Micrus Endovascular

Micrus Microcoil Delivery Systems

Micrus Microcoil Delivery System Instructions for Use Rev A

Instructions for Use

13 Pages

Micrus® Microcoil Delivery System Instructions for Use  Carefully read all instructions prior to use... bserve all warnings and precautions... AUTION: Federal (USA) law restricts this device to sale by or on the order of a physician... English 2 Français Deutsch日本語 Español... ItalianoPortuguêsNederlandsČesky... Еλληνικά... agyarPolskiSvenska... ürkçe  Instructions for Use  English  System Description The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB)... ach component is sold separately... • As shown in Figure 1, the Micrus Microcoil System consists of an embolic microcoil attached to a device positioning unit (DPU) wire... t is covered by an introducer sheath system... he microcoil’s shape can be straight, spherical, complex, or helical... he DPU wire is a variable stiffness pushing system and has a radiopaque marker band located three (3) cm from its distal end... he introducer sheath system has three main components: a light green introducer tip, a translucent introducer body, and a green re‑sheathing tool... ub connector  re-sheathing tool  introducer sheath body  device positioning unit (DPU) Fig... : Micrus Microcoil System  introducer sheath tip  microcoil  •• The connecting cable delivers the energy needed to detach the coil from the Microcoil System’s detachment zone... he connecting cable is connected between the Microcoil System’s hub connector on the DPU Wire and the output connector on the DCB... ts length is approximately 5 ft (1... m)... • The Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU wire... INDICATIONS FOR USE The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms... PRECAUTIONS •• The Micrus Microcoil System shall be used only by physicians trained in interventional neuroradiology and in all aspects of the system... • Do not attempt to sterilize any component of the Micrus Microcoil Delivery System... he Microcoil System and connecting cable are provided sterile... hey are intended for single patient use only... o not use the Microcoil System or connecting cable if sterile packaging is damaged... o not attempt to reuse the Microcoil System or the connecting cable... fter use, dispose of the residual components of the Microcoil System and connecting cable in accordance with hospital, administrative, and/or local government policy... • The Detachment Control Box (DCB) is provided NON‑STERILE... nless placed in a sterile sleeve, it should remain outside of the sterile field during use... he DCB is the only reusable portion of the Micrus Microcoil Delivery System... pon receipt of the DCB, inspect the shipping carton and the unit for signs of damage... f unit presents with physical damage upon shipment, immediately notify Micrus Endovascular for replacement... • Verify the functionality of the Micrus Microcoil Delivery System before proceeding with microcoil placement... efer to the section Microcoil System Preparation on how to verify the functionality... WARNINGS The Micrus Microcoil Delivery System should only be used as a complete system...  complete system requires a Micrus Detachment Control Box, a Micrus connecting cable, and Micrus Microcoil System... O NOT SUBSTITUTE any components or devices from other manufacturers with the Micrus Detachment Control Box or injury to the patient or user could result... ADVERSE EVENTS Possible adverse events include, but are not limited to, the following: hematoma at site of entry, vessel perforation, infection, emboli, hemorrhage, ischemia or vasospasm, neurological deficits including stroke, and possibly death... 2
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