Around 5%-10% of newborn babies require some form of resuscitation at birth and heart rate (HR) is the best guide of efficacy. We report the development and first trial of a device that continuously monitors neonatal HR, with a view to deployment in the delivery room to guide newborn resuscitation. The device uses forehead reflectance photoplethysmography (PPG) with modulated light and lock-in detection. Forehead fixation has numerous advantages including ease of sensor placement, whilst perfusion at the forehead is better maintained in comparison to the extremities. Green light (525 nm) was used, in preference to the more usual red or infrared wavelengths, to optimize the amplitude of the pulsatile signal. Experimental results are presented showing simultaneous PPG and electrocardiogram (ECG) HRs from babies (n = 77), gestational age 26-42 weeks, on a neonatal intensive care unit. In babies ⩾32 weeks gestation, the median reliability was 97.7% at ±10 bpm and the limits of agreement (LOA) between PPG and ECG were +8.39 bpm and -8.39 bpm. In babies <32 weeks gestation, the median reliability was 94.8% at ±10 bpm and the LOA were +11.53 bpm and -12.01 bpm. Clinical evaluation during newborn deliveries is now underway.

Barrie Hayes-Gill 2 | Don Sharkey 1 This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Background A novel medical device has been developed to address an unmet need of standardizing and facilitating heart rate recording during neonatal resuscitation. In a time-critical emergency resuscitation, where failure can mean death of an infant, it is vital that clinicians are provided with information in a timely, precise, and clear manner to capacitate appropriate decision making. This new technology provides a hands-free, wireless heart rate monitoring solution that easily fits the clinical pathway and procedure for neonatal resuscitation. Objective This study aimed to understand the requirements of the interface design for a new device by using a human factors approach. This approach combined a traditional user-centered design approach with an applied cognitive task analysis to understand the tasks involved, the cognitive requirements, and the potential for error during a neonatal resuscitation scenario. Methods Fourteen clinical staff were involved in producing the final design requirements. Two pediatric doctors supported the development of a visual representation of the activities associated with neonatal resuscitation. This design was used to develop a scenario-based workshop. Two workshops were carried out in parallel and involved three pediatric doctors, three neonatal nurses, two advance neonatal practitioners, and four midwives. Both groups came together at the end to reflect on the findings from the separate sessions. Results The outputs of this study have provided a comprehensive description of information requirements during neonatal resuscitation and enabled product developers to understand the preferred requirements of the user interface design for the device. The study raised three key areas for the designers to consider, which had not previously been highlighted: (1) interface layout and information priority, as heart rate should be central and occupy two-thirds of the screen; (2) size and portability, to enable positioning of the product local to the baby’s head and allow visibility from all angles; and (3) auditory feedback, to support visual information on heart rate rhythm and reliability of the trace with an early alert for intervention while avoiding parental distress. Conclusions This study demonstrates the application of human factors and the applied cognitive task analysis method, which identified previously unidentified user requirements. This methodology provides a useful approach to aid development of the clinical interface for medical devices.

The capability of accurately estimating pitch damping values for missile-like geometries over a range of Mach numbers and at high angles of attack using state-of-the-art CFD techniques has been investigated. Toward this effort three geometries were examined: the Army-Navy Finner model, the extended Army-Navy Finner model, and the M823 research store. Pitch damping values are predicted using forced oscillation calculations performed with the RavenCFD Navier-Stokes flow solver. Additionally, pitch decay calculations and aerodynamic build-up methods are also employed using the RavenCFD solver. These methods are compared to both experimental results and AP09, a fast-running engineering tool. Pitch damping variations due to geometric changes, Mach number changes, and angle of attack changes are explored with each method. Overall, each CFD method exhibits an outstanding agreement with experiment and range data at the lower angles of attack. Both pitch decay and forced oscillation approaches provide good agreement for low-to-moderate angles. At angles of attack greater than 30 degrees, the forced oscillation approach provides the best agreement. Pitch damping variations at angles higher than 60-70 degrees for the Army-Navy Finner have been shown to be a peripheral effect of the extreme unsteadiness of the wake flow at these conditions. NomenclatureA = amplitude of oscillation k = reduced frequency c = chord C m = pitching moment coefficient ̇ = pitch damping sum = normal force coefficient = normal force curve slope d ref = reference length (typically missile diameter) FOA = Forced Oscillation Approach yy I = moment of inertia about the pitch axis k = reduced frequency, M = Mach number ncyc = number of points per cycle PD = Pitch Decay Approach 2 q = dynamic pressure, = reference area tp = time for given peak (used in pitch decay) t = time U ∞ = freestream velocity w = aerodynamic load = x-location of the i th missile panel (used in build-up approaches) xcg = x-location of the center of gravity xcp = x-location of the model center of pressure α = angle of attack α m = mean angle of attack α o = angle of attack amplitude α p = peak pitch angle (used in pitch decay) t = time step = width of the i th missile panel (used in build-up approaches)  = ratio of specific heats  = density  = angular frequency

