ACT Plus
®
Automated Coagulation Timer
Operator’s Manual
Explanation of symbols on product or package
Conformité Européenne (European Conformity). This symbol means that
the device fully complies with the European Council Directive 98/79/EC
(27 October 1998, on in vitro diagnostic medical devices).
Attention, See Instructions for Use
Consult Instructions for Use
Fuse
On (power)
Off (power)
Alternating Current
Medical equipment with respect to electric shock,
hazards only in accordance with IEC 61010-1:2001 and CSA C22.2
No. 61010-1.
In Vitro Diagnostic Device
For US Audiences Only
Quantity
Serial Number
e and mechanical
fir
Catalog Number
Authorized Representative in the European Community
Fragile, Handle with Care
This Way Up
Main Menu
Quality Control Menu
Stop
Date of Manufacture
1
Biological Risks
Nonionizing Electromagnetic Radiation
Manufactured I
Cancel
Enter
Clear
Temperature Limitation
Humidity Limitation
Manufacturer
Do not dispose of this product in the unso
Dispose of this product according to local regulations. See
http://recycling.medtronic.com for instructions on proper disposal of this
product.
China RoHS Standard (SJ/T11364-2006) Electronic Information Products
Pollution
be used before it must be recycled (environmental protection use period).
n
rted municipal waste stream.
C
ontrol Symbol. The number represents the years the device can
2
Table of Contents
Section 1: System Description 9
Intended Use 9
Principle of Clot Detection 9
Data Storage 9
Test Cartridge 9
Reagent Chamber 10
Reaction Chamber 10
Plunger Assembly 11
Section 2: Precautions 12
General Precautions 12
No Unapproved Instrument Use 12
Explosive Anesthetics 12
Main Power Off and Disconnect Access 12
Electric Shock 12
Proper Maintenance and Calibration 13
No User-Serviceable Parts 13
Cleaning/Decontamination 13
Biohazard 13
Use of Cartridges an
d Co
ntrols 13
Section 3: Instrument Components 14
Actuator Heat Block Assembly 14
Section 4: Installation 15
Unpacking 15
Power ON: Initial Checkout Procedure 15
Setup 16
Section 5: Instrument Controls 17
User Interface 17
ACT Plus® Operator’s Manual English 3
Rear Panel 18
Instrument Bottom 19
Optional Bar Code Scanner 19
Section 6: Data Entry 20
Main Menu 20
Enter Patient and User IDs 21
Manual Entry 21
Bar Code Entry 22
Select Cartridge Type 22
Enter ACTtrac® Serial Number 23
Enter Cartridge Lot Number an
d Exp
iration Date 23
Manual Entry 23
Bar Code Entry 24
View Test Results for the Last 20 Tests Performed 24
Transmit Patient and Quality Control (QC) Test Results 25
Transmission Using Floppy Drive 25
Transmission Using USB Port 25
Set Instrument Parameters 26
Quality Control (QC) Menu 27
General Quality Control (QC) Functions 27
Select the Control Type 28
Enter Control Lot Number, Expiration Date, and Range 28
Manual Entry 28
Bar Code Entry 29
To verify/record the ACT Plus
®
actuator heat block temperature 30
To view the due status for quality control testing 30
QC Manager Functions 30
Select the location for the ACT Plus
®
instrument: 32
Add/delete User IDs: 32
Add a User ID: 32
Delete a User ID: 32
Enable User Lockout: 32
4 English ACT Plus® Operator’s Manual
Change the QC Manager Password: 33
Download User IDs: 33
Transfer User IDs from ACT Plus
Instruments: 33
Select the Time Interval for Clearing Patient and User IDs: 33
Select the QC Lockout Function: 33
Set the QC Interval for Liquid and Electronic Controls: 34
To set the liquid QC interval: 34
To set the ACTtrac® e
lectronic QC interval: 34
Enable or Disable Test Cartridge Types: 34
Download All of the Instrument Settin
Device: 34
Set the Permanent Record or the Mode by Which the ACT Plus®
Instrument Maintains a Record of Downloaded Data: 34
Upload Software Upgrades from a Floppy Disk or USB Storage
