RxDx Analysis Module Heparin and Protamine Dosing. Operator s Manual English. Response TABLE OF CONTENTS

Transcription

1 RxDx Analysis Module Heparin and Protamine Dosing Response Operator s Manual English TABLE OF CONTENTS This manual is published by International Technidyne Corporation (ITC) for use with the HEMOCHRON Response ver or higher. Questions or comments regarding the content of this manual can be directed to the address at the back of this manual or to your ITC representative. HEMOCHRON and RxDx are registered trademarks of ITC. Celite is a registered trademark of Celite Corporation. 2003, This document is the copyright of ITC and must not be copied or reproduced in any form without prior consent. ITC reserves the right to make technical improvements to this equipment and documentation without prior notice as part of a continuous program of product development.

2 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. These calculations are used to determine the doses of heparin to be administered before and during these procedures, the dose of protamine needed to reverse the effects of heparin after the procedure is completed, and the patient's clotting time and residual heparin level after protamine has been administered. The results that are obtained are saved to an internal database and can be printed or downloaded to a personal computer. Note: Refer to the HEMOCHRON Response Whole Blood Coagulation System Operator's Manual for the intended use and instructions for the use of the HEMOCHRON Response Whole Blood Coagulation System. SUMMARY AND EXPLANATION Heparin is used to maintain hemostasis during cardiac surgery and percutaneous coronary interventional (PCI) procedures. However, its administration can pose significant risk to the patient. Since individual patients can vary as much as twelve-fold in heparin sensitivity, overdosing heparin can result in dangerous bleeding and underdosing heparin can lead to thrombosis. Therefore, monitoring heparin therapy is vital in guarding against these undesirable side effects. The doses of heparin to be administered before and during the procedure, the dose of protamine to administer after the procedure, and the patient's clotting time and residual heparin level are determined by running a series of clotting time tests. This series of tests for a patient is referred to as an RxDx case. Note: In this manual, a case is the patient information and the series of test results that are associated with a specific patient ID. Prior to administration of heparin, an Activated Clotting Time (ACT) and Heparin Response Time (HRT) test are run on the HEMOCHRON Response Whole Blood Coagulation System. These tests measure the patient's baseline clotting time and determine how the patient will respond to heparin. The patient blood volume can then be directly entered (if available) or calculated by the system based upon the patient's height, weight and gender. The initial heparin dose (referred to as the bolus heparin dose) is then calculated by the system. During this process, the case is in the heparin mode. Once the patient has received heparin, additional ACT or High Dose Thrombin Time (HiTT) tests are run to measure the coagulation status, determine the efficacy of heparin, and calculate additional heparin doses that may be needed to maintain the target clotting time in the patient. The case is now in the additional heparin mode. After the cardiac surgery or cardiac angioplasty procedure is completed, the effects of administered heparin can be reversed by administration of protamine. Like heparin, protamine must be administered in the correct dose to prevent dangerous bleeding or thrombosis. For this reason, a Protamine Response Time (PRT) test is performed, and the results of this test and the most recent ACT test are used to determine the dose of protamine that is required. The case is now in the protamine mode. Once the protamine has been administered, the patient's clotting time and residual heparin level are measured, using an ACT and a Protamine Dose Assay - Orange (PDA-O) test to determine the postprotamine clotting time and residual heparin level in the patient's blood. Dual Thrombin Time and Heparin Neutralized Thrombin Time (TT/HNTT) tests can also be run after protamine administration to identify the presence of heparin rebound or abnormal fibrinogen function. Since Celite (diatomaceous earth) is sensitive to the presence of serine protease inhibitors such as aprotinin, it is recommended that kaolin test tubes are used instead of Celite test tubes when aprotinin is on board. 2

