i-SENS i-Smart 300 Operator'S Manual Download Page 8

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1. Introduction

1-3

i-Smart 300 Blood Gas Analyzer

Symbols and Terms

Symbols

Symbol

Description

CE mark

Consult operating instructions

Authorized representative in the European

community

Serial number

Caution: Attention, see operating instructions

Manufacturer

Temperature limitation

Catalogue number

Batch code

Contains sufficient for <n> tests

Use by

Biological risk

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 2002/96/EC.

Printer

DC power port

Off (power)

On (power)

Summary of Contents for i-Smart 300

Page 2: ...Operators should read the entire manual before installing and operating the analyzer...

Page 3: ...tion 2 2 Power On 2 3 Printer Paper Installation 2 5 Cartridge Installation 2 7 3 Analyzer Settings Screen Menus 3 1 Sample Setup 3 11 QC Setup 3 14 Instrument Setup 3 16 Interface Setup 3 20 Species...

Page 4: ...7 6 Analyzer Status 7 7 Cleaning 7 8 8 Troubleshooting Troubleshooting 8 1 Error Code 8 6 9 Specification Operating Specification 9 1 Analyzer Specification 9 2 Cartridge Specification 9 3 Measuring...

Page 5: ...1 Introduction 1 Introduction Safety 1 1 Symbols and Terms 1 3 Product Description 1 5...

Page 6: ...t The rear vent of the analyzer must be free of obstruction and not covered by cloth or any other material Do not install or operate the analyzer in an area where ferromagnetic fields are generated e...

Page 7: ...All biohazardous materials should be handled and disposed of in accordance with applicable rules and regulations of the hospital laboratory or other testing facility Wear appropriate personal protecti...

Page 8: ...ctions Manufacturer Temperature limitation Catalogue number Batch code Contains sufficient for n tests Use by Biological risk This marking indicates that you must not discard this electrical electroni...

Page 9: ...zed calcium cCl Concentration of chloride ion Hct Hematocrit Cal Calibration Cal 1 1 Point calibration Cal 2 2 Point calibration QC Quality control Warning A statement that alerts the operator to the...

Page 10: ...an automated system that measures pH pCO2 pO2 cNa cK cCl cCa2 and hematocrit in whole blood It is for in vitro Veterinary Diagnostic Use only Touchscreen Sampler cover Cartridge door Barcode scanner P...

Page 11: ...1 Introduction Operator s Manual 1 6 Product Description continued Accessories of analyzer Power adapter Power code Printer papers Cartridge Cartridge cover i Smart 300 VET Cartridge...

Page 12: ...1 Introduction 1 7 i Smart 300 Blood Gas Analyzer This page is intentionally left blank...

Page 13: ...2 Installation 2 Installation Installation Requirements 2 1 Power Cable Connection 2 2 Power On 2 3 Printer Paper Installation 2 5 Cartridge Installation 2 7...

Page 14: ...tion This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection aga...

Page 15: ...et Use only the power cord and power adapter provided by the manufacture Electrical plugs and sockets vary by countries If necessary use appropriate power plug or power strips to connect the provided...

Page 16: ...e from the analyzer before turning the power switch on Turn Power Switch On 2 Facing the back of the analyzer flip the black power switch on the lower left side marked to the position 3 The screen wil...

Page 17: ...yzer and the electrical outlet If no loose power connection is found and the power cord icon still does not appear call a service engineer immediately 6 Check the date and time of the analyzer and if...

Page 18: ...Printer Paper Installation Install Printer Paper 1 Facing the back of the analyzer push the PUSH button and flip down the printer cover 2 Place the paper roll into the paper compartment and place the...

Page 19: ...Installation Operator s Manual 2 6 Printer Paper Installation continued Install Printer Paper continued 3 Close the printer cover Note The printer will cut the paper exposed to the outside automatical...

Page 20: ...te After opening the cartridge it must be installed directly to the analyzer 1 Take out the cartridge from the cartridge box 2 Press down the cover lock and remove the cartridge cover 3 Press Install...

