hemochron_jr-_signature_operators_manual.pdf
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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 .................................................. 7
SPECIFICATIONS..................................................... 8
PREPARING THE INSTRUMENT............................. 8
STARTING THE INSTRUMENT.............................. 12
SETTING OPERATOR LOCKOUT CODE .............. 13
RUNNING A TEST .................................................. 13
QUALITY CONTROL............................................... 15
OPERATING PRECAUTIONS................................. 17
LIMITATIONS .......................................................... 18
RESULTS MANAGEMENT ..................................... 18
TROUBLESHOOTING ............................................ 20
SERVICE AND MAINTENANCE ............................. 21
SAFETY STANDARDS ........................................... 22
INDEX ..................................................................... 23
This manual is published by International Technidyne Corporation (ITC) for use with the HEMOCHRON Jr.
Signature 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.
HEMOCHRON® is a registered trademark of ITC.
ReportMaker™ is a trademark of ITC.
Celite® is registered trademark of Celite Corporation. Microsoft® and Windows® are registered trademarks
of Microsoft Corporation.
©2000, 2003, 2004. This document is the copyright of ITC and must not be copied or reproduced in any form
without prior consent. ITC reserves the right to make technical improvements to this equipment and
documentation without prior notice as part of a continuous program of product development.
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INTENDED USE
The HEMOCHRON 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
234 patient results and 85 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 ReportMaker™ software, provided separately, allows the user to connect a personal
computer to an instrument and perform various data management and data reporting functions.
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.
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.
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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, and
Operator ID, if entered. Quality control results can be tagged with the appropriate level (Normal or
Abnormal). Up to 234 patient test results and 85 quality control test results can be stored on the instrument
for later printing or downloading.
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
International Normalized Ratio
INR
Liquid Quality Control
LQC
Operator Identification Number
OID
Patient Identification Number
PID
Point of Care Coordinator
POCC
Prothrombin Time
PT
Quality Control
QC
Temperature Verification Cartridge
TQC
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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
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.
number pad/
option keys
START key
action keys
Key
Purpose
START
Initiate a test after the test cuvette has reached 37 ±1.0 °C and the sample is
added.
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.
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.
Delete patient or QC records.
Print results on an external printer for the last test result, patient database, or
quality control database.
0 through 9
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:
1=LST 2=PAT 3=QC
Select the appropriate command by pressing the indicated numeric key. For example, to print the last
patient result, select the 1 key.
The commands displayed for each action key are summarized below:
Menu
Commands
ID
QC
DATA
BASE
(First)
(Successive, for QUERY)
(Successive, for ERASE)
1=PATIENT
2=OPER
1=N
2=Abn
3=Pat
1=QUERY
2=ERASE
1=PATIENT
2=QC
Sure?
1=YES
2=NO
1=LST
2=PAT
3=QC
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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
overflow area
detection
window
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.
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 234 patient tests and 85 QC tests can be stored
• stored results can be printed and/or downloaded to a personal computer
• optional entry of Operator ID (OID) or Patient ID (PID)
• optional operator lockout
• instrument self checks are automatically performed
• Electronic Quality Control (EQC) cartridges are used to check instrument operation at two levels
• a Temperature Verification Cartridge (TQC) 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
• Patient/QC test reports can be created using a personal computer and HEMOCHRON
ReportMaker software
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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.
Operator Lockout
A single operator lockout code can be entered into the instrument by use of the HEMOCHRON Jr.
Commander Cuvette. If this feature is enabled, only operators with the assigned code can operate the
instrument. The code can be changed or disabled by the Supervisor. The operator code is stored in the
instrument database and is not printed with test results. See Setting Operator Lockout Code on page 13.
Prewarming
The 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 prewarming 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)
0.34 kg (0.7 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 1,005 seconds
37 °C ±1.0 °C
30 seconds to 90 seconds
2 to 3 hours (minimum)
500 recharges
Nickel Cadmium
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
1.
2.
Note: Inspect each component for damage when unpacking. If damage is observed, contact
your shipper or service representative immediately.
Remove any protective packaging that may be present around the instrument.
Examine the packaging material to be sure that the power supply and 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
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)
Commander Cuvette
Operator’s Manual
Materials Required, But Not Provided
Article
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 (Data Management Software)
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 should be disconnected from the instrument when charging
is completed.
