82-01.54.455691-1.6 I15 Blood Gas and Chemistry Analysis System User Manual-ES

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文件名称(Document Name)：i15 Blood Gas and Chemistry Analysis System

User Manual，英文，EDAN
文件编号(Number)：01.54.455691
版本(Version)：1.6
产品型号(Product Model)：i15
项目编码(Project Code)：3300L-1000
签批信息(Signature):
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作者(Originator) : 龚, 静 (gongjing) 2015-11-12 16:36:34
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审核人(Reviewers) : 谢, 瑛瑛 (xieyingying) 2015-11-13 19:14:35
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审核人(Reviewers) : 师, 红霞 (shihongxia) 2015-11-16 08:59:47
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审核人(Reviewers) : 李, 国霞 (liguoxia) 2015-11-16 16:10:05
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批准人(Approvers) : 陈, 沁 (chenqin) 2015-11-16 18:00:02

批准人(Approvers) : 陈, 浩杰 (chenhaojie) 2015-11-16 17:39:48
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版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

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About this Manual
P/N: 01.54.455691
MPN: 01.54.455691016
Release Date: Jan., 2015
© Copyright EDAN INSTRUMENTS, INC. 2013-2015. All rights reserved
Statement
This manual will help you to better understand the operation and maintenance of the product. It
is reminded that the product should be used strictly in compliance with this manual. User
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operation failing to comply with this manual may result in malfunction or accident for which
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EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
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EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
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languages.
Materials protected by the copyright law, including but not limited to confidential information
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such as technical information and patent information contained in this manual, shall not be
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disclosed to any irrelevant third party.

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The user shall understand that nothing in this manual grants him, expressly or implicitly, any
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right or license to use any of the intellectual properties of EDAN.

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EDAN holds the rights to modify, update, and ultimately explain this manual.
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Responsibility of the Manufacturer

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EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

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persons authorized by EDAN, and
The electrical installation of the relevant environment complies with national standards, and
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The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
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information to help qualified technicians maintain and repair some parts, which EDAN may
configure as user serviceable.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
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A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
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NOTE
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A NOTE provides useful information regarding a function or a procedure.
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i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide
Table of Contents
Chapter 1 Safety Guide ........................................................................................................ 7
1.1 Indications for Use/Intended Use .............................................................................. 7
1.2 Warnings and Cautions.............................................................................................. 7
1.2.1 Safety Warnings ............................................................................................. 7
1.2.2 Safety Cautions ............................................................................................ 11
1.3 Symbols and Definitions ......................................................................................... 12
Chapter 2 System Overview ............................................................................................... 15
2.1 Introduction ............................................................................................................. 15
2.2 System Frame .......................................................................................................... 17
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2.3 Analyzer Appearance .............................................................................................. 19
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2.4 System Parts ............................................................................................................ 20
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2.4.1 Thermal Printer ............................................................................................ 20
2.4.2 Test Cartridge ............................................................................................... 20
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2.4.3 Power Indicator ............................................................................................ 23
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2.4.4 LCD Screen and Touch Screen .................................................................... 23
2.4.5 I/O Ports ....................................................................................................... 23
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2.4.6 On/Off Button .............................................................................................. 24
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2.4.7 Calibrant Fluid Pack..................................................................................... 24

2.4.8 Bar Code Scanner ......................................................................................... 26
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2.4.9 Exhaust Fan .................................................................................................. 27

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2.4.10 Electronic Simulator................................................................................... 27

2.4.11 Peripherics .................................................................................................. 28
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2.5 Configuration .......................................................................................................... 28

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2.5.1 Standard Configuration ................................................................................ 28

2.5.2 Options ......................................................................................................... 29
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Chapter 3 Installation Guide.............................................................................................. 30

3.1 Unpacking Inspection.............................................................................................. 30
3.2 Installation Requirements........................................................................................ 30
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3.2.1 Environmental Requirements ....................................................................... 30

3.2.2 Power Requirements .................................................................................... 31
3.3 Setting Up ............................................................................................................... 31
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3.3.1 Connecting to AC Power .............................................................................. 31

3.3.2 Installing the Battery .................................................................................... 31
3.3.3 Installing the Printer Paper ........................................................................... 33
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3.3.4 Turning On/Off the Analyzer ....................................................................... 34

3.3.5 User Login and Logout ................................................................................ 35
3.3.6 Setting the Date and Time ............................................................................ 36
3.3.7 Viewing Training Videos .............................................................................. 36
3.3.8 Replacing a Calibrant Fluid Pack ................................................................. 37
3.3.9 DEMO Test .................................................................................................. 41
3.3.10 Connecting Peripherics .............................................................................. 44
Chapter 4 Setup ................................................................................................................... 47
4.1 Getting into the Setup Screen .................................................................................. 47
4.2 System Setup ........................................................................................................... 48
4.2.1 Printer Setup ................................................................................................. 48
4.2.2 Network Setup .............................................................................................. 50
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4.2.3 Date & Language Setup ............................................................................... 53
4.2.4 Backlight & Volume Setup ........................................................................... 53
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4.2.5 Diagnostics ................................................................................................... 54
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4.2.6 About the Analyzer ....................................................................................... 55
4.3 Test Setup ................................................................................................................ 55
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4.3.1 QC Lockout Setup ........................................................................................ 56
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4.3.2 Patient Information Setup ............................................................................ 56
4.3.3 Reference Ranges Setup ............................................................................... 60
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4.3.4 Units Setup ................................................................................................... 61
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4.3.5 Correlation Factors Setup............................................................................. 63

4.3.6 Internal Simulator Setup .............................................................................. 63
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4.3.8 Calibration Setup.......................................................................................... 64

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Chapter 5 Patient Analyzing .............................................................................................. 65

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5.1 Sample Collection and Preparation ......................................................................... 65

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5.1.1 Sample Collection ........................................................................................ 65

5.1.2 Anticoagulants .............................................................................................. 65
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5.1.3 Collection Devices and Volume ................................................................... 66

5.1.4 Notes ............................................................................................................ 66
5.2 Patient Analyzing .................................................................................................... 67
5.2.1 Procedures for Patient Analyzing ................................................................. 67
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5.2.2 Understanding Result Symbols .................................................................... 75

5.3 Patient Sample Database ......................................................................................... 76
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5.3.1 Searching for Patient Sample Data .............................................................. 77

5.3.2 Viewing Details of Patient Sample Data ...................................................... 78
5.3.3 Editing Patient Information Data ................................................................. 79
5.3.4 Exporting/Uploading/Printing Patient Sample Data .................................... 80
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Chapter 6 Quality Control (QC) Tests .............................................................................. 81

6.1 Control Test ............................................................................................................. 81
6.1.1 Controls ........................................................................................................ 81
6.1.2 Procedures for Control Test.......................................................................... 83
6.1.3 Temperature Correction for pO2 and pCO2 .................................................. 90
6.1.4 Control Database .......................................................................................... 90
6.2 Proficiency Test ....................................................................................................... 94
6.2.1 Procedures for Proficiency Test ................................................................... 94
6.2.2 Proficiency Database .................................................................................. 101
6.3 Calibration Verification Test ................................................................................. 103
6.3.1 Calibration Verification Controls ............................................................... 103
6.3.2 Procedures for Calibration Verification Test .............................................. 104
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6.3.3 Calibration Verification Database .............................................................. 112
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6.4 Simulator Test ....................................................................................................... 115
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6.4.1 Procedures for External Simulator Test ..................................................... 115
6.4.2 Simulator Database .................................................................................... 117
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Chapter 7 Data Management ........................................................................................... 121
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7.1 Introduction ........................................................................................................... 121
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7.2 Databases............................................................................................................... 121
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7.2.1 Security Database ....................................................................................... 122

7.2.2 Diagnosis Database .................................................................................... 126
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7.2.3 Events Log Database .................................................................................. 126

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7.2.4 Backup ....................................................................................................... 129

Chapter 8 Troubleshooting ............................................................................................... 130
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Chapter 9 Cleaning, Care and Maintenance .................................................................. 134

9.1 Cleaning and Disinfecting the Analyzer ............................................................... 134
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9.1.1 Cleaning and Disinfecting the Exterior Surfaces ....................................... 134

9.1.2 Cleaning and Disinfecting the Screen ........................................................ 135
9.1.3 Cleaning the Printer Head .......................................................................... 137
9.2 Care and Maintenance ........................................................................................... 137
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9.2.1 Recharging and Replacement of Battery.................................................... 137

9.2.2 Printer Paper ............................................................................................... 139
9.2.3 Maintenance of the Analyzer ..................................................................... 139
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Chapter 10 Theory ............................................................................................................ 140

10.1 Measurement Method.......................................................................................... 140
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10.2 Determination of Test Results ............................................................................. 141

10.2.1 Determination of the Analyte Concentration ........................................... 141
10.2.2 Determination of Cell Concentration ....................................................... 142
10.3 Equations for Calculated Parameters .................................................................. 142
Chapter 11 Parameters ..................................................................................................... 146
11.1 pH ........................................................................................................................ 146
11.1.1 Intended Use ............................................................................................. 146
11.1.2 Traceability ............................................................................................... 146
11.1.3 Temperature Correction ............................................................................ 146
11.1.4 Performance Characteristics ..................................................................... 147
11.1.5 Interfering Substances .............................................................................. 148
11.2 pCO2 .................................................................................................................... 148
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11.2.1 Intended Use ............................................................................................. 148
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11.2.2 Traceability ............................................................................................... 149
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11.3 pO2 ....................................................................................................................... 151
11.3.1 Intended Use ............................................................................................. 151
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11.3.2 Traceability ............................................................................................... 151
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11.4 Sodium (Na+)....................................................................................................... 153

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11.4.1 Intended Use ............................................................................................. 153

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11.4.2 Traceability ............................................................................................... 153

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11.5 Potassium (K+) .................................................................................................... 155
11.5.1 Intended Use ............................................................................................. 156
11.5.2 Traceability ............................................................................................... 156
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11.6 Ionized Calcium (Ca++) ....................................................................................... 158
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11.6.1 Intended Use ............................................................................................. 158

11.6.2 Traceability ............................................................................................... 158
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11.7 Chloride (Cl-)....................................................................................................... 160

11.7.1 Intended Use ............................................................................................. 160
11.7.2 Traceability ............................................................................................... 160
11.8 Hematocrit (Hct) ................................................................................................. 162
11.8.1 Intended Use ............................................................................................. 162
11.8.2 Traceability ............................................................................................... 162
11.9 Glucose (Glu) ...................................................................................................... 164
11.9.1 Intended Use ............................................................................................. 164
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11.9.2 Traceability ............................................................................................... 164
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11.10 Lactate (Lac) ..................................................................................................... 167
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11.10.1 Intended Use ........................................................................................... 167
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11.10.2 Traceability ............................................................................................. 167
11.10.3 Performance Characteristics ................................................................... 167
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11.10.4 Interfering Substances ............................................................................ 169
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Chapter 12 Warranty and Service ................................................................................... 170

12.1 Warranty .............................................................................................................. 170
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12.2 Contact Information ............................................................................................ 170

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Appendix 1 Specifications ................................................................................................ 171

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A1.1 Environment Requirements ................................................................................ 171

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A1.2 Analyzer Specifications ...................................................................................... 172

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A1.3 Performance Specifications ................................................................................ 172

A1.4 Printer ................................................................................................................. 172
A1.5 Rechargeable Battery ......................................................................................... 172
A1.6 Safety Specifications .......................................................................................... 173
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Appendix 2 Measurement Ranges ................................................................................... 174

A2.1 Measurement Ranges for Measured Parameters ................................................ 174
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A2.2 Measurement Ranges for Calculated Parameters ............................................... 174

Appendix 3 Reference Ranges.......................................................................................... 176
Appendix 4 EMC Information ......................................................................................... 177
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Appendix 5 FCC Information .......................................................................................... 180

A5.1 FCC Statement ................................................................................................... 180
A5.2 FCC RF Radiation Exposure Statement ............................................................. 180
Appendix 6 HIS/LIS Interface Guide.............................................................................. 181
A6.1 Principle ............................................................................................................. 181
A6.1.1 Communication Design ........................................................................... 181
A6.1.2 Data Transmission ................................................................................... 181
A6.1.3 HL7 Lower Layer Protocol (MLLP) ....................................................... 182
A6.1.4 Message Encoding Types ........................................................................ 182
A6.2 HL7 Messages .................................................................................................... 183
A6.2.1 Message Syntax ....................................................................................... 183
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A6.2.2 Supporting Message Types ...................................................................... 183
A6.2.3 ACK Messages ........................................................................................ 183
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A6.2.4 Report Transmission................................................................................ 184
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A6.3 Appendix ............................................................................................................ 185
A6.3.1 Message Segment .................................................................................... 185
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A6.3.2 Examples ......................................................................................... 195
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Chapter 1 Safety Guide

1.1 Indications for Use/Intended Use
The 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 pH
and blood gases (PCO2, PO2), electrolytes (Na+, K+, Ca++, Cl-) and hematocrit in whole blood
samples. The system is intended for in-vitro diagnostic use only by trained health care
professionals in a laboratory environment, near patient or point-of-care settings.
1.2 Warnings and Cautions
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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
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system and proper operation procedures before use. Always keep this manual with the analyzer.
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Please pay attention to the following warning and caution information.
1.2.1 Safety Warnings

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NOTE:
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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
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out:
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WARNING
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Safety Warnings
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1. The analyzer is not intended for treatment.

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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
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the interior of the analyzer. Only authorized service personnel could remove the
analyzer enclosure.
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5. To avoid electrical shock, never modify the analyzer’s AC power circuits.
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WARNING
6. The analyzer is intended for use only by trained technologists, nurses, physicians
and therapists. Operators should be familiar with the contents of this user manual
before operation.
7. The results given by the system should be examined based on the overall clinical
condition of the patient, and should not be a substitute for regular checking.
8. To ensure grounding reliability, only connect the system to a hospital-grade power

receptacle.
9. DO not position the analyzer so that it is difficult to disconnect the AC plug.
10. Connect the analyzer to a grounded socket and make certain that the mains supply
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meets the requirements specified in the user manual.
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11. Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system.
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12. SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet
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hands. Make certain that your hands are clean and dry before touching a power cord.
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13. If you have any questions about the power adaptor or the power cord, use the battery
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but not the AC power supply. Prior to using AC power supply, inspection of the power
adaptor and the power cord is recommended. If it is necessary, consult EDAN or its
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authorized distributors for service.

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14. The analyzer is not waterproof. Do not use it in locations where water or any liquid
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leakage may occur.

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15. Do not cast any fluid onto the system surface, as fluid seepage into the electrical
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circuitry may cause excessive leakage current or system failure.
16. Do not spray cleaning fluids on the system, as this may force cleaning fluid into the
system and damage electronic components. It is also possible for solvent fumes to
build up and form flammable gases or damage internal components.
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17. To avoid the possibility of electrostatic shock and damage to the system, avoid using
aerosol spray cleansers on the analyzer screen.
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18. EXPLOSION HAZARD – The analyzer is not suitable for use in the presence of a
flammable anesthetic mixture with oxygen or other flammable compounds.
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WARNING
19. To avoid electrical shock, never use the system in altitude exceeding 3,000 meters
above sea level.
20. LASER RADIATION – The bar code scanner is a Class 1M laser product. Do not
view directly with optical instruments.
21. Periodically have the safety of the system checked by a qualified service engineer.
22. Only accessories supplied or recommended by the manufacturer should be used.
Otherwise, performance and electric shock protection can not be guaranteed.
23. Blood samples should be collected according to proper medical guidelines which
contains collection details, such as site selection, collection procedures, sample
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handling, etc. Sterile techniques should be followed to prevent the site from being
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contaminated. 文
24. Handle blood samples and collection devices with care, and wear approved
protective gloves to avoid direct contact with samples.
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25. To avoid electrical shock and damage to the system, turn off the analyzer and
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disconnect the analyzer from the AC power source before cleaning and disinfecting.
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26. To avoid the airinlet and airoutlet of the fan being blocked by foreign matters, check
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them regularly. Keep the exhuast opening away from the wall or similar items that can
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block it. Always use the system in a room with good ventilation.
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27. To avoid being injured, never touch the stitch of a calibrant fluid pack.
28. To avoid being hurt, never look into the scanner beam light.
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29. The system is for in vitro diagnostic use only.

30. Perform quality control (QC) tests regularly to make certain that the system works
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smoothly.
31. The disposable test cartridges should only be used a single time.
32. Never replace a calibrant fluid pack when the analyzer is off.
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33. A calibrant fluid pack is intended for single use only. If a calibrant fluid pack is
removed from the system, it can not be inserted into the system again.
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34. The sample is contained in the test cartridge, so test cartridges should be
disposed of as biohazardous waste, complying with local regulatory guidelines.
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WARNING
35. Never use an external electronic simulator under electromagnetic environment,

and never touch it by hand during an external simulator test.
36. Do not use the analyzer after its life cycle, and it should be disposed of according to
local regulations after its life cycle.
Battery Care
37. Improper operation may cause the lithium battery (hereinafter called battery) to be
hot, ignited or explode, and it may lead to the declination of the battery capacity. It is
necessary to read the user manual carefully and pay attention to warning messages.
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38. The battery of the same model and specifications provided by the manufacturer
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should be used.
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39. Danger of explosion - Do not reverse the anode and the cathode when installing the
battery.
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40. Do not heat or splash the battery or throw it into fire or water.
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41. Do not crack or pick the battery.
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42. When there is leakage or a foul smell, stop using the battery immediately. If your skin
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or clothes come into contact with the leakage liquid, cleanse it with clean water at
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once. If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them
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with clean water first and seek medical assistance immediately.

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43. The analyzer and accessories are to be disposed of according to local regulations
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after their useful lives. Alternatively, they can be returned to the dealer or the
manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do not
dispose of them together with house-hold garbage. At the end of their lives hand the
batteries over to the applicable collection points for the recycling of waste batteries.
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For more detailed information about recycling of this product or the battery, please
contact your local Civic Office, or the shop where you purchased the product.
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44. Remove the battery from the analyzer when the analyzer is not used for a long time.
45. If the battery is stored alone and not used for a long time, we recommend that the
battery should be charged at least once every 6 months to prevent overdischarge.
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1.2.2 Safety Cautions
CAUTION
1. Do not use the analyzer in a dusty environment with bad ventilation or in the
presence of corrosives.
2. To avoid misdiagnosis, make sure that the time and date of the system are correct.
3. The system is only intended to analyze whole blood samples. Never use it to analyze
serum or plasma.
4. If there are clots or bubbles in the blood sample, discard it and collect samples again.
5. Perform the sample test immediately after its collection to get the most accurate
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results. Measure samples for blood gases and Ca++ within 10 minutes, and measure
samples for other analytes within 30 minutes.
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6. Transport, store and use the analyzer, test cartridges, calibrant fluid packs and
quality control (QC) materials according to the user manual.
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7. Never perform any rude operation, such as rudely inserting/removing test
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cartridges/calibrant fluid packs.
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8. Only those accessories (such as test cartridges, calibrant fluid packs, quality control
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(QC) materials, etc) supplied by EDAN or its authorized distributors should be used.
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9. Connect the analyzer with those peripherics recommended by EDAN.

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10. Maintain the system as described in the user manual to avoid potential damage.
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11. Do not clean the analyzer and accessories with abrasive fabric.
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12. Do not immerse the analyzer into liquid under any circumstances.
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13. Make sure that there is no intense electromagnetic interference source around the
analyzer, such as radio transmitters, mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment is likely to bring electromagnetic
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interference.
14. Extreme humidity may affect test results. A relative humidity greater than 80% may
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cause inaccurate results.
15. Use this system at a temperature between 10 °C and 31 °C. Outside this range, the
system may produce inaccurate results.
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1.3 Symbols and Definitions
The following symbols will appear on the packaging of the system:
No. Symbol Description

1. Caution! Chapter 1.2.1 of this user manual must
be consulted where this symbol is used on the
product in order to find out the nature of the
potential HAZARD and any actions which have
to be taken.
2.
Consult instructions for use
3. Biohazard
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(Background colour-yellow; symbol and
outline-black)
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4.
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5.
Recycle
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6. The symbol indicates that the device complies

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with the European Council Directive
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98/79/EEC concerning medical devices.

7. This device complies with Part 15 of the FCC
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Rules. Operation conditions: (1) this device

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may not cause harmful interference, and (2) this

device must accept any interference received,
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including interference that may cause undesired

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operation.
8. Conforms to UL Std. 61010-1, IEC Std.
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61010-2-010, 61010-2-081, 61010-2-101

Certified to CSA Std. 61010-1, IEC Std.
61010-2-010, 61010-2-081, 61010-2-101
9.
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On/Off button
10.
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Network port
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11.
Serial port
12.
USB (Universal Serial Bus) connection
13.
Trademark
14.
Test cartridge insert direction
15.
Calibrant fluid pack chamber door is closed.
16.
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Calibrant fluid pack chamber door is open.
17.
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文 In vitro diagnostic device
18. Indicates that the device should be sent to
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special agencies according to local regulations
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for separate collection after its useful life.
19. Authorized representative in the European
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Community
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20.
Manufacturer
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21.
Date of manufacture
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22.
Temperature limitations
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23.
Do not reuse
24.
Use by
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25.
Contains sufficient for (n) tests
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26.
Control
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27.
Serial number
28.
Batch code
29. Caution: Federal (U.S.) Law restricts this

device to sale by or on the order of a physician.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
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
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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
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in the blood. These concentration levels are displayed on the screen of the analyzer, stored in
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memory, and can be transmitted by communication link or Wi-Fi to the Data Management
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System (DMS) or HIS/LIS.
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The following tables list the parameters that can be determined by the system:
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Measured Parameters:
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Symbol Description
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pH Negative logarithm of the hydrogen ion concentration

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pCO2 Partial pressure of carbon dioxide

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pO2 Partial pressure of oxygen
K+
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Potassium ion concentration
Na+ Sodium ion concentration
Cl- Chloride ion concentration

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Ca++ Concentration of ionized calcium
Hematocrit: the volume occupied by red blood cells in a given volume of whole
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Hct
blood.
Glu Glucose concentration
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Lac Lactate concentration
Calculated Parameters:
Symbol Description
cH+ Hydrogen ion concentration
cH+ (T) Hydrogen ion concentration corrected for entered patient temperature
pH (T) pH value corrected for entered patient temperature
pCO2 (T) pCO2 corrected for entered patient temperature
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pO2 (T) pO2 corrected for entered patient temperature
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HCO3-act Bicarbonate ion concentration
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HCO3-std Bicarbonate ion concentration normalized to a pCO2 of 40mmHg
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BB (B) Buffer base
BE (B) Base excess (B)

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BE (ecf) Base excess (ecf)

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ctCO2 Total carbon dioxide

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Ca++ (7.4) The ionized calcium concentration of blood normalized to pH 7.4

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An approximation of the difference between measured cations and measured

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AnGap
anions in the sample
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tHb (est) An estimation of the hemoglobin contained in the sample
An estimation of hemoglobin oxygen saturation: a ratio of the amount of

sO2 (est) hemoglobin bound to oxygen to the total amount of hemoglobin able to bind
AN
oxygen
pO2 (A-a) Alveolar-arterial oxygen tension difference

ED
Alveolar-arterial oxygen tension difference corrected for entered patient

pO2 (A-a) (T)
temperature
- 16 -
pO2 (a/A) Arterial-alveolar oxygen tension ratio
pO2 (a/A) (T) Arterial-alveolar oxygen tension ratio corrected for entered patient temperature
Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure

RI
difference to arterial pO2
Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure

RI (T) difference to arterial pO2 when both values are corrected for patient
temperature
pO2/FIO2 The ratio of arterial pO2 to the fraction of inspired oxygen
The ratio of arterial pO2 to the fraction of inspired oxygen corrected for the
件
pO2 (T)/FIO2
entered patient temperature
AL
mOsm Milliosmole
文
Configuration: main unit, printer, scanner, and simulator.
TI
密
2.2 System Frame
EN
Blood Gas and Hospital /Laboratory
保
Chemistry Information System

Data Management
Analyzer (HIS/ LIS)
ID
System (DMS)
邦
 Blood Gas and Chemistry Analyzer

NF
The Blood Gas and Chemistry Analyzer is an electronic instrument which is used to analyze
理
whole blood samples (measuring blood gases, electrolytes, metabolites, and hematocrit). The
CO
analyzer can:
 Scan bar codes of test cartridges, calibrant fluid packs, controls, calibration verification
controls, patient and operator ID, etc.
AN
 Identify the types of test cartridges.
 Control the flow of fluids.

ED
 Maintain sample temperature at 37 C.
 Measure the ambient barometric pressure and ambient temperature.
- 17 -
 Measure electrical signals generated by chemical sensors and biosensors.
 Analyze and display the concentrations of analytes in whole blood samples.
 Transmit test results to the Data Management System (DMS) or HIS/LIS.
 Store all kinds of test results and data, such as patient sample results, control test results,
proficiency test results, calibration verification test results, simulator test results, etc.
 Animatedly demonstrate the operating process.
 Data Management System (DMS)
DMS refers to a computer which is loaded with the data management system software. With
the DMS, you can:
件
 Enter test application data.
AL
文
 Edit patient information, view, check and print test results.
 View, check and print quality control (QC) test results.
TI
密
 Search for patient test results by patient name, patient ID, date and time, department, etc.
EN
 Calculate the amount of work of a physician, the results for a parameter of a patient
保
during a period, the test times and the fee of a parameter, and print the statistics results.
ID
 Set the following items: tester, department, sample status, printing, bar code, etc.
邦
 Backup and restore data, view logs.

