HEMOCHRON Jr. Signature+ Operators Manual

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. Data management capabilities are included with the instrument. These capabilities include storage of up to 400 patient results and 400 quality control results, designation of quality control levels, tagging of test results with date and time, entry of Patient ID and/or Operator ID, and printing of results. HEMOCHRON Configuration Manager software is included. This software allows the user to connect a personal computer to an instrument and perform system configuration functions using the fast and convenient Microsoft® Windows® user interface. ITC data management software programs, provided separately, allow the user to connect a personal computer to an instrument and perform various data management and data reporting functions. Refer to the operating instructions for these programs for information on use in conjunction with the HEMOCHRON Jr. Signature+. For in vitro Diagnostic Use. SUMMARY AND EXPLANATION Events that lead to formation of a blood clot are simplified in coagulation theory into two interactive coagulation cascades that are referred to as the intrinsic and the extrinsic pathways. The clotting factors involved in these pathways are numbered I through V and VII through XIII. The intrinsic pathway begins with the contact activation of factor XII and, through the interaction of several coagulation factors, results in the conversion of soluble fibrinogen to insoluble fibrin strands. The extrinsic pathway is initiated through the interaction of tissue factor with factor VII. Platelets, essential co-factors in this reaction, provide the platelet phospholipid (PF3) surface on which coagulation reactions occur. Heparin is used to maintain hemostasis during cardiac surgery and percutaneous coronary interventional (PCI) procedures. However, its administration can pose significant risk to the patient since individual patients can vary as much as twelve-fold in heparin sensitivity. Overdosing heparin can result in dangerous bleeding, and underdosing heparin can lead to thrombosis. Therefore, monitoring heparin therapy is vital in guarding against these undesirable side effects. Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate) tests are general coagulation screening tests that are used to measure the functionality of the blood coagulation cascade. The ACT test is the method of choice for monitoring heparin therapy during cardiac surgery and PCI. Fresh whole blood is added to an activator (Celite®, silica, kaolin, or glass particles), and then timed for the formation of a clot. The type of activator used will affect the degree of prolongation of the ACT to a given heparin dose. The HEMOCHRON Jr. ACT+ test uses a mixture of silica, kaolin, and phospholipids as an activator to create a rapid and highly sensitive alternative to existing ACT tests. This test demonstrates linearity at heparin concentrations ranging from 1.0 to 6.0 units of heparin per mL of blood, and it is not affected by high dose aprotinin therapy. The HEMOCHRON Jr. ACT-LR test uses a Celite activator due to its excellent heparin sensitivity. The test demonstrates linearity at heparin concentrations up to 2.5 units of heparin per mL of blood. The test is not intended for use with aprotinin therapy. The HEMOCHRON Jr. APTT test measures the intrinsic coagulation pathway and involves all coagulation factors except factors VII and III (tissue factor). The APTT test improves the 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 HEMOCHRON Jr. APTT test is formulated to provide optimal heparin sensitivity at heparin concentrations up to 1.5 units of heparin per mL of blood. The HEMOCHRON Jr. APTT Citrate test performs the same measurement as the APTT test, using a citrated whole blood sample.

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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. PT Citrate test performs the same measurement as the PT test, using a citrated whole blood sample. PRINCIPLES OF OPERATION The HEMOCHRON Jr. Signature+ 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, and a streamlined user-interface panel. The system measures whole blood clotting times using HEMOCHRON Jr. disposable single-use cuvettes. Each cuvette contains all of the reagents necessary for a specified test. The operator inserts a cuvette for the test into the instrument and then enters information about the sample (if desired). After the cuvette has warmed to 37 °C ±1.0 °C, the instrument beeps, signaling the operator that a blood sample can be added to the cuvette and the test started. The operator then places a drop of blood in the sample well of the cuvette and presses the START key. The instrument measures the required volume of blood and automatically moves it into the cuvette test channel, where it is mixed with reagents. The remainder of the blood sample, not needed for testing, is automatically drawn out of the sample well and into an enclosed waste channel on the cuvette. After mixing with the reagent, the sample is moved back and forth at a predetermined rate within the test channel and monitored for clot formation. The test channel is maintained at 37 °C ±1.0 °C during the test. The rate of movement of the sample is monitored by a series of LED optical detectors that are aligned with the test channel. When the blood clots, the flow of the blood sample within the test channel is impeded, reducing its rate of flow between the optical detectors. This reduction in flow below a predetermined value signals to the instrument that a clot has formed. The instrument also emits an audible beep when clot formation occurs, indicating the end of the test. An internal timer measures the elapsed time between the start of the test and the clot formation. During the test, the whole blood clotting time (in seconds) is displayed. APTT and APTT Citrate results are displayed as plasma equivalent (PE) values, and PT and PT Citrate results are displayed as the International Normalized Ratios (INR) and PE values. ACT+ and ACT-LR results are displayed as Celite ACT equivalent time. The results will remain on the display while the cuvette remains in the instrument. The result can be automatically printed along with the time and date the test was run, the Patient ID, Operator ID, and other information, if entered. The result is also saved in an internal database. Up to 400 patient test results and 400 quality control test results can be stored on the instrument for later printing or downloading. Individual HEMOCHRON Jr. Signature+ instruments can be customized so that designated quality control tests must be performed whenever a specified period of time has elapsed. The instruments can also be configured so that only authorized operators can operate the system and/or operators cannot perform certain functions such as deleting test results from the instrument database. These and other configuration options are entered using HEMOCHRON Configuration Manager Software on a personal computer.

