522330 - RNA Medical
Transcription
522330 - RNA Medical
star star M2 Key 29 M1 Y M C K GRAY 75 CVC 223 Level 5 M Y Key 28 M1 M2 CVC 223 CO-Oximeter Calibration Verification Controls 2017-04 C 55226 CVC 223 CO-Oximeter Calibration Verification Controls tHb g/dL O2Hb % COHb % MetHb % Set: 522330 IL mean M C Synthesis Series GEM OPL 75 682 GEM 4000 75 range DNA2 20.7 19.2 21.3 20.3 482 K Y Key 27 M2 M1 75 75 K Expected Values Chart Analyzers mean 18.7 - 22.7 17.2 - 21.2 19.1 - 23.5 18.3 - 22.3 range mean DNA2 1.6 –0.9 - 4.1 3.8 1.3 - 6.3 0.8 –7.2 - 8.8 2.4 –0.1 - 4.9 range mean DNA2 97.4 92.4 - 102.4 95.8 90.8 - 100.8 ORL1 95.8 90.8 - 100.8 DNA2 0.5 0.0 0.5 0.1 range –1.5 - 2.5 –2.0 - 2.0 –2.4 - 3.4 –1.9 - 2.1 M2 Key 26 M1 C OSM 3 GRAY Radiometer K CCX 75 ABL 500 Series M2 ABL 600 Series ABL 80 Series ABL 800 Series M Y Key 25 M1 ABL 700 Series NPT 7 C –2.1 - 3.7 89.2 - 99.2 0.2 –1.8 - 2.2 PRODUCT DESCRIPTION 93.8 94.8 94.8 93.7 DNA2 93.7 DNA2 88.8 89.8 89.8 88.7 0.7 0.5 0.5 3.3 DNA2 3.3 DNA2 –1.3 - 2.7 –1.5 - 2.5 –1.5 - 2.5 1.3 - 5.3 94.8 92.8 89.8 - 99.8 87.8 - 97.8 0.7 1.2 –1.3 - 2.7 –0.8 - 3.2 3.8 1.3 –4.2 -11.8 –6.7 - 9.3 ORL1 23.8 21.8 - 25.8 4.5 2.0 - 7.0 94.2 21.9 22.1 21.7 19.8 DNA2 19.8 DNA2 4.1 1.6 3.7 1.2 4.1 1.6 2.1 –0.4 DNA2 2.1 –0.4 DNA2 23.9 24.1 23.7 21.8 17.8 - 21.8 6.6 6.2 6.6 4.6 4.6 - 98.8 99.8 99.8 98.7 88.7 - 98.7 CVC 223 is provided in five (5) distinct levels of total hemoglobin, oxyhemoglobin, and carboxyhemoglobin covering the physiologically significant range of instrument performance. It also contains methemoglobin. CVC 223 is packaged in sealed glass ampuls, each containing 1.2 mL of solution. Ampuls are packaged in kits containing four (4) ampuls of each level. 1.3 - 5.3 K Roche 20.4 18.4 - 22.4 20.4 18.4 - 22.4 50 Cobas b 221 50 OMNI Series 2.2 3.1 –0.3 - 4.7 0.6 - 5.6 M2 21.8 19.8 - 23.8 22.1 20.1 - 24.1 22.3 20.3 - 24.3 M1 Key 24 1200 Series 4.2 - 9.2 3.7 - 8.7 4.2 - 9.2 91.6 92.8 91.6 86.6 - 96.6 87.8 - 97.8 86.6 - 96.6 0.1 0.0 0.1 –1.9 - 2.1 –2.0 - 2.0 –1.9 - 2.1 C K 50 50 M Y Key 23 M1 M2 For Roche OMNI Analyzers: Create a new file of aqueous QC material in the QC Set-up function. Set the ranges for the CO-Oximeter parameters as follows: Analyte tHb (g/dL) Hb Derivatives (%) C K GRAY Consult Instructions for Use For In Vitro Diagnostic Use Y Key 22 M1 M2 50 Catalog Number Store At Manufactured For Use By K 50 25 M2 Key 21 M1 Y M General Instructions for all other CO-Oximeters: 1. Calibrate your CO-Oximeter according to the manufacturer’s recommendations. If the analyzer is a combination blood gas/CO-Oximetry system, a two-point calibration is suggested. 2. Beginning with level 1, gently invert the ampul to mix the solution. Tap the ampul to restore the liquid to the bottom of the ampul. 3. Open the ampul by snapping off the tip at the score. Use the Snapper provided to protect fingers from cuts. C K 25 M2 25 Key 20 High Limit 25.0 110.0 For Siemens (Bayer) 800 Series Analyzers: Follow steps one (1) through five (5) below under “General Instructions.” Alternate running human blood samples with the CVC 223 samples. Complete steps six (6) through eight (8) under “General Instructions.” Verify the analyzer performance with daily QC. If a shift in the daily QC values for oximetry is observed, perform the following corrective action: ● Clean the CO-Ox sample chamber per the maintenance instructions in section 3 of the Operator's Manual. ● Verify the performance with QC. ● If you still see a shift in QC, run a quantity of 10-12 normal human blood samples through the system (CO-Ox only mode is sufficient). ● Verify performance with QC. ● Contact Siemens Technical Support for assistance if the problem persists. RNA Medical, Division of Bionostics, Inc. 7 Jackson Road Devens, MA 01434 USA 978-772-9070 ● 800-533-6162 www.RNAMedical.com M1 Low Limit 0.0 -10.0 Run the CVC 223 samples as a QC sample in the new file, following steps one (1) through eight (8) below under “General Instructions.” C M Lot Number Y EXPECTED VALUES It is best to run CVC 223 in the same manner as patient samples, however, please refer to any specific instructions for your analyzer regarding the use of these or any other control materials. INSTRUMENT MANUFACTURERS Instrumentation Laboratory, Lexington, MA International Technidyne Corporation, Edison, NJ Nova Biomedical, Waltham, MA Radiometer America, Westlake, OH Roche Diagnostics, Indianapolis, IN Siemens Healthcare Diagnostics, Deerfield, IL H1231 Rev. 4/2012 ® 4. Introduce the liquid from the ampul to the analyzer. Use direct aspiration, syringe transfer, or capillary mode techniques. 5. Record the results on the Data Collection and Linearity Worksheet provided for each analyte. 6. Repeat steps 2 through 5 for the remaining ampuls of level 1 until three (3) replicates are completed. (A fourth ampul of each level is provided in the event of accidental breakage or obvious sampling error.) Test levels 2, 3, 4, and 5 the same way. Record all values on the worksheets. 7. Calculate the mean value for each test analyte and compare your mean to the range on the Expected Values Chart. If your mean is within the range, circle "Y" at the question “OK?” If your mean is outside the range, circle "N" and take corrective action. 