NF
 View data for instrument diagnosis.

理
 Import patient information from HIS/LIS, and transmit data to it.

CO
 Manage up to 20 analyzers simultaneously, storing test results transmitted by analyzers.
NOTE:
Sample ID on analyzers connected to the same DMS should be different.

AN
 HIS/LIS
ED
HIS/LIS transmits patient information to the DMS, and receives data from both the analyzer
and the DMS.
- 18 -
2.3 Analyzer Appearance Test

Cartridge
Port
Test
Thermal
Cartridge
Printer
Ejector Cap
LCD
Screen
I/O
Ports
件
AL
文 Power
Indicator
On/Off
Button
TI
密
EN
Calibrant
保
Fluid Pack
Chamber
ID
Lock
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Bar Code
Scanner
NF
Exhaust
理
Fan
Calibrant
CO
Fluid Pack Handle

Ejector
Calibrant
Fluid Pack
AN
Chamber
ED
- 19 -
Battery
Compartment
件
AL
文
Figure 2-1 Analyzer Major Components
TI
密
2.4 System Parts

EN
保
2.4.1 Thermal Printer

ID
The thermal printer is located at the upper left top of the analyzer. It can print patient sample test
邦
results, quality control (QC) test results, calibration results, etc.

NF
2.4.2 Test Cartridge

理
Next to the thermal printer is the test cartridge port. A test cartridge is inserted into the analyzer
CO
through the test cartridge port. An indicator is located inside the test cartridge port. If the test
cartridge is inserted properly, the indicator will turn green. If not, the indicator will turn red, and
the system will prompt you. If you want to perform an external electronic simulator test, you also
need to insert the simulator into the test cartridge port.
AN
The unit-use test cartridge is intended to be used together with the analyzer. The fluidic chamber
on the test cartridge is used to hold used calibrants and sample fluids. The sensors on the test
cartridge can generate electrical signals that can be measured by the analyzer. The sample fillport
ED
is used to connect the syringe/capillary tube for automatically aspirating samples. Test cartridges
are available in different configurations concerning the type of parameters reported by them. For
details, please refer to the table below.
- 20 -
Fillport
Fluidic
Chamber
Sensor
Arrays
Electrical
Contacts
Figure 2-2 Test Cartridge

Table 2-1 Test Cartridge Types
件
Cartridge Measured Parameters
Calculated Parameters
AL
Type
cH+, HCO3-act, HCO3-std, BE(ecf), BE(B), BB(B), ctCO2,
pH, pCO2, pO2, Na+, K+,
文
sO2(est), Ca++(7.4), AnGap, tHb(est), pO2(A-a), pO2(a/A),
BG10
Cl-, Ca++, Glu, Lac, Hct RI, pO2/FIO2, cH+(T), pH(T), pCO2(T), pO2(T),
TI
pO2(A-a)(T), pO2(a/A)(T), RI(T), pO2(T)/FIO2, mOsm
密
pH, pCO2, pO2, Na+, K+, sO2(est), Ca++(7.4), AnGap, tHb(est), pO2(A-a), pO2(a/A),
EN
BG9
Cl-, Ca++, Glu, Hct RI, pO2/FIO2, cH+(T), pH(T), pCO2(T), pO2(T),
保

ID
pH, pCO2, pO2, Na+, K+, sO2(est), Ca++(7.4), AnGap, tHb(est), pO2(A-a), pO2(a/A),
邦
BG8
Cl-, Ca++, Hct RI, pO2/FIO2, cH+(T), pH(T), pCO2(T), pO2(T),
NF

理
pH, pCO2, pO2, Lac sO2(est), pO2(A-a), pO2(a/A), RI, pO2/FIO2, cH+(T),
BG4
pH(T), pCO2(T), pO2(T), pO2(A-a)(T), pO2(a/A)(T),
CO
RI(T), pO2(T)/FIO2
sO2(est), pO2(A-a), pO2(a/A), RI, pO2/FIO2, cH+(T),
BG3 pH, pCO2, pO2
pH(T), pCO2(T), pO2(T), pO2(A-a)(T), pO2(a/A)(T),
AN
RI(T), pO2(T)/FIO2
BC4 Na+, K+, Cl-, Ca++, Hct tHb(est), mOsm

ED
Packaging
1. The type of the cartridge is labeled on the test cartridge.
- 21 -
2. Each test cartridge is sealed in a foil pouch containing a strip of desiccant.
3. The bar code on the foil pouch contains information such as the cartridge type, lot number
and expiration date, etc.
4. 25 test cartridges are packaged per box, and 4 boxes are packaged into a shipping carton.
Shipping Control
Test cartridge shipping cartons include one temperature monitor, which turns gray when the
shipping temperature is outside the specified range.
Temperature Monitor
件
AL
文
TI
密
EN
Figure 2-3 Test Cartridge Shipping Carton
保
The temperature monitor should be checked when test cartridges are received to verify that the
ID
temperature limits were not exceeded during shipment. If the temperature monitor turns gray,
邦
perform control tests (analyze at least two levels of controls in duplicates) with the received test
cartridges. If test cartridges pass the tests, they can be used. If test cartridges fail the tests, do not
NF
use them, and contact EDAN immediately for exchange of the test cartridges.
理
NOTE:
CO
Never use test cartridges failing control tests.
Storage
Test cartridges room temperature should be stored at 4 – 30 °C (39 – 86°F).

AN
Test cartridges refregirated storage should be stored at 2 - 8°C (35.6-46.4°F) (avoid freezing).
Disposal
ED
The sample is contained in the test cartridge, so test cartridges should be disposed of as
biohazardous waste, complying with local regulatory guidelines.
- 22 -
NOTE:
 If the pouch has been damaged, the test cartridge should not be used.
 Only test cartridges provided by EDAN or its authorized distributors should be used.
 Only test cartridges properly stored should be used.
 Never reuse test cartridges.

 Never touch the fillport or electrical contacts of a test cartridge.
 Use test cartridges before the expiration date as labeled on the package, and use
them immediately after removing them from their pouches.
 Test cartridges should be kept out of direct sunlight and heat.
件
 The analyzer, test cartridges and the testing environment should be at the same
temperature prior to a test.
AL
 Test cartridges should not be dropped or stressed.
文
2.4.3 Power Indicator
TI
密
The power indicator is on the lower left bottom of the analyzer. During the operation you can see
one of the following:
EN
保
 Green Light: The analyzer is on and the power supply is normal. The analyzer can be
powered either by the rechargeable lithium battery or AC power. Or the system is off and has
ID
been connected to AC power.

邦
 Blinking Yellow Light: The power is supplied by the rechargeable lithium battery and the
NF
battery is low.
理
 Yellow Light: The rechargeable lithium battery is being charged.

CO
2.4.4 LCD Screen and Touch Screen

The activities of the analyzer are communicated to you through the LCD screen, displaying the
analyzer activities, test results, database information, prompts, etc. You communicate with the
AN
analyzer through the touch screen which allows you to perform tests, make selections, enter data,
and view information, etc.
ED
2.4.5 I/O Ports

On the left side of the analyzer are I/O ports:
- 23 -
USB Interfaces (4): allow you to connect your analyzer with peripherics such
as scanners, printers, etc.
Serial Port: allows engineers from the factory to perform debugging.
Network Port: allows network connection to the DMS or HIS/LIS.
2.4.6 On/Off Button
The On/Off button is on the left side of the analyzer.
2.4.7 Calibrant Fluid Pack
件
The calibrant fluid pack chamber is on the right side of the analyzer. You can install the calibrant
AL
fluid pack in it for sensor calibration. The calibrant fluid pack ejector beside the door is used to
文
open the chamber door. On the calibrant fluid pack ejector is a calibrant fluid pack chamber lock
to help users close the calibrant fluid chamber door securely.
TI
密
A calibrant fluid pack containing calibrant solutions is intended to be used together with the
analyzer to perform one-point sensor calibration. Calibrant fluid packs are available for 100 and
EN
200 sampling operations. Contact EDAN or its authorized distributors to order calibrant fluid
保
packs for your system.

ID
邦
NF
理
CO
AN
Figure 2-4 Calibrant Fluid Pack

ED
Packaging
1. The calibrant fluid pack is sealed in a foil pouch filled with protective gases.
- 24 -
2. The bar code on the foil pouch contains information such as the lot number and expiration
date.
3. Each calibrant fluid pack is packaged into a box, and 6 boxes are packaged into a shipping
carton.
Shipping Control
Calibrant fluid pack shipping cartons include one temperature monitor, which turns gray when
the shipping temperature is outside the specified range.
件
AL
Temperature
文 Monitor
TI
密
EN
Figure 2-5 Calibrant Fluid Pack Shipping Carton
保
The temperature monitor should be checked when calibrant fluid packs are received to verify that
the temperature limits were not exceeded during shipment. If the temperature monitor turns gray,
ID
邦
perform control tests (analyze at least two levels of controls in duplicates) with the received
calibrant fluid packs. If calibrant fluid packs pass the tests, they can be used. If calibrant fluid
NF
packs fail the tests, do not use them, and contact EDAN immediately for exchange of the
理
calibrant fluid packs.

CO
NOTE:
Never use calibrant fluid packs failing control tests.
Storage
AN
Calibrant fluid packs should be stored at 2 – 8 °C (avoid freezing) with the ambient pressure of
65 - 106.6 kPa. A calibrant fluid pack expires 30 days after its installation or after exceeding the
ED
labeled expiration date, whichever comes first. The remaining days and usages are displayed on
the status bar at the bottom of the screen.
Before Use
- 25 -
Calibrant fluid packs should be brought to room temperature before use. Allow at least 24 hours
for a calibrant fluid pack to equilibrate to room temperature.
NOTE:
 If the pouch has been damaged or there is any leakage, the calibrant fluid pack
should not be used.
 Only those calibrant fluid packs provided by EDAN or its authorized distributors
should be used.
 Use a calibrant fluid pack before the expiration date as labeled on the package.
 A calibrant fluid pack is intended for single use only. If a calibrant fluid pack is
件
removed from the system, it cannot be inserted into the system again.
AL
2.4.8 Bar Code Scanner 文
On the same side as the calibrant fluid pack chamber is the built-in scanner for scanning bar
TI
codes on test cartridges, calibrant fluid packs, controls, calibration verification controls, operator
密
ID, patient ID, sample ID, etc. The analyzer can also be connected to external scanners as
mentioned in 2.4.11.
EN
保
Follow the steps below to scan a bar code:

ID
1. Press Scan Barcode or to activate the bar code scanner, and the scanner will emit a red
邦
beam.
NF
2. Align the bar code with the red beam so that the red beam covers the whole bar code.
理
NOTE:
CO
The distance between the analyzer and the bar code should be 6 – 15 cm.
3. If the bar code is scanned successfully, the analyzer will beep and automatically turn off the
scanner.
AN
4. If the scanned data is valid, the system will display the screen for the next procedure. If the
scanned data is invalid, a message will pop up to prompt you.
ED
- 26 -
CAUTION
1. In order to avoid injury, never look into the red beam.
2. To avoid damage, never scratch the protective glasses of the scanner with hard
objects.
3. To avoid damage and injury, never strike the protective glasses of the scanner.
4. To avoid unsuccessful scanning, clean the scanner with a lint-free cloth when there is
visible dirt.
2.4.9 Exhaust Fan
件
The exhaust fan is located at the rear of the analyzer to prevent the analyzer from overheating.
When the analyzer temperature is over preset threshold, the fan will be automatically turned on.
AL
NOTE:
文
 Make sure that the vents of the analyzer are not obstructed to ensure good
TI
密
ventilation.
 If the exhaust fan does not run properly, please contact EDAN or its authorized
EN
distributors for assistance.
保
2.4.10 Electronic Simulator

ID
邦
Electronic simulators are quality control devices for checking the analyzer’s ability to take
accurate measurements of voltage, current and conductivity from test cartridges.
NF
理
Internal Electronic Simulator
Internal electronic simulator is self-contained in the analyzer for automatically conducting

CO
simulator tests at the preset frequency.
External Electronic Simulator
Users can run the external electronic simulator test according to their own needs, and EDAN
AN
recommends that users run it every 24 hours. Each external electronic simulator is packaged
separately. When you have doubt about the reliability of test results, you can run the external
ED
electronic simulator test to help troubleshoot.
- 27 -
Contact pads
Figure 2-4 External Electronic Simulator
If the contact pads have been contaminated, please clean the external electronic simulator.
Follow the steps below to clean the external electronic simulator:
件
1. Moisten a lint-free cloth with 100% alcohol;
AL
2. Wipe the external electronic simulator with the lint-free cloth.
文
NOTE:
 Never immerse the simulator into any liquids.
TI
密
 The cloth should be wet but not dripping.
EN
2.4.11 Peripherics
保
Only the following external scanners should be connected to the analyzer through USB ports:
ID
Honeywell 1900.
邦
Only the following external printers should be connected to the analyzer through USB ports: HP
NF
LaserJet P401DN, and HP LaserJet P1606DN.

理
NOTE:
 Only peripherics recommended by EDAN should be connected to the analyzer.
CO
 When connecting a Honeywell 1900 scanner to the analyzer, the scanner should be
set.
2.5 Configuration
AN
2.5.1 Standard Configuration

 1 analyzer
ED
 1 power cable
 1 power adaptor
- 28 -
 12 printer paper
 1 rechargeable lithium battery
 1 screwdriver
 1 user manual
 1 quick reference card
 1 certificate of approval
 1 packing list
2.5.2 Options
件
 Test cartridges
AL
 Calibrant fluid pack
 External electronic simulator

文
 Capillary adaptor
TI
密
 Controls
EN
 Calibration verification controls
保
 Data management system software

ID
 Honeywell 1900 scanner

邦
NF
理
CO
AN
ED
- 29 -
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide
Chapter 3 Installation Guide

3.1 Unpacking Inspection
Visually examine the package prior to unpacking. If there are any signs of mishandling or damage,
contact the carrier to claim for damage. After unpacking the device, customers should follow the
PACKING LIST to check the product carefully and to make sure no damage occurred during
transportation. Then, install the device according to the installation requirements and procedures.
If there is any problem, contact the manufacturer or its authorized distributors immediately.
WARNING
件
DO NOT use the analyzer if it is damaged or defective.
AL
NOTE: 文
Keep the package for future transportation or for storage.
3.2 Installation Requirements

TI
密
3.2.1 Environmental Requirements

EN
保
Location is of great importance for the smooth running of your analyzer. Prior to installing the
analyzer, choose a site that meets the following requirements:
ID

邦
Convenient for the analyzer to be connected to a grounded electrical receptacle in case it is

powered by AC power.
NF
 Keep the analyzer away from direct exposure to strong sunlight.

理
 Ambient Temperature between 10 °C and 31 °C.

CO
 Relative Humidity of 25% - 80% (non-condensing).

 Ambient Pressure within 70 - 106.6 kPa (525 – 800 mmHg).
 Placed onto a clean and flat surface with good ventilation.
AN
 Keep the analyzer away from equipment with strong electric field and strong magnetic field.
 Keep the analyzer away from explosive gases or vapors.
ED
NOTE:
The requirements above also apply when your analyzer is powered by a rechargeable
lithium battery.
- 30 -
3.2.2 Power Requirements

The analyzer needs to be connected to a grounded electrical outlet with the voltage between
100±10% VAC - 240±10% VAC and the frequency of 50/60 Hz.
3.3 Setting Up
Now you can prepare your analyzer for operation.
First, please place the analyzer on a secure table surface with environments that meet the
requirements as described in section 3.2.
3.3.1 Connecting to AC Power
件
1. Insert the power adaptor into the power connector on the analyzer.
AL
2. Plug the power cord into the power adaptor.
文
3. Plug the power cord into a grounded electrical outlet.
NOTE:
TI
密
 Make sure the power requirements as described in 3.2.2 are met.
EN
 To avoid the analyzer and other electronic devices being damaged by electrical power
保
spikes, a surge protector is recommended.

ID
3.3.2 Installing the Battery

邦
WARNING
NF
理
Switch off the analyzer and unplug it before installing or removing the battery.
CO
If the analyzer is powered by a rechargeable lithium battery, please install the battery first.
 Battery Installation
Follow the steps below to install the battery:

AN
1. Turn off the analyzer, disconnect the power supply, and remove the power adaptor and other
connecting cables.
ED
2. Place the analyzer upside down on a flat surface covered with cloth or another type of
protecting pad.
3. Remove the screws of the battery compartment using a cross-head screw driver, and then
- 31 -
remove the battery compartment cover.
4. Take the battery out from its package and put it into the compartment. Make sure the battery
件
connector is on the right and the battery label faces down. Install the battery into the
compartment.
AL
文
TI
密
EN
保
ID
邦
WARNING
Do not touch the battery connector with fingers or metallic materials, to avoid the hazards
NF
posed by the short-circuit to you and the battery.

理
5. Arrange the battery flat in the compartment, and push the strip at the end of the battery into
CO
the gap.
AN
ED
- 32 -
6. Shut the battery compartment cover and secure it with the screws.
 Battery Removal
Remove the battery in reverse order. You can pull the strip at the end to take the battery out from
the compartment.
NOTE:
 The battery needs to be charged prior to using it.
 Only those batteries supplied by EDAN or its authorized distributors should be used
with the analyzer.
 When the analyzer is powered by the battery and the battery is low, the system will
件
prompt you to connect the analyzer to an external power outlet. At the same time, the
battery indicator icon on the status bar at the bottom of the screen will also blink.
AL
 The battery will automatically be charged whenever the analyzer is connected to an
electrical outlet.
文
3.3.3 Installing the Printer Paper
TI
密
The analyzer utilizes rolled thermal paper with the width of 50 mm. When the printer paper runs
EN
out during the printing or is not loaded, the warning message “No Paper in Printer” will appear
保
on the screen. Then you should load or replace the printer paper immediately.
ID
 Procedures for Loading Rolled Thermal Paper

邦
1. Open the casing.

NF
2. Gently place the paper in the paper tray with the outside of the paper facing the thermal print
理
head.
CO
AN
ED
3. Pull about 2 cm of paper out and shut the printer casing.
- 33 -
 Procedures for Replacing Rolled Thermal Paper
The procedures for replacing rolled thermal paper is almost the same as loading rolled thermal
paper, except that you need to remove the remained rolled thermal paper prior to step 2.
CAUTION
1. Only use the printer paper provided by EDAN or its authorized distributors, otherwise
the printer may be damaged. This kind of damage is not covered by warranty.
2. Do not touch the thermosensitive print head or the paper sensor by hand, in case
they are damaged by static electricity.
NOTE:
件
Unless when replacing paper or troubleshooting, do not leave the printer casing open.
AL
3.3.4 Turning On/Off the Analyzer
文
NOTE:
TI
Make sure that all the cables are securely connected before you turn on the analyzer.
密
 Turn On the Analyzer
EN
保
Press the On/Off button on the left side of the analyzer to turn it on.
 Turn Off the Analyzer

ID
邦
1. Press on the bottom left of the screen, the following message will pop up:
NF
理
CO
AN
Figure 3-1 Turn Off Analyzer

ED
2. Press , and press OK in the pop up dialog box.

NOTE:
Never turn off the system when it is performing tests or printing data.
- 34 -
3.3.5 User Login and Logout
 User Login
1. Press the On/Off button on the left hand side of the analyzer to turn it on.
2. Enter the user name and password manually, and press .
To enter the user name with the bar code scanner, press first, and then scan the user
name bar code.
件
AL
文
TI
密
Figure 3-2 Enter User Name and Password

EN
When logging in for the first time, use the user name admin and password 123456. After
保
entering the system, you can edit your password and add more users by using the procedures
ID
introduced in 7.2.1.5 Changing System Password and 7.2.1.2 Adding an Operator.

邦
 User Logout
NF
理
1. Press on the bottom left of the screen, the following message will pop up:
CO
AN
ED
Figure 3-3 User Logout
2. Press , and press OK in the pop up dialog box. The system will go to the User
- 35 -
Login screen. Enter a user name and password to change users.
NOTE:
Never log out of the system when it is performing tests or printing data.
3.3.6 Setting the Date and Time
1. On the Main screen, press to access the System Setup screen.
2. Press to access the Date & Language Setup screen.

3. Select the desired date and time, and press OK in the pop up dialogue box.
4. Press OK to accept the changes.
5. Press Return to return to the Main screen.
件
CAUTION
AL
文
1. Make sure the current date and time of the system are correct, or it may cause
misdiagnosis.
TI
密
2. Changing date and time directly affects date and time saved with each test data.
EN
3.3.7 Viewing Training Videos
保
The system has training videos for guiding your operations.

ID
Follow the steps below to view training videos:

邦
1. Press on the bottom right of the screen to access the Help screen.
NF
理
CO
AN
ED
Figure 3-4 Help Screen
2. Press to view the video for replacing a calibrant fluid pack.
- 36 -
3. Press to view the video for analyzing syringe samples.
4. Press to view the video for analyzing ampoule samples.
5. Press to view the video for analyzing capillary samples.
6. Press Return to go back to the Main screen.
3.3.8 Replacing a Calibrant Fluid Pack
WARNING
1. Never replace a calibrant fluid pack when the analyzer is off.
件
2. A calibrant fluid pack is intended for single use only. If a calibrant fluid pack is
AL
removed from the system, it can not be inserted into the system again.
文
Follow the steps below to replace a calibrant fluid pack:
TI
1. Examine the expiration date on the package of a calibrant fluid pack to ensure it has not
密
expired.
2. Remove the calibrant fluid pack from its package, and equilibrate it to room temperature.
EN
保
The calibrant fluid pack needs to stand at room temperature for at least 24 hours.
3. Wipe any moisture from the foil pouch with a dry clean cloth.
ID
邦
4. On the Main screen, press to go to the System Setup screen.

NF
5. Press . The system will go to the screen below:

理
CO
AN
ED
Figure 3-5 Open Chamber Door
- 37 -
6. Open the foil pouch, and remove the calibrant fluid pack from it.
NOTE:
Avoid tearing the bar code on the foil pouch.
7. Remove the calibrant fluid pack cap, and remove the key by pushing it with your finger in
the direction as shown by the arrow in the picture below.
Key Valve
件
AL
文
TI
密
EN
NOTE:
保
Avoid pushing the valve when removing the key.

ID
邦
8. Unlock the calibrant fluid pack chamber lock with the key, and then pull the calibrant fluid
pack ejector to open the calibrant fluid pack chamber door.
NF
9. Remove the used calibrant fluid pack from the system. The system will go to the screen for
理
the next procedure, and the scanner will be turned on automatically.

CO
AN
ED
Figure 3-6 Remove Old Calibrant Fluid Pack
- 38 -
10. Scan the bar code on the new calibrant fluid pack foil pouch with the bar code scanner.
If the bar code is scanned successfully, the system will beep and the scanner will be turned off
automatically. If the scanned data is valid, the system will display the screen for the next
procedure. If the scanned data is invalid, a message will pop up to prompt you.
If the scanner is turned off automatically, press first, and then scan the bar code.
件
AL
文
TI
密
EN
Figure 3-7 Scan Bar Code
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11. Insert the new calibrant fluid pack into its chamber, and push it gently to make sure that it
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clicks into place. The system will go to the screen for the next procedure.
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Figure 3-8 Install Calibrant Fluid Pack
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12. Close the chamber door.
Figure 3-9 Close Chamber Door
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13. Lock the calibrant fluid pack chamber lock to close the chamber door securely.
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14. Press OK in the pop up message. The system will then go to the Main screen.
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Figure 3-10 Replacement Success

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NOTE:
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 Always follow the proper procedures to replace a calibrant fluid pack, or else the
system will not run smoothly, and the following message will pop up:
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Figure 3-11 Calibrant Fluid Pack Improper Removal
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 If the bar code is that of a used calibrant fluid pack, the following message will pop up:
Figure 3-12 Calibrant Fluid Pack was Used
 If the bar code is that of an expired calibrant fluid pack, the following message will pop
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up:
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Figure 3-13 Calibrant Fluid Pack Expired

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3.3.9 DEMO Test

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The system can demonstrate the sample testing process and the calibrant fluid pack replacing
process through animation.
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3.3.9.1 DEMO Sample Tests
Follow the steps below to perform a DEMO sample test:

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1. Logout of the system. The system will access the User Login screen.
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2. Enter demo in both the user name and password fields, and then press . The system
will go to the following screen:
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Figure 3-14 DEMO Sample Test Screen 1

3. Press Scan Barcode.
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4. Press Next.
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ID
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5. The system simulates aspirating calibrant.

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6. The system simulates calibration.
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7. The system simulates sampling.
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8. The system simulates testing.

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9. The system simulates displaying test results.
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10. Press Home to return.

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11. Follow the steps as described in 3.3.5 to logout of the system.

