Description

Enhance precision and safety in ultrasound-guided interventions with this disposable, sterile needle guide. Designed for single use, it significantly reduces the risk of cross-contamination, making it an essential tool for medical professionals during endocavity procedures such as tissue biopsy, fluid aspiration, and catheter placement.

Key Features

• Universal Compatibility: Fits a wide range of ultrasound transducer brands, ensuring versatile application across various models.
• Needle Guidance: Provides a reliable path for needles or instruments, accommodating sizes typically ranging from 16-18GA, with options for other gauges depending on the model.
• Adjustable Angles: Available in multiple insertion angles to meet diverse procedural needs, enhancing accuracy and effectiveness.

Design and Comfort

The guide features a contoured, low-profile design for patient comfort and stable positioning. Its single-piece construction often includes quick-release or snap-in mechanisms, allowing for secure attachment and easy removal. Many models come with accessories such as latex or NeoGuard covers, sterile gel, and mounting components for seamless integration with the transducer.

Material and Biocompatibility

Crafted from high-quality materials like ABS or polycarbonate thermoplastics and T304 hypodermic grade stainless steel, the device is non-toxic, non-sensitizing, and non-irritating. It undergoes sterilization through ethylene oxide or irradiation, ensuring readiness for immediate use.

Packaging and Storage

Typically packaged in quantities of 20 or 24 per box, each guide is individually wrapped, maintaining sterility until use. With a shelf life of up to three years, it should be stored in a dry environment, away from sunlight, at room temperature, and with relative humidity not exceeding 85%.

Intended Use

Ideal for diagnostic procedures in transvaginal and transrectal applications, including IVF oocyte retrieval and prostate biopsy. The guide is intended for use by trained medical professionals, with clear instructions to attach securely, use appropriate covers and gels, and dispose of after a single use.

Precautions

Not suitable for use in the central cardiovascular system or in patients with specific medical conditions unless deemed appropriate by a physician. Users should inspect the device and packaging integrity before use and adhere to all disposal regulations.

Regulatory Information

Classified as a Class II medical device, it is intended for prescription use only. The guide meets stringent biocompatibility and safety standards, providing healthcare providers with a reliable tool for enhancing procedural outcomes.