Hemochron Response User manual

Operator’s Manual
English
TABLE OF CONTENTS
INTENDED USE.............................................................. 2
SUMMARY AND EXPLANATION.................................... 2
PRINCIPLES OF OPERATION ....................................... 2
ATTENTION LABEL ........................................................ 4
SPECIFICATIONS........................................................... 5
GETTING STARTED....................................................... 5
SETTING SUPERVISOR OPTIONS ............................. 11
SETTING OUTPUT OPTIONS ...................................... 18
SETTING PROGRAM OPTIONS .................................. 20
CUSTOMIZING THE PRINTED HEADING ................... 21
OPERATION ................................................................. 21
QUALITY CONTROL (QC)............................................ 27
OPERATING PRECAUTIONS....................................... 29
LIMITATIONS ................................................................ 29
RESULTS MANAGEMENT ........................................... 30
DEFAULT SETTINGS ................................................... 32
TROUBLESHOOTING .................................................. 33
SYSTEM TESTS ........................................................... 35
MAINTENANCE ............................................................ 38
SPECIFICATIONS FOR PERIPHERALS ...................... 39
SAFETY STANDARDS ................................................. 41
INDEX ........................................................................... 42
This manual is published by International Technidyne Corporation (ITC) 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 ITC representative.
HEMOCHRON
®
and RxDx
®
are registered trademarks of ITC.
idms™ is a trademark of ITC.
Celite
®
is registered trademark of Celite Corporation.
©2000, 2001, 2002, 2003, 2004. 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.
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INTENDED USE
The HEMOCHRON
®
Response Whole Blood Coagulation System is a dual-well microprocessor-controlled
coagulation testing instrument with an integral test type barcode reader, RS232 communication interface
capability, and a printer. The system runs coagulation tests such as Activated Clotting Time (ACT), Activated
Partial Thromboplastin Time (APTT), Prothrombin Time (PT) and other specialty tests that are currently
available from ITC.
SUMMARY AND EXPLANATION
Events that lead to formation of a blood clot are simplified in coagulation theory into two interactive
coagulation cascades. The Activated Clotting Time (ACT), Activated Partial Thromboplastin Time (APTT) and
Prothrombin Time (PT) tests are general coagulation screening tests that are used to measure the
functionality of these cascades.
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.
The APTT test measures the intrinsic coagulation pathway and involves all coagulation factors except factors
VII and III (tissue factor). The APTT test improves the earlier PTT test through use of a contact activating
substance which standardizes activation of Factor XII to provide a more precise and sensitive assay for low
level heparin monitoring.
The PT test measures the extrinsic coagulation pathway and is sensitive to coagulation factors VII, X, V, II,
and fibrinogen. PT results may be abnormal in patients with liver disease or Vitamin K deficiency, and the
test is widely used to monitor oral anticoagulant therapy.
Under clinical conditions, the coagulation cascade may be affected by either naturally occurring or
administered procoagulants or anticoagulants. Endogenous changes in hemostasis, such as disseminated
intravascular coagulation, can result in extreme clotting factor depletion. In order to determine which
pathway is being affected, a panel of coagulation assays may be performed. Results of these tests are used to
diagnose the hemostatic abnormality and to determine the appropriate therapeutic intervention.
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.
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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.
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:
ACT Activated Clotting Time
APTT Activated Partial Thromboplastin Time
DB Database
ESV Electronic System Verification
HRDM HEMOCHRON Response Data Manager software program
idms Integrated Data Management System
INR International Normalized Ratio
LQC Liquid Quality Control
OID Operator Identification Number
PIN Operator Personal Identification Number
PID Patient Identification Number
POCC Point of Care Coordinator
PPID Fibrinogen Product Performance ID Code
PT Prothrombin Time
QC Quality Control
TVT Temperature Verification Tube
Overview of Operation
Important: Disposable ready-to-use test tubes for use with the system can be obtained from ITC. 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.
Printer
Test
Wells
Keypad
Display
Panel
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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 ITC barcoded test tubes are used
• Successful or errant results are automatically stamped with date and time
• Results are available in minutes
• Results are displayed appropriately as whole blood or plasma equivalent or INR (PT assay only)
• 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
• Patient/QC test reports can be created using a personal computer and ITC data management
software programs
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.
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SPECIFICATIONS
Specifications for the HEMOCHRON Response Whole Blood Coagulation System are listed below.
