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INTENDED USE ® ® The HEMOCHRON RxDx Analysis Module is a supplementary module for the HEMOCHRON Response Whole Blood Coagulation System that provides automated calculations for use during cardiopulmonary bypass surgery and cardiac catheterization procedures.
PRINCIPLES OF OPERATION Refer to the HEMOCHRON Response Whole Blood Coagulation System Operator's Manual for a complete description of the HEMOCHRON Response Whole Blood Coagulation System. Once the HEMOCHRON RxDx Analysis Module is installed on the HEMOCHRON Response, an RxDx case is automatically initiated whenever the operator runs an HRT, PRT, or PDA-O test or manually selects the RxDx menu. Each RxDx case is tracked by a numeric Patient ID (PID).
Blood Volume Calculation Blood volume can either be directly entered, or it can be calculated from the patient's height and weight. The system automatically calculates the blood volume once values for the patient's height, weight, and gender have been entered, using the algorithm described by Allen, et al.1 If the patient's blood volume is entered by the operator, that value is used instead. If the entered weight is less than 20 kg, the message OUT OF RANGE WEIGHT is displayed.
Calculation of Heparin Level The heparin level will be calculated automatically whenever a PRT, PDA-O or HiTT test is performed. For the PRT and PDA-O assays, this assumes an average heparin neutralization potency of 118 units/mg protamine. Heparin concentrations for the HiTT assay are based on a quantitative chromogenic assay using the inhibition of Factor IIa (thrombin). See the HiTT package insert for detailed information.
ATTENTION LABEL An attention label on the rear of the HEMOCHRON Response instrument alerts users to accompanying documentation: Before using the HEMOCHRON Response instrument, it is essential that the contents of this Operator’s Manual are read and understood by the operator. Handle and open the container with care. GETTING STARTED RxDx Analysis Module software is loaded onto the HEMOCHRON Response during manufacture. The software must be activated before it can be used.
SETTING SUPERVISOR OPTIONS The supervisor can specify default values for heparin units, target ACT, heparin and protamine dose adjustments, and patient height and weight units. The supervisor can also specify whether the additional heparin calculation screen is automatically displayed when an ACT result falls below the target ACT.
Specifying the Default Percentage for Adjusting the Dose The percentage dose adjustment is the factor by which the calculated dose is increased prior to being displayed. The factory default settings are 10% for heparin and 10% for protamine. These are the same as on the RxDx calculator, but different from the HEMOCHRON 8000 system, which uses default settings of 10% for heparin and 30% for protamine. 1. Display page 3 of the Supervisor menu. 2. Press 5 (RxDx Settings) to display the Customize RxDx screen.
OPERATION Entering RxDx The RxDx mode of operation is entered by any of the following: • Selecting RxDx from the ID Selections menu. • Inserting a barcoded HRT, PRT or PDA-O tube into either well. • Selecting an HRT, PRT or PDA-O test from the test menu. • Selecting RxDx from the HiTT menu. Note: Whenever RxDx is entered, both wells are operational and results of tests run in either well are copied into the case.
Selecting a Different Case or Modifying the PID for the Selected Case 1. Display the Patient Info screen: 2. 3. 4. 5. Press 1 to display the screen for entering PID. Enter the desired PID, and then press YES. If the entered PID does not correspond to a stored case, the user is prompted whether a new case is to be created: Note: If a PID for an open case is entered, that case is selected and the Patient Info screen is displayed.
6. 7. 8. 9. 10. Use the numeral keys to enter the patient weight (from 20 to 300 kilograms, or from 44.1 to 666.3 pounds, depending upon the units chosen). If a decimal point is used, it is automatically entered. Press YES to store the entered weight and display it on the Patient Info screen. Note: If one or more values is entered outside of the stated ranges, the message Out of Range Weight/Height is displayed for manual entry of the blood volume.
Determining the Bolus Heparin Dose Once the baseline ACT result for a patient is known, the bolus heparin dose can be determined, either by performing an HRT or by entering a previously determined HRT value. Note: Refer to the appropriate test package insert for information on required sample volume, procedures for sample addition, and mixing and running the test. 1. Dispense the patient's sample into the HRT test tube and simultaneously press the START key. 2. Mix the contents of the test tube. 3.
