Braun ThermoScan IRT 6020 Manual page 48

‫ﺍﻟﺩﻟﻳﻝ ﺍﻹﺭﺷﺎﺩﻱ ﻭﺑﻳﺎﻥ ﺍﻟﺷﺭﻛﺔ ﺍﻟ ﻣ ُ ﺻ ﻧ ﱢ ﻌﺔ - ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ‬
.‫ﻫﺫﺍ ﻣ ُﻌﺩ ﻟﻼﺳﺗﺧﺩﺍﻡ ﻓﻲ ﺍﻟﺑﻳﺋﺔ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﺍﻟﻣﺣﺩﺩﺓ ﺃﺩﻧﺎﻩ‬
.‫ﻋﻠﻰ ﺍﺳﺗﺧﺩﺍﻣﻪ ﻓﻲ ﻫﺫﻩ ﺍﻟﺑﻳﺋﺔ‬ ‫ﻳﺟﺏ ﺃﻥ ﻳﺣﺭﺹ ﺍﻟﻌﻣﻳﻝ ﺃﻭ ﻣﺳﺗﺧﺩﻡ ﺍﻟﺟﻬﺎﺯ ﺍﻟﻁﺑﻲ ﺍﻟﻛﻬﺭﺑﺎﺋﻲ‬
IRT 6520/6020
‫ﺍﻟﺑﻳﺋﺔ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ - ﺍﻟﺩﻟﻳﻝ ﺍﻹﺭﺷﺎﺩﻱ‬
‫ﻳﺳﺗﺧﺩﻡ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﺍﻟﻁﺑﻲ ﺍﻟﻛﻬﺭﺑﺎﺋﻲ ﻁﺎﻗﺔ ﺫﺍﺕ ﺗﺭﺩﺩ ﺭﺍﺩﻳﻭﻱ ﻷﺩﺍء‬
‫ﻭﻅﻳﻔﺗﻪ ﺍﻟﺩﺍﺧﻠﻳﺔ ﻓﻘﻁ. ﻭﻣﻥ ﺛﻡ ﻓﺈﻥ ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺫﺍﺕ ﺍﻟﺗﺭﺩﺩ ﺍﻟﺭﺍﺩﻳﻭﻱ‬
‫ﺍﻟﻣﻧﻁﻠﻘﺔ ﻣﻧﻪ ﺗﻛﻭﻥ ﻗﻠﻳﻠﺔ ﺟ ﺩ ً ﺍ ﻭﻻ ﻳﺭﺟﺢ ﺃﻥ ﺗﺳﺑﺏ ﺃﻱ ﺗﺩﺍﺧﻝ ﻣﻊ ﺃﻱ ﺟﻬﺎﺯ‬
.‫ﺇﻟﻛﺗﺭﻭﻧﻲ ﻗﺭﻳﺏ‬
‫ﻣﺗﻭﺍﻓﻕ‬
.‫ﻳﻌﺗﻣﺩ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﺍﻟﻁﺑﻲ ﺍﻟﻛﻬﺭﺑﺎﺋﻲ ﻋﻠﻰ ﺍﻟﺑﻁﺎﺭﻳﺎﺕ ﻓﻘﻁ ﻛﻣﺻﺩﺭ ﻟﻠﻁﺎﻗﺔ‬
‫ﺣﺳﺎﺏ ﺍﻟﻣﺳﺎﻓﺔ ﺍﻟﻔﺎﺻﻠﺔ ﻟﻸﺟﻬﺯﺓ ﻏﻳﺭ ﺍﻟﺩﺍﻋﻣﺔ ﻟﻠﺣﻳﺎﺓ‬
(‫ﻓﻭﻟﺕ/ﻣﺗﺭ‬ / ‫ﻓﻭﻟﺕ ﺟﺫﺭ ﻣﺗﻭﺳﻁ ﻣﺭﺑﻊ‬
3
(‫ﺍﻟﻣﺳﺎﻓﺔ ﺍﻟﻔﺎﺻﻠﺔ ﻭﻓ ﻘ ً ﺎ ﻟﺗﺭﺩﺩ ﺟﻬﺎﺯ ﺍﻹﺭﺳﺎﻝ )ﺑﺎﻟﻣﺗﺭ‬
‫ﺟﻳﺟﺎ ﻫﺭﺗﺯ‬ ‫ﻣﻳﺟﺎ ﻫﺭﺗﺯ ﺇﻟﻰ‬ ‫ﻣﻳﺟﺎ ﻫﺭﺗﺯ‬
2,5 800 80
‫ﻣﻳﺟﺎ‬ ‫ﺇﻟﻰ‬
800
‫ﻫﺭﺗﺯ‬
7 3,5
d = [ ] P d = [ ] P
E E
1 1
0,23 0,12
0,74 0,37
2,33 1,17
7,38 3,69
23,33 11,67
92
‫ﺍﻟﺟﻬﺎﺯ ﺍﻟﻁﺑﻲ ﺍﻟﻛﻬﺭﺑﺎﺋﻲ‬
IRT 6520/6020
‫ﺍﻟﺗﻭﺍﻓﻕ‬ ‫ﺍﺧﺗﺑﺎﺭ ﺍﻻﻧﺑﻌﺎﺛﺎﺕ‬
‫ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺫﺍﺕ ﺍﻟﺗﺭﺩﺩ‬
