Osprey Medical R-RRL Gebrauchsanweisung Seite 49

Contrast Monitoring Display ‫ﺃﻭ‬ Smart Monitor
.‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻣﻌﻠﻭﻣﺎﺕ ﺍﻻﻣﺗﺛﺎﻝ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ ﺍﻟﺧﺎﺻﺔ ﺑﻬﺫﺍ ﺍﻟﺟﻬﺎﺯ‬
‫ﻳﺧﺹ‬ ‫ﺿﻣﻧﻲ‬ ‫ﺿﻣﺎﻥ‬ ‫ﺃﻱ‬ ‫ﺍﻟﺣﺻﺭ‬ ‫ﻻ‬ ‫ﺍﻟﻣﺛﺎﻝ‬ ‫ﺳﺑﻳﻝ‬
OSPREY MEDICAL ( ‫ﻣﻧﺗﺟﺎﺕ‬ ) ‫ﻣﻧﺗﺞ‬ ‫ﺑﺧﺻﻭﺹ‬
‫ﺗﻘﻊ‬ ‫ﻻ‬ ،‫ﺍﻟﻣﻁﺎﺑﻘﺔ‬ ‫ﻋﺩﻡ‬ ‫ﺣﺎﻟﺔ‬ ‫ﻓﻲ‬ ‫ﺃﻭ‬ ( ‫ﺍﻟﻣﻧﺗﺟﺎﺕ‬ ) ‫ﺍﻟﻣﻧﺗﺞ‬
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‫ﻣﻥ‬ ‫ﺣﺎﻝ‬ ‫ﻭﺑﺄﻱ‬ ‫ﺍﻟﻣﺷﺗﺭﻱ‬ ‫ﺇﻟﻰ‬ ( ‫ﺍﻟﻣﻧﺗﺟﺎﺕ‬ ) ‫ﺍﻟﻣﻧﺗﺞ‬
‫ﺗﺑﻌﻳﺔ‬ ‫ﺃﻭ‬ ‫ﻣﺑﺎﺷﺭﺓ‬ ‫ﻏﻳﺭ‬ ‫ﺃﻭ‬ ‫ﻣﺑﺎﺷﺭﺓ‬ ‫ﺃﺿﺭﺍﺭ‬ ‫ﺃﻱ‬
‫ﺃﺧﺭﻯ‬ ‫ﻧﻅﺭﻳﺔ‬ ‫ﺃﻱ‬ ‫ﺃﻭ‬ ‫ﻭﺍﺿﺣﺔ‬ ‫ﺗﻘﺻﻳﺭﻳﺔ‬ ‫ﻣﺳﺅﻭﻟﻳﺔ‬
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OSPREY MEDICAL ‫ﺗﺗﺣﻣﻝ‬ ‫ﻻ‬ ‫ﺍﺳﺗﺧﺩﺍﻣﻪ‬
‫ﺃﻱ‬ ‫ﺗﻔﻭﺽ‬ ‫ﺃﻭ‬ OSPREY MEDICAL ‫ﻣﻧﺗﺟﺎﺕ‬
‫ﺑﻣﺎ‬ ، Osprey Medical ‫ﻣﻥ‬ ‫ﺍﻟﻣﻁﺑﻭﻋﺔ‬ ‫ﺍﻟﻣﻭﺍﺩ‬
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‫ﺻﺭﻳﺣﺔ‬ ‫ﺿﻣﺎﻧﺔ‬ ‫ﺃﻱ‬ ‫ﺗﺷﻛﻝ‬ ‫ﻭﻻ‬ ‫ﺍﻟﺗﺻﻧﻳﻊ‬ ‫ﻓﺗﺭﺓ‬ ‫ﺧﻼﻝ‬
‫ﺍﻟﺗﻌﺑﺋﺔ‬
‫ﻣ ُ ﻌﻘﻡ ﺑﻭﺍﺳﻁﺔ ﺃﻛﺳﻳﺩ‬
STERILE │EO
‫ﺍﻹﻳﺛﻳﻠﻳﻥ‬
‫ﺭﻗﻡ ﺍﻟﻁﺭﺍﺯ‬ REF
‫ﺍﻟﻣﺿﺎﺩ ﻹﺯﺍﻟﺔ‬
LOT
‫ﺭﻗﻡ ﺍﻟﺗﺷﻐﻳﻠﺔ‬
‫ﻏﻳﺭ ﺁﻣﻥ ﻟﻼﺳﺗﺧﺩﺍﻡ ﻓﻲ‬ ‫ﻻ ﺗﺳﺗﺧﺩﻡ ﺇﺫﺍ ﻛﺎﻧﺕ ﺍﻟﻌﺑﻭﺓ‬
‫ﺑﻳﺋﺔ ﺍﻟﺭﻧﻳﻥ ﺍﻟﻣﻐﻧﺎﻁﻳﺳﻲ‬
‫ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﺗﻌﺭﻳﻑ ﺍﻟﺣﺎﺟﺯ ﺍﻟﻣﻌﻘﻡ‬