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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 Prothrombin Time PT Quality Control QC Temperature Verification Cartridge TQC DESCRIPTION The HEMOCHRON Jr. Signature+ 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. Operator instructions are shown on the display panel, and the operator enters commands and information using the keypad. When the test is completed, the results are shown on the display panel and stored in system memory for printing or downloading. display panel keypad test chamber

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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.

number pad/ option keys

START key action keys

Key

Purpose

START

Start the instrument or turn off instrument. Initiate a test after the test cuvette has reached 37 ±1.0 °C and the sample is added.

NOTE

Select a laboratory-defined note (from nine choices programmed via HEMOCHRON Configuration Manager) for entry into the record for the current test.

ID

Enter a Patient ID or Operator ID.

QC

Specify that the QC sample being run is a normal (Level 1) or abnormal (Level 2) control. (For QC Lockouts) Display the length of time remaining before Quality Control testing for a particular test must be successfully completed.

DATABASE

Display the number of patient or QC test results that are currently stored in the instrument and the number of additional test results that can be stored. Display results of the last 100 patient or QC tests. Delete patient or QC records.

PRINT

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.

0 (zero key)

(When no tests are running and no menu is active) Display the main menu.

0 through 9

Select a menu option. Enter numeric information (e.g., a Patient ID, an Operator ID, a time, or a date).

CANCEL

Cancel an operation and return to the previous state.

ENTER

Accept a numeric entry (e.g., a Patient ID, an Operator ID, a time, or a date).

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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. The display is momentarily illuminated after a key is pressed or when results of a completed test are displayed. While a test is running, the display can be momentarily illuminated by pressing the CANCEL or ENTER key or any numeric key. Menus The action keys display the various commands for operating and configuring the system. Display a menu by pressing the corresponding action key. For example, press the PRINT key to display the print menu title: PRINT MENU

Display each command on a menu by pressing the action key again (or the zero key). For example, if the PRINT menu is displayed, press the PRINT key or 0 repeatedly to scroll through the commands on the PRINT menu: 1–Print Last

3–Print QC DB

6–Enter Header

2–Print PAT DB

4–Print by PID

7–Print System

5–Print Check

Execute a command by pressing the ENTER key while the command is displayed or by pressing the numeric key for that option when the menu is displayed. For example, press 3 while PRINT MENU (or any command on the PRINT menu) is displayed to print the QC database: Printing QC DB

The commands displayed after successive keystrokes on each action key are summarized below: Menu Action Key Commands (First) (Successive) (First) (Successive)

Note

NOTE

ID SELECTS

ID

QC SELECTS

QC

(First) (Successive)

DB SELECTS

DATA BASE

(First) (Successive)

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Enter Note# Predefined Notes 1 through 9 ID SELECTS 1–Enter PID 2–Enter OID QC SELECTS 1–QC Normal 2–QC Abnormal 3–Patient Result 4–QC Status DB SELECTS 1–Pat DB Totals 2–QC DB Totals 3–Pat DB Erase 4–QC DB Erase 5–Display Pat DB 6–Display QC DB

