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This document provides a premarket notification summary for the Paragon Infusion System with Bolus, including device specifications, intended use, and compliance with FDA regulations.
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How to fill out Paragon Infusion System with Bolus

01
Gather all necessary supplies: Paragon Infusion System, IV solution, and bolus medication.
02
Ensure that the Paragon Infusion System is clean and ready for use.
03
Connect the IV solution bag to the infusion system following the manufacturer's instructions.
04
Prime the IV line to remove any air bubbles.
05
Prepare the bolus medication according to the prescribed dosage.
06
Administer the bolus medication through the designated port of the IV line.
07
Monitor the patient for any immediate reactions or side effects.
08
Adjust the flow rate of the infusion as required after the bolus administration.

Who needs Paragon Infusion System with Bolus?

01
Patients who require continuous medication administration, such as those with chronic illnesses.
02
Individuals who need rapid medication delivery, often in emergency situations.
03
Healthcare facilities and home health care providers that manage infusion therapy.
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The Paragon Infusion System with Bolus is a medical device designed to deliver medications efficiently through infusion, allowing for both calculated continuous delivery and bolus doses as needed.
Healthcare providers and facilities that utilize the Paragon Infusion System with Bolus for patient treatment are required to file relevant documentation to ensure compliance with medical regulations.
To fill out the Paragon Infusion System with Bolus, follow the manufacturer's instructions, which typically include steps for setting dosages, programming bolus parameters, and ensuring proper connections and safety checks.
The purpose of the Paragon Infusion System with Bolus is to provide a reliable method for administering medications via infusion, allowing for controlled and rapid delivery of drugs to patients based on their specific medical needs.
Information that must be reported on the Paragon Infusion System with Bolus includes patient identifiers, medication types, infusion rates, bolus dosages, and any adverse events or incidents related to the infusion process.
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