SUNSET HEALTHCARE SOLUTIONS, INC. RES013-10-10 Respiratory Accessory

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 T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.

The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.

Standalone software as medical device (SaMD) designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results. HepaFatSmart is intended for the quantitative evaluation of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and liver steatosis grading.It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.When interpreted by a trained physician, the results provide information that can aid in diagnosis.HepaFatSmart is indicated to:• Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease; • Assessment of liver fat content to support the subsequent clinical decision-making processes for patients under management of diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), viral hepatitis. • Support the subsequent clinical decision-making processes for patients Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision-making processes for the management of fatty liver related diseases.

Precision Thin Offset (10.0 x 0.38 x 43.0mm)

2108 Series Sagittal Blade (28.9 x 0.64 x 58.7mm)

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).

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.

Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of nine (9) plastic tubes (30mL) containing different concentrations of nickel chloride (NiCl2) in agarose. T2CMR Phantom is provided to MRI Centres for the verification of T2-mapping stability across different 1.5T and 3T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T2 standard”.

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 T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.

The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.

Standalone software as medical device (SaMD) designed to automatically analyse within seconds magnetic resonance imaging (MRI) datasets to generate an estimate of the patient’s volumetric liver fat fraction (VLFF), converted into proton density fat fraction (PDFF) and steatosis grade. No user input is required for the analysis thus minimising the impact of human error on obtained results. HepaFatSmart is intended for the quantitative evaluation of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF) and liver steatosis grading.It utilises magnetic resonance images that exploit the difference in resonance frequencies between hydrogen nuclei in water and triglyceride fat. The quantitative triglyceride fat fraction is based on the measurement of a magnetic resonance parameter that reflects the ratio of the proton density signal of triglyceride fat to the total proton density signal in the liver.When interpreted by a trained physician, the results provide information that can aid in diagnosis.HepaFatSmart is indicated to:• Support clinical diagnoses in individuals with confirmed or suspected fatty liver disease; • Assessment of liver fat content to support the subsequent clinical decision-making processes for patients under management of diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), viral hepatitis. • Support the subsequent clinical decision-making processes for patients Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver fat content, the subsequent clinical decision-making processes for the management of fatty liver related diseases.