Medtronic RACT100 Operator's Manual

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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

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).

rted municipal waste stream.

ontrol Symbol. The number represents the years the device can

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. 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.

[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

instructions.

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).

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

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

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.

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].

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].

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.

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

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].

. 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].

Enter ACTtrac® Serial Number

From the Main Menu:

1. Select [Cartridge Lot].

2. To navigate through the list, use the arrows on either side of the box.

When the ACTtrac appear: [Add Lot Number] and [Exit to Main Menu].

1. To enter the serial number, select [Add Lo

2. If the serial number has an “AT” at the beginning of it, press the “.” key and the “AT” will appear in the serial number field.

3. Enter the rest of the serial number using the numeric keypad.

4. To confirm the entry, press [Enter].

cartridge type is activated, the following variable function keys

t Number].

Enter Cartridge Lot Number and Expiration Date

Manual Entry

From the Main Menu:

1. Select [Ca

2. To navigate through the list, use the arrows on either side of the box.

When there are no lot numbers for a cartridge type, the following variable function keys appear: [Add Lot Numbe

1. To enter the lot number, select [Add Lot

Enter the cartridge lot number using the numeric keypad.

3. To confirm the entry, press [Enter].

4. To enter the expiration date for the selected lot number, select [Add Exp Date]. The date format is yy-mm-dd.

5. Enter the cartridge expiration date.

6. To confirm the entry, press [Enter].

When a cartridge type has a single lot number entered and a second lot is to be entered, the following variable function keys will appear: [Add Lot], [Remove Lot], [Edit Lot/Exp Date] and [Exit to Main Menu].

1. To enter the second lot number, select [Add Lot].

2. To enter the lot number, select [Add Lot Number].

3. Enter the cartridge lot number using the numeric keypad.

4. To confirm the entry, press [Enter].

5. To enter the expiration date for the selected lot number, select [Add Exp Date]. The date format is yy-mm-dd.

6. Enter the cartridge expiration date.

7. To confirm the entry, press [Enter].

rtridge Lot].

r], [Add Exp Date], and [Exit to Main Menu].

Number].

ACT Plus® Operator’s Manual English 23

When there are 2 lot numbers entered for a cartridge type, the following variable function keys will appear: [Toggl e Ac tive ], [Remove Lot], [Edit Lot/Exp Date] and [Exit to Main Menu].

To change the lot number of the currently active cartridge:

1. Select [Toggle Active].

2. Move the “*” to the cartridge lot number that is currently in use.

To remove a cartridge lot:

1. Select [Rem

2. To select the lot to be removed, use the up/down arrows (↑↓) to toggle to the appropriate lot number.

3. To delete the selected cartridge lot number, select [Remov

ove Lot].

e Selected Lot].

Bar Code Entry

From the Main Menu:

1. Select [Ca will appear.

When there is no or 1 lot number for a cartridge type:

1. Scan the bar code on the cartridge box. T will automatically populate their respective fields.

2. To return to the Main Menu, press [Main

When 2 lot numbers exist for a cartridge type:

1. Select [Remove Lot].

2. To remove 1 of the lot numbers, toggle to the appropriate lot number.

3. To delete the selected cartridge lot number, select [Remove Selected Lot].

4. Scan the bar code on the cartridge box. The lot number and expiration date will automatically populate their respective fields.

5. To return to the Main Menu, select [Main Menu].

rtridge Lot]. Page 1 of the Cartridge Lot/Expiration Date screen

he lot number and expiration date

Menu].

View Test Results for the Last 20 Tests Performed

1. To display the results for the last 20 tests, select [View Test Results].

2. Use the up/down arrows (↑↓) on the left and right of the screen to scroll through the test data.

3. The date, time, patient ID and test results will be displayed.

Note: If the ACT Plus® power is cycled, the ability to display previous results is lost; however, they are not erased from the result log.

24 English ACT Plus® Operator’s Manual

Transmit Patient and Quality Control (QC) Test Results

Patient and QC test results can be transmitted using the floppy drive, USB port, or serial port. The transmit destination is set from the Instrument Parameters Menu.

Transmission Using Floppy Drive

From the Main Menu:

1. Select [Transmit Test Results]. The following variable function keys will appear: [Transmit All Patient Tests], [Transmit Unsent Patient Tests], [Transmit By Patient ID], [Transmit All QC Tests], [Transmit Unsent QC Tests ], and [Exit to Main Menu].

2. Insert a 3.5-inch IBM formatted floppy disk.

3. To transmit all patient test results in the memory Tests ].

4. To transmit the patient test results that h selected output location, select [Transmit Unsent Patient Tests].

5. To transmit all results for a specific patient, select [Tr Then enter the Patient ID and press [Enter].

6. To transmit all QC test results (liquid and electronic), select [Tra Tests ]. All QC tests in the memory will be sent to the selected output location.

7. To transmit all QC test results that have not been previously sent to the selected

Note: When transmission is complete, the number of test records sent will be displayed.

8. To return to the Main Menu, press [Main

output location, select [Transmit Unsent QC Tests].

Transmission Using USB Port

2. Insert a USB storage device.

3. To transmit all patient test results in the memory Tests ].

4. To transmit the patient test results that h selected output location, select [Transmit Unsent Patient Tests].

5. To transmit all results for a specific patient, select [Tr Then enter the Patient ID and press [Enter].

6. To transmit all QC test results (liquid and electronic), select [Tra Tests ]. All QC tests in the memory will be sent to the selected output location.

7. To transmit all QC tests that have not been previously sent to the selected output location, select [T

ransmit Unsent QC Tests].

, select [Transmit All Patient

ave not previously been sent to the

ansmit By Patient ID].

nsmit All QC

Menu].

, select [Transmit All Patient

ave not previously been sent to the

ansmit By Patient ID].

nsmit All QC

ACT Plus® Operator’s Manual English 25

Note: When transmission is complete, the number of test records sent will be displayed.

Note: When transmission is complete, it is safe to remove the USB storage device.

8. To return to the Main Menu, press [Main Menu].

Set Instrument Parameters

Parameters for the ACT Plus® instrument are set at the time of installation. This must be completed prior to any other data entry.

1. Select [Instrume appear: [Date - yyyy-mm-dd], [Time – hh:mm], [Audio Tone], [Language], [Go to Page 2 of 2], and [Exit to Main Menu].

2. To set the current date, select [Date - yyyy-mm-dd]. The following ranges are acceptable for the year, month, and day entries: yyyy = year (accepted range, 1998 to 2097), mm = month (accepted range, 01 to 12), and dd = days (accepted range, 01 to 31).

3. To confirm the date entry, press [Enter].

Note:

The current date must be entered before cartridge and/or control lot

rs and expiration dates are entered.

numbe

4. To set the current time, select [Tim a 24-hour clock where hh = hours (accepted range, 00 to 23) and mm = minutes (accepted range, 00 to 59).

5. To confirm the time entry, press [Enter].

6. To set the audio tone to ON or OFF, select [Audio Tone].

7. To confirm the selection, press [Enter].

8. To select a language, select [Language]. The options are English, French (Français), Italian (Italiano), German (Deutsch), Spanish (Español), Swedish (Svenska), Greek (Ελληνικά), Danish (Dansk), or Norwegian (Norsk).

9. To view the choices, continue to press [La English.

10. To confirm the selection, press [Ente

The following variable function keys appear on p Parameters screens: [Screen Contrast Adjustment], [Output Location], [Back to Page 1 of 2], and [Exit to Main Menu].

1. To adjust the contrast on the Adjustment]. The (-) key will lighten the text, and the (+) key will darken the text.

2. To select the output mode for transferring patient and QC data, select [Output Location].

3. To view the choices, [Fl Location].

4. To confirm the selection, press [Ente

nt Parameters]. The following variable function keys

e – hh:mm]. The current time is based on

uage]. The default language is

r].

age 2 of the Instrument

LCD screen, select [Screen Contrast

oppy], [USB], or [Serial], continue to press [Output

r].

26 English ACT Plus® Operator’s Manual

5. To return to the Main Menu, press [Main Menu].

--->> QC <<---

Tem p : 3 7 . 1° C

QC Due Status

QC Manager Setup

Exit to

Main Menu

QUALITY CONTROL MENU

Control Type  [HR-NM]

Control Lot  46372985102

Temperature  Adjustment

Quality Control (QC) Menu

To access the Quality Control Menu select the [Quality Control] key on the right below the data entry screen. If User Lockout is turned ON, a valid User ID will be needed. Enter the valid User ID from the keypad or scan the user’s badge.

The following variable function keys appear on the Quality Control Menu: [Contro

Type], [Control Lot], [Temperature Adjustment], [QC Due Status], [QC Manager Set Up], and [Exit to Main Menu].

