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Helena Laboratories Actalyke XL Operator's Manual

Activated clotting time test system
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Actalyke
XL
Activated Clotting Time Test System
Operator's Manual
Catalog Number 5770, 110-220 VAC, 50-60 Hz

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Summary of Contents for Helena Laboratories Actalyke XL

  • Page 1 ® Actalyke Activated Clotting Time Test System Operator’s Manual Catalog Number 5770, 110-220 VAC, 50-60 Hz...
  • Page 2 THREE AND FOUR. Actalyke XL Program License Agreement This copy of the Actalyke XL program is sold on the condition that the purchaser agrees to the terms of this license agreement. 1. THE COMPUTER PROGRAM AND THE ENCLOSED INSTRUCTIONAL MATERIALS ARE SOLD “AS IS”, WITHOUT ANY WARRANTY OF ANY KIND, EXPRESSED OR IMPLIED,...

  • Page 3: Table Of Contents

    ACTALYKE XL Table of Contents List of Sections Section 1 - Instrument Use and Function ................1-1 Section 2 - Principles of Operation ..................2-1 Section 3 - Precautions and Limitations ................3-1 Section 4 - Hazards ....................... 4-1 Section 5 - Installation Instruction ..................5-1 5.1.
  • Page 4 ACTALYKE XL Table of Contents 6.3. Paper Feed ......................... 6-16 6.4. Archive ........................6-16 6.4.1. Save Parameters ....................6-16 6.4.2. Restore Parameters ..................... 6-16 6.4.3. Print Setup Parameters ..................6-16 6.4.4. Save Operator IDs ....................6-20 6.4.5. Restore Operator IDs ................... 6-20 6.4.6.
  • Page 5 Figure 5-1. Actalyke XL, Front View..................5-3 Figure 5-3. Actalyke XL, Top View ..................5-4 Figure 5-4. Actalyke XL, Top View with Paper ..............5-4 Figure 5-5. Actalyke XL, Left Side ..................5-5 Figure 5-6. Actalyke XL, Left Side ..................5-5 Figure 5-7.
  • Page 6 ACTALYKE XL Table of Contents Figure 6-11. Set Backlight Screen..................6-23 Figure 6-12. Setup Printer Screen ..................6-23 Figure 6-13. Printer Contrast Adjustment Screen ............6-24 Figure 6-14. Setup Export Parameters Screen ..............6-24 Figure 6-15. Set Spreadsheet Parameters Screen ............6-24 Figure 6-16.
  • Page 7 ACTALYKE XL Table of Contents Figure 7-5. Select Patient Height Screen ................7-12 Figure 7-6. Select Patient Weight Screen ................. 7-12 Figure 7-7. Heparin Dosage Documentation Screen* ............7-12 Figure 7-8. Results ACT Chart Screen ................7-12 Figure 7-9. Results ACT Chart Printout ................7-13 Figure 8-1.

  • Page 8: Section 1 - Instrument Use And Function

    System (Figure 1-1) is used to perform the precision. Activated Clotting Time (ACT) test, a whole The ACTALYKE XL System is a dual-detector blood coagulation assay used at the patient analyzer with a printer. The instrument is site to monitor heparin therapy.
  • Page 9 ACTALYKE XL ONE - Instrument Use and Function Figure 1-1. ACTALYKE XL...

  • Page 10: Section 2 - Principles Of Operation

    ACTALYKE XL TWO - Principles of Operation Section 2 - Principles of Operation Note: The floppy disk from the Actalyke XL has been removed. Any functions associated with it are no longer available. Operation is controlled by a microprocessor, its program and memory, and a touch screen...

  • Page 11: Figure 2-1. Block Diagram

    ACTALYKE XL TWO - Principles of Operation External Devices Barcode Keyboard Wand Floppy Drive Computer LCD Display Touch Screen Motor Temperature Printer Sensors 0° Hall Sensors Alarm Controller 90° Hall Sensors Heater Driver Test Tube Heaters Barcode Readers PCB Power Supply...

  • Page 12: Section 3 - Precautions And Limitations

    Section 3 - Precautions and Limitations Thermometer, or an item this manual indicates as appropriate. Note: The floppy disk from the Actalyke XL has been removed. Any functions associated 3.12. If resistance is encountered when with it are no longer available.
  • Page 13 ACTALYKE XL THREE - Precautions and Limitations operating technique excessive on minimizing biohazard risk, see to section temperature variations will also affect the test 3.15. results. 3.24. Storage and transport environmental 3.18. The ACT test results may be affected by...

