150 Appendix D: Downstream Occlusion
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
APPENDIX D: DOWNSTREAM OCCLUSION
Time to Occlusion Alarm
At the minimum downstream occlusion setting and minimum flow rate of 0.5mL/hr, the time for
activation of the downstream occlusion alarm is 20 minutes or less for at least 51% of alarms (95%
Confidence Interval), with a maximum time for alarm activation of 1.5 hours.
At the Maximum downstream occlusion setting and minimum flow rate of 0.5mL/hr, the time for
activation of the downstream occlusion alarm is 2.5 hours or less for at least 51% of alarms (95%
Confidence Interval), with a maximum time for alarm activation of 5 hours.
The maximum time for activation of the downstream occlusion alarm at the intermediate flow rate
of 25 mL/hr is 50 seconds at the minimum occlusion threshold setting. It is 3 minutes at the
maximum occlusion alarm threshold setting.
Bolus Volume
The maximum bolus volume generated as a result of operation at 25 mL/hr and reaching the
minimum downstream occlusion alarm threshold is 0.25 mL.
The maximum bolus volume generated as a result of operation at 25 mL/hr and reaching the
maximum downstream occlusion alarm threshold is 0.8 mL.
WARNING Specifications for Downstream Occlusion detection times and
bolus volume, after release of occlusion, are based on specific
test conditions.
The analytical related conditions are:
A distance of 1.2 m (48 in) from the point of the downstream
occlusion to the SIGMA Spectrum Infusion System’s Downstream
Occlusion sensor (approximately the distance from the IV
administration set’s exit from the pumping channel to the point of
occlusion).
The 1.2 m (48 in) test administration set contained one Y injection
site (no filters or other components).
Testing was at the nominal room temperature 22.2°C ±1.1°C
(72°F ±2°F).
Time to Downstream Occlusion and Bolus Volume release will
generally increase under the following conditions: longer distances to
the occlusion point, additional fluid volumetric area (from filters or
other components within the IV set length), hotter room temperatures
and higher Downstream Occlusion Pressure Thresholds or Limits.
For additional information on Downstream Pressure Limits, see
Appendix G: “Default Settings” on page 160.
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