8. To graph the linearity of your results: a) Using the graph area provided, plot the Test Value (mean) against the Expected Value. b) Connect the plotted points to visualize linearity. STORAGE CVC 223 should be analyzed immediately after removal from refrigeration. FOOTNOTES: 1. ORL - Outside Reportable Limits of Analyzer 2. DNA - Data Not Available at time of printing CVC 223 2017-05 2017-04 2017-04 2017-04 2017-04 Note: Steps 7 and 8 may be performed on-line as a feature of PeerQC® described below. DIRECTIONS FOR USE M Y 800 Series 6.7 6.2 6.7 Level 1: Level 2: Level 3: Level 4: Level 5: Active Ingredients: CVC 223 is a purified bovine hemoglobin solution that has been saturated with carbon monoxide or treated with precise concentrations of carbon monoxide. This control contains no preservatives and no human-based materials. It is considered good laboratory practice to follow the recommended "Universal Precautions" when handling any blood product. The expiration date stated on the CVC 223 packaging is for product stored at 2-8 °C. Avoid exposure to freezing and temperatures greater than 8 °C. Siemens (Bayer) 400 Series Set: 2017-04 0.8 21.4 19.2 - 23.6 21.2 19.0 - 23.4 19.9 20.1 19.7 17.8 - 55127 54851 54947 55042 55226 RNA Medical® Brand CVC 223 CO-Oximeter Calibration Verification Controls are assayed materials used for confirming the calibration and linearity of total hemoglobin and hemoglobin fractions on CO-Oximeter analyzers. Nova M Y AVOXimeter 4000 Level 1: Level 2: Level 3: Level 4: Level 5: INTENDED USE ITC AVOXimeter 1000E 5 Levels The values for each control analyte on the enclosed Expected Values Chart are based on multiple determinations performed on randomly selected samples from each lot. The listing for each instrument represents the expected range and mean value of this range. The Expected Values are provided as a guide in evaluating analyzer performance. Since instrument design and operating conditions may vary, each laboratory should establish its own acceptance criteria. STATISTICAL SUPPORT RNA Medical PeerQC, available at www.RNAMedical.com, features webbased graphing and reporting for its Calibration Verification Controls and is available at no charge to RNA Medical customers. The graphing steps outlined above may be performed on-line as a feature of this service. Please contact RNA Medical or visit our website for information about utilizing PeerQC for this product. LIMITATIONS 1. Extended exposure to temperatures greater than 8 °C will affect product performance. If CVC 223 has turned brown in color, this change indicates deterioration and the formation of methemoglobin. In such a case, the control is not suitable for use and should be discarded. 2. The methemoglobin in this control can confirm product storage temperature integrity as well as the performance of the MetHb channel on COOximeters. Because of its limited range of values, it will not be of significant value in determining linearity, calibration verification, and reportable range for MetHb. 3. CVC 223 is sensitive to many instrument related factors that would affect analytical results. It is a bovine blood-based material but does not contain red cells. Therefore, it may not detect certain malfunctions that would affect the testing of human blood. 4. This product is intended for use as a quality control material and can assist in evaluating the performance of laboratory instruments. It is not for use as a calibration standard and its use should not replace other aspects of a complete quality control program. RNA Medical is a registered trademark and PeerQC is a registered service mark of Bionostics, Inc. ® GRAY K C M 4 M Level 5 2017-04 CVC 223 CO-Oximeter Calibration Verification Controls Expected Values Chart C K mean O2Hb % range mean COHb % range mean MetHb % range mean Set: 522330 range IL DNA2 20.7 19.2 21.3 20.3 482 682 Synthesis Series P GEM OPL M+C GEM 4000 18.7 - 22.7 17.2 - 21.2 19.1 - 23.5 18.3 - 22.3 DNA2 1.6 –0.9 - 4.1 3.8 1.3 - 6.3 0.8 –7.2 - 8.8 2.4 –0.1 - 4.9 DNA2 97.4 92.4 - 102.4 95.8 90.8 - 100.8 ORL1 95.8 90.8 - 100.8 DNA2 0.5 0.0 0.5 0.1 –1.5 - 2.5 –2.0 - 2.0 –2.4 - 3.4 –1.9 - 2.1 M2 Y Key 17 M1 AVOXimeter 1000E AVOXimeter 4000 M C K ABL 600 Series ABL 700 Series M ABL 80 Series ABL 800 Series C Y Key 16 M2 GRAY Y+C ABL 500 Series M1 OSM 3 –2.1 - 3.7 89.2 - 99.2 0.2 –1.8 - 2.2 PRODUCT DESCRIPTION 93.8 94.8 94.8 93.7 DNA2 93.7 DNA2 88.8 89.8 89.8 88.7 0.7 0.5 0.5 3.3 DNA2 3.3 DNA2 –1.3 - 2.7 –1.5 - 2.5 –1.5 - 2.5 1.3 - 5.3 94.8 92.8 89.8 - 99.8 87.8 - 97.8 0.7 1.2 –1.3 - 2.7 –0.8 - 3.2 3.8 1.3 –4.2 -11.8 –6.7 - 9.3 ORL1 23.8 21.8 - 25.8 4.5 2.0 - 7.0 94.2 21.9 22.1 21.7 19.8 DNA2 19.8 DNA2 4.1 1.6 3.7 1.2 4.1 1.6 2.1 –0.4 DNA2 2.1 –0.4 DNA2 NPT 7 23.9 24.1 23.7 21.8 17.8 - 21.8 6.6 6.2 6.6 4.6 4.6 - 98.8 99.8 99.8 98.7 88.7 - 98.7 CVC 223 is provided in five (5) distinct levels of total hemoglobin, oxyhemoglobin, and carboxyhemoglobin covering the physiologically significant range of instrument performance. It also contains methemoglobin. CVC 223 is packaged in sealed glass ampuls, each containing 1.2 mL of solution. Ampuls are packaged in kits containing four (4) ampuls of each level. 1.3 - 5.3 Y+M K Roche 20.4 18.4 - 22.4 20.4 18.4 - 22.4 Cobas b 221 3 4 OMNI Series 2.2 3.1 –0.3 - 4.7 0.6 - 5.6 M2 Key 15 M1 Y 21.8 19.8 - 23.8 22.1 20.1 - 24.1 22.3 20.3 - 24.3 800 Series 4.2 - 9.2 3.7 - 8.7 4.2 - 9.2 91.6 92.8 91.6 86.6 - 96.6 87.8 - 97.8 86.6 - 96.6 0.1 0.0 0.1 –1.9 - 2.1 –2.0 - 2.0 –1.9 - 2.1 K 4 3 4 3 1/2/3/4 Y 1/2/3/4 M1 1 2 1 2 M2 Key 14 M1 For Roche OMNI Analyzers: Create a new file of aqueous QC material in the QC Set-up function. Set the ranges for the CO-Oximeter parameters as follows: Analyte tHb (g/dL) Hb Derivatives (%) Low Limit 0.0 -10.0 High Limit 25.0 110.0 C M Y EXPECTED VALUES It is best to run CVC 223 in the same manner as patient samples, however, please refer to any specific instructions for your analyzer regarding the use of these or any other control materials. K GRAY 4 3 Consult Instructions for Use For In Vitro Diagnostic Use M Y Key 13 M1 M2 1/2/3/4 M 1 2 Catalog