‫ﻣﻣﺛﻝ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ ﺍﻟﻣﻌﺗﻣﺩ‬
MedPass SAS
95 bis Boulevard Pereire
75017 Paris - France
‫ﺍﻷﺳﺗﺭﺍﻟﻲ‬ ‫ﺍﻟﺭﺍﻋﻲ‬
Osprey Medical, Pty
Level 13, 41 Exhibition Street
Melbourne, Victoria 3000 Australia
. Osprey Medical
.‫. ﺟﻣﻳﻊ ﺍﻟﺣﻘﻭﻕ ﻣﺣﻔﻭﻅﺔ‬
‫ﻳ ُﻣﻛﻧﻙ ﺍﻟﺭﺟﻭﻉ ﺇﻟﻰ ﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ ﺟﻬﺎﺯ‬
‫ﺍﻟﺗﻌﻭﻳﺽ‬ ‫ﺩﺍﺋﺭﺓ‬ ‫ﻭﺗﺿﻳﻳﻖ‬ ‫ﺍﻟﺿﻣﺎﻥ‬ ‫ﻣﺳﺅﻭﻟﻳﺔ‬
‫ﻋﻠﻰ‬ ‫ﺫﻟﻙ‬ ‫ﻓﻲ‬ ‫ﺑﻣﺎ‬ ،‫ﺿﻣﻧ ﻳ ًﺎ‬ ‫ﺃﻡ‬ ‫ﻛﺎﻥ‬ ‫ﺻﺭﻳ ﺣ ً ﺎ‬ ‫ﺿﻣﺎﻥ‬
‫ﻣﺣﺩﺩ‬ ‫ﻟﻐﺭﺽ‬ ‫ﺍﻟﻣﻼءﻣﺔ‬ ‫ﺃﻭ‬ ‫ﺍﻷﺳﻭﺍﻕ‬ ‫ﻓﻲ‬ ‫ﻟﻠﻁﺭﺡ‬
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‫ﻫﺫﺍ‬ ‫ﻓﻲ‬ ‫ﺧﻠﻝ‬ ‫ﺃﻱ‬ ‫ﺣﺩﻭﺙ‬ ‫ﺣﺎﻟﺔ‬ ‫ﻓﻲ‬ ‫ﺍﻟﻧﺷﺭﺓ‬ ‫ﻫﺫﻩ‬
‫ﺍﻟﺷﺭﺍء‬ ‫ﺳﻌﺭ‬ ‫ﺗﺟﺎﻭﺯ‬ ‫ﻓﻲ‬ OSPREY MEDICAL
‫ﻋﻥ‬ ‫ﺍﻟﻣﺳﺅﻭﻟﻳﺔ‬ OSPREY MEDICAL ‫ﺗﺗﺣﻣﻝ‬
‫ﺃﻭ‬ ‫ﺍﻹﻫﻣﺎﻝ‬ ‫ﺃﻭ‬ ‫ﺑﺎﻟﻌﻘﺩ‬ ‫ﺍﻹﺧﻼﻝ‬ ‫ﺃﻭ‬ ‫ﺑﺎﻟﺿﻣﺎﻥ‬ ‫ﺍﻹﺧﻼﻝ‬
‫ﺇﻋﺎﺩﺓ‬ ‫ﺃﻭ‬ ‫ﺍﺳﺗﺧﺩﺍﻣﻪ‬ ‫ﺃﻭ‬ ( ‫ﺍﻟﻣﻧﺗﺟﺎﺕ‬ ) ‫ﺍﻟﻣﻧﺗﺞ‬ ‫ﻫﺫﺍ‬ ‫ﺷﺭﺍء‬
‫ﻣﻥ‬ ‫ﺑﻣﻧﺗﺞ‬ ‫ﺻﻠﺔ‬ ‫ﺫﺍﺕ‬ ‫ﺇﺿﺎﻓﻳﺔ‬ ‫ﻣﺳﺅﻭﻟﻳﺔ‬ ‫ﺃﻭ‬ ‫ﺇﺿﺎﻓﻲ‬
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ً ‫ﻧﻳﺎﺑ ﺔ‬
‫ﻓﻲ‬ ‫ﺍﻟﻣﻭﺟﻭﺩﺓ‬ ‫ﺍﻟﻣﻭﺍﺻﻔﺎﺕ‬ ‫ﺃﻭ‬ ‫ﺍﻷﻭﺻﺎﻑ‬ ‫ﻋﻧﻬﺎ‬
‫ﻋﺎﻡ‬ ‫ﺑﺷﻛﻝ‬ ‫ﺍﻟﻣﻧﺗﺞ‬ ‫ﻟﻭﺻﻑ‬ ‫ﻓﻘﻁ‬ ‫ﻣﺧﺻﺻﺔ‬ ،‫ﺍﻟﻧﺷﺭﺓ‬
‫ﺭﻣﺯ‬ ‫ﺗﻌﺭﻳﻔﺎﺕ‬
‫ﺗﺎﺭﻳﺦ ﺍﻟﺻﻼﺣﻳﺔ‬
. YYYY-MM
‫ﺍﻟﺷﺭﻛﺔ ﺍﻟﻣﺻﻧﻌﺔ‬
‫ﺍﻻﺳﺗﺧﺩﺍﻡ ﺣﺗﻰ ﺁﺧﺭ‬
.( MM ) ‫ﻳﻭﻡ ﻓﻲ ﺍﻟﺷﻬﺭ‬
‫ﺭﺍﺟﻊ ﺗﻌﻠﻳﻣﺎﺕ‬
