HEMOCHRON® Jr. Signature+ Whole Blood Microcoagulation System Operator’s Manual English TABLE OF CONTENTS INTENDED USE.....................................................................2 SUMMARY AND EXPLANATION...........................................2 PRINCIPLES OF OPERATION ..............................................3 DESCRIPTION .......................................................................4 ATTENTION LABEL ...............................................................9 SPECIFICATIONS...
INTENDED USE The HEMOCHRON Jr. Signature+ 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). The system is intended to be used with test cuvettes that are available from ITC.
The HEMOCHRON Jr. 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. The test is widely used to monitor oral anticoagulant therapy. The PT test is a unitized test system utilizing a highly sensitive thromboplastin for improved specificity and sensitivity. The HEMOCHRON Jr.
Definitions and Terms The following acronyms and abbreviations are used in this manual, instrument screens, and printouts: Activated Clotting Time ACT Activated Partial Thromboplastin Time APTT Database DB Electronic System Verification Cartridge (EQC) EQC Integrated Data Management System idms International Normalized Ratio INR Liquid Quality Control LQC Operator Identification Number OID Patient Identification Number PID Operator Personal Identification Number PIN Point of Care Coordinator POCC Prothrombi
Keypad The front panel contains a keypad with various action keys as well as a number pad. The operator uses the keypad to select a command or enter information. Action keys display a menu of commands according to the label on the key. For example, the PRINT key displays printing commands. Number pad (or option) keys are used to enter numerals for IDs or selection of commands. Note: The 0 (zero) key is used as both a numeral key and an action key.
Display Panel The instrument communicates with the operator by means of the display panel. For example, ADD SAMPLE and PRESS START are alternately displayed after a test cuvette reaches 37 ±1.0 °C: Add Sample The display is illuminated to enhance visibility in low light conditions. To conserve power during battery operation, the display is not illuminated when the test well is empty or when a test is running.
Menu Action Key Commands PRINT MENU PRINT (First) (Successive) MAIN MENU 0 (Zero) (First) (Successive) PRINT MENU 1–Print Last 2–Print Pat DB 3–Print QC DB 4–Print by PID 5–Print Check 6–Enter Header 7–Print System MAIN MENU 1–Power Level 2–System Time 3–System Date 4–Shutdown 5–System Info Instrument Shutdown To shutdown the HEMOCHRON Jr. Signature+, press 0 (zero) to display the main menu and then press 4. Or, press and hold down the START key for four seconds.
Features The HEMOCHRON Jr. Signature+ has a number of performance and convenience features.
ATTENTION LABEL An attention label on the rear of the HEMOCHRON Jr. Signature+ instrument alerts users to accompanying documentation: Before using the HEMOCHRON Jr. Signature+ 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. 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.
SPECIFICATIONS Specifications for the HEMOCHRON Jr. Signature+ Whole Blood Microcoagulation System are listed below. Dimensions and Weight Depth Width Height Weight 9 cm (3.5 in) 19 cm (7.5 in) 5 cm (2.0 in) 0.60 kg (1.3 lbs) Performance Test Precision ≤ 10% C.V. Operation Test Chamber Timing Range Incubation Temperature Incubation Warm-Up Time Full-Charge Operating Time Battery Life Battery Type Throughput (Full Charge) Operating Environment 1 0 second to 1005 seconds 37 °C ±1.
PREPARING THE INSTRUMENT Unpacking and Inspection Note: Inspect each component for damage when unpacking. If damage is observed, contact your shipper or service representative immediately. 1. Remove any protective packaging that may be present around the instrument. 2. 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 below. Note: Do not discard the packaging material.
Battery Warning The message CHARGE BATTERY is displayed intermittently when the remaining battery power is below a predetermined level. The message BATTERY DEAD 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. Checking the Battery 1. Press START to turn on the instrument. 2. Press 0 (zero) to display the main menu: MAIN MENU 3. Press 1.
Connecting a Computer or Printer An IBM-compatible laboratory computer or a serial printer (Seiko DPU-414 is recommended) can be used with the system. The connector port for these devices is located at the side of the instrument. connector port for AC/DC power module connector port for computer or printer To Connect a Printer: 1. Obtain a printer interface cable. Note: The printer interface cable is included with the optional HEMOCHRON Jr. PKIT (Printer Kit) only.
The cable configurations used for connecting a serial printer or a computer are shown below: Connecting the instrument to the Seiko DPU-414 printer with a DB9S connector Connecting the instrument to any personal 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: Insert the cuvette with the label facing up. Push the cuvette all the way in until it stops.
