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 1-2

 

Operator’s Manual – OPTI CCA-TS2

1 INTRODUCTION

When calibration is verified, the analyzer aspirates the blood sample into the cassette and across 

the optode sensors. Fluorescence emission is then measured after equilibrating with the blood 

sample. After a single measurement, the cassette, containing the blood sample, is removed from 

the analyzer and discarded. The analyzer contains no reagents, blood or waste.

1.3   Contents

Before you begin installing your OPTI CCA-TS2 Analyzer, take a moment to look over the 

contents to ensure you have the following:

• 

Power supply with power cord

• 

Battery

• 

1 Multi-level Standard Reference Cassette (SRC) (Levels 1, 2 and 3)

• 

Thermal printer paper

• 

tHB calibration cassette 

 

You will also need the following consumables prior to setup:

• 

OPTI sensor cassettes

• 

Gas bottle

• 

Quality Control Material - OPTI CHECK or OPTI CHECK PLUS (with glucose or BUN 

cassettes)

 

Summary of Contents for CCA-TS2

Page 1: ...OPTI CCA TS2 Analyzer Operator s Manual ...

Page 2: ... or industrial property rights covering this document or subject matter in this document The furnishing of this document does not give a license to these property rights except as expressly provided in any written license agreement from OPTI Medical Systems 2013 OPTI Medical Systems Inc All rights reserved OPTI the OPTI Medical logo and ComfortSampler are trademarks or registered trademarks of OPT...

Page 3: ...es 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 influences beyond the manufacturer s control Therefore the test results from this instrument must be carefully examined by an expert before f...

Page 4: ...or short circuit the fuse holders This device is a Class 1 Laser product according to the requirements of IEC 60825 1 The LEDs have been certified as an EXEMPT RISK GROUP in compliance with IEC 62471 The maximum energy output is as follows 670 nm LED 40 Microwatts max for 400ms 780 nm Laser 40 Microwatts max for 400ms 850 nm Laser 40 Microwatts max for 400ms Caution Use of controls or adjustments ...

Page 5: ...y which is not designed for use with the equipment j Do not mix cells of different manufacture capacity size or type within a device k Keep cells and batteries out of reach of children l Seek medical advice immediately if a cell or a battery has been swallowed m Always purchase the correct cell or battery for the equipment n Keep cells and batteries clean and dry o Wipe the cell or battery termina...

Page 6: ... 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 7: ...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 8: ...ratory 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 reading Chapters 1 and 2 F...

Page 9: ...p 3 2 3 2 1 QC Setup 3 3 3 2 1 1 Setting up the Quality Control Material 3 3 3 2 1 2 Selecting QC Lockout 3 5 3 2 2 Customizing Patient Information 3 8 3 2 2 1 Setting up Patient Information 3 8 3 2 2 2 Suppressing Results for Measured Parameters 3 11 3 2 2 3 Setting up Calculated Parameters 3 12 3 2 2 4 Setting up Limits for Measurement Parameters 3 13 3 2 2 5 Setting up Limits for Calculated Par...

Page 10: ...QC Sample 4 8 4 5 2 1 Running Controls OPTI CHECK OPTI CHECK PLUS 4 8 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 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 Conditio...

Page 11: ...n 7 2 7 4 Annual Maintenance 7 6 7 4 1 Replacing Peri Pump Cartridge 7 6 7 4 2 Replacing Gas I O Port 7 8 7 5 As Needed Maintenance 7 9 7 5 1 Changing the Gas Bottle 7 9 7 5 2 Changing the Printer Paper 7 11 7 5 3 Performing Routine Cleaning 7 11 8 DIAGNOSTICS AND TROUBLESHOOTING 8 1 8 1 System Error and Warning Messages 8 1 8 1 1 System Warning Messages 8 2 8 1 2 System Error Messages 8 6 8 1 3 S...

Page 12: ...oubleshooting Procedure for tHb SO2 8 34 8 3 2 Troubleshooting Procedure for Bar Code Scanner 8 35 9 OPERATING PRINCIPLES 9 1 9 1 Intended Use 9 1 9 2 Principles of Procedure 9 1 9 3 Operation 9 2 9 4 Specimen Collection and Handling 9 3 9 4 1 Safety 9 3 9 4 2 Sample Requirements 9 3 9 4 3 Anticoagulants and Sample Collection Devices 9 3 9 4 4 Syringes 9 3 9 4 5 Capillary Tubes 9 3 9 4 6 OPTI Medi...

Page 13: ...ical Assistance 10 3 10 9 Warranty Registration U S Market Only 10 4 ANALYTES 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 Hemo...

Page 14: ...ly for Instrument A 6 Overvoltage Category A 6 Dimensions and Weight A 6 Classifications A 7 Calculated Parameters A 7 Temperature A 7 Units Used in Measured and Input Parameters for Calculations A 7 Conversion Table for Units A 8 Equations 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 Statisti...

Page 15: ...Operator s Manual OPTI CCA TS2 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 8 ...

Page 16: ...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 17: ...analyzer and discarded The analyzer contains no reagents blood or waste 1 3 Contents Before you begin installing your OPTI CCA TS2 Analyzer take a moment to look over the contents to ensure you have the following Power supply with power cord Battery 1 Multi level Standard Reference Cassette SRC Levels 1 2 and 3 Thermal printer paper tHB calibration cassette You will also need the following consuma...

Page 18: ...alyzer it is important to familiarize yourself with the analyzer s components On Off Button Gas Bottle Bar Code Scanner Printer Status Light SMC Latch Touch Screen Display Printer Release Button Fig 1 1 OPTI CCA TS2 Major Components Battery Sample Measurement Chamber SMC Stylus Power Connector Handle Tilt Stand ...

Page 19: ...easurement and waiting for user action Blinking Green Light System is in process of calibration or measurement Do not open the cover Red Light A red status light indicates an error that will terminate the process 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 Cas...

Page 20: ... 1 6 The printer uses heat sensitive paper to 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 peristaltic pump cartridge is...

Page 21: ...ompartment that can hold an extra paper roll the SRC other supplies or accessories Fig 1 9 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 TS2 without having to plug the unit into an electrical outlet The battery is charged automatically whenever the analyzer s external po...

Page 22: ...o be used as a tilt stand to place the instrument at a convenient viewing angle for the user To extend the handle to carrying position place the analyzer on its back and position your fingers in the cutouts on each side of the handle Push up until the handle is fully extended Fig 1 12 To use the handle as a tilt stand pull down the handle Fig 1 13 and lock it in the lower position Fig 1 14 Turn an...

Page 23: ...ncludes a removable syringe adapter for sampling with a syringe For sampling with a capillary simply remove the adapter Fig 1 17 NOTE The syringe adapter may be removed while the cassette is inside the SMC NOTE DO NOT INJECT the sample It will be aspirated automatically The Standard Reference Cassette SRC Fig 1 18 is a reusable sensor cassette used for daily quality control testing The multi level...

Page 24: ...CCA TS2 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 20 The TS2 will only work with gas bottles with a red base BP7162 Congratulations You have just learned the basic components of the analyzer and are now ready to install your system Gas Bottle Fig 1 20 Gas Bottle ...

Page 25: ...Operator s Manual OPTI CCA TS2 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 TS2 Analyzer 2 2 ...

Page 26: ...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 30º C 50 86 F Maximum relative humidity of 95 non condensing ...

Page 27: ...ctrical power spikes OPTI Medical recommends 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 TS2 Fig 2 2 NOTE The battery will need to be charged for at least 2 5 hours prior to using the OPTI CCA TS2 on battery power It will be charged automatically whenever the analyzer s external power supply is ...

Page 28: ...e bar code scanner located 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 If the bar code is not recognized by the scanner the first time try scanning the barcode again Record the date of installation on the gas bottle for later reference NOTE If the insert sheet is misplac...

Page 29: ...lay appears Fig 2 9 press 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 New Gas Bottle prompt The next screen will prompt you to enter the number of weeks in service using the numeric keypad See section 7 5 3 Here you may refer back to the installation date which was recorded on the gas bottle The OPT...

Page 30: ...er Fig 2 11 Place the roll of printer paper into the paper tray Pull the end of the paper upward and slightly out of the paper tray Fig 2 12 Hold the paper and close the printer cover Fig 2 13 The paper will automatically feed through as the printer starts printing Fig 2 11 Open Printer Cover Fig 2 12 Install Printer Paper Fig 2 13 Close Printer Cover ...

Page 31: ... of the analyzer Fig 2 14 NOTE A tHb calibration can also be run from the QC menu by pressing QC Manager QC tHb Calibrator instead of scanning the barcode in the Ready screen 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 If Non Secure User ID Entry is enabled in the security settings see Section 3 2 3 you will be ...

Page 32: ...oth Fig 2 17 Press Open the SMC cover by pressing down on the red latch Fig 2 18 Gently wipe both sides 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 Fig 2 18 Open Cover Fig 2 19 Wipe and Insert Cassette Fig 2 17 Clean Optics ...

Page 33: ...nd begin calibration Fig 2 21 After the calibration is complete you will be prompted to open the sample chamber cover and remove the cassette Fig 2 22 Place the calibrator cassette back into its pouch immediately after removal from the instrument NOTE Make sure to keep the calibrator cassette with the instrument at all times Fig 2 22 Remove Calibrator Fig 2 21 tHb Calibration Fig 2 20 Close Cover ...

Page 34: ...howing calibration results and calibration factors Fig 2 23 Once the Hb Calibration is complete the Ready display will appear Fig 2 24 and the analyzer is ready for operation OPTI Medical recommends that you run controls prior to running patient samples on a new analyzer You must set up your OPTI Check control lot information in your new analyzer prior to running them SRCs do not require setup and...

Page 35: ...a Manager This menu allows you to print out patient control and diagnostic information It also provides you with the ability to import export data For more information on printing and importing exporting data see Chapter 6 Data Management QC Manager This menu allows you to perform control measurements For more information see Chapter 4 Calibration and Quality Control System Manager This menu conta...

Page 36: ...ters 3 15 3 2 2 6 Setting up Test Panels 3 17 3 2 2 7 Setting up Correlation Factors 3 19 3 2 3 Setting up Security 3 20 3 2 3 1 Selecting Security Settings 3 20 3 2 3 1 1Security Settings 3 21 3 2 3 1 2Setting up User IDs 3 22 3 2 3 1 3Setting up User Groups 3 24 3 2 3 2 Setting up a Password 3 26 3 2 3 3 System Reinitialization 3 27 3 2 4 Miscellaneous System Settings 3 28 3 2 4 1 Setting the Pr...

Page 37: ...rity the OPTI CCA TS2 customization can be protected by configuring security to allow only authorized users to make changes see security section 3 2 3 All system setup selections entered will reside in the instrument memory even after the system power is turned off 3 1 Setting Time and Date 1 To set the time and date press System Manager in the main menu Fig 3 1 2 Press Time and Date in the System...

Page 38: ...pt the changes 7 To log off after making the changes press the Log Off button in the bottom right corner of the screen 8 Press to return to the System screen or to return to the main menu 3 2 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 The Setup menu consists of three screens ...

Page 39: ... for programming QC ranges as described below is identical for all levels NOTE The OPTI CCA TS2 can save information for one lot of OPTI CHECK and one lot of OPTI CHECK PLUS concurrently for each level 1 In the main menu select System Manager and Setup 2 Enter security information if enabled see Section 3 2 3 1 3 On the Patient QC tab select Control Fig 3 6 4 Take the bar code sheet out of the OPT...

Page 40: ...code is unavailable press the button and enter the numbers using the keypad 9 Press Ranges 2 to go to the next display to enter the ranges for all other measured parameters available with this control material Fig 3 10 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 mul...

