About this Manual P/N: 01.54.455691-11 Release Date: July, 2013 © Copyright EDAN INSTRUMENTS, INC. 2013. 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 operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
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 label advises against actions 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.
Table of Contents Chapter 1 Safety Guide ................................................................................................................ 1 1.1 Intended Use....................................................................................................................... 1 1.2 Warnings and Cautions....................................................................................................... 1 1.2.1 Safety Warnings .................................................................
3.3.10 Connecting Peripherics ...................................................................................... 35 Chapter 4 Setup ........................................................................................................................... 37 4.1 Getting into the Setup Screen........................................................................................... 37 4.2 System Setup ........................................................................................................
Chapter 7 Data Management ..................................................................................................... 98 7.1 Introduction ...................................................................................................................... 98 7.2 Databases.......................................................................................................................... 98 7.2.1 Security Database ...............................................................................
12.3.2 Traceability....................................................................................................... 129 12.3.3 Temperature Correction.................................................................................... 129 12.3.4 Performance Characteristics............................................................................. 129 12.3.5 Interfering Substances ...................................................................................... 131 12.4 Sodium (Na+) ............
Appendix 3 Reference Ranges.................................................................................................. 148 Appendix 4 EMC Information ................................................................................................. 149 Appendix 5 FCC Information .................................................................................................. 153 A5.1 FCC Statement ........................................................................................................
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, Test Cartridge) is a portable, automated system that measures blood gases, blood chemistries, and hematocrit in whole blood samples. The system is intended for use only by trained technologists, nurses, physicians and therapists.
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.
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.
i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide WARNING 33. Never use an external electronic simulator under electromagnetic environment, and never touch it by hand during an external simulator test. 34. 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 35.
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 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.
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.
i15 Blood Gas and Chemistry Analysis System User Manual Safety Guide Indicates that the device should be sent to special agencies according to local regulations for separate collection after its useful life.
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.
i15 Blood Gas and Chemistry Analysis System User Manual System Overview Calculated Parameters: Symbol cH+ Description Hydrogen ion concentration cH+ (T) Hydrogen ion concentration corrected for entered patient temperature pH (T) pH value corrected for entered patient temperature pCO2 (T) pO2 (T) pCO2 corrected for entered patient temperature pO2 corrected for entered patient temperature HCO3-act Bicarbonate ion concentration HCO3-std Bicarbonate ion concentration normalized to a pCO2 of 40mmHg
i15 Blood Gas and Chemistry Analysis System User Manual RI System Overview Respiratory index: the ratio of the alveolar-arterial blood oxygen-pressure 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 pO2 (T)/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
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.
i15 Blood Gas and Chemistry Analysis System User Manual 2.
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 printer is located at the upper left top of the analyzer. It can print patient sample test results, quality control test results, calibration results, etc. 2.4.2 Test Cartridge Next to the thermal printer is the test cartridge port. A test cartridge is inserted into the analyzer through the test cartridge port.
i15 Blood Gas and Chemistry Analysis System User Manual System Overview Fillport Fluidic Chamber Sensor Arrays Electrical Contacts Figure 2-2 Test Cartridge Table 2-1 Test Cartridge Types Cartridge Type Measured Parameters BG8 pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct BG3 pH, pCO2, pO2 Calculated Parameters cH+, HCO3-act, HCO3-std, BE (ecf), BE (B), BB (B), ctCO2, sO2 (est), Ca++ (7.
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.
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.
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 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. Storage and Usage Calibrant fluid packs should be stored at 2 - 8°C (avoid freezing) with the ambient pressure of 65 - 106.
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 scanned successfully, the analyzer 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 the 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.
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.
i15 Blood Gas and Chemistry Analysis System User Manual 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.
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.
i15 Blood Gas and Chemistry 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.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide remove the battery compartment cover. 4. Take the battery out from its package and put it into the compartment. Make sure the battery connector is on the right and the battery label faces down. Install the battery into the compartment. WARNING Do not touch the battery connector with fingers or metallic materials, to avoid the hazards posed by the short-circuit to you and the battery. 5.
i15 Blood Gas and Chemistry Analysis System User Manual 6. Installation Guide 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.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide 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.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide 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. Figure 3-2 Enter User Name and Password User Logout 1.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide 3.3.6 Setting the Date and Time 1. On the Main screen, press to access the System Setup screen. 2. Press 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. to access the Date & Language Setup screen. CAUTION 1. Make sure the current date and time of the system are correct, or it may cause misdiagnosis. 2.
i15 Blood Gas and Chemistry Analysis System User Manual 5. Press 6. Press Return to go back to the Main screen. Installation Guide to view the video for analyzing capillary samples. 3.4.8 Replacing a Calibrant Fluid Pack WARNING 1. The replacement of a calibrant fluid pack should be performed only when the analyzer is on. 2. 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.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide 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 NOTE: Avoid pushing the valve when removing the key. 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. 9.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide 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.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide 12. Close the chamber door. Figure 3-9 Close Chamber Door 13. Lock the calibrant fluid pack chamber lock to close the chamber door securely. 14. Press OK in the pop up message. The system will then go to the Main screen.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide If the bar code is not that of a calibrant fluid pack, the following message will pop up: Figure 3-12 Unidentified Bar Code If the bar code is that of a used calibrant fluid pack or that of an expired calibrant fluid pack, the following message will pop up: Figure 3-13 Calibrant Fluid Pack Can Not be Used 3.3.9 DEMO Test The system can demonstrate the sample testing processes through animation.