Note: All QC testing (liquid and electronic) must be performed from the Quality

Cont

rol Menu in order to log the controls in the QC files of the Data Manager.

Figure 5. Quality Control Menu Screen

General Quality Control (QC) Functions

The [Control Type] variable function key is used to select the type of control to be performed. The following control types are available and will be determined by the test cartridge being used:

■

The ACTtrac® electronic control has 3 settings: 98-102, 190-204, and 490-510.

■

High Range ACT (HR-ACT) cartridge: Normal (HR-NM) and Abnormal (HR-AB) controls.

■

Low Range ACT (LR-ACT) cartridge: Normal Citrated Whole Blood (CWB) and Abnormal (LR-AB) controls.

■

High Range Heparinase (HR-HTC) cartridge: Normal (HR-NM) and Heparinase (HTC) controls.

■

Recalcified ACT (RACT) cartridge: Normal Citrated Whole Blood (CWB) and Abnormal (RACT-AB) controls.

ACT Plus® Operator’s Manual English 27

The [Control Lot] variable function key is used to enter, remove, or edit the lot number, expiration date, and range of the selected control. Up to 2 lots of each control type may be entered into the database at a time.

The [Temperature Adjustment] varia heat block temperature (refer to Section 9, Maintenance, for additional information).

The [QC Due Status] electronic controls, including the date and time that the control tests must be performed.

variable function key displays the status of liquid and

ble function key is used to verify the actuator

Select the Control Type

The correct control type must be selected before the control test is initiated.

From the Quality Control Menu:

1. To select the type of control to be performed, select [Control Type].

2. To view the complete list of choices, continue to press [Control Type].

3. To confirm the selection, press [Enter]. This selection will display only the available control types for the test selected in the Main Menu.

Enter Control Lot Number, Expiration Date, and Range

Manual Entry

From the Quality Control Menu:

1. Select [Control Lot].

2. To select the desired control, highlight the control in the list.

When there are no lot numbers entered for a keys appear: [Add Lot Number], [Add Exp Date], [Set Range], and [Exit to Quality Control Menu].

1. To enter the lot number, select [Add Lot Number].

. Enter the lot number using the keypad.

3. To confirm the selection, press [Ente

4. To enter the expiration date for the selected lot number, select [Add Exp Date]. The date format is yy-mm-dd.

5. Enter the expiration date.

6. To confirm the entry, press [Enter].

7. To enter the range for the control, select [Set Ra the control range is “lll-hhh,” where “lll” is the low end and “hhh” is the high end of the control range.

Note: If the low range is less than 100, a zero must precede the 2-digit number

, eg, “099.”

8. Enter the range.

control, the following variable function

r].

nge]. The format for entering

28 English ACT Plus® Operator’s Manual

9. To confirm the entry, press [Enter].

10. To return to the “Add Lot Number” selection, select [Exit Add Selection].

When a control type has a single lot number entered and a second lot is to be entered, the follo [Remove Lot], [Edit Range] and [Exit to Quality Control Menu].

1. To add a second control lot for a cartridge type, select [Add Lot/EXP Date].

2. To enter the second lot number, see the instructions above (when there are no lot numbers).

When there are 2 lot numbers entered for a control type, the following variable

nction ke

Quality Control Menu].

To change the lot number of the active control:

1. Select [T currently being used.

To remove a control lot:

1. Select [R

2. To select the lot to be removed, use the up/down arrows (↑↓) to toggle to the appropriate lot number.

3. Select [Re

To edit the range of an existing control lot:

1. Select [Edit Range].

2. To select the lot of the control to be edited, use the arrows to change the high

3. Enter the range for the control.

To confirm the entry, press [Enter].

wing variable function keys appear: [Add Lot/EXP Date],

ys appear: [Toggle Active], [Remove Lot], [Edit Range], and [Exit to

oggle Active] to move the “*” to the control lot number that is

ve Lot].

emo

move Selected Lot] to delete the selected control lot number.

lighted lot.

Bar Code Entry

From the Quality Control Menu:

1. Select [Cont

When there is no or 1 lot number for a control type:

1. Scan the bar code on the control box. The lot number and expiration date will automatically popu

2. To enter the range for the control, select [Set Ra the control range is “lll-hhh,” where “lll” is the low end and “hhh” is the high end of the control range.

3. To confirm the entry, press [Enter].

4. To return to the Quality Control Menu, select [Exit to Qu

ACT Plus® Operator’s Manual English 29

rol Lot].

late their respective fields.

nge]. The format for entering

ity Control Menu].

When a control type has 2 lot numbers entered for a control type:

1. To remove one of the lot numbers for the control type, select [Remov

e Lot].

2. To delete the selected control lot number, toggle to the appropriate lot number

and select [Remove Selected Lot].

3. To enter the new lot number, scan the bar code on the control box. The lot number a

4. To enter the range for the control, select [Set Ra

nd expiration date will automatically populate their respective fields.

nge]. The format for entering

the control range is “lll-hhh,” where “lll” is the low end and “hhh” is the high end of the control range.

5. To confirm the entry, press [Enter].

6. To return to the Quality Control Menu, select [Exit to Quality Control Menu].

To verify/record the ACT Plus® actuator heat block temperature

For detailed instructions on verifying and recording the actuator heat block temperature, refer to Section 9, Maintenance.

To view the due status for quality control testing

From the Quality Control Menu:

1. Select [QC Due electronic controls for the cartridges that have been enabled with the following message options:

■

The date and time when the next control tests are due.

■

QC due, if the controls for a test are past due.

■

QC not performed, if controls have never been run for a cartridge type.

Status]. The ACT Plus® instrument will display all liquid and

QC Manager Functions

The QC Manager Setup Menu is accessed from the Quality Control Menu; it is a password-protected area. The default password is provided in a separate envelope. If this card is lost, contact Medtronic Technical Service for assistance (800-328-3320). Non-US customers, please contact a local/regional Medtronic sales office.

The following variable function keys appear in the QC [Location], [User ID Setup], [Clear ID Interval], [QC Lockout], [QC Interval Setup], [Cartridge Enable Setup], [Download Settings], [Perm Record], and [Instrument Upgrade].

Note: QC Manager parameters must be set before general QC information is entered and before any tests are performed.

30 English ACT Plus® Operator’s Manual

Manager Setup Menu:

The [Location] variable function key is used to select the location of the ACT Plus®

--->> QC Manager <<---

[

]

QC MANAGER SETUP

(Page 1 of 2)

QC MANAGER SETUP

(Page 2 of 2)

Cartridge  Enable Setup

Perm Record

[USB]

Instrument

Upgrade

Exit to Quality

Control Menu

Download  Settings

Go to  Page 1 of 2

Location  [CVOR]

User ID Setup

Clear ID Interval [20 minutes]

instrument. Location options include the following: CVOR (cardiovascular operating room), Cath Lab (Cardiac Catheterization Lab), ECMO (Extracorporeal Membrane Oxygenation), Dialysis, ICU/CCU (Intensive Care/Coronary Care Units), Lab, and Other.

The [User ID Setup] variable function key displays the screens for the following fu changing the QC Manager Password, downloading User IDs to a floppy disk or USB storage device, and uploading User IDs from a floppy disk or USB storage device to the ACT Plus

The [Clear ID In (none, 5 minutes, 10 minutes, 20 minutes, 60 minutes, or 120 minutes) that will elapse before the Patient and User IDs are cleared. Once cleared, the PID and UID will need to be reentered prior to testing.

The [QC Lockout] variable function key is used to set QC Lockout to 1 of the following options: OFF, Warning, or ON.

The [QC Interval Setup] variable function key is used to set the required interval for performing liquid and electronic QC tests. The options for liquid are the following: None, 8 hours, or 7 days. The options for ACTtrac are None or 8 hours.

The [Cartridge Enable Setup] varia the various cartridge types that may be run on the ACT Plus

The [Download Settings] va parameters and settings to a floppy disk or USB storage device.

The [Per the results that have been downloaded. The options are None, Floppy, USB, or Electronic.

The [Instrument Upgrade] variab ACT Plus

ACT Plus® Operator’s Manual English 31

Figure 6. QC Manager Setup Screen

nctions: adding and deleting User IDs, turning ON or OFF User Lockout,

user database.

terval] variable function key is used to select the time interval

ble function key is used to enable or disable

instrument.

riable function key is used to download all instrument

m Record] variab

software.

le function key designates the official mode of tracking

le function key is used to install upgrades to the

Select the location for the ACT Plus® instrument:

From the QC Manager Setup:

1. To change the desired location, select [Loca

2. Continue to press [Location] until the correct location is found.

3. To confirm the selection, press [Enter].

tion].

Add/delete User IDs:

Note: Up to 600 User IDs can be entered into the ACT Plus.

