Appendix B: Flow Rate Accuracy
143
SIGMA Spectrum Infusion System
Pump Operating Software Version 8.00
Operator’s Manual
For Use With MDL Version 8.0
Always check to ensure the IV set’s clamp is not closed above the
Pump and respond appropriately to all primary and secondary
check flow prompts.
Small bore catheters or needles may cause excessive back
pressure at high flow rates.
Size the catheters according to expected flow rate and fluid
viscosity.
Standard Conditions
■
Ambient Temperature: 22.2°C (72°F ± 2°F)
■
Fluid Temperature: 22.2°C (72°F ± 2°F)
■
Solution Container Head Height: 610 ± 51 mm (24 in ± 2 in)
■
Test Solution: Deionized Water, ISO Class III
■
Distal Positive Pressure (Back pressure): 0 mmHg
■
Needle: 18 Gauge or equivalent as per Sub-Clause 50.102 of IEC 60601-2-24
■
Set Type: Compatible DEHP IV set, or equivalent. For a list of compatible IV sets, see
“Compatible IV Sets” on page 123.
The percent variation of mean flow rate accuracy over a specific observation period may be
quantified with the use of a trumpet graph. Using the rationale for development of a statistical
trumpet graph as defined in IEC 60601-2-24, a presentation of the SIGMA Spectrum Infusion
System mean flow over a specific measurement interval is provided.
NOTE:
It is important for the clinician to understand the pharmacological influence of specific
drugs based on concentrations and patient response when used in conjunction with the
SIGMA Spectrum Infusion System.
Pumping mechanisms produce fluctuation in fluid flow by design based on the specific mechanism
type (peristaltic, piston, rotary, and so forth), electronic control system and other factors related to
the administration set’s characteristics. Specific flow profiles are helpful in determining the correct
clinical application for the infusion pump. Data is presented as requested by the applicable
standards and represents the typical flow rate function of the SIGMA Spectrum Infusion System for
short- and long-term operation. To facilitate visualization of the flow inconsistencies that are typical
of most infusion pumps, the start-up graphs and trumpet curves are extended to include the
minimum rate (0.5 mL/hr) and intermediate rate (25 mL/hr) for the SIGMA Spectrum Infusion
System.
NOTE:
The SIGMA Spectrum Infusion System is best classified as a “Volumetric Infusion
Pump” as defined by the applicable standards. Reference IEC 60601-2-24 and AAMI
ID26:2004, Medical electrical equipment – Part 2: Particular requirements for the safety
of infusion pumps and controller.