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OPTIMedical OPTI CCA-TS Operator'S Manual Download Page 27

Operator’s Manual – OPTI CCA-TS 

 

 2-i

2 SETUP

2 SETUP  ................................................................................................2-1

2.1 Important Safety Instructions ..............................................................................2-1

2.2 Choosing a Location .............................................................................................2-1

2.3 Setting up the OPTI CCA-TS Analyzer ................................................................2-2

Summary of Contents for OPTI CCA-TS

Page 1: ...OPTI CCA TS Analyzer Operator s Manual ...

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Page 3: ...does not give a license to these property rights except as expressly provided in any written license agreement from OPTI Medical Systems 2016 OPTI Medical Systems Inc All rights reserved OPTI the OPTI Medical logo and ComfortSampler are trademarks or registered trademarks of OPTI Medical Systems Inc in the United States and or other countries Other trademarks are the property of their respective o...

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Page 5: ...ies and supplies either delivered by or approved by OPTI Medical Systems are to be used with the instrument Due to this instrument s operating principle analytical accuracy not only depends on correct operation and function but also upon a variety of external inf uences beyond the manufacturer s control Therefore the test results from this instrument must be carefully examined by an expert before ...

Page 6: ...ke sure that it is of the proper size and is properly grounded Any breakage of the ground lead inside or outside the instrument or a loose ground connection can cause a hazardous condition when operating the instrument Intentional disconnection of the grounding is not permitted When replacing the fuses make sure that they are of the same type and rating as the original fuses Never use repaired fus...

Page 7: ... located to the right of this symbol This symbol is located on all products which are controlled via a lot number Do Not Re use Symbol Identifies products which are not to be used for more than the specified period of time as defined in the product instructions This symbol is located on all applicable product packaging Recycle Plastic Symbol Identifies the clear plastic material polyethylene terep...

Page 8: ...components which contain this symbol must be stored within the specified temperature range For in vitro diagnostic use This product fulfils the requirements of Directive 98 79 EC on in vitro diagnostic medical devices Catalog number Please read pack insert Follow the instrument s instructions for use Manufactured by Authorized European Community Representative REF C F C F EC REP ...

Page 9: ...ence of your own laboratory This manual will help guide you through setting up your analyzer and will help you start analyzing samples As you become familiar with the operation of the unit you should use the manual as a reference for day to day routines and as a guide for maintenance and troubleshooting How to use this manual If you have an analyzer that is not yet set up you should begin by readi...

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Page 11: ...er 2 2 3 CUSTOMIZATION 3 1 3 1 Data Manager 3 1 3 2 Setting Time and Date 3 1 3 3 Setup 3 2 3 3 1 QC Setup 3 3 3 3 1 1 Setting Up the Standard Reference Cassette SRC 3 3 3 3 1 2 Setting up the Quality Control Material Lot and Level 3 4 3 3 2 Customizing Patient Information 3 7 3 3 2 1 Selecting Which Patient Information is Requested and Printed 3 7 3 3 2 2 tHb Prompt 3 9 3 3 2 3 Selecting Which Pa...

Page 12: ...4 4 Calibration Verification 4 2 4 5 QC Recommendations 4 3 4 5 1 Running an SRC Measurement 4 4 4 5 2 Printing SRC Results 4 7 4 5 3 Running a QC Sample 4 8 4 5 3 1 Running Controls OPTI CHECK OPTI CHECK PLUS 4 8 4 5 4 Printing Control Reports 4 14 4 5 5 Sending Data to a Computer 4 15 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 5 1 Specimen Collection and Handling 5 1 5 1 1 Safety 5 1 5 1 2 Sample...

Page 13: ...HOOTING 7 1 7 1 Error Displays 7 1 7 2 Maintenance 7 1 7 3 Diagnostics 7 13 7 3 1 Checking Versions 7 13 7 3 2 Checking System Temperatures 7 14 7 3 3 Checking Gas Pressure 7 14 7 3 4 Checking the LEDs 7 15 7 3 5 Verifying Barometric Pressure 7 15 7 3 6 Checking the Battery Voltage 7 16 7 3 7 Checking the Cooling Fan 7 16 7 3 8 Checking the Gas Valve 7 17 7 3 9 Checking the Valve Drive 7 17 7 3 10...

Page 14: ...r Bar Code Scanner 7 35 8 OPERATING PRINCIPLES 8 1 8 1 Intended Use 8 1 8 2 Principles of Procedure 8 1 8 3 Operation 8 2 8 4 Specimen Collection and Handling 8 3 8 4 1 Safety 8 3 8 4 2 Sample Requirements 8 3 8 4 3 Anticoagulants and Sample Collection Devices 8 3 8 4 4 Syringes 8 3 8 4 5 Capillary Tubes 8 3 8 4 6 OPTI Medical ComfortSamplers 8 4 8 4 7 Handling and Storage of Samples 8 4 8 5 Proce...

Page 15: ...YTES pH pH 1 pH Dry Sensor B Lac Cassette pH B 1 PCO2 PCO2 1 PCO2 Dry Sensor B Lac Cassette PCO2 B 1 PO2 PO2 1 PO2 Dry Sensor B Lac Cassette PO2 B 1 Sodium Na Na 1 Potassium K K 1 Ionized Calcium Ca Ca 1 Chloride Cl Cl 1 Glucose Glu Glu 1 BUN Urea BUN 1 Lactate B Lac Cassette Lac 1 Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO2 THB SO2 1 SOFTWARE UPGRADES Use this section...

Page 16: ...oltage Category A 6 Dimensions and Weight A 7 Classifications A 7 Calculated Parameters A 7 Temperature A 7 Units Used in Measured and Input Parameters for Calculations A 8 Conversion Table for Units A 8 APPENDIX B MENU STRUCTURE B 1 APPENDIX C MAINTENANCE LOG C 1 APPENDIX D REPORT FORMATS D 1 Basic Patient Report D 1 SRC Measurement Report D 2 SRC Statistics Report D 3 Controls Measurement Report...

Page 17: ...Operator s Manual OPTI CCA TS 1 i 1 INTRODUCTION 1 INTRODUCTION 1 1 1 1 Intended Use 1 1 1 2 Principles of Operation 1 1 1 3 Contents 1 2 1 4 Analyzer Components 1 3 1 5 Consumables 1 7 ...

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Page 19: ...O2 x mmHg kPa 10 200 1 0 1 PO2 x mmHg kPa 10 700 1 0 1 Na x x x mmol L mg dL 100 180 1 0 1 K x x x mmol L mg dL 0 8 9 99 0 1 0 01 Ca x x x mmol L mg dL 0 2 3 0 0 01 Cl x x x mmol L mg dL 50 160 1 0 1 Glu x x x mg dL mmol L 30 400 1 7 22 1 0 1 BUN urea x x x mg dL mmol L 2 8 112 0 1 40 0 1 0 01 Lac x mmol L mg dL 0 3 17 5 0 01 0 01 tHb x g dL mmol L g L 5 25 0 1 SO2 x 60 100 1 0 1 1 2 Principles of...

Page 20: ...om the analyzer and discarded The analyzer contains no reagents blood or waste 1 3 Contents Before you begin installing your OPTI CCA TS Analyzer take a moment to look over the contents to ensure you have the following Power supply with power cord Battery 2 Standard Reference Cassettes SRC Level 1 and 3 Thermal printer paper tHB calibration cassette You will also need the following consumables pri...

Page 21: ... setting up the OPTI CCA TS Analyzer it is important to familiarize yourself with the analyzer s components On Off Switch Gas Bottle Bar Code Scanner Printer Status Light Sample Measurement Chamber SMC Touch Screen Display On Off Switch Fig 1 1 OPTI CCA TS Major Components Battery ...

Page 22: ...he following Green Light System is ready for measurement Blinking Green Light System is in process of calibration or measurement Do not open the cover Red Light Major error has occurred system has stopped Blinking Red Light System has encountered a problem and needs operator interaction before it will proceed Inside the top of the unit is the Sample Measurement Chamber SMC for the OPTI Cassette To...

Page 23: ...s heat sensitive paper to output information in 27 columns The analyzer can print measured values quality control values calibration values as well as patient and diagnostic information Contained within the same compartment is a peristaltic pump cartridge which is used to transport liquids and gases Fig 1 7 All liquids are contained within the OPTI Cassette and do not enter the instrument NOTE The...

Page 24: ...h Card slot CF Slot for software updates and data archiving On the left side of the unit is the rechargeable battery pack It is removed by squeezing the handle and sliding it out Fig 1 10 The battery allows you to operate the OPTI CCA TS without having to plug the unit into an electrical outlet The battery may either be charged in the OPTI CCA TS unit or independently in the optional Battery Charg...

Page 25: ... allowing safe clean sample disposal Fig 1 12 The sample fillport is contained in the OPTI Cassette and projects from the chamber for easy automatic sampling It includes a removable syringe adapter for sampling with a syringe For sampling with a capillary simply remove the adapter Fig 1 13 NOTE The syringe adapter may be removed while the cassette is inside the SMC NOTE DO NOT INJECT the sample It...

Page 26: ...ette Fig 1 15 is used for the quarterly calibration of the OPTI CCA TS Analyzer See Section 6 3 Quarterly Maintenance Performing tHb Calibration During calibration the OPTI CCA TS uses a precision gas which is completely self contained in a disposable low pressure bottle The bottle is inserted on the right side of the unit after scanning the bar code Fig 1 16 Congratulations You have just learned ...

Page 27: ...Operator s Manual OPTI CCA TS 2 i 2 SETUP 2 SETUP 2 1 2 1 Important Safety Instructions 2 1 2 2 Choosing a Location 2 1 2 3 Setting up the OPTI CCA TS Analyzer 2 2 ...

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Page 29: ...ssette according to local regulations 2 2 Choosing a Location Location is important for trouble free operation of your analyzer Before you begin setup choose a site that is convenient for your sampling needs and meets the following physical requirements of the unit Grounded electrical outlet Away from direct sunlight Room temperature within 10 32º C 50 90 F Maximum relative humidity of 95 Ample ro...

Page 30: ... the use of a surge protector 2 Install the Battery Pack in its Housing Push the battery pack into the opening on the left hand side of the OPTI CCA TS Fig 2 2 NOTE The battery will need to be charged for at least 6 hours prior to using the OPTI CCA TS on battery power It will be charged automatically whenever the analyzer s external power supply is plugged into an electrical outlet The status LED...

Page 31: ... The system will now prompt you to enter the current time using the numeric keypad Fig 2 5 Enter hour and minutes and press You will then be asked to enter the month Fig 2 6 Select the month from the keypad and press Fig 2 5 Enter Time Fig 2 6 Select Month Fig 2 4 Startup screen STOP Memory Error Database Deleted OK STOP Memory Error Database Deleted OK ...

Page 32: ...cated on the bottom right hand corner of the analyzer The red line from the bar code scanner should cover the entire bar code The analyzer will beep when the bar code is accepted The bar code can be found on the gas bottle instructional insert Record the date of installation on the gas bottle for later reference NOTE To enter the bar code manually press Manual and enter the bar code using the nume...

Page 33: ...ress to install a new gas bottle NOTE If after the initial installation you need to remove a gas bottle and reinstall the same bottle respond to the prompt New Gas Bottle The next screen will prompt you to enter the number of weeks in service using the numeric keypad See section 6 5 3 Here you may refer back to the installation date which was recorded on the gas bottle The OPTI CCA TS will now beg...

Page 34: ...nter detects the paper it will automatically feed the paper completely through the printer The paper advance button should only be used if paper is present To advance paper after the initial installation press the red paper advance button located on the left side of the printer Fig 2 12 NOTE The red paper advance button is only active when the printer detects paper in the printer Fig 2 11 Insertin...

Page 35: ...d in the storage compartment in the back of your analyzer In the Ready display select QC Manager In the QC Manager menu select tHb Calibrator Fig 2 13 Use the numeric keypad to enter the password factory default 404 Fig 2 14 Use the alphanumeric keypad to enter the Operator ID or press to bypass this function Fig 2 15 If Secure Op IDs is activated under Setup see Section 3 3 2 4 3 your 4 digit PIN...

