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 System Overview

- 8 -

Chapter 2 System Overview

NOTE:

The pictures and interfaces in this manual are for reference only.

2.1 Introduction

The system is for in-vitro analysis of whole blood, designed to deliver quantitative results for a

panel of tests. The product consists of an analyzer incorporating a user interface with a large color

touch screen interfacing to the electronic analyzer. The user interface module contains the

analyzer CPU and all of the required electronic interfaces for external communication and data

storage. The product consists of a single-use cartridge into which the sample is introduced. The

cartridge contains electrochemical sensors which generate signals related to concentration levels

in the blood. These concentration levels are displayed on the screen of the analyzer, stored in

memory, and can be transmitted by communication link or Wi-Fi to the Data Management

System (DMS).

The following tables list the parameters that can be determined by the system:

Measured Parameters:

Symbol Description

pH Negative logarithm of the hydrogen ion concentration

pCO

Partial pressure of carbon dioxide

Partial pressure of oxygen

Potassium ion concentration

Sodium ion concentration

Chloride ion concentration

Concentration of ionized calcium

Hct

Hematocrit: the volume occupied by red blood cells in a given volume of whole

blood.