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Battery Warning
The message CHARGE BATTERY is displayed intermittently when the remaining battery power is below a
predetermined level.
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.
1.
Press and hold down the CANCEL key.
2.
While holding down the CANCEL key, insert a cuvette or EQC/TQC.
3.
Release the CANCEL key when the PRESS START message is displayed.
4.
Press the START key to display the time:
TIME:
8:26
5.
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).
6.
Press ENTER. The entry is saved, and the date is displayed:
7.
Type the new date using the numeric keys.
DATE:
6/01/2004
Note: The date format is MM/DD/YYYY). The leading zero is required for single digit dates
(i.e., enter 06/01/2004 for June 1, 2004).
8.
9.
Press ENTER. The entry is saved.
Remove the cuvette or cartridge to return to normal operation.
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 techservices@itcmed.com.
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.
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To Connect a Personal Computer:
1.
Obtain a computer interface cable.
Note: The computer interface cable is not included with the instrument. An optional 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 a RJ45 to DB9 adapter. Numbering
of the pins on the RJ45 connectors is shown below:
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
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STARTING THE INSTRUMENT
Start the instrument 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.
Insert Cuvette
"HEMOCHRON Jr"
is Displayed
Test Name is
Displayed
Operator
Lockout
Enabled?
Yes
Password Prompt is
Displayed
Password
Verified
No
Initialization Prompts
Displayed
Press START to
Run Test
When a test cuvette (eg. PT) is inserted to turn on the instrument, the following prompts are displayed:
1)
HEMOCHRON Jr
3)
Systems.….…..OK
2)
Test . . . . . . . . . . . PT
4)
Priming Pump
5)
WARMING……....
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.
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SETTING OPERATOR LOCKOUT CODE
The HEMOCHRON Jr. Commander Cuvette can be used to enable operator lockout. If operator lockout is
enabled, an operator must enter a code in order to use the instrument.
1.
2.
3.
Press and hold down the 1 key.
While holding down the 1 key, insert the HEMOCHRON Jr. Commander Cuvette into the
instrument.
Release the 1 key. A prompt is displayed to enter the code:
PWD=
4.
Type the code, using the numeric keys.
5.
Note: The code can contain up to twelve digits. The code cannot be 0 (zero).
Press ENTER. The entry is saved.
Note: The lockout code can be designated (or changed) at any time. The requirement to enter
a lockout code can be disabled by entering 0 (zero) in Step 4 or by pressing the ENTER key
without entering a number.
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.
Insert a test cuvette into the instrument.
2.
Press QC to display the QC menu:
1=N 2=Abn 3=PAT
3.
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 menu is displayed, the sample type can be selected by pressing the
numeric key corresponding to the desired sample type. The sample type can be designated
either before or after the test is run, while the test cuvette is still inserted in the instrument.
Entry of QC levels cannot be performed while a test is running.
Note: To exit the QC menu, press and hold the CANCEL key for three seconds.
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. When entering an optional PID or OID,
any ID (up to twelve digits) can be entered.
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To Enter an Optional Patient ID:
1.
Insert a test cuvette into the instrument.
2.
Press ID to display the ID menu:
1=PATIENT 2=OPER
3.
Press 1 to enter a numeric PID:
PID= . . . . . . . . . . . .
4.
5.
Type the PID using the numeric keys.
Press ENTER. The entry is confirmed as saved.
Note: The PID can be designated (or changed) before or after a test is run, while the cuvette is
in the instrument. 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.
Insert a test cuvette into the instrument.
2.
Press ID to display the ID menu:
1=PATIENT 2=OPER
3.
Press 2 enter a numeric ID.
OID= . . . . . . . . . . . .
4.
5.
Type the OID using the numeric keys.
Press ENTER. The entry is confirmed as saved.
Note: The OID can be designated (or changed) before or after a test is run, while the cuvette is
in the instrument. If an OID is not entered for a test, the OID is stored as 0 (zero) in the
database.
Note: Entry of identification numbers cannot be performed while a test is running.
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.
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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: Older versions of the HEMOCHRON Jr. Signature instrument may not recognize newer
assays such as Citrate PT and Citrate APTT. In this case, the instrument will display COD=.
