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EDAN INSTRUMENTS
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I15EDAN
User Manual
151 pgs4.11 Mb2
Table of contents
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EDAN INSTRUMENTS I15EDAN User Manual

About this Manual

P/N: 01.54.455691-11 Release Date: July, 2013 © Copyright EDAN INSTRUMENTS, INC. 2013. All rights reserved

Statement

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 languages.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.

Responsibility of the Manufacturer

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and
The electrical installation of the relevant environment complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technicians maintain and repair some parts, which EDAN may configure as user serviceable.
I

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
A CAUTION lab el advises against a ctions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure.
II

Table of Contents

Chapter 1 Safety Guide ................................................................................................................ 1
1.1 Intended Use....................................................................................................................... 1
1.2 Warnings and Cautions ....................................................................................................... 1
1.2.1 Safety W arnings ..................................................................................................... 1
1.2.2 Safety Cautions ...................................................................................................... 5
1.3 Symbols and Definitions .................................................................................................... 6
Chapter 2 System Overview ......................................................................................................... 8
2.1 Introduction ........................................................................................................................ 8
2.2 System Frame ................................................................................................................... 10
2.3 Analyzer Appearance ....................................................................................................... 12
2.4 System Parts ..................................................................................................................... 13
2.4.1 Thermal Printer .................................................................................................... 13
2.4.2 T est Cartridge ....................................................................................................... 13
2.4.3 Power Indicator .................................................................................................... 15
2.4.4 LCD Screen and Touch Screen ............................................................................ 15
2.4.5 I/O Ports ............................................................................................................... 16
2.4.6 On/Off Button ...................................................................................................... 16
2.4.7 Calibrant Fluid Pack ............................................................................................. 16
2.4.8 Bar Code Scanner ................................................................................................. 17
2.4.9 Exhaust Fan .......................................................................................................... 18
2.4.10 Electronic Simulator........................................................................................... 18
2.4.11 Peripherics .......................................................................................................... 19
2.5 Configuration ................................................................................................................... 20
2.5.1 Standard Configuration ........................................................................................ 20
2.5.2 Options ................................................................................................................. 20
Chapter 3 Installation Guide ...................................................................................................... 21
3.1 Unpacking Inspection....................................................................................................... 21
3.2 Installation Requirements................................................................................................. 21
3.2.1 Environmental Requirements ............................................................................... 21
3.2.2 Power Requirements ............................................................................................ 22
3.3 Setting Up ........................................................................................................................ 22
3.3.1 Connecting to AC Power ...................................................................................... 22
3.3.2 Installing the Battery ............................................................................................ 22
3.3.3 Installing the Printer Paper ................................................................................... 24
3.3.4 Turning On/Off the Analyzer ............................................................................... 25
3.3.5 User Login and Logout ........................................................................................ 26
3.3.6 Setting the Date and Time .................................................................................... 27
3.4.7 V iewing T r aining Videos ...................................................................................... 27
3.4.8 Replacing a Calibrant Fluid Pack ......................................................................... 28
3.3.9 DEMO Te st .......................................................................................................... 32
III
3.3.10 Connecting Peripherics ...................................................................................... 35
Chapter 4 Setup ........................................................................................................................... 37
4.1 Getting into the Setup Screen ........................................................................................... 37
4.2 System Setup .................................................................................................................... 38
4.2.1 Printer Setup ......................................................................................................... 39
4.2.2 Network Setup ...................................................................................................... 40
4.2.3 Date & Language Setup ....................................................................................... 42
4.2.4 Backlight & Volume Setup ................................................................................... 43
4.2.5 Diagnostics ........................................................................................................... 43
4.2.6 About the Analyzer ............................................................................................... 44