When a test cuvette (eg. PT) is inserted to turn on the instrument, the following prompts are displayed: 1) HEMOCHRON Sig+ 3) Priming Pump 2) Test . . . . . . . . . . . PT 4) WARMING…….... (scrolls right) Note: The test name for the inserted cuvette is displayed after Test........ . Check the display for fault messages while the cuvette is warming. Refer to the Troubleshooting section for the procedure to resolve a fault message. When the cuvette reaches 37 °C ±1.
To Enter an Optional Patient ID: 1. Select ID to display the ID SELECTS menu: ID SELECTS 2. Note: To enter ID SELECTS, a cuvette must be inserted into the instrument. Press 1 to enter a numeric PID. PID= . . . . . . . . . . . . 3. 4. Type the PID using the numeric keys. Press ENTER. The entry is confirmed as saved. Note: The PID can be designated (or changed) anytime. Check the PID by pressing ID and then pressing 1 to display the entered value.
Entering a Mandatory PID, OID, and/or PIN Entry of a Patient ID (PID), Operator ID (OID), and/or Operator Personal Identification Number (PIN) can be required for completion of a test (see the Configuration Manager section on page 26). If entry of one or more of these IDs is required, appropriate prompts for entry of PID, OID and/or PIN are automatically displayed. To Enter a Mandatory Patient ID: 1. The PID prompt is automatically displayed: PID= . . . . . . . . . . . .
Prompts for Mandatory QC Tests Electronic quality control (EQC) tests and/or liquid quality control (LQC) tests can also be required to be run at specified intervals (see the Configuration Manager section on page 26). When it is time for a required QC test to be run, the required QC test must be successfully completed before the specific patient test(s) can be run. If EQC is required, no patient tests can be run until successful completion of EQC.
Specimen Collection Collect blood specimens according to NCCLS document H21-2, entitled Collection, Transport and Processing of Blood Specimens for Coagulation Testing and General Performance of Coagulation Assays. Important: Collect blood specimens in a manner that prevents contamination with tissue thromboplastin, indwelling intravenous (I.V.) solutions, or alcohol cleansing solution. Discard samples that are not properly collected or contain visible clots or debris.
QUALITY CONTROL (QC) The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recommends that medical and laboratory instrumentation be enrolled in a quality assurance program adequate in maintaining accurate and reliable performance of the equipment. Complete records of such quality control must be kept. Routine quality control testing should be part of a comprehensive quality assurance program. Quality control testing of the HEMOCHRON Jr.
QC Using Liquid Quality Control Products: 1. Obtain the liquid quality control products. Note: HEMOCHRON Jr. Quality Controls are recommended. Refer to the package insert for the liquid quality control products for storage and handling information. 2. Select QC NORMAL (or QC ABNORMAL) and enter an Operator ID (optional) for the test. Important: LQC results will be stored in the patient database if QC NORMAL or QC ABNORMAL is not selected for the test. 3.
OPERATING PRECAUTIONS The AC/DC Power Module should be plugged into a standard AC outlet to charge the instrument when it is not in use. DO NOT remove the AC/DC Power Module from the instrument by pulling on the cord. Although the AC/DC Power Module can be left plugged into an AC outlet when the instrument is unplugged, it is recommended that the AC/DC Power Module be unplugged from the AC outlet when it is not being used to charge the instrument.
RESULTS MANAGEMENT Up to 400 patient test results and 400 quality control test results can be stored in the instrument. In addition to test results, the date and time of each test, PID, and OID are also stored. Note: PID and/or OID are stored as 0 (zero) if a value is not entered when the test is run. A PID is not required for any QC test. To Print Results: 1. Press PRINT to display the PRINT menu: PRINT Then perform one of the following procedures: To Print Results of the Last Test: 1. Press 1.
To Print System Information: 1. Press 7 to print the system software version, system serial number, and program parameters. To Abort Printing of Results: 1. Pressing CANCEL for three seconds will abort data transmission to the printer. Any data previously transmitted will complete printing. Note: If an error is encountered with the test or the sample, the error message for the error will be included on the printout. Refer to page 46 for error messages, their cause, and their resolution.
To Review Results of the QC Database: 1. Press 6. The first line of the results for the most current test record is displayed. 01 QCN EQC To review each additional line of the results, press 0 or 8 to scroll up or down through the record. 3. To scroll through additional test records, press ENTER (for the next record) or CANCEL (for the previous record). To Exit Database Operations: 1. Press and hold CANCEL for two seconds. 2.