From the QC Manager Setup screen:

1. Select [User ID Setup].

From the User ID Setup screen:

1. Select [Add/Delete User IDs]. The following keys appear: [Add], [Delete], and [Exit to User ID Setup].

Add a User ID:

From the Add/Delete User IDs screen:

1. Select [Add].

2. Enter the User ID using the numeric keypad. Press the decimal point “.” on the keypad to activate alpha characters.

3. To select the desired character, use the [A…Z] and

4. To confirm the selection, press [Enter].

[Z…A] keys.

Delete a User ID:

From the Add/Delete User ID screen:

1. Select [Del

2. Use the arrows on either side of the displayed box to navigate up or down to select the desired User ID.

3. To remove the User ID from the list, select [Delete Selection].

. To return to the User ID Setup screen, select [Exit to User ID Setup].

ete].

Enable User Lockout:

From the User ID Setup screen:

1. Select [User L

2. To view the choices, [ON] or [OFF], continue to press [User Lockout].

3. To confirm the selection, press [Enter].

32 English ACT Plus® Operator’s Manual

ockout].

Change the QC Manager Password:

From the User ID Setup screen:

1. Select [QC Mgr Password].

Enter up to a 6-digit numeric password.

3. Enter the password a second time to verify.

4. To confirm, press [Enter].

5. Record the new password in a secure location.

Download User IDs:

From the User ID Setup screen:

1. Insert a formatted disk into the floppy drive or insert a USB storage device into the USB port.

Select [Down to the floppy drive or USB storage device.

Note: When transmission is complete, it is safe

load User IDs]. All of the User IDs entered will be downloaded

to remove the USB storage device.

Transfer User IDs from ACT Plus® Instrument to Multiple Instruments:

From the User ID Setup screen:

1. Insert either a formatted disk or a USB storage device containing downloaded User IDs into the appropriate drive.

2. Select [Uplo

Note: When transmission is complete, it is safe

User IDs also can be uploaded to the ACT Plus from the ACT Plus for specific instructions.

ad User IDs].

to remove the USB storage device.

External Data Manager (EDM). Refer to the EDM Instructions

instrument using a file generated

Select the Time Interval for Clearing Patient and User IDs:

From the QC Manager Setup screen:

1. Select [Cl

2. To view the choices, [None], [5 minutes], [10 minutes], [20 minutes], [60 minutes], and [12

3. To confirm the choice, press [Enter].

ear ID Interval].

0 minutes], continue to press [Clear ID Interval].

Select the QC Lockout Function:

From the QC Manager Setup screen:

1. Select [QC

2. To view the choices, [ON], [Warning], or [OFF], continue to press [QC Lockout].

3. To confirm the choice, press [Enter].

ACT Plus® Operator’s Manual English 33

Lockout].

Set the QC Interval for Liquid and Electronic Controls:

From the QC Manager Setup screen:

1. Select [QC Interval Setup]. T [Liquid Interval], [ACTtrac

he following variable function keys appear:

Interval] and [Exit to QC Manager Setup].

To set the liquid QC interval:

1. Select [Liquid Interval].

2. To view the choices, [None], [8 hours] or [7 days], continue to press [Liquid Interval].

3. To confirm the choice, press [Enter].

To set the ACTtrac® electronic QC interval:

1. Select [ACTtrac® Interval].

2. To view the choices, [None] or [8 hours], continue to press [ACTtrac® Interval].

3. To confirm the choice, press [Enter].

Enable or Disable Test Cartridge Types:

From page 2 of the QC Manager Setup screens:

1. Select [Ca

2. To select the desired cartridge, use the arrows on either side of the display of cartridges to navigate up or down.

3. Select the desired cartridge.

4. To view the choices, [ON] or [OFF],

5. To confirm the choice, press [Enter].

rtridge Enable Setup].

continue to press the desired cartridge.

Download All of the Instrument Settings to a Floppy Disk or USB Storage Device:

From page 2 of the QC Manager Setup screens:

1. Insert a formatted disk or USB Storage Device into the appropriate drive.

2. Select [Down

load Settings].

Set the Permanent Record or the Mode by Which the ACT Plus® Instrument Maintains a Record of Downloaded Data:

From page 2 of the QC Manager Setup screens:

1. Select [Perm Record].

To view the choices, [None], [Floppy], [USB] or [Electronic], continue to press [Perm Record].

34 English ACT Plus® Operator’s Manual

3. To confirm the choice, press [Enter].

Note: This does not affect the output location previously selected in

Instrument Parameters. This selection will warn only if test records will be overwritten.

Upload Software Upgrades from a Floppy Disk or USB Storage Device:

From page 2 of the QC Manager Setup screens:

1. Insert the floppy disk or USB Storage Device containing the Medt

ronic-released software upgrade for the ACT Plus

appropriate drive.

2. Select [Instrument Upgrad

e].

3. Enter the Upgrade Password sent with the software upgrade.

4. Select [Start Software Upgrade].

5. When the software upgrade is complete, power OFF then ON.

instrument into the

ACT Plus® Operator’s Manual English 35

Section 7: Test Methods

General

Notes:

■

Lot numbers and expiration dates for cartridges and controls must be entered prior to running a test (refer to Section 6, Data Entry for detailed instructions).

■

The User ID and Patient ID numbers must be entered prior to running a test (refer to Section 6, Data Entry for detailed instructions).

Power ON the ACT Plus actuator heat block to reach a temperature of 37.0°C ±0.5°C.

Note: When the heat block temperature is less than 36.0°C the software will not allo

patient test to be initiated. The message “Heat Block Lockout

w a

<36.0°C” is displayed.

2. From the Main Menu, select [Ca the correct cartridge is selected. Press [Enter] to confirm.

3. Prewarm the cartridges for at least 3 minutes before col sample. Cartridges for HR-ACT, LR-ACT, and RACT may be prewarmed for up to 12 hours without affecting performance. For specific information, consult the package insert that accompanies each cartridge.

4. Tap the cartridge to resuspend the reagent in the chamber before adding the test sample.

5. Fill each cartridge chamber with the appropriate sample volume. The sample leve

should be between the upper and lower fill lines in each reaction

l chamber. Allow the sample to flow down the back of the chamber, taking care to avoid getting the sample on the plunger tang (see Figure 1).

6. Insert the cartridge into the actuator heat block and rotate the block to the

closed

position.

7. Reagent is delivered into the reaction chamber, and the time to clot formation is measured

8. When clot formation is detected, or if the test i sounds, and the actuator heat block automatically rotates to the open position.

instrument. Allow at least 10 minutes for the

dge Type]. Continue to press this key until

rtri

lecting the test

s terminated, an audible tone

36 English ACT Plus® Operator’s Manual

Activated Clotting Times: High Range (HR-ACT), Low Range (LR-ACT), and Recalcified (RACT) Cartridges

Table 1 lists the Medtronic Activated Clotting Time Cartridges available for use with the Medtronic ACT Plus

Table 1. Medtronic Activated Clotting Time Cartridges

Product Sample Type Channel Sample

HR-ACT Fresh drawn 0.4 mL Cardiovascular or

LR-ACT Fresh drawn 0.2 mL Therapeutic (0-1.5

RACT Citrated 0.2 mL Therapeutic (0-1.5

instrument.

Vol ume

Intended Use

Cath Lab (1 U Heparin/mL or more)

s Hep

Unit

Units Hep

nit

arin/mL)

Table 2 displays the cartridge reagents (0.1 mL per channel) a

nd maximum

prewarm times for each cartridge type and cartridges with sample:

Table 2. Cartridge Reagents and Prewarm Limits

Cartridge Type Reagent Cartridge Max.

HR-ACT 12% Kaolin

LR-ACT 0.75% Kaolin

RACT 2.2% Kaolin

HEPES (hydroxyethyl-piperazine-ethanesulfonic acid) buffer.

Sodium azide is a bacteriostatic agent.

Kaolin concentration may vary slightly.

0.05M CaCl HEPES buffer Sodium azide

0.0025M CaCl HEPES buffer Sodium azide

M CaCl

0.05 HEPES buffer Sodium azide

Prewarm Limits

12 hours Nonapplicable

12 hours 5 minutes

Cartridge + Sample Prewarm Limits

m test

Perfor immediately.

Perfor

m test

immediately.

Results

Duplicate channel results should fall within 10% of each other for baseline (unheparinized) samples and within 12% of each other for extended or heparinized samples.

ACT Plus® Operator’s Manual English 37

Sample Calculation:

Channel 1 clotting time 210 seconds

Channel 2 clotting time 200 seconds

Mean clotting time 205 seconds

Difference 10 seconds

12% 25 seconds

The difference of 10 seconds is less than 12%,

which is 25 seconds. These results

are acceptable. The instrument’s operable range is 25 to 999 seconds.