Page 41: ...d New Lot Option 1 SRC Lockout Enable Fig 3 12 When this option is enabled SRC measurements must be performed at specified intervals for patient measurements to be allowed 1 To specify the number of SRC measurements to be performed make sure Lockout By Level Enable is not selected and select 1 2 or 3 in the By Number option 2 To specify the levels to run select Lockout By Level Enable and the leve...

Page 42: ... during which QC measurements must be run Options are 8 12 24 hours 7 days and 1 month 4 By default the analyzer is set to run 3 levels of external controls at 1 month intervals 5 To disable QC lockouts deselect QC Lockout Enable 6 Press to accept the changes NOTE The selected time interval starts with the time this feature is activated NOTE More than one option can be selected For instance labora...

Page 43: ... QC measurements to be performed make sure Lockout By Level Enable is not selected and select 1 2 or 3 in the By Number option 2 To specify the levels to run select Lockout By Level Enable and the levels to run in the By Level option 3 By default this option is set to run 3 levels of QC with each new lot 4 To disable New Lot lockouts deselect New Lot Lockout Enable 5 Press to accept the changes 6 ...

Page 44: ...alf shows the selected options 1 To add patient entry options to your list select the desired option in the Available Functions field in the top half of the screen Fig 3 16 Press the blue Down arrow to move this option to your list in the Selected Functions field on the bottom 2 To remove options from your list press the Up arrow 3 Press Required Fig 3 17 to make a patient entry option a required ...

Page 45: ...MM Sample Type Art Ven MixVen Cap Cord CPB where Art Arterial Ven Venous MixVen Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass 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 Femoral Cord Cord Scalp Scalp Allen s Test unknown positive or negative tHb Type adult or fetal default is adult By...

Page 46: ...0 mL PS default value 0 PEEP default value 0 Rate f default value 0 bpm CPAP default value 0 tHb default value 15 0 g dL FIO2 default value 0 21 MCHC default value 33 3 RQ default value 0 84 P50 default value 26 7 mmHg Bilevel Pressure default value 0 00 0 00 I E Ratio default value 0 Comment field 50 alphanumeric characters 5 The options will be shown in the patient entry form during a patient me...

Page 47: ...ress results for all patient and control measurements for all cassette styles deselect the specific parameters in the parameter list By default all parameters are activated Press to save your selection The Settings screen contains the following options Fig 3 22 Last Barcode Enable enables the Last Entry button on the main screen so that the previous barcode scanned can be used for the current pati...

Page 48: ... inclusion in or exclusion from the printout NOTE The display will always let you view all available calculated parameters 1 In the main menu select System Manager and Setup 2 On the Patient QC tab press Calculated Parameters Fig 3 23 3 Select the cassette type Fig 3 24 4 Select the parameters to be printed 5 Press to accept the changes 6 Press to return to the Setup screen or to return to the mai...

Page 49: ...cked against the limit values programmed here and flagged accordingly 1 In the main menu select System Manager and Setup 2 On the Patient QC tab press Measurement Limits Fig 3 25 3 On the Reference tab Fig 3 26 select the parameter you want to change and press to enter the new limit value By default reference ranges are enabled 4 Press to access pages 2 and 3 with the remaining parameters Fig 3 27...

Page 50: ...ning parameters Fig 3 29 and Fig 3 30 9 Press to accept the new limit values The instrument is preset to the measurement ranges of the OPTI CCA TS2 pH 6 600 7 800 PCO2 10 0 200 0 mmHg PO2 10 0 700 0 mmHg Na 100 0 180 0 mmol L K 0 80 9 99 mmol L Cl 50 0 160 0 mmol L Ca 0 20 3 00 mmol L Glu 30 0 400 0 mg dL Glu 1 7 22 0 mmol L BUN 2 8 112 0 mg dL Urea 1 0 40 0 mmol L Lac 0 30 17 50 mmol L tHb 5 0 25...

Page 51: ...alues programmed here and flagged accordingly 1 In the main menu select System Manager and Setup Press Calculated Limits on the Patient QC tab Fig 3 31 2 On the Reference tab Fig 3 32 select the parameter you want to change and press to enter the new limit value By default reference ranges are enabled 3 Press to access Pages 2 3 and 4 with the remaining parameters Fig 3 33 4 Press to accept the ne...

Page 52: ...6 and press to accept the new values The instrument is preset to the measurement ranges of the TS2 HCO3 1 0 200 0 mmol L BE 40 0 40 0 mmol L BEecf 40 0 40 0 mmol L BEact 40 0 40 0 mmol L BB 0 0 100 0 mmol L tCO2 1 0 200 0 mmol L st HCO3 1 0 200 0 mmol L st pH 6 500 8 000 SO2 c 0 0 100 0 O2ct 0 0 56 0 mL dL Hct c 15 0 75 0 cH 10 0 1000 0 nmol L AaDO2 0 0 800 0 mmHg AnGap 3 0 30 0 mmol L P50 15 0 35...

Page 53: ...2 On the Patient QC tab press Panel Fig 3 37 3 In the Panel menu Fig 3 38 press Enable By default this option is disabled When this option is enabled a pop up screen will appear when a cassette is scanned showing available panels The cassette default is always available Only panels with parameters that are available on the cassette will be displayed E g if you set up a panel with Na K and Ca this ...

Page 54: ...ss to delete an existing panel The default panel cannot be edited or deleted 9 Use the Up and Down arrows to reorder the panels in the list 10 Use the Previous and Next buttons to display the previous or next page of panel configurations 11 Press to return to the Setup screen or to return to the main menu Fig 3 40 Panels ...

Page 55: ...e next screen Fig 3 43 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 return to the Setup screen...

Page 56: ... and return to the system default settings See section 3 2 3 3 1 To access this menu select System Manager and Setup in the main menu 2 In the System Setup screen press the Security tab Fig 3 44 3 2 3 1 Selecting Security Settings The Settings menu contains three screens Settings with various security options Users to set up User IDs Groups to set up User Groups 1 Select System Manager and Setup i...

Page 57: ...e protected by the ADMIN password such as changing the time and date and the security setup menu 3 Secure User ID Entry Fig 3 49 will enable the option to set up secure user IDs and create groups of users with certain privileges This option must be selected to enable passwords and user ID expiration When this option is enabled users will be asked to log in to the OPTI before they can perform any o...

Page 58: ...ssword in the security tab see Section 3 2 3 2 NOTE You can create another user ID with ADMIN rights if you do not wish to use ADMIN as your user ID 4 Press Fig 3 52 to enter a new user to be added to the list of authorized users The analyzer can store up to 300 user IDs Fig 3 52 Users Expiration Enable Fig 3 50 allows an administrator to set an expiration date for each user ID Logon Timeout Fig 3...

Page 59: ...reated see Section 3 2 3 1 3 The first time users log in to the OPTI they will be asked to create a password 8 To edit an existing user select the user Fig 3 54 and press to make the changes Press Reset Password Fig 3 53 to reset the user s password 9 To delete a user from the list of valid users currently stored in memory select the user and press the button 10 Press to select all entries 11 Pres...

Page 60: ...ed or deleted 2 To add a new user group press in the top section of the screen Fig 3 55 3 In the subsequent screen Fig 3 56 press and type a unique name for the user group Press 4 To assign group functions to a user group press Functions Fig 3 56 The top half of the Select Group Functions screen Fig 3 57 displays all available options the bottom half shows the selected options 5 To add group funct...

Page 61: ...ter Setup Maintenance Setup Security Setup B Lac Setup 7 To remove options from your list select the option and press the Up arrow 8 Press to accept the changes 9 To add users to this group press in the Users section in the bottom half of the screen Fig 3 59 10 To delete a user from a user group select the user and press the button 11 To edit an existing user group select the group in the Group se...

Page 62: ...s 1 In the main menu select System Manager and Setup 2 On the Security tab press Change Password Fig 3 60 NOTE This function is only active if security is enabled and the user is logged in 3 Press to enter the new password Fig 3 61 4 Retype the password and press to accept the changes CAUTION Make sure the password is kept confidential and in a safe place Passwords can not be retrieved 5 Press to ...

Page 63: ...figuration may be downloaded and then reloaded after reinitialization to restore user IDs groups and other setup options 1 In the main menu select System Manager and Setup 2 In the System Setup Security menu press Reinitialize Fig 3 62 3 Enter ADMIN user ID and password 4 A message will be displayed asking you to confirm your choice Fig 3 63 5 Press to return to the Setup screen or to return to th...

Page 64: ... menu Fig 3 65 you can select to have a patient control and SRC report printed after each measurement In the default settings these options are activated You can also select to add a calibration report and reference and critical limits to each patient report 1 Select the options to be enabled 2 Press to accept the changes 3 Press to return to the Setup screen or to return to the main menu In the H...

Page 65: ...ure temperature output resolution total hemoglobin Ca Glu BUN urea and Lac 1 In the main menu select System Manager and Setup 2 In the System Setup menu press the System tab then press Units Fig 3 68 3 In the System screen select the units for the displayed parameters Fig 3 69 4 The selection for Resolution on this menu determines the number of digits displayed and printed past the decimal point f...

Page 66: ...mmol L BUN 18 5 mg dL BUN 18 5 mg dL Lac 14 5 mmol L Lac 14 5 mmol L tHb 14 6 g dL tHb 14 6 g dL SO2 90 SO2 89 8 5 Press the Parameter tab to go to the next screen Fig 3 70 and select the units for the remaining parameters Your OPTI CCA TS2 has been factory preset to the following units Baro Partial Pressure mmHg Temperature o C Resolution High tHb g dL Electrolytes mmol L Glucose mg dL BUN mg dL ...

Page 67: ... to use for displays and printouts 1 In the main menu select System Manager and Setup 2 In the System Setup menu press the System tab and then Language Fig 3 71 3 Select the desired language Fig 3 72 4 Press to accept the changes 5 Press to return to the Setup screen or to return to the main menu Fig 3 71 Select Language Fig 3 72 Select Language ...

Page 68: ...ss to accept the changes 5 Press to return to the Setup screen or to return to the main menu CAUTION Use the absolute barometric pressure and not the altitude corrected pressure check with your local weather service or airport NOTE You may change barometric pressure units from mmHg to mbar See section 3 2 4 2 NOTE You should check the barometric pressure periodically 3 2 4 4 Hardware Settings Fig ...

Page 69: ...e audible alarm Beep 1 In the main menu select System Manager and Setup 2 In the System Setup menu press the System tab and then Hardware 3 Select Beep Enable Fig 3 75 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 the main menu Fig 3 75 Enable Beep ...

Page 70: ...the system will automatically go into Standby after a certain time of analyzer inactivity When you enable this option you can select the number of minutes before the OPTI will go into standby mode NOTE The screen will appear dark when the analyzer is in standby mode Press the touch screen to exit standby mode and resume normal operation Shutdown Enable will shut down the instrument after a certain...

Page 71: ... In the main menu select System Manager and Setup 2 In the System Setup menu press the System tab and then Comm Fig 3 77 In the System Setup Communications screen Fig 3 78 you can select the communications Protocol ASCII Serial ASCII Ethernet ASTM Serial ASTM Ethernet POCT1AEthernet Removable Media ASCII Serial Fig 3 79 Data in easy to read OPTI Medical custom format The OPTI CCA TS2 exports data ...

Page 72: ...nd all data is sent in a single message with acknowledgment Full communication is established and each record is sent separately with an acknowledgement Press to accept the changes ASTM Ethernet Fig 3 82 Complies with ASTM standard Please refer to OPTI CCA TS2 interface specifications for more information Enter IP address of the host computer and port Select ASTM Handshaking None all data is sent ...

