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4400-0024-EN Rev A
6. Insert the enCheck unit into the Warmer so the bottom end of the unit is keyed similarly as the Warmer Cartridge, so that it only fits in the correct
orientation (curved section on the left side), and close the Warmer covers.
7. Switch the Main power switch on the back of enFlow Controller to the ON or position.
8. Verify that the Orange “power” LED indicator is illuminated on the enCheck.
9. After waiting, for approximately 30 to 60 seconds, confirm the temperature on the Calibrated Thermometer is reading in the range of
40 °C ± 2 °C, and that the Green “Normal” LED on the enCheck is illuminated.
10. Disconnect the enCheck temperature probe connector that is connected to the Calibrated Thermometer.
11. Place the Switch on the enCheck to the “Overheat” position and verify that the Red “Overheat” LED is illuminated on the enCheck.
12. At this time, observe the enFlow Controller display until the temperature rises to greater than 45 °C; the controller display should be Red and the audible
alarm should sound, the Green “TEMP” LED on the enFlow Warmer should also have changed from a solid Green to a flashing Red.
13. Place the Switch on the enCheck to the “Normal” position and re-connect the enCheck temperature probe connector to the Calibrated Thermometer.
14. Verify the LED and display indicators are red. Monitor the temperature on the Calibrated Temperature meter and on the enFlow Controller display; the
temperature will gradually drop, and as it falls below 45 °C, the Controller display and the Warmer LED should change state from Red to Yellow. Verify
that the Warmer LED and the Controller display indicators change to yellow as the temperature transitions through the 44 °C and 43 °C temperature
window; the Controller indicators and the LED will return to green as soon as the temperature drops to 42 °C and will remain green, until the temperature
drops to below 35 °C.
B. Alternative method
Equipment
enFlow system
Power source
Infusion pump capable of maintaining up to 100 mL/min
IV line set
Water bath
Source of distilled water or normal fluid – 0.5 L at 50 °C ± 2.0 °C
2 extension sets - 22.9 cm (9 in)
Thermometer - capable of measuring 10 °C to 60 °C accurate to ± 0.1 °C, plus 2 external probes
Waste water container
Purpose
The purpose of this test is to determine that the over-temperature alarm on the Warmer is working properly.
Procedure
1. Use the Simulated Use Performance Testing- Alternative Method setup described in steps 1-5 above.
2. Use a clamp to stop the flow in the IV line.
Wire probe connected
to thermometer
Wire probe connected
to thermometer
Empties into waste water container
Connected to IV line that
is connected to pump