Device: 35
Section 7: Test Methods 36
General 36
Activated Clotting Times: High Range
and Recalcified (RACT) Cartridges 37
Results 37
High Range Heparina
se (HR-HTC) 38
®
Instrument to Multiple
Floppy Disk or USB Storage
gs to a
(HR
-ACT), Low Range (LR-ACT),
Section
8: Quality Assurance 39
Instrument Self-Test 39
Liquid QC 39
Electronic QC (ACTtrac®) 39
Section 9: Maintenance 41
Instrument Case Cleaning 41
Actuator Assembly Cleaning 41
Actuator Heat Block Temperature 42
Temperature Verification Cartridge 42
Verification with Thermometer 43
Fuse Replacement 43
Preventive Maintenance 44
ACT Plus® Operator’s Manual English 5
Section 10: Service and Troubleshooting 45
Service 45
Instrument Return 45
End of Life Disposition 45
Troubleshooting 45
Message Types 45
Message Priorities 46
Alerts 48
Error Messages 49
Temperature 50
Section 11: Specifications 51
Instrument 51
Electrical 51
Default Operating Parameters 52
Electromagnetic Emissions and Immunity Declarations 53
Appendix A: Optional Bar Code Scanner LS1900 57
Introduction 57
Parts of the LS1900 Series Scanner 57
Scanning in Hand-Held Mode 58
Setting Bar Code Format Options 58
Code 39 58
Interleave 2 of 5 59
Codabar 60
Troubleshooting 60
Defaults 60
Procedure for setting the defaults: 61
Appendix B: Optional Bar Code Scanner LS2208 65
Introduction 65
Parts of the LS2208 Scanner 65
Scanning in Hand-Held Mode 66
Setting Bar Code Format Options 66
6 English ACT Plus® Operator’s Manual
Bar Code Scanner Installation Instructions 70
Appendix C: Warranties 71
EQUIPMENT LIMITED WARRANTY 71
EQUIPMENT LIMITED WARRANTY 72
ACT Plus® Operator’s Manual English 7
8 English ACT Plus® Operator’s Manual
Section 1: System Description
The Medtronic ACT Plus® Automated Coagulation Timer is a
microprocessor-controlled electromechanical coagulation instrument intended for
in vitro determination of coagulation endpoints in fresh and citrated whole blood
samples. The ACT Plus
Medtronic disposable cartridges: High Range ACT, Low Range ACT, Recalcified
ACT, and High Range Heparinase.
Intended Use
The ACT Plus® instrument is intended for in vitro diagnostic testing in either a
hospital laboratory setting or a point of care (decentralized) setting (eg, in the
operating room, cardiac catheterization lab, intensive care unit, or clinic, etc.).
Principle of Clot Detection
Test reactions occur at 37°C ±0.5°C in single use cartridges placed in the Actuator
Heat Block Assembly. Fibrin formation is the endpoint of tests performed on the
ACT Plus
the plunger-flag mechanism in each cartridge channel. The plunger assembly falls
rapidly at programmed timed intervals through an unclotted sample. The fibrin web
formed during clotting impedes the fall rate of the plunger and is detected by a
photo-optical system located in the ACT Plus® instrument’s actuator assembly.
Tests are performed in duplicate, and the clotting time results are displayed on the
red Light Emitting Diode (LED) display and on the Liquid Crystal Display (LCD)
screen of the ACT Plus
®
instrument. Fibrin formation is detected by measuring the rate of fall of
Data Storage
The ACT Plus® stores a total of 1000 test results, any combination of patient and
quality control tests. Test data is stored in the order performed. Patient and quality
control test data may be transferred to the ACT Plus EDM (external data manager)
using the floppy drive or USB port. Test data may be transferred to a laboratory or
hospital information system using the serial communication port with vendor
neutral connectivity software.
®
instrument is designed for use with the following
®
instrument.
Test Cartridge
Test cartridges for the ACT Plus® instrument consist of the reagent chamber, the
reaction chamber, and the plunger assembly.