Page 36: ...the prompt open the SMC cover by pressing the button Fig 2 17 Gently clean the optics window and the inside top cover of the sample chamber with a soft lint free cloth Fig 2 18 Press Fig 2 18 Clean Optics and Inside of Cover Fig 2 17 Open Cover Fig 2 16 Enter Lot Number Clean Optics and Inside of Cover Optics OK Clean Optics and Inside of Cover Optics OK ...

Page 37: ...s of the Calibrator Cassette with a clean dry cloth and examine it to ensure it is clean Insert it into the chamber and press down to properly seat the cassette Fig 2 19 Close the sample chamber cover Fig 2 20 Fig 2 20 Close Cover Fig 2 19 Wipe and Insert Cassette ...

Page 38: ...l Report OPTI Medical OPTI CCA Calibration Report DD MMM YY HH MM S N XXXX Version ABCX XX Operator ID HbCal Type tHb Calibrator HbCal LOT XXXXXX HbCal Date DD MMM YY Calibration Results Meas d Cal d tHb 12 9 13 0 S02 74 6 74 9 Calibration Factors OLD NEW F1 1 023 1 014 F2 1 087 1 080 F3 1 089 1 094 F4 0 000 0 000 OPTI Medical recommends that you run controls prior to running patient samples on a ...

Page 39: ... 3 2 2 tHb Prompt 3 9 3 3 2 3 Selecting Which Parameters Are Blanked Disabled 3 10 3 3 2 4 Selecting Which Calculated Parameters Are Printed 3 11 3 3 2 5 Setting Normal Ranges or Alarm Limits 3 12 3 3 2 6 Setting up Correlation Factors 3 14 3 3 2 7 Defining Units 3 15 3 3 3 Miscellaneous 3 17 3 3 3 1 Setting up Security 3 17 3 3 3 2 Entering the Barometric Pressure 3 21 3 3 3 3 Beep Adjustment 3 2...

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Page 41: ...ng the correct security code All system setup selections entered will reside in the instrument memory even after the system power is turned off 3 1 Data Manager This menu allows you to print out Measurement Diagnostics Reports and Statistics It also provides you with the ability to export information if connected to a computer You can find procedures for printing information in Chapter 4 Calibrati...

Page 42: ...light Savings Time manually select the option Daylight Savings Enable 6 Press to accept the changes 7 Press to return to the System screen or to return to Ready 3 3 Setup Setup menus let you set up quality control materials program the setup of the printed reports set up system security and customize several other system features 1 From the Ready display press System Manager to access the System m...

Page 43: ...f this security function has been activated under Setup 3 In the System Setup menu press SRC Fig 3 6 4 Take an SRC pouch and scan the bar code by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer Fig 3 7 The red line from the bar code scanner should cover the entire bar code A beep indicates a valid bar code A red status light indicates ...

Page 44: ...reens 6 When using OPTI CHECK PLUS scan the third 36 digit bar code marked SCAN C for the applicable level NOTE If bar code is damaged and won t scan press Manual Entry on the Scan Barcode screen and enter the barcode information manually Fig 3 9 Select Control NOTE If previous SRC data exists the unit will prompt the user to either print and or delete this data from the database NOTE If no previo...

Page 45: ...m lot number expiration date and control type on the package insert supplied with the control material Fig 3 10 If the bar code is damaged and won t scan press Manual Entry on the Scan Barcode screen and enter the barcode information manually 2 Press to accept NOTE If previous QC data exists the unit will prompt the user to either print and or delete this data from the database NOTE If no previous...

Page 46: ... control material Fig 3 12 Enter 0 0 for unassayed parameters You will find the assay ranges printed on the data sheet in the box of control material Alternately you may develop your own assay ranges from multiple measurements according to your hospital s procedures Although it is recommended you review all analyte assay ranges you may press at any time after the bar code is scanned and the ranges...

Page 47: ...menu press Patient Entry Fig 3 13 3 In the Info 1 screen select the options to be enabled Fig 3 14 4 Select Optional or Required for Patient ID Operator ID Accession Number 5 Other options to be selected are Temperature Sex DOB tHb Type 6 Press the Info 2 tab to access and enable the following parameters Fig 3 15 Puncture Site Liter Flow Bypass TVOL VT Sample Type PS O2 Mode PEEP I E Ratio Rate f ...

Page 48: ...off Exceptions are the Hb type and P50 which remain at the selected value until the system is powered off The first parameter is tHb Fig 3 16 This is the tHb value used in calculations of various parameters if measured tHb is not available Press Enable to display the default value for this parameter 15 0 g dL Press to change this value using the numeric keypad NOTE Units for the tHb and P50 may be...

Page 49: ...rompt is turned on When the prompt is turned off the analyzer uses a default value for the following calculated parameters BE Base Excess BEact Base excess actual st pH standard pH and st HCO3 standard bicarbonate If tHb is suppressed and the prompt to enter tHb is turned off then BB and O2Ct will be suppressed if a tHB value has not been entered To enter a tHb value press the Patient Information ...

Page 50: ...ed Parameters Fig 3 19 3 Press Allow Blanking to allow parameter blanking Fig 3 20 If blanking is enabled the user is prompted to choose which measured parameter will be disabled or removed from the record after each patient sample measurement If for example Ca is disabled this result will not appear in the stored patient results or on the printout 4 Select the parameters to be disabled 5 Press to...

Page 51: ... for inclusion in or exclusion from the printout NOTE The display will always let you view all available calculated parameters 1 From the Ready display select System Manager and Setup 2 In the System Setup menu press Calculated Parameters Fig 3 21 3 Select the cassette type Fig 3 22 4 Select the parameters to be printed 5 Press to accept the changes 6 Press to return to the Setup screen or to retu...

Page 52: ...e printout explaining each arrow using the name selected here NOTE When the patient temperature has been changed both the uncorrected and corrected parameters will be checked against the limit values programmed here and flagged accordingly 1 From the Ready display select System Manager and Setup 2 In the System Setup menu press Normal Ranges Alarm Limits Fig 3 23 3 On the Limits 1 tab select the l...

Page 53: ... tHb 12 17 g dL SO2 90 100 Units may be changed See section 3 3 2 6 In all data input screens if unreasonable numbers are entered the system automatically flags the error and displays the valid range If you wish to turn off limits flagging enter the system ranges for each parameter For instance for pH the low is 6 600 and the high is 7 800 See Analytes Section for specifications of the reportable ...

Page 54: ...ess Factors 2 to go to the next screen Fig 3 29 5 When entering the actual offset value select whether it is an additive or subtractive value using the keys NOTE The factory setting is 1 0 00 for all slopes and 0 0 00 for the offsets This deactivates the correlation factors 6 Continue through the other parameters setting their correlation factors as above 7 Press to accept the changes 8 Press to r...

Page 55: ...inted past the decimal point for all measured parameters NOTE The selection applies to sample results only Resolution is always High for Control and SRC results Resolution examples are shown in the following table Low High pH 7 34 pH 7 341 PCO2 43 mmHg PCO2 43 2 mmHg PO2 87 mmHg PO2 86 8 mmHg Na 143 mmol L Na 143 3 mmol L K 4 6 mmol L K 4 57 mmol L Cl 103 mmol L Cl 103 1 mmol L Ca 1 21 mmol L Ca 1...

Page 56: ...been factory preset to the following units Baro Partial Pressure mmHg Temperature o C Resolution Low tHb g dL Electrolytes mmol L Glucose mmol L BUN mg dL Lac mmol L NOTE The OPTI CCA TS automatically recalculates the units stored in the database to the changed unit value 6 Press to accept the changes 7 Press to return to the Setup screen or to return to Ready Fig 3 32 Select Units ...

Page 57: ...cess to the setup menus and certain database functions The correct password will have to be entered to grant access to these menus and functions The password is especially useful to ensure that only authorized operators can alter customized settings The factory default password is 404 The factory set password can be changed to any number between 0 and 9999 up to 4 digits 1 Select Password Enable i...

Page 58: ...run patient measurements will not be allowed 8hr Requires SRCs to be run every 8 hours 12hr Requires SRCs to be run every 12 hours 24hr Requires SRCs to be run every 24 hours 7dy Requires SRCs to be run every 7 days 1 Select the desired option 2 Press to accept the changes 3 Press to return to the Setup screen or to return to Ready NOTE The selected time interval starts with the time this feature ...

Page 59: ...assette type Patient measurements will not be allowed unless all analytes on that cassette have satisfied the lockout requirements for number of control levels and required time period Option 3 New Lot Lockout Enable Controls must be run with every new lot of cassettes At least one level must have passed within the previous 60 days If this is not done the system will not allow patient samples to b...

Page 60: ...er the Operator ID number up to 11 digits and a unique 4 digit personal identification number PIN to be added to the list of authorized users The analyzer can store up to 300 Operator IDs and associated PINs NOTE The 4 digit PIN must be unique and will be required by the operator to access analyzer functions The Operator ID number will be printed on all reports associated with their PIN OR 2 Selec...

Page 61: ...nager and Setup 2 In the System Setup menu press the Miscellaneous tab and then Hardware to select this function Fig 3 37 3 In the Settings menu press to enter an offset from the true barometric pressure Fig 3 38 4 Type in the new numbers and press to accept the value 5 Press to return to the Setup screen or to return to Ready CAUTION Use the absolute barometric pressure and not the altitude corre...

Page 62: ... Beep 1 From the Ready display select System Manager and Setup 2 In the System Setup menu press the Miscellaneous tab and then Hardware 3 In the Settings screen select Beep Enable Fig 3 39 4 Select High or Low for Beep Volume 5 Press to accept the changes 6 Press to return to the Setup screen or to return to Ready Fig 3 39 Enable Beep ...

Page 63: ...e display will turn off automatically after the selected duration NOTE The screen will appear dark when the analyzer is in standby mode and Backlight Auto Off is enabled Press the touch screen to exit standby mode and resume normal operation Battery Save Mode will put the instrument into standby mode which turns off the sample measurement chamber heaters to conserve the battery Battery save mode h...

Page 64: ...rnal printer output ASTM Complies with ASTM standard Please refer to OPTI CCA TS interface specifications for more information CF Compact Flash is used for archiving data to a Compact Flash Card An Export Kit is available BP7140 with a properly formatted card instructions and card reader The database can be exported to the Compact Flash card in CSV format and then read by a PC Select Comma or Semi...

Page 65: ...44 Choose communication format ASCII or ASTM Change communication link from Serial to Ethernet Choose the Ethernet tab Fig 3 45 Set TCP Port to what your data manager specifies is your instrument port Each analyzer type may have a different port specified Enter your computer s host IP address into the Host IP field Press Format E1394 IP Type Dynamic and UDP Port fields should remain at default 6 P...

Page 66: ...port to each patient report The next option lets you add reference ranges to each patient report The last option lets you select how many copies will be printed 3 Select the options to be enabled 4 Press to accept the changes 5 Press to return to the Setup screen or to return to Ready NOTE This setting affects the patient report only All other print functions are still active even if the patient r...

Page 67: ...n Japanese language is selected and using the Epson TM U295 printer 1 From Ready display select System Manager then Setup 2 In the System Setup menu press the Miscellaneous tab then Printer Fig 3 47 3 On the Settings tab Fig 3 49 select External Serial Printer 4 Connect a DB 9 null modem or null modem cable to the serial connector on the back of the instrument 5 Connect the supplied printer cable ...

Page 68: ...esired language Fig 3 53 4 Press to accept the changes 5 Press to return to the Setup screen or to return to Ready Fig 3 52 Select Language Fig 3 53 Select Language In the Maintenance menu Fig 3 51 you can select Replace Pump Reminder to alert you when the peristaltic pump needs replacement If you enable the option Cleaning Reminder the system will alert you when weekly or monthly cleaning is due ...

