Osprey Medical DyeTect Instrucciones De Uso página 81

‫ﻟﻡ‬ – ‫ﺃﻭ ﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ‬ Smart Syringe ‫ﻳ ُﻣﻛﻥ ﺃﻥ ﻳﺗﺳﺑﺏ ﺇﺟﺭﺍء ﺃﻱ ﺗﻌﺩﻳﻼﺕ ﺃﻭ ﺗﻐﻳﻳﺭﺍﺕ ﻓﻲ ﺟﻬﺎﺯ ﺍﻟﻣﺭﺍﻗﺑﺔ ﺃﻭ‬
.‫ﻓﻲ ﺇﻟﻐﺎء ﺻﻼﺣﻳﺔ ﺍﻟﻣﺳﺗﺧﺩﻡ ﻟﺗﺷﻐﻳﻝ ﺍﻟﻣﻌﺩﺍﺕ‬
‫ﻗﺩ ﺗﺅﺛﺭ ﺃﺟﻬﺯﺓ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻼﺳﻠﻛﻳﺔ ﺍﻟﻣﺣﻣﻭﻟﺔ ﻭﺍﻟﻣﺗﻧﻘﻠﺔ ﻋﻠﻰ ﺍﻷﺟﻬﺯﺓ. ﻳﻧﺑﻐﻲ ﺍﻻﻣﺗﻧﺎﻉ ﻋﻥ ﺍﺳﺗﺧﺩﺍﻡ ﺟﻬﺎﺯ ﺍﻟﻣﺭﺍﻗﺑﺔ‬
‫ﺑﺎﻟﻘﺭﺏ ﻣﻥ ﺃﺟﻬﺯﺓ ﺃﺧﺭﻯ ﺃﻭ ﻓﻲ ﻭﺿﻊ ﻣﻼﺻﻖ ﻟﻬﺎ. ﻭﺇﺫﺍ ﻛﺎﻥ ﺍﻻﺳﺗﺧﺩﺍﻡ ﺑﺎﻟﻘﺭﺏ ﻣﻥ ﺃﺟﻬﺯﺓ ﺃﺧﺭﻯ ﺃﻭ ﻓﻲ ﻭﺿﻊ‬
.‫ﺎ، ﻓﻳﺗﻌﻳﻥ ﻣﻼﺣﻅﺔ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﻟﻠﺗﺣﻘﻖ ﻣﻥ ﻋﻣﻠﻬﺎ ﺑﺷﻛﻝ ﻁﺑﻳﻌﻲ‬
‫ﺇﻟﻰ‬ Osprey Medical ‫ﻗﺩ ﻳﺅﺩﻱ ﺍﺳﺗﺧﺩﺍﻡ ﻣﻠﺣﻘﺎﺕ ﻭﻣﺣﻭﻻﺕ ﻭﻛﺎﺑﻼﺕ ﺑﺧﻼﻑ ﺗﻠﻙ ﺍﻟﺗﻲ ﺣﺩﺩﺗﻬﺎ ﺃﻭ ﻭﻓﺭﺗﻬﺎ ﺷﺭﻛﺔ‬
‫ﺯﻳﺎﺩﺓ ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﺃﻭ ﺍﻧﺧﻔﺎﺽ ﺍﻟﻣﻧﺎﻋﺔ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﻟﻬﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻭﺍﻟﺗﺳﺑﺏ ﻓﻲ ﺍﻟﺗﺷﻐﻳﻝ ﺑﺷﻛﻝ‬
‫ﻳﻧﺑﻐﻲ ﺍﺳﺗﺧﺩﺍﻡ ﺃﺟﻬﺯﺓ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻼﺳﻠﻛﻳﺔ ﺍﻟﻣﺣﻣﻭﻟﺔ )ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ ﺍﻷﺟﻬﺯﺓ ﺍﻟﻁﺭﻓﻳﺔ ﻣﺛﻝ ﻛﺎﺑﻼﺕ ﺍﻟﻬﻭﺍﺋﻲ ﻭﺍﻟﻬﻭﺍﺋﻳﺎﺕ‬
‫ﺑﻭﺻﺔ( ﻣﻥ ﺃﻱ ﺟﺯء ﻣﻥ ﺟﻬﺎﺯ ﺍﻟﻣﺭﺍﻗﺑﺔ ﺃﻭ ﺍﻷﺩﻭﺍﺕ ﺍﻟﻣﺻﻣﻣﺔ‬
‫ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ، ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ ﺍﻟﻛﺎﺑﻼﺕ ﺍﻟﻣﺣﺩﺩﺓ ﺑﻭﺍﺳﻁﺔ ﺟﻬﺔ ﺍﻟﺗﺻﻧﻳﻊ. ﻭﺇﺫﺍ ﻟﻡ ﻳﺗﻡ ﺫﻟﻙ، ﻓﻘﺩ ﻳﺗﺩﻫﻭﺭ ﺃﺩﺍء ﻫﺫﺍ‬
Contrast Monitoring Display
.‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻣﻌﻠﻭﻣﺎﺕ ﺍﻻﻣﺗﺛﺎﻝ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ ﺍﻟﺧﺎﺻﺔ ﺑﻬﺫﺍ ﺍﻟﺟﻬﺎﺯ‬
‫ﻓﻲ ﺣﺎﻟﺔ ﺣﺩﻭﺙ ﺃﻋﻁﺎﻝ ﺃﻭ ﺗﻐﻳﺭﺍﺕ ﻏﻳﺭ ﻣﺗﻭﻗﻌﺔ ﻓﻲ ﺃﺩﺍء ﺍﻟﺟﻬﺎﺯ، ﺗﻭﻗﻑ ﻋﻥ ﺍﺳﺗﺧﺩﺍﻣﻪ ﻋﻠﻰ ﺍﻟﻔﻭﺭ ﻭﺃﺑﻠﻎ ﻣﻣﺛﻝ‬
‫ﺩﻭﻧﻬﺎ. ﺇﺫﺍ ﻛﺎﻥ‬ ‫ﺑﻣﺎ ﺣﺩﺙ. ﺇﺫﺍ ﻟﻡ ﻳﺗﻭﻓﺭ ﻣﺭﺍﻗﺑﺔ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ، ﻓﻳﻣﻛﻥ ﻣﺗﺎﺑﻌﺔ ﺍﻹﺟﺭﺍء ﺍﻟﻁﺑﻲ‬
‫ﺍﻟﻭﺍﻗﻌﺔ ﻣﻥ ﺍﻟﻧﻭﻉ ﺍﻟﺫﻱ ﺗﺷﺗﺭﻁ ﺍﻟﺳﻠﻁﺔ ﺍﻟﺗﻧﻅﻳﻣﻳﺔ ﺍﻹﺑﻼﻍ ﻋﻧﻪ )ﺃﻱ ﺃﻧﻬﺎ ﺟﺳﻳﻣﺔ(، ﻓ ﻳ ُﺭﺟﻰ ﺍﻟﺣﺭﺹ ﻛﺫﻟﻙ ﻋﻠﻰ ﺇﺑﻼﻍ‬
.‫ﻟﻐﻳﺭ ﺍﻟﻐﺭﺽ ﺍﻟﻣﻘﺻﻭﺩ ﺇﻟﻰ ﺣﺩﻭﺙ ﺁﺛﺎﺭ ﻏﻳﺭ ﻣﺭﻏﻭﺑﺔ ﻣﺛﻝ ﺗﻌﺫﺭ ﻣﺭﺍﻗﺑﺔ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ‬
‫ﻭﻛﻣﺎ ﻫﻭ ﺍﻟﻭﺿﻊ ﻣﻊ ﺃﻱ ﺟﻬﺎﺯ ﻳﺳﺗﺧﺩﻡ ﻟﺣﻘﻥ ﺃﻭﺳﺎﻁ ﺗﺑﺎﻳﻥ ﻓﻲ ﺍﻟﻣﺭﺿﻰ، ﻳﺗﻌﻳﻥ ﺍﻟﺣﺭﺹ ﻋﻠﻰ ﺍﻟﺗﺄﻛﺩ ﻣﻥ ﻁﺭﺩ ﺍﻟﻬﻭﺍء‬
‫ﺧﻔﻳﻑ ﺇﺫﺍ ﻟﺯﻡ ﺍﻷﻣﺭ ﻹﺧﺭﺍﺝ ﺍﻟﻬﻭﺍء ﺃﺛﻧﺎء ﺗﺣﺿﻳﺭ ﺍﻟﺟﻬﺎﺯ. ﺗﺟﻧﺏ ﺍﺳﺗﺧﺩﺍﻡ ﺍﻷﺩﻭﺍﺕ )ﻣﻠﻘﻁ‬
‫ﺃﻭ ﻭﺣﺩﺓ‬ ‫/ ﻭ‬ Smart Syringe ‫ﺍﺣﺭﺹ ﻋﻠﻰ ﻋﺩﻡ ﺍﻹﺳﺭﺍﻑ ﻓﻲ ﺇﺣﻛﺎﻡ ﺭﺑﻁ ﻭﺻﻼﺕ "ﻟﻭﺭ" ﻋﻧﺩ ﺗﻭﺻﻳﻝ ﺳﺭﻧﺟﺔ‬
.‫ﻟﺿﻐﻁ ﻓﻲ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﺃﻭ ﺍﻟﻣﺣﻠﻭﻝ ﺍﻟﻣﻠﺣﻲ‬
‫ﺇﺟﺭﺍءﺍﺕ ﺍﻟﻣﺳﺗﺷﻔﻰ ﻭﺗﻭﺻﻳﺎﺕ ﺍﻟﻁﺑﻳﺏ ﻓﻳﻣﺎ ﻳﺗﻌﻠﻖ ﺑﺈﺟﻣﺎﻟﻲ‬
‫ﺍﻟﺣﺟﻡ ﺍﻟﺗﺭﺍﻛﻣﻲ ﻷﻭﺳﺎﻁ ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﻣﺳﺗﺧﺩﻣﺔ ﻣﻊ ﺍﻟﻣﺭﻳﺽ. ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻏﻳﺭ ﻣﺧﺻﺹ ﻟﻣﻧﻊ ﺍﻟﺣﻘﻥ ﺍﻟﻳﺩﻭﻱ ﻷﻭﺳﺎﻁ‬
‫ﺛﺎﻧﻳﺔ‬ 2 1 / ‫ﻋﻥ ﺍﻟﻌﻣﻝ ﻟﻣﺩﺓ ﻻ ﺗﻘﻝ ﻋﻥ‬ Smart Syringe
Osprey ‫)ﺯﻣﻥ ﺍﻟﺗﻭﻗﻑ( ﻗﺑﻝ ﺍﻟﺗﺑﺩﻳﻝ ﺑﻳﻥ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﻭﺍﻟﻣﺣﻠﻭﻝ ﺍﻟﻣﻠﺣﻲ ﻋﻧﺩ ﺍﻟﺳﺣﺏ. ﺇﺫﺍ ﻟﺯﻡ ﺍﻷﻣﺭ، ﻓﺗﻭﺍﺻﻝ ﻣﻊ‬
