i-SENS i-Smart 300 Operator's Manual
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i-SENS i-Smart 300 Operator's Manual

i-SENS i-Smart 300 Operator's Manual

Blood gas analyzer
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PDNAA-000007 REV0
2021/06

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  • Page 1 PDNAA-000007 REV0 2021/06...
  • Page 2 Inc. 43, Banpo-daero 28-gil, Seocho-gu, Seoul 06646, Korea [Manufacturing facility] i-SENS Songdo Factory 12, Harmony-ro 275beon-gil, Yeonsu-gu, Incheon 22014, Korea Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 66386 St. Ingbert, Germany Copyright © 2021 i-SENS, Inc. All Rights Reserved...
  • Page 4 Please take time to read this operator’s manual before setting up and operating the analyzer.

  • Page 6: Table Of Contents

    Table of Contents Table of Contents 1 Introduction Safety ............................ 8 Symbols and Terminology ....................10 Product Description ......................13 2 Installation Installation Requirements ....................16 Power Cable Connection ....................17 Power-on ..........................18 Printer Paper Installation ..................... 20 Cartridge Installation ......................22 3 Instrument Settings Screen Menu ........................
  • Page 7 Table of Contents 6 Shutdown Analyzer Shutdown ......................98 Power Recovery ........................ 100 7 Maintenance Calibration ......................... 102 Cartridge Removal......................105 System Information ......................108 Event Log .......................... 109 Analyzer Status ........................110 Cleaning ..........................111 8 Troubleshooting Troubleshooting ......................... 114 Error Code .........................

  • Page 8: Introduction

    1. Introduction 1. Introduction Safety ............................8 Symbols and Terminology .....................10 Product Description ......................13...

  • Page 9: Safety

    ‰ When disposing the analyzer and provided electrical accessories, contact your local distributor where you purchased them. ‰ Electronic devices must be recycled accordingly following the environment protection and resource recycling policies. Please do not dispose at residential waste facilities. i-Smart 300 Blood Gas Analyzer...
  • Page 10 1. Introduction Safety, continued Biohazard Caution ‰ Please handle all devices used to collect blood samples from patients as potential biohazard materials as it can become the source of infection. ‰ All biohazard materials must be handled and/or disposed in accordance with the instructions from hospitals, clinical labs, or testing facilities.

  • Page 11: Symbols And Terminology

    This marking indicates that you must not discard this electrical/electronic product in domestic household waste. Distributors of this product within the EU have taken the necessary step to comply with the Waste Electrical and Electronic Equipment (WEEE) Directive i-Smart 300 Blood Gas Analyzer...
  • Page 12 1. Introduction Symbols and Terminology, continued Symbols, Symbol Description continued Printer DC Power port Power off Power on This way up: indicates correct upright position of the transport package. Keep dry Fragile, handle with care Stacking limit by number: maximum number of identical packages which may be stacked on one another Operator's Manual...
  • Page 13 A statement that alerts the operator to the possibility of device malfunction, device failure, damage to the Caution device or damage to other property associated with the use or misuse of the device. i-Smart 300 Blood Gas Analyzer...

  • Page 14: Product Description

    1. Introduction Product Description The i-Smart 300 Blood Gas Analyzer is an automated system that Intended Use measures pH, pCO , pO , Na , Cl , Ca and hematocrit in whole blood. The i-Smart 300 Blood Gas Analyzer is intended for in vitro diagnostic use and for use by healthcare professionals.
  • Page 15 1. Introduction Product Description, continued Accessories Power adapter Power cord Printer Paper Cartridge Cartridge Cover i-Smart 300 Cartridge / i-Smart 300E Cartridge i-Smart 300 Blood Gas Analyzer...

  • Page 16: Installation

    2. Installation 2. Installation Installation requirements .......................16 Power Cable Connection ......................17 Power-On ..........................18 Printer Paper Installation .......................20 Cartridge Installation ......................22...

  • Page 17: Installation Requirements

    ‰ Volt AC : 100 ~ 240 Va.c., grounded electrical supply ‰ Electric Current : 1.5 A ‰ Frequency : 50/60 Hz ‰ Power Cord : 3-wire, approved ‰ Power adapter : +24 Vd.c., 2.7 A (Output) i-Smart 300 Blood Gas Analyzer...

