Helena Laboratories Actalyke XL Operator'S Manual Download

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Actalyke

Activated Clotting Time Test System

Operator’s Manual

Catalog Number 5770, 110-220 VAC, 50-60 Hz

Summary of Contents for Actalyke XL

Page 1: ...Actalyke XL Activated Clotting Time Test System Operator s Manual Catalog Number 5770 110 220 VAC 50 60 Hz...

Page 2: ...Actalyke XL Activated Clotting Time Test System Operator s Manual...

Page 3: ...INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF PERFORMANCE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE PURCHASER ASSUMES ALL RISKS AS TO THE PERFORMANCE AND RESULTS OF THE PROGRAM IN NO EVENT WI...

Page 4: ...r 6 3 6 1 5 1 Contrast 6 4 6 1 5 2 Header Footer 6 4 6 1 6 Export 6 4 6 1 6 1 Export Parameters 6 5 6 1 7 Spreadsheet 6 5 6 1 7 1 Spreadsheet Parameters 6 5 6 1 8 System Timers 6 6 6 1 8 1 System Shut...

Page 5: ...ion 7 6 7 1 2 2 Test 7 6 7 1 3 View Chart 7 6 7 1 4 Change Operator 7 7 7 2 To Abort Operation 7 7 7 3 Results 7 7 7 4 Battery 7 8 7 4 1 Battery Charge 7 8 7 4 2 Battery Conservation 7 8 7 4 3 Battery...

Page 6: ...Actalyke XL front view 5 3 Figure 5 2 Actalyke XL rear 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 view 5 5 Figure 5 6...

Page 7: ...Figure 6 34 Save Restore Print Screen 6 28 Figure 7 1 Enter Operator ID Screen 7 10 Figure 7 2 Run Test Screen 7 10 Figure 7 3 Patient Demographics Screen 7 10 Figure 7 4 Patient ID Entry Selection S...

Page 8: ...CMO Percutaneous Transluminal Coronary Angioplasty Cardiac Catherization Critical Care The ACTALYKE XL System provides an alternative to other Activated Clotting Time ACT methodologies The instrument...

Page 9: ...ACTALYKE XL ONE Instrument Use and Function 1 2 Figure 1 1 ACTALYKE XL...

Page 10: ...tate magnetic detectors located in the test well One magnetic detector is located at 0 and the other at 90 with respect to the test tube When a test tube is inserted into a test well the detector at 0...

Page 11: ...agram Controller Computer LIS Barcode Wand Keyboard Floppy Drive LCD Display Touch Screen Motor Temperature Sensors 0 Hall Sensors 90 Hall Sensors Test Tube Barcode Readers Heaters Heater Driver Alarm...

Page 12: ...ith the Actalyke Thermometer or an item this manual indicates as appropriate 3 12 If resistance is encountered when inserting a tube into the test well or there is resistance when the tube is rotating...

Page 13: ...alfunction See section 3 8 and 10 2 3 23 Requirements for handling biohazards Due to potential biohazard risk from human blood guidelines pertaining to Universal Precautions shall be adhered to when h...

Page 14: ...220 V AC is prohibited This instrument requires a zero reference on AC input so cannot be run on 220V AC in the US Fire protection is not assured if this is not followed 4 5 Do not lubricate the inst...

Page 15: ...e Blood QC for C ACT K ACT MAX ACT AQC L Actalyke Whole Blood QC for G ACT 5 2 Installation This instrument is a Category II device under EN 61010 1 for use in a laboratory or similar environment 1 Se...

Page 16: ...iver push the holder in and rotate clockwise until it is seated 5 3 Verification of Functionality Read the entire Operator s Manual With the instrument turned On complete the applica ble section of th...

Page 17: ...ACTALYKE XL FIVE Installation Instructions 5 3 Figure 5 1 Actalyke XL front view Figure 5 2 Actalyke XL rear view Test Wells Display Carrying Handle Stand IEC Power Cord Connection Fuses...

Page 18: ...L FIVE Installation Instructions 5 4 Figure 5 3 Actalyke XL top view Figure 5 4 Actalyke XL top view with paper Serrated Plate Adjustment Screws Adjustment Screws Paper Out Paper In Power Switch Paper...

