OPTi CCA-TS2 Operator's Manual

Table of Contents

Quick Links

Download this manual

OPTI

CCA-TS2

Analyzer

™

Operator's Manual

Table of Contents

Troubleshooting

Need help?

Do you have a question about the CCA-TS2 and is the answer not in the manual?

Questions and answers

Summary of Contents for OPTi CCA-TS2

Page 1 OPTI CCA-TS2 Analyzer ™ Operator’s Manual...
Page 2 OPTI Medical Systems, Inc. OPTI Medical Systems, Inc. may have patents or pending patent applications, trademarks, copyrights or other intellectual or industrial property rights covering this document or subject matter in this document.
Page 3 The instrument is only to be operated by qualified personnel capable of observing these prerequisites. Only accessories 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.
Page 4 Operating Safety Information • Overvoltage Category II when connected to a branch circuit. • This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. Caution: •...
Page 5 Operating Safety Information Recommendations for Usage and Storage of Lithium Ion Battery Pack: a) Do not dismantle, open or shred secondary cells or batteries. b) Do not expose cells or batteries to heat or fire. Avoid storage in direct sunlight. c) Do not short-circuit a cell or a battery.
Page 6 Symbol Definitions The symbols described below are used on the packaging of OPTI™ CCA-TS2 related products. Symbol Explanation Attention Symbol – Refer to the Operator’s Manual or Service Manual for further instructions. This symbol is located on the inside of the instruments and product packaging.
Page 7 Symbol Explanation Biohazard Symbol – Products and/or components containing this symbol should be handled as biohazardous material after use. Temperature Limit Symbol – Products and/or 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.
Page 8: Preface
PREFACE PREFACE Welcome Your OPTI™ CCA-TS2 Analyzer is a powerful tool designed to help you quickly, accurately and efficiently conduct basic testing of hydrogen ion concentration (pH), carbon dioxide partial pressure (PCO ), oxygen partial pressure (PO ), sodium (Na...
Page 9: Table Of Contents
Analyzer Components ..................1-3 Consumables ....................1-8 2 SETUP ....................2-1 Important Safety Instructions ................2-1 Choosing a Location ..................2-1 Setting up the OPTI CCA-TS2 Analyzer ............2-2 3 CUSTOMIZATION ................3-1 Setting Time and Date ..................3-1 Setup ........................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...
Page 10 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 5 SAMPLE HANDLING AND PATIENT TESTING ........5-1 Specimen Collection and Handling ..............5-1 5.1.1 Safety ..........................5-1 5.1.2 Sample Requirements ....................
Page 11 8.2.2 Checking System Temperatures .................. 8-19 8.2.3 Checking Gas Pressure ....................8-19 8.2.4 Checking the LEDs ...................... 8-20 8.2.5 Verifying Barometric Pressure ..................8-20 8.2.6 Checking the Battery Voltage ..................8-21 8.2.7 Checking the Cooling Fan ................... 8-21 Operator’s Manual – OPTI CCA-TS2...
Page 12 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 Medical ComfortSamplers™ ................9-4 9.4.7 Handling and Storage of Samples ................. 9-4 Procedure ......................9-5 9.5.1 Materials Needed ......................9-5 9.5.2 Test Conditions ......................
Page 13 ) ......................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 (SO %) ............THB/SO2-1 Operator’s Manual – OPTI CCA-TS2...
Page 14 APPENDIX D - REPORT FORMATS ............D-1 Basic Patient Report .........................D-1 SRC Measurement Report .......................D-2 SRC Statistics Report .......................D-3 Controls Measurement Report ....................D-4 Controls Statistics Report ......................D-5 Maintenance Report ........................D-6 Error Report ..........................D-7 B-Lac Setup Report ........................D-8 INDEX......................I-1 Operator’s Manual – OPTI CCA-TS2...
Page 15 1 INTRODUCTION 1 INTRODUCTION .................. 1-1 Intended Use .....................1-1 Principles of Operation ..................1-1 Contents ......................1-2 Analyzer Components ..................1-3 Consumables ....................1-8 Operator’s Manual – OPTI CCA-TS2...
Page 16: Introduction
1 INTRODUCTION INTRODUCTION Intended Use OPTI™ CCA-TS2 Critical Care Analyzer is intended to be used for the measurement of hydrogen ion concentration (pH), carbon dioxide partial pressure (PCO ), oxygen partial pressure ), sodium (Na ), potassium (K ), ionized calcium (Ca...
Page 17: Contents
The analyzer contains no reagents, blood or waste. 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...
Page 18: Analyzer Components
1 INTRODUCTION Analyzer Components Before setting up the OPTI CCA-TS2 Analyzer, it is important to familiarize yourself with the analyzer’s components: Printer Stylus Printer Release Button Touch Screen Display Sample Measurement Chamber (SMC) Status Light SMC Latch Gas Bottle Bar Code Scanner...
Page 19 Sample Measurement Chamber (SMC) Inside the top of the unit is the Sample Measurement Chamber (SMC) for the OPTI Cassette. To open the cover, press down on the red SMC latch, and the cover will pop up (Fig. 1-4). Several LEDs and two infrared lasers are located inside the sample measuring chamber.
Page 20 Peristaltic Pump 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 a replaceable item (See Maintenance Section 7.4.1).
Page 21: 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 power supply is plugged into an...
Page 22: Power Button
Power Connector and Power Button Next to the battery pack is the power connector where you can connect the OPTI CCA-TS2 to an external power supply (Fig. 1-11). The power button is located on the left side of the unit next to the power connector (Fig. 1-11).
Page 23: Consumables
(Fig. 1-16). Fig. 1-16 OPTI Sensor Cassette Sample Fillport and Syringe Adapter The sample fillport is contained in the OPTI Cassette and projects from the chamber for easy, automatic sampling. It includes a removable syringe adapter for sampling with a syringe.
Page 24 1 INTRODUCTION tHb Calibration Cassette The reusable tHb Calibration Cassette (Fig. 1-19) is used for the quarterly calibration of the OPTI CCA-TS2 Analyzer (See Section 7.3 Quarterly Maintenance - Performing tHb Calibration). Fig. 1-19 tHb Calibration Cassette Gas Bottle During calibration, the OPTI CCA-TS2 uses a precision gas which is completely self-contained in a disposable low-pressure bottle.
Page 25: Important Safety Instructions
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 Operator’s Manual – OPTI CCA-TS2...
Page 26: Setup
2 SETUP SETUP 2.1 Important Safety Instructions Before you begin installing your OPTI™ CCA-TS2 Analyzer, carefully read the overview information in this chapter. For your own safety and the proper operation of your equipment, always follow these precautions when working with your OPTI CCA-TS2: •...
Page 27: Setting Up The Opti Cca-Ts2 Analyzer
2 SETUP 2.3 Setting up the OPTI CCA-TS2 Analyzer You are now ready to prepare your OPTI CCA-TS2 Analyzer for operation. Begin by placing the analyzer on a secure table top that allows plenty of working space and is convenient to a power connection.
Page 28 • 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. Fig. 2-6 Scan Barcode NOTE: If the insert sheet is misplaced, you can enter the lot number on the gas bottle label manually. Press <Manual> in the Scan Bar Code Screen and enter the number using the numeric keypad. Operator’s Manual – OPTI CCA-TS2...
Page 29 7.5.3). Here you may refer back to the installation date, which was recorded on the gas bottle. The OPTI CCA-TS2 will now begin to warm up and perform a gas purge, which will be indicated by a progress bar displayed on the screen. Once the warm-up is complete, the <Ready> display appears (Fig. 2-10).
Page 30 (Fig. 2-12). Fig. 2-12 Install Printer Paper • Hold the paper and close the printer cover (Fig. 2-13). • The paper will automatically feed through as the printer starts printing. Fig. 2-13 Close Printer Cover Operator’s Manual – OPTI CCA-TS2...
Page 31 The tHb Calibrator Cassette should be run prior to patient testing when first setting up your analyzer. The tHb calibrator should then be run every three months. Your OPTI CCA-TS2 will remind you when the tHb calibration is due. The tHb Calibrator Cassette can be found in the storage compartment in the back of your analyzer.
Page 32 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. 2-19 Wipe and Insert Cassette Operator’s Manual – OPTI CCA-TS2...
Page 33 (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 Operator’s Manual – OPTI CCA-TS2...
Page 34 • 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 can be found in the storage compartment in the back of your analyzer.