‫ﺍﻟﻣﺟﻣﻭﻋﺔ‬
1
،‫ﺍﻟﺭﺍﺩﻳﻭﻱ‬
CISPR 11
‫ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺫﺍﺕ ﺍﻟﺗﺭﺩﺩ‬
‫ﺍﻟﻔﺋﺔ ﺏ‬
،‫ﺍﻟﺭﺍﺩﻳﻭﻱ‬
CISPR 11
‫ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺍﻟﻣﺗﺟﺎﻧﺳﺔ‬
‫ﻻ ﻳﻧﻁﺑﻕ‬
IEC 61000-3-2
‫ﺗﻘﻠﺑﺎﺕ ﺍﻟﺟﻬﺩ/ﺍﻻﻧﺑﻌﺎﺛﺎﺕ‬
‫ﻻ ﻳﻧﻁﺑﻕ‬
‫ﺍﻟﻭﺍﻣﺿﺔ‬
‫)ﺗﻭﺍﻓﻕ‬
3
‫ﻛﻳﻠﻭ ﻫﺭﺗﺯ ﺇﻟﻰ‬
80 150
‫ﺃﻗﺻﻰ ﺗﻘﺩﻳﺭ ﻟﻠﻁﺎﻗﺔ ﺍﻟﺧﺎﺭﺟﺔ‬
‫ﻣﻳﺟﺎ ﻫﺭﺗﺯ ﻓﻲ‬
(‫ﻣﻥ ﺟﻬﺎﺯ ﺍﻹﺭﺳﺎﻝ )ﺑﺎﻟﻭﺍﺕ‬
‫ﺍﻟﻧﻁﺎﻗﺎﺕ ﺍﻟﻼﺳﻠﻛﻳﺔ‬
‫ﺍﻟﺻﻧﺎﻋﻳﺔ ﻭﺍﻟﻌﻠﻣﻳﺔ‬
( ) ‫ﻭﺍﻟﻁﺑﻳﺔ‬
ISM
3,5
d = [ ] P
V
1
0,12 0,01
0,37 0,1
1,17 1
3,69 10
11,67 100
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬
108-93,2)
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬
104-50)
(‫)-31–131 ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ ‫-52–55 ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬
(‫ﺭﻁﻭﺑﺔ ﻧﺳﺑﻳﺔ 01-59% )ﺩﻭﻥ ﺗﻛﺛﻳﻑ‬
‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ ﺃﻭ ﻓﻬﺭﻧﻬﺎﻳﺕ‬
‫ﺍﻟﺣﺩ ﺍﻷﻗﺻﻰ ﻟﻠﺧﻁﺄ ﺍﻟﻣﺧﺑﺭﻱ‬
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬
0,4 ±)
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬
0,5 ±)
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬
0,26 ±)
‫ﻗﻳﺎﺱ‬
‫ﺿﻐﻁ ﺟﻭﻱ‬ ‫ﺿﻐﻁ ﺟﻭﻱ ﺃﻭ ﻋﻧﺩ ﺍﺭﺗﻔﺎﻋﺎﺕ ﺫﺍﺕ ﺿﻐﻁ ﺟﻭﻱ ﻳﺻﻝ ﺇﻟﻰ‬
1
‫ﺃﺑﻘﻪ ﺟﺎ ﻓ ً ﺎ‬ ‫ﺩﺭﺟﺔ ﺣﺭﺍﺭﺓ ﺍﻟﺗﺧﺯﻳﻥ‬
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.