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3.3.9.2 DEMO Calibrant Fluid Pack Replacing
Follow the steps as described in 3.3.8 to perform a calibrant fluid pack replacing process.
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3.3.10 Connecting Peripherics

Connect peripherics with the system through USB ports, and make sure that the system meets the
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requirements in IEC60601-1-1.
- 44 -
NOTE:
 Only peripherics recommended by EDAN should be connected.
 Make sure that the whole system meets the requirements in IEC60601-1-1.
Follow the steps below to set a Honeywell 1900 scanner:
1. Connect a Honeywell 1900 scanner to the analyzer through a USB port.

2. Hold the scanner with your right hand, and trigger the scanner with your forefinger.
3. Scan the following bar codes in sequence.
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4. Use the scanner to scan the bar code of a test cartridge. If the bar code is successfully
scanned, the scanner is successfully set.
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i15 Blood Gas and Chemistry Analysis System User Manual Setup
Chapter 4 Setup
The system can be configured according to your clinical needs. The setup can only be done by
authorized operators. You can perform the following setup with the Setup menu:
 Printer Setup
 Network Setup
 Date & Language Setup
 Backlight & Volume Setup
 QC Lockout Setup
 Patient Information Setup
 Reference Ranges Setup
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 Units Setup
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 Correlation Factors Setup 文
 Internal Simulator Setup
 Calibration Setup
NOTE:
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 Only administrators, service engineers and engineers from the manufacturer can get
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access to this function.
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 The system will remember all the changes in setup even after the system is turned
off.
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4.1 Getting into the Setup Screen

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2. Enter the user name and password manually, and press .

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name bar code.
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3. Press on the Main screen, and the system will go to the Setup screen.
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4.2 System Setup
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The system displays the System Setup screen after pressing on the Main screen by default.
If you are now on the Test Setup screen, press System Setup to get to the System Setup screen.
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Figure 4-2 Setup-System Setup Screen
You can perform the following actions:

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4.2.1 Printer Setup

This menu lets you configure the printer that the system uses, what are printed in reports, the
- 48 -
number of copies it prints, and the calculated parameters to be printed on the patient report.
NOTE:
The display will always let you view all the available calculated parameters.
1. Press to access the Printer Setup screen.
2. There are two tabs: Basic and Calculated Parameter Output.
 Basic Setup
1) Press Basic Setup to go to the Basic Setup Screen.
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Figure 4-3 Printer – Basic Setup Screen
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2) On the Basic Setup screen, you can:

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 Select whether to print patient information. The mark √ will appear if Patient Info is
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selected, and the default is to print patient information.

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 Select whether to print reference ranges. The mark √ will appear if Reference Ranges
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is selected, and the default is to not print them. If Reference Ranges is selected, the
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reference ranges will be contained in the patient sample report, and the acceptable
ranges will be contained in the quality control (QC) test report.
 Select the printer to be used. There are two options: Thermo Printer and USB Printer.
The default is Thermo Printer.
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 Select whether to turn on Auto Print. The mark √ will appear if Auto Print is turned
on, and the default is to turn on Auto Print.
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 Select the number of copies. There are two options: 1 and 2. The default is 1.
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Note:
Calibration Results can’t be selected and the default is not to print them.
3) Press OK to accept the changes, and the system will return to the System Setup screen.
 Calculated Parameter Output Setup

1) Press Calc Para Output to access the Calculated Parameter Output Setup screen.
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Figure 4-4 Printer – Calculated Parameter Output Setup Screen

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2) Select the desired parameters. √ indicates the parameter is selected.
NOTE:
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 Select All to select all the parameters on the screen.
 For calculated parameters not available on the test cartridge, the system will
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not print out them, even though they are selected.

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3) Press OK to accept the changes, and the system will return to the System Setup screen.
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4.2.2 Network Setup

This menu allows you to configure the communication methods, transmitting methods, and the
manner that the analyzer is connected to the network.
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Follow the directions below to configure the network:

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1. Press to access the Network Setup screen.

2. There are three tabs: Communication, Local IP, and WIFI.
 Network Setup
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1) Press Communication to go to the Communication Setup screen.
Figure 4-5 Network – Communication Setup Screen
2) On the Communication Setup screen, you can:
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 Select the communication protocols. There are two options: POCT 1-A and
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HL7×2.4. The default is POCT 1-A.
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 Select whether to transmit patient sample results automatically. There are two
options: On and Off. If your selection is On, patient sample results will be
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transmitted automatically after each measurement. The default is On.
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 Select the communication methods. There are two options: Network and WIFI.
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The default is Network.
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 Enter the IP address of the DMS or HIS/LIS to which your analyzer is

connected.
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3) Press OK to accept the changes, and the system will return to the System Setup
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screen.
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 Local IP Setup
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1) Press Local IP to access the Network-Local IP Setup screen.

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Figure 4-6 Network – Local IP Setup Screen
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2) Select the way that the analyzer is connected to the network. There are two options:
DHCP (dynamic host configuration protocol) and Static IP addresses. The Default is
DHCP. If the latter one is selected, the following information should be entered: IP
address, the default gateway, and the network mask.
NOTE:
 The static IP address should be in the same area network with the IP address
of the DMS or HIS/LIS.
 IP addresses for analyzers connected to the same DMS or HIS/LIS should be
different.
 Only when both the DMS or HIS/LIS and the analyzer have been connected
to network successfully can the analyzer transmit data to the DMS or
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HIS/LIS.
3) Press OK to accept the changes, and the system will return to the System Setup
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screen.
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 WIFI Connection
1) Press WIFI to access the WIFI Setup screen.
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Figure 4-7 Network - WIFI Setup Screen

2) Press Search WIFI, the system will automatically search networks and display them.
If the system displays Lock for the network password, it is necessary to enter its
password to connect the system to it.
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3) Press the network you want to connect, and press Connect WIFI.
NOTE:
The selected network should be in the same area network with that of the DMS or
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HIS/LIS.
4) Press Return, and the system will return to the System Setup screen.
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4.2.3 Date & Language Setup

With this menu you can set the time and date, the date format, and the language the analyzer uses
for displays and printouts.
Follow the instructions below to set the date and language:
1. Press to go to the Date & Language Setup screen.
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文
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Figure 4-8 Date & Language Setup Screen
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2. On the Date & Language Setup screen, you can:

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 Change the time and date of the system.

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 Select the date format. There are three formats: MM-DD-YYYY, YYYY-MM-DD and
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DD-MM-YYYY. The default is YYYY-MM-DD.

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 Select the language for displays and printouts. The default language is English.
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3. Press OK to accept the changes, and the system will return to the System Setup screen.
4.2.4 Backlight & Volume Setup

This menu allows you to define the idle time after which the backlight will be automatically
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turned off, the brightness of the backlight, the key tones and the volume.
1. Press to go to the Backlight & Volume Setup screen.

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Figure 4-9 Backlight & Volume Setup Screen
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2. On the Backlight Setup screen, you can:
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 Adjust the brightness of the backlight with the slider.
文
 Select the idle time after which the backlight will be automatically turned off. The
options are: never, 10 seconds, 1 minute, 3 minutes and 5 minutes. The default setting is
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密
1 minute.
NOTE:
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The system will enter standby mode after the backlight is turned off. Press the LCD
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screen to resume normal operation mode.

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 Set the key tones. There are two options: On and Off. If On is selected, and the volume is
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not mute, the system will beep after each effective press.
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 Select the volume of the system. There are four options: High, Medium, Low and Mute.
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The default is Medium.

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3. Press OK to accept the changes, and the system will return to the System Setup screen.
4.2.5 Diagnostics
This menu lets you diagnose some modules of the analyzer to check its operation. It helps to
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troubleshoot.
NOTE:
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Only service engineers and engineers from the manufacturer can perform this action.
- 54 -
4.2.6 About the Analyzer

The system contains information about your analyzer which makes it convenient for you to know
more about your analyzer and call for technical assistance if necessary.
1. Press to go to the About screen.
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Figure 4-10 About Screen
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2. View the information on the screen.
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3. If necessary, press to update the software version.
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4. Press Return to get access to the System Setup screen.
4.3 Test Setup

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Press Test Setup on the Setup screen to access the Test Setup screen, and then you can perform
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the following operations:

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Figure 4-11 Setup – Test Setup Screen
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4.3.1 QC Lockout Setup

This menu allows you to configure QC lockout. If QC lockout function is enabled, the system
will not report test results for those parameters that have failed quality control (QC) tests, and the
results for these parameters will be flagged with xxx. If QC lockout function is disabled, the
system will report test results for those parameters that have failed quality control (QC) tests, and
the test results for these parameters will be flagged with ***. The default setting is enabling QC
Lockout function.
Follow the procedures below to set QC Lockout:
1. Press to go to the QC Lockout Setup screen.
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Figure 4-12 QC Lockout Setup Screen

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2. Select whether to enable QC Lockout function. √ will appear if QC Lockout function is

enabled.
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3. Press OK to accept the changes, and the system will return to the Test Setup screen.
4.3.2 Patient Information Setup

This menu allows you to select which parameters will be displayed on the Edit Patient
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Information screen during each patient sample test. The default displayed parameters are patient
ID, temperature, FIO2 and operator ID. The table below lists the parameters for patient
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information.
- 56 -
Table 4-1 Patient Information
Parameter Range Resolution Unit

Patient ID 1 - 16 digits N/A N/A
Operator ID 1 - 16 digits N/A N/A
Sample ID 1 - 16 digits N/A N/A
14.0 – 44.0 0.1 °C
Temperature
57.2 – 111.2 0.1 ℉
Sex Male, Female, / N/A N/A
1.0 – 26.0 0.1 g/dL
tHb (Total
10 - 260 1 mg/dL
hemoglobin)
0.6 – 16.1 0.1 mmol/L
0.15 - 1.00 0.01 x.xx
FIO2
15 - 100 1 %
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MCHC (Mean
29.0 - 37.0 0.1 g/dL
corpuscular
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hemoglobin
concentration)
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290 - 370 1 g/L
RQ (respiratory
0.70 - 2.00 0.01 x.xx
quotient)
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Hemoglobin
Adult, Children, Newborn N/A N/A
type
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LR/RR/LB/RB/LF/RF/Cord/Scalp/LHF/
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RHF/LH/RH/AIC, PA Catheter,
CPB or Other, where:
ID
LR=Left Radial
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RR= Right Radial

LB= Left Brachial
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RB= Right Brachial

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LF= Left Femoral

Puncture site RF= Right Femoral N/A N/A
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LHF= Left Hand Finger

RHF= Right Hand Finger
LH= Left Heel
RH= Right Heel
AIC= Arterial Indwelling Catheter
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CPB= Cardiopulmonary Bypass

PA Catheter= PA Catheter
Other= Other
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Bypass Pump Off / Pump On N/A N/A

Rm air, Mask, T-P, NC, Vent, Bag, Hood or
O2 mode Other, where: N/A N/A
Rm Air=Room Air
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Mask= Mask
T-P= T-Piece
NC= Nasal Cannula
Vent= Ventilator
Bag= Bag (manual resuscitation)
Hood= Hood
Other= Other
I/E Ratio 0.2 - 9.9/0.2 - 9.9 0.1 x.xx
No, SIMV, PSV, PCV, CMV/AC, CPAP,
PCIVR, or BIPAP, where:
No= None
SIMV= Synchronized Intermittent Mandatory
Ventilation
PSV= Pressure Support Ventilation
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Vent mode N/A N/A
PCV= Pressure Control Ventilation
CMV/AC= Controlled Mechanical Ventilation/
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Assist Control
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CPAP= Continuous Positive Airway Pressure
PCIVR= Pressure Control Inverse Ratio
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BIPAP= Bi-Level Positive Airway Pressure
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Pplat (Plateau
0 - 100 1 cmH2O
Pressure)
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MVol (Minute
0 - 120 1 Lpm
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Volume)
PIP (Peak
ID
Inspiratory 0 - 140 1 cmH2O

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Pressure)
Liter Flow 0 - 300 1 Lpm
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TVol (Tidal
0 - 4000 1 mL/kg
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Volume)
PS (Pressure
0 - 99.9 0.1 cmH2O
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Support)
PEEP (Positive
End Expiratory 0 - 50 1 cmH2O
Pressure)
Rate 0 - 155 1 Bpm
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CPAP
(Continuous
0 - 50 1 cmH2O
Positive Airway
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Pressure)
Bi-Level
0.2 - 9.9/0.2 - 9.9 0.1 x.xx
Pressure
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NOTE:
 There is no barometric pressure item in patient information. If the barometric
pressure sensor malfunctions, the system will not report results for the parameters
related to oxygen.
 The selected items will be printed out in patient sample reports if Patient Info is
selected in section 4.2.1 Printer Setup.
Follow the instructions below to select which patient information is required:
1. Press to get access to the Patient Information Setup screen.

2. Press Patient Info 1, and select the desired parameters. √ indicates the parameter is selected.
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Figure 4-13 Patient Information 1 Screen

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3. Press Patient Info 2, and select the desired parameters. √ indicates the parameter is selected.
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Figure 4-14 Patient Information 2 Screen

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NOTE:
Select All to select all the parameters on each screen.
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4.3.3 Reference Ranges Setup

With this menu you can set the reference range for each measured parameter. There are three
options: Arterial, Venous, and Other. The default is Arterial. A result that is out of the reference
range will be flagged with an up/down arrow. Reference ranges are factory set to be the
measurement ranges for each measured parameter. Values outside reference ranges are not
flagged with an up/down arrow. Therefore reference ranges must be set according to internal
procedures at your individual institution. Because reference ranges may vary with demographic
factors such as age, gender and heritage, it is recommended that reference ranges be set according
to the population being tested.
Follow the instructions below to set the reference ranges:
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1. Press to access the Reference Ranges Setup screen.
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文
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ID
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Figure 4-15 Reference Ranges Setup Screen

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2. Select the desired reference range, and edit the limits for those parameters you want to
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change.
NOTE:
 If unacceptable values are entered, the system will display the correct range.
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 The limits entered will be saved in the system even after the system is shut down.
 If arterial blood/capillary blood is selected, the screen of Reference Ranges Setup will
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display arterial blood reference ranges automatically. If venous blood is selected, the screen
of Reference Ranges Setup will display venous blood reference ranges automatically. If
- 60 -
mixed venous blood/CPB/aqueous solution is selected, the screen of Reference Ranges Setup
will display others reference ranges automatically
4.3.4 Units Setup

This function allows you to select the units for measured parameters, calculated parameters and
parameters of patient information.
Table 4-2 Units for Parameters
Parameter Default Unit Alternate Units
Ca++ mmol/L mg/dL
pCO2 mmHg kPa
pO2 mmHg kPa
Glu mmol/L mg/dL
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Lac mmol/L mg/dL
Hct % x.xx
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Cre μmol/L
文 mg/dL
BUN mmol/L mg/dL
tHb(est) g/dL g/L,mmol/L
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sO2(est) % x.xx
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pO2(A-a) mmHg kPa
pO2(a/A) x.xx %
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RI x.xx %
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pO2/FIO2 mmHg mmHg/%, kPa, kPa/%

Ca++(7.4) mmol/L mg/dL
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pCO2(T) mmHg kPa

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pO2(T) mmHg kPa

pO2(A-a)(T) mmHg kPa
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pO2(a/A)(T) x.xx %
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RI(T) x.xx %
pO2(T)/FIO2 mmHg mmHg/%, kPa, kPa/%
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Temperature °C ℉
FIO2 x.xx %
tHb g/dL g/L, mmol/L
MCHC g/dL g/L
Baro/Partial Pressure mmHg kPa
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Follow the directions below to select the desired units for the parameters:
1. Press to get access to the Units Setup screen.

2. Press Units 1, and select the desired units for the parameters whose units you want to
change.
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Figure 4-16 Units Setup 1 Screen
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3. Press Units 2, and select the desired units for the parameters whose units you want to
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change.
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Figure 4-17 Units Setup 2 Screen
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NOTE:
The results stored in the system are automatically converted to match new units.
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4.3.5 Correlation Factors Setup
NOTE:
Only service engineers and engineers from the manufacturer can perform this action.
4.3.6 Internal Simulator Setup

This menu allows you to set whether to run the internal simulator test, and set the time at which
the system performs the test every day.
1. Press to access the Internal Simulator Setup screen.
件
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文
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密
EN
保
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Figure 4-19 Internal Simulator Setup Screen

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2. Select whether to run the internal simulator test. The mark √ will appear if Internal Simulator
is selected, and the default is to select it.
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3. If the Internal Simulator is selected, enter the time at which the system performs the test. The
default is 01:00:00.
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4.3.8 Calibration Setup

NOTE:
If one or more of the selected parameters fail calibration tests, the test will halt.
1. Press to go to the Calibration Setup screen.
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Figure 4-20 Calibration Setup Screen
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2. Select the desired parameters. √ indicates the parameter is selected. Select All if you want to
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select all the parameters on the screen.

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i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing
Chapter 5 Patient Analyzing

NOTE:
Take safety measures when working with biological samples, such as wearing
approved gloves, etc.
5.1 Sample Collection and Preparation
5.1.1 Sample Collection

Blood samples should be collected according to proper medical guidelines containing collection
details, such as site selection, collection procedures, sampling devices, sample handling, etc.
件
Sterile techniques should be followed to prevent the site from being contaminated.
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WARNING
文
Handle blood samples and collection devices with care, and wear approved protective
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gloves to avoid direct contact with samples.
密
NOTE:
 Only fresh whole blood samples are recommended for use.
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 When taken for electrolyte analysis, venous samples should not be collected from a
保
central venous catheter containing silver sulfadiazine or chlorhexidine, because they

ID
have a great influence on sodium levels.

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 Samples should be collected by trained professionals.

 For mixed venous samples, the system reports only pO2 result.
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5.1.2 Anticoagulants
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Only those sample devices containing the proper amount of calcium-titrated (balanced) heparin or
lithium heparin as the anticoagulant should be used to collect whole blood samples. If
calcium-titrated (balanced) heparin is used as an anticoagulant, the minimum heparin-to-blood
ratio should be 2.3 units of heparin per 1.0mL of blood sample. If a sample is analyzed for
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ionized calcium, the maximum heparin-to-blood ratio should be 15 units of heparin per 1.0mL of
blood sample; if not, the maximum heparin-to-blood ratio should be 50 units of heparin per
1.0mL of blood sample.
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CAUTION
If there are clots in the blood sample, discard it and collect samples again.
- 65 -
NOTE:
Don’t use the following anticoagulants: EDTA, citrate, and oxalate, because they have a
great influence on test results for pH and electrolytes.
5.1.3 Collection Devices and Volume

Samples can be introduced into the system with the following devices: syringes and capillary
tubes. It is recommended that VITREX® Blood Gas Capillary Tubes with a minimum volume,
filled of 175 μL (Article Number: 182413) or 220 μL (Article Number: 182313) should be used.
NOTE:
 The system uses 140 μL samples for analysis, and make sure it can aspirate enough
件
sample.
AL
 The minimum fill volume for a 1 mL syringe is 500 μL.
文
 The minimum fill volume for a 2 mL syringe is 800 μL.
 The minimum fill volume for a 5 mL syringe is 1.5 mL.
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密
 Dislodge bubbles from the syringe, and cover it as soon as the sample is collected.
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Cork should never be used to cover the syringe.
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 A capillary tube should be filled to capacity and covered securely. Cork or clay should
ID
never be used to cover the capillary tube.

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5.1.4 Notes
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Follow the notes below to ensure that test results are accurate:
理
1. Cover the sample device immediately after collection to prevent it from being
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contaminated by air.
2. Mix blood samples thoroughly prior to sample introduction.
3. Make sure there are no clots in blood samples, or else the results will be inaccurate.
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4. Perform the sample test immediately after its collection to get the most accurate
results. Measure samples for blood gases and Ca++ within 10 minutes, and measure
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samples for other analytes within 30 minutes.
5. Used sample devices are biohazardous waste, and should be handled abiding by
local regulatory guidelines.
- 66 -
5.2 Patient Analyzing
NOTE:
Ensure that the displayed date and time are correct before each sample test, because
they are part of the patient sample data. Contact the administrator if the date and/or time
are incorrect.
5.2.1 Procedures for Patient Analyzing

2. Enter the user name and password manually, and then press .
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name bar code.
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密
EN
保
ID
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NF
理
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3. Press the button for the blood sample type on the Main screen. √ will appear if the button is
selected. The default type is Arterial.
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- 67 -
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Figure 5-2 the Main Screen
CAUTION
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文
Make sure that the selected sample type button is consistent with the blood sample, or
the result may be inaccurate.
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密
4. Press Scan Barcode, and scan the bar code on a new cartridge foil pouch.
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If the bar code is scanned successfully, the system will beep and the scanner will be
保
automatically turned off. If the scanned data is valid, the system will display the screen for
the next procedure. If the scanned data is invalid, a message will pop up to prompt you.
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5. Open the foil pouch and remove the cartridge from it.
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NOTE:
理
 Avoid tearing the bar code on the foil pouch.

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 For sample introduction with a capillary tube, insert a capillary adaptor into the fillport
after removing the cartridge.
6. Roll the syringe or capillary tube between palms and gently invert it end over end for several
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times to mix the sample completely.

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- 68 -
Figure 5-3 Mix Sample and Insert Cartridge

NOTE:
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 To avoid inaccurate test results, mix the sample thoroughly prior to sample
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introduction. 文
 To avoid inaccurate test results, make sure there are no trapped bubbles or clots in
the sample.
TI
密
7. Insert the syringe or capillary tube into the fillport of the cartridge.
EN
NOTE:
保
 When using a syringe, discard the first 2 drops of blood sample first, then remove the
ID
needle from it, and finally insert it into the fillport.

邦
 When using a capillary tube, insert the capillary tube into the adaptor till the tube
reaches the interface between the adaptor and the cartridge.
NF
理
8. Gently insert the cartridge into the cartridge port, and carefully press down to ensure it clicks
into place.
CO
For a valid cartridge, the indicator in the cartridge port will turn green, and the system will
automatically aspirate calibrant. For an invalid cartridge, the indicator will turn red, the
cartridge will be ejected and a message will pop up to prompt you.
AN
NOTE:
 Never inject the sample. It will be aspirated automatically.

ED
 The cartridge can not be removed from the analyzer until the measurement is
complete.
- 69 -
9. Enter patient information. The screen displayed depends on the selection in section 4.3.2
Patient Information Setup. The screen for the default patient information setup is shown
below:
件
AL
Figure 5-4 Enter Patient Data
文
NOTE:
TI
 It is not necessary to enter all the above parameters. You can press OK at any time.
密
 If no parameters are selected in section 4.3.2 Patient Information Setup, the system
EN
will go to the Aspirating Calibrant screen when the test cartridge is properly inserted.
保
 The system can not go back to the screen for entering patient information after you
ID
press OK, and patient information has to be edited in the patient sample database.
邦
10. Press OK. The system will go to the following screens:

NF
a). If the system is aspirating calibrant, the system will go to the following screen:
理
CO
AN
ED
Figure 5-5 Aspirating Calibrant…
- 70 -
b). If the system is calibrating sensors, the system will go to the screen below:
Figure 5-6 Calibration in Progress
件
c). If the system is sampling, the system will go to the screen below:
AL
文
TI
密
EN
保
ID
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Figure 5-7 Sampling…

NF
d). If the system is analyzing patient samples, the system will go to the screen below:
理
CO
AN
ED
Figure 5-8 Measurement in Progress
- 71 -
e). If the test is complete, the system will go to the screen below:
Figure 5-9 Sample Results
件
NOTE:
AL
 Upon the completion of the test, the indicator in the cartridge port will be off, the
文
message “Please Remove Cartridge” will be displayed on the status bar at the
TI
bottom of the screen, and the cartridge will be ejected.
密
 If the screen has not been touched for 10 seconds after the test is complete, the test
EN
results will be displayed automatically even if you do not press OK.
保
 If patient temperature is entered, the test results will be displayed both at 37°C and at
the patient’s temperature.
ID
邦
 If Auto Transmit is turned on in section 4.2.2 Network Setup, patient sample results
will be transmitted to the DMS automatically.
NF
理
 If Auto Print is selected in section 4.2.1 Printer Setup, patient sample results will be
printed automatically. If it is not selected, press Print to print the test results.
CO
11. View the test results. The system displays the results for measured parameters by default.
Press Calculated to view the results for calculated parameters.