Number Lot Number Store At For Siemens (Bayer) 800 Series Analyzers: Follow steps one (1) through five (5) below under “General Instructions.” Alternate running human blood samples with the CVC 223 samples. Complete steps six (6) through eight (8) under “General Instructions.” Verify the analyzer performance with daily QC. If a shift in the daily QC values for oximetry is observed, perform the following corrective action: ● Clean the CO-Ox sample chamber per the maintenance instructions in section 3 of the Operator's Manual. ● Verify the performance with QC. ● If you still see a shift in QC, run a quantity of 10-12 normal human blood samples through the system (CO-Ox only mode is sufficient). ● Verify performance with QC. ● Contact Siemens Technical Support for assistance if the problem persists. Use By 3 3 Key 12 General Instructions for all other CO-Oximeters: 1. Calibrate your CO-Oximeter according to the manufacturer’s recommendations. If the analyzer is a combination blood gas/CO-Oximetry system, a two-point calibration is suggested. 2. Beginning with level 1, gently invert the ampul to mix the solution. Tap the ampul to restore the liquid to the bottom of the ampul. 3. Open the ampul by snapping off the tip at the score. Use the Snapper provided to protect fingers from cuts. C M Y M1 M2 4 4 1/2/3/4 C 1 2 1/2/3/4 K 1 2 K C Manufactured For Run the CVC 223 samples as a QC sample in the new file, following steps one (1) through eight (8) below under “General Instructions.” INSTRUMENT MANUFACTURERS Instrumentation Laboratory, Lexington, MA International Technidyne Corporation, Edison, NJ Nova Biomedical, Waltham, MA Radiometer America, Westlake, OH Roche Diagnostics, Indianapolis, IN Siemens Healthcare Diagnostics, Deerfield, IL Key 11 H1231 Rev. 4/2012 ® The values for each control analyte on the enclosed Expected Values Chart are based on multiple determinations performed on randomly selected samples from each lot. The listing for each instrument represents the expected range and mean value of this range. The Expected Values are provided as a guide in evaluating analyzer performance. Since instrument design and operating conditions may vary, each laboratory should establish its own acceptance criteria. STATISTICAL SUPPORT RNA Medical PeerQC, available at www.RNAMedical.com, features webbased graphing and reporting for its Calibration Verification Controls and is available at no charge to RNA Medical customers. The graphing steps outlined above may be performed on-line as a feature of this service. Please contact RNA Medical or visit our website for information about utilizing PeerQC for this product. LIMITATIONS 1. Extended exposure to temperatures greater than 8 °C will affect product performance. If CVC 223 has turned brown in color, this change indicates deterioration and the formation of methemoglobin. In such a case, the control is not suitable for use and should be discarded. 2. The methemoglobin in this control can confirm product storage temperature integrity as well as the performance of the MetHb channel on COOximeters. Because of its limited range of values, it will not be of significant value in determining linearity, calibration verification, and reportable range for MetHb. 3. CVC 223 is sensitive to many instrument related factors that would affect analytical results. It is a bovine blood-based material but does not contain red cells. Therefore, it may not detect certain malfunctions that would affect the testing of human blood. 4. This product is intended for use as a quality control material and can assist in evaluating the performance of laboratory instruments. It is not for use as a calibration standard and its use should not replace other aspects of a complete quality control program. RNA Medical is a registered trademark and PeerQC is a registered service mark of Bionostics, Inc. ® M Y M1 M2 75 75 K RNA Medical, Division of Bionostics, Inc. 7 Jackson Road Devens, MA 01434 USA 978-772-9070 ● 800-533-6162 www.RNAMedical.com 4. Introduce the liquid from the ampul to the analyzer. Use direct aspiration, syringe transfer, or capillary mode techniques. 5. Record the results on the Data Collection and Linearity Worksheet provided for each analyte. 6. Repeat steps 2 through 5 for the remaining ampuls of level 1 until three (3) replicates are completed. (A fourth ampul of each level is provided in the event of accidental breakage or obvious sampling error.) Test levels 2, 3, 4, and 5 the same way. Record all values on the worksheets. 7. Calculate the mean value for each test analyte and compare your mean to the range on the Expected Values Chart. If your mean is within the range, circle "Y" at the question “OK?” If your mean is outside the range, circle "N" and take corrective action. 8. To graph the linearity of your results: a) Using the graph area provided, plot the Test Value (mean) against the Expected Value. b) Connect the plotted points to visualize linearity. STORAGE CVC 223 should be analyzed immediately after removal from refrigeration. FOOTNOTES: 1. ORL - Outside Reportable Limits of Analyzer 2. DNA - Data Not Available at time of printing CVC 223 2017-05 2017-04 2017-04 2017-04 2017-04 Note: Steps 7 and 8 may be performed on-line as a feature of PeerQC® described below. DIRECTIONS FOR USE C M 1200 Series 6.7 6.2 6.7 Level 1: Level 2: Level 3: Level 4: Level 5: Active Ingredients: CVC 223 is a purified bovine hemoglobin solution that has been saturated with carbon monoxide or treated with precise concentrations of carbon monoxide. This control contains no preservatives and no human-based materials. It is considered good laboratory practice to follow