  • Page 18: Power Cable Connection

    2. Installation Power Cable Connection Caution ‰ Check that the power switch is in “ ” (OFF) position. ‰ Connect to the power following the instructions listed on this manual. ‰ Always use a grounded electrical outlet. ‰ Use only the power cord and power adapter provided by the manufacturer.

  • Page 19: Power-On

    9 If the machine is rebooted with a usable cartridge, Cartridge Restart will be automatically performed. 9 If the machine is rebooted with an unusable cartridge, “Expired Cartridge” status will appear. i-Smart 300 Blood Gas Analyzer...
  • Page 20 2. Installation Power-On, continued Turn on the power, 4. Please check the power cord icon is indicated on the top of the continued screen. Note: 9 If the power cord icon does not appear, please check whether the power cable is connected loosely or the electrical outlet has the power.

  • Page 21: Printer Paper Installation

    Install printer paper 1. Open the printer cover by pressing the PUSH button located in the top of the analyzer’s back side. 2. Place the paper roll in the holder, and align the edge of the paper to the printer output part when the printer cover is closed. i-Smart 300 Blood Gas Analyzer...
  • Page 22 2. Installation Printer Paper Installation, continued 3. Place the edge of the printer paper so it will not be out of the printer Install printer paper, output area, and close the printer cover. continued Note: 9 Once the cover is closed, any excess paper out of the printer will cut off automatically.

  • Page 23: Cartridge Installation

    1. Open the cartridge package and remove from the box. 2. Open the cartridge cover by pressing the cover lock button and remove the cover. Note: 9 Be careful to handle the cartridge once the cover is removed. Sharp edged and components are exposed. i-Smart 300 Blood Gas Analyzer...
  • Page 24 2. Installation Cartridge Installation, continued 3. Following the instruction on the screen, press “INSTALL” button. You Install Cartridge, will hear the click sound as the cartridge door is unlocked. continued Note: 9 When the analyzer is running on a battery and the battery level is below 20 %, the cartridge install is not available.
  • Page 25 You will hear ‘click’ locking sound if the door has been closed normally. 7. Once the analyzer recognizes the cartridge’s RFID information automatically and the RFID information is valid, Cartridge Warm-Up will begin. i-Smart 300 Blood Gas Analyzer...
  • Page 26 2. Installation Cartridge Installation, continued 8. Warming up the new cartridge takes about 25 minutes. Install Cartridge, continued Note: 9 Caution on the sharp edges exposed after the cartridge cover is removed. 9 The sampler cover is locked when it is not Ready. 9.
  • Page 27 2. Installation This page is intentionally left blank i-Smart 300 Blood Gas Analyzer...

  • Page 28: Instrument Settings

    3. Instrument Settings Instrument Settings Screen Menu .........................28 Instrument Setup........................36 Parameter Setup ........................45 Unit Setup ..........................47 Sample Setup........................49 QC Setup ..........................55 L-J Chart Setup ........................58 Interface Setup ........................60...

  • Page 29: Screen Menu

    Interface setup status ④ Power connect status ⑤ Battery Status ⑥ Current Date and Time ⑦ Menu Button ⑧ Current status of each sensor Pressing each button twice will display the latest slope of the ⑨ sensor. i-Smart 300 Blood Gas Analyzer...
  • Page 30 3. Instrument Settings Screen Menu, continued Using Menu 1. When pressing MENU, the first row of the screen will show icons of the most frequently used items and Remove Cartridge, Shutdown Analyzer menu. The second row will show the 5 categories. 2.
  • Page 31 3. Instrument Settings Screen Menu, continued Menu options i-Smart 300 Blood Gas Analyzer...
  • Page 32 3. Instrument Settings Screen Menu, continued Icons and buttons Button, icons Function Print results or settings on screen Transmit results to LIS/HIS Cancel and return to main screen Go to the list screen Go to the search screen View result screen Scroll to previous/next page from the list Go to previous/next result screen...
  • Page 33 Run QC sampling Accept or discard QC results Delete QC Lot information Scan QC barcode Delete all information entered in the current tab Restore default values Save Return to the previous screen Copy cartridge data to USB i-Smart 300 Blood Gas Analyzer...
  • Page 34 3. Instrument Settings Screen Menu, continued Icons and buttons, Button, icons Function continued Deselect an item on the list Select an item on the list Items sent to LIS/HIS Select the items to be sent to LIS/ Scan barcode for data entry Show keyboard for data entry Show number keypad for data entry...
  • Page 35 3. Instrument Settings Screen Menu, continued Keyboards i-Smart 300 Blood Gas Analyzer will display the keyboard as follows on the screen. Alphabet keyboard Numbers and special characters keyboard Date entry keypad Time entry keypad Numeric keypad i-Smart 300 Blood Gas Analyzer...
  • Page 36 3. Instrument Settings Screen Menu, continued Display auto When the analyzer is inactive longer than 10 minutes, the screen saver will brightness be turned on and the LCD screen brightness will be adjusted to dim. Note: 9 In Sample - Results and QC - Results screens, LCD brightness will not be adjusted.

