Osprey Medical DyeTect Instrucciones De Uso página 84

‫ﻣ ُ ﻌﻘﻡ ﺑﻭﺍﺳﻁﺔ ﺃﻛﺳﻳﺩ‬
STERILE │EO
‫ﺍﻹﻳﺛﻳﻠﻳﻥ‬
‫ﺭﻗﻡ ﺍﻟﻁﺭﺍﺯ‬ REF
LOT
‫ﺭﻗﻡ ﺍﻟﺗﺷﻐﻳﻠﺔ‬
‫ﺍﻟﺟﺯء ﺍﻟﻣﺳﺗﺧﺩﻡ ﻣﻥ‬
‫ﺍﻟﻣﺿﺎﺩ ﻹﺯﺍﻟﺔ‬ CF ‫ﺍﻟﻧﻭﻉ‬ ‫ﻛﺎﻧﺕ ﺍﻟﻌﺑﻭﺓ‬
‫ﺍﻟﺭﺟﻔﺎﻥ ﻭﻓﻖ ﺍﻟﻣﻌﻳﺎﺭ‬
EN IEC 60601-1
‫ﺭﺍﺟﻊ ﺗﻌﻠﻳﻣﺎﺕ ﺍﻻﺳﺗﺧﺩﺍﻡ‬
‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻣﻌﻠﻭﻣﺎﺕ‬
.‫ﻣﻬﻣﺔ‬
‫ﺍﻟﺳﺭﻧﺟﺔ‬
‫ﻋﻼﻣﺔ ﻫﻳﺋﺔ ﺍﻻﺗﺻﺎﻻﺕ ﻭﺍﻹﻋﻼﻡ ﺍﻷﺳﺗﺭﺍﻟﻳﺔ‬
MedPass SAS
95 bis Bd Pereire , 75017 Paris , France
‫ﺍﻷﺳﺗﺭﺍﻟﻲ‬ ‫ﺍﻟﺭﺍﻋﻲ‬
Osprey Medical, Pty
Level 13, 41 Exhibition Street
Melbourne, Victoria 3000 Australia
2797
.
Osprey Medical
.‫. ﺟﻣﻳﻊ ﺍﻟﺣﻘﻭﻕ ﻣﺣﻔﻭﻅﺔ‬
‫ﺍﻟﺗﻌﺑﺋﺔ‬ ‫ﺭﻣﺯ‬ ‫ﺗﻌﺭﻳﻔﺎﺕ‬
‫ﺗﺎﺭﻳﺦ ﺍﻧﺗﻬﺎء ﺍﻟﺻﻼﺣﻳﺔ‬
‫ﺍﻟﺳﻧﺔ‬ - ‫ﺍﻟﺷﻬﺭ‬
‫ﺍﻟﺷﺭﻛﺔ ﺍﻟﻣﺻﻧﻌﺔ‬
‫ﻳ ُﺳﺗﺧﺩﻡ ﻗﺑﻝ ﺍﻧﺗﻬﺎء ﺁﺧﺭ‬
.(‫)ﺍﻟﺷﻬﺭ‬ ‫ﻳﻭﻡ ﻣﻥ ﺷﻬﺭ‬
‫ﺭﺍﺟﻊ ﺗﻌﻠﻳﻣﺎﺕ‬
‫ﺣﺎﻓﻅ ﻋﻠﻳﻪ ﺟﺎ ﻓ ً ﺎ‬
‫ﺍﻻﺳﺗﺧﺩﺍﻡ ﺍﻹﻟﻛﺗﺭﻭﻧﻳﺔ‬
‫ﻣﺻﻣﻡ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ‬
‫ﺍﻟﻣﻁﺎﺑﻘﺔ ﺍﻷﻭﺭﻭﺑﻳﺔ‬
‫ﻻ ﺗﺳﺗﺧﺩﻡ ﺇﺫﺍ‬ ‫ﻳ ُﺻﺭﻑ ﺑﻭﺻﻔﺔ ﻁﺑﻳﺔ‬
‫ﺗﺎﻟﻔﺔ‬
‫ﻏﻳﺭ ﺁﻣﻥ ﻟﻼﺳﺗﺧﺩﺍﻡ ﻓﻲ‬
‫ﺟﻬﺎﺯ ﻁﺑﻲ‬
‫ﺑﻳﺋﺔ ﺍﻟﺭﻧﻳﻥ ﺍﻟﻣﻐﻧﺎﻁﻳﺳﻲ‬
‫ﺣﺩ ﺩﺭﺟﺔ ﺍﻟﺣﺭﺍﺭﺓ‬ ‫ﺗﻌﺭﻳﻑ ﺍﻟﺣﺎﺟﺯ ﺍﻟﻣﻌﻘﻡ‬
DyeTect
‫ﻣﻣﺛﻝ ﺍﻻﺗﺣﺎﺩ ﺍﻷﻭﺭﻭﺑﻲ‬
Osprey Medical Inc.