‫ﺣﺎﻓﻅ ﻋﻠﻳﻪ ﺟﺎ ﻓ ً ﺎ‬
‫ﺍﻻﺳﺗﺧﺩﺍﻡ ﺍﻹﻟﻛﺗﺭﻭﻧﻳﺔ‬
‫ﺍﻟﺟﺯء ﺍﻟﻣﺳﺗﺧﺩﻡ ﻣﻥ‬
CF ‫ﺍﻟﻧﻭﻉ‬ ‫ﻣﺻﻣﻡ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ‬
‫ﺍﻟﺭﺟﻔﺎﻥ ﻭﻓﻖ ﺍﻟﻣﻌﻳﺎﺭ‬ ‫ﻭﺍﺣﺩﺓ‬
EN IEC 60601-1
‫ﻳ ُﺻﺭﻑ ﺑﻭﺻﻔﺔ ﻁﺑﻳﺔ‬
‫ﺗﺎﻟﻔﺔ‬ ‫ﻓﺣﺳﺏ‬
‫ﺭﺍﺟﻊ ﺗﻌﻠﻳﻣﺎﺕ‬
‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻣﻌﻠﻭﻣﺎﺕ‬ ‫ﺟﻬﺎﺯ ﻁﺑﻲ‬
.‫ﻣﻬﻣﺔ‬
‫ﺍﻟﺳﺭﻧﺟﺔ‬
‫ﺩﺭﺟﺔ ﺍﻟﺣﺭﺍﺭﺓ‬
‫ﺍﻟﻣﻁﺎﺑﻘﺔ ﺍﻷﻭﺭﻭﺑﻳﺔ‬
2797
Osprey Medical Inc.
5600 Rowland Road, Suite 250
Minnetonka, MN 55343
: ‫ﺍﻟﺧﻁ ﺍﻟﻣﺟﺎﻧﻲ ﻟﺧﺩﻣﺔ ﺍﻟﻌﻣﻼء‬
1-855-883-4365 : ‫ﻓﺎﻛﺱ‬ 1-855-860-7584
customerservice@ospreymed.com
www.ospreymed.com
‫ﻫﻲ ﻋﻼﻣﺎﺕ ﺗﺟﺎﺭﻳﺔ ﻟﺷﺭﻛﺔ‬ DyeTect ‫ﻭ‬ DyeVert
Osprey Medical ‫ﻣﺣﻔﻭﻅﺔ ﻟﺷﺭﻛﺔ‬ 2020 ‫ﺣﻘﻭﻕ ﺍﻟﻁﺑﻊ ﻭﺍﻟﻧﺷﺭ ﻟﻌﺎﻡ‬
: ‫ﺗﺣﺫﻳﺭ‬ DyeVert Plus EZ
‫. ﻳﺗﺿﻣﻥ ﺫﻟﻙ‬ DyeTect Contrast Monitoring System
‫ﻭﻭﺣﺩﺓ ﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ )ﻭﺣﺩﺓ‬
‫ﺃﻭ ﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ(. ﻗﺑﻝ ﺍﻻﺳﺗﺧﺩﺍﻡ، ﺭﺍﺟﻊ‬
DyeVert Plus
‫ﺇﺧﻼء‬
DyeTect Contrast Monitoring System
‫ﺃﻱ‬ ‫ﻳﻭﺟﺩ‬ ‫ﻻ‬
‫ﺍﻟﺻﻼﺣﻳﺔ‬
‫ﻓﻲ‬ ‫ﺍﻟﻣﻭﺻﻭﻑ‬
‫ﻣﺳﺅﻭﻟﻳﺔ‬ .‫ﺎﻩ ﺍﻟﺣﺟﻡ ﺍﻟﺗﺭﺍﻛﻣﻲ‬
‫ﺗﺷﻳﺭ ﺇﻟﻰ ﺃﻥ ﺍﻟﺟﻬﺎﺯ ﻗﺩ ﺗﻡ ﺇﻳﻘﺎﻓﻪ ﻣﺅﻗ ﺗ ً ﺎ ﻭﻟﻥ ﻳﺗﻡ ﺍﺣﺗﺳﺎﺏ ﺍﻟﺣﻘﻧﺎﺕ ﺿﻣﻥ ﺍﻟﺣﺟﻡ ﺍﻟﺗﺭﺍﻛﻣﻲ‬
‫ﻻ‬ ،‫ﺍﻷﺣﻭﺍﻝ‬
‫ﺇﻟﻰ‬ ‫ﻣﺳﺗﻧﺩﺓ‬
‫ﻋﻥ‬ ‫ﻧﺎﺟﻣﺔ‬
‫ﺍﻟﺗﺯﺍﻡ‬ ‫ﺃﻱ‬
‫ﺍﻟﻣﻭﺟﻭﺩﺍﻥ ﻋﻠﻰ ﺳﺭﻧﺟﺔ‬
