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If not, the purchaser should return the unopened disk package to Helena Laboratories to obtain a refund. Retention of the product will constitute acceptance of this license. 1. Helena Laboratories Corp. (Helena) warrants to the ORIGINAL PURCHASER ONLY (Purchaser) that the disk on which the computer program is contained shall be free of defects in materials and workmanship under normal use for 6 months from the date of purchase.
AggRAM ONE - Instrument Use and Function Section 1 - Instrument Use and Function The AggRAM (Figure 1–1) is a platelet aggregation recorder. It measures human platelet aggregation absorbance method using up to four channels per module simultaneously. The absorbance curve for each channel is displayed during data acquisition.
AggRAM TWO - Principles of Operation Section 2 - Principles of Operation absorbance is caused by light scattered by the floating platelets in the solution. This A block diagram of the AggRAM system is absorbance is nearly proportional to the shown in Figure 2–1.
AggRAM TWO - Principles of Operation calibrator dilutions added proportional to the number of platelets in the platelet/ristocetin mixtures and the reaction solution. The photo detector converts the measured. The slope of the reaction light intensity into an analog signal, which is (agglutination vs.
AggRAM TWO - Principles of Operation Keyboard and Monitor Mouse Memory Printer Magnetic Disk Drive Computer Stirrers Heaters and Temperature Monitors Optics Figure 2–1 Block Diagram...
100,000/mm have a quantitative 3.17. Installation should not be attempted platelet problem irrespective of any qualitative unless a representative of Helena Laboratories, or functional defect. its subsidiaries, or its distributors is present, or, verbal or written permission to proceed has...
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AggRAM THREE - Precautions and Limitations Laboratories, subsidiaries, distributors. 3.18. Instructions for the "responsible body*" (*Under IEC 61010–2–101:2002 –– the person(s) responsible for the use and maintenance of equipment and for ensuring that operators are adequately trained for eliminating and reducing hazards involved in removal from use, transportation, or disposal.) 3.19.
AggRAM FOUR - Hazards Section 4 - Hazards 4.1. If the instrument is used in a manner not specified by this manual, the protection provided by equipment design may be impaired. 4.2. This device contains very high voltages that extremely dangerous.
4. Inspect the instrument for any obvious 5367 Epinephrine signs of damage. If damage is found, notify 5368 Collagen the shipping carrier and Helena Laboratories. 5369 Platelet aggregation Kit 5370 Ristocetin Cofactor Assay Kit 5. Inventory all items: If any parts are missing,...
3. Plug the other end of the printer interface Transformer specifications are available from cable into the USB port on the back of the Helena Laboratories. computer. 5.2.2. Component Interface and 4. Plug the female end of the power cord into Power Connections the back of the printer.
ID and password will also monitor, the system is operating correctly. If have to be entered in the Login window. an error message appears instead, refer to section 10.2. 8. Place the label onto the computer for reference if contacting Helena Laboratories.
5.4.3. Module Identification 5. Return the report and calibration printout to multiple modules in use, once Helena Laboratories per the instructions on installation of the entire system is complete, the report. determine the letter designation of each module. Access...
AggRAM FIVE - Installation Instructions 5.6.3. HemoRAM/AggRAM Displays and Manual In understanding this manual, keep the following things in mind: “click” or “double click” – refers to the instructions given in section 5.6.1. “field” – is the area into which information is entered.
AggRAM FIVE - Installation Instructions Ambient Wells Channel Buttons Optics Cover Filter Communication Status (Light on indicates the sending/ Power Status receiving of (Light on information) indicates power is on) Figure 5–2 AggRAM Module...
AggRAM SIX - Setup Section 6 - Setup 6.1. Patient Demographics 1. Turn power on for the module, printer, and The patient demographics setup for use are monitor, and then for the computer. the same for all tests. Once patient demographics are setup and data has been ®...
AggRAM SIX - Setup not a per test setting. Select this feature if it is Multi–Reagent/Concentration Tests – preferred that certain patient demographic following applies to each set of four channels in information is entered in a standardized way. use: Otherwise, inactivate this feature.
AggRAM SIX - Setup 4. No. of Modules to use for test – if more f. Test Sequence – For information on this than one module is in use, use the drop down feature, see section 6.2.3. list to select the applicable number. g.
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AggRAM SIX - Setup Factory Programmed c. Concentration – select from the drop Ristocetin Cofactor Test down list or use the keyboard to enter/alter. To delete a concentration from the list, select Channel Unit of Measure Concentration the appropriate one and double–click. Confirm message displays.