Page 19: ...e will resemble either Figure 5 5 or 5 6 Figure 5 5 Actalyke XL left side view Figure 5 6 Actalyke XL left side view Keyboard or Barcode Reader Connection External Computer LIS Serial Connection Exter...

Page 20: ...ACTALYKE XL FIVE Installation Instructions 5 6 Figure 5 7 Actalyke XL right side view 3 Floppy Disk Drive...

Page 21: ...ghts and Setup Access operators only section 6 2 1 either 1 Enter an appropriate Supervisor Full Rights or Setup Access Operator ID and Password per the instructions in step 3 b 2 Or to access the ins...

Page 22: ...ure 6 2 2 Select Interface Parameters Figure 6 3 3 Select Time Date Figure 6 4 4 Select Date Figure 6 6 5 On the Set Date screen Figure 6 8 use the keypad the key to move the cursor to the left and th...

Page 23: ...ered to affect the screens contrast To alter the backlight setting use the following steps beginning from the Run Test screen Figure 6 2 1 Select Setup Figure 6 2 2 Select Interface Parameters Figure...

Page 24: ...elections return to the Run Test screen Figure 6 2 by selecting OK until the Run Test screen appears 6 1 5 2 Header Footer The printout may contain a header and or a footer To enter a header and or a...

Page 25: ...lly included data and by selections made in setup a For patient tests patient ID must be in use for data to be saved section 6 2 2 1 The minimum data saved is the type of test run the date and time th...

Page 26: ...ng on the battery To select the amount of time desired to elapse before shutdown use the following steps beginning from the Run Test screen Figure 6 2 1 Select Setup Figure 6 2 2 Select Interface Para...

Page 27: ...combination is setup with Operation Only access this feature is no longer available 4 The three security access levels are a Operation only allows access to run patient tests QC tests and enter patien...

Page 28: ...d To save selections return to the Run Test screen Figure 6 2 by selecting OK until the Run Test screen appears 6 2 1 3 Archive and Retrieve Operator IDs The currently entered list of operator identif...

Page 29: ...If the information is not entered before running a test once the test is started the instrument prompts the user that patient information must be entered If the information is not entered during the...

Page 30: ...ted time interval has elapsed for the prompt to run an ACT test to display the instrument must not be in QC mode and the Run Test screen must be clear of any clotting time results a Select Yes to set...

Page 31: ...numbers and or range limits for an ACT control see section 6 2 4 3 step 4 c To save selections return to the Run Test screen Figure 6 2 by selecting OK until the Run Test screen appears If any levels...

Page 32: ...QC screen Figure 6 25 displays and see step 12 8 Use the QC Mean and Range screen Figure 6 29 to enter or edit the range limits Select the desired Level of 1 2 or 3 Note that only the levels for which...

Page 33: ...the Run Test screen are cleared To select the desired time interval between ECT tests use the following steps beginning from the Run Test screen Figure 6 2 1 Select Setup Figure 6 2 2 Select General...

Page 34: ...If No is selected the results can be saved at user request see section 7 1 3 Note if patient data is to be saved Patient ID Entry section 6 2 2 must be in use e Save QC spreadsheet select Yes to have...

Page 35: ...rameters are saved to the instru ment and the Save Restore Print screen displays 6 To complete the restore turn the instru ment Off wait 10 seconds and turn the instrument On The instrument is now rea...

Page 36: ...XL Parameter Version printout will list current software version information Instrument S N instrument serial number printout will list the pre programmed instrument serial number Operator ID the ide...

Page 37: ...level 1 upper limit level 2 upper limit level 3 upper limit K ACT level 1 upper limit level 2 upper limit level 3 upper limit C ACT level 1 upper limit level 2 upper limit level 3 upper limit range_lo...

Page 38: ...ull On linterm Spreadsheet Parameters Line Termination String x0 x0 x0 x0 x0 Up to five line terminators may be selected The four most common codes to printout are x0 no line terminator selected xd ca...

Page 39: ...Select Setup Figure 6 2 2 Select Archive Figure 6 3 3 Select PRINT Operator ID List Figure 6 3 The screen prompts with the length of time the printout will take To proceed select Yes 4 A printout cont...

Page 40: ...nterface Parameters Archive Paper Feed Maintenance Must return to main screen for changes to be saved Figure 6 3 Setup Screen Time Date Setup Interface Parameters OK Export Sound Backlight Printer Key...