‫ﻳﻔﺿﻠﻪ ﺍﻟﻣﺳﺗﺧﺩﻡ. ﻗﺩ ﻳﺗﻡ ﻋﺭﺽ‬ ‫ﻟﻳﺗﻣﺎﺷﻰ ﻣﻊ ﻣﺎ‬ Smart Syringe
‫ﻗﻳﻣﺔ ﻏﻳﺭ ﺩﻗﻳﻘﺔ ﻟﻠﺣﺟﻡ ﺍﻟﺗﺭﺍﻛﻣﻲ ﺇﺫﺍ ﻟﻡ ﻳﺗﻡ ﺍﻟﻭﺻﻭﻝ ﺇﻟﻰ ﺯﻣﻥ ﺍﻟﺗﻭﻗﻑ ﻗﺑﻝ ﺍﻟﺗﺑﺩﻳﻝ ﺑﻳﻥ ﺳﺣﺏ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﻭﺳﺣﺏ‬
.‫ﺍﻻﻧﺻﻣﺎﻡ ﺍﻟﻬﻭﺍﺋﻲ، ﺍﻟﻌﺩﻭﻯ‬
( . EO ) ‫ﺃﺩﺍﺓ ﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ، ﺗﻡ ﺗﻌﻘﻳﻡ ﻣﻛﻭﻧﺎﺕ ﺟﻬﺎﺯ ﺍﻟﺗﻌﻘﻳﻡ ﺑﺎﺳﺗﺧﺩﺍﻡ ﺃﻛﺳﻳﺩ ﺍﻹﻳﺛﻳﻠﻳﻥ‬
‫ﺑﻳﻥ‬ DyeTect Disposable Kit ‫ﻟﻠﻭﺻﻭﻝ ﺇﻟﻰ ﻋﻣﺭ ﺍﻓﺗﺭﺍﺿﻲ ﻣﺛﺎﻟﻲ ﻟﻠﺑﻁﺎﺭﻳﺔ، ﺍﺣﺭﺹ ﻋﻠﻰ ﺗﺧﺯﻳﻥ ﻣﺟﻣﻭﻋﺔ‬
‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬ 30 ‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ( ﻭﻻ ﺗﺗﺟﺎﻭﺯ‬
‫ﻭﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﻭﻣﺻﺩﺭ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﻣﺻﻣﻡ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ ﻭﻓﻖ‬
‫ﻭﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﺑﻁﺭﻳﻘﺔ ﺗﺿﻣﻥ ﺍﻻﻣﺗﺛﺎﻝ ﻟﻠﻭﺍﺋﺢ ﺍﻟﻣﺗﻌﻠﻘﺔ ﺑﻧﻔﺎﻳﺎﺕ ﺍﻟﺑﻁﺎﺭﻳﺎﺕ. ﻓﻲ‬
‫ﻧﻬﺎﻳﺔ ﺍﺳﺗﺧﺩﺍﻡ ﺍﻟﺟﻬﺎﺯ، ﺗﻛﻭﻥ ﺍﻟﺑﻁﺎﺭﻳﺎﺕ ﺍﻟﻘﻠﻭﻳﺔ ﻣﻭﺟﻭﺩﺓ ﺩﺍﺧﻝ ﺟﻬﺎﺯ ﻁﺑﻲ ﺣﺎﻣﻝ ﻟﻠﻌﺩﻭﻯ. ﻓﻲ ﻫﺫﻩ ﺍﻟﺣﺎﻟﺔ، "ﻻ" ﻳﻧﻁﺑﻖ‬
‫ﺔ ﻭﻻ ﺍﻟﻘﺎﻧﻭﻥ ﺍﻟﻔﻳﺩﺭﺍﻟﻲ ﻋﻠﻰ‬ ‫( ﻭﻻ ﺗﻭﺟﻳﻪ ﻧﻔﺎﻳﺎﺕ ﺍﻟﻣﻌﺩﺍﺕ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ ﻭﺍﻹﻟﻛﺗﺭﻭﻧﻳ‬
‫ﺗﺟﻣﻳﻊ ﺍﻟﺑﻁﺎﺭﻳﺔ ﺍﻟﻘﻠﻭﻳﺔ ﺃﻭ ﻣﻌﺎﻟﺟﺔ ﻧﻔﺎﻳﺎﺗﻬﺎ.ﺍﺗﺑﻊ ﺍﻟﻘﻭﺍﻧﻳﻥ ﺍﻟﺣﺎﻛﻣﺔ ﺍﻟﻣﺣﻠﻳﺔ ﺍﻟﻣﺗﻌﻠﻘﺔ ﺑﻛﻳﻔﻳﺔ ﺍﻟﺗﺧﻠﺹ ﻣﻥ ﺍﻟﻧﻔﺎﻳﺎﺕ. ﺗﺟﻧﺏ‬
.‫ﺇﺣﺭﺍﻕ ﺍﻟﻣﻧﺗﺞ ﺇﺫ ﺇﻥ ﺍﻟﺑﻁﺎﺭﻳﺎﺕ ﺍﻟﻣﺭﻓﻘﺔ ﻗﺩ ﺗﻧﻔﺟﺭ ﻋﻧﺩ ﺩﺭﺟﺎﺕ ﺍﻟﺣﺭﺍﺭﺓ ﺍﻟﺯﺍﺋﺩﺓ‬
: ‫ﻟﺑﻳﺋﺔ ﻣﻌﻳﺎﺭﻳﺔ ﻟﻣﺧﺗﺑﺭ ﺍﻟﻘﺳﻁﺭﺓ ﻓﻲ ﺍﻟﻣﺳﺗﺷﻔﻰ ﺑﻣﻭﺟﺏ ﺍﻟﺷﺭﻭﻁ ﺍﻵﺗﻳﺔ‬
