Independent Functional Testing of Patient Monitors Models From Different Manufactures

About Client

A leading US-based company and pioneer in patient monitoring and diagnostic solutions.

Client’s Challenge

Detailed testing of ten patient monitor models from two different manufacturers was required to support product portfolio expansion and market reach.

While clinical evaluation and cybersecurity testing were conducted by the client, comprehensive functional testing was necessary to ensure performance and reliability.

iOrbit Solution

iOrbit offered to conduct independent functional testing of the monitors to help client in decision making related to short-listing of the monitor makes and models. iOrbit also did retesting and regression testing after the reported issues were fixed by the monitor's development team.

iOrbit Scope

iOrbit conducted independent testing of the patient monitors to address the following -

Does monitor provide output as expected / claimed?
Is monitor comparable to the reference monitor?
Is IFU in sync with monitor features and functions?
The testing was focused on below functionalities and features

All parameters value, waveform and alarms checking including ECG (3/5/12 leads), HR, ST, Resp wave, RR, SpO2, PR, PPG wave, NIBP, Temp, pacer

Arrhythmias
Overall user interface, settings, configurations, view options
Trend data and graph, recording
Calculations
Other features like remote bed view
CMS connected to multiple monitors, network settings
User manual Vs monitor gap analysis
Retesting and Regression testing for all issues reported in earlier versions
Software and hardware update process checking
User role based permissions

iOrbit used patient simulator, manual inspection, comparative analysis, document reviews to conduct the testing.

Key Outcomes

Independent testing done by iOrbit, along with client's internal evaluation, helped client to finalize the makes and models to be considered.

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