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ITC HEMOCHRON Signature Elite Operator's Manual

Whole blood microcoagulation system
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HEMOCHRON
Whole Blood Microcoagulation System
Intended Use.......................................................................................... 2
Summary And Explanation .............................................................. 2
Principles Of Operation................................................................... 3
Description ............................................................................................ 5
Important Labels And Symbols .................................................. 11
Specifications .................................................................................... 13
Preparing The Instrument ............................................................ 14
Starting The Instrument ............................................................... 26
Running A Test .................................................................................... 27
Quality Control (Qc) ....................................................................... 36
Operating Precautions .................................................................. 38
Limitations ........................................................................................... 39
Results Management ...................................................................... 39
Communication With A Pc Or Network ..................................... 46
Configuration Manager................................................................. 48
Master File Maintenance ............................................................... 69
CONFIGURATION MANAGER UTILITIES............................................... 70
Troubleshooting .............................................................................. 75
Service And Maintenance .............................................................. 79
Safety Standards............................................................................. 80
Index ....................................................................................................... 82
This manual is published by International Technidyne Corporation (ITC) for use with the HEMOCHRON Signature
Elite Whole Blood Microcoagulation System.
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.
ITC, HEMOCHRON and HEMOCHRON Signature Elite are registered trademarks of International Technidyne
Corporation in the United States and other jurisdictions.
ITC, ReportMaker, idms, HEMOCHRON and HEMOCHRON Signature Elite are trademarks of International
Technidyne Corporation throughout the world.
®
Celite
is registered trademark of Celite Corporation. Microsoft
Corporation.
©2006. 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.
CAUTION: This manual provides safety instructions for instruments equipped with class 1 or class 2
barcode scanner lasers. Please refer to the back panel of the instrument to identify the class of laser and
follow appropriate instructions provided in this manual.
Operatorʼs Manual
English

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®
®
and Windows
1
are registered trademarks of Microsoft

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  • Page 1 Microsoft Corporation. ©2006. 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.

  • Page 2: Intended Use

    INTENDED USE ® The HEMOCHRON Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate).

  • Page 3: Principles Of Operation

    HEMOCHRON Signature Elite instrument. PRINCIPLES OF OPERATION The HEMOCHRON Signature Elite Whole Blood Microcoagulation System provides many features for ease of use and reliability, including a patented clot detection system, a data storage module, interfaces for a laboratory computer and/or printer, a streamlined user-interface panel, and an integrated barcode scanner.
  • Page 4 Definitions and Terms The following acronyms and abbreviations are used in this manual, instrument screens, and printouts: Activated Clotting Time APTT Activated Partial Thromboplastin Time CVlot Cuvette Lot Number Database Electronic Quality Control (System Verification) HEMOCHRON Configuration Manager International Normalized Ratio idms Integrated Data Management System Liquid Quality Control...

  • Page 5: Description

    DESCRIPTION The HEMOCHRON Signature Elite instrument is a hand-held device. It contains a test chamber which warms a test cuvette to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cuvette and the test is started by the operator.
  • Page 6 PRINT/SCAN Print results on an external printer for the last test result, patient database, quality control database, or all test results for a specified patient. Test the printer. Enter a customized header. Print instrument system information. Scan a barcode ID when Enter PID, Enter OID, Enter PIN, Enter CVLot, Enter QCLot, or Scan Lot is displayed.
  • Page 7 Menus The action keys are used to display and activate various commands for operating and configuring the system. The principal menus are shown below: Menu Commands Access Main Menu Press the 0 (zero) key when no tests are running and no other menu is active. Configuration Press the 6 key while the Main Menu is Menu...
  • Page 8 Menu Commands Access Print by Patient Press the 4 key while the Print Menu 1 is Menu displayed. Print by QC Press the 5 key while the Print Menu 1 is Menu displayed. Print/Scan Press the 7 key while Print Menu 1 is Menu 2 displayed.
  • Page 9 Note: Refer to the package insert accompanying the HEMOCHRON Jr. test cuvettes for storage and handling instructions. Features The HEMOCHRON Signature Elite has a number of performance and convenience features. These are summarized below: • the system is portable for bedside use •...
  • Page 10 Instrument Lockouts The instrument can be configured to allow use only by authorized operators and/or to allow use only if specified QC has been performed. If one or more of these lockouts is enabled, processing of the lockout(s) occurs before any other instrument functions. Prewarming If the lockout checks are passed, a cuvette is automatically prewarmed to 37 °C ±1.0 °C when it is placed in the test chamber.