High Range Heparinase (HR-HTC)

The HR-HTC cartridge is a modification of the High Range Activated Clotting Time Cartridge used to identify the presence of heparin in a fresh whole blood sample. One of the cartridge channels contains a purified heparinase, an enzyme specific for heparin, which can rapidly neutralize up to 6 U/mL of heparin in a test sample.

For detailed instructions on using the HR-HTC Cartridge, refer to the Activated Clotting Time Cartridges Instructions for Use.

38 English ACT Plus® Operator’s Manual

Section 8: Quality Assurance

Instrument Self-Test

The ACT Plus® instrument performs the following self-tests when powered ON:

1. The actuator assembly cycles and opens the a

it is closed.

2. An audio beep will sound, the Startup screen will appear, and the message, “Self-Te

3. The message, “Self-Test Pass,” is displa to the Main Menu.

Note: If any of the instrument’s self-tests software will display the message “Self-Test: FAIL XXX,” where XXX is a 3-digit number indicating a System Error Code. Record this code (if displayed), and notify the Medtronic Service Department or an authorized representative before continuing (refer to Section 10, Service and Troubleshooting).

4. The temperature will be displayed automatica

Note: Allow a minimum of 10 minutes of warm-up time for the actuator heat bloc actual warm-up time will depend on the instrument’s ambient temperature.

st in Progress” will be displayed.

k to reach the desired temperature before performing any tests. The

Liquid QC

Liquid controls are used to verify instrument and cartridge performance and operator technique. When only liquid controls are used the minimum QC requirements are 2 levels of control performed every 8 hours that the device is used for patient testing. CLOTtrac Low Range, Recalcified, and High Range Heparinase cartridges.

Coagulation Controls are available for High Range,

ctuator heat block assembly if

yed followed by automatic transition

fail or are not completed, the

lly.

Electronic QC (ACTtrac®)

The ACTtrac® Electronic Quality Control is an interactive, mechanical, software-controlled verification device that includes both quantitative and qualitative results. It interacts with the ACT Plus emulating certain functions of a test cartridge. The ACTtrac aspects of the ACT Plus flag sensor function, reagent delivery pin height, lift wire height, and 3-level tests (emulated clotting time ranges).

ACT Plus® Operator’s Manual English 39

instrument that relate to proper test cartridge function:

instrument by mechanically

checks the following

Notes:

■

The ACTtrac® may be used to supplement liquid quality control testing. Refer to the current regulatory agency guidelines on the acceptability and use of electronic controls.

■

Refer to the ACTtrac® Operator’s Manual for the specific instructions and additional information.

40 English ACT Plus® Operator’s Manual

Section 9: Maintenance

Instrument Case Cleaning

The instrument case and exposed surfaces of the actuator and dispenser should be kept clean. Clean the case routinely by wiping off dust and dried blood with a cloth dampened with water or 1 of the following chemicals: isopropyl alcohol, bleach, Liqui-Nox or mild detergent. The ACT cleaning kit can be areas in the dispenser. Cleaning kits can be obtained from Medtronic Customer Service or an authorized representative.

Actuator Assembly Cleaning

The actuator assembly should be cleaned at least once a month and more frequently if required. If blood should get into the actuator assembly (see Figure 7), it is critical that the instrument is cleaned as soon as possible.

®1

, hydrogen peroxide, Sani-Cloth®2, Clorox®3 Germicidal wipes,

used to clean difficult-to-reach

Figure 7. ACT Plus® Actuator Assembly

1. Detectors

2. Cover

3. Flag Lift Wire

4. Heat Block

Liqui-Nox® is a registered trademark of Alconox, Inc.

Sani-Cloth® is a registered trademark of Nice-Pak Products Inc.

Clorox® is a registered trademark of the Clorox Company.

ACT Plus® Operator’s Manual English 41

An instrument cleaning kit (Catalog number 303-58) is provided with each ACT

Plus

instrument. Use the materials in the kit to perform the following cleaning

procedure:

1. Dip the swab provided in the enclosed packet in the Liqui-Nox

solution.

2. Swab the flag lift wire, removing all blood.

3. Swab inside the actuator assembly cover, especially the detector and emitter areas of the photo-optical sensor.

4. Remove any excess Liqui-Nox

solution with a dry swab.

5. If blood should get into the detector of the lamp area and cannot be removed with a swab, Error Code “4” may be displayed.

Note: Cleaning kits can be obtained from Medtronic Customer Service or an authorized representative.

Actuator Heat Block Temperature

The actuator heat block temperature should be checked once a month to verify that it is 37°C ± 0.5°C. The ACT Plus into its temperature log.

Temperature Verification Cartridge

1. Turn the ACT Plus® instrument ON and allow the instrument to warm up for 15 minutes.

2. Place the Temperature Verification Cartridge (Catalog No. 313-11) into the actuator heat blo

3. Wait for temperature equilibration to occur (minimum 10 minutes) and check the T

emperature Verification Cartridge reading.

4. The instrument-displayed temperature Cartridge temperature should both be within 36.5°C to 37.5°C. The Temperature Verification Cartridge temperature should be within ± 0.5°C of th

e instrument-disp

From the Quality Control Menu:

5. To change the temperature, if n been verified, select [Temperature Adjustment].

6. Enter the temperature verification cartridge reading using the numeric keypad (values

must be between 35°C and 39°C).

7. To accept the entry, press [Ente temperature verification cartridge and the display will be recorded in the temperature log.

Note: If the temperature is still not wit adjustments can be repeated after a minimum of 10 minutes. To repeat adjustmen

ts, select [Repeat Adjustment].

ck.

layed temperature.

instrument records all temperature adjustments

and the Temperature Verification

eede

d, or to record that the temperature has

r]. The time, date, and temperatures of the

hin the specified range (see Step 5),

42 English ACT Plus® Operator’s Manual

8. If you are unable to calibrate the display to match the temperature on the Temperature Verification Cartridge, contact the Medtronic Service Representative or an authorized distributor.

Verification with Thermometer

1. Turn the ACT Plus® instrument ON and allow it to warm for 15 minutes.

2. Use a cartridge, with the plunger assembly removed and filled with 0.2 to

0.3 mL of water. Insert the cartridge into th

3. Place a calibrated thermometer in one of the cartridge reaction chambers.

4. Wait for temperature equilibration to occur (minimum 10 minutes) and check the thermometer reading.

5. The instrument-displayed temperature and thermometer-measured temperature shou thermometer-measured temperature should be within ± 0.5°C of the instrument-disp

From the Quality Control Menu:

6. To change the temperature, if needed, or been verified, select [Temperature Adjustment].

7. Enter the thermometer reading using the keypad (values must be between 35°C and 39°C).

To accept the value, press [Enter]. The ti thermometer and the display will be logged in the temperature log.

Note: If the temperature is sti adjustments can be repeated after a minimum of 10 minutes. To repeat adjustme

nts, select [Repeat Adjustment].

9. If you are unable to calibrate the display to match the thermometer-measured temperature, con distributor.

ld both read within 36.5°C to 37.5°C. The

ayed temperature.

ll not wit

tact the Medtronic Service Representative or an authorized

hin the specified range (see Step 5),

e actuator heat block.

record

that the temperature has

me, date, and temperatures of the

Fuse Replacement

Two fuses are located in the Power Inlet Module on the ACT Plus® instrument’s rear panel. To replace or examine the fuses:

1. Disconnect the power cord.

2. Open the cover of the fuse holders using a small flathead screwdriver.

3. Slide the fuse holders out and, if necessary, replace the fuses with T2A 250-V fuses.

4. Insert the fuse holders back into the Power Inlet Module.

5. Close the cover.

6. Power ON the instrument to power failure.

ACT Plus® Operator’s Manual English 43

determine

if replacing the fuse(s) corrected the

Note: If fuses blow repeatedly, contact a Medtronic Service Representative or an authorized representative.

Preventive Maintenance

Annual preventive maintenance is recommended for the ACT Plus® to ensure accurate performance and reliability. A qualified Medtronic Service Representative should perform all maintenance or service. The inspection and maintenance may be performed at your site or at Medtronic.

44 English ACT Plus® Operator’s Manual

Section 10: Service and Troubleshooting

Service

For all repair requests in the United States, contact Medtronic CardioVascular Service at 1-800-433-4311. Non-US customers, please contact a local/regional Medtronic sales office.

Service training for Medtronic products is available to qualified hospital personnel

request. Detailed information, such as circuit diagrams, component parts

upon lists, and calibration instructions, is available for qualified technical personnel.

Do not attempt to ser period, as any manufacturer’s warranty will be voided.

WARNING: Do not adjust, modify, repair, or touch

actions could injure the operator or cause faulty operation of the ACT Plus these actions may injure the operator or cause malfunction of the instrument.