Page 41: ...Preferred Keypad Screen Date Format Setup Time Date OK Date Time Figure 6 6 Setup Time Date Screen dd mm yy Set Date Format OK yy mm dd mm dd yy dd mm yyyy yyyy mm dd mm dd yyyy MMM dd yyyy Figure 6 7...

Page 42: ...Error NONE NONE 1 1 5 5 3 3 2 2 4 4 Figure 6 10 Setup Sound Screen Set Backlight OK Select Backlight Brightness Level Off 3 1 2 4 5 6 Full on Figure 6 11 Set Backlight Screen Contrast Setup Printer O...

Page 43: ...xport Parameters Screen Set Spreadsheet Parameters OK Item Separation Character Column Delimiter CR LF Clear Other line termination characters may be added via an external keyboard Tab Line Terminatio...

Page 44: ...al Parameters Screen New Operator ID 3333 1111 2222 0 9 8 7 6 5 4 3 2 1 Enter Operator ID List OK 4444 Enter Edit Password Bksp Clear Delete Selected Sel S T Save Restore Access Level Total Quant 4 TT...

Page 45: ...Limits Setup Test Parameters OK ACT Timing Sequence NO YES YES NO NO YES Allow 2nd Operator for well 2 Figure 6 22 Setup Test Parameters Screen 0 9 8 7 6 5 4 3 2 1 Perform ACT every ACT Timing Sequenc...

Page 46: ...2 1 Figure 6 25 Setup QC Screen 0 9 8 7 6 5 4 3 2 1 Run QC every QC Schedule OK hours Bksp Clear Figure 6 26 QC Schedule Screen Level QC Lot Numbers OK Lot Number 1 2 3 Test C ACT Figure 6 27 QC Lot...

Page 47: ...creen 0 9 8 7 6 5 4 3 2 1 Enter Lower Limit sec OK Bksp Clear Figure 6 30 Enter Lower Upper Limit Screen Set ECT Schedule Setup ECT OK ECT levels which must pass 3 2 1 Figure 6 31 Setup ECT screen 0 9...

Page 48: ...ave QC spreadsheet ALL ONE NO None YES Simple NO Print Make Selections for Automatic Chart Figure 6 33 Setup Automatic Output Screen Save Parameters Save Restore Print OK Save Operator IDs PRINT Setup...

Page 49: ...If the instrument has not been setup to use any operator ID number password combinations then this allows Supervisor Full Rights access to the instru ment 4 If saving data for use on a spreadsheet in...

Page 50: ...ording to the procedure The Tube status located on the bottom left of the Run Test screen should read In for the test well in use If the status reads Out rotate the tube clockwise to ensure the tube i...

Page 51: ...on 7 1 2 1 2 step 2 b To select a demographic sex height and or weight see step 2 of section 7 1 2 1 3 7 1 2 1 4 and or 7 1 2 1 5 respectively c To delete any test data for the currently displayed pat...

Page 52: ...dicate the applicable sex for the current patient ID use the following beginning from the Run Test screen Figure 7 2 1 Select Patient ID and the Patient Demo graphics screen Figure 7 3 displays 2 To s...

Page 53: ...weight measurement in the equivalent pounds 5 With the correct weight indicated press Select 6 With the selected weight displayed in the Current Weight field select from OK 7 From the Patient Demogra...

Page 54: ...t the other well see section 7 1 2 1 1 step 2 b To enter select a patient ID and or test type see section 7 1 2 1 2 step 2 c To select a demographic sex height and or weight see step 2 of section 7 1...

Page 55: ...2 Operator Main Well 2 a To enter the ID assigned to well 1 this ID will determine the access level for both users select Main and see step 3 b To enter the ID assigned to well 2 select Well 2 The En...

Page 56: ...non use the display turns off leaving the screen black After the pre selected time interval of non use has elapsed section 6 1 8 1 the instrument powers down To continue using the instrument on batter...

Page 57: ...splays Error Log File Exists Move it to floppy No Yes then to maintain maximum memory capacity it is recommended the file be moved to a floppy disk Insert a blank floppy disk into the floppy disk driv...

Page 58: ...5555555 0666666666 Well 1 Test C ACT Figure 7 4 Patient ID Entry Selection Screen Input Field Phone Keypad format shown Batt Left if the instrument is running on battery power Paper Feed key if the le...