Page 21: ...tinued 5 Insert the new cartridge into the analyzer follow the instructions on the screen 6 Facing the cartridge label insert the cartridge into the analyzer 7 Close the cartridge door and slide up th...

Page 22: ...tridge continued 8 If the RFID tag information of the cartridge is valid the analyzer will change to the Cartridge Warming Up screen 9 The cartridge warming up will take approximately 25 minutes Note...

Page 23: ...3 Analyzer Setting 3 Analyzer Setting Screen Menus 3 1 Sample Setup 3 11 QC Setup 3 14 Instrument Setup 3 16 Interface Setup 3 20 Species Type Setup 3 22...

Page 24: ...mple number and date of the installed cartridge Current state of interface setup Current state of power connection Current state of and battery recharge level Current date and time of the analyzer Men...

Page 25: ...3 Analyzer Setting Operator s Manual 3 2 Screen Menus continued Menu options...

Page 26: ...us and the category menus will appear 2 Press the current screen box at the top right corner to show the current menu options Note The Menu button is disabled on the following screens Install Cartridg...

Page 27: ...ttons Icons and Buttons Description Canine icon Feline icon Bovine icon Equine icon Porcine icon Other Species icon Print results or settings on screen Transmit results to LIS HIS Transfer complete Cl...

Page 28: ...3 Analyzer Setting 3 3 i Smart 300 Screen Menus continued Icons and Buttons Icons and Buttons Description Scroll to previous or next page Go to previous or next result screen...

Page 29: ...continued Icons and Buttons Description Execute search Run 1 point calibration or 2 point calibration Run QC Accept or discard QC results Add or delete QC lot information Delete entered data on curren...

Page 30: ...d Buttons continued Icons and Buttons Description Unselected item Selected item Item that were transmitted to LIS HIS Selected item that were transmitted to LIS HIS Show keyboard for data entry Show k...

Page 31: ...3 Analyzer Setting 3 6 Screen Menus continued Keyboards The analyzer offers following keyboards for data entry Alphabetic Keyboard Numeric Special Character Keyboard Date and Time Entry Keyboards...

Page 32: ...3 Analyzer Setting 3 7 i Smart 300 Screen Menus continued Keyboards continued Numerical Keyboard...

Page 33: ...the screen informs following information A current task that is about to begin or in progress Action to take in operating the analyzer such as introducing sample or replacing cartridge An error that n...

Page 34: ...Gas Analyzer Sample Setup Reference Ranges 1 Go to Menu Setup Setup menu is protected by password Reference Ranges Setup The following screen will appear 2 Press each box and enter low and high limits...

Page 35: ...ed values to confirm that Values for both low and high limits are entered Low limit value is lower than high limit value If any of the entered values are not valid the analyzer will not save the setup...

Page 36: ...ranges should be established by individual institutions The reference ranges in the table below are shown only as general guidelines Parameter Unit Reference Range pH 7 350 7 450 pCO2 mmHg 35 0 48 0 p...

Page 37: ...entered data press Current Tab Clear Before saving the setup the analyzer will validate the entered values to confirm that Values for both low and high limits are entered Low limit value is lower than...

Page 38: ...er Setting 3 13 i Smart 300 Sample Setup continued Critical Limits continued Note High limit value is high than high limits of the reference range Low limit value is low than low limits of the referen...

Page 39: ...up menu is protected by password QC Setup The following screen will appear 2 Select the empty list on the left column Entry tabs to enter QC lot information is activated on the right side as follow 3...

Page 40: ...sired QC lot information 5 To delete the previously saved QC lot information press the desired QC lot on the left column and press Delete 6 To modify the previously saved QC lot information delete the...

Page 41: ...e following screen will appear Note Changing the Time Date and Date Format of the analyzer is only allowed before cartridge is installed on the analyzer Once the cartridge is installed the time date a...

Page 42: ...3 17 i Smart 300 Blood Gas Analyzer Instrument Setup continued Date and Time continued 3 Press Date box and enter the current date using the keyboard 4 Press Time box and enter the current local time...