Refer all repair requests to a Medtronic Instrument Service Representative. In the United States: Medtronic CardioVascular. Refer to the back cover for contact information.

Instrument Return

To return an ACT Plus® instrument for service, contact your Medtronic Service Representative. Original shipping materials should be used to return the ACT Plus® instrument; it should be enclosed within the foam inserts and placed in the box. The actuator heat block should be in the closed position when it is shipped. If the original box is no longer available, notify Medtronic Instrument Service or an authorized representative to obtain shipping materials.

vice the ACT Plus® instrument during the warranty

the internal circuitry. These

End of Life Disposition

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See instructions on proper disposal of this product.

http://recycling.medtronic.com for

Troubleshooting

The ACT Plus® instrument self-diagnoses many error and precautionary conditions, which are displayed on the LCD screen.

Message Types

The ACT Plus® instrument provides 3 types of messages to indicate its operating condition: Information/Status; Alerts; and System Alarms. These messages, with the exception of System Alarms, appear in the screen’s Status Message area.

ACT Plus® Operator’s Manual English 45

■

Information/Status: Screen message with no audio tone.

■

Alerts: Screen message with a 3-beep audio tone (audio is active when the [Audio Tone] parameter is set to ON).

■

System Alarms: Screen message with a single, long audio tone (audio is always active). System Alarms are presented when the ACT Plus

instrument’s self-testing mechanism detects a condition that may affect the ability of the instrument to function properly. These messages are displayed, if possible, and may be accompanied by a 3-digit Error Code, which service personnel use to identify the system error.

Message Priorities

Messages are displayed in a priority structure. If multiple error or precautionary conditions occur simultaneously, only the highest-priority message appears on the display.

System Messages Cause/Resolution

Both lot numbers are filled. OR Both cartridge lots full.

Bar code is not a cartridge type. The user is trying to scan a control lot on the

Bar code is not a control type. The user is trying to scan a cartridge lot on

Bar code is not

valid. The bar code information was not valid as a

Expired cartridge lot. OR Expired control lot.

Cartridge lot already exists. OR Control lot already exists.

Cartridge is not enabled. The cartridge selected is not enabled in the

Cartridge for control is not enabled. The user is trying to scan in a lot number for

Expiration date edited. QC due. The expiration date for the cartridge lot has

The user is trying to add a lot number when 2 already exist for the selected cart

ridge.

Remove 1 of the lot numbers.

dge setup screen.

cartr

the control setup screen.

dge or control. Rescan the bar code.

cartri Reprogram the bar code scanner.

The user is attempting to run a test with a

dge/control that is beyond the

cartr expiration date. Make sure that the expiration date on the packaging matches the date in the cartridge lot entry screen.

The user is trying to scan a lot number when that lot number

already exist

s for the

selected cartridge/control.

Man

ager Setup screen. Contact your QC

QC Manager to enable the selected cartridge.

a control whe

n the cartridge th

at uses that control is not enabled in the QC Manager Setup. Contact your QC Manager to enable the selected cartridge.

d; con

been change

trol tests must be repeated for this lot. Repeat the controls for this lot number.

46 English ACT Plus® Operator’s Manual

Expiration date is not valid. OR Invalid expiration date.

The expiration date is not in a valid format. The proper format for the expiration date for a cartridge or control lot is yy-mm-dd.

Test will overwrite saved test history. The current test will overwrite test results in

the per

manent r

ecord. Transmit all unsent

test records to the output source.

Invalid password. The password that was entered is not

Run ACTtrac

ct. Enter the correct p

from QC Menu. The user is attempting to run an ACTtrac®

corre

test from the Main Menu. Go to the QC Menu screen to run ACTtrac

tests.

assword.

No cartridge lot number active. The user is attempting to run a test without

an active cartrid

ge lot number. Enter the

cartridge lot number for this test type.

Cartridge not recognized. OR

All cartridges have been disabled. Have the QC Manager

enable the app

ropriate tests. There are no active cartridges to edit. OR There are no active cartridges.

No control lot number active. The user is attempting to run a control test

without an ac

tive control lot number. Enter a

valid lot number for the control.

There are no other active cartridges. Only the selected test is enabled. Have the

QC Manager

enable test

No test results available. No test results are available to view on the

ew Current Test Results screen.

Patient ID required. Patient ID is required to run a patient test.

Enter a Patient

ID in the Enter ID screen.

Preventive maintenance due. Preventive maintenance is due. Call

onic Instrument Service to schedule a

Medtr preventive maintenance check.

Value Out of Range. Enter 35 – 39. The Actuator Heat Block temperature cannot

be adjusted out of

the 35-to-

39 range. If the

Actuator Heat Block cannot be adjusted within the 35-to-39 range, call Medtronic Instrument Service.

There are no intervals set. The QC Manager has not set the intervals

liquid or electronic controls. Have the QC

for Manager set QC intervals in the QC Manager screen.

QC Due: HH:MM. The QC for this cartridge will run out at the

cribed time (hh = hour; mm = minute).

pre

QC not performed. The QC test for this cartridge has not been

performed or

has failed. Perform QC tests

for this cartridge.

ACT Plus® Operator’s Manual English 47

The passwords do not match. When changing the password for the QC

Manager, the Confirm Password screen did not match the Change Password screen. Reenter the same password in the Confirm Password screen that was entered in the Change Password screen.

QC past due. The QC for this cartridge has passed its

erform QC tests for this cartridge.

interval.

Test terminated before clot detect. The test stopped before clots were detected

in both channels. Repeat test.

No User ID

s to download. The QC Manager is trying to download User

IDs to the floppy disk or USB storage device,

User IDs are in the memory. Add User

but no IDs to the memory and download to the floppy drive or USB storage device.

No valid User IDs in file. The QC Manager is trying to upload User

the flo

IDs from device, but there are no User IDs in the file. Download User IDs from an ACT Plus instrument or an ACT Plus

ppy disk or USB storage

External Data

Manager (EDM) to the floppy disk or USB storage device, and use that floppy disk or USB storage device to upload them.

Test requires valid User ID. The QC Manager has set User Lockout to

ID is r

ON so that a User

equired to run a patient test. Enter a valid User ID in the Enter ID screen.

Alerts

Bar code scan timeout. A bar code input sequence was detected,

> 10% spread error. The channels of the controls tested are not

> 12% spread error. The channels of the controls tested are not

Error - File not found. The ACT Plus

t it did not complete corr

ectly. Rescan the

bar code.

thin 10%. Repeat the control test.

thin 12%. Repeat the control test.

instrument is trying to read a file on a floppy disk or USB storage device, but cannot find it.

48 English ACT Plus® Operator’s Manual

Error Messages

Disk error - Disk is faulty. The ACT Plus® instrument is trying to read a

Serial port error. An error occurred in accessing the serial

Motor stall. Power OFF then ON (E9). The motor has been inhibited. To reset the

System error. Power OFF then ON. The system has become unstable. To reset

Bad Reference in Ch1 and Ch2. OR Bad Reference in Ch1. OR Bad Reference in Ch2.

Error: E1 No cartridge is detected. Place a car

Error: E2 or E3 A software error has occurred. Call

No flags. OR No flag in Ch1. OR No flag in Ch2. OR No flags in Ch1 or Ch2. Insufficient data. The channels of the control timed out at 999.

Error: Invalid reply. Internal communication error. Call Medtronic

Light path failure in Ch1 and Ch2 (E4). OR Light path failure in Ch1 (E4). OR Light path failure in Ch2 (E4). Motor stall. The motor is inhibited. Press STOP to reset.

tor stall, cycle power (E8). The motor is inhibited. To reset, power OFF

No reply. Internal communication error. Call Medtronic

File system error. Call Medtronic Instrument Service. Comm. Error; Invalid data. Call Medtronic Instrument Service.

floppy disk or USB storage device and cannot read it. Insert a floppy disk or USB storage device that meets the specification listed in Section 11, Specifications.

port. Retry transfer

system, turn th

the system, tur

The ACT Plus baseline drop time for Channel 1, Channel and both channels. Repeat test.

the actuator assembly and retest.

ronic Instrument Service.

Med

The ACT Plus flag in Channel 1, Channel 2, or both channels. Repeat the test.

Repeat the

ument Ser

Instr The flag sensor has failed. Clean the

or assembly cover per the instructions

actua in the Maintenance section of this manual. If the error is not corrected, call Medtronic Instrument Service.

Repeat the

then ON.

ument Ser

Instr

e power OFF then ON.

n the power

instrument could not get a

instrument did not sense a

contr

ol.

vice.

test.

vice.