4.3 T est Setup ......................................................................................................................... 44
4.3.1 QC Lockout Setup ................................................................................................ 45
4.3.2 Patient Information Setup .................................................................................... 45
4.3.3 Reference Ranges Setup ....................................................................................... 49
4.3.4 Units Setup ........................................................................................................... 50
4.3.5 Correlation Factors Setup ..................................................................................... 52
4.3.6 Hct Setup .............................................................................................................. 53
Chapter 5 Patient Analyzing ...................................................................................................... 54
5.1 Sample Collection and Preparation .................................................................................. 54
5.1.1 Sample Collection ................................................................................................ 54
5.1.2 Anticoagulants ...................................................................................................... 54
5.1.3 Collection Devices and Volume ........................................................................... 55
5.1.4 Notes .................................................................................................................... 55
5.2 Patient Analyzing ............................................................................................................. 56
5.2.1 Procedures for Patient Analyzing ......................................................................... 56
5.2.2 Understanding Result Symbols ............................................................................ 64
5.3 Patient Sample Database .................................................................................................. 65
5.3.1 Searching for Patient Sample Data ...................................................................... 66
5.3.2 Viewing Details of Patient Sample Data .............................................................. 67
5.3.3 Editing Patient Information Data ......................................................................... 68
5.3.4 Exporting/Uploading/Printing Patient Sample Data ............................................ 69
Chapter 6 Quality Control (QC) Tests ...................................................................................... 70
6.1 Control Test ...................................................................................................................... 70
6.1.1 Controls ................................................................................................................ 70
6.1.2 Procedures for Control Test.................................................................................. 72
6.1.3 Control Database .................................................................................................. 80
6.2 Proficiency Test ................................................................................................................ 83
6.2.1 Procedures for Proficiency Test ........................................................................... 83
6.2.2 Proficiency Database ............................................................................................ 89
6.3 Simulator Test .................................................................................................................. 92
6.3.1 Procedures for External Simulator Test ............................................................... 92
6.3.2 Simulator Database .............................................................................................. 94
IV
Chapter 7 Data Management ..................................................................................................... 98
7.1 Introduction ...................................................................................................................... 98
7.2 Databases.......................................................................................................................... 98
7.2.1 Security Database ................................................................................................. 99
7.2.2 Diagnosis Database ............................................................................................ 103
7.2.3 Events Log Database .......................................................................................... 103
7.2.4 Backup ............................................................................................................... 106
Chapter 8 Online Update .......................................................................................................... 107
8.1 Introduction .................................................................................................................... 107
8.2 Procedures for Online Update ........................................................................................ 107
10.1 Cleaning and Disinfecting the Analyzer ...................................................................... 112
10.1.1 Cleaning and Disinfecting the Exterior Surfaces ............................................. 112
10.1.2 Cleaning and Disinfecting the Screen .............................................................. 113
10.1.3 Cleaning the Printer Head ................................................................................ 114
10.2 Care and Maintenance .................................................................................................. 115
10.2.1 Recharging and Replacement of Battery .......................................................... 115
10.2.2 Printer Paper ..................................................................................................... 116
10.2.3 Maintenance of the Analyzer ........................................................................... 117
Chapter 11 Theory ..................................................................................................................... 118
11.1 Measurement Method ................................................................................................... 118
11.2 Determination of Test Results ...................................................................................... 119
11.2.1 Determination of the Analyte Concentration ................................................... 119
11.2.2 Determination of Cell Concentration ............................................................... 120
11.3 Equations for Calculated Parameters ........................................................................... 120
Chapter 12 Parameters ............................................................................................................. 124
12.1 pH ................................................................................................................................. 124
12.1.1 Intended Use..................................................................................................... 124
12.1.2 Traceability ....................................................................................................... 124