the recommended "Universal Precautions" when handling any blood product. The expiration date stated on the CVC 223 packaging is for product stored at 2-8 °C. Avoid exposure to freezing and temperatures greater than 8 °C. Siemens (Bayer) 400 Series Set: 2017-04 0.8 21.4 19.2 - 23.6 21.2 19.0 - 23.4 19.9 20.1 19.7 17.8 - 55127 54851 54947 55042 55226 RNA Medical® Brand CVC 223 CO-Oximeter Calibration Verification Controls are assayed materials used for confirming the calibration and linearity of total hemoglobin and hemoglobin fractions on CO-Oximeter analyzers. Nova CCX Level 1: Level 2: Level 3: Level 4: Level 5: INTENDED USE ITC Radiometer 1/2/3/4 M2 1 2 tHb g/dL Analyzers Komori/GATF M Y Key 18 M1 M2 25 25 Part No. K-40-6(D) K C 55226 5 Levels 75 GRAY K C 4 Key 10 M Y M1 M2 CVC 223 CVC 223 CO-Oximeter Calibration Verification Controls C Level 5 2017-04 75 K 55226 CVC 223 CO-Oximeter Calibration Verification Controls tHb g/dL Key 9 mean DNA2 20.7 19.2 21.3 20.3 C 482 K 682 75 Synthesis Series M2 GEM OPL Key 8 AVOXimeter 1000E AVOXimeter 4000 M Y M1 M2 GEM 4000 C K CCX range mean range mean Set: 522330 range 18.7 - 22.7 17.2 - 21.2 19.1 - 23.5 18.3 - 22.3 DNA2 1.6 –0.9 - 4.1 3.8 1.3 - 6.3 0.8 –7.2 - 8.8 2.4 –0.1 - 4.9 DNA2 97.4 92.4 - 102.4 95.8 90.8 - 100.8 ORL1 95.8 90.8 - 100.8 DNA2 0.5 0.0 0.5 0.1 –1.5 - 2.5 –2.0 - 2.0 –2.4 - 3.4 –1.9 - 2.1 GRAY M1 OSM 3 ABL 500 Series –2.1 - 3.7 89.2 - 99.2 0.2 –1.8 - 2.2 PRODUCT DESCRIPTION 93.8 94.8 94.8 93.7 DNA2 93.7 DNA2 88.8 89.8 89.8 88.7 0.7 0.5 0.5 3.3 DNA2 3.3 DNA2 –1.3 - 2.7 –1.5 - 2.5 –1.5 - 2.5 1.3 - 5.3 94.8 92.8 89.8 - 99.8 87.8 - 97.8 0.7 1.2 –1.3 - 2.7 –0.8 - 3.2 –4.2 -11.8 –6.7 - 9.3 ORL1 23.8 21.8 - 25.8 4.5 2.0 - 7.0 94.2 21.9 22.1 21.7 19.8 DNA2 19.8 DNA2 4.1 1.6 3.7 1.2 4.1 1.6 2.1 –0.4 DNA2 2.1 –0.4 DNA2 Key 7 ABL 600 Series M C ABL 700 Series ABL 800 Series NPT 7 17.8 - 21.8 6.6 6.2 6.6 4.6 4.6 CVC 223 is provided in five (5) distinct levels of total hemoglobin, oxyhemoglobin, and carboxyhemoglobin covering the physiologically significant range of instrument performance. It also contains methemoglobin. CVC 223 is packaged in sealed glass ampuls, each containing 1.2 mL of solution. Ampuls are packaged in kits containing four (4) ampuls of each level. - 98.8 99.8 99.8 98.7 88.7 - 98.7 1.3 - 5.3 Siemens (Bayer) 20.4 18.4 - 22.4 20.4 18.4 - 22.4 21.8 19.8 - 23.8 22.1 20.1 - 24.1 22.3 20.3 - 24.3 800 Series 1200 Series 2.2 3.1 6.7 6.2 6.7 –0.3 - 4.7 0.6 - 5.6 4.2 - 9.2 3.7 - 8.7 4.2 - 9.2 91.6 92.8 91.6 86.6 - 96.6 87.8 - 97.8 86.6 - 96.6 0.1 0.0 0.1 –1.9 - 2.1 –2.0 - 2.0 –1.9 - 2.1 It is best to run CVC 223 in the same manner as patient samples, however, please refer to any specific instructions for your analyzer regarding the use of these or any other control materials. 50 50 Key 5 M2 M1 K C M Y For Roche OMNI Analyzers: Create a new file of aqueous QC material in the QC Set-up function. Set the ranges for the CO-Oximeter parameters as follows: GRAY 25 M2 Key 4 M1 For In Vitro Diagnostic Use C M Y Consult Instructions for Use Manufactured For Store At 25 25 Key 3 M2 M1 Y C M General Instructions for all other CO-Oximeters: 1. Calibrate your CO-Oximeter according to the manufacturer’s recommendations. If the analyzer is a combination blood gas/CO-Oximetry system, a two-point calibration is suggested. 2. Beginning with level 1, gently invert the ampul to mix the solution. Tap the ampul to restore the liquid to the bottom of the ampul. 3. Open the ampul by snapping off the tip at the score. Use the Snapper provided to protect fingers from cuts. Key 2 M Y M1 M2 25 25 K RNA Medical, Division of Bionostics, Inc. 7 Jackson Road Devens, MA 01434 USA 978-772-9070 ● 800-533-6162 www.RNAMedical.com C High Limit 25.0 110.0 For Siemens (Bayer) 800 Series Analyzers: Follow steps one (1) through five (5) below under “General Instructions.” Alternate running human blood samples with the CVC 223 samples. Complete steps six (6) through eight (8) under “General Instructions.” Verify the analyzer performance with daily QC. If a shift in the daily QC values for oximetry is observed, perform the following corrective action: ● Clean the CO-Ox sample chamber per the maintenance instructions in section 3 of the Operator's Manual. ● Verify the performance with QC. ● If you still see a shift in QC, run a quantity of 10-12 normal human blood samples through the system (CO-Ox only mode is sufficient). ● Verify performance with QC. ● Contact Siemens Technical Support for assistance if the problem persists. Use By ® Low Limit 0.0 -10.0 Run the CVC 223 samples as a QC sample in the new file, following steps one (1) through eight (8) below under “General Instructions.” K Lot Number H1231 Rev. 4/2012 4. Introduce the liquid from the ampul to the analyzer. Use direct aspiration, syringe transfer, or capillary mode techniques. 5. Record the results on the Data Collection and Linearity Worksheet provided for each analyte. 6. Repeat steps 2 through 5 for the remaining ampuls of level 1 until three (3) replicates are completed. (A fourth ampul of each level is provided in the event of accidental breakage or obvious sampling error.) Test levels 2, 3, 4, and 5 the same way. Record all values on the worksheets. 7. Calculate the mean value for each test analyte and compare your mean to the range on the Expected Values Chart. If your mean is within the range, circle "Y" at the question “OK?” If your mean is outside the range, circle "N" and take corrective action. 