‫ﺑﺫﻟﻙ‬ ‫ﺷﺧﺹ‬
.‫ﺑﺎﻟﻧﻣﻁ ﻧﻔﺳﻪ ﻋﻠﻰ ﺍﻟﻧﺣﻭ ﺍﻟﻣﻭﺿﺢ ﻋﻠﻰ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﻹﺟﺭﺍء ﺗﺣﺩﻳﺩ ﺻﺣﻳﺢ‬
‫ﻫﺫﻩ‬ ‫ﺫﻟﻙ‬ ‫ﻓﻲ‬
.‫ﺍﻟﺳﺭﻧﺟﺔ ﺗﻭﻣﺽ‬
‫ﺛﻭﺍﻥ ٍ ﺑﻣﺟﺭﺩ ﺗﻭﺻﻳﻝ‬
RxOnly
. Smart Syringe
‫ﺣﺩ‬
CF ‫ﺍﻟﺟﺯء ﺍﻟﻣﺳﺗﺧﺩﻡ ﻣﻥ ﺍﻟﻧﻭﻉ‬
‫ﻻ ﻳﺟﻭﺯ‬ 1 ( ) :
‫ﻳﺟﺏ ﺃﻥ ﻳﺗﻘﺑﻝ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﺃﻱ ﺗﺩﺍﺧﻝ ﻳﺳﺗﻘﺑﻠﻪ، ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ‬
Osprey ‫ﺩﻭﻥ ﻣﻭﺍﻓﻘﺔ ﺻﺭﻳﺣﺔ ﻣﻥ‬
‫ﺍﻟﻔﺋﺔ ﺏ، ﻭﻓﻖ ﻣﻌﻳﺎﺭ‬
USA ‫ﻭﺩ ﻟﺗﻭﻓﻳﺭ ﺣﻣﺎﻳﺔ ﻣﻌﻘﻭﻟﺔ ﻣﻥ ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﺿﺎﺭ. ﺇﺫﺍ ﻟﻡ ﻳﺗﻡ ﺗﺭﻛﻳﺏ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻭﺍﺳﺗﺧﺩﺍﻣﻪ ﻭﻓﻖ ﺍﻟﺗﻌﻠﻳﻣﺎﺕ، ﻓﻘﺩ‬
‫ﻳﺗﺳﺑﺏ ﻓﻲ ﺣﺩﻭﺙ ﺗﺩﺍﺧﻝ ﺿﺎﺭ ﻣﻊ ﺍﻷﺟﻬﺯﺓ ﺍﻷﺧﺭﻯ. ﺭﻏﻡ ﺫﻟﻙ، ﻟﻳﺱ ﻫﻧﺎﻙ ﺿﻣﺎﻥ ﺑﻌﺩﻡ ﺣﺩﻭﺙ ﺗﺩﺍﺧﻝ ﻓﻲ ﺗﺭﻛﻳﺏ‬

‫ﻳﻣﻛﻥ ﺗﺣﺩﻳﺩﻩ ﻋﻥ ﻁﺭﻳﻖ ﺗﺷﻐﻳﻝ‬
‫ﺍﻟﺟﻬﺎﺯ ﻭﺇﻳﻘﺎﻑ ﺗﺷﻐﻳﻠﻪ، ﻓﺈﻧﻧﺎ ﻧﺣﺙ ﺍﻟﻣﺳﺗﺧﺩﻡ ﻋﻠﻰ ﻣﺣﺎﻭﻟﺔ ﺗﺻﺣﻳﺢ ﺍﻟﺗﺩﺍﺧﻝ ﻣﻥ ﺧﻼﻝ ﺇﺟﺭﺍء ﻭﺍﺣﺩ ﺃﻭ ﺃﻛﺛﺭ ﻣﻥ‬
‫ﻭ‬ Osprey ‫ﺇﻥ‬
©
‫ﺍﻟﻌﺭﺽ‬ ‫ﺷﺎﺷﺔ‬
‫ﻭﺿﻊ‬ ‫ﻓﻲ‬ ‫ﺃﻭ‬
Osprey
‫ﺇﻟﻰ ﺯﻳﺎﺩﺓ ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﺃﻭ ﺍﻧﺧﻔﺎﺽ ﺍﻟﻣﻧﺎﻋﺔ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﻟﻬﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻭﺍﻟﺗﺳﺑﺏ ﻓﻲ‬
‫ﻟﻣﺣﻣﻭﻟﺔ )ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ ﺍﻷﺟﻬﺯﺓ ﺍﻟﻁﺭﻓﻳﺔ، ﻣﺛﻝ ﻛﺎﺑﻼﺕ ﺍﻟﻬﻭﺍﺋﻲ‬
