Hemochron Response Operators Manual

This manual is published by Accriva Diagnostics, Inc. (Accriva) for use with the Hemochron Response V2.00 or above. Questions or comments regarding the contents of this manual can be directed to the address at the back of this manual or to your Accriva representative. Hemochron® and RxDx® are registered trademarks of Accriva. Celite® is registered trademark of Celite Corporation. ©2014. This document is the copyright of Accriva and must not be copied or reproduced in any form without prior consent. Accriva reserves the right to make technical improvements to this equipment and documentation without prior notice as part of a continuous program of product development.

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INTENDED USE The Hemochron® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following Hemochron Whole Blood Coagulation Assays: Activated Clotting Time (ACT), Protamine Dose Assay (PDA), Heparin Response Time (HRT) and Protamine Response Time (PRT). For in vitro diagnostic use only. For Professional Use. SUMMARY AND EXPLANATION The ACT test is the method of choice for monitoring heparin therapy. Administration of heparin to maintain hemostasis during cardiac surgery and cardiac angioplasty procedures 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. ACT is performed by adding a clotting activator such as Celite®, silica, kaolin, or glass particles to a blood sample and then measuring the length of time required for clot formation. The particular clotting activator that is used influences the time required for clot formation. Celite (diatomaceous earth) is the standard ACT reagent used for high level heparin monitoring because of its excellent activating properties. However, serine protease inhibitors such as aprotinin that may be administered to certain patients to decrease postoperative bleeding can prolong the Celite activated ACT. When aprotinin is on-board, a kaolin-activated ACT tube should be used. PRINCIPLES OF OPERATION The patented Hemochron clot detection module contains two test wells into which disposable unitized coagulation test tubes can be inserted. The test tubes (provided in a separately purchased test kit) contain reagents for a particular test and a precision magnet. Immediately after the sample is added to the test tube, the START button is pressed, the test tube is agitated, and the test tube is placed into the test well by the operator. There, it is automatically rotated at a controlled speed and incubated at 37 °C ±1.0 °C. When a fibrin clot begins to form, it causes the magnet in the test tube to be displaced. Two magnetic detectors located in the test well continuously monitor the precise magnet position. When a specific displacement of the magnet occurs, the elapsed time between the beginning of the test and the clot endpoint is displayed as the coagulation time (in seconds). The instrument also emits an audible beep when clot formation occurs, indicating the end of the test. The coagulation time is displayed on the LCD screen. The operator may choose to print the result (if automatic printing of results is not specified) or simply proceed to the next desired assay. The system (Figure 1) contains a dual-well patented clot detection module. User interface is through a keypad and display panel. Test results are shown on the display panel on completion of the test, and can be printed.

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Display Panel

Printer Test Wells Keypad

Figure 1. Hemochron Response Whole Blood Coagulation System Two RS232 serial ports and a Centronix parallel port are included so that results and other information from the data storage module can be downloaded to the laboratory computer or printed elsewhere. The RS232 serial ports can also be used to connect an external barcode reader for importing Patient ID (PID) and/or Operator ID (OID). Definitions and Terms The following acronyms and abbreviations are used in this manual, instrument screens and printouts: Activated Clotting Time ACT Database DB Electronic System Verification ESV Hemochron Response Data Manager software program HRDM Liquid Quality Control LQC Operator Identification Number OID Operator Personal Identification Number PIN Patient Identification Number PID Point of Care Coordinator POCC Quality Control QC Temperature Verification Tube TVT Overview of Operation Important: Disposable ready-to-use test tubes for use with the system are available for purchase separately. Test tubes from other manufacturers can be run, but the test being run will not be identified and the clotting time results may be significantly different. The laboratory should verify performance if test tubes from other manufacturers are used. The system rotates the test tube at a constant rate while continuously monitoring the contents. An integrated test type barcode reader decodes the test name and expiration date imprinted on the tube label.