Page 35 Calibration and Quality Control. <System Manager> - This menu contains • the following settings and functions: - Time and Date (Chapter 3.1) - Setup (Chapter 3.2) - Maintenance (Chapter 3.2.5 and 7.1) - Diagnostics (Chapter 8.2) 2-10 Operator’s Manual – OPTI CCA-TS2...
Page 36 3.2.4.4 Hardware Settings ......................3-32 3.2.4.4.1 Entering the Barometric Pressure .................. 3-32 3.2.4.4.2 Beep Adjustment ......................3-33 3.2.4.4.3 Standby .......................... 3-34 3.2.4.5 Setting up Communications ...................3-35 3.2.4.6 Configuring Ethernet Settings ..................3-38 3.2.5 Maintenance Setup ...................... 3-40 Operator’s Manual – OPTI CCA-TS2...
Page 37: Customization
For safety and security 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).
Page 38: Setup
The <Setup> menu consists of three screens, <Patient/QC>, <Security> and <System>. 1. In the main screen, press <System Manager> to access the <System> menu. 2. Press <Setup> to select this function (Fig. 3-5). Fig. 3-5 Setup Operator’s Manual – OPTI CCA-TS2...
Page 39: Qc Setup
(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 OPTI CHECK box and scan Barcode A for the applicable level of OPTI CHECK or OPTI CHECK PLUS (Fig. 3-7).
Page 40 6. When using OPTI CHECK PLUS, scan Barcode C for the applicable level. 7. Confirm lot number, expiration date and control type on the package insert supplied with the control material (Fig.
Page 41: Selecting Qc Lockout
3.2.1.2 Selecting QC Lockout This menu can be used to ‘lock out’ operators unless some form of QC is peformed. OPTI Medical recommends using each option described below. Each facility should develop their own policies on the frequency and type of QC based on the regulatory requirements.
Page 42 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, laboratories can require that a combination of SRCs and liquid QC is run on a daily basis. This should be based on hospital policy. NOTE: Control lockouts are based on data stored in the Controls database (see Section 4). This database may include data measured with any cassette lot or cassette type. Operator’s Manual – OPTI CCA-TS2...
Page 43 QC with each new lot. 4. To disable New Lot lockouts, deselect <New Lot Lockout Enable>. 5. Press to accept the changes. 6. Press to return to the <Setup> screen or to return to the main menu. Operator’s Manual – OPTI CCA-TS2...
Page 44: Customizing Patient Information
• Patient ID (25 alphanumeric characters) • Accession No. (25 alphanumeric characters) • Date of Birth (DOB) (Month, DD, YYYY) • Sex (unknown, male or female) • Temperature (default value 37.0 °C) Fig. 3-17 Patient Information Operator’s Manual – OPTI CCA-TS2...
Page 45 • O2 Mode (Rm Air/Mask/T-P/NC/Vent/Bag/ Hood/Other), where: RmAir = Room Air Mask = Mask T-P = T-Piece NC = Nasal Canula Vent = Vent Bag = Bag (Manual Resuscitation) Hood = Hood Other = Other Operator’s Manual – OPTI CCA-TS2...
Page 46 (Fig. 3-19) to move the option up or down in the list. 6. Press to accept the changes. 7. Press to return to the <Setup> screen or to return to the main menu. Fig. 3-19 Patient Information 3-10 Operator’s Manual – OPTI CCA-TS2...
Page 47: Suppressing Results For Measured Parameters
By default, this option is disabled. • <Minimum Patient ID Digits> lets you set a minimum number of required digits for the Patient ID. • Press to save the settings. Fig. 3-22 Settings Operator’s Manual – OPTI CCA-TS2 3-11...
Page 48: Setting Up Calculated Parameters
3. Select the cassette type (Fig. 3-24). 4. Select the parameters to be printed. 5. Press to accept the changes. to return to the <Setup> screen or 6. Press to return to the main menu. Fig. 3-24 Select Parameters 3-12 Operator’s Manual – OPTI CCA-TS2...
Page 49: Setting Up Limits For Measurement Parameters
Glu: 3.3 - 6.6 mmol/L BUN: 5.9 - 19.9 mg/dL Urea: 2.1 - 7.1 mmol/L Lac: 0.90 - 1.70 mmol/L tHb: 12.0 - 17.0 g/dL 90.0 - 100.0 % Fig. 3-27 Enter Limits 2 Operator’s Manual – OPTI CCA-TS2 3-13...
Page 50 The limits entered here will reside in the instrument memory even after system power is turned off. to return to the <Setup> screen or 10. Press to return to the main menu. Fig. 3-30 Critical Limits 3 3-14 Operator’s Manual – OPTI CCA-TS2...
Page 51: Setting Up Limits For Calculated Parameters
15.0 - 23.0 mL/dL Hct(c): 34.0 - 51.0 % 36.0 - 44.0 nmol/L AaDO2: 5.0 - 20.0 mmHg mmol/L AnGap: 10.0 - 20.0 P50: 25.0 - 29.0 mmHg mmol/L 0.10 - 3.00 Fig. 3-33 Enter Limits 2 Operator’s Manual – OPTI CCA-TS2 3-15...
Page 52 The limits entered here will reside in the instrument memory even after system power is turned off. 8. Press to return to the <Setup> screen or to return to the main menu. Fig. 3-36 Critical Limits 3 3-16 Operator’s Manual – OPTI CCA-TS2...
Page 53: Setting Up Test Panels
5. In the subsequent screen (Fig. 3-39), press and enter a name for the test panel. Select the parameters to be included in the panel. 6. Press to accept the settings. Fig. 3-39 Select Parameters Operator’s Manual – OPTI CCA-TS2 3-17...
Page 54 10. Use the <Previous> and <Next> buttons to display the previous or next page of panel configurations. to return to the <Setup> screen or 11. Press Fig. 3-40 Panels to return to the main menu. 3-18 Operator’s Manual – OPTI CCA-TS2...
Page 55: Setting Up Correlation Factors
3 CUSTOMIZATION 3.2.2.7 Setting up Correlation Factors Correlation factors let you correlate results from your OPTI CCA-TS2 to other analyzers. Correlation factors are available for all measured parameters. NOTE: Slope is a multiplicative factor and Offset is an additive factor, using the following formula: Correlated value = Raw value * slope + offset. 1. In the main menu, select <System Manager>...
Page 56: Setting Up Security
3 CUSTOMIZATION 3.2.3 Setting up Security The OPTI CCA-TS2 has three types of security options (Fig. 3-44): • <Settings> - Use this option to set up various security settings including User IDs and User Groups (See section 3.2.3.1). • <Change Password>...
Page 57: Security Settings
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 Fig. 3-48 Non-secure User ID any operations. The OPTI will verify the login and only allow the user to perform duties assigned to that user.
Page 58: Setting Up User Ids
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 3-22 Operator’s Manual – OPTI CCA-TS2...
Page 59 <Groups> at this time, or you can do this later, once custom groups have been created (see Section 3.2.3.1.3) The first time users log in to the OPTI, they will be asked to create a password. Fig. 3-53 User Information 8.
Page 60: Setting Up User Groups
The default options for user group functions are: Patient Measurement Control Measurement SRC Measurement tHb Calibrator Perform Maintenance Control Setup Fig. 3-57 Group Functions 3-24 Operator’s Manual – OPTI CCA-TS2...
Page 61 12. To delete a user group from the list, select the group and press the button. 13. Press to return to the <Setup> screen or Fig. 3-59 User Groups to return to the main screen. Operator’s Manual – OPTI CCA-TS2 3-25...
Page 62: Setting Up A Password
3 CUSTOMIZATION 3.2.3.2 Setting up a Password The OPTI CCA-TS2 has a password function which, when activated, will deny access to the setup menus and certain database functions. The factory default user ID and password is ADMIN. The factory-set password can be changed to any number/letter combination (up to 25 alphanumeric characters).
Page 63: System Reinitialization
3. Enter ADMIN user ID and password. 4. A message will be displayed asking you to confirm your choice (Fig. 3-63). to return to the <Setup> screen or 5. Press to return to the main screen. Fig. 3-63 Reinitialize Operator’s Manual – OPTI CCA-TS2 3-27...
Page 64: Miscellaneous System Settings
1. Select <Custom Header Enable>, press and enter the custom header. 2. Press to accept the changes. 3. Press to return to the <Setup> screen or to return to the main menu. Fig. 3-66 Header 3-28 Operator’s Manual – OPTI CCA-TS2...
Page 65: Defining Units
3 CUSTOMIZATION The OPTI CCA-TS2 can be connected to an external printer. In the <Configuration> menu (Fig. 3-67), you can select the printer configuration. 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.
Page 66 90 % 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 •...
Page 67: Selecting A Language
3 CUSTOMIZATION 3.2.4.3 Selecting a Language This menu lets you choose the language you want the OPTI CCA-TS2 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>...
Page 68: Hardware Settings
3.2.4.4.1 Entering the Barometric Pressure adjust the tracking barometer within the OPTI CCA-TS2, follow the instructions below: 1. In the main menu, select<System Manager> and <Setup>. 2. In the <System Setup> menu, press the <System>...
Page 69: Beep Adjustment
(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 Fig. 3-75 Enable Beep to return to the main menu. Operator’s Manual – OPTI CCA-TS2 3-33...
Page 70: Standby
