Medical-grade Devices Research Articles

B-PO01-097 DO APPLE IPHONE 12 MAGSAFE MAGNETS TRIGGER MAGNET MODE IN CARDIAC DEVICES?

Cardiac devices (pacemaker and defibrillators) have a magnet sensitive switch. Magnet application on a pacemaker generally causes an asynchronous pacing mode. Magnet application on a defibrillator temporarily suspends all anti-tachycardia therapies. Suspending anti-tachycardia therapies on a defibrillator can result in inhibition of potential life-saving therapies. The new Apple iPhone 12 line contain new magnets as part of their MagSafe charging system. Apple has recently released a warning for their iPhone 12 series and MagSafe accessories to keep a safe distance of more than 6 inches away from cardiac devices. This study aims to study the safety of Apple iPhone 12 with MagSafe near cardiac devices and to see how often then may trigger magnet mode. During clinic device checks or in hospital new cardiac device implant or generator changes, an Apple iPhone 12 with MagSafe cover will be used to see if magnet mode can be triggered on the cardiac device. Three sites were tested (<6 inches), holding the phone near the mouth, near the ear on the cardiac device implanting side and physically on top of the device. Magnet mode was first confirmed by using a standard medical grade device magnet while connected to an ECG or device interrogator. The Apple iPhone 12 with MagSafe cover was tested at 3 different sites to see if magnet mode could be triggered. The Apple iPhone 12 was tested on 30 devices for a total of 90 different positions. Manufacturer breakdown was 18 from Abbott, 10 from Medtronic and 2 from Boston Scientific. Device type breakdown was 20 pacemakers, 10 transvenous ICD and 1 SubQ ICD. Magnet response occurred in 0/30 near mouth position, 0/30 ear position and 3/30 over the device position. The 3 magnet responses were on Abbott pacemakers. One magnet response was easy to induce on an older generation of Abbott CRT pacemaker before generator change. The other 2 magnet responses were on current generation of Abbott pacemakers but was very positional. Apple iPhone 12 with MagSafe can be safely used with cardiac devices in normal phone use. Even with extreme close contact, only 10% of the time we were able to elicit magnet response. On current generation of devices, it was very positional to elicit magnet response.

Comparison of Wearable and Clinical Devices for Acquisition of Peripheral Nervous System Signals.

A key access point to the functioning of the autonomic nervous system is the investigation of peripheral signals. Wearable devices (WDs) enable the acquisition and quantification of peripheral signals in a wide range of contexts, from personal uses to scientific research. WDs have lower costs and higher portability than medical-grade devices. However, the achievable data quality can be lower, and data are subject to artifacts due to body movements and data losses. It is therefore crucial to evaluate the reliability and validity of WDs before their use in research. In this study, we introduce a data analysis procedure for the assessment of WDs for multivariate physiological signals. The quality of cardiac and electrodermal activity signals is validated with a standard set of signal quality indicators. The pipeline is available as a collection of open source Python scripts based on the pyphysio package. We apply the indicators for the analysis of signal quality on data simultaneously recorded from a clinical-grade device and two WDs. The dataset provides signals of six different physiological measures collected from 18 subjects with WDs. This study indicates the need to validate the use of WDs in experimental settings for research and the importance of both technological and signal processing aspects to obtain reliable signals and reproducible results.

Wearables for arrhythmia care: Challenges and future prospects

Wearables for arrhythmia care: Challenges and future prospects

Assessment of the Potential of Wrist-Worn Wearable Sensors for Driver Drowsiness Detection.

Drowsy driving imposes a high safety risk. Current systems often use driving behavior parameters for driver drowsiness detection. The continuous driving automation reduces the availability of these parameters, therefore reducing the scope of such methods. Especially, techniques that include physiological measurements seem to be a promising alternative. However, in a dynamic environment such as driving, only non- or minimal intrusive methods are accepted, and vibrations from the roadbed could lead to degraded sensor technology. This work contributes to driver drowsiness detection with a machine learning approach applied solely to physiological data collected from a non-intrusive retrofittable system in the form of a wrist-worn wearable sensor. To check accuracy and feasibility, results are compared with reference data from a medical-grade ECG device. A user study with 30 participants in a high-fidelity driving simulator was conducted. Several machine learning algorithms for binary classification were applied in user-dependent and independent tests. Results provide evidence that the non-intrusive setting achieves a similar accuracy as compared to the medical-grade device, and high accuracies (>92%) could be achieved, especially in a user-dependent scenario. The proposed approach offers new possibilities for human–machine interaction in a car and especially for driver state monitoring in the field of automated driving.