5600 Rowland Road, Suite 250
Minnetonka, MN 55343
: ‫ﺍﻟﻣﺟﺎﻧﻲ ﻟﺧﺩﻣﺔ ﺍﻟﻌﻣﻼء‬
1-855-883-4365 : ‫ﻓﺎﻛﺱ‬ 1-855-860-7584
[email protected]
www.ospreymed.com
‫ﻋﻼﻣﺗﻳﻥ ﺗﺟﺎﺭﻳﺗﻳﻥ ﻟﺷﺭﻛﺔ‬ DyeTect
Osprey Medical ‫ﻣﺣﻔﻭﻅﺔ ﻟﺷﺭﻛﺔ‬ 2020 ‫ﺣﻘﻭﻕ ﺍﻟﻁﺑﻊ ﻭﺍﻟﻧﺷﺭ ﻟﻌﺎﻡ‬
- ‫ﺍﻟﻳﻭﻡ‬
CF
‫ﻻ ﻳﺟﻭﺯ‬ 1 (
‫ﻭﺍﺣﺩﺓ‬ ‫ﻳﺟﺏ ﺃﻥ ﻳﺗﻘﺑﻝ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﺃﻱ ﺗﺩﺍﺧﻝ ﻳﺳﺗﻘﺑﻠﻪ، ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ‬
‫ﺃﻭ ﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ‬
RxOnly
‫ﻓﺣﺳﺏ‬
‫ﺍﻟﺭﺍﺑﻊ. ﺗﻡ ﻭﺿﻊ ﻫﺫﻩ ﺍﻟﺣﺩﻭﺩ ﻟﺗﻭﻓﻳﺭ ﺣﻣﺎﻳﺔ ﻣﻌﻘﻭﻟﺔ ﻣﻥ ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﺿﺎﺭ. ﺇﺫﺍ ﻟﻡ‬
‫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 ﻣﻌﻳﻥ. ﺇﺫﺍ ﺗﺳﺑﺏ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﺑﺎﻟﻔﻌﻝ ﻓﻲ ﺗﺩﺍﺧﻝ ﺿﺎﺭ ﻣﻊ‬
‫ﺎ ﻧﺣﺙ ﺍﻟﻣﺳﺗﺧﺩﻡ ﻋﻠﻰ ﻣﺣﺎﻭﻟﺔ‬
‫ﻭﺣﺩﺓ‬
‫ﻗﺩ ﺗﺅﺛﺭ ﺃﺟﻬﺯﺓ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻼﺳﻠﻛﻳﺔ ﺍﻟﻣﺣﻣﻭﻟﺔ ﻭﺍﻟﻣﺗﻧﻘﻠﺔ ﻋﻠﻰ ﺍﻷﺟﻬﺯﺓ. ﻳﻧﺑﻐﻲ ﺍﻻﻣﺗﻧﺎﻉ ﻋﻥ ﺍﺳﺗﺧﺩﺍﻡ ﺟﻬﺎﺯ‬