• <Shutdown Enable> will shut down the instrument after a certain time period of analyzer inactivity to conserve power. When you enable this option you can select the number of minutes before the OPTI will shut down. To restart, push the power button. 4. Press to accept the changes.
Page 71: Setting Up Communications
3 CUSTOMIZATION 3.2.4.5 Setting up Communications The OPTI CCA-TS2 has a USB Type B port and an Ethernet port that may be used to communicate with a remote computer. These ports may be selected to transmit data in ASCII, ASTM or POCT1 format.
Page 72 3 CUSTOMIZATION <ASCII Ethernet> (Fig. 3-80) - Data in easy to read OPTI Medical custom format. The OPTI CCA-TS2 exports data string identical to the internal printer output. • Enter IP address of the host computer and port. • Press to accept the changes.
Page 73 • Select <Comma> or <Semicolon> for your CSV file delimiter in MS Excel. • Press to accept the changes. Press to return to the <Setup> screen or • to return to the main menu. Fig. 3-84 Removable Media Operator’s Manual – OPTI CCA-TS2 3-37...
Page 74: Configuring Ethernet Settings
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. 3-87 Ethernet Test 3-38 Operator’s Manual – OPTI CCA-TS2...
Page 75 5. Press to accept the changes. 6. Press to return to the <Setup> screen or to return to the main menu. When network connection is enabled, the status bar displays the network icon (Fig. 3-88). Operator’s Manual – OPTI CCA-TS2 3-39...
Page 76: Maintenance Setup
Reminder>, the system will alert you when weekly or monthly cleaning is due. Select <Monthly> cleaning if the analyzer is not used weekly. Refer to Chapter 7 for maintenance procedures. Fig. 3-91 Reminder Options 3-40 Operator’s Manual – OPTI CCA-TS2...
Page 77 QC Overview .....................4-2 Proficiency Testing ...................4-2 Calibration Verification ..................4-3 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 Operator’s Manual – OPTI CCA-TS2...
Page 78: Calibration And Quality Control
4 CALIBRATION AND QUALITY CONTROL CALIBRATION AND QUALITY CONTROL 4.1 Calibration Each lot of OPTI cassettes is calibrated during the manufacturing process. The calibration is performed using high precision standard solutions and gravimetrically-prepared gas mixtures to determine the cassette’s measurement characteristics at multiple points within the analyte’s measurable range.
Page 79: Qc Overview
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has published a protocol for establishing a quality assurance program. The Health Care Financing Administration (HCFA) and the Clinical and Laboratory Standards Institute (CLSI formerly NCCLS) have published standards for quality assurance in medical laboratories. Operator’s Manual – OPTI CCA-TS2...
Page 80: Calibration Verification
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.
Page 81: Running An Src Measurement
4 CALIBRATION AND QUALITY CONTROL 4.5.1 Running an SRC Measurement OPTI Medical Systems recommends running levels 1 and 3 (high and low values) of the Standard Reference Cassette (SRC) as a daily quality control for the OPTI CCA-TS2 analyzer. 1. In the main menu,...
Page 82 (Fig. 4-5). Fig. 4-5 Open Cover 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. 4-6 Insert SRC Operator’s Manual – OPTI CCA-TS2...
Page 83 Fig. 4-8 SRC Measurement • 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) Operator’s Manual – OPTI CCA-TS2...
Page 84 SMC with alcohol and a lint-free cloth and repeat this process. If it fails again, refer to the troubleshooting section in Chapter 8 of this manual. NOTE: For application of QC Lockout, please refer to section 3.2.1.2. NOTE: Verify with your particular regulatory agency and your internal policy regarding number of levels and frequency of SRCs to be run. Operator’s Manual – OPTI CCA-TS2...
Page 85: Running A Qc Sample
4 CALIBRATION AND QUALITY CONTROL 4.5.2 Running a QC Sample Policies regarding the measurement of QC samples are at the discretion of the individual hospital. OPTI Medical Systems recommends that QC solutions be run, as a minimum, with each new lot number of cassettes and at monthly intervals thereafter.
Page 86 NOTE: If a new lot number of QC material is used, make sure the ranges have been entered into the system prior to running a sample. (See Section 3.2.1.1). 4. Scan the bar-coded strip on the OPTI Cassette package by holding it 2-3 inches (5-8 cm) from the bar code scanner located on the bottom right-hand corner of the analyzer to automatically record the lot and calibration information for the specific cassette (Fig.
Page 87 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 than 2 minutes. Fig. 4-17 Insert Cassette 8. Close the SMC cover (Fig. 4-18). Fig. 4-18 Close Cover 4-10 Operator’s Manual – OPTI CCA-TS2...
Page 88 15. Hold the ampoule at a 45° angle during aspiration (Fig. 4-20). Use a new ampoule for each sample. 16. When using capillary tubes, push the tube firmly into the fillport (Fig. 4-21). 17. Press (Fig. 4-20). Fig. 4-21 Attach Capillary Tube Operator’s Manual – OPTI CCA-TS2 4-11...
Page 89 • Upon completion of the measurement, the results are displayed (Fig. 4-23). • The OPTI CCA-TS2 Analyzer will indicate whether the values are within or outside the programmed ranges with a <Pass/Fail> display next to the parameter label.
Page 90 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 Sample Preparation ..................5-4 5.2.1 Whole Blood Samples ....................
Page 91: Sample Handling And Patient Testing
Na , Cl , Glu and BUN (urea) in serum and plasma. The analyzer will accept specimens directly from most syringes, capillary tubes and the OPTI Medical ComfortSampler™ through the fillport on the OPTI Cassette. NOTE: Always follow proper safety procedures when handling biological samples.
Page 92: Syringes
Do not use clay-capped capillary tubes as the rough, broken edge left when the capillary is cut may cause damage to the OPTI cassette fill port. Use only capillary tubes with fire-polished ends to prevent damage to the cassette. If a mixing flea is used, as required in some capillary tubes, take care to remove the flea prior to sample introduction to avoid damage to the cassette.
Page 93: Handling And Storage Of Samples
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.
Page 94: Test Conditions
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 anticoagulants. CAUTION: Sedimentation of red cells may occur rapidly in whole heparinized blood. This may affect your tHb results. Make sure your sample is free of trapped gas bubbles and completely mixed, by rolling the syringe between the palms of your hands and inverting end over end for at least one minute, just prior to sample introduction. Operator’s Manual – OPTI CCA-TS2...
Page 95: Running A Patient Sample
The OPTI CCA-TS2 Analyzer is fast and easy to operate. Whenever the <Ready> screen appears, the unit is ready for sample measurement. 1. Turn on the OPTI CCA-TS2 and wait until this display appears (Fig. 5-1). 2. If security is enabled (see Section 3.2.3), log in...
Page 96 5 SAMPLE HANDLING AND PATIENT TESTING • During warm-up, the OPTI CCA-TS2 checks the gas pressure. Once it reaches 5% or less, the value will be displayed in red. If the pressure is too low, a warning will appear asking you to install a new gas bottle (see Section 7.5.1).
Page 97 5. Press down on the red latch to open the Sample Measurement Chamber (SMC) (Fig. 5-6). Fig. 5-6 Open SMC Cover 6. Insert the cassette as follows: • Open the OPTI Sensor Cassette pouch and remove the cassette (Fig. 5-7). After opening the pouch, proceed with the following steps immediately.
Page 98 Verify that patient ID and all other input parameters are correct for every patient sample measurement. • Press the <Patient Info> button to enter new patient information or to not use the last patient info as the default. Operator’s Manual – OPTI CCA-TS2...
Page 99 14. Attach the sample to the cassette fillport using a syringe and adapter, capillary or ComfortSampler, and press (Fig. 5-12). • When using a syringe, make sure the red syringe adapter is not touching the syringe plunger. Operator’s Manual – OPTI CCA-TS2...
Page 100 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 will start automatically when the first results are displayed. This feature may be turned off in setup (See Section 3.2.4.1). NOTE: If ASTM, POCT1, or removable media is enabled, the results will not be printed until the user exits the measurement process. The data will also be exported when it is printed. Additional information on printing Fig. 5-15 Measurement results reports and exporting data can be found in Chapter 6, Data Management. 5-10 Operator’s Manual – OPTI CCA-TS2...
Page 101 • When a possible measurement error occurs, the OPTI will flag patient results with a “?” on the display and printout and a blinking result on the screen. Repeat the measurement if possible.
Page 102: Data Management