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. If not in use, the instrument will automatically shutdown after five minutes. Test Cuvettes Tests are performed with single-use disposable HEMOCHRON Jr. test cuvettes. Each test cuvette contains a label, a sample well, a test channel containing reagents, an enclosed waste reservoir, and optical detection windows. label

test channel sample well

detection window

overflow area

The cuvette label is human- and instrument-readable. The current test is automatically read by the instrument and displayed for confirmation when the operator inserts the cuvette into the test chamber. After the cuvette has warmed to 37 ±1.0 °C, ADD SAMPLE and PRESS START are displayed by the instrument, alerting the operator to place a drop of blood in the sample well and begin the test by pressing the START key. Note: Refer to the package insert accompanying the HEMOCHRON Jr. test cuvettes for storage and handling instructions.

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Features The HEMOCHRON Jr. Signature+ has a number of performance and convenience features. These are summarized below: • the system is portable for bedside use • fresh whole blood or citrated whole blood can be used (assay dependent) • only one drop of blood is required • results are available in minutes • results are displayed appropriately as whole blood, plasma equivalent, Celite equivalent seconds, or INR • test type is automatically read from the cuvette • test results are automatically stamped with date and time • results from 400 patient tests and 400 QC tests can be stored • stored results can be printed and/or downloaded to a personal computer • stored results can be searched by Patient ID • instrument self checks are automatically performed • Electronic Quality Control (EQC) cuvettes are used to check instrument operation at two levels • a Temperature Verification cuvette can be additionally used to check test chamber temperature • the display is illuminated for viewing in low light • the user is alerted when the battery is low • an optional printer can be connected • the system can be customized using a personal computer and HEMOCHRON Configuration Manager software • User Notes can be entered to add additional information to the test results • Patient/QC test reports can be created using a personal computer and ITC data management software programs

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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. 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. The instrument will sound one short beep when pre-warming is complete. Automatic Interrupt To ensure accurate test results, incubation of a cuvette stops automatically if START is not pressed within five minutes after ADD SAMPLE and PRESS START are displayed. Test Termination A test terminates and operation of the test chamber automatically shuts off if clot formation is not detected within a test-specific, preset maximum time. Note: Results that are greater than the time noted in the package insert for a test are beyond the sensitivity range of the test. They should be repeated immediately and, if confirmed, reported as greater than the maximum sensitivity range.

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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 ±1.0 °C 30 seconds to 90 seconds 2 to 3 hours (minimum) 500 recharges Nickel Metal Hydride 49 test cycles (at 150 sec per test) 17 test cycles (> 500 sec per test) 15 °C to 30 °C

AC/DC Power Module USA/Canada Input Power Output Power

120 VAC, 60 Hz, 35 VA 9.0 VDC, 1.38 Amps maximum

Europe Input Power Output Power

230 VAC, 50 Hz, 30 VA 9.0 VDC, 1.15 Amps maximum

Japan Input Power Output Power

100 VAC, 50/60 Hz, 40 VA 9.0 VDC, 1.3 Amps maximum

Calibration The Signature+ instrument is calibrated at the manufacturer facility to test and verify all functions. The instrument is also self-calibrating, as all instrument functions are continuously monitored and verified by the instrument software when a test is performed. The instrument does not require additional calibration by the user.

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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. Materials Provided Article

Quantity

HEMOCHRON Jr. Signature+ Microcoagulation Instrument PC Cable (ITC Part No. HJ7405; see Connecting a Computer or Printer on the following page) AC/DC Power Module (see note below) USA/Canada (ITC Part No. HJ7353) Europe (ITC Part No. HJ7436) Japan (ITC Part No. HJ7409) Electronic System Verification Cartridges (EQC) Temperature Verification Cartridge (TQC) Operator’s Manual HEMOCHRON Configuration Manager CD Materials Required, But Not Provided Article

1 1 1

2 1 1 1 Quantity

HEMOCHRON Jr. Test Cuvettes HEMOCHRON Jr. Quality Control Products

As Needed As Needed

Optional Materials Article

Quantity

HEMOCHRON Jr. PKIT (Printer Kit) HEMOCHRON Jr. PCKIT (Personal Computer Interface Cable) HEMOCHRON Jr. CBL-SIG (Serial Printer Interface Cable) HEMOCHRON ReportMaker 4.0 or higher CD (Data Management Software) idms v7.1 or higher (Integrated Data Management System)

1 1 1 1 1

Note: The AC/DC Power Module that is provided is the one that is appropriate for the country to which the HEMOCHRON Jr. Signature+ instrument is being shipped. An AC power cord is not provided with the European AC/DC Power Module (ITC Part No. HJ7436). Charging the Battery The battery of the system should be charged before the system is 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 on the side of the instrument. 3. Allow the battery to charge for at least 16 hours. Note: The AC/DC Power Module can remain connected all the time.