For information on adding new assays to the instrument, contact ITC Technical Service or your
ITC sales representative at (800) 631-5945 or (732) 548-5700.
Note: START TIMEOUT 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-LR and ACT+.
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 and the PID/OID (if entered) are printed with the test result.
Instrument Shutdown
If not in use, the instrument will automatically shutdown after five minutes.
QUALITY CONTROL
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.
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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 EQC Cartridge into the instrument. Enter an Operator ID (optional) for the test. The
instrument will display:
E-QC ……..Test
and
... WARMING
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.
2.
After a short interval, the instrument will beep once and alternately display:
3.
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 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. Then remove the
EQC Cartridge.
Repeat the procedure using the other EQC Cartridge.
Press E-QC ……..
4.
5.
6.
and
16
…….. Start Now
Page 17
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.
Obtain a cuvette for the test to be validated and insert it into the instrument.
4.
When ADD SAMPLE and PRESS START are displayed, add the appropriate liquid control sample
and run the test in the same manner as for a patient sample.
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.
QC of Cuvettes
Cuvette validation is carried out using the appropriate HEMOCHRON Quality Control Product kit and the test
procedure provided.
Acceptable performance ranges for the HEMOCHRON Jr. cuvettes are included with each HEMOCHRON QC
product kit. The cause of out-of-range results is likely attributable to test technique, control material,
cuvette and/or the instrument.
Additional Method to Verify Instrument Temperature
A Quality Control temperature evaluation of the HEMOCHRON Jr. Signature instrument is performed
automatically each time a test is run (see the Self-Check section on page 16). However, for purposes of your
QC program, it may be preferred to additionally perform a temperature QC evaluation using the ITC
Temperature Verification Cartridge to verify that a temperature of 37 °C ±1.0 °C is maintained. The
Temperature Verification Cartridge can be obtained from ITC.
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.
DO NOT use cuvettes that are past their marked expiration date or which have been improperly stored.
DO NOT force a cuvette into the instrument. If resistance to insertion is encountered, gently remove the
cuvette and examine the cuvette slot. Remove any obstruction before attempting further use of the
instrument (see Service and Maintenance on page 21).
DO NOT use excessive force in pressing the instrument keys.
DO NOT expose the instrument to extreme temperatures (above 37 °C).
DO NOT drop the instrument.
The HEMOCHRON Jr. Signature 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.
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All biohazard safety guidelines pertaining to the handling and disposal of human blood should be strictly
adhered to when collecting and handing blood specimens and when operating the HEMOCHRON Jr.
Signature Microcoagulation instrument.
Used HEMOCHRON Jr. test cuvettes should be considered as potentially infectious. They should be handled
according to individual institutional policies concerning the disposal of potentially infectious materials.
HEMOCHRON Jr. Signature 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. Samples with a hematocrit less than 20% or
greater than 55% are not recommended, due to an optical density outside the detection level of the
HEMOCHRON Jr. Signature Microcoagulation instrument.
CAUTION: Verify that any third-party connectivity software to be used is compatible with the
software version of the HEMOCHRON Signature instrument in use. Transferred data will be lost
if third-party connectivity software is used with non-compatible versions of HEMOCHRON
Signature software.
LIMITATIONS
Test results of the HEMOCHRON Jr. Signature Microcoagulation instrument are affected by poor technique
during blood collection and delivery to the sample well. The accuracy of the test is largely dependent upon
the quality of the blood specimen, including the blood sample collection and the transfer of blood to the test
cuvette. Refer to the individual assay package insert for specific limitations.
RESULTS MANAGEMENT
Up to 234 patient test results and 85 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 (if entered) 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.
Insert a test cuvette or EQC/TQC into the instrument.
2.
Press PRINT to display the Print menu:
1=LST 2=PAT 3=QC
Then perform one of the following procedures:
To Print Results of the Last Test:
1.
Press 1. Results of the last test are printed.
To Print All Results in a Database:
1.
Press 2 to print all of the results in the patient database. Or, press 3 to print all of the results in
the QC database.
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: Printing of large databases may be interrupted if the cuvette is removed during the
printing process.
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Other Database Operations
The total number of test results that are currently stored and the total number of additional test results that
can be stored can be displayed. Also, the results in either the patient database or the quality control
database can be erased to make room for additional test results.
