Operators Manual
78 Pages
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ACT Plus_fcv.fm 4/17/12 10:09 AM 5.5" x 7.75" (139.7 mm x 196.85 mm)
ACT Plus® Automated Coagulation Timer
Operator’s Manual
M950403A001
Rev 1A
Medtronic Confidential CS0010
ACT Plus_fcv.fm 4/17/12 10:09 AM 5.5" x 7.75" (139.7 mm x 196.85 mm)
M950403A001
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ACT_sym.fm 4/17/12 10:09 AM 5.5" x 7.75" (139.7 mm x 196.85 mm)
Medtronic Confidential CS0010
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, fire and mechanical 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 Catalog Number Authorized Representative in the European Community Fragile, Handle with Care This Way Up Main Menu Quality Control Menu Stop Date of Manufacture
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Biological Risks Nonionizing Electromagnetic Radiation Manufactured In Cancel Enter Clear Temperature Limitation Humidity Limitation Manufacturer Do not dispose of this product in the unsorted municipal waste stream. 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 Control Symbol. The number represents the years the device can be used before it must be recycled (environmental protection use period).
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Table of Contents Section 1: System Description
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Intended Use 9 Principle of Clot Detection 9 Data Storage
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Test Cartridge
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Reagent Chamber 10 Reaction Chamber 10 Plunger Assembly 11 Section 2: Precautions
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General Precautions
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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
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Use of Cartridges and Controls
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Section 3: Instrument Components 14 Actuator Heat Block Assembly Section 4: Installation
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Unpacking 15 Power ON: Initial Checkout Procedure 15 Setup
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Section 5: Instrument Controls 17 User Interface
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Rear Panel
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Instrument Bottom 19 Optional Bar Code Scanner 19 Section 6: Data Entry Main Menu
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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 and Expiration Date
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Manual Entry 23 Bar Code Entry 24 View Test Results for the Last 20 Tests Performed
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Transmit Patient and Quality Control (QC) Test Results
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Transmission Using Floppy Drive 25 Transmission Using USB Port 25 Set Instrument Parameters
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Quality Control (QC) Menu
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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
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Change the QC Manager Password: 33 Download User IDs: 33 Transfer User IDs from ACT Plus® Instrument to Multiple 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® electronic QC interval: 34 Enable or Disable Test Cartridge Types: 34 Download All of the Instrument Settings to a Floppy Disk or USB Storage 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 General
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Activated Clotting Times: High Range (HR-ACT), Low Range (LR-ACT), and Recalcified (RACT) Cartridges 37 Results 37 High Range Heparinase (HR-HTC) Section 8: Quality Assurance Instrument Self-Test
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Liquid QC 39 Electronic QC (ACTtrac®) Section 9: Maintenance
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Instrument Case Cleaning
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Actuator Assembly Cleaning 41 Actuator Heat Block Temperature 42 Temperature Verification Cartridge 42 Verification with Thermometer 43 Fuse Replacement 43 Preventive Maintenance 44
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Section 10: Service and Troubleshooting Service
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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
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Default Operating Parameters
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Electromagnetic Emissions and Immunity Declarations Appendix A: Optional Bar Code Scanner LS1900
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Introduction 57 Parts of the LS1900 Series Scanner Scanning in Hand-Held Mode
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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:
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Appendix B: Optional Bar Code Scanner LS2208
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Introduction 65 Parts of the LS2208 Scanner 65 Scanning in Hand-Held Mode
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Setting Bar Code Format Options 66
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Bar Code Scanner Installation Instructions 70 Appendix C: Warranties 71 EQUIPMENT LIMITED WARRANTY 71 EQUIPMENT LIMITED WARRANTY 72
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ACT_CH.fm 4/17/12 10:10 AM 5.5" x 7.75" (139.7 mm x 196.85 mm)
Medtronic Confidential CS0010
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® instrument is designed for use with the following 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® instrument. Fibrin formation is detected by measuring the rate of fall of 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.
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.
Test Cartridge Test cartridges for the ACT Plus® instrument consist of the reagent chamber, the reaction chamber, and the plunger assembly.
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4 5 6 7 Figure 1. Test Cartridge
1. 2. 3. 4. 5. 6. 7. 8. 9.
Flag Plunger Tang Reaction Chamber Daisy Reagent Chamber Bottom Plug Upper Fill Line 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.
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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 element for the formation of a clot. As the plunger rises and falls, the “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.
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Section 2: Precautions General Precautions ■
The ACT Plus® instrument is intended for in vitro diagnostic use only.
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For use by healthcare professionals.
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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.
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The screen values shown in this manual are intended for illustration only; they are not intended to match actual test results.
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Cartridge channels must be filled to the proper level for testing. Refer to the specific cartridge package insert for details.
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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® instrument must be used in 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.
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.
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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.
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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.
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Section 4: Installation Unpacking 1. The ACT Plus® instrument is shipped with the following items: ■ Operator's manual ■ Power cord ■ Temperature verification cartridge ■ Point of care quick start envelope ■ Quick reference guide ■ Actuator assembly cleaning kit ■ USB storage device 2. Check the box for damage, and report any damage to the carrier. 3. Remove the protective bag. 4. Set the ACT Plus® instrument on a level surface. 5. Check the ACT Plus® instrument for visible damage. 6. Retain all shipping materials.
Power ON: Initial Checkout Procedure 1. Connect the power cord to an AC power source with the same voltage rating that is listed on the serial plate located on the bottom of the ACT Plus® instrument. 2. Rotate the actuator heat block to the closed position. 3. [Optional] Attach the optional bar code scanner. 4. Turn the power switch, located on the rear panel, to the ON position. The actuator heat block should rotate to the open position, followed by illumination of all clotting time display segments, with the LCD indicating “Self-Test Pass.” An audible tone indicating the end of the self-test should accompany this sequence. The version of the ACT Plus® software will display during this step. 5. From the Main Menu, select [Cartridge 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 used; if no bar code scanner is used, see Section 6, Data Entry, for detailed instructions. 6. From the Main Menu, select [Cartridge Type]. 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
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8. Rotate the actuator heat block to the closed position. The instrument should begin a test. 9. Terminate the test by pressing the Stop key. The actuator heat block should rotate to the open position. 10. Insert the temperature verification cartridge. After 10 minutes, check both the temperature indicator on the front panel and the temperature verification 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 [Transmit Test Results], then [Transmit 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).
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.
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Section 5: Instrument Controls User Interface Figure 2 identifies the User Interface components. A bar code scanner (not shown) is optional. 1 2 3 3
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Figure 2. User Interface
1. 2. 3. 4. 5. 6. 7. 8. 9. 10.
Clot Time Display Data Entry Display Variable Function Keypad Quality Control Key Cancel Key Enter Key Numeric Keypad Clear Key Stop Key Main Menu Key
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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. 5. The Cancel Key is used to cancel any currently active function. 6. The Enter Key is used to accept entered numbers or data in an active field. 7. The Numeric Keypad is used to enter data into acceptable fields (ie, lot numbers, user identification numbers [UIDs], and patient identification numbers [PIDs]). 8. The Clear Key is used to clear the field. 9. The Stop Key is used to stop a test in progress. 10. The Main Menu Key is used to access the Main Menu.
Rear Panel Figure 3 identifies the Rear Panel components. 6 1
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Figure 3. Rear Panel Components
1. Handle 2. Fuse Holder 3. Main Power Switch (ON/OFF) 4. Power Inlet Module 5. Equal Potential Terminal ACT Plus® Operator’s Manual
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