OFF then ON.

ridge in

ACT Plus® Operator’s Manual English 49

Notes: If a System Alarm occurs that cannot be resolved by cycling the power OFF then ON, record the 3-digit Error Code (if displayed), and contact Medtronic Instrument Service for assistance.

Tempera t u re

Heat Block Temp XX.X°C. The current actuator heat block temperature

Heat Block Temp > 44°C (E99). The actuator heat block temperature is

Heat Block Temp < 5°C (E00). The actuator heat block temperature is less

(XX.X°C) is displayed when it is between 20°C and 41°C.

than 44°C.

greate

than 5°

50 English ACT Plus® Operator’s Manual

Section 11: Specifications

Instrument

Number of Channels: Timing Range (Seconds): Actuator Heat Block Temperature:

Range: Resolution: Accuracy:

Electrical

Note: Technical data, features, and options referenced in this manual are based on

the latest information available at the time of printing. Medtronic reserves the right to change specifications without notice.

Classification (IEC 61010):

2 6 - 999

37.0°C ± 2°C

0.1°C ± 0.5°C

Class I, IPX0, Continuous operation

Power:

Voltage: Frequency: Maximum current: Fuse: Power cord: Length: Type:

Safety Standards:

EMC Standards:

Physical Dimensions:

Depth: Width: Height: Weight:

Environmental:

Operating temperature: Operating humidity: Storage temperature: Storage humidity: Instrument use: Altitude: Mains supply voltage fluctuation: Transient overvoltages: Pollution degree:

100 - 240 V~ Single phase 50 - 60 Hz

1.0 A (100 - 240) T2A 250 V 2 wires plus a ground (earth) connector

3.1 m (10 ft.) 3-prong hospital grade (USA only)

IEC 61010-1: 2001  CSA C22.2 NO. 61010-1

IEC 60601-1-2: 2007

33 cm (13.0 in) 20 cm (8.0 in) 27 cm (11.0 in)

5.22 kg (11.5 lb)

14°C to 32°C (57°F to 90°F) 10% to 90%, noncondensing 0°C to 49°C (32°F to 120°F) 5% to 90%, noncondensing Indoor ≤ 2000 meters Not to exceed ± 10% of nominal voltage Category II 2

ACT Plus® Operator’s Manual English 51

Data Ports:

Serial data port: USB port:

Bar code scanner port:

Floppy drive:

19200 baud, 8 data bits, 1 stop bit, no parity Used with Medtronic approved USB storage device,

M930703A001. Used with the optional Bar Code Scanner LS1900 or

LS 2208. PC compatible, 1.44 MB, 3.5-inch floppy disk.

Default Operating Parameters

The ACT Plus® instrument is shipped with the following default parameter settings:

Patient Parameters

Patient ID User ID Cartridge Lot Number Cartridge Exp Date Control Lot Number Control Exp Date

None None 1111111111 11/ 11/11 1111111111 11/ 11/11

Instrument Parameters

Date - yy-mm-dd Time - hh:mm Audio Tone Language Screen Contrast Adjustment Output Location

Preset by manufacturer Preset by manufacturer [ON] Preset by manufacturer Preset by manufacturer [Floppy]

Quality Control (QC) Manager Parameters

User Lockout Permanent Record QC Lockout Liquid Interval ACTtrac® Interval Cartridges Enabled Location Clear ID Interval

[OFF] [None] [OFF] [None] [None] All CVOR [None]

52 English ACT Plus® Operator’s Manual

Electromagnetic Emissions and Immunity Declarations

IEC 60601-1-2 Table 201,

Guidance and manufacturer's declaration - electromagnetic emissions

The ACT Plus® is intended for use in the electromagnetic environment specified below. The customer or the user of the ACT Plus environment.

Emissions test Compliance Electromagnetic environment - guidance

RF Emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Group 1 The ACT Plus

Class A The ACT Plus

Class A

Complies

should assure that it is used in such an

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

uses RF energy only for its internal

is suitable for use in all establishments

ACT Plus® Operator’s Manual English 53

IEC 60601-1-2 Table 202,

Guidance and manufacturer's declaration - electromagnetic immunity

The ACT Plus® is intended for use in the electromagnetic environment specified below. The customer or the user of the ACT Plus environment.

Immunity test IEC 60601

test level

Electrostatic discharge

±6 kV contact ±8 kV air

(ESD)

61000-4-2

IEC

Electrical fast

ansient/bur

tr IEC 61000-4-4

±2 kV for power

supply lines ±1 kV for input/output lines

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±2 kV line(s) to earth

Voltage dips, short

uptions

interr and volt

age variations on power supply input lines IEC

-4-1

61000

<5% U (>95% dip in UT) for

0.5 cycle 40% U (60% dip in UT) for 5 cycles 70% U (30% dip in UT) for

25 cycles <5% U (>95% dip in UT) for

5 seconds

Power

equency

fr (5

0/60 Hz)

3 A/m 3 A/m Power frequency magnetic

magnetic field IEC 61000-4-8

Note: U

is the a.c. mains voltage prior to application of the test level.

should assure that it is used in such an

Compliance level Electromagnetic

ment - guidance

environ

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If

e covered with

floors ar synthetic material, the relative humidity should be at least 30%.

r power

±2 kV fo supply lines ±1 kV for input/output lines

±1 kV differential mode ±2 kV common mode

Mains power quality should

that of a typical

be commercial o

r hospital environment. If the user of the ACT Plus requires continued operation during power mains interruptions, it is recommended that the ACT

be powered from an

Plus uninterruptible power supply or a battery.

<5% U

(>95% dip in UT) for

0.5 cycle 40% U

(60% dip in UT) for 5 cycles 70% U

(30% dip in UT) for 25 cycles <5% U

(>95% dip in UT) for 5 seconds

Mains power quality should be that of a typical commercial o

r hospital environment. If the user of the ACT Plus requires continued operation during power mains interruptions, it is recommended that the ACT

be powered from an

Plus uninterruptible power supply or a battery.

fields should be at levels

cteristic of a typical

chara location in a typical commercial or hospital environment.

54 English ACT Plus® Operator’s Manual

IEC 60601-1-2: 2001 Table 204

Guidance and manufacturer's declaration - electromagnetic immunity

The ACT Plus® is intended for use in the electromagnetic environment specified below. The customer or the user of the ACT Plus environment.

Immunity test IEC 60601

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

evel

test l

3 Vrms 150 kHz to 80

3 V/m 80 MHz to 2.5 GHz

should assure that it is used in such an

Compliance Level

rms d = 1.2

3 V

3 V/m d = 1.2

Electromagnetic environment guidance

Portable and mobile RF communications equipment should be used no closer

, including cables, than the

Plus recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

√P

√P 80 MHz to 800 MHz √P 800 MHz to 2.5 GHz

d = 2.3 where P is the maximum output power rating of the transmitter in watt according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF

smitters, as deter

tran electromagnetic site survey, less than the compliance level in each frequency r Interference may occur in the vicinity of equipment marked with the following symbol:

ange.

to any part of the ACT

s (W)

mined by an

should be

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is af

ed by absorption and reflection from structures, objects and people.

fect

ACT Plus® Operator’s Manual English 55

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ACT Plus exceeds the applicable RF compliance level above, the ACT Plus verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ACT Plus

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

should be observed to

is used

Recommended separation distances between portable and mobile RF

IEC 60601-1-2: 2001 Table 206

communications equipment and the ACT Plus®

The ACT Plus® is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ACT Plus electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ACT Plus below, according to the maximum output power of the communications equipment.

Rated

imum

max

output power

of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80

MHz

√P

d = 1.2

80 MHz to 800 MHz

√P

d = 1.2

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended

aration dist

sep

ance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation

ed by absorption and reflection from structures, objects and people.

fect

is af

Cautions:

• Do not use non-Medtronic components with Medtronic in-line-pow

The use of non-Medtronic components may result in damage to Medtronic components, increased emissions, or decreased electromagnetic immunity of the Medtronic devices or systems.

• Do not use Medtronic in-line-powered external devices a

djacent to, o other electronic devices. Using Medtronic devices in these configurations may result in decreased electromagnetic immunity of the Medtronic devices or systems.

can help prevent

as recommended

800 MHz to 2.5 GHz

d = 2.3√P

ered external devices.

r stacked with,

56 English ACT Plus® Operator’s Manual

Appendix A: Optional Bar Code Scanner LS1900

Introduction

The Symbol®1 LS1900 Series scanner is compatible with the ACT Plus® instrument. The scanner will read the following barcode formats:

■

Code 39

■

Code 39 With Check Digit (Mod 10)

■

Code 39 Full ASCII

■

Interleave 2 of 5

■

Interleave 2 of 5 with Check Digit (Mod 49)

■

Codabar

■

Code128

Parts of the LS1900 Series Scanner

Figure 8. Bar Code Scanner

1. Light Emitting Diode (LED)

2. Beeper

3. Trigger

4. Exit Window

Symbol® is a registered trademark of Symbol Technologies, Inc.