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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. The battery status is displayed:

4.

Note: Battery status is displayed as OK, LOW, or Weak. Press CANCEL to return to normal operation.

BAT-OK

9.0V

Setting the System Time and Date: The time and date a test is run is saved with the test results. The system time and date can be reset by the operator unless the system is in a lockout condition or the time and date are permanently locked (see the Configuration Manager section on page 26). Note: If the unit has been off for an extended period of time or the battery is very weak, the operator will be prompted to enter or verify that the time and date are correct. To Set the System Time: 1. Press START to turn on the instrument. 2. Press 0 (zero) to display the main menu: MAIN MENU 3.

Press 2 to display the time:

4.

Enter the new time using the numeric keys. Note: Use the 24-hour format (i.e., enter 15:30 for 3:30 pm). The leading zero is required for single digit times (i.e., enter 06:30 for 6:30 am).

5.

Press ENTER. DATA STORED is displayed and the entry is saved.

6.

Press CANCEL to return to normal operation.

TIME:

8:26

To Set the System Date: 1. Press START to turn on the instrument. 2. Press 0 (zero) to display the main menu: MAIN MENU 3.

Press 3 to display the date: DATE:

4.

5. 6.

Type the new date using the numeric keys. Note: Use the European (i.e., DD/MM/YYYY) or the US (i.e., MM/DD/YYYY) date format. The leading zero is required for single digit dates (i.e., enter 06/01/2004 for June 1, 2004). Press ENTER. DATA STORED is displayed and the entry is saved. Press CANCEL to return to normal operation. Note: The main menu cannot be accessed if a cuvette or EQC/TQC cartridge is in the test well. If a cuvette or EQC/TQC cartridge is used to turn on the instrument, it must be removed to access the main menu.

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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. 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. For additional information on printer configuration, contact ITC Technical Service at (800) 631-5945 or (732) 548-5700, or by e-mail at [email protected]. 2. Connect one end of the cable to the connector port on the side of the instrument. 3. Connect the other end of the printer cable to the printer. To Connect a Personal Computer: 1. Obtain a computer interface cable. Note: The computer interface cable is included with the instrument. A replacement PCKIT (Personal Computer Interface Cable) can be obtained from ITC, or a cable can be prepared as outlined below. Contact ITC Technical Service for instructions on setting up the personal computer. 2. Connect one end of the cable to the connector port on the side of the instrument. 3. Connect the other end of the cable to an unused serial communication port on the computer. Preparing a Printer or Computer Interface Cable Cabling and connectors can be purchased locally at an electronics store. Use a 6-wire or 8-wire RJ45 to RJ45 modular straight through connecting cable (no longer than 25 feet) plus an RJ45 to DB9 adapter. Numbering of the pins on the RJ45 connectors is shown below:

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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. Allow cuvettes to reach room temperature (15 to 30 °C) before opening the pouch. This may take up to 60 minutes. Consult the cuvette package insert for additional information concerning cuvette storage and handling. The prompts that are displayed after the instrument is started depend upon whether the START key or a cuvette is used and whether or not lockouts are enabled (see the Configuration Manager section on page 26): Press START

Insert Cuvette

"HEMOCHRON SIG+" is Displayed

"HEMOCHRON SIG+" is Displayed

"Insert" and "Cuvette" are Displayed

Insert Cuvette

Test Name is Displayed

Lockout(s) Enabled?

No

Initialization Prompts Displayed

Press START to Run Test

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Yes

Lockout Prompts are Displayed

Satisfy Requirements

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 ±1.0 °C, the instrument will beep and alternately display: Add Sample...

and

... Press Start

The sample can now be added. After the sample is added, press START to run the test. RUNNING A TEST Samples are designated as patient samples by default. If a control is being run, the sample type must be changed from patient sample to QC Normal or QC Abnormal. If a patient sample is being run, this step is unnecessary. Important: Failure to select QC Normal or QC Abnormal for a control sample will result in storage of the control results as patient results in the patient database. 1. Select QC to display the QC SELECTS menu: QC SELECTS 2.