Page 73: ...If enabled the patient list is sent from remote computer Operator List If enabled the Operator IDs are sent from remote computer Vendor Directives If enabled vendor directives are supported Press to accept the changes Removable Media Fig 3 84 Use this option to import or export data using a USB mass storage device Select Comma or Semicolon for your CSV file delimiter in MS Excel Press to accept th...

Page 74: ...n the System Setup menu press the System tab and then Ethernet Fig 3 85 3 The System Setup Ethernet menu will appear Fig 3 86 To set up Ethernet communication 1 Connect the instrument to an active network 2 In the main menu select System Manager Diagnostics Tests Ethernet 3 Verify that the test status is Connected and that the displayed instrument IP address is valid not all zeros Fig 3 87 Fig 3 8...

Page 75: ...work administrator if you are unsure of the value Gateway Enter the gateway address if IP type is set to static The gateway address is network specific Ask your network administrator if you are unsure of the value Discovery Port is used for instrument discovery Use for static and dynamic IP types The discovery port is set to 6703 by default but can be changed if needed NOTE If static IP type is se...

Page 76: ... the analyzer 1 From the Ready display select System Manager and Maintenance Fig 3 89 2 Enter User ID if enabled 3 In the Maintenance menu Fig 3 90 press Setup 4 In the Setup screen Fig 3 91 you can select Replace Pump Reminder to alert you when the peristaltic pump needs replacement 5 If you enable the option Cleaning Reminder the system will alert you when weekly or monthly cleaning is due Selec...

Page 77: ...TION AND QUALITY CONTROL 4 1 4 1 Calibration 4 1 4 2 QC Overview 4 2 4 3 Proficiency Testing 4 2 4 4 Calibration Verification 4 3 4 5 QC Recommendations 4 3 4 5 1 Running an SRC Measurement 4 4 4 5 2 Running a QC Sample 4 8 4 5 2 1 Running Controls OPTI CHECK OPTI CHECK PLUS 4 8 ...

Page 78: ...cassette style In addition an optical zero point calibration of all optical channels is performed During the calibration and measurement processes diagnostic tests are automatically performed to assure correct operation of the instrument and measurement of the cassette These tests include automatic checks of the cassette for packaging integrity temperature control fluidic control during calibratio...

Page 79: ...uidelines to assist the staff in determining if patient results are acceptable a clear set of corrective actions to be taken in out of control situations 4 3 Proficiency Testing Proficiency testing complements the above Quality Control program and has become an integral part of a complete laboratory Quality Assurance program The analysis of unknown samples demonstrates that your results are unbias...

Page 80: ...ters measured by the analyzer are consistent The OPTI will subject the SRC sensors to different levels of light to simulate low normal and high patient measurements Level 1 and level 3 represent high and low samples and are the system default settings based on the OPTI Medical QC recommendations The results obtained should fall within limits contained in the SRC barcode NOTE Hospitals should devel...

Page 81: ... measurements can also be run from the QC menu by pressing QC Manager QC SRC 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 an invalid bar code e g SRC expired NOTE If the bar code is damaged or unreadable press Manual Entry and enter the bar code digits using the keypad 2 If Non Secure User ID Entry is enabled...

Page 82: ...e desired levels Fig 4 4 and press 5 Open the sample chamber cover by pressing down on the red latch Fig 4 5 6 Examine the SRC to ensure it is clean and insert it into the chamber Press down to properly seat the SRC Fig 4 6 Fig 4 4 Select Level Fig 4 5 Open Cover Fig 4 6 Insert SRC ...

Page 83: ... Fig 4 7 After the cover has been closed the instrument begins the measurement process which is indicated on the display screen Fig 4 8 During this time about 60 seconds per level a progress bar is displayed When the measurement is complete the unit displays the results Fig 4 9 8 Press to display additional results Fig 4 10 Fig 4 9 SRC Results 1 ...

Page 84: ...ion 3 2 4 1 Additional information on printing reports can be found in Chapter 6 Data Management 10 Press Fig 4 10 to exit the results screen 11 You will then be prompted to open the sample chamber cover and remove the SRC Fig 4 11 12 Place the SRC back into its pouch immediately after removal from the instrument 13 Close the sample chamber cover If the SRC test failed gently clean the SRC the opt...

Page 85: ...e 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 measured paramete...

Page 86: ...he bar code scanner located on the bottom right hand corner of the analyzer to automatically record the lot and calibration information for the specific cassette Fig 4 15 The red line from the barcode scanner should cover the entire bar code The unit will beep and the status light will turn green to confirm a valid bar code In case of an expired cassette the light will turn red NOTE Refer to speci...

Page 87: ...moisture from the cassette with a clean dry cloth NOTE If the QC sample is to be introduced with a capillary tube remove the syringe adapter before placing the cassette into the chamber 7 Insert the cassette into the chamber Press down to ensure that the cassette is seated properly Fig 4 17 NOTE Run cassettes immediately after opening pouch Do not run if cassette has been out of pouch for more tha...

Page 88: ...ox 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 results 12 Gently tap the head of the ampoule with your fingernail to remove any liquid 13 Carefully open the ampoule by breaking off the top NOTE Protect your fingers by using gloves or tissue while breaking ...

Page 89: ...sults are acceptable and the results will be stored in the Control Database Select Reject to reject the results Rejected results will not be stored in the Control Database Select Review to view the results again NOTE 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 re...

Page 90: ...ng 5 1 5 1 1 Safety 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 ...

Page 91: ...refer 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 sam...

Page 92: ...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 93: ...ckly 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 TS2 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 TS2 The OPTI CCA TS2 ...

Page 94: ...illary 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 CAUTION 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 an...

Page 95: ... Fig 5 1 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 and error message indicates an invalid bar code e g cassette expired See Chapter 8 Troubleshooting NOTE Refer to special handling instructions inside the cassette box for refrigerated cassettes NOTE If the bar code is damaged or unreadable p...

Page 96: ... Entry is enabled in the security settings see Section 3 2 3 you will be asked to enter the user ID Fig 5 3 NOTE Bar coded user IDs may be entered from this screen using the bar code scanner If customized test panels have been set up in Setup see Section 3 2 2 6 the Select Panel screen Fig 5 4 will appear and display a list of available panels Select the desired panel and press If Allow Blanking h...

Page 97: ...duction with a capillary tube or a ComfortSampler remove the syringe adapter before placing the cassette into the chamber Gently wipe both sides of the cassette with a clean dry cloth to remove excess moisture Insert the cassette in the chamber Press down to ensure the cassette is properly seated Fig 5 7 Close the SMC cover by pressing it down firmly Fig 5 8 The green status light starts to blink ...

Page 98: ...he sample will then be automatically aspirated after calibration and the measurement will begin 8 You can enter patient information while calibration is in progress by pressing Patient Info Fig 5 10 Press the Last Patient Info button Fig 5 10 to use the last patient info as the default for the current patient information if this option is enabled in Setup see Section 3 2 2 2 This option will popul...

Page 99: ...data entry screens if configured in Setup Section 3 2 2 1 NOTE If patient data parameters have been set up as Required you will not be able to exit the Results screen until that information has been entered 12 Press when you are finished editing patient info 13 After the successful calibration the status light will stop blinking and the display will prompt you to mix and place the sample Fig 5 12 ...

Page 100: ...8 When the analysis is completed the status light stops blinking and the instrument alerts you that the measurement has been completed with a beep At this time you may continue entering or editing the patient information until you have completed it If the screen has not been touched for approximately three 3 minutes the Measurement Results will automatically be displayed Fig 5 15 NOTE The printout...

Page 101: ...ers may be configured HIGH Na 156 4 mmol L or LOW Na 156 mmol L in the setup menu See section 3 2 4 2 The OPTI CCA TS2 Analyzer indicates when values are above or below the programmed ranges with 1 UP or DOWN arrow if they are outside the reference ranges or 2 arrows if they are outside the critical ranges Values outside the reference ranges appear amber and values outside the critical ranges appe...

Page 102: ...rol Measurement Reports 6 5 6 1 5 Control Statistics Reports 6 6 6 2 Printing Diagnostics Reports 6 7 6 2 1 Patient Diagnostics Reports 6 7 6 2 2 SRC Diagnostics Reports 6 8 6 2 3 Controls Diagnostics Reports 6 9 6 2 4 Error Report 6 10 6 3 Miscellaneous Reports 6 11 6 3 1 Maintenance Report 6 11 6 4 Importing Exporting Data 6 12 6 4 1 Exporting Measurement Data 6 12 6 4 2 Exporting Configuration ...

Page 103: ... Patient Measurement Reports The Data Manager menu allows you to print out patient measurement reports You can print out individual measurement results groups of measurement results or all the results in memory In the default setting patient reports are set to print automatically after each measurement Information on how to change these settings can be found in Section 3 2 4 1 1 To print a patient...

Page 104: ...int individual results highlight the desired measurement Fig 6 3 6 To print groups of results highlight the first measurement to be printed press Mark and select the last measurement to be printed All the measurements in between will be selected 7 Press All to select all results 8 Press Print to print your selection 9 Records can be deleted from the database by marking them and pressing Delete NOT...

Page 105: ...u 2 On the Measurement tab select SRC Fig 6 5 3 In the Data SRC Measurement screen Fig 6 6 select a measurement and press the View button to display the measurement results Fig 6 7 4 Use the Previous and Next buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 6 6 To print groups of results highlight the first measureme...

Page 106: ...ics report to be printed 4 Select Level and Lot 5 Use the Previous and Next buttons to display the previous or next page of measurements 6 To print results for individual lots highlight the desired lot Fig 6 9 7 To print groups of results highlight the first lot to be printed press Mark then select the last lot to be printed All the lot numbers in between will be selected 8 Press All to select all...

Page 107: ...ment screen Fig 6 11 select a measurement and press the View button to display the measurement results Fig 6 12 4 Use the Previous and Next buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 11 6 To print groups of results highlight the first measurement to be printed press Mark and select the last measurement to be pr...

Page 108: ...stics report to be printed 4 Select Level and Lot 5 Use the Previous and Next buttons to display the previous or next page of measurements 6 To print results for individual lots highlight the desired lot and level Fig 6 14 7 To print groups of results highlight the first lot to be printed press Mark then select the last lot to be printed All the lot numbers in between will be selected 8 Press All ...

Page 109: ... Fig 6 15 3 In the Data Patient Diagnostics screen Fig 6 16 select the desired measurement and press the View button to display the measurement results Fig 6 17 4 Use the Previous and Next buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 16 6 To print groups of results highlight the first measurement to be printed pr...

Page 110: ... SRC Diagnostics screen Fig 6 19 select the desired measurement and press the View button to display the measurement results Fig 6 20 4 Use the Previous and Next buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 19 6 To print groups of results highlight the first measurement to be printed press Mark and select the las...

Page 111: ...he Data Control Diagnostics screen Fig 6 22 select the desired measurement and press the View button to display the measurement results Fig 6 23 4 Use the Previous and Next buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 22 6 To print groups of results highlight the first measurement to be printed press Mark and sel...

Page 112: ...nostics tab and select Errors Fig 6 24 3 Press to print the error report Fig 6 25 4 Press to delete the error database NOTE If you do not have permission to delete records the button will not be active 5 Confirm your choice by pressing in the Delete the Error Log screen Fig 6 26 6 Press to return to the Data screen or to return to the main menu Fig 6 24 Select Errors Fig 6 25 Print or Delete Error...

Page 113: ...menu 2 In the Data screen on the Measurement tab select Maintenance Fig 6 27 3 Press to print the maintenance report Fig 6 28 4 Press to delete the maintenance database NOTE If you do not have permission to delete records the button will not be active 5 Confirm your choice by pressing in the Delete the Maintenance Log screen Fig 6 29 6 Press to return to the Data screen or to return to the main me...