(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬ 80 ‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ ﺇﻟﻰ‬ 50
‫ﻋﺎﻟﻳﺔ ﺍﻟﺗﺭﺩﺩ ﺣﻳﺙ ﻳ ُﻣﻛﻥ ﺃﻥ ﺗﻛﻭﻥ ﻛﺛﺎﻓﺔ‬ ‫ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻏﻳﺭ ﻣﺧﺻﺹ ﻟﻼﺳﺗﺧﺩﺍﻡ ﺑﺎﻟﻘﺭﺏ ﻣﻥ ﻣﻌﺩﺍﺕ ﺟﺭﺍﺣﻳﺔ ﻧﺷﻁﺔ‬
Osprey Medical –
ً ‫ﻣﻼﺻﻖ ﻟﻬﺎ ﺿﺭﻭﺭ ﻳ‬
12 ) ‫ﺳﻡ‬ 30 ‫ﺍﻟﺧﺎﺭﺟﻳﺔ( ﻋﻠﻰ ﻣﺳﺎﻓﺔ ﻻ ﺗﻘﻝ ﻋﻥ‬
‫ﺃﻭ‬ Smart Monitor ‫ﻳ ُﻣﻛﻧﻙ ﺍﻟﺭﺟﻭﻉ ﺇﻟﻰ ﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ ﺟﻬﺎﺯ‬
Osprey Medical
.‫ﺍﻟﺳﻠﻁﺔ ﺍﻟﺗﻧﻅﻳﻣﻳﺔ ﺍﻟﺗﺄﻫﻳﻠﻳﺔ ﺑﺷﺄﻥ ﺍﻟﻭﺍﻗﻌﺔ‬
DyeTect
.‫ﺑﺎﻟﻛﺎﻣﻝ ﻣﻥ ﺍﻷﻧﺎﺑﻳﺏ ﻗﺑﻝ ﺇﺟﺭﺍء ﺍﻟﺣﻘﻥ ﻟﺗﺟﻧﺏ ﺣﺩﻭﺙ ﺍﻧﺻﻣﺎﻡ ﻫﻭﺍﺋﻲ‬
‫ﻳﻣﻛﻧﻙ ﻓﻘﻁ ﺍﻟﺿﻐﻁ ﺑﺷﻛﻝ‬
.(‫ﻗﻁﻊ ﺍﻟﻧﺯﻳﻑ ﺃﻭ ﺍﻟﻣﻌﺩﺍﺕ ﺍﻷﺧﺭﻯ‬
‫ﺃﻭ ﻭﺣﺩﺓ ﺍ‬ Smart Syringe ‫ﻳﺗﻌﻳﻥ ﻋﺩﻡ ﻏﻣﺭ ﺳﺭﻧﺟﺔ‬
/ ‫ﺍﻟﻣﺳﺗﺧﺩﻣﻳﻥ ﺑﺎﺗﺑﺎﻉ ﺳﻳﺎﺳﺔ‬ Osprey Medical
‫ﻳﺟﺏ ﻋﻠﻰ ﺍﻟﻣﺳﺗﺧﺩﻡ ﺍﻟﺗﺄﻛﺩ ﻣﻥ ﺗﻭﻗﻑ ﻣﻛﺑﺱ ﺳﺭﻧﺟﺔ‬
‫ﻟﺿﺑﻁ ﺯﻣﻥ ﺍﻟﺗﻭﻗﻑ ﻟﻣﻛﺑﺱ ﺳﺭﻧﺟﺔ‬
‫ﺍﻷﺣﺩﺍﺙ ﺍﻟﺳﻠﺑﻳﺔ ﺍﻟﻣﺣﺗﻣﻠﺔ ﻟﻠﻣﺭﻳﺽ‬
: ‫ﺗﺗﺿﻣﻥ ﺍﻵﺛﺎﺭ ﺍﻟﺟﺎﻧﺑﻳﺔ ﺍﻟﻣﺣﺗﻣﻠﺔ ﻋﻠﻰ ﺳﺑﻳﻝ ﺍﻟﻣﺛﺎﻝ ﻻ ﺍﻟﺣﺻﺭ‬
.‫ﻳﻣﻛﻥ ﺗﻭﻓﻳﺭ ﺇﻋﻼﻥ ﺍﻟﻣﻁﺎﺑﻘﺔ ﺍﻟﺧﺎﺹ ﺑﺎﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﻋﻧﺩ ﺍﻟﻁﻠﺏ‬
77 ‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ ﻭ‬ 50 ) ‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ‬ 25 ‫ﺩﺭﺟﺎﺕ ﻣﺋﻭﻳﺔ ﻭ‬
.(‫ﺩﺭﺟﺔ ﻓﻬﺭﻧﻬﺎﻳﺕ‬
.‫ﺍﻟﺻﻳﺎﻧﺔ ﻏﻳﺭ ﻣﻁﻠﻭﺑﺔ‬
Smart Syringe
.‫ﺇﺟﺭﺍءﺍﺕ ﺍﻟﻣﺳﺗﺷﻔﻰ‬
Smart Syringe
2006/66/EC
‫ﺍﻟﺟﻬﺎﺯ ﻣﺧﺻﺹ ﻟﻼﺳﺗﺧﺩﺍﻡ ﻭﻓ ﻘ ً ﺎ‬
‫ﺩﺭﺟﺔ ﻣﺋﻭﻳﺔ )ﻣﻥ‬ 27 ‫ﺩﺭﺟﺎﺕ ﻣﺋﻭﻳﺔ ﺇﻟﻰ‬ 10
‫، ﻏﻳﺭ ﻣﺗﻛﺛﻔﺔ‬ % 85 ‫ﺇﻟﻰ‬ % 0
.‫ﺍﻻﺿﻁﺭﺍﺑﺎﺕ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﻋﺎﻟﻳﺔ‬
‫ﺗﻭﺍﻓﻖ ﻋﻠﻳﻬﺎ ﺷﺭﻛﺔ‬
DyeTect
.‫ﻏﻳﺭ ﺳﻠﻳﻡ‬
. ‫ﻣﻧﻬﻡ‬
Smart Syringe
‫ﻭﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﺑﻐﺭﺽ ﺍﺳﺗﺧﺩﺍﻣﻬﺎ ﻣﻊ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﺧﻼﻝ ﺍﻟﺗﺳﺭﻳﺏ ﺍﻟﺧﺎﺿﻊ ﻟﻠﺗﺣﻛﻡ ﻣﻥ ﺃﺟﻝ ﺍﻹﺟﺭﺍءﺍﺕ ﺍﻟﻁﺑﻳﺔ ﺍﻟﺗﻲ‬
.‫ﺍﻟﺟﻬﺎﺯ‬
‫ﺇﻣﻛﺎﻧﻳﺔ ﻣﺭﺍﻗﺑﺔ ﻭﻋﺭﺽ‬
‫ﺧﺩﺍﻣﻬﺎ ﻣﻊ ﺍﻟﻣﺷﺎﻋﺏ ﺍﻟﻣﺟﻬﺯﺓ ﺑﺗﺭﻛﻳﺑﺎﺕ "ﻟﻭﺭ"، ﻭﺍﻟﺗﻲ ﺛﺑﺕ ﺍﻣﺗﺛﺎﻟﻬﺎ ﻟﻠﻣﻌﻳﺎﺭ‬
‫ﻟﻠﺳﺭﻧﺟﺎﺕ ﻭﺍﻹﺑﺭ ﻭﺑﻌﺽ ﺍﻟﻣﻌﺩﺍﺕ‬
‫ﺍﺣﺗﻳﺎﻁﺎﺕ‬
‫ﻗﺩ ﻳﺅﺩﻱ ﺍﺳﺗﺧﺩﺍﻡ‬
CF
.‫ﺍﻟﺿﻐﻁ ﺑﻣﺷﻌﺏ‬
‫ﺗﻭﺻﻲ‬
.‫ﺍﻟﺗﺑﺎﻳﻥ‬
‫ﻭﻭﺣﺩﺓ ﺿﻐﻁ‬
‫ﺑﻐﺭﺽ ﺍﺳﺗﺧﺩﺍﻣﻬﺎ ﻣﻊ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﺧﻼﻝ ﺍﻟﺗﺳﺭﻳﺏ ﺍﻟﺧﺎﺿﻊ ﻟﻠﺗﺣﻛﻡ ﻣﻥ ﺃﺟﻝ ﺍﻹﺟﺭﺍءﺍﺕ ﺍﻟﻁﺑﻳﺔ ﺍﻟﺗﻲ ﺗﺗﻁﻠﺏ ﺣﻘﻥ‬
‫ﺇﻣﻛﺎﻧﻳﺔ‬ Osprey Medical
Medical
.‫ﺍﻟﻣﺣﻠﻭﻝ ﺍﻟﻣﻠﺣﻲ‬
Smart Syringe
‫ﻭﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﺑﻐﺭﺽ ﺍﺳﺗﺧﺩﺍﻣﻬﺎ ﻣﻊ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﺧﻼﻝ ﺇﺟﺭﺍءﺍﺕ ﺍﻟﺗﺻﻭﻳﺭ ﺍﻟﻭﻋﺎﺋﻲ ﺃﻭ ﺍﻟﺗﺻﻭﻳﺭ ﺍﻟﻣﻘﻁﻌﻲ‬
‫ﻛﻳﻔﻳﺔ ﺗﻭﺍﻓﺭ ﺍﻟﺟﻬﺎﺯ‬
‫ﻡ ﺍﻟﺗﺧﻠﺹ ﻣﻧﻬﺎ ﺑﻌﺩ ﺍﻻﺳﺗﺧﺩﺍﻡ. ﺗﺟﻧﺏ ﺇﻋﺎﺩﺓ ﺍﺳﺗﺧﺩﺍﻣﻬﺎ ﺃﻭ ﻣﻌﺎﻟﺟﺗﻬﺎ ﺃﻭ‬
‫ﺍﻟﺗﺧﺯﻳﻥ‬
‫ﺗﻌﻘﻳﻣﻬﺎ. ﻓﻘﺩ ﺗﺗﺳﺑﺏ ﺇﻋﺎﺩﺓ ﺍﺳﺗﺧﺩﺍﻣﻬﺎ ﺃﻭ ﻣﻌﺎﻟﺟﺗﻬﺎ ﺃﻭ ﺗﻌﻘﻳﻣﻬﺎ ﻓﻲ ﺧﻁﺭ ﺍﻧﺗﻘﺎﻝ ﻋﺩﻭﻯ ﺇﻟﻰ ﺍﻟﻣﺭﻳﺽ، ﻣﺎ ﻗﺩ ﻳﻌﺭﺿﻪ‬
10
86 )
‫ﻓﻘﻁ ﺑﺄﺟﻬﺯﺓ ﻣﺻﺎﺩﺭ ﻋﻭﺍﻣﻝ‬
‫ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ. ﻻ ﺗﻣﻧﻊ ﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﺍﻧﺗﻘﺎﻝ ﺍﻟﺗﻠﻭﺙ ﺃﻭ ﺩﺧﻭﻝ ﺍﻟﻣﻳﻛﺭﻭﺑﺎﺕ ﺇﻟﻰ ﻣﺻﺩﺭ ﻋﺎﻣﻝ‬
DyeTect
‫ﺍﻟﺻﻳﺎﻧﺔ ﻭﺍﻹﺻﻼﺡ‬
‫ﺑﻣﺎ ﻓﻲ‬ –
.‫ﺑﻌﺩ ﺇﺗﻣﺎﻡ ﺍﻹﺟﺭﺍء ﺍﻟﻁﺑﻲ‬
‫ﺍﻟﺗﺧﻠﺹ‬
‫ﺗﺧﻠﺹ ﻣﻥ ﺳﺭﻧﺟﺔ‬
‫ﺽ ﻭﺍﺣﺭﺹ ﻋﻠﻰ ﺍﺗﺑﺎﻉ ﺟﻣﻳﻊ ﺗﻭﺟﻳﻬﺎﺕ ﺍﻟﻣﻠﺻﻘﺎﺕ ﻭﺗﻌﻠﻳﻣﺎﺕ‬
