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

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Chapter 1 Safety Guide

1.1 Intended Use

i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer,

Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures blood gases,

blood chemistries, and hematocrit in whole blood samples. The system is intended for use only

by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory

environment, near patient or point-of-care settings. By timely providing test results, the system

helps the medical professionals make faster decisions about patient treatment, and thus improves

the quality of patient care.

1.2 Warnings and Cautions

In order to use the system safely and effectively, and avoid possible dangers caused by improper

operation, please read through the user manual and be sure to be familiar with all functions of the

system and proper operation procedures before use. Always keep this manual with the analyzer.

Please pay attention to the following warning and caution information.

1.2.1 Safety Warnings

NOTE:

The reliability of the analyzer and the safety of operators are considered during product

design and production. The following safety and preventive measures should be carried

out:

WARNING

Safety Warnings

1. The analyzer is not intended for treatment.

2. The analyzer is not intended for home use.

3. Do not use the analyzer if it is damaged or defective.

4. The analyzer should be installed by a qualified service engineer. Do not try to access

the interior of the analyzer. Only authorized service personnel could remove the

analyzer enclosure.

5. To avoid electrical shock, never modify the analyzer’s AC power circuits.