  • Page 37: Instrument Setup

    9 Date format, Date and Time can be setup only when the cartridge is not installed. Once the cartridge is installed, the set up for these 3 items will be inactive. 3. Press Date Format box and select the desired date format from the drop-down list. i-Smart 300 Blood Gas Analyzer...
  • Page 38 3. Instrument Settings Instrument Setup, continued 4. Press Date box and enter the current date using the keyboard. Date and Time, continued 5. Press Time box and enter the current local time using the keyboard. Operator's Manual...
  • Page 39 3. Instrument Settings Instrument Setup, continued Instrument Name 1. Press Instrument Name box and enter the desired name using the keyboard. Note: 9 The entered instrument name will appear on set-up printouts and network-transmitted messages. i-Smart 300 Blood Gas Analyzer...
  • Page 40 3. Instrument Settings Instrument Setup, continued Barometric 1. Click the Barometric Pressure Default Value box to enter the Pressure Setup pressure value of the space where the analyzer will be operated. Note: 9 Barometric Pressure Default Value is set to 760 mmHg by default.
  • Page 41 9 The selected language applies to the UI, voice and print output. Speaker Volume 1. To adjust speaker volume, press button under Speaker Volume. 2. Using Mute or Max button to mute the sound or set to the max volume. i-Smart 300 Blood Gas Analyzer...
  • Page 42 3. Instrument Settings Instrument Setup, continued LCD Brightness 1. The LCD screen brightness can be adjusted to 15 different levels using Setup button under LCD Brightness. Note: 9 Use Min or Max button to set the LCD to the brightest and dim setting.
  • Page 43 9 Selecting Summary will only print the information entered on the Sample information page. 3. Select On or Off for Auto Print. 4. Select On or Off for Auto Cut. 5. Press Save to save the setup and exit to main screen. i-Smart 300 Blood Gas Analyzer...
  • Page 44 3. Instrument Settings Instrument Setup, continued Password Setup 1. Select Password tab. The following screen will appear. 2. If Password Activation is set to on, Current Password, New Password and Confirm New Password field will be enabled. 3. Please enter the Current Password. Note: 9 The initial password is set to 0000 when using the analyzer for the first time.
  • Page 45 9 Once the password is activated, the setup Menu will be locked. To access the Setup Menu, a correct password must be entered. 9 If press a Close button, the changed settings will not be saved but return to the main screen. i-Smart 300 Blood Gas Analyzer...

  • Page 46: Parameter Setup

    3. Instrument Settings Parameter Setup Parameter Setup 1. Select MENU > Setup > Parameter. The following screen will appear. Note: 9 When i-Smart 300E Cartridge (6 parameters) is installed, the screen will display only pH, Na , Ca , Cl and Hct under the Measured Parameters, and their relevant Calculated Parameters will appear on the screen.
  • Page 47 – Setup - Correlation Factors. – Calibration - Cal 1 Results, Calibration - Cal 2 Results. – Calibration - List. – Cal 1 Results, Cal 2 Results print. – Setup - QC. – Sample and QC result print. i-Smart 300 Blood Gas Analyzer...

  • Page 48: Unit Setup

    3. Instrument Settings Unit Setup Unit Setup 1. Select MENU > Setup > Unit. The following screen will appear. 2. Units of parameters used in the analyzer (Measured Value, Calculated Value, and User input values) can be selected from the drop down lists. Operator's Manual...
  • Page 49 9 The selected unit will be applied to all screens and printout. 9 The values in this manual are shown in default units. 3. Press Save to save the setup and go back to the main screen. i-Smart 300 Blood Gas Analyzer...