6.2.3 Controls Diagnostics Reports ..................6-9 6.2.4 Error Report ......................... 6-10 Miscellaneous Reports...................6-11 6.3.1 Maintenance Report .....................6-11 Importing/Exporting Data ................6-12 6.4.1 Exporting Measurement Data ..................6-12 6.4.2 Exporting Configuration Data ..................6-14 6.4.3 Exporting the Database ....................6-15 Operator’s Manual - OPTI CCA-TS2...
Page 103: Data Management
Section 3.2.4.1. 1. To print a patient report, select <Data Manager> in the main menu (Fig. 6-1). Fig. 6-1 Data Manager 2. On the <Measurement> tab, select <Patient> (Fig. 6-2). Fig. 6-2 Select Patient Report Operator’s Manual - OPTI CCA-TS2...
Page 104 9. Records can be deleted from the database by marking them and pressing <Delete> NOTE: If you do not have permission to delete records, the button will not be active. to return to the <Data> screen or 10. Press to return to the main menu. Fig. 6-4 Measurement Results Operator’s Manual - OPTI CCA-TS2...
Page 105: Src Measurement Reports
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> NOTE: If you do not have permission to delete records, the button will not be active. Fig. 6-7 View SRC Results Operator’s Manual - OPTI CCA-TS2...
Page 106: Src Statistics Reports
6 DATA MANAGEMENT 6.1.3 SRC Statistics Reports The OPTI CCA-TS2 allows you to print out the statistics of the most recent 30 days of SRC measurements for all levels. 1. In the main menu, select <Data Manager> <SRC>. 2. In the <Data - SRC Measurement> screen, press the <Statistics>...
Page 107: Control Measurement Reports
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> NOTE: If you do not have permission to delete records, the button will not be active. Fig. 6-12 View Control Results Operator’s Manual - OPTI CCA-TS2...
Page 108: Control Statistics Reports
6 DATA MANAGEMENT 6.1.5 Control Statistics Reports The OPTI CCA-TS2 allows you to print out a statistical report of the last 30 control measurements or more, if available in the database. 1. In the main menu, select <Data Manager> <Control>.
Page 109: Printing Diagnostics Reports
All the measurements in between will be selected. 7. Press <All> to select all results. 8. Press <Print> to print your selection. Press to return to the <Data> screen or to return to the main menu. Fig. 6-17 Patient Diagnostics Operator’s Manual - OPTI CCA-TS2...
Page 110: Src Diagnostics Reports
All the measurements in between will be selected. 7. Press <All> to select all results. 8. Press <Print> to print your selection. to return to the <Data> screen or Press to return to the main menu. Fig. 6-20 SRC Diagnostics Operator’s Manual - OPTI CCA-TS2...
Page 111: Controls Diagnostics Reports
All the measurements in between will be selected. 7. Press <All> to select all results. 8. Press <Print> to print your selection. 9. Press to return to the <Data> screen or to return to the main menu. Fig. 6-23 Control Diagnostics Operator’s Manual - OPTI CCA-TS2...
Page 112: Error Report
5. Confirm your choice by pressing in the <Delete the Error Log?> screen (Fig. 6-26). Press to return to the <Data> screen or to return to the main menu. Fig. 6-26 Delete Error Log 6-10 Operator’s Manual - OPTI CCA-TS2...
Page 113: Miscellaneous Reports
5. Confirm your choice by pressing in the <Delete the Maintenance Log?> screen (Fig. 6-29). Press to return to the <Data> screen or Fig. 6-29 Delete Maintenance Log to return to the main menu. Operator’s Manual - OPTI CCA-TS2 6-11...
Page 114: Importing/Exporting Data
6 DATA MANAGEMENT 6.4 Importing/Exporting Data The OPTI CCA-TS2 provides you with the ability to export Patient and QC information to a connected computer or HIS/LIS. Prior to sending data to a computer, the OPTI CCA-TS2 communication port must be configured <Communications Setup>...
Page 115 An acknowledgement screen will be displayed Fig. 6-34 Eject USB device when it is safe to remove the device. 8. Press to return to the <Data> screen or to return to the main menu. Operator’s Manual - OPTI CCA-TS2 6-13...
Page 116: Exporting Configuration Data
An acknowledgement screen will be displayed when it is safe to remove the device. Fig. 6-37 Eject USB device to return to the <Data> screen or 7. Press to return to the main menu. 6-14 Operator’s Manual - OPTI CCA-TS2...
Page 117: Exporting The Database
An acknowledgement screen will be displayed when it is safe to remove the device. Fig. 6-40 Eject USB device 7. Press to return to the <Data> screen or to return to the main menu. Operator’s Manual - OPTI CCA-TS2 6-15...
Page 118 7.4.1 Replacing Peri Pump Cartridge ..................7-6 7.4.2 Replacing Gas I/O Port ....................7-8 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 Operator’s Manual – OPTI CCA-TS2...
Page 119: Maintenance
7 MAINTENANCE MAINTENANCE 7.1 Daily Maintenance No daily maintenance is required for the OPTI™ CCA-TS2 system. 7.2 Weekly Maintenance Once a week, the Sample Measurement Chamber (SMC) must be cleaned. Open the top cover and clean the optics surface as well as the underside of the SMC cover with a lint-free cloth, dampened with a dilute alcohol or ammonia-based cleaner as needed.
Page 120: Quarterly Maintenance - Performing Thb Calibration
Fig. 7-4 Enter User ID running Hb calibrators may be restricted. NOTE: Bar-coded user IDs may be entered from this screen using the bar code scanner. 3. A warning will be displayed the first time a new tHb Calibrator lot is used (Fig. 7-5). Press <Continue>. Fig. 7-5 New Calibrator Operator’s Manual – OPTI CCA-TS2...
Page 121 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. 7-8 Wipe and Insert Cassette Operator’s Manual – OPTI CCA-TS2...
Page 122 (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 Operator’s Manual – OPTI CCA-TS2...
Page 123 1.023 1.014 1.087 1.080 1.089 1.094 0.000 0.000 0.000 0.000 1.062 1.087 1.082 Fig. 7-12 HbCal Report • Once the Hb Calibration is complete, the <Ready> display will appear (Fig. 7-13). Fig. 7-13 Ready Screen Operator’s Manual – OPTI CCA-TS2...
Page 124: Annual Maintenance
(keyway) in the pump cartridge roller. Press the cartridge firmly down until it is fully seated on the housing of the instrument (Fig. 7-16). Fig. 7-16 Install New Cartridge Operator’s Manual – OPTI CCA-TS2...
Page 125 Make sure the control measurement passes without errors. Fig. 7-17 Push on Pump Roller The OPTI CCA-TS2 has a function that allows you to select maintenance reminder options which will 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.
Page 126: Replacing Gas I/O Port
3. Perform a <Pump Test> (see section 8.2.16) Fig. 7-20 Gas I/O Port 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 measurement passes without errors. Operator’s Manual – OPTI CCA-TS2...
Page 127: As Needed Maintenance
NOTE: The gas bottle should always be stored with the cap on. 5. When prompted (Fig. 7-23), install the new gas bottle. 6. Insert the bottle into its housing and turn it clockwise until finger-tight (Fig. 7-24). Press (Fig. 7-23). Fig. 7-24 Gas Bottle Operator’s Manual – OPTI CCA-TS2...
Page 128 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). Fig. 7-27 Ready screen 7-10 Operator’s Manual – OPTI CCA-TS2...
Page 129: Changing The 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 wiping the exterior analyzer surfaces including touch screen with a soft, damp cloth.
Page 130 8.2.19 Gas Test ........................8-30 8.2.20 Setting up the B-Lac Cassette ..................8-31 8.2.21 Cassette Detect ......................8-33 Troubleshooting ....................8-34 8.3.1 Troubleshooting Procedure for tHb/SO ..............8-34 8.3.2 Troubleshooting Procedure for Bar Code Scanner ............8-35 Operator’s Manual – OPTI CCA-TS2...
Page 131: Diagnostics And Troubleshooting
System errors are stored in memory and an error report can be printed (see Section 6.2.4). If your OPTI CCA-TS2 does not perform correctly after conducting the basic steps outlined in this chapter, you should contact OPTI Medical Systems for technical assistance.
Page 132: System Warning Messages
• For lactate cassettes, you have the option of continuing the measurement by pressing or stopping by pressing If you continue, no results will be provided for the defective sensor or any calculated result, which utilizes this measurement in its calculation. Operator’s Manual – OPTI CCA-TS2...
Page 133 <WARNING! - Gas Test!> The <Gas Test> is designed exclusively for use by authorized OPTI Medical personnel to check for leaks in the gas system. This test will last 2 hours and can only be interrupted by switching the analyzer off.
Page 134 Calibrator Cassette on hand or ordered. <WARNING! - New tHb Calibrator> This message is displayed to alert the user that a new tHb calibrator is being used. • Press to continue measurement with the new tHb calibrator. Operator’s Manual – OPTI CCA-TS2...
Page 135 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 patient ID with the required number of characters. Operator’s Manual – OPTI CCA-TS2...
Page 136: System Error Messages
<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.
Page 137 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. Operator’s Manual – OPTI CCA-TS2...