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Page 70: ...QC Overview 4 1 4 3 Proficiency Testing 4 2 4 4 Calibration Verification 4 2 4 5 QC Recommendations 4 3 4 5 1 Running an SRC Measurement 4 4 4 5 2 Printing SRC Results 4 7 4 5 3 Running a QC Sample 4 8 4 5 3 1 Running Controls OPTI CHECK OPTI CHECK PLUS 4 8 4 5 4 Printing Control Reports 4 14 4 5 5 Sending Data to a Computer 4 15 ...

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Page 72: ...quilibrium behavior of the sensors during calibration and measurement automatic detection of bubbles and short sample during aspiration and automatic detection of low gas low battery dirty optics or worn pump conditions Calibration of the tHb channel is required every 3 months This calibration is performed using the tHb Calibration Cassette in a manner similar to other instruments that measure tHb...

Page 73: ...lsions The Joint Commission on Accreditation of Healthcare Organizations JCAHO has published a protocol for establishing a quality assurance program The Health Care Financing Administration HCFA and the Clinical and Laboratory Standards Institute CLSI formerly NCCLS have published standards for quality assurance in medical laboratories 4 4 Calibration Verification Calibration verification allows f...

Page 74: ...als should develop their own policy and procedures on the number of QC samples to be run on a daily basis as mandated by the regulatory agency under which they operate After receipt of a shipment of cassettes and at monthly intervals thereafter validation should be performed by analysis of OPTI CHECK or OPTI CHECK PLUS Blood Gas Controls or other equivalent material as recommended by OPTI Medical ...

Page 75: ...pass this function press NOTE If Operator ID is configured as required in Setup you cannot go to the next step unless a valid Op ID is entered NOTE If Secure Op IDs is activated under Setup you will be prompted for your 4 digit PIN instead of your Op ID NOTE Bar coded Operator IDs may be entered using the bar code scanner 4 Open the sample chamber cover by pressing the button Fig 4 3 Fig 4 1 Selec...

Page 76: ... Fig 4 5 After the cover has been closed the instrument will automatically detect which level of SRC has been inserted and prompt you to verify the lot number and level Fig 4 6 This information can be found on both the SRC cassette itself and its storage pouch If the information shown on the display is correct press to continue If this information is incorrect press to interrupt this sequence and ...

Page 77: ...nal drift is detected Fail will be displayed 8 Open the sample chamber cover and remove the SRC 9 Place the SRC back into its pouch immediately after removal from the instrument 10 Close the sample chamber cover If the SRC test failed gently clean the SRC the optics window and the inside cover of the SMC with alcohol and a lint free cloth and repeat this process If it fails again refer to the trou...

Page 78: ...t groups of results highlight the first measurement to be printed press then select the last measurement to be printed All the measurements in between will be selected Press to select all results 5 Press to print your selection 6 Press the Statistics button to print out the statistics from the most recent 30 days of SRC measurements for all levels 7 After printout the database can be deleted by pr...

Page 79: ... is opened be sure to enter the lot number information into the analyzer as described in Chapter 3 Customization NOTE Store controls at temperature recommended by the manufacturer NOTE The target value of PO2 is very sensitive to storage conditions and barometric pressure High altitude environments may see recovery outside the target range The control material should provide target values for all ...

Page 80: ... for your 4 digit PIN instead of your Op ID NOTE Bar coded Operator IDs may be entered using the bar code scanner 4 Select the desired level Fig 4 15 and press 5 Press if the lot number is correct Fig 4 16 NOTE If a new lot number of QC material is entered make sure the ranges have been entered into the system prior to running a sample See Chapter 3 Customization If the password function is enable...

Page 81: ... the cassette box for refrigerated cassettes NOTE If the bar code is damaged or unreadable press Manual Entry and enter the bar code digits printed on the bar code label using the numeric keypad NOTE A control measurement may be made using any cassette lot or cassette type 7 Open the sample chamber cover by pressing the release button Fig 4 18 8 Tear open the cassette pouch being careful not to te...

Page 82: ...the green status light is blinking the cassette calibration will be cancelled and the cassette must be discarded 12 Calibration is complete and it is time to place a sample Fig 4 22 Remove an ampoule from the box of controls and invert gently to resuspend the scattering particles being careful not to heat it with your hands NOTE Do not shake ampoule vigorously Excessive bubble formation may affect...

Page 83: ...small amount of control material from the ampoule for aspiration 13 Hold the ampoule at a 45 angle during aspiration Fig 4 23 Use a new ampoule for each sample 14 If using capillary tubes push the tube firmly into the fillport see Fig 4 24 15 Press The QC sample is aspirated into the cassette and the measurement starts Fig 4 25 At this time the status light begins flashing green indicating that th...

Page 84: ...ntrol Database Select Reject to reject the results Rejected results will not be stored in the Control Database Select Review to view the results again In either case the results will be printed when the data input is complete Please follow the regulatory guidelines of your hospital for documenting corrective action if results are rejected If any of the results are outside of the OPTI CCA TS s meas...

Page 85: ...urement Fig 4 30 To print groups of results highlight the first measurement to be printed press then select the last measurement to be printed All the measurements in between will be selected Press to select all results 5 Press to print your selection 6 Press the Statistics button to print a statistical report of the last 30 control measurements or more if available in database 8 After printout th...

Page 86: ...mputer must be made Before exporting to the Compact Flash CF Card included in CF Export Kit BP7140 make sure that the Compact Flash card is properly inserted in the CF port 1 In the Ready display select Data Manager 2 Select Patient SRC or Controls Fig 4 32 3 Select the data to be exported and press to start the data transfer Fig 4 33 A warning will be displayed asking you to confirm your choice F...

Page 87: ...A TS 4 CALIBRATION AND QUALITY CONTROL Fig 4 35 Enter Password If the password has been activated under Setup you will be asked to enter the password to initiate the procedure 4 Use the numeric keypad to enter the password Fig 4 35 ...

Page 88: ...ty 5 1 5 1 2 Sample Requirements 5 1 5 1 3 Anticoagulants and Sample Collection Devices 5 1 5 1 4 Syringes 5 2 5 1 5 Capillary Tubes 5 2 5 1 6 OPTI Medical ComfortSamplers 5 2 5 1 7 Handling and Storage of Samples 5 3 5 1 8 Test Conditions 5 4 5 2 Sample Preparation 5 4 5 2 1 Whole Blood Samples 5 4 5 3 Running A Patient Sample 5 5 5 4 Printing Patient Reports 5 14 ...

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Page 90: ... to CLSI document M29 A3 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition March 2005 for further information on safe handling of these specimens 5 1 2 Sample Requirements Refer to CLSI document H11 A4 Procedures for the Collection of Arterial Blood Specimens Approved Standard Fourth Edition September 2004 for detailed information on sample c...

Page 91: ...r samples taken for the analysis of lithium Samples may be collected in capillary tubes after warming the area or otherwise stimulating it to promote arterial circulation before the puncture The puncture should be made deeply enough to ensure a free and rapid flow of blood Do not use clay capped capillary tubes as the rough broken edge left when the capillary is cut may cause damage to the OPTI ca...

Page 92: ...ickly in syringes containing pathologic blood samples and may adversely affect the measurement of ctHb in any analyzer To prevent such errors first insert the OPTI CCA TS cassette into the analyzer to initiate calibration Next mix the syringe sample well by rolling the syringe for at least 60 seconds after expelling any trapped bubbles then immediately measure in the OPTI CCA TS The OPTI CCA TS sy...

Page 93: ...ry tube or a ComfortSampler Whole blood samples should be analyzed as soon as possible ideally within 5 minutes after collecting the sample For brief storage of up to one hour the sample should be iced WARNING Whole blood samples require the proper amount of anticoagulant to prevent the sample from clotting DO NOT use anticoagulants such as EDTA citrate oxalate etc Use only heparin salts as antico...

Page 94: ...er to section 6 5 1 of this manual to remove and install a new gas bottle 3 Scan the bar code on the OPTI cassette package by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer Fig 5 3 The red line from the bar code scanner should cover the entire bar code A beep and a green status light indicates a valid bar code A red status light indic...

Page 95: ...assette should be run immediately after opening the pouch but no later than 15 minutes after opening NOTE For sample introduction with a capillary tube or a ComfortSampler remove the syringe adapter before placing the cassette into the chamber NOTE If possible avoid tearing the bar code when opening the cassette pouch Gently wipe both sides of the cassette with a clean dry cloth to remove excess m...

Page 96: ... SO2 have been disabled see Section 3 3 2 2 you may attach the sample at any time during calibration and press The sample will then be automatically aspirated after calibration and the measurement will begin 6 After the successful calibration the status light will stop blinking and the display will prompt you to mix and place the sample Fig 5 8 Mix the syringe sample well by rolling it between the...

Page 97: ...spirated The sample will then be aspirated Fig 5 11 Next the sample is measured During the measurement the status light is blinking and a progress bar is displayed Fig 5 12 Do not open the cover of the sample measurement chamber during the measurement If you do the cassette and the sample must be discarded 8 To enter patient information while measurement is in progress press Patient Info Fig 5 12 ...

Page 98: ...e measurement Press the Patient Info button to enter new patient info or to not use the last patient info as the default 9 The first patient data entry screen contains the following information Fig 5 14 Operator ID 11 alphanumeric characters Patient ID 15 alphanumeric characters Accession No 12 alphanumeric characters Date of Birth DOB Temperature default value 37 0 C Sex unknown male or female NO...

Page 99: ...alp 13 Press for the following information Fig 5 17 Vent Mode No SIMV PSV PCV CMV AC CPAP PCIVR BIPAP PRVC where No None SIMV Synchronized Intermittent Mandatory Ventilation PSV Pressure Supported Ventilation PCV Pressure Control Ventilation CMV AC Controlled Mechanical Ventilation Assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive ...

Page 100: ...VE default value 0 L PIP default value 0 Pplat default value 0 PS default value 0 15 Press again and select the following Fig 5 19 BiLevel Pressure default value 0 00 0 00 I E Ratio default value 0 16 The last set of patient data contains the following information Fig 5 20 User Field 1 9 alphanumeric characters User Field 2 9 alphanumeric characters User Field 3 9 alphanumeric characters Blanking ...

Page 101: ...cording to the type of sensor cassette used See Chapter 9 2 Sensor Cassettes The resolution of the measured parameters may be configured HIGH Na 156 4 mmol L or LOW Na 156 mmol L in the setup menu See section 3 3 2 6 The OPTI CCA TS Analyzer flags values that are above or below the programmed ranges with an up or down arrow If the value is outside the measurable range a HIGH or LOW will be display...

Page 102: ...bration preceding the measurement Fig 5 23 19 Open the cover and remove the cassette and press to go to the next sample To edit the patient data press Patient Data NOTE The printout will automatically start when the first results are displayed This feature may be turned off in setup See Section 3 3 3 6 Fig 5 23 Calibration results ...

Page 103: ...nding to descending by pressing the column header 4 To print individual results highlight the desired measurement To print groups of results highlight the first measurement to be printed press then select the last measurement to be printed All the measurements in between will be selected Press to select all results 5 Press to print your selection 6 After printing patient data may be deleted by pre...

Page 104: ...erly Maintenance Performing tHb Calibration 6 1 6 3 1 Performing HbCal tHb Calibrator 6 1 6 4 Annual Maintenance 6 6 6 4 1 Replacing Peri Pump Cartridge 6 6 6 4 2 Replacing Gas I O Port 6 7 6 5 As Needed Maintenance 6 8 6 5 1 Changing the Gas Bottle 6 8 6 5 2 Changing the Printer Paper 6 10 6 5 3 Performing Routine Cleaning 6 11 ...

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Page 106: ...ptics surface as well as the underside of the SMC cover with a lint free cloth dampened with a dilute alcohol or dilute bleach cleaner as needed Be sure to remove all blood residue A cotton swab may be used for cleaning the smaller parts of the SMC 6 3 Quarterly Maintenance Performing tHb Calibration 6 3 1 Performing HbCal tHb Calibrator 1 In the Ready display select QC Manager 2 In the QC Manager...