CAUTION: Results from the oldest test are overwritten if a test is run when the database is full.
Therefore, it is important to periodically check, print, archive, and erase the database
contents.
To Perform Other Database Operations:
1.
Insert a test cuvette or EQC/TQC into the instrument.
2.
Press DATABASE to display the DATABASE menu:
1=QUERY 2=ERASE
Then perform one of the following procedures:
To Display Total Tests and Remaining Tests in the Database:
1.
Press 1. The Query menu is displayed:
1=Patient
2.
2=QC
Press 1. The total number of stored patient records and the number of records that can still be
added to the patient database are displayed:
41
Tests 193 Left
Or, press 2. The total number of stored QC records and the number of records that can still be
added to the QC database are displayed:
12
Tests 73 Left
To Delete All Results from a Database:
1.
Press 2. The Erase menu is displayed:
1=Patient
2.
3.
2=QC
Press 1 to erase the patient database. (Or, press 2 to erase the QC database.)
The instrument displays a prompt to confirm deletion of the database:
Sure? 1-YES 2-NO
4.
Press 1 to confirm deletion. Completed! is displayed for two seconds.
Note: Press 2 or CANCEL to cancel erasing of the database.
To Exit Database Operations:
1.
Press and hold CANCEL for two seconds.
Downloading QC/Patient Data to Your PC
For information on downloading QC/Patient data to your PC without Report Maker software, contact ITC
Technical Service for instructions.
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TROUBLESHOOTING
Instrument Error Messages
The error messages that may be displayed while operating the HEMOCHRON Jr. Signature instrument are
listed below. The probable cause and corrective action are shown for each message.
If needed, contact ITC Technical Service by phone at +1-732-548-5700, by FAX at +1-732-548-9824, or by
e-mail at techservice@itcmed.com.
Error Message
Cause
Corrective Action
CHARGE BATTERY
Battery power depleted below
predetermined level.
Connect to AC/DC Power
Module and charge battery for
16 hours.
Heater Too Cool
Incubator remained below 36 °C after
90 seconds of warming on external
power or for up to 150 seconds on
battery.
Repeat test, then charge
battery. If message persists,
contact ITC Technical Service.
Heater Too Hot
Incubator exceeded 38 °C for 2.5
seconds.
Repeat test with new cuvette. If
message persists, contact ITC
Technical Service.
Redo, then chrge
Heater too cool
Incubator remained below 37 °C after
90 seconds of warming on external
power or for up to 150 seconds on
battery.
Repeat test with new cuvette. If
message persists, contact ITC
Technical Service.
Detector blocked
Light path between LED and detectors
is blocked.
Repeat test with new cuvette. If
message persists, contact ITC
Technical Service.
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.
Repeat test with new cuvette.
Premature Sample
Sample was detected at front detector
before specified time period. May
occur if sample is added before
pump-priming sequence is complete.
Repeat test with new cuvette. If
message persists, contact ITC
Technical Service.
MEMORY FAULT
Malfunction in the computer's
memory.
Contact ITC Technical Service.
START timeout
START key was not pressed within 5
minutes after entering ready mode.
Remove cuvette and repeat test
with new cuvette.
Premature Clot
Sample has clotted prematurely, or
did not mix correctly in cuvette.
Bubbles may be present.
Repeat test with new cuvette. If
message persists, contact ITC
Technical Service.
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Error Message
Cause
Corrective Action
Bubbles, Repeat
Bubbles are present in the sample.
Remove cuvette and repeat test
with a new cuvette.
Invalid code
Invalid cuvette
Invalid cuvette code entered by
Operator.
Re-enter information.
Use new cuvette
Used cuvette was reinserted into
instrument. Occurs if cuvette
channel is blocked or if sample is
added before pump priming
sequence is complete.
Remove cuvette and repeat test
with new cuvette.
INR< 0.8
INR > 10.0
APTT < 20
Out of Range-Lo
Out of Range-Hi
Test result is outside clinical range.
Repeat test with new cuvette.
Pump Fault 2
Pump Fault 3
Sample has not reached or departed
the rear detector in the specified
time.
Repeat test with new cuvette. If
message persists, contact ITC
Technical Service.