‫ﺑﻭﺻﺔ( ﻣﻥ ﺃﻱ ﺟﺯء ﻣﻥ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﺃﻭ ﺍﻷﺩﻭﺍﺕ‬
‫ﺍﻟﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ، ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ ﺍﻟﻛﺎﺑﻼﺕ ﺍﻟﻣﺣﺩﺩﺓ ﺑﻭﺍﺳﻁﺔ ﺟﻬﺔ ﺍﻟﺗﺻﻧﻳﻊ. ﻭﺇﺫﺍ ﻟﻡ ﻳﺗﻡ ﺫﻟﻙ، ﻓﻘﺩ ﻳﺗﺩﻫﻭﺭ‬
‫ﺇﺫﺍ ﺗﻌﻁﻝ ﺍﻟﺟﻬﺎﺯ ﺃﻭ ﺗﺩﻫﻭﺭ ﻣﺳﺗﻭﻯ ﺃﺩﺍﺋﻪ ﺑﺳﺑﺏ ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ، ﻓﻳﻣﻛﻥ ﻣﻭﺍﺻﻠﺔ ﺍﻹﺟﺭﺍء ﺍﻟﻁﺑﻲ ﺩﻭﻥ‬
Bluetooth
‫ﺗﺳﺗﺧﺩﻡ ﻣﻭﺟﺎﺕ ﺍﻟﺭﺍﺩﻳﻭ ﺫﺍﺕ ﺍﻟﺗﺭﺩﺩ ﻓﻭﻕ ﺍﻟﻌﺎﻟﻲ ﻭﺍﻟﻁﻭﻝ ﺍﻟﻣﻭﺟﻲ ﺍﻟﻘﺻﻳﺭ ﻓﻲ ﺍﻟﻧﻁﺎﻕ ﺍﻟﺻﻧﺎﻋﻲ ﻭﺍﻟﻌﻠﻣﻲ ﻭﺍﻟﻁﺑﻲ‬
‫ﺑﺑﺙ ﺇﺷﺎﺭﺓ ﻗﻭﻳﺔ ﺑﺣﺩ ﺃﻗﺻﻰ‬
‫ﻭﻓ ﻘ ً ﺎ ﻟﻣﻌﻳﺎﺭ‬
GSFM
. 4.0 +
‫ﻭ‬ DyeVert Plus ‫ﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﺧﺩﺍﻡ ﻣﻊ ﺟﻬﺎﺯﻱ‬
Smart Monitor
DyeVert Plus EZ Module
‫ﺃﻭ ﺟﻬﺎﺯ‬ DyeVert Plus Contrast Reduction System
‫ﺃﻭ ﺟﻬﺎﺯ‬
.‫ﻟﺗﻭﻓﻳﺭ ﻣﻼﺣﻅﺎﺕ ﻟﻠﻣﺳﺗﺧﺩﻡ‬ LED ‫ﻋﻠﻰ ﻣﺻﺑﺎﺣﻲ‬
‫ﺛﻭﺍﻥ ٍ ( ﺇﻟﻰ ﺍﺳﺗﻣﺭﺍﺭ ﺣﺳﺎﺏ ﺍﻟﺣﻘﻥ ﻓﻲ ﺍﺗﺟ‬ 10
‫ﻻﺳﻠﻛ ﻳ ً ﺎ ﺑﺷﺎﺷﺔ ﻋﺭﺽ ﻣﺭﺍﻗﺑﺔ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ‬
. Smart Syringe ‫ﻣﻥ ﺳﺭﻧﺟﺔ‬
LED ‫)ﺣﺎﻟﺔ ﺟﺩﻳﺩﺓ(. ﺑﻌﺩ ﺇﺟﺭﺍء ﺍﻟﻣﺳﺢ، ﺳﻳﻭﻣﺽ ﻣﺻﺑﺎﺣﺎ‬
‫ﻣﻝ‬ ‫ﺑﻣﻘﺩﺍﺭ‬
‫ﻟﺗﺄﻛﻳﺩ ﺃﻥ‬ > 2 Smart Syringe
.‫)ﻻ( ﺇﻟﻰ ﺇﺟﺭﺍء ﺍﻟﻣﺯﻳﺩ ﻣﻥ ﺍﻟﻔﺣﺹ‬
10 ‫ﺍﻷﺧﺿﺭ ﺍﻟﻣﻭﺟﻭﺩ ﻋﻠﻰ ﺍﻟﺟﻬﺎﺯ ﻓﻲ ﻭﺿﻊ ﺍﻟﺗﺷﻐﻳﻝ ﻟﻣﺩﺓ‬