i15 Blood Gas and Chemistry Analysis System User Manual Figure 3-14 DEMO Test Screen 1 3. Press Scan Barcode. 4. Press Next. Figure 3-15 DEMO Test Screen 2 5. The system simulates aspirating calibrant.
i15 Blood Gas and Chemistry Analysis System User Manual 6. The system simulates calibration. Figure 3-17 DEMO Test Screen 4 7. The system simulates sampling. Figure 3-18 DEMO Test Screen 5 8. The system simulates testing.
i15 Blood Gas and Chemistry Analysis System User Manual Installation Guide 9. The system simulates displaying test results. Figure 3-20 DEMO Test Screen 7 10. Press Home to return. 11. Follow the steps as described in 3.3.5 to logout of the system. 3.3.10 Connecting Peripherics Connect peripherics with the system through USB ports, and make sure that the system meets the requirements in IEC60601-1-1. NOTE: Only peripherics recommended by EDAN should be connected.
i15 Blood Gas and Chemistry Analysis System User Manual 4. Installation Guide Use the scanner to scan a bar code of a test cartridge. If the bar code is successfully scanned, the scanner is successfully set.
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.
i15 Blood Gas and Chemistry Analysis System User Manual Setup Figure 4-1 Enter User Name and Password 3. Press on the Main screen, and the system will go to the Setup screen. 4.2 System Setup 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.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 4.2.1 Printer Setup This menu lets you configure the printer that the system uses, what are printed in reports, and the number of copies it prints. Follow the steps below to set the printer: 1. Press to access the Printer Setup screen. Figure 4-3 Printer Setup Screen 2. On the Printer Setup screen, you can: Select whether to print patient information.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 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. Follow the directions below to configure the network: 1. Press to access the Network Setup screen. 2. There are three tabs: Communication, Network, and WIFI. Network Setup 1) Press Communication to go to the Communication Setup screen.
i15 Blood Gas and Chemistry Analysis System User Manual Setup Network Setup 1) Press Network to access the Network-Network Setup screen. Figure 4-5 Network – Network Setup Screen 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.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 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. 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. 4) Press Return, and the system will return to the System Setup screen. 4.2.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 4.2.4 Backlight & Volume Setup This menu allows you to define the idle time after which the backlight will be automatically turned off, the brightness of the backlight, the key tones and the volume. 1. Press to go to the Backlight & Volume Setup screen. Figure 4-8 Backlight & Volume Setup Screen 2. On the Backlight Setup screen, you can: Adjust the brightness of the backlight with the slider.
i15 Blood Gas and Chemistry Analysis System User Manual Setup NOTE: Only service engineers and engineers from the manufacturer can perform this action. 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. Figure 4-9 About Screen 2. View the information on the screen. 3. Press Return to get access to the System Setup screen.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 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 tests, and the results for these parameters will be flagged with xxx.
i15 Blood Gas and Chemistry Analysis System User Manual Setup Table 4-1 Patient Information Parameter Patient ID Operator ID Sample ID Temperature Sex tHb (Total hemoglobin) FIO2 MCHC (Mean corpuscular hemoglobin concentration) RQ (respiratory quotient) Hemoglobin type Puncture site Bypass O2 mode Range 1 - 16 digits 1 - 16 digits 1 - 16 digits 14.0 – 44.0 57.2 – 111.2 Male, Female, / 1.0 – 26.0 10 - 260 0.6 – 16.1 0.21 - 1.00 21 - 100 Resolution N/A N/A N/A 0.1 0.1 N/A 0.1 1 0.1 0.
i15 Blood Gas and Chemistry Analysis System User Manual I/E Ratio Vent mode Pplat (Plateau Pressure) MVol (Minute Volume) PIP (Peak Inspiratory Pressure) Liter Flow TVol (Tidal Volume) PS (Pressure Support) PEEP (Positive End Expiratory Pressure) Rate CPAP (Continuous Positive Airway Pressure) Bi-Level Pressure Mask= Mask T-P= T-Piece NC= Nasal Cannula Vent= Ventilator Bag= Bag (manual resuscitation) Hood= Hood Other= Other 0.2 - 9.9/0.2 - 9.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 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.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 4.3.3 Reference Ranges Setup With this menu you can set the reference range for each measured parameter. There are three options: Reference Range 1, Reference Range 2, and Reference Range 3. The default is Reference Range 1. 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.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 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 Ca++ pCO2 pO2 Glu Lac Hct Cre BUN tHb(est) sO2(est) pO2(A-a) pO2(a/A) RI pO2/FIO2 Ca++(7.4) pCO2(T) pO2(T) pO2(A-a)(T) pO2(a/A)(T) RI(T) pO2(T)/FIO2 Temperature FIO2 tHb MCHC Default Unit mmol/L mmHg mmHg mmol/L mmol/L % μmol/L mmol/L g/dL % mmHg x.xx x.
