Dose-Syring

Product Specification: Dose-Syringe  Control Syringe

1. Intended Use

The Dose-Syringe  Control Syringe is a single-use, sterile medical device specifically indicated for the controlled manual injection of iodinated radiographic contrast media in diagnostic and interventional radiological procedures. It is designed for both intra-arterial and intravenous administration under the supervision of qualified healthcare professionals.

2. Key Features & Technical Specifications

• Precision Dosing: Features a clear, dual-scale (mL and cc) barrel with high-visibility, laser-etched graduations (typically in 0.5 mL or 1 mL increments) to ensure accurate measurement and volume control of contrast media.

• Enhanced Control & Safety:

• Luer-Lock Tip: Standardized ISO 594-2 Luer-Lock connector provides a secure, leak-resistant connection to catheters, needles, or tubing, preventing accidental disconnection under pressure.

• Anti-Reflux Design (Optional/Feature Specific): Some models incorporate a passive or active valve mechanism to minimize the risk of blood reflux into the syringe, enhancing procedural safety.

• Ergonomic Flanged Plunger: Designed for secure grip and smooth, controlled injection, reducing hand fatigue during prolonged procedures and allowing for steady, operator-defined flow rates.

• Pressure Tolerance: Engineered to withstand typical hand-injection pressures encountered during arterial injections (e.g., in angiography), with a clearly marked maximum volume line to prevent overfilling and excessive pressure generation.

• Material & Compatibility:

• Barrel: Constructed from medical-grade, transparent polypropylene or COC (Cyclic Olefin Copolymer) for excellent chemical compatibility with all standard ionic and non-ionic contrast agents, ensuring clarity and resistance to cracking.

• Plunger: Features a soft, elastomeric piston (e.g., bromobutyl rubber) for a smooth, consistent glide and an effective seal to prevent leakage. The plunger rod is typically made of rigid polypropylene.

• Sterility: Each unit is individually packaged and sterilized using Ethylene Oxide (EtO) or Gamma Irradiation, validated to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.

• Non-Pyrogenic: Confirmed to be pyrogen-free, meeting USP <151> standards.

• Available Sizes: Common capacities include 10 mL, 20 mL, 30 mL, and 50 mL to accommodate a range of procedural requirements from bolus injections to sustained flushing.

3. Clinical Benefits

• Procedural Efficacy: Enables precise control over injection speed and volume, which is critical for achieving optimal vascular opacification and high-quality diagnostic images in CT, angiography, and urography.

• Patient Safety: Reduces the risk of dose errors and potential complications related to inconsistent or uncontrolled injection rates (e.g., vessel injury, contrast extravasation).

• Operator Efficiency: The ergonomic design and reliable performance streamline the injection process, saving time and reducing operator variability in clinical settings