.(‫)ﺑﺩء ﺍﻟﺣﺎﻟﺔ‬ Start Case ‫ﺗﺄﻛﺩ ﻣﻥ ﺇﺗﻣﺎﻡ ﺍﻟﺗﺣﺿﻳﺭ ﺑﺎﻟﻛﺎﻣﻝ ﻗﺑﻝ ﺍﻟﺿﻐﻁ ﻋﻠﻰ‬
.‫ﺃﻭ ﻭﺣﺩﺓ ﺿﻐﻁ ﻻﺳﻠﻛ ﻳ ًﺎ ﺑﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ‬ DyeVert Plus Module
.‫ﻟﺑﺩء ﺣﺳﺎﺏ ﺣﺟﻡ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ‬
‫ﺳﻳﺅﺩﻱ ﺇﻧﻬﺎء ﺍﻟﺣﺎﻟﺔ ﺇﻟﻰ ﺗﻌﻁﻳﻝ ﺍﻻﺗﺻﺎﻝ ﺑﺷﻛﻝ ﺩﺍﺋﻡ ﺑﻳﻥ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﻭﺳﺭﻧﺟﺔ‬
Smart Syringe
Smart Syringe: 2AHUPSS
IEC 60601-1 / UL 60601-1:
‫ﻣﺗﻘﻁﻊ‬
‫ﻣﻥ ﻗﻭﺍﻋﺩ ﻟﺟﻧﺔ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻔﻳﺩﺭﺍﻟﻳﺔ. ﻳﺧﺿﻊ ﺍﻟﺗﺷﻐﻳﻝ ﻟﻠﺷﺭﻁﻳﻥ ﺍﻵﺗﻳﻳﻥ‬
(
.‫ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﺫﻱ ﻗﺩ ﻳﺗﺳﺑﺏ ﻓﻲ ﻣﺳﺗﻭﻯ ﺗﺷﻐﻳﻝ ﻏﻳﺭ ﻣﺭﻏﻭﺏ ﻓﻳﻪ‬
Smart Syringe ‫ﻗﺩ ﻳﺅﺩﻱ ﺇﺟﺭﺍء ﺗﻐﻳﻳﺭﺍﺕ ﺃﻭ ﺗﻌﺩﻳﻼﺕ ﻓﻲ ﺳﺭﻧﺟﺔ‬
.‫ﺇﻟﻰ ﺇﺑﻁﺎﻝ ﺻﻼﺣﻳﺔ ﺍﻟﻣﺳﺗﺧﺩﻡ ﻟﺗﺷﻐﻳﻝ ﺍﻟﺟﻬﺎﺯ‬
1 ‫ﺗﻡ ﺍﺧﺗﺑﺎﺭ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻭﺛﺑﺕ ﺍﻣﺗﺛﺎﻟﻪ ﻟﻠﺣﺩﻭﺩ ﺍﻟﻣﻭﺿﻭﻋﺔ ﻟﺟﻬﺎﺯ ﻣﻥ ﺍﻟﻣﺟﻣﻭﻋﺔ‬
‫ﺍﻟﺭﺍﺑﻊ. ﺗﻡ ﻭﺿﻊ‬
‫ﻣﻌﻳﻥ. ﺇﺫﺍ ﺗﺳﺑﺏ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﺑﺎﻟﻔﻌﻝ ﻓﻲ ﺗﺩﺍﺧﻝ ﺿﺎﺭ ﻣﻊ ﺃﺟﻬﺯﺓ ﺃﺧﺭﻯ، ﻭﺍﻟﺫﻱ‬
.
‫ﻣﻭﻗﻌﻬﺎ‬
.
‫ﺍﻷﺧﺭﻯ‬ ‫ﻭﺍﻷﺟﻬﺯﺓ‬
.
‫ﺍﻟﻌﺭﺽ‬ ‫ﺷﺎﺷﺔ‬ ‫ﺑﻬﺎ‬ ‫ﺗﺗﺻﻝ‬ ‫ﺍﻟﺗﻲ‬ ‫ﻋﻥ‬ ‫ﻣﺧﺗﻠﻔﺔ‬ ‫ﺑﺩﺍﺋﺭﺓ‬
.
‫ﻣﺳﺎﻋﺩﺓ‬ ‫ﻋﻠﻰ‬
.
‫ﺍﺳﺗﺧﺩﺍﻡ‬ ‫ﻋﺩﻡ‬ ‫ﻳﺟﺏ‬ ‫ﺍﻷﺟﻬﺯﺓ‬ ‫ﻋﻠﻰ‬ ‫ﻭﺍﻟﻣﺗﻧﻘﻠﺔ‬ ‫ﺍﻟﻣﺣﻣﻭﻟﺔ‬
.
‫ﺃﺧﺭﻯ‬ ‫ﺃﺟﻬﺯﺓ‬ ‫ﻣﻥ‬ ‫ﺑﺎﻟﻘﺭﺏ‬ ‫ﺍﻻﺳﺗﺧﺩﺍﻡ‬ ‫ﻛﺎﻥ‬ ‫ﻭﺇﺫﺍ‬
.