ACT Plus® Operator’s Manual English 9
Figure 1. Test Cartridge
1
2
3
4
5
6
7
8
9
1. Flag
2. Plunger
3. Tang
4. Reaction Chamber
5. Daisy
6. Reagent Chamber
7. Bottom Plug
8. Upper Fill Line
9. Lower Fill Line
Reagent Chamber
The reagent chamber contains the activator and other reagents which initiate and
contribute to formation of a clot. The reagent chamber is enclosed on the top by the
“daisy” and on the bottom by a flexible plug.
Reaction Chamber
The reaction chamber is located above the reagent chamber. The test sample is
introduced into the reaction chamber. Upon test initiation the plunger assembly is
lifted and the bottom plug of the reagent chamber is pushed up. This action delivers
the contents of the reagent chamber into the reaction chamber and mixes the
reagents with the test sample.
10 English ACT Plus® Operator’s Manual
Plunger Assembly
The plunger assembly consists of the “daisy”, the plunger and the “flag”.
The “daisy” provides the upper seal for the reagent chamber and is the mechanical
sensing eleme
“daisy” moves up and down through the test sample/reagent mixture. Clot
formation impedes the movement of the “daisy” through the sample.
The “flag” is located at the top of the plunger. A photo-optical system senses motion
of the plunger tang through the reaction mixture. When a decrease in the plunger’s
fall rate is detected, the timer stops and the clotting time results are displayed.
nt for the formation of a clot. As the plunger rises and falls, the
ACT Plus® Operator’s Manual English 11
Section 2: Precautions
General Precautions
■
The ACT Plus® instrument is intended for in vitro diagnostic use only.
■
For use by healthcare professionals.
■
The ACT Plus® instrument is intended for use while positioned on a level
surface.
■
To obtain valid results, the ACT Plus® instrument’s operating parameters
must be set up appropriately.
■
The screen values shown in this manual are intended for illustration only; they
are not intended to match actual test results.
■
Cartridge channels must be filled to the proper level for testing. Refer to the
specific cartridge package insert for details.
■
Dropping, soaking, or otherwise misusing the ACT Plus® instrument may
prevent it from functioning properly.
No Unapproved Instrument Use
Do not use the ACT Plus® instrument in any manner not specified in the operator’s
manual or other applicable labeling. The ACT Plus
accordance with all the instructions and labeling provided by Medtronic. Any other
use may adversely affect the safe and effective use of the instrument.
Explosive Anesthetics
The instrument must not be used in the presence of explosive gases or
anesthetics.
®
instrument must be used in
Main Power Off and Disconnect Access
Do not locate the ACT Plus® instrument in a place that restricts quick and easy
access to the main-power switch or the power cord. The main-power switch (on/off)
at the rear of the instrument and the power cord must be accessible at all times,
because they are the means to turn off or disconnect the instrument from its power
source.
Electric Shock
Electric shock hazard exists; do not remove the instrument cover. Refer all
servicing to Medtronic Technical Service or other authorized service
representative.
12 English ACT Plus® Operator’s Manual
Proper Maintenance and Calibration
It is important that the ACT Plus® be maintained in good working order and
calibrated on a regular basis by a Medtronic-qualified service technician.
Otherwise, a reduction in the accuracy of a measuring function may occur.
No User-Serviceable Parts
There are no user-serviceable parts inside the ACT Plus® instrument case. Only a
Medtronic Service Representative or authorized representative should repair or
service the instrument.
Cleaning/Decontamination
Do not steam, autoclave, or immerse the ACT Plus® instrument. Refer to Section 9,
Maintenance, for cleaning instructions.
Biohazard
All blood samples, controls, blood filled cartridges, syringes, and needles should
be considered potentially hazardous and handled with universal precautions to
protect against blood-borne pathogens. Dispose of all blood samples and these
products in accordance with the guidelines established for the specific institution.
The user must wear protective gloves when handling potentially infectious
substances.
Use of Cartridges and Controls
Please refer to the specific cartridge and control package inserts for additional
detailed warnings and precautions regarding use. Treat all blood samples as
potentially infectious.