Page 107: ...ress to bypass this function Fig 6 3 NOTE If Operator ID is configured as required in Setup you cannot go to the next step unless a valid Op ID is entered NOTE If Secure Op IDs is activated under Setup you will be prompted for your 4 digit PIN instead of your Op ID NOTE Bar coded Operator IDs may be entered using the bar code scanner Fig 6 3 Enter Operator ID Fig 6 2 Enter Password ...

Page 108: ... 4 6 At the prompt open the SMC cover by pressing the button Fig 6 5 7 Gently clean the optics window and the inside top cover of the sample chamber with a soft lint free cloth Fig 6 6 Press Fig 6 5 Open Cover Fig 6 4 Enter Lot Number Fig 6 6 Clean Optics and Inside of Cover Clean Optics and Inside of Cover Optics OK Clean Optics and Inside of Cover Optics OK ...

Page 109: ...er Fig 6 8 After the cover has been closed the instrument will automatically detect the presence of the calibrator cassette and begin calibration Fig 6 9 11 After the calibration is complete you will be prompted to open the sample chamber cover and remove the cassette 12 Place the calibrator cassette back into its pouch immediately after removal from the instrument NOTE Make sure to keep the calib...

Page 110: ...000 The unit will now begin printing the tHb Calibration Report showing both the old and new calibration results and calibration factors Fig 6 10 13 After completion of Hb Calibration it is necessary to delete and reload the current SRC data for each level Refer to section 3 3 1 1 Setting up the Standard Reference Cassette 14 Press Fig 6 11 to proceed to the SRC Setup menu 15 Verify performance by...

Page 111: ...as needed Remove the old pump seals with a pair of hemostats or tweezers Fig 6 13 Carefully grasp the seal and pull it out CAUTION When removing the seals take extra care to avoid damaging the nipples located at the bottom of the seal recess 3 Press the new pump seals into the seal recess with the large side facing up 4 Install the new pump cartridge by first rotating the flat surface on the pump ...

Page 112: ...ke sure the pump rotates smoothly without excessive noise In addition run one sample in control mode Make sure the control measurement passes without errors Fig 6 17 Gas I O Port Fig 6 15 Push on Pump Roller 5 Press the pump cartridge roller down until it firmly seats on the shaft of the pump motor Fig 6 15 6 Perform a Pump Test see section 7 2 16 to ensure correct operation Make sure the pump rot...

Page 113: ...code is accepted The barcode can be found on the gas bottle instructional insert Record the date of installation on the gas bottle for later reference NOTE To enter the bar code manually press Manual and enter the bar code using the numeric keypad NOTE The gas bottle should always be stored with the cap on NOTE The bar code contains expiration information The OPTI CCA TS will alert the operator tw...

Page 114: ...need to remove the gas bottle and reinstall it respond at the prompt New Gas Bottle You will then be prompted to enter the number of weeks in service using the numeric keypad Fig 6 24 Here you may refer back to the installation date which was recorded on the gas bottle 8 The unit will then return to the Ready screen Fig 6 25 Fig 6 22 New Gas Bottle Fig 6 24 Enter Number of Weeks in use Fig 6 23 Pu...

Page 115: ...f paper in the chamber and thread it into the feeder Use the diagram in the paper well to make sure the paper is inserted correctly Fig 6 27 5 As soon as the printer detects the paper it will automatically feed the paper completely through the printer The paper advance button should only be used if the paper is present 6 To advance paper after the initial installation press the red paper advance b...

Page 116: ...ng The OPTI CCA TS Analyzer is designed to require very little maintenance Routine cleaning consists of wiping the exterior analyzer surfaces with a soft damp cloth NOTE Do not use cleaners with ammonia or that contain abrasives or greater than 10 bleach on the OPTI CCA TS Analyzer ...

Page 117: ... Checking the Bar Code Scanner 7 18 7 2 12 Checking the Printer 7 19 7 2 13 Checking the Optics 7 20 7 2 14 Checking the RS232 Interface 7 21 7 2 15 Checking the Pump Flow 7 22 7 2 16 Checking the Pump Motor 7 23 7 2 17 Checking the Display 7 23 7 2 18 Checking the Touch Screen 7 24 7 2 19 Gas Test 7 25 7 2 20 Lactate Setup 7 26 7 2 21 Checking the Ethernet Interface 7 28 7 2 22 Calibration Report...

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Page 119: ...ed and not clotted and does not contain air bubbles Wait for the system to recalibrate Remix sample carefully Press to notify the system that the sample is reattached and reaspirate sample The displayed measured parameter is unstable NOTE This message is a warning The analyzer will however display a result for the parameter concerned Remove cassette and check for aspirated bubbles If bubbles are p...

Page 120: ...e Otherwise use the diagnostic routine to perform the purge See Section 6 5 1 NOTE The gas bottle expires 9 months after installation or after exceeding the labeled expiration date whichever comes first The peristaltic pump is getting worn Press to continue measurement Perform pump diagnostic see Section 7 2 16 if this warning persists If the pump diagnostic fails replace the pump cartridge see se...

Page 121: ...ent report until the pump is replaced and the done button is selected on the system maintenance menu See section 6 4 1 for instruction If maintenance reminders are enabled the cleaning reminder will appear once when due during cassette installation Afterwards a reminder message will be appended to the end of every patient and QC measurement report until the instrument is cleaned and the done butto...

Page 122: ...nt data and add the required information A new printout will be given with the required information NOTE If the required information is not entered results will be displayed and printed out however the system will not return to Ready Two or more measured parameter sensors are bad Press discard the cassette and repeat the test with a new cassette A sample error has occurred This may be due to a clo...

Page 123: ...fter installation or after exceeding the labeled expiration date whichever comes first Check the gas bottle label Make sure it is for this particular gas bottle and the expiration date has not been exceeded If expired insert a new gas bottle Check proper date setting in System Time and Date The cassette was not properly placed into the chamber or it was previously used Open the SMC cover Reinsert ...

Page 124: ... the power back on and retry The cassette or its packaging is defective Press discard the cassette and repeat test with a new cassette Make sure to wipe the new cassette dry before inserting it into the SMC If the message still appears with a different cassette turn the power off and wait 30 seconds Then then turn power back on and retry The instrument did not calibrate due to problems with the ca...

Page 125: ... attempted to restart the aspiration and was not able to aspirate enough sample Press and discard the cassette The bar code was invalid The OPTI CCA TS either misread the bar code label or it is an invalid bar code for the OPTI CCA TS Press to retry If the error message appears again check the product package for intended use Check the bar code scanner see Section 7 2 11 Clean the bar code scanner...

Page 126: ...e level and lot number Press to continue The cassette placed in the SMC is invalid Verify that the cassette placed in the SMC is a valid tHb calibrator Press to continue The QC lot is invalid Press to continue Configure the control material under Setup and retry The SRC type is invalid Press to continue Remove the SRC Configure the SRC data in Setup and retry ERROR Invalid Barcode Check Time and D...

Page 127: ...optics glass and inside the sample measurement chamber top cover Press to continue Check the LEDs See Section 7 2 4 The Operator ID already exists in the database Press to continue Enter a unique Operator ID The PIN number does not exist in current Secure Op ID database Press to continue Retry with a valid PIN number The PIN number already exists in database Press to continue Enter a unique PIN nu...

Page 128: ...ection is greater than 10 To retry Replace the Hb calibrator The battery is low Install a freshly charged battery or recharge for up to 6 hours before the next sample is run or operate the analyzer on AC power The battery is low Install a freshly charged battery or recharge for up to 6 hours before the next sample is run or operate the analyzer on AC power Turn the power off wait 30 seconds and th...

Page 129: ...the lactate parameter If QC lockout has been activated in Setup this message will be displayed if controls have not been run within the specified time Press and run control materials The temperature is out of range during any kind of measurement Press and continue If the error message appears again check the temperature under System Diagnostics STOP Low Gas Replace Now OK STOP Low Gas Replace Now ...

Page 130: ...zer to reach the correct temperature Cycle the power if the analyzer does not go to Ready within a few minutes If the analyzer does not become Ready within a reasonable time check the temperature under System Diagnostics Check that ambient temperature is within operating specifications on page 2 1 The battery voltage is low Operate the analyzer on AC power and or recharge the battery ...

Page 131: ...iagnostics Fig 7 1 The Diagnostics screen contains three tabs with various diagnostic functions Sensors Control and Tests 7 2 1 Checking Versions Fig 7 1 Diagnostics From the Ready display press System Manager Diagnostics The first option on the Sensors screen Versions Fig 7 2 allows you to check the software version version of the optical module as well as the GUI version Fig 7 2 Versions ...

Page 132: ...king Gas Pressure Fig 7 4 Gas Pressure The Gas Level option allows you to check the percent remaining of the gas bottle Fig 7 4 With a new gas bottle in place the pressure should be approx 99 with the bottle removed the pressure should be 00 From the Ready display press System Manager and Diagnostics To install a new gas bottle press Scan the bar code located on the side of the gas bottle to insta...

Page 133: ...ressure for setting the barometer Fig 7 6 Barometric Pressure 7 2 5 Verifying Barometric Pressure Fig 7 5 LEDs The purpose of this test is to check proper functioning of the LEDs This test should be performed only by trained service personnel From the Ready display press System Manager Diagnostics The following information is displayed in the LEDs section Fig 7 5 Front Rear Ion fluid light gates C...

Page 134: ...8 When On is selected you should feel the draft of the fan by placing your hand over the fan at the back side of the analyzer Press to return to the System screen Fig 7 8 Cooling Fan 7 2 6 Checking the Battery Voltage This selection lets you check the battery voltage From the Ready display press System Manager and Diagnostics The second display in the Miscellaneous section shows the battery voltag...

Page 135: ...on under Gas Valve to start the test Fig 7 9 A faint hissing sound may be heard with the pump cartridge removed and the gas valve open Press to return to the System screen Fig 7 9 Gas Valve This diagnostic checks the proper operation of the cassette valve drive mechanism From the Ready display press System Manager and Diagnostics Select the Control tab Press to start the test Fig 7 10 Enter the va...

Page 136: ... tab Press Barcode to start the test Fig 7 12 To test the bar code scanner scan a bar code label of e g a sensor cassette Fig 7 13 The display will show a sequence of numbers Fig 7 14 Compare the numbers with those printed on the cassette bar code label Matching information confirms the proper function of the bar code scanner Press to return to the Tests screen Press to return to the System screen...

Page 137: ...t Fig 7 15 The printer will output a test print Check if the alphanumeric printout is legible and all the characters are properly printed If the printout is deficient your printer may need replacement To replace the printer follow the steps below Turn the OPTI CCA TS off Remove the paper roll and pump cartridge Unscrew the two thumbscrews holding the printer in place Pull printer up and out toward...

Page 138: ...om the Ready display press System Manager and Diagnostics Select the Tests tab Press Optics to start the test Fig 7 16 Insert an SRC and press Fig 7 17 The system will now check the optics Fig 7 18 At the completion of the test a printout of the results will be printed and the Remove SRC message will be displayed Fig 7 19 Test in Process Optics Test Test in Process Optics Test Remove SRC Optics Te...

Page 139: ...e test Fig 7 20 It is important to have pins 2 and 3 send and receive see Appendix A p A 6 shorted together Fig 7 21 Press and the system will send out a test string and check if it can be received The instrument will display a Pass or Fail message Fig 7 22 Press to return to the Tests screen Fig 7 20 RS232 Interface Fig 7 21 Jumper Pins 2 to 3 Fig 7 22 Interface Test Pass Jumper pins 2 to 3 RS232...

Page 140: ...tes are out of range the test fails Repeat test or replace the pump cartridge if the test fails See replacement instructions in Chapter 6 NOTE It is possible that the test fails the first time even if the pump cartridge is working correctly Remove the cassette Fig 7 27 Fig 7 23 Flow Test Fig 7 25 Flow Test in Process Fig 7 24 Insert Cassette Fig 7 26 Flow Test Fail Fig 7 27 Remove Cassette Insert ...

