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ABX Pentra 80 RAB108EA, User Manual

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Pentra

80

8–2

Pentra

80 - User Manual - RAB108EA

Section 8: Specifications

PENTRA 80

specifications includes the following:

1. Technical specifications,

2. Physical specifications,

3. Summary of performance data*,

4. Limitations,

5. Reagent Specifications,

1. Technical specifications

PENTRA 80

system is a fully automated hematology anlyzer used for the in vitro diagnostic

testing of whole blood specimen.

1.1. Parameters

Tab. 8–1: CBC Parameters

PCT, PDW, ALY and LIC have not been established as indications for this product, in
the United States. The use of PCT, PDW, ALY and LIC should be restricted to research
and Investigational measurements only.

WBC

White Blood Cell

RBC

Red Blood Cell

HGB

Hemoglobin Concentration

HCT

Hematocrit

MCV

Mean Corpuscular Volume

MCH

Mean Corpuscular Hemoglobin

MCHC

Mean Corpuscular Hemoglobin Concentration

RDW

Red Distribution Width

PLT

Platelets

PDW

Platelets Distribution Width

MPV

Mean Platelet Volume

PCT

Plateletcrit

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Summary of Contents for Pentra 80 RAB108EA

Page 1: ...User Manual P n RAB108EA ABX Diagnostics B P 7290 34184 MONTPELLIER Cedex 4 FRANCE...

Page 2: ...potentially hazardous conditions one of the bold captioned headings which are described below is provided wherever necessary throughout this text Flags a procedure that if not followed properly can pr...

Page 3: ...1 9 3 5 Electromagnetic environment check 1 9 3 6 Environmental protection 1 9 3 7 Transportation and storage conditions 1 10 3 8 Installation 1 10 3 9 Interconnections 1 11 3 10 Racks 1 12 4 Software...

Page 4: ...Open tube 2 7 3 Running specimen 2 9 3 1 Sample identification with internal barcode reader 2 9 3 2 Non identified sample with external barcode reader 2 9 3 3 Stat mode 2 11 3 4 Run in progress 2 12...

Page 5: ...Data Grid screen 3 17 2 4 Batch content 3 18 2 5 XB limits 3 19 3 Within run 3 20 3 1 Accessing the Within Run Data Grid 3 20 3 2 Closed tube sample setting 3 22 3 3 Running cycles 3 22 4 Calibration...

Page 6: ...rklist function 4 14 2 3 Worklist grid 4 15 2 4 Rack view 4 20 3 Sample collection mixing 4 24 3 1 Recommended anticoagulant 4 24 3 2 Blood sample stability 4 24 3 3 Microsampling 4 24 3 4 Mixing 4 24...

Page 7: ...f variation ranges 5 12 4 Rules 5 13 4 1 Accessing the Rules screen 5 13 4 2 Rerun conditions 5 13 4 3 Print conditions 5 15 4 4 Transmit conditions 5 16 5 System 5 17 5 1 Accessing the System screen...

Page 8: ...6 8 1 Accessing the Types parameters menu 5 33 8 2 Pathological limits 5 36 8 3 Alarms Curve thresholds 5 37 8 4 Age range 5 41...

Page 9: ...iew 6 2 1 2 Left side view 6 2 1 3 Right side view 6 3 1 4 Stat tube holder 6 3 1 5 Rear view 6 4 2 Automatic mode principles 6 5 3 Measuring principles 6 9 3 1 Multi distribution sampling sytem MDSS...

Page 10: ...19 3 3 Right hand side panel removal 7 19 3 4 Left hand side panel removal 7 20 4 Service menu description 7 21 5 Super User menu description 7 22 5 1 Mechanical menu 7 23 5 2 Hydraulical menu 7 30 5...