8. To graph the linearity of your results: a) Using the graph area provided, plot the Test Value (mean) against the Expected Value. b) Connect the plotted points to visualize linearity. EXPECTED VALUES Analyte tHb (g/dL) Hb Derivatives (%) Catalog Number The values for each control analyte on the enclosed Expected Values Chart are based on multiple determinations performed on randomly selected samples from each lot. The listing for each instrument represents the expected range and mean value of this range. The Expected Values are provided as a guide in evaluating analyzer performance. Since instrument design and operating conditions may vary, each laboratory should establish its own acceptance criteria. STATISTICAL SUPPORT RNA Medical PeerQC, available at www.RNAMedical.com, features webbased graphing and reporting for its Calibration Verification Controls and is available at no charge to RNA Medical customers. The graphing steps outlined above may be performed on-line as a feature of this service. Please contact RNA Medical or visit our website for information about utilizing PeerQC for this product. LIMITATIONS 1. Extended exposure to temperatures greater than 8 °C will affect product performance. If CVC 223 has turned brown in color, this change indicates deterioration and the formation of methemoglobin. In such a case, the control is not suitable for use and should be discarded. 2. The methemoglobin in this control can confirm product storage temperature integrity as well as the performance of the MetHb channel on COOximeters. Because of its limited range of values, it will not be of significant value in determining linearity, calibration verification, and reportable range for MetHb. 3. CVC 223 is sensitive to many instrument related factors that would affect analytical results. It is a bovine blood-based material but does not contain red cells. Therefore, it may not detect certain malfunctions that would affect the testing of human blood. 4. This product is intended for use as a quality control material and can assist in evaluating the performance of laboratory instruments. It is not for use as a calibration standard and its use should not replace other aspects of a complete quality control program. RNA Medical is a registered trademark and PeerQC is a registered service mark of Bionostics, Inc. ® C M Key 1 Y M1 M2 25 GRAY K 4 1010750 Bionostics INS01231 Rev. K K CVC 223 STORAGE CVC 223 should be analyzed immediately after removal from refrigeration. INSTRUMENT MANUFACTURERS Instrumentation Laboratory, Lexington, MA International Technidyne Corporation, Edison, NJ Nova Biomedical, Waltham, MA Radiometer America, Westlake, OH Roche Diagnostics, Indianapolis, IN Siemens Healthcare Diagnostics, Deerfield, IL 2017-05 2017-04 2017-04 2017-04 2017-04 Note: Steps 7 and 8 may be performed on-line as a feature of PeerQC® described below. DIRECTIONS FOR USE FOOTNOTES: 1. ORL - Outside Reportable Limits of Analyzer 2. DNA - Data Not Available at time of printing Level 1: Level 2: Level 3: Level 4: Level 5: Active Ingredients: CVC 223 is a purified bovine hemoglobin solution that has been saturated with carbon monoxide or treated with precise concentrations of carbon monoxide. This control contains no preservatives and no human-based materials. It is considered good laboratory practice to follow the recommended "Universal Precautions" when handling any blood product. The expiration date stated on the CVC 223 packaging is for product stored at 2-8 °C. Avoid exposure to freezing and temperatures greater than 8 °C. K M 400 Series C Key 6 50 M2 OMNI Series M1 50 Roche Cobas b 221 Set: 2017-04 0.8 3.8 1.3 23.9 24.1 23.7 21.8 55127 54851 54947 55042 55226 RNA Medical® Brand CVC 223 CO-Oximeter Calibration Verification Controls are assayed materials used for confirming the calibration and linearity of total hemoglobin and hemoglobin fractions on CO-Oximeter analyzers. 21.4 19.2 - 23.6 21.2 19.0 - 23.4 19.9 20.1 19.7 17.8 - Level 1: Level 2: Level 3: Level 4: Level 5: INTENDED USE Radiometer M2 M1 mean MetHb % Nova K Y range COHb % ITC ABL 80 Series Y O2Hb % IL M Y M1 M2 75 Expected Values Chart Analyzers 5 Levels 1010750 Bionostics INS01231 Rev. K 1 A Spot Process PANTONE 5 Black 1 2 3 4 Cyan Magenta Yellow 2748 U Y Key 19 M1 M2 25 CVC 223 CVC 223 CO-Oximeter Calibration Verification Controls K C M Y M1 Key 6 M2 1010750 Bionostics INS01231 Rev. K 50 50 K 54947 2017-04 M2 2017-05 M1 55127 Y Level 3 M Level 1 C CVC 223 CO-Oximeter Calibration Verification Controls Key 7 CVC 223 CO-Oximeter Calibration Verification Controls O2Hb % COHb % Expected Values Chart MetHb % tHb g/dL O2Hb % COHb % MetHb % GRAY tHb g/dL M1 Expected Values Chart K range mean range mean range mean range mean Analyzers range mean range mean range mean range C mean Analyzers 482 682 Synthesis Series GEM OPL GEM 4000 12.1 12.3 12.5 11.7 DNA2 81.7 83.9 82.9 83.8 77.7 79.9 78.6 79.8 13.6 13.7 12.5 - 14.7 12.6 - 14.8 81.2 82.5 14.1 13.1 - 15.1 14.1 14.6 14.2 13.6 DNA2 13.6 DNA2 13.1 13.6 13.2 12.6 - 14.1 14.3 14.7 13.7 DNA2 19.2 18.1 17.6 17.4 15.2 14.1 13.1 13.4 76.9 - 85.5 78.2 - 86.8 17.7 85.1 81.1 - 89.1 13.4 82.8 81.7 82.9 84.1 DNA2 84.1 DNA2 78.8 77.7 78.9 80.1 - 85.7 87.9 87.2 87.8 DNA2 0.6 0.4 0.7 0.3 –1.4 –1.6 –2.2 –1.7 - 13.2 - 22.2 0.8 –2.1 - 3.7 9.4 - 17.4 0.5 –1.5 - 2.5 18.2 14.2 - 22.2 17.5 13.5 - 21.5 17.0 13.0 - 21.0 13.6 9.6 - 17.6 DNA2 13.4 9.4 - 17.4 DNA2 1.0 1.0 0.8 1.5 DNA2 1.5 DNA2 –1.0 –1.0 –1.2 –0.5 - - 23.2 22.1 22.1 21.4 2.6 2.4 3.6 2.3 75 DNA2 13.1 13.3 13.6 12.7 M2 30.2 28.5 DNA2 0.6 –1.4 - 2.6 0.3 –1.7 - 2.3 0.9 –2.0 - 3.8 ORL1 M2 5.0 4.9 DNA2 72.6 68.6 - 76.6 69.1 65.1 - 73.1 ORL1 ORL1 M1 DNA2 28.2 25.2 - 31.2 31.7 28.7 - 34.7 27.8 23.2 - 32.4 ORL1 Y DNA2 4.9 4.3 - 5.5 4.7 4.1 - 5.3 5.0 4.4 - 5.6 ORL1 Key 8 482 682 Synthesis Series GEM OPL GEM 4000 M IL IL ITC ITC 25.6 - 34.8 23.9 - 33.1 71.3 64.3 - 78.3 1.3 AVOXimeter 1000E AVOXimeter 4000 –1.6 - 4.2 C 4.4 - 5.6 4.3 - 5.5 K AVOXimeter 1000E AVOXimeter 4000 M Nova Nova 33.3 30.3 - 36.3 65.7 61.7 - 69.7 0.7 –1.3 - 2.7 CCX 64.6 61.7 61.7 62.6 24.7 - 30.7 26.4 - 32.4 68.0 69.5 5.6 - 6.8 4.3 - 5.5 5.3 - 6.5 33.6 28.2 34.0 30.6 - 36.6 25.2 - 31.2 31.0 - 37.0 65.6 70.6 65.6 29.2 - 35.2 - 72.6 69.7 69.7 70.6 1.0 1.1 1.1 2.5 DNA2 2.5 DNA2 –1.0 –0.9 –0.9 0.5 64.0 - 72.0 65.5 - 73.5 1.0 1.5 –1.0 - 3.0 –0.5 - 3.5 61.6 - 69.6 66.6 - 74.6 61.6 - 69.6 0.5 0.6 0.4 –1.5 - 2.5 –1.4 - 2.6 –1.6 - 2.4 62.6 - 70.6 - OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 3.0 3.1 3.1 4.5 0.5 - 4.5 - 15.1 15.6 15.2 14.6 12.6 - 14.6 - 86.8 85.7 86.9 88.1 80.1 - 88.1 3.0 3.0 2.8 3.5 –0.5 - 3.5 Roche Roche 12.8 13.0 11.8 - 13.8 12.0 - 14.0 83.3 83.6 79.3 - 87.3 79.6 - 87.6 15.4 14.5 11.4 - 19.4 10.5 - 18.5 0.8 1.3 –1.2 - 2.8 –0.7 - 3.3 14.5 13.3 14.4 13.5 - 15.5 12.3 - 14.3 13.4 - 15.4 83.8 81.3 83.8 79.8 - 87.8 77.3 - 85.3 79.8 - 87.8 15.5 17.6 15.5 11.5 - 19.5 13.6 - 21.6 11.5 - 19.5 0.4 0.5 0.4 –1.6 - 2.4 –1.5 - 2.5 –1.6 - 2.4 75 Cobas b 221 OMNI Series M2 Cobas b 221 OMNI Series M1 68.6 65.7 65.7 66.6 DNA2 66.6 DNA2 Y 27.7 29.4 35.6 37.2 38.2 35.2 M 4.0 - 5.2 4.0 - 5.2 4.0 - 5.2 - C 29.6 31.2 32.2 29.2 K 32.6 34.2 35.2 32.2 DNA2 32.2 DNA2 75 6.2 4.9 5.9 5.8 5.9 5.9 5.2 75 4.6 4.6 - M2 4.6 4.7 4.7 4.0 Key 10 5.2 5.3 5.3 4.6 DNA2 4.6 DNA2 M1 Radiometer OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 Y 4.8 - 6.0 Key 9 5.4 CCX Radiometer C 400 Series 800 Series 1200 Series K 400 Series 800 Series 1200 Series GRAY Siemens (Bayer) Siemens (Bayer) M Y Key 11 M1 Level 4 55042 2017-04 75 54851 M2 Level 2 2017-04 75 range mean COHb % range mean Expected Values Chart MetHb % range mean range mean Analyzers O2Hb % range mean COHb % range mean MetHb % range mean range 89.2 - 98.2 91.0 - 100.0 2.2 1.3 1.1 0.2 - 10.2 9.3 9.1 8.2 DNA2 0.8 0.7 0.8 0.6 –1.2 –1.3 –2.1 –1.4 - ITC DNA2 16.3 16.2 16.8 15.7 482 682 Synthesis Series GEM OPL GEM 4000 2.8 2.7 3.7 2.6 DNA2 53.7 59.0 54.9 56.2 49.7 55.0 50.6 52.2 16.8 15.5 - 18.1 16.8 15.5 - 18.1 54.5 54.5 18.2 17.0 - 19.4 17.4 18.0 17.6 16.4 DNA2 16.4 DNA2 15.1 15.0 15.5 14.5 - 17.5 17.4 18.1 16.9 DNA2 46.5 44.7 44.9 44.7 42.5 40.7 39.6 40.7 - 50.2 - 58.8 50.2 - 58.8 44.7 58.2 54.2 - 62.2 40.7 56.2 55.5 56.6 57.7 DNA2 57.9 DNA2 52.2 51.5 52.6 53.7 - 57.7 63.0 59.2 60.2 DNA2 0.3 0.2 0.4 0.0 –1.7 –1.8 –2.5 –2.0 - 39.4 - 50.0 0.4 –2.5 - 3.3 36.7 - 44.7 0.2 –1.8 - 2.2 43.7 39.7 - 47.7 43.7 39.7 - 47.7 43.0 39.0 - 47.0 41.1 37.1 - 45.1 DNA2 41.1 37.1 - 45.1 DNA2 0.7 0.5 0.5 2.6 DNA2 2.5 DNA2 –1.3 –1.5 –1.5 0.6 - 50.5 48.7 50.2 48.7 2.3 2.2 3.3 2.0 C 93.7 95.5 DNA2 6.2 5.3 5.1 4.2 K 7.1 - 8.5 7.1 - 8.5 99.3 102.2 100.3 101.4 ITC 1.0 AVOXimeter 1000E AVOXimeter 4000 –1.9 - 3.9 Nova 7.1 - 8.5 97.6 92.6 - 102.6 1.8 –2.2 - 5.8 0.6 –1.4 - 2.6 CCX M2 7.8 CCX M1 Nova Y 1.1 - 9.1 M 5.1 Key 13 AVOXimeter 1000E AVOXimeter 4000 90.1 89.8 89.8 90.7 - 100.1 99.8 99.8 100.7 1.8 1.4 1.4 –1.9 - 9.8 9.4 9.4 6.1 - 2.9 3.1 3.1 3.5 OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 –0.5 - 3.5 - 18.6 19.2 18.8 17.6 15.2 -17.6 - 60.2 59.5 60.6 61.7 53.9 - 61.9 2.7 2.5 2.5 4.6 0.5 - 4.5 3.9 3.2 –0.1 - 7.9 –0.8 - 7.2 1.0 1.0 –1.0 - 3.0 –1.0 - 3.0 9.1 7.4 8.7 8.4 - 9.8 6.7 - 8.1 8.0 - 9.4 95.5 94.1 95.5 90.5 - 100.5 89.1 - 99.1 90.5 - 100.5 3.9 5.1 3.9 –0.1 - 7.9 1.1 - 9.1 –0.1 - 7.9 0.7 0.7 0.7 –1.3 - 2.7 –1.3 - 2.7 –1.3 - 2.7 Siemens (Bayer) Cobas b 221 OMNI Series 16.0 14.8 - 17.2 16.1 14.9 - 17.3 55.0 56.5 51.0 - 59.0 52.5 - 60.5 42.5 40.3 38.5 - 46.5 36.3 - 44.3 0.6 1.2 –1.4 - 2.6 –0.8 - 3.2 17.3 16.1 - 18.5 17.1 15.9 - 18.3 17.4 16.2 - 18.6 58.0 55.2 58.0 54.0 - 62.0 51.2 - 59.2 54.0 - 62.0 41.3 44.1 41.3 37.3 - 45.3 40.1 - 48.1 37.3 - 45.3 0.1 0.1 0.1 –1.9 - 2.1 –1.9 - 2.1 –1.9 - 2.1 K 89.8 - 99.8 90.7 - 100.7 4 94.8 95.7 3 7.3 - 8.7 6.6 - 8.0 4 8.0 7.3 3 Roche Cobas b 221 OMNI Series Siemens (Bayer) C M Y 400 Series 800 Series 1200 Series Key 15 400 Series 800 Series 1200 Series 1/2/3/4 Y 1/2/3/4 M1 1 2 1 2 Roche 16.2 16.8 16.4 15.2 M2 –1.1 –0.9 –0.9 –0.5 M1 –1.9 - 6.1 0.9 1.1 1.1 1.5 DNA2 1.5 DNA2 Y 90.5 - 100.5 5.8 5.4 5.4 2.1 DNA2 2.1 DNA2 M 7.1 - 8.5 95.1 94.8 94.8 95.7 DNA2 95.5 DNA2 C 9.1 9.0 8.9 8.5 K - GRAY 7.7 7.6 7.5 7.1 Key 14 8.4 8.3 8.2 7.8 DNA2 7.8 DNA2 OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 4 Radiometer 1/2/3/4 M 1 2 3 Radiometer 1/2/3/4 C 1 2 7.8 7.8 - 1/2/3/4 K 1 2 89.3 92.2 91.3 91.4 M2 DNA2 94.3 97.2 95.8 96.4 4 8.3 8.0 8.5 8.0 - 3 6.9 6.6 7.1 6.6 4 DNA2 7.6 7.3 7.8 7.3 3 482 682 Synthesis Series GEM OPL GEM 4000 M1 IL Y Key 12 IL tHb g/dL M mean Analyzers O2Hb % C tHb g/dL K Expected Values Chart M1 M2 3 3 4 1/2/3/4 M2 1 2 2 Y+M K 2017-04 M2 54947 2017-05 M1 55127 Y Level 3 M Level 1 C CVC 223 CO-Oximeter Calibration Verification Controls Key 16 CVC 223 CO-Oximeter Calibration Verification Controls Y+C range mean COHb % range mean Expected Values Chart MetHb % range mean range tHb g/dL mean Analyzers O2Hb % range mean COHb % range mean MetHb % range mean C mean Analyzers O2Hb % K tHb g/dL GRAY Expected Values Chart range M IL AVOXimeter 1000E AVOXimeter 4000 4.4 - 5.6 4.3 - 5.5 25.6 - 34.8 23.9 - 33.1 71.3 64.3 - 78.3 1.3 AVOXimeter 1000E AVOXimeter 4000 –1.6 - 4.2 14.1 14.6 14.2 13.6 DNA2 13.6 DNA2 13.1 13.6 13.2 12.6 –2.1 - 3.7 5.4 CCX 4.8 - 6.0 33.3 30.3 - 36.3 65.7 61.7 - 69.7 0.7 –1.3 - 2.7 CCX 85.1 81.1 - 89.1 13.4 9.4 - 17.4 0.5 –1.5 - 2.5 82.8 81.7 82.9 84.1 DNA2 84.1 DNA2 78.8 77.7 78.9 80.1 18.2 14.2 - 22.2 17.5 13.5 - 21.5 17.0 13.0 - 21.0 13.6 9.6 - 17.6 DNA2 13.4 9.4 - 17.4 DNA2 1.0 1.0 0.8 1.5 DNA2 1.5 DNA2 –1.0 –1.0 –1.2 –0.5 - Radiometer Radiometer 32.6 34.2 35.2 32.2 DNA2 32.2 DNA2 