3 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). Once a PID is entered, it is applied to tests in both wells. At the outset of the case, the operator enters the PID plus the patient's height, weight and gender (for calculating blood volume). Calculations performed by the system for determining patient blood volume, bolus heparin dose, additional heparin dose, and protamine dose are summarized below. Definitions and Terms The following acronyms and abbreviations are used in this manual, instrument screens and printouts: ACT AdditionalHepDose/Addl Hep Base ACT Bld Vol, Blood Vol Bolus Hep CalcDse Cur ACT EstBV Hep Gvn Hep Lvl HiTT HRT OID Pat Info PDA-O PID PIN PostBolusACT ProtDose PRT Pump Hep QC Tot Hep/THep Activated clotting time (FTCA510/FTK-ACT) Additional heparin dose (units) Baseline ACT (seconds) Blood volume (ml) Bolus heparin dose (units) Calculated heparin dose (units) Most recent ACT result Estimated blood volume (ml) Heparin dose given to the patient (units) Patient heparin level (units/ml or mg/kg) High Dose Thrombin Time Heparin Response Time (R-HRT480P/R-HRT480PK) Operator Identification Number Patient demographics information Protamine Dose Assay - Orange (PDAO/PDAOK) Patient Identification Number Operator Personal Identification Number ACT result following bolus heparin dose Protamine dose (mg) Protamine Response Time (R-PRT200/R-PRT200K) (R-PRT400/R-PRT400K) Amount of heparin added to the pump (units) Quality Control Calculated total heparin dose given, including bolus dose heparin in the pump and additional heparin given (units) 3

4 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. The blood volume for the patient must then be manually entered. Bolus Heparin Dose Calculation (Heparin Mode) The bolus heparin dose is calculated using the baseline ACT, HRT, targeted ACT and patient blood volume, based upon standard dose response techniques described by Bull, et al. 2 The bolus heparin dose is calculated if the baseline ACT and current HRT values are within these ranges: The baseline ACT must be within 70 to 250 seconds. The current HRT must be within 200 to 1,500 seconds, and at least 100 seconds greater than the baseline ACT. Note: If a user-entered value is outside these ranges, an error message is displayed. If the calculated bolus heparin dose is greater than 6.7 units per ml of blood volume (or 5 mg/kg by body weight), a warning message is displayed. Additional Heparin Dose Calculation (Additional Heparin Mode) After the bolus heparin dose is administered, any additional heparin doses can be calculated using the current ACT and heparin dose given, as described by Bull, et al. 2 The additional heparin dose is calculated if the post bolus ACT, baseline ACT, target ACT, and current ACT values are within these ranges: The post bolus ACT must be greater than the baseline ACT. The target ACT must be greater than the current ACT. Note: If the values are outside these ranges, a message is displayed. Protamine Dose Calculation (Protamine Mode) The protamine dose is calculated using the PRT (or PDA-O), the most recent ACT, targeted ACT value and the patient s blood volume, as described by Bull, et al. 2 When a PRT test is run, the protamine dose is calculated if the Current PRT and Status ACT values are within these ranges: The current PRT must be within 70 to 800 seconds. The status ACT must be within 200 to 1,500 seconds and greater than the PRT. Note: If the values are outside these ranges, an error message is displayed. When a PDA-O test is run, the protamine dose is calculated if the Current PDA-O and Status ACT values are within these ranges: The current PDA-O must be within 70 to 300 seconds. The status ACT must be within 150 to 1,500 seconds and greater than the PDA-O. Note: If the values are outside these ranges, an error message is displayed. If the calculated protamine dose is greater than 500 mg, a warning message is displayed. If the calculated protamine dose is greater than 800 mg, the message Dose >800 mg is displayed in place of the protamine dose. 4

5 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. For the HiTT test, heparin level expressed as heparin units/ml of blood is displayed when the value is below 10 units/ml. Heparin levels can also be expressed as mg/kg. The HiTT test will only report heparin levels between 1.5 and 7.0 mg/kg. Case Status Ten cases can be stored on the system. Each case is identified by the PID. The active case is the case that is currently being run. An open case is any case on which at least one RxDx test was run on the system during the past eight hours. Additional RxDx tests can be run and added to an open case. A closed case is any case on which an RxDx test has not been run on the system during the past eight hours. Additional RxDx tests cannot be added to a closed case. Note: The patient information from a closed case can be reused to create a new case. See page 19 for details. RxDx Features The RxDx system, incorporated into the HEMOCHRON Response Whole Blood Coagulation System, provides a set of software features that will calculate heparin and protamine doses for patients prior to and during cardiopulmonary bypass surgery and cardiac catheterization procedures. RxDx software features include: Patient data can be input to calculate patient blood volume. Up to ten (10) RxDx cases can be stored. RxDx is capable of generating different report types (see REPORTS). A pound symbol (#) follows any result that has been manually entered by the user. A tilde (~) follows any calculated result that uses values manually entered by the user. Database Specifications The RxDx database can store up to ten (10) RxDx cases. The following information is stored for each case: PID Height Weight Gender Blood volume Bolus heparin dose Target ACT for HRT Target ACT for PRT Baseline ACT Total heparin given Status ACT Protamine dose Results of all RxDx tests run during case OID and Date/Time are recorded for all test results If a non-recommended PRT tube type is used, the results are flagged Test results from an RxDx case are stored in both the RxDx database and HEMOCHRON Response database. Dose and other calculations are only stored in the RxDx database. 5