  • Page 50: Sample Setup

    3. Instrument Settings Sample Setup Reference Range 1. Select MENU > Sample > Reference Ranges Setup. The following screen will appear. Note: 9 The Reference Range Setup cannot be selected for the items not selected in the Setup - Parameter. 9 The unit selected from Setup - Unit will be displayed.
  • Page 51 1.15 ~ 1.33 mmol/L 98 ~ 107 Male: 41 ~ 51 Female: 35 ~ 45 Reference: 1) TIETZ, Fundamentals of Clinical Chemistry. 6th ed. 2008 2) HENRY’S Clinical Diagnosis and Management by Laboratory Methods, 22nd ed., 2011 i-Smart 300 Blood Gas Analyzer...
  • Page 52 3. Instrument Settings Sample Setup, continued Critical Limits 1. Select MENU > Sample > Critical Limits Setup. The following screen will appear. Note: 9 The Critical Limits cannot be set up for the items not selected in the Setup - Parameter. 9 The unit selected from Setup - Unit will be displayed.
  • Page 53 9 The high value must be set higher than the high value of the reference range. 9 The low value must be set lower than the low value of the reference range. i-Smart 300 Blood Gas Analyzer...
  • Page 54 3. Instrument Settings Sample Setup, continued Correlation Factors 1. Select MENU > Sample > Correlation Factors Setup. Setup The following screen will appear. Note: 9 The Correlation Factors Setup cannot be selected for the measurement parameters not selected in the Setup - Parameter. 9 When i-Smart 300E Cartridge (6 parameters) is installed, only pH, , Ca , Cl...
  • Page 55 4. Press Print button to print out all entered correlation factor values. 5. Press Save to save the setup and go back to the main screen. Note: 9 Pressing Default button will reset all the entered values to default values. i-Smart 300 Blood Gas Analyzer...

  • Page 56: Qc Setup

    3. Instrument Settings QC Setup QC Lot Setup 1. Select MENU > Setup > QC. The following screen will appear. 2. Select an empty row on the list located in the left to enable the QC Lot setup window to the right as shown below. Note: 9 The QC Setup cannot be selected for the measurement parameters not selected in the Setup - Parameter.
  • Page 57 3. Instrument Settings QC Setup, continued 3. When using the QC material with the QC barcode provided by i-SENS, QC Lot Setup, press QC Barcode button. Then, scan the barcode printed on the continued insert sheet. 4. QC Lot information will be automatically populated once the QC barcode is recognized.
  • Page 58 3. Instrument Settings QC Setup, continued 5. If it is not QC barcode provided by i-SENS, Enter QC lot information QC Lot Setup, manually. continued Note: 9 When the unit is changed in Setup - Unit and the QC Information is manually entered, the QC Range Values must be entered in the changed value.

  • Page 59: L-J Chart Setup

    1. Select MENU > QC > L-J Chart Setup. The following screen will appear. 2. Select QC level on the top of the screen. 3. To set up the SD range, select the SD range in each unit’s SD selection field. i-Smart 300 Blood Gas Analyzer...
  • Page 60 3. Instrument Settings L-J Chart Setup, continued 4. To manually set up the lower and upper limit, select Lower Limit and L-J Chart Setup, Upper Limit located on the right. continued 5. Using the numeric keypad, enter low and high limits. 6.

  • Page 61: Interface Setup

    Default is ONE. 4. Press Parity Bit box and select the desired option from the drop-down list. Default is None. 5. Press Handshake box and select the desired option from the drop- down list. Default is None. i-Smart 300 Blood Gas Analyzer...
  • Page 62 3. Instrument Settings Interface Setup, continued TCP/IP Setup 1. Select the TCP/IP Setup tap. The following screen will appear. Note: 9 If the analyzer is connected to a network. IP information of IP and DNS automatically appears in the TCP/IP Setup tab. 9 If the analyzer is disconnected from a network.
  • Page 63 5. Press Save to save the settings and return to the main screen. TCP/IP Setup, continued Note: 9 If press Close button, the changed settings are not saved and return to the main screen. i-Smart 300 Blood Gas Analyzer...

