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Calibration of Infusion Pumps Analyser

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XXII World Congress of the International Measurement Confederation (IMEKO 2018) IOP Publishing
IOP Conf. Series: Journal of Physics: Conf. Series 1065 (2018) 092003 doi:10.1088/1742-6596/1065/9/092003

Calibration of Infusion Pumps Analyser

E Batista1, J Alves e Sousa1, Á Ribeiro2, L Martins2, M Pereira3, H. Navas3

1
IPQ, Rua António Gião, 2, 2829-513 Caparica, Portugal
2
LNEC, Av. do Brasil 101, 1700-066 Lisboa, Portugal
3
FCT/UNL, UNIDEMI, 2829-516 Caparica, Portugal

ebatista@ipq.pt

Abstract. Nowadays, infusion pumps such as syringe pumps and peristaltic pumps are
commonly used for drug delivery, in situations where the delivery dose has stringent limits and
high risk impact. In order to ensure the metrological traceability of these flow and volume
measuring equipment it is necessary to use suitable calibration methods and standards. One of
the methods typically used in hospitals is relying on an Infusion Device Analyser (IDA). This
is a secondary method, and consists on comparing directly the flow generated by the infusion
pump with the IDA. The IDA can be calibrated by gravimetric or by the use of a precision
syringe pump. In this paper the results of the two calibration methods are compared. Moreover,
a new calibration method using a Coriolis meter is evaluated. The uncertainty budgets of the
three methods are described in detail.

1. Introduction
Medical infusion instruments are widely used, as they are fundamental for primary health care,
namely for providing drugs, nutrition and hydration to patients. Hence, it is crucial that the volume
and flow generated by the devices are the most accurate and precise as possible, especially in
situations related to neonatology (newborn babies) or cancer treatment. To ensure this, it is necessary
to have appropriate calibration methods, including appropriate measurement uncertainty evaluation.
The Metrology for Drug Delivery (MeDD) project [1] funded by the European Metrology Research
programme (EMRP), developed during 2012-2015, had a major goal of studying such calibration
methods [2].
The outcomes of this project were discussed in several international conferences and presented in
scientific papers, reports and best practice guides that can be found in www.drugmetrology.com.
Nonetheless, this data was never formalized in the way of amendments to the relevant standards,
specifically ISO 7886-2 [3] and IEC 60601-2-24 [4].
Aiming to disseminate the knowledge obtained from MeDD JRP, a new project (Support for
Impact Project (SIP) 15SIP03 – Infusion Uptake) funded by the European Metrology of Innovation
and Research Programme (EMPIR) has started in May 2016. It has two main goals, to develop an
E-learning module made available on the E-learning platform of the European Society for Intensive
Care Medicine (ESICM) and to incorporate the best metrology practices relating calibration of
infusion devices in international standards, namely ISO 7886-2 [3] and IEC 60601-2-24 [4].
In order to develop the E-learning modules and to identify the necessary contents to incorporate in
the standards it was necessary to identify the different calibration methods and to validate them. This
work was done in [5]. One of the methods described was a comparison method that used an Infusion
Device Analyzer (IDA). In order to ensure traceability it is necessary to calibrate the IDA. There are
several calibration methods that can be used. The methods used in this work will be explained in the
next section. Finally, experience has shown [6] that in micro flow and volume, measurement
uncertainty becomes critical and this will also be discussed in this paper.

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XXII World Congress of the International Measurement Confederation (IMEKO 2018) IOP Publishing
IOP Conf. Series: Journal of Physics: Conf. Series 1065 (2018) 092003 doi:10.1088/1742-6596/1065/9/092003

2. Calibration methods
In this work three different calibration methods were used to calibrate an Infusion Device Analyzer –
IDA – 1S (Figure 1), namely the gravimetric method, the precision pump method and the Coriolis
meter method.