Page 59: ...T TT Figure 7 6 Select Patient Weight Screen 0 9 8 7 6 5 4 3 2 1 Heparin Dosage OK Bksp Clear Cancel Enter Dosage IU Figure 7 7 Heparin Dosage Documentation Screen 1 SSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSS 4...

Page 60: ...e different i Test results outside of ACT Test Range Limits H if above high limit and L if below low limit included if ACT range limits 6 2 3 in use and the test results are not within range j Test we...

Page 61: ...he following a Select Cancel and then OK to return to the Run Test screen Figure 8 1 b Select Well 1 or Well 2 for the de sired test well and proceed to step 4 4 From the displayed options 100 seconds...

Page 62: ...rformed and the screen returns to the QC Biological screen Figure 8 3 5 For the test well being used select 1 2 or 3 for the level of the test being run 6 QC tests can be run on both wells simul taneo...

Page 63: ...gure 8 1 1 Select QC Figure 8 1 2 Select Delete Complete QC Test Data Figure 8 2 3 The instrument displays Select Well for QC ECT Well 1 Well 2 Select the appropriate well number 4 The instrument disp...

Page 64: ...K until the Run Test screen displays 8 1 6 Temperature QC Test Well Temperature Check 1 If using an Actalyke Thermometer Catalog Number 5757 to perform temperature checks of the test wells refer to th...

Page 65: ...SSSSSSSSSSSSSSSSSSSSSSSSSSSSS 2 SSSSSSSSSSSSSSSSSSSSSSSSSSSSS 1 SSSSSSSSSSSSSSSSSSSSSSSSSSSSS 0 SSSSSSSSSSSSSSSSSSSSSSSSSSSSS 1 SSSSSSSSSSSSSSSSSSSSSSSSSSSSS 2 SSSSSSSSSSSSSSSSSSSSSSSSSSSSS 3 SSSSSSS...

Page 66: ...printed information a Header b Printout Title c Test d Well number e Level f Lot numbers g Mean h Standard Deviation i Quantity of tests run for each level j QC result time charted k Test date if the...

Page 67: ...p Expiration date of tubes 9 2 System Performance Characteristics 9 2 1 MAX ACT REFERENCE RANGES MAX ACT test tubes were run on normal healthy patients using multiple Actalyke Models XL A2P and MINI a...

Page 68: ...were run on Actalyke instruments Model A2P MINI and XL and Hemochron Instrument Model 8000 Quality control tests were performed on each instrument prior to testing of Actalyke tubes for this study Eac...

Page 69: ...a tions yielding the following results Heparin Sensitivity Celite Response to Heparin Kaolin Response to Heparin Glass Beads Response to Heparin Key to Graphs Instrument Tube A A Actalyke Actalyke M A...

Page 70: ...erivative clean the area contaminated with a commercial virucidal and germicidal agent Clean spills with a soft cloth or sponge Do not use corrosive or abrasive cleansers Dry the unit before plugging...

Page 71: ...and allow the obstruction to fall out Take care when handling the obstruction in the event it has sharp edges and or is a biohazard Dispose of the obstruction as necessary If there is liquid in the t...

Page 72: ...s Touch the screen to continue Remove the ECTs and touch the screen a If the calibration was successful the Maintenance screen displays see step 8 b If the calibration failed an error mes sage display...

Page 73: ...ocating tabs Four sets of slots located on the left and right panels of the unit provide access to the locating tabs Beginning from the set of slots forward on the left panel of the unit and going clo...

Page 74: ...p cover by aligning the four locating tabs and pushing down on the cover The cover will snap into position 12 Prior to applying power the F2 fuse must be removed Insert a small flathead screw driver i...

Page 75: ...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 Use the lid key on the BOTTOM slot 10 LID KEY 11...

Page 76: ...Items Clean the Test Wells As Needed Replace Printer Paper Replace fuse s Mag Sensor Calibration Drain Battery Replace Battery Touch Screen Calibration Note Duplicate this page for maintenance copies...

Page 77: ...roblem Verify Clotting Time QC section 8 1 1 if OK rerun patient test if out of range call Helena Labora tories Excessive sample clotting time High heparin concentration sample Verify QC section 8 1 i...

