHUPLVLEOH
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

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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: 323103217

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