Land: Hvíta-Rússland
Tungumál: rússneska
Heimild: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Abbott Vascular, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Abbott Vascular
2020-09-03
БЪЛГАРСКИ / BULGARIAN ROMÂNĂ / ROMANIAN PPL2122126-02 (2019-03-26) English MULTI-LINK MINI VISION Coronary Stent Systems 1.0 DEVICE DESCRIPTION The MULTI-LINK MINI VISION RX Coronary Stent System and the MULTI-LINK MINI VISION OTW Coronary Stent System (MULTI-LINK MINI VISION Coronary Stent and RX or OTW Delivery System) include: • A pre-mounted L-605 cobalt chromium alloy (CoCr) (major elements include cobalt, chromium, tungsten, nickel) stent. • Two radiopaque markers, located underneath the balloon, which fluoroscopically mark the working length of the balloon and the expanded stent length. • Two proximal Delivery System shaft markers (95 cm and 105 cm from the distal tip) that indicate the relative position of the Delivery System to the end of a brachial or femoral guiding catheter. Working catheter length is 143 cm. • For the MULTI-LINK MINI VISION RX Coronary Stent System only, a shaft color change denotes the guide wire exit notch. Table 1: _in vitro_ Device Specifications Stent Diameter (mm) Stent Length (mm) *Minimum Guiding Catheter Compatibility ID 5F (0.056” / 1.42 mm) **_in vitro_ Stent Nominal Pressure (atm) Rated Burst Pressure -RBP (atm) Stent Free % Area 2.0 8, 12, 15, 18, 23, 28 5F 8 16 81 2.25 8, 12, 15, 18, 23, 28 5F 9 16 83 2.5 8, 12, 15, 18, 23, 28 5F 9 16 85 *See Individual manufacturer specifications for (F) equivalent. **Assure full deployment of the stent (See Clinician Use Information – Deployment Procedure). Deployment pressures should be based on lesion characteristics. 2.0 HOW SUPPLIED Sterile. This device is sterilized with electron beam radiation. Non-pyrogenic. Do not use if the package is open or damaged. This single use device cannot be reused on another patient, as it is not designed to perform as intended after the first usage. Changes in mechanical, physical, and / or chemical characteristics introduced under conditions of repeated use, cleaning, and / or resterilization may compromise the integrity of the design and / or materials, leading to contamina Lestu allt skjalið