  • Page 11: Important Labels And Symbols

    IMPORTANT LABELS AND SYMBOLS Serial Number Label A serial number label on the rear of the HEMOCHRON Signature Elite instrument alerts users to the following: Class 1 Barcode Scanner Class 2 Barcode Scanner CAUTION: This manual provides safety instructions for instruments equipped with class 1 or class 2 barcode scanner lasers.
  • Page 12 Other Symbols Before using the HEMOCHRON Signature Elite system, it is essential that the contents of this Operator’s Manual, any labels on the instrument or its packaging, and instructions accompanying HEMOCHRON Jr. cuvettes are read and understood by the operator. These materials make reference to additional symbols that are explained below: Handle with care.

  • Page 13: Specifications

    SPECIFICATIONS Specifications for the HEMOCHRON Signature Elite Whole Blood Microcoagulation System are listed below. Dimensions and Weight Depth 9.4 cm (3.7 in) Width 19 cm (7.5 in) Height 5 cm (2.0 in) Weight 0.53 kg (1.2 lbs) Performance Test Precision ≤...

  • Page 14: Preparing The Instrument

    Materials Provided Article Quantity HEMOCHRON Signature Elite Microcoagulation Instrument PC Cable (ITC Part No. HJ7405; see Connecting a Computer or Printer on page 25) AC/DC Power Module (ITC Part No. HX1025) Operator’s Manual HEMOCHRON Configuration Manager CD V3.0 or higher Note: An AC power cord is provided in the United States, Canada, and Japan only.
  • Page 15 Battery Warnings The message CHARGE BATTERY is displayed intermittently when the remaining battery power is insufficient to ensure test completion. The message BATTERY FAULT is displayed when the battery is completely discharged and cannot be used to run additional tests. The AC/DC Power Module must be used for additional tests until the battery is recharged.
  • Page 16 Displaying System Information The instrument software version, instrument serial number, and other system software information for the HEMOCHRON Signature Elite instrument can be displayed. Press and hold START to turn on the instrument. Press 0 (zero) to display the main menu:...
  • Page 17 Configuring Display Brightness, Contrast, and Illumination The brightness and contrast of the display can be adjusted and the length of time that the display remains illuminated after a test is completed or a key is pressed can be set. Press and hold START to turn on the instrument. Press 0 (zero) to display the main menu.
  • Page 18 Displaying Available Languages English is the only language that is available in HEMOCHRON Signature Elite software. Additional languages will be available in future software versions. To Display the Menu of Available Languages: Press and hold START to turn on the instrument.
  • Page 19 Scanning Lot Information for Cuvettes or Quality Control Materials On the Supervisor menu, press 1 to display the Scan Lot screen: Hold the instrument over the barcode on the cuvette wrapper or QC package: (cuvette wrapper) barcode (QC package) barcode Note: Position the scanner port of the instrument approximately four inches from the barcode (see page 5).
  • Page 20 Specifying the Time Zone The time zone setting is used to compare the instrument time to Greenwich Mean Time (GMT). This allows the instrument to communicate with other devices in accordance with CLSI Standard POCT-1A. On the Supervisor menu, press 5 to display the Time Zone screen: Enter the difference (in hours and minutes) between the local time zone and GMT.
  • Page 21 From the Supervisor menu, press 7 to display the Communications menu: Press 1 to select the desired communication protocol. (Display OFF to use the ITC proprietary communication protocol, or display ON to use the CLSI POCT-1A compliant communication protocol.)
  • Page 22 Press 4 to start the XPORT Setup module. The message XPORT Setup Please Wait is displayed, followed by the first page of the XPORT Setup module: Note: If the message XPORT Setup NOT RESPONDING! is displayed, contact ITC Technical Support at (800) 631-5945 or (732) 548-5700, or by e-mail at techsupport@itcmed.com.
  • Page 23 Press 0 to display the next page (for entering IP Address and Gateway settings): Press 1 to display the screen for entry of the IP Address: Enter the IP Address using the numeral keys: Note: Press Enter to move to the next field without entering a numeral. Press Cancel to move to the previous field.
  • Page 24 Microsoft Windows Hyperterminal. Note: Description of XPORT Setup menus and commands using terminal emulator software is beyond the scope of this Operator’s Manual. If needed, contact ITC Technical Support for assistance at (800) 631-5945 or (732) 548-5700, or by e-mail at techsupport@itcmed.com.
  • Page 25 Note: The printer interface cable is included with the optional HEMOCHRON Jr. PKIT (Printer Kit) only. A separate CBL-SIG (Serial Printer Interface Cable) can be obtained from ITC, or a cable can be prepared as outlined below. If a printer is connected, the serial printer communication parameters must be set to 9600 baud with no parity, 8 data bits and 1 stopbit using XON/XOFF 3-wire software protocol.