i15 Blood Gas and Chemistry Analysis System User Manual Setup Figure 4-15 Units Setup 1 Screen 3. Press Units 2, and select the desired units for the parameters whose units you want to change. Figure 4-16 Units Setup 2 Screen 4. Press OK to accept the changes, and the system will return to the Test Setup screen. NOTE: The results stored in the system are automatically converted to match new units.
i15 Blood Gas and Chemistry Analysis System User Manual Setup 4.3.5 Correlation Factors Setup Correlation factors allow you to correlate results obtained from the system to results obtained from another system. The ranges for the slope and offset of each parameter are listed in table 4-3. Table.4-3 Correlation Factors 1. Parameter pH Slope Range 1.200 – 0.800 pCO2 1.200 – 0.800 pO2 1.200 – 0.800 Na+ K+ ClCa++ 1.200 – 0.800 1.200 – 0.800 1.200 – 0.800 1.200 – 0.800 Glu 1.200 – 0.800 Lac 1.
i15 Blood Gas and Chemistry Analysis System User Manual Setup NOTE: The default value is 1.0 for all slopes and 0.0 for all offsets. Changing correlation factors affects future test results, but does not affect past, stored test results. 4.3.6 Hct Setup When only Hct levels are measured for whole blood samples, this menu allows you to select the anticoagulants. 1. Press to get access to the Hct Setup screen. Figure 4-18 Hct Setup Screen 2. Select the desired anticoagulant.
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.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing 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 175μL (Article Number: 182413) should be used.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing 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 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 then press .
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing CAUTION Make sure that the selected sample type button is consistent with the blood sample, or the result may be inaccurate. 4. Press Scan Barcode, and scan the bar code on a new cartridge foil pouch. If the bar code is scanned successfully, the system will beep and the scanner will be automatically turned off. If the scanned data is valid, the system will display the screen for the next procedure.
i15 Blood Gas and Chemistry Analysis System User Manual 7. Patient Analyzing Insert the syringe or capillary tube into the fillport of the cartridge. NOTE: When using a syringe, discard the first 2 drops of blood sample first, then remove the needle from it, and finally insert it into the fillport. When using a capillary tube, insert the capillary tube into the adaptor till the tube reaches the interface between the adaptor and the cartridge. 8.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing NOTE: It is not necessary to enter all the above parameters. You can press OK at any time. If no parameters are selected in section 4.3.2 Patient Information Setup, the system will go to the Aspirating Calibrant screen when the test cartridge is properly inserted.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing c). If the system is sampling, the system will go to the screen below: Figure 5-7 Sampling… d). If the system is analyzing patient samples, the system will go to the screen below: Figure 5-8 Measurement in Progress e).
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing NOTE: Upon the completion of the test, the indicator in the cartridge port will be off, the message “Please Remove Cartridge” will be displayed on the status bar at the bottom of the screen, and the cartridge will be ejected. If the screen has not been touched for 10 seconds after the test is complete, the test results will be displayed automatically even if you do not press OK.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing Figure 5-11 Calibration Parameters Symbols such as > may appear on the Results screen, refer to section 5.2.2 Understanding Result Symbols to understand their meanings. WARNING Never make treatment decisions according to test results containing symbols as described in section 5.2.2 Understanding Result Symbols. 12. Remove the test cartridge from the system. 13. Press Home to return to the Main screen.
i15 Blood Gas and Chemistry Analysis System User Manual Temperature Sex tHb FIO2 MCHC RQ Hb type Puncture site Bypass O2 mode I/E Ratio Vent mode ...... 37 ℃ Female 30 g/dL 20 g/dL Adult LR (Left Radial) Pump Off 0/0 None Calibration Results pH Fail pCO2 Pass pO2 Pass + Na Pass + K Pass ++ Ca Pass Cl Pass Glu Pass Lac Pass Hct Pass Cre Pass BUN Pass Results for Measured Parameters pH --pCO2 xxx mmHg pO2 70 mmHg + Na ??? mmol/L + K 1.
i15 Blood Gas and Chemistry Analysis System User Manual pCO2(T) pO2(T) - 1 1 1 1 1 1 Patient Analyzing *** > < HCO3 act HCO3-std BE(ecf) Ca++(7.4) … Reference Ranges pH [7.35 - 7.45] pCO2 [35.0 - 45.0] pO2 [80.0 - 100.0] + Na [138.0 - 146.0] + K [3.50 - 4.90] ++ Ca [1.12 - 1.32] Cl [98 - 109] Glu [3.9 - 5.8] Lac [0.36 - 1.7] Hct [35 – 51] Cre [0.6 - 1.3] BUN mmHg mmHg mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L % mg/dL 5.2.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing 5.3 Patient Sample Database The patient sample database displays patient sample data for the most recent month by default, and it can store up to 10000 data entries. The system displays 50 pieces of data 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).
