Philips Expression MR400 Nachtrag Zur Bedienungsanleitung Seite 20

‫ﻣﻥ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ ﺑﺎﻟﻣﻭﺍﺻﻔﺎﺕ ﺍﻟﺑﻳﺋﻳﺔ‬
‫ﺩﺭﺟﺔ‬ 95 ‫ﺇﻟﻰ‬ 50 ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ )ﻣﻥ‬
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬
‫ﺇﻟﻰ‬ 15 ‫ﻭﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ ﺍﻟﻘﻠﺏ ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ: ﻣﻥ‬
‫ﻭﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ‬
‫ﻭﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ‬
‫ﻭﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ‬
‫ﺗﺷﻳﺭ ﻫﺫﻩ ﺍﻟﻌﺑﺎﺭﺓ ﺇﻟﻰ ﻋﺩﺩ ﺍﻟﻘﻁﻊ ﺍﻟﻣﺗﻭﻓﺭﺓ ﻓﻲ ﺍﻟﻌﻠﺑﺔ ﺃﻭ ﺍﻟﻐﻼﻑ. ﻋﻧﺩ ﺇﺩﺭﺍﺝ ﺭﻗﻡ ﻓﻲ ﺍﻟﺭﻣﺯ ﻟﻺﺷﺎﺭﺓ ﺇﻟﻰ ﻋﺩﺩ ﺍﻟﻘﻁﻊ‬
‫ﺗﺷﻳﺭ ﻫﺫﻩ ﺍﻟﻌﺑﺎﺭﺓ ﺇﻟﻰ ﺃﻥ ﺍﻟﻣﻌﻠﻭﻣﺎﺕ ﺍﻟﻣﺗﻌﻠﻘﺔ ﺑﺎﺳﺗﺧﺩﺍﻡ ﺍﻟﻣﻧﺗﺞ ﻣﺗﻭﻓﺭﺓ ﻓﻲ ﺷﻛﻝ ﺇﻟﻛﺗﺭﻭﻧﻲ ﺑﺎﻹﺿﺎﻓﺔ ﺇﻟﻰ ﺗﻭﻓﺭﻫﺎ ﻓﻲ‬
.‫ﺗﺷﻳﺭ ﻫﺫﻩ ﺍﻟﻌﺑﺎﺭﺓ ﺇﻟﻰ ﺍﻟﻣﻌﻠﻭﻣﺎﺕ ﺍﻟﻣﺗﻌ ﻠ ّ ﻘﺔ ﺑﻣﻌﺭﻑ ﺍﻟﺟﻬﺎﺯ ﺍﻟﻔﺭﻳﺩ ﺍﻟﻣﺫﻛﻭﺭﺓ ﻋﻠﻰ ﺍﻟﻣﻠﺻﻖ‬
‫، ﻣﻠﺣﻖ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ‬ MR400
E ‫: ﺍﻟﻣﻭﺍﺻﻔﺎﺕ"، ﻓﻲ ﺍﻟﻘﺳﻡ "ﻣﻌﻠﻭﻣﺎﺕ ﻋﺎﻣﺔ"، ﻓﻲ ﺍﻟﻘﺳﻡ ﺍﻟﻔﺭﻋﻲ "ﺍﻟﺑﻳﺋﺔ"، ﻳﺗﻡ ﺍﺳﺗﺑﺩﺍﻝ ﺍﻟﻣﻭﺍﺻﻔﺎﺕ ﻓﻲ ﺍﻟﻣﺭﺍﺟﻌﺔ‬
35 ‫ﺩﺭﺟﺎﺕ ﻣﺋﻭﻳﺔ ﺇﻟﻰ‬ 10 ‫ﺍﻟﻌﺭﺑﺔ ﻭﻛﻝ ﺍﻟﻣﻠﺣﻘﺎﺕ ﺍﻷﺧﺭﻯ ﺍﻟﺗﻲ ﻟﻡ ﻳﺗﻡ ﺗﺣﺩﻳﺩﻫﺎ ﺃﺩﻧﺎﻩ: ﻣﻥ‬
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ 75 ‫ﺇﻟﻰ‬ 64 ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ )ﻣﻥ‬