AN
ED
- 72 -
件
Figure 5-10 Calculated Parameters
Press Calibration to view the calibration results.
AL
文
TI
密
EN
保
ID
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NF
理
Figure 5-11 Calibration Parameters

CO
Symbols such as > may appear on the Results screen, refer to section 5.2.2 Understanding Result
Symbols to understand their meanings.
WARNING
AN
Never make treatment decisions according to test results containing symbols as

described in section 5.2.2 Understanding Result Symbols.
ED
12. Remove the test cartridge from the system immediately.
13. Press Home to return to the Main screen.
- 73 -
The contents of a patient sample report depend on the type of the test cartridge you have used, the
options selected in section 4.2.1 Printer Setup and section 4.3.2 Patient Information Setup, and
the errors and alarms the system detects during the measurement. The table below is an example
of a patient sample report:
EDAN i15
System ID M13704860027
Report Type Patient Sample
Sample Type Arterial
Print Time 2016-01-21 17:26:36
Test Time 2016-11-03 00:02:13
PatientID
Operator ID edan
件
Patient Information
AL
Sample ID
Temperature 37.00
文 ℃
Sex
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tHb 30.00 g/dL
密
FIO2 20.00 x.xx
RQ xxx
EN
Hb type
保
Puncture site
Bypass
ID
O2 mode
邦
I/E Ratio
Vent mode
NF
......
理
Blood Gas Values

pH > 8.000
CO
pCO2 < 10.0 mmHg

pO2 145 mmHg
Oximetry Values
Hct 15 %
AN
sO2(est),r 100 *** %

tHb(est),r 5.3 g/dL
ED
Electrolyte Values
Na+ 160 *** mmol/L
K+ 4.7 *** mmol/L
- 74 -
Ca++ 1.35 *** mmol/L

Ca++(7.4),r …… mmol/L
Cl- 100 *** mmol/L
Acid-Base Status
HCO3-act,r 30.6 *** mmol/L
HCO3-std,r 40 *** mmol/L
BE(ecf),r 18.5 *** mmol/L
BE(B),r 16.4 *** mmol/L
BB(B),r 60.3 *** mmol/L
ctCO2,r 31 *** mmol/L
AnGap,r 34 *** mmol/L
cH+,r < *** mmol/L
mOsm,r 315.4 *** mmol/L
件
pO2/FIO2,r …… mmHg
RI,r 0.00 ***
AL
pO2(A-a),r 0 *** mmHg
pO2(a/A),r 1.00
文 ***
Reference Ranges
TI
密
pH 7.35 7.45
pCO2 35 45 mmHg
EN
pO2 80 100 mmHg
保
Na+ 138 146 mmol/L

K+ 3.5 4.9 mmol/L
ID
Ca++ 1.12 1.32 mmol/L

邦
Cl- 98 109 mmol/L

GLu 3.9 5.8 mmol/L
NF
Lac 0.36 1.7 mmol/L

理
Hct 35 51 %
CO
Notes
,r calculated values
*** out control/unlock
...... invalid values
> >measured range
AN
< <measured range

ED
5.2.2 Understanding Result Symbols

The following table shows the symbols that may appear on the screen:
- 75 -
Symbol Description
> or < The result is above or below the measurement range.
↑ or ↓ The result is above or below the reference range.
--- The measured parameter fails calibration.
The measured parameter fails quality control (QC) tests, and QC lockout function is
xxx
enabled in Setup.
The measured parameter fails quality control (QC) tests, and QC lockout function is
disabled in Setup.
*** The result for the calculated parameter is valid, but the measured parameter used to
determine this calculated parameter fails quality control (QC) tests, and QC lockout
function is disabled in Setup.
…… The result for the measured parameter is invalid.
件
NOTE:
 Invalid test result for a calculated parameter will not be displayed on the screen.
AL
文
 Valid test result for a calculated parameter will not be displayed on the screen, if the
measured parameter used to determine the result fails quality control (QC) tests, and
QC lockout function is enabled in Setup.
TI
密
5.3 Patient Sample Database

EN
保
The patient sample database displays patient sample data for the most recent month by default,
ID
and it can store up to 10000 data entries. The system displays 50 pieces of data on every page.
邦
Press Prev. and Next to page through the screens of the displayed data entries. When 80% of the
space is occupied, the system will prompt you to export the stored data to a removable disk (such
NF
as a USB drive). If data is not exported, the system will continue to save new data. When the
理
database is full, the system will always prompt you to export data. If data is still not exported, the
CO
system will automatically delete the oldest one to accommodate a new one. The following
operations can be performed in the patient sample database: transmitting patient sample data to
the Data Management System (DMS) or HIS/LIS through Wi-Fi or the network, exporting patient
sample data to a removable disk (such as a USB drive), viewing the details of patient sample data,
AN
editing patient information, searching for and printing patient sample data, etc.
NOTE:
ED
 Only patient information data can be edited.
 Test results for calculated parameters may be changed due to the alteration of patient
- 76 -
information data.
On the Database screen, press to access the Patient Sample Database screen.
件
AL
文
Figure 5-12 Patient Sample Database Screen
5.3.1 Searching for Patient Sample Data

TI
密
1. On the Patient Sample Database screen, press Search.

EN
保
2. Enter the search conditions, and press OK.

ID
邦
NF
理
CO
AN
Figure 5-13 Enter Search Conditions

ED
- 77 -
3. The system automatically begins the search and displays the results.
件
AL
Figure 5-14 Search Results
文
4. Press Return to go back to the Patient Sample Database screen.
5.3.2 Viewing Details of Patient Sample Data
TI
密
1. Press the patient sample data you want to view.
EN
2. Press Details. The system displays the details of measured parameters by default.
保
ID
邦
NF
理
CO
AN
Figure 5-15 Details of Measured Parameters

ED
- 78 -
3. Press Calculated to view the details of calculated parameters.
件
Figure 5-16 Details of Calculated Parameters
AL
4. Press Patient Info to view the details of patient information.
文
TI
密
EN
保
ID
邦
NF
理
CO
Figure 5-17 Details of Patient Information
5. Press Return to go back to the Patient Sample Database screen.
5.3.3 Editing Patient Information Data

AN
1. Select the desired patient sample data, and then press Edit.
2. Edit the patient information data. The following screen will be displayed for the default
ED
patient information setup:
- 79 -
件
Figure 5-18 Edit Patient Data
NOTE:
AL
The screen displayed depends on the selection in section 4.3.2 Patient Information
Setup.
文
3. Press OK to save the changes, and the system will return to the Patient Sample Database
TI
密
screen.
5.3.4 Exporting/Uploading/Printing Patient Sample Data

EN
保
1. Open the patient sample database.

ID
2. Select the desired patient sample data.

邦
To Do this
NF
Export Insert a removable disk into the analyzer, and then press Export.
理
Upload Press Upload.

CO
Print Press Print.
NOTE:
If no patient sample data is selected before pressing Export/Upload/Print, all of the data
AN
stored in the patient sample database will be exported/uploaded/printed.

ED
- 80 -
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests
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.
件
You doubt test results.
AL
文
TI
密
EN
保
ID
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Figure 6-1 Quality Control Screen

NF
6.1 Control Test

理
CO
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
AN
Controls are intended for use to monitor test cartridge performance at multiple points within the
clinical range. Controls used are EDAN Blood Gas and Electrolyte Controls and EDAN
ED
Hematocrit Controls. RNA Medical® QC823 Blood Gas●Electrolyte●Metabolite●BUN Controls

and RNA Medical® QC900 Hematocrit Controls can also be used on the i15 Blood Gas and
Chemistry Analysis System. The concentrations of reactive ingredients in various levels of
- 81 -
controls are known. Controls contain no human or biological materials. Acceptable ranges for
controls specific to the i15 Blood Gas and Chemistry Analysis System are programmed in the bar
code on the user manual for controls provided by EDAN.
Packaging
1. EDAN Blood Gas and Electrolyte Controls are contained in 2.5mL glass ampoules, and
EDAN Hematocrit Controls are contained in 1.7mL glass ampoules.
2. The controls package contains information such as the control name, level, lot number and
expiration date, etc.
Storage
件
Store controls according to the controls user manual.
AL
Before Use 文
Controls should be equilibrated to room temperature before use. If oxygen is to be measured, the
ampoule needs to stand at room temperature for at least 4 hours. If not, the ampoule needs to
TI
密
stand at room temperature for 30 minutes.
Immediately before use, mix controls completely by shaking the ampoule gently, and always hold
EN
an ampoule at tip and at bottom with forefinger and thumb to minimize increasing controls
保
temperature. Tap the tip of the ampoule carefully with your fingernail to remove any solution.
ID
NOTE:
邦
 Store and use controls according to the user manual, and use them before the
NF
expiration date as labeled on the package.

理
 Only controls provided by EDAN or its authorized distributors should be used.

CO
 Avoid contaminating controls.
 For test cartridges with pH, pCO2, pO2, Ca++ sensors, a new ampoule and syringe or
capillary tube should be used for each test. For test cartridges without pH, pCO2, pO2,
AN
Ca++ sensors, the remaining solution can still be used if the ampoule is opened within
10 minutes.
ED
 The test results should fall within the acceptable ranges programmed in the bar code
on the user manual for controls provided by EDAN.
- 82 -
6.1.2 Procedures for Control Test

Follow the steps below to perform a control test:
1. Examine the package label of controls to ensure they have not expired.
2. Remove an ampoule from the box of controls and equilibrate it to room temperature.
If oxygen is to be measured, the ampoule needs to stand at room temperature for at least 4
hours. If not, the ampoule needs to stand at room temperature for 30 minutes.
件
AL
name bar code.
文
TI
密
EN
保
ID
邦
NF
理
CO
5. On the Main screen, press to go to the Quality Control screen.
6. Select the desired control type.

AN
Press to perform a control test for blood gases and blood chemistries.
ED
Press to perform a control test for Hct.
- 83 -
件
AL
文
TI
密
EN
NOTE:
保

ID
 For sample introduction with a capillary tube or an ampoule, insert a capillary

邦
adaptor/ampoule adaptor into the fillport after removing the cartridge.

NF
 When inserting an ampoule adaptor into the fillport of a test cartridge, make sure the
理
indent of the adaptor is on the upside as shown in the picture below:

CO
AN
ED
- 84 -
9. Press Scan Barcode, and scan the bar code on the controls user manual.
件
AL
文
NOTE:
TI
密
Keep the controls user manual for a future control test use.
EN
10. Mix the controls completely by shaking the ampoule gently, and then tap the tip of the
保
ampoule carefully with your fingernail to remove any solution.

ID
邦
NF
理
CO
AN
Figure 6-5 Mix Controls and Insert Cartridge

ED
NOTE:
Avoid heating the ampoule with your hands when shaking the ampoule.
- 85 -
11. Open the ampoule by snapping off the top and immediately transfer control solution by
slowly drawing an appropriate amount of solution with a syringe or capillary tube from the
bottom of the ampoule.
NOTE:
 When using an ampoule for sample introduction, you need not transfer control
solution. Insert the ampoule into the adaptor after opening it, and directly go to step
13.
 Take protective measures when opening the ampoule, such as using gloves, tissue,
etc.
件
NOTE:
AL
文
 When using a syringe, discard the first 2 drops of solution first, then remove the
TI
密
 When using a capillary tube, directly insert the capillary tube into the adaptor till the
tube reaches the interface between the adaptor and the cartridge.
EN
保
 To avoid inaccurate test results, make sure there are no bubbles in the sample. If
bubbles continually exist, use a new ampoule and syringe or capillary tube to collect
ID
samples again.
邦
13. Gently insert the cartridge into the cartridge port, and carefully press down to ensure that it
NF
clicks into place.

理
CO
NOTE:
AN
complete.
ED
- 86 -
14. The system automatically aspirates calibrant.
件
15. The system automatically performs calibration.
AL
文
TI
密
EN
保
ID
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NF
16. The system automatically aspirates samples when calibration is complete.

理
CO
AN
ED
- 87 -
17. The system automatically analyzes the sample upon the completion of sampling.
件
18. The system automatically displays the test results upon the completion of the test.
AL
文
TI
密
EN
保
ID
邦
NF
Figure 6-10 Control Test Results

理
19. View the results.

CO
NOTE:
 The system will indicate whether the results are within or outside the acceptable
ranges with Under Control/Out of Control.
AN
 If a parameter fails calibration, the system will not be able to determine whether it is
under control, and will display Calibration Failure to prompt you.
ED
 The system will not report the result for a parameter failing the control test in the
patient sample analysis, if QC Lockout function is enabled in Setup. To report the
result for the parameter, repeat the control test till the parameter passes it.
- 88 -
 If the results are outside the acceptable ranges, check the following items first, and
then perform another test.
 Refer to the user manual to confirm that the test procedures are correct.
 Test cartridges and controls are stored properly and have not expired.
 The system passes the electronic simulator test.
If all the above items are verified, but the results are still outside the acceptable
ranges, please stop using the system and contact EDAN or its authorized distributors
for assistance.
件
21. Press Print to print the results.
AL
文
The contents of a control test report depend on the type of controls you have used, the type of the
TI
test cartridge you have used，the options selected in section 4.2.1 Printer Setup and the errors and
密
alarms the system detects during the analysis. Here is an example of a control test report.
EN
Control Test Report
保
EDAN i15
ID
System ID 201303200023
邦
Report Type Control Test

Print Time 2012-03-20 15:20:00
NF
Test Time 2012-03-20 15:00:00

理
Operator ID 55555
Lot Number 21209
CO
Control Results
pH 7.161
pCO2 68.2 mmHg
AN
pO2 66.0 mmHg

+
Na 114.8 mmol/L
+
K 6.90 mmol/L
++
Ca 1.52 mmol/L
ED
-
Cl 77 mmol/L
Glu 4.33 mmol/L
Lac 0.69 mmol/L
- 89 -
pH Under Control
pCO2 Under Control
pO2 Under Control
Na+ Under Control
K+ Under Control
Ca++ Under Control
Cl- Under Control
Glu Under Control
Lac Under Control
Control Ranges
pH [7.111 - 7.211]
pCO2 [60.2 – 76.2] mmHg
件
pO2 [51.0 – 81.0] mmHg
+
Na [109.8 – 119.8] mmol/L
AL
+
K [1.44 - 2.44] mmol/L
Ca ++
[1.32 – 1.72]
文
mmol/L
-
Cl [72 – 82] mmol/L
Glu [3.43 - 5.23] mmol/L
TI
密
Lac [0.19 – 1.19] mmol/L
EN
6.1.3 Temperature Correction for pO2 and pCO2
保
It is known that pO2 and pCO2 results are inversely affected by ambient temperature. You can
adjust the acceptable ranges to account for ambient temperature effects using the table below. For
ID
example, if your laboratory typically operates at 24 – 26 C and the pCO2 range for level 1 is 60.2
邦
– 76.2 mmHg, the range can be adjusted by substracting 0.74 mmHg to upper and lower limits:
Adjusted range = (60.2 – 76.2) mmHg – 0.74 = 59.46 – 75.46 mmHg.
NF
mmHg Level 10 - 12 C 13 - 15C 15 - 17C 18 - 20C 21 - 23C 24 - 26C 27 - 28C 29 - 31C

理
pO2 1 3.37 2.53 1.69 0.84 0.00 -0.84 -1.69 -2.53

pCO2 1 2.94 2.21 1.47 0.74 0.00 -0.74 -1.47 -2.21
pO2 2 6.92 5.19 3.46 1.73 0.00 -1.73 -3.46 -5.19
CO
pCO2 2 1.47 1.10 0.74 0.37 0.00 -0.37 -0.73 -1.10

pO2 3 10.48 7.86 5.24 2.62 0.00 -2.62 -5.24 -7.86
kPa Level 10 - 12 C 13 - 15C 15 - 17C 18 - 20C 21 - 23C 24 - 26C 27 - 28C 29 - 31C

AN
pO2 1 0.45 0.34 0.22 0.11 0.00 -0.11 -0.22 -0.34

pCO2 1 0.39 0.29 0.20 0.10 0.00 -0.10 -0.20 -0.29
pO2 2 0.92 0.69 0.46 0.23 0.00 -0.23 -0.46 -0.69
pCO2 2 0.20 0.15 0.10 0.05 0.00 -0.05 -0.10 -0.15
pO2 3 1.40 1.05 0.70 0.35 0.00 -0.35 -0.70 -1.05
ED
6.1.4 Control Database

The control database displays control test data for the most recent month by default, and it can
- 90 -
hold up to 1000 data entries. The system displays 50 data entries on every page. Press Prev. and
Next to page through the screens of the displayed data entries. When 80% of the space is
occupied, the system will prompt you to export the stored data to a removable disk (such as a
USB drive). If data is not exported, the system will continue to save new data. When the database
is full, the system will always prompt you to export the stored data. If data is still not exported,
the system will automatically delete the oldest one to accommodate a new one. The following
operations can be performed in the control database: transmitting control test data to the Data
Management System (DMS) or HIS/LIS through Wi-Fi or the network, exporting control test data
to a removable disk (such as a USB drive), viewing the details of control test data, searching for
and printing control test data, etc.
件
On the Database screen, press to get to the Control Database screen.
AL
文
TI
密
EN
保
ID
邦
Figure 6-11 Control Database Screen

NF
理
CO
AN
ED
- 91 -
6.1.4.1 Searching for Control Test Data
1. On the Control Database screen, press Search.
件
AL
文
TI
密
EN
保
ID
邦
NF
理
CO
AN
4. Press Return to go back to the Control Database screen.

ED
- 92 -
6.1.4.2 Viewing Details of Control Test Data
1. Press the control test data you want to view.
2. Press Details. The system displays the details:
件
AL
文
TI
Figure 6-14 Details of Control Test Results
密
3. View the details.
EN
保
4. Press Return to go back to the Control Database screen.

ID
6.1.4.3 Exporting/Uploading/Printing Control Test Data

邦
1. Open the control database.

NF
理
2. Select the desired control test data.
To Do this
CO

AN
Print Press Print.
NOTE:
ED
If no control test data is selected before pressing Export/Upload/Print, all of the data
stored in the control database will be exported/uploaded/printed.
- 93 -
6.2 Proficiency Test
Proficiency tests are also called external quality control tests. In proficiency tests, the analysis of
unknown samples from external quality control providers can reflect the accuracy of the system.
6.2.1 Procedures for Proficiency Test

Follow the directions below to perform a proficiency test:
1. Examine the package label of proficiency samples to ensure they have not expired.
2. Remove an ampoule from the box and equilibrate it to room temperature.
件
AL
文
TI
密
EN
name bar code.
保
ID
邦
NF
理
CO
AN

ED
5. On the Main screen, press to go to the Quality Control screen, and then press .
- 94 -
件
AL
文
TI
密
EN
保
NOTE:

ID
邦
 For sample introduction with a capillary tube or an ampoule, please insert a capillary
NF
理
CO
AN
ED
- 95 -
8. Enter the lot number of the proficiency sample, and then press Enter.
To enter the lot number information with the bar code scanner, press first, and then scan
the bar code.
件
AL
文
TI
Figure 6-17 Enter Information
密
NOTE:
Only lot number information within 1-16 digits is acceptable.

EN
保
9. Mix the proficiency sample completely by shaking the ampoule gently, and then tap the tip of
the ampoule carefully with your fingernail to remove any solution.
ID
邦
NF
理
CO
AN
ED
Figure 6-18 Mix Proficiency Sample and Insert Cartridge

NOTE:
- 96 -
10. Open the ampoule by snapping off the top and immediately transfer proficiency solution by
slowly drawing an appropriate amount of solution with a syringe or capillary tube from the
bottom of the ampoule.
NOTE:
 When using an ampoule, you need not transfer the proficiency solution. Insert the
ampoule into the adaptor after opening it, and directly go to step 12.
etc.
件
NOTE:
AL
文
TI
密
EN
保
samples again.
ID
邦
clicks into place.
NF
理
CO
NOTE:
AN
complete.

ED
- 97 -
件
AL
文
TI
密
EN
保
ID
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NF

理
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AN
ED
- 98 -
件
AL
文
TI
密
EN
保
ID
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NF
Figure 6-23 Proficiency Test Results

理

CO

AN
ED
- 99 -
Here is an example of a proficiency test report.

Proficiency Test Report
EDAN i15
System ID 201303200023
Report Type Proficiency Test
Print Time 2012-03-20 15:20:00
Test Time 2012-03-20 15:10:00
Operator ID 55555
Lot Number 21209
Proficiency Results
pH 7.4
件
pCO2 40 mmHg
pO2 90 mmHg
AL
文
TI
密
EN
保
ID
邦
NF
理
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AN
ED
- 100 -
6.2.2 Proficiency Database

The proficiency database displays all the proficiency test data by default, and it can store up to
1000 data entries. The system displays 50 data entries on every page. Press Prev. and Next to
page through the screens of the displayed data entries. The following operations can be
performed in the proficiency database: transmitting proficiency test data to the Data Management
System (DMS) or HIS/LIS through Wi-Fi or the network, exporting proficiency test data to a
removable disk (such as a USB drive), viewing the details of proficiency test data, searching for
and printing proficiency test data, etc.
On the Database screen, press to get access to the Proficiency Database screen.
件
AL
文
TI
密
EN
保
Figure 6-24 Proficiency Database Screen

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6.2.2.1 Searching for Proficiency Test Data

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1. On the Proficiency Database screen, press Search.

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4. Press Return to go back to the Proficiency Database screen.
6.2.2.2 Viewing Details of Proficiency Test Data
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1. Press the proficiency test data you want to view.

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Figure 6-27 Details of Proficiency Test Results

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4. Press Return to go back to the Proficiency Database screen.
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6.2.2.3 Exporting/Uploading/Printing Proficiency Test Data
1. Open the proficiency database.
2. Select the desired proficiency test data.
To Do this
Print Press Print.
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NOTE:
If no proficiency test data is selected before pressing Export/Upload/Print, all of the data
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stored in the proficiency database will be exported/uploaded/printed.
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6.3 Calibration Verification Test
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Calibration verification tests are intended to verify the accuracy of results over the entire
measurement range of a test.
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6.3.1 Calibration Verification Controls

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Calibration verification controls are intended for use to confirm the lineary of the i15 Blood Gas
and Chemistry Analysis System. Calibration verification controls used are RNA Medical®
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CVC123 Calibration Verification Controls and RNA Medical® CVC9005 Hematocrit Calibration
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Verification Controls. The concentrations of reactive ingredients in various levels of calibration

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verification controls are known. Calibration verification controls do not contain human or
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biological materials. Acceptable ranges for calibration verification controls specific to the i15
Blood Gas and Chemistry Analysis System are programmed in the bar code on the user manual
for calibration verification controls provided by EDAN.
Packaging
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1. RNA Medical® CVC123 Calibration Verification Controls are contained in 2.5mL glass
ampoules, and RNA Medical® CVC9005 Hematocrit Calibration Verification Controls are
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contained in 1.7mL glass ampoules.
2. The calibration verification controls package contains information such as the calibration
verification control name, level, lot number and expiration date, etc.
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Storage
Store calibration verification controls according to the calibration verification controls user
manual.
Before Use
Calibration verification controls should be equilibrated to room temperature before use. If oxygen
is to be measured, the ampoule needs to stand at room temperature for at least 4 hours. If not, the
ampoule needs to stand at room temperature for 30 minutes.
Immediately before use, mix calibration verification controls completely by shaking the ampoule
gently, and always hold an ampoule at tip and at bottom with forefinger and thumb to minimize
increasing calibration verification controls temperature. Tap the tip of the ampoule carefully with
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your fingernail to remove any solution.
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NOTE:
文
 Store and use calibration verification controls according to the user manual, and use
them before the expiration date as labeled on the package.
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 Only calibration verification controls provided by EDAN or its authorized distributors
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should be used.
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 Avoid contaminating calibration verification controls.

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 For test cartridges with pH, pCO2, pO2, Ca++ sensors, a new ampoule and syringe or
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capillary tube should be used for each test. For test cartridges without pH, pCO2, pO2,
Ca++ sensors, the remaining solution can still be used if the ampoule is opened within
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10 minutes.
 The test results should fall within the acceptable ranges programmed in the bar code
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on the user manual for calibration verification controls provided by EDAN.
6.3.2 Procedures for Calibration Verification Test

Follow the steps below to perform a calibration verification test:
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1. Examine the package label of calibration verification controls to ensure they have not
expired.
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2. Remove an ampoule from the box of calibration verification controls and equilibrate it to
room temperature.
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name bar code.
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5. On the Main screen, press to go to the Quality Control screen.

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6. Select the desired calibration verification type.

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Press to perform a calibration verification test for blood gases and blood chemistries.
Press to perform a calibration verification test for Hct.
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NOTE:
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 For sample introduction with a capillary tube or an ampoule, insert a capillary
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9. Press Scan Barcode, and scan the bar code on the calibration verification controls user
manual.
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NOTE:
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Keep the calibration verification controls user manual for a future calibration verification
test use.
文
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10. Mix the calibration verification controls completely by shaking the ampoule gently, and then
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tap the tip of the ampoule carefully with your fingernail to remove any solution.
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Figure 6-31 Mix Calibration Verification Controls and Insert Cartridge

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NOTE:
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11. Open the ampoule by snapping off the top and immediately transfer calibration verification
control solution by slowly drawing an appropriate amount of solution with a syringe or
capillary tube from the bottom of the ampoule.
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NOTE:
 When using an ampoule for sample introduction, you need not transfer calibration
verification control solution. Insert the ampoule into the adaptor after opening it, and
directly go to step 13.
etc.
NOTE:
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samples again.
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clicks into place.
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NOTE:
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complete.