CONFIGURATION MANAGER HEMOCHRON Configuration Manager (HCM) software V1.1 or higher allows the supervisor to configure HEMOCHRON Jr. Signature+ instruments so they meet the needs of the laboratory. The configuration is performed on a personal computer that is connected to the instrument by means of a computer interface cable. Refer to the online Help in HCM software for additional information.
Starting Configuration Manager 1. Select the ITC CM program icon. The Startup window is displayed: 2. 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. Click OK.
c. Enter information about your institution and COM port used (if needed), then click OK. The User Master File Maintenance dialog box is displayed: d. To change the default user name and password, click Add and enter a new user name and password, being sure that the Yes button is selected for Supervisor access. Click Save, then select the previous record containing the default user name and password and click Delete. Note: The default user name and password should be changed as shown above.
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 Configuration Module dialog box. This dialog box allows the operator to set the various configuration options (see page 31). Reports Display and print listings of configuration parameters, instruments, and operators (see page 38). Master File Maintenance Display, modify, add, and delete instrument information.
Selecting a Configuration File Select Configuration in the Configuration Manager main menu. The Read Configuration Data dialog box is displayed: Note: HEMOCHRON Configuration Manager uses a Microsoft Windows user interface. Software features are intuitive and easy to learn. Refer to Windows documentation for instructions on navigation, access to commands and Help, execution of commands, and shortcuts that can be taken.
2. Click Start. The connected HEMOCHRON Jr. Signature+ instrument is turned on and displays: 3. Verify that the instrument is linked to the PC (see page 26). Note: Progress of reading of configuration data is displayed in the status line. When reading of configuration data is completed, click OK. The Configuration Module dialog box is displayed. Linked to PC 4. To Display an Existing Configuration File: 1. Select the file from the Select Existing Configuration drop-down list. 2.
Button Purpose Lock-Out Control a. QC Lockout 1. Specify whether normal and/or abnormal electronic quality control (EQC) testing must be run after a specified time interval has elapsed. 2. For each test type, specify whether normal and/or abnormal liquid quality control (LQC) testing must be run after a specified time interval has elapsed. 3. Prohibit specific test(s) from being performed on the instrument. b. QC Exceptions 1.
Operator ID Options 1. Not Require Operator ID, Valid Operator ID and Valid PIN: Select if entry of an Operator ID (OID) or PIN is not required when running a test. 2. Require Operator ID: Select to require entry of an OID when running a test. 3. Require Valid Operator ID from Operator Table: Select to allow operation of the instrument only after an authorized OID is entered. 4.
To Specify Lockout Parameters: 1. Select Lock-Out Control from the Configuration Module screen. The EQC/LQC Lockout dialog box is displayed: 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Select the QC Lock Out Requirements tab (if needed). Use the drop-down arrow to select the test type (e.g., PT or EQC) for which QC lockout parameters are to be specified. Enter a check mark in the QC Normal Required box to require QC Normal testing to be run at a specified interval.
To Specify QC Exceptions: 1. Select Lock-Out Control from the Configuration Module screen. The EQC/LQC Lockout dialog box is displayed. 2. Select the QC Exceptions tab: 911 Limit 1. Enter the maximum number of patient tests (the 911 Limit, from 0 to 240 tests) that can be run after the specified EQC/LQC lockout interval has been reached. When the 911 limit is reached, the instrument cannot be used until reset through Configuration Manager.
To Unlock an Instrument that has Reached QC Failure Limit or the 911 Limit: Note: The HEMOCHRON Jr. Signature+ must be connected to the Configuration Manager and the instrument configuration information read by clicking on Read Configuration from Instrument. 1. Select Lock-Out Control from the Configuration Module screen. The EQC/LQC Lockout dialog box is displayed. 2. Use the drop-down arrow to select the test (e.g., PT or EQC) for which QC failed.
Specifying User Notes Up to nine customized notes can be entered into the User Notes menu of an instrument. Up to two of these notes can be selected and appended to a test record by the operator when the test is run. 1. Select User Notes from the Configuration Module screen to display the User Notes dialog box. Each field is labeled with the instrument key for that note on the User Notes menu: 2. 3. Enter a note (up to 16 characters) for each key. Note: NOTE NOT USED is displayed on the HEMOCHRON Jr.