‫ﻁﺑﻳﻌﻲ‬ ‫ﺑﺷﻛﻝ‬ ‫ﻋﻣﻠﻬﺎ‬ ‫ﻣﻥ‬ ‫ﻟﻠﺗﺣﻘﻖ‬ ‫ﺍﻟﻌﺭﺽ‬
‫ﻗﺩ ﻳﺅﺩﻱ ﺍﺳﺗﺧﺩﺍﻡ ﻣﻠﺣﻘﺎﺕ ﻭﻣﺣﻭﻻﺕ ﻭﻛﺎﺑﻼﺕ ﺑﺧﻼﻑ ﺗﻠﻙ ﺍﻟﺗﻲ ﺣﺩﺩﺗﻬﺎ ﺃﻭ ﻭﻓﺭﺗﻬﺎ ﺷﺭﻛﺔ‬
‫ﻳﺟﺏ ﺍﺳﺗﺧﺩﺍﻡ ﺃﺟﻬﺯﺓ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻼﺳﻠﻛﻳﺔ ﺍ‬
12 ) ‫ﺳﻡ‬ 30
‫ﺗﺣﺗﻭﻱ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﻭﺍﻷﺩﻭﺍﺕ ﺍﻟﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ ﻋﻠﻰ ﺃﺟﻬﺯﺓ ﺇﺭﺳﺎﻝ ﻭﺍﺳﺗﻘﺑﺎﻝ‬
Smart Syringe ‫ﺟﻳﺟﺎﻫﺭﺗﺯ. ﺗﻘﻭﻡ ﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﻭ‬
‫ﻟﻣﻌﺎﻳﺭﺓ‬ ‫ﺩﻳﺳﻳﺑﻝ ﻣﻳﻠﻲ ﻭﺍﺕ ﻟﻠﻁﺎﻗﺔ ﺍﻟﻣﺷﻌﺔ ﺍﻟﻔﻌﺎﻟﺔ( ﺑﺎﺳﺗﺧﺩﺍﻡ ﺃﺟﻬﺯﺓ ﺍ‬
‫ﺑﺈﺻﺩﺍﺭ‬ Bluetooth SIG ‫ﻭﻣﻭﺍﺻﻔﺎﺕ ﻣﺟﻣﻭﻋﺔ ﺍﻟﻌﻣﻝ‬
‫ﺗﻭﺟﻳﻬﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
Smart Syringe ‫ﺇﻥ ﺳﺭﻧﺟﺔ‬
‫ﺃﻭ ﺟﻬﺎﺯ‬ Contrast Reduction System
‫ﺷﺎﺷﺔ ﻋﺭﺽ ﻣﺭﺍﻗﺑﺔ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ ﺃﻭ ﺟﻬﺎﺯ‬
‫ﺃﻭ‬ DyeVert Plus Module
‫ﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ ﺟﻬﺎﺯ‬
EZ Contrast Reduction System
.‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻣﻌﻠﻭﻣﺎﺕ ﺇﺿﺎﻓﻳﺔ‬
Smart Syringe ‫ﺗﺣﺗﻭﻱ ﺳﺭﻧﺟﺔ‬
‫)ﻳﻛﻭﻥ ﻧﺷ ﻁ ً ﺎ ﻟﻣﺩﺓ‬
‫ﻳﺷﻳﺭ ﺍﻟﻠﻭﻥ ﺍﻷﺧﺿﺭ ﺍﻟﺛﺎﺑﺕ‬ 3 .
‫ﺇﺿﺎءﺓ ﺻﻔﺭﺍء ﻭﺍﻣﺿﺔ‬ 4 .
Smart Syringe ‫ﺻ ِ ﻝ ﺳﺭﻧﺟﺔ‬
‫ﺃﺯ ِ ﻝ ﻟﺳﺎﻥ ﺳﺣﺏ ﺍﻟﺑﻁﺎﺭﻳﺔ ﺍﻟﺑﺭﺗﻘﺎﻟﻲ‬ 1 .
New Case ‫ﺣ ﺩ ّﺩ‬ 2 .