‫ﺻ ُ ﻣ ّ ِ ﻣﺕ ﺳﺭﻧﺟﺔ‬
) ‫ﺗﻭﺟﻳﻪ ﺍﻟﺑﻁﺎﺭﻳﺎﺕ‬
‫ﺎﺕ ﺍﻟﺟﺭﻋﺔ ﻭﺍﻟﺗﺣﺫﻳﺭﺍﺕ ﻭﻣﻭﺍﻧﻊ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﻭﺍﻟﺗﻔﺎﺻﻳﻝ ﺍﻟﺧﺎﺻﺔ ﺑﺄﻧﻭﺍﻉ ﺍﻷﺣﺩﺍﺙ ﺍﻟﺳﻠﺑﻳﺔ ﺍﻟﻣﺑﻠﻎ ﻋﻧﻬﺎ ﻭﺗﻭﺟﻳﻬﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ ﺍﻟﻣﻔﺻﻠﺔ ﺍﻟﻣﺭﺗﺑﻁﺔ ﺑﺈﻋﻁﺎء ﻋﺎﻣﻝ‬
‫ﻅﺭﻭﻑ ﺍﻟﺗﺷﻐﻳﻝ‬
‫، ﺗﺄﻛﺩ ﻣﻥ ﺗﻌﺑﺋﺔ ﺳﺭﻧﺟﺔ‬
‫ﻣﻥ‬ : ‫ﺩﺭﺟﺔ ﺍﻟﺣﺭﺍﺭﺓ‬
‫ﻭﺍﺣﺗﻭﺍء ﻣﺻﺩﺭ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﻋﻠﻰ ﻋﺎﻣﻝ ﺗﺑﺎﻳﻥ‬
‫ﺍﻟﺭﻁﻭﺑﺔ ﺍﻟﻧﺳﺑﻳﺔ ﻣﻥ‬
™ Contrast Monitoring Disposable Kit
‫ﺍﻻﺳﺗﺧﺩﺍﻡ‬ ‫ﺗﻌﻠﻳﻣﺎﺕ‬
‫ﺑﻁﻠﺏ‬ ‫ﺃﻭ‬ ‫ﺍﻷﻁﺑﺎء‬ ‫ﺑﻭﺍﺳﻁﺔ‬ ‫ﺇﻻ‬ ‫ﺍﻟﺟﻬﺎﺯ‬ ‫ﻫﺫﺍ‬
™
‫ﻣﻥ ﺳﺭﻧﺟﺔ‬ DyeTect Contrast Monitoring Disposable Kit
DyeTect Contrast Monitoring System
% 6 ‫ﻣﺳﺗﺩﻕ ﺑﻧﺳﺑﺔ‬ ' ‫ﻟﻭﺭ‬
‫ﺍﻷﺩﻭﺍﺕ ﺍﻟﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ‬
‫ﻣﻘﺑﺽ ﺣﻠﻘﻲ‬ – ‫ﻗﻔﻝ ﻟﻭﺭ، ﻣﻛﺑﺱ ﺣﻠﻘﻲ‬
‫ﻣﻘﺑﺽ ﺣﻠﻘﻲ‬ –
‫ﻣﻘﺑﺽ ﻣﺟﻧﺢ‬ –
‫ﺣﻠﻘﻲ‬ ‫ﻣﻘﺑﺽ‬ – ‫ﺣﻠﻘﻲ‬ ‫ﻣﻛﺑﺱ‬
‫ﺣﻠﻘﻲ‬ ‫ﻣﻘﺑﺽ‬ – ‫ﻛﻔﻲ‬ ‫ﻣﻛﺑﺱ‬
‫ﻣﺟﻧﺢ‬ ‫ﻣﻘﺑﺽ‬ – ‫ﻛﻔﻲ‬ ‫ﻣﻛﺑﺱ‬
‫ﺍﻟﺟﺯء ﺍﻟﻣﺳﺗﺧﺩﻡ )ﺍﻟﻣﺻﺭﺡ ﻟﻪ ﺑﻣﻼﻣﺳﺔ ﺍﻟﺟﺳﻡ( ﻫﻭ ﻣﻥ ﺍﻟﻧﻭﻉ‬
‫ﺍﻟﺟﻬﺎﺯ ﻏﻳﺭ ﻣﻧﺎﺳﺏ ﻟﻼﺳﺗﺧﺩﺍﻡ ﻓﻲ ﻭﺟﻭﺩ ﻣﺧﺎﻟﻳﻁ ﻗﺎﺑﻠﺔ ﻟﻼﺷﺗﻌﺎﻝ‬
. DyeTect Pressure Module
.‫ﺟﻣﻳﻊ ﺍﻷﺟﺯﺍء ﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ ﻭﻳﺗﻡ ﺍﻟﺗﺧﻠﺹ ﻣﻧﻬﺎ ﺑﻌﺩ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
Smart Syringe ‫ﻣﻥ ﺳﺭﻧﺟﺔ‬ Contrast Monitoring Disposable Kit
‫ﻣﻥ‬ DyeTect Contrast Monitoring System
.‫ﻣﺭﺍﻗﺑﺔ ﻛﻣﻳﺎﺕ ﻋﻭﺍﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﻣﺣﻘﻭﻧﺔ ﻳﺩﻭ ﻳ ًﺎ ﻭﻋﺭﺿﻬﺎ ﻓﻲ ﺍﻟﻭﻗﺕ ﺍﻟﻔﻌﻠﻲ‬