An Integrated Wearable Wireless Vital Signs Biosensor for Continuous Inpatient Monitoring

A compact, light-weight and low-power wireless vital signs monitoring system based on Wireless Body Area Network (WBAN) protocol has been developed. The system, VySys, includes two compact wearable wireless biosensor devices for continuous vital signs capturing and transmission, a gateway to relay the message collected from the biosensors to cloud, and finally a client apps to access and display the stored data in the cloud. Both biosensor devices can last for 24 hours and weigh less than 22 g and 44 g, respectively. They consist of proprietary in-house bio-sensing integrated circuit (IC) and commercial off-the-shelf Bluetooth Low Energy (BLE) module. VySys has been deployed in clinical trials with 14 subjects. From the studies, the accuracy and advantage of VySys are evaluated and the five vital signs captured (heart rate (HR), respiration rate (RR), temperature (TMP), oxygen saturation (SpO2) and systolic blood pressure (SBP)) are benchmarked against a commercial medical-grade device. The results show strong statistical correlation ( $ {r} > 0.68$ ). In terms of clinical significance, all its mean difference are within limits of accepted clinical discrepancies. In terms of efficacy by comparing against the best known reported results, (1) VsSys is more precise by 28.2%, 36.2%, 70.0%, 37.6% and 34.4% for HR, RR, TMP, SpO2 and SBP, respectively and (2) has a narrower 95% limit of agreement (LoA) by 24.5%, 23.9%, 50.6%, 37.4% and 34.4% for HR, RR, TMP, SpO2 and SBP, respectively.

BabyLux device: a diffuse optical system integrating diffuse correlation spectroscopy and time-resolved near-infrared spectroscopy for the neuromonitoring of the premature newborn brain.

The BabyLux device is a hybrid diffuse optical neuromonitor that has been developed and built to be employed in neonatal intensive care unit for the noninvasive, cot-side monitoring of microvascular cerebral blood flow and blood oxygenation. It integrates time-resolved near-infrared and diffuse correlation spectroscopies in a user-friendly device as a prototype for a future medical grade device. We present a thorough characterization of the device performance using test measurements in laboratory settings. Tests on solid phantoms report an accuracy of optical property estimation of about 10%, which is expected when using the photon diffusion equation as the model. The measurement of the optical and dynamic properties is stable during several hours of measurements within 3% of the average value. In addition, these measurements are repeatable between different days of measurement, showing a maximal variation of 5% in the optical properties and 8% for the particle diffusion coefficient on a liquid phantom. The variability over test/retest evaluation is . The integration of the two modalities is robust and without any cross talk between the two. We also perform in vivo measurements on the adult forearm during arterial cuff occlusion to show that the device can measure a wide range of tissue hemodynamic parameters. We suggest that this platform can form the basis of the next-generation neonatal neuromonitors to be developed for extensive, multicenter clinical testing.

Techniques for developing and viewing stereoscopic three-dimensional teaching videos for transoral robotic surgery (TORS).

Advances in three-dimensional (3D) video recording and playback have expanded the availability of stereoscopic videos for consumption with specialized televisions, computer monitors, and virtual reality (VR) headsets. The built-in stereoscopic vision of the da vinci surgical system (Intuitive Surgical, Sunnyvale, CA) enables the recording of both camera views. However, medical-grade devices for direct stereoscopic video recording can be cost-prohibitive. We describe methods of producing and viewing 3D videos in transoral robotic surgery (TORS) without acquisition of dedicated 3D recording equipment. The video output from the left and right cameras of the da Vinci Si endoscope were recorded during a TORS radical tonsillectomy using non-stereoscopic media devices. Raw video was processed using commercially available video-editing software to create stereoscopic videos clips. 3D videos were successfully observed using a low-cost mobile phone VR headset. 3D stereoscopic surgical videos were successfully developed using widely available software, applications, computer peripherals, and mobile devices. The methods described confer significant cost savings when compared to the purchase of specialized recording equipment despite the requirements of time and intermediate computer skills. Future studies will investigate the utility of stereoscopic videos in medical student and resident education.

