*mymedicalexpo

SPASY

Product catalog summary

Overview: This document provides technical specifications and procedural guidelines for a spinal alignment system used in treating vertebral compression fractures (VCF) due to osteoporosis, osteolytic fractures, and metastatic bone fractures. The system includes various components such as balloon catheters, balloon expanders, bone marrow needles, guide wires, cannulas, bone drills, and bone cement fillers.

Kit Composition: The document outlines two kit compositions, each containing different quantities of the components. The first kit includes one of each component, while the second kit includes two of each component, except for the bone drill, which remains one, and the bone cement filler, which is increased to three sets.

Procedures: The document details the surgical technique for using the balloon expander and catheter. Key steps include filling the cylinder with a contrast agent, removing air from the system, and inflating the balloon catheter. The procedure emphasizes the importance of locking and unlocking mechanisms to control air removal and balloon inflation.

Surgical Technique - Bone Access System: This section describes the steps for accessing the vertebral body, including positioning the working cannula, removing the guide wire and trocar, inserting the bone drill, and smoothing the cavity to prevent balloon damage. The transpedicular access technique is also detailed, involving the insertion of a bone puncture needle and guide wire.

Specifications: Detailed specifications for each component are provided, including total length, working length, diameter, and PSI rating for balloon catheters. The document also lists dimensions for the needle pipe, needle pin, cannula, trocar, cement pusher, and cement filter.

Special Features: The system includes a pressure gauge and release button to control compression and decompression. The balloon catheters are available in three sizes: SWS10 (10mm), SWS15 (15mm), and SWS20 (20mm).

Contact Information: The document provides contact details for the manufacturer, located in Bucheon-si, Gyeonggi-do, Republic of Korea.

Catalog excerpts

Surgical Technique - Balloon Expander & Catheter SPASY Spinal Alignment System for VCF Step-1 1Kit Composition Description SPASY10-1A / SPASY15-1A / SPASY20-1A SWS20 Balloon Expander SWMP 1ea Bone Marrow Needle SWMVP 1set Bone Cement Filler SWM-4 1set(2ea) • Osteolytic fracture • Metastatic bone fractures The seal of the balloon expander (SWMP) remains locked Turn the handle to the right just before”0” marking to remove air from the cylinder. Connecting Balloon Catheter/ Removing residual air from the system Remove the cover of the balloon Catheter(SWS10 or SWS15 or SWS20). The 3way valve points to the open connection with “off) Step-5 To Remove the air from the balloon Catheter(SWS10 or SWS15 or SWS20), move the locking mechanism to the “unlock”position. Pull the handle of the balloon catheter and move the locking mechanism to the “lock” position. SEAWON v^editech 33, Bucheon-ro 298beon-gil, Wonmi-gu, Bucheon-si, Gyeonggi-do, Rep. of KOREA TEL. +82 32 684 7071~4 FAX. +82 32 684 7075 E-mail: [email protected]

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SWMP Balloon Expander Bone Marrow Needle with Slant Tip Other needle models of bevelled tip / trocar tip also available Pressure Gauge Release Button Pressure Gauge indicates the pressure of the ballon Release Buttun helps to control compression and decompression by turning on “LOCK” and “UNLOCK”. Surgical Technique - Bone Access System Working Diameter Length Needle Pipe Special Feature Total Length Guide Wire Inserting guide wire Transpedicular Acess Removing the stylet Guide Wire Transpedicular with the bone puncture needle(SWMVP) up to 5mm into the vertebral body. Name Working Diameter Length...

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