  • Page 14: Section 4 - Hazards

    4.12. WARNING: External equipment (barcode reader, keyboard, computer) that is Note: The floppy disk from the Actalyke XL connected to the instrument must have no live has been removed. Any functions associated parts that are accessible. with it are no longer available.

  • Page 15: Section 5 - Installation Instruction

    Actalyke XL Battery Pack installation or device operation. C-ACT Celite Tube K-ACT Kaolin Tubes Note: The floppy disk from the Actalyke XL G-ACT Glass Bead Tubes has been removed. Any functions associated MAX-ACT MAX-ACT Tubes with it are no longer available.

  • Page 16: Verification Of Functionality

    220V AC in the instrument turned complete US. Fire protection is not assured if this is not applicable section of the Actalyke XL followed. Installation Report as the following steps are 4. To connect the instrument and the performed: optional barcode reader or an external 1.

  • Page 17: Figure 5-1. Actalyke Xl, Front View

    ACTALYKE XL FIVE - Installation Instructions Display Test Wells Figure 5-1. Actalyke XL, Front View Fuses Power Cord Clip IEC / Power Cord Connection Figure 5-2. Actalyke XL, Back View...

  • Page 18: Figure 5-3. Actalyke Xl, Top View

    ACTALYKE XL FIVE - Installation Instructions Serrated Plate Adjustment Screws Adjustment Screws Figure 5-3. Actalyke XL, Top View Paper Out Paper Retainer Paper In Figure 5-4. Actalyke XL, Top View with Paper...

  • Page 19: Figure 5-5. Actalyke Xl, Left Side

    ACTALYKE XL FIVE - Installation Instructions The instrument’s left side will resemble either Figure 5-5 or 5-6 External Computer (LIS) Serial Connection Figure 5-5. Actalyke XL, Left Side Keyboard or Barcode Reader Connection USB Ports External Computer (LIS) Serial Connection...

  • Page 20: Figure 5-7. Actalyke Xl, Right Side

    ACTALYKE XL FIVE - Installation Instructions Figure 5-7. Actalyke XL, Right Side...

  • Page 21: Section 6 - Setup

    Section 6 - Setup Enter an appropriate Supervisor Full Rights or Setup Access Operator ID and Note: The floppy disk from the Actalyke XL Password per the instructions in step 3.b. has been removed. Any functions associated with it are no longer available.

  • Page 22: Time And Date

    ACTALYKE XL SIX - Setup 6.1.2. Time and Date 1. Select Setup (Figure 6-2). The instrument allows for the desired date 2. Select Interface Parameters (Figure 6-3). format to be selected and the current date and 3. Select Time & Date (Figure 6-4).

  • Page 23: Sound

    ACTALYKE XL SIX - Setup format to change the entered time to its 24 6. To save selections, return to the Run Test hour equivalent. screen (Figure 6-2) by selecting OK until the Run Test screen appears. 7. Use the keypad, the < key (to move the cursor to the left), and the >...

  • Page 24: Contrast

    ACTALYKE XL SIX - Setup b. Operator ID - the operator ID of the c. Note that higher contrast settings may operator who ran the test and/or the cause problems with printouts requiring the operator currently in use. contrast setting be lowered.

  • Page 25: Export

    ACTALYKE XL SIX - Setup 7. Select OK to return to the Setup Printer 1. Select Setup (Figure 6-2). screen (Figure 6-12). 2. Select Interface Parameters (Figure 6-3). 8. Select one of the following: 3. Select Export (Figure 6-4). a. To enter a header or footer, return to 4.

  • Page 26: Spreadsheet Parameters

    ACTALYKE XL SIX - Setup serial number; the date and/or time the data b. For QC tests, with all available data is saved; and the operator's ID. saved, the labels are: Test, Level, Well No., Run Date, Run Time, Clotting Time (sec), 6.1.7.1.

  • Page 27: Operator Id Entry

    ACTALYKE XL SIX - Setup 6.1.8.2. Operator ID Entry then from the Setup screen, select General Parameters. The instrument can be setup to require an operator ID be entered after a selected time 6.2.1. Operator ID/Passwords interval of remaining idle. When setup to do 1.