  • Page 64: Sample Analysis

    4. Sample Analysis 4. Sample Analysis Blood Sample........................64 QC Sample ..........................74...

  • Page 65: Blood Sample

    2. The introduce sample screen will appear when the sampler cover is lifted. Note: 9 To cancel the sample analysis, close the sampler cover to the original position before pressing ASPIRATE button. 9 Once ASPIRATE is pressed, the sample analysis cannot be cancelled. i-Smart 300 Blood Gas Analyzer...
  • Page 66 4. Sample Analysis Blood Sample, continued 3. Measured parameters for the sample being analyzed can be changed Introduce Sample, during the analysis by pressing “Parameter Setup” at the bottom of continued the screen. Note: 9 Parameter Setup items selected from the Introduce Sample screen apply only to the analysis in progress.
  • Page 67 11. If the sample aspiration process was not done properly or the sample aspiration amount is insufficient, the message “Insufficient sample error. Sample is being aborted.” will appear and will not proceed to the Sample - Information page. i-Smart 300 Blood Gas Analyzer...
  • Page 68 4. Sample Analysis Blood Sample, continued Sample Information 1. Once the sample is introduced without error and the sampler cover is closed, the following Sample - Information screen will appear. Note: 9 Items with units will display the unit selected from Setup - Unit. 9 When i-Smart 300E Cartridge (6 parameters) is installed, Time Drawn, Patient Temp., tHb, sO , FIO...
  • Page 69 4. Sample Analysis Blood Sample, continued 3. If the barcode scan is difficult, enter information by clicking each item Sample Information, or keyboard button. continued i-Smart 300 Blood Gas Analyzer...
  • Page 70 4. Sample Analysis Blood Sample, continued Note: Sample Results 9 Results will be displayed only for the measuring parameters and calculated parameters that had been selected from the Setup - Parameter. 9 Sample Results Screen, Printouts, and Interface messages will display the units selected from Setup - Unit.
  • Page 71 10. If you choose Calculated Quantity tab, the calculated output using formulae will be shown. Note: 9 Any value that cannot be calculated under Calculated Quantity tab will appear blank with the red capital letter C. i-Smart 300 Blood Gas Analyzer...
  • Page 72 4. Sample Analysis Blood Sample, continued 11. More detailed information on the current blood sample is available Sample Results, under More Info. Tab. continued Note: 9 Sample information will be displayed only for the samples that had been selected in the Sample - Information screen. Operator's Manual...
  • Page 73 9 If the analyzer is running on a battery, when the battery level is below 20 %, the print function will not be available. 13. When the auto-print option is set to ON, the sample result will appear on the screen and will be printed in real time. i-Smart 300 Blood Gas Analyzer...
  • Page 74 4. Sample Analysis Blood Sample, continued 14. When Summary is selected in the print option, only the sample Sample Results, information entered will be printed. continued 15. To send the result to LIS/HIS, press Send button. 16. Press Close to save the results and exit to main screen. 17.

  • Page 75: Qc Sample

    9 If idle more than 60 seconds at the “Lift sampler cover for QC sampling” screen, it will go back to Ready screen. 3. When the message “Position QC sample for aspiration” appears, insert the end of the Sampler probe into the QC sample, and press Aspirate button. i-Smart 300 Blood Gas Analyzer...
  • Page 76 4. Sample Analysis QC Sample, continued Introduce QC 4. The “Aspirating QC sample... Please wait” message will appear as sample, the QC Sample is being aspirated. continued Note: 9 To cancel QC sample analysis, close the sampler cover to the original position without pressing the ASPIRATE button.
  • Page 77 3. If needed, enter the Operator ID using the barcode or on- screen keyboard, and enter the QC Comment using the on-screen keyboard. 4. Select the matching QC Lot item with the QC sampling and press OK. QC - Results screen will appear. i-Smart 300 Blood Gas Analyzer...
  • Page 78 4. Sample Analysis QC Sample, continued Note: QC Results 9 QC results will be displayed only for the parameters that had been selected in the Setup - Parameter. 9 QC screen results, Printouts, and Interface messages will display the unit selected from Setup - Unit. 1.
  • Page 79 QC Results, A printout similar to following will be printed. continued Note: 9 If the analyzer is running on a battery, when the battery level is below 20 %, the print function will not be available. i-Smart 300 Blood Gas Analyzer...
  • Page 80 4. Sample Analysis QC Sample, continued 4. When Summary is selected in the print option, only the QC information QC Results, entered will be printed. continued 5. To send the result to LIS/HIS, press Send button. 6. Press Close to save the results and return to main screen. Operator's Manual...
  • Page 81 4. Sample Analysis This page is intentionally left blank i-Smart 300 Blood Gas Analyzer...

