User's Manual

ManualsBrandsEDAN INSTRUMENTS ManualsElectronicsBlood Gas and Chemistry Analyzer

Table Of Contents

About this Manual
Statement
Responsibility of the Manufacturer
Terms Used in this Manual
Table of Contents
Chapter 1 Safety Guide
- 1.1 Intended Use
- 1.2 Warnings and Cautions
  - 1.2.1 Safety Warnings
  - 1.2.2 Safety Cautions
- 1.3 Symbols and Definitions
Chapter 2 System Overview
- 2.1 Introduction
- 2.2 System Frame
- 2.3 Analyzer Appearance
- 2.4 System Parts
- 2.5 Configuration
  - 2.5.1 Standard Configuration
  - 2.5.2 Options
Chapter 3 Installation Guide
- 3.1 Unpacking Inspection
- 3.2 Installation Requirements
  - 3.2.1 Environmental Requirements
  - 3.2.2 Power Requirements
- 3.3 Setting Up
Chapter 4 Setup
- 4.1 Getting into the Setup Screen
- 4.2 System Setup
- 4.3 Test Setup
Chapter 5 Patient Analyzing
- 5.1 Sample Collection and Preparation
- 5.2 Patient Analyzing
  - 5.2.1 Procedures for Patient Analyzing
  - 5.2.2 Understanding Result Symbols
- 5.3 Patient Sample Database
Chapter 6 Quality Control (QC) Tests
- 6.1 Control Test
- 6.2 Proficiency Test
  - 6.2.1 Procedures for Proficiency Test
  - 6.2.2 Proficiency Database
- 6.3 Simulator Test
  - 6.3.1 Procedures for External Simulator Test
  - 6.3.2 Simulator Database
    - 6.3.2.1 Searching for Simulator Test Data
    - 6.3.2.2 Exporting/Uploading/Printing Simulator Test Data
Chapter 7 Data Management
- 7.1 Introduction
- 7.2 Databases
Chapter 8 Online Update
- 8.1 Introduction
- 8.2 Procedures for Online Update
Chapter 9 Troubleshooting
Chapter 10 Cleaning, Care and Maintenance
- 10.1 Cleaning and Disinfecting the Analyzer
- 10.2 Care and Maintenance
Chapter 11 Theory
- 11.1 Measurement Method
- 11.2 Determination of Test Results
  - 11.2.1 Determination of the Analyte Concentration
  - 11.2.2 Determination of Cell Concentration
- 11.3 Equations for Calculated Parameters
Chapter 12 Parameters
- 12.1 pH
- 12.2 pCO2
- 12.3 pO2
- 12.4 Sodium (Na+)
- 12.5 Potassium (K+)
- 12.6 Ionized Calcium (Ca++)
- 12.7 Chloride (Cl-)
- 12.8 Hematocrit (Hct)
Chapter 13 Warranty and Service
- 13.1 Warranty
- 13.2 Contact Information
Appendix 1 Specifications
- A1.1 Environment Requirements
- A1.2 Analyzer Specifications
- A1.3 Performance Specifications
- A1.4 Printer
- A1.5 Rechargeable Battery
- A1.6 Safety Specifications
Appendix 2 Measurement Ranges
- A2.1 Measurement Ranges for Measured Parameters
- A2.2 Measurement Ranges for Calculated Parameters
Appendix 3 Reference Ranges
Appendix 4 EMC Information
Appendix 5 FCC Information
- A5.1 FCC Statement
- A5.2 FCC RF Radiation Exposure Statement
Appendix 6 Order List

i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests

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Chapter 6 Quality Control (QC) Tests

Quality Control (QC) tests could ensure the normal operation of the system and the reliability of

test results. Policies related to the measurement of QC samples are at the discretion of your

individual institution. It is recommended to perform QC tests in the following situations:

 You are using the system for the first time.

 You wish to verify the performance of newly received test cartridges.

 You wish to verify the storage condition of test cartridges.

 You wish to verify the performance of the system.

 You doubt test results.

Figure 6-1 Quality Control Screen

6.1 Control Test

Control tests are intended to verify the efficient performance of the system. To verify the

performance of each lot of newly received test cartridges, analyze at least two levels of controls

in duplicate using a verified analyzer.

6.1.1 Controls

Controls are intended for use to monitor test cartridge performance at multiple points within the

clinical range. Controls used are RNA Medical

QC823 Blood

Gas●Electrolyte●Metabolite●BUN controls and RNA Medical

QC900 Hematocrit controls. The

concentrations of reactive ingredients in various levels of controls are known. Controls do not

contain human serum or serum products, but do contain buffers and preservatives. Acceptable