ACT Plus® Operator’s Manual English 13
Section 3: Instrument Components
Actuator Heat Block Assembly
The actuator heat block is the receptacle for test cartridges. The ACT Plus®
software maintains the actuator heat block temperature at 37.0°C ±0.5°C. The
actuator heat block rotates between the open and closed positions. Cartridges
can be inserted into and removed from the actuator heat block when it is in the
open position. To initiate a clotting test, the operator rotates the actuator heat block
to the closed position. At termination of a test, the actuator heat block will
automatically rotate to the open position, and the results will be displayed. A test
can be terminated manually and the actuator heat block rotated to the open
position by depressing the Stop key on the front panel.
14 English ACT Plus® Operator’s Manual
Section 4: Installation
Unpacking
1. The ACT Plus® instrument is shipped with the following items:
■
Operator's manual
■
Power cord
■
Temperature verification cartridge
■
Point of care quick start envelope
■
Quick reference guide
■
Actuator assembly cleaning kit
■
USB storage device
2. Check the box for damage, and report any damage to the carrier.
3. Remove the protective bag.
4. Set the ACT Plus® instrument on a level surface.
5. Check the ACT Plus® instrument for visible damage.
6. Retain all shipping materials.
Power ON: Initial Checkout Procedure
1. Connect the power cord to an AC power source with the same voltage rating
that is listed on the serial plate located on the bottom of the ACT Plus
instrument.
2. Rotate the actuator heat block to the closed position.
3.
[Optional] Attach the optional bar code scanner.
4. Turn the power switch, located on the rear panel, to the ON position. The
actuator heat block should rotate to the open position, followed by
illumination of all clotting time display segments, with the LCD indicating
“Self-Test Pass.” An audible tone indicating the end of the self-test should
accompany this sequence. The version of the ACT Plus
®
software will display
during this step.
5. From the Main Menu, select [Ca
rtridge Lot]. Scan the bar code label on the
cartridge package. The cartridge lot number and expiration date should be
entered in the appropriate cartridge-type fields.
Note: For manual data entry, refer to Section 6, Data Entry. For data entry
using the bar code scanner, refer to Appendix A or Appendix B.
Note: The lot number and expiration date must be entered before a cartridge
is u
ed; if no bar code scanner is used, see Section 6, Data Entry, for detailed
s
instructions.
6.
From the Main Menu, select [Cartridge Ty
pe]. Select the cartridge type
entered in Step 5, and press Enter.
7. Insert an empty cartridge into the actuator heat block.
®
ACT Plus® Operator’s Manual English 15
8. Rotate the actuator heat block to the closed position. The instrument should
begin a test.
9. Terminate the test by pressing the Sto
rotate to the open position.
10. Insert the temperature verification cartridge. After 10 minutes, check both the
erature indicator on the front panel and the temperature verification
temp
cartridge to confirm that both show a temperature of 37°C ±0.5°C. Adjust the
temperature, if necessary (see Section 9, Maintenance, “Temperature
Verification Cartridge”, for detailed instructions).
11. Insert a floppy disk or a USB storage device into the appropriate drive.
12. From the Main Menu, select [T
Unsent Patient Tests]. The results of the previous test should be sent to the
floppy disk or USB storage device.
13. If the instrument does not function properly, contact a Medtronic Service
Representative (see Section 10, Service and Troubleshooting).
r
p key. The actuator heat block should
ansmit Test Results], then [Transmit
Setup
Medtronic suggests taking the following steps prior to running tests with the ACT
®
Plus
instrument. Consult your Point of Care Coordinator for details.
1. Set Instrument Parameters (see page 26).
2. Set QC Manager parameters (see page 30):
a. Enter Instrument Location.
b. Enter User IDs.
c. Select QC Interval.
d. Set QC Lockout.
e. Enable Cartridge Type.
f. Set Permanent Record.
