ﻟﻣﺭﺍﻗﺑﺔ ﺍﻟﻣﺭﺿﻰ ﺃﺛﻧﺎء ﺍﻟﺗﺻﻭﻳﺭ ﺑﺎﻟﺭﻧﻳﻥ ﺍﻟﻣﻐﻧﺎﻁﻳﺳﻲMR400 ﺍﻟﻁﺭﺍﺯExpression ﻧﻅﺎﻡ
، ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ ﻭﺃﺣﺯﻣﺔ ﻗﻳﺎﺱ ﺿﻐﻁ ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ
( 547/7102. ﺇﻥ ﺍﻟﻣﻣﺛﻝ ﺍﻟﻣﻌﺗﻣﺩ ﻟﻼﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ )ﺗﺑ ﻌ ً ﺎ ﻟﻣﺎEU MDR) ﻋﺑﺎﺭﺓ ﻋﻥ ﻣﻠﺣﻘﺎﺕ ﻣﻥ ﺍﻟﻔﺋﺔ ﺍﻷﻭﻟﻰ، ﺗﺗﻭﺍﻓﻖ ﻣﻊ ﺍﻟﻘﺎﻧﻭﻥ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ
، ﻭﻭﺍﺟﻬﺔ ﺍﻟﺗﺑﻭﻳﺏ ﺍﻟﻌﺎﻣﺔ ﻭﺃﺣﺯﻣﺔ ﻗﻳﺎﺱ ﺿﻐﻁ
(EU MDR) ﺍﻟﺩﻡ ﻏﻳﺭ ﺍﻟﺑﺎﺿﻊ ﻛﻣﻠﺣﻘﺎﺕ ﻣﻥ ﺍﻟﻔﺋﺔ ﺍﻷﻭﻟﻰ، ﺗﺗﻭﺍﻓﻖ ﻣﻊ ﻗﺎﻧﻭﻥ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ
.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
:"ﻓﻲ ﺍﻟﻔﻘﺭﺓ ﺍﻷﻭﻟﻰ ﺍﻟﺗﻣﻬﻳﺩﻳﺔ، ﺗﻣﺕ ﺇﺿﺎﻓﺔ ﺍﻟﻔﻘﺭﺍﺕ ﺍﻟﺛﺎﻧﻭﻳﺔ ﺍﻟﺗﺎﻟﻳﺔ ﺇﻟﻰ ﻓﻘﺭﺓ "ﺍﻟﺟﻬﺎﺕ ﺍﻟﺗﻧﻅﻳﻣﻳﺔ
SpO
ﺇﻥ ﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ ﺍﻟﻘﻠﺏ، ﻭﺍﻟﻣﻼﻗﻁ ﻭﺍﻟﻣﻘﺎﺑﺽ ﻟﻘﻳﺎﺱ ﺗﺷ ﺑ ّﻊ ﺍﻷﻛﺳﺟﻳﻥ
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:( ﻫﻭEU MDR ﻳﻔﺭﺿﻪ ﺍﻟﻘﺎﻧﻭﻥ 547/7102 ﺍﻟﺻﺎﺩﺭ ﻋﻥ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﺗﻌﻠ ّ ﻖ ﺑﺎﻷﺟﻬﺯﺓ ﺍﻟﻁﺑﻳﺔ
SpO
ﺇﻥ ﺍﻟﻛﺑﻼﺕ ﻭﺍﻷﻗﻁﺎﺏ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻟﻣﺧﻁﻁ ﻛﻬﺭﺑﻳﺔ ﺍﻟﻘﻠﺏ، ﻭﺍﻟﻣﻼﻗﻁ ﻭﺍﻟﻣﻘﺎﺑﺽ ﻟﻘﻳﺎﺱ ﺗﺷ ﺑ ّﻊ ﺍﻷﻛﺳﺟﻳﻥ
2
:"ﺗ ﻣ ّ ﺕ ﺇﺿﺎﻓﺔ ﺍﻟﺑﻳﺎﻥ ﺍﻟﺗﺎﻟﻲ ﺇﻟﻰ ﺍﻟﻔﺻﻝ ﺍﻟﻣﻌﻧﻭﻥ "ﻣﻌﻠﻭﻣﺎﺕ ﻣﻬﻣﺔ" ﻓﻲ ﻓﻘﺭﺓ "ﻟﻣﺣﺔ ﻋﻥ ﺍﻟﻣﻧﺗﺞ
ﻣﻠﺣﻖ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ - ﺍﻟﻌﺭﺑﻳﺔ
ﻳﺗﺿ ﻣ ّ ﻥ ﻫﺫﺍ ﺍﻟﻣﻠﺣﻖ ﻻﺋﺣﺔ ﺑﺎﻟﺗﻐﻳﻳﺭﺍﺕ ﻭﺍﻟﻣﻌﻠﻭﻣﺎﺕ ﺍﻟﺟﺩﻳﺩﺓ ﺍﻟﻣﺗﻌ ﻠ ّ ﻘﺔ
ﺑﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ
.. ﺍﺣﺗﻔﻅ ﺑﻬﺫﺍ ﺍﻟﻣﻠﺣﻖ ﻣﻊ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ
Philips Medical Systems Nederland B.V.
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Straße 2
71034 , Böblingen
ﺍﻟﺟﻬﺔ ﺍﻟﺭﺍﻋﻳﺔ ﺍﻟﺑﺭﺍﺯﻳﻠﻳﺔ ﻭﺟﻬﺔ ﺍﻟﺗﺳﺟﻳﻝ
Philips Medical Systems Ltda.
Av. Marcos Penteado de Ulhoa Rodrigues, 401 Setor
Parte 39 - Tamboré, Barueri/SP,
E ﺍﻟﻣﺭﺍﺟﻌﺔ
ﺍﻟﻣﻣﺛﻝ ﺍﻟﻣﻌﺗﻣﺩ
Veenpluis 6
5684PC, Best
The Netherlands
CE ﻋﻼﻣﺔ
ﺍﻟﻣﺳﺗﻭﺭﺩ ﻣﻥ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ
Germany
Registro ANVISA
10216710332
Responsável Técnico:
Thiago Medeiros de Abreu
CREA/SP: 5070149021
Detentor do Registro
Brasil – CEP 06460-040
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