29.6 31.2 32.2 29.2 4.0 - 5.2 4.0 - 5.2 27.7 29.4 5.6 - 6.8 4.3 - 5.5 5.3 - 6.5 33.6 28.2 34.0 4.0 - 5.2 - 35.6 37.2 38.2 35.2 68.6 65.7 65.7 66.6 DNA2 66.6 DNA2 64.6 61.7 61.7 62.6 24.7 - 30.7 26.4 - 32.4 68.0 69.5 30.6 - 36.6 25.2 - 31.2 31.0 - 37.0 65.6 70.6 65.6 29.2 - 35.2 - 72.6 69.7 69.7 70.6 1.0 1.1 1.1 2.5 DNA2 2.5 DNA2 –1.0 –0.9 –0.9 0.5 64.0 - 72.0 65.5 - 73.5 1.0 1.5 –1.0 - 3.0 –0.5 - 3.5 61.6 - 69.6 66.6 - 74.6 61.6 - 69.6 0.5 0.6 0.4 –1.5 - 2.5 –1.4 - 2.6 –1.6 - 2.4 62.6 - 70.6 - OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 3.0 3.1 3.1 4.5 0.5 - 4.5 - 15.1 15.6 15.2 14.6 12.6 - 14.6 - 86.8 85.7 86.9 88.1 80.1 - 88.1 3.0 3.0 2.8 3.5 –0.5 - 3.5 Roche Cobas b 221 OMNI Series 11.8 - 13.8 12.0 - 14.0 83.3 83.6 79.3 - 87.3 79.6 - 87.6 15.4 14.5 11.4 - 19.4 10.5 - 18.5 0.8 1.3 –1.2 - 2.8 –0.7 - 3.3 14.5 13.3 14.4 13.5 - 15.5 12.3 - 14.3 13.4 - 15.4 83.8 81.3 83.8 79.8 - 87.8 77.3 - 85.3 79.8 - 87.8 15.5 17.6 15.5 11.5 - 19.5 13.6 - 21.6 11.5 - 19.5 0.4 0.5 0.4 –1.6 - 2.4 –1.5 - 2.5 –1.6 - 2.4 GRAY 12.8 13.0 25 Cobas b 221 OMNI Series M2 Roche Siemens (Bayer) Siemens (Bayer) C M 400 Series 800 Series 1200 Series K 400 Series 800 Series 1200 Series M1 M2 25 Level 4 55042 2017-04 2017-04 25 54851 Y Key 20 Level 2 M1 6.2 4.9 5.9 5.8 5.9 5.9 5.2 M 4.6 4.6 - C 4.6 4.7 4.7 4.0 K 5.2 5.3 5.3 4.6 DNA2 4.6 DNA2 Key 19 OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 Y 13.1 - 15.1 0.8 25 14.1 13.2 - 22.2 25 17.7 Nova Nova M2 76.9 - 85.5 78.2 - 86.8 2.6 2.4 3.6 2.3 M1 81.2 82.5 –1.4 –1.6 –2.2 –1.7 - 23.2 22.1 22.1 21.4 Y 12.5 - 14.7 12.6 - 14.8 DNA2 0.6 0.4 0.7 0.3 - M 15.2 14.1 13.1 13.4 85.7 87.9 87.2 87.8 C 13.6 13.7 DNA2 19.2 18.1 17.6 17.4 - K 77.7 79.9 78.6 79.8 14.1 14.3 14.7 13.7 ITC ITC K range mean COHb % range mean Expected Values Chart MetHb % range mean range mean Analyzers O2Hb % range mean COHb % range mean MetHb % range mean range IL 7.1 - 8.5 7.1 - 8.5 93.7 95.5 89.2 - 98.2 91.0 - 100.0 99.3 102.2 100.3 101.4 DNA2 6.2 5.3 5.1 4.2 2.2 1.3 1.1 0.2 - 10.2 9.3 9.1 8.2 DNA2 0.8 0.7 0.8 0.6 –1.2 –1.3 –2.1 –1.4 - ITC DNA2 16.3 16.2 16.8 15.7 482 682 Synthesis Series GEM OPL GEM 4000 2.8 2.7 3.7 2.6 DNA2 53.7 59.0 54.9 56.2 49.7 55.0 50.6 52.2 16.8 15.5 - 18.1 16.8 15.5 - 18.1 54.5 54.5 18.2 17.0 - 19.4 17.4 18.0 17.6 16.4 DNA2 16.4 DNA2 15.1 15.0 15.5 14.5 - 17.5 17.4 18.1 16.9 DNA2 46.5 44.7 44.9 44.7 42.5 40.7 39.6 40.7 - 50.2 - 58.8 50.2 - 58.8 44.7 58.2 54.2 - 62.2 40.7 56.2 55.5 56.6 57.7 DNA2 57.9 DNA2 52.2 51.5 52.6 53.7 - 57.7 63.0 59.2 60.2 DNA2 0.3 0.2 0.4 0.0 –1.7 –1.8 –2.5 –2.0 - 39.4 - 50.0 0.4 –2.5 - 3.3 36.7 - 44.7 0.2 –1.8 - 2.2 43.7 39.7 - 47.7 43.7 39.7 - 47.7 43.0 39.0 - 47.0 41.1 37.1 - 45.1 DNA2 41.1 37.1 - 45.1 DNA2 0.7 0.5 0.5 2.6 DNA2 2.5 DNA2 –1.3 –1.5 –1.5 0.6 - 50.5 48.7 50.2 48.7 2.3 2.2 3.3 2.0 1.1 - 9.1 1.0 AVOXimeter 1000E AVOXimeter 4000 –1.9 - 3.9 Nova Key 22 5.1 M ITC AVOXimeter 1000E AVOXimeter 4000 7.1 - 8.5 97.6 92.6 - 102.6 1.8 –2.2 - 5.8 0.6 –1.4 - 2.6 CCX 50 7.8 CCX Radiometer M2 Nova 90.1 89.8 89.8 90.7 - 100.1 99.8 99.8 100.7 1.8 1.4 1.4 –1.9 - 9.8 9.4 9.4 6.1 –1.9 - 6.1 –1.1 –0.9 –0.9 –0.5 - 2.9 3.1 3.1 3.5 OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 –0.5 - 3.5 - 18.6 19.2 18.8 17.6 15.2 -17.6 - 60.2 59.5 60.6 61.7 53.9 - 61.9 2.7 2.5 2.5 4.6 0.5 - 4.5 50 Roche 16.2 16.8 16.4 15.2 M2 0.9 1.1 1.1 1.5 DNA2 1.5 DNA2 Roche 89.8 - 99.8 90.7 - 100.7 3.9 3.2 –0.1 - 7.9 –0.8 - 7.2 1.0 1.0 –1.0 - 3.0 –1.0 - 3.0 9.1 7.4 8.7 8.4 - 9.8 6.7 - 8.1 8.0 - 9.4 95.5 94.1 95.5 90.5 - 100.5 89.1 - 99.1 90.5 - 100.5 3.9 5.1 3.9 –0.1 - 7.9 1.1 - 9.1 –0.1 - 7.9 0.7 0.7 0.7 –1.3 - 2.7 –1.3 - 2.7 –1.3 - 2.7 Siemens (Bayer) Cobas b 221 OMNI Series 16.0 14.8 - 17.2 16.1 14.9 - 17.3 55.0 56.5 51.0 - 59.0 52.5 - 60.5 42.5 40.3 38.5 - 46.5 36.3 - 44.3 0.6 1.2 –1.4 - 2.6 –0.8 - 3.2 17.3 16.1 - 18.5 17.1 15.9 - 18.3 17.4 16.2 - 18.6 58.0 55.2 58.0 54.0 - 62.0 51.2 - 59.2 54.0 - 62.0 41.3 44.1 41.3 37.3 - 45.3 40.1 - 48.1 37.3 - 45.3 0.1 0.1 0.1 –1.9 - 2.1 –1.9 - 2.1 –1.9 - 2.1 C Siemens (Bayer) M 400 Series 800 Series 1200 Series Key 24 400 Series 800 Series 1200 Series M1 94.8 95.7 Y 7.3 - 8.7 6.6 - 8.0 K 8.0 7.3 50 Cobas b 221 OMNI Series M1 90.5 - 100.5 5.8 5.4 5.4 2.1 DNA2 2.1 DNA2 Y 7.1 - 8.5 95.1 94.8 94.8 95.7 DNA2 95.5 DNA2 M 9.1 9.0 8.9 8.5 C - K 7.7 7.6 7.5 7.1 Key 23 8.4 8.3 8.2 7.8 DNA2 7.8 DNA2 GRAY Radiometer OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 M1 7.8 7.8 - Y 89.3 92.2 91.3 91.4 C DNA2 94.3 97.2 95.8 96.4 K 8.3 8.0 8.5 8.0 - 50 6.9 6.6 7.1 6.6 25 DNA2 7.6 7.3 7.8 7.3 M2 482 682 Synthesis Series GEM OPL GEM 4000 M1 IL tHb g/dL Y mean Analyzers O2Hb % M tHb g/dL C Expected Values Chart Key 21 1010750 Bionostics INS01231 Rev. K 1 B Spot Process PANTONE 5 Black 1 2 3 4 Cyan Magenta Yellow 2748 U DNA2 81.7 83.9 82.9 83.8 - P 12.1 12.3 12.5 11.7 M+C DNA2 13.1 13.3 13.6 12.7 M2 482 682 Synthesis Series GEM OPL GEM 4000 M1 30.2 28.5 DNA2 0.6 –1.4 - 2.6 0.3 –1.7 - 2.3 0.9 –2.0 - 3.8 ORL1 Part No. K-40-6(D) 5.0 4.9 DNA2 72.6 68.6 - 76.6 69.1 65.1 - 73.1 ORL1 ORL1 Key 18 DNA2 28.2 25.2 - 31.2 31.7 28.7 - 34.7 27.8 23.2 - 32.4 ORL1 Komori/GATF DNA2 4.9 4.3 - 5.5 4.7 4.1 - 5.3 5.0 4.4 - 5.6 ORL1 Y 482 682 Synthesis Series GEM OPL GEM 4000 Key 17 IL M2 50 2 3 50 K C mean range mean Expected Values Chart MetHb % range mean range tHb g/dL mean Analyzers O2Hb % range mean COHb % range mean MetHb % range mean range M range COHb % C mean O2Hb % K tHb g/dL GRAY Expected Values Chart 2017-04 75 54947 2017-05 Analyzers M2 55127 482 682 Synthesis Series GEM OPL GEM 4000 DNA2 13.1 13.3 13.6 12.7 12.1 12.3 12.5 11.7 DNA2 81.7 83.9 82.9 83.8 77.7 79.9 78.6 79.8 13.6 13.7 12.5 - 14.7 12.6 - 14.8 81.2 82.5 14.1 13.1 - 15.1 14.1 