Page 114: ...mmunications Setup see Section 3 2 4 5 and a physical connection to the receiving computer must be made 6 4 1 Exporting Measurement Data 1 To export measurement results select Data Manager in the main menu 2 On the Measurement tab select Patient SRC or Controls Fig 6 30 NOTE Data will be exported using the setting selected in the Communications Setup see Section 3 2 4 5 3 Select the data to be exp...

Page 115: ...the status bar at the top of the screen or the button Eject USB Mass Storage Device to remove the USB device safely Fig 6 33 6 You will be asked to eject the USB device safely Fig 6 34 7 Select to remove the device An acknowledgement screen will be displayed when it is safe to remove the device 8 Press to return to the Data screen or to return to the main menu Fig 6 33 Eject USB device Fig 6 34 Ej...

Page 116: ... Configuration Fig 6 35 3 Insert a USB device and select Export or Import as desired Fig 6 36 4 To remove the USB device safely touch the USB icon in the status bar at the top of the screen or the button Eject USB Mass Storage Device Fig 6 35 5 You will be asked to eject the USB device safely Fig 6 37 6 Select to remove the device An acknowledgement screen will be displayed when it is safe to remo...

Page 117: ...b and select Database Fig 6 38 3 Insert a USB device and select Export Fig 6 39 4 To remove the USB device safely touch the USB icon in the status bar at the top of the screen Fig 6 38 5 You will be asked to eject the USB device safely Fig 6 40 6 Select to remove the device An acknowledgement screen will be displayed when it is safe to remove the device 7 Press to return to the Data screen or to r...

Page 118: ...tenance 7 1 7 3 Quarterly Maintenance Performing tHb Calibration 7 2 7 4 Annual Maintenance 7 6 7 4 1 Replacing Peri Pump Cartridge 7 6 7 4 2 Replacing Gas I O Port 7 8 7 5 As Needed Maintenance 7 9 7 5 1 Changing the Gas Bottle 7 9 7 5 2 Changing the Printer Paper 7 11 7 5 3 Performing Routine Cleaning 7 11 ...

Page 119: ...s a function that allows you to select maintenance reminder options which will alert you when analyzer cleaning is due Any maintenance actions that you perform through the maintenance reminders will be captured in the maintenance log of the analyzer 1 From the Ready display select System Manager and Maintenance 2 Enter User ID if enabled 3 In the Maintenance menu Fig 7 1 press Setup 4 In the Setup...

Page 120: ... can also be run from the QC menu by pressing QC Manager QC tHb Calibrator instead of scanning the barcode in the Ready screen 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 2 If Non Secure User ID Entry is enabled in the security settings see Section 3 2 3 you will be asked to enter the user ID Fig 7 4 Depending o...

Page 121: ...Press Fig 7 6 5 At the prompt open the SMC cover by pressing down on the red latch Fig 7 7 6 Gently wipe both sides of the tHb 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 7 8 Fig 7 7 Open Cover Fig 7 8 Wipe and Insert Cassette Fig 7 6 Clean Optics ...

Page 122: ... and begin calibration Fig 7 10 8 After the calibration is complete you will be prompted to open the sample chamber cover and remove the cassette Fig 7 11 9 Place the calibrator cassette back into its pouch immediately after removal from the instrument NOTE Make sure to keep the calibrator cassette with the instrument at all times Fig 7 11 Remove Calibrator Fig 7 10 tHb Calibration Fig 7 9 Close C...

Page 123: ...mplete the Ready display will appear Fig 7 13 Fig 7 12 HbCal Report OPTI CCA TS2 HbCal Report DD MMM YY HH MM S N XXXX Version X XX XXXX User ID User 123 HbCal LOT XXXXXX Exp Date MMM YYYY 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 F5 0 000 0 000 G1 1 062 G2 1 087 G3 1 082...

Page 124: ... seals Fig 7 15 only if they are damaged or clogged Remove the old pump seals with a pair of hemostats or tweezers 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 rotat...

Page 125: ...alert you when the next pump replacement is due Any maintenance actions that you perform through the maintenance reminders will be captured in the maintenance log of the analyzer 1 From the Ready display select System Manager and Maintenance 2 Enter User ID if enabled 3 In the Maintenance menu Fig 7 18 press Setup 4 In the Setup screen Fig 7 19 you can select the option Replace Pump Reminder The a...

Page 126: ...ld part 2 Install the new gas I O port with the rounded surface pointing up and press it into the recess When fully seated the I O port is approximately 1 8 inch 3mm above the surrounding surface 3 Perform a Pump Test see section 8 2 16 to ensure correct operation Make sure the pump rotates smoothly without excessive noise In addition run one sample in control mode Make sure the control measuremen...

Page 127: ...nner should cover the entire barcode The analyzer will beep when the barcode is accepted Record the date of installation on the gas bottle for later reference NOTE If the insert sheet is misplaced you can enter the lot number on the gas bottle label manually Press Manual Fig 7 22 and enter the number using the numeric keypad NOTE The bar code contains expiration information The OPTI CCA TS2 will a...

Page 128: ...umeric keypad Fig 7 26 Here you may refer back to the installation date which was recorded on the gas bottle NOTE The gas bottle in use expiration is 6 months from installation or the shelf life of the gas bottle whichever comes first The analyzer will initiate a purge of the system which will be indicated by a progress bar displayed on the screen and will then return to the main screen Fig 7 27 F...

Page 129: ...d and slightly out of the paper tray Fig 7 29 4 Hold the paper and close the printer cover Fig 7 30 The paper will automatically feed through as the printer starts printing Fig 7 28 Open Printer Cover Fig 7 29 Install Printer Paper Fig 7 30 Close Printer Cover 7 5 3 Performing Routine Cleaning The OPTI CCA TS2 Analyzer is designed to require very little maintenance Routine cleaning consists of wip...

Page 130: ...2 6 Checking the Battery Voltage 8 21 8 2 7 Checking the Cooling Fan 8 21 8 2 8 Checking the Gas Valve 8 22 8 2 9 Checking the Valve Drive 8 22 8 2 10 Checking the Factory Settings FSet 8 23 8 2 11 Checking the Bar Code Scanner 8 23 8 2 12 Checking the Printer 8 24 8 2 13 Checking the Optics 8 25 8 2 14 Checking the Ethernet Interface 8 26 8 2 15 Checking the Pump Flow 8 27 8 2 16 Checking the Pum...

Page 131: ...ical assistance 8 1 System Error and Warning Messages The OPTI CCA TS2 displays the following types of system status messages SYSTEM WARNING MESSAGES System warning messages notify the operator of conditions requiring operator intervention to complete the current measurement SYSTEM ERROR MESSAGES These errors occur during sample analysis and are specific to the current sample being analyzed Error ...

Page 132: ...arning The analyzer will however display a result for the parameter concerned For lactate cassettes you have the option of continuing the measurement by pressing or stopping by pressing For all other cassettes press to continue Once the measurement is complete remove cassette and check for aspirated bubbles If bubbles are present over a sensor do not report that parameter WARNING Bad Sensor pH The...

Page 133: ... cassette Inspect the cassette and optics on bottom and top plate Clean if necessary Reinsert the cassette and press to rerun the test WARNING Gas expires soon The gas bottle will expire in four weeks Press to continue Make sure you have another gas bottle on hand or ordered NOTE The gas bottle expires 6 months after installation or after exceeding the labeled expiration date whichever comes first...

Page 134: ... Lot This message is displayed to alert the user that a new SRC lot is being used Press to continue measurement with the new SRC WARNING Hb Calibration expires soon The Hb calibration will expire in four weeks Press to continue WARNING Hb Calibrator expires soon The Hb Calibrator cassette will expire in four weeks Press to continue Make sure you have another Calibrator Cassette on hand or ordered ...

Page 135: ...n set up as Required in the Setup menu Section 3 2 2 the required information will have to be entered before the user can exit this screen Press and enter the required information WARNING Text Length Less Than Minimum Characters Required If a minimum number of characters has been set up for patient ID entry Section 3 2 2 2 the patient ID entered must meet the required minimum Press and enter a pat...

Page 136: ...d This may be due to a clot or blockage preventing sample aspiration Press and discard cassette ERROR B Lac Setup failed This error message appears when the reproducibility of the OPTI Check controls during the lactate setup procedure is out of range Repeat lactate setup procedure Make sure to aspirate the OPTI Check directly from the ampoule Repeat the lactate setup using a different lactate cass...

Page 137: ...e 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 back on and retry ERROR Cassette Misseat 2 The cassette was not properly placed into the chamber or it was previously used Press discard the cassette and repeat test with a new cassette If the message still appears with a different cassette turn th...

Page 138: ... 8 2 4 ERROR Calibration Expired The cassette has been holding the calibration for more than 10 minutes without a sample being attached This error can also be triggered if any sample is detected on the front light gate but is not a short sample like a small slug of sample Press and discard the cassette ERROR Unstable Sensors A sample error has occurred This may be due to a clot or large air bubble...

Page 139: ... the scanner clean Retry the bar code ERROR Invalid Barcode Check Time and Date The bar code was invalid The OPTI CCA TS2 either misread the bar code or the product i e gas bottle cassette or SRC has expired Press to retry If the error message appears again check the date in System Time and Date Verify the product expiration date ERROR Invalid Barcode Different QC Lot The bar code was invalid Veri...

Page 140: ...ol material under Setup and retry ERROR Need Setup QC A measurement of QC materials was attempted prior to setting up Press to continue Configure the QC material under Setup and retry ERROR User ID Already Exists The selected user ID already exists in the database Press to continue Enter a unique user ID ERROR Invalid User ID The user ID does not exist in current user database Press to continue Re...

Page 141: ...continue Information on setting up user permissions can be found in Section 3 2 3 1 3 Range Error This error may occur during Hb calibration The error is triggered when the correction is greater than 10 Press and replace the Hb calibrator ERROR Not enough records in Level 2 There are not enough records in the database to generate a statistics report Press to continue ERROR Group Name Already Exist...

Page 142: ...le limits Shut down the system and restart to attempt to clear the error STOP Barometer Error The barometer reading is outside the measurement range Shut down the system and restart to attempt to clear the error STOP B Lac Setup Required This error message will appear if you try to run lactate cassettes and the lactate parameter has not been set up on your analyzer Refer to section 8 2 20 for inst...

Page 143: ...u will have to reinstall the same gas bottle Press New Gas Bottle and reinstall the gas bottle See Section 7 5 1 Not Ready Gas Expired The in use 6 months or labeled shelf life of the gas bottle has expired Press New Gas Bottle and replace the gas bottle see Section 7 5 1 Not Ready Low Battery The battery voltage is low Operate the analyzer on AC power and or recharge the battery 8 1 4 Not Ready M...

Page 144: ...er 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 Not Ready Temperature Error The SMC temperature exceeds 39 C for more than 20 seconds Press Data Manager or System Manager to exit this screen Contact ...

Page 145: ...ocked remotely and cannot be used Press Data Manager QC Manager or System Manager to exit this screen Not Ready FSet Error The factory settings have been corrupted and are not valid Shut down the system and restart to attempt to clear the error If the error cannot be cleared by cycling the power contact Technical Support for assistance Measurement Access Prohibited The user does not have privilege...

Page 146: ...l Support for assistance Fatal Error Cassette Valve The cassette valve failed to find the home position Shut down the system and restart to attempt to clear the error If the error cannot be cleared by cycling the power contact Technical Support for assistance Fatal Error Dark Currents Dark currents exceed allowable limits Shut down the system and restart to attempt to clear the error If the error ...