122 ‫ﺩﺭﺟﺎﺕ ﺇﻟﻰ‬ 4 - ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ )ﻣﻥ‬
90 ‫ﺇﻟﻰ‬ 50 ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ )ﺃﻭ‬
‫ﺑﺎﻟﻣﺋﺔ، ﻣﻥ ﺩﻭﻥ ﺗﻛﺛﻳﻑ‬ 80
SpO2 ‫ﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺿﻐﻁ ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ، ﻭﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺍﻟﺗﺷ ﺑ ّﻊ ﺑﺎﻷﻛﺳﻳﺟﻳﻥ‬
SpO2 ‫ﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺿﻐﻁ ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ، ﻭﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺍﻟﺗﺷ ﺑ ّﻊ ﺑﺎﻷﻛﺳﻳﺟﻳﻥ‬
SpO2 ‫ﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺿﻐﻁ ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ، ﻭﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺍﻟﺗﺷ ﺑ ّﻊ ﺑﺎﻷﻛﺳﻳﺟﻳﻥ‬
‫ﺍﻟﻘﺭﺍﺭ ﺍﻟﺗﻧﻅﻳﻣﻲ ﻟﻼﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ ﺭﻗﻡ‬
2017/745
.‫ﺗﺷﻳﺭ ﻫﺫﻩ ﺍﻟﻌﺑﺎﺭﺓ ﺇﻟﻰ ﺃﻥ ﻫﺫﺍ ﺍﻟﻣﻧﺗﺞ ﺟﻬﺎﺯ ﻁﺑﻲ‬
.‫ﻟﻺﺷﺎﺭﺓ ﺇﻟﻰ ﺍﻟﺟﻬﺔ ﺍﻟﺗﻲ ﺗﺳﺗﻭﺭﺩ ﺍﻟﺟﻬﺎﺯ ﺍﻟﻁﺑﻲ ﺇﻟﻰ ﺍﻟﺑﻠﺩ ﺍﻟﻣﺣﻠﻲ‬
‫ﺍﻟﻘﺭﺍﺭ ﺍﻟﺗﻧﻅﻳﻣﻲ ﻟﻼﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌ ﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ ﺭﻗﻡ‬
2017/745
‫ﺍﻟﻁﺭﺍﺯ‬ Expression ‫ﻧﻅﺎﻡ ﻣﺭﺍﻗﺑﺔ ﺍﻟﻣﺭﺿﻰ ﺃﺛﻧﺎء ﺍﻟﺗﺻﻭﻳﺭ ﺑﺎﻟﺭﻧﻳﻥ ﺍﻟﻣﻐﻧﺎﻁﻳﺳﻲ‬
24 ‫ﺇﻟﻰ‬ 18 ‫ﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ: ﻣﻥ‬
