13
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System delivery
accuracy
± 6% (nominal). At low infusion rates, this accuracy may not be achieved for
short periods. During the total infusion time, the accuracy averages out.
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 overdelivery of
medication.
Using CADD
™
medication
cassette reservoirs
± 6% (nominal) at 15°C to 40°C with no back pressure
•
An additional ± 2.5% change may be seen at ± 100 mmHg (± 1.9 psi).
Using CADD
®
administration sets
± 6% (nominal) at 15°C to 40°C with no back pressure.
•
An additional ± 2.5% change may be seen at ± 100 mmHg (± 1.9 psi).
Using CADD
®
high volume
administration sets
± 6% (nominal) at 15°C to 40°C with no back pressure
•
An additional ± 5% change may be seen at ± 100 mmHg (± 1.9 psi).
System definition
CADD
®
-Solis pump with 1 of the following attached:
•
Medication cassette reservoir and CADD
®
extension set
•
Medication cassette reservoir with Flow Stop feature and CADD
®
extension set
•
CADD
®
administration set
•
CADD
®
administration set with Flow Stop feature
High pressure
alarm threshold
1.24 bar ± 0.62 bar
18 ± 9 psi
Air detector alarm
Sensitivity:
•
Low: Single bubble > 400 μL
•
High: Single bubble > 150 μL
Accumulated Air:
Greater than 1 mL air over 15 minutes (nominal)
Bolus accuracy
specification: ± 6%
Actual test data for bolus accuracy at 0.05 mL:
Average
0.0508 mL
% Error
1.6%
Minimum Error %
–3.0%
Maximum Error %
4.2%
Actual test data for bolus accuracy at 50 mL:
Average
50.77 mL
% Error
1.55%
Minimum Error %
–0.07%
Maximum Error %
2.35%
Maximum volume
infused under
single-fault
conditions
•
CADD
®
administration set: 0.15 mL
•
CADD
®
high volume administration set: 0.30 mL