‫ﻣﻥ ﺳﺭﻧﺟﺔ‬
DyeTect ™ Contrast Monitoring Disposable Kit
.‫ﺍﻟﻣﺣﻭﺳﺏ ﺍﻟﺗﻲ ﺗﺗﻁﻠﺏ ﺍﻟﺗﺳﺭﻳﺏ ﺍﻟﺧﺎﺿﻊ ﻟﻠﺗﺣﻛﻡ ﻷﻭﺳﺎﻁ ﺗﺑﺎﻳﻥ ﻅﻠﻳﻠﺔ ﻟﻸﺷﻌﺔ‬
DyeTect Contrast Monitoring Disposable Kit
‫ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﻣﺻﻣﻡ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ ﺃﻭ ﻣﻧﻪ ﻭﻻ ﺗﺣﻣﻲ ﻣﻥ ﻭﻗﻭﻋﻪ. ﻳﺗﻌﻳﻥ ﺍﻟﺗﺧﻠﺹ ﻣﻥ ﻣﺟﻣﻭﻋﺔ‬
‫ﺻﺩﺭ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﻣﺻﻣﻡ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ‬
– ‫ﺫﻟﻙ ﺃﻱ ﻣﺣﻠﻭﻝ ﺗﺑﺎﻳﻥ ﻣﺗﺑ ﻖ ٍ ﻓﻲ ﻣﺻﺩﺭ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﻣﺻﻣﻡ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ‬
.‫ﻻ ﺗﺳﺗﺧﺩﻡ ﺍﻟﻣﺟﻣﻭﻋﺔ ﺇﺫﺍ ﺍﺗﺿﺢ ﺃﻥ ﻋﺑﻭﺓ ﺍﻟﻣﻧﺗﺞ ﻗﺩ ﺗﻡ ﺍﻟﻌﺑﺙ ﺑﻬﺎ‬
‫ﻭﺍﻟﻣﻠﺻﻘﺎﺕ ﺍﻟﺧﺎﺻﺔ ﺑﻪ، ﺃﻭ‬
‫ﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ ﺷﺎﺷﺔ ﻋﺭﺽ ﻣﺭﺍﻗﺑﺔ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﻭﺍﻟﻣﻠﺻﻘﺎﺕ ﺍﻟﺧﺎﺻﺔ ﺑﻬﺎ‬
‫ﻳ ُﺭﺟﻰ ﺍﻟﺭﺟﻭﻉ ﺇﻟﻰ ﺍﻟﻣﻠﺻﻘﺎﺕ ﺍﻟﺧﺎﺻﺔ ﺑﻌﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﻟﻼﻁﻼﻉ ﻋﻠﻰ ﺗﻭﺻﻳ‬
Smart Syringe ‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻗﻳﻡ ﺩﻗﻳﻘﺔ ﺑﺎﻟﻧﺳﺑﺔ ﺍﻟﻣﺋﻭﻳﺔ ﻟﺗﺭﻛﻳﺯ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﻓﻲ ﺳﺭﻧﺟﺔ‬
% 100
‫ﻣﺟﻣﻭﻋﺔ‬
‫ﺑﻳﻊ‬ ( ‫ﺍﻷﻣﺭﻳﻛﻲ‬ ) ‫ﺍﻟﻔﻳﺩﺭﺍﻟﻲ‬ ‫ﺍﻟﻘﺎﻧﻭﻥ‬ ‫ﻳﻘﺻﺭ‬
‫ﻭﺻﻑ ﺍﻟﺟﻬﺎﺯ‬
‫ﺗﺗﻛﻭﻥ ﻣﺟﻣﻭﻋﺔ‬
‫ﺗﺗﻁﻠﺏ ﺣﻘﻥ ﺃﻭﺳﺎﻁ ﺗﺑﺎﻳﻥ. ﻳﺗﻳﺢ ﺟﻬﺎﺯ‬
. ‫ﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﺍﻟﺗﻲ ﺗﻡ ﺣﻘﻧﻬﺎ ﻳﺩﻭ ﻳ ًﺎ‬ ‫ﻛﻣﻳﺎﺕ ﻋﻭﺍ‬