AggRAM SIX - Setup 6.2.3. Test Sequence 7. To exit, select the X located on the top right of the window. 1. From the Test Parameters window, select Test Sequence for the desired channel. 8. If a Confirm window displays, changes were made and not saved.
AggRAM SIX - Setup 6. Save – select to save the currently c. Month–to–Date – select for the mean to displayed Shown list. be automatically figured based on all the QC per lot for a user specified period (section 7. To exit, select the X located on the top right 7.7.11).
AggRAM SIX - Setup if the Mean Calculation Method in use is 11. If a Confirm window displays, changes Assigned. were made and not saved. To save the changes and proceed, select Yes. 9. Save – select to save the currently proceed without saving, select No.
AggRAM SIX - Setup 6. To exit, select the X located on the top right a. View/Edit (File –> View/Edit File –> of the window. Print) 7. If a Confirm window displays, changes i. Include with TestTypes: – were made and not saved. To save the accessible with View/Edit selected.
AggRAM SIX - Setup Auto–Output Parameters window (Error! Reference source not found.) displays: 1. For each of the Run Types needed, select Display and/or LIS from the Devices columns have test data automatically displayed/sent once a run is complete. Regardless of the selections made on this window, test data can be transmitted and/or displayed at user request (section 7.7).
AggRAM SEVEN - Operating Instructions Section 7 - Operating Instructions their laboratory. All default settings for the AggRAM are for Micro volumes; however, the 7.1. Preparing the Instrument for Use settings can be altered if using Standard volumes (section 6.2.1). 1.
AggRAM SEVEN - Operating Instructions into a cuvette. If the channels will be used for different patients and/or controls, prepare each of the needed PPPs. Set the PPP each PRP sample, which set the 0% blank(s) aside. aggregation level, and the PPP value, which set the 100% level.
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AggRAM SEVEN - Operating Instructions Volumes 6. Prepare the needed aggregation blank: Pipette, into a cuvette with a stir bar, the Micro Standard needed volumes (micro or standard) of Platelet 125µL 250µL platelet suspension and Tris–buffered saline. suspension 7. Use the aggregation blank to set 100% Tris–buffered 125µL 250µL...
AggRAM SEVEN - Operating Instructions 12. Withdraw the pipette tip from the cuvette Westgard Failure Resolution, see section taking care not to pull the cuvette up. 7.7.11. 13. If the Steps window is displayed, the 0% 21. Once all cuvettes have been removed, activity value is shown as PRP O.D.
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AggRAM SEVEN - Operating Instructions and 3) the correct demographic and standard b. Pipette the needed volume (micro or parameters are entered for all, and only, the standard) of platelet suspension into the channels to be used. The parameters are cuvette(s).
AggRAM SEVEN - Operating Instructions the data is exported and/or the View/Edit 3. Grid/List – allows the user to enter the table window displays the results, see section 7.7. in a table format. 20. With Westgard rules in use, if a QC was 4.
AggRAM SEVEN - Operating Instructions worklist, select Yes. To retain the worklist, (section 6.1). Enter using the keyboard or the select No. drop down list. With a selection made for channel 1, to copy that same selection to the 4. Worklist – other channels, select Copy Ch1 PatID.
AggRAM SEVEN - Operating Instructions 3. Delete – with a worklist displayed, select to Copy Ch1 Std. All the channels to be used remove the worklist. A Confirm message must have a selection. displays. To permanently remove the e. Concentration – select from the drop worklist, select Yes.
AggRAM SEVEN - Operating Instructions 5. TestType – confirm as selected or use the 7.6. Run and Steps Windows drop down list to select Ristocetin Cofactor. 7.6.1. Run Window Prior to 6. RunType – confirm as selected or select Beginning a Test Standard.
AggRAM SEVEN - Operating Instructions 7.6.2.1. Abort Run 7.6.2.3.2. View If the entire test needs to be aborted, from the From the Run window, select View and then Run window, select Abort Run. If needed, one of the following: individual channels can be aborted, see 1.
AggRAM SEVEN - Operating Instructions 7.6.2.3.5. Stop 10. PPP O.D. From the Run window, select Stop and then a. For Platelet Aggregation tests, PPP either Stop All Channels or the applicable O.D. indicates the 100% aggregation value of channel number to stop the step that the the platelet poor plasma blank.
AggRAM SEVEN - Operating Instructions 6. To delete the curves within a worklist or an b. Preview/Export/Print – select to access entire worklist, see section 7.7.6. the Report Preview window (Figure 7–7). See section 7.7.5 for information on this 7. With Platelet Aggregation curve...