6 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. Activating RxDx Analysis Module Software 1. Obtain the serial number of the HEMOCHRON Response, software version 2.00 and above, on which the RxDx Analysis Module software is to be activated. Note: The serial number is printed on the label at the rear of the instrument. 2. Contact ITC Customer Service (phone: or , or via fax: ) to obtain the activation code (serial number specific) for the system. 3. Press MENU to display the first page of the main menu. 4. Press 1 to display the ID Selections. 5. Press 4 to display the RxDx System screen: 6. Enter up to a nine-digit code. Note: The code may be entered with or without leading zeros. 7. Press YES to complete the activation. 8. RxDx system default settings can be configured in the Supervisor menu. Refer to SETTING SUPERVISOR OPTIONS below for instructions. Note: Refer to the HEMOCHRON Response Operator's Manual for complete operating instructions. Refer to the Setting Configuration Options and Setting Supervisor Options sections of the HEMOCHRON Response Operator's Manual for instructions to enter the correct date and time and to configure the instrument. 6

7 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. Finally, the supervisor can erase the entire RxDx database, erase a single case, re-start a closed case, temporarily deactivate the RxDx module, and restore the factory default settings for RxDx. Erasing the RxDx Database or a Single Case 1. Display page 3 of the Supervisor menu: Note: The supervisor must exit RxDx to display the Supervisor menu. 2. Press 1 to erase the RxDx database. Press YES to confirm. 3. Press 2 to erase a case. Enter the PID for the case at the prompt and press YES. Re-Starting a Closed Case 1. Display page 3 of the Supervisor menu. 2. Press 3. Enter the PID for the case at the prompt and press YES. Temporarily Deactivating the RxDx Module 1. Display page 3 of the Supervisor menu. 2. Press 4 to change RxDx On to NO (or vice versa). Specifying Default Heparin Units 1. Display page 3 of the Supervisor menu. 2. Press 5 (RxDx Settings) to display the Customize RxDx screen: 3. Press 1 to change Hep Units from U/mL to mg/kg (or vice versa). Specifying the Default Value for Target ACT for HRT, PRT, or PDA-O 1. Display page 3 of the Supervisor menu. 2. Press 5 (RxDx Settings) to display the Customize RxDx screen. 3. Press 2 to display the Target ACT screen: 4. Select the test (HRT, PRT, or PDA-O) for the target ACT. 5. Enter the new default value. 6. Press YES to save the value. 7

8 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. 3. Press 3 to display the Dose Adjust screen: 4. Select the dose (heparin or protamine) adjustment to change. 5. Enter the new default value (from 0 to 30). 6. Press YES to save the value. Specifying Default Units for Patient Height and Weight 1. Display page 3 of the Supervisor menu. 2. Press 5 (RxDx Settings) to display the Customize RxDx screen. 3. Press 4 to change Units from m, kg to ft, in, lb (or vice versa). Specifying Display of the Additional Heparin Calculation Screen 1. Display page 3 of the Supervisor menu. 2. Press 5 (RxDx Settings) to display the Customize RxDx screen. 3. Press 5 to change the display from AUTO to MANUAL (or vice versa). Restoring RxDx Factory Defaults 1. Display page 3 of the Supervisor menu. 2. Press 6. The factory default settings are restored. Defining a Note Up to nine customized notes can be defined. Up to two of these notes can be selected and appended to a test record by the operator when the test is run. Note: Refer to the HEMOCHRON Response Operator's Manual for instructions to define a note. 8

