ORTHOMEDFLEX LLC AC-344 OrthoMedFlex

Gri-fill Peristaltic Set is an IV fluid transfer set to be used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one source substance is channeled repeatedly to an IV container. It consists of a silicone tube linking a male luer-lock connector and a spike (with a 0.2 µm hydrophobic air filter), and a female luer-lock connection.

FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (LIC) from MRI images for the full spectrum of R2 and LIC known clinically. It automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo.The software application is intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.FerriSmart is indicated to: • Support clinical diagnoses in individuals with confirmed or suspected liver iron overload; • Assessment of liver iron loading to support the subsequent clinical decision-making for patients under management of diseases such as thalassaemia disorders or hereditary haemochromatosis. • Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver iron concentration, the subsequent clinical decision-making processes for the management of iron overload diseases.

Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.

The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a dialysis center in the monitored areas. It can be used to switch off dialysis water supply systems, dialysis concentrate preparation systems, dialysis concentrate supply systems, booster pump assemblies, and pre-filtration devices that are connected to the central control unit.This device can be used with the AquaA and AquaBplus water purification systems.

The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g. the reverse osmosis water treatment system).The status of a connected device is signaled:– Visually by three indicator lights (green, yellow, and red)– Acoustically by a sound generatorAn acoustic status signal can be muted temporarily at the touch of a button.The signaling device can currently be operated with the following reverse osmosis systems from Fresenius:– AquaA– AquaBplus

The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).