4. 5. 6. 7. Note: This allows confirmation that failure counts and 911 use counts will be reset on cloning. If a box is left blank, the corresponding count will not be reset. Click OK to continue. The Write Configuration dialog box is displayed: Click Start. Progress information is displayed in the status line. When writing of configuration data is completed, click Exit.
MASTER FILE MAINTENANCE The Master File Maintenance function of HEMOCHRON Configuration Manager allows the following: • Serial Number Master File: Add, modify, or delete a record for a HEMOCHRON Jr. Signature+ instrument. • Test Type: Display test name records. Adding an Instrument The supervisor can add a new instrument to the table of instrument serial numbers and unit locations. 1. Select Serial Number from the Master File Maintenance menu.
Setting Test Type List The list of test types can be set in Configuration Manager for display, reports, or selection. Select Test Type from the Master File Maintenance menu to display a dialog box for viewing the Test Type Maintenance records for resident tests. These records show the “hole code” used to identify each test on the instrument and the correlation equation used for that test. Note: Only the Inactive flags can be modified. This modification does not affect assay availability on the instrument.
CONFIGURATION MANAGER UTILITIES The HEMOCHRON Configuration Manager Utilities allow supervisors to perform certain functions of the HCM database: Function Description System Configuration Update institution name, address, and contact information. Enter the PC COM port used, or automatically detect it. Security Update or delete HCM user records, including user name file, password, or security level. Set Real Time Clock Synchronize the time between an instrument and the PC.
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. Once a supervisor is defined, only the supervisor can create and edit any files in Configuration Manager. All other users will only be allowed to view and print. 1. Select Security from the Utilities menu.
Updating a User Record The supervisor can modify or delete a record for an existing user. 1. Select Security from the Utilities menu. The User Master File Maintenance dialog box is displayed listing information for the first user 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. 2. Use the scroll buttons at the bottom of the dialog box to display the record to be updated. 3.
Purging Configuration Data An existing configuration file can be removed from the Configuration Manager database. A record of the file removal is maintained in the audit trail. 1. Select Purge Configuration Data from the Utilities menu. The Purge Configuration Data dialog box is displayed: 2. 3. Use the drop-down arrow to select the configuration file that is to be purged. The information for the configuration file is displayed. Note: The information is read-only and can not be changed by the user.
Converting the Database 1. Select Convert HCM Data from Ver 1.0 to 1.1 from the Utilities menu. The Convert HCM Data from Ver 1.0 to 1.1 dialog box is displayed: Note: The source and destination paths are shown. These cannot be modified. 2. Click OK to start the conversion. A progress bar is displayed during the conversion, and a message box confirms the data is successfully converted.
TROUBLESHOOTING Configuration Manager Error Messages Problem Cause Corrective Action CHKSUM error during data transfer Other software applications are open during data transfer. Close all applications including anti-virus programs during communications. Communication error/ Initialization error Incorrect cable is used or cable is not completely connected. Ensure proper cable is being used. Check cable connections. No COM Port No COM Port available.
Error Message Cause Corrective Action MACHINE LOCKED CALL SUPERVISOR The EQC failure limit has been exceeded. Contact the Supervisor. Sample Not Seen Sample has not reached front detector in specified time period. Repeat test with new cuvette. If message persists, contact ITC Technical Service. Cuvette Removed Cuvette was prematurely removed from instrument while testing in progress. Repeat test with new cuvette. Sample Too Large/ Sample Too Small Excess or insufficient sample.
Error Message Cause Corrective Action INR< 0.8 INR > 10.0 APTT < 20 Test result is outside clinical range. Repeat test with new cuvette. Out of Range-Lo Test result is outside clinical range. Sample has clotted prematurely, or did not mix correctly in cuvette. Bubbles may be present. Repeat test with new cuvette. Out of Range-Hi Test result is outside clinical range. Repeat test with new cuvette. Check Time/Date Low Battery or RTC has lost its Time/Date Tracking. Enter or Verify Time & Date.
SAFETY STANDARDS The HEMOCHRON Jr. Signature+ instrument complies with the following safety standard requirements and directives: CSA C22.2. 601.1.
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INDEX action keys.........................................................5 adding a user...................................................42 attention label ...................................................9 automatic shutdown .........................................9 battery care ............................................................48 charging .....................................................11 checking.....................................................12 life 10 low warning..............
weight.........................................................10 specifying QC lockout ......................................33 specimen collection ........................................19 starting a test...................................................19 starting instrument .........................................14 terms.................................................................4 test running ......................................................15 starting ....................................