9 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. All PID and OID entry requirements and QC lockout conditions are suspended until the operator exits the RxDx case. 1. Enter RxDx (see above). A prompt to enter a PID is displayed: RxDx mode of Operation Note: An R is displayed on the divider bar of each screen to designate that the system is in the RxDx mode of operation. Note: The PID prompt is not displayed if a stored RxDx case is selected from the View menu of the RxDx System screen (page 18). 2. Enter the PID (up to 9 numeric digits) for the case and then press YES. The Patient Info screen is displayed for review or entry of patient information: Note: If the entered PID does not correspond to that of a stored RxDx case, a new case is created for that PID. Up to ten (10) RxDx cases can be stored on the system. If an eleventh case is initiated, the operator is warned that the oldest case will be deleted. 3. For a new case, or to revise information for a stored case, enter the height, weight, and gender of the patient for calculation of blood volume, or enter the blood volume directly. See below for the procedure. 4. Press YES. The RxDx System screen is displayed for the case: Heparin mode Note: If the active case is an open case (page 5), the mode of the case (heparin, additional heparin, or protamine, as detailed on page 2) is designated by the corresponding letter (H, A or P) in the title bar of the RxDx System screen. 9

10 Selecting a Different Case or Modifying the PID for the Selected Case 1. Display the Patient Info screen: 2. Press 1 to display the screen for entering PID. Enter the desired PID, and then press YES. 3. 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. If a PID for a closed case is entered, the Closed Case menu is displayed to allow the operator to either re-use patient information from that case or delete the case (page 19). 4. Press YES if a new case is to be created. Otherwise, press NO to display a prompt to modify the case PID: 5. Enter the new PID, and then press YES. Entering or Revising Patient Information 1. Display the Patient Info screen: 2. Press 2 to display the Enter Height screen: or 3. Use the numeral keys to enter the patient height (from 0.3 to 2.5 meters, or from 1 foot, 0 inches to 8 feet, 3 inches, depending upon the units chosen). If a decimal point is used, it is automatically entered. 4. Press YES to store the entered height and display it on the Patient Info screen. Note: If an incorrect entry is made, press CANCEL, NO or a MENU key to cancel the entry and redisplay the Patient Info screen. 5. Press 3 to display the Enter Weight screen: or 10

11 6. Use the numeral keys to enter the patient weight (from 20 to 300 kilograms, or from 44.1 to pounds, depending upon the units chosen). If a decimal point is used, it is automatically entered. 7. 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. 8. If necessary, change the gender (M or F) by pressing 4. The selected gender is stored and displayed on the Patient Info screen. Note: Once values are stored for a patient's height, weight and gender, the system displays the patient's calculated blood volume. 9. If the patient's blood volume is to be entered rather than calculated by the system, press 5 to display the Enter Blood Volume screen: Then, use the numeral keys to enter the patient's blood volume (in milliliters, from 50 to 9,999 ml), and press YES to store the entered blood volume and display it on the Patient Info screen. Note: If the patient's blood volume is entered by the user rather than calculated by the system, a pound symbol (#) follows the blood volume in all displays and reports. 10. Press YES to store the information and cancel display of the Patient Info screen. Tagging a Test Type If non-barcoded tests are used, the test type can be tagged as follows: 1. Display the RxDx System screen. 2. Press 6 to display the Select Assay screen. 3. Press the numeric key corresponding to the test to be selected. Depending on the test in use, another submenu may be displayed for further test selection information. 4. Press YES to store the information. Note: If barcoded tests are used, the system will automatically read the bar code and identify the test. Running a Baseline ACT Test In order to calculate the bolus heparin dose, the result of a baseline ACT test on the patient is needed. Note: The result of an ACT test that was previously run on the patient can be used. The test must have been started within 90 minutes before and two minutes after the start of the most recent HRT test. Note: Refer to the appropriate test package insert for information on required sample volume, procedures for sample addition, mixing, and running the test. 1. Dispense the sample into the ACT test tube and simultaneously press the START key. 2. Mix the contents of the test tube. 3. Insert the test tube in the well. The tube is rotated automatically in the well until clot formation is detected and the results are displayed. 11

