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 Safety Guide

- 6 -

1.3 Symbols and Definitions

The following symbols will appear on the packaging of the system:

Symbol Description

Caution!

Consult instructions for use

Biological risks

Static electricity sensitive

Recycle

The symbol indicates that the device complies with the European Council

Directive 98/79/EEC concerning medical devices.

On/Off button

Network port

Serial port

USB (Universal Serial Bus) connection

Trademark

Test cartridge insert direction

Calibrant fluid pack chamber door is closed.

Calibrant fluid pack chamber door is open.

In vitro diagnostic device