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APPENDIX D - Downstream Occlusion
SIGMA Manual Number 41018
Revision AR
APPENDIX D - DOWNSTREAM OCCLU-
SION
Time to Occlusion
The maximum time for activation of the downstream occlusion alarm at the minimum flow rate of
0.5mL/hr is 1 hour at the minimum occlusion threshold setting. It is 3 hours at the maximum occlu-
sion alarm threshold setting.
The maximum time for activation of the downstream occlusion alarm at the intermediate flow rate
of 25mL/hr is 50 seconds at the minimum occlusion threshold setting. It is three minutes at the max-
imum occlusion alarm threshold setting.
Bolus Volume
The maximum bolus volume generated as a result of operation at 25 mL/hr and reaching the mini-
mum downstream occlusion alarm threshold is 0.25mL.
The maximum bolus volume generated as a result of operation at 25 mL/hr and reaching the maxi-
mum downstream occlusion alarm threshold is 0.8mL.
CAUTION:
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 48” from the point of the downstream occlusion to the SIGMA
Spectrum’s Downstream Occlusion sensor (approximately the distance from the
IV administration set’s exit from the pumping channel to the point of occlusion).
-
The 48” test administration set contained one “y”-site (no filters, or other
components).
-
Testing was at the nominal room temperature (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) and
hotter room temperatures.