140 Appendix B: Flow Rate Accuracy
Manual 41018v0800 SIGMA Spectrum Infusion System
Revision B Operator’s Manual
APPENDIX B: FLOW RATE ACCURACY
Effect of Fluid Container Height
The performance of the SIGMA Spectrum Infusion Pump will be influenced by the forces of gravity
on the fluid being administered to the patient. When a fluid container is positioned above or below
the patient’s administration site, pressure forces associated with the fluid’s head-height (distance
measured from the center of the Pump to the top of the fluid in the source container) will cause
deviations in the nominal specification for device flow rate accuracy. The nominal head-height
used for the flow rate specification is 610 ±51 mm (24 ±2 in). (Reference: AAMI ID26:2004, Sub-
clause 50.102.)
NOTE: The fluid container must be vented or a collapsible bag.
Always hang the fluid container such that the level of fluid in the container is 610 ±51 mm (24 ±2
in) above the center of the infusion Pump.
As an example, flow rate accuracy may deviate by up to -4% from the nominal accuracy when
operating at 25 mL/hr delivery rate with a -50 cm (-20 in) fluid head-height, resulting in a flow rate
accuracy of +5% to -9%.
Effect of Back Pressure
Positive back pressure can influence the flow rate accuracy of the infusion. Back pressure
equivalent to 300 mmHg may reduce the flow rate, causing a deviation in accuracy by -9%.
Negative back pressure of -100 mmHg may increase flow rate, causing a deviation in accuracy of
7% in Baxter IV Sets.
WARNING Baxter IV Sets.
1. Minidrip chambers should not
be used for flow rate settings
greater than 200 mL/hr. Doing so may influence flow rate
accuracy and cause air in line or upstream occlusion alarms.
2. When using sets with backcheck valves, flow rate settings should
not exceed 500 mL/hr. Doing so may influence flow rate accuracy
or cause air in line or upstream occlusion alarms. Secondary flow
rates above 300 mL/hr may cause fluid to siphon from the
primary container.
NOTE: Not applicable with non-DEHP tubing because 250 mL/hr is
the maximum flow rate per warning statement.
3. When using sets with rigid polyethylene lined tubing, as is often
used in nitroglycerine sets, flow rate settings should not exceed
500 mL/hr. Doing so may influence flow rate accuracy.
4. Partially occluded filters can cause air in line, upstream occlusion
or downstream occlusion alarms or negatively affect flow rate
accuracy.