Dimensions and Weight
Depth 19 cm (7.5 in)
Width 27 cm (10.5 in)
Height 22 cm (8.7 in)
Weight 2.90 kg (6.4 lbs)
Operation
Test Wells 2
Timing Range 22 seconds to 1500 seconds
Incubation Temperature 37 °C ±1.0 °C
Incubation Warm-Up Time 30 seconds to 90 seconds
Full-Charge Operating Time 8 hours (minimum)
Battery Life 500 recharges
Throughput (Full Charge) 49 test cycles (at 150 sec per test)
17 test cycles (> 500 sec per test)
AC/DC Power Module
Input Power 90 to 264 VAC, 50/60 Hz, 1.2 Amps maximum
Output Power +12 Volts DC, 3.5 Amps maximum (42 Watts,
144 BTU/hr)
Environmental
Ambient Temperature 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.
4. Remove protective packaging.
5. 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
ITC, if repair is necessary.
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Materials Provided
RS232 Computer Interface Cable 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
idms v7.1 or later (Integrated Data Management System) As Needed
Note: A power cord is provided only in those countries that provide 110 volt power.
Connecting External Components
An IBM-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.
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 preparation is needed when
connecting a parallel printer. For additional information, contact ITC Technical Service.
1. Obtain a printer cable (not included). Refer to page 39 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 19).
Article Quantity
HEMOCHRON Response Whole Blood Coagulation Instrument 1
AC/DC Power Module ITC Part Number HR1283 1
Power cord (see note below) 1
Seiko Thermal Paper 1 roll
Operator’s Manual 1
HRDM V3.0 software program 1
Printer Paper Door
COM 1 Serial Port
Parallel Printer Port
COM 2 Serial Port
AC/DC Power Module Connector
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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 39 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 19.
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 39 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 19.
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.
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 19) 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.
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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.
Keypad
The use of each of the keys is summarized below:
Key Purpose
START 1, START 2, 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.
Printer Operations
Well Status Indicator LEDs
Number Pad/Option Selector
START
Menu Selections
Operator Answe
r
Keys
Display Panel
Power Indicators
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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).
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).
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).
Figure 5. Display of Results
Well 1
Commands
Divider Ba
r
Divider Ba
r
Well 2
Commands
Well 1 Test
Results and
Prom
p
ts
Divider Ba
r
Divider Ba
r
Well 2 Test
Results and
Prom
p
ts
Divider Ba
r
Arrows
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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 PT FWB 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 PT FWB 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 1or 2to 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 Purpose
Power The system is turned ON.
Charge The AC/DC Power Module is used.
Detect 1/2 The test tube magnet is in the detector zone in Well 1/Well 2.
Heater 1/2 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. Alternately, press the 0key to display the
next page of commands or press the 9key 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
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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 3to 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 by ITC 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.
ITC 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 22.
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 ITC Technical Service for an interim passcode.
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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 0or 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.
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 1to select the 12-hour clock mode. Press 2to 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 1to select the MON/DAY/YEAR mode. Press 2to select the YEAR/MON/DAY mode.
5. Press YES or CANCEL.
Note: The arrow points to the currently selected option.
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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 5to 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 5again 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 6to 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 0to 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 9or 0to 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.
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 2to display the PID Setup menu:
3. Press 1if 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 2to display the PID Setup menu.
3. Press 2to display the Enter PID Digits prompt. Enter the number of digits.
Note: 0or 3to 9can be entered. If 0is entered, any number of digits up to 9 can be entered
for PID.
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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 2to display the PID Setup menu.
3. Press 3to display the Enter Reuse Hrs prompt. Enter the number of hours.
Note: 0to 240 can be entered. If 0is 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 3to display the OID Setup menu:
3. Press 1to display the OID Requirements menu:
4. Specify whether and how OID entry will be required (only one can be specified):
• Press 1if entry of OID or PIN will not be required.
• Press 2if entry of OID (any OID) will be required.
• Press 3if entry of a valid OID will be required.
• Press 4if 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.
Note: A valid OID is one that is entered on the Edit User Codes list (page 15).
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 3to display the OID Setup menu.
3. Press 5to display the Enter Reuse Hrs prompt. Enter the number of hours.
Note: 0to 240 can be entered. If 0is entered, the entered OID will not be reused.
If valid PIN is required, reuse is not allowed.
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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 3to display the OID Setup menu.
3. Press 2. The Edit User Codes list is displayed:
Note: Up to 504 users can be specified.
4. Locate the user record. If needed, press 0or 9to display the next or preceding page.
5. Press the numeral key corresponding to the user. The OID, PIN, and test permissions for that
user are displayed on the Edit Lockout menu:
6. To enter an OID, press 1and enter the OID (up to 9 digits). Press YES to save the OID and return
to the Edit Lockout screen.