12 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. Insert the test tube in the well. 4. Upon clot detection, the information is displayed on the Bolus Hep Calc screen: Note: If a value for Baseline ACT (from 70 to 250), HRT (from 200 to 1,500), or blood volume is entered by the operator, a pound symbol (#) follows that value in all displays and reports. 5. If necessary, enter or edit Baseline ACT, HRT, or Target ACT by pressing the corresponding numeral key to display the edit screen, entering the value, and pressing YES to store the new value. Note: Press 4 to update Patient Information. The PID cannot be changed at this time. 6. Press YES. The information is stored and the Bolus Heparin Dose screen is displayed: Note: CalcDse is the calculated bolus heparin dose (in heparin units). Calculated values are designated by a tilde (~) on the screen and in reports if based on manually entered values. Manually entered values are designated by a pound symbol (#). 7. If the administered bolus heparin dose is different from that calculated, press 1 to display the edit screen, enter the HepGvn value, and press YES to store the actual value. Important: The HepGvn value is used to report the total amount of heparin given. Be sure that the actual value is entered if it is different from the calculated value. 8. Press YES. The bolus heparin dose information is stored and the RxDx System screen is displayed. Determining Additional Heparin Dose After the bolus heparin dose for a patient is calculated and administered, the ACT test is run again to determine if an additional heparin dose is needed. 1. Display the RxDx System screen. 2. Press 2. The Heparin Dose screen is displayed. 3. Press 2. The Additional Heparin Calculation screen is displayed: Note: If AutoCalc is selected in the setup menu and the ACT value is less than the target ACT, then Steps 2 and 3 are not necessary. 4. If necessary, enter or edit Baseline ACT, Bolus Heparin Dose Given, Post Bolus ACT, Target ACT, or Current ACT by pressing the corresponding numeral key to display the edit screen, entering the value, and pressing YES to store the value. 12

13 5. 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. 6. 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. Important: The HepGvn value is used to report the total amount of heparin given. Be sure that the actual value is entered if it is different than the calculated value. 7. Press YES. The additional heparin dose information is stored and added to the total heparin given for the case. Then, the RxDx System screen is displayed. Entering Pump Heparin Heparin used in a device (such as a pump) can be included for an accurate PRT tube identification. 1. Display the RxDx System screen. 2. Press 4. The Total Heparin Given screen is displayed: 3. Press 1 to display the pump heparin edit screen. 4. Enter the amount of heparin (in heparin units) used in the device. 5. Press YES. The pump heparin information is stored and added to the total heparin given for the case. Then, the RxDx System screen is displayed. Determining the Protamine Dose When surgery is completed, a PRT test is performed. The results of this test and the most recent ACT test are used to determine the dose of protamine that is required to reverse the effects of the administered heparin. Note: Use a PRT200 (peach top) test tube if the total heparin given is equal to or less than 6.5 units per ml of blood volume. Use a PRT400 (red top) test tube if the total heparin given is greater than 6.5 units per ml of blood volume. Heparin used in a connected device (such as a pump) can be entered by the operator so that it is included in the calculation for PRT tube selection. Note: Refer to the appropriate test package insert for information on required sample volume, procedures for sample addition, mixing, and running the test. 1. Dispense the patient sample into the PRT test tube and simultaneously press the START key. 2. Mix the contents of the test tube. 3. Insert the test tube in the well. 4. Upon clot detection, the information is displayed on the Prot Dose Calc screen: Note: ProtDose is the calculated protamine dose. 5. If necessary, enter or edit Target ACT, Status ACT, or the measured PRT results by pressing the corresponding numeral key to display the edit screen, entering the value, and pressing YES to store the value. Press 4 to display Hep in alternate units (mg/kg body weight or Units/mL blood volume). 13