Page 138 If a bubble was detected, the system attempted to restart the aspiration and was not able to aspirate enough sample. • Press and discard the cassette. Operator’s Manual – OPTI CCA-TS2...
Page 139 8 DIAGNOSTICS AND TROUBLESHOOTING <ERROR! - Invalid Barcode> The bar code was invalid. The OPTI CCA-TS2 either misread the bar code label or it is an invalid bar code for the OPTI CCA-TS2. • Press to retry. • If the error message appears again, check the product package for intended use.
Page 140 The user ID does not exist in current user database. • Press to continue. • Retry with a valid user ID. <ERROR! - User Expired> The user ID expired. • Press to continue. • Update the user information. 8-10 Operator’s Manual – OPTI CCA-TS2...
Page 141 There are not enough records in the database to generate a statistics report. • Press to continue. <ERROR! - Group Name Already Exists> The selected group name already exists in the database. • Press to continue. • Enter a unique group name. Operator’s Manual – OPTI CCA-TS2 8-11...
Page 142: System Stop Messages
<STOP! - Temperature Out of Range> The temperature is out of range during any kind of measurement. • Press and continue. • If the error message appears again, check the temperature under <System - Diagnostics>. 8-12 Operator’s Manual – OPTI CCA-TS2...
Page 143: Not Ready Messages
• 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. Operator’s Manual – OPTI CCA-TS2 8-13...
Page 144 If <SRC Lockout> has been activated in <Setup> (see Section 3.2.1.2), this message will be displayed if SRCs have not been run within the specified time. • Press <Run SRC> and run SRCs (see Section 4.5.1). 8-14 Operator’s Manual – OPTI CCA-TS2...
Page 145 <Measurement Access Prohibited> The user does not have privileges to run a patient measurement as defined by the security settings (Section 3.2.3). • Press <Data Manager>, <QC Manager> or <System Manager> to exit this screen. Operator’s Manual – OPTI CCA-TS2 8-15...
Page 146: Fatal Error Messages
Dark currents exceed allowable limits. • 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. 8-16 Operator’s Manual – OPTI CCA-TS2...
Page 147 • 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. Operator’s Manual – OPTI CCA-TS2 8-17...
Page 148: Diagnostics
8 DIAGNOSTICS AND TROUBLESHOOTING 8.2 Diagnostics Your OPTI CCA-TS2 has a number of useful diagnostic programs. In the main menu, press <System Manager-> Diagnostics> (Fig. 8-1). The <Diagnostics> screen contains three tabs with various diagnostic functions: <Sensors>, <Hardware> and <Tests>.
Page 149: Checking System Temperatures
• Scan the gas bottle bar code located on the insert sheet to install a new gas bottle (see Section 7.5.1 “Changing Gas Bottle”) . Fig. 8-4 Gas Pressure to return to the <System> screen • Press to return to the main menu. Operator’s Manual – OPTI CCA-TS2 8-19...
Page 150: Checking The Leds
• If the barometric pressure requires adjustment, refer to Setup, Section 3.2.4.4.1 “Entering the Barometric Pressure” for setting the barometer. • Press to return to the <System> screen to return to the main menu. Fig. 8-6 Barometric Pressure 8-20 Operator’s Manual – OPTI CCA-TS2...
Page 151: Checking The Battery Voltage
• You should feel the draft of the fan by placing your hand over the fan at the back side of the analyzer. • Press to return to the <System> screen to return to the main menu. Fig. 8-8 Cooling Fan Operator’s Manual – OPTI CCA-TS2 8-21...
Page 152: Checking The Gas Valve
(allowed positions are 1 - 12) to verify the valve drive moves smoothly and precisely. • Press to return to the <System> screen to return to the main menu. Fig. 8-10 Valve Drive 8-22 Operator’s Manual – OPTI CCA-TS2...
Page 153: Checking The Factory Settings (Fset)
8 DIAGNOSTICS AND TROUBLESHOOTING 8.2.10 Checking the Factory Settings (FSet) The <FSet> function (Fig. 8-11) is designed exclusively for use by authorized OPTI Medical personnel and requires a special User ID and password. • Press to return to the <System> screen to return to the main menu.
Page 154: Checking The Printer
If the printout is deficient, your printer may need Fig. 8-15 Printer Test 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.
Page 155: Checking The Optics
Fig. 8-18 Insert Cassette operation of the optical system. • At the completion of the test, the results will be printed and you will be asked to remove the cassette (Fig. 8-19). Fig. 8-19 Remove Cassette Operator’s Manual – OPTI CCA-TS2 8-25...
Page 156: Checking The Ethernet Interface
Fig. 8-20 Ethernet Test • The system will send out data and check if they are received (Fig. 8-21). • Press to return to the <System> screen to return to the main menu Fig. 8-21 Ethernet Test 8-26 Operator’s Manual – OPTI CCA-TS2...
Page 157: Checking The Pump Flow
• Repeat test or replace the pump cartridge, if Fig. 8-25 Flow Test Pass 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. 8-26). Fig. 8-26 Remove Cassette Operator’s Manual – OPTI CCA-TS2 8-27...
Page 158: Checking The Pump Motor
• The display will turn red, green and blue. If this is not the case, your display is defective and needs to be replaced. • Press to return to the <System> screen to return to the main menu. Fig. 8-29 Display Test 8-28 Operator’s Manual – OPTI CCA-TS2...
Page 159: Checking The Touch 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 to return to the main menu. Fig. 8-32 Touch Calibration Operator’s Manual – OPTI CCA-TS2 8-29...
Page 160: Gas Test
8 DIAGNOSTICS AND TROUBLESHOOTING 8.2.19 Gas Test 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. Fig. 8-33 Gas Test • Press to cancel this test (Fig. 8-34).
Page 161: Setting Up The B-Lac Cassette
This message (Fig. 8-37) is displayed if lactate is already set up. • Press to keep the current settings and cancel the setup process. • Press to start the setup process. Fig. 8-37 B-Lac Setup Operator’s Manual – OPTI CCA-TS2 8-31...
Page 162 8 ampoules of OPTI Check level 2 (Fig. 8-38). Please make sure you have at least 8 ampoules of the same lot of OPTI Check and 8 B-Lac cassettes of the same lot on hand before starting setup. •...
Page 163: Cassette Detect
• Remove the cassette and leave the cover open (Fig. 8-43). Fig. 8-43 Remove Cassette • Close the SMC cover (Fig. 8-44). Fig. 8-44 Close Cover • The system performs a Cassette Detection Calibration (Fig. 8-45). Fig. 8-45 Calibration Operator’s Manual – OPTI CCA-TS2 8-33...
Page 164: Troubleshooting
8 DIAGNOSTICS AND TROUBLESHOOTING 8.3 Troubleshooting 8.3.1 Troubleshooting Procedure for tHb/SO If your OPTI fails an Hb calibration or QC measurement for tHb or SO , OPTI Medical recommends that you clean the SMC cover of your analyzer and then repeat the measurement.
Page 165: Troubleshooting Procedure 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. Operator’s Manual – OPTI CCA-TS2 8-35...
Page 166: Operating Principles
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 Medical ComfortSamplers™ ................9-4 9.4.7 Handling and Storage of Samples ................. 9-4 Procedure ......................9-5 9.5.1 Materials Needed ......................9-5 9.5.2 Test Conditions ......................
Page 167: Operating Principles
9 OPERATING PRINCIPLES OPERATING PRINCIPLES 9.1 Intended Use OPTI™ CCA-TS2 Critical Care Analyzer is intended to be used for the measurement of hydrogen ion concentration (pH), carbon dioxide partial pressure (PCO ), oxygen partial pressure (PO ), sodium ), potassium (K...
Page 168: Operation
9 OPERATING PRINCIPLES 9.3 Operation The OPTI CCA-TS2 is a microprocessor-based instrument measuring optical fluorescence. A disposable, single-use cassette contains all the elements needed for calibration, sample measurement and waste containment. After scanning the calibration information specific to a cassette into the instrument by holding the cassette package in front of a convenient bar code scanner, the cassette is placed into the measurement chamber.
Page 169: Specimen Collection And Handling
Capillary blood specimens should be collected using capillary tubes which have a minimum volume, filled, of 125 µL. The OPTI Medical capillary tubes (MC0024) are ideally suited with a minimum volume, filled, of 200 µL. The capillary tubes for pH, blood gas, and electrolyte analysis should not be used for samples taken for the analysis of lithium.
Page 170: Opti Medical Comfortsamplers
Do not use clay-capped capillary tubes as the rough, broken edge left when the capillary is cut may cause damage to the OPTI cassette fill port. Use only capillary tubes with fire-polished ends to prevent damage to the cassette. If a mixing flea is used, as required in some capillary tubes, take care to remove the flea prior to sample introduction to avoid damage to the cassette.
Page 171: Procedure
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.
Page 172: Test Conditions