i15 Blood Gas and Chemistry Analysis System User Manual 5.3.1 Searching for Patient Sample Data 1. On the Patient Sample Database screen, press Search. 2. Enter the search conditions, and press OK. Figure 5-13 Enter Search Conditions 3. The system automatically begins the search and displays the results. Figure 5-14 Search Results 4. Press Return to go back to the Patient Sample Database screen.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing 5.3.2 Viewing Details of Patient Sample Data 1. Press the patient sample data you want to view. 2. Press Details. The system displays the details of measured parameters by default. Figure 5-15 Details of Measured Parameters 3. Press Calculated to view the details of calculated parameters. Figure 5-16 Details of Calculated Parameters 4. Press Patient Info to view the details of patient information.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing 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 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 patient information setup: Figure 5-18 Edit Patient Data NOTE: The screen displayed depends on the selection in section 4.
i15 Blood Gas and Chemistry Analysis System User Manual Patient Analyzing 5.3.4 Exporting/Uploading/Printing Patient Sample Data 1. Open the patient sample database. 2. Select the desired patient sample data. To Do this Export Insert a removable disk into the analyzer, and then press Export. Upload Press Upload. Print Press Print. NOTE: If no patient sample data is selected before pressing Export/Upload/Print, all of the data stored in the patient sample database will be exported/uploaded/printed.
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.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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. RNA Medical® QC823 Blood Gas●Electrolyte●Metabolite●BUN controls are contained in 2.5mL glass ampoules, and RNA Medical® QC900 Hematocrit controls are contained in 1.7mL glass ampoules. 2.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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 4 hours. If not, the ampoule needs to stand at room temperature for only about 30 minutes. 3.
i15 Blood Gas and Chemistry Analysis System User Manual 7. Quality Control (QC) Tests Press Scan Barcode, and scan the bar code on a new cartridge foil pouch. If the bar code is scanned successfully, the system will beep and the scanner will be 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. Figure 6-3 Scan Bar Code 8.
i15 Blood Gas and Chemistry Analysis System User Manual 9. Quality Control (QC) Tests Press Scan Barcode, and scan the bar code on the controls user manual. If the bar code is scanned successfully, the system will beep and the scanner will be 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.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 14. The system automatically aspirates calibrant. Figure 6-6 Aspirating Calibrant… 15. The system automatically performs calibration. Figure 6-7 Calibration in Progress 16. The system automatically aspirates samples when calibration is complete.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 17. The system automatically analyzes the sample upon the completion of sampling. Figure 6-9 Measurement in Progress 18. The system automatically displays the test results upon the completion of the test. Figure 6-10 Control Test Results 19. View the results. NOTE: The system will indicate whether the results are within or outside the acceptable ranges with Under Control/Out of Control.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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. If the results are outside the acceptable ranges, check the following items first, and then perform another test.
i15 Blood Gas and Chemistry Analysis System User Manual Control Test Results pH 7.5 pCO2 --mmHg pO2 70 mmHg + Na K+ Ca++ ClGlu Lac Hct Cre BUN pH pCO2 pO2 Na+ K+ Ca++ ClGlu Lac Hct Cre BUN Under Control Calibration Failure Under Control Under Control Under Control Under Control Under Control Under Control Under Control Under Control Under Control Under Control Control Ranges pH [7.35 - 7.45] pCO2 [35.0 - 45.0] pO2 [80.0 - 100.0] + Na [138.0 - 146.0] + K [3.50 - 4.90] ++ Ca [1.12 - 1.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 6.1.3 Control Database The control database displays control test data for the most recent 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 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).
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests Figure 6-12 Enter Search Conditions 3. The system automatically begins the search and displays the results. Figure 6-13 Search Results 4. Press Return to go back to the Control Database screen. 6.1.3.2 Viewing Details of Control Test Data 1. Press the control test data you want to view. 2. Press Details.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests Figure 6-14 Details of Control Test Results 3. View the details. 4. Press Return to go back to the Control Database screen. 6.1.3.3 Exporting/Uploading/Printing Control Test Data 1. Open the control database. 2. Select the desired control test data. To Do this Export Insert a removable disk into the analyzer, and then press Export. Upload Press Upload. Print Press Print.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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.
i15 Blood Gas and Chemistry Analysis System User Manual 6. Quality Control (QC) Tests Press Scan Barcode, and scan the bar code on a new cartridge foil pouch. If the bar code is scanned successfully, the system will beep and the scanner will be 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. Figure 6-16 Scan Bar Code 7.
i15 Blood Gas and Chemistry Analysis System User Manual 8. Quality Control (QC) Tests 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. Figure 6-17 Enter Information NOTE: Only lot number information within 1-16 digits is acceptable. 9.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 13. The system automatically aspirates calibrant. Figure 6-19 Aspirating Calibrant… 14. The system automatically performs calibration. Figure 6-20 Calibration in Progress 15. The system automatically aspirates samples when calibration is complete.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 16. The system automatically analyzes the sample upon the completion of sampling. Figure 6-22 Measurement in Progress 17. The system automatically displays the test results upon the completion of the test. Figure 6-23 Proficiency Test Results 18. View the results. 19. Remove the test cartridge from the system. 20. Press Print to print the results. 21. Press Home to return to the Main screen.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests Here is an example of a proficiency test report. Proficiency Test Report EDAN i15 System ID Report Type Print Time Test Time Operator ID Lot Number 201303200023 Proficiency Test Report 2012-03-20 15:20:00 2012-03-20 15:10:00 55555 21209 Calibration Results pH Pass pCO2 Pass pO2 Pass … Proficiency Test Results pH 7.4 pCO2 40 mmHg pO2 90 mmHg + Na 140 mmol/L + K 4.0 mmol/L ++ Ca 1.2 mmol/L Cl 101 mmol/L Glu 4.