7. To enter a PIN, press 2and 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.
8. Specify test permissions for the user:
• Press 3to allow the user to run patient tests. Pwill be displayed.
• Press 4to allow the user to run liquid quality control tests. Lwill be displayed.
• Press 5to allow the user to run ESV tests. Ewill be displayed.
Note: Press the numeral key again to select the alternate choice.
Searching for an OID
1. Display the first page of the Supervisor menu.
2. Press 3to 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 3to 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.
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Specifying QC Lockouts
1. Display the second page of the Supervisor menu.
2. Press 6to display the first page of the QC Lockout menu:
3. To specify whether LQC must be run at specified intervals, press 1until the desired selection is
displayed:
• -designates that LQC testing will not be monitored by the instrument.
• 1designates that a single level of LQC per well must be tested at specified intervals.
• 2designates that two levels of LQC per well must be tested at specified intervals.
4. To specify the frequency at which LQC must be run, press 2and enter the frequency in hours
(from 0to 1080 hours).
Note: Enter 0to specify that LQC testing will not be monitored by the instrument.
A non-zero entry will be ignored if LQC/EQC Lockout are both -.
5. To specify whether ESV must be run at specified intervals, press 3until the desired selection is
displayed:
• -designates that ESV will not be monitored by the instrument.
• 1designates that one level of ESV per well must be run at specified intervals.
• 2designates that two levels of ESV per well must be run at specified intervals.
6. To specify the frequency at which ESV must be run, press 4and enter the frequency in hours
(from 0to 1080 hours).
Note: Enter 0to specify that ESV will not be monitored by the instrument.
7. Specify the time and date when the instrument should begin monitoring LQC and ESV tests:
• Press 5and enter the starting hour.
• Press 6and 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.
3. Press 1to enter the number of tests (0to 99) that will be permitted for Well 1.
4. Press YES to save the value.
5. Press 2to enter the number of tests (0to 99) that will be permitted for Well 2.
6. 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.
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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 1to hide the results. Yis 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 (1to 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:
4. Press 8to move the selection block right one character, press 7to move the selection block left
one character, press 9to move the selection block up one line, or press 0to move the selection
block down one line.
5. When the selection block is on the correct character, press YES to enter the selected character
and move the cursor to the position for the next character.
6. Repeat Steps 4and 5for each character to be entered in the note.
Note: The note can be edited after characters have been entered. Press NO to move the cursor
one space to the right; press BACKSPACE to move the cursor one space to the left. When the
cursor is at the desired position, press 2to overwrite a character with a space, press 3to
insert a space before the selected character, or press 4to delete the character at the selected
position. Press 1to clear the note.
7. When the note is completed, press CANCEL to save the note and exit the screen.
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Downloading Records
Patient and QC records can be downloaded to a personal computer from the system. ITC data management
software programs can be installed on the personal computer to which the records are being downloaded to
provide the reporting functions.
1. Connect the COM 1 or the COM 2 port of the HEMOCHRON Response to the personal computer.
2. Using the corresponding MENU key (MENU 1 for the COM 1 port, MENU 2 for the COM 2 port)
display the second page of the Supervisor menu.
3. Press 4. COMMANDER HR is displayed.
4. Refer to the HEMOCHRON Data Manager (HRDM V. 3.0 or higher) for additional information.
Changing the Language
The language can be specified. Choices are English, German, Italian, Spanish, French and Portuguese.
1. Display the second page of the Supervisor menu.
2. Press 5to display the Select Languages menu.
3. Press the numeral key that corresponds to the language to be used.
4. Press YES or CANCEL to return to the previous menus.
Specifying the Supervisor Passcode
The Supervisor passcode may be changed.
1. Display the first page of the Supervisor menu.
2. Press 4. The Supervisor Passcode prompt is displayed with the current passcode.
3. Enter the new passcode.
4. Press YES to save the new passcode and return to the first page of the Supervisor menu.
5. Press CANCEL to return to the previous menus without saving.
Erasing Results
Results must be periodically erased to prevent overwriting the database.
Caution: Results cannot be retrieved after they have been erased from the database. Do not erase
results until they have been printed or transmitted to the laboratory computer.
1. Display the second page of the Supervisor menu.
2. Press 1 (for patient records) or 2(for QC records) to erase the current records from the
database.
3. Press YES to erase the records or NO to abort.
Specifying the Baud Rate
The speed at which data is transmitted to an external source via the COM Ports can be specified.
1. Verify that the external source is properly connected to either the COM 1 or the COM 2 port of the
HEMOCHRON Response.