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NF

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Figure 6-36 Calibration Verification Test Results

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NOTE:
 The system will indicate whether the results are within or outside the acceptable
ranges with Under Control/Out of Control.
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 If a parameter fails calibration, the system will not be able to determine whether it is
under control, and will display Calibration Failure to prompt you.
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 The system will not report the result for a parameter failing the calibration verification
test in the patient sample analysis, if QC Lockout function is enabled in Setup. To
report the result for the parameter, repeat the calibration verification test till the
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parameter passes it.
 If the results are outside the acceptable ranges, check the following items first, and
then perform another test.
 Refer to the user manual to confirm that the test procedures are correct.
 Test cartridges and calibration verification controls are stored properly and have
not expired.
 The system passes the electronic simulator test.
If all the above items are verified, but the results are still outside the acceptable
ranges, please stop using the system and contact EDAN or its authorized distributors
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for assistance.
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文
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The contents of a calibration verification test report depend on the type of calibration verification
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controls you have used, the type of the test cartridge you have used，the options selected in
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section 4.2.1 Printer Setup, and the errors and alarms the system detects during the analysis. Here
is an example of a calibration verification test report.
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Calibration Verification Test Report

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EDAN i15
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System ID 201303200023
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Report Type Cal Ver Test

Print Time 2012-03-20 15:20:00
Test Time 2012-03-20 15:00:00
Operator ID 55555
Lot Number 21209
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Cal Ver Results

pH 7.161
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pCO2 68.2 mmHg

pO2 66.0 mmHg
+
Na 114.8 mmol/L
+
K 6.90 mmol/L
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Ca++ 1.52 mmol/L

Cl- 77 mmol/L
pH Under Control
pCO2 Under Control
pO2 Under Control
Na+ Under Control
K+ Under Control
Ca++ Under Control
Cl- Under Control
Cal Ver Ranges

pH [7.111 - 7.211]
pCO2 [60.2 – 76.2] mmHg
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pO2 [51.0 – 81.0] mmHg
+
Na [109.8 – 119.8] mmol/L
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+
K [1.44 - 2.44] mmol/L
Ca ++
[1.32 – 1.72]
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mmol/L
-
Cl [72 – 82] mmol/L
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6.3.3 Calibration Verification Database
The calibration verification database displays calibration verification test data for the most recent
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month by default, and it can hold up to 1000 data entries. The system displays 50 data entries on
every page. Press Prev. and Next to page through the screens of the displayed data entries. When
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80% of the space is occupied, the system will prompt you to export the stored data to a removable
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disk (such as a USB drive). If data is not exported, the system will continue to save new data.
When the database is full, the system will always prompt you to export the stored data. If data is
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still not exported, the system will automatically delete the oldest one to accommodate a new one.
The following operations can be performed in the calibration verification database: transmitting
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calibration verification test data to the Data Management System (DMS) or HIS/LIS through
Wi-Fi or the network, exporting calibration verification test data to a removable disk (such as a
USB drive), viewing the details of calibration verification test data, searching for and printing
calibration verification test data, etc.
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On the Database screen, press to get to the Calibration Verification Database screen.
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Figure 6-37 Calibration Verification Database Screen
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6.3.3.1 Searching for Calibration Verification Test Data
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1. On the Calibration Verification Database screen, press Search.
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ID
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4. Press Return to go back to the Calibration Verification Database screen.
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6.3.3.2 Viewing Details of Calibration Verification Test Data
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1. Press the calibration verification test data you want to view.

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Figure 6-40 Details of Calibration Verification Test Results

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4. Press Return to go back to the Calibration Verification Database screen.
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6.3.3.3 Exporting/Uploading/Printing Calibration Verification Test Data
1. Open the calibration verification database.
2. Select the desired calibration verification test data.
To Do this
Print Press Print.
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NOTE:
If no calibration verification test data is selected before pressing Export/Upload/Print, all
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data stored in the calibration verification database will be exported/uploaded/printed.
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6.4 Simulator Test
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6.4.1 Procedures for External Simulator Test
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Follow the procedures below to perform an external simulator test:
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To scan the bar code of the user name, press first, and then scan the bar code.
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3. On the Main screen, press to go to the Quality Control screen, and then press .
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4. Gently insert the external electronic simulator into the cartridge port, and press down to
ensure it clicks into place. If the electronic simulator is inserted properly, the system will
automatically perform a simulator test.
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Figure 6-42 Insert External Simulator
NOTE:
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 Avoid touching the contact pads.
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 Never touch the simulator after inserting it into the system.
5. The system automatically starts to perform an external simulator test.

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6. The system automatically displays the test result upon the completion of the test.
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Figure 6-44 External Simulator Test Result
7. View the result.
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NOTE:
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 Upon the completion of the test, the message “Please Remove Cartridge” will be
displayed on the status bar at the bottom of the screen, and the simulator will be
ejected.
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 If the system passes the external simulator test, it can be used to analyze samples.
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 If the system fails the external simulator test, perform the test again or try another
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simulator. If it passes the test, it can be used to analyze samples. If it fails again,
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contact EDAN or its authorized distributors for assistance.

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8. Press Home to go to the Main screen.

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9. Remove the external simulator from the system, and put it back.
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NOTE:
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Never remove the external simulator until the test is complete.
6.4.2 Simulator Database

The simulator database displays all of the simulator test data by default, and it can store up to
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2000 data entries. The system displays 50 data entries on every page. Press Prev. and Next to
page through the screens of the displayed data entries. When 80% of the space is occupied, the
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system will prompt you to export the stored data to a removable disk (such as a USB drive). If
data is not exported, the system will continue to save new data. When the database is full, the
system will always prompt you to export data. If data is still not exported, the system will
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automatically delete the oldest one to accommodate a new one. The following operations can be
performed in the simulator database: transmitting simulator test data to the Data Management
System (DMS) or HIS/LIS through Wi-Fi or the network, exporting simulator test data to a
removable disk (such as a USB drive), searching for and printing simulator test data, etc.
On the Database screen, press to get access to the Simulator Database screen.
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Figure 6-45 Simulator Database Screen
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6.4.2.1 Searching for Simulator Test Data
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1. On the Simulator Database screen, press Search.

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4. Press Return to go back to the Simulator Database screen.
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6.4.2.2 Exporting/Uploading/Printing Simulator Test Data
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密
1. Open the simulator test database.
2. Select the desired simulator test data.

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To Do this
ID
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Print Press Print.

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NOTE:
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If no simulator test data is selected before pressing Export/Upload/Print, all of the data
stored in the simulator database will be exported/uploaded/printed.
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Here are examples of simulator test reports:
External Simulator Test Report
EDAN i15
System ID 201303200023
Report Type External Simulator
Print Time 2012-03-20 15:20:00
Test Time 2012-03-20 15:20:00
Operator ID admin
Simulator Pass
Internal Simulator Test Report
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EDAN i15
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System ID 201303200023
Report Type Internal Simulator
Print Time 2012-03-20 15:20:00
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Test Time 2012-03-20 15:20:00
Operator ID admin
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Simulator Pass
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i15 Blood Gas and Chemistry Analysis System User Manual Data Management
Chapter 7 Data Management

7.1 Introduction
The system has powerful data management ability. It can logically manage the results for
different tests and transmit them to the DMS or HIS/LIS.
There are two ways of transmitting data:
 With a removable disk such as a USB drive
 Through LAN/WLAN
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NOTE:
The transmitted data can only be opened by the DMS.
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On the Main screen, press
文
to get access to the Database screen.
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Figure 7-1 Database Screen
7.2 Databases
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The following databases have been described in the previous chapters: Patient Sample Database,
Control Database, Proficiency Database, Calibration Verification Database, Simulator Database.
In this part, the databases below will be described: Security Database, Diagnosis Database,
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Events Log Database and Backup.
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7.2.1 Security Database
NOTE:
Only administrators can get access to the security database.
The security database displays all the security data by default, and it can store up to 100 data
entries. The system displays 50 data entries on every page. Press Prev. and Next to page through
the screens of the displayed data entries. The following operations can be performed in the
security database: deleting security data, searching for operators, adding and editing security data,
etc.
On the Database screen, press to get access to the Security Database screen.
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Figure 7-2 Security Database Screen

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Operators are divided into four levels according to their access rights: operators, administrators,
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service engineers and engineers from the manufacturer. If an operator cannot access a function,
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the following message will appear:

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Figure 7-3 No Access Rights
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7.2.1.1 Searching for an Operator
1. On the Security Database screen, press Search.
2. Enter the operator ID, and press OK.
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4. Press Return to go back to the Security Database screen.

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7.2.1.2 Adding an Operator
1. On the Security Database screen, press Add.
2. Enter the operator ID, password and re-enter the same password.
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Figure 7-6 Add Operator
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3. Press OK to save the changes, and press OK in the pop up dialog box. The system will
go to the Security Database screen.
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NOTE:
 The operator ID is case sensitive, and should be 1 - 16 characters long (including

ID
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both letters and numbers). "admin/demo/service/edan", or upper and lower case

combinations of these words are not permitted.
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 The password is case sensitive, and should be 4 - 16 characters long (including both
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letters and numbers).

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7.2.1.3 Changing Operator Password
1. Select the operator data you want to edit.

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2. Press Edit.
3. Enter the password, and re-enter the same password.

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Figure 7-7 Change Operator Password
4. Press OK to save the changes, and press OK in the pop up dialog box. The system will
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go to the Security Database screen.
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NOTE:
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The password is case sensitive, and should be 4 - 16 characters long (including both
letters and numbers).
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7.2.1.4 Deleting Security Data

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1. Select the desired security data.

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2. Press Delete, and press OK in the pop up message.

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NOTE:
If no security data is selected before pressing Delete, all of the data stored in the security
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database will be deleted.
7.2.1.5 Changing System Password

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1. Press Administrator on the Security Database screen.
2. Press Edit.
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3. Enter the current system password, enter the new system password and re-enter the same
password.
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Figure 7-8 Change System Password
4. Press OK to accept the changes, and press OK in the pop up dialog box. The system will
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go to the User Login screen.
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NOTE: 文
 The default factory system password is 123456.
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 Only administrators can change the system password (Even engineers from the
密
manufacturer can not change it, although they can retrieve the password to the
default factory setting).
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7.2.2 Diagnosis Database

The diagnosis database displays diagnosis data for the most recent month by default, and it can
ID
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store up to 10000 data entries. The following operations can be performed in the diagnosis
database: exporting diagnosis data to a removable disk (such as a USB drive), viewing the details
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of diagnosis data, searching for and printing diagnosis data, etc.

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NOTE:
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Only service engineers and engineers from the manufacturer can get access to the
diagnosis database.
7.2.3 Events Log Database

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The events log database records the following information: User Login and Logout, changing
time and date, changing slopes and offsets, changing patient information, deleting data stored in
databases, replacing a calibrant fluid pack. It can store up to 10000 data entries. The system
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displays 50 data entries on every page. Press Prev. and Next to page through the screens of the
displayed data entries. You can export, search for and print the events with the events log
database.
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On the Database screen, press to get access to the Events Log Database screen.
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Figure 7-9 Events Log Database Screen
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7.2.3.1 Searching for Events Data
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1. On the Events Log Database screen, press Search.
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4. Press Return to go back to the Events Log Database screen.
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7.2.3.2 Exporting/Printing Events Data
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1. Open the events log database.
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2. Select the desired event data.
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To Do this
ID
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Print Press Print.

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NOTE:
If no event data is selected before pressing Export/Print, all of the data stored in the
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events log database will be exported/printed.

Here is an example of an event log report:
EDAN i15
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System ID 201303200023
Report Type Events Log Report
Print Time 2012-03-20 15:20:00
Log Time 2012-03-20 15:20:00
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Operator ID 1111
Operation Change date and time
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7.2.4 Backup
With this function, all of the stored data in the following databases can be backed up: Patient
Sample Database, Control Database, Proficiency Database, Calibration Verification Database,
and Simulator Database.
Follow the steps below to backup data:
1. On the Database screen, press to access the Backup screen.
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Figure 7-12 Backup Screen

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2. Select the database you want to backup. √ indicates the database is selected.
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3. Press OK, and press OK in the pop up dialog box, the system will backup all of the data
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stored in the database.

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4. Press OK in the pop up dialog box to delete all of the data in the backup database.
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CAUTION
Deleting data in the backup database is permanent. Deleted data can not be recovered
after deletion.
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i15 Blood Gas and Chemistry Analysis System User Manual Troubleshooting
Chapter 8 Troubleshooting
The following table lists some problems you may encounter to assist in troubleshooting.
Table 9-1 Troubleshooting Examples
Item Problem Solution
If the system is running smoothly, remove

A test cartridge will not be ejected the test cartridge ejector cap, pull the middle
1
automatically when a test is complete. hole with a pointed object, and remove the
test cartridge from the system immediately.
Remove the test cartridge ejector cap, pull
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A test cartridge is inserted into the system the middle hole with a pointed object, and
2
prior to a test. remove the test cartridge from the system
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文 immediately.
Remove the test cartridge ejector cap, pull
A simulator will not be ejected automatically
3 the middle hole with a pointed object, and
TI
when a simulator test is complete.
remove the simulator from the system.
密
Connect the system to AC power, and turn
on the system. After about 1 minute, the test
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cartridge will be ejected automatically. If it
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A test cartridge can not be removed because

4 is not ejected automatically, remove the test
of power interruption during operation.
cartridge ejector cap, pull the middle hole
ID
with a pointed object, and remove the test

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cartridge from the system immeidately.

Reboot the system. After about 1 minute,
NF
the test cartridge will be ejected

理
A test cartridge can not be ejected because automatically. If it is not ejected

5 the system malfunctions, for example, the automatically, remove the test cartridge
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system is dead. ejector cap, pull the middle hole with a

pointed object, and remove the test cartridge
from the system immediately.
Perform an electronic simulator test to
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confirm that the system is working

smoothly. If the system passes the simulator
The prompt “Cartridge is not Qualified”
6 test, perform sample tests with new test
appears.
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cartridges. If the problem continues after

several attempts, please contact EDAN or
its authorized distributors for assistance.
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Perform the test again with a new test

The prompt “POGO_PIN does Not Contact cartridge. If the prompt appears again,
7
Well” appears. please contact EDAN or its authorized
Verify that the current date is correct. If the
prompt appears again, check that the test
8 The prompt “Cartridge Expired” appears.
cartridge has not expired. If it has expired,
use a new test cartridge that has not expired.
The prompt “Calibrant is Not Aspirated cartridge. If the prompt appears again,
9
Properly” appears. please contact EDAN or its authorized
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The prompt “Air is Not Aspirated Properly” cartridge. If the prompt appears again,
10
appears. please contact EDAN or its authorized
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文 Check that there are no clots in the blood
The prompt “Sample Error. Maybe Clots are
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11 sample. If there are clots, discard it and
Detected in Sample” appears.
collect samples again.
密
Verify that a simulator is inserted during a
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12 The prompt “Insertion Error” appears. simulator test and a test cartridge is inserted
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during a sample test.

Verify that the current date is correct. If the
ID
The prompt “Calibrant Pack Expired, prompt appears again, check that the
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13 Confirm Date Setup and Calibrant Pack’s calibrant fluid pack has not expired. If it has
Expiration Date” appears. expired, replace the calibrant fluid pack
NF
following the user manual instructions.

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The calibrant fluid pack has expired.

14 The prompt “Remaining Days: 0” appears. Replace the calibrant fluid pack following
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the user manual instructions.

The calibrant fluid pack has been depleted.
The prompt “Calibrant Pack Depleted”
15 Replace the calibrant fluid pack following
appears.
the user manual instructions.
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The date is earlier than the manufacture date

16 The prompt “Current Date Error” appears. of the calibrant fluid pack. Ensure that the
current date is correct.
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The prompt “Calibrant Pack Improper The calibrant fluid pack is removed from
17 Removal. Please Replace Calibrant Pack” the system improperly. Replace the calibrant
appears. fluid pack following the user manual
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instructions.
The prompt “Barcode Cannot be Identified” Ensure that the bar code is that of a calibrant
18
appears. fluid pack.
Ensure that the bar code is that of a new

The prompt “Calibrant Pack Can’t be Used,
19 calibrant fluid pack and that the new
Please Scan Again” appears.
calibrant fluid pack has not expired.
Ensure that the calibrant fluid pack chamber
The calibrant fluid pack chamber door can
20 lock has been unlocked before opening the
not be opened.
door.
Check that the calibrant fluid pack or test
The system fails to scan the calibrant fluid
21 cartridge bar code is not destroyed, and scan
pack or test cartridge bar code.
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it again.
Open the printer casing, adjust the paper
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22 Paper does not run from the paper tray. position carefully, and close the printer
文 casing. Press Print to print a record.
If a jam occurs for the first time, it might be
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caused by an inappropriate placement of the
密
paper. In this case, open the paper casing,
remove the paper from the paper tray,
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remove the paper with rumples, put the
保
23 Paper-jam appears.
paper in the paper tray again, adjust the
position of the paper carefully and close the
ID
casing. If the problem continues, please

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contact EDAN or its authorized distributors

for assistance.
NF
Check whether there is paper in the paper

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tray. If it has been depleted, load paper

24 The prompt “No Paper in Printer” appears. again, and shut the printer casing. If the
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problem continues, please contact EDAN or

There is no sound after you successfully

25 Check the volume setup.
press the touch screen.
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Ensure that the intensity of the network

The system can not be connected to a
26 signal is strong and that the network setup is
network through Wi-Fi.
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correct.
The system can not communicate with the Ensure that the network or Wi-Fi is
27
DMS. successfully connected, and that the IP
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address of the DMS is correct.
Clean and disinfect the screen following the

28 Fluids have been spilled on the screen.
user manual instructions.
Check the scanner type. If it is the type

recommended by EDAN, remove the
29 The USB scanner does not work smoothly.
scanner from the system, and insert it again.
Set the scanner, and scan a bar code again.
For an operator, contact the administrator
for assistance. For an administrator, contact
30 Forget the user name or password.
EDAN or its authorized distributors for
assistance.
件
Install the lithium battery following the user
manual instructions. Connect the system to
AL
AC power. The system will be charged
31 The lithium battery can not be charged.
文 automatically. If it still can not be charged,
please contact EDAN or its authorized
TI
密
Move the analyzer horizontally, and clear
the fluids. Remove the calibrant fluid pack
EN
There are fluids flowing from the bottom of from the analyzer and check whether it is
32
保
the analyzer. damaged. If it is not damaged, perform a

simulator test and a control test to ensure the
ID
proper performance of the system.

邦
Check that the ambient temperature is

within 10 – 31 C, and that the air vents are
The prompt “Ambient Temperature Out of
NF
33 not obstructed. Reboot the system. If the

Range” appears.
理
problem continues, please contact EDAN or

CO
Please contact EDAN or its authorized

34 The prompt “Heating Abnormally” appears.
The prompt “Abnormal Cam Location” Please contact EDAN or its authorized
35
appears. distributors for assistance.
AN
The date setup can not be saved after you Please contact EDAN or its authorized
36
shut down the system. distributors for assistance.
ED
Please contact EDAN or its authorized

37 The system makes abnormal sounds.
- 133 -
i15 Blood Gas and Chemistry Analysis System User Manual Cleaning, Care and Maintenance
Chapter 9 Cleaning, Care and Maintenance

The system needs little care and maintenance. Clean and maintain it periodically to ensure its
optimum performance.
9.1 Cleaning and Disinfecting the Analyzer
Follow proper safety procedures and take protective measures such as wearing approved
gloves when cleaning and disinfecting the system.
NOTE:
 Follow the instructions in this manual when cleaning and disinfecting the system.
件
 Inside the test cartridge port should never be cleaned.
AL
 A test cartridge and a calibrant fluid pack should never be cleaned.
文
9.1.1 Cleaning and Disinfecting the Exterior Surfaces
TI
密
Clean and disinfect the exterior surfaces to remove dust, splatters, etc. Policies regarding the
cleaning and disinfecting intervals are at the discretion of your individual institution.
EN
Following the procedures below to clean and disinfect the exterior surfaces:
保
1. Turn off the analyzer.

ID
2. Disconnect the power cord and the power adaptor.

邦
Disconnect the connecting cables if the system is connected to other pieces of equipment.
NF
3. Dampen a lint-free cloth with detergents or disinfectants.

理
If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required
CO
to be used for the disinfection step.
NOTE:
The cloth should be wet but not dripping.

AN
4. Clean the exterior surfaces with the wet cloth.
5. Clean the surfaces with the wet cloth to disinfect them after the surfaces are completely dry.
ED
NOTE:
 Clean the surfaces prior to disinfecting them.
 Make sure the surfaces are thoroughly dry before disinfecting them.
- 134 -
6. When the surfaces are thoroughly dry, reconnect the power cord, power adaptor and other
connecting cables.
NOTE:
The validated detergents for cleaning the system are:
 Mild near neutral detergent
 Ethanol (75%)
 Isopropanol (70%)
The validated disinfectants for cleaning the system are:
 Ethanol (75%)
件
 Isopropanol (70%)
AL
9.1.2 Cleaning and Disinfecting the Screen 文
Clean and disinfect the screen to remove dust, splatters, etc. Policies regarding the cleaning and
TI
disinfecting intervals are at the discretion of your individual institution. Follow the steps below to
密
clean and disinfect the screen:
EN
1. Dampen a lint-free cloth with detergents or disinfectants.
保
NOTE:
ID
The cloth should be wet but not dripping.

邦
2. On the Main screen, press to go to the Setup screen.

NF
理
3. Press on the System Setup screen.

CO
4. Select the desired time period during which the system will have no response when you
touch the screen. There are four options: 30 seconds, 1 minute, 2 minutes and 5 minutes. The
default is 30 seconds.
AN
ED
- 135 -
Figure 9-1 Select Clean Time
件
5. Press Clean Screen. The system will display the screen below:
AL
文
TI
密
EN
保
ID
邦
NF
理
Figure 9-2 Remaining Time
6. Clean the screen with the lint-free cloth.

CO
7. Repeat steps 4-6 to disinfect the screen with the lint-free cloth after the screen is thoroughly
dry.
NOTE:
AN
 Clean the screen prior to disinfecting it.
 Make sure that the screen is thoroughly dry before disinfecting it.
ED
8. Press Return twice to return to the Main screen.
- 136 -
9.1.3 Cleaning the Printer Head

Dirty and soiled thermal printer heads will decrease the printing definition, so printer heads
should be cleaned at least once a month.
Open the printer casing and remove the printer paper. Clean the printer head gently with a clean
soft cloth dampened in 75% alcohol. For stubborn stains, soak the stain with a little alcohol first
and wipe it off with a clean soft cloth. After air drying, load the printer paper and shut the printer
casing.
CAUTION
1． Prevent the detergent from seeping into the system while cleaning. Do not immerse
件
the analyzer in liquid under any circumstances.
AL
2． Do not clean the system with abrasive fabric.
文
9.2 Care and Maintenance
TI
密
9.2.1 Recharging and Replacement of Battery
 Capacity Identification
EN
保
Current capacity of the rechargeable battery can be identified according to the battery
symbol on the status bar at the bottom of the LCD screen:
ID
邦
: Full capacity.
NF
理
Capacity is not full.

CO
: Capacity is limited, and recharging should be taken into account.
: Capacity is low, the battery should be recharged soon.

AN
: Capacity is empty. The battery should be recharged immediately.
NOTE:
ED
 If the system is powered only by AC power, the symbol for the adaptor will
appear on the status bar at the bottom of the screen.
- 137 -
 If the analyzer is powered only by the battery, one of the symbols above will appear
on the status bar at the bottom of the screen.
 If the analyzer is powered by both the battery and AC power, and the battery is not
being charged, the symbol will appear on the status bar at the bottom of the
screen.
 Recharging
The analyzer is equipped with a recharge control circuit together with a rechargeable lithium
battery. When the analyzer is connected to the mains supply, the battery will be recharged
automatically. Because of the capacity consumption during storage and transport, the battery
件
capacity will not be full when it is used for the first time. Battery recharging should be
considered before the first use.
AL
NOTE:
文
If the battery has not been used for more than two months, it should be recharged before
use.
TI
密
 Replacement
EN
保
When the useful life of the battery is over, or there is a foul smell or leakage, please contact
EDAN or its authorized distributors for replacement.
ID
邦
WARNING
1. Only the battery of the same model and specifications provided by EDAN should be
NF
used.
理
2. Danger of explosion - Do not reverse the anode and the cathode when installing the
CO
battery.
3. Remove the battery from the system if it is not used for a long time.
4. If the battery is stored alone and not used for a long time, it is recommended that the
AN
battery should be charged at least once every 6 months to prevent overdischarge.
5. When the battery’s useful life is over, contact EDAN or the local distributor for
ED
disposal or dispose of the battery according to local regulations.
- 138 -
9.2.2 Printer Paper
CAUTION
Only use the printer paper provided by EDAN or its authorized distributors, otherwise the
printer may be damaged. This kind of damage is not covered by warranty.
Storage Requirements:
 Do not put the printer paper under fluorescence for a long time.
 Printer paper should be stored in a dry, dark and cool area, avoiding excessive temperature,
humidity and sunshine.
件
 Make sure there is no polyvinyl chloride or other chemicals in the storage environment,
which will lead to color change of the paper.
AL
文
9.2.3 Maintenance of the Analyzer
TI
密
The following safety checks should be performed at least once every 24 months by a qualified
person who has adequate training, knowledge, and practical experience to perform these tests.
EN
保
a) Inspect the analyzer and accessories for mechanical and functional damage.
ID
b) Inspect the safety related labels for legibility.

邦
c) Verify the analyzer functions properly as described in the instructions for use.
NF
If the analyzer is not functioning properly or fails any of the above tests, it has to be repaired.
理
WARNING
CO
Failure on the part of the responsible individual institution employing this equipment to
implement a satisfactory maintenance schedule may cause undue equipment failures.
Analyzer:
AN
 Avoid excessive temperatures, sunshine, humidity or dirt.