  • Page 28: Enter/Edit Operator Id/ Passwords

    ACTALYKE XL SIX - Setup level will have access to all of instrument b. To remove any operator IDs, see setup. section 6.2.1.2 step 4. 6.2.1.1. Enter/Edit Operator ID/ c. To archive the current operator IDs to Passwords a floppy disk, see section 6.2.1.3 step 4.

  • Page 29: Archive And Retrieve Operator Ids

    ACTALYKE XL SIX - Setup e. To save selections, return to the Run 7. The screen returns to Enter Operator ID Test screen (Figure 6-2) by selecting OK List (Figure 6-20). If IDs were restored, turn until the Run Test screen appears.

  • Page 30: Patient

    ACTALYKE XL SIX - Setup c. To archive the current operator IDs to entered before running a test, once the test is a floppy disk, see section 6.1.2.3 step 4. started, the instrument prompts the user that patient information must be entered. If the d.

  • Page 31: Test

    ACTALYKE XL SIX - Setup Always or Immediate to use any of the e. If the operator ID is set to printout demographics. (Note that if Patient IDs are (section 6.1.5), then if the results chart is currently attributed to the test wells and then...

  • Page 32: Qc (Bio)

    ACTALYKE XL SIX - Setup ACT test and will print, save and transmit the instrument’s touch screen to key in the with all patient data generated. information, see section 6.2.4.3. a. Select Yes to enter, or change, the 6.2.4.1. QC(bio) Levels Which Must limits.

  • Page 33: C-Act, K-Act, G-Act, And Max-Act

    ACTALYKE XL SIX - Setup To select the desired time interval between beginning from the Run Test screen (Figure biological QC tests, use the following steps 6-2): beginning from the Run Test screen (Figure 1. Select Setup (Figure 6-2). 6-2): 2.

  • Page 34: Ect

    ACTALYKE XL SIX - Setup entered limits. To enter or edit limits for 3. Select ECT (Figure 6-19). other levels, see step 8. To return to the 4. The Setup ECT screen (Figure 6-32) Setup QC(bio) screen (Figure 6-26), select displays.

  • Page 35: Auto Output

    ACTALYKE XL SIX - Setup 6. To return to the Setup ECT screen complete. For patient data, if Patient ID without restarting the timer or changing the Entry is not in use, this automatic printing is time, select Cancel. the only way to print test results.

  • Page 36: Paper Feed

    ACTALYKE XL SIX - Setup e. Save QC (spreadsheet) - select Yes to disk drive, use the following steps beginning have the QC results containing all data per from the Run Test screen (Figure 6-2): lot-to-date automatically saved on a 3½”...
  • Page 37 K-ACT: C-ACT: 4. A printout containing following qc_forced: information plus the instruments currently ect_forced: entered settings for each parameter prints. qc_sched: ect_sched: Actalyke XL Parameters REPORT/INTERFACE PARAMETERS ================== date_format: Version time_mode: Instrument S/N: snd_click: Operator ID: snd_warn: Date: snd_RunDone: Time:...

  • Page 38: Test Parameters

    For example, 0 can represent Off, No or adataprint (automatically Print): none. 0 (None), 1 (Simple) or 2 (Chart) atransmit (automatically Transmit chart): Actalyke XL Parameter 0 (No), 1 (One) or 2 (All) apatstorage (automatically Save Patient): =================== 0 (No) or 1 (Yes)
  • Page 39 ACTALYKE XL SIX - Setup (level 2 upper limit), ect_forced (ECT Levels Which Must Pass): 0 (none), 1 (1), 2 (2), 3 (1 and 2), 4 (3), (level 3 upper limit) 5 (1 and 3), 6 (2 and 3), or 7 (1, 2 and 3)

  • Page 40: Save Operator Ids

    ACTALYKE XL SIX - Setup linterm (Spreadsheet Parameters Line 1. Select Setup (Figure 6-2). Termination String): x0 x0 x0 x0 x0 2. Select Archive (Figure 6-3). [Up to five line terminators may be 3. From the Save/Restore/Print screen selected. The four most common codes to (Figure 6-35), select Restore Operator IDs.

  • Page 41: Figure 6-1. Enter Operator Id Screen

    ACTALYKE XL SIX - Setup * Enter Operator ID* *Setup* Bksp Clear General Interface Parameters Parameters Operator ID 0123  Archive Maintenance Password  **** Paper Feed Must return to main screen for changes to be saved Figure 6-1. Enter Operator ID Screen* Figure 6-3.