Figure 1 – Infusion Device Analyzer 1S

2.1. Gravimetric method

The gravimetric method is considered as a primary method and is commonly used by the National
Metrology Institutes [2,7, 8] to calibrate syringe pumps and infusion pumps analyzers. This relies on
weighing the mass of water delivered by the pump during a period of time. The flow rate is then
determined by the quotient of the mass of reference liquid, usually water, and the time interval,
including some corrections and further details on this method can be found in [5].

2.2. Precision syringe pump

This method relies on the use of a precision syringe pump (Figure 2), calibrated by gravimetry and
consists on comparing directly the flow generated by the precision syringe pump with the IDA. In this
work a Nexus 3000 syringe was used.

Figure 2 – Nexus 3000

Before starting the calibration all the apparatus under test (precision syringe pump and the IDA)
and the reference liquid should reach a steady state condition as close as possible to the reference
temperature of 20 ºC (during 24 hours).
During the calibration, the temperature of the water and the air temperature, relative humidity and
atmospheric pressure should be continually measured and/or recorded.
The Nexus pump is filled with degassed ultrapure water [9]. The line should then be filled by
running the syringe pump at a high rate until a steady flow of drops comes out at the end of the tube.
Finally, the tube is connected with the IDA.
Next, the target flow is programmed in the Nexus pump. Data acquisition of IDA begins after 10
minutes of steady flow and over at least 15 minutes. The data can be directly recorded by software or
read at the display as the average flow rate. The described time measurements were obtained by
experimental work in the Volume and Flow Laboratory (LVC) of the Portuguese Institute for Quality.

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XXII World Congress of the International Measurement Confederation (IMEKO 2018) IOP Publishing
IOP Conf. Series: Journal of Physics: Conf. Series 1065 (2018) 092003 doi:10.1088/1742-6596/1065/9/092003

The recording time depends on the flow rate, bearing in mind that the lower the flow the larger should
be the recording data time.

2.3. Coriolis meter

This method uses a Coriolis meter with an incorporated pump, calibrated by gravimetry and consists in
comparing directly the flow generated by the Coriolis meter with the IDA. In this work a Bronkhorst
M13 Coriolis meter (Figure 3) was used.

Figure 3 – M13 Coriolis meter with pump

Before starting the calibration all the apparatus under test (Coriolis meter and the IDA) and the
reference liquid should reach a steady state condition as close as possible to the reference temperature
of 20 ºC (during 24 hours).
During the calibration, the temperature of the water and the air temperature, relative humidity and
atmospheric pressure should be continually measured and/or recorded.
The Coriolis meter is filled with degassed ultrapure water [9]. The line should then be filled by
running the Coriolis meter at a high rate until a steady flow of drops comes out at the end of the tube.
Finally, the tube is connected with the IDA.
Next, the target flow is programmed in Coriolis meter. Data acquisition of IDA begins after 10
minutes of steady flow and over at least 15 minutes. The data can then be recorded directly by
software or read at the display as the average flow rate.

3. Method comparison results

The IDA 1 S instrument was calibrated at different flow rates using the different methods described
above. The results can be found in the following figures.

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XXII World Congress of the International Measurement Confederation (IMEKO 2018) IOP Publishing
IOP Conf. Series: Journal of Physics: Conf. Series 1065 (2018) 092003 doi:10.1088/1742-6596/1065/9/092003

Figure 4 – Calibration of IDA 1s using the gravimetric method and the Coriolis meter

Figure 5 – Calibration of IDA 1s using the gravimetric method and the syringe pump

It can be verified from figure 4 and 5 that the methods are all consistent with each other but the
Coriolis meter has a very large uncertainty when compared with the other two methods. This is due to
the instable behaviour of the device when connect to IDA1S. This variability can be identified in
figure 6.