i15 Blood Gas and Chemistry Analysis System User Manual On the Database screen, press Quality Control (QC) Tests to get access to the Proficiency Database screen. Figure 6-24 Proficiency Database Screen 6.2.2.1 Searching for Proficiency Test Data 1. On the Proficiency Database screen, press Search. 2. Enter the search conditions, and press OK. Figure 6-25 Enter Search Conditions 3. The system automatically begins the search and displays the results.
i15 Blood Gas and Chemistry Analysis System User Manual Figure 6-26 Search Results 4. Press Return to go back to the Proficiency Database screen. 6.2.2.2 Viewing Details of Proficiency Test Data 1. Press the proficiency test data you want to view. 2. Press Details. The system displays the details: Figure 6-27 Details of Proficiency Test Results 3. View the details. 4. Press Return to go back to the Proficiency Database screen.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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 Export Insert a removable disk into the analyzer, and then press Export. Upload Press Upload. Print Press Print.
i15 Blood Gas and Chemistry Analysis System User Manual 3. On the Main screen, press Quality Control (QC) Tests to go to the Quality Control screen, and then press . 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. Figure 6-29 Insert External Simulator NOTE: Avoid touching the contact pads.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 6. The system automatically displays the test result upon the completion of the test. Figure 6-31 External Simulator Test Result 7. View the result. NOTE: 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. If the system passes the external simulator test, it can be used to analyze samples.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 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 automatically delete the oldest one to accommodate a new one.
i15 Blood Gas and Chemistry Analysis System User Manual Quality Control (QC) Tests 3. The system automatically begins the search and displays the results. Figure 6-34 Search Results 4. Press Return to go back to the Simulator Database screen. 6.3.2.2 Exporting/Uploading/Printing Simulator Test Data 1. Open the simulator test database. 2. Select the desired simulator test data. To Do this Export Insert a removable disk into the analyzer, and then press Export. Upload Press Upload.
i15 Blood Gas and Chemistry Analysis System User Manual Here are examples of simulator test reports: External Simulator Test Report EDAN i15 System ID Report Type Print Time Test Time Operator ID Result 201303200023 External Simulator Test Report 2012-03-20 15:20:00 2012-03-20 15:20:00 admin Pass Internal Simulator Test Report EDAN i15 System ID Report Type Print Time Test Time Operator ID Result 201303200023 Internal Simulator Test Report 2012-03-20 15:20:00 2012-03-20 15:20:00 admin Pass - 97 - Qual
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. There are two ways of transmitting data: With a removable disk such as a USB drive Through LAN/WLAN NOTE: The transmitted data can only be opened by the DMS. On the Main screen, press to get access to the Database screen.
i15 Blood Gas and Chemistry Analysis System User Manual Data Management 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.
i15 Blood Gas and Chemistry Analysis System User Manual 7.2.1.1 Searching for an Operator 1. On the Security Database screen, press Search. 2. Enter the operator ID, and press OK. Figure 7-4 Enter Search Conditions 3. The system automatically begins the search and displays the results. Figure 7-5 Search Results 4. Press Return to go back to the Security Database screen.
i15 Blood Gas and Chemistry Analysis System User Manual Data Management 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. Figure 7-6 Add Operator 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. NOTE: The operator ID is case sensitive, and should be 1 - 16 characters long (including both letters and numbers).
i15 Blood Gas and Chemistry Analysis System User Manual Data Management 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 go to the Security Database screen. NOTE: The password is case sensitive, and should be 4 - 16 characters long (including both letters and numbers). 7.2.1.4 Deleting Security Data 1. Select the desired security data. 2. Press Delete, and press OK in the pop up message.
i15 Blood Gas and Chemistry Analysis System User Manual Data Management 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 go to the User Login screen. NOTE: The default factory system password is 123456. Only administrators can change the system password (Even engineers from the manufacturer can not change it, although they can retrieve the password to the default factory setting). 7.2.
i15 Blood Gas and Chemistry Analysis System User Manual On the Database screen, press Data Management to get access to the Events Log Database screen. Figure 7-9 Events Log Database Screen 7.2.3.1 Searching for Events Data 1. On the Events Log Database screen, press Search. 2. Enter the search conditions, and press OK.
i15 Blood Gas and Chemistry Analysis System User Manual Data Management 3. The system automatically begins the search and displays the results. Figure 7-11 Search Results 4. Press Return to go back to the Events Log Database screen. 7.2.3.2 Exporting/Printing Events Data 1. Open the events log database. 2. Select the desired event data. To Export Print Do this Insert a removable disk into the analyzer, and then press Export. Press Print.