  • Page 42: Figure 6-5. Select Preferred Keypad Screen

    ACTALYKE XL SIX - Setup *Select Preferred Keypad* *Set Date Format* dd/mm/yy dd/mm/yyyy yy/mm/dd yyyy/mm/dd mm/dd/yy mm/dd/yyyy MMM dd, yyyy Phone Calculator Figure 6-7. Set Date Format Screen Figure 6-5. Select Preferred Keypad Screen *Set Date* *Setup Time & Date*...

  • Page 43: Figure 6-9. Set Time Screen

    ACTALYKE XL SIX - Setup *Set Time* *Set Backlight* Current Time Select Backlight Brightness Level 09:01:00 AM Full on New Time < > 09:01:00 AM 12/24 Hr AM/PM Set Time Exit Figure 6-9. Set Time Screen* Figure 6-11. Set Backlight Screen...
  • Page 44 ACTALYKE XL SIX - Setup *Printer Contrast Adjustment* *Set Spreadsheet Parameters* Item Separation Character (Column Delimiter)  Line Carriage Contrast: 10 Termination  Return Linefeed String  <CR> <LF>  Other line termination characters may be added via an external keyboard...
  • Page 45 ACTALYKE XL SIX - Setup *General Parameters* *Select Shutdown Time-out* On battery power, system will Patient shut-down after the specified Operator ID/ time of inactivity. Passwords Test  3Hr - 0 min Auto Output  QC (Bio) Figure 6-19. General Parameters Screen Figure 6-17.
  • Page 46 ACTALYKE XL SIX - Setup Enter password *Setup Test Parameters* Allow 2nd Operator------- Bksp Clear for well 2 ACT Timing Sequence--- High/Low Limits------------ Figure 6-23. Setup Test Parameters Figure 6-21. Passwords Screen* Screen *ACT Timing Sequence* *Select Editable Demographics* Bksp...
  • Page 47 ACTALYKE XL SIX - Setup *ACT Test Range Limit* *QC(bio) Schedule* Bksp Clear Bksp Clear Enter Acceptable Limits Run QC(bio) every Lower Upper hour(s) (seconds) (seconds) Cancel Figure 6-25. ACT Test Range Limits Figure 6-27. QC(bio) Schedule Screen* Screen* *QC Lot Numbers*...
  • Page 48 ACTALYKE XL SIX - Setup or Upper Enter Lot Number Enter Lower Limit (sec) Bksp Clear Bksp Clear Figure 6-29. Enter Lot Number Screen* Figure 6-31. Enter Lower/Upper Limit Screen* *QC Mean and Range* *Setup ECT* Test: C-ACT ECT levels which...
  • Page 49 ACTALYKE XL SIX - Setup *ECT Schedule* *Save/Restore/Print* Save Save Operator Bksp Clear Parameters Run ECT every Restore Restore hours Parameters Operator IDs PRINT Setup PRINT Operator Parameters ID List Cancel Figure 6-33. ECT Schedule screen* Figure 6-35. Save/Restore/Print Screen...

  • Page 50: Section 7 - Operating Instructions

    Section 7 - Operating Instructions Only access, then this allows Operation Only access to the instrument. Note: The floppy disk from the Actalyke XL has been removed. Any functions associated If the instrument has not been with it are no longer available.

  • Page 51: Patient Id/Patient Demographics

    ACTALYKE XL SEVEN - Operating Instructions patient, the first result is deleted from the Results ACT chart, see memory and the most recent 25 results are section 7.1.2 for information on using and retained. exiting this screen. 3. Collect the patient sample according to a prompt to enter the type of test the procedure for the tube in use.

  • Page 52: Well Number

    ACTALYKE XL SEVEN - Operating Instructions is set to On with ID Auto Entry Interval setup 1. Select Patient ID and the Patient for use and the time interval has expired, or if Demographics screen (Figure 7-3) displays. the Patient ID Entry is set to Always (section 2.

  • Page 53: Sex

    ACTALYKE XL SEVEN - Operating Instructions If the ID being changed has b. To select a demographic, sex, height, already been used and has data attributed and/or weight, see step 2 of section 7.1.1.1.3, to it, the screen displays, "Patient ID X 7.1.1.1.4, and/or 7.1.1.1.5, respectively.

