Technical Specifications:
The document describes a medical device classified as Class IIa, compliant with EN ISO 10079-3: 2009. It is a compact, ergonomic vacuum regulator with both intermittent and continuous modes. The device features a vacuum gauge that glows in the dark and a switch-button for mode selection. The intermittent mode is preset to 16 seconds ON and 8 seconds OFF, with adjustable settings, and a flow rate of 8 l/min. The continuous mode offers a flow rate of 0 to 70 l/min. The gauge accuracy is ±1.6% of the full scale. Safety features include positive and negative-pressure relief valves. The device comes with a 100 ml safety jar with an anti-overflow valve and a single-use antibacterial filter, made of autoclavable polycarbonate.
Versions and Configurations:
Various vacuum levels are available, displayed in mbar and mmHg, with configurations in single or twin setups. Inlet options include 12x100 F, 1/4G M, 1/8NPT F, and 3/8G BSP F. The device can connect to wall outlets via direct probe or rail mounting systems, adhering to multiple international standards. The weight with the safety jar and AFNOR probe is 735 g, and dimensions are 270 mm x 80 mm x 150 mm.
Filter and Maintenance:
The document emphasizes the importance of changing the antibacterial filter for each new patient to prevent infections. The device should be cleaned with water and soap, avoiding immersion. The safety jar requires sterilization only in specific cases. The device should be serviced every 1 to 3 years based on usage.
Usage:
The vacuum regulator is used for measuring and adjusting vacuum levels in medical and surgical contexts, offering intermittent mode for gastric drainage and continuous mode for tracheal, pharyngeal, or surgical suction.
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