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After a clot forms, the instrument beeps and the clotting time is displayed on the display panel. The result is also stored in the system database with the date and time the test was performed, and the assay type. If entered, the PID and OID are stored with the test result. Features The system has a number of performance and convenience features: • The system is portable for bedside use • A multi-test menu is resident on the system • Fresh whole blood or citrated whole blood can be used with the appropriate test tubes • A sample size of up to 2 mL of whole blood is required • Test name and expiration date are automatically read when Accriva barcoded test tubes are used • Successful or errant results are automatically stamped with date and time • Results are available in minutes • Results of 600 patient tests and 300 QC tests can be stored for each well, with optional entry of PID, OID, and user notes • Dose-response calculations are performed with the RxDx® module (if activated) • 504 operator identification codes can be stored with OID/PIN and permissions • Operator lockout can be configured by OID, valid OID, or PIN, using HRDM V3.0 or higher software or the keypad • QC lockout can be configured at one or two levels by time interval • Stored results can be reviewed by test type, PID, OID, or date • Stored results can be downloaded to a personal computer • System self checks are automatically performed • An ESV tube is available to check test well operation and detector electronics • A Temperature Verification Tube (TVT) can be additionally used to check test well temperature • The display is illuminated for viewing in low light • The display can indicate the percentage of battery power remaining numerically or graphically • The user is alerted when the battery is low • The system includes an on-board printer • Two external serial ports and a Centronics parallel port are provided

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IMPORTANT LABELS AND SYMBOLS Before using the Hemochron Response system, it is essential that the contents of this Operator’s Manual, any labels on the instrument or its packaging, and instructions accompanying Hemochron Response tubes are read and understood by the operator. These materials make reference to additional symbols that are explained below:

Handle with care. Handle and open the container with care. Expiration Date of Tubes Lot Number of Tubes Lower and Upper Temperature Limitations (For Storage or Use) Consult Instructions for Use RS232 Output Port for Data Transfer. Serial Number of Device For In vitro Diagnostic Use Attention - Read accompanying documentation or instructions Manufactured date Manufacturer Medical Equipment per Annex 1A, Item 8 Directive 2002/96/EC For Electronic Equipment Waste – Contact Technical Support Catalogue number

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SPECIFICATIONS Specifications for the Hemochron Response Whole Blood Coagulation System are listed below. Dimensions and Weight Depth Width Height Weight Transport/Storage Transport and Storage Temperature Operation Test Wells Timing Range Incubation Temperature Incubation Warm-Up Time Full-Charge Operating Time Battery Life Throughput (Full Charge) AC/DC Power Module Input Power Output Power

Environmental Ambient Temperature

19 cm (7.5 in) 27 cm (10.5 in) 22 cm (8.7 in) 2.90 kg (6.4 lbs) -20 °C to 50 °C

2 22 seconds to 1500 seconds 37 °C ±1.0 °C 30 seconds to 90 seconds 16 hours (minimum) 500 recharges 49 test cycles (at 150 sec per test) 17 test cycles (> 500 sec per test) 90 to 264 VAC, 50/60 Hz, 1.2 Amps maximum +12 Volts DC, 3.5 Amps maximum (42 Watts, 144 BTU/hr) 15 to 30 °C

Note: For more technical information, refer to the Hemochron Response Whole Blood Coagulation System Service Manual. GETTING STARTED Unpacking and Inspection Before unpacking the system, determine the area where the system will be located. You will need a level and flat area that is approximately 30 cm (12 in) wide, 30 cm (12 in) deep, and 30 cm (12 in) high. To Unpack the Instrument: 1. Unpack the carton. 2. Inspect each component for damage when unpacking. If damage is observed, contact your shipper or service representative immediately. 3. Place the instrument where it is to be located.

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4. 5.

Remove protective packaging. Examine the packaging material to be sure that the power supply, connecting cables or other components have been removed. The materials that are provided are listed on the following page. Note: Do not discard the packing material. It should be kept for shipping the instrument to the manufacturer, if repair is necessary.

Materials Provided Article Hemochron Response Whole Blood Coagulation Instrument AC/DC Power Module Accriva Part Number HR1283 Power cord (see note below) Seiko Thermal Paper Operator’s Manual HRDM V3.0 software program RS232 Computer Interface Cable

Quantity 1 1 1 1 roll 1 1 1

Materials Required But Not Provided Article Quantity Electronic System Verification Tube 1 Hemochron Test Tube Assays As Needed Hemochron Liquid Quality Control As Needed Temperature Verification Tube As Needed Note: A power cord is provided only in those countries that provide 110 volt power.

Connecting External Components A PC-compatible laboratory computer and a serial or a parallel external printer can be used with the system. The connector ports for these devices are located at the rear of the instrument (Figure 2). Important: The power cord must be disconnected and the power to the personal computer and the printer must be switched OFF while connections are being made.