‫ﺍﻟﻣﻌﺗﻣﺩ‬
‫ﺍﻟﻣﺭﺍﻗﺑﺔ ﺑﺎﻟﻘﺭﺏ ﻣﻥ ﺃﺟﻬﺯﺓ ﺃﺧﺭﻯ ﺃﻭ ﻓﻲ ﻭﺿﻊ ﻣﻼﺻﻖ ﻟﻬﺎ. ﻭﺇﺫﺍ ﻛﺎﻥ ﺍﻻﺳﺗﺧﺩﺍﻡ ﺑﺎﻟﻘﺭﺏ ﻣﻥ ﺃﺟﻬﺯﺓ ﺃﺧﺭﻯ ﺃﻭ ﻓﻲ‬
‫ﺇﻟﻰ ﺯﻳﺎﺩﺓ ﺍﻻﻧﺑﻌﺎﺛﺎﺕ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﺃﻭ ﺍﻧﺧﻔﺎﺽ ﺍﻟﻣﻧﺎﻋﺔ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻳﺔ ﻟﻬﺫﺍ ﺍﻟﺟﻬﺎﺯ‬
USA
‫ﻳﻧﺑﻐﻲ ﺍﺳﺗﺧﺩﺍﻡ ﺃﺟﻬﺯﺓ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻼﺳﻠﻛﻳﺔ ﺍﻟﻣﺣﻣﻭﻟﺔ )ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ ﺍﻷﺟﻬﺯﺓ ﺍﻟﻁﺭﻓﻳﺔ ﻣﺛﻝ ﻛﺎﺑﻼﺕ ﺍﻟﻬﻭﺍﺋﻲ‬
‫ﺍﻟﺧﻁ‬
 ‫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
‫ﻣﻭﺍﺻﻠﺔ ﺍﻹﺟﺭﺍء ﺍﻟﻁﺑﻲ ﺩﻭﻥ‬
‫ﺗﺳﺗﺧﺩﻡ‬ Bluetooth
‫ﺇﻟﻰ‬ 2.4 ‫ﻣﻭﺟﺎﺕ ﺍﻟﺭﺍﺩﻳﻭ ﺫﺍﺕ ﺍﻟﺗﺭﺩﺩ ﻓﻭﻕ ﺍﻟﻌﺎﻟﻲ ﻭﺍﻟﻁﻭﻝ ﺍﻟﻣﻭﺟﻲ ﺍﻟﻘﺻﻳﺭ ﻓﻲ ﺍﻟﻧﻁﺎﻕ ﺍﻟﺻﻧﺎﻋﻲ ﻭﺍﻟﻌﻠﻣﻲ ﻭﺍﻟﻁﺑﻲ ﻣﻥ‬
‫ﻣﻳﺟﺎ ﻭﺍﺕ‬
IEEE 802.15.1
‫ﻭ‬ Osprey ‫ﺗﻣﺛﻝ‬
©
Contrast Monitoring Display
‫ﻻ ﻳﻭﺟﺩ ﺃﻱ ﺿﻣﺎﻥ ﺻﺭﻳ ﺣ ً ﺎ ﻛﺎﻥ ﺃﻡ ﺿﻣﻧ ﻳ ًﺎ، ﺑﻣﺎ ﻓﻲ ﺫﻟﻙ ﻋﻠﻰ ﺳﺑﻳﻝ ﺍﻟﻣﺛﺎﻝ ﻻ ﺍﻟﺣﺻﺭ ﺃﻱ ﺿﻣﺎﻥ ﺿﻣﻧﻲ ﻳﺧﺹ‬
