Delfi Medical Innovations Portable Tourniquet System 9-2100-001

Inspect the unit for the following external issues

Check connections and locking mechanisms

Ensure secure connection and locking of the power cord plug to the receptacle on the P.T.S. unit

Ensure secure connection and locking of the hose connectors on the P.T.S. unit to the hose assembly

Inspect the hose assembly for kinks or damage

Set the P.T.S. unit to standby mode

Disconnect AC power before opening the battery compartment

Charge the battery for at least 8 hours

Remove the AC power supply and power up the P.T.S. unit

Is the battery indicator symbol visible with all 6 segments darkened?

Connect the P.T.S. to a tourniquet cuff and inflate to 350 mmHg

Are less than 5 segments in the battery indicator darkened after 1 hour?

Leak testing should be performed at least once every six months, or if leak alarms occur without an obvious cuff or hose leak. The P.T.S. is capable of maintaining cuff pressure even with a substantial leak in the system; however any leak may become worse and lead to loss of occlusion during a procedure, so it is important to find and correct leaks as soon as possible.

a) Connect a leak-free Delfi Contour Lower Leg cuff, Contour Arm cuff, or a similar sized cuff to the P.T.S. using the hose assembly.

b) Adjust the pressure set point to 475 mmHg.

c) Inflate the cuff and allow the pressure to stabilize.

d) Set the unit to standby as follows: Press the ‘ON/STANDBY’ button until the alarm message "CUFF NOT DEFLATED" appears. Release the ‘ON/STANDBY’ button and within 5 seconds of the alarm discontinuing, press and hold the ‘ON/STANDBY’ button again. Hold the button in for 10 seconds. The unit will switch to standby.

NOTE: During the 10 seconds, the alarm message will be displayed, the alarm will continue to sound and cannot be silenced.

e) Wait for 10 +/- 1 minutes and turn the unit back on. Operation will resume with a “PRESSURE” alarm (See ‘Cuff pressurized during power up’ condition, Table 2.1). Momentarily press and release the ‘PRESSURE+ ’ button to cancel the alarm and display the new pressure set point (shown with a trailing asterisk). The set point should be at least 400 mmHg.

f) If the new set point is less than 400 mmHg, there is a significant leak in either in the test cuff and hose or in the P.T.S. internal pneumatics. Repeat the test with a variety of different cuffs and hose assemblies.

If the unit continues to fail, the leak is internal and the P.T.S. unit must be serviced by Delfi.

Inspect the P.T.S. for any visible damage or wear

Record the battery level of the P.T.S.

Is the battery level sufficient for operation?

Is the calibration within acceptable limits?

Remove the battery cover screw and battery cover from the P.T.S. unit

Remove and unplug the old battery pack

Recycle or dispose of the old battery pack according to local regulations

Install the new Delfi battery pack by connecting it to the two-pin plug inside the P.T.S. unit

Is the new battery pack installed correctly?

Plug the P.T.S. unit into AC power for at least 8 hours to fully charge the new battery