12.1.3 T empe rature Correction .................................................................................... 124
12.1.4 Performance Characteristics............................................................................. 125
12.1.5 Interfering Substances ...................................................................................... 126
12.2 pCO2 ............................................................................................................................. 126
12.2.1 Intended Use..................................................................................................... 126
12.2.2 Traceab ility ....................................................................................................... 127
12.2.3 T empe rature Correction .................................................................................... 127
12.2.4 Performance Characteristics............................................................................. 127
12.2.5 Interfering Substances ...................................................................................... 128
12.3 pO2 ............................................................................................................................... 129
12.3.1 Intended Use..................................................................................................... 129
V
12.3.2 Traceability ....................................................................................................... 129
12.3.3 T empe rature Correction .................................................................................... 129
12.3.4 Performance Characteristics............................................................................. 129
12.3.5 Interfering Substances ...................................................................................... 131
12.4 Sodium (Na+) ............................................................................................................... 131
12.4.1 Intended Use..................................................................................................... 131
12.4.2 Traceability ....................................................................................................... 132
12.4.3 Performance Characteristics............................................................................. 132
12.4.4 Interfering Substances ...................................................................................... 133
12.5 Potassium (K+) ............................................................................................................. 133
12.5.1 Intended Use..................................................................................................... 134
12.5.2 Traceability ....................................................................................................... 134
12.5.3 Performance Characteristics............................................................................. 134
12.5.4 Interfering Substances ...................................................................................... 135
12.6 Ionized Calcium (Ca++) ................................................................................................ 136
12.6.1 Intended Use..................................................................................................... 136
12.6.2 Traceability ....................................................................................................... 136
12.6.3 Performance Characteristics............................................................................. 136
12.6.4 Interfering Substances ...................................................................................... 137
12.7 Chloride (Cl-) ............................................................................................................... 138
12.7.1 Intended Use..................................................................................................... 138
12.7.2 Traceability ....................................................................................................... 138
12.7.3 Performance Characteristics............................................................................. 139
12.7.4 Interfering Substances ...................................................................................... 140
12.8 Hematocrit (Hct) .......................................................................................................... 140
12.8.1 Intended Use..................................................................................................... 141
12.8.2 Traceability ....................................................................................................... 141
12.8.3 Performance Characteristics............................................................................. 141
12.8.4 Interfering Substances ...................................................................................... 142
Chapter 13 Warranty and Service ........................................................................................... 143
13.1 W a rranty ....................................................................................................................... 143
13.2 Contact Information ..................................................................................................... 143
Appendix 1 Specifications ........................................................................................................ 144
A1.1 Environment Requirements ......................................................................................... 144
A1.2 Analyzer Specifications ............................................................................................... 145
A1.3 Performance Specifications ......................................................................................... 145
A1.4 Printer .......................................................................................................................... 145
A1.5 Rechargeable Battery .................................................................................................. 146
A1.6 Safety Specifications ................................................................................................... 146
Appendix 2 Measurement Ranges ........................................................................................... 147
A2.1 Measurement Ranges for Measured Parameters ......................................................... 147
A2.2 Measurement Ranges for Calculated Parameters ........................................................ 147
VI
Appendix 3 Reference Ranges .................................................................................................. 148
Appendix 4 EMC Information ................................................................................................. 149
Appendix 5 FCC Information .................................................................................................. 153
A5.1 FCC Statement ............................................................................................................ 153
A5.2 FCC RF Radiation Exposure Statement ...................................................................... 153
Appendix 6 Order List .............................................................................................................. 154
VII
i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide

Chapter 1 Safety Guide

1.1 Intended Use

i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Te st Cartridge) is a portable, automated system that measures blood gases, blood chemistries, and hematocrit in whole blood samples. The system is intended for use only by trained technologists, nurses, physicians and therapists. It is intend ed for use in a laboratory environment, near patient or point -of-care settings. By timely providing test results, the system helps the medical professionals make faster decisions about patient treatment, and thus improves the quality of patient care.

1.2 Warnings and Cautions

In order to use the system safely and effectively, and avoid possible dangers caused by improper operation, please read through the user manual and be sure to be familiar with all functions of the system and proper operation procedures before use. Always keep this manual with the analyzer. Please pay attention to the following warning and caution information.

1.2.1 Safety Warnings

NOTE: The reliability of the analyzer and the safety of operators are considered during product
design and production. The following safety and preventive measures should be carried out:
WARNING
Safety Warnings
1. The analyzer is not intended for treatment.
2. The analyzer is not intended for home use.
3. Do not use the analyzer if it is damaged or defective.
4. The analyzer should be installed by a qualified service engineer. Do not try to access the interior of the analyzer. Only authorized service personnel could remove the analyzer enclosure.
5. To avoid electrical shock, never modify the analyzer’s AC power circuits.
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i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide
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. Connect the analyzer to a grounded socket and make certain that the mains supply meets the requirements specified in the user manual.
10. Do not exceed the maximum permitted load when using multiple portable socket-outlets to supply the system.
11. SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands. Make cer tain that your hands are c l ea n a nd dr y before touching a power cord.
12. If you have any q uest ions about the power adaptor or the power cord, use the battery 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 authorized distributors for service.
13. The analyzer is not waterproof. Do not use it in locations where water or any liquid leakage may occur.
14. Do not cast any fluid onto the system surface, as fluid seepage into the electrical circuitry may cause excessive leakage current or system failure.
15. 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.
16. To avoid the possibility of electrostatic shock and damage to the system, avoid using aerosol spray cleansers on the analyzer screen.
17. EXPLOSION HAZARD – The analyzer is not suitable for use in the presence of a flammable anesthetic mixture with oxygen or other fla mm abl e compounds.
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i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide
WARNING
18. To avoid electrical shock, never use the system in altitude exceeding 3,000 meters above sea level.
19. Periodically have the safety of the system checked by a qualified service engineer.
20. Only accessories supplied or recommended by the manufacturer should be used. Otherwise, performance and electric shock protection can not be guaranteed.
21. Blood samples should be collected according to proper medical guidelines which contains collection details, such as site selection, collection procedures, sample handling, etc. Sterile techniques should be followed to prevent the site from being contaminated.
22. Handle blood samples and collection devices with care, and wear approved protective gloves to avoid direct contact with samples.
23. To avoid electrical shock and damage to the system, turn off the analyzer and disconnect the analyzer from the AC power source before cleaning and disinfecting.
24. To avoid the airinlet and airoutlet of the fan being blocked by foreign matters, check them regularly.
25. To avoid being injured, never touch the stitch of a calibrant fluid pack.
26. To avoid being hurt, never look into the scanner beam light.
27. The system is for in vitro diagnostic use only.
28. Perform quality control (QC) tests regularly to make certain that the system works smoothly.
29. The disposable test cartridges should only be used a single time.
30. Never replace a calibrant fluid pack when the analyzer is off.
31. 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.
32. Test cartridges are biohazardous waste after u se. They should be disposed of according to local regulatory guidelines.
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i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide
WARNING
33.
Never use a n external electronic simulator u nder elec tro magne tic environment,
and never touch it by hand during an external simulator test .
34. Do not u se the analyzer afte r its life cycle, and it should be disposed of according to local regulations after its life cycle.
Battery Care
35. 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.
36. The battery of the same model and specifications provided by the manufacturer should be used.
37. Danger of explosion - Do not revers e the anode and the cathod e when installing the battery.
38. Do not heat or splash the battery or throw it into fire or water.
39. When there is leakage or a foul smell, stop using the battery immediately. If your skin or clothes come into contact with the leakage liquid, cleanse it with clean water at once. If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with clean water first and seek medical assistance immediately.
40. The analyzer and accessories are to be disposed of according to local regulations 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. For more detailed information about recycling of this product or the battery, please contact your local Civic Off ice, or the shop where you purchased the product .
41. Remove the battery from the analyzer when the analyzer is not used for a long time.
42. 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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i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide

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 i nte nded to analyze whole blood samples. Nev er use i t to analyze serum or plasma.
4. If there are cl o t s or bubbles in the blood sample, discard it and collect s a mples again.
5. 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 samples for other analytes within 30 minutes.
6. Transport, store and use the analyzer, test cartridges, calibrant fluid packs and controls according to the user manual.
7. Only those accessories (such as test cartridges, calibrant fluid packs, controls, etc) supplied by EDAN or its authorized distributors should be used.
8. Connect the analyzer with those peripherics recommended by EDAN.
9. Maintain the system as described in the user manual to avoid potential damage.
10. Do not clean the analyzer and accessories with abrasive fabric.
11. Do not immerse the analyzer into liquid under any circumstances.
12. 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 interference.
13. Extreme humidity may affect test results. A relative humidity greater than 80% may cause inaccurate results.
14. Use this system at a temperature between 10°C and 31°C. Outside this ran ge, the system may produce inaccurate results.
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i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide

1.3 Symbols and Definitions

The following symbols will appear on the packaging of the system:
Symbol Description
Caution!
Consult instructions for use
Biological risks
Static electricity sensitive
Recycle
The symbol indicates that the device complies with the European Council Directive 98/79/EEC concerning medical devices.
On/Off button
Network port
Serial port
USB (Universal Serial Bus) connection
Trademark
Test cartridge insert direction
Calibrant fluid pack chamber door is closed.
Calibrant fluid pack chamber door is open.
In vitro diagnostic device
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i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide
Indicates that the device should be sent to special agencies accordi n g to local regulations for separate collection after its useful life.
Authorized representative in the European Community
Manufacturer
Date of manufacture
Temperature limitations
Do not reuse
Use by
Contains sufficient for (n) tests
Control
Serial number
Catalog number
Batch code
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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 fo r 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 el ectronic interfaces for external comm unication and data storage. The product consists of a single-use cartridge into which the sample is introduced. The cartridge contain s electrochemical senso rs which generat e signals related to concentration levels in the blood. These concentration levels are displayed on the screen of the analyzer, stored in memory, and can be transmitted by communication link or Wi-Fi to the Data Management System (DMS).
The following tables list the parameters that can be determined by the system:
Measured Parameters:
Symbol Description
pH Negative logarithm of the hydrogen ion concentration
pCO2 Partial pressure of carbon dioxide
pO2 Partial pressure of oxygen
K+ Potassium ion concentration
Na+ Sodium ion concentration
Cl- Chloride ion concentration
Ca++ Concentration of ionized calcium
Hematocrit: the volume occupied by red blood cells in a given volume of whole
Hct
blood.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
the amount of
corrected for entered patient
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
pO2 (T) pO2 corrected for entered patient temperature
-
HCO
HCO
act Bicarbonate ion concentration
3
-
std Bicarbonate ion concentration normalized to a pCO2 of 40mmHg
3
BB (B) Buffer base
BE (B) Base excess (B)
BE (ecf) Base excess (ecf)
ctCO2 Total carbon dioxide
Ca++ (7.4) The ionized calcium concentration of blood normalized to pH 7.4
An approximation of the difference between measured cations and measured
AnGap
anions in the sample
tHb (est) An estimation of the hemoglobin contained in the sample
An estimation of hemoglobin oxygen saturation: a ratio of
sO2 (est)
hemoglobin bound to oxygen to the total amount of hemoglobin able to bind oxygen
pO2 (A-a) Alveolar-arterial oxygen tension difference
Alveolar-arterial oxygen tension difference
pO2 (A-a) (T)
temperature
pO2 (a/A) Arterial-alveolar oxygen tension ratio
pO2 (a/A) (T) Arterial-alveolar oxygen tension ratio corrected for entered patient temperature
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
when both values are corrected for patient
System (DMS)
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 temperature
pO2/FIO
The ratio of arterial pO2 to the fraction of inspired oxygen
2
The ratio of arterial pO2 to the fraction of inspired oxygen corrected for the
pO2 (T)/FIO2
entered patient temperature
Configuration: main unit, printer, scanner, and simulator.

2.2 System Frame

Blood Gas and Chemistry Analyzer
Blood Gas and Chemistry Analyzer
Data Management
Laboratory/Hospital Information System (LIS/HIS)
The Blood Gas and Chemistry Analyzer is an electronic instrument which is used to analyze whole blood samples (measuring blood gases, electrolytes, metabolites, and hematocrit). The analyzer can:
Scan bar cod es of test cartridges, calibrant flu id packs, controls, p atient an d operator ID,
etc.
Identify the types of test cartridges. Control the flow of fluids. Maintain sample temperature at 37°C. Measure the ambient barometric pressure and ambient temperature. 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).
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
Store all kinds of test results and data, such as patient sample results, control test results,
proficiency 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 software. With the DMS, you can:
Enter test application data. Edit patient information, view, check and print test results. View, check and print quality control (QC) test results. Search for patient test results by patient name, patient ID, date and time, department, etc. Calculate the amount of work of a physician, the results for a parameter of a patient
during a period, the test times and the fee of a parameter, and print the statistics results.
Set the following items: operator, department, sample status, printing, bar code, etc. Backup and restore data, view logs. View data for instrument diagnosis. Import patient information from LIS/HIS. Manage up to 20 analyzers simultaneously, storing test results transmitted by analyzers.
NOTE:
Sample ID should b e di fferent on analyzers connecting to the same DMS.
HIS/LIS
HIS/LIS transmits patient information to the DMS.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
Lock
Port

2.3 Analyzer Appearance

Thermal Printer
I/O Ports
On/Off Button
Test Cartridge
Test Cartridge Ejector Cap
LCD Screen
Power Indicator
Calibrant Fluid Pack Chamber
Bar Code Scanner
Calibrant Fluid Pack Ejector
Calibrant Fluid Pack Chamber
Exhaust Fan
Handle
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
Battery Compartment
Figure 2-1 Analyzer Major Components

2.4 System Parts

2.4.1 Thermal Printer

The thermal print er is located at the upper left top of t he anal yzer. It can print patient sample tes t results, quality control test results, calibration results, etc.

