PALL CORPORATION TNA1 Pall® Total Nutrient Admixture Filter

Aurora Xi Plasmapheresis System Software Version 1.2

The NeXus-10 MKII is designed for medical use, not restricted to a specific medical indication, for acquisition of (electro)-physiological signals (e.g. EEG, EMG or ECG). The product is intended to be used by medical/acces professionals in a laboratory setup or medical office, or to be set-up in such an environment after which the subject/patient can be sent out while signal acquisition continues on memory. The NeXus 10 MKII is not intended for use in diagnosis, nor in critical and/or life supporting applications.The NeXus 10 MKII is intended for use on humans.The NeXus 10 MKII is intended to be used with approved NeXus 10 MKII accessories only. Specifically, (active) sensors intended to measure specific physiological signals, shall be designed in accordance with the specifications of the NeXus-10 MKII and may require interpretation by user or application software.

Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The SafeCT is a software package of a PACS server, which is connected to the clinics' LocalArea Network (LAN), receives, processes and transfers CT images, using the DICOM protocol.The processing enhances image quality by reduction of the image noise.

The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images.The image processing provide enhanced quality by reducing the image noise level.