AggRAM SEVEN - Operating Instructions the slope is either a negative or zero. The square that is now blinking or the slope's slope must be corrected, either re–edited or arrow buttons to change the slope location. returned to the automatic slope selection, to 4.
AggRAM SEVEN - Operating Instructions Slope Search Start. The Slope Search Start and apply the selections made, select Apply window displays. Use the keyboard to and OK. To exit the window without applying enter/alter the number of seconds to delay the selections, select Cancel.
AggRAM SEVEN - Operating Instructions the desired worklist. The following describes 8. Once all the needed selections are made, the drop down lists based on the selected the desired worklist/curve chart, demographic search criteria: information, and/or result parameters are displayed according to the current View a.
AggRAM SEVEN - Operating Instructions d. Select Start. Once selected, View/Edit window provides the additional search criteria Select 2. With the current data achieved, the Curve Sequence Number. If the worklist previously stored data is retrieved by making contains multiple channels matching the the following selections: search criteria (section 7.7.3), use these a.
AggRAM SEVEN - Operating Instructions b. To add only specific curves from the 7.7.4.6. Display Demographics displayed worklist, select No and a second To toggle between the demographics (Figure Confirm prompt displays: 7–8) being displayed and not displayed, with i. To add the curve sequence number at least one patient curve displayed, from the indicated, select Yes;...
AggRAM SEVEN - Operating Instructions 1. M – indicates the slope has been manually iii. Select a Page – select, enter the edited. desired page number, and select OK to view a different page of a multi–page report. 2. N/A – indicates the slope is less than or equal to zero.
AggRAM SEVEN - Operating Instructions 2. If a multi–curve worklist is displayed, the 7.7.8. Limit Days first Confirm prompt displayed allows for all Limit to Days is available for use with all the curves in the worklist to be deleted. Search criteria except Date Range and Date a.
AggRAM SEVEN - Operating Instructions 5. See section 7.7.10.1 through 7.7.10.3 for c. This prompt allows for the next curve in information on the features available on this the worklist to be deleted. Continue as window. needed to delete the appropriate curves. 6.
AggRAM SEVEN - Operating Instructions See section 7.7.5 for information on this 3. Enter Final Activity – enter/alter using the window. keyboard. c. Print – select to access the Print 4. Cancel – select to exit the window without window and either select OK to print or see entering a point.
AggRAM SEVEN - Operating Instructions 6. Cancel – select to exit without altering the 11. To exit, select the X on the top right of the begin date. window. 12. If a Confirm window displays, changes 7.7.11.8. Westgard Resolutions were made and not saved. To save the 1.
AggRAM SEVEN - Operating Instructions 2. Select Function – select the option needed. displays, answer as needed. The data is The options available depend on the selection handled as specified. made for Section. 7. To exit, select the X located on the top left a.
AggRAM SEVEN - Operating Instructions 12. The disc is ejected once complete. 5. To exit without saving, select Cancel. Remove the CD and label it appropriately. 7.11. Error Messages 7.9. Change Operator To view recent error messages, either select To change the Operator ID in use, from the F2 or, from the main menu, select File, and main menu, select File, and then Change then Error Messages.
To view the version number of the currently loaded software, from the main menu, select Help and About. The About window displays the software version number, the software serial number, and Helena Laboratories contact information. 7.14. Results Adobe Reader is a registered trademark of Adobe...
AggRAM SEVEN - Operating Instructions Run Window – Platelet Aggregation Run Window – Ristocetin Cofactor – Standard Run Window – Ristocetin Cofactor – Patient Run Window – During a Test Figure 7–2 Run 7-27...
AggRAM EIGHT - Quality Control Section 8 - Quality Control 8.2.4. Westgard Rules The instrument automatically performs a self– The software automatically keeps a record of test any time the power is turned on. Should control values from each run. Five Westgard an error message appear on the display, see Rules are included in the software to allow section 10.2.
AggRAM NINE - Instrument Specifications Section 9 - Instrument Specifications Test Types: Platelet Aggregation and Ristocetin Cofactor Charts: –20% to 110% activity (± 0.5%) versus time Absorbance Range: 0.0 to 2.0 O.D. Optical Chambers per module: Four chambers for combined or individual measurements Cuvettes: 8 mm x 60 mm (silicone coated glass)
1. Beginning from the main menu, select File, maintenance procedures. For instrument Maintenance, and Optical Channel Check. calibration or for maintenance not described 2. The Optical Calibration Check window in this manual, call Helena Laboratories for (Figure 10–2) displays. Note that any assistance. previously obtained...