  • Page 54: Height

    ACTALYKE XL SEVEN - Operating Instructions 7.1.1.1.4. Height d. To delete any test data for the currently displayed patient ID, see section If the demographic Height is setup for use 7.1.1.1.6 step 2. (section 6.2.1.4), to indicate the height for the current patient ID, use the following beginning e.

  • Page 55: Clear Act Points

    ACTALYKE XL SEVEN - Operating Instructions b. To enter/select a patient ID and/or test d. To enter heparin dosage type, see section 7.1.1.1.2 step 2. information for the currently displayed patient ID, see section 7.1.1.1.7 step 2. c. To select a demographic, sex and/or height, see step 2 of section 7.1.1.1.3 and/or...

  • Page 56: Test

    ACTALYKE XL SEVEN - Operating Instructions a. To select the other well, see section be viewed and printed in chart form and/or 7.1.1.1.1 step 2. transmitted to an LIS. Additionally, data for all current and stored patients can be saved to a b.

  • Page 57: Change Operator

    ACTALYKE XL SEVEN - Operating Instructions 4. Use the  up and the  down keys to regardless of when the tests were started or concluded. This ordering holds true for the move between the Operator ID and plotted chart results both on the display and Password fields.

  • Page 58: Battery Charge

    "Remove disk from instead of the display turning off, an alarm drive A:, reboot, and see Actalyke XL sounds. Once the error message is cleared, Operator's Manual Software Installation the battery conservation timer will begin again section for further instruction."...
  • Page 59 ACTALYKE XL SEVEN - Operating Instructions 3. Turn the instrument Off, wait 10 seconds, instrument displays, "Warning: This will and turn the instrument On. The screen delete all data files (QC, patients, & displayed should contain current parameters) and set batch files to start in software version.
  • Page 60 ACTALYKE XL SEVEN - Operating Instructions If the Allow 2nd Operator for Well 2 feature is in use and Once a Patient ID Number of ACT points Change Operator and then Well 2 are selected, then this is is entered, the ID attributed to the patient and the Enter Well 2 Operator ID screen.
  • Page 61 ACTALYKE XL SEVEN - Operating Instructions *Heparin Dosage* *Select Patient Height*  Bksp Clear 0.0m - 0' 0"  Current Height 0.1m - 0' 3" 0.2m - 0' 7" 0.0m - 0' 0" Select Enter Dosage 0.3m - 0' 11"...
  • Page 62 ACTALYKE XL SEVEN - Operating Instructions Description of printed information To include/exclude from printout, see section a) Header 6.1.5.2 b) Printout title always included c) Patient ID 6.2.2 & 7.1.1.1 d) Test always included e) Operator ID currently in use 6.1.5...

  • Page 63: Section 8 - Test Functions And Quality Control

    2. Select Run ECT Self Check (Figure 8-2). Control 3. The instrument displays, “Select Well for Note: The floppy disk from the Actalyke XL QC ECT: Well #1 Well #2 Cancel.” Select has been removed. Any functions associated one of the following: with it are no longer available.

  • Page 64: Run Biological Qc Test (Qc Of Individual Coagulation Assays)

    ACTALYKE XL EIGHT - Test Functions and Quality Control 8.1.2. Run Biological QC Test (QC of 3. From the QC (Biological) screen (Figure Individual Coagulation Assays) 8-3), select Change Test for the test well to be used. Each box of Actalyke Activated Clotting Time tubes contains 50 tubes from a single 4.

  • Page 65: View/Output View Chart (Levey-Jennings Chart)

    ACTALYKE XL EIGHT - Test Functions and Quality Control 8.1.3. View/Output View Chart 8.1.4. Delete Complete QC Test Data (Levey-Jennings Chart) The data generated from one test well for a Levey-Jennings Chart’s maximum specific QC test cad be deleted. Note that...