  • Page 26: Starting The Instrument

    The cable configurations used for connecting a serial printer or a computer are shown below: Connecting the instrument to the Seiko Connecting the instrument to any personal DPU-414 printer with a DB9S connector computer with a DB9P connector STARTING THE INSTRUMENT Start the instrument by pressing and holding down the START key or by inserting a cuvette: Note: Allow cuvettes to reach room temperature (15 to 30 °C) before opening the pouch.

  • Page 27: Running A Test

    Starting the Instrument by Inserting a Cuvette When a test cuvette (e.g., ACT+) is inserted to turn on the instrument, the following prompts are briefly displayed: (example only) followed by Note: The test name for the inserted cuvette is displayed in the upper left-hand corner of the screen.
  • Page 28 Entering an Optional Patient ID (PID) and/or an Operator ID (OID) A Patient ID (PID) and/or an Operator ID (OID) can be entered for each test. The IDs will be stored with the test results. Entry of a PID and/or OID is optional unless a mandatory entry is specified (see the Configuration Manager section on page 56).
  • Page 29 To Enter an Operator ID: Select ID to display the ID SELECTS menu: Note: A cuvette must be inserted into the instrument to display the ID SELECTS menu. Press 2 to display the screen for entering the OID: Scan the OID from a barcode label using the internal barcode scanner, or enter it using the keypad. a.
  • Page 30 Note: Cuvette lot numbers that are manually entered into the HEMOCHRON Signature Elite instrument are only saved to the current test record. They are not uploaded to Configuration Manager.
  • Page 31 Entering a Mandatory PID and/or OID or PIN Entry of a Patient ID (PID) and/or an Operator ID (OID) or Operator Personal Identification Number (PIN) can be required for completion of a test (see the Configuration Manager section on page 56). If entry of one or more of these IDs is required, appropriate prompts for entry of PID and/or OID or PIN are automatically displayed.
  • Page 32 To Enter a Mandatory Operator PIN: The PIN prompt is automatically displayed when a cuvette is inserted: Enter the PIN using the keypad. Press and hold ENTER. If an acceptable PIN is entered, operation of the instrument continues: followed by Note: An acceptable PIN is any string of up to nine numeric digits (other than 0) that matches a PIN in the Operator Table.
  • Page 33 Note: QC lot numbers that are manually entered into the HEMOCHRON Signature Elite instrument are only saved to the current test record. They are not uploaded to Configuration Manager.
  • Page 34 Enter the QC information using the numeral keys: Note: The QC information field consists of numerical characters (1406122890515200 in the example). The expiration date and expected range of the control is encoded in the QC information. After the QC information has been entered, press and hold ENTER to continue with the test. Adding a Note Up to two operator-selectable notes can be added to the record for each test and will be printed with the final record.
  • Page 35 Starting the Test After initialization is completed the instrument beeps once, signaling the instrument is ready for the sample. Add Sample and Press Start are displayed with a countdown to START TIMED OUT (see the note below), and the blood sample can be placed into the cuvette and the test started. Note: START TIMED OUT is displayed if the test is not started within five minutes.

  • Page 36: Quality Control (Qc)

    • controls. Self-Check The HEMOCHRON Signature Elite instrument performs a “self-check” every time it is activated and a test is performed. When a test is initiated by inserting a cuvette, system checks are automatically performed and include: Verification of adequate battery power to complete a full test.
  • Page 37 QC Using EQC: Display the QC Status menu: Note: Display the QC Status menu by pressing the QC key before a cuvette is inserted. If EQC is run while a cuvette is inserted, the message Detector Blocked is displayed and the EQC test fails. Press 1.

  • Page 38: Operating Precautions

    IEC 60601-1 or IEC 60601-1-1, may lead to a reduced level of safety in the resulting system. The HEMOCHRON Signature Elite instrument should only be used by healthcare professionals trained and certified in the use of the system and operated in accordance with facility policies and procedures.