Internet of Medical Things: A Review of Recent Contributions Dealing With Cyber-Physical Systems in Medicine

The Internet of Medical Things (IoMT) designates the interconnection of communication-enabled medical-grade devices and their integration to wider-scale health networks in order to improve patients' health. However, because of the critical nature of health-related systems, the IoMT still faces numerous challenges, more particularly in terms of reliability, safety, and security. In this paper, we present a comprehensive literature review of recent contributions focused on improving the IoMT through the use of formal methodologies provided by the cyber-physical systems community. We describe the practical application of the democratization of medical devices for both patients and health-care providers. We also identify unexplored research directions and potential trends to solve uncharted research problems.

Detection of physiological deterioration by the SNAP40 wearable device compared to standard monitoring devices in the emergency department: the SNAP40-ED study

BackgroundIn recent years, there has been increasing focus on the earlier detection of deterioration in the clinical condition of hospital patients with the aim of instigating earlier treatment to reverse this deterioration and prevent adverse outcomes. This is especially important in the ED, a dynamic environment with large volumes of undifferentiated patients, which carries inherent patient risk. SNAP40 is an innovative medical-grade device that can be worn on the upper arm that continuously monitors patients’ vital signs including relative changes in systolic blood pressure, respiratory rate, heart rate, movement, blood oxygen saturation and temperature. It uses automated risk analysis to potentially allow clinical staff to easily and quickly identify high-risk patients. The aim of this study is to investigate whether the SNAP40 device is able to identify deterioration in the vital sign physiology of an ED patient earlier than current standard monitoring and observation charting techniques.Methods/designSingle centre, teaching hospital ED open label, prospective, observational cohort study recruiting 250 high acuity participants aged 16 years or over presenting to the ED. Participants will be approached and enrolled in the ED and after consent will have the SNAP40 wearable monitoring device attached which will be used alongside standard care monitoring. Participants will be observed throughout their time in the ED. Any SNAP40 device alarm, standard monitoring alarms or standard practice vital sign observations indicating a deterioration in a patient’s vital sign physiology (defined as an increase in NEWS score) will be recorded. Primary outcome is time to detection of deterioration. Secondary outcomes include staff time spent performing observations and responding to standard monitoring alarms, clinical escalation of care when deterioration is detected and participants and staff rating of experience of both SNAP40 and current monitoring.DiscussionThe SNAP40-ED study aims to recruit 250 patients. It will be the first study to compare the ability of a novel ambulatory monitoring device to detect deterioration compared to standard care in the ED. It may allow the earlier detection of deterioration in the clinical condition of ED patients and therefore earlier treatment to reverse this deterioration and prevent adverse outcomes.Trial registrationNCT03179267 ClinicalTrials.gov. Registered on June 17, 2017

The open D1NAMO dataset: A multi-modal dataset for research on non-invasive type 1 diabetes management

Abstract The usage of wearable devices has gained popularity in the latest years, especially for health-care and well being. Recently there has been an increasing interest in using these devices to improve the management of chronic diseases such as diabetes. The quality of data acquired through wearable sensors is generally lower than what medical-grade devices provide, and existing datasets have mainly been acquired in highly controlled clinical conditions. In the context of the D1NAMO project — aiming to detect glycemic events through non-invasive ECG pattern analysis — we elaborated a dataset that can be used to help developing health-care systems based on wearable devices in non-clinical conditions. This paper describes this dataset, which was acquired on 20 healthy subjects and 9 patients with type-1 diabetes. The acquisition has been made in real-life conditions with the Zephyr BioHarness 3 wearable device. The dataset consists of ECG, breathing, and accelerometer signals, as well as glucose measurements and annotated food pictures. We open this dataset to the scientific community in order to allow the development and evaluation of diabetes management algorithms.

A Wireless Health Monitoring System Using Mobile Phone Accessories

This paper presents the design and prototype of a wireless health monitoring system using mobile phone accessories. We focus on measuring real-time electrocardiogram (ECG) and heart rate monitoring using a smartphone case. With the increasing number of cardiac patients worldwide, this design can be used for early detection of heart diseases. Unlike most of the existing methods that use an optical sensor to monitor heart rate, our approach is to measure real-time ECG with dry electrodes placed on smartphone case. The collected ECG signal can be stored and analyzed in real time through a smartphone application for prognosis and diagnosis. The proposed hardware system consists of a single chip microcontroller (RFduino) embedded with Bluetooth low energy, hence miniaturizing the size and prolonging battery life. The system called “smart case” has been tested in a laboratory environment. We also designed a 3-D printed smartphone case to validate the feasibly of the system. The results demonstrated that the proposed system could be comparable to medical grade devices.