Page 43: ...3 Analyzer Setting 3 18 Instrument Setup continued Volume 1 To adjust the volume press or button of the Speaker Volume 2 To turn off sound playback press Mute To turn to maximum volume press Max...

Page 44: ...the LCD brightness press or button of the LCD Brightness Brightness can be adjusted in 15 steps Note To turn to minimum or maximum brightness press Min or Max 2 Press Save to save the setup and go bac...

Page 45: ...d to the analyzer before starting interface setup 1 Go to Menu Setup Setup menu is protected by password Interface Setup The following screen will appear 2 Check Sample QC Cal 1 and or Cal 2 to transm...

Page 46: ...own list Default is 8 3 Press Stop Bit and select the desired option from the drop down list Default is ONE 4 Press Parity and select the desired option from the drop down list Default is None 5 Press...

Page 47: ...g Operator s Manual 3 22 Species Type Setup Species Type Setup 1 Go to Menu Setup Species type Setup The following screen will appear 2 Select the species that will be analyzed its blood sample from t...

Page 48: ...3 Analyzer Setting 3 23 i Smart 300 Blood Gas Analyzer This page is intentionally left blank...

Page 49: ...4 Sample Analysis 4 Sample Analysis Blood Samples 4 1 QC Samples 4 8...

Page 50: ...n the analyzer is not in Ready state the sampler cover cannot be lifted because it is locked 1 Check that the analyzer is in Ready state 2 Lift up the sampler cover The following message will appear N...

Page 51: ...obe into the sample container Note Be careful not to introduce air bubbles clots or foreign substances along with sample to the analyzer 4 For a capillary sample lift the sampler cover all the way up...

Page 52: ...equately immersed in the sample press Aspirate to begin aspiration 6 The Aspirating sample Please wait message will appear 7 If the aspiration is completed the Remove sample now message will appear Re...

Page 53: ...closed the Sample Information screen will appear 2 If the sample information is available in barcode scan the barcode using the barcode scanner that is located in front of the analyzer 3 To manually e...

Page 54: ...esult values will appear in blue color if the reference ranges have not been setup in the analyzer 3 If the reference ranges have been setup in the analyzer and a result is within the reference range...

Page 55: ...r has occurred the corresponding result will be accompanied by D in red color 6 If any result falls outside of the reportable range the corresponding result will not be reported Instead R will appear...

Page 56: ...battery power the printout is only available in more than 50 battery levels 10 If the analyzer has been set to auto print the analyzer will print the results as soon as they are reported 11 To transm...

Page 57: ...nu and select Run QC The following screen will appear 2 Press Yes The following screen will appear Note The Run QC menu will be available only when the QC lot s has been setup at QC Setup menu 3 When...

Page 58: ...for aspiration message appears immerse the end of the sampler probe into the QC sample and press Aspirate 5 The Aspirating QC sample Please wait message will appear Note To cancel QC sample lower the...

Page 59: ...roduce QC sample continued 6 If the aspiration is completed the Remove QC sample now message will appear Remove QC sample from the sampler probe 7 Wait a second until the Close sampler cover message w...

Page 60: ...ples continued Enter QC Information 1 Once the sampler cover is closed the QC Information screen will appear 2 Select the QC lot of the QC sample 3 If necessary enter Operator ID and QC Comment using...

Page 61: ...ng Note If a result is within the QC range the value will appear in blue color If a result is above the QC range the value will appear in red color along with an up arrow If a result is below the QC r...

Page 62: ...3 Press Print to print out the results A printout similar to following will be printed Note If the analyzer is on battery power the printout is only available in more than 50 battery levels 4 To tran...

Page 63: ...5 Database 5 Database Blood Sample Data 5 1 QC Data 5 5 Calibration Data 5 9 Cartridge Data 5 12...

Page 64: ...sed through Menu Last Sample Results 2 To view the screen of the next blood sample results or the previous blood sample results press Next Results or Prev Results 3 To go to the list of blood sample r...

Page 65: ...ge Down to scroll the list of analysis results 3 To view a blood sample results select a desired row from the list 4 To view more the desired sample results press View Result The corresponding blood s...