Note: To enter QC SELECTS, a cuvette must be inserted into the instrument. Press 1 to designate the sample as a normal control: QC Normal

Or press 2 to designate the sample as an abnormal control: QC Abnormal

Note: Once the QC SELECTS menu is displayed, the sample type can be selected by pressing QC repeatedly until the desired sample type is displayed or by pressing the numeric key corresponding to the desired sample type. The sample type can be designated either before, during, or after the test is run, while the test cuvette is still inserted in the instrument (unless QC lockout features are enabled). Once QC is selected, repressing the QC key will briefly display the QC level and assay being run. To exit the QC menu, press and hold the CANCEL Key for three seconds. Important: Once a QC type is selected, it cannot be changed. Note: If any error messages appear on the instrument screen, do not change any previous patient/QC tags. Remove cuvette and repeat test using a new cuvette. A numeric Patient ID (PID) and/or Operator ID (OID) can be entered for each test. The IDs will be stored with the results for the test. Entry of a PID and/or OID is optional unless specified otherwise (see the Configuration Manager section on page 26). When entering an optional PID or OID, any ID (up to nine characters) other than 0 (zero) can be entered.

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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. If a PID is not entered for a test, the PID is stored as 0 (zero) in the database.

To Enter an Optional Operator ID: 1. Select ID to display the ID SELECTS menu: ID SELECTS 2.

Press 2 enter a numeric ID. OID=...

3. 4.

Type the OID using the numeric keys. Press ENTER. The entry is confirmed as saved. Note: The OID can be designated (or changed) anytime. Check the OID by pressing ID and then pressing 2 to display the entered value. If an OID is not entered for a test, the OID is stored as 0 (zero) in the database.

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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=...

Note: When PID=… is displayed, pressing the QC button will allow a QC test to be performed without fulfilling the PID requirement. 2. 3.

Type the PID using the numeric keys. Press ENTER. If an acceptable PID is entered, operation of the instrument continues: Priming Pump

Note: An acceptable PID is any number other than zero (0). The number of digits to be entered for PID (from 3 to 9, or 0 for any number of digits up to 9) may be designated via Configuration Manager. Selecting 3 to 9 digits requires that the operator enter exactly that length. Check the PID by pressing ID and then pressing 1 to display the entered value. To Enter a Mandatory Operator ID: 1. The OID prompt is automatically displayed: OID=... 2. 3.

Type the OID using the numeric keys. Press ENTER. If an acceptable OID is entered, operation of the instrument continues: Priming Pump

Note: If entry of any OID is specified, an acceptable OID is any number (up to 9 digits) other than zero (0). If entry of a valid OID is specified, an acceptable OID is any number contained in the Operator Table (see page 36 ). Check the OID by pressing ID and then pressing 2 to display the entered value. 4. If an unacceptable OID is entered, ID IS NOT VALID is displayed followed by the OID prompt. Operation of the instrument will not continue until an acceptable OID is entered. To Enter a Mandatory Operator PIN: 1. The PIN prompt is automatically displayed: PIN=... 2.

3.

Type the Operator PIN using the numeric keys. Note: The Operator PIN will be displayed as ** on the display panel. The corresponding OID will be stored and printed with results. Press ENTER. If an acceptable PIN is entered, operation of the instrument continues: Priming Pump

4.

Note: An acceptable PIN is any number contained in the Operator Table. If an unacceptable PIN is entered, ID IS NOT VALID is displayed followed by the PIN prompt. Operation of the instrument will not continue until an acceptable PIN is entered.

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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. Note: A specified limited number of additional tests (911 exceptions) can be run after a mandatory QC interval has been reached. Consult the Configuration Manager section for details. To Run a Mandatory QC Test: 1.

The prompt for the required QC test is automatically displayed:

2.

Enter mandatory ID or PIN information (if prompted). If acceptable information is entered, operation of the instrument continues:

1-QN 2-QA

Priming Pump 3.

Run the QC test according to the displayed prompts. If the results for the QC test are acceptable, affected patient tests can now be run.

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. The notes are selected from a menu of nine available notes. Note: Consult the Configuration Manager section for the procedure to add a new userselectable note to the Note Table. 1. Press NOTE: Enter Note#= 2.

