Sigma Spectrum Infusion Pump User Manual

FLOW RATE ACCURACYEffect of Fluid Container Height 1, 2The performance of the infusion pump will be influenced by the forces of gravity on the fluid beingadministered to the patient. When a fluid container is positioned above or below the patient’sadministration site, pressure forces associated with the fluid’s head-height (distance measuredfrom the center of the pumping mechanism to the top of the fluid in the source container) willcause deviations in the nominal specification for device flow rate accuracy. The nominal headheightused for the flow rate specification is 24” (61 cm). A deviation of as much as -4% mayoccur if the fluid in the source container is located to a head-height of -20” (-50 cm).Effect of Back Pressure 1Positive back pressure can influence the flow rate accuracy of the infusion. Back pressureequivalent 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 of7% Hospira and 3% Baxter IV Sets.Notes:1. Reference: AAMI ID26:1998, Sub-clause 50.1022. Note: Liquid container must be vented or a collapsible bagEffect of TemperatureNominal temperature range for pump calibration and accuracy testing is 72 ±2°F. The SIGMASpectrum has been designed with temperature compensation that opposes the influence of coldand hot temperature extremes. This design is currently validated to control deviation in flow rateaccuracy within 10% at 60°F and 7% at 90°F temperature limits for Hospira IV Sets and ± 5%from 60°F to 90°F for Baxter IV Sets.Flow ProfileThe SIGMA Spectrum Infusion pump has the following start-up flow rate accuracy curve shapeassociated with stability through time. These graphs represent the variation in flow rate that isrecorded from the time the infusion is started to the end of a two hour period. The graph isintended to give a picture of the “general stability” with time of the infusion. The graph iscommonly called a “start-up curve”. The techniques and methods of test and generation of thisgraph are as detailed in IEC 60601-2-24, Medical electrical equipment – Part 2-24: Particularrequirements for the safety of infusion pumps and controllers.- 44 -