Printer Paper Door COM 1 Serial Port Parallel Printer Port COM 2 Serial Port AC/DC Power Module Connector

Figure 2. Location of Connectors Connecting a Printer If a serial printer is used, set the printer communication parameters to 9600 baud with no parity, 8 data bits and 1 stopbit using XON/XOFF 3-wire software protocol. No special

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preparation is needed when connecting a parallel printer. For additional information, contact Accriva Technical Support. 1. Obtain a printer cable (not included). Refer to page 46 for serial printer cable information. 2. Connect one end of the printer cable to the port marked PRINTER (for a parallel printer) or COM 1 or COM 2 (for a serial printer) (Figure 2). 3. Connect the other end of the printer cable to the printer. 4. Specify use of an external printer (page 24). Connecting a Personal Computer The system can be connected to a personal computer using a standard NULL modem cable. 1. Obtain an RS232 cable (provided). Refer to page 46 for cable information. 2. Connect one end of the cable to the port marked COM 1 or COM 2 (Figure 2). 3. Connect the other end of the cable to an unused serial communication port on the computer. Note the location (COM 1 or COM 2) of the port. 4. Set the COM port location as described on page 23. Connecting a Bar Code Reader A bar code reader can be attached to the Hemochron Response for use in entering parameters such as OID and PID. Note: Refer to page 46 for information on connecting the bar code reader and configuring the cable. 1. Connect the cable to the port selected in Set Output Options. 2. Set the COM port location as described on page 23. Note: Only one COM port can be designated for a bar code reader at a time. Charging the Battery The battery of the system must be charged before the system can be used. 1. Plug the AC/DC Power Module into an electrical service outlet. Caution: Ensure that the input voltage requirements of the AC/DC Power Module match the voltage used in the laboratory. 2. Connect the AC/DC Power Module cord to the Power connector (Figure 2). 3. Allow the battery to charge for at least 16 hours. Note: The AC/DC Power Module can remain connected indefinitely. BATTERY PRECAUTIONS Do not open the analyzer. The designed nickel cadmium battery is not user replaceable. Opening the analyzer violates the warranty and/or maintenance agreement. The Hemochron Response instrument is designed to safely function with the Accriva provided nickle cadmium battery pack. Only authorized service centers are approved to replace the battery pack. The battery pack is to be charged only with the power supply provided for use with the Hemochron Response instrument. Refer to section Charging the Battery for instructions. The battery pack may become warm during charging. This is normal. For optimizing battery life refer to section Battery Care for instructions. In the event of a battery pack leak, do not allow the liquid to come in contact with the skin or eyes. If contact has been made, wash the affected area with water and seek medical advice.

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In the event that the battery leaks or is not functioning appropriately, please contact the manufacturer to arrange for service of the instrument. If disposal is necessary, follow local regulations for disposal of nickel cadmium batteries. Low Battery Warning The battery supplies power whenever the system is operated without the AC/DC Power Module. The system will operate for at least eight hours on a fully charged battery. The amount of charge remaining is displayed, either as a numerical percentage or as a bar indicator (page 23) whenever the battery is used to operate the system. CHARGE BATTERY is displayed and the battery power display blinks when the battery power drops to 30 percent of full charge. The system can still be used until the battery power drops to 10 percent. BATTERY TOO WEAK TO RUN TESTS is displayed when the battery power drops to 10 percent of full charge. SHUTDOWN IN XX SECONDS is displayed beginning 30 seconds before the system is automatically shut down. Loading Paper in the Internal Printer Printer paper must be loaded if the internal printer is to be used. Important: Red lines on the sides of the paper indicate an empty roll. As soon as red lines appear, replace the roll with a new roll to avoid a paper jam. 1. Open the paper door and remove the spent roll. 2. Unroll the end of the new roll and cut off the corners to form a pointed end. 3. Holding the roll of paper so the pointed end is pointing away from you and up, thread the pointed end into the paper slot until it appears at the top of the printer. 4. Grasp the pointed end pull it upwards. 5. Place the new roll into the printer and close the door. Prewarming The test wells can be prewarmed to 37 °C ±1.0 °C on command. On completion, 3 short beeps are emitted. Note: Refer to assay package inserts for prewarming requirements. Automatic Shutdown When operating from the battery, the system shuts down automatically after 15 minutes of inactivity. This 15-minute interval cannot be changed. When operating from the AC/DC Power Module, the system automatically shuts down after an interval of inactivity defined by the supervisor. Note: The factory default setting is 60 minutes. All stored data is retained after an automatic shutdown. Test Termination A test is terminated if clot formation is not detected within 1,500 seconds after starting the test. A FAULT >1500 message is then displayed and stored in the database, indicating the test result is outside of the specified range. Note: Results that are greater than the specified time are beyond the sensitivity range of the test. They should be repeated immediately and, if confirmed, reported as greater than the maximum time. A test is automatically terminated if after pressing START a test tube is not inserted into that well within 60 seconds or if a stable magnet is not detected in that well within 75 seconds.