3. Enter Cartridge Lot Information (see page 23).
4. Enter Control Lot Information (see page 28).
5. Run Controls.
16 English ACT Plus® Operator’s Manual
Section 5: Instrument Controls
1
2
3
4
5
6
7
8
9
10
3
User Interface
Figure 2 identifies the User Interface components. A bar code scanner (not shown)
is optional.
Figure 2. User Interface
1. Clot Time Display
2. Data Entry Display
3. Variable Function Keypad
4. Quality Control Key
5. Cancel Key
6. Enter Key
7. Numeric Keypad
8. Clear Key
9. Stop Key
10. Main Menu Key
ACT Plus® Operator’s Manual English 17
1. The Clot Time Display is a red, seven-segment display of the clotting times
7
9
8
6
1
2
3
4
5
for Channels 1 and 2.
2. The Data
Entry Display, an LCD screen, displays clotting times. It also is
used to select a test, enter data, and navigate through the screens (see
Section 6, Data Entry, for detailed instructions).
3. The Variable Function Keypad is used to select the desired field in the
various screen options.
4. The Quality Control Key is used to access the Quality Control Menu.
5.
The Cancel Key is used to cancel any currently active function.
6. The Enter Key is used to accept entered numbers or data in an active field.
7. The Numeric Keypad is used to enter data into acceptable fields (ie, lot
numbers, user identification numbers [UIDs], and patient identification
numbers [PIDs]).
8. The Clear Key is used to clear the field.
9. The Stop Key is used to stop a test in progress.
10. The Main Menu Key is used to access the Main Menu.
Rear Panel
Figure 3 identifies the Rear Panel components.
Figure 3. Rear Panel Components
1. Handle
2. Fuse Holder
3. Main Power Switch
4. Power Inlet Module
(ON/OFF)
5. Equal Potential Terminal
18 English ACT Plus® Operator’s Manual
6. Serial Port (RS-232)
7. Serial Port (USB)
8. Bar Code Scanner Port
9. Floppy Drive
1. Handle.
2. The Fuse Holder is located
Maintenance, for fuse replacement.
3. The Main Power Switch is a rocker-type s
indicates OFF. It is located in the Power Inlet Module.
4. The Powe
instrument.
5. The Equal Potential Terminal
Plus
6. The Serial Port (RS-232) is a female DB-9 connector (see Section 11,
Specifications, for details).
7. The USB Port is u
8. The Bar Code Scanner Port is the connection for the optional bar code
scanner (see Section 11, Specifications, for details).
9. The Floppy Drive
information.
r Inlet Module is used to connect the power cord to the ACT Plus®
®
instrument to other instruments that may be used in a clinical setting.
sed to transfer and store patient and QC test information.
is used to transfer and store patient and QC test
in the Power Inlet Module. See Section 9,
witch: “|” indicates ON and “O”
is used to connect the ground of the ACT
Instrument Bottom
The Serial Number Label, which contains the serial number and safety agency
approvals, is located on the bottom of the ACT Plus
®
instrument.
Optional Bar Code Scanner
See Appendix A, Optional Bar Code Scanner LS1900, and Appendix B, Optional
Bar Code Scanner LS2208, for additional information.
ACT Plus® Operator’s Manual English 19
Section 6: Data Entry
MAIN MENU
View Test
Results
Transmit Test
Results
Instrument
Parameters
Enter ID
Cartridge Type
[HR-ACT]
Cartridge Lot
9710000772
Tem p : 3 7 . 1° C
PID:
Main Menu
The following variable function keys appear on the Main Menu: [Enter ID],
[Cartridge Type], [Cartridge Lot], [View Test Results], [Transmit Test Results],
and [Instrument Parameters].
The Main Menu can be accessed from any screen by pressing the [Main Menu]
n the left-hand side, below the display screen.
key o
Figure 4. Main Menu Screen
The [Enter ID] variable function key is used to enter patient (PID) and user (UID)
identification numbers. This information may be alphanumeric and is entered using
the numeric keypad.
The [Cartridge Type]
of cartridge for the test that is being performed (HR-ACT, LR-ACT, HTC, RACT,
GPC, or ACTtrac
and to the package insert for the specific cartridge.