Page 141: ...defective and needs to be replaced Press to return to the System screen Fig 7 30 Display Test 7 2 16 Checking the Pump Motor The purpose of this test is to check the proper functioning of the peristaltic pump motor From the Ready display press System Manager Diagnostics Select the Tests tab Press Pump to start the test Fig 7 28 The pump will automatically step through all the speeds used during no...

Page 142: ...Fig 7 31 Touch the screen and a dot should appear under the touched location Fig 7 32 If not press Calibrate to perform a touch calibration Press to return to the System screen Using a finger stylus or pointed object e g syringe adapter touch the center of the calibration mark as it moves around the screen Fig 7 33 NOTE Do not use sharp objects since they may damage the screen When finished press ...

Page 143: ...ESHOOTING 7 2 19 Gas Test The Gas Test Fig 7 34 is designed exclusively for use by authorized OPTI Medical personnel to check for leaks in the gas system NOTE This test will last 2 hours It can only be interrupted by switching the analyzer off Fig 7 34 Gas Test ...

Page 144: ...ng procedure Call Technical Support for further assistance From the Ready display press System Manager Diagnostics Select the Tests tab Press Lactate Setup Fig 7 35 Enter the setup password 404 to access the setup functions If the factory set password was changed enter the currently valid password Enter the Operator ID or press to bypass this function Fig 7 36 If Operator ID is configured as requi...

Page 145: ... you will return to this screen Fig 7 39 You will not receive a results screen or printout until the setup procedure is complete Continue to run the OPTI check with the same lot of cassettes and OPTI check until prompted You may run from 5 to 8 OPTI checks After running the required number of samples the lactate parameter is enabled Fig 7 40 Press to exit the menu You will receive a lactate setup ...

Page 146: ...est is to check for proper functioning of the Ethernet interface From the Ready display press System Manager Diagnostics Select the Tests tab Press Ethernet to start the test Fig 7 41 The system will send out data and check if they are received Fig 7 42 Press to return to the Tests screen Fig 7 41 Ethernet Fig 7 42 Ethernet Test ...

Page 147: ...o print a patient calibration report select Calibration Reports Patient in the Data screen Fig 7 43 In the Data Patient Diagnostics screen Fig 7 44 select the desired measurement and press the button to display the results Fig 7 45 Use the and buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 7 44 To print groups of results hi...

Page 148: ...the desired measurement and press the button to display the SRC results Fig 7 48 Use the and buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 7 47 To print groups of results highlight the first measurement to be printed press then select the last measurement to be printed All the measurements in between will be selected Press...

Page 149: ...ct the desired measurement and press the button to display the control results Fig 7 51 Use the and buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 7 50 To print groups of results highlight the first measurement to be printed press then select the last measurement to be printed All the measurements in between will be selecte...

Page 150: ...ect Calibration Reports Errors in the Data screen Fig 7 52 Press to print the error log Fig 7 53 Press to delete the error database Confirm your choice by pressing in the Delete the Error Log screen Fig 7 54 Press to return to the Data screen Fig 7 52 Select Errors Fig 7 53 Print or Delete Error Log Fig 7 54 Delete Error Log Delete the Error Log Errors Yes No Delete the Error Log Errors Yes No ...

Page 151: ... be printed and kept in a safe place for later reference 7 2 22 5 Configuration Report Fig 7 55 Configuration Report This printout reports all logged maintenance events To print a maintenance log select Maintenance in the Data screen Fig 7 55 Press to print the maintenance log Fig 7 56 Press to delete the maintenance database Confirm your choice by pressing in the Delete the Maintenance Log screen...

Page 152: ...ty causing the tHb and SO2 to fail calibration or OPTI Check controls The simple cleaning procedure below can be used for OPTI CCA OPTI CCA TS or OPTI R analyzers and may correct tHb and SO2 failures 1 Open the SMC cover and locate the two small optical channels pictured below Fig 7 58 Fig 7 58 Locate Optical Channels 2 Clean the optical channels using a cotton swab or lint free cloth dipped in al...

Page 153: ...cedure for Bar Code Scanner If you experience difficulty scanning bar codes clean the bar code scanner window with alcohol and a lint free cloth If difficulty continues check the bar code scanner window for scratches Call OPTI Medical Technical Support for a replacement bar code scanner window ...

Page 154: ...le Collection Devices 8 3 8 4 4 Syringes 8 3 8 4 5 Capillary Tubes 8 3 8 4 6 OPTI Medical ComfortSamplers 8 4 8 4 7 Handling and Storage of Samples 8 4 8 5 Procedure 8 5 8 5 1 Materials Needed 8 5 8 5 2 Test Conditions 8 6 8 5 3 Input Values 8 6 8 5 4 Calculated Values 8 9 8 5 5 Calibration 8 9 8 5 6 Quality Control 8 10 8 5 7 Reference Intervals 8 11 8 5 8 Specific Performance Characteristics 8 1...

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Page 156: ...energy of an appropriate color electrons in the molecules of the fluorescent chemical are excited A very short time later the electrons return to a resting state and in this process sometimes emit a small amount of light energy This energy is less than the excitation energy and so has a different color That is the emitted light fluorescence emission is red shifted from the excitation light and is ...

Page 157: ...ters so that photons of a specific color are transmitted to the sensors causing them to emit fluorescence The intensity of this emitted light depends upon the partial pressure of oxygen PO2 carbon dioxide PCO2 hydrogen ion concentration pH electrolyte concentration Na K Ca Cl or metabolite concentration glucose BUN urea lactate of the blood in direct contact with the sensors as described above The...

Page 158: ...are the only acceptable anticoagulants for blood gas analysis Other anticoagulants such as EDTA citrate oxylate and fluoride have a significant effect on blood pH and electrolyte levels and should not be used Lithium heparin should not be used for samples taken also for analysis of lithium 8 4 4 Syringes If liquid heparin is used as an anticoagulant collection devices should be no larger than the ...

Page 159: ...parated within these time limits 8 4 7 Handling and Storage of Samples Please refer to CLSI Document H18 A3 Procedures for the Handling and Processing of Blood Specimens Approved Guideline Third Edition November 2004 for a detailed discussion of guidelines for the collection of acceptable specimens instrument calibration and quality control in pH and blood gas analysis including details of many po...

Page 160: ... sample Serum samples should be obtained by collecting blood in an untreated blood collecting tube The sample should stand for 30 minutes to allow the clot to form prior to centrifugation After centrifugation remove the serum from the clot and cap or seal the sample tube If storage is required the sample should be tightly capped refrigerated at 4 to 8 C for no longer than 48 hours and allowed to r...

Page 161: ... BUN urea Lac and reflectance tHb SO2 8 5 3 Input Values Parameter Range Default Display Units Resolution Patient ID 15 alphanumeric characters Blank Operator ID 11 alphanumeric characters Blank Accession Number 12 alphanumeric characters Blank Patient temperature T 14 to 44 37 0 0 1 C 58 to 111 0 1 F Patient Sex Male female or Hemoglobin type adult or fetal adult DOB MMM DD YYYY Puncture Site LR ...

Page 162: ...0 01 mmol L Mean corpuscular hemoglobin 29 0 to 37 0 33 3 0 1 concentration MCHC O2 Mode Rm Air Mask T P NC Rm Air Vent Bag Hood or Other where Rm Air Room Air Mask Mask T P T Piece NC Nasal Cannula Vent Ventilator Bag Bag manual resuscitation Hood Hood Other Other FIO2 0 21 to 1 0 0 21 0 01 respiratory quotient RQ 0 70 to 2 00 0 84 0 10 P50 15 to 40 26 7 0 1 mmHg Vent Mode No SIMV PSV PCV No CMV ...

Page 163: ...re Tidal Volume VT 0 to 4000 0 1 mL Minute Volume VE 0 to 120 0 1 L Peak Inspiratory Pressure PIP 0 to 140 0 1 Plateau Pressure Pplat 0 to 100 0 0 1 Pressure Support Value PS 0 to 99 9 0 0 1 Positive End Expiratory 0 to 50 0 1 Pressure PEEP Continuous Positive Airway 0 to 50 0 1 Pressure CPAP Rate f 0 to 155 0 1 bpm Flow Rate Liter Flow FR 0 to 300 0 1 LPM Inspiratory Expiratory Ratio 0 2 9 9 0 2 ...

Page 164: ...using specially targeted calibration standards focusing on the clinically critical ranges Every cassette package has a bar code label containing this calibration information as well as its lot number and expiration date Prior to running a sample the cassette s bar code is scanned into the analyzer by holding the cassette package in front of a conveniently located bar code scanner The cassette is t...

Page 165: ...he above minimal recommendations for quality control verification The OPTI CCA TS s equivalent QC method Standard Reference Cassette SRC is a relatively new concept in quality control testing In traditional blood gas analyzers liquid quality control QC material is run several times a day to verify the system measurement including reagents used for patient testing On these systems multiple patient ...

Page 166: ...nce intervals should not however be used as absolute indicators of health and disease due to variability among methods laboratories locations and other considerations Individual laboratories should generate their own set of reference intervals Guidelines for defining and determining reference intervals are published in the 2000 NCCLS C28 A2 guideline How to Define and Determine Reference Intervals...

Page 167: ...uleaux formation4 This is observable as rapid sedimentation and clarification due to erythrocyte aggregates falling to the bottom of the syringe within minutes of mixing The OPTI CCA TS breaks up most of the rouleaux and other aggregates by rapidly aspirating the whole blood sample with high shear rate however in rare pathologic cases the rouleaux aggregates persist or reform during the aspiration...

Page 168: ...l or higher and showed no interference to any measured analyte including blood gas electrolytes and tHb SO2 Bile Acids 30 µmol dL Bilirubin 40 mg dL Beta Carotene 3 0 mg dL Hemolysis 10 During hemolysis K is released from the blood cells thereby increasing the measured K In the same manner protein released from the cells binds ionized Ca and decreases the concentration While an accurate value is r...

Page 169: ...ot number are printed on each cassette container label Standard Reference Cassettes SRCs Use For diagnostic and daily QC check of the OPTI CCA TS Contents Each package contains one reusable SRC Cassette Composition Stabilized optode sensors with assay values Level 1 Level 2 Optional Level 3 BP7536 BP7554 BP7543 pH 7 080 7 120 7 380 7 420 7 580 7 620 pH units PCO2 68 0 72 0 38 0 42 0 18 0 22 0 mmHg...

Page 170: ...by OPTI Medical Systems could void the warranty Once used the sample cassette holds human body fluids which may be potentially infectious handle with appropriate care to avoid skin contact or ingestion For in vitro diagnostic use For professional use only Bibliography 1 Guilbault GG Ed Practical Fluorescence 2nd Edition Marcel Dekker 1990 2 Tietz Burtis C et al Eds Textbook of Clinical Chemistry a...

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Page 172: ...PLIES 9 SUPPLIES 9 1 9 1 Analyzer 9 1 9 2 Cassettes 9 1 9 3 Controls Calibrators 9 1 9 4 Consumable Items 9 2 9 5 Accessories 9 2 9 6 Manuals 9 2 9 7 Spare Parts 9 3 9 8 Technical Assistance 9 3 9 9 Warranty Registration U S Market Only 9 4 ...

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Page 174: ...y assistance you may require Description Part Number 9 1 Analyzer OPTI CCA TS Analyzer GD7013 with Accessory Kit 9 2 Cassettes OPTI Cassette B 25 per box BP7562 OPTI Cassette E 25 per box BP7587 OPTI Cassette E Ca 25 per box BP7560 OPTI Cassette E Cl 25 per box BP7559 OPTI Cassette E Glu 25 per box BP7564 OPTI Cassette E BUN urea 25 per box BP7588 OPTI Cassette B Lac 25 per box BP7561 OPTI Cassett...