Aesthetic preference recognition of 3D shapes using EEG.

Recognition and identification of aesthetic preference is indispensable in industrial design. Humans tend to pursue products with aesthetic values and make buying decisions based on their aesthetic preferences. The existence of neuromarketing is to understand consumer responses toward marketing stimuli by using imaging techniques and recognition of physiological parameters. Numerous studies have been done to understand the relationship between human, art and aesthetics. In this paper, we present a novel preference-based measurement of user aesthetics using electroencephalogram (EEG) signals for virtual 3D shapes with motion. The 3D shapes are designed to appear like bracelets, which is generated by using the Gielis superformula. EEG signals were collected by using a medical grade device, the B-Alert X10 from advance brain monitoring, with a sampling frequency of 256Hz and resolution of 16 bits. The signals obtained when viewing 3D bracelet shapes were decomposed into alpha, beta, theta, gamma and delta rhythm by using time-frequency analysis, then classified into two classes, namely like and dislike by using support vector machines and K-nearest neighbors (KNN) classifiers respectively. Classification accuracy of up to 80% was obtained by using KNN with the alpha, theta and delta rhythms as the features extracted from frontal channels, Fz, F3 and F4 to classify two classes, like and dislike.

3‐dimensional imaging and quantification of cell adherence on curved surfaces of medical grade devices using confocal lasers‐canning microscopy

3‐D confocal laser‐scanning microscopy is an ideal way to visualize a sample with a curved surface. An application of this method involves the quantification of activated blood leukocytes and platelets adhering to the surface of medical grade catheters. Human blood was perfused across treated and untreated catheters using a microperfusion system and fixed with paraformaldehyde. Portions of each catheter were immunostained and 5 random fields were imaged using a Leica SP2 microscope (20× objective; 2× optical zoom). Image stacks were loaded into image analysis software and transformed into a max intensity projection. From this 2‐D projection, area occupied by fluorescence was calculated by implementing a binary threshold layer above isotypic control. Area fluorescence was divided by the mean area of a single cell, generating a cell count per unit area. Results are presented as adherent cells/mm2 ± SEM. The treated surface showed reduced adherent cell counts (monocytes: 0.67 ± 1.03, polymorphs: 1.33 ± 3.99, lymphocytes: 0.62 ± 1.86, platelets: 1.33 ± 3.99) compared to the untreated surface (monocytes: 302.43 ± 215.55, polymorphs: 1647.56 ± 615.54, lymphocytes: 38.46 ± 29.59, platelets: 4076.23 ± 2867.3). This method can be used to capture and quantify large amounts of data that may be obscured or otherwise unavailable when imaging curved surfaces, such as in biocompatibility assessment of medical devices.

Biaxial strength of multilaminated extracellular matrix scaffolds

Xenogeneic extracellular matrix (ECM) can be harvested and configured to function as a bioscaffold for tissue and organ reconstruction. The mechanical properties of the ECM vary depending upon the tissue from which it is harvested. Likewise, the manufacturing steps required to develop ECMs into medical grade devices will affect the surface morphology and the mechanical properties of the bioscaffold; important properties for constructive tissue remodeling. The present study compared the ball-burst strength of five different ECM scaffolds before and after treatment with peracetic acid (PAA): porcine small intestinal submucosa (SIS), porcine urinary bladder submucosa (UBS), porcine urinary bladder matrix (UBM), a composite of UBS+UBM, and canine stomach submucosa (SS). This study also compared the mechanical properties of 2- and 4-layer ECM scaffolds. Results showed 2-layer SS devices had the highest ball-burst value of all 2-layer ECM devices. Moreover, all 4-layer ECM devices had similar ball-burst strength except for 4-layer UBM devices which was the weakest. PAA-treatment decreased the ball-burst strength of SS and increased the ball-burst strength of UBS 2-layer devices. This study showed the material properties of the ECM scaffolds could be engineered to mimic those of native soft tissues (i.e. vascular, musculotendinous, etc) by varying the number of layers and modifying the disinfection/sterilization treatments used for manufacturing.