Page 66: ...t 300 Blood Gas Analyzer Blood Sample Data continued Sample Results List continued 6 To transmit blood sample results to the LIS HIS select desired results from the list and press Send 7 Press Close t...

Page 67: ...appear Note Search criteria for blood results are as following From To Species Type Patient ID Sample ID Patient Last Name Patient First Name Operator ID 2 Enter desired search criteria in appropriat...

Page 68: ...3 To view the screen of the next QC results or the previous QC results press Next Results or Prev Results 4 To transmit the results to the LIS HIS press Send 5 Press Close to exit to main screen QC Re...

Page 69: ...ase Operator s Manual 5 6 QC Data continued QC Results List continued 3 To view a QC results screen select a desired row from the list and press View Result 4 The corresponding QC results screen will...

Page 70: ...ults List continued 5 To transmit blood sample results to the LIS HIS select desired results from the list and press Send 6 To search QC results press Search on the QC Results List screen Refer to the...

Page 71: ...ear Note Search criteria for QC results are as following From To QC Lot Either Accepted or Discarded QC results only or all results Operator ID 2 Enter desired search criteria in appropriate boxes 3 P...

Page 72: ...of the next Cal 1 results or the previous Cal 1 results press Next Results or Prev Results 3 To transmit the results to the LIS HIS press Send 4 To print out the results press Print 5 To go to the li...

Page 73: ...of the next Cal 2 results or the previous Cal 2 results press Next Results or Prev Results 3 To transmit the results to the LIS HIS press Send 4 To print out the results press Print Note If the analyz...

Page 74: ...List The following screen will appear 2 The latest Cal 2 results are listed on the top Use Page Up or Page Down to scroll the list of Cal 2 results 3 To view a Cal 2 results screen select a desired r...

Page 75: ...the list of cartridge data 3 Select desired cartridge data and press Copy The following screen will appear 4 Insert an USB memory into any of available USB ports on the analyzer 5 The Data copy in pro...

Page 76: ...5 Database 5 13 i Smart 300 Blood Gas Analyzer This page is intentionally left blank...

Page 77: ...6 Shutdown 6 Shutdown Analyzer Shutdown 6 1 Cartridge Restart 6 3...

Page 78: ...cedure can cause damage to the data or the analyzer To disconnect the power cables from the analyzer first unplug the power cord from the outlet Then unplug the adapter from the analyzer The cartridge...

Page 79: ...hutdown Analyzer continued 3 Wait until the analyzer completes a power cycle and the following screen appears 4 Wait until the progress circle reaches 100 5 Facing the back of the analyzer flip the bl...

Page 80: ...ns within 1 hour The analyzer was analyzing a sample when the power was interrupted and the power returns within 20 minutes The analyzer was analyzing a QC sample when the power was interrupted and th...

Page 81: ...7 Maintenance 7 Maintenance Calibration 7 1 Cartridge Removal 7 4 Analyzer Information 7 6 Analyzer Diagnosis 7 7 Cleaning 7 8...

Page 82: ...7 Maintenance 7 1 i Smart 300 Blood Gas Analyzer Calibration Run Cal 1 Go to Menu Run Cal 1 The following screen will appear 2 Go to Menu Run Cal 2 The following screen will appear...

Page 83: ...ift error has occured Cal 1 is in progress Please wait message will appear Cal 2 Auto Repeat If the slope error of a sensor has occurred in the previous Cal 2 the analyzer will automatically repeat Ca...

Page 84: ...each sensor will appear as okay in blue background drift error in yellow background or slope error in red background at the main screen based on the results of the last calibration 2 Press the Sensor...

Page 85: ...Remove Expired Cartridge 1 The analyzer will automatically display the Cartridge Expired screen in one of following situations The uselife of the cartridge has expired All tests of the cartridge have...

Page 86: ...cartridge in use The following screen will appear Note To cancel the cartridge removal press No The removed cartridge cannot be reused 2 Press Yes The following screen will appear 3 Remove the cartri...

Page 87: ...ing screen will appear 2 The following information will appear Software Version and Firmware Version Cartridge Serial Number Lot Number Installation Date Time Expiration Date Time Age Calibration Info...