  • Page 39: Limitations

    Refer to the individual assay package insert for specific limitations. HEMOCHRON Signature Elite test results should always be scrutinized in light of a specific patient’s condition or anticoagulant therapy. Any test results exhibiting inconsistency with the patient’s clinical status should be repeated or supplemented with additional diagnostic tests.
  • Page 40 b. To print results obtained by a specific operator, press 2 to display the Print by OID screen. Scan or type the OID, then press ENTER. All patient test results obtained by the specified operator are printed. c. To print results obtained on a specific date, press 3 to display the Print by Date screen: Enter the date using the keypad, then press ENTER.
  • Page 41 b. To print results obtained on a specific date, press 2 to display the Print by Date screen: Enter the date using the keypad, then press ENTER. All QC results obtained on the specified date are printed. c. To print all results for a specific assay, press 3 to display the Print by Assay screen: Note: If the desired assay is not shown, press 7 to display additional assays.
  • Page 42 This feature allows creation of a custom header to appear on the top of each printout. The default header is - - -ITC - - -. A custom header can contain up to 20 characters. Display the second page of the Print menu.
  • Page 43 Other Database Operations Results can be reviewed for both patient and QC tests. The total number of test results that are currently stored can be displayed, the total number of additional test results that can be stored can be displayed, and the results in either the patient database or the quality control database can be erased to make room for additional test results.
  • Page 44 Note: Refer to Communication with a PC or Network on page 46 for additional information. To Exit Database Operations: Press CANCEL to exit. Downloading QC/Patient Data to Your PC For information on printing QC/Patient data through your PC using ITC data management software, contact ITC Technical Support.
  • Page 45 Acronyms for Error Messages The following table lists the acronyms for Error Messages when viewing stored Patient or QC records: Acronym Description Display Message Out of Range High Out of Range-Hi Out of Range Low Out of Range-Lo Sample Not Seen Sample Not Seen Sample Too Small Sample Too Small...

  • Page 46: Communication With A Pc Or Network

    An ITC proprietary communication protocol that allows records to be transferred from the • instrument and allows the instrument to be configured using ITC software such as HEMOCHRON Configuration Manager. A communication protocol that meets CLSI POCT-1A standards. This protocol allows the instrument •...
  • Page 47 Communicating When the ITC Proprietary Communication Protocol is Used When the ITC proprietary communication protocol is used, communication must be initiated from the personal computer or network. If necessary, check the instrument Communications menu and verify that the ITC proprietary communication protocol and the desired communication port (NET or COM) are specified: Note: The Communications menu is accessed from the Supervisor menu (page 21).