Page 147: ...ure detected in optics system Shut down the system and restart to attempt to clear the error If the error cannot be cleared by cycling the power contact Technical Support for assistance Exception Processor exception occurred Press to exit the screen and contact Technical Support for assistance ...

Page 148: ...ostics Fig 8 1 The Diagnostics screen contains three tabs with various diagnostic functions Sensors Hardware and Tests 8 2 1 Checking Versions Fig 8 1 Diagnostics In the main menu press System Manager Diagnostics The first option on the Sensors screen Versions Fig 8 2 allows you to check the system versions Press to return to the System screen or to return to the main menu Fig 8 2 Versions ...

Page 149: ... the System screen or to return to the main menu Fig 8 3 Temperature 8 2 3 Checking Gas Pressure Fig 8 4 Gas Pressure The Gas Level option allows you to check the percent remaining of the gas bottle Fig 8 4 With a new gas bottle in place the pressure should be approx 99 with the bottle removed the pressure should be 00 In the main menu press System Manager and Diagnostics To install a new gas bott...

Page 150: ...s to return to the System screen or to return to the main menu Fig 8 6 Barometric Pressure 8 2 5 Verifying Barometric Pressure Fig 8 5 LEDs This menu can be used to check proper functioning of the LEDs and is designed for use by trained service personnel only In the main menu press System Manager Diagnostics The following information is displayed in the LEDs section Fig 8 5 Front Rear Ion fluid li...

Page 151: ...by placing your hand over the fan at the back side of the analyzer Press to return to the System screen or to return to the main menu Fig 8 8 Cooling Fan 8 2 6 Checking the Battery Voltage This selection lets you check the battery voltage In the main menu press System Manager Diagnostics The second display in the Miscellaneous section shows the battery voltage Fig 8 7 If the voltage is below 9 0V ...

Page 152: ...t the test Fig 8 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 or to return to the main menu Fig 8 9 Gas Valve This diagnostic checks the proper operation of the cassette valve drive mechanism In the main menu press System Manager Diagnostics Select the Hardware tab Press Fig 8 10 and enter the various positions all...

Page 153: ...o check the function of the bar code scanner In the main menu press System Manager Diagnostics Select the Tests tab Press Barcode to start the test Fig 8 12 To test the bar code scanner scan a bar code label of e g a sensor cassette Fig 8 13 The display will show a sequence of numbers Fig 8 14 Compare the numbers with those printed on the cassette bar code label Matching information confirms the p...

Page 154: ...est 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 TS2 off Remove the paper roll and pump cartridge Unscrew the two thumbscrews holding the printer in place Pull printer up and out towards the paper tray Disconnect the cable...

Page 155: ...d for trained service personnel In the main menu press System Manager Diagnostics Select the Tests tab Press Optics to start the test Fig 8 16 Select the Cassette type and press Fig 8 17 Insert the cassette and close the cover Fig 8 18 An optics tests will be performed to verify operation of the optical system At the completion of the test the results will be printed and you will be asked to remov...

Page 156: ...of this test is to check for proper functioning of the Ethernet interface In the main menu press System Manager Diagnostics Select the Tests tab Press Ethernet to start the test Fig 8 20 The system will send out data and check if they are received Fig 8 21 Press to return to the System screen or to return to the main menu Fig 8 21 Ethernet Test ...

Page 157: ...esults Fig 8 24 The two numbers indicate the actual flow rates clockwise and counter clockwise Fig 8 25 If one of the two or both rates are out of range the test fails Repeat test or replace the pump cartridge if the test fails See replacement instructions in Chapter 7 4 1 NOTE It is possible that the test fails the first time even if the pump cartridge is working correctly Remove the cassette Fig...

Page 158: ...s defective and needs to be replaced Press to return to the System screen or to return to the main menu Fig 8 29 Display Test 8 2 16 Checking the Pump Motor The purpose of this test is to check the proper functioning of the peristaltic pump motor In the main menu press System Manager Diagnostics Select the Tests tab Press Pump to start the test Fig 8 27 The pump will automatically step through all...

Page 159: ... the screen and a dot should appear under the touched location Fig 8 31 If not press Calibrate to perform a touch calibration 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 8 32 NOTE Do not use sharp objects since they may damage the screen When finished press Press to return to the System screen or to return t...

Page 160: ...The Gas Test Fig 8 33 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 Press to cancel this test Fig 8 34 Fig 8 33 Gas Test Fig 8 34 Gas Test ...

Page 161: ...o order a B Lac Setup Kit BP7657 free of charge This is not a troubleshooting procedure Call Technical Support for further assistance In the main menu press System Manager Diagnostics Select the Tests tab Press Setup B Lac Fig 8 35 Enter the security information if enabled Fig 8 36 Information on security functions can be found in Section 3 2 3 NOTE Bar coded user IDs may be entered from this scre...

Page 162: ...k is run you will return to this screen Fig 8 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 8 40 Press to exit the menu You will receive a B Lac ...

Page 163: ... Manager Diagnostics Select the Tests tab Press Cassette Detect to start the calibration Fig 8 41 Insert a patient cassette Fig 8 42 Remove the cassette and leave the cover open Fig 8 43 Close the SMC cover Fig 8 44 The system performs a Cassette Detection Calibration Fig 8 45 Fig 8 41 Cassette Detect Fig 8 42 Insert Cassette Fig 8 44 Close Cover Fig 8 45 Calibration Fig 8 43 Remove Cassette ...

Page 164: ...hese channels may get clogged or dirty causing the tHb and SO2 to fail calibration or OPTI Check controls The simple cleaning procedure below can be used for OPTI CCA TS2 analyzers and may correct tHb and SO2 failures 1 Open the SMC cover and locate the two small optical channels pictured below Fig 8 46 Fig 8 46 Locate Optical Channels 2 Clean the optical channels using a cotton swab or lint free ...

Page 165: ...ocedure 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 166: ...le Collection Devices 9 3 9 4 4 Syringes 9 3 9 4 5 Capillary Tubes 9 3 9 4 6 OPTI Medical ComfortSamplers 9 4 9 4 7 Handling and Storage of Samples 9 4 9 5 Procedure 9 5 9 5 1 Materials Needed 9 5 9 5 2 Test Conditions 9 6 9 5 3 Input Values 9 6 9 5 4 Calculated Values 9 9 9 5 5 Calibration 9 9 9 5 6 Quality Control 9 10 9 5 7 Reference Intervals 9 11 9 5 8 Specific Performance Characteristics 9 1...

Page 167: ... 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 168: ...lters 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 Th...

Page 169: ... 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 9 4 4 Syringes If liquid heparin is used as an anticoagulant collection devices should be no larger than the...

Page 170: ...eparated within these time limits 9 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 p...

Page 171: ...n the 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...

Page 172: ...c characters Blank Accession Number 25 alphanumeric characters Blank Date of Birth Month DD YYYY Patient Sex Male female or unknown unknown Patient temperature T 14 0 to 44 0 C 37 0 C 57 2 to 111 2 F 98 6 F Medical Record Number 25 alphanumeric characters Blank Account Number 25 alphanumeric characters Blank Test ID 25 alphanumeric characters Blank Patient Name 25 alphanumeric characters Blank Age...

Page 173: ...n Pump Off Pump 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 Ventilator Mode No SIMV PSV PCV No CMV AC CPAP PCIVR or BIPAP where No None SIMV Synchronized Intermittent Mandatory Ventilation PSV Pressure Support Ventilation PCV Pressure Control Ventilation CMV ...

Page 174: ...EEP Rate f 0 to 155 bpm 0 Continuous Positive Airway 0 to 50 0 Pressure CPAP Total hemoglobin tHb 1 0 to 26 0 g dL 15 0 g dL 0 62 to 16 14 mmol L 9 31 mmol L 1 to 260 g L 150 g L FIO2 0 21 to 1 0 0 21 Mean corpuscular hemoglobin 29 0 to 37 0 33 3 concentration MCHC Respiratory quotient RQ 0 70 to 2 00 0 84 P50 15 0 to 40 0 mmHg 26 7 mmHg 2 0 to 5 33 kPa 3 56 kPa Bi Level Pressure Numerator 0 2 9 9...

Page 175: ... parameters are determined 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 cod...

Page 176: ...ese systems multiple patient samples are run using the same reagent system On the OPTI CCA TS2 all reagents needed to run a single patient measurement are pre packaged in a single disposable cassette Each cassette is an individual reagent and sensor system The traditional method of running a liquid QC material several times each day does not check these individual reagent and sensor systems Theref...

Page 177: ...Determine Reference Intervals in the Clinical Laboratory Approved Guideline Second Edition The analyzer is preset to adult reference intervals derived from Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4th Ed Elsevier Saunders 2006 pps 2252 2302 The preset intervals and procedures for adjusting the intervals to those derived for the individual laboratory are des...

Page 178: ...ity is well known Measurements of such materials are more prone to pre analytic error as well as analyzer specific errors compared to similar measurements of whole blood The OPTI CCA TS2 system is no exception to this and demonstrates somewhat poorer PO2 precision with aqueous controls than with whole blood due to the large amount of plastic material comprising its disposable measurement chamber T...

Page 179: ...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 reported it will reflect the actual changes cau...

Page 180: ...ntainer label Multi Level Standard Reference Cassettes SRCs BP7652 Use For diagnostic and daily QC check of the OPTI CCA TS2 Contents Each package contains one reusable SRC Cassette Composition Stabilized optode sensors with assay values Level 1 Level 2 Level 3 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 PO2 57 0 63 0 97 0 103 0 167 0 173 0 mmHg Na 123 0...

Page 181: ...ions calibration gas or optodes not manufactured 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 Bu...

Page 182: ... SUPPLIES 10 1 10 1 Analyzer 10 1 10 2 Cassettes 10 1 10 3 Controls Calibrators 10 1 10 4 Consumable Items 10 2 10 5 Accessories 10 2 10 6 Manuals 10 2 10 7 Spare Parts 10 3 10 8 Technical Assistance 10 3 10 9 Warranty Registration U S Market Only 10 4 ...

Page 183: ...r Entry representatives will gladly provide any assistance you may require Description Part Number 10 1 Analyzer OPTI CCA TS2 Analyzer GD7046 with Accessory Kit 10 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 O...

Page 184: ... 250 pcs MC0024 ComfortSampler with Accessories BP0600 ComfortSampler Basic Kit BP0610 ComfortSampler Bulk w Needle BP0620 ComfortSampler Bulk w o Needle BP0630 ComfortSampler Bulk Needle w Protector BP0640 10 5 Accessories Battery Assembly EI7019 Case Carrying YB7025 Assembly Wand Touch Screen BP7245 10 6 Manuals CD Operator s Manual PD7300 Operator s Manual PD7301 ...

Page 185: ...ndable 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 1 800 490 6784 OPTI to request t...

Page 186: ... OPTI Medical Systems Inc to ensure warranty support if you ever need warranty assistance The model and serial numbers of your OPTI CCA TS2 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 ...

Page 187: ... 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 ...

Page 188: ...al 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 ...

Page 189: ...TI CCA platform with a standard OPTI style pH sensor No changes were made to the sensor or the measurement principle so the interference of the OPTI CCA TS2 is equivalent to the OPTI CCA Substance Amount pH change Sodium fluorescein 26 mg dL unstable Cardio indocyanine green 0 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 ...

Page 190: ...age 7 134 7 341 7 518 St Dev 0 004 0 006 0 009 CV 0 05 0 08 0 13 n 10 10 10 Linearity Wherever possible linearity for the OPTI CCA TS2 measurement has been established against reference materials or methods The linearity of the pH sensor on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with different CO2 gas mixtures to establ...

