Instructions

9392
ΞΗϧϣϟ΍ ΕΎϔλ΍ϭϣ
(ΕϳΎϬϧέϬϓ ΔΟέΩ 108-93,2) Δϳϭ΋ϣ ΔΟέΩ 42,2-34 :Δοϭέόϣϟ΍ Γέ΍έΣϟ΍ ΔΟέΩ ϕΎρϧ
(ΕϳΎϬϧέϬϓ ΔΟέΩ 104-50) Δϳϭ΋ϣ ΔΟέΩ 40-10 :ϝϳϐηΗϟ΍ ρϳΣϣ Γέ΍έΣ ΔΟέΩ ϕΎρϧ
(ΕϳΎϬϧέϬϓ ΔΟέΩ 131–13-) Δϳϭ΋ϣ ΔΟέΩ 55–25- :ϥϳίΧΗϟ΍ Γέ΍έΣ ΔΟέΩ ϕΎρϧ
(ϑϳΛϛΗ ϥϭΩ) %95-10 ΔϳΑγϧ ΔΑϭρέ :ϥϳίΧΗϟ΍ϭ ϝϳϐηΗϠϟ ΔϳΑγϧϟ΍ ΔΑϭρέϟ΍
ΕϳΎϬϧέϬϓ ϭ΃ Δϳϭ΋ϣ ΔΟέΩ 0.1 :νέόϟ΍ ΔϗΩ
ϱέΑΧϣϟ΍ ΄ρΧϠϟ ϰλϗϷ΍ ΩΣϟ΍ Δοϭέόϣϟ΍ Γέ΍έΣϟ΍ ΔΟέΩ ϕΎρϧ ΔϗΩ
Δϳϭ΋ϣ ΔΟέΩ
42-Δϳϭ΋ϣ ΔΟέΩ 35
(ΕϳΎϬϧέϬϓ ΔΟέΩ 0,4 ±) Δϳϭ΋ϣ ΔΟέΩ 0,2 ± :(ΕϳΎϬϧέϬϓ ΔΟέΩ 107,6-ΕϳΎϬϧέϬϓ ΔΟέΩ 95)
(ΕϳΎϬϧέϬϓ ΔΟέΩ 0,5 ±) Δϳϭ΋ϣ ΔΟέΩ 0,3 ± :ϕΎρϧϟ΍ ΍Ϋϫ ΝέΎΧ
(ΕϳΎϬϧέϬϓ ΔΟέΩ 0,26 ±) Δϳϭ΋ϣ ΔΟέΩ 0,14 ± :ϲϛϳϧϳϠϛϹ΍ ΩΩέΗϟ΍
αΎϳϗ
600/ϥΎϣΎϋ :ΔϳέΎρΑϟ΍ έϣϋ
Ε΍ϭϧγ
5 :ΔϣΩΧϟ΍ έϣϋ
ϱϭΟ ρϐο 1 ϰϟ· ϝλϳ ϱϭΟ ρϐο Ε΍Ϋ ΕΎϋΎϔΗέ΍ Ωϧϋ ϭ΃ ϱϭΟ ρϐο 1 Ωϧϋ ϝϣόϠϟ ιλΧϣ ΍Ϋϫ Γέ΍έΣϟ΍ αΎϳϘϣ
.(ϝΎϛγΎΑ ϭΗϛϫ 1060 – 700)
ϡ΍ΩΧΗγϻ΍ ΕΎϣϳϠόΗ έυϧ΍
ΔϘΑρϣ ϊρϗ ϊϣ ίΎϬΟϟ΍
BF ωϭϧϟ΍ ϥϣ
10 °C
40 °C
ϝϳϐηΗϟ΍ Γέ΍έΣ ΔΟέΩ
Ύ
˱
ϓΎΟ ϪϘΑ΃
ϥϳίΧΗϟ΍ Γέ΍έΣ ΔΟέΩ
.έΎόη· ϥϭΩ έϳϳϐΗϠϟ Δοέϋ
:ΔϳϟΎΗϟ΍ έϳϳΎόϣϠϟ ίΎϬΟϟ΍ ΍Ϋϫ ϝΛΗϣϳ
Standard Reference Edition Title:
EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with
maximum device).
EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
EN ISO 14971: 2014 Medical devices – Application of risk management to medical devices.
EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process.
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
EN 980: 2008 Symbols for use in labeling of medical devices.
EN 1041: 2008 Information supplied by the manufacturer of medical devices.
EN 60601-1-11: 2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and
essential performance -- Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment.
ΔϳΑϭέϭϷ΍ ΔϧΟϠϟ΍ ΔϘϳΛϭ ρϭέηϟ ΞΗϧϣϟ΍ ΍Ϋϫ ϝΛΗϣϳ
ΕΎΑϠρΗϣϟ ϲϠϳλϔΗ ϑλϭϟ .ϲγϳρΎϧϐϣϭέϬϛϟ΍ ϕϓ΍ϭΗϟΎΑ ϕϠόΗϳ Ύϣϳϓ ΔλΎΧ Δϳ΋Ύϗϭ έϳΑ΍ΩΗ ϰϟ· ΝΎΗΣΗ Δϳ΋ΎΑέϬϛϟ΍ ΔϳΑρϟ΍ ΓίϬΟϷ΍
.(ϥΎϣοϟ΍ ΔϗΎρΑ έυϧ΍) ϙΑ ιΎΧϟ΍ ΩϣΗόϣϟ΍ ϲϠΣϣϟ΍ ΔϣΩΧϟ΍ ίϛέϣΑ ϝΎλΗϻΎΑ ϝοϔΗ (
EMC) ϲγϳρΎϧϐϣϭέϬϛϟ΍ ϕϓ΍ϭΗϟ΍
.ΔϳΑέϬϛϟ΍ ΔϳΑρϟ΍ ΓίϬΟϷ΍ ϰϠϋ έΛ΅Η ϥ΃ ϱϭϳΩ΍έϟ΍ ΩΩέΗϟ΍ Ε΍Ϋ ΔϠϘϧΗϣϟ΍ ϝΎλΗϻ΍ ΓίϬΟ΃ϭ ΔϟϭϣΣϣϟ΍ ϝΎλΗϻ΍ ΓίϬΟϷ ϥϛϣϳ
.Ϫϣ΍ΩΧΗγ΍ έϣϋ ΔϳΎϬϧ ϲϓ Δϳϟίϧϣϟ΍ ΕΎϳΎϔϧϟ΍ ϲϓ ΞΗϧϣϟ΍ ϥϣ ιϠΧΗϟ΍ ϡΩϋ ϰΟέϳ
.ΔϳϠΣϣϟ΍ ϭ΃ Δϳϧρϭϟ΍ ΢΋΍ϭϠϟ Ύ
˱
ϘΑρ Δϣ΋ϼϣϟ΍ ϊϣΟϟ΍ ϊϗ΍ϭϣ ϲϓ ΔϏέΎϔϟ΍ ΕΎϳέΎρΑϟ΍ ϥϣ ιϠΧΗ ˬΔ΋ϳΑϟ΍ ΔϳΎϣΣϟ
ΔϳγϳρΎϧϐϣϭέϬϛϟ΍ ΕΎΛΎόΑϧϻ΍ - Δό

ϧλ
˵
ϣϟ΍ Δϛέηϟ΍ ϥΎϳΑϭ ϱΩΎηέϹ΍ ϝϳϟΩϟ΍
