Flow rate accuracy
Accuracy of the fill-level sensor
(this sensor measures the contents of the
pump reservoir)
Material
Medical grade silicone elastomers; barium sulfate
Inner diameter
0.6 mm
Outer diameter
2.4 mm
Length
100 cm
Volume
0.00283 mL/cm
Total volume: 0.283 mL
Pump Catheter length/volume conversion table
Length of
20 cm
30 cm
catheter
Volume
0.057 mL
0.085 mL
The flow rate accuracy is within ±10% with 99% conformance at 95% confidence.
Bench testing was performed with bacteriostatic water at nominal conditions (atmospheric pressure: 1013 mbar
[sea level]; temperature: 37ºC).
The accuracy data are valid for all pump flow rates (0.1 mL/day to 4.0 mL/day) and all reservoir capacities
(20 mL and 40 mL).
The testing includes all pump emptying behavior from maximum capacity (20 mL or 40 mL) to 2 mL.
The effects of temperature and outlet pressure on flow rate are cumulative.
See Appendix A for additional information.
The accuracy of the fill-level sensor is within ±1 mL with 97.9% conformance at 95% confidence.
Bench testing was performed with bacteriostatic water.
The accuracy data are valid for all levels of reservoir contents (from maximum level of 20 mL or 40 mL to 2 mL),
in temperature range of 36ºC to 42ºC.
Table 6
Pump Catheter Specifications
40 cm
50 cm
60 cm
0.113 mL
0.141 mL
0.17 mL
70 cm
80 cm
90 cm
0.198 mL
0.226 mL
0.254 mL
100 cm
0.283 mL
19