Page 175: ...n Gas Bottle 1 pc BP7001 Capillary Tubes 250 pcs MC0024 ComfortSampler with Accessories BP0600 ComfortSampler Basic Kit BP0610 ComfortSampler Bulk w o Needle BP0630 ComfortSampler Bulk Needle w Protector BP0640 9 5 Accessories Battery Assembly BP7007 CF Export Kit BP7140 9 6 Manuals Operator s Manual PD7040 Service Manual PD7041 ...

Page 176: ...erience necessary to provide dependable technical assistance The OPTI Medical Service Hotline U S market only is staffed to provide prompt troubleshooting assistance seven 7 days per week twenty four 24 hours per day Should you need troubleshooting assistance or application information regarding your OPTI Medical analyzer just contact the OPTI Medical Service Hotline for assistance In the U S call...

Page 177: ...PTI Medical Systems Inc to ensure warranty support if you ever need warranty assistance The model and serial numbers of your OPTI CCA TS are on the bottom panel of the unit Please read the Instrument Warranty Terms and Conditions and become familiar with this agreement Each new analyzer purchased has a one year warranty from the date the analyzer is placed into service Contact the OPTI Medical Ser...

Page 178: ...PO2 PO2 1 PO2 Dry Sensor B Lac Cassette PO2 B 1 Sodium Na Na 1 Potassium K K 1 Ionized Calcium Ca Ca 1 Chloride Cl Cl 1 Glucose Glu Glu 1 BUN Urea BUN 1 Lactate B Lac Cassette Lac 1 Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO2 THB SO2 1 ANALYTES Operator s Manual OPTI CCA TS A i ...

Page 179: ...l disorders an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute as the result of pulmonary edema airway obstruction or medication or may be chronic as the result of obstructive or restrictive respiratory diseases Measurement Principle The pH optode measurement principle is b...

Page 180: ... 5 mg dL 0 04 Methylene blue 25 mg dL 0 16 Only clear uncolored quality control materials such as OPTI CHECK or OPTI CHECK PLUS brand aqueous controls should be used with the OPTI CCA TS system Colored materials including proficiency testing materials may interfere with the pH measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision...

Page 181: ...sting instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9269 0 534 0 9789 0 013 7 19 7 56 103 Analyzer B whole blood 1 0800 0 579 0 9954 0 009 7 01 7 55 173 Analyzer C whole blood 1 126 0 018 0 946 0 134 0 9868 0 018 7 09 7 58 105 Analyzer D whol...

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Page 183: ...ertain renal disorders an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute as the result of pulmonary edema airway obstruction or medication or may be chronic as the result of obstructive or restrictive respiratory diseases Measurement Principle The pH optode measurement pri...

Page 184: ...erence Acetaminophen 1 66 mM 7 170 NO 7 520 NO Acetylsalicylic acid 3 33 mM 7 170 NO 7 520 NO Ascorbic acid 0 23 mM 7 170 NO 7 520 NO B Hydroxybutyric acid 16 03 mM 7 170 NO 7 520 NO Bilirubin 0 26 mM 7 170 NO 7 520 NO Cardiogreen 0 0065 mM 7 170 NO 7 520 NO Cystein 6 41 mM 7 170 NO 7 520 NO Ethanol 86 8 mM 7 170 NO 7 520 NO Evans blue 0 0104 mM 7 170 0 140 7 520 NO Glycolic acid 10 mM 7 170 NO 7 ...

Page 185: ...Level 1 7 17 0 011 0 014 0 008 0 007 0 005 0 006 Level 2 7 44 0 010 0 010 0 010 0 010 0 004 0 005 Level 3 7 65 0 011 0 011 0 007 0 007 0 004 0 006 Whole Blood Within Run precision in whole blood samples was evaluated at three different pH concentrations using multiple instruments and multiple cassette lots pH in Whole Blood Level 1 Level 2 Level 3 Average 7 170 7 306 7 610 St Dev 0 008 0 007 0 011...

Page 186: ...her pH Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different CO2 gas mixtures to generate a wide range of pH values The blood samples were analyzed in parallel on the B Lac cassette and other laboratory instruments Comparative Method Slope Intercept R2 Sy x Range n Analyzer B 1 03 0 21 0 996 0 016 6 578 7 661 174 Analyzer C 1 03 0 19 0...

Page 187: ...es Measurement Principle The PCO2 optode measurement principle is based upon placing a pH optode behind an ion impermeable membrane2 just as conventional PCO2 blood gas electrodes employ the Severinghaus CO2 electrode construction As such PCO2 optodes may suffer interference from volatile acids and bases in blood just as conventional PCO2 electrodes The PCO2 partial pressure is influenced by the l...

Page 188: ...bration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Precision and Recovery on Whole Blood Whole blood was tonometered at 37 C to various levels of gravimetrically prepared ...

Page 189: ...ed on the OPTI CCA after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9751 1 623 0 9871 1 16 28 72 103 Analyzer B whole blood 0 9740 2 66 0 9937 1 12 24 92 173 Analyzer C whole blood 0 988 0 022 ...

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Page 191: ...tructive lung disease drug overdose or chronic metabolic acid base disturbances Measurement Principle The PCO2 sensor measurement principle is based upon placing a pH optode behind a gas permeable membrane to measure a hydrogen concentration change in the internal solution when CO2 permeates through the gas permeable membrane The reaction sequence is outlined below CO2 H2 O H2 CO3 H HCO3 The hydro...

Page 192: ...mmHg NO 17 mmHg NO Ascorbic acid 0 23 mM 83 mmHg NO 17 mmHg NO B Hydroxybutyric acid 16 03 mM 83 mmHg NO 17 mmHg NO Bilirubin 0 26 mM 83 mmHg NO 17 mmHg NO Cardiogreen 0 0065 mM 83 mmHg NO 17 mmHg NO Cystein 6 41 mM 83 mmHg NO 17 mmHg NO Ethanol 86 8 mM 83 mmHg NO 17 mmHg NO Evans blue 0 0104 mM 83 mmHg 24 68 mmHg 17 mmHg NO Glycolic acid 10 mM 83 mmHg NO 17 mmHg NO Halothane 0 759 mM 83 mmHg NO 1...

Page 193: ...93 2 08 2 36 0 91 0 92 Whole Blood Within Run precision in whole blood samples was evaluated at three different PCO2 concentrations using multiple instruments and multiple cassette lots PCO2 in Whole Blood Level 1 Level 2 Level 3 Average 78 6 39 3 17 0 St Dev 1 8 1 7 1 8 CV 2 3 4 4 10 6 n 18 18 18 Linearity2 The linearity of the dry PCO2 sensor was established using whole blood samples tonometered...

Page 194: ... Support OPTI CCA TS with B Lac Cassette vs other PCO2 Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different CO2 gas mixtures to generate a wide range of PCO2 values The blood samples were analyzed in parallel on the B Lac cassette and other laboratory instruments Comparative Method Slope Intercept R2 Sy x Range n OPTI CCA std PCO2 sen...

Page 195: ...iple is based upon luminescence quenching first documented in the 1930 s2 and commercially utilized to measure blood PO2 in 19833 The relationship of luminescence to PO2 is quantified by the Stern Volmer equation I0 I 1 kP which describes how the fluorescence emission intensity I is reduced as the PO2 P is increased Unlike conventional electrochemical Clark PO2 electrodes the oxygen optode does no...

Page 196: ...ion and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Precision and Recovery on Whole Blood Whole blood was tonometered at 37 C to various levels of gravimetrically prepared gase...

Page 197: ...trolled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9419 3 28 0 9875 18 27 36 563 103 Analyzer B whole blood 1 0192 4 13 0 9969 4 10 34 291 173 Analyzer C whole blood 0 918 0 087 8 083 1 402 0 9954 8 032 29 407 105 Analyzer D whole blood 1 041 0 006 6 244 0 931 0 9969 6 379 37 598 174 Analyzer E whole blood...

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Page 199: ...sed upon luminescence quenching first documented in the 1930 s2 and commercially utilized to measure blood PO2 in 19833 The relationship of luminescence to PO2 is quantified by the Stern Volmer equation I0 I 1 kP which describes how the fluorescence emission intensity I is reduced as the PO2 P is increased Unlike conventional electrochemical Clark PO2 electrodes the oxygen optode does not consume ...

Page 200: ...mmHg NO Ascorbic acid 0 23 mM 48 mmHg NO 416 mmHg NO B Hydroxybutyric acid 16 03 mM 48 mmHg NO 416 mmHg NO Bilirubin 0 26 mM 48 mmHg NO 416 mmHg NO Cardiogreen 0 0065 mM 48 mmHg NO 416 mmHg NO Cystein 6 41 mM 48 mmHg NO 416 mmHg NO Ethanol 86 8 mM 48 mmHg NO 416 mmHg NO Evans blue 0 0104 mM 48 mmHg 31 16 mmHg 416 mmHg NO Glycolic acid 10 mM 48 mmHg NO 416 mmHg NO Halothane 0 759 mM 48 mmHg NO 416 ...

Page 201: ...1 89 1 76 2 19 1 31 1 69 Whole Blood Within Run precision in whole blood samples was evaluated at three different PO2 concentrations using multiple instruments and multiple cassette lots PO2 in Whole Blood Level 1 Level 2 Level 3 Average 48 4 83 3 398 8 St Dev 1 5 2 7 13 6 CV 3 1 6 0 3 4 n 18 18 18 Linearity4 The linearity of the dry PO2 sensor was established using whole blood samples tonometered...

Page 202: ...with different O2 gas mixtures to generate a wide range of PO2 values The blood samples were analyzed in parallel on the B Lac cassette and other laboratory instruments Comparative Method Slope Intercept R2 Sy x Range n OPTI CCA Std PO2 sensor 0 94 4 84 0 998 9 77 19 9 642 8 161 Analyzer B 0 95 6 32 0 992 18 25 17 0 635 7 161 For more information on specific analyzers used please contact OPTI Medi...

Page 203: ... insipidus or diabetic acidosis increased renal sodium conservation in hyperaldosteronism Cushing s syndrome inadequate water intake because of coma or hypothalamic diseases dehydration or excessive saline therapy The sodium value obtained may be used in the diagnosis or monitoring of all disturbances of the water balance infusion therapies vomiting diarrhea burns heart and kidney insufficiencies ...

Page 204: ...A oxalate and fluoride cause significant interferences to the electrolyte sensors The following exogeneous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver Substance amount Na change mmol L Sodium fluorescein 26 mg dL unstable Cardio indocyanine green 0 5 mg dL 18 Methylene b...

Page 205: ...specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept ...

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Page 207: ...te imbalance in the diagnosis and treatment of infusion therapies shock heart or circulatory insufficiency acid base imbalance therapy with diuretics all kinds of kidney problems diarrhea hyper and hypo function of adrenal cortex and other diseases involving electrolyte imbalance Measurement Principle The K ion optodes are closely related to the more familiar Ion Selective Electrodes ISEs The opto...

Page 208: ...rferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver Substance amount K change mmol L Sodium fluorescein 26 mg dL 0 7 Cardio indocyanine green 0 5 mg dL 0 4 Methylene blue 25 mg dL 2 4 Only clear uncolored quality control materials such as OPTI CHECK or OPTI CHECK PLUS brand aqueous ...

Page 209: ...s from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Int...

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Page 211: ...re often have altered concentrations of calcium phosphate albumin magnesium and pH Since these conditions tend to change ionized calcium independently of total calcium ionized calcium is the preferred method of accurately monitoring calcium status in renal disease2 Ionized calcium is important for diagnosis or monitoring of hypertension management parathyroidism renal diseases malnutrition kidney ...

Page 212: ...d materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA instruments Ionized calcium values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK...

Page 213: ...pment in hospital laboratories The blood was analyzed on the OPTI CCA after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 8732 0 064 0 8392 0 07 0 68 1 34 103 Analyzer B whole blood 0 9548 0 024 0...

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Page 215: ...nt Principle The Cl ion optodes are closely related to the more familiar Ion Selective Electrodes ISEs The optodes use ion selective recognition elements ionophores similar to those used in ISEs however the ionophores are linked to fluorescent dyes instead of electrodes These types of dyes have been used since the 1970 s to visualize and quantify cellular ion levels in fluorescence microscopy and ...

