User's Manual

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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 Parameters

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each level of materials were analyzed in parallel on the i15 Blood Gas and Chemistry Analysis

System and the Rapidpoint 400 system. Reference materials used were RNA Medical

CVC 9005

Hematocrit Calibration Verification Controls, and they were traceable to NIST standards. In the table

below, Sy.x refers to the standard error of estimate.

Parameter N Slope Intercept

Correlation

Coefficient

Sy.x Range

Hct 15 0.99 0.56 0.99988 0.34811 15.0 – 62.0

In the comparison study, samples were analyzed in parallel on the i15 Blood Gas and Chemistry

Analysis System and the Rapidpoint 400 system. Two replicates of each sample were analyzed

on each system.

Parameter N Slope Intercept

Correlation

Coefficient

Sy.x Range

Hct

215

0.9729 1.0199 0.9932 0.7518 23 - 53

12.8.4 Interfering Substances

The substances interfering with the hematocrit measurement are listed below:

 A significant increase in white blood cell count may increase the hematocrit results.

 Total protein level will increase the hematocrit results.

 Abnormally high lipids may increase the hematocrit results.

 Factors interfering with sodium results will also interfering with hematocrit results.

NOTE:

It is possible that there are other substances interfering with the hematocrit

measurement.