Page 191: ...ation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Correlation Coefficient Sy x Range n Analyzer A whole blood 0 9269 0 534 0 9789 0 013 7 17 to 7 52 103 Analyzer B whole blood 1 0800 0 579 0 9954 0 009 7 01 to 7 55 173 Analyzer C whole blood 1 126 0 018 0 946 0 134 0 9868 0 018 7 09 to 7 58 105 Analyzer D...

Page 192: ... of Samples 126 Range 6 927 to 7 705 Slope 0 97 Offset 0 18 R2 0 998 Sy x 0 008 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Peterson JI et al A Fiber Optic pH Probe for Physiological Use Anal Chem 53 p 864 1980 3 Wolfbeis OS Offenbacher H Fluorescence Sensor for Monitoring Ionic Strength and Physiological pH Values Sensors and...

Page 193: ...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 194: ... CCA TS platform with a standard OPTI style pH sensor No changes were made to the sensor or the measurement principle so the interference of the OPTI CCA TS2 is equivalent to the OPTI CCA TS Chemical Interferent Concentration pH Level Interference 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 ...

Page 195: ...ere determined from 2 runs per day with 2 replicates per run over a period of 20 days following the CLSI guideline EP5 A2 Typical results for 3 different control levels are shown below Dry pH OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 7 168 7 418 7 632 Within Run St Dev Swr 0 011 0 008 0 007 Within Run CV 0 2 0 1 0 1 Total Precision St Dev ST 0 015 0 0...

Page 196: ...sor on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with different CO2 gas mixtures to establish the correlation Parameter and Specification Value Number of Samples 81 Slope 0 99 Offset 0 09 R2 0 998 Sy x 0 015 6 4 6 6 6 8 7 7 2 7 4 7 6 7 8 8 6 4 6 6 6 8 7 7 2 7 4 7 6 7 8 8 Dry pH TS2 DrypH TS Scatter Plot with Fit Identity L...

Page 197: ...fficient Sy x Range n OPTI R 0 96 0 27 0 984 0 019 6 78 to 7 54 147 Analyzer A 1 03 0 20 0 968 0 015 7 091 to 7 538 111 For more information on specific analyzers used please contact OPTI Medical Technical Support OPTI CCA TS with B Lac Cassette vs other pH Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different CO2 gas mixtures to gener...

Page 198: ...e 6 477 to 7 915 Slope 0 99 Offset 0 09 R2 0 998 Sy x 0 013 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Wolfbeis OS Offenbacher H Fluorescence Sensor for Monitoring Ionic Strength and Physiological pH Values Sensors and Actuators 9 p 85 1986 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer sl...

Page 199: ...and bases in blood just as conventional PCO2 electrodes The PCO2 partial pressure is influenced by the local barometric pressure as dictated by Dalton s law The OPTI CCA TS2 incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The OPTI CCA TS2 has been factory calibrated to the absolute barometric pressure Measurement Range R...

Page 200: ...PTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 74 5 45 0 24 8 Within Run St Dev Swr 0 8 0 3 0 3 Within Run CV 1 1 0 7 1 1 Total Precision St Dev ST 0 9 0 5 0 4 Total CV 1 3 1 0 1 5 Whole Blood Within run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI CCA TS2 The table below shows the Averages Standard Deviations and CV calculated from...

Page 201: ... pCO2 sensor on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with different CO2 gas mixtures to establish the correlation Parameter and Specification Value Number of Samples 72 Slope 0 98 Offset 0 45 R2 0 999 Sy x 0 975 0 50 100 150 200 250 0 50 100 150 200 250 PCO2 TS2 PCO2 TS Scatter Plot with Fit Identity Linear fit 0 45 0...

Page 202: ...isting instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Correlation Coefficient Sy x Range n Analyzer A whole blood 0 9751 1 623 0 9871 1 16 28 to 72 103 Analyzer B whole blood 0 9740 2 66 0 9937 1 12 24 to 92 173 Analyzer C whole blood 0 988 0 022 0 807 1 015 0 9750 2 584 23 to 81 105 Analyzer...

Page 203: ...f Samples 117 Range 14 3 to 198 9 Slope 0 97 Offset 0 87 R2 0 999 Sy x 1 114 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Vurek GG Feustel PJ Severinghaus JW A Fiber Optic PCO2 Sensor Ann Biomed Eng 11 p 499 1983 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method resul...

Page 204: ...ctive 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 hydrogen...

Page 205: ...nterference of the OPTI CCA TS2 is equivalent to the OPTI CCA TS Chemical Interferent Concentration PCO2 Level Interference Acetaminophen 1 66 mM 83 mmHg NO 17 mmHg NO Acetylsalicylic acid 3 33 mM 83 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 ...

Page 206: ...1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 72 6 43 1 22 5 Within Run St Dev Swr 0 8 0 3 0 3 Within Run CV 1 1 0 7 1 4 Total Precision St Dev ST 1 2 0 6 0 4 Total CV 1 6 1 3 2 0 Whole Blood Within run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI CCA TS2 The table below shows the Averages Standard Deviations and CV calculated f...

Page 207: ...the pCO2 sensor on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with different CO2 gas mixtures to establish the correlation Parameter and Specification Value Number of Samples 81 Slope 1 01 Offset 1 19 R2 0 998 Sy x 1 973 0 50 100 150 200 250 0 50 100 150 200 250 Dry PCO2 TS2 DryPCO2 TS Scatter Plot with Fit Identity Linear ...

Page 208: ...x Range n OPTI R 0 99 4 15 0 984 3 53 21 to 184 146 Analyzer A 0 94 1 88 0 982 1 62 22 7 to 93 2 112 For more information on specific analyzers used please contact OPTI Medical Technical Support OPTI CCA TS with B Lac Cassette vs other Blood Gas Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different CO2 gas mixtures to generate a wide r...

Page 209: ...us the OPTI CCA TS Parameter and Specification Value Number of Samples 63 Range 14 7 to 87 9 Slope 1 00 Offset 1 13 R2 0 995 Sy x 1 523 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b 10 20 30 40 50 60 7...

Page 210: ...he PO2 P is increased Unlike conventional electrochemical Clark PO2 electrodes the oxygen optode does not consume oxygen molecules during the measurement The PO2 partial pressure is influenced by the local barometric pressure as dictated by Dalton s law The OPTI CCA TS2 incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The...

Page 211: ... Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 71 6 100 0 137 7 Within Run St Dev Swr 1 3 1 4 1 4 Within Run CV 1 8 1 4 1 0 Total Precision St Dev ST 1 5 1 7 1 8 Total CV 2 1 1 7 1 3 Whole Blood Within run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI CCA TS2 The table below shows the Averages Standard Deviations and CV calculated from ...

Page 212: ...on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with different O2 gas mixtures to establish the correlation Parameter and Specification Value Number of Samples 90 Slope 0 99 Offset 2 57 R2 0 999 Sy x 4 938 0 100 200 300 400 500 600 700 800 0 100 200 300 400 500 600 700 800 PO2 TS2 PO2 TS Scatter Plot with Fit Identity Linear ...

Page 213: ...ing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Correlation Coefficient Sy x Range n Analyzer A whole blood 0 9419 3 28 0 9976 18 27 36 to 563 103 Analyzer B whole blood 1 0192 4 13 0 9969 4 10 34 to 291 173 Analyzer C whole blood 0 918 0 087 8 083 1 402 0 9954 8 032 29 to 407 105 Analyzer...

Page 214: ...uide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Kautsky H Quenching of Luminescence by Oxygen Transactions Faraday Society 35 p 216 1939 3 CDI 3M Healthcare System 200 Extracorporeal Blood Gas Monitor See for example Lubbers DW Gehrich J Opitz N Fiber Optics Coupled Flourescence Sensors for Continuous Monitoring of Blood Gases in the Extracorporeal Circuit Life Supports S...

Page 215: ...pon 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 oxyge...

Page 216: ...of the OPTI CCA TS2 is equivalent to the OPTI CCA TS Chemical Interferent Concentration PO2 Level Interference Acetaminophen 1 66 mM 48 mmHg NO 416 mmHg NO Acetylsalicylic acid 3 33 mM 48 mmHg NO 416 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...

Page 217: ... 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 73 5 103 5 139 1 Within Run St Dev Swr 1 4 0 9 1 4 Within Run CV 1 8 0 9 1 0 Total Precision St Dev ST 1 6 1 3 2 0 Total CV 2 2 1 3 1 5 Whole Blood Within run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI CCA TS2 The table below shows the Averages Standard Deviations and CV calculate...

Page 218: ...sensor on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with different O2 gas mixtures to establish the correlation Parameter and Specification Value Number of Samples 72 Slope 0 99 Offset 0 43 R2 0 999 Sy x 3 528 0 100 200 300 400 500 600 700 0 100 200 300 400 500 600 700 Dry PO2 TS2 DryPO2 TS Scatter Plot with Fit Identity L...

Page 219: ...on Coefficient Sy x Range n OPTI R 1 04 2 76 0 968 8 72 27 to 288 148 Analyzer A 0 97 3 73 0 992 5 24 27 0 to 423 8 110 For more information on specific analyzers used please contact OPTI Medical Technical Support OPTI CCA TS with B Lac Cassette vs other Blood Gas Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different O2 gas mixtures to...

Page 220: ... Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Kautsky H Quenching of Luminescence by Oxygen Transactions Faraday Society 35 p 216 1939 3 CDI 3M Healthcare System 200 Extracorporeal Blood Gas Monitor See for example Lubbers DW Gehrich J Opitz N Fiber Optics Coupled Flourescence Sensors for Continuous Monitoring of Blood Gases in the Extracorporeal Circuit Life Supports...

Page 221: ...sipidus 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 cen...

Page 222: ...n extra source of variability at the extreme values Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the electrolyte sensors The following exogenous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being m...

Page 223: ...ble below shows the Averages Standard Deviations and CV calculated from 10 samples for each level Na mmol L Whole Blood Level 1 Level 2 Level 3 Average 136 5 167 4 112 7 St Dev 0 4 0 2 0 4 CV 0 26 0 13 0 33 n 10 10 10 Linearity Wherever possible linearity for the OPTI CCA measurement has been established against reference materials or methods Sodium linearity is established by measurement of gravi...

Page 224: ... CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with mid level mixtures and spiked or diluted to establish the correlation Parameter and Specification Value Number of Samples 63 Slope 1 00 Offset 0 18 R2 0 999 Sy x 0 781 80 100 120 140 160 180 200 220 80 100 120 140 160 180 200 220 Na TS2 Na TS Scatter Plot with Fit Identity Linear fit ...

Page 225: ...ntation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Correlation Coefficient Sy x Range n Analyzer A whole blood 0 6500 50 15 0 5721 2 21 126 to 149 103 Analyzer B whole blood 0 9313 9 34 0 9180 1 95 129 to 156 173 Analyzer C whole Blood 1 084 0 226 14 929 3 176 0 9784 1 826 128 to 174 105 Analyzer D whole...

Page 226: ...nge 109 0 to 179 4 Slope 0 99 Offset 1 57 R2 0 999 Sy x 0 390 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m co...

Page 227: ...e 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 optod...

Page 228: ...half lives within the body before being metabolized by the liver This testing was done on the OPTI CCA platform with a standard OPTI style Potassium sensor No changes were made to the sensor or the measurement principle so the interference of the OPTI CCA TS2 is equivalent to the OPTI CCA Substance Amount K change mmol L Sodium fluorescein 26 mg dL 0 7 Cardio indocyanine green 0 5 mg dL 0 4 Methyl...