ED
Avoid shaking the analyzer violently when moving it to another place.
 Prevent any liquid from seeping into the analyzer.
- 139 -
i15 Blood Gas and Chemistry Analysis System User Manual Theory
Chapter 10 Theory
The system utilizes potentiometry and amperometry to determine the concentrations of blood gases
and blood chemistries, and utilizes conductivity to determine the concentration of Hct. Many
parameters can also be calculated such as cH+, HCO3-act, HCO3-std, BE(ecf), BE(B), BB(B), and
so on.
10.1 Measurement Method
Methods
Measurements are performed on undiluted specimens. Undiluted methods are also called direct
件
methods, whereas methods that dilute the sample are called indirect methods.
AL
For electrolytes, direct methods measure the free ion concentration of analyte (apparent or free
文
ion activity) per unit volume of plasma water, and indirect methods measure the concentration of
analyte per unit volume of plasma. It is known that the direct method gives the clinically
TI
significant result for electrolytes. When there is disagreement between the methods, such as when
密
the patient has abnormal total protein or lipid levels, it results from interference on the indirect
EN
method. At normal levels of protein and lipids the systematic offset between methods is often
保
corrected for in commercial direct measuring instruments so that the normal ranges for all
instruments are in agreement. Sensors have been calibrated in the manufacture so that normal
ID
ranges are in agreement with indirect reference methods at normal levels of total protein and
邦
lipids.
NF
Direct measurement of hematocrit by the conductometric technique gives a result related to the
理
non-conducting excluded volume fraction of the sample. Red blood cell volume is the
predominant component of the nonconducting volume, but proteins, lipids, and white blood cells
CO
also contribute. Elevated hematocrit readings are expected at abnormally elevated levels of these
components. Decreased hematocrit readings are expected at abnormally low levels of protein,
such as found in hemodiluted samples taken from cardiopulmonary bypass. Osmotic imbalance
AN
causes a discrepancy between direct (conductometric, spun) and indirect (Coulter) measurements
because of variation in the meancell volume.
ED
Sensors
Sensor refers to the electrode embedded in test cartridges. There are three different types of
sensors:
- 140 -
 Potentiometric Sensor
 Amperometric Sensor
 Conductometric Sensor
Potentiometry: A potential is recorded using a voltmeter, which relates to the concentration of

the sample. A reference electrode is used to provide a stable, fixed potential against which other
potential differences can be measured. This measurement technique is used for pH, pCO2 and
electrolytes.
Amperometry: The magnitude of an electrical flow of current is proportional to the
concentration of the substance being oxidized or reduced at an electrode. This measurement
technique is used for pO2, glucose and lactic acid.
件
Conductivity: The specific impedance of a sample as measured by two conducting electrodes
AL
held at a constant voltage is directly proportional to the conductive properties of the sample. This
文
technique is used for Hct.
TI
10.2 Determination of Test Results
密
10.2.1 Determination of the Analyte Concentration
EN
The concentration of the analyte is determined with the potentiometric and amperometric sensors.
保
For both sensors, the analyte concentration is calculated using:

ID
 The known analyte concentration of calibrant solution;

邦
 The measured voltage or current of the calibrant solution.

NF
 The measured voltage or current of the sample.

理
For potentiometric sensors, the analyte activity in the sample is calculated from the Nerst
CO
equation:
Esample – Ecalibrant = S log (αsample/αcalibrant)
Where E denotes the potential, α denotes the activity of an ion, and S denotes the slope of the
AN
sensor.
ED
- 141 -
10.2.2 Determination of Cell Concentration
Hct
In whole blood, the cellular constituents, red and white blood cells and platelets do not conduct
electricity, while plasma does. For a sample whose electrolyte concentration is given, the more
cells, the less conductivity. The total cell concentration of the whole blood is determined from:
 The known value of the electrolyte concentration in the calibrant.
 The measured electrolyte concentration of the sample.
 The measured conductivity signal generated by the calibrant.
 The measured conductivity signal generated by the sample.
件
CPB
AL
文
When samples with abnormally low protein levels are tested, the system need to use the CPB
compensation algorithm. The CPB compensation algorithm is specially intended for use when
TI
samples are taken from patients on cardiopulmonary bypass. It also applies to the adult whose
密
protein levels are abnormally low.
EN
10.3 Equations for Calculated Parameters
保
cH+
ID
邦
Hydrogen ion concentration

NF
cH+ = 10 (9 – pH) [nmol/L]

理
HCO3-act
CO
Bicarbonate ion concentration
HCO3-act = 0.0307 × pCO2 × 10(pH - 6.105) [mmol/L]
HCO3-std
AN
Bicarbonate ion concentration normalized to a pCO2 40 mmHg
HCO3-std = 24.5 + 0.9 × A + [(A - 2.9)2 × (2.65 + 0.31 × tHb (est))] / 1000 [mmol/L]
ED
Where A = BE (B) – [0.2 × tHb (est) × (100 - sO2 (est))] / 100, tHb (est) can be entered by users,
and the default value for tHb (est) is 15 g/dL.
- 142 -
BE (ecf)
Base excess (ecf)
BE (ecf) = HCO3-act - 24.8 + (16.2 × (pH - 7.40)) [mmol/L]
BE (B)
Base excess (B)
BE (B) = (1 - 0.014 × tHb (est)) × [HCO3-act - 24.8 + (1.43 × tHb (est) + 7.7) × (pH - 7.40)]
[mmol/L]
Where tHb (est) can be entered by users, and the default value for tHb (est) is 15g/dL.
件
BB (B)
AL
Buffer Base 文
BB (B) = BE (B) + 41.7 + 0.42 × tHb (est) [mmol/L]
TI
Where tHb (est) can be entered by users, and the default value for tHb (est) is 15 g/dL.
密
ctCO2
EN
Total carbon dioxide
保
ctCO2 = HCO3-act + 0.0307 × pCO2 [mmol/L]

ID
Ca++ (7.4)
邦
The ionized calcium concentration of blood normalized to pH 7.4

NF
理
Ca++ (7.4) = Ca++ × 10 [0.178 ×(pH - 7.40)] [mmol/L]

CO
AnGap
An approximation of the difference between measured cations and measured anions in the sample
AnGap = (Na+ + K+) - (Cl- + HCO3-act) [mmol/L]

AN
tHb (est)
An estimation of the hemoglobin contained in the sample

ED
tHb (est) = MCHC × Hct / 100 [g/dL]
Where MCHC is the mean corpuscular hemoglobin concentration, and can be entered by users.
- 143 -
The default value for MCHC is 34 g/dL. The unit for Hct is %PCV.
sO2 (est)
An estimation of hemoglobin oxygen saturation: a ratio of hemoglobin bound to oxygen to the

total amount of hemoglobin able to bind oxygen
pO2    pO2
*3 *
sO 2 (est )   100
pO2    pO2  
*3 *
[%]
pO2 (A-a)
Alveolar-arterial oxygen tension difference
件
pO2 (A-a) = pO2 (A) - pO2 (a) [mmHg]
AL
pO2 (a/A) 文
Arterial-alveolar oxygen tension ratio
pO2 (a/A) = pO2 (a) / pO2 (A) [mmHg]
TI
密
RI
EN
Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure difference to arterial
保
pO2
ID
RI = pO2 (A-a) / pO2 (a)

邦
pO2 / FIO2
NF
The ratio of arterial pO2 to the fraction of inspired oxygen

理
pO2 / FIO2 = pO2 / FIO2 [mmHg]

CO
pH (T)
pH value corrected for entered patient temperature

AN
pH (T) = pH – [0.0147 + 0.0065 × (pH – 7.4)] (T – 37)
cH+ (T)
ED
Hydrogen ion concentration corrected for entered patient temperature
cH+ (T) = 10 (9 – pH (T)) [nmol/L]
- 144 -
pCO2 (T)
pCO2 corrected for entered patient temperature
pCO2 (T) = pCO2 × 100.019(T - 37) [mmHg]
pO2 (T)
pO2 corrected for entered patient temperature
[mmHg]
件
pO2 (A-a) (T)
Alveolar-arterial oxygen tension difference corrected for entered patient temperature
AL
文
pO2 (A-a) (T) = pO2 (A) (T) - pO2 (a) (T) [mmHg]
TI
pO2 (a/A) (T)
密
Arterial-alveolar oxygen tension ratio corrected for entered patient temperature
EN
pO2 (a/A) (T) = pO2 (a) (T) / pO2 (A) (T) [mmHg]
保
RI (T)
ID
Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure difference to arterial
邦
pO2 when both values are corrected for patient temperature

NF
RI (T) = pO2 (A-a) (T) / pO2 (a) (T)

理
pO2 (T)/FIO2
CO
The ratio of arterial pO2 to the fraction of inspired oxygen corrected for the entered patient
temperature
pO2 (T) / FIO2 = pO2 (T) / FIO2 [mmHg]

AN
ED
- 145 -
i15 Blood Gas and Chemistry Analysis System User Manual Parameters
Chapter 11 Parameters
11.1 pH
pH reflecting the acid-base status of a patient is the negative logarithm of the hydrogen ion
concentration.
pH is measured by potentiometry with a pH selective membrane electrode. The concentration of

hydrogen ions is determined by the measured potential through the Nernst equation.
If test results are inconsistent with the clinical assessment, the sample should be analyzed again
with a new test cartridge.
件
11.1.1 Intended Use
AL
The pH test is intended for the quantification of pH in arterial, venous, or capillary whole blood
samples.
文
pH is an important clinical indicator to assess the acid-base imbalance caused by pathologic
TI
密
conditions, such as ventilatory dysfunction and renal inadequency. The reasons for abnormal
blood pH values are:
EN
 primary bicarbonate deficit - metabolic acidosis
保
 primary bicarbonate excess - metabolic alkalosis

ID
邦
 primary hypoventilation - respiratory acidosis

NF
primary hyperventilation - respiratory alkalosis

理
11.1.2 Traceability
CO
pH values assigned to calibrant, controls and calibration verification controls are traceable to
NIST standards.
11.1.3 Temperature Correction

AN
pH is a temperature dependent quantity which is measured at 37 °C on the system. The pH value

can be corrected to the patient’s temperature other than 37 °C. Patient temperature can be entered
on the Enter Patient Information screen during each patient sample test.
ED
The pH at the patient’s temperature is calculated as follows:
pH (T) = pH – [0.0147 + 0.0065(pH – 7.4)] (T – 37)
- 146 -
11.1.4 Performance Characteristics

Experiments are designed according to the following CLSI guidelines: CLSI EP6-A for linearity
studies, CLSI EP9-A2 for method comparison studies, and CLSI EP7-A2 for interference studies.
Typical performance data presented below were obtained by technologists, nurses, physicians and
therapists trained in the use of the system and the comparative method.
Repeatability on RNA Medical® QC823 Blood Gas●Electrolyte●Metabolite●BUN Controls was
estimated using one lot of test cartridges, and 20 replicates of each control level were
successively analyzed on one i15 Blood Gas and Chemistry Analysis System.
In the repeatability data table below, SD refers to the standard deviation.
Controls Mean SD
件
Level 1 7.161 0.0061
AL
Level 2 7.401 0.0104
文
Level 3 7.565 0.0074
TI
Precision and recovery on whole blood samples was estimated using multiple whole blood
密
samples with pH values spanning the measurement range. In the table below, Swr refers to within
EN
run standard deviation.
保
Parameter N Expected Observed Swr Bias %Recovery

ID
9 7.085 7.110 0.021 0.025 100.4%

邦
9 7.325 7.357 0.020 0.032 100.4%

NF
pH
理
9 7.581 7.559 0.011 -0.022 99.7%

CO
9 7.656 7.673 0.010 0.017 100.2%
Linearity was estimated using reference materials and reference methods. Three replicates of
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® CVC123
AN
Calibration Verification Controls. In the table below, Sy.x refers to the standard error of estimate.
Correlation
ED
Parameter N Slope Intercept Sy.x Range

Coefficient
pH 15 0.98 0.12 0.99996 0.00397 6.715 – 7.768
- 147 -
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.
Correlation
Coefficient
pH 215 1.0259 -0.1934 0.9919 0.0126 7.137 – 7.720
11.1.5 Interfering Substances

Aqueous sample was spiked by addition of a potentially interfering substance to the following
test concentration to test for interferences. Twelve replicates of both the spiked sample and the
件
unspiked sample were tested on two i15 Blood Gas and Chemistry Analysis Systems with one lot
of test cartridges. The interference was computed using the difference between the mean of the
AL
spiked sample and the unspiked sample.
文
The following substances were tested and found not to be clinically significant for the pH
TI
measurement: 24 mmol/L Hydroxyurea, 1.0 mmol/L Magnesium, 20 mmol/L Lactate, 4.00
密
mmol/L Salicylate, 37.5 mmol/L Bromide, and 20 mmol/L β -hydroxybutyrate.
EN
NOTE:
保
It is possible that there are other substances interfering with the pH measurement.
ID
邦
11.2 pCO2
NF
pCO2, the partial pressure of carbon dioxide, is measured by potentiometry. pCO2 is determined
理
by the measured potential through the Nernst equation.

CO
11.2.1 Intended Use

AN
The pCO2 test is intended for the quantification of pCO2 in arterial, venous, or capillary whole
blood samples.
ED
pCO2 is an important indicator to reflect respiratory acid-base balance. If pCO2 is above the
normal range, it is termed respiratory acidosis. If pCO2 is below the normal range, it is termed
respiratory alkalosis. Metabolic factors can also cause pCO2 increase/decrease: metabolic
- 148 -
acidosis leads to decreased pCO2, and metabolic alkalosis leads to increased pCO2. pCO2 along
with pH is a more persuasive tool to assess acid-base balance.
11.2.2 Traceability
pCO2 values assigned to calibrant, controls, and calibration verification controls are traceable to
NIST standards.

pCO2 is a temperature dependent quantity which is measured at 37 °C on the system. The pCO2
value can be corrected to the patient’s temperature other than 37 °C. Patient temperature can be
entered on the Enter Patient Information screen during each patient sample test.
件
The pCO2 at the patient’s temperature is calculated as follows:
AL
pCO2 (T) = pCO2 × 100.019(T - 37) 文
TI
密
EN
保

ID
邦
estimated using one lot of test cartridges, and 20 replicates of each level were successively
analyzed on one i15 Blood Gas and Chemistry Analysis System.
NF

理
Controls Mean SD
CO
Level 1 68.63 2.650
Level 2 43.97 1.368

AN
Level 3 24.41 1.886
ED
samples with pCO2 values spanning the measurement range. In the table below, Swr refers to
within run standard deviation.
- 149 -
9 123.2 124.9 4.5 1.7 101.4%
9 42.8 42.5 1.2 -0.3 99.3%

pCO2
9 21.3 20.1 1.5 -1.2 94.4%
9 10.6 10.0 1.1 -0.6 94.3%
件
Correlation
AL
Coefficient
pCO2 15 1.00 0.22

文 0.99998 0.215 17.8 – 84.0
TI
密
EN
on each system.
保
Correlation
ID
Coefficient
邦
pCO2 215 0.9394 1.4498 0.9868 1.5950 11.5 – 73.8

NF

理
CO
AN

The following substances were tested and found not to be clinically significant for the pCO2
measurement: 24 mmol/L hydroxyurea, 1.0 mmol/L magnesium, 20 mmol/L lactate, 4.00
ED
mmol/L Salicylate, 37.5 mmol/L bromide, and 20 mmol/L β -hydroxybutyrate.

NOTE:
It is possible that there are other substances interfering with the pCO2 measurement.
- 150 -
11.3 pO2
pO2, the partial pressure of oxygen, is measured by amperometry. The oxygen reduction current
is proportional to the dissolved oxygen concentration.
11.3.1 Intended Use

The pO2 test is intended for the quantification of pO2 in arterial, venous, or capillary whole blood
samples.
件
The pO2 value of arterial blood is important in assesing the efficiency of pulmonary gas
exchange.
AL
11.3.2 Traceability
文
pO2 values assigned to calibrant, controls, and calibration verification controls are traceable to
NIST standards.
TI
密

EN
保
pO2 is a temperature dependent quantity which is measured at 37 °C on the system. The pO2
value can be corrected to the patient’s temperature other than 37 °C. Patient temperature can be
ID
entered on the Enter Patient Information screen during each patient sample test.
邦
The pO2 at the patient’s temperature is calculated as follows:

NF
理
CO

AN
ED

- 151 -
Controls Mean SD
Level 1 65.3 2.95
Level 2 103.0 3.02
Level 3 150.8 4.189
samples with pO2 values spanning the measurement range. In the table below, Swr refers to
件
AL
9 21.4
文
21.7 1.3 0.3 101.4%
TI
9 149.7 151.6 3.7 1.9 101.3%
pO2
密
9 271.8 270.8 8.0 -1.0 99.6%
EN
9 422.2 421.7 18.7 -0.5 99.9%
保
ID
邦
NF
理
Correlation
Coefficient
CO
pO2 15 0.92 4.51 0.99989 2.58604 39.6 – 448.2
AN
on each system.
Correlation
ED

Coefficient
pO2 215 0.9811 1.3173 0.9986 2.0303 20.4 – 191.0
- 152 -

The following substances were tested and found not to be clinically significant for the pO2
NOTE:
件
It is possible that there are other substances interfering with the pO2 measurement.
AL
11.4 Sodium (Na+)
文
TI
Sodium is measured by potentiometry with an ion-selective electrode. The concentration of
密
sodium ions is determined by the measured potential through the Nernst equation. The system
uses a direct (undiluted) method to measure sodium and the obtained values may differ from
EN
those obtained by an indirect (diluted) method.
保
ID

邦
11.4.1 Intended Use

NF
理
The sodium test is intended for the quantification of sodium in arterial, venous, or capillary whole
blood samples.
CO
Sodium is the major cation in the extracellular space in the body. It plays an important part in
maintaining osmotic pressure and acid-base balance.
Monitoring blood sodium level is important in the diagnosis or monitoring of diseases involving
AN
electrolyte imbalance and all disturbances of the water balance, heart and kidney insufficiencies,
and so on.
ED
11.4.2 Traceability
Sodium ion concentration values assigned to calibrant, controls, and calibration verification
controls are traceable to NIST standards.
- 153 -


件
Controls Mean SD
Level 1 114.6 0.83
AL
Level 2
文 140.1 0.83
TI
Level 3 168.7 0.92
密
EN
samples with Na+ values spanning the measurement range. In the table below, Swr refers to
保

ID
邦
9 111.2 111.7 0.7 0.5 100.4%
Na+
NF
9 140.5 140.8 1.6 0.3 100.2%

理
9 166.0 167.3 3.1 1.3 100.8%

CO
AN
Correlation
Coefficient
ED
Na+ 15 0.98 1.30 0.99999 0.1924 102.6 – 180.3
- 154 -
on each system.
Correlation
Coefficient
Na+ 215 0.9813 2.3952 0.9961 1.1661 102.3 – 164.9

件
AL
文
The substances that interfere with the Na+ measurement are listed below:
TI
密
37.5 mmol/L bromide will increase Na+ results by 5.5 mmol/L.
The following substances were tested and found not to be clinically significant for the Na+
EN
保

ID
邦
NOTE:
It is possible that there are other substances interfering with the Na+ measurement.
NF
理
11.5 Potassium (K+)

CO
Potassium is measured by potentiometry with an ion-selective electrode. The concentration of

potassium ions is determined by the measured potential through the Nernst equation. The system
uses a direct (undiluted) method to measure potassium and the obtained values may differ from
AN
ED
- 155 -
11.5.1 Intended Use

The potassium test is intended for the quantification of potassium in arterial, venous, or capillary
whole blood samples.
Potassium is the most abundant cation in the intracellular fluid, and plays an important role in
nerve conduction and muscle function. It also helps maintain acid-base balance and osmotic
pressure.
Potassium value is important for patients who are undergoing infusion therapies, who are
experiencing heart insufficiency, and so on.
11.5.2 Traceability
件
Potassium ion concentration values assigned to calibrant, controls, and calibration verification
AL
文
TI
密
EN
保

ID
邦

NF

理
Controls Mean SD
CO
Level 1 1.92 0.014
Level 2 4.51 0.041
Level 3 6.70 0.047

AN
samples with K+ values spanning the measurement range. In the table below, Swr refers to within
ED
- 156 -
9 3.40 3.35 0.04 -0.05 98.5%
K+ 9 4.00 4.01 0.03 0.01 100.3%
9 9.37 9.36 0.20 -0.01 99.9%
Correlation
件
Coefficient
K+ 1.82 – 12.09
AL
15 1.0 -0.04 文 0.99997 0.03787
TI
密
on each system.
Correlation
EN
Coefficient
保
K+ 215 1.0068 -0.0409 0.9983 0.0594 2.55 – 6.70

ID
邦

NF
理
CO
The following substances were tested and found not to be clinically significant for the K+
AN

ED
NOTE:
It is possible that there are other substances interfering with the K+ measurement.
- 157 -
11.6 Ionized Calcium (Ca++)
Ionized calcium (Ca++) is measured by potentiometry with an ion-selective electrode. The

concentration of ionized calcium is determined by the measured potential through the Nernst
equation.
11.6.1 Intended Use

The ionized calcium test is intended for the quantification of ionized calcium in arterial, venous,
or capillary whole blood samples.
件
Ca++, the physiologically active form of calcium, plays an important role in muscle contraction,
transmission of nerve impulses, and cardiac functions.
AL
For patients who are in critical care situations, especially those who need to receive large
文
amounts of blood, the Ca++ level should be monitored closely.
11.6.2 Traceability
TI
密
Ionized calcium concentration values assigned to calibrant, controls, and calibration verification
EN
保

ID
邦
NF
理
CO
AN
Controls Mean SD
Level 1 1.47 0.029

ED
Level 2 1.16 0.026
Level 3 0.46 0.009
- 158 -
samples with Ca++ values spanning the measurement range. In the table below, Swr refers to
9 1.05 1.05 0.03 0.00 100.0%
Ca++ 9 1.21 1.20 0.01 -0.01 99.2%
9 2.68 2.68 0.07 0.00 100.0%
件
AL
Correlation
Parameter N Slope Intercept
文 Coefficient
Sy.x Range
Ca++ 15 0.98 0.37 0.99998
TI 0.00972 0.15 – 3.74

密
EN
保
on each system.
ID
Correlation
邦
Coefficient
NF
Ca++ 215 0.9987 0.0019 0.9910 0.0265 0.61 – 1.73

理

CO
AN
ED
The substances that interfere with the Ca++ measurement are listed below:
 12.5 mmol/L bromide will increase Ca++ results by 0.07 mmol/L.
 37.5 mmol/L bromide will increase Ca++ results by 0.17 mmol/L.
- 159 -
The following substances were tested and found not to be clinically significant for the Ca++
mmol/L Salicylate, and 20 mmol/L β -hydroxybutyrate.
NOTE:
It is possible that there are other substances interfering with the Ca++ measurement.
11.7 Chloride (Cl-)
Chloride is measured by potentiometry with an ion-selective electrode. The concentration of

chloride ions is determined by the measured potential through the Nernst equation. The system
uses a direct (undiluted) method to measure chloride, and the obtained values may differ from
件
AL
文
11.7.1 Intended Use
TI
密
The chloride test is intended for the quantification of chloride in arterial, venous, or capillary
EN
保
Cl-, the major anion in the extracellular space in the body, plays a role in the regulation of the
ID
acid-base balance, and regulates osmotic pressure together with Na+.

邦
Monitoring Cl- value is vital for patients who suffer from hypertension, cardiac distress, etc.
NF
11.7.2 Traceability
理
Chloride ion concentration values assigned to calibrant, controls, and calibration verification
CO

AN
ED

- 160 -
Controls Mean SD
Level 1 78.8 0.62
Level 2 96.7 0.84
Level 3 127.1 0.76
samples with Cl- values spanning the measurement range. In the table below, Swr refers to within
件
AL
9 80.0
文
80.0 0.3 0.0 100.0%
TI
Cl- 9 106.5 106.6 1.3 0.1 100.1%
密
9 133.0 133.0 1.8 0.0 100.0%
EN
保
ID
邦
Correlation
NF

理
Coefficient
Cl- 15 0.98 0.37 0.99998 0.2404 72 - 146

CO
on each system.
AN
Correlation
Coefficient
ED
Cl- 215 0.9955 0.2967 0.9961 0.9802 77 - 132
- 161 -

The substances interfering with the Cl- measurement are listed below:
 12.5 mmol/L bromide will increase Cl- results by 15.5 mmol/L.
 4.00 mmol/L Salicylate will increase Cl- results by 15.0 mmol/L.
件
The following substances were tested and found not to be clinically significant for the Cl-
measurement: 24 mmol/L hydroxyurea, 1.0 mmol/L magnesium, 20 mmol/L lactate, and 20
AL
mmol/L β -hydroxybutyrate.
文
NOTE:
TI
密
It is possible that there are other substances interfering with the Cl- measurement.
EN
11.8 Hematocrit (Hct)
保
Hematocrit is a measurement of the volume occupied by red blood cells in whole blood samples.
ID
Hematocrit is determined by conductometry with two gold electrodes. The conductance of the
邦
blood sample is inversely related to the hematocrit value.