50 ‫ﺇﻟﻰ‬ 20 - ‫ﺍﻟﻌﺭﺑﺔ ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ: ﻣﻥ‬
32 ‫ﻭ‬ 10 ‫ﺃﻗﻁﺎﺏ ﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ ﺍﻟﻘﻠﺏ: ﻣﺎ ﺑﻳﻥ‬
SpO2 ‫ﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺍﻟﺗﺷ ﺑ ّﻊ ﺑﺎﻷﻛﺳﻳﺟﻳﻥ‬
‫، ﻣﻥ ﺩﻭﻥ ﺗﻛﺛﻳﻑ‬
‫ﺇﻟﻰ‬ 10 ‫ﻣﻠﺣﻘﺎﺕ ﻗﻳﺎﺱ ﺿﻐﻁ ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ: ﻣﻥ‬
:‫ﺍﻟﻘﻠﺏ ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ‬
‫%، ﻣﻥ ﺩﻭﻥ ﺗﻛﺛﻳﻑ‬ 80
:‫ﺍﻟﻘﻠﺏ ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ‬
‫ﻫﻳﻛﺗﻭﺑﺎﺳﻛﺎﻝ‬ 1020 ‫ﻫﻳﻛﺗﻭﺑﺎﺳﻛﺎﻝ ﺇﻟﻰ‬
:‫ﺍﻟﻘﻠﺏ ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ‬
‫ﻫﻳﻛﺗﻭﺑﺎﺳﻛﺎﻝ‬ 1020 ‫ﻫﻳﻛﺗﻭﺑﺎﺳﻛﺎﻝ ﺇﻟﻰ‬
:‫: ﺍﻟﻣﻭﺍﺻﻔﺎﺕ"، ﻓﻲ ﺍﻟﻘﺳﻡ "ﺗﻔﺳﻳﺭ ﺍﻟﺭﻣﻭﺯ"، ﺗﻣﺕ ﺇﺿﺎﻓﺔ ﻣﺎ ﻳﻠﻲ‬
‫ﺍﻟﻣﻌﻧﻰ‬
‫ﻭﺣﺩﺓ ﺍﻟﻌﺑﻭﺓ‬
ISO 7000-2794
.‫ﺍﻟﻣﺗﻭﻓﺭﺓ ﻓﻲ ﺍﻟﻌﻠﺑﺔ ﺃﻭ ﺍﻟﻐﻼﻑ‬
‫ﺟﻬﺎﺯ ﻁﺑﻲ‬
‫ﺍﻟﻣﺳﺗﻭﺭﺩ‬
ISO 7000-3725
‫ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ ﺍﻹﻟﻛﺗﺭﻭﻧﻳﺔ‬
ISO 7000-3500
.‫ﺷﻛﻝ ﻣﻁﺑﻭﻉ‬
‫ﻣﻌﺭ ّ ﻑ ﺍﻟﺟﻬﺎﺯ ﺍﻟﻔﺭﻳﺩ‬
B ‫ﺍﻟﻘﻁﻌﺔ ﺍﻟﺛﺎﻧﻭﻳﺔ‬ 21CFR 801
A ‫ﻓﻲ "ﺍﻟﻣﻠﺣﻖ‬
‫ﺍﻟﻣﻭﺍﺻﻔﺎﺕ‬ ‫ﻧﻭﻉ ﺍﻟﻣﻭﺍﺻﻔﺎﺕ‬
‫ﻧﻁﺎﻕ ﺩﺭﺟﺎﺕ ﺣﺭﺍﺭﺓ ﺍﻟﺗﺷﻐﻳﻝ‬
(‫ﻓﻬﺭﻧﻬﺎﻳﺕ‬
‫ﻧﻁﺎﻕ ﺩﺭﺟﺎﺕ ﺍﻟﺣﺭﺍﺭﺓ ﺃﺛﻧﺎء ﺍﻟﺗﺧﺯﻳﻥ‬
‫ﻧﻁﺎﻕ ﺍﻟﺭﻁﻭﺑﺔ ﺍﻟﻧﺳﺑﻳﺔ ﻟﻠﺗﺷﻐﻳﻝ‬
80%
‫ﻧﻁﺎﻕ ﺩﺭﺟﺎﺕ ﺍﻟﺭﻁﻭﺑﺔ ﺍﻟﻧﺳﺑﻳﺔ ﺃﺛﻧﺎء‬
‫ﺇﻟﻰ‬ 5 ‫ﻣﻥ‬
‫ﻧﻁﺎﻕ ﺿﻐﻁ ﺍﻟﺗﺷﻐﻳﻝ‬
708 ‫ﻣﻥ‬
‫ﻧﻁﺎﻕ ﺍﻟﺿﻐﻁ ﺃﺛﻧﺎء ﺍﻟﺗﺧﺯﻳﻥ ﻭﺍﻟﻧﻘﻝ‬
570 ‫ﻣﻥ‬
A ‫ﻓﻲ "ﺍﻟﻣﻠﺣﻖ‬
22
:‫ﺍﻟﺗﺎﻟﻳﺔ‬
‫ﻭﺍﻟﻧﻘﻝ‬
‫ﺍﻟﺗﺧﺯﻳﻥ ﻭﺍﻟﻧﻘﻝ‬
23
‫ﺍﻟﺭﻣﺯ‬
16