OSPREY MEDICAL
‫ﺍﻟﻣﻁﺎﺑﻘﺔ، ﻻ ﺗﻘﻊ‬
‫ﻓﻲ ﺗﺟﺎﻭﺯ ﺳﻌﺭ ﺍﻟﺷﺭﺍء ﺍﻟﻣﻧﺗﺞ )ﺍﻟﻣﻧﺗﺟﺎﺕ( ﺇﻟﻰ ﺍﻟﻣﺷﺗﺭﻱ. ﻭﺑﺄﻱ ﺣﺎﻝ ﻣﻥ‬
‫ﺍﻟﻣﺳﺅﻭﻟﻳﺔ ﻋﻥ ﺃﻱ ﺃﺿﺭﺍﺭ ﻣﺑﺎﺷﺭﺓ ﺃﻭ ﻏﻳﺭ ﻣﺑﺎﺷﺭﺓ ﺃﻭ ﺗﺑﻌﻳﺔ‬
‫ﺗﻘﺻﻳﺭﻳﺔ ﻭﺍﺿﺣﺔ ﺃﻭ ﺃﻱ ﻧﻅﺭﻳﺔ ﺃﺧﺭﻯ‬
OSPREY MEDICAL
‫ﺃﻭ ﺗﻔﻭﺽ ﺃﻱ‬
‫، ﺑﻣﺎ‬ Osprey Medical
.‫ﻓﻲ ﺫﻟﻙ ﻫﺫﻩ ﺍﻟﻧﺷﺭﺓ، ﻣﺧﺻﺻﺔ ﻓﻘﻁ ﻟﻭﺻﻑ ﺍﻟﻣﻧﺗﺞ ﺑﺷﻛﻝ ﻋﺎﻡ ﺧﻼﻝ ﻓﺗﺭﺓ ﺍﻟﺗﺻﻧﻳﻊ ﻭﻻ ﺗﺷﻛﻝ ﺃﻱ ﺿﻣﺎﻧﺔ ﺻﺭﻳﺣﺔ‬
Contrast Monitoring System
2AHUPSS : Smart Syringe
2AHUPPM
: IEC 60601-1 / UL 60601-1
‫ﺍﻟﺟﺯء ﺍﻟﻣﺳﺗﺧﺩﻡ ﻣﻥ ﺍﻟﻧﻭﻉ‬
‫ﻣﺗﻘﻁﻊ‬
: ) ‫ﻣﻥ ﻗﻭﺍﻋﺩ ﻟﺟﻧﺔ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻔﻳﺩﺭﺍﻟﻳﺔ. ﻳﺧﺿﻊ ﺍﻟﺗﺷﻐﻳﻝ ﻟﻠﺷﺭﻁﻳﻥ ﺍﻵﺗﻳﻳﻥ‬
.‫ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﺫﻱ ﻗﺩ ﻳﺗﺳﺑﺏ ﻓﻲ ﻣﺳﺗﻭﻯ ﺗﺷﻐﻳﻝ ﻏﻳﺭ ﻣﺭﻏﻭﺏ ﻓﻳﻪ‬
Smart Syringe ‫ﻳ ُﻣﻛﻥ ﺃﻥ ﻳﺗﺳﺑﺏ ﺇﺟﺭﺍء ﺃﻱ ﺗﻌﺩﻳﻼﺕ ﺃﻭ ﺗﻐﻳﻳﺭﺍﺕ ﻓﻲ ﺟﻬﺎﺯ ﺍﻟﻣﺭﺍﻗﺑﺔ ﺃﻭ‬
.‫ﺣﻳﺔ ﺍﻟﻣﺳﺗﺧﺩﻡ ﻟﺗﺷﻐﻳﻝ ﺍﻟﻣﻌﺩﺍﺕ‬ ‫ﻓﻲ ﺇﻟﻐﺎء ﺻﻼ‬
‫ﺍﻟﻔﺋﺔ ﺏ، ﻭﻓﻖ ﻣﻌﻳﺎﺭ‬ 1 ‫ﺗﻡ ﺍﺧﺗﺑﺎﺭ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻭﺛﺑﺕ ﺍﻣﺗﺛﺎﻟﻪ ﻟﻠﺣﺩﻭﺩ ﺍﻟﻣﻭﺿﻭﻋﺔ ﻟﺟﻬﺎﺯ ﻣﻥ ﺍﻟﻣﺟﻣﻭﻋﺔ‬
