Philips Expression MR200 Gebrauchsanweisung Seite 15

. MR200 ‫ﺍﻟﻁﺭﺍﺯ‬ Expression
‫، ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ ﻭﺃﺣﺯﻣﺔ ﻗﻳﺎﺱ ﺿﻐﻁ ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ‬
‫. ﺍﻟﻣﻣﺛﻝ ﺍﻟﻣﻌﺗﻣﺩ ﻟﻼﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ )ﺗﺑ ﻌ ً ﺎ ﻟﻣﺎ ﻳﻔﺭﺿﻪ‬
‫، ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ ﻭﺃﺣﺯﻣﺔ ﻗﻳﺎﺱ ﺿﻐﻁ‬
( EU MDR
.‫ﻳﺟﺏ ﺍﻹﺑﻼﻍ ﻋﻥ ﺃﻱ ﺣﺎﺩﺙ ﺧﻁﻳﺭ ﻓﻲ ﻣﺎ ﻳﺗﻌﻠ ّ ﻖ ﺑﻬﺫﺍ ﺍﻟﺟﻬﺎﺯ ﺇﻟﻰ ﺷﺭﻛﺔ ﻓﻳﻠﻳﺑﺱ ﻭﺍﻟﺳﻠﻁﺔ ﺍﻟﻣﺧﺗﺻﺔ ﺍﻟﺧﺎﺻﺔ ﺑﺎﻟﺩﻭﻟﺔ ﺍﻟﻌﺿﻭ ﺣﻳﺙ ﻳﻘﻳﻡ ﺍﻟﻣﺳﺗﺧﺩﻡ ﻭ/ﺃﻭ ﺍﻟﻣﺭﻳﺽ‬
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‫ﻧﻅﺎﻡ ﻣﺭﺍﻗﺑﺔ ﺍﻟﻣﺭﺿﻰ ﺃﺛﻧﺎء ﺍﻟﺗﺻﻭﻳﺭ ﺑﺎﻟﺭﻧﻳﻥ ﺍﻟﻣﻐﻧﺎﻁﻳﺳﻲ‬
SpO
‫ﺇﻥ ﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ ﺍﻟﻘﻠﺏ، ﻭﺍﻟﻣﻼﻗﻁ ﻭﺍﻟﻣﻘﺎﺑﺽ ﻟﻘﻳﺎﺱ ﺗﺷ ﺑ ّﻊ ﺍﻷﻛﺳﺟﻳﻥ‬
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2017/745 ( EU MDR
SpO
‫ﺇﻥ ﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ ﺍﻟﻘﻠﺏ، ﻭﺍﻟﻣﻼﻗﻁ ﻭﺍﻟﻣﻘﺎﺑﺽ ﻟﻘﻳﺎﺱ ﺗﺷ ﺑ ّﻊ ﺍﻷﻛﺳﺟﻳﻥ‬
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) ‫ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ ﻛﻣﻠﺣﻘﺎﺕ ﻣﻥ ﺍﻟﻔﺋﺔ ﺍﻷﻭﻟﻰ، ﺗﺗﻭﺍﻓﻖ ﻣﻊ ﻗﺎﻧﻭﻥ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌ ﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ‬
‫، ﻣﻠﺣﻖ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﻣﻠﺣﻖ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ - ﺍﻟﻌﺭﺑﻳﺔ‬
‫ﻳﺗﺿ ﻣ ّ ﻥ ﻫﺫﺍ ﺍﻟﻣﻠﺣﻖ ﻻﺋﺣﺔ ﺑﺎﻟﺗﻐﻳﻳﺭﺍﺕ ﻭﺍﻟﻣﻌﻠﻭﻣﺎﺕ ﺍﻟﺟﺩﻳﺩﺓ ﺍﻟﻣﺗﻌ ﻠ ّ ﻘﺔ‬
‫ﺑﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ‬
:"‫ﻓﻲ ﺍﻟﻔﻘﺭﺓ ﺍﻷﻭﻟﻰ ﺍﻟﺗﻣﻬﻳﺩﻳﺔ، ﺗﻣﺕ ﺇﺿﺎﻓﺔ ﺍﻟﻔﻘﺭﺍﺕ ﺍﻟﺛﺎﻧﻭﻳﺔ ﺍﻟﺗﺎﻟﻳﺔ ﺇﻟﻰ ﻓﻘﺭﺓ "ﺍﻟﺟﻬﺎﺕ ﺍﻟﺗﻧﻅﻳﻣﻳﺔ‬
) ‫ﻋﺑﺎﺭﺓ ﻋﻥ ﻣﻠﺣﻘﺎﺕ ﻣﻥ ﺍﻟﻔﺋﺔ ﺍﻷﻭﻟﻰ، ﺗﺗﻭﺍﻓﻖ ﻣﻊ ﺍﻟﻘﺎﻧﻭﻥ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ‬
‫ﺍﻟﺻﺎﺩﺭ ﻋﻥ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ‬
:( EU MDR
Philips Medical Systems Nederland B.V
Philips Medizin Systeme Böblingen GmbH
Av. Marcos Penteado de Ulhoa Rodrigues, 401 Setor
:‫ﺗﻣﺕ ﺇﺿﺎﻓﺔ ﺍﻟﺑﻳﺎﻥ ﺍﻟﺗﺎﻟﻲ ﺇﻟﻰ ﺍﻟﻔﺻﻝ ﺍﻟﻣﻌﻧﻭﻥ "ﻣﻌﻠﻭﻣﺎﺕ ﻣﻬﻣﺔ"، ﻓﻲ ﺍﻟﻣﻘﺩﻣﺔ‬
MR200 ‫ﺍﻟﻁﺭﺍﺯ‬ Expression
. ‫ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﺍﻟﻣﻣﺛﻝ ﺍﻟﻣﻌﺗﻣﺩ‬
2017/745
.
Veenpluis 6
5684PC, Best
The Netherlands
‫ﺍﻟﻣﺳﺗﻭﺭﺩ ﻣﻥ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ‬
Hewlett-Packard Straße 2
71034 , Böblingen
Germany
‫ﺍﻟﺟﻬﺔ ﺍﻟﺭﺍﻋﻳﺔ ﺍﻟﺑﺭﺍﺯﻳﻠﻳﺔ ﻭﺟﻬﺔ ﺍﻟﺗﺳﺟﻳﻝ‬
Registro ANVISA
10216710332
Responsável Técnico
Thiago Medeiros de Abreu
CREA/SP: 5070149021
Detentor do Registro
Philips Medical Systems Ltda.
Parte 39 - Tamboré, Barueri/SP ,
Brasil – CEP 06460-040
‫ﻧﻅﺎﻡ ﻣﺭﺍﻗﺑﺔ ﺍﻟﻣﺭﺿﻰ ﺃﺛﻧﺎء ﺍﻟﺗﺻﻭﻳﺭ ﺑﺎﻟﺭﻧﻳﻥ ﺍﻟﻣﻐﻧﺎﻁﻳﺳﻲ‬
‫ﺍﺣﺗﻔﻅ ﺑﻬﺫﺍ ﺍﻟﻣﻠﺣﻖ ﻣﻊ‬
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‫ﺍﻟﻘﺎﻧﻭﻥ‬
CE ‫ﻋﻼﻣﺔ‬
:
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