ACT Plus® Operator’s Manual English 57

Scanning in Hand-Held Mode

1. Connect the scanner cable to the ACT Plus® instrument. The scanner will beep when power is on.

2. Aim the scanner at the bar code and press the trigger.

3. Be sure that the red line from the scann

Figure 9. Correct scan location

When the scanner has successfully decoded the bar code, the scanner will beep, and the information will be entered into the ACT Plus

goes across the entire bar code.

instrument.

Setting Bar Code Format Options

The scanner is preset to read UIDs and PIDs in format Code 39 With Check Digit (Mod 10), Interleave 2 of 5 with Check Digit (Mod 49), Codabar and Code 128. It is also preset to read the cartridge/ control information.

To set additional barcode format options:

Code 39

Scan the “Enable Code 39 Check Digit” barcode if the UID/PID barcodes use Code 39 check digit to verify a correct scan.

Figure 10. Enable Code 39 Check Digit

Scan the “Disable Code 39 Check Digit” barcode if the UID/PID barcodes do not use Code 39 check digit to verify a correct scan. The default setting is Code 39 Disabled, so this b in the previous step.

Note: Disabling the Code 39 Check Digit will allow the scanner to scan a barcode that

has the check digit and add it to the data.

58 English ACT Plus® Operator’s Manual

arcode should only be used if Code 39 was mistakenly enabled

Figure 11. Disable Code 39 Check Digit

Scan the "Code 39 Full ASCII Conversion" bar code to allow for use of Code 39 full ASCII barcodes.

Figure 12. Enable Code 39 Full ASCII

Interleave 2 of 5

Scan the "Enable Interleave 2 of 5 Check Digit" barcode if the UID/PID barcodes use Interleave 2 of 5 check digit to verify a correct scan.

Figure 13. USS Check Digit

Scan the "Interleave 2 of 5 Any Length" bar code for use of Interleave 2 of 5 barcodes with any lengths.

Figure 14. 2 of 5 - Any Length

Scan the "Disable Interleave 2 of 5 Check Digit" barcode if the UID/PID barcodes do not use Interleave 2 of 5 check digit to verify a correct scan. The default setting is Interleave 2 of 5 Disabled so this barcode should only be used if Interleave 2 of 5 was mistakenly enabled in the previous step.

Note: Disabling the Interleave 2 of 5 Check Digit will allow the scanner to scan a barcode that has the check digit and add it to the data.

Figure 15. Disable

ACT Plus® Operator’s Manual English 59

Codabar

Scan the "Codabar" bar code to allow the use of Codabar for scanning User and Patient IDs.

Figure 16. Enable Codabar

Scan the "NOTIS Editing Enable" barcode if the UID/PID barcodes use Codabar barcode format. The NOTIS Editing Enable barcode will remove the Start/Stop characters imbedded in the Codabar barcodes.

Figure 17. Enable NOTIS Editing

Troubleshooting

Nothing happens when you follow the operating instructions.

The laser comes on, but the symbol does not decode.

The symbol is decoded, but not transmitted to the host.

Interface/power cables are loose. Check for loose cable connections.

The scanner is not programmed for the correct bar code type. Be sure is programmed to read the type of bar code you are scanning. The bar code symbol is unreadable. Check

e symbol to make su

th Try scanning test symbols of the same bar code type. The distance between the scanner and bar code is incorr to the bar code.

he scanner is not programmed for the correct bar code type. Be sure the scanner is programmed to read the type of bar code being scanned.

ect. Move

the scanner

re it is not defaced.

the scanner closer

Defaults

If the bar code scanner does not read the bar code on the ACT Plus® disposable packaging, reset the defaults before calling Medtronic Instrument Service. To reset the defaults, follow this procedure, and try to rescan the packaging.

60 English ACT Plus® Operator’s Manual

Procedure for setting the defaults:

1. To ensure that the scanner is reset, first scan the Set All Defaults bar code.

Figure 18. Set All Defaults bar code

2. Scan the “Low Volume” bar code, unless a different volume is desired.

Figure 19. Low Volume bar code

3. Scan the "Transmit Code ID" barcode to allow the barcode scanner to transmit the ID of Barcode format along with the data of the barcode that was just scanned.

Figure 20. Transmit Code ID

4. Scan the “Enable UCC/EAN-128” bar code. The cartridges and controls use this format.

Figure 21. Enable UCC/EAN-128 bar code

5. Scan the “Scan Prefix” bar code, then scan the following numbers: 1, 0, 0, 2.

Figure 22. Scan Prefix bar code

Figure 23. 1 bar code

ACT Plus® Operator’s Manual English 61

Figure 24. 0 bar code

Figure 25. 0 bar code

Figure 26. 2 bar code

6. Scan the “Scan Suffix” bar code, then scan the following numbers: 1, 0, 0, 3.

Figure 27. Scan Suffix bar code

Figure 28. 1 bar code

Figure 29. 0 bar code

Figure 30. 0 bar code

Figure 31. 3 bar code

62 English ACT Plus® Operator’s Manual

7. Scan the “Scan Options” bar code, then scan the "Prefix Data Suffix" bar code.

Figure 32. Scan Options bar code

Figure 33. Prefix Data Suffix bar code

8. Scan the “Enter” bar code. This completes the procedure. The bar code scanner will now work with the ACT Plus

Figure 34. Enter bar code

instrument.

ACT Plus® Operator’s Manual English 63

64 English ACT Plus® Operator’s Manual

Appendix B: Optional Bar Code Scanner LS2208

1. Light Emitting Diode (LED)

2. Beeper

3. Trigger

4. Exit Window

Introduction

The Symbol®1 LS2208 scanner is compatible with the ACT Plus® instrument. The scanner will read the following bar code formats:

■

Code 39

■

Code 39 with Check Digit (Mod 10)

■

Code 39 Full ASCII

■

Interleave 2 of 5

■

Interleave 2 of 5 with Check Digit (Mod 49)

■

Codabar

■

Code128

Parts of the LS2208 Scanner

Symbol® is a registered trademark of Symbol Technologies, Inc.

Figure 35.

ACT Plus® Operator’s Manual English 65

Scanning in Hand-Held Mode

1. Connect the scanner cable to the bar code scanner and the ACT Plus® instrument. The scanner will beep when power is on.

2. Aim the scanner at the bar code and press the trigger.

3. Be sure that the red line from the scann

Figure 36. Correct scan location

When the scanner has successfully decoded the bar code, the scanner will beep, and the information will be entered into the ACT Plus

goes across the entire bar code.

instrument.

Setting Bar Code Format Options

1. Scan the following bar codes in sequence. The scanner will beep when it successfully reads a setup bar code. If you make an error, start over.

2. Scan the "Reset Default Values" bar code (Figure 37).

Figure 37. Reset Default Values bar code

3. Scan the "IBM PC/AT & IBM PC compatibles" bar code (Figure 38) to set communication to a PC.

Figure 38. IBM PC/AT and IBM PC Compatibles bar code

4. Scan the "Low Volume" bar code (Figure 39) to set the volume mode to Low.

Figure 39. Low Volume bar code

5. Scan the "Interleave 2 of 5 to Any Length" bar code (Figure 40).

66 English ACT Plus® Operator’s Manual

Figure 40. 2 of 5 Any Length bar code

6. Scan the “Enable Codabar” bar code (Figure 41).

Figure 41. Enable Codabar bar code

7. Scan the "Enable NOTIS Editing" bar code to enable Notis editing for Codabar format (Figure 42).

Figure 42. Enable Notis Editing bar code

8. Scan the "Transmit code ID" bar code to enable the Transmit Code ID function (Figure 43).

Figure 43. Transmit Code ID bar code

9. To format UCC/EAN-128 for reading cartridges/controls, scan the "Scan Prefix" bar code, then scan the following numbers: 1, 0, 0, 2.

Figure 44. Scan Prefix bar code

Figure 45. 1 bar code

ACT Plus® Operator’s Manual English 67

Figure 46. 0 bar code

Figure 47. 0 bar code

Figure 48. 2 bar code

10. To format UCC/EAN-128 for reading cartridges/controls, scan the "Scan Suffix" bar code, then scan the following numbers: 1, 0, 0, 3.