14.6 14.2 13.6 DNA2 13.6 DNA2 13.1 13.6 13.2 12.6 - 14.1 14.3 14.7 13.7 DNA2 19.2 18.1 17.6 17.4 15.2 14.1 13.1 13.4 76.9 - 85.5 78.2 - 86.8 17.7 85.1 81.1 - 89.1 13.4 82.8 81.7 82.9 84.1 DNA2 84.1 DNA2 78.8 77.7 78.9 80.1 - 85.7 87.9 87.2 87.8 DNA2 0.6 0.4 0.7 0.3 –1.4 –1.6 –2.2 –1.7 - 13.2 - 22.2 0.8 –2.1 - 3.7 9.4 - 17.4 0.5 –1.5 - 2.5 18.2 14.2 - 22.2 17.5 13.5 - 21.5 17.0 13.0 - 21.0 13.6 9.6 - 17.6 DNA2 13.4 9.4 - 17.4 DNA2 1.0 1.0 0.8 1.5 DNA2 1.5 DNA2 –1.0 –1.0 –1.2 –0.5 - - 23.2 22.1 22.1 21.4 2.6 2.4 3.6 2.3 K 25.6 - 34.8 23.9 - 33.1 71.3 64.3 - 78.3 1.3 AVOXimeter 1000E AVOXimeter 4000 –1.6 - 4.2 M 4.4 - 5.6 4.3 - 5.5 Nova Nova 4.8 - 6.0 33.3 30.3 - 36.3 65.7 61.7 - 69.7 0.7 –1.3 - 2.7 CCX M2 5.4 CCX 27.7 29.4 5.6 - 6.8 4.3 - 5.5 5.3 - 6.5 33.6 28.2 34.0 35.6 37.2 38.2 35.2 68.6 65.7 65.7 66.6 DNA2 66.6 DNA2 64.6 61.7 61.7 62.6 24.7 - 30.7 26.4 - 32.4 68.0 69.5 30.6 - 36.6 25.2 - 31.2 31.0 - 37.0 65.6 70.6 65.6 29.2 - 35.2 - 72.6 69.7 69.7 70.6 1.0 1.1 1.1 2.5 DNA2 2.5 DNA2 –1.0 –0.9 –0.9 0.5 64.0 - 72.0 65.5 - 73.5 1.0 1.5 –1.0 - 3.0 –0.5 - 3.5 61.6 - 69.6 66.6 - 74.6 61.6 - 69.6 0.5 0.6 0.4 –1.5 - 2.5 –1.4 - 2.6 –1.6 - 2.4 62.6 - 70.6 - OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 3.0 3.1 3.1 4.5 0.5 - 4.5 - 15.1 15.6 15.2 14.6 12.6 - 14.6 - 86.8 85.7 86.9 88.1 80.1 - 88.1 3.0 3.0 2.8 3.5 –0.5 - 3.5 12.8 13.0 11.8 - 13.8 12.0 - 14.0 83.3 83.6 79.3 - 87.3 79.6 - 87.6 15.4 14.5 11.4 - 19.4 10.5 - 18.5 0.8 1.3 –1.2 - 2.8 –0.7 - 3.3 14.5 13.3 14.4 13.5 - 15.5 12.3 - 14.3 13.4 - 15.4 83.8 81.3 83.8 79.8 - 87.8 77.3 - 85.3 79.8 - 87.8 15.5 17.6 15.5 11.5 - 19.5 13.6 - 21.6 11.5 - 19.5 0.4 0.5 0.4 –1.6 - 2.4 –1.5 - 2.5 –1.6 - 2.4 GRAY Cobas b 221 OMNI Series 75 Cobas b 221 OMNI Series M2 Roche Roche C M 400 Series 800 Series 1200 Series M1 Key 29 400 Series 800 Series 1200 Series K Siemens (Bayer) Siemens (Bayer) Y 4.0 - 5.2 4.0 - 5.2 4.0 - 5.2 - M1 29.6 31.2 32.2 29.2 Y 32.6 34.2 35.2 32.2 DNA2 32.2 DNA2 M 6.2 4.9 5.9 5.8 5.9 5.9 5.2 C 4.6 4.6 - K 4.6 4.7 4.7 4.0 75 5.2 5.3 5.3 4.6 DNA2 4.6 DNA2 Key 28 OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 75 Radiometer Radiometer M1 Key 27 AVOXimeter 1000E AVOXimeter 4000 C ITC ITC Y 30.2 28.5 DNA2 0.6 –1.4 - 2.6 0.3 –1.7 - 2.3 0.9 –2.0 - 3.8 ORL1 75 5.0 4.9 DNA2 72.6 68.6 - 76.6 69.1 65.1 - 73.1 ORL1 ORL1 75 DNA2 28.2 25.2 - 31.2 31.7 28.7 - 34.7 27.8 23.2 - 32.4 ORL1 M2 DNA2 4.9 4.3 - 5.5 4.7 4.1 - 5.3 5.0 4.4 - 5.6 ORL1 M1 482 682 Synthesis Series GEM OPL GEM 4000 Y Key 26 IL IL M1 Level 3 Y Level 1 M CVC 223 CO-Oximeter Calibration Verification Controls Key 25 CVC 223 CO-Oximeter Calibration Verification Controls M2 star Level 4 55042 2017-04 range mean range mean range Analyzers mean O2Hb % range mean COHb % range mean MetHb % range mean range M2 IL tHb g/dL IL 7.1 - 8.5 7.1 - 8.5 93.7 95.5 89.2 - 98.2 91.0 - 100.0 99.3 102.2 100.3 101.4 DNA2 6.2 5.3 5.1 4.2 2.2 1.3 1.1 0.2 - 10.2 9.3 9.1 8.2 DNA2 0.8 0.7 0.8 0.6 –1.2 –1.3 –2.1 –1.4 - 2.8 2.7 3.7 2.6 ITC 1.1 - 9.1 1.0 –1.9 - 3.9 54.5 54.5 18.2 17.0 - 19.4 17.4 18.0 17.6 16.4 DNA2 16.4 DNA2 DNA2 0.3 0.2 0.4 0.0 –1.7 –1.8 –2.5 –2.0 - 50.2 - 58.8 50.2 - 58.8 44.7 39.4 - 50.0 0.4 –2.5 - 3.3 58.2 54.2 - 62.2 40.7 36.7 - 44.7 0.2 –1.8 - 2.2 56.2 55.5 56.6 57.7 DNA2 57.9 DNA2 52.2 51.5 52.6 53.7 43.7 39.7 - 47.7 43.7 39.7 - 47.7 43.0 39.0 - 47.0 41.1 37.1 - 45.1 DNA2 41.1 37.1 - 45.1 DNA2 0.7 0.5 0.5 2.6 DNA2 2.5 DNA2 –1.3 –1.5 –1.5 0.6 - 50.5 48.7 50.2 48.7 2.3 2.2 3.3 2.0 AVOXimeter 1000E AVOXimeter 4000 97.6 92.6 - 102.6 1.8 –2.2 - 5.8 0.6 –1.4 - 2.6 CCX GRAY 7.1 - 8.5 Radiometer 90.1 89.8 89.8 90.7 - 100.1 99.8 99.8 100.7 90.5 - 100.5 1.8 1.4 1.4 –1.9 - 9.8 9.4 9.4 6.1 –1.9 - 6.1 0.9 1.1 1.1 1.5 DNA2 1.5 DNA2 –1.1 –0.9 –0.9 –0.5 - 2.9 3.1 3.1 3.5 –0.5 - 3.5 OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 16.2 16.8 16.4 15.2 - 18.6 19.2 18.8 17.6 15.2 -17.6 - 60.2 59.5 60.6 61.7 53.9 - 61.9 2.7 2.5 2.5 4.6 0.5 - 4.5 star 5.8 5.4 5.4 2.1 DNA2 2.1 DNA2 M2 7.1 - 8.5 95.1 94.8 94.8 95.7 DNA2 95.5 DNA2 M 9.1 9.0 8.9 8.5 C - K 7.7 7.6 7.5 7.1 Key 32 8.4 8.3 8.2 7.8 DNA2 7.8 DNA2 Y+M Roche 3.9 3.2 –0.1 - 7.9 –0.8 - 7.2 1.0 1.0 –1.0 - 3.0 –1.0 - 3.0 9.1 7.4 8.7 8.4 - 9.8 6.7 - 8.1 8.0 - 9.4 95.5 94.1 95.5 90.5 - 100.5 89.1 - 99.1 90.5 - 100.5 3.9 5.1 3.9 –0.1 - 7.9 1.1 - 9.1 –0.1 - 7.9 0.7 0.7 0.7 –1.3 - 2.7 –1.3 - 2.7 –1.3 - 2.7 Cobas b 221 OMNI Series 16.0 14.8 - 17.2 16.1 14.9 - 17.3 55.0 56.5 51.0 - 59.0 52.5 - 60.5 42.5 40.3 38.5 - 46.5 36.3 - 44.3 0.6 1.2 –1.4 - 2.6 –0.8 - 3.2 17.3 16.1 - 18.5 17.1 15.9 - 18.3 17.4 16.2 - 18.6 58.0 55.2 58.0 54.0 - 62.0 51.2 - 59.2 54.0 - 62.0 41.3 44.1 41.3 37.3 - 45.3 40.1 - 48.1 37.3 - 45.3 0.1 0.1 0.1 –1.9 - 2.1 –1.9 - 2.1 –1.9 - 2.1 Key 33 M2 400 Series 800 Series 1200 Series M Siemens (Bayer) M1 89.8 - 99.8 90.7 - 100.7 Y 94.8 95.7 C 7.3 - 8.7 6.6 - 8.0 K 8.0 7.3 M1 42.5 40.7 39.6 40.7 - 57.7 63.0 59.2 60.2 Y DNA2 46.5 44.7 44.9 44.7 - star 7.8 Siemens (Bayer) 400 Series 800 Series 1200 Series 16.8 15.5 - 18.1 16.8 15.5 - 18.1 17.5 17.4 18.1 16.9 Nova Roche Cobas b 221 OMNI Series 49.7 55.0 50.6 52.2 - M2 5.1 Radiometer OSM 3 ABL 500 Series ABL 600 Series ABL 700 Series ABL 80 Series ABL 800 Series NPT 7 DNA2 53.7 59.0 54.9 56.2 15.1 15.0 15.5 14.5 ITC Nova CCX DNA2 16.3 16.2 16.8 15.7 Key 31 AVOXimeter 1000E AVOXimeter 4000 482 682 Synthesis Series GEM OPL GEM 4000 M1 7.8 7.8 - Y 89.3 92.2 91.3 91.4 M DNA2 94.3 97.2 95.8 96.4 C 8.3 8.0 8.5 8.0 - K 6.9 6.6 7.1 6.6 star DNA2 7.6 7.3 7.8 7.3 star 482 682 Synthesis Series GEM OPL GEM 4000 M1 mean Expected Values Chart MetHb % Y range COHb % M mean O2Hb % Key 30 Analyzers tHb g/dL C Expected Values Chart 2017-04 K 54851 star Level 2 Y+C 3 C+M 2 K C M Y M1 Key 34 M2 P GRAY