Sample Collection Time Month, DD, YY, HH:MM Blank Sample Type Art, Ven, MixVen, Cap, Cord, CPB, where: Art = Arterial Ven = Venous MixVen = Mixed Venous Cap = Capillary Cord = Cord CPB = Cardio-Pulmonary Bypass Operator’s Manual – OPTI CCA-TS2...
Page 173 PSV = Pressure Support 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 Operator’s Manual – OPTI CCA-TS2...
Page 174 2.0 to 5.33 kPa 3.56 kPa Bi-Level Pressure Numerator 0.2 - 9.9 Bi-Level Pressure Denominator 0.2 - 9.9 I/E Ratio Numerator 0.2 - 9.9 I/E Ratio Denominator 0.2 - 9.9 Comment Field 50 alphanumeric characters Blank Operator’s Manual – OPTI CCA-TS2...
Page 175: Calculated Values
0.1 to 3.0 mmol/L 9.5.5 Calibration Each lot of OPTI cassettes is calibrated during the manufacturing process. The process utilizes high precision standard solutions spanning the operating range for pH and ions. For O , CO , tHb and SO the calibration parameters are determined using specially targeted calibration standards focusing on the clinically critical ranges.
Page 176: Quality Control
On these 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.
Page 177: Reference Intervals
3.2.2.4 of this manual. 9.5.8 Specific Performance Characteristics All performance data in this section was generated on OPTI CCA-TS2 systems with the SRC run daily to check QC. Quality control material was run with each new lot of cassettes.
Page 178: Limitations
PO measurement, as well as pH was evaluated over a 20 day period using two OPTI CCA-TS2 systems with two replicates per run using a commercially available solution of reduced bovine hemoglobin which has been demonstrated to be comparable to tonometered whole blood.
Page 179: Interferences
These substances were selected on the basis of their optical absorbance or fluorescence properties likely to affect the optical signal measured by the OPTI CCA-TS2, or the optical properties of the sensor measured by the analyzer. To cause interference to the optical sensors, the substances must be highly mobile (low molecular weight) and highly colored, in order to penetrate the optode membrane barriers quickly (within the 90 sec.
Page 180: Accessories
, PO , Lac, tHb, SO Type “B60”, BP7586 (pH, PCO , PO Use: For measurement of various analytes with the OPTI CCA-TS2 Analyzer. Contents: Box contains 25 individually packaged cassettes. Each disposable plastic cassette contains buffer and optical sensors. Composition: Aqueous HEPES-bicarbonate buffer solution 0.2 mL with biocides.
Page 181 Precautions Use of calibration solutions, 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;...
Page 182 10 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 Operator’s Manual – OPTI CCA-TS2 10-i...
Page 183: Supplies
10 SUPPLIES 10 SUPPLIES Each OPTI™ CCA-TS2 is shipped with maintenance supplies and other accessories. Below is a listing of all necessary supplies and accessories. To order replacement supplies and accessories, contact your local authorized OPTI Medical Distributor or, in the U.S., call the OPTI Medical Order Entry Department at 1-800-490-6784 (OPTI) Monday through Friday, 8 AM to 5 PM eastern time.
Page 184: Consumable Items
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 10-2 Operator’s Manual – OPTI CCA-TS2...
Page 185: Spare Parts
Seal SMC Gas I/O Port RE7030 10.8 Technical Assistance Most often, problems with your OPTI CCA-TS2 can be resolved over the telephone, getting the analyzer back in service within minutes. Our technicians have the training and experience necessary to provide dependable technical assistance.
Page 186: Warranty Registration (U.s. Market Only)
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.
Page 187: Analytes
) ........................... 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 (SO %) ............... THB/SO2-1 Operator’s Manual – OPTI CCA-TS2...
Page 188 Measurement Range Range Resolution (Low/High) Units 6.6 to 7.8 0.01/0.001 pH units Standard Reference Cassette (SRC) Limit Values NORMAL HIGH Units 7.100 ± 0.02 7.400 ± 0.02 7.600 ± 0.02 pH units Operator’s Manual – OPTI CCA-TS2 pH-1...
Page 189 This testing was done on the OPTI 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.
Page 190 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 %CO mixtures to establish the correlation.
Page 191 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on the OPTI CCA-TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures.
Page 192 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 193: Ph (Dry Sensor - B-Lac Cassette)
<< pKa). pH optodes do not need a reference electrode to measure pH, however, they exhibit a small sensitivity to the ionic strength of the sample being measured Measurement Range Range Resolution (Low/High) Units 6.6 to 7.8 0.01/0.001 pH units Operator’s Manual – OPTI CCA-TS2 pH-B-1...
Page 194 EP7-A2, showing 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-TS platform, with a standard OPTI style pH sensor. No changes were made to the sensor or the measurement principle, so the interference of...
Page 195 0.1% 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 10 samples for each level. Dry pH Whole Blood...
Page 196 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 %CO mixtures to establish the correlation.
Page 197 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on the OPTI CCA-TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures.
Page 198 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 199: Pco
Interference testing was done on the OPTI CCA platform, with a standard OPTI style pCO 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.
Page 200 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 10 samples for each level. (mmHg) Whole Blood...
Page 201 The linearity of the pCO 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 %CO mixtures to establish the correlation. Scatter Plot with Fit...
Page 202 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on the OPTI CCA-TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures.
Page 203 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 204: Pco (Dry Sensor - B-Lac Cassette)
1/0.1 mmHg 1.33 to 26.66 0.1/0.01 Standard Reference Cassette (SRC) Limit Values NORMAL HIGH Units 70.0 ± 2.0 40.0 ± 2.0 20.0 ± 2.0 mmHg 9.33 ± 0.27 5.33 ± 0.27 2.67 ± 0.27 Operator’s Manual – OPTI CCA-TS2 PCO2-B-1...
Page 205 This testing was done on the OPTI CCA-TS platform, with a standard OPTI style pCO 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...
Page 206 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 from 10 samples for each level. Dry PCO (mmHg)
Page 207 The linearity of the pCO 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 %CO mixtures to establish the correlation. Scatter Plot with Fit...
Page 208 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on the OPTI CCA-TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures.
Page 209 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 210 Interference testing was done on the OPTI CCA platform, with a standard OPTI style pO 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.
Page 211 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 10 samples for each level. (mmHg) Whole Blood...
Page 212 The linearity of the pO 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 %O mixtures to establish the correlation. Scatter Plot with Fit...
Page 213 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on the OPTI CCA-TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures.
Page 214 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 215: Po (Dry Sensor - B-Lac Cassette)
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.
Page 216 This testing was done on the OPTI CCA-TS platform, with standard an OPTI style PO 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...
Page 217 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 10 samples for each level. Dry PO (mmHg)
Page 218 The linearity of the pO 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 %O mixtures to establish the correlation. Scatter Plot with Fit...
Page 219 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on the OPTI CCA-TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures.
Page 220 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 221: Sodium (Na
Like the pH optode, the ion optodes do not need a reference electrode, however, several of them do exhibit a small pH sensitivity which is automatically compensated in the OPTI CCA-TS2 using the measured pH. Measurement Range...
Page 222 This testing was done on the OPTI CCA platform, with a standard OPTI style Sodium 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.
Page 223 ) and by measurement of N.I.S.T. Standard Reference Material956a Electrolytes in Human Serum (Sodium ). No changes were made to the sensor NIST or the measurement principle, so the traceability of the OPTI CCA-TS2 is equivalent to the OPTI CCA. Correlation Slope Intercept Correlation Sy.x...
Page 224 Direct linearity for the OPTI CCA-TS2 measurement has been established against reference materials or methods. The linearity of the Sodium 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.