  • Page 66: Temperature Qc (Test Well Temperature Check)

    ACTALYKE XL EIGHT - Test Functions and Quality Control steps beginning from the Run Test screen To return to the QC Point Deletion (Figure 8-1): screen without removing the clot point, select No. 1. Select QC (Figure 8-1). 12. To return to the Run Test screen (Figure 2.
  • Page 67 ACTALYKE XL EIGHT - Test Functions and Quality Control or ECT Sched:, which ECT for ECT QC or Indicates test type in use. ever has the least time QC(bio) for Biological remaining. Time shown QC. 1, 2 or 3 depending...
  • Page 68 ACTALYKE XL EIGHT - Test Functions and Quality Control Description of printed information a) Header b) Printout Title c) Test d) Well number e) Level Lot numbers g) Mean h) Standard Deviation Quantity of tests run for each level QC result time charted...

  • Page 69: Section 9 - Performance Specifications

    Equipment protected throughout by double insulation or reinforced insulation (equivalent 9.1. Instrument Performance Specifications Class Voltage Directive Note: The floppy disk from the Actalyke XL 72/23/EEC). has been removed. Any functions associated Pollution degree 2 with it are no longer available. Microprocessor controlled enhanced reliability and reporting of fault conditions.

  • Page 70: Section 10 - Maintenance, Troubleshooting, Warranty

    Section 10 - Maintenance, 10.1.1. Instrument Cleaning Troubleshooting, Warranty TURN OFF THE POWER AND UNPLUG Note: The floppy disk from the Actalyke XL POWER CORD BEFORE PROCEEDING. has been removed. Any functions associated Allow the instrument to cool, if necessary.

  • Page 71: Test Well Temperature Check

    ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty the Levey-Jennings chart (Figure 8-4), 6. Repeat steps for the other test well. depending on selections made in setup. 10.1.4. Test Well Cleaning (See section 8.1.3 for information on the TURN OFF THE POWER AND UNPLUG Levey-Jennings chart.)

  • Page 72: Printer Paper Replacement

    "Please power. If the fuse immediately blows again, REMOVE calibration tubes. Touch the call Helena Laboratories for assistance. screen to continue." Remove the ECTs and touch the screen. a. If the calibration was successful, the Maintenance screen displays (see step 8).

  • Page 73: Battery Replacement

    10.1.9. Battery Replacement 4. The battery is located along the center of the right panel of the unit under a clear To replace the battery, use the Actalyke XL bracket. The bracket is secured with two kep Battery Pack,...
  • Page 74 ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty the PCB. The locking clip on the battery's 12. Prior to applying power, the F2 fuse connector should face the rear of the unit. must be removed. Insert a small flathead screwdriver into the slot on the F2 fuse 9.
  • Page 75 ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty 1. Use the lid key on the TOP slot 2. Use the lid key on the BOTTOM slot 3. BATTERY CONNECTOR 4. STANDOFFS 5. BATTERY CABLE 6. KEP NUTS 7. BRACKET 8. BATTERY 9.
  • Page 76 ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty Figure 10-2. Preventive Maintenance schedule Checklist 10-7...

  • Page 77: Troubleshooting

    The following tables list other symptoms and possible fault conditions and causes (Table 10-2, Troubleshooting and Table 10-3, Prompts and Error Messages). Note: The floppy disk from the Actalyke XL has been removed. Any functions associated with it are no longer available.
  • Page 78 ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty Symptom Possible Cause(s) Action Required Faulty tube Remove tube and insert ECT, if detector changes to In, discard tube. Detector malfunction Perform the Mag Sensor Calibration (section 10.1.8). Tube will not rotate Obstruction in test well Clean test well.
  • Page 79 Enter new range limits (section range limits not updated 6.2.4.3) and repeat test. Faulty tube Repeat test. If remains out of range, call Helena Laboratories. No power to instrument Power cord unplugged and Plug cord into wall outlet and turn insufficient charge in battery On to use and charge battery.
  • Page 80 If instrument not on battery power Perform Temperature QC (8.1.6) or the problem persists, possible and call Helena Laboratories. instrument malfunction. Maximum entries per patient (=8) The maximum of eight heparin Clear clot times (7.1.1.1.6) reached.
  • Page 81 ACTALYKE XL TEN - Maintenance, Troubleshooting, Warranty Message Possible Cause(s) Action Required Barcode is missing or unreadable Barcode missing or unreadable Select the appropriate test from in well X. Please select test. and test type was not manually those shown.

  • Page 82: Warranty

    This warranty is provided to the original purchaser for one year from date of sale. Particular Exclusions Unauthorized modification of any part of the Actalyke XL instrument will void this Warranty. 10.4. Regulatory Information The Actalyke XL System conforms to the following...

