Validation

INFUSCALE has been developed since 1990 starting as DOS version and later transferred to Windows. It has been designed according to the draft standard IEC 62D(CO)61 and the published standard IEC 60601-2-24 / EN 60601-2-24.

The software has been developed in Turbo Pascal 5.0, Borland Pascal 7.0, Delphi 2 and recently Delphi 5 compilers which have been in use worldwide for many years and which are widely accepted.

The following verification and validation steps have been taken:

INFUSCALE has been tested and compared to other procedures for measuring pump  accuracy as described in the thesis towards a Diploma in Engineering (Dipl.Ing.) by Ralph Hubka, dated September 1990

Data files received from measurements with continuously running infusion pumps were taken and were calculated independently in MICROSOFT EXCEL according to the standard.

Example: Data file BSP2.PMP from minute 126 to 186:

The Excel results were then compared with the INFUSCALE results:

The results were identical, rounding was correct.

The measured INFUSCALE results were also compared to the set flow rate of a high number of different pumps ranging from 1 mL/24h to 4 L/h. No inconcistencies were observed.

Data files received from measurements with pumps running in the bolus delivery mode (e.g. PCA pumps) were taken and were calculated independently in MICROSOFT EXCEL. The results were identical.

The measured INFUSCALE results were also compared with the set bolus volume of several infusion pumps ranging from 1.4 mikroliter to 33 ml

An example is a measurement made with a Braun Perfusor FT. The pump had been set to bolusses of 5 ml volume. The following picture shows one of these bolusses.

INFUSCALE calculated this bolus between minute 64 and 70 to 4.9404 ml (Volume increase).

The same data calculated in Excel resulted in 4.940391 ml.

In addition several other tests like evaporation and correct timing were carried out.  The results and recommendations for setting up the measurement system can be found in the INFUSCALE handbook as well as accuracy tables for several scales.

INFUSCALE has been used by TÜV-SÜD PRODUCT SERVICE since 1990.