  • Page 82: Database

    5. Database 5. Database Sample Data..........................82 QC Data ..........................86 Calibration Data ........................92 Cartridge Data ........................95...

  • Page 83: Sample Data

    2. Press Next Results, Prev Results to see the next and previous results. 3. Press List to go to the list of Sample results. 4. Press Send button to send results to LIS/HIS. 5. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...
  • Page 84 5. Database Sample Data, continued Sample Results 1. Select MENU > Sample > Results List. The following screen will appear. List 2. The sample results list will be displayed in descending order (the last result on top). Use Page UP or Page Down to scroll the results. 3.
  • Page 85 List screen. The sample result search screen will display. 6. To send the sample results to LIS/HIS, select the results to send and press the Send button. 7. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...
  • Page 86 5. Database Sample Data, continued Sample Results 1. Select MENU > Sample > Results Search. The following screen will Search appear. Note: 9 Search criteria are as follows: ‰ From and To date of the search date range ‰ Sample Type ‰...

  • Page 87: Qc Data

    2. Press List to go to the list of QC results. 3. Use Next Results, Prev Results button to browse previous and next results. 4. Press Send button to send results to LIS/HIS. 5. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...
  • Page 88 5. Database QC Data, continued QC Results List 1. Select MENU > QC > Results List. The following screen will appear. 2. The QC Results will display in descending order (the most recent result on top). Use Page Up or Page Down to scroll the QC results. 3.
  • Page 89 6. To search the results, click Search button from the QC - Results List screen. The QC result search screen will display. Refer to the next section regarding the QC results search. 7. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...
  • Page 90 5. Database QC Data, continued QC Results Search 1. Select MENU > QC > Results Search. The following screen will appear. Note: 9 Search criteria are as follows: ‰ From and To date of the search date range ‰ QC Lot ‰...
  • Page 91 20 %, the print function is not available. 6. To copy the QC statistics data, insert a USB memory in the USB port and press Download button. 7. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...
  • Page 92 5. Database QC Data, continued L-J Chart 1. Select MENU > QC > L-J Chart. The following screen will appear. 2. Select QC Lot, Level and Parameter on the top of the screen. The following chart appears for the selected parameters. Note: 9 The most recent data is indicated to the right and values (up to 30) are displayed in the chart.

  • Page 93: Calibration Data

    9 If the analyzer is running on a battery, when the battery level is below 20 %, the print function will not be available. 5. Press List button and the Calibration List will display. 6. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...
  • Page 94 5. Database Calibration Data, continued Cal 2 Results 1. Select MENU > Calibration > Cal 2 Results. The following screen will appear. Note: 9 Cal 2 results will be displayed only for the parameters that had been selected in the Setup - Parameter. 9 Cal 2 results, Printouts, and Interface messages will display the unit selected from Setup - Unit.
  • Page 95 3. Press View Results button to display the Cal 2 Results page for the selected item. 4. Press Send button to send Cal 2 results to LIS/HIS. 5. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...

  • Page 96: Cartridge Data

    5. Database Cartridge Data Cartridge Data 1. Select MENU > Ststus > Cartridge Data. The following screen will appear. 2. Cartridge Data list will display in descending order (the most recent result on top) Use Page Up or Page Down to scroll the cartridge log. 3.
  • Page 97 5. Database This page is intentionally left blank i-Smart 300 Blood Gas Analyzer...

  • Page 98: Shutdown

    6. Shutdown 6. Shutdown Analyzer Shutdown .......................98 Power Recovery ........................100...

  • Page 99: Analyzer Shutdown

    Shutdown Analyzer 1. Select MENU > Shutdown Analyzer. The following screen will appear. 2. Press Yes and the following message appears. Note: 9 After shutdown, if the analyzer is not restarted within 12 hours, the installed cartridge will be no longer usable. i-Smart 300 Blood Gas Analyzer...
  • Page 100 6. Shutdown Analyzer Shutdown, continued 3. Press Yes and the following message will appear. Shutdown Analyzer, continued 4. When the progress bar reached to 100 %, “Turn off the analyzer” message will appear. 5. When the message is displayed, Turn off the power by pushing the power button so that “...

  • Page 101: Power Recovery

    1. Cartridge Restart screen will appear once the Cartridge restart is in progress. 2. Cartridge Restart normally takes about 10 minutes. 3. After the warm up, the analyzer will return to the Ready status. i-Smart 300 Blood Gas Analyzer...