2.4.2 Test Cartridge

Next to the thermal printer is the test cart ridge port. A test cartridge is inserted into the analyzer 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. The unit-use test cartridge is intended to be used togeth er 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 el ectrical si gnals that c an b e measur ed b y th e anal yzer. The sample fillport 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 b y them. For details, please refer to the table below.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
-
-
-
-
Chamber
Fillport
Fluidic
Sensor Arrays
Electrical
Figure 2-2 Test Cartridge
Table 2-1 Test Cartridge Types
Contacts
Cartridge
Measured
Calculated Parameters
Type
BG8
Parameters
pH, pCO2, pO2, Na+, K+, Cl-, Ca++,
cH+, HCO sO2 (est), Ca
act, HCO
3
++
(7.4), AnGap, tHb (est), pO2 (A-a), pO2 (a/A),
std, BE (ecf), BE (B), BB (B), ctCO2,
3
RI, pO2/FIO2, cH+ (T), pH (T), pCO2 (T), pO2 (T),
Hct
pO2 (A-a) (T), pO2 (a/A) (T), RI (T), pO2 (T)/FIO2 cH+, HCO
act, HCO
3
std, BE (ecf), BE (B), BB (B), ctCO2,
3
sO2 (est), pO2 (A-a), pO2 (a/A), RI, pO2/FIO2, cH+ (T), pH (T),
BG3
pH, pCO2, pO2
pCO2 (T), pO2 (T), pO2 (A-a) (T), pO2 (a/A) (T), RI (T), pO2 (T)/FIO2
Packaging
1. The type of the cartridge is labeled on the test cartridge.
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 su ch 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.
Storage and Usage
Test cartridges should be stored at 4 - 30°C, and should be used at 10 - 31°C with the relative humidity of 25% - 80% (non-condensing).
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
Disposal
The sample is contained in the test cartridge, so test cartridges should be disposed of as
biohazardous waste, complying with local regulatory guidelines.
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 their 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. The analyzer, test cartridges and the testing environment should be at the same
temperature prior to a test.
Test cartridges shoul d not be dr opp ed or stressed.

2.4.3 Power Indicator

The power indicator is on the lower left bottom of the anal yzer. During the operation you can see one of the following:
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 been connected to AC power.
Blinking Yellow Light: The power is supplied by the rechargeable lithium battery and the
battery is low.
Yellow Light: The rechargeable lithium battery is being charged.

2.4.4 LCD Screen and Touch Screen

The activities of th e analyzer are communicated to you through the LCD screen, displaying the analyzer activities, test results, database information, prompts, etc. You communicate with the analyzer through the touch screen which allows you to perform tests, make select ions, ent er data, and view information, etc.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview

2.4.5 I/O Ports

On the left side of the analyzer are I/O ports:
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.

2.4.6 On/Off Button

The On/Off button is on the left side of the analyzer.

2.4.7 Calibrant Fluid Pack

The calibrant fluid pack chamber is on the right side of the analyzer. You can install the calibrant fluid pack in it for sensor calibration. The calibrant fluid pack ejector beside the door is used to open the chamber door. On the calibrant flu id pack ejector i s a calibrant fluid pack chamber lock to help users close the calibrant fluid chamber door securely.
A calibrant fluid pack containing calibrant solutions is intended to be used together with the analyzer to perfo rm one-point sensor calibration. Calibrant fluid packs are av ailable for 100 and 200 sampling operations. Contact EDAN or its authorized distributors to order calibrant fluid packs for your system.
Figure 2-3 Calibrant Fluid Pac k
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
Packaging
1. The calibrant fluid pack is sealed in a foil pouch filled with protective gases.
2. The bar cod e 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 shippin g carton.
Storage and Usage
Calibrant fluid packs should be stored at 2 - 8°C (avoid freezi ng) with the ambient pressure of 65
- 106.6kPa, and should be used at 10 - 31°C with the relative humidity of 25% - 80%
(non-condensing). The calibrant fluid pack expires 30 days after its installation or after exceedi n g the labeled exp iration date, whichever comes f irst. The remaining days and usages are displayed on the status bar at the bottom of the screen.
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 calibrant fluid packs before their expiration date as labeled on the package. A calibrant fluid pack is intended for single use only. If a calibrant fluid pack is
removed from the system, it cannot be inserted into the system again.

