Citizen CTD 505 User manual

INSTRUCTION MANUAL
FOR
DIGITAL EAR THERMOMETER
Model: CTD505
(Antibacterial Model)
English
Español
1801

– Eng 1 –
/PUF"OZBSUJlDJBMDIBOHFTUPUIFPSJHJOBM
HPPETNBZSFTVMUJONFBTVSFNFOUFSSPS
Accessory:
One +3V CR2032 Lithium Battery
Do not immerse CTD505 in water, or any other liquid.
Español English

– Eng 2 –
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.
Each measurement takes about 1 ~ 3 seconds.
3. If the CTD505 has saved past results, the LCD screen
automatically displays the latest result. If not, skip to next step.
4.
Español English

– Eng 3 –
Small children may choke on battery, or tiny component parts by accident.
Note: Please dispose of worn-out device and batteries per local regulations.
Once deleted, your data can not be restored.
Español English

– Eng 4 –
Be sure to clean CTD505 up before disinfection. Please wash your hands with soap
Afterwards, use the same alcohol swab to clean exterior area back and forth for
another 15 seconds (around 20 times).
and water before disinfection.
During Cleaning and Disinfection, beware of following signs of deterioration:
If any signs listed above occur, please contact your local distributor.
Signs of Deterioration
Ŗ)NQUU[UWTHCEGQH%6&DNWTU
Ŗ0QTGCEVKQPCVCNNVQYCTFQRGTCVKPI
Ŗ+PFGNKDNGYCVGTUVCKPQPVJG.%&UETGGP
Ŗ7PCDNGVQOGCUWTG
Español English

– Eng 5 –
3.
4.
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

– Eng 6 –
Español English

– Eng 7 –
Español English
Degrees of protection provided by enclosures
Temperature limitation
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 –
TYPE BF APPLIED PART
Date of Manufacture
Prinsessegracht 20, 2514 AP The Hague, The Netherlands
Serial Number
Español English
Factory:
Health & Life (Suzhou) Co., Ltd.
No.1428 Xiang Jiang Road, Suzhou New District,
Suzhou City 215129, Jiangsu Province, China
Batch code
0DQXIDFWXUHU
Authorized Representative in the European Community:

Type BF applied part
– Eng 9 –
Product Life 5 Years
* The contents and specifications in this manual are subject to change for
improvement without notice.
Español English
Display
Liquid Crystal Display
Maximum
Permissible Range
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
Operating ambient
conditions
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
Conditions
Temperature: -25 °C ~ 55 °C (-13.0 °F ~ 131.0 °F)
Humidity: ≦95 % R.H.

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:

To prove the accuracy of CTD505, 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.
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
REPEAT$%,/,7<ıU
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

n&TQn
/PUB$VBMRVJFSDBNCJPBSUJlDJBMFOMPT
BSUÀDVMPTPSJHJOBMFTQPESÀBQSPWPDBS
VOFSSPSFOMBNFEJDJÅO
Accesorio:
Una pila de litio CR2032 de +3V
1RVXPHUMDODXQLGDG&7'HQDJXDQLHQQLQJ~QRWUROtTXLGR
Español English

n&TQn
1RPRGLILTXHHVWHHTXLSRVLQODDXWRUL]DFLyQGHOIDEULFDQWH
/DXQLGDGHVWiSHQVDGDSDUDTXHODXWLOLFHHOSDFLHQWH
/DXQLGDG&7'HVXQWHUPyPHWURFOtQLFRGHPRGRDMXVWDGRPRGRDXGLWLYR
 6LJDORVSDVRVGHODVHFFLyQ³/LPSLH]D\GHVLQIHFFLyQ´SDUDOLPSLDUODXQLGDG&7'

&DGDPHGLFLyQWDUGDHQWUH\VHJXQGRV

6LQRVDOWHDOSDVRVLJXLHQWH

Español English

n&TQn
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.
Español English
Una vez eliminados, los datos no se pueden restaurar.

n&TQn
$VHJ~UHVHGHOLPSLDUODXQLGDG&7'DQWHVGHUHDOL]DUODGHVLQIHFFLyQ
/iYHVHODVPDQRVFRQMDEyQ\DJXDDQWHVGHUHDOL]DUODGHVLQIHFFLyQ
'XUDQWHODOLPSLH]D\GHVLQIHFFLyQVHDFRQVFLHQWHGHORVVLJXLHQWHVVtQWRPDVGHGHWHULRUR
Ć/DVXSHUILFLHEULOODQWHGHVX&7'VHYXHOYHERUURVD
Ć$XVHQFLDGHUHDFFLyQDODVRSHUDFLRQHV
Ć0DQFKDGHDJXDLQGHOHEOHHQODSDQWDOOD/&'
Ć1RVHSXHGHPHGLU
6LVHSURGXFHDOJXQRGHORVVtQWRPDVHQXPHUDGRVDQWHULRUPHQWHSyQJDVHHQFRQWDFWRFRQ
VXGLVWULEXLGRUORFDO
6tQWRPDVGHGHWHULRUR
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).

n&TQn

Zona del cuerpo Intervalo normal
%RFD
$[LOD
5HFWR
2tGR
aĈ&
aĈ)
aĈ&
aĈ)
aĈ&
aĈ)
aĈ&
aĈ)
&KDPEHUODLQ-07HUQGUXS7(/RVRtGRVORVWLHQHQ
8VRHLQWHUSUHWDFLyQGHORVWHUPyPHWURVWLPSiQLFRV
$GYDQFH3$)HEUHURGH
Español English

n&TQn
Español English