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Keypad Printer Operations Operator Answer Keys

Well Status Indicator LEDs

Display Panel

Number Pad/Option Selector

Power Indicators

START Menu Selections

The use of each of the keys is summarized below: Key START 1, START 2,

Purpose Switch power ON or OFF. Initiate a test when blood is added to a test tube.

MENU 1, MENU 2

Display the first (press once) or second (press twice) page of the main menu for Well 1 or Well 2, respectively. Display following page(s) of other screens.

CANCEL

Cancel an operation or return to the previous selection.

PRINT

Print results on an external and/or internal printer.

PAPER FEED

Advance the printer paper one line.

BACKSPACE

(Before entering Yes or No) Undo the previous keypad entry.

0 through 9

Enter PID, OID, PIN (optional), ESV serial number, and QC ranges. Select a menu option.

YES (ENTER)

Save the response to a prompt or the entered ID or PIN.

NO

Reject the response to a prompt.

,

Left/Right Cursor Positioning.

,

Page Up/Page Down.

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Display Panel Operations such as running a test and prewarming a well can be carried out simultaneously on both wells. However, commands, prompts, and test results that appear on the display panel apply to a single well. The well for which commands are displayed is designated by the position of the divider bar (the bar in which the time and remaining battery power are displayed) (Figure 3).

Arrows Divider Bar

Figure 3. Display Panel Commands and results for Well 1 are shown in the upper portion of the of the display panel, while commands and results for Well 2 are shown in the lower portion of the display panel (Figure 4).

Well 1 Commands

Divider Bar

Divider Bar

Well 2 Commands

Figure 4. Display of Commands Press the appropriate MENU key to display a menu of commands for the corresponding well. Press the appropriate START key to start a test in the corresponding well. During testing and other operations, the divider bar indicates the well for which results or prompts are displayed (Figure 5).

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Well 1 Test Results and Prompts

Divider Bar

Divider Bar Well 2 Test Results and Prompts

Figure 5. Display of Results The arrows designate the operation that will be halted if the CANCEL key is pressed. If an operation is canceled, the arrows will point to the next operation that can be canceled. If an operation cannot be canceled, arrows are not displayed. Note: Pressing CANCEL shuts down a test, removes any related menus, sets the assay to the default assay, sets the record type to Patient, resets the OID or PIN and resets all lockouts. Operation for either well can be stopped by ensuring that the arrows point to the display for that well and then pressing CANCEL. Note: For example, if ACT is run in Well 1, information and results for the test are displayed on the upper portion of the display panel. Then, if another test is run in Well 2 while ACT is being run in Well 1, the display will show information and results for the second test on the lower portion of the display panel and arrows will indicate that the Well 2 operation will be stopped if CANCEL is pressed. Note: During operation, press 1 or 2 to point the arrows towards the display for the corresponding well. During display of a menu, press a MENU key to display the menu for the corresponding well. When using the AC/DC Power Module, the display is fully illuminated for the flashlight time specified by the operator. While running on the battery, the display dims after one minute. Pressing any key or test completion restores the display. When the battery is used, the percentage of battery power remaining is displayed either as a numerical percentage or as a bar indicator, as specified during setting of Output Options. Indicator LEDs The indicator LEDs are illuminated as described below: LED Power Charge Detect 1/2 Heater 1/2

Purpose The system is turned ON. The AC/DC Power Module is used. The test tube magnet is in the detector zone in Well 1/Well 2. Heat is applied to Well 1/Well 2.