NF
理

CO
11.8.1 Intended Use

The hematocrit test is intended for the quantification of hematocrit in arterial, venous, or capillary
AN
Hematocrit is a useful indicator for assessing states of blood volume, such as anemia and
erythrocytosis.
ED
11.8.2 Traceability
Hematocrit values assigned to controls and calibration verification controls are traceable to the
standard method: CLSI H7-A3 procedure for measuring packed cell volume by the
- 162 -
microhematocrit method.

Repeatability on RNA Medical® QC900 Hematocrit Controls was estimated using one lot of test
cartridges, and 20 replicates of each level were successively analyzed on one i15 Blood Gas and
Chemistry Analysis System.
件
Controls Mean SD
AL
Low
文 20.3 0.93
TI
High 49.7 0.47
密
EN
samples with Hct values spanning the measurement range. In the table below, Swr refers to
保

ID

邦
9 25.5 26.2 0.5 0.7 102.7%

NF
Hct 9 44.0 44.6 0.9 0.6 101.4%

理
9 64.0 62.5 1.5 -1.5 97.7%

CO
System and the Rapidpoint 400 system. Reference materials used were RNA Medical® CVC 9005
AN
Hematocrit Calibration Verification Controls. In the table below, Sy.x refers to the standard error of
estimate.
Correlation
ED

Coefficient
Hct 15 0.99 0.56 0.99988 0.34811 15.0 – 62.0
- 163 -
on each system.
Correlation
Coefficient
Hct 215 0.9729 1.0199 0.9932 0.7518 23 - 53

The substances interfering with the hematocrit measurement are listed below:
 A significant increase in white blood cell count may increase the hematocrit results.
件
 An increase in total protein level will increase the hematocrit results.
AL
文
 Abnormally high lipids may increase the hematocrit results.
 Factors interfering with sodium results will also interfering with hematocrit results.
TI
密
NOTE:
EN
It is possible that there are other substances interfering with the hematocrit
保
measurement.
ID
11.9 Glucose (Glu)

邦
Glu, the concentration of Glucose, is measured by amperometry. It is the key molecule of

NF
carbonhydrate metabolism.
理
CO
11.9.1 Intended Use

The Glucose test is intended for use by trained medical professionals as an in vitro diagnostic
AN
device for the quantitative testing of samples of arterial, venous or capillary whole blood in the
laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism
ED
disorders including diabetes mellitus, idiopathic hypoglycemia and of pancreatic islet cell tumors.
11.9.2 Traceability
Glucose values assigned to calibrant, controls, and calibration verification controls are traceable
- 164 -
to NIST standards.

件
Controls Mean SD
Level 1 4.42 0.059
AL
Level 2
文 10.95 0.167
TI
Level 3 16.38 0.197
密
EN
samples with Glu values spanning the measurement range. In the table below, Swr refers to
保

ID
邦
9 2.4 2.28 0.13 -0.12 95.1%

NF
Glu 9 6.1 6.22 0.23 0.12 102.0%

理
9 17.4 17.22 0.62 -0.18 99.0%

CO
System and the iSTAT1 system. Reference materials used were RNA Medical® CVC123
AN
Correlation
Coefficient
ED
Glu 15 0.9534 0.3101 0.9996 0.3417 0.5 – 39.5
- 165 -
Analysis System and the iSTAT1 system. Two replicates of each sample were analyzed on each
system.
Correlation
Coefficient
Glu 207 0.9949 0.0810 0.9952 0.7873 1.3 – 37.70

The following substances were tested and the results are listed below:
Parameter Interfering Interfering Clinical 13100201 13100301 13100401 Conclusion
Substances Substances Significant Interference Interference Interference
件
Concentration Level Value Value Value
Requirement
AL
dmax
Ascorbic acid 3 mg/dL
文 0.09 0.13 0.2 Meet with the
requirements
Salicylic acid 50 mg/dL 0.04
TI 0.04 0.08 Meet with the

密
requirements
Acetamidophenol 20 mg/dL 0.21 0.21 8.50% Meet with the
EN
requirements
保
Hydroxyurea 100 umol/L 0.2 6.30% 6.30% Meet with the

requirements
ID
Sodium bromide 37.5 mmol/L 0.18 0.23 7.60% Meet with the
邦
requirements
Ethanol 6.40% 0.1 0.04 Meet with the
NF
10 mg/dL
absolute requirements
理
±10% or
Glu Acetoxybenzoic 50 mg/dL 0.19 0.03 0.05 Meet with the
0.33 mmol/L
acid requirements
CO
Dopamine 0.1 mg/dL 0.05 0.05 0.08 Meet with the

requirements
Dobutamine 10 mg/dL 0.08 0.17 0.14 Meet with the
requirements
AN
Heparin sodium 90 U/mL 0.03 0.25 0.12 Meet with the

requirements
Pralidoxime 128 μg / mL 0.28 0.27 0.04 Meet with the
ED
iodide requirements
Sodium 24 mg/dL 7.60% 0.03 0.28 Meet with the
sulfocyanate requirements
Uric acid 12 mg/dL 0.11 0.01 0.06 Meet with the
- 166 -
requirements
Hydroxybutyric 16 mmol/L 0.24 0.16 7.20% Meet with the
acid requirements
Acetoxyacetic 10 mmol/L 0.17 0.2 0.3 Meet with the
acid requirements
Ibuprofen 40 mg/dL 0.01 0.07 0.09 Meet with the
requirements
Levodopa 7 mg/dL 0.08 0.29 6.60% Meet with the
requirements
Creatinine 5 mg/dL 0.07 0.01 0.09 Meet with the
requirements
11.10 Lactate (Lac)
件
Lac, the concentration of Lactate, is measured by amperometry. It is the product from cell
AL
anaerobic respiration.
文
TI
密
11.10.1 Intended Use
EN
保
The Lactate test is intended for use by trained medical professionals as an in vitro diagnostic
device for the quantitative testing of samples of arterial, venous or capillary whole blood in the
ID
laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.
邦
Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and
treatment of lactic acidosis (abnormally high acidity of the blood).
NF
理
11.10.2 Traceability
CO
Certified standard reference material for lactate is not available at present. Lactate values
assigned to controls and calibration verification materials are traceable to a working calibrator
prepared from L (+) Lactic acid from Sigma-Aldrich Co., Item Number 46937(1),>99% purity.

AN
ED
- 167 -


Controls Mean SD
Level 1 0.69 0.058
Level 2 2.66 0.038
Level 3 7.18 0.125
件
samples with Lac values spanning the measurement range. In the table below, Swr refers to
AL
Parameter N Expected
文
Observed Swr Bias %Recovery
9 1.85 1.80 0.19
TI -0.05 97.35%
密
Lac 9 4.8 4.74 0.25 -0.06 98.81%
EN
9
保
8.3 8.27 0.33 -0.03 99.65%
ID
邦
System and the iSTAT1 system. Reference materials used were RNA Medical® CVC123
NF
理
Correlation
Coefficient
CO
Lac 15 0.9946 0.0717 0.9998 0.1263 0.2 – 20.6
Analysis System and the iSTAT1 system. Two replicates of each sample were analyzed on each
AN
system.
Correlation
ED

Coefficient
Lac 207 0.9775 0.0328 0.9900 0.6107 0.55 – 19.06
- 168 -

The following substances were tested and the results are listed below:
Parameter Interfering Interfering Clinical 13100201 13100301 13100401 Conclusion
Substances Substances Significant Interference Interference Interference
Concentration Level Value Value Value
Requirement
dmax
Ascorbic acid 3 mg/dL 0.1 0.08 0.04 Meet with
the
requirements
Salicylic acid 50 mg/dL 0.19 0.14 0.13 Meet with
件
the
requirements
AL
Acetamidophenol 20 mg/dL 文 0.2 0.34 0.31 Meet with
the
requirements
TI
Hydroxyurea 100 umol/L 0.25 0.27 0.1 Meet with
密
the
±12% or 0.6 requirements
Lac
EN
Sodium bromide 37.5 mmol/L mmol/L 0.12 0.09 0.08 Meet with
the
保
requirements
ID
L－Cysteine 0.1 mmol/L 0.11 0.19 0.02 Meet with

the
邦
requirements
Acetamidophenol 10 mmol/L 0.06 0.04 0.09 Meet with
NF
the
理
requirements
Acetaldehyde 0.6 mg/dL 0.19 0.18 0.07 Meet with
CO
the
requirements
AN
ED
- 169 -
i15 Blood Gas and Chemistry Analysis System User Manual Warranty and Service
Chapter 12 Warranty and Service

12.1 Warranty
EDAN warrants that EDAN’s products meet the labeled specifications of the products and
will be free from defects in materials and workmanship that occur within the warranty
period.
The warranty is void in cases of:
a) Damage caused by mishandling during shipping.
b) Subsequent damage caused by improper use or maintenance.
件
c) Damage caused by alteration or repair by anyone not authorized by EDAN.
AL
d) Damage caused by accidents.
文
e) Replacement or removal of serial number label and manufacture label.
TI
密
If a product covered by this warranty is determined to be defective because of defective
materials, components, or workmanship, and the warranty claim is made within the warranty
EN
period, EDAN will, at its discretion, repair or replace the defective part (s) free of charge.
保
EDAN will not provide a substitute product for use when the defective product is being
ID
repaired.
邦
12.2 Contact Information

NF
理
If you have any question about maintenance, technical specifications or malfunctions of

devices, contact your local distributor.
CO
Alternatively, you can send an email to EDAN service department at: [email protected].
AN
ED
- 170 -
i15 Blood Gas and Chemistry Analysis System User Manual Specifications
Appendix 1 Specifications
A1.1 Environment Requirements
Temperature 10 – 31 °C
Humidity 25% - 80% (non-condensing)

Usage
Ambient 70 - 106.6 kPa
Blood Gas
Pressure (525 – 800 mmHg)
and
Chemistry Temperature -20 – 60 °C
Analyzer
Transport and Humidity 25% - 93% (non-condensing)
Storage
件
AL
Temperature
文 10 – 31 °C

Usage
TI
Pressure
密
(525 – 800 mmHg)
Temperature -10 – 37 °C
EN
Humidity ≤ 93% (non-condensing)
保
Test
Transport
Cartridge
ID

邦
NF
Humidity ≤ 93% (non-condensing)

Storage
理

CO

Usage
AN

Calibrant
Fluid Pack Temperature 2 – 8 °C (avoid freezing)
ED
Transport and Humidity ≤ 93% (non-condensing)

Storage
- 171 -
A1.2 Analyzer Specifications
Size 315*238*153mm (length ×width ×height)
Weight 3.8 Kg (rechargeable battery included, adaptor not included)

LCD Screen 7 inch, 800*480, Color TFT
Power Supply Input 100V - 240V~

Input Current 1.2 A - 0.5 A
Power Frequency 50 Hz/60 Hz
Rechargeable Battery 14.8 VDC/4200 mAh or 5000mAh
件
Main Unit Input 19 VDC, 3.5 A
USB Interface 4 USB Interfaces
AL
Serial Port DB9
文
Bar Code Scanner embedded
A1.3 Performance Specifications

TI
密
EN
Sample Volume 140 uL
保
Test Time It takes no more than 70s from sampling to display of test results.
ID
A1.4 Printer
邦
Printer Built-in thermal printer, thermal printer paper

NF
理
Paper Width 48 mm
A1.5 Rechargeable Battery

CO
Type Rechargeable lithium battery

When the battery is fully charged, the system can analyze and print
Working Time
50 samples.
AN
Necessary Charge time No more than 8 hours
Rated Capacity 4200 mAh or 5000mAh

ED
Rated voltage 14.8 V

Charge Mode Constant voltage/current
- 172 -
Charge Current (standard) 0.2C5A
Charge Temperature 0 °C - +50 °C (+32 °F - +122 °F)
Operating Temperature -20 °C - +60 °C (-4 °F - +140 °F)

Short Term (within 1 month): -20 °C - +60 °C (-4 ºF - +140 ºF)
Middle Term (within 3 months): -20 °C - +45 °C (-4 ºF - +113 ºF)
Storage
Long Term (within 1 year): -20 °C - +20 °C (-4 ºF - +68 ºF)
During storage, recharge the battery at least every six months.
Cycle Life ≥300 times
A1.6 Safety Specifications
EN 61010-1: 2001, EN 61010-2-101: 2002,
件
Comply with
EN 61326-1: 2006, EN 61326-2-6: 2006
The system meets the requirements of IEC 61010-1: 2001 at 5 –
AL
Safety temperature
40 °C, but it cannot work at the temperature greater than 31 °C.
文
Maximum relative humidity 80% for temperatures up to 31 °C
Safety humidity range
decreasing linearly to 50% relative humidity at 40 °C.
TI
密
Pollution degree 2
Degree of protection against
Ordinary equipment (Sealed equipment without water proof)
EN
harmful ingress of water
保
Degree of safety in presence

Equipment not suitable for use in presence of flammable gases
of flammable gases
ID
邦
EMC CISPR 11 Group 1, Class A
Mode of operation Continuous (Indoor use only)

NF
理
CO
AN
ED
- 173 -
i15 Blood Gas and Chemistry Analysis System User Manual Measurement Ranges
Appendix 2 Measurement Ranges

A2.1 Measurement Ranges for Measured Parameters
Parameter Measurement Range

pH 6.5~ 8.0
pO2 10mmHg ~ 700mmHg
pCO2 10.0mmHg ~ 150.0mmHg
K+ 2.0mmol/L ~ 9.0mmol/L
Na+ 100mmol/L ~ 180mmol/L
Cl- 65mmol/L ~ 140mmol/L
Ca++ 0.25mmol/L ~ 2.50mmol/L
Glu 10%PCV ~ 75%PCV
件
Lac 1.1mmol/L ~ 38.9mmol/L
AL
Hct 文 0.30mmol/L ~ 20.00mmol/L
A2.2 Measurement Ranges for Calculated Parameters
Parameter Measurement Range
TI Unit
密
tHb(est) 2.9 ~ 27.7 g/dL
ctCO2 1 ~ 100 mmol/L
EN
cH+ 10.0 ~ 316.2 nmol/L
保
HCO3-act 1.0 ~ 99.9 mmol/L

HCO3-std 1.0 ~ 99.9 mmol/L
ID
BE(ecf) (-38.0) ~ (+38.0) mmol/L

邦
BE(B) (-38.0) ~ (+38.0) mmol/L

BB(B) 4.9 ~ 91.3 mmol/L
NF
sO2(est) 1 ~ 100 %
理
pO2 (A-a) 0 ~ 733 mmHg

pO2 (a/A) 0.00 ~ 1.00
CO
RI 0 ~ 73.30
pO2/FIO2 10 ~ 3333 mmHg
Ca++(7.4) 0.23 ~ 2.71 mmol/L
AnGap (-137) ~ (+123) mmol/L
cH+ (T) 10.0 ~ 316.2 nmol/L
AN
pH(T) 6.5 ~ 8.0

pCO2(T) 10.0 ~ 150.0 mmHg
pO2(T) 10 ~ 700 mmHg
ED
pO2(A-a)(T) 0 ~ 733 mmHg

pO2(a/A)(T) 0.00 ~ 1.00
RI(T) 0 ~ 73.30
- 174 -
i15 Blood Gas and Chemistry Analysis System User Manual Measurement Ranges
pO2(T)/FIO2 10 ~ 3333 mmHg

mOsm 200.9 ~ 449.4 mOsm/L
件
AL
文
TI
密
EN
保
ID
邦
NF
理
CO
AN
ED
- 175 -
i15 Blood Gas and Chemistry Analysis System User Manual Reference Ranges
Appendix 3 Reference Ranges

NOTE:
Because reference ranges may vary with demographic factors such as age, gender and
heritage, it is recommended that the individual institutions should establish their own
reference ranges according to the population being tested. The following reference
ranges are for reference only.
Reference Range
Parameter
Arterial Venous
pH 7.35 - 7.45 7.31 - 7.41
pO2(mmHg) 80 - 105 35 - 40
件
pCO2(mmHg) 35 - 45 41 - 51
Na+(mmol/L) 138 - 146 138 - 146
AL
K+(mmol/L) 3.5 - 4.9 3.5 - 4.9
Cl-(mmol/L)
文
98 - 109 98 - 109
Ca++(mmol/L) 1.12 - 1.32 1.12 - 1.32
Glu 3.3 – 5.6
TI 3.3 – 5.6
密
Lac 0.50 – 1.60 0.50 – 2.20
Hct (%) 38 - 51 38 - 51
EN
保
ID
邦
NF
理
CO
AN
ED
- 176 -
i15 Blood Gas and Chemistry Analysis System User Manual EMC Information
Appendix 4 EMC Information

NOTE:
 The system complies with the emission and immunity requirements of IEC61326.
 The system has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
 The electromagnetic environment should be evaluated prior to operation of the

system.
 Do not use the system in close proximity to sources of strong electromagnetic
件
radiation (e.g. unshielded intentional RF sources), as these may interfere with the
AL
proper operation.
文
Guidance and manufacture’s declaration - electromagnetic emissions-
TI
for all EQUIPMENT and SYSTEMS
密
Guidance and manufacture’s declaration – electromagnetic emission
EN
The system is intended for use in the electromagnetic environment specified below. The user of
保
the system should ensure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance
ID
邦
The system uses RF energy only for its internal

RF emissions function. Therefore, its RF emissions are very low and
NF
Group 1
CISPR 11 are not likely to cause any interference to nearby
理
electronic equipment.
CO
RF emissions
Class A
CISPR 11
Harmonic
The system is suitable for use in all establishments
AN
emissions Class A
other than domestic and those directly connected to the
IEC 61000-3-2
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Voltage
ED
fluctuations/ flicker
Complies
emissions
IEC 61000-3-3
- 177 -
Guidance and manufacture’s declaration - electromagnetic immunity -

for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity

The system is intended for use in the electromagnetic environment specified below. The customer
or the user of the system should ensure that it is used in such an environment.
IEC 61326 Electromagnetic
Immunity test Compliance level
test level environment -guidance
Electrostatic ±4 kV contact ±4 kV contact Floors should be wood,
discharge (ESD) ±8 kV air ±8 kV air concrete or ceramic tile.
IEC 61000-4-2 If floor is covered with
synthetic material, the
relative humidity should
be at least 30%.
件
Electrical fast ±1 kV for power ±1 kV for power supply Mains power quality
transient/burst IEC supply lines lines should be that of a typical
AL
61000-4-4 commercial or hospital
文 environment.
Surge ±1 kV line to line ±1 kV line to line Mains power quality
IEC 61000-4-5 ±2 kV line to ground
TI
±2 kV line to ground should be that of a typical
密
commercial or hospital
environment.
EN
Power frequency 3 A/m 3 A/m Power frequency
保
(50 Hz/60 Hz) magnetic fields should be

magnetic field at levels characteristic of
ID
IEC 61000-4-8 a typical location in a

typical commercial or
邦
hospital environment.
Voltage dips, short 0% UT (100% dip in 0% UT (100% dip in Mains power quality
NF
interruptions and UT) for 1 cycle UT) for 1 cycle should be that of a typical
理
voltage variations commercial or hospital

on power supply 40% UT (60% dip in 40% UT (60% dip in environment. If the user
CO
input lines UT) for 5/6 cycles UT) for 5/6 cycles of the system requires
IEC 61000-4-11 continuous operation
70% UT (30% dip in 70% UT (30% dip in during power mains
UT) for 25/30 cycles UT) for 25/30 cycles interruptions, it is
recommended that the
AN
<5% UT (>95% dip in <5% UT (>95% dip in system be powered from

UT) for 250/300 cycles UT) for 250/300 cycles an uninterruptible power
supply or a battery.
ED
- 178 -
Field strengths from

fixed RF transmitters, as
determined by an
electromagnetic site
a
Conducted RF IEC 3 Vrms 3 Vrms survey, should be less
61000-4-6 150 kHz to 80 MHz than the compliance level
in each frequency range.b
Interference may occur in
3 V/m the vicinity of equipment
Radiated RF 80 MHz to 2.0 GHz marked with the
IEC 61000-4-3 3 V/m following symbol:
件
NOTE 1 UT is the a.c. mains voltage prior to application of the test level.
AL
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
文
NOTE 3: Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
TI
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
密
can not be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
EN
strength in the location in which the system is used exceeds the applicable RF compliance level
保
above, the system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the system.
ID
邦
NF
理
CO
AN
ED
- 179 -
i15 Blood Gas and Chemistry Analysis System User Manual FCC Information
Appendix 5 FCC Information

A5.1 FCC Statement
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment
件
off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
AL
 Reorient or relocate the receiving antenna.
文
 Increase the separation between the equipment and receiver.
TI
密
 Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
EN
 Consult the dealer or an experienced radio/TV technician for help.
保
This device complies with Part 15 of FCC Rules.

ID
邦
Operation is subject to the following two conditions:
This device may not cause harmful interference, and this device must accept any interference
NF
理
received, including interference that may cause undesired operation.
NOTE:
CO
The manufacturer is not responsible for any radio or TV interference caused by

unauthorized modifications to this equipment. Such modifications could void the user’s
authority to operate this equipment.
AN
A5.2 FCC RF Radiation Exposure Statement

ED
This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled
environment. This equipment should be installed and operated with a minimum distance of 20
centimeters between the radiator and your body.
- 180 -
i15 Blood Gas and Chemistry Analysis System User Manual HIS/LIS Interface Guide
Appendix 6 HIS/LIS Interface Guide

NOTE:
When connecting the i15 system to HIS/LIS, please set the TCP/IP port of HIS/LIS to
8000.
A6.1 Principle
A6.1.1 Communication Design
HL7 messages can be transmitted via network or serial port, and the i15 system ustilises network
件
to transmit them. EDAN HL7 protocol defines that the network connection uses C/S mode. The
i15 system transmits data to HIS/LIS.
AL
The i15 system and HIS/LIS should be in the same local area network to exchange data. The i15
文
system converts data to HL7 messages, and transmits them to HIS/LIS. HIS/LIS also transmits
TI
HL7 messages to the i15 system.
密
EN
保
ID
邦
NF
理
Figure A6-1 System Design

CO
A6.1.2 Data Transmission
The i15 system transmits ORU messages only in the unsolicited transmission mode, and
receives acknowledgements from HIS/LIS. If HIS/LIS engineers require the i15 system should
AN
handle the acknowledgements, it will also transmit response messages.

ED
- 181 -
件
Figure A6-2 Data Transmission
A6.1.3 HL7 Lower Layer Protocol (MLLP)
AL
文
To label the edges of HL7 messages, HL7 lower layer protocol is utilized.
The format is shown below:
TI
密
0x0B HL7 Message 0x1C 0x0D
EN
Figure A6-3 HL7 Message Diagram
保
 If messages begin with ASCII<VT> characters, hexadecimal is represented as 0x0B.

ID
 If messages end with ASCII<FS> and <CR>, hexadecimal is represented as 0x1C and 0x0D.
邦
NOTE:
NF
Only when the service application transmits original HL7 data should there be start characters
理
and end characters. If the service application selects XML format, the diagram above is not
CO
applicable. There are only HL7 messages, and they are encoded into XML format.
A6.1.4 Message Encoding Types
The i15 system utilizes UTF8 to encode and decode messages. If HIS/LIS does not utilize UTF8,
AN
it should add UTF8.

ED
- 182 -
A6.2 HL7 Messages
A6.2.1 Message Syntax
For details about HL7 message syntax, please refer to HL7 Standards.
Each HL7 message consists of some segments, and segments are ended with <CR>.
Each segment consists of a three-character segment name and variable numbers of data fields.
Data fields consist of components and subcomponents. Separators are defined in the MSH
segment.
For example:
MSH|^~\&|||||||ORU^R01|0001|P|2.4
件
The five separators behind MSH are used to separate fields, components and subcomponents.
AL
Although they can be any non-text character, the following characters are recommended in HL7
文
Standards:
Character Definition
TI
密
| Field separator
^ Component separator
EN
& Subcomponent separator
~ Repetition separator
保
\ Escape character
ID
Message Rules: [ ] represents the segment can be selected.

邦
{ } represents that the segment can be repeated 0, once, or many times.