Page 88: ...e Analyzer temperature Battery level States of Cartridge installation Cartridge door and Sampler cover 3 Press Run Cal 1 or Run Cal 2 to initiate Cal 1 or Cal 2 on the current screen 4 Press Close to...

Page 89: ...er cleaning in accordance with the laboratory s established procedures for disposing of biohazardous materials Cleaning Procedure 1 Use 0 5 hypochlorite cleaning solution Note Commercial Clorox contai...

Page 90: ...7 Maintenance 7 9 i Smart 300 Blood Gas Analyzer This page is intentionally left blank...

Page 91: ...8 Troubleshooting 8 Troubleshooting Troubleshooting 8 1 Error Code 8 6...

Page 92: ...nned in front of the marking BARCODE SCAN 2 If there does not show a red light beam press the SCAN button on the rear of the analyzer by a sharp object like a needle Then retry to read the barcodes It...

Page 93: ...he power switch of the analyzer 4 The analyzer will turn on and the battery will begin to recharge 5 If the analyzer does not turn on turn off the power switch of the analyzer 6 Recharge the battery f...

Page 94: ...USB port 3 If it still doesn t work try a different USB memory If Cartridge data copy has failed message appears during data copy 1 Close the message and try again from the beginning 2 Select desired...

Page 95: ...3 Turn on the power switch of the analyzer 4 If the analyzer does not turn on turn off the power switch of the analyzer 5 Recharge the battery for 10 minutes 6 Turn on the power switch of the analyze...

Page 96: ...of range appears on the results screen A result is suspicious 1 Try sample analysis again with the same sample 2 If the same error is repeated run Cal 2 3 Try sample analysis again 4 Repeat Cal 2 a f...

Page 97: ...eration the following error code will appear on the screen Error Code Description ESYS001 ESYS999 Hardware error EDB001 EDB999 Database error ESW001 ESW999 Software error 2 Memo the error code 3 Turn...

Page 98: ...8 Troubleshooting 8 7 i Smart 300 Blood Gas Analyzer This page is intentionally left blank...

Page 99: ...9 Specification 9 Specifications Operating Specifications 9 1 Analyzer Specifications 9 2 Cartridge Specifications 9 3 Measuring Principles 9 4...

Page 100: ...5 15 00 0 01 cCl mmol L 50 150 20 250 1 Hct 10 70 5 75 1 Sample types whole blood Anticoagulant heparin Sample volume 80 L Sample introduction method aspiration Sample analysis time 50 seconds Sample...

Page 101: ...put power 24 V d c 2 7 A Internal battery 14 8 V d c 4 4 Ah Lithium ion cells 4S2P Discharge time maximum two hours Battery life 20 reduced capacity for charging discharging for 300 times Replace when...

Page 102: ...selife maximum 2 weeks Shelf life 6 months from manufactured date Storage temperature 15 25 C Components Sensors Sampler Waste bag Valve and tubing Solution bag Cal 1solution approx 500 g Cal 2 soluti...

Page 103: ...cK cCa2 cCl Hematocrit Hct The i Smart 300 blood gas analyzer calibrates the sensors using Cal 1 and Cal 2 solutions according to the pre determined two point calibration schedule during the lifetime...

Page 104: ...9 Specification 9 5 i Smart 300 Blood Gas Analyzer This page is intentionally left blank...

Page 105: ...es use containers syringe capillary blood collection tube treated with heparin We recommend using a dry sprayed heparin tube or a solid heparin tube We do not recommend using a tube treated with antic...

Page 106: ...lood gas electrolyte 6200 1 box 30 ampuls QC 623 Level 2 blood gas electrolyte 6201 1 box 30 ampuls QC 623 Level 3 blood gas electrolyte 6202 1 box 30 ampuls QC 623 Multi Level blood gas electrolyte 6...

Page 107: ...n the product was broken by using components or optional items that are not specified by the manufacturer When the user did not read and understand the precautions the installation and operation metho...

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i-SENS i-Smart 300, Operator'S Manual, Page: 8 / 107

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