‫ﺃﺟﻬﺯﺓ ﺃﺧﺭﻯ، ﻭﺍﻟﺫﻱ ﻳﻣﻛﻥ ﺗﺣﺩﻳﺩﻩ ﻋﻥ ﻁﺭﻳﻖ ﺗﺷﻐﻳﻝ ﺍﻟﺟﻬﺎﺯ ﻭﺇﻳﻘﺎﻑ ﺗﺷﻐﻳﻠﻪ، ﻓﺈﻧﻧ‬
: ‫ﺗﺻﺣﻳﺢ ﺍﻟﺗﺩﺍﺧﻝ ﻣﻥ ﺧﻼﻝ ﺇﺟﺭﺍء ﻭﺍﺣﺩ ﺃﻭ ﺃﻛﺛﺭ ﻣﻥ ﺍﻹﺟﺭﺍءﺍﺕ ﺍﻵﺗﻳﺔ‬
.‫ﺇﻋﺎﺩﺓ ﺗﻭﺟﻳﻪ ﺍﻷﺟﻬﺯﺓ ﺍﻷﺧﺭﻯ ﺃﻭ ﺗﻐﻳﻳﺭ ﻣﻭﻗﻌﻬﺎ‬
.‫ﺍﺣﺭﺹ ﻋﻠﻰ ﺯﻳﺎﺩﺓ ﺍﻟﻣﺳﺎﻓﺔ ﺍﻟﻔﺎﺻﻠﺔ ﺑﻳﻥ ﺟﻬﺎﺯ ﺍﻟﻣﺭﺍﻗﺑﺔ ﻭﺍﻟﻣﻌﺩﺍﺕ ﺍﻷﺧﺭﻯ‬
.‫ﺑﻬﺎ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ‬ ‫ﺗﻭﺻﻳﻝ ﺍﻷﺟﻬﺯﺓ ﺍﻷﺧﺭﻯ ﺑﻣﻘﺑﺱ ﻣﺗﺻﻝ ﺑﺩﺍﺋﺭﺓ ﻣﺧﺗﻠﻔﺔ ﻋﻥ ﺍﻟﺗﻲ ﺗﺗﺻﻝ‬
.‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻣﺳﺎﻋﺩﺓ‬
.‫ﻬﺎ ﺑﺷﻛﻝ ﻁﺑﻳﻌﻲ‬ ‫ﻭﺿﻊ ﻣﻼﺻﻖ ﻟﻬﺎ ﺿﺭﻭﺭ ﻳ ًﺎ، ﻓﻳﺗﻌﻳﻥ ﻣﻼﺣﻅﺔ ﺷﺎﺷﺔ ﺍﻟﻌﺭﺽ ﻟﻠﺗﺣﻘﻖ ﻣﻥ ﻋﻣﻠ‬
‫ﻗﺩ ﻳﺅﺩﻱ ﺍﺳﺗﺧﺩﺍﻡ ﻣﻠﺣﻘﺎﺕ ﻭﻣﺣﻭﻻﺕ ﻭﻛﺎﺑﻼﺕ ﺑﺧﻼﻑ ﺗﻠﻙ ﺍﻟﺗﻲ ﺣﺩﺩﺗﻬﺎ ﺃﻭ ﻭﻓﺭﺗﻬﺎ ﺷﺭﻛﺔ‬
12 ) ‫ﺳﻡ‬
‫ﺇﺫﺍ ﺗﻌﻁﻝ ﺍﻟﺟﻬﺎﺯ ﺃﻭ ﺗﺩﻫﻭﺭ ﻣﺳﺗﻭﻯ ﺃﺩﺍﺋﻪ ﺑﺳﺑﺏ ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ، ﻓﻳﻣﻛﻥ‬
‫ﻳﺣﺗﻭﻱ ﺟﻬﺎﺯ ﺍﻟﻣﺭﺍﻗﺑﺔ ﻭﺍﻷﺩﻭﺍﺕ ﺍﻟﻣﺻﻣﻣﺔ ﻟﻼﺳﺗﻌﻣﺎﻝ ﻣﺭﺓ ﻭﺍﺣﺩﺓ ﻋﻠﻰ ﺃﺟﻬﺯﺓ ﺇﺭﺳﺎﻝ ﻭﺍﺳﺗﻘﺑﺎﻝ‬
0.063 ‫ﺑﺑﺙ ﺇﺷﺎﺭﺓ ﻗﻭﻳﺔ ﺑﺣﺩ ﺃﻗﺻﻰ‬ Smart Syringe