The [Cartridge Lot]
and expiration date. Up to 2 lots of each cartridge type may be entered in the
database at a time.
The [View Test Results] va
last 20 tests performed including date, time, patient ID and test results.
variable function key is used to select the appropriate type
®
). For test method instructions, refer to Section 7 of this manual
variable function key is used to enter the cartridge lot number
riable function key is used to display the results of the
20 English ACT Plus® Operator’s Manual
The [Transmit Test Results] variable function key is used to transmit patient and
Quality Control (QC) results to an external location. Results may be exported to a
1.44 MB, 3.5-inch PC-formatted diskette using the floppy drive on the lower right
side of the instrument panel, a USB storage device using the USB port or results
may be exported via the serial port to a secure network interface (SNI) for
transmission to a Laboratory Information System (LIS) using vendor neutral
connectivity software. A message will display the number of test records
transmitted.
The [Instr
instrument settings: current date, current time, audio tone, language, screen
contrast adjustment, and output location.
ument Parameters] vari
able function key is used to enter the following
Enter Patient and User IDs
A Patient ID must be entered before a test can be run. The Patient ID can include
up to 12 alpha-numeric characters. Non alpha-numeric characters will be removed
when the Patient ID is scanned.
A User ID must be entered if the User Locko
User ID can include up to 15 alpha-numeric characters. Non alpha-numeric
characters will be removed when the User ID is scanned.
Note: Up to 600 user IDs can be entered.
Manual Entry
From the Main Menu:
1. Select [Enter ID]. The
Patient and User ID numbers.
To enter a Patient ID:
1. Select [Pat
2. Enter the Patient ID using the numerical keypad.
3. For an alpha character, press the decimal point “.” An alpha character will
appear in the Patient ID
4. To change the character, press the [A…Z] and [Z…
character is shown.
5. To accept the character select the decimal point
another alpha character or enter from the numeric keypad.
6. To continue entering numbers, select the
7. After entering the last alpha character or number in the Patient ID, press
[Enter] to confirm the ID.
8. The Patient ID will appear in the upper right-hand corner of the Enter ID
screen.
ent ID].
i
Enter ID screen will appear with options for entering
field.
ut option has been turned ON. The
A] keys until the desired
if you would like to enter
number using the numerical keypad.
ACT Plus® Operator’s Manual English 21
To enter a User ID:
1. Select [User ID].
2.
Enter the User ID using the numerical keypad.
3. For alpha entry, press the decimal point “.” An alpha character will appear in
the User ID field.
4. To select a character, press the [A…Z] and [Z…
character is shown.
5. Select the decimal point again if you would like to enter another alpha
character or enter from the numeric keypa
6. After entering the last alpha character or number of the User ID, press [Enter]
confirm the ID.
to
7. A message will appear, “Load Cartridge, Close Actuator.”
8. To return to the Main Menu, press [Main Menu]. A messag
top of the screen, “Verify Patient and User ID.”
A] keys until the desired
d.
e will appear at the
Bar Code Entry
From the Main Menu:
1. Select [Enter ID]. The
Patient and User ID numbers.
To enter a Patient ID:
1. Select [Pati
2. Scan the Patient ID from the patient band.
3. The Patient ID will appear in the upper right-hand corner of the Enter ID
screen.
To enter a User ID:
1. Select [User ID].
2
. Scan the User ID from the user's badge.
3. A message will appear, “Load Cartridge, Close Actuator.”
4. To return to the Main Menu, press [Main Menu]. A messag
top of the screen, “Verify Patient and User ID.”
ent ID].
Enter ID screen will appear with options for entering
e will appear at the
Select Cartridge Type
The cartridge type (including the electronic control) should be selected or verified
before each test.
From the Main Menu:
1. Select [Ca
2. To view the complete list of choices, [HR-ACT], [LR-ACT], [HTC], [RACT],
[GPC], and [ACTtrac
3. To confirm the selection, press [Enter].
22 English ACT Plus® Operator’s Manual
rtridge Type].
®
], continue to press [Cartridge Type].
Loading...