5. 6. 7. Press YES. The information is stored and the Additional Heparin Dose screen is displayed: Note: AddlHep is the calculated additional heparin dose (in heparin units). The PRT test tube that should be used for determining the protamine dose is also indicated. If the additional heparin dose that was administered is different than that calculated, press 1 to display the edit screen, enter the HepGvn value, and press YES to store the actual value.
6. Press YES. The protamine dose information is stored and the RxDx screen is displayed. If YES is not pressed, the dose will not be stored. Determining Circulating Heparin Level Using a PRT or PDA-O Test Tube Note: Refer to the appropriate test package insert for information on required sample volume, procedures for sample addition, and mixing and running the test. 1. Dispense the patient sample into a PRT or PDA-O test tube and simultaneously press the START key. 2. Mix the contents of the test tube. 3.
Determining Circulating Heparin Level (in mg/kg) Using a HiTT Test Tube When Not in the RxDx Mode Note: Refer to the appropriate test package insert for information on required sample volume, procedures for sample addition, and mixing and running the test. 1. Prewarm and perform the HITT test. Note: Refer to the HEMOCHRON Response Operator's Manual for instructions. 2. Upon insertion of the test tube in the well, the HiTT Selects screen is displayed: 3. Select 3.
Appending User Notes User Notes can be tagged to a test result to denote additional information. When a note is appended, the numeral corresponding to that note is displayed on the screen and in the RxDx case report. The full note is stored in the general Response database. Note: Refer to the HEMOCHRON Response Operator's Manual for instructions to define a note. 1. Display the RxDx System screen. 2. Press 7 to display the notes screen: Press NO until the desired note is displayed.
QUALITY CONTROL Routine quality control testing should be part of a comprehensive quality assurance program. Quality control testing of the HEMOCHRON RxDx test tubes is described in the individual test tube and Liquid Quality Control package inserts. QC requirements and lockouts are disabled when an RxDx case is selected. The operator must exit RxDx in order to run an RxDx QC test. Running a QC Test for an RxDx Assay 1.
RESULTS MANAGEMENT Up to ten (10) RxDx cases can be contained on a HEMOCHRON Response with an activated HEMOCHRON RxDx Analysis Module. Note: If a new case is started on a system already containing ten cases, a warning prompt is displayed that the case that has been inactive the longest will be deleted if the operator elects to proceed. Reviewing Information for the Active RxDx Case 1. Display the RxDx System screen. 2. Press 5 to display the View screen: 3. 4.
Printing the Test Record, Patient Record, Case List, or Bolus Dose Report 1. Return to the main RxDx menu, and press the PRINT key to display the RxDx Print menu: 2. 3. 4. 5. Press 1 or 2 to print the record for the last test run in Well 1 or Well 2, respectively. Press 3 to print the patient record for the case. Press 4 to print the Case List. Press 6 to print the Bolus Dose Report. Note: This report is only available after a dose has been calculated. Note: Press 5 to interrupt the printing.
REPORTS Data from an RxDx case that was run on the HEMOCHRON Response can be retrieved and reported at any time. Seven RxDx reports are available: Report Description Patient Record Bolus Heparin Dose All information for the case. Bolus heparin dose calculated and given, plus information used in the calculation. Additional heparin dose calculated and given, plus information used in the calculation. Total heparin calculated and given, plus information used in the calculation.
Displaying and Printing a Report Display and/or print various reports as summarized below: Report Description Patient Record Display the Patient Record (page 18) and press PRINT while the Patient Record or the RxDx screen is displayed. Display the Bolus Heparin Dose Calculation or the Bolus Heparin Dose screen (page 12) and press PRINT while either screen is displayed. Display the Additional Heparin Dose screen (page 13) and press PRINT while the screen is displayed.
INDEX determination ............................................12 pump heparin entering......................................................12 Reports ............................................................19 additional heparin dose .............................19 bolus heparin dose ....................................19 displaying ...................................................20 HiTT ...........................................................19 patient report ...................................
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