Page 216: ... mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 1 76 8 0 12 0 2 0 51 0 7 0 53 0 7 Level 2 100 2 0 10 0 1 0 74 0 7 0 75 0 8 Level 3 116 8 0 11 0 1 0 45 0 4 0 47 0 4 Serum 97 6 0 06 0 1 1 03 1 1 1 03 1 1 Reduced Bovine Hemoglobin 79 2 0 07 0 1 0 78 1 0 0 80 1 0 Solution All specific performance characteristics tests were run with default instrument calibratio...

Page 217: ...lyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9965 0 95 0 9246 1 96 92 117 173 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co ...

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Page 219: ...or both It is a common condition which is diagnosed according to strict criteria that rely upon measurement of the blood glucose level Nondiabetic causes of hyperglycaemia include postprandial occurs immediately after a carbohydrate containing meal factitious blood taken from an arm where glucose is being infused drugs produce a tissue insensitivity to insulin non pancreatic endocrine disease exce...

Page 220: ...be proportional to the rate at which the oxygen is consumed Measurement Range Range Resolution Low High Units 30 to 400 0 1 mg dL 70 to 400 mg dL for samples with PO2 levels between 401 700 mmHg 1 7 to 22 0 01 mmol L Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 40 0 4 110 0 4 300 0 4 mg dL 2 2 0 22 6 1 0 22 16 65 0 22 mmol L Interferences The OPTI CCA TS Glu sensor does exhib...

Page 221: ...mance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity2 Wherever possible linearity for the OPTI CCA...

Page 222: ...zer A whole blood mg dL 1 0081 5 16 0 9735 11 81 27 328 106 mmol L 1 0081 0 29 0 9735 0 66 1 5 18 2 106 Analyzer B plasma mg dL 0 9986 2 34 0 9933 8 5 49 398 167 mmol L 0 9986 0 13 0 9866 0 47 2 4 22 1 167 OPTI CCA mg dL 1 058 2 36 0 97 21 6 37 395 103 whole blood vs plasma mmol L 1 058 0 13 0 97 1 20 2 1 21 9 103 Analyzer C serum 0 950 5 73 0 9784 10 51 78 294 68 Analyzer D serum 0 991 3 99 0 977...

Page 223: ... associated with a low glomerular filtration rate GFR This can be due to a number of reasons which can be classified as pre renal uraemia due to dehydration renal uraemia due to intrinsic failure in the kidney or postrenal uraemia due to an obstruction to urine outflow Causes of low blood urea levels 2 1 mmol L urea 6 mg dL BUN These are less common than high levels and can be due to decreased pro...

Page 224: ... aqueous control solution Urea mmol L 21 6 0 02 0 1 0 15 0 7 0 15 0 7 OPTI CHECK PLUS Level 2 BUN mg dL 20 3 0 02 0 1 0 12 0 6 0 12 0 6 aqueous control solution Urea mmol L 7 2 0 01 0 1 0 04 0 6 0 04 0 6 OPTI CHECK PLUS Level 3 BUN mg dL 4 4 0 01 0 2 0 10 2 2 0 10 2 2 aqueous control solution Urea mmol L 1 57 0 003 0 2 0 035 2 2 0 035 2 2 Serum BUN mg dL 11 2 0 01 0 1 0 1 0 8 0 1 0 8 Urea mmol L 4...

Page 225: ...tive Method Slope Intercept Coefficient Sy x Range n Analyzer A serum 0 940 2 97 0 9975 1 046 8 89 68 Analyzer B serum 1 058 3 04 0 9988 1 12 4 106 102 Analyzer C plasma 0 993 0 44 0 9953 1 00 6 65 47 Analyzer D plasma 0 971 0 27 0 9822 0 98 5 42 50 Analyzer E whole blood mg dL 1 069 0 62 0 9928 1 04 3 1 48 113 For more information on specific analyzers used please contact OPTI Medical Technical S...

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Page 227: ...ia include Anemic Hypoxia Hypoxia due to lowered oxygen carrying capacity of the blood this may be either from a decrease in total hemoglobin or a change in components of the hemoglobin Stagnant Hypoxia A type seen when not enough oxygen is transported by the blood because blood flow is reduced such as with heart failure Histotoxic Hypoxia Hypoxia that is due to impaired use of oxygen by tissues H...

Page 228: ...t interference from tHb in the range 5 g dL to 20 g dL For samples with tHb values greater than 20mg dL the Lactate value is not reported The following substances were tested following the CLSI guideline EP7 A2 Chemical Test level Concentration d max Lactate Level mM Interference Acetaminophen 1 66 mM 0 2mM 2 NO 5 NO Acetylsalicylic acid 3 33 mM 0 2mM 2 NO 5 NO Ascorbic acid 0 23 mM 0 2mM 2 NO 5 N...

Page 229: ...om 2 runs per day with 2 replicates per run over a period of 20 days following the CLSI guideline EP5 A2 Typical results for three different lots of B Lac cassettes are shown below Lactate values in mmol L Material mean Lot 1 Lot 2 Lot 3 OPTI CHECK aqueous control solution Swr ST Swr ST Swr ST Level 1 0 89 0 12 0 14 0 09 0 1 0 06 0 09 Level 2 2 39 0 17 0 19 0 16 0 18 0 09 0 13 Level 3 4 20 0 28 0 ...

Page 230: ...to Other Methods2 OPTI CCA TS vs other Lactate Instruments on whole blood in a typical setting Lactate analysis of heparinized whole blood samples was performed at multiple clinical sites Samples were analyzed on the OPTI CCA TS in parallel with laboratory instrumentation operated by hospital personnel and controlled following the hospital s established procedures Correlation Comparative Method Sl...

Page 231: ...onary disease and congestive heart failure ctHb gives valuable information in an emergency situation if interpreted not in an isolated fashion but in conjunction with other pertinent laboratory data ctHb is used to screen for disease associated with anemia to determine the severity of anemia to follow the response to treatment for anemia and to evaluate polycythemia Hemoglobin Oxygen Saturation SO...

Page 232: ...te forms of adult and fetal hemoglobin absorb similarly within the 750 850 nm wavelength range The red wavelength is utilized for the SO2 measurement because it is much more strongly absorbed by deoxyhemoglobin than all other hemoglobins and it is picked close to the isosbestic point for oxy and carboxyhemoglobin Sensitivity to erythrocyte aggregation rouleaux formation is minimized by maintaining...

Page 233: ...2 0 13 0 2 OPTI CHECK PLUS Level 2 ctHb 14 2 0 02 0 1 0 07 0 5 0 08 0 5 aqueous control solution SO2 86 8 0 03 0 1 0 11 0 1 0 11 0 1 OPTI CHECK PLUS Level 3 ctHb 8 84 0 009 0 1 0 05 0 5 0 05 0 6 aqueous control solution SO2 95 4 0 02 0 1 0 14 0 1 0 14 0 2 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality contr...

Page 234: ... 0 14 0 9715 0 37 6 9 14 8 173 SO2 0 7972 18 81 0 9064 1 81 64 100 173 Analyzer C whole blood ctHb 1 077 0 020 0 284 0 227 0 9650 0 739 5 4 17 4 215 SO2 1 021 0 016 2 920 1 522 0 9752 1 470 62 100 215 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 19...

Page 235: ...d copy of the instrument Setup This report is located in the Data Manager menu Warning All instrument settings patient data and QC data will be deleted from the system during the update if your data needs to be exported please do so prior to performing the update 2 Turn the analyzer OFF 3 Locate the CF card slot on the back of the instrument 4 Insert the CF card with the label facing up and the ar...

Page 236: ...te the ejector button located in the CF card slot b Press the ejector button using a pen or other similar object c Remove the CF card after it is ejected from the slot 9 Turn the instrument power ON 10 Installation is now complete SW 2 Operator s Manual OPTI CCA TS SOFTWARE UPGRADES ...

Page 237: ...t 1 800 490 6784 option 1 or technicalsupport optimedical com if you have questions regarding any technical bulletins Outside the USA Please contact your Authorized OPTI Medical distributor Please Insert Technical Bulletin in this section TECHNICAL BULLETIN Operator s Manual OPTI CCA TS TB 1 ...

Page 238: ...rvoltage Category A 6 Dimensions and Weight A 7 Classifications A 7 Calculated Parameters A 7 Temperature A 7 Units Used in Measured and Input Parameters for Calculations A 8 Conversion Table for Units A 8 APPENDIX B MENU STRUCTURE B 1 APPENDIX C MAINTENANCE LOG C 1 APPENDIX D REPORT FORMATS D 1 Basic Patient Report D 1 SRC Measurement Report D 2 SRC Statistics Report D 3 Controls Measurement Repo...

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Page 240: ...0 01 mmol L Ca 0 2 to 3 0 0 01 mmol L Cl 50 to 160 1 0 1 mmol L Glu 30 to 400 0 1 mg dL 70 to 400 for samples with PO2 levels between 401 700 mmHg Glu 1 7 to 22 0 01 mmol L BUN 2 8 to 112 0 1 mg dL Urea 1 to 40 0 01 mmol L Lac 0 3 to 17 5 0 01 mmol L tHb 5 to 25 0 1 g dL SO2 60 to 100 1 0 1 Barometric Pressure 300 to 800 mmHg Operating Altitude Up to 3048m 10 000ft Pollution Degree Degree 2 normal...

Page 241: ...nce Input Values Patient ID 15 alphanumeric characters Operator ID 11 alphanumeric characters Accession Number 12 alphanumeric characters Patient Temperature 14 44 C 58 111 F Patient Sex male female or Date of birth MMM DD YYYY Hemoglobin Type adult or fetal Puncture Site LR RR LB RB LF RF Cord Scalp where LR Left Radial RR Right Radial LB Left Brachial RB Right Brachial LF Left Femoral RF Right F...

Page 242: ...sure Control Ventilation CMV AC Controlled Mechanical Ventilation Assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive Airway Pressure PRVC Pressure Regulated Volume Control Tidal Volume TVol VT 0 4000 Minute Volume MVOL VE 0 120 Peak Inspiratory Pressure PIP 0 140 Plateau Pressure Pplat 0 100 Pressure Support Value PS 0 99 9 Positive...

Page 243: ...rd bicarbonate st HCO3 1 0 200 0 mmol L Standard pH st pH 6 500 8 000 Oxygen saturation SO2 0 0 100 0 Oxygen content O2 ct 0 0 56 0 mL dL Hematocrit Hct c 15 75 Hydrogen ion concentration cH 10 0 1000 0 nmol L Alveolar arterial oxygen partial pressure 0 0 800 0 mmHg difference AaDO2 Anion Gap AG 3 30 mmol L P50 15 0 35 0 mmHg nCa 0 1 3 0 mmol L Temperature Corrected Values Parameter Range Display ...

Page 244: ...n SO2 c 95 0 to 98 0 Henry2 page 1453 Oxygen content O2 ct vol 15 0 to 23 0 Tietz1 page 2200 Hematocrit Hct c 34 to 51 Tietz1 page 2192 Hydrogen ion concentration cH nmol L 36 to 44 Tietz1 page 2201 Alveolar arterial oxygen partial mmHg 5 to 20 Henry2 page 157 pressure difference AaDO2 Anion Gap AG mmol L 10 to 20 Tietz1 page 2178 P50 mmHg 25 to 29 Tietz1 page 1392 Normalized ionized calcium nCa m...

Page 245: ...ic Typical storage capacity is 150 patient records QC data for 1 month at 3 levels SRC data for 1 month at 3 levels RS232C Pin Configuration 1 2 6 7 5 4 9 8 3 REAR VIEW OF OPTI CCA TS Pin 1 No Connection Pin 2 RxD Pin 3 TxD Pin 4 DTR Pin 5 GND Pin 6 DSR Pin 7 No Connection Pin 8 CTS Pin 9 No Connection Mains Supply for External Power Supply 100 10 VAC to 240 10 VAC 50 60 Hz Overvoltage Category Ca...