i15 Blood Gas and Chemistry Analysis System User Manual Data Management 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 and Simulator Database. Follow the steps below to backup data: 1. On the Database screen, press to access the Backup screen. Figure 7-12 Backup Screen 2. Select the database you want to backup. √ indicates the database is selected. 3.
i15 Blood Gas and Chemistry Analysis System User Manual Online Update Chapter 8 Online Update 8.1 Introduction Online update refers to analog board software update. The system can download the latest version of the update program from the network and automatically install it. Only engineers from the manufacturer can perform this action. 8.2 Procedures for Online Update NOTE: Avoid interruption of the power supply during the update process. 1. Press Setup Diagnostics Analog Update. 2.
i15 Blood Gas and Chemistry Analysis System User Manual Troubleshooting Chapter 9 Troubleshooting The following table lists some problems you may encounter to assist in troubleshooting. Table 9-1 Troubleshooting Examples Item Problem Solution 1 If the system is running smoothly, remove A test cartridge will not be ejected the test cartridge ejector cap, pull the middle automatically when a test is complete. hole with a pointed object, and remove the test cartridge from the system.
i15 Blood Gas and Chemistry Analysis System User Manual Well” appears. Troubleshooting please contact EDAN or its authorized distributors for assistance. Verify that the current date is correct. If the prompt appears again, check that the test cartridge has not expired. If it has expired, use a new test cartridge that has not expired. 8 The prompt “Cartridge Expired” appears. 9 Perform the test again with a new test The prompt “Calibrant is Not Aspirated cartridge.
i15 Blood Gas and Chemistry Analysis System User Manual Troubleshooting 18 The prompt “Barcode Cannot be Identified” Ensure that the bar code is that of a calibrant appears. fluid pack. 19 Ensure that the bar code is that of a new The prompt “Calibrant Pack Can’t be Used, calibrant fluid pack and that the new Please Scan Again” appears. calibrant fluid pack has not expired.
i15 Blood Gas and Chemistry Analysis System User Manual Troubleshooting Fluids have been spilled on the screen. Clean and disinfect the screen following the user manual instructions. The USB scanner does not work smoothly. Check the scanner type. If it is the type recommended by EDAN, remove the scanner from the system, and insert it again. Set the scanner, and scan a bar code again. Forget the user name or password. For an operator, contact the administrator for assistance.
i15 Blood Gas and Chemistry Analysis System User Manual Cleaning, Care and Maintenance Chapter 10 Cleaning, Care and Maintenance The system needs little care and maintenance. Clean and maintain it periodically to ensure its optimum performance. 10.1 Cleaning and Disinfecting the Analyzer Follow proper safety procedures and take protective measures such as wearing approved gloves when cleaning and disinfecting the system.
i15 Blood Gas and Chemistry Analysis System User Manual Cleaning, Care and Maintenance 10.1.2 Cleaning and Disinfecting the Screen Clean and disinfect the screen to remove dust, splatters, blood, etc. Policies regarding the cleaning and disinfecting intervals are at the discretion of your individual institution. Follow the steps below to clean and disinfect the screen: 1. Dampen a lint-free cloth with 0.5% sodium hypochlorite solution. NOTE: The cloth should be wet but not dripping. 2.
i15 Blood Gas and Chemistry Analysis System User Manual Cleaning, Care and Maintenance Figure 10-2 Remaining Time 6. Clean the screen with the lint-free cloth. 7. Repeat steps 4-6 to disinfect the screen with the lint-free cloth after the screen is thoroughly dry. NOTE: Clean the screen prior to disinfecting it. Make sure that the screen is thoroughly dry before disinfecting it. 8. Press Return twice to return to the Main screen. 10.1.
i15 Blood Gas and Chemistry Analysis System User Manual Cleaning, Care and Maintenance 10.2 Care and Maintenance 10.2.1 Recharging and Replacement of Battery Capacity Identification 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: : Full capacity. : Capacity is not full. : Capacity is limited, and recharging should be taken into account. : Capacity is low, the battery should be recharged soon.
i15 Blood Gas and Chemistry Analysis System User Manual Cleaning, Care and Maintenance NOTE: If the battery has not been used for more than two months, it should be recharged before use. Replacement 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. WARNING 1. Only the battery of the same model and specifications provided by EDAN should be used. 2.
i15 Blood Gas and Chemistry Analysis System User Manual Cleaning, Care and Maintenance 10.2.3 Maintenance of the Analyzer 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. a) Inspect the analyzer and accessories for mechanical and functional damage. b) Inspect the safety related labels for legibility.
i15 Blood Gas and Chemistry Analysis System User Manual Theory Chapter 11 Theory The system utilizes the electrochemical method to determine the concentrations of blood gases and blood chemistries, and utilizes the conductivity method 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. 11.1 Measurement Method Methods Measurements are performed on undiluted specimens.
i15 Blood Gas and Chemistry Analysis System User Manual Potentiometric Sensor Amperometric Sensor Conductometric Sensor Theory 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.