  • Page 102: Maintenance

    7. Maintenance 7. Maintenance Calibration ...........................102 Cartridge Removal ......................105 System Information ......................108 Event Log ..........................109 Analyzer Status ........................110 Cleaning ..........................111...

  • Page 103: Calibration

    Cal 1 Results, Cal 2 Results, Calibration - List page. 9 Sent calibration results data can be confirmed from the Cal 1 Results, Cal 2 Results, and Calibration - List page. i-Smart 300 Blood Gas Analyzer...
  • Page 104 7. Maintenance Calibration, continued Repeat 1. When the analyzer runs into Drift error after the real time Drift check, it Auto Cal 1 will automatically Cal 1 process up to 1 time. 2. While the auto Cal 1 is in progress, “Drift error has occurred. Cal 1 is in progress.
  • Page 105 (Drift Error) or red (Slope Error) depending on the status. 2. When pressing a sensor status icon twice, the slope and the allowable slope range of the corresponding sensor obtained from the last calibration will display. i-Smart 300 Blood Gas Analyzer...

  • Page 106: Cartridge Removal

    7. Maintenance Cartridge Removal Caution ‰ Handle any used cartridge as a biological hazard. ‰ The used cartridge must be disposed according to the laboratory’s biohazard waste disposal guidelines and procedures. ‰ Before disposing of the used cartridge, please wear protective gear and gloves for protection from any biological hazard.
  • Page 107 2. Press REMOVE button from the Cartridge Expired screen and the following screen will appear. 3. Proceed with the cartridge removal following the instructions on the screen. 4. To install a new cartridge, refer to 2. Installation > Cartridge Installation for detailed procedure. i-Smart 300 Blood Gas Analyzer...
  • Page 108 7. Maintenance Cartridge Removal, continued Remove cartridge in 1. To remove a cartridge currently in use, select MENU > Remove Cartridge and the following pop-up will appear. Note: 9 To cancel cartridge removal, press No. 9 Removed cartridge cannot be reused even if the expiration date and the number of tests are still available.

  • Page 109: System Information

    , Cl and Hct will appear on the screen. 9 Cal 1 and Cal 2 values from Cartridge information will display the unit selected from Setup - Unit. 3. Press Close to exit to main screen. i-Smart 300 Blood Gas Analyzer...

  • Page 110: Event Log

    7. Maintenance Event Log Event Log 1. Select MENU > Ststus > Event Log. The following screen will appear. Note: 9 The Event Log is displayed in the language that was set when the log was recorded. 2. The following events occurred during the analyzer operation will be recorded in the Event Log: ‰...

  • Page 111: Analyzer Status

    , Ca , Cl and Hct will appear on the screen. 9 Temperature unit will be the one selected from Setup - Unit. 9 The Service Mode is for service engineers ONLY and protected by password. i-Smart 300 Blood Gas Analyzer...

  • Page 112: Cleaning

    7. Maintenance Cleaning Caution ‰ To prevent infection, please wear protective clothes and gloves while cleaning. ‰ Perform routine cleaning of the analyzer. ‰ Do not spray cleaning solution directly on the analyzer. ‰ Use caution when using the cleaning solution and make sure it does not get inside of the analyzer.
  • Page 113 7. Maintenance This page is intentionally left blank i-Smart 300 Blood Gas Analyzer...

  • Page 114: Troubleshooting

    8. Troubleshooting 8. Troubleshooting Troubleshooting ........................114 Error Code ...........................119...

  • Page 115: Troubleshooting

    ‰ The screen does not respond to touch ‰ The screen is frozen ‰ Abnormal screen is displayed 1. Turn off the power switch of the analyzer. 2. Wait for 10 seconds. 3. Turn on the power switch of the analyzer. i-Smart 300 Blood Gas Analyzer...
  • Page 116 9. Check the battery level while the analyzer is on, and in case the charge level does not go up over even when it is plugged in for some time, contact your reseller or © i-SENS Customer Service center. 10. The analyzer will operate normal as long as it is connected with the power cable until the battery is replaced.
  • Page 117 ‰ The screen does not proceed to the Warm-up screen after a cartridge Installation is installed in the analyzer. 1. Check that the cartridge is an i-Smart 300 cartridge. 2. Check that the cartridge is not past its expiration date. 3. Check that the cartridge has not been previously used.
  • Page 118 8. Troubleshooting Troubleshooting, continued Power ‰ Power Cable icon is not indicated while power cable is plugged into the analyzer. 1. Check if the connection between the analyzer and the power cable is loose. 2. Fix the loose power connection. In case you experience one of the following issues: ‰...
  • Page 119 4. Repeat Cal 2 a few times if the same problem occurs. 5. Try QC solutions for analysis. If the QC results are within the QC range, the analyzer is okay for sample analysis. 6. Check Appendix A for sample collection and handling procedure. i-Smart 300 Blood Gas Analyzer...