  • Page 83: Section 11 - Symbology

    ACTALYKE XL ELEVEN - Symbology Section 11 - Symbology NOTE: The following symbols may be used in this manual, or on the instrument, to provide information necessary to the user, if applicable. Caution, electric shock hazard, high voltages capable of causing personal...
  • Page 84 ACTALYKE XL ELEVEN - Symbology Serial number Consult instructions for use Catalog number Temperature Limitation In vitro diagnostic medical device 11-2...

  • Page 85: Section 12 - Communication Specifications

    ACTALYKE XL TWELVE - Communication Specifications Section 12 - Communication unless the Actalyke XL is to be connected to Specifications a terminal. Note: The floppy disk from the Actalyke XL XON-XOFF Flow Control: has been removed. Any functions associated Data is transmitted and received as ASCII text with it are no longer available.
  • Page 86 ACTALYKE XL TWELVE - Communication Specifications The system with information available initiates Intermediate Frame: <STX> FN "data" the establishment phase. After the sender <ETB> C1 C2 <CR> <LF> determines the data link is in a neutral state, it End Frame: <STX> FN "data" <ETX> C1 C2 transmits the <ENQ>...

  • Page 87: Data Transfer Format

    There are 5 neutral state. record types used by the Actalyke XL: Header Record (H), Patient Record (P), Test Order Timeouts Record (O), Result Record (R), and the The sender and receiver both use timers to Terminator Record (L).
  • Page 88 Order Record included in the record to ensure that the i'th field can be found by counting (i-1) delimiters. The Actalyke XL will transmit an order record Delimiters are not included for trailing null immediately preceding any results records for fields;...
  • Page 89 ACTALYKE XL TWELVE - Communication Specifications The Actalyke XL currently does not recognize The terminator record must be the last record test order records transmitted by the computer in a transmission. When the Actalyke XL system. transmits a terminator record it will have the following format: L|1|<CR>...

  • Page 90: Section 13 - Menu Flowchart

    ACTALYKE XL THIRTEEN - Menu Flowchart Section 13 - Menu Flowchart 13-1...
  • Page 91 ACTALYKE XL THIRTEEN - Menu Flowchart 13-2...
  • Page 92 ACTALYKE XL THIRTEEN - Menu Flowchart 13-3...
  • Page 93 ACTALYKE XL THIRTEEN - Menu Flowchart 13-4...
  • Page 94 ACTALYKE XL THIRTEEN - Menu Flowchart 13-5...

  • Page 95: Section 14 - Index

    7-2, 7-7, 8-2, 8-3, 8-4 Actalyke Thermometer, 5-1, Contrast, 6-4, 6-24 General Parameters, 6-7, 6- 8-4, 10-2 8, 6-9, 6-10, 6-11, 6-12, Actalyke XL Battery Pack, 6-13, 6-14, 6-15, 6-25 5-1, 10-4 Data Bits, 6-5, 6-19 Additional Materials, 5-1 Date, 6-2, 6-3, 6-19, 6-22...
  • Page 96 ACTALYKE XL FOURTEEN - Index Password, 6-1, 6-7, 6-26, 7- Restore Parameters, 6-16 1, 7-8 Results, 7-8 K-ACT, 5-1, 6-13, 6-18, 6- Patient, 6-9, 6-10 Results ACT Chart, 6-15, 7- 19, 7-1, 7-2, 7-7, 8-2, 8-3, Storage Capacity, 7-1 2, 7-6, 7-7, 7-12, 7-13...
  • Page 97 ACTALYKE XL FOURTEEN - Index Transmit, 6-15, 6-18, 7-7, 8- Temperature QC, 8-4 Warranty, 10-1, 10-13 Troubleshooting, 10-1, 10-8 Test, 6-11, 6-26, 7-7, 8-3 Weight, 6-10, 6-17, 7-5, 7- Test Tube, 9-1 12, 9-1 Test Well Temperature Well 2 Operator ID. See...
  • Page 98 ® Actalyke Catalog Number 5770 Software Version 1.70 Operator's Manual For additional information, call Helena Laboratories at 800-231-5663, toll free. Helena Laboratories, Corp. Advena Ltd. 1530 Lindbergh Drive Tower Business Centre, 2nd Flr., Beaumont, TX 77707 Tower Street, Swatar, BKR 4013 Malta ©...

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