Figure 49. Scan Suffix bar code

Figure 50. 1 bar code

Figure 51. 0 bar code

Figure 52. 0 bar code

68 English ACT Plus® Operator’s Manual

Figure 53. 3 bar code

11. To format UCC/EAN-128 for reading cartridges/controls, scan the "Scan Options" and "Prefix Data Suffix" bar codes.

Figure 54. Scan Options bar code

Figure 55. Prefix Data Suffix bar code

12. Scan the "Enter" bar code to accept the entered values.

Figure 56. Enter bar code

ACT Plus® Operator’s Manual English 69

Bar Code Scanner Installation Instructions

1. Remove the 2 Phillips screws using a #2 screwdriver.

2. Install the bracket as shown in Figure 57 and secure with the 2 screws removed in Step 1.

Figure 57.

3. Plug the interface modular connector into the cable interface port on the bottom of the scanner handle.

4. Connect the other end of the cable to Plus (Figure 58).

connector on the back of the ACT

the

Figure 58.

70 English ACT Plus® Operator’s Manual

Appendix C: Warranties

EQUIPMENT LIMITED WARRANTY

The following LIMITED WARRANTY Applies to U

nited States Customers

Only:

A. This LIMITED WARRANTY provides the follo

wing assurance to the purchaser of the Medtronic® Automated Coagulation Timer Plus®, hereafter referred to as the “Equipment”:

(1) Should the Equipment fail to function within normal tolerances due to a

n materials or workmanship within a period of one (1) year,

defect i commencing with the delivery of the Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any part or parts of the Equipment; (b) issue a credit to the purchaser equal to the Purchase Price, as defined in Subsection A(2), against the purchase of the replacement Equipment; or (c) provide a functionally comparable replacement Equipment at no charge.

(2) As used herein, Purchase Price shall mean the lesser of the net invoiced

price of th

original, or current functionally comparable, or replacement

Equipment.

B. To qualify for the repair, replacement or credit set forth in Section A, the

follo

wing conditions must be met:

(1) The Equipment must be returned to Medtronic within thirty (30) days after

discovery of th

e defect (Medtronic may, at its option, repair the Equipment

on the Customer’s site).

(2) The Equipment must not have been repaired or altered either (i) outside

of Med

tronic's factory or (ii) by any person not authorized by Medtronic to repair the Equipment in any way which, in the judgment of Medtronic, affects its stability and reliability. The Equipment must not have been subjected to misuse, abuse or accident.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) Except as expressly provided by this LIMITED WARRANTY,

MED

RONIC IS NOT RESPONSIBLE FOR ANY INDIRECT,

T INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE OR MALFUNCTION OF THE Equipment, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE.

(2) This LIMITED WARRANTY is made o

ly to the purchaser of the Equipment. EXCEPT AS SET FORTH IN THIS LIMITED WARRANTY, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR

This LIMITED WARRANTY is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN

55432. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the LIMITED WARRANTY.

ACT Plus® Operator’s Manual English 71

OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO THE CUSTOMER.

(3) The exclusions and limitations set out above are not intended to, and

shou

ld not be construed

so as to, contravene mandatory provisions of applicable law. If any part or term of this LIMITED WARRANTY is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. This LIMITED WARRANTY gives the purchaser specific legal rights. The purchaser may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation,

cond

iti

on or warranty with respect to the Equipment other than as set forth

in this LIMITED WARRANTY.

EQUIPMENT LIMITED WARRANTY

(FOR REPAIRABLE EXTERNAL EQUIPMENT/OUTSIDE THE U.S.)

e following Limited Warranty Applies to Customers Outside the United

ates:

A. This LIMITED WARRANTY provides the fo

wing assurance to the

llo purchaser of the Medtronic® Automated Coagulation Timer Plus®, hereafter referred to as the “Equipment,” that should the Equipment fail to function within normal tolerances due to a defect in materials or workmanship within a period of one (1) year, commencing with the delivery of the Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any defective part or parts of the Equipment; (b) issue a credit equal to the original Equipment purchase price (but not to exceed the value of the replacement Equipment), against the purchase of replacement Equipment; or (c) provide functionally comparable replacement Equipment at no charge.

B. To qualify for this repair, replacement or credit, the

following conditions must

be met: (1) The Equipment must be returned to Medtronic within sixty (60) days after

discovery of th

e defect (Medtronic may, at its option, repair the Equipment

on site).

(2) The Equipment must not have been repa

ired or altered by someone other than Medtronic in any way which, in the judgment of Medtronic, affects its stability and reliability.

(3) The Equipment must not have been subjected to misuse, abuse or

accide

nt.

This LIMITED WARRANTY is provided by Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN

55432. Areas outside the United States should contact their local Medtronic representative for exact terms of the LIMITED WARRANTY.

72 English ACT Plus® Operator’s Manual

C. This LIMITED WARRANTY is limited to its express terms. In particular,

Medtronic is not responsible for any incidental or consequential damages based on any use, defect or failure of the Equipment, whether the claim is based on warranty, contract, tort or otherwise.

D. The exclusions and limitations set out above are not intended to, and should

not be construed so as to, If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable or in conflict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

contravene mandatory provisions of applicable law.

ACT Plus® Operator’s Manual English 73

74 English ACT Plus® Operator’s Manual

Europe

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland Internet: www.medtronic.co.uk Tel. 41-21-802-7000 Fax 41-21-802-7900

Authorized Representative in the European Community

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-45-566-8000 Fax 31-45-566-8668

Asia-Pacific

Japan

Medtronic Japan Comodio Shiodome 5F 2-14-1 Higashi-Shimbashi, Minato-ku Tokyo 105-0021 Japan Tel. 81-3-6430-2011 Fax 81-3-6430-7140

Australia

Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde NSW 2113 Australia Tel. 61-2-9857-9000 Fax 61-2-9878-5100

Asia

Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313

Americas

Latin America

Medtronic Latin America 3750 NW 87th Avenue Suite 700 Miami, FL 33178 USA Tel. 305-500-9328 Fax 786-709-4244

Canada

Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada Tel. 905-460-3800 Fax 905-826-6620 Toll-free: 1-800-268-5346

United States

Manufacturer:

Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA Internet: www.medtronic.com Tel. 763-514-4000 Fax 763-391-9100 Toll-free: 1-800-328-2518 (24-hour consultation service)

Medtronic Perfusion Systems or Manufacturing Facility:

7611 Northland Drive Minneapolis, MN 55428 Tel. 763-391-9000 Fax 763-391-9100 Customer Service and Product Orders Toll-free: 1-800-854-3570 Visit Medtronic at www.perfusionsystems.com

*m950403A001*

Medtronic RACT100 Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Section 1: System Description

Intended Use

Principle of Clot Detection

Data Storage

Test Cartridge

Reagent Chamber

Reaction Chamber

Plunger Assembly

Section 2: Precautions

General Precautions

No Unapproved Instrument Use

Explosive Anesthetics

Main Power Off and Disconnect Access

Electric Shock

Proper Maintenance and Calibration

No User-Serviceable Parts

Cleaning/Decontamination

Biohazard

Use of Cartridges and Controls

Section 3: Instrument Components

Actuator Heat Block Assembly

Section 4: Installation

Unpacking

Power ON: Initial Checkout Procedure

Setup

Section 5: Instrument Controls

User Interface

Rear Panel

Instrument Bottom

Optional Bar Code Scanner

Section 6: Data Entry

MAIN MENU

Enter Patient and User IDs

Manual Entry

Bar Code Entry

Select Cartridge Type

Enter ACTtrac® Serial Number

Enter Cartridge Lot Number and Expiration Date

Manual Entry

Bar Code Entry

View Test Results for the Last 20 Tests Performed

Transmit Patient and Quality Control (QC) Test Results

Transmission Using Floppy Drive

Transmission Using USB Port

Set Instrument Parameters

Quality Control (QC) Menu

General Quality Control (QC) Functions

Select the Control Type

Enter Control Lot Number, Expiration Date, and Range

Manual Entry

Bar Code Entry

To verify/record the ACT Plus® actuator heat block temperature

To view the due status for quality control testing

QC Manager Functions

Select the location for the ACT Plus® instrument:

Add/delete User IDs:

Add a User ID:

Delete a User ID:

Enable User Lockout:

Change the QC Manager Password:

Download User IDs:

Transfer User IDs from ACT Plus® Instrument to Multiple Instruments:

Select the Time Interval for Clearing Patient and User IDs:

Select the QC Lockout Function:

Set the QC Interval for Liquid and Electronic Controls:

To set the liquid QC interval:

To set the ACTtrac® electronic QC interval:

Enable or Disable Test Cartridge Types:

Download All of the Instrument Settings to a Floppy Disk or USB Storage Device:

Set the Permanent Record or the Mode by Which the ACT Plus® Instrument Maintains a Record of Downloaded Data:

Upload Software Upgrades from a Floppy Disk or USB Storage Device:

Section 7: Test Methods

General

Activated Clotting Times: High Range (HR-ACT), Low Range (LR-ACT), and Recalcified (RACT) Cartridges

Results

High Range Heparinase (HR-HTC)