‫ﻭﻓ ﻘ ً ﺎ ﻟﻣﻌﻳﺎﺭ‬
GSFM ‫ﺩﻳﺳﻳﺑﻝ ﻣﻳﻠﻲ ﻭﺍﺕ ﻟﻠﻁﺎﻗﺔ ﺍﻟﻣﺷﻌﺔ ﺍﻟﻔﻌﺎﻟﺔ( ﺑﺎﺳﺗﺧﺩﺍﻡ ﺃﺟﻬﺯﺓ ﺍﻟﻣﻌﺎﻳﺭﺓ‬
. 4.0+ ‫ﺑﺈﺻﺩﺍﺭ‬ Bluetooth SIG
‫ﺃﻭ‬ Smart Monitor
.‫ﻟﻠﺣﺻﻭﻝ ﻋﻠﻰ ﻣﻌﻠﻭﻣﺎﺕ ﺍﻻﻣﺗﺛﺎﻝ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ ﺍﻟﺧﺎﺻﺔ ﺑﻬﺫﺍ ﺍﻟﺟﻬﺎﺯ‬
(‫ﺍﻟﺻﻼﺣﻳﺔ ﻟﻠﻁﺭﺡ ﻓﻲ ﺍﻷﺳﻭﺍﻕ ﺃﻭ ﺍﻟﻣﻼءﻣﺔ ﻟﻐﺭﺽ ﻣﺣﺩﺩ ﺑﺧﺻﻭﺹ ﻣﻧﺗﺞ )ﻣﻧﺗﺟﺎﺕ‬
‫ﺍﻟﻣﻭﺻﻭﻑ ﻓﻲ ﻫﺫﻩ ﺍﻟﻧﺷﺭﺓ. ﻓﻲ ﺣﺎﻟﺔ ﺣﺩﻭﺙ ﺃﻱ ﺧﻠﻝ ﻓﻲ ﻫﺫﺍ ﺍﻟﻣﻧﺗﺞ )ﺍﻟﻣﻧﺗﺟﺎﺕ( ﺃﻭ ﻓﻲ ﺣﺎﻟﺔ ﻋﺩﻡ‬
‫ﻣﺳﺗﻧﺩﺓ ﺇﻟﻰ ﺍﻹﺧﻼﻝ ﺑﺎﻟﺿﻣﺎﻥ ﺃﻭ ﺍﻹﺧﻼﻝ ﺑﺎﻟﻌﻘﺩ ﺃﻭ ﺍﻹﻫﻣﺎﻝ ﺃﻭ ﻣﺳﺅﻭﻟﻳﺔ‬
‫ﻧﺎﺟﻣﺔ ﻋﻥ ﺷﺭﺍء ﻫﺫﺍ ﺍﻟﻣﻧﺗﺞ )ﺍﻟﻣﻧﺗﺟﺎﺕ( ﺃﻭ ﺍﺳﺗﺧﺩﺍﻣﻪ ﺃﻭ ﺇﻋﺎﺩﺓ ﺍﺳﺗﺧﺩﺍﻣﻪ. ﻻ ﺗﺗﺣﻣﻝ‬
OSPREY MEDICAL ‫ﺃﻱ ﺍﻟﺗﺯﺍﻡ ﺇﺿﺎﻓﻲ ﺃﻭ ﻣﺳﺅﻭﻟﻳﺔ ﺇﺿﺎﻓﻳﺔ ﺫﺍﺕ ﺻﻠﺔ ﺑﻣﻧﺗﺞ ﻣﻥ ﻣﻧﺗﺟﺎﺕ‬
‫ﺷﺧﺹ ﺑﺫﻟﻙ ﻧﻳﺎﺑ ﺔ ً ﻋﻧﻬﺎ. ﺍﻷﻭﺻﺎﻑ ﺃﻭ ﺍﻟﻣﻭﺍﺻﻔﺎﺕ ﺍﻟﻣﻭﺟﻭﺩ‬
‫ﺓ ﻓﻲ ﺍﻟﻣﻭﺍﺩ ﺍﻟﻣﻁﺑﻭﻋﺔ ﻣﻥ‬
‫ﻣﻌﻠﻭﻣﺎﺕ ﻟﺟﻧﺔ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻔﻳﺩﺭﺍﻟﻳﺔ ﻟﺟﻬﺎﺯ‬
‫ﻣﻌﺭ ّ ﻑ ﻟﺟﻧﺔ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻔﻳﺩﺭﺍﻟﻳﺔ ﻟﺳﺭﻧﺟﺔ‬
