Operator's Manual

75
RefeRences and TRoubleshooTing
RefeRences and
TRoubleshooTing
Patient Selection
It is important to consider patient selection with regard to clinical factors and
environmental factors. These factors can include the route of administration,
the prescribed medication, and the system configuration chosen to ensure
acceptable delivery accuracy is appropriate for your patient.
Consideration of Continuous Flow at Low Rates
Delivery accuracy is not tested below 10 mL/hr. When intending to deliver
therapies that require a low continuous flow rate, consider using another type
of infusion pump, such as a syringe pump.
Challenge Conditions
The adjusted flow rate accuracy for non-nominal environmental conditions
when using a CADD® Administration Set with Flow Stop Free Flow Protection
is summarized below as determined per testing methods defined in industry
standard IEC 60601-2-24.
Challenge Conditions System Delivery Accuracy
Pump & reservoir height approximately four feet below the
infusion site (backpressure increase of 100mmHg)
-10% to 5%
Backpressure increase of 300mmHg -17% to -7%
Pump & reservoir height approximately four feet above the
infusion site (backpressure decrease of 100mmHg)
-6% to 11%
Reservoir height 0.3 m below pump & infusion site -12% to 7%
Temperature at 2°C, 20% RH -12% to -1%
Temperature at 40°C, 90% RH -10% to 10%
21 Gauge Epidural Catheter -20% to -1%
Bolus accuracy
specification: ± 6%
Tested with CADD®
administration set
with Flow Stop free
flow protection
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%
Challenge test conditions (min and max % error from set value):
0.05 mL at 2°C, 20
% RH
-14% to -1%
0.05 mL at 40°C, 90
% RH
-1% to 12%
50 mL at 2°C, 20
% RH
-16% to -7%
50 mL at 40°C, 90
% RH
-8% to 2%