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5. 510(k) SummaryGemLyte Electrolyte Analyzer(1) Submitted by:
Diamond Diagnostics
333 Fisk St.
Hollis ton, MA 01 746
(2) Contact Person:
Luann Too, Director of Quality Assurance and Scientific Development629
5084290450
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How to fill out electrolyte analyzer
How to fill out an electrolyte analyzer:
01
Ensure that the analyzer is turned on and connected to a power source.
02
Open the analyzer and locate the sample chamber or tray where the electrolyte samples will be placed.
03
Prepare the electrolyte samples according to the manufacturer's instructions. This may involve collecting blood samples, diluting them with a specific reagent, or using pre-packaged electrolyte cartridges.
04
Carefully place the electrolyte samples into the designated slots or chambers of the analyzer, making sure to follow any specific instructions for sample placement.
05
Close the analyzer and initiate the testing process as per the manufacturer's guidelines. This may involve pressing a specific button or starting a software program.
06
Allow the analyzer to analyze the electrolyte samples for the specified amount of time, which can vary depending on the specific analyzer model and manufacturer.
07
Once the analysis is complete, the electrolyte analyzer will provide the results, typically displayed on a screen or printed out. Take note of these results for further analysis or documentation.
Who needs an electrolyte analyzer?
01
Hospitals and medical laboratories: Electrolyte analyzers are commonly used in hospitals and medical laboratories to measure the levels of various electrolytes in blood samples. This information is essential in diagnosing and managing certain medical conditions, such as kidney disorders or electrolyte imbalances.
02
Clinics and healthcare centers: Healthcare facilities that offer on-site blood testing or require quick and accurate analysis of electrolyte levels may benefit from having an electrolyte analyzer.
03
Research institutions: Researchers conducting studies on electrolyte imbalances, new diagnostic techniques, or drug development may use electrolyte analyzers to analyze blood samples in their experiments.
04
Sports and fitness centers: Electrolyte analyzers can also be used by sports and fitness centers to monitor athletes' electrolyte levels and ensure appropriate hydration during intense physical activities.
Overall, electrolyte analyzers play a crucial role in the healthcare industry, research institutions, and fitness centers by providing accurate and timely measurements of electrolyte levels in various samples.
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What is electrolyte analyzer?
An electrolyte analyzer is a medical device used to measure the levels of electrolytes in a patient's blood.
Who is required to file electrolyte analyzer?
Medical professionals such as doctors, nurses, and lab technicians are required to use and file electrolyte analyzer results.
How to fill out electrolyte analyzer?
To fill out an electrolyte analyzer, the operator must follow the manufacturer's instructions for sample collection, analysis, and result interpretation.
What is the purpose of electrolyte analyzer?
The purpose of an electrolyte analyzer is to help diagnose and monitor medical conditions by measuring electrolyte levels in the blood.
What information must be reported on electrolyte analyzer?
The electrolyte levels (sodium, potassium, chloride, etc.) in the patient's blood must be reported on the electrolyte analyzer.
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