‫ﺻ ُ ﻣ ّ ِ ﻣﺕ ﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﺑﻐﺭﺽ ﺍﺳﺗ‬
' ‫"ﺍﻟﺗﺭﻛﻳﺑﺎﺕ ﺍﻟﻣﺧﺭﻭﻁﻳﺔ ﺍﻟﻣﺯﻭﺩﺓ ﺑﻁﺭﻑ‬ ISO 594
."‫ﺍﻟﻁﺑﻳﺔ ﺍﻷﺧﺭﻯ‬
- ‫ﺗﺣﺩﻳﺩ ﺭﻗﻡ ﺍﻟﻁﺭﺍﺯ‬
‫ﺍﻟﺳﺭﻧﺟﺔ‬ ‫ﻭﺻﻑ‬ ‫ﺍﻟﻁﺭﺍﺯ‬ ‫ﺭﻗﻡ‬
RRL
‫ﻗﻔﻝ ﻟﻭﺭ، ﻣﻛﺑﺱ ﻛﻔﻲ‬ PRL
‫ﻗﻔﻝ ﻟﻭﺭ، ﻣﻛﺑﺱ ﻛﻔﻲ‬ PWL
،‫ﺩﻭﺍﺭ‬ ‫ﻟﻭﺭ‬ ‫ﻗﻔﻝ‬ RRS
،‫ﺩﻭﺍﺭ‬ ‫ﻟﻭﺭ‬ ‫ﻗﻔﻝ‬ PRS
،‫ﺩﻭﺍﺭ‬ ‫ﻟﻭﺭ‬ ‫ﻗﻔﻝ‬ PWS
CMS ‫ﺗﺻﻧﻳﻑ ﺟﻬﺎﺯ‬
1 . ‫ﺍﻟﻔﺋﺔ‬ : ‫ﻧﻭﻉ ﺍﻟﺣﻣﺎﻳﺔ ﻣﻥ ﺍﻟﺻﺩﻣﺔ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ‬
: ‫ﺩﺭﺟﺔ ﺍﻟﺣﻣﺎﻳﺔ ﻣﻥ ﺍﻟﺻﺩﻣﺎﺕ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ‬
(‫)ﻣﺻﺭﺡ ﻟﻪ ﺑﻣﻼﻣﺳﺔ ﺍﻟﻘﻠﺏ ﺩﻭﻥ ﺗﺛﺑﻳﺕ‬
‫ﺍﻟﻣﺳﺗﺧﺩﻣﺔ‬ ‫ﺍﻷﺟﺯﺍء‬
‫ﻭﻣﺣﻭﻝ ﺍﻟﺿﻐﻁ ﻟﻭﺣﺩﺓ‬ Smart Syringe
‫ﺍﻟﻐﺭﺽ ﻣﻥ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﺗﺗﻛﻭﻥ ﻣﺟﻣﻭﻋﺔ‬
‫ﺃﻭﺳﺎﻁ ﺗﺑﺎﻳﻥ. ﻳﺗﻳﺢ ﺟﻬﺎﺯ‬
‫ﺩﻭﺍﻋﻲ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﺗﺗﻛﻭﻥ ﻣﺟﻣﻭﻋﺔ‬
‫ﻣﻭﺍﻧﻊ ﺍﻻﺳﺗﻌﻣﺎﻝ‬
.‫ﻻ ﺗ ُ ﺳﺗﺧﺩﻡ ﻣﻊ ﺍﻟﻣﺣﺎﻗﻥ ﺍﻟﻛﻬﺭﺑﺎﺋﻳﺔ‬
‫ﺗﺣﺫﻳﺭﺍﺕ‬
‫ﺍﻷﺩﻭﺍﺕ ﺍﻟﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ ﻳﺗ‬
.‫ﻟﻺﺻﺎﺑﺔ ﺃﻭ ﺍﻟﻣﺭﺽ ﺃﻭ ﺍﻟﻭﻓﺎﺓ‬
‫ﻳﺗﻌﻳﻥ ﺗﻭﺻﻳﻝ ﻣﺟﻣﻭﻋﺔ‬
‫ﻭﻣ‬ Contrast Monitoring Disposable Kit
‫ﺭﺍﺟﻊ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ ﺍﻟﻣﺣﺩﺩﺓ ﻟﺷﺎﺷﺔ ﺍﻟﻌﺭ‬
: ‫ﺍﻻﺳﺗﺧﺩﺍﻡ‬
Smart Monitor ‫ﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ ﺟﻬﺎﺯ‬
‫ﺑﺷﻛﻝ ﺃﻭﻟﻲ ﺑﺄﻭﺳﺎﻁ ﺗﺑﺎﻳﻥ ﺑﻧﺳﺑﺔ‬ Smart S yringe
. % 100
8176-M Jan 2020
: ‫ﺗﻧﺑﻳﻪ‬
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‫ﺳﺭﻧﺟﺔ‬
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.‫ﺍﻟﺗﺑﺎﻳﻥ‬
‫ﺑﻧﺳﺑﺔ‬