Exploration Atmosphere Demonstration of A Multi-Functional Integrated Medical Device (Tempus Pro)

INTRODUCTION
The Exploration Medical Capability (ExMC) element within the Human Research Program and the Exploration Medical Integrated Product Team (XMIPT) within the Mars Campaign Office seek to advance medical system design and risk-informed decision-making for exploration missions. This includes assessment of candidate devices and their compatibility within a variety of increasingly Earth-independent medical scenarios. The Tempus Pro (Remote Diagnostic Technologies, Ltd., Philips Corp., Farnborough, UK) is a commercial-off-the-shelf (COTS), multi-functional integrated medical device capable of vital signs monitoring, with built-in procedure support (iAssist), patient record and telemedicine communication features, and medical imaging (e.g., camera, laryngoscope, ultrasound) that meets multiple exploration medical capability needs. One of several hypobaric atmospheres being considered for exploration vehicles is 8.2 psi with 34% oxygen. To assess the useability of the Tempus Pro in such environments by individuals without formal medical training, the unit was tested in May and June of 2023 at the Johnson Space Center 20-Foot Exploration Atmosphere Chamber in conjunction with the Exploration Atmospheres-2 (EA-2) study.

TECHNOLOGY DEMONSTRATION
Eight subjects in the EA-2 study were assigned roles as the caregiver or patient – or both in the case of a self-exam – and caregivers were asked to place sensors for 3-Lead ECG, non-invasive blood pressure (NIBP), pulse oximetry (SpO2), and temperature using Tempus Pro’s iAssist. Depending on the procedure, additional tasks included an oropharyngeal exam of the throat with the laryngoscope and capturing ultrasound images of a cardiac subxiphoid view or of the user’s choice from a pre-specified list. Scenarios ranged from remote-guided to fully autonomous operations and surveyed the effectiveness of support, amount of support desired, and importance of support by type (e.g., written crew procedures, iAssist and device guidance, remote console guidance, etc.). Feedback from the subjects and the support personnel was also gathered to inform future designs for training and support and to determine what operations are plausible given different levels of each. An unweighted NASA task load index (TLX) was used to profile the demands of using the device, however the sample size does not support statistics. The research was exploratory in nature and qualitative information was the main goal. Calibration checks on the Tempus Pro were conducted before and after chamber testing to ensure the device was in useable condition.

RESULTS
All subjects performed their tasks successfully and found the Tempus Pro easy to use with the support provided. The calibration checks outside the chamber showed that the Tempus Pro remained unchanged and measurements inside the chamber were within normal values. Caregivers taking the NASA TLX reported mean scores ≤ 41/100 showing the tasks to be undemanding and less demanding with repeated use (~20/100). Novice users were able to easily connect sensors and take vital signs with the guidance from Tempus Pro’s iAssist feature. For more complex tasks, such as the oropharyngeal exam and ultrasound image acquisition, guidance beyond iAssist was needed, primarily from a supporting physician. Feedback on the importance of support types varied by person and scenario but greater than 50% of the support used by each was non-native to the device. Overall opinions were positive, but the ultrasound users expressed a lack of confidence in their results and 3 out of 4 desired more time, training, or support. Subjects found the sensors to be comfortable and comparable to prior experiences with such devices, except for the blood pressure cuff, which squeezed too tightly for uncomfortably long periods. Many observations provoked discussion, especially regarding ultrasound, that will aide decisions about future demonstrations.