i15 Blood Gas and Chemistry Analysis System User Manual Theory 11.2.2 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: 1) The known value of the electrolyte concentration in the calibrant.
i15 Blood Gas and Chemistry Analysis System User Manual Theory 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. BB (B) Buffer Base BB (B) = BE (B) + 41.7 + 0.
i15 Blood Gas and Chemistry Analysis System User Manual Theory The default value for MCHC is 34g/dL. The unit for Hct is %PCV.
i15 Blood Gas and Chemistry Analysis System User Manual Theory pCO2 (T) pCO2 corrected for entered patient temperature pCO2 (T) = pCO2 × 100.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters Chapter 12 Parameters 12.1 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.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters 12.1.4 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.
i15 Blood Gas and Chemistry Analysis System User Manual Parameter N Slope Intercept pH 15 0.98 0.12 Parameters Correlation Sy.x Range 0.00397 6.715 – 7.768 Coefficient 0.99996 In the comparison study, samples were analyzed in parallel on the i15 Blood Gas and Chemistry Analysis System and the Rapidpoint 400 system. Two replicates of each sample were analyzed on each system. Parameter N Slope Intercept pH 215 1.0259 -0.1934 Correlation Sy.x Range 0.0126 7.137 – 7.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters 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 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. 12.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters samples with pCO2 values spanning the measurement range. Parameter N Expected Observed Swr bias %Recovery 9 123.2 124.9 4.5 1.7 101.4% 9 42.8 42.5 1.2 -0.3 99.3% 9 21.3 20.1 1.5 -1.2 94.4% 9 10.6 10.0 1.1 -0.6 94.3% pCO2 Linearity was estimated using reference materials and reference methods.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters salicyte, 37.5mmol/L bromide, and 20mmol/L β-hydroxybutyrate. NOTE: It is possible that there are other substances interfering with the pCO2 measurement. 12.3 pO2 pO2, the partial pressure of oxygen, is measured by amperometry. The oxygen reduction current is proportional to the dissolved oxygen concentration. If test results are inconsistent with the clinical assessment, the sample should be analyzed again with a new test cartridge. 12.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters 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 level were successively analyzed on one i15 Blood Gas and Chemistry Analysis System. RNA Medical® QC823 Blood Gas●Electrolyte●Metabolite●BUN controls are traceable to NIST standards.
i15 Blood Gas and Chemistry Analysis System User Manual Parameter N Slope Intercept pO2 215 0.9811 1.3173 Correlation Coefficient 0.9986 Parameters Sy.x Range 2.0303 20.4 – 191.0 12.3.5 Interfering Substances Aqueous sample was spiked by addition of a potentially interfering substance to the following test concentration to test for interferences.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters and so on. 12.4.2 Traceability Sodium ion concentration values assigned to calibrant and controls are traceable to NIST standards. 12.4.3 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.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters refers to the standard error of estimate. Parameter N Slope Intercept Na+ 15 0.98 1.30 Correlation Coefficient 0.99999 Sy.x Range 0.1924 102.6 – 180.3 In the comparison study, samples were analyzed in parallel on the i15 Blood Gas and Chemistry Analysis System and the Rapidpoint 400 system. Two replicates of each sample were analyzed on each system. Parameter N Slope Intercept Na+ 215 0.9813 2.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters If test results are inconsistent with the clinical assessment, the sample should be analyzed again with a new test cartridge. 12.5.1 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.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters samples with K+ values spanning the measurement range. Parameter K+ N Expected Observed Swr bias %Recovery 9 3.40 3.35 0.04 -0.05 98.5% 9 4.00 4.01 0.03 0.01 100.3% 9 9.37 9.36 0.20 -0.01 99.9% Linearity was estimated using reference materials and reference methods.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters NOTE: It is possible that there are other substances interfering with the K+ measurement. 12.6 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. If test results are inconsistent with the clinical assessment, the sample should be analyzed again with a new test cartridge. 12.6.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters Controls Mean SD Level 1 1.47 0.029 Level 2 1.16 0.026 Level 3 0.46 0.019 Precision and recovery on whole blood samples was estimated using multiple whole blood samples with Ca++ values spanning the measurement range. Parameter Ca++ N Expected Observed Swr bias %Recovery 9 1.05 1.05 0.03 0.00 100.0% 9 1.21 1.20 0.01 -0.01 99.2% 9 2.68 2.68 0.07 0.00 100.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters 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 spiked sample and the unspiked sample. The substances that interfere with the Ca++ measurement are listed below: 12.5mmol/L bromide will increase Ca++ results by 0.07mmol/L. 37.5mmol/L bromide will increase Ca++ results by 0.17mmol/L.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters 12.7.3 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.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters In the comparison study, samples were analyzed in parallel on the i15 Blood Gas and Chemistry Analysis System and the Rapidpoint 400 system. Two replicates of each sample were analyzed on each system. Parameter N Slope Intercept Cl- 215 0.9955 0.2967 Correlation Sy.x Range 0.9802 77 - 132 Coefficient 0.9961 12.7.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters 12.8.1 Intended Use The hematocrit test is intended for the quantification of hematocrit in arterial, venous, or capillary whole blood samples. Hematocrit is a useful indicator for assessing states of blood volume, such as anemia and erythrocytosis. 12.8.2 Traceability Hematocrit values assigned to calibrant and controls are traceable to NIST standards. 12.8.