SERVICE AND MAINTENANCE
Routine Maintenance
Inspect and clean the cuvette opening as required. Remove residual dried blood or other foreign matter
using water moistened cotton swabs.
Remove any residual water with dry cotton swabs. If a disinfectant is needed, use a 0.5% solution of sodium
hypochlorite or a 10% dilution of household bleach in water. Wipe instrument with a water-dampened cloth
to removal residual disinfectant from the plastic surfaces.
Apply solution to clean and disinfect areas contaminated with blood. DO NOT use solvents or strong
cleaning solutions as they may damage the instrument’s plastic components. Routine maintenance other
than cleaning normally is not required.
Service
The HEMOCHRON Jr. Signature instrument is almost completely self-monitoring.
It monitors internal circuitry and reports problems to the display screen automatically. Malfunctions are
indicated by error messages detailed in the Troubleshooting section.
Battery Care
To optimize battery life, it is recommended that the HEMOCHRON Jr. Signature instrument be run on its
battery during the day. It can be plugged into a standard AC outlet overnight to allow the batteries to
recharge. The life of the nickel-cadmium battery is optimized when the battery is exercised in this manner.
A fully charged battery will operate as defined in the Operation specifications section on page 8.
When the batteries are drained to the point that valid testing cannot be performed, the instrument will
display “CHARGE BATTERY” (see the Troubleshooting section). At this point, the instrument must be
plugged in for operation and recharging. Once plugged into an AC outlet, the instrument can be used
immediately.
Instrument Disposal
If disposal is necessary, follow local regulations for disposal of electronic devices.
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SAFETY STANDARDS
The HEMOCHRON Jr. Signature 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 /
IEC 60601-1
Medical Electrical Equipment – General Requirements for Safety
EN 60601-1-2 /
IEC 60601-1-2/
UL 60601-1
Medical Electrical Equipment – Part 1-2 – General Requirements for
Safety – Collateral Standard: Electromagnetic Compatibility –
Requirements and Tests
EN 61000-3-2
Electromagnetic Compatibility – Limits – Limits for Harmonic Current
Emissions
EN 61000-3-3
Electromagnetic Compatibility – Limits – Limitation of Voltage Changes,
Voltage Fluctuations and Flicker in Public Low-voltage Supply Systems
EN 55011
Industrial, Scientific and Medical (ISM) Radio Frequency Equipment –
Radio Disturbance Characteristics – Limits and Methods of Measurement
EN 61326
Electrical Equipment for Measurement, Control and Laboratory Use –
EMC Requirements
Directives: 89/336/EEC and as amended by 91/263/EEC, 92/31/EEC, 93/68/EEC, 98/13/EC, and
98/79/EC.
All the relevant documentation is kept on file at ITC in Edison, NJ.
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INDEX
action keys.........................................................4
attention label ...................................................7
automatic shutdown .........................................7
battery
care ............................................................21
charging .......................................................9
life 8
low warning................................................10
type...............................................................8
cable configurations........................................11
charging battery.................................................9
connecting
computer .............................................10, 11
printer........................................................10
cuvette ...............................................................6
cuvette validation ............................................17
definitions .........................................................3
description
features ........................................................6
overview .......................................................4
display panel .....................................................5
erase patient database.....................................19
erase QC database ...........................................19
error messages................................................20
features .............................................................6
intended use......................................................2
interface cable.................................................11
keypad ...............................................................4
limitations .......................................................18
liquid controls .................................................17
maintenance ...................................................21
materials
optional ........................................................9
provided .......................................................9
required .......................................................9
menus ...............................................................5
operating precautions .....................................17
overview.............................................................2
precautions .....................................................17
Quality Control
electronic ...................................................16
instrument performance ...........................16
liquid....................................................16, 17
results
management..............................................18
running a test..................................................13
service .............................................................21
setting
time............................................................10
shutdown
automatic.....................................................7
specifications
AC/DC Power Module ...................................8
dimensions ..................................................8
performance ................................................8
weight...........................................................8
specimen collection ........................................14
starting a test...................................................15
starting instrument .........................................12
terms.................................................................3
test
running ......................................................13
starting .......................................................15
test cuvettes.......................................................6
test termination.................................................7
time and date ..................................................10
troubleshooting ...............................................20
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HJ5632
10/04