.ϩΎϧΩ΃ ΓΩΩΣϣϟ΍ ΔϳγϳρΎϧϐϣϭέϬϛϟ΍ Δ΋ϳΑϟ΍ ϲϓ ϡ΍ΩΧΗγϼϟ Ωό
˵
ϣ ΍Ϋϫ IRT 6520/6020 ϲ΋ΎΑέϬϛϟ΍ ϲΑρϟ΍ ίΎϬΟϟ΍
.Δ΋ϳΑϟ΍ ϩΫϫ ϲϓ Ϫϣ΍ΩΧΗγ΍ ϰϠϋ IRT 6520/6020 ϲ΋ΎΑέϬϛϟ΍ ϲΑρϟ΍ ίΎϬΟϟ΍ ϡΩΧΗγϣ ϭ΃ ϝϳϣόϟ΍ ιέΣϳ ϥ΃ ΏΟϳ
ΕΎΛΎόΑϧϻ΍ έΎΑΗΧ΍ϕϓ΍ϭΗϟ΍ϱΩΎηέϹ΍ ϝϳϟΩϟ΍ - ΔϳγϳρΎϧϐϣϭέϬϛϟ΍ Δ΋ϳΑϟ΍
ΩΩέΗϟ΍ Ε΍Ϋ ΕΎΛΎόΑϧϻ΍
CISPR 11 ˬϱϭϳΩ΍έϟ΍
1 ΔϋϭϣΟϣϟ΍
˯΍ΩϷ ϱϭϳΩ΍έ ΩΩέΗ Ε΍Ϋ ΔϗΎρ ϲ΋ΎΑέϬϛϟ΍ ϲΑρϟ΍ ίΎϬΟϟ΍ ΍Ϋϫ ϡΩΧΗγϳ
ϱϭϳΩ΍έϟ΍ ΩΩέΗϟ΍ Ε΍Ϋ ΕΎΛΎόΑϧϻ΍ ϥΈϓ ϡΛ ϥϣϭ .ρϘϓ ΔϳϠΧ΍Ωϟ΍ ϪΗϔϳυϭ
ίΎϬΟ ϱ΃ ϊϣ ϝΧ΍ΩΗ ϱ΃ ΏΑγΗ ϥ΃ ΢Οέϳ ϻϭ ΍
˱
ΩΟ ΔϠϳϠϗ ϥϭϛΗ Ϫϧϣ ΔϘϠρϧϣϟ΍
.Ώϳέϗ ϲϧϭέΗϛϟ·
ΩΩέΗϟ΍ Ε΍Ϋ ΕΎΛΎόΑϧϻ΍
CISPR 11 ˬϱϭϳΩ΍έϟ΍
Ώ Δ΋ϔϟ΍ϕϓ΍ϭΗϣ
ΔγϧΎΟΗϣϟ΍ ΕΎΛΎόΑϧϻ΍
IEC 61000-3-2
ϕΑρϧϳ ϻ
.ΔϗΎρϠϟ έΩλϣϛ ρϘϓ ΕΎϳέΎρΑϟ΍ ϰϠϋ ϲ΋ΎΑέϬϛϟ΍ ϲΑρϟ΍ ίΎϬΟϟ΍ ΍Ϋϫ ΩϣΗόϳ
ΕΎΛΎόΑϧϻ΍/ΩϬΟϟ΍ ΕΎΑϠϘΗ
Δοϣ΍ϭϟ΍
ϕΑρϧϳ ϻ
ΓΎϳΣϠϟ Δϣϋ΍Ωϟ΍ έϳϏ ΓίϬΟϸϟ ΔϠλΎϔϟ΍ ΔϓΎγϣϟ΍ ΏΎγΣ
(έΗϣ/Εϟϭϓ 3 / ϊΑέϣ ργϭΗϣ έΫΟ Εϟϭϓ 3 ϕϓ΍ϭΗ)
ΔΟέΎΧϟ΍ ΔϗΎρϠϟ έϳΩϘΗ ϰλϗ΃
(Ε΍ϭϟΎΑ) ϝΎγέϹ΍ ίΎϬΟ ϥϣ
(έΗϣϟΎΑ) ϝΎγέϹ΍ ίΎϬΟ ΩΩέΗϟ Ύ
˱
Ϙϓϭ ΔϠλΎϔϟ΍ ΔϓΎγϣϟ΍
80 ϰϟ· ίΗέϫ ϭϠϳϛ 150
ϲϓ ίΗέϫ ΎΟϳϣ
ΔϳϛϠγϼϟ΍ ΕΎϗΎρϧϟ΍
ΔϳϣϠόϟ΍ϭ ΔϳϋΎϧλϟ΍
(ISM) ΔϳΑρϟ΍ϭ
ίΗέϫ ΎΟϳϣ 80
ΎΟϳϣ 800 ϰϟ·
ίΗέϫ
ίΗέϫ ΎΟϳΟ 2,5 ϰϟ· ίΗέϫ ΎΟϳϣ 800
0,01
0,120,120,23
0,1
0,370,370,74
1
1,171,172,33
10
3,693,697,38
100
11,6711,6723,33
d = [
3,5
] P
V
1
d = [
3,5
] P
E
1
d = [
7
] P
E
1