i15 Blood Gas and Chemistry Analysis System User Manual Parameters each level of materials were analyzed in parallel on the i15 Blood Gas and Chemistry Analysis System and the Rapidpoint 400 system. Reference materials used were RNA Medical® CVC 9005 Hematocrit Calibration Verification Controls, and they were traceable to NIST standards. In the table below, Sy.x refers to the standard error of estimate. Parameter N Slope Intercept Hct 15 0.99 0.56 Correlation Coefficient 0.99988 Sy.x Range 0.
i15 Blood Gas and Chemistry Analysis System User Manual Warranty and Service Chapter 13 Warranty and Service 13.1 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.
i15 Blood Gas and Chemistry Analysis System User Manual Specifications Appendix 1 Specifications A1.1 Environment Requirements Usage Analyzer Transport and Storage Usage Test Cartridge Transport Storage Usage Calibrant Fluid Pack Transport and Storage Controls Usage Temperature 10 - 31°C Humidity 25% - 80% (non-condensing) Ambient Pressure Temperature 70 - 106.6kPa (525 - 800mmHg) -20 - 60°C Humidity 25% - 93% (non-condensing) Ambient Pressure Temperature 40 - 106.
i15 Blood Gas and Chemistry Analysis System User Manual Transport Storage Specifications Humidity 25% - 80% (non-condensing) Ambient Pressure Temperature 70 - 106.6kPa (525 - 800mmHg) 2 - 30°C Humidity 25% - 93% (non-condensing) Ambient Pressure Temperature 40 - 106.6kPa (300 - 800mmHg) 2 - 8°C (avoid freezing) Humidity 25% - 93% (non-condensing) Ambient Pressure 40 - 106.6kPa (300 - 800mmHg) A1.2 Analyzer Specifications Size 315*238*153mm (length ×width ×height) Weight 3.
i15 Blood Gas and Chemistry Analysis System User Manual Specifications A1.5 Rechargeable Battery Type Working Time Necessary Charge time Rechargeable lithium battery When the battery is fully charged, the system can analyze and print 50 samples. No more than 8 hours Rated Capacity 4200mAh Rated voltage 14.8V Charge Mode Constant voltage/current Charge Current (standard) 0.
i15 Blood Gas and Chemistry Analysis System User Manual Measurement Ranges Appendix 2 Measurement Ranges A2.1 Measurement Ranges for Measured Parameters Parameter pH pO2 pCO2 K+ Na+ ClCa++ Hct Measurement Range 6.500 - 8.000 10 - 700mmHg 10 - 150mmHg 2.0 - 9.0mmol/L 100 - 180mmol/L 65 - 140mmol/L 0.25 - 2.50mmol/L 10 - 75 %PCV A2.2 Measurement Ranges for Calculated Parameters Parameter cH+ cH+(T) pH(T) pCO2(T) pO2(T) HCO3-act HCO3-std BB(B) BE(B) BE(ecf) ctCO2 Ca++(7.
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. Parameter pH pO2(mmHg) pCO2(mmHg) Na+(mmol/L) K+(mmol/L) Cl-(mmol/L) Ca++(mmol/L) Hct (%) Reference Range Arterial 7.
i15 Blood Gas and Chemistry Analysis System User Manual EMC Information Appendix 4 EMC Information Guidance and manufacture’s declaration - electromagnetic emissionsfor all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission The system is intended for use in the electromagnetic environment specified below. The user of the system should ensure that it is used in such an environment.
i15 Blood Gas and Chemistry Analysis System User Manual EMC Information Electrical fast ±1kV for power supply ±1kV for power supply Mains power quality transient/burst IEC lines lines should be that of a typical 61000-4-4 commercial or hospital environment. Surge ±1kV line to line ±1kV line to line Mains power quality IEC 61000-4-5 ±2kV line to ground ±2kV line to ground should be that of a typical commercial or hospital environment.
i15 Blood Gas and Chemistry Analysis System User Manual Conducted 3Vrms RF IEC 150kHz to 61000-4-6 80MHz Radiated RF IEC 61000-4-3 3V/m 80MHz to 2.7GHz 3Vrms EMC Information Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 3.5 d= P V1 3V/m 3.
i15 Blood Gas and Chemistry Analysis System User Manual EMC Information Recommended separation distances between portable and mobile RF communication equipment and the EQUIPMENT or SYSTEMFor EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the system The system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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.
i15 Blood Gas and Chemistry Analysis System User Manual Order List Appendix 6 Order List WARNING Only accessories supplied or recommended by EDAN should be used. Otherwise, the performance and electric shock protection can not be guaranteed. The following accessories are recommended to be used on the analyzer. Part Name Part Number Power Adaptor Printer Paper 21.21.064186 01.57.471304-10 Rechargeable Lithium-ion Battery 01.21.
