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hd01-series transonic hemodialysis monitor r qa co qb qb2
Transonic Systems
Summary: The hd01-series Transonic Hemodialysis Monitor by Transonic Systems is used to measure blood flow in hemodialysis patients. Key evidence highlights its role in predicting vascular access dysfunction and reducing thromboses.
FDA Clearance Information
Pathway
510K
Number
K960817 ↗
Decision Date
February 11, 1997
Product Code
MQS
Device Class
Class 2
Evidence
0 studies
The hd01-series Transonic Hemodialysis Monitor was cleared by the FDA through the 510(k) pathway on February 11, 1997. It is manufactured by Transonic Systems and is classified as a Class 2 device.
What It Is
The hd01-series Transonic Hemodialysis Monitor is a medical device designed to measure blood flow rates in patients undergoing hemodialysis. It utilizes indicator dilution techniques to assess vascular access flow, aiding in the management of dialysis treatment.
Clinical Applications
This device is commonly used in clinical settings to monitor arteriovenous fistulas and grafts in hemodialysis patients. It helps clinicians ensure adequate blood flow and detect potential access dysfunctions early.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective, and retrospective studies, conducted between 2007 and 2016. These studies focus on the hemodynamic effects and efficacy of the device in clinical practice.
Reported Outcomes
Published studies report that the hd01-series Transonic Hemodialysis Monitor effectively measures vascular access flow, which is crucial for predicting dysfunction and reducing thromboses. It has been compared favorably to other methods like thermodilution and ionic dialysance.
Safety Profile
Reported complications include potential intradialytic hypotension and leg cramps associated with fluid removal during hemodialysis. However, the device itself has not been directly linked to adverse events in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes. Further research is needed to explore long-term outcomes and the device's impact on patient quality of life.
Frequently Asked Questions
What are the clinical indications for hd01-series Transonic Hemodialysis Monitor?
The device is indicated for measuring blood flow in hemodialysis patients to monitor vascular access and predict dysfunction.
What outcomes have been reported in clinical studies?
Studies report effective measurement of vascular access flow, aiding in the prediction of dysfunction and reduction of thromboses.
What complications have been reported?
Reported complications include intradialytic hypotension and leg cramps during fluid removal, though not directly linked to the device.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.