Type the number (1 through 9) corresponding to the note that is to be entered or press the NOTE key repeatedly until the desired note is displayed. For example: USER TRAINING

Note: “NOTE NOT USED” is displayed if a note is not defined for that note number. 3.

Press ENTER. The number for the selected note is displayed: Enter Note#= 6,0

4.

Note: The number corresponding to the first note is displayed before the comma. The 0 (zero) character after the comma indicates that a second note has not yet been defined. (If needed) Type the numeral corresponding to a second note and press ENTER. The number for the second note is displayed: Enter Note#= 2,6

5.

Note: If a third note is entered, the first note (Note 6 in this example) is cancelled. Currently entered notes can be cancelled by entering 0 (zero) for both notes. Press CANCEL to return to normal operation.

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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. Use a 23 gauge or larger needle if a syringe is used for blood collection. If a sample is expelled through the same needle, do it slowly to prevent hemolysis. Consult the cuvette package insert for additional information concerning specimen collection and storage. 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, 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. If this occurs, repeat the test using a new cuvette. 1. Place a drop of blood into the sample well of the cuvette: lower wall sample well overflow area

2.

3.

4.

Note: Fill the sample well from the bottom up. Add enough blood so that the lower wall of the center sample well is completely filled. If the meniscus of the blood sample extends above the lower wall, push the excess blood into the overflow area. A transfer needle can be used to transfer blood. Press the START key. The elapsed time (in seconds) is displayed until the sample clots. Note: SAMPLE TOO SMALL, SAMPLE TOO LARGE, or SAMPLE NOT SEEN is displayed if an incorrect amount of sample was added. Repeat the test using a new cuvette. When a clot is detected, the instrument beeps once. Final results of the test are calculated and displayed. Note: The whole blood clotting times are converted to plasma equivalent values (for APTT and APTT Citrate), or plasma equivalent values and International Normalized Ratio (for PT and PT Citrate). Press the START key to display the whole blood clotting times (for three seconds). Celite equivalent values are displayed for ACT+ and ACT-LR. Remove the cuvette and discard it. Note: Results are saved in the database and printed if a printer is connected. The date and time of the test, the PID, OID, notes (if entered), and error message (if a fault is detected for the test or sample) are printed with the test result.

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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. Signature+ consists of the following operations: • Testing system performance using Electronic System Verification Cartridges at two levels every eight hours of operation. • Testing cuvettes in accordance with the Package Insert for each assay using two levels of liquid controls. Self-Check The HEMOCHRON Jr. Signature+ 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. • Verification of the test type on the screen display to insure that the LEDs used for identifying the test are functioning properly. • Verification that the cuvette temperature is warmed to 37± 1.0 ºC. If this temperature is not achieved or is exceeded, an appropriate error message will be displayed and testing is prohibited. • Verification that the sample is present and is of sufficient size to run test. This insures that the pumps and sample sensing LEDs are functioning properly and that the cuvette is adequately sealed. If these instrument and sample parameters are not appropriate, the test is terminated and an error message displayed. • Verification that the internal timers function correctly for each test. If the system timer and assay timer disagree, a real-time clock error message is displayed and the test result is not reported. QC of Instrument Performance The instrument should be tested at two levels once every eight hours of operation. Electronic quality control cartridges (EQC Cartridges) can be used to provide a two-level electronic verification of instrument performance, or liquid quality control products can be used. QC Using EQC Cartridges: 1. Insert the corresponding EQC Cartridge into the instrument. Enter an Operator ID (optional) for the test. The instrument will beep once and display: E-QC ……..TEST

2.

Note: System verification checks are performed during this process. If a fault is encountered, the instrument will beep several times and display the error message. Refer to the Troubleshooting section for the procedure to resolve an error message. After a short interval, the instrument will beep once and alternately display: Press E-QC ……..

3. 4.

5. 6.

and

…….. Start Now

Press the Start button on the EQC Cartridge. The instrument displays the elapsed time (in seconds) until the EQC Cartridge simulates an endpoint. When the EQC Cartridge simulates an endpoint, the instrument beeps twice. Final results of the test, along with a PASS or FAIL designation, are displayed and saved in the database when the cartridge is removed. Note: If a printer is connected, the results are printed when the EQC Cartridge is removed. Compare the displayed time with the acceptable range for the EQC Cartridge and remove the EQC Cartridge. Repeat the procedure using the other EQC Cartridge.

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