2. Using the corresponding MENU key (MENU 1 for the COM 1 port, MENU 2 for the COM 2 port)
display the second page of the Supervisor menu.
3. Press 3to display the Baud Rate menu and select the corresponding numeral key.
4. Press YES to save and return to the Supervisor menu.
SETTING OUTPUT OPTIONS
1. Press MENU twice and press 1to display the Set Outputs menu:
2. Select the appropriate output.
Note: Pressing the numeral key toggles through all choices for a given setting.
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Enabling Display of Remaining Battery Power
The amount of power remaining in the battery can be displayed either as a numerical percentage or as a
bar indicator.
1. Press 1 in Set Outputs. YES is displayed after the Battery % line:
1 – Battery % - YES
2. Press 1again to display a graph of remaining battery power. NO is displayed.
Note: The battery power display disappears when the instrument is connected to an electrical
outlet using the AC/DC Power Module.
Enabling Plotting of Test Data
Utilize this feature to indirectly observe the motion of the magnet during an assay. If plotting is enabled, two
lines are displayed representing the magnet in the test tube. The position of the lines changes in accordance
with the motion of the magnet until clot formation, when the lines cross.
1. Press 2 in Set Outputs. YES is displayed after the Plot Test line:
2 – Plot Test YES
Specifying the Device Connected to COM1 or COM2
If an external computer or a barcode reader is connected to the System, the COM port to which the device is
connected must be specified. Only one COM port can be set to RDR at a given time.
1. Press 3in Set Outputs to specify COM 1 or press 4to specify COM 2. YES will be displayed,
designating that an external computer is connected to the specified COM port:
3 – COM 1 Port YES
2. Press 3or 4a second time to designate that a barcode reader is connected to the specified COM
port:
3 – COM 1 Port RDR
3. Press 3or 4a third time to designate that no device is connected to the specified COM port:
3 – COM 1 Port NO
Cycling through COM Port options resets the Baud Rate to 9600. Turning the device OFF or ON will set the
Baud Rate to its initial setting.
Specifying Use of the Internal Printer
The internal printer is designed for printing single test results. The internal printer cannot be used for
database printing. It can be deactivated to save power during battery operation.
1. Press 5to select one of the three printer modes:
1 –No (No internal print)
2 –Yes (Permits printing of the last test result when the PRINT key is pressed)
3 –AUT (Automatically prints the test results when the test tube is removed)
Specifying Use of an External Printer
If the system is connected to an external parallel printer, this selection must be activated.
1. Press 6in Set Outputs to specify connection to an external printer. YES will be displayed after the
External Printer line:
6 – EXT Print YES
Note: To print either database, an external printer must be used.
Note: The printer output is the IBM Layout (PC-8) standard.
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Enabling Logging of Data
The data-logging feature is used to send raw data, obtained during an assay, to an external computer or
printer. This feature is most useful for troubleshooting.
Note: An external printer or computer must be connected and enabled before the data-logging
feature can be operated. Well 1 data are sent to COM 1 and Well 2 data are sent to COM 2.
1. Press 7in Set Outputs to enable data logging. YES will be displayed after the Log Data line:
7 – Log Data YES
SETTING PROGRAM OPTIONS
Program options allow the volume of audible signals and contrast, brightness, and illumination of the
display to be adjusted. Settings range from 0% (lowest level) to 100% (highest level). Press 7or 8to
increase or decrease the level by five percent. Press 9or 0to increase or decrease the level by one percent.
Pressing and holding a key for more than one second causes it to auto-repeat.
1. Press MENU twice and press 2to display the Program Options menu:
2. Select the appropriate command.
Adjusting Beep Volume
The volume of the beep can be adjusted , so that it is lower (less audible) or higher (more audible).
1. Press 1 in Program Options. The beep volume setting is displayed:
2. Adjust the volume and press YES.
Setting Display Contrast
Display contrast can be set so characters are darker (more contrast) or lighter (less contrast).
1. Press 2 in Program Options. The contrast setting is displayed.
2. Set the contrast and press YES.
Setting Display Brightness
Display brightness can be set so the display background is darker or lighter.
1. Press 3 in Program Options. The brightness setting is displayed.
2. Set the brightness and press YES.
Note: The factory default is 50%.
Setting Flashlight Time
Flashlight Time specifies the length of time that the display is fully illuminated when a test is completed or a
key is pressed.
1. Press 4 in Program Options. The duration of illumination is displayed.
2. Enter the length of time (from 1to 30 minutes) that the display should remain illuminated.
3. Press YES.
Note: The factory default is 30 minutes. Flashlight time during battery operation is set to one
minute and cannot be changed.
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