14 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. Insert the test tube in the well. If the HEMOCHRON Response is not operating in the RxDx mode, the system enters the RxDx mode and prompts for entry of a PID: Enter the PID for the desired case, press YES to display the Patient Info screen for the case, and press YES to acknowledge the patient information. 4. The calculated circulating heparin level is displayed on the Prot Dose Calc screen: 5. Press CANCEL to exit the Prot Dose Calc screen. Note: Do not press YES unless a new protamine dose is to be saved. Determining Circulating Heparin Level Using a HiTT Test Tube While 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. To prewarm the HiTT test tube, select 6 from the RxDx System screen, then select 3 from the Select Assay screen. The HiTT Assay screen is displayed: Note: If the HiTT test tube is not to be prewarmed, proceed to Step Select 3 from the HiTT Assay screen. 3. Insert the HiTT tube into the well. The time remaining (in seconds) until pre-warming is complete is displayed. When prewarming is completed, 0 is displayed and three beeps will sound (if the instrument is configured to beep). 4. Remove the test tube from the well. 5. Dispense the patient sample into the test tube and simultaneously press the START key. 6. Mix the contents of the test tube and insert the test tube in the well. Upon clot detection, the results are displayed: 7. Press CANCEL to exit the HiTT Results screen. Note: Press 1 to review patient demographic information. 14

15 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. The system enters the RxDx mode and prompts for entry of the PID: Enter the PID for the desired case and press YES to display the Patient Info screen for the case. Enter the required information (if needed) and press YES to acknowledge the patient information. 4. The calculated circulating heparin level is displayed on the HiTT Results screen: 5. Press CANCEL to exit the HiTT Results screen. Determining if Additional Protamine is Needed After administration of the protamine dose, the residual heparin level can be measured and an additional protamine dose can be applied if necessary. 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 a PDA-O test tube and simultaneously press the START key. 2. Mix the contents of the test tube. 3. Insert the test tube in the well. Upon clot detection, the results are displayed. 4. Press YES. The information is stored and the PDA-O Dose Calc screen is displayed: 5. If necessary, enter or edit Target ACT and/or Status ACT by pressing 1 or 2 to display the edit screen, entering the value, and pressing YES to store the value. Press 4 to display Hep in alternate units (mg/kg body weight or Units/mL blood volume). 6. Press YES. The calculated protamine dose is stored and the RxDx System screen is displayed. 15

16 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: 3. Press NO until the desired note is displayed. 4. Press YES to select the note. 5. Repeat Steps 3 and 4 to select additional notes. Only the last two entered note numbers will be stored with the test result. 6. Press YES to enter the notes into the case. Exiting RxDx 1. Press the CANCEL key until the Exiting RxDx screen is displayed: 2. Press YES to exit RxDx. Note: The Exiting RxDx screen is also displayed with an option to abort the non-rxdx test if a non-rxdx test tube (e.g., APTT) is run while RxDx is active. Press 1 to abort the non-rxdx test or press YES to exit RxDx. All QC lockout conditions are reactivated upon exiting RxDx. 16

17 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. Press the CANCEL key until the Exiting RxDx screen is displayed: 2. Press YES to exit RxDx. 3. Display the first page of the main menu. 4. Press 2. The QC Selections menu is displayed. Note: If the current operator is not allowed to run liquid controls, an information message is displayed and the operator cannot proceed. 5. Press 1 or 2, corresponding to whether a normal or abnormal control is being run. The QC menu for the selected control level is displayed. 6. Press 1. The current lower limit for the control range is displayed with the cursor positioned where the first character of the new lower limit is to be entered. 7. If needed, enter the new lower limit (up to 4 characters). If needed, press BACKSPACE to undo an entry for retyping. 8. Press YES. 9. Press 2. Repeat Steps 6 and 7 for the upper limit. 10. Press 3. Enter the lot number for the control. 11. Prepare the QC material and dispense as specified in the QC package insert. 12. Simultaneously press the START key. Note: Alternately, the operator can start the RxDx QC test (Steps 11 and 12) and then exit the RxDx mode and tag the test as a QC test while the test is running (Steps 1 through 10). Note: Refer to the HEMOCHRON Response Operator's Manual for additional instructions on running QC tests. 17

18 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. Press 1 to display the record for the current patient: Note: To display the next page of the record, press the 0 key. To display the previous page, press the 9 key. To print the record, press the PRINT key. 4. Press YES, CANCEL or NO to cancel display of the information and return to the RxDx System screen. Reviewing Information for Stored RxDx Cases 1. Display the RxDx System screen. 2. Press 5 to display the View screen. 3. Press 2 to view the Case List: Note: DONE designates a closed case in the Case List. 4. Press the numeral key (use 0 for the number 10) for a case to view information for that case. 18