  • Page 48: Configuration Manager

    If a network interface cable is used, connect one end of the cable to the Ethernet port on the side of the HEMOCHRON Signature Elite instrument and the other end to a network connection port. Refer to page 25 for connection details.
  • Page 49 Starting Configuration Manager Select the ITC CM program icon. The Startup window is displayed: When HEMOCHRON Configuration Manager software is run for the first time, instructions are displayed to logon using the default user name and password: a. Click OK and then click Start Program. The Logon dialog box is displayed with the default user name (supervisor) and password (supervisor): b.
  • Page 50 c. Enter the institution name, address, and/or contact information. Click Auto-Detect to automatically detect the PC COM port that is being used when connected to Signature Elite. Alternately, click the drop-down arrow in the COM Port box and select the number of the COM port used.
  • Page 51 Menus Menus for HEMOCHRON Configuration Manager functions are displayed at the top of the main window: The use of each menu is described below: Menu Purpose Configuration Display the Read Configuration Data dialog box. This dialog box allows the operator to set the various configuration options (see page 54).
  • Page 52 If a configuration is read from a connected instrument, the instrument type is automatically detected and displayed. Note: Load the default HEMOCHRON Signature Elite settings by selecting Factory Default from the Configuration/Revision drop-down list. These settings can be modified and saved under a different configuration file name.
  • Page 53 Read Configuration dialog box. Progress of reading of configuration data is displayed in the status lines. Note: If the ITC proprietary communication protocol is used, Transferring Data is displayed on the connected HEMOCHRON Signature Elite instrument during data transfer. If the connection is not made, an error message is displayed on the personal computer.
  • Page 54 Setting Configuration Options Reading a configuration file from an instrument or loading a configuration file from the database will open the Configuration Module dialog box (page 53). Buttons on the dialog box allow the supervisor to display and/or modify the instrument configuration: Button Purpose Instrument Options...
  • Page 55 Supervisor PIN: Enter an optional PIN number (from 1 to 9 digits) to control access to the Supervisor menu in the HEMOCHRON Signature Elite instrument. Flashlight: Enter the number of minutes that the display will be illuminated after a cuvette is inserted and after results are displayed.
  • Page 56 Operator ID Options Not Required: Select if entry of an Operator ID (OID) or PIN is not required when running a test. OID Required: Select to require entry of an OID (any OID) when running a test. Valid OID Required: Select to require entry of an OID that is included in the Operator Table and is within the expiration period (if an expiration date is enabled for that user).
  • Page 57 Pre-stored only: Enter a check mark to specify the cuvette information can only be selected from a list of lot numbers specified by the supervisor. Note: Up to five cuvette lot numbers and expiration dates can be specified for each assay (see page 64).
  • Page 58 Specifying QC Lockout Parameters QC lockout parameters specify the maximum length of time that can elapse before liquid quality control (LQC) or electronic quality control (EQC) must be successfully run (QC Interval). When the lockout interval has elapsed and the test cuvette is inserted into the instrument, the user will be prompted to perform the appropriate If 911 Limits are enabled, the user will be offered the choice to run a patient test.
  • Page 59 Note: If Required, Scan only, and/or Pre-stored only is specified for QC Lot Options, the Low and High fields are not displayed. (If the QC testing displayed on the tab is required) Enter the maximum length of time (the QC Interval, from 0 to 1080 hours) that can elapse before the QC testing must be successfully run.
  • Page 60 Auto EQC: Enter a check mark to specify that EQC should be automatically run at the specified interval. Note: It Auto EQC is selected and the HEMOCHRON Signature Elite is connected to a power adapter, the instrument will remain on and perform the required EQC test at the appropriate interval.
  • Page 61 To Unlock an Instrument that has Reached QC Failure Limit or the 911 Limit Note: The HEMOCHRON Signature Elite must be connected to the Configuration Manager and the instrument configuration information read by clicking on Read Configuration from Instrument.
  • Page 62 Specifying Operator IDs and/or Personal Identification Numbers The Operator Table allows the supervisor to enter a name for each operator and then specify an Operator ID (OID), Personal Identification Number (PIN), and/or certification expiration date for each operator (or a group of operators).
  • Page 63 Notes menu is displayed on the instrument (page 34): Enter a note (up to 16 characters) for each key. Note: No note is displayed on the HEMOCHRON Signature Elite instrument if a note is not entered for that note number.
  • Page 64 Note: Cuvette lot numbers may be scanned using the barcode scanner through the Supervisor menu and uploaded to Configuration Manager (page 19). Note: Cuvette lot numbers that are manually entered into the HEMOCHRON Signature Elite instrument when running a test are only saved to that particular test record and are not uploaded to Configuration Manager.
  • Page 65 Configuration Manager. Note: QC lot number information that is manually entered into the HEMOCHRON Signature Elite instrument when running a QC test is only saved to that particular QC test record and is not uploaded to Configuration Manager.
  • Page 66 Enter the QC lot number, expiration date, and low and high limits for level 1 (normal) and/or level 2 (abnormal) controls. The limits that are entered may be from the expected range contained in the labeling for the controls or from an expected range specified by the supervisor. Click Save to save the QC lot number information for the specified assay.
  • Page 67 Click Start. Progress information is displayed in the status line. Note: If the ITC proprietary communication protocol is used, Transferring Data is displayed on the connected HEMOCHRON Signature Elite instrument during data transfer. If the connection is not made, an error message is displayed on the personal computer.
  • Page 68 A message box is displayed when writing of the configuration data is complete. Click OK to acknowledge the message. Printing Instrument Configuration Data All of the configuration parameters for an individual instrument or a configuration file can be printed. (If needed) Connect the instrument to the PC (see page 48). (If needed) Start HEMOCHRON Configuration Manager and select the configuration file that is to be downloaded (see page 52) or click on Read Configuration From Instrument.

  • Page 69: Master File Maintenance

    MASTER FILE MAINTENANCE The Master File Maintenance function of HEMOCHRON Configuration Manager allows a record for a HEMOCHRON Signature Elite instrument or IP address to be added, modified, or deleted. Manually Adding an Instrument The supervisor can add a new instrument to the table of instrument serial numbers and unit locations.

