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NOVA BIOMEDICAL Stat Profile PRIME User Manual

NOVA BIOMEDICAL Stat Profile PRIME
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Stat Profile® PRIME™
CCS Analyzer
Instructions for
Use Manual
52920
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NOVA BIOMEDICAL Stat Profile PRIME Specifications

General IconGeneral
TypeBlood Gas Analyzer
DisplayColor touchscreen
Measurement ParameterspH, PCO2, PO2, Na+, K+, Cl-, Glucose, Lactate, Hct
Sample TypeWhole blood, plasma
Sample Volume100 microliters
Analysis TimeApproximately 60 seconds
CalibrationAutomatic
ConnectivityUSB, Ethernet
Power Requirements100-240 VAC, 50/60 Hz
Operating Temperature15-30°C (59-86°F)
Humidity Range10-90% non-condensing

Summary

NOVA BIOMEDICAL SYMBOL DIRECTORY

Preface

Ordering Information

Information on how to order the Stat Profile® PRIME™ CCS Instructions for Use Manual.

Authorized Representative

Contact details for the authorized representative in the European Community.

Trademark and Patents

Information on registered trademarks of Nova Biomedical Corporation.

Copyright

Copyright notice for the Stat Profile® PRIME™ CCS Instructions for Use Manual.

Technical Assistance

Introduction

About This Manual

Explains the manual's purpose, conventions (NOTE, CAUTION, WARNING).

Safety

General safety information and procedures for operating the analyzer.

General Safety

Outlines essential safety precautions for operating the analyzer.

Electrical Safety

Safety guidelines related to the analyzer's electrical components and power supply.

FCC Notice

Compliance statement for Federal Communications Commission rules.

RSS Notice

Compliance statement for Industry Canada licence-exempt RSS standards.

Chemical and Biological Safety

Precautions for handling chemical and biological materials with the analyzer.

Installation and Use

Covers installation requirements and procedures for the analyzer.

Requirements

Details environmental, electrical, and humidity requirements for the analyzer.

Intended Use, Tests Performed, and Clinical Utility

Describes the analyzer's purpose, measured parameters, and clinical applications.

The Sample

Information on sample types, minimum volume, and handling requirements.

Getting Started

Power Up Procedure

Step-by-step guide for powering on the analyzer and its initialization process.

The Home Screen: Ready

Description of the analyzer's main operational screen and its components.

Automatic Calibrations

Explains the analyzer's automated calibration process and its importance.

Sample Analysis

Analyzing Patient Samples

Detailed steps for analyzing patient samples, including login and sample preparation.

Utilizing the Luer Station

Instructions on how to use the Luer station for sample aspiration.

Analyzing Sample from a Blood Collection Tube

Procedure for analyzing samples from standard blood collection tubes.

Analyzing Sample from a Capillary Tube

Procedure for analyzing samples from capillary tubes.

The Sample Results Display

Explanation of how sample results are displayed, including bar graphs.

Analyzing QC and Proficiency Samples

Procedures for running internal and external quality control and proficiency samples.

Consumable Replacements

Scheduled Replacements

Guidance on performing preventive maintenance and scheduled component replacements.

Calibrator Cartridge and Control Cartridge Changing

Detailed steps for replacing the calibrator and control cartridges.

Change Sensor Card

Instructions for replacing the sensor card in the analyzer.

Periodic Replacements

Pump Tubing Replacement

Steps for replacing the pump tubing.

Probe Replacement

Procedure for replacing the analyzer probe or air detector.

Reference Sensor Replacement

Instructions for replacing the reference sensor.

Printer Paper Replacement

Guide for replacing the paper roll in the analyzer's printer.

Safety Sample Port Replacement

Procedure for replacing the safety sample port.

Troubleshooting

Troubleshooting Procedures

General methods and steps to diagnose and resolve analyzer errors.

Error Log

How to access and interpret the analyzer's error logs.

Operator Flow Test

Procedure to verify fluid flow through the system and identify clogs or leaks.

Appendix

Specifications

Technical specifications for the Stat Profile Prime CCS Analyzer, including measurement ranges.

Analytical Specificity

Details on how substances may interfere with test results.

Analytical Performance Studies

Results from studies comparing the analyzer's performance to other models.

Syringe Method Comparison Study Results

Data from method comparison studies using syringe samples.

Precision Study Results

Data on the analyzer's precision and repeatability.

Run-to-Run Precision Performance

Performance data related to precision across multiple runs.

Calibrator Cartridge

Information about the calibrator cartridge, including traceability.

Reference Values

Provides reference values for various analytes measured by the analyzer.

Ordering Information

List of supplies and parts available for order from Nova Biomedical.

Warranty

Details the warranty terms and conditions for the analyzer.

Principles of Measurement

Measured Values

Describes how key parameters like electrolytes and gases are measured.

Calculated Values

Explains the equations used to calculate derived parameters from measured values.

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