  • Page 120: Error Code

    8. Troubleshooting Error Code Error code 1. In case the following error codes appear during the operation of the analyzer: Error Code Description ESYS001 ~ ESYS999 Hardware errors EDB001 ~ EDB999 Database errors ESW001 ~ ESW999 Software errors 2. Take notes of the error code. 3.
  • Page 121 8. Troubleshooting This page is intentionally left blank i-Smart 300 Blood Gas Analyzer...

  • Page 122: Product Specification

    9. Product Specifications 9. Product Specifications Operation Specifications .....................122 Instrument Specifications ....................124 Cartridge Specifications ......................125 Principles..........................126...

  • Page 123: Operation Specifications

    15 to 35 °C for the desirable performance. ‰ Operating humidity : 5 ~ 85 % (relative humidity) ‰ Operating altitude : Below 3,000 m ‰ Power supply : 100 ~ 240 Va.c. 50-60 Hz i-Smart 300 Blood Gas Analyzer...
  • Page 124 9. Product Specifications Operation Specifications, continued Input Parameters ‰ Input Parameters and Ranges Parameter Description Unit Input range Default Patient Patient Temp. °C 15.0 ~ 45.0 37.0 temperature Total g/dL 0.0 ~ 28.0 hemoglobin Oxygen 0 ~ 100 saturation Fraction of inspired 0 ~ 100 oxygen...

  • Page 125: Instrument Specifications

    ‰ Storage temperature: -20 ~ 50 °C ‰ Storage Humidity: 0 ~ 90 % (relative humidity) ‰ Dimension (width x height x depth): 257 mm x 394 mm x 252 mm ‰ Weight: 7.5 kg (accessories excluded) i-Smart 300 Blood Gas Analyzer...

  • Page 126: Cartridge Specifications

    9. Product Specifications Cartridge Specifications Cartridge ‰ Packaging unit: 1 cartridge ‰ Uselife : Maximum 2 weeks or 3 weeks after installation on the analyzer (opened). See Appendix B: ordering information. ‰ Shelf life : 6 months from the manufacturing date (unopened) ‰...

  • Page 127: Principles

    9. Product Specifications Principles Measuring The i-Smart 300 Blood Gas Analyzer measures pH, blood gas (pCO Principles ), electrolytes (Na , Ca , Cl ) and hematocrit (Hct) using the potentiometry (ion selective electrode), amperometry and conductometry. Measuring principles for each parameter are as follows:...

  • Page 128: Appendices

    Appendices Appendix A: Collecting and Handling Samples Caution ‰ Observe standard precautions required by a hospital, laboratory, or other research facilities. ‰ Handle and dispose all biological hazard in accordance with the relevant provisions and procedures. ‰ Treat the used cartridge with blood, blood samples and blood sample tools and blood as a biohazard risk.

  • Page 129: Appendix B: Order Information

    100 Tests / 3 weeks 6725 200 Tests / 3 weeks 6726 3. Quality Control Please contact your authorized i-SENS sales representative or visit www.i-sens.com for more information on obtaining quality control materials. 4. Analyzer Accessories Product Description Part No.

  • Page 130: Appendix C: Warranty

    ‰ Any damage caused during the disassemble, repair or the remodel of the analyzer by a person not authorized from © i-SENS ‰ Breakdown caused by using wrong electrical power ‰ Failure from the user’s negligence or lack of care ‰...
  • Page 131 This product is CE marked according to the provisions of the Directive 98/79/EC on in vitro diagnostic medical devices and Radio Equipment Directive 2014/53/EU. Hereby, i-SENS, Inc. declares that this product is in compliance with the essential requirements and other relevant provisions of Directive 98/79/EC and Directive 2014/53/EU.

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