NF
A6.2.2 Supporting Message Types

理
The following message types are supported:

CO
Patient Results / QC Results: ORU^R01.
A6.2.3 ACK Messages

AN
The structure of acknowledgement meassages is as follows:
MSH Message Header

ED
MSA Message Acknowledgement
Where the MSA segment contains a confirmation code and message control ID. If it is an error,
- 183 -
there will be an error string.
MSH|^~\&|EDAN|i15|LIS||20130929174802||ACK^R01|1|P|2.4||||0|| UNICODE UTF-8|||
MSA|AA|1|Message accepted
A6.2.4 Report Transmission
A6.2.4.1 ORU^R01 Messages
Patient results and QC results are transmitted to HIS/LIS in the form of ORU^R01 messages.
The rules for ORU^R01 messages are as follows: "MSH {[PID [PD1] <NK1> <NTE> [PV1
[PV2]]] {[ORC] OBR <NTE> [CTD] {[OBX] <NTE>} <FT1> <CTI>}} [DSC]". Where, PID
件
segment is for patient information. OBR contains sample ID and the time when OBX data are
AL
generated. OBX segment depicts the parameter values at OBR.
文
A6.2.4.2 Patient Results
TI
密
Patient results contain the following information:

EN
Item Information (Test Time, Item Name)
保
 Sample Information (Sample ID, Sample Type, Operator ID)

ID
 Patient Information
邦
 Test Results
NF
The transmission structure of patient results is as follows:

理
ORU Observational Results (Unsolicited) Description

CO
MSH Message Header (Item Name, Message Date)
PID Patient Information (Patient ID, Sex)
OBR Observation Report (Sample ID, Sample Type, Operator ID)

AN
{OBX} Test Results (Test Date, Patient Information, Measured Results, Calculated Results,
Calibration Results)
ED
A6.2.4.3 QC Results
QC results contain the following information:

- 184 -
 Item Information (Current Date, Item Name)
 QC Related Information (Test Date, QC Name, QC Type, Lot Number, Level, Operator ID)
 Test Results (Parameter Name, Value, Unit, Status (Under Control, Out of Control,
Calibration Failure), Reference Range, Calibration Result)
The transmission structure of QC results is as follows:
ORU Observational Results (Unsolicited) Description
MSH Message Header (Item Name, Test Date)
OBR QC Results (QC Name, QC Type, Lot Number, Level, Operator ID)
OBX Test Results (QC Results)
件
A6.3 Appendix
AL
A6.3.1 Message Segment
文
TI
密
A6.3.1.1 MSH
EN
For example: MSH|^~\&|EDAN|i15|LIS||20130929174802||ORU^R01|1|P|2.4||||0|| UNICODE
保
UTF-8|||
ID
The following fields of the MSH Segment are utilized:

邦
No. Length Type Field Name Description

It contains segment ID and
NF
the first field separator. It

理
1. Field Separator 1 defines field separators of

the remaining parts of a
CO
message.
It contains component
separators, repetition
separators, escape
2. 4 ST Encoding Characters
characters, and
AN
subcomponent separators
(^~\&).
3. 180 HD Sending Application It is Edan by default.
ED
4. 180 HD Sending Facility Product Model

5. 180 HD Receiving Application It is HIS/ LIS by default.
6. 180 HD Receiving Facility Not Present
7. 26 TS Date/Time of Message It is the UTC time of the
- 185 -
system.
8. 40 ST Security Not Present, Retain
For example, ORU^R01.
ORU^R01 messages are
mainly used to transmit test
9. 13 CM_MSG_TYPE Message Type results in HL7. The i15
system uses them to
transmit patient results/ QC
results to HIS/LIS.
It identifies a message. The
10. 20 ST Message Control ID i15 system number
messages from 1.
11. 3 PT Processing ID It is P (Product).
HL7 Protocol Version: 2.4
12. 60 VID Version ID
件
(Default Setting)
13. 15 NM Sequence Number Not Present, Retain
AL
14. 180 ST Continuation Pointer
文 Not Present, Retain
Accept Acknowledgment
15. 2 ID Not Present, Retain
Type
TI
The i15 system uses it as
result type:
密
Application Acknowledgment 0- Patient Result;
16. 2 ID
Type 1- Control Result;
EN
2- Calibration Verification
保
Result.
17. 3 ID Country Code Not Present, Retain
ID
It is UNICODE UTF-8 by
18. 16 ID Character Set
邦
default.
Principal Language Of
19. 250 CE Not Present, Retain
NF
Message
理
Alternate Character Set

20. 20 ID Not Present, Retain
Handling Scheme
CO
21. 10 ID Conformance Statement ID Not Present, Retain
Remarks: this segment appears in all the messages. The 3rd and 4th fields are made by the HIS/LIS
developer. The 5th field should be EDAN, the 6th field should be i15, the 10th and 16th fields
should be integer, and other fields should be strings.
AN
A6.3.1.2 OBR (Patient Sample)

ED
OBR segments are used to transmit clinical order information about test reports.
For patient results data (when MSH-16 is 0), Test Time, Sample ID, and Sample Type should be
transmitted.
- 186 -
For example: OBR|||20131009001|EDANî15|||20131001093000||||||||Artrial|opr001
The following fields are used:

1 4 SI Set ID-OBR Not Present
2 22 EI Placer Order Not Present
Number
3 22 EI Filler Order The i15 system uses it as sample
Number ID.
4 250 CE Universal Service Manufacturer ^ Model:
ID EDANî15
5 2 ID Priority Not Present, Retain.
6 26 TS Requested Not Present, Retain.
Date/Time
件
7 26 TS Observation The i15 uses it as test time.
AL
Date/Time
8 26 TS Observation End Not Present, Retain
文 Date/Time
9 20 CQ Collection Volume Not Present, Retain
10 250 XCN Collector Identifier
TI Not Present, Retain

密
11 1 ID Specimen Action Not Present, Retain
Code
EN
12 250 CE Danger Code Not Present, Retain
保
13 300 ST Relevant Clinical Not Present

Info.
ID
14 26 TS Specimen Rcvd Not Present, Retain.

邦
Date/Time
15 300 CM_SPECIMEN_SO Specimen Source The i15 system uses it as sample
NF
URCE type. There are six sample

理
types: Arterial, Venous, Mixed

Venous, Capillary, Aqueous,
CO
CPB.
16 250 XCN Ordering Provider The i15 system uses it as
operator ID.
17 250 XTN Order Call Back Not Present
Phone Num
AN
18 60 ST Placers Field Not Present

Number1
19 60 ST Placers Field Not Present, Retain
Number2
ED
20 60 ST Fillers Field Not Present, Retain

Number1
21 60 ST Fillers Field Not Present, Retain
- 187 -
Number2
22 26 TS Results Rpt/Status Not Present, Retain
Chg-dt
23 40 CM_CHARGE_PRA Charge to Practice Not Present, Retain
CTICE
24 10 ID Diagnostic Serv Not Present, Retain
Sect ID
25 1 ID Result Status Not Present, Retain
26 400 CM_PARENT_RES Linked Results Not Present, Retain
ULT
27 200 TQ Quantity/Timing Not Present, Retain
28 250 XCN Result Copies to Not Present, Retain
29 200 CM_PARENT_ORD Parent Accession# Not Present, Retain
ER
件
30 20 ID Transportation Not Present, Retain
Mode
AL
31 250 CE 文Reason for Study Not Present, Retain
32 200 CM_RESULT_PERS Principal Result Not Present, Retain
ON Interpreter
TI
33 200 CM_RESULT_PERS Assistant Result Not Present, Retain
ON Interpreter
密
34 200 CM_RESULT_PERS Technician Not Present, Retain
ON
EN
35 200 CM_RESULT_PERS Transcriptionist Not Present, Retain
保
ON
36 26 TS Scheduled Not Present, Retain
ID
Date/Time
邦
37 4 NM Number of Sample Not Present, Retain

Containers
NF
38 60 CE Transport Logistics Not Present, Retain

理
of Collected
Sample
CO
39 250 CE Collector’s Not Present, Retain

Comment
40 250 CE Transport Not Present, Retain
Arrangement
Responsibility
AN
41 30 ID Transport Arranged Not Present, Retain

42 1 ID Escort Required Not Present, Retain
43 250 CE Planned Patient Not Present, Retain
ED
Transport
Comment
44 250 CE Ordering Facility Not Present, Retain
Name
- 188 -

Address
Phone Number
47 250 CE Ordering Provider Not Present, Retain
Address
Remarks: this message segment is contained in ORU^R01 messages only. The 1st, 3rd, 37th fields
should be integer, the 9th field should be floating-point, and other fields should be strings.
A6.3.1.3 OBR (QC)
For QC results (when MSH-16 is 1 or 2), QC Name, QC Type, Lot Number, Level, and Operator
ID should be transmitted.
件
For example:
AL
文
OBR||2|Calver|EDANî15|||2013100109300000||||||CommonQC|21219||opr001
OBR||2|LiquidCtl|EDANî15|||2013100109300000||||||CommonQC|21219||opr001
TI
密
EN
1 4 SI Set ID-OBR Not Present
保
2 22 EI Placer Order The i15 system uses it as QC

Number level: 1, 2, 3, 4, 5; Low, High.
ID
3 22 EI Filler Order The i15 system uses it as QC

邦
Number name. Control: Control

Calibration Verification: Calver
NF
4 250 CE Universal Service Manufacturer ^ Model:

理
ID EDANî15
5 2 ID Priority Not Present, Retain
CO
6 26 TS Requested Not Present, Retain

Date/Time
7 26 TS Observation The i15 system uses it as QC test
Date/Time time.
8 26 TS Observation End Not Present, Retain
AN
Date/Time
9 20 CQ Collection Not Present, Retain
Volume
ED
10 250 XCN Collector Not Present, Retain

Identifier
11 1 ID Specimen Action Not Present
Code
- 189 -
12 250 CE Danger Code Not Present

13 300 ST Relevant Clinical The i15 system uses it as QC type.
Info. Hct: HctQc
Blood Gas and Electrolyte: BGQc
14 26 TS Specimen Rcvd QC Solution Lot Number
Date/Time
15 300 CM_SPECIMEN_SO Specimen Source Not Present
URCE
16 250 XCN Ordering The i15 system uses it as operator
Provider ID
17 250 XTN Order Call Back Not Present
Phone Num
Number 1
件
Number 2
AL
20 60 ST Fillers Field
文 Not Present
Number 1
21 60 ST Fillers Field Not Present
TI
Number 2
22 26 TS Results Not Present
密
Rpt/Status Chg-dt
23 40 CM_CHARGE_PRAC Charge to Not Present, Retain
EN
TICE Practice
保
24 10 ID Diagnostic Serv Not Present, Retain

Sect ID
ID
25 1 ID Result Status Not Present

邦
26 400 CM_PARENT_RESU Linked Results Not Present, Retain

LT
NF
27 200 TQ Quantity/Timing Not Present, Retain

理
28 250 XCN Result Copies to Not Present, Retain

29 200 CM_PARENT_ORDE Parent Not Present, Retain
CO
R Accession#
30 20 ID Transportation Not Present, Retain
Mode
31 250 CE Reason for Study Not Present, Retain
32 200 CM_RESULT_PERSO Principal Result Not Present, Retain
AN
N Interpreter
33 200 CM_RESULT_PERSO Assistant Result Not Present, Retain
N Interpreter
ED
34 200 CM_RESULT_PERSO Technician Not Present, Retain

N
35 200 CM_RESULT_PERSO Transcriptionist Not Present, Retain
N
- 190 -
36 26 TS Scheduled Not Present, Retain

Date/Time
37 4 NM Number of Not Present, Retain
Sample
Containers
Logistics of
Collected Sample
39 250 CE Collector’s Not Present, Retain
Comment
Arrangement
Responsibility
41 30 ID Transport Not Present, Retain
件
Arranged
42 1 ID Escort Required Not Present, Retain
AL
43 250 CE 文Planned Patient Not Present, Retain
Transport
Comment
Name
TI
密
Address
EN
保
Phone Number
47 250 CE Ordering Not Present, Retain
ID
Provider Address
邦
Remarks: This message segment is contained in ORU^R01 messages only. The 1st, 11th, and 37th
NF
fields should be integer, and other fields should be strings.

理
A6.3.1.4 OBX
CO
OBX are mainly used to transmit test information in report messages.
Patient results:
AN
Patient Information (Patient ID, Temperature, Sex, etc.)
Test Results
ED
For example:
Patient Results:
OBX|1|NM|0|pH|121|mmHg|-9^300|N||||||20131001093000||opr001
- 191 -
OBX|2|ST|2|O2MODE|RoomAir|||||||||20131001093000||opr001
QC Results:
Test Results (Parameter Name, Value, Unit, Status (Under Control, Out of Control, Calibration
Failure), Reference Range, Calibration Result)
OBX|1|NM|1|pH|121|mmHg|-9^300||||||undercontrol|20131001093000||opr001

1 4 SI Set ID-OBX It determines different
OBX segments.
2 2 ID Value Type It is used as result type.
NM (numeric) is used for
quantitative items, and ST
件
(string) is used for
qualitative items.
AL
3 250 CE Observation Identifier
文 The i15 system uses it as
item ID. Measured
Parameter: 0; Calculated
Parameter: 1; Patient
TI Information: 2.
密
4 20 ST Observation Sub-ID The i15 system uses it as
item name, such as pH,
EN
Na+, Ca++.
保
5 65536 WILDCARD Observation Value The i15 system uses it as

test value, such as 134, ???
ID
6 250 CE Units Parameter unit, such as

邦
mmol/L, mmHg.
7 60 ST Reference Range The normal range for a
NF
parameter, such as 39^45.

理
8 5 IS Abnormal Flags Descriptions for the test

result: L – Low; H – High;
CO
N - Normal;
***: Out of control, and
QC-Lockout disabled;
↓: Lower than reference
range;
↑: Higher than reference
AN
range.
9 5 NM Probability Not Present
10 2 ID Nature of Abnormal Test Not Present
ED
11 1 ID Observe Result Status Not Present

12 26 TS Date Last Obs Normal Not Present, Retain
Values
- 192 -
13 20 ST User Defined Access Calibration Results:

Checks Pass, Fail;
QC Results: Under Control
,Out of Control,
Calibration Failure
14 26 TS Date/Time of the The i15 system uses it as
Observation test time.
15 250 CE Producer's ID Not Present, Retain
16 250 XCN Responsible Observer The i15 system uses it as
operator ID.
17 250 CE Observation Method Not Present, Retain
18 22 EI Equipment Instance Not Present, Retain
Identifier
19 26 TS Date/Time of the Analysis Not Present, Retain
件
Remarks: This message segment is contained in ORU^R01 messages only. The 1st, 3rd, and 9th
fields should be integer, the 5th and 13th fields should be floating-point, and other fields should be
AL
strings.
文
TI
A6.3.1.5 PID
密
PID segment is mainly used to build patient information. It is used in patient results only to
EN
transmit patient ID and sex. For example: PID|||PatientID|||||M.
保

ID

邦
1 4 SI Set ID-Patient ID Not Present

2 20 CX Patient ID(External ID) Not Present
NF
3 250 CX Patient Identifier List Patient ID, required.

理
4 20 CX Alternate Patient ID Not Present

5 250 XPN Patient Name Not Present
CO
6 250 XPN Mother's Maiden Name Not Present

7 26 TS Date/Time of Birth Not Present
8 1 IS Sex Male: M; Femail: F; Other: O;
Unknown: U.
9 250 XPN Patient Alias Not Present
AN
10 250 CE Race Not Present, Retain

11 250 XAD Patient Address Not Present
12 4 IS County Code Not Present
ED
13 250 XTN Phone Number-Home Not Present

14 250 XTN Phone Number-Business Not Present, Retain
15 250 CE Language-Patient Not Present, Retain
16 250 CE Marital Status Not Present, Retain
- 193 -
17 250 CE Religion Not Present

18 250 CX Patient Account Number Not Present
19 16 ST SSN Number-Patient Not Present
20 25 DLN Drivers License Number- Patient Not Present
21 250 CX Mother's Identifie Not Present
22 250 CE Ethnic Group Not Present
23 250 ST Birth Place Not Present
24 1 ID Multiple Birth Indicator Not Present, Retain
25 2 NM Birth Order Not Present, Retain
26 250 CE Citizenship Not Present
27 250 CE Veterans Military Status Not Present, Retain
28 250 CE Nationality Not Present
29 26 TS Patient Death Date and Time Not Present
30 1 ID Patient Death Indicator Not Present
件
31 1 ID Identity Unknown Indicator Not Present
32 20 IS Identity Reliability Code Not Present
AL
33 26 TS Last Update Date/Time
34 40 HD
文
Last Update Facility
35 250 CE Species Code Not Present
TI
36 250 CE Breed Code Not Present
密
37 80 ST Strain
38 250 CE Production Class Code
EN
Remarks: This message segment is contained in ORU^R01 messages only. The 1st and 9th fields
保
should be integer, the 24th and 30th fields should be bool data, and other fields should be strings.
ID
A6.3.1.6 MSA
邦
NF

1 2 ID Acknowledgement Code AA: Accept;
理
AE: Error;
AR: Reject.
CO
2 20 ST Message Control ID It is the same as the MSH-10 of the

sending facility.
3 80 ST Text Message A text log for an error or reject. It
corresponds to the 6th field, and it is
AN
used to log error.

4 15 NM Expected Sequence Retain
Number
5 1 ID Delayed Ack Type Retain
ED
6 250 CE Error Condition Retain
Remarks: This message segment can be contained in ACK^R01, QCK^Q02, and ACK^Q03
messages.
- 194 -
A6.3.2 Examples
A6.3.2.1 Patient Results
Patient Results:
件
AL
文
TI
Figure A6-4 Patient Results
密
Measured Results:
EN
保
ID
邦
NF
理
CO
Figure A6-5 Measured Results

AN
ED
- 195 -
Calculated Results:
件
Figure A6-6 Calculated Results
Patient Information:
AL
文
TI
密
EN
保
ID
邦
NF
理
Figure A6-7 Patient Information
HL Data:
CO
MSH|^~\&|EDAN|i15|LIS||20131213162551||ORU^R01||P|2.4||||0||UNICODE UTF-8||||
PID|||1|||||U|||||||||||||||||||||||||||||||
OBR|||20131117002|EDANî15|||20131117043117||||||||CPB|edan||||||||||||||||||||||||||||||||
AN
OBX|0|ST|0|pH|---||6.500^8.000||||||Fail|20131117043117||edan||||
ED
OBX|1|ST|0|pO2|24.3|kPa|1.3^93.3|***|||||Pass|20131117043117||edan||||
OBX|2|ST|0|pCO2|???|kPa|1.33^20.00||||||Pass|20131117043117||edan||||
OBX|3|ST|0|Na|>|mmol/L|100^180|180|||||Pass|20131117043117||edan||||
- 196 -
OBX|4|ST|0|K|8.2|mmol/L|2.0^9.0|***|||||Pass|20131117043117||edan||||
OBX|5|ST|0|Ca|0.58|mmol/L|0.25^2.50||||||Pass|20131117043117||edan||||
OBX|6|ST|0|Cl|>|mmol/L|65^140|140|||||Pass|20131117043117||edan||||
OBX|7|ST|0|Hct|24|%|10^75|***|||||Pass|20131117043117||edan||||
OBX|8|ST|1|tHbest|10|g/dL|3.4^25.5|||||||20131117043117||edan||||
OBX|9|ST|1|cH|120.5|nmol/L|10.0^316.2|||||||20131117043117||edan||||
OBX|10|ST|1|HCO3act10.1mmol/L|1.0^99.9|||||||20131117043117||edan||||
OBX|11|ST|1|HCO3std|12.3|mmol/L|1.0^99.9|||||||20131117043117||edan||||
件
OBX|12|ST|1|BEecf|???|mmol/L|-30.0^30.0|||||||20131117043117||edan||||
OBX|13|ST|1|BEB|6.3|mmol/L|-30.0^30.0|||||||20131117043117||edan||||
AL
文
OBX|14|ST|1|BBB|???|mmol/L|13.1^82.4|||||||20131117043117||edan||||
TI
OBX|15|ST|1|ctCO2|???|mmol/L|1^100|||||||20131117043117||edan||||
密
OBX|16|ST|2|HbType|Adult|||||||||20131117043117||edan||||
EN
OBX|17|ST|2|PunctureSite|LR|||||||||20131117043117||edan||||
保
OBX|18|ST|2|VentMode|None|||||||||20131117043117||edan||||
ID
OBX|19|ST|2|O2Mode|Room Air|||||||||20131117043117||edan||||
邦
OBX|20|ST|2|Bypass|Pump Off|||||||||20131117043117||edan||||
NF
Data Field Definition Analysis

理
MSH Analysis:
CO
AN
ED
- 197 -
PID Analysis:
OBR Analysis:
件
OBX Analysis:
AL
文
TI
密
EN
保
ID
邦
OBX Analysis:
NF
理
CO
AN
ED
- 198 -
A6.3.2.2 Control Results (BG)
Control Data:
件
AL
文
Figure A6-8 Control Data
Control Test Results:
TI
密
EN
保
ID
邦
NF
理
CO
Figure A6-9 Control Test Results
HL7 Data:
AN
PID|||||||||||||||||||||||||||||||||||||||
OBR||1|Control|EDANî15|||20131117040651||||||BGQc|00000000||edan||||||||||||||||||||||||||||||||
ED
OBX|0|ST|0|pH|---||7.120^7.201||||||CaliFail|20131117040651||edan||||
OBX|1|ST|0|pO2|12.7|kPa|7.4^10.1||||||OutControl|20131117040651||edan||||
- 199 -
OBX|2|ST|0|pCO2|7.31|kPa|8.02^10.16||||||OutControl|20131117040651||edan||||
OBX|3|ST|0|Na|131|mmol/L|111^119||||||OutControl|20131117040651||edan||||
OBX|4|ST|0|K|3.4|mmol/L|1.4^2.4||||||OutControl|20131117040651||edan||||
OBX|5|ST|0|Ca|1.29|mmol/L|1.27^1.77||||||UnderControl|20131117040651||edan||||
OBX|6|ST|0|Cl|???|mmol/L|73^81||||||OutControl|20131117040651||edan||||
Data Field Definition Analysis
MSH Analysis:
件
AL
OBR Analysis:
文
TI
密
EN
保
ID
OBX Analysis:
邦
NF
理
CO
AN
ED
- 200 -
A6.3.2.3 Calibration Verification Results (Hct)
Calibration Verification Data:
件
AL
文
Figure A6-10 Calibration Verification Data
TI
Calibration Verification Test Results:
密
EN
保
ID
邦
NF
理
CO
Figure A6-11 Calibration Verification Test Results
HL7 Data:
AN
PID|||||||||||||||||||||||||||||||||||||||
ED
OBR||2|CalVer|EDANî15|||20131117041311||||||HctQc|00000000||edan||||||||||||||||||||||||||||||||
OBX|0|ST|0|Hct|6|%|17^23||||||OutControl|20131117041311||edan||||
- 201 -
ED 理
AN 邦
CO 保
NF 密
ID 文
EN 件
TI
AL

82-01.54.455691-1.6 I15 Blood Gas and Chemistry Analysis System User Manual-ES

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文件名称(Document Name)：i15 Blood Gas and Chemistry Analysis System

批准人(Approvers) : 陈, 沁 (chenqin) 2015-11-16 18:00:02

版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

Release Date: Jan., 2015

© Copyright EDAN INSTRUMENTS, INC. 2013-2015. All rights reserved

disclosed to any irrelevant third party.

right or license to use any of the intellectual properties of EDAN.

Responsibility of the Manufacturer

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

persons authorized by EDAN, and

The instrument is used in accordance with the instructions for use.

Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.

2.4.7 Calibrant Fluid Pack..................................................................................... 24

2.4.9 Exhaust Fan .................................................................................................. 27

2.4.10 Electronic Simulator................................................................................... 27

2.5 Configuration .......................................................................................................... 28

2.5.1 Standard Configuration ................................................................................ 28

Chapter 3 Installation Guide.............................................................................................. 30

3.2.1 Environmental Requirements ....................................................................... 30

3.3.1 Connecting to AC Power .............................................................................. 31

3.3.4 Turning On/Off the Analyzer ....................................................................... 34

4.3.5 Correlation Factors Setup............................................................................. 63

4.3.8 Calibration Setup.......................................................................................... 64

Chapter 5 Patient Analyzing .............................................................................................. 65

5.1 Sample Collection and Preparation ......................................................................... 65

5.1.1 Sample Collection ........................................................................................ 65

5.1.3 Collection Devices and Volume ................................................................... 66

5.2.2 Understanding Result Symbols .................................................................... 75

5.3.1 Searching for Patient Sample Data .............................................................. 77

Chapter 6 Quality Control (QC) Tests .............................................................................. 81

7.2.1 Security Database ....................................................................................... 122

7.2.3 Events Log Database .................................................................................. 126

7.2.4 Backup ....................................................................................................... 129

Chapter 9 Cleaning, Care and Maintenance .................................................................. 134

9.1.1 Cleaning and Disinfecting the Exterior Surfaces ....................................... 134

9.2.1 Recharging and Replacement of Battery.................................................... 137

Chapter 10 Theory ............................................................................................................ 140

10.2 Determination of Test Results ............................................................................. 141

11.3.3 Temperature Correction ............................................................................ 151

11.3.5 Interfering Substances .............................................................................. 153

11.4 Sodium (Na+)....................................................................................................... 153

11.4.1 Intended Use ............................................................................................. 153

11.4.2 Traceability ............................................................................................... 153

11.4.4 Interfering Substances .............................................................................. 155

11.5.3 Performance Characteristics ..................................................................... 156

11.6.1 Intended Use ............................................................................................. 158

11.7 Chloride (Cl-)....................................................................................................... 160

Chapter 12 Warranty and Service ................................................................................... 170

12.2 Contact Information ............................................................................................ 170

Appendix 1 Specifications ................................................................................................ 171

A1.1 Environment Requirements ................................................................................ 171

A1.2 Analyzer Specifications ...................................................................................... 172

A1.3 Performance Specifications ................................................................................ 172

Appendix 2 Measurement Ranges ................................................................................... 174

A2.2 Measurement Ranges for Calculated Parameters ............................................... 174

Appendix 5 FCC Information .......................................................................................... 180