Smart Syringe
‫ﺗﺄﻛﻳﺩ ﺍﻻﺗﺻﺎﻝ ﺍﻟﻼﺳﻠﻛﻲ‬
‫ﺃﻭ ﺣﺭ ّ ِ ﻙ ﻣﻛﺑﺱ ﺳﺭﻧﺟﺔ‬ ‫ﻧﻌﻡ‬
( ) Yes ‫ﺣ ﺩ ّﺩ‬ ‫( ﺃ‬
No ‫ﺳﻳﺅﺩﻱ ﺗﺣﺩﻳﺩ‬ : ‫ﻣﻠﺣﻭﻅﺔ‬
LED ‫ﺳﻳﺑﻘﻰ ﻣﺻﺑﺎﺡ‬ : ‫ﻣﻠﺣﻭﻅﺔ‬
.‫ﺍﻟﺟﻬﺎﺯ ﺑﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ‬
‫ﺗﺄﻛﺩ ﻣﻥ ﺗﻭﺻﻳﻝ ﻭﺣﺩﺓ‬
( ‫ﺑﺩء ﺍﻟﺣﺎﻟﺔ‬ ) Start Case ‫ﺣ ﺩ ّﺩ‬ ‫( ﺏ‬
‫ﻧ ﻔ ّ ِ ﺫ ﺍﻹﺟﺭﺍء ﺍﻟﻁﺑﻲ‬
(
: ‫ﺗﻧﺑﻳﻪ‬
‫ﻣﻌﻠﻭﻣﺎﺕ ﻟﺟﻧﺔ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻔﻳﺩﺭﺍﻟﻳﺔ ﻟﺳﺭﻧﺟﺔ‬
‫ﻣﻌﺭ ّ ﻑ ﻟﺟﻧﺔ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻔﻳﺩﺭﺍﻟﻳﺔ ﻟﺳﺭﻧﺟﺔ‬
‫ﺍﻟﺗﺻﻧﻳﻔﺎﺕ ﻭﻓﻖ ﻣﻌﻳﺎﺭ‬
: ‫ﺩﺭﺟﺔ ﺍﻟﺣﻣﺎﻳﺔ‬
: ‫ﻭﺿﻊ ﺍﻟﺗﺷﻐﻳﻝ‬
15 ‫ﻳﻣﺗﺛﻝ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻟﻠﻔﻘﺭﺓ‬
) 2 ‫ﺃﻥ ﻳﺗﺳﺑﺏ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻓﻲ ﺣﺩﻭﺙ ﺗﺩﺍﺧﻝ ﺿﺎﺭ ﻭ‬
: ‫ﺗﺣﺫﻳﺭ‬
Medical
‫ﺍﺣﺗﻳﺎﻁﺎﺕ ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ ﻟﻠﺟﻬﺎﺯ‬
‫، ﺍﻹﺻﺩﺍﺭ‬ IEC/EN 60601 1 - 2 -
‫ﻫﺫﻩ ﺍﻟﺣﺩ‬
: ‫ﺍﻹﺟﺭﺍءﺍﺕ ﺍﻵﺗﻳﺔ‬
‫ﺗﻐﻳﻳﺭ‬ ‫ﺃﻭ‬ ‫ﺍﻷﺧﺭﻯ‬ ‫ﺍﻷﺟﻬﺯﺓ‬ ‫ﺗﻭﺟﻳﻪ‬ ‫ﺇﻋﺎﺩﺓ‬ 1 .
‫ﺍﻟﻌﺭﺽ‬ ‫ﺷﺎﺷﺔ‬ ‫ﺑﻳﻥ‬ ‫ﺍﻟﻔﺎﺻﻠﺔ‬ ‫ﺍﻟﻣﺳﺎﻓﺔ‬ ‫ﺯﻳﺎﺩﺓ‬ 2 .
‫ﻣﺗﺻﻝ‬ ‫ﺑﻣﻘﺑﺱ‬ ‫ﺍﻷﺧﺭﻯ‬ ‫ﺍﻷﺟﻬﺯﺓ‬ ‫ﺗﻭﺻﻳﻝ‬ 3 .
‫ﻟﻠﺣﺻﻭﻝ‬ Osprey Medical ‫ﺍﺳﺗﺷﺎﺭﺓ‬ 4 .
‫ﺍﻟﻼﺳﻠﻛﻳﺔ‬ ‫ﺍﻻﺗﺻﺎﻻﺕ‬ ‫ﺃﺟﻬﺯﺓ‬ ‫ﺗﺅﺛﺭ‬ ‫ﻗﺩ‬ : ‫ﺗﺣﺫﻳﺭ‬
‫ﻟﻬﺎ‬ ‫ﻣﻼﺻﻖ‬ ‫ﻭﺿﻊ‬ ‫ﻓﻲ‬ ‫ﺃﻭ‬ ‫ﺃﺧﺭﻯ‬ ‫ﺃﺟﻬﺯﺓ‬ ‫ﻣﻥ‬ ‫ﺑﺎﻟﻘﺭﺏ‬
‫ﺷﺎﺷﺔ‬ ‫ﻣﻼﺣﻅﺔ‬ ‫ﻓﻳﺗﻌﻳﻥ‬ ،‫ﺿﺭﻭﺭ ﻳ ًﺎ‬ ‫ﻟﻬﺎ‬ ‫ﻣﻼﺻﻖ‬
: ‫ﺗﺣﺫﻳﺭ‬
Medical
.‫ﺍﻟﺗﺷﻐﻳﻝ ﺑﺷﻛﻝ ﻏﻳﺭ ﺳﻠﻳﻡ‬
: ‫ﺗﺣﺫﻳﺭ‬
‫ﻭﺍﻟﻬﻭﺍﺋﻳﺎﺕ ﺍﻟﺧﺎﺭﺟﻳﺔ( ﻋﻠﻰ ﺑﻌﺩ ﻣﺳﺎﻓﺔ ﻻ ﺗﻘﻝ ﻋﻥ‬
.‫ﺃﺩﺍء ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ‬
.‫ﻣﺭﺍﻗﺑﺔ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ‬
2.485 ‫ﺇﻟﻰ‬ 2.4 ‫ﻣﻥ‬
-12 ) ‫ﻣﻳﺟﺎ ﻭﺍﺕ‬ 0.063
Bluetooth ‫ﻟﻧﻅﺎﻡ‬ IEEE 802.15.1
8259-F Jan 2020
‫ﺟـ‬