Operator's Manual

74
RefeRences and TRoubleshooTing
RefeRences and
TRoubleshooTing
System Delivery
Accuracy
± 6% at nominal (at 90/90 tolerance level).
At low infusion rates, stated accuracy may not be achieved for short periods.
During the total infusion time, the accuracy averages out.
System delivery accuracy is determined under the following nominal
conditions:
• Infusion rate of 10mL/hr
• Ambient temperature of 22 degree C
• Fluid viscosity of 0.89 cP (i.e., water)
• 0.2 mmHg (0.004 PSI) back pressure (i.e., 2 inch 18Ga needle)
• Pump and Reservoir both placed at the same height as the infusion site
• CADD Administration Set with Flow Stop Free Flow
Protection (i.e., 21-7322-24)
Accuracy testing was performed using 22 CADD®-Solis Ambulatory Infusion
Pumps and 22 CADD® Administration Sets with Flow Stop Free Flow
Protection. All accuracy is stated for a 90/90 tolerance level.
Intermediate Rate
Accuracy testing methods defined in industry standard IEC 60601-2-24 is
performed using an `intermediate rate’ representative of typical rates for
various therapies. The intermediate rate of 10 mL/hr is representative for use
with standard volume administration sets.
WARNING:
• Ensure that the ± 6% system delivery accuracy specification is taken
into account when programming the pump and/or filling the reservoir.
Failure to do so may result in medication in the reservoir becoming
depleted sooner than expected. If the pump is being used to deliver
critical or life sustaining medication, the interruption in the delivery of
medication could result in patient injury or death.
• System delivery inaccuracies beyond ± 6% may occur as a result of back
pressure or fluid resistance, which depends upon temperature, drug
viscosity, catheter size, extension set tubing (for example, microbore),
in-line components (such as filters and needleless access connectors),
and placing the infusion reservoir and/or pump above or below the level
of the patient. System delivery inaccuracy may result in under or over
delivery of medication, which could result in patient injury or death.
Alternate System Configurations at Nominal
Conditions
System Delivery
Accuracy
Flow Stop administration set with air eliminating filter
(0.2 μm and 1.2 μm)
-8% to 8%
Non-Flow Stop administration set -9% to 2%
All 50/100 mL medication cassette reservoirs with
21-7046-24 extension set
-9% to 11%
All 250 ml medication cassette reservoirs with
21-7046-24 extension set
-13% to 8%