  • Page 70: Configuration Manager Utilities

    Updating an Instrument Record The supervisor can modify or delete a record for an existing instrument. Select Serial Number from the Master File Maintenance menu. The Serial Number Master File Maintenance dialog box is displayed listing information for the first instrument record in the database. Note: The record number and total number of records in the database are displayed at the bottom of the dialog box.
  • Page 71 Adding a User The supervisor can add a new user to the table of operators of HEMOCHRON Configuration Manager. The new user will be assigned a password and access level. Note: Any user can perform all operations until at least one user with an access level of Supervisor is defined.
  • Page 72 Setting the Instrument Date and Time The time clock of the HEMOCHRON Signature Elite instrument must be synchronized with that of the HEMOCHRON Configuration Manager PC so that correct starting times are used for system lockouts. Note: The time and date format that are used on an instrument may not be the same as that used in HEMOCHRON Configuration Manager.
  • Page 73 Setting the Instrument Date and Time when the POCT-1A Communication Protocol is Used: Start HEMOCHRON Configuration Manager (see page 49). Read the configuration from the instrument that is connected over the network (see page 52). Note: When the POCT-1A communication protocol is used, HEMOCHRON Configuration Manager cannot communicate with the instrument over the COM port.
  • Page 74 Select the operation (Compress Database, or Repair and Compress Database) that is to be performed. Click OK. The databases are repaired and/or compressed. Converting the Database Select Convert HCM Data from Ver 1.0 (or 2.0) from the Utilities menu. The Convert HCM Data from Version 1.0 (or 2.0) dialog box is displayed: Note: The source and destination paths are shown.

  • Page 75: Troubleshooting

    Some messages designate a test or sample fault. This message is included in the printed results for the affected sample. A list of these messages can be found in Acronyms for Error Messages on page 45. If needed, contact ITC Technical Support by phone at +1-732-548-5700, by FAX at +1-732-548-9824, or by e- mail at techsupport@itcmed.com.
  • Page 76 Unsupported Assay Cuvette cannot be identified by Remove cuvette and repeat test instrument. with new cuvette. Use ITC cuvettes only. No Data Stored Operator attempted to print data when none is stored in database. User Abort The test was aborted by the user.
  • Page 77 Contact ITC Technical Support. Unsupported The POCT-1A communication Set POCT-1A to run over NET, protocol was attempted to be set or set ITC to run over COM or POCT >> COM while the COM Port is selected, or NET. vice versa.
  • Page 78 Verification of Barcode Scanner Check the barcode scanner by scanning a test barcode. To Test the Barcode Scanner: Press PRINT/SCAN to display the Print menu: Press 7 to display the second page of the Print menu: Press 3 to test the scanner: Position the scanner port (see page 5) approximately four inches from the barcode label that is shown below: Note: The barcode shown above is formatted as Code 128.

  • Page 79: Service And Maintenance

    CAUTION: CLASS 2 LASER RADIATION WHEN OPEN. DO NOT STARE INTO THE BEAM. Battery Care To optimize battery life, it is recommended that the HEMOCHRON Signature Elite instrument be run on its battery during the day. It can be plugged into a Hospital Grade AC outlet overnight to allow the batteries to recharge.

  • Page 80: Safety Standards

    SAFETY STANDARDS The HEMOCHRON Signature Elite instrument complies with the following safety standard requirements and directives: CSA C22.2. 601.1. Medical Electrical Equipment – General Requirements for Safety EN 60601-1 / Medical Electrical Equipment – General Requirements for Safety IEC 60601-1/...
  • Page 81 (This page intentionally left blank.)

  • Page 82: Index

    INDEX acronyms used.............4 deleting a user record .........69, 70 action keys............5 description adding a user............ 70 features ............9 attention label........... 11 overview ............5 battery disallowed assay..........58 care.............. 78 display panel ............6 charging ............13 EQC..............57 checking ............14 erasing life ............... 12 patient database ..........42 low warning ..........
  • Page 83 addition............33 running a test ........... 26 operating precautions........37 scanning operator ID (OID) Operator ID (OID)........28 entering............28 Operator IDs ..........18 entering a mandatory operator ID....30 patient ID (PID) .......... 27 overview...............2 QC lot numbers ........... 18 patient ID (PID) service..............
  • Page 84 HX1101 0310...

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