Menus Note: Some commands (such as Prewarm Well) are specific to a single well and the corresponding key (MENU 1 or MENU 2) must be used. Other commands (such as System OFF) apply to the entire system and either key can be used. Whenever a menu has more than one page of commands, the page symbol is displayed on the right side of the display. Display subsequent pages by pressing a MENU key.

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Alternately, press the 0 key to display the next page of commands or press the 9 key to display the previous page of commands. Press a MENU key once to display the first page of the main menu (Figure 6):

Figure 6. First Page of the Main Menu Select a command by pressing the corresponding numeral key while the command is displayed. For example, if a PID or OID/PIN is to be entered using the ID Selects command, press 1. Press a MENU key twice to display the second page of the main menu (Figure 7):

Figure 7. Second Page of the Main Menu Tests The test menu is contained on four pages, accessed by selecting the ID Selects command from the first page of the main menu and then selecting 3 to display the first Test ID page (Figure 8). Press 0 (or a MENU key) to display following pages, press 9 (or the CANCEL key) to display previous pages.

Figure 8. Test Lists Note: The test menu may be updated as new tests are available. Reagents Reagents are contained in disposable Hemochron test tubes. The reagents are ready to use. Note: Refer to the package insert accompanying the Hemochron test tubes for storage and handling instructions. Test tubes for the Hemochron Response Whole Blood Coagulation System contain a barcode label imprinted with the test name and expiration. When these tubes are placed in the test well, the instrument automatically reads this information and selection of the test from the test menu is unnecessary. For specifying a test, refer to Specifying the Test to be Run on page 27.

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SETTING SUPERVISOR OPTIONS Supervisor options allow the laboratory administrator to configure the system to meet the needs of the laboratory and operators. Note: Supervisor options are password protected. Access to Supervisor Options The Supervisor Menu is contained on several pages. Access to these menus requires entry of a passcode. Important: The supervisor passcode is factory set to 0 (for none). Until the supervisor passcode is set to a value other than zero (0), anyone can access the Supervisor menu by pressing YES. Once the supervisor passcode is set to a value other than zero, the supervisor menu cannot be accessed unless the passcode is entered correctly. Note: If the passcode is lost, contact Accriva Technical Support for an interim passcode. To Display the Supervisor Menu: 1. Display the second page of the main menu. 2. Press 4 to display the Enter Passcode prompt. Enter the passcode. 3. Press YES to accept. The first page of the Supervisor menu is displayed. 4. Press MENU once or twice to display the second or third page of the Supervisor menu. Note: The next or previous pages can also be displayed by pressing 0 or 9. Setting the Time The time that a test is performed is automatically recorded with the test result. Specify the time format prior to setting the time. Note: Use a 24-hour or a 12-hour format. 1. Display the first page of the Supervisor menu. 2. Press 1. The Time/Date Setup menu is displayed. 3. Press 1. The Set Time prompt is displayed with the current time. 4. Enter the correct time using the numeral keys. 5. Press YES to save the new time. Note: Pressing CANCEL cancels the procedure without saving the new time. Setting the Date The date the test is performed is automatically recorded with the test result. 1. Display the first page of the Supervisor menu. 2. Press 1. The Time/Date Setup menu is displayed. 3. Press 2. The Set Date prompt is displayed with the current date. 4. Enter the correct date using the numeral keys. Note: The date can be entered using either a MON/DAY/YEAR or a YEAR/MON/DAY format. 5. Press YES to save the new date. Note: Pressing CANCEL cancels the procedure without saving the new date.