Page 11: ...ion ratios 8 5 2 6 HGB measurement 8 5 2 7 Counting aperture diameters 8 5 2 8 Reagent consumption ml 8 6 2 9 Recommended Anticoagulant 8 6 3 Summary of performance data 8 7 3 1 Precision Reproducibil...

Page 12: ...10 Section9 Glossary 1 Glossary 9 2 2 Index 9 4 3 9 11...

Page 13: ...mperature conditions 1 9 3 5 Electromagnetic environment check 1 9 3 6 Environmental protection 1 9 3 7 Transportation and storage conditions 1 10 3 8 Installation 1 10 3 9 Interconnections 1 11 3 10...

Page 14: ...he use of any other reagents and accessoiries may place at risk the perfor mance of the instrument engaging the Users reponsability In this case ABX Diagnostics takes no responsability for the device...

Page 15: ...ry always use the same and or equivalent type recommended by the manufacturer Dispose of used batteries according to the manufacturer s specific instructions Moving parts It is strictly forbidden to d...

Page 16: ...C Standards and Directives named in the Declaration of Conformity Caution consult accompanying documents Biological risk Reagent Up Fragile handle with care Keep dry Do not stack Temperature limitatio...

Page 17: ...Introduction Labels Pentra 80 User Manual RAB108EA 1 5 2 Labels 2 1 Input Output Labels Fig 1 1 Rear panel labels 2 1 1 Identification label Fig 1 2 Serial number label...

Page 18: ...ion used for Waste level detection on Waste Alarm posi tion Diluent input Connection used for Diluent input tubing on Diluent position Fig 1 3 Reagent and waste label 2 1 3 Output label Fig 1 4 Ouput...

Page 19: ...troduction Labels Pentra 80 User Manual RAB108EA 1 7 2 2 PC connections label Fig 1 5 Internal PC connections 1 Mouse 2 Keyboard Refer to 3 9 Interconnections page 1 11 for other peripheral connection...

Page 20: ...iagnostics representative for information regarding operation locations when it does not comply with the recommended specifications 3 2 Location The Pentra 80 should be placed on a clean and leveled t...

Page 21: ...fore it can be used for operation 3 5 Electromagnetic environment check The Pentra 80 has been designed to produce less than the accepted level of electromag netic interference in order to operate in...

Page 22: ...3 8 Installation An ABX Diagnostics representative will install your instrument software and printer Package contents Verify that all of the parts from the package list are present Tab 1 1 Package lis...

Page 23: ...2 2 PC connections label page 1 7 Fig 1 7 Computer connections 3 9 2 Printer connection see 2 1 3 Output label page 1 6 3 9 3 Reagent connections see 2 1 Reagent replacement page 7 5 1 VGA 2 Mouse 3 K...

Page 24: ...s The ABX PENTRA 80 racks are identified on the system by means of Barcode labeling These labels must be placed on the racks in the following manner Fig 1 8 Rack barcode Identification and Rack type F...

Page 25: ...Contextual toolbar see 4 2 Contextual toolbar description page 1 15 on the right The Main menu access keys see 4 3 Main Menu description page 1 16 are featured in the center portion of the touch scree...

Page 26: ...2 Contextual toolbar Keys Name Function Description Help Help Brings up the help file Details Details Details displays supplementary information Insert Insertion Inserts new data Edit Modification Ed...

Page 27: ...Stop Stops the analyzer Alarm Launches Alarm menu Flashes when an alarm is triggered See Section 7 8 Error messages page 7 43 Worklist Opens Worklist Displays the number of orders See Section 4 2 Work...

Page 28: ...e gauge on the bottom status bar progresses at the same time as the cycle Logs Launch the Logs menu Section 3 5 Logs page 3 32 Quality Assurance Launches the Quality Assurance menu Section 3 Fig 3 1 Q...

Page 29: ...re status Menu headings are displayed at the top of the screen when a menu is selected Hints can be displayed by moving and holding the cursor on menus keys see Fig 1 11 page 1 17 Fig 1 11 Software ar...