Results from computational fluid dynamics (CFD) predictions of roll damping on three elementary missile configurations are presented in this work. RavenCFD, a threedimensional unstructured-grid Navier-Stokes solver, is used in conjunction with a rigid body motion (RBM) capability and an embedded six-degree-of-freedom (6-DOF) solver to simulate both prescribed rolls and free-to-roll configurations.Several different methodologies are applied to both prescribed-roll and free-to-roll CFD calculations to obtain estimates of roll damping coefficient across a broad range of Mach numbers. In general, the computational results agree well with experimental roll-damping measurements across the range of Mach numbers and angles of attack considered. Nomenclatureα = Angle of attack ϕ = Roll angle C lp = Roll damping coefficient C l = Rolling moment coefficient d = Configuration base diameter I xx = Moment of inertia about roll axis M ∞ = Freestream Mach number U ∞ = Freestream velocity T ∞ = Freestream temperature p = Roll rate pd/2U ∞ = Nondimensional roll rate p ∞ = Freestream pressure q ∞ = Freestream dynamic pressure S = Configuration reference area

<b><i>Background:</i></b> International newborn resuscitation guidelines recommend electrocardiogram (ECG) heart rate (HR) monitoring at birth. We evaluated the application time of pre-set ECG electrodes fixed to a polyethene patch allowing adhesive-free attachment to the wet skin of the newborn chest. <b><i>Objectives:</i></b> Using a three-electrode pre-set ECG patch configuration, application success was calculated using video analysis and measured at three time points, the time to (1) apply electrodes; (2) detect recognizable QRS complexes after application; and (3) display a HR after application. <b><i>Method:</i></b> A prospective observational study in two UK tertiary maternity units was undertaken with 71 newborns including 23 who required resuscitation. <b><i>Results:</i></b> The median (IQR) time for ECG patch application was 8 (6–10) seconds, detection of recognizable QRS complexes 8 (2–12) seconds, and time to output HR was 23 (15–37) seconds. <b><i>Conclusion:</i></b> Pre-set ECG chest electrodes allow rapid HR information at birth without electrode detachment or compromising skin integrity.

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BACKGROUND A novel medical device has been developed to address an unmet need in standardising and facilitating heart rate recording during neonatal resuscitation. In a time critical emergency resuscitation, where failure can mean death of an infant, it is vital that clinicians are provided with information in a timely, precise and clear manner to capacitate appropriate decision making. This new technology provides a hands free, wireless heart rate monitoring solution that easily fits the clinical pathway and procedure for neonatal resuscutation. To understand the requirements of the interface design for this new device, a human factors approach was implemented. This combined a traditional user-centred design approach with an Applied Cognititive Task Analysis (ACTA) to understand the tasks involved, the cognitive requirements and the potential for error during a neonatal resusciation scenario. OBJECTIVE 1. To understand the cognitive requirements of clinicians for a novel medical device to facilitate neonatal resuscitation; 2. To apply a human factors approach and a traditional user-centred design approach to provide a device interface specification. METHODS Fourteen clinical staff were involved in producing the final design requirements. Two paediatric doctors supported the development of a visual representation of the activities associated with neonatal resucitation. This was used to develop a scenario based workshop. Two workshops were carried out in parallel and involved three paediatric doctors, three neonatal nurses, two advance neonatal practitioners and four midwives. Both groups came together at the end to reflect on the findings which emerged during the separate sessions. RESULTS The outputs of this study have provided a comprehensive description of information requirements during neonatal resuscitation, and enabled product developers to understand the core and preferred requirements of the user interface design for the device. The study raised three key areas for the designers to consider, which had not previously been highlighted. These related to interface layout and information priority, size and portability of the device and auditory feedback. CONCLUSIONS This study demonstrates the value of the ACTA approach to inform the development of resuscitation devices, and more generally for medical device development.