Page 229: ...the OPTI CCA measurement has been established against reference materials or methods Potassium linearity is established by measurement of gravimetrically prepared N I S T traceable aqueous standard solutions Potassium ST and by measurement of N I S T Standard Reference Material 956a Electrolytes in Human Serum Potassium NIST No changes were made to the Potassium sensor or the measurement principle...

Page 230: ... sensor on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with mid level mixtures and spiked or diluted to establish the correlation Parameter and Specification Value Number of Samples 72 Slope 1 00 Offset 0 00 R2 0 999 Sy x 0 32 0 2 4 6 8 10 12 0 2 4 6 8 10 12 K TS2 K TS Scatter Plot with Fit Identity Linear fit 0 00 1 00x ...

Page 231: ...tation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Correlation Coefficient Sy x Range n Analyzer A whole blood 1 0816 0 138 0 9857 0 13 2 1 to 6 4 103 Analyzer B whole blood 1 0225 0 008 0 9673 0 15 2 4 to 6 0 173 Analyzer C whole blood 1 021 0 019 0 087 0 077 0 9830 0 197 2 3 to 9 4 105 Analyzer D whole ...

Page 232: ...ber of Samples 54 Range 0 9 to 8 1 Slope 1 01 Offset 0 01 R2 0 999 Sy x 0 031 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 3 OPTI Medical Model equation for regression statistics is results of OPTI Ana...

Page 233: ...nts with renal disease caused by glomerular failure 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 p...

Page 234: ...ng interferences to dyes which typically have short half lives within the body before being metabolized by the liver This testing was done on the OPTI CCA platform with a standard OPTI style Ionized Calcium sensor No changes were made to the sensor or the measurement principle so the interference of the OPTI CCA TS2 is equivalent to the OPTI CCA Substance Amount Ca change mmol L Sodium fluorescein...

Page 235: ...ard Deviations and CV calculated from 10 samples for each level Ca mmol L Whole Blood Level 1 Level 2 Level 3 Average 1 21 2 58 0 82 St Dev 0 004 0 010 0 005 CV 0 35 0 40 0 59 n 10 10 10 Linearity Wherever possible linearity for the OPTI CCA measurement has been established against reference materials or methods Ionized Calcium linearity is established by measurement of gravimetrically prepared N ...

Page 236: ... on the OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with mid level mixtures and spiked or diluted to establish the correlation Parameter and Specification Value Number of Samples 72 Slope 0 99 Offset 0 01 R2 0 999 Sy x 0 017 0 0 5 1 1 5 2 2 5 3 3 5 0 0 5 1 1 5 2 2 5 3 3 5 Ca TS2 Ca TS Scatter Plot with Fit Identity Linear fit 0 ...

Page 237: ...tors of measurement equipment in hospital laboratories The sample was analyzed on the OPTI CCA TS 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 Correlation Coefficient Sy x Range n Analyzer A whole blood 0 8732 0 064 0 8392 0 07 0 7 to 1 3 ...

Page 238: ...linical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Burritt MF Pierides AM Offord KP Comparative studies of total and ionized serum calcium values in normal subjects and in patients with renal disorders Mayo Clinic proc 55 606 1980 3 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 4 OPTI ...

Page 239: ...rement 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 ...

Page 240: ... with the OPTI CCA TS2 system Colored materials including proficiency testing materials may interfere with the chloride measurement or fail to be properly aspirated Reproducibility Controls Within run precision Swr and Total Precision ST were determined from 2 runs per day with 2 replicates per run over a period of 10 days following the CLSI guideline EP5 A2 Typical results for 3 different control...

Page 241: ... prepared N I S T traceable aqueous standard solutions Chloride ST Chloride linearity in serum is established against Chloridometry Chloride CL No changes were made to the Chloride sensor or the measurement principle so the traceability of the OPTI CCA TS2 is equivalent to the OPTI CCA Correlation Slope Intercept Correlation Coefficient Sy x Range n ChlorideST 1 0076 0 56 0 99984 0 68 58 to 160 15...

Page 242: ...OPTI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with mid level mixtures and spiked or diluted to establish the correlation Parameter and Specification Value Number of Samples 63 Slope 0 99 Offset 0 21 R2 0 999 Sy x 1 218 40 60 80 100 120 140 160 180 40 60 80 100 120 140 160 180 Cl TS2 Cl TS Scatter Plot with Fit Identity Linear fit ...

Page 243: ...ators of measurement equipment in hospital laboratories The sample was analyzed on the OPTI CCA TS 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 Correlation Coefficient Sy x Range n Analyzer A whole blood 0 9965 0 95 0 9246 1 96 92 to 117 1...

Page 244: ...Range 64 4 to 145 7 Slope 0 98 Offset 0 87 R2 0 999 Sy x 0 863 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m c...

Page 245: ...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 246: ...e SRC Limit Values LOW NORMAL HIGH Units 40 0 4 0 110 0 4 0 300 0 4 0 mg dL 2 2 0 22 6 1 0 22 16 65 0 22 mmol L Interferences The OPTI CCA Glucose sensor does exhibit interference from PO2 levels that exceed 700 mmHg The Glucose sensor corrects for PO2 values up to 700 mmHg Glucose values are suppressed when PO2 values are 700 mmHg This testing was done on the OPTI CCA platform with a standard OPT...

Page 247: ...r each level Glucose mg dL Whole Blood Level 1 Level 2 Level 3 Average 82 7 166 1 34 6 St Dev 3 8 8 2 2 4 CV 4 65 4 91 6 94 n 10 10 10 Linearity Wherever possible linearity for the OPTI CCA measurement has been established against reference materials or methods Glucose linearity is established by measurement of gravimetrically prepared N I S T traceable aqueous standard solutions Glucose ST Glucos...

Page 248: ...as been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with mid level mixtures and spiked or diluted to establish the correlation Parameter and Specification Value Number of Samples 63 Slope 1 02 Offset 4 19 R2 0 991 Sy x 13 362 0 50 100 150 200 250 300 350 400 450 500 0 50 100 150 200 250 300 350 400 450 500 Glu TS2 Glu TS Scatter Plot with Fit Identit...

Page 249: ...nstrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Correlation Coefficient Sy x Range n Analyzer A whole blood mg dL 1 0079 0 7539 0 9932 6 509 30 to 400 138 Analyzer B plasma mg dL 0 9986 2 34 0 9866 8 500 44 to 398 167 OPTI CCA mg dL whole blood vs plasma mmol L 1 058 1 058 2 36 0 13 0 9700 0 97...

Page 250: ... OPTI CCA TS Parameter and Specification Value Number of Samples 54 Range 69 4 to 361 3 Slope 0 99 Offset 0 44 R2 0 983 Sy x 12 849 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b 50 100 150 200 250 300 ...

Page 251: ...s 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 pr...

Page 252: ... CCA Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the BUN urea sensor Only clear uncolored quality control materials such as OPTI CHECK PLUS brand aqueous controls should be used with the OPTI CCA TS2 system Colored materials including proficiency testing materials may interfere with the BUN u...

Page 253: ... St Dev 0 03 0 25 0 97 CV 0 53 0 93 1 13 n 10 10 10 Linearity Wherever possible linearity for the OPTI CCA measurement has been established against reference materials or methods BUN urea linearity in serum is by measurement of N I S T Standard Reference Material 909b in Frozen Human Serum BUN NIST No changes were made to the BUN urea sensor or the measurement principle so the traceability of the ...

Page 254: ...TI CCA TS2 has been established versus the same sensor on the OPTI CCA TS using whole blood samples tonometered with mid level mixtures and spiked or diluted to establish the correlation Parameter and Specification Value Number of Samples 63 Slope 1 00 Offset 0 08 R2 0 998 Sy x 1 703 0 20 40 60 80 100 120 140 160 0 20 40 60 80 100 120 140 160 BUN TS2 BUN TS Scatter Plot with Fit Identity Linear fi...

Page 255: ...he OPTI CCA TS 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 Correlation Coefficient Sy x Range n Analyzer A plasma mg dL 0 940 2 97 0 9975 1 056 8 to 89 68 Analyzer B plasma mg dL 1 058 3 04 0 9988 1 12 4 to 106 102 Analyzer C serum mg dL ...

Page 256: ... Number of Samples 45 Range 5 5 to 103 2 Slope 1 01 Offset 0 20 R2 0 999 Sy x 0 883 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tietz Burtis C Ed Textbook of Clinical Chemistry and Molecular Diagnostics 4th Ed Elsevier Saunders 2006 p 802 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope...

Page 257: ... 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 Hyp...

Page 258: ...g was done on the OPTI CCA TS platform with a standard OPTI style Lactate sensor No changes were made to the sensor or the measurement principle so the interference of the OPTI CCA TS2 is equivalent to the OPTI CCA TS 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...

Page 259: ...ate mmol L OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 1 02 2 50 4 59 Within Run St Dev Swr 0 06 0 11 0 18 Within Run CV 5 6 4 2 4 0 Total Precision St Dev ST 0 07 0 11 0 22 Total CV 6 4 4 5 4 8 Whole Blood Within run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI CCA TS2 One repeat was run on 10 different analy...

Page 260: ...ope Intercept Correlation Coefficient Sy x Range n Lactate gravimetric 0 93 0 08 0 993 0 47 0 3 to 17 5 107 Linearity was also established versus the i STAT analyzer using whole blood samples that had been spiked with lactic acid to cover the measurement range Correlation Slope Intercept Correlation Coefficient Sy x Range n Lactate vs i STAT 1 00 0 00 0 978 0 67 1 06 to 16 91 405 Direct linearity ...

Page 261: ...boratories The sample was analyzed on the OPTI CCA TS 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 Correlation Coefficient Sy x Range n Analyzer A whole blood 0 96 0 01 0 944 0 64 0 78 to 13 96 175 Analyzer B whole blood 1 18 0 54 0 953 0 ...

Page 262: ...S Parameter and Specification Value Number of Samples 45 Range 0 7 to 13 8 Slope 1 01 Offset 0 08 R2 0 994 Sy x 0 327 References 1 Tietz 2006 Clinical Chemistry and Molecular Diagnostics 4th Edition ed C A Burtis E R Ashwood D E Burns Eds St Louis Missouri Elsevier Saunders 2 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results interc...

Page 263: ...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 264: ...r in the instrument The infrared wavelengths are selected for the hemoglobin measurement because they are largely independent of SO2 that is the predominate 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 i...

Page 265: ...ene blue 25 mg dL 3 0 37 ENDOGENOUS Substance Amount tHb change g dL SO2 change Carboxyhemoglobin 10 2 0 2 Carboxyhemoglobin 20 3 3 2 Methemoglobin 13 1 7 7 Rapidly sedimenting blood samples should be mixed thoroughly and immediately aspirated into the OPTI cassette as described in Section 5 1 7 Handling and Storage of Samples to ensure accurate tHb measurements If allowed to sediment the blood sa...

Page 266: ... ST 0 2 0 1 0 2 Total CV 0 9 0 8 2 5 SO2 OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 81 2 89 8 96 4 Within Run St Dev Swr 0 1 0 3 0 4 Within Run CV 0 2 0 3 0 4 Total Precision St Dev ST 0 5 0 5 0 7 Total CV 0 6 0 6 0 8 Whole Blood Within run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI CCA TS2 The table below ...

Page 267: ...ation Slope Intercept Correlation Coefficient Sy x Range n tHb g dL 0 984 0 165 0 995 0 59 5 2 to 22 0 84 Wherever possible linearity for the OPTI CCA TS2 measurement has been established against reference materials or methods The linearity of the tHb measurement on the OPTI CCA TS2 has been established versus the OPTI CCA TS using whole blood samples that were prepared with different amounts of r...