Page 30: ...er or edit data within the menu The Edit key must be selected to access a Scrolling list Fig 1 13 Scrolling list 4 4 4 Checked box A Checked Box will enable or disable an option in a specific menu Pla...

Page 31: ...elected to modify the Radio button 4 4 6 Data Fields These fields are rectangular areas within a specific menu that are used to display input or edit specific information within each field For example...

Page 32: ...6 data Fields The Edit key must be selected to modify a data field 4 4 7 Sliders When data can not be displayed within the same window a horizontal or vertical slider will appear Drag it or click the...

Page 33: ...w page 1 25 For sample Runs and Results see 5 3 Runs and results overview page 1 24 These menus are defined as followed 5 1 Order overview An order is the set of data which is used for requesting an a...

Page 34: ...Pentra 80 1 22 Pentra 80 User Manual RAB108EA Fig 1 18 Order management Patient Sample Service Order LIS P80...

Page 35: ...are removed from the Worklist after analysis The minimum information required for an order is Sample Id Sample type Male Female ect Test to perform CBC or DIF Fig 1 19 Orders and Sample ID New entries...

Page 36: ...s are defined as Runs Individual parameter se lection allows an easier verification of the final result Sample results are determined from runs automatic reruns and manual runs required for an order S...

Page 37: ...ults that can be accessed by the user Using two different modes available on the PENTRA 80 can access the archives Review by date or Review by patient Fig 1 21 Review by date See Section 4 7 Results A...

Page 38: ...Pentra 80 1 26 Pentra 80 User Manual RAB108EA Fig 1 22 Review by Patient Search by Patient Id Date 1 Date 2 Date 3 Date 4...

Page 39: ...to a specific order Fig 1 23 Matched results Unmatched Results Results without any order indicated Fig 1 24 Unmatched results Order 1 Order 2 Order 3 Order n Sample Id1 Sample Id2 Sample Id3 Sample I...

Page 40: ...Pentra 80 1 28 Pentra 80 User Manual RAB108EA 6 Printer Use the printer supplied or approved by ABX DIAGNOSTICS...

Page 41: ...Quality Control 2 7 2 1 Closed tube Mode with barcode 2 7 2 2 Open tube 2 8 3 Running specimen 2 10 3 1 Sample identification with internal barcode reader 2 10 3 2 Non identified sample with external...

Page 42: ...5 1 1 Waste levels At the beginning of each operating day check the Waste container to see if it may need to be emptied Wastes must be handled according to your local national regulations See Section...

Page 43: ...r the available options checked or unchecked are recorded See Nota on next page When the computer boots up to the Login informa tion window press CTRL ALT and DEL or CTRL ALT and SUPPR simultaneously...

Page 44: ...a new working day date changed the Begin of day time See A on Fig 2 1 System screen page 2 4 is over Fig 2 1 System screen The background count results are printed out Verify that the Background count...

Page 45: ...80 User Manual RAB108EA 2 5 1 4 Status Press the Status key of the Main Menu screen This screen indicates the current levels of reagents If reagents levels are low and need repla cement refer to Secti...

Page 46: ...aterial is specifically designed for use on the ABX PENTRA 80 which includes a com plete Blood Count and 5 part White blood cell differential CBC DIFF Features include Barco des batch numbering logs e...

Page 47: ...See Section 3 1 6 New blood control setup page 3 10 2 Rerun the control material 3 Perform a concentrated cleaning on the system See Section 7 5 2 4 Clean Cycles page 7 33 then rerun the control mater...

Page 48: ...r door re opens remove and recap the vial If any parameter results and or any statistical data are displayed in red perform the following steps 1 Verify that the analyzed QC results correlates with co...

Page 49: ...er 3 2 Non identified sample with external barcode reader Position the sample tubes into the cassettes as indi cated in the picture barcode label facing out and to the front Place the cassette into th...