19 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. Press 1 or 2 to print the record for the last test run in Well 1 or Well 2, respectively. 3. Press 3 to print the patient record for the case. 4. Press 4 to print the Case List. 5. 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. Reviewing, Creating a New Case From, or Erasing a Closed Case Note: A closed case is designated as DONE on the Case List. 1. Display the RxDx Case List. 2. Select the closed case to display the Closed RxDx Case screen. 3. Press 1 to review the case. 4. Press 2 to create a new case from the case. Important: All test results for a closed case are removed from the case if a new case is created from the closed case. 5. Press 3 to erase the case. 19

20 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 Patient Record Bolus Heparin Dose Additional Heparin Dose Total Heparin Given Protamine Dose HiTT PDA-O Description 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. Protamine dose calculated and given, plus heparin level and information used in the calculation. Results of the HiTT test and circulating heparin level. Results of the post-procedure PDA-O test, plus protamine dose (if any), heparin level, and information used in the calculation. Each of the seven types of reports contains the same information in the report header: OID PID Case Starting Date Case Starting Time Patient Height Patient Weight Patient Gender Patient Blood Volume An example of a Total Heparin Given report is shown below: T o t a l H e p a r i n G i v e n O p e r I D = P a t I D = D a t e = 1 2 / 1 2 / T i m e = 1 2 : 5 5 H e i g h t = 1. 6 m W e i g h t = k g G e n d e r = F e m a l e B l o o d V o l = m l B o l u s D o s e = 4, u P u m p H e p = 5, u A d d l H e p = 5, u T o t H e p G i v = 3 5, u # U s e r S e l e c t e d Note: On all reports, a pound symbol (#) appears next to any manual entry and a tilde (~) appears after any calculated result based on a manual entry. 20

21 Displaying and Printing a Report Display and/or print various reports as summarized below: Report Patient Record Bolus Heparin Dose Additional Heparin Dose Protamine Dose Total Heparin Given HiTT PDA-O Description 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. Display the Protamine Dose screen (page 13) and press PRINT while the screen is displayed. Display the Total Heparin Given screen (page 13) and press PRINT while the screen is displayed. Display the HiTT results (page 14) and press PRINT while the results are displayed. Display the PDA-O results (page 14) and press PRINT while the results are displayed. REFERENCES 1. Allen, T.H., M.T. Peng, K.P. Chen, T.F. Huang, C. Chang and H.S. Fang Prediction of Blood Volume and Adiposity in Man from Body Weight and Cube of Height. Metabolism 5: Bull, B.S, W.H. Huse, F.S. Brauer and R.A. Korpman Heparin therapy during extracorporeal circulation. II. The use of a dose-response curve to individualize heparin and protamine dosage. J. Thorac. Cardiovasc. Surg. 69: HEMOCHRON Response Whole Blood Coagulation System Operator s Manual. International Technidyne Corporation. Note: Refer to the HEMOCHRON Response Whole Blood Coagulation System Operator s Manual for troubleshooting information. 21

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23 INDEX Additional Heparin Dose calculation...4 determination...11 baseline ACT...10 blood volume...10 calculation...4 bolus heparin dose calculation...4 determination...11 Calculation additional heparin dose...4 blood volume...4 bolus heparin dose...11 heparin level...5 protamine dose...4 Celite...2 circulating heparin level determination...13 configuration user notes...8 Definitions...3 entering patient information...9 entering RxDx...8 exiting RxDx...15 Heparin administration...2 doses...2 intended use...2 patient ID...3 patient information...3 entering...8 printing...20 protamine dose calculation...4 determination...12 pump heparin entering...12 Reports...19 additional heparin dose...19 bolus heparin dose...19 displaying...20 HiTT...19 patient report...19 PDA-O...19 printing...20 protamine dose...19 total heparin given...19 residual heparin level determination...14 revising patient information...9 RxDx activation...6 RxDx case...2 case status...5 reviewing...17 starting...8 Supervisor Options deactivating the RxDx module...6 defining a note...8 erasing a single case...6 erasing the RxDx database...6 restarting a closed case...6 restoring factory defaults...7 specifying default values...7 Terms...3 User Notes

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