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Specifying the Time Format The time can be entered and reported in either 24-hour format or 12-hour format. 1. Display the first page of the Supervisor menu. 2. Press 1. The Time/Date Setup menu is displayed. 3. Press 3. The time formats are displayed. 4. Press 1 to select the 12-hour clock mode. Press 2 to select the 24-hour clock mode. 5. Press YES or CANCEL. Note: The arrow points to the currently selected option. Specifying the Reported Date Format The date can be reported in either MON/DAY/YEAR format or YEAR/MON/DAY format. To Change the Date Format: 1. Display the first page of the Supervisor menu. 2. Press 1. The Time/Date Setup menu is displayed. 3. Press 4. The date formats are displayed. 4. Press 1 to select the MON/DAY/YEAR mode. Press 2 to select the YEAR/MON/DAY mode. 5. Press YES or CANCEL. Note: The arrow points to the currently selected option. Displaying the Clock The time can be displayed on the separator bar of the display panel. 1. Display the first page of the Supervisor menu. 2. Press 5 to display the Clock line. ON will be displayed after the Clock line. Note: Displaying the clock operates as a toggle. If clock is already specified (displayed as ON), it can be canceled by pressing 5 again to display OFF. Specifying Auto Shutdown Time When operated with the AC/DC Power Module, the maximum time that the instrument can remain inactive before it automatically shuts down can be specified; this is preset at the factory to 60 minutes. Note: When the instrument is operated from the battery, it shuts down automatically after 15 minutes, regardless of the specified Auto Shutdown time. 1. Display the first page of the Supervisor menu. 2. Press 6 to display the Enter Auto Shutdown Time prompt. 3. Enter the time (1 to 999 minutes) that the instrument can remain inactive before it will automatically shutdown. Or, enter 0 to disable this feature. 4. Press YES to save the new time interval and display the first page of the Supervisor menu. Specifying the Default Assay The instrument will automatically identify a test as the default assay if a test has not been otherwise specified by the barcode on the test tube or by the operator. If an illegible barcode is identified, the test will be labeled “Unknown”. 1. Display the first page of the Supervisor menu. 2. Press 7. The first page of the Assay List is displayed. 3. Select the desired test. If needed, press 9 or 0 to display another page of the Assay List. 4. Press YES to save the new default assay. 5. The Default Assay will appear on the display panel for each well until another test is selected.

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Requiring Entry of PID Entry of a PID can be required before a test can be run. 1. Display the first page of the Supervisor menu. 2. Press 2 to display the PID Setup menu:

3.

Press 1 if entry of a PID will be required. Y (YES) will be displayed after Required. Note: Press the numeral key again to select the alternate choice. If entry of a PID is specified as required, the message PID Required will appear on the instrument display panel.

Specifying the Required Number of Digits in the PID The required number of digits that must be entered for PID can be specified. 1. Display the first page of the Supervisor menu. 2. Press 2 to display the PID Setup menu. 3. Press 2 to display the Enter PID Digits prompt. Enter the number of digits. Note: 0 or 3 to 9 can be entered. If 0 is entered, any number of digits up to 9 can be entered for PID. Specifying the Length of Time a PID will be Reused After a PID is entered, it can be displayed as a default entry for a specified number of hours. 1. Display the first page of the Supervisor menu. 2. Press 2 to display the PID Setup menu. 3. Press 3 to display the Enter Reuse Hrs prompt. Enter the number of hours. Note: 0 to 240 can be entered. If 0 is entered, the entered PID will not be reused. Requiring Entry of an OID or PIN 1. Display the first page of the Supervisor menu. 2. Press 3 to display the OID Setup menu:

Press 1 to display the OID Requirements menu:

3.

4.

Specify whether and how OID entry will be required (only one can be specified): Press 1 if entry of OID or PIN will not be required. Press 2 if entry of OID (any OID) will be required. Press 3 if entry of a valid OID will be required. Press 4 if entry of a PIN will be required. Note: If entry of an OID or PIN is specified as required, a reminder message will appear on the instrument display panel. Only the OID is printed with results or stored in the database.

• • • •

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Note: A valid OID is one that is entered on the Edit User Codes list (page 18). Specifying the Length of Time an OID will be Reused After an OID is entered, it can be displayed as a default entry for a specified number of hours. 1. Display the first page of the Supervisor menu. 2. Press 3 to display the OID Setup menu. 3. Press 5 to display the Enter Reuse Hrs prompt. Enter the number of hours. Note: 0 to 240 can be entered. If 0 is entered, the entered OID will not be reused. If valid PIN is required, reuse is not allowed. Specifying OID, PIN, and Test Permissions for an Operator Note: HRDM V. 3.0 or higher software can be used to manage operator tables. 1. Display the first page of the Supervisor menu. 2. Press 3 to display the OID Setup menu. 3. Press 2. The Edit User Codes list is displayed:

4.

5.

6.

7.

8.