Page 268: ... sensor on the OPTI CCA TS using whole blood samples tonometered with different O2 gas mixtures to establish the correlation Parameter and Specification Value Number of Samples 72 Slope 0 96 Offset 3 23 R2 0 991 Sy x 1 325 55 60 65 70 75 80 85 90 95 100 55 60 65 70 75 80 85 90 95 100 SO2 TS2 SO2 TS Scatter Plot with Fit Identity Linear fit 3 23 0 96x ...

Page 269: ...led following their established procedures Correlation tHb Comparative Method Slope Intercept Correlation Coefficient Sy x Range n Analyzer A whole blood 1 0284 0 375 0 9778 0 47 6 0 to 16 1 103 Analyzer B whole blood 0 9877 0 14 0 9715 0 37 6 9 to 14 8 173 Analyzer C whole blood 1 077 0 020 0 284 0 227 0 9650 0 74 5 4 to 17 4 215 Correlation SO2 Comparative Method Slope Intercept Correlation Coef...

Page 270: ...tal protocol recommended in the CLSI guideline EP9 A2 Volume 15 Number 19 using whole blood samples on the OPTI CCA TS2 versus the OPTI CCA TS tHb Parameter and Specification Value Number of Samples 45 Range 7 7 to 21 2 Slope 1 01 Offset 0 09 R2 0 996 Sy x 0 298 6 8 10 12 14 16 18 20 22 6 8 10 12 14 16 18 20 22 tHb TS2 tHb TS Scatter Plot with Fit Identity Linear fit 0 09 1 01x ...

Page 271: ... Ed Elsevier Saunders 2006 pps 2252 2302 3 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4th Ed Elsevier Saunders 2006 p 1004 4 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b 5 NCCLS Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood Approve...

Page 272: ...pply for Instrument A 6 Overvoltage Category A 6 Dimensions and Weight A 6 Classifications A 7 Calculated Parameters A 7 Temperature A 7 Units Used in Measured and Input Parameters for Calculations A 7 Conversion Table for Units A 8 Equations 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 Statis...

Page 273: ... 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 274: ...phanumeric characters Date of birth Month DD YYYY Patient Sex Male female or unknown Patient Temperature 14 0 44 0 C 57 2 111 2 F Medical Record Number 25 alphanumeric characters Account Number 25 alphanumeric characters Test ID 25 alphanumeric characters Patient Name 25 alphanumeric characters Age 1 150 Attending Physician 25 alphanumeric characters Patient Location 25 alphanumeric characters Sam...

Page 275: ...port 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 Airway Pressure PRVC Pressure Regulated Volume Control Plateau Pressure Pplat 0 0 100 0 Minute Volume MVOL VE 0 120 Peak Inspiratory Pressure PIP 0 140 Flow Rate Liter Flow FR 0 00 300 00 Tida...

Page 276: ...e excess ecf BEecf 40 40 mmol L Base excess actual BEact 40 40 mmol L Buffer bases BB 0 0 100 0 mmol L Total CO2 tCO2 1 0 200 0 mmol L Standard 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...

Page 277: ...on 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 ...

Page 278: ...TS2 is dynamic Storage capacity is up to 500 patient records QC data for 1 month at 3 levels SRC data for 1 month at 3 levels Mains Supply for External Power Supply 100 10 VAC to 240 10 VAC 50 60 Hz 1 8A 10 DC Supply for Instrument 16V 10 3 75A 10 Overvoltage Category Category II when connected to a branch circuit Dimensions and Weight Height 4 7 in 12 0 cm Width 14 2 in 36 2 cm Depth 9 1 in 23 0 ...

Page 279: ...60825 1 Explosion Protection This device is not designed for operation in explosive environments Calculated Parameters The calculated parameters in the OPTI CCA TS2 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 Units Used in Measured and Input Parameters for Calculations pH pH unit Cl mmol L PCO2 mmHg Glu mmol L PO2 mmHg BUN mg dL Na mmol L Lac mmol...

Page 280: ...111 mmol L Equations6 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 gas mixture having a PCO2 40 mmHg st pH tHb BE CO pH 2 08262 0 01296 0 006942 0 025 lg P pH unit 6 HCO3 Bicarbonate concentration in plasma HCO CO 3 pH 0 0307 10 2 6 105 P mmol L 1 5 Bu...

Page 281: ...hich 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 quantity that reflects only the non respiratory components of acid base balance tHb 5 g dL 3 ecf HCO 8 24 4 7 pH 2 16 BE mmol L 7 BE act Base excess at actual oxygen satu...

Page 282: ... most critical clinical state The OPTI CCA TS2 has the capability to provide a measured SO2 from the blood sample It is recommended that this measured value if available should be used in preference to the calculated SO2 If not available from measurement and if calculation is selected 5 21 BE 0 0013 26 7 21 5 lg 7 4 pH 0 48 O lg O lg 4 113 10 1 3632 O lg 2 9 lgQ Fetal 26 7 BE 0 0013 26 7 26 7 lg 7...

Page 283: ...ue can only be determined by interpolation after measurement of oxygen saturation of a blood specimen tonometered to levels of oxygen to provide an oxyhemoglobin slightly greater than and slightly less than 50 with pH and PO2 held constant at 7 4 and 40 mmHg respectively the OPTI CCA TS2 allows for the estimation of P50 from measured SO2 PO2 and pH If a measured SO2 is not available the P50 value ...

Page 284: ...ncentration 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 CO t t 2 2 0 019 37 10 mmHg 7 PO2 t PO2 value corrected to patient temperature other than 37 ºC P P 2 P P O O t O O t 2 5 4910 11 2 3 88 0 071 9 7210 9 2 3 88 2 30 37 10 mmHg 6 AaDO2 t Alveolar to arterial oxygen tension dif...

Page 285: ...efault 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 ionized calcium value normalized to pH 7 40 For blood nCa pH 7 4 Ca 10 0 22 pH 7 4 mmol L For plasma or serum nCa pH 7 4 Ca 10 0 24 pH 7 4 mmol L 9 Simmons A ed Hematology A Co...

Page 286: ...easurement Reports Diagnostics Reports Miscellaneous Reports Setup Tests Touch Test Cal Sensors Hardware Versions Temperature Gas Level LEDs Miscellaneous Fan Gas Valve Valve Drive FSet Barcode Printer Optics Ethernet Flow Pump Display Touch Gas Setup B Lac Cass Detect Control Lockout Patient Entry Meas Param Calc Param Meas Limits Calc Limits Panel Correlation Printer Units Language Hardware Comm...

Page 287: ...tial 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 ...

Page 288: ...e Adult Bypass off pump O2 Mode RmAir Vent Mode No Sample No 291 ACID BASE pH 7 143 PCO2 76 0 mmHg PO2 74 5 mmHg BE 6 0 mmol L tCO2 27 3 mmol L HCO3 24 9 mmol L HEMOGLOBIN OXYGEN STATUS tHb g dL SO2 Hct c ENTERED PARAMETERS Pplat 62 0 Mvol VE 50 L PIP 6 Liter Flow 165 00 Lpm Tvol VT 50 mL PS 49 0 PEEP 19 Rate f 60 bpm CPAP 61 tHb 15 0 g dL FIO2 0 21 MCHC 33 3 RQ 0 84 P50 26 7 mmHg BiLevel 1 0 1 0 ...

Page 289: ... YY HH MM S N 123 Version 1 23 4567 Level 3 SRCID 12345678 Exp MMMYYYY 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 65 1 42 148 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 Operator123 ____________________________ ...

Page 290: ...50 OK Feb4 125 0 2 50 OK Feb4 125 0 2 50 OK Feb4 125 0 2 50 OK Feb7 125 0 2 50 OK Feb7 125 0 2 50 79 8 OK Mean 125 0 2 50 0 0 SD 000 0 0 00 0 0 CV 000 0 0 00 0 0 HEMOGLOBIN LIMITS tHb 18 5 21 5 g dL SO2 68 0 72 8 Date tHb SO2 OK Feb4 20 0 70 0 OK Feb4 19 9 69 9 OK Feb4 19 9 69 9 OK Feb4 20 0 70 0 OK Feb7 20 0 70 0 OK Feb7 19 9 70 0 OK Mean 19 9 69 9 SD 0 1 0 1 CV 0 3 0 3 ADDITIONAL LIMITS Ca 1 70 ...

Page 291: ...el 3 OPTI CHECK Sample No 2 QCLot 1234 Exp MMMYYYY 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 65 1 42 148 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 Control Test Result PASS Store to Database Yes Barometer 734 6mmHg Operator ID Operator123 Lot 123456 MESSAGES ______________________________ ...

Page 292: ...50 43 9 96 3 OK Feb7 7 431 44 3 102 6 OK Mean 7 441 23 7 134 1 SD 0 013 15 9 27 0 CV 0 181 67 2 20 2 ELECTROLYTE LIMITS Na 136 0 150 0 mmol L K 4 50 5 30 mmol L Date Na K OK Feb4 OK Feb4 OK Feb4 5 03 N Feb4 OK Feb7 OK Feb7 142 9 4 88 OK Mean 4 96 SD 0 11 CV 2 14 HEMOGLOBIN LIMITS tHb 12 2 15 2 g dL SO2 87 0 93 8 Date tHb SO2 OK Feb4 14 2 88 6 OK Feb4 14 3 88 8 OK Feb4 14 0 88 5 OK Feb4 14 2 88 6 O...

Page 293: ...CCA TS2 APPENDIX D REPORT FORMATS Maintenance Report OPTI CCA TS2 MAINTENANCE REPORT DD MMM YY HH MM S N XXXX Version 1 23 4567 DDMMMYY HH MM Pump Replaced DOM0213D DDMMMYY HH MM Cleaning Completed _______________________________ ...

Page 294: ...Report OPTI CCA TS2 ERROR Report DD MMM YY HH MM S N 123 Version 1 23 4567 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 295: ...Setup Report DD MMM YY HH MM Level 2 OPTI Check QCLot 1234 Exp MMMYYYY 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 B Lac Setup PASS S N 2999 LOT 020651 __________________________ ...

Page 296: ...Reproducibility BUN 2 SRC Limit Values BUN 2 C Calcium See Ionized Calcium Calculated limits 3 14 Calculated parameters 3 11 A 7 Calculated values 8 9 A 4 Calibration 4 1 8 9 report setup 3 26 tHb troubleshooting 7 37 touch screen 7 25 Capillary tubes 8 3 sample collection 5 2 8 3 Carbon dioxide partial pressure PCO2 clinical significance PCO2 1 correlation to other methods PCO2 3 linearity PCO2 3...

Page 297: ...nterferences Ca 2 linearity Ca 3 measurement principle Ca 1 measurement 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 4 Measurement principle Lac 1 Measurement range Lac 1 Reference intervals La...

Page 298: ...e PO2 B 1 Correlation to Other Methods PO2 B 4 Interferences PO2 B 2 Measurement principle PO2 B 1 Measurement range PO2 B 1 Reference intervals PO2 B 1 References PO2 B 4 Reproducibility PO2 B 3 SRC Limit Values PO2 B 1 Pollution degree A 1 Potassium K K 1 clinical significance K 1 correlation to other methods K 3 interferences K 2 linearity K 2 measurement principle K 1 measurement range K 1 ref...

Page 299: ...cations A 1 Temperature corrected values A 4 Temperatures system checking 7 15 Test conditions 5 4 8 6 Test panels setting up 3 16 tHb Calibration Cassette 1 9 Thermal printer See Printer Tilt stand 1 7 Time and date setting 2 3 3 1 Total CO2 8 9 calculation A 9 reference ranges A 5 Total hemoglobin concentration ctHb clinical significance THB SO2 1 Correlation to Other Methods THB SO2 4 Interfere...

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