A-A-51438B
Type I.
The container shall be divided into separate chambers as described below:
a. Suction Control Chamber: The suction control chamber shall be numerically marked in centimeters (cm) of water 5 cm intervals to 25 (minimum), and marked from 0 to 25 cm in 1 cm intervals and shall incorporate an atmospheric vent that provides an opening for filling the suction control chamber and venting to atmosphere. The unit shall be provided with a muffler that allows air to enter the suction control chamber; a self sealing diaphragm on the face of the unit; suction regulator tubing 30 cm long (± 7.62 cm), inner diameter 0.622 cm (± 0.254 cm), outer diameter 1.092 cm (± 0.254 cm).
b. Water Seal Chamber: The water seal chamber shall act as a one way value to allow air to exit from the pleural space; serve as a manometer to measure the negativity in the patient’s thoracic cavity; allow for the observation of the degree of air leak. The chamber shall have a water seal scale clearly marked for water seal level at 2 cm of water to -20 cm (minimum). A patient air leak meter shall indicate the approximate degree of of air leak from the thoracic cavity. The meter shall be labeled from low (1) to High (7). The unit shall be provided with a positive pressure relief valve to prevent pressure accumulation in excess water seal in the presence of high negativity; a filtered high negativity relief valve to vent excessive negativity.
c. Collection Chamber: The collection chamber shall have a fluid capacity of 2500 cc, and shall be calibrated in 1 cc increments up to 100 cc, and 2 cc increments up to 250 cc. Over 250 cc calibrations shall be in 5 cc increments. The surface of the chamber shall accept markings in pen or pencil. The unit shall be provided with latex collection tubing a minimum of 183 cm long, 0.927 cm inner diameter and 1.18 cm outer diameter. The collection tube shall be provided with an anti-kink coil or other design feature to prevent kinking and to ensure safe operation. The system shall allow the evacuation of air at the rate of at least 15 liters per minute.
The unit shall be provided with a floor that is secure, suitable and stable for routine operation, set up and use.
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