Page 225 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators 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.
Page 226 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 227: Potassium (K
Like the pH optode, the ion optodes do not need a reference electrode, however, several of them do exhibit a small pH sensitivity which is automatically compensated in the OPTI CCA-TS2 using the measured pH. Measurement Range...
Page 228 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.
Page 229 ) and by measurement of N.I.S.T. Standard Reference Material 956a Electrolytes in Human Serum (Potassium ). No changes were made to the NIST Potassium sensor or the measurement principle, so the traceability of the OPTI CCA-TS2 is equivalent to the OPTI CCA. Correlation Slope...
Page 230 Direct linearity for the OPTI CCA-TS2 measurement has been established against reference materials or methods. The linearity of the Potassium 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.
Page 231 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators 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.
Page 232 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 233: Ionized Calcium (Ca
The OPTI CCA-TS2 measures the ionized portion of the total calcium. In certain disorders such as pancreatitis and hyperparathyroidism, ionized calcium is a better indicator for diagnosis than total calcium.
Page 234 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.
Page 235 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 10 samples for each level. (mmol/L) Whole Blood...
Page 236 Direct linearity for the OPTI CCA-TS2 measurement has been established against reference materials or methods. The linearity of the Ionized Calcium 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.
Page 237 Excess blood aliquots from specimens collected for electrolyte analyses were analyzed by both traditional and non-traditional operators 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.
Page 238 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 239: Chloride (Cl
Like the pH optode, the ion optodes do not need a reference electrode, however, several of them do exhibit a small pH sensitivity which is automatically compensated in the OPTI CCA-TS2 using the measured pH. Measurement Range...
Page 240 This testing was done on the OPTI CCA platform, with a standard OPTI style Chloride 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.
Page 241 N.I.S.T. traceable aqueous standard solutions (Chloride ). Chloride linearity in serum is established against Chloridometry (Chloride ). 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 Sy.x...
Page 242 Direct linearity for the OPTI CCA-TS2 measurement has been established against reference materials or methods. The linearity of the Chloride 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.
Page 243 Excess blood aliquots from specimens collected for electrolyte analyses were analyzed by both traditional and non-traditional operators 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.
Page 244 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 245: Glucose (Glu)
Reactive Hypoglycaemia occurs, within 5-hours of a carbohydrate meal in otherwise normal patients, in patients with early adult onset diabetes mellitus and in patients who have had gastric surgery. Fasting Hypoglycaemia can be due to insulinomas, non-pancreatic tumors, endocrine disorders, liver failure, sepsis, renal failure or autoimmune disorders. Operator’s Manual – OPTI CCA-TS2 Glu-1...
Page 246 700 mmHg. Glucose values are suppressed when PO values are > 700 mmHg. This testing was done on the OPTI CCA platform, with a standard OPTI style Glucose 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.
Page 247 3.0% 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 from 10 samples for each level. Glucose (mg/dL) Whole Blood...
Page 248 Direct linearity for the OPTI CCA-TS2 measurement has been established against reference materials or methods. The linearity of the Glucose 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.
Page 249 ANALYTES GLUCOSE Correlation to Other Methods OPTI CCA-TS vs other Glucose Instruments on Whole Blood, Plasma and Serum in a typical setting Excess sample aliquots from specimens collected for metabolyte analyses were analyzed by both traditional and non-traditional operators 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.
Page 250 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 251 The ammonium ions are measured by an ammonium-selective fluorescence-based optical sensor (optode). The amount of urea present is proportional to the ammonium concentration detected. Measurement Range Range Resolution (Low/High) Units 2.8 to 112.0 0.1/0.1 mg/dL 1 to 40 0.01/0.01 mmol/L Operator’s Manual – OPTI CCA-TS2 BUN-1...
Page 252: Bun/Urea
At extreme hyperammonemia (plasma levels of 3000µmol/L), the OPTI CCA BUN(urea) sensor will show an offset of +4.8 mg/dL BUN (1.7 mmol/L urea). This testing was done on the OPTI CCA platform, with a standard OPTI style BUN(urea) 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.
Page 253: Bun/Urea
BUN(urea) linearity in serum is by measurement of N.I.S.T. Standard Reference Material 909b in Frozen Human Serum (BUN ). No changes were made to the BUN(urea) sensor or NIST the measurement principle, so the traceability of the OPTI CCA-TS2 is equivalent to the OPTI CCA. Correlation Slope Intercept Correlation Sy.x...
Page 254 Direct linearity for the OPTI CCA-TS2 measurement has been established against reference materials or methods. The linearity of the BUN (urea) 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.
Page 255 BUN/UREA Correlation to Other Methods OPTI CCA-TS vs other BUN (urea) Instruments on Plasma and Serum in a typical setting Excess sample aliquots from specimens collected for metabolyte analyses were analyzed by both traditional and non-traditional operators 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.
Page 256 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 257: Lactate (B-Lac Cassette)
• Ischemic Hypoxia: Hypoxia that occurs when blood flow to tissue is low. Measurement Principle The OPTI Medical lactate biosensor contains the enzyme lactate oxidase to selectively catalyze the reaction between lactate and oxygen, as outlined in the reaction sequence.
Page 258: Lactate (B-Lac Cassette)
EP7-A2, showing 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-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.
Page 259 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 analyzers in parallel due to the rapid change of lactate in whole blood. The table below shows the Averages, the Standard Deviations and the %CV calculated from 10 samples for each level.
Page 260 Direct linearity for the OPTI CCA-TS2 measurement has been established against reference materials or methods. The linearity of the Lactate 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.
Page 261 Excess sample aliquots from specimens collected for metabolyte analyses were analyzed by both traditional and non-traditional operators 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.
Page 262 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 263: Total Hemoglobin Concentration (Cthb) And Hemoglobin Oxygen Saturation (So %)
Hb), defined as a fraction of total available hemoglobin, may also be caused by unusually large amounts of non-functional hemoglobins, high concentrations of deoxyhemoglobin, chemically altered hemoglobin or factors affecting the affinity of hemoglobin for oxygen, including: temperature, pH, PCO , 2,3-DPG concentration and type of hemoglobin Operator’s Manual – OPTI CCA-TS2 THB/SO2-1...
Page 264: Thb/So2-1
60 to 100 1/0.1 Standard Reference Cassette (SRC) Limit Values NORMAL HIGH Units 20.0 ± 1.5 14.0 ± 1.5 8.0 ± 1.5 g/dL NORMAL HIGH Units 70.0 ± 2.0 90.0 ± 2.0 98.0 ± 2.0 THB/SO2-2 Operator’s Manual – OPTI CCA-TS2...
Page 265 This testing was done on the OPTI CCA platform, with a standard OPTI style cassette. No changes were made to the sensor or the measurement principle for the tHb and SO measurement, so the interference of the OPTI CCA-TS2 is equivalent to the OPTI CCA.
Page 266 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 shows the Averages, Standard Deviations and % CV calculated from 10 samples for each level. tHb (g/dL) Whole Blood...
Page 267 Total hemoglobin content linearity is established by the photometric determination of cyanmethemoglobin . No standard method exists for the measurement of oxygen saturation. No changes were made to the tHb measurement principle, so the linearity of the OPTI CCA-TS2 is equivalent to the OPTI CCA-TS Correlation...
Page 268 ANALYTES The linearity of the SO % measurement on the OPTI CCA-TS2 has been established versus the same sensor on the OPTI CCA-TS using whole blood samples tonometered with different %O gas mixtures to establish the correlation. Scatter Plot with Fit...