‫ﺍﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﺗﺣﺗﺎﺝ ﺇﻟﻰ ﺗﺩﺍﺑﻳﺭ ﻭﻗﺎﺋﻳﺔ ﺧﺎﺻﺔ ﻓﻳﻣﺎ ﻳﺗﻌﻠﻕ ﺑﺎﻟﺗﻭﺍﻓﻕ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ. ﻟﻭﺻﻑ ﺗﻔﺻﻳﻠﻲ ﻟﻣﺗﻁﻠﺑﺎﺕ‬
.(‫( ﺗﻔﺿﻝ ﺑﺎﻻﺗﺻﺎﻝ ﺑﻣﺭﻛﺯ ﺍﻟﺧﺩﻣﺔ ﺍﻟﻣﺣﻠﻲ ﺍﻟﻣﻌﺗﻣﺩ ﺍﻟﺧﺎﺹ ﺑﻙ )ﺍﻧﻅﺭ ﺑﻁﺎﻗﺔ ﺍﻟﺿﻣﺎﻥ‬
.‫ﻳﻣﻛﻥ ﻷﺟﻬﺯﺓ ﺍﻻﺗﺻﺎﻝ ﺍﻟﻣﺣﻣﻭﻟﺔ ﻭﺃﺟﻬﺯﺓ ﺍﻻﺗﺻﺎﻝ ﺍﻟﻣﺗﻧﻘﻠﺔ ﺫﺍﺕ ﺍﻟﺗﺭﺩﺩ ﺍﻟﺭﺍﺩﻳﻭﻱ ﺃﻥ ﺗﺅﺛﺭ ﻋﻠﻰ ﺍﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ ﺍﻟﻛﻬﺭﺑﻳﺔ‬
.‫ﻳﺭﺟﻰ ﻋﺩﻡ ﺍﻟﺗﺧﻠﺹ ﻣﻥ ﺍﻟﻣﻧﺗﺞ ﻓﻲ ﺍﻟﻧﻔﺎﻳﺎﺕ ﺍﻟﻣﻧﺯﻟﻳﺔ ﻓﻲ ﻧﻬﺎﻳﺔ ﻋﻣﺭ ﺍﺳﺗﺧﺩﺍﻣﻪ‬
.‫ﻟﺣﻣﺎﻳﺔ ﺍﻟﺑﻳﺋﺔ، ﺗﺧﻠﺹ ﻣﻥ ﺍﻟﺑﻁﺎﺭﻳﺎﺕ ﺍﻟﻔﺎﺭﻏﺔ ﻓﻲ ﻣﻭﺍﻗﻊ ﺍﻟﺟﻣﻊ ﺍﻟﻣﻼﺋﻣﺔ ﻁﺑ ﻘ ً ﺎ ﻟﻠﻭﺍﺋﺢ ﺍﻟﻭﻁﻧﻳﺔ ﺃﻭ ﺍﻟﻣﺣﻠﻳﺔ‬
‫ﻣﻭﺍﺻﻔﺎﺕ ﺍﻟﻣﻧﺗﺞ‬
:‫ﻧﻁﺎﻕ ﺩﺭﺟﺔ ﺍﻟﺣﺭﺍﺭﺓ ﺍﻟﻣﻌﺭﻭﺿﺔ‬
42,2-34
:‫ﻧﻁﺎﻕ ﺩﺭﺟﺔ ﺣﺭﺍﺭﺓ ﻣﺣﻳﻁ ﺍﻟﺗﺷﻐﻳﻝ‬
40-10
:‫ﻧﻁﺎﻕ ﺩﺭﺟﺔ ﺣﺭﺍﺭﺓ ﺍﻟﺗﺧﺯﻳﻥ‬
:‫ﺍﻟﺭﻁﻭﺑﺔ ﺍﻟﻧﺳﺑﻳﺔ ﻟﻠﺗﺷﻐﻳﻝ ﻭﺍﻟﺗﺧﺯﻳﻥ‬
:‫ﺩﻗﺔ ﺍﻟﻌﺭﺽ‬
0.1
‫ﺩﻗﺔ ﻧﻁﺎﻕ ﺩﺭﺟﺔ ﺍﻟﺣﺭﺍﺭﺓ ﺍﻟﻣﻌﺭﻭﺿﺔ‬
‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬ ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬
42-
:(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ ‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬
0,2 ± 107,6-
:‫ﺧﺎﺭﺝ ﻫﺫﺍ ﺍﻟﻧﻁﺎﻕ‬
0,3 ±
:‫ﺍﻟﺗﺭﺩﺩ ﺍﻹﻛﻠﻳﻧﻳﻛﻲ‬
0,14 ±
‫ﻋﺎﻣﺎﻥ‬ :‫ﻋﻣﺭ ﺍﻟﺑﻁﺎﺭﻳﺔ‬
600/
‫ﺳﻧﻭﺍﺕ‬ :‫ﻋﻣﺭ ﺍﻟﺧﺩﻣﺔ‬
5
‫ﻣﻘﻳﺎﺱ ﺍﻟﺣﺭﺍﺭﺓ ﻫﺫﺍ ﻣﺧﺻﺹ ﻟﻠﻌﻣﻝ ﻋﻧﺩ‬
1
‫ﻫﻛﺗﻭ ﺑﺎﺳﻛﺎﻝ‬
.( 1060 – 700)
40 °C
10 °C
‫ﺩﺭﺟﺔ ﺣﺭﺍﺭﺓ ﺍﻟﺗﺷﻐﻳﻝ‬ ‫ﺍﻟﺟﻬﺎﺯ ﻣﻊ ﻗﻁﻊ ﻣﻁﺑﻘﺔ ﺍﻧﻅﺭ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﻣﻥ ﺍﻟﻧﻭﻉ‬
BF
.‫ﻋﺭﺿﺔ ﻟﻠﺗﻐﻳﻳﺭ ﺩﻭﻥ ﺇﺷﻌﺎﺭ‬
:‫ﻳﻣﺗﺛﻝ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻟﻠﻣﻌﺎﻳﻳﺭ ﺍﻟﺗﺎﻟﻳﺔ‬
‫ﻳﻣﺗﺛﻝ ﻫﺫﺍ ﺍﻟﻣﻧﺗﺞ ﻟﺷﺭﻭﻁ ﻭﺛﻳﻘﺔ ﺍﻟﻠﺟﻧﺔ ﺍﻷﻭﺭﻭﺑﻳﺔ‬
) ‫ﺍﻟﺗﻭﺍﻓﻕ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ‬
EMC
35
)
95
93