: ‫ﻣﻌﺭ ّ ﻑ ﻟﺟﻧﺔ ﺍﻻﺗﺻﺎﻻﺕ ﺍﻟﻔﻳﺩﺭﺍﻟﻳﺔ ﻟﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ‬
‫ﺍﻟﺗﺻﻧﻳﻔﺎﺕ ﻭﻓﻖ ﻣﻌﻳﺎﺭ‬
: ‫ﺩﺭﺟﺔ ﺍﻟﺣﻣﺎﻳﺔ‬
: ‫ﻭﺿﻊ ﺍﻟﺗﺷﻐﻳﻝ‬
15 ‫ﻳﻣﺗﺛﻝ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻟﻠﻔﻘﺭﺓ‬
( ) 2 ‫ﺃﻥ ﻳﺗﺳﺑﺏ ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ ﻓﻲ ﺣﺩﻭﺙ ﺗﺩﺍﺧﻝ ﺿﺎﺭ ﻭ‬
: ‫ﺗﺣﺫﻳﺭ‬
Osprey Medical – ‫ﻟﻡ ﺗﻭﺍﻓﻖ ﻋﻠﻳﻬﺎ ﺷﺭﻛﺔ‬
‫ﺍﺣﺗﻳﺎﻁﺎﺕ ﺍﻟﺗﺩﺍﺧﻝ ﺍﻟﻛﻬﺭﻭﻣﻐﻧﺎﻁﻳﺳﻲ‬
‫، ﺍﻹﺻﺩﺍﺭ‬ IEC/EN 60601 1 - 2 -
‫ﻳﺗﻡ‬
Osprey Medical ‫ﺍﺳﺗﺷﺎﺭﺓ‬
: ‫ﺗﺣﺫﻳﺭ‬
: ‫ﺗﺣﺫﻳﺭ‬
Osprey Medical
.‫ﻭﺍﻟﺗﺳﺑﺏ ﻓﻲ ﺍﻟﺗﺷﻐﻳﻝ ﺑﺷﻛﻝ ﻏﻳﺭ ﺳﻠﻳﻡ‬
: ‫ﺗﺣﺫﻳﺭ‬
30 ‫ﺗﻘﻝ ﻋﻥ‬ ‫ﻭﺍﻟﻬﻭﺍﺋﻳﺎﺕ ﺍﻟﺧﺎﺭﺟﻳﺔ( ﻋﻠﻰ ﻣﺳﺎﻓﺔ ﻻ‬
.‫ﺃﺩﺍء ﻫﺫﺍ ﺍﻟﺟﻬﺎﺯ‬
.‫ﻣﺭﺍﻗﺑﺔ ﻋﺎﻣﻝ ﺍﻟﺗﺑﺎﻳﻥ‬
‫ﺟﺎﻫﺭﺗﺯ. ﺗﻘﻭﻡ ﻭﺣﺩﺓ ﺍﻟﺿﻐﻁ ﻭ‬ ‫ﺟﻳ‬ 2.485
-12
‫ﻭﻣﻭﺍﺻﻔﺎﺕ ﻣﺟﻣﻭﻋﺔ ﺍﻟﻌﻣﻝ‬ Bluetooth ‫ﻟﻧﻅﺎﻡ‬
‫ﻳ ُﻣﻛﻧﻙ ﺍﻟﺭﺟﻭﻉ ﺇﻟﻰ ﺗﻌﻠﻳﻣﺎﺕ ﺍﺳﺗﺧﺩﺍﻡ ﺟﻬﺎﺯ‬ : ‫ﺗﺣﺫﻳﺭ‬
‫ﺇﺧﻼء ﻣﺳﺅﻭﻟﻳﺔ ﺍﻟﺿﻣﺎﻥ ﻭﺗﺿﻳﻳﻖ ﺩﺍﺋﺭﺓ ﺍﻟﺗﻌﻭﻳﺽ‬
OSPREY MEDICAL ‫ﻣﺳﺅﻭﻟﻳﺔ‬
OSPREY MEDICAL ‫ﺍﻷﺣﻭﺍﻝ، ﻻ ﺗﺗﺣﻣﻝ‬
8176-M Jan 2020
–




)