Page 78: ...erature quality control not in range Test well control problem Call Helena Laboratories Unable to use barcode reader to scan in new QC range limits Incorrect screen displayed when barcode label was sc...

Page 79: ...ttery is retaining charge memory Perform Drain Battery section 10 1 8 Battery percentage when Charging never exceeds 85 Other Call Helena Laboratories Power cord dislodged Plug in power cord Spent bat...

Page 80: ...r well X Must clear to save more The maximum of 25 tests have been run and attributed to one patient ID Clear clot times 7 1 2 1 6 Exceeded maximum number of samples for this patient for well X Sample...

Page 81: ...chantability and fitness for a particular purpose In no event will Helena Laborato ries be liable for indirect incidental or consequential damages the original user s remedies being limited to repair...

Page 82: ...azards Sections 3 and 4 of Operator s Manual before proceeding Direct current Alternating current Both direct and alternating current Ground earth terminal Protective conductor terminal grounded condu...

Page 83: ...flow When exporting the Actalyke XL will recog nize an XOFF character and stop transmission until an XON character is received There is no error checking or correction when using this protocol ASTM P...

Page 84: ...X FN data ETB C1 C2 CR LF End Frame STX FN data ETX C1 C2 CR LF Where STX Start of text transmission character FN single digit frame number 0 to 7 data data content C1 first character of checksum 0 9...

Page 85: ...tting the ENQ If a reply of an ACK NAK or ENQ is not received within 15 seconds a timeout occurs and the sender regards the link to be in the neutral state During the establishment phase if the comput...

Page 86: ...oes not overwrite existing data in the receiving system The transmission of a double quote ASCII 34 in a field tells the receiving system to replace any existing value with a null value Each field may...

Page 87: ...umber always 1 test name Name of the test performed nnnn Clotting time unit of measure seconds nnnn nnnn User defined reference range date time started Date and time the test was started yyyymmddhhmms...

Page 88: ...ypad Select Preferred Keypad Setup Time Date Setup Interface Parameters Backlight Time Date Date Format Time Date Set Date Format Set Date Set Time Setup Sound Set Backlight Setup Printer Contrast Hea...

Page 89: ...al Parameters Test QC Bio Select Editable Demographics Setup Test Parameters set Op 2 set Sequence set Limits ACT Timing Sequence ACT Test Range Limits Setup QC set must pass levels Set QC Schedule QC...

Page 90: ...ntenance Mag Sensor Calibration Drain Battery Draining Battery for Cycling Continue Continue Remove all tubes insert ECTs Run Test continued Setup continued General Parameters continued Touch Panel Ca...

Page 91: ...ACT Points Heparin Dosage Test Heparin Select Patient Weight Weight select test OR View Chart Result ACT Well Save Print Chart Transmit Change Operator Enter Operator ID Patient Demographics Well Pati...

Page 92: ...C Test Data Delete Single QC Clot Point select Well 1 or 2 select seconds QC Biological Change Test select test select level Levey Jennings Chart Next Page Save Print Chart Transmit Well Previous Page...

Page 93: ...6 18 6 21 Delete 7 4 8 3 8 4 Delete Complete QC Test Data 8 3 Delete Patient ID 7 4 Delete Single QC Clot Point 8 3 Demographics 6 9 6 25 7 3 Dimensions 9 1 Drain Battery 10 3 E ECT 5 1 6 12 6 13 6 1...

Page 94: ...ge 6 12 6 17 6 27 QC of Individual Coagulation Assays 8 1 QC Point Deletion 8 3 QC Schedule 6 11 6 18 6 26 7 1 Quality Control 8 1 R Regulatory Information 10 12 Reset 7 2 Restore 6 8 6 18 Restore Ope...

Page 95: ...EN Index 14 3 V Verification of Functionality 5 2 View Chart 6 13 6 16 7 6 7 7 8 2 View Output 8 2 W Warranty 10 1 10 12 Weight 6 9 6 16 7 5 7 11 9 1 Well 2 Operator ID See Allow 2nd Operator for Well...

Page 96: ...yke XL Operator s Manual For additional information call Helena Laboratories at 800 231 5663 toll free Helena Laboratories Helena Laboratories UK Ltd P O Box 752 Colima Avenue Beaumont Texas 77704 075...

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