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XXII World Congress of the International Measurement Confederation (IMEKO 2018) IOP Publishing
IOP Conf. Series: Journal of Physics: Conf. Series 1065 (2018) 092003 doi:10.1088/1742-6596/1065/9/092003

Figure 6 – Coriolis flow meter variability

Coriolis flow meter are very sensible to pressure changes and each time the IDA 1s records a value
there is a pressure drop that can be observed in the Coriolis flow meter chart. This leads to a very large
standard deviation that reflects on the uncertainty and also on the error, being the flow much smaller
than for the other two methods.

4. Uncertainty determination
The uncertainty budget of the calibration methods was estimated based on the Guide to the Expression
of Uncertainty in Measurement (GUM) and supplements [10,11] and additional work [12,13].
The uncertainty budget for the gravimetric method is well explained in [6]. For the comparison
method using the Nexus 3000 pump or the Coriolis meter the uncertainty budget is explained below.
The uncertainty of the comparison method includes the calibration uncertainty (namely, possible
drift and error) of the standard, Nexus pump or Coriolis meter (u(Qstd)cal), its resolution (u(Qstd)res) and
repeatability of measurements (u(Qstd)rep). The instrument to be calibrated (IDA) will contribute to the
uncertainty with its resolution (u(QIDA)res). The uncertainty of the temperature of the water is obtained
considering the calibration uncertainty of the thermometer used (u(T)cal), and the expansion of the IDA
material (u(. Finally, the uncertainty due to water loss (u(δloss)) is also taken into account in the
uncertainty budget. Detailed information regarding the uncertainty sources is described in Table 1.

Table 1 - Uncertainty components in the calibration of IDA by comparison method

Source / Symbol Standard Evaluation Evaluation Distribution
uncertainty process type
component
Standards flow / Qstd u(Qstd)cal Calibration A Normal
u(Qstd)res Resolution B Rectangular
u(Qstd)rep Flow measurement A Normal
standard-deviation
IDA flow / QIDA u(QIDA)res Resolution B Rectangular
Water temperature / T u(T)cal Calibration A Normal
u(T)res Resolution B Rectangular

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XXII World Congress of the International Measurement Confederation (IMEKO 2018) IOP Publishing
IOP Conf. Series: Journal of Physics: Conf. Series 1065 (2018) 092003 doi:10.1088/1742-6596/1065/9/092003

u(T)rep Temperature B Rectangular

measurement
standard-deviation
Water loss / δloss u(δloss) Estimation B Rectangular
Temperature expansion u() Literature B Rectangular
coefficient / 

5. Conclusions
Infusion device analysers are widely used in hospitals to calibrate or check the infusion pumps. This
procedure ensures traceability of the measurements, being needed to calibrate the IDA using
appropriate methods. In this work several methods were described along with the uncertainty budget.
In general, both the syringe method and gravimetric method can be used to calibrate the IDA with
acceptable uncertainty values. The Coriolis method has some problems with the pressure drop of the
device and so it’s not recommended to be used. This information should now be disseminated in the
appropriated standards, since there is no document that describes in detail the calibration methodology
for these devices.

This work has been developed in the framework of the project EMPIR 15SIP03.

References
[1] Lucas, P., Klein, S., Metrology for drug delivery, Biomedical Engineering, 2015, 60(4), 271-275
[2] Bissig, H., Petter, H.T., Lucas, P., Batista, E., et all, Primary standards for measuring flow rates from 100
nl/min to 1 ml/min – gravimetric principle, Biomedical Engineering, 2015, 60(4), 301-316
[3] ISO 7886-2:1996, Sterile hypodermic syringes for single use, Part 2: Syringes for use with power-driven
syringe pumps
[4] IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the safety of
infusion pumps and controllers
[5] Batista, E., et all, Comparison of infusion pumps calibration methods, Measurement, 2017, 28
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measurements, AMCTM X, 2015, vol 86, 98-104
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Acknowledgments
The EMPIR project “17NRM05-EMUE” is carried out with funding of European Union under the EMPIR. The
EMPIR is jointly funded by the EMPIR participating countries within EURAMET and the European Union.