2.4.8 Bar Code Scanner

On the same side as the calibrant fluid pack chamber is the built-in scanner for scanning bar codes on test cartridges, calib rant fluid packs, controls, operator ID, patient ID, sample ID, etc. The analyzer can also be connected to external scanners as mentioned in 2.4.11.
Follow the steps below to scan a bar code:
1. Press Scan Barcode or to acti vate the bar code s canner, and the scanner will emit a red
beam.
2. Align the bar code with the red beam so that the red beam covers the whole bar code.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
NOTE:
The distance between the analyzer and the bar code should be 6 - 15cm.
3. If the bar code is scanne d successfully, the anal yzer will beep and automatically turn off the
scanner.
4. If the scanned data is valid, the system will display the screen for the next procedure. If t he
scanned data is invalid, a message will pop up to prompt you.
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 av oid unsuccess ful scanning, clean the s canner w ith a li nt-free clot h when there is visible dirt.

2.4.9 Exhaust Fan

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.
NOTE:
Make sure that the vents of the analyzer are not obstructed to ensure good
ventilation.
If the exhaust fan does not run properly, please contact EDAN or its authorized
distributors for assistance.

2.4.10 Electronic Simulator

Electronic simulators are quality control devices for checking the analyzer’s ability to take accurate measurements of voltage, current and conductivity from test cartridges.
Internal Electronic Simulator
Internal electronic simulator is self-contained in the analyzer for automatically conducting simulator tests at the preset frequency.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview
External Electronic Simulator
Users can run the external electronic simulator test according to their own needs, and EDAN 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 electronic simulator test to help troubleshoot.
Contact pads
Figure 2-4 External Electr onic Simulator
If the contact pads have been contaminated, please clean the external electronic simulator.
Follow the steps below to clean the external electronic simulator:
1. Moisten a lint-free cloth with 100% alcohol;
2. Wipe the external electronic simulator with the lint-free cloth.
NOTE:
Never immerse the simulator into any liquids. The cloth should be wet but not dripping.

2.4.11 Peripherics

Only the following external scanners should be connected to the analyzer through USB ports: Honeywell 1900.
Only the following external printers should be connected to the analyzer through USB ports: H P LaserJet P401DN, and HP LaserJet P1606DN.
NOTE:
Only peripherics recommended by EDAN should be connected to the analyzer. When connecting a Honeywell 1900 scanner to the analyzer, the scanner should be
set.
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i15 Blood Gas and Chemistry Analysis System User Manual System Overview

2.5 Configuration

2.5.1 Standard Configuration

i15 analyzer 1 power cable 1 power adaptor 4 printer paper 1 rechargeable lithium battery 1 user manual 1 warranty card 2 packing lists

2.5.2 Options

Test cartridges Calibrant fluid pack External electronic simulator Capillary adaptor Controls Data management system software Honeywell 1900 scanner
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i15 Blood Gas and Chemis t r y 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 carri er to claim for damage. Aft er unpacki ng the devic e, custom ers 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
DO NOT use the analyzer if it is damaged or defective.
NOTE:
Keep the package for futur e transportation or for storage.

3.2 Installation Requirements

3.2.1 Environmental Requirements

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:
Convenient for the analyzer to be connected to a grounded elect rical receptacle i n case it is
powered by AC power.
Keep the anal yzer away from direct exposure to strong sunlight. Ambient Temperature between 10°C and 31°C. Relative Humidity of 25% - 80% (non-condensing). Ambient Pressure within 70 - 106.6kP (525 - 800mmHg). Placed onto a clean and flat surface with good ventilation. Keep the analyzer away from equipment with strong electric field and strong magnetic field. Keep the analyzer away from explosive gases or vapors.
NOTE:
The requirements above also apply when your analyzer is powered by a rechargeable lithium battery.
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i15 Blood Gas and Chemis t r y Analysis System User Manual Installation Guide

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 50/60Hz.

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

1. Insert the power adaptor into the power connector on the analyzer.
2. Plug the power cord into the power adaptor.
3. Plug the power cord into a grounded electrical outlet.
NOTE:
Make sure the power requirements as described in 3.2.2 are met. To avoid the anal yz er and other elec tro nic dev ic es being damag ed by elec tric al pow er
spikes, a surge protector is recommended.

3.3.2 Installing the Battery

WARNING
Switch off the analyzer and unplug it before installing or removing the battery.
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:
1. Turn off the analyzer, disconnect the power supply, and remove the power adaptor and other connecting cables.
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
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