Note: Up to 504 users can be specified. Locate the user record. If needed, press 0 or 9 to display the next or preceding page. Press the numeral key corresponding to the user. The OID, PIN, and test permissions for that user are displayed on the Edit Lockout menu:

To enter an OID, press 1 and enter the OID (up to 9 digits). Press YES to save the OID and return to the Edit Lockout screen. To enter a PIN, press 2 and enter the PIN (up to 9 digits). Press YES to save the PIN and return to the Edit Lockout screen. Note: Duplicate OID or PIN entries will not be saved. Specify test permissions for the user: • Press 3 to allow the user to run patient tests. P will be displayed. • Press 4 to allow the user to run liquid quality control tests. L will be displayed. • Press 5 to allow the user to run ESV tests. E will be displayed. Note: Press the numeral key again to select the alternate choice.

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Searching for an OID 1. Display the first page of the Supervisor menu. 2. Press 3 to display the OID Setup menu. 3. Press 3. A prompt to enter an OID is displayed. 4. Enter the desired OID and press YES. The Edit User Codes list is displayed at the page containing the record for that OID. Deleting All Operator Records 1. Display the first page of the Supervisor menu. 2. Press 3 to display the OID Setup menu. 3. Press 4. A prompt to confirm is displayed. 4. Press YES. All OIDs and PINs are deleted. Caution: Operator records cannot be retrieved after they have been deleted. Specifying QC Lockouts 1. Display the second page of the Supervisor menu. 2. Press 6 to display the first page of the QC Lockout menu:

3.

4.

5.

6.

7.

To specify whether LQC must be run at specified intervals, press 1 until the desired selection is displayed: • - designates that LQC testing will not be monitored by the instrument. • 1 designates that a single level of LQC per well must be tested at specified intervals. • 2 designates that two levels of LQC per well must be tested at specified intervals. To specify the frequency at which LQC must be run, press 2 and enter the frequency in hours (from 0 to 1080 hours). Note: Enter 0 to specify that LQC testing will not be monitored by the instrument. A non-zero entry will be ignored if LQC/EQC Lockout are both -. To specify whether ESV must be run at specified intervals, press 3 until the desired selection is displayed: • - designates that ESV will not be monitored by the instrument. • 1 designates that one level of ESV per well must be run at specified intervals. • 2 designates that two levels of ESV per well must be run at specified intervals. To specify the frequency at which ESV must be run, press 4 and enter the frequency in hours (from 0 to 1080 hours). Note: Enter 0 to specify that ESV will not be monitored by the instrument. Specify the time and date when the instrument should begin monitoring LQC and ESV tests: • Press 5 and enter the starting hour. • Press 6 and enter the starting date.

Specifying 911 Attempts Once QC is timed out, only a specified number of patient tests can be performed. These additional tests are 911 Attempts 1. Display the second page of the Supervisor menu. 2. Press 6 to display the QC Lockout menu. Press 7 to display the 911 Attempts prompt.

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3. 4. 5. 6.

Press 1 to enter the number of tests (0 to 99) that will be permitted for Well 1. Press YES to save the value. Press 2 to enter the number of tests (0 to 99) that will be permitted for Well 2. Press YES to save the value. Note: The number of 911 attempts used for patient testing will be deducted from the set value and is cumulative for both ESV and LQC. Once all the attempts have been used, the instrument will not allow another patient test to be run unless the required QC is performed with acceptable results or the Supervisor changes the number of attempts permitted.

Note: If a 911 attempt is used to enter the RxDx module, QC lockouts will not be enabled until the case is completed. Suppressing Results Display During a QC Test Display of the clotting time during a QC test (on the screen, printed result, and in the database) can be suppressed. 1. Display the second page of the Supervisor menu. 2. Press 6 to display the QC Lockout menu. Press MENU or 0 to display the second page. 3. Press 1 to hide the results. Y is displayed. Note: Press the numeral key again to select the alternate choice. Note: If QC Hide is enabled, a QC test result will be displayed as Pass/Fail without a clotting time. The actual test record with all results is stored and can be downloaded or accessed by turning off QC Hide. Defining a User Note Up to nine customized notes of up to 16 characters in length 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: HRDM V. 3.0 or higher software can be used to enter notes on a PC and transfer them to the instrument. 1. Display the second page of the Supervisor menu. 2. Press 7. In response to the prompt, enter the number of the note (1 to 9) to be created or changed. 3. The User Note screen is displayed, with the cursor positioned on the first character of the note and the selection block positioned at the space:

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