DEVICE: BioStamp nPoint™ (G012BRCP01)

A collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).

A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.

A body-worn, battery-powered component of an electromyography telemetric monitoring system designed to continuously measure and wirelessly transmit electromyographic (EMG) signals to the system's receiver. The transmitter typically includes an antenna and attached sensors (e.g., lead wires and electrodes) that are connected to the patient. This is a reusable device.

A body-worn, battery-powered component of an electrocardiography telemetric monitoring system designed to continuously measure and wirelessly transmit real-time electrocardiographic (ECG) signals [and sometimes additional parameters such as heart rate, skin temperature, or haemoglobin oxygen saturation (SpO2)] to a remote receiver (e.g., central station server); it may in addition record/analyse data during a period of time for later retrieval (Holter reporting). The transmitter typically includes an antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, and may be provided with dedicated data management/communication software. This is a reusable device.

A collection of devices designed to measure intra-abdominal pressure (IAP) through the bladder. It typically includes a tube with graduated markings in mm Hg (manometer tube), clamps, a filter, and a urine collection bag. The assembled device is connected to an indwelling urethral catheter (Foley), and IAP is measured by the manometer tube based on urine level in the tube. It is typically used to measure IAP in patients at risk of intra-abdominal hypertension (IAH) such as following abdominal surgery, abdominal trauma, ventilated patients with organ dysfunction, and patients suspected of abdominal compartment syndrome (ACS). This is a single-use device.