11. To exit, select the X located on the top any additional calibration must be performed by right of the window. Helena Laboratories or their representatives. 12. Once all cuvettes have been removed, User IDs with Run Only access cannot perform replace the optics cover.
AggRAM TEN - Maintenance, Troubleshooting, Warranty 10. Repeat steps 8 and 9 for each channel 2. The Module Parameter Entry window (for all modules). (Figure 10–4) displays. 11. Once both scale sets are run, the Result 3. For each module in use, a letter is displayed. (V/O.D.) for each channel is calculated and Select the letter of the Module needed.
AggRAM TEN - Maintenance, Troubleshooting, Warranty the Temperature Offset is as needed, select Save to save the parameters displayed. 5. To obtain a printout of the selected module's parameter information, select Print. 6. To exit, select the X located on the top right of the window.
AggRAM TEN - Maintenance, Troubleshooting, Warranty 10.2. Troubleshooting If the recommended solutions should fail to solve a problem, call Helena Laboratories for assistance. Table 10–2 Troubleshooting Problem Possible Cause(s) Solution No power to instrument Power cords unplugged Plug cords into properly grounded wall outlet.
Solution At power on, no response Not plugged in Check connections at both ends of power cord. Electrical problem Call Helena Laboratories. At power on printer is not Printer power off Press power button on printer. ready Printer off line Reset printer for use.
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–– division by 0) (or curves associated with the npts<3 –– npts–2 is a denominator – standard. – therefore division by 0) WARNING: Stir motor(s) for Stir motor(s) stopped. Call Helena Laboratories. channel(s): n of Module X stopped Sensor failure. running during WrkLstNum=–nnnn." 10-10...
The foregoing warranties are in lieu of all warranties expressed or implied, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. In no event will Helena Laboratories liable indirect, incidental consequential damages; the original user’s...
AggRAM 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 injury –...
AggRAM TWELVE - Communication Specifications Section 12 - Communication When exporting, the HemoRAM software will Specifications recognize an XOFF character and stop transmission until an XON character is INTERFACE SPECIFICATIONS: received. There is no error checking or HemoRAM software import/export correction when using this protocol.
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AggRAM TWELVE - Communication Specifications it is ready. With this sequence of events, the C1 – first character of checksum establishment phase ends and the transfer "0" – "9" & "A" – "F" phase begins. C2 – second character of checksum "0"...
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AggRAM TWELVE - Communication Specifications 1 – any character errors are detected (parity sets a timer. If an <ENQ> is not received error, framing error, etc.) within 20 seconds, a timeout occurs and the receiver regards the link to be in the neutral 2 –...
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For a patient: O|1||7|^^^Platelet Aggregation HemoRAM software transmits a header ^*Screen1^Collagen^Patient^104551188||||||||| record, it will have the following format: ||||||||||||F H|\^&|||Helena Laboratories^HemoRAM^n.n For a QC: O|1||123|^^^Ristocetin ^Ristocetin .n.nn^Sns|||||||P|1394–97|yyyymmddhhmmss ^Ristocetin^QC^2035301– If the message is being sent for a QC rather 2^1^SomeStandard ^99.9...
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AggRAM TWELVE - Communication Specifications The HemoRAM software currently does not For QC result record: R|1|^^^^^^^^^^^50^ recognize test order records transmitted by FinalActivity|13.80|%||||F|||20020502094336|2 the computer system. 0020502094546| Result Record For a standard result record: R|1|^^^^^^^^^^ ^^Activity|66.4|%||||F|||20050502082335|2005 Each parameter will be transmitted as a 0502094546| separate result record.
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AggRAM TWELVE - Communication Specifications StdRefID – For a standard or any run referencing a standard, this is the ID of that standard. For a reference, this is the ID of that reference. RefLvl – If this run references a standard, then this is the Reference level associated with that standard.
AggRAM THIRTEEN - Reports Section 13 - Reports The following is a list of possible symbols used on reports and their meanings: 1. L – indicates the PRP O.D. is out of range, less than 0.2, implying low platelet count or that calibration may be off.
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AggRAM System Catalog Number 1484 and 1487 Software Version 1.3.3.0 Operator’s Manual For additional information, call Helena Laboratories toll free at 1–800–231–5663. Helena Laboratories Helena Laboratories UK, Ltd., P.O. Box 752 Queensway South, Beaumont, TX 77704-0752 Team Valley Trading Estate,...
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