Page 269 Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non-traditional operators of blood gas equipment in hospital laboratories. The blood was analyzed on the OPTI CCA-TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures.
Page 270 OPTI CCA-TS2 vs OPTI CCA-TS on whole blood in a typical setting In Method Comparisons carried out following the experimental 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.
Page 271 (Elsevier Saunders, 2006) pps. 2252-2302. 3. Tietz; Burtis C, et al (Eds.), Textbook of Clinical Chemistry and Molecular Diagnostics, 4 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). NCCLS. Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; – Approved Standard 3 Edition;...
Page 272: Appendix A - Technical Specifications
APPENDIX D - REPORT FORMATS ............D-1 Basic Patient Report .........................D-1 SRC Measurement Report .......................D-2 SRC Statistics Report .......................D-3 Controls Measurement Report ....................D-4 Controls Statistics Report ......................D-5 Maintenance Report ........................D-6 Error Report ..........................D-7 B-Lac Setup Report ........................D-8 Operator’s Manual – OPTI CCA-TS2...
Page 273 5 to 25 g/dL 60 to 100 1/0.1 Barometric Pressure 300 to 800 mmHg Operating Altitude Up to 3048m (10,000ft) Pollution Degree Degree 2, normal indoor laboratory environment. Air contains only non-conductive pollutants with occasional condensation. Operator’s Manual – OPTI CCA-TS2...
Page 274: Operating Parameters
Cord = Cord CPB = Cardio-Pulmonary Bypass Puncture Site LR/RR/LB/RB/LF/RF/Cord/Scalp, where: LR/RR = Left Radial/Right Radial LB/RB = Left Brachial/Right Brachial LF/RF = Left Femoral/Right Femoral Cord = Cord Scalp = Scalp Allen’s Test Unknown, positive, negative Operator’s Manual – OPTI CCA-TS2...
Page 275 Positive End Expiratory Pressure, PEEP 0 – 50 Rate (f) 0 – 155 Continuous Positive Airway Pressure, 0 – 50 CPAP Total Hemoglobin, tHb 1.0 - 26.0 g/dL 0.62 – 16.14 mmol/L 1 – 260 g/L 0.21 – 1.00 Operator’s Manual – OPTI CCA-TS2...
Page 276: Temperature Corrected Values
3 - 30 mmol/L 15.0 - 35.0 mmHg 0.1 - 3.0 mmol/L Temperature Corrected Values Parameter Range Display Units Resolution (Lo/Hi) 6.6 - 7.8 0.01/0.001 pH units 10 - 200 1/0.1 mmHg 10 - 700 1/0.1 mmHg Operator’s Manual – OPTI CCA-TS2...
Page 277: Reference Ranges
W.B. Saunders Co., 1994. Henry JB, “Clinical Diagnosis and Management by Laboratory Methods”, 19th Edition, Philadelphia, W.B. Saunders Co., 1996 Shapiro BA, Peruzzi WT, Kozelowski-Templin R. “Clinical Application of Blood Gases”, 5th Ed.,(Chicago: Mosby, 1994) Operator’s Manual – OPTI CCA-TS2...
Page 278: Data Management
1 x USB Type A port, 1 x USB Type B port, 1 x Ethernet port Format ASCII, ASTM, POCT1 and CSV. Storage Data storage on the OPTI CCA-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 ±...
Page 279: Classifications
This device is a Class 1 laser device according to IEC 60825-1 Explosion Protection: This device is not designed for operation in explosive environments Calculated Parameters The calculated parameters in the OPTI CCA-TS2 are based on the CLSI Standard C12-A, when available. Temperature ° ⋅ °...
Page 280: Conversion Table For Units
[mmol/L] Burtis AB, Ashwood ER, “Tietz Textbook of Clinical Chemistry” 2 Ed. (Philadelphia, W.B. Saunders 1994), p. 46. Marsoner HJ, “Quantities and Algorithms Related to Blood Gas and Acid Base Analysis”, AVL Medizintechnik Graz, 1995. Operator’s Manual – OPTI CCA-TS2...
Page 281 − (act)   − ⋅ ⋅ −     [mmol/L ] CLSI. Blood Gas and pH Analysis and Related Measurements; Approved Guideline. NCCLS document C46-A, 2001. Zander R., Die korrekte Bestimmung des Base Excess (BE mmol/l) im Blut. Anesthesiol. Intensivmed. Notfallmed. Schmerzther. Operator’s Manual – OPTI CCA-TS2...
Page 282 2,3 diphosphoglycerate (2,3 DPG) content. Although it is possible to calculate this value, the assumptions which are made in the calculation can cause significant errors in the resulting value for those patients who are in the most critical clinical state. The OPTI CCA-TS2 has the capability to provide a measured SO from the blood sample.
Page 283 50% with pH and PO held constant at 7.4 and 40 mmHg respectively, the OPTI CCA- TS2 allows for the estimation of P50 from measured SO and pH.
Page 284 + (1 – FIO )/R] total with PH = 47 * 10 [0.0237 – 0.0001 (t-37)] (t-37) and PACO = PaCO (alveolar PCO = arterial PCO Apply above equation for PAO , otherwise PAO ≥ PO = PO A-12 Operator’s Manual – OPTI CCA-TS2...
Page 285 (pH = 7.4) = Ca * 10 [mmol/L] 0.22*(pH-7.4) For plasma or serum: (pH = 7.4) = Ca * 10 [mmol/L] 0.24*(pH-7.4) Simmons A, ed. Hematology, “A Combined Theoretical & Technical Approach”, pp. 28-29 (Philadelphia, W.B. Saunders, 1989) Operator’s Manual – OPTI CCA-TS2 A-13...
Page 286: Appendix B - Menu Structure
APPENDIX B - MENU STRUCTURE APPENDIX B - MENU STRUCTURE Operator’s Manual – OPTI CCA-TS2...
Page 287 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 Operator’s Manual – OPTI CCA-TS2...
Page 288: Basic Patient Report
ACID/BASE pH under 7.200 (Ref.Lim) ↓ 7.143 PCO2 over 50.0 (Ref.Lim) PCO2 ↑ 76.0 mmHg tHb Result suppressed. 74.5 mmHg SO2 Result suppressed. ↓ - 6.0 mmol/L ___________________________ tCO2 27.3 mmol/L HCO3 ↑ 24.9 mmol/L Operator’s Manual – OPTI CCA-TS2...
Page 289: Src Measurement Report
Version: 1.23.4567 Level: 3 SRCID: 12345678 Exp: MMMYYYY Result Limits 7.601 7.580-7.620 PCO2 20.0 18.0-22.0 170.0 167.0-173.0 65.1 42-148 7.00 6.70-7.30 Ca++ 0.70 0.60-0.80 6.5- 9.5 98.6 96.0-100.0 SRC Test Result: PASS Operator ID: Operator123 ____________________________ Operator’s Manual – OPTI CCA-TS2...
Page 290: Src Statistics Report
1.00 OK Feb4 125.0 2.50 Feb7 40.0 1.00 OK Feb4 125.0 2.50 Mean: 40.0 1.00 Feb7 125.0 2.50 0.00 Feb7 125.0 2.50 79.8 OK CV%: 0.9 0.00 Mean: 125.0 2.50 000.0 0.00 ___________________________ CV%: 000.0 0.00 Operator’s Manual – OPTI CCA-TS2...
Page 291: Controls Measurement Report
42 - 148 7.00 6.70 - 7.30 Ca++ 0.70 0.60 - 0.80 6.5 - 9.5 98.6 96.0 - 100.0 Control Test Result: PASS Store to Database: Yes Barometer: 734.6mmHg Operator ID: Operator123 Lot: 123456 MESSAGES ______________________________ Operator’s Manual – OPTI CCA-TS2...
Page 292: Controls Statistics Report
0.013 15.9 27.0 CV%: 0.181 67.2 20.2 ELECTROLYTE LIMITS 136.0 - 150.0 mmol/L 4.50 - 5.30 mmol/L Date Feb4 Feb4 Feb4 ---- 5.03 Feb4 Feb7 Feb7 142.9 4.88 Mean: ---- 4.96 ---- 0.11 CV%: ---- 2.14 Operator’s Manual – OPTI CCA-TS2...
Page 293: Maintenance Report
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 _______________________________ Operator’s Manual – OPTI CCA-TS2...
Page 294: Error Report
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 ___________________ Operator’s Manual – OPTI CCA-TS2...
Page 295: B-Lac Setup Report
7.4232 / 7.4336 7.4250 / 7.4354 7.4037 / 7.4142 7.4251 / 7.4356 7.4208 / 7.4313 ------ / ------ AVG pH 7.4196 / 7.4300 0.00805 Outliers: 0 Scalar: 1.011741 B-Lac Setup : PASS S/N:2999 LOT:020651 __________________________ Operator’s Manual – OPTI CCA-TS2...
Page 296: Index
PCO2-1 Diagnostics 7-1, 7-14 actual 8-9 SRC limit values PCO2-1 Dimensions and weight A-6 actual, reference ranges A-5 temperature corrected A-12 Display test 7-24 acutal, calculation A-8 Carrying handle 1-7 standard 8-9 standard, calculation A-9 Operator’s Manual – OPTI CCA-TS2...
Page 297 A-5 linearity PO2-3 Last Barcode 3-10 Hemoglobin oxygen saturation measurement principle PO2-1 Last Patient Info 3-10 8-9, A-10 measurement range PO2-1 LEDs calculation A-10 precision and recovery PO2-2 checking 7-16 reference ranges A-5 Operator’s Manual – OPTI CCA-TS2...
Page 298 SRC limit values pH-1 Proficiency testing 4-2 Sample measurement chamber (SMC) temperature corrected A-12 Protocol description 1-4 pH (Dry Sensor - B-Lac Cassette) communications 3-33 Security pH-B-1 Pump flow setting up 3-19 Clinical significance pH-B-1 checking 7-23 Operator’s Manual – OPTI CCA-TS2...
Page 299 Temperature corrected values A-4 Warranty registration 9-4 Temperatures Whole blood samples 5-4 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 Operator’s Manual – OPTI CCA-TS2...

OPTi CCA-TS2 Operator's Manual

Preface

Welcome

How to Use this Manual

1 Introduction

2 Setup

3 Customization

4 Calibration and Quality Control

5 Sample Handling and Patient Testing

6 Data Management

7 Maintenance

8 Diagnostics and Troubleshooting

9 Operating Principles

10 Supplies

Analytes

Ph (Dry Sensor - B-Lac Cassette)

Pco

PCO (Dry Sensor - B-Lac Cassette)

PO (Dry Sensor - B-Lac Cassette)

Sodium (Na

Potassium (K

Ionized Calcium (Ca

Chloride (Cl

Glucose (Glu)

Bun/Urea

Lactate (B-Lac Cassette)

Total Hemoglobin Concentration (Cthb) and Hemoglobin Oxygen Saturation (so %)

Appendix A - Technical Specifications

Appendix B - Menu Structure

Appendix C - Maintenance Log

Appendix D - Report Formats

Index

Quick Links

Troubleshooting

Need help?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for OPTi CCA-TS2

Summary of Contents for OPTi CCA-TS2