Page 246: ... A Mode of Operation Continuous Operation Laser Classification This device is a Class 1 laser device according to IEC 60825 1 Explosion Protection This device is not designed for operation in explosive environments Calculated Parameters The calculated parameters in the OPTI CCA TS are based on the CLSI Standard C12 A when available Temperature4 32 5 9 C T F T 32 9 5 F T C T 4 Burtis AB Ashwood ER ...

Page 247: ... 1 mmol L urea 2 801 mg dL BUN Lactate 1 mmol L 9 01 mg dL 1 mg dL 0 111 mmol L Equations6 Note Depending on the instrument set up entered or default tHb value will be used if htere is not measured tHb value cH Concentration activity of hydrogen ions in plasma cH pH 10 9 nmol L 6 st pH Standard pH of the blood is defined as the pH value of a blood sample which has been equilibrated at 37 ºC with a...

Page 248: ...d CO2 and bicarbonate tCO HCO 0 0307 CO 2 3 2 P mmol L 7 BE The base excess of the blood results from a calculation to determine the titratable base of the blood which in principle is measured by titration of the blood with a strong acid or base to a pH of 7 4 with PCO2 40 mmHg at 37 ºC 3 HCO 24 8 7 4 pH 7 7 tHb 43 1 tHb 0 014 1 BE mmol L 7 BEecf The base excess of extracellular fluid is a quantit...

Page 249: ...H PCO2 temperature and 2 3 diphosphoglycerate 2 3 DPG content Although it is possible to calculate this value the assumptions which are made in the calculation can cause significant errors in the resulting value for those patients who are in the most critical clinical state The OPTI CCA TS has the capability to provide a measured SO2 from the blood sample It is recommended that this measured value...

Page 250: ...2 is not available ctO2 is calculated with PO2 90 mmHg P50 The oxygen partial pressure at half saturation P50 is defined as the PO2 value for a given blood sample at which 50 of the hemoglobin is saturated with oxygen While the actual P50 value can only be determined by interpolation after measurement of oxygen saturation of a blood specimen tonometered to levels of oxygen to provide an oxyhemoglo...

Page 251: ...al 47 FIO2 PACO2 FIO2 1 FIO2 R mmHg 7 PACO2 PaCO2 alveolar PCO2 Apply above equation for PAO2 PO2 otherwise PAO2 PO2 pHt pH corrected to patient temperature other than 37 ºC 37 t 4 7 pH 0065 0 0147 0 pH pHt pH unit 7 cH t Concentration of hydrogen ions corrected to patient temperature other than 37 ºC cHt pHt 10 9 nmol L 6 PCO2 t PCO2 value corrected to patient temperature other than 37 ºC P P CO ...

Page 252: ...t c tHb g dl MCHC 100 10 Where MCHC is the Mean Cell Hemoglobin Concentration representing the average concentration by weight of hemoglobin inside the average red cell Default value of MCHC 33 3 input range 29 0 to 37 0 AG The anion gap is a calculated parameter used to express the difference in concentrations of major cations and anions in the blood specimen AG Na K Cl HCO3 mmol L nCa The ionize...

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Page 254: ...Operator s Manual OPTI CCA TS B 1 APPENDIX B MENU STRUCTURE APPENDIX B MENU STRUCTURE ...

Page 255: ......

Page 256: ...ial Date Initial Clean Sample Measurement Chamber QUARTERLY Date Initial Date Initial Date Initial Date Initial Perform tHb Calibration ANNUALLY Date Initial Date Initial Date Initial Date Initial Replace peristaltic pump cartridge AS NEEDED Date Initial Date Initial Date Initial Date Initial Clean analyzer surfaces Change gas bottle Change printer paper APPENDIX C MAINTENANCE LOG ...

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Page 258: ...Hg I E 1 1 0 BE 3 7 mmol L BiLevel 0 0 0 0 tCO2 23 0 mmol L PuncSite LR HCO3 21 0 mmol L Bypass On Pump ELECTROLYTES Na 140 2 mmol L Barometer 739 6 mmHg K 3 67 mmol L Operator ID 123456789012 S N 123456 LOT 123456 HEMOGLOBIN OXYGEN STATUS tHb 14 4 g dL Ref Lim SO2 95 7 pH 7 20 7 60 Hct c 43 2 PCO2 30 50 mmHg PO2 70 700 mmHg METABOLITES Na 135 145 mmol L Glu 62 1 mg dL K 3 5 5 1 mmol L Cl 95 115 m...

Page 259: ...CA TS SRC Measurement DD MMM YY HH MM Level 3 SRC ID XXXXX Exp MMMYY RESULT LIMITS OK pH 7 601 7 580 7 620 OK PCO2 20 0 18 0 22 0 OK PO2 170 0 167 0 173 0 OK Na 165 1 142 148 OK K 7 00 6 70 7 30 OK Ca 0 70 0 60 0 80 OK tHb 8 5 6 5 9 5 OK SO2 98 6 96 0 100 0 OK SRC Test Result PASS Operator ID 123456789012 S N 123456 ...

Page 260: ... 2 58 6 OK 12Aug 7 07 67 8 58 8 OK 13Aug 7 08 67 3 57 3 OK 14Aug 7 09 67 4 57 4 OK 15Aug 7 11 71 5 56 8 OK 16Aug 7 09 68 0 56 3 OK 17Aug 7 08 68 0 57 1 OK 19Aug 7 10 68 0 56 2 OK 20Aug 7 11 68 1 55 4 OK 21Aug 7 12 68 8 55 6 OK 22Aug 7 13 69 3 55 5 OK 23Aug 7 12 70 1 54 5 OK 24Aug 7 11 70 2 54 5 OK 25Aug 7 10 70 5 53 7 OK 26Aug 7 10 71 5 53 7 OK 27Aug 7 11 68 0 54 1 OK 28Aug 7 11 71 8 54 2 OK 29Aug...

Page 261: ...M YY HH MM Level 2 OPTI check Sample No 2345 QCLot 1234 Exp MMMYYYY RESULT LIMITS OK pH 7 551 7 48 7 56 OK PCO2 69 8 65 75 OK PO2 99 8 96 105 OK Na 144 2 142 148 OK K 4 46 4 0 4 8 OK Ca 1 10 1 0 1 2 OK tHb 14 7 14 0 15 3 OK SO2 98 3 96 99 OK Control Test Result PASS Store to Database YES Barometer 744 5 mmHg Operator ID 12345678901 S N 1234 Lot 123456 ...

Page 262: ...ug 7 101 70 3 75 2 OK 12Aug 7 123 67 8 68 0 OK 13Aug 7 101 69 7 66 8 OK 14Aug 7 076 67 9 75 9 OK 15Aug 7 080 73 7 78 5 OK 16Aug 7 093 72 5 66 3 OK 17Aug 7 099 71 5 69 0 OK 18Aug 7 105 73 5 68 1 OK 19Aug 7 119 76 7 70 7 OK 20Aug 7 104 69 3 77 6 OK 21Aug 7 098 67 0 65 9 OK 22Aug 7 079 66 9 77 0 OK 23Aug 7 084 70 5 62 9 OK 24Aug 7 123 70 2 77 7 OK 25Aug 7 078 73 9 68 9 OK 26Aug 7 129 71 9 67 0 OK 27A...

Page 263: ... 0 mmHg PO2 62 0 86 0 mmHg Na 121 0 131 0 mmol L K 2 60 3 40 mmol L Cl 84 0 94 0 mmol L Ca 1 44 1 74 mmol L Glu 30 0 400 0 mg dL BUN 2 8 112 0 mg dL Lac 0 70 1 10 mmol L tHb 18 2 22 2 g dL SO2 76 0 82 0 QCLot 9169 Exp Mar2012 Lev 2 LimMin LimMax pH 7 360 7 480 PCO2 37 0 45 0 mmHg PO2 90 0 114 0 mmHg Na 137 0 151 0 mmol L K 4 40 5 20 mmol L Cl 102 0 112 0 mmol L Ca 1 14 1 34 mmol L Glu 30 0 400 0 m...

Page 264: ... Hct c E Glu BE tCO2 HCO3 st HCO3 Hct c E BUN BE tCO2 HCO3 st HCO3 Hct c FSET Values System Version 3 00 0037 GUI App 3 00 0037 CCA App 3 00 0037 GUI Boot 3 00 0000 CCA Boot 3 00 0001 IDAC1 1464 IDAC2 2024 IDAC3 708 S N XXXX pH False 583 O2 False 2116 CO2 False 663 Ca False 1855 K False 9151 Na False 2335 Low Limit 278 Up Limit 1985 Low offset 500 000 Up factor 0 800 Home offset 240 PHR Correction...

Page 265: ...anual OPTI CCA TS APPENDIX D REPORT FORMATS Maintenance Report OPTI Medical OPTI CCA TS MAINTENANCE REPORT DD MMM YY HH MM S N XXXX Version ABCX XX DDMMMYY HH MM Pump Replaced DOM0213D DDMMMYY HH MM Cleaning Completed ...

Page 266: ...ror Report OPTI Medical OPTI CCA TS ERROR Report DD MMM YY HH MM S N XXXX Version ABCX XX DDMMMYY HH MM ERROR Cassette Misseat 1 DDMMMYY HH MM ERROR Cassette Misseat 2 DDMMMYY HH MM ERROR Gas Expired DDMMMYY HH MM Warning Bubble Detected DDMMMYY HH MM Stop Low Gas ...

Page 267: ...l OPTI CCA TS Lactate Setup Report DD MMM YY HH MM Level 2 OPTI check QCLot XXXX Exp MMMYY pH setup point Run pre post 1 7 4232 7 4336 2 7 4250 7 4354 3 7 4037 7 4142 4 7 4251 7 4356 5 7 4208 7 4313 AVG pH 7 4196 7 4300 SD 0 00805 Outliers 0 Scalar 1 011741 Scalar Setup PASS S N 2999 LOT 020651 ...

Page 268: ...e BUN 1 Measurement range BUN 1 Reference intervals BUN 2 References BUN 3 Reproducibility BUN 2 SRC Limit Values BUN 2 C Calcium See Ionized Calcium Calculated parameters 3 10 A 7 Calculated values 8 9 A 4 Calibration 4 1 8 9 gas bottle 8 15 report setup 3 24 tHb troubleshooting 7 33 touch screen 7 23 Capillary tubes 8 3 attach sample 5 7 sample collection 5 2 5 10 8 3 Carbon dioxide partial pres...

Page 269: ...urement range Ca 1 normalized A 13 reference intervals Ca 2 reference ranges A 5 references Ca 3 reproducibility Ca 2 unit conversion A 8 L Lactate B Lac Cassette Clinical significance Lac 1 Correlation to Other Methods Lac 4 Interferences Lac 2 Linearity Lac 3 Measurement principle Lac 1 Measurement range Lac 1 Reference intervals Lac 2 References Lac 4 Reproducibility Lac 3 SRC Limit Values Lac ...

Page 270: ...e K 1 measurement range K 1 reference intervals K 2 references K 3 reproducibility K 2 SRC limit values K 1 Principles of operation 1 1 Principles of procedure 8 1 Printer description 1 5 test 7 18 Printer paper changing 6 11 installing 2 4 Proficiency testing 4 2 Pump flow checking 7 21 Pump motor test 7 22 Q QC lockouts 3 16 3 17 overview 4 1 recommendations 4 3 results 4 13 setup 4 4 QC Sample ...

Page 271: ...entration ctHb clinical significance THB SO2 1 Correlation to Other Methods THB SO2 4 Interferences THB SO2 2 Linearity THB SO2 3 measurement principle THB SO2 2 measurement range THB SO2 2 reference intervals THB SO2 2 References THB SO2 4 Reproducibility THB SO2 3 SRC Limit Values THB SO2 2 Touch screen description 1 4 test 7 23 Troubleshooting 7 1 bar code scanner 7 34 procedure for tHb SO2 7 3...

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