Page 50: ...wed 1 Sample information 2 Patient information 3 Test selection CBC yellow DIF green Press the OK key to confirm the order of each sam ple tube Place the tube in the rack then repeat the data entry fo...

Page 51: ...k Press the STAT MODE key The Stat order screen will be displayed as Enter the identification information of the sample that you run as a STAT Sample ID Use the Search Sample key if the sam ple has al...

Page 52: ...e automa tic mode is interrupted Place the STAT sample into the appropriate position of the tube holder and close the tube holder door When the Stat analysis is complete the tube holder door will open...

Page 53: ...ge 2 14 4 1 Printing a result series Results of the day can be reviewed by selecting the RESULTS key on the generic toolbar located on the right vertical portion of the touch screen Place a Check in t...

Page 54: ...a 80 2 14 Pentra 80 User Manual RAB108EA 4 2 Unmatched results Unmatched results are sample results that are not mat ched to a Worklist order These results can be reviewed by selecting the ASSOCIATION...

Page 55: ...ric toolbar Open the calendar of the Daily results view select Running Date and then select the date of the results you wish to review Press the PATIENT RESULTS key Press the SEARCH PATIENT key and ty...

Page 56: ...erformed at least once a day The Shutdown cycle can be programmed for specific cycle intervention if needed See Sec tion 5 5 5 Cycle option page 5 25 or manually activated by selection From the Main M...

Page 57: ...aphs 3 16 2 3 XB Data Grid screen 3 17 2 4 Batch content 3 18 2 5 XB limits 3 19 3 Within run 3 20 3 1 Accessing the Within Run Data Grid 3 20 3 2 Closed tube sample setting 3 22 3 3 Running cycles 3...

Page 58: ...Pentra 80 3 2 Pentra 80 User Manual RAB108EA 5 7 Error logs 3 35 5 8 Host logs 3 35 5 9 Blank cycle logs 3 35 5 10 Patient logs 3 36...

Page 59: ...the Quality Assurance key from the Main Menu screen Fig 3 1 Quality Assurance access key Four functions are available in this menu Quality Control see 1 Quality control page 3 4 XB see 2 Patient Quali...

Page 60: ...stability of the instrument A total of 24 Control lots can be saved in Quality control All QC functions are described in the following sections 1 1 Access to the Quality Control Menu page 3 4 1 2 L J...

Page 61: ...n a full screen mode see Graphics screen page 3 8 Control Name Selection of a new control lot see Selection of a control page 3 10 24 controls can be saved 12 in CBC 12 in DIF Tab DIFF CBC Switches fr...

Page 62: ...e parameter view can be made by selecting the parameter tabs WBC RBC HGB HCT PLT MPV MCV MCHC HCT MCH and NEU EOS BAS LYM MON see Fig 3 3 page 3 6 The date displayed is the date of the control run whi...

Page 63: ...its The coefficients of variation are displayed in red when they are greater than the coeffi cients set by the operator See Section 5 3 4 Coefficients of variation ranges page 5 12 When a Quality Cont...

Page 64: ...ol lot 1 4 Graphics screen From the L J Graphs or Data screen grid select the Matrix key to display the last QC result Fig 3 5 QC graphics screen Flag and alarm definitions are described in detail in...

Page 65: ...n Selected Unselected and ALL results can be printed by selec tion choice as indicated in Fig 3 6 page 3 9 Fig 3 6 QC print options L J graphs L J graphs can also be printed from the L J Graphs screen...

Page 66: ...or to the analysis of the new lot Selection of a control Select the Target key see Tab 3 1 Quality Control Keys page 3 5 in order to open the Target modify window Scroll through the Control name list...

Page 67: ...entry Read the label with the external Barcode reader or manually type in the lot Use the Tab key to move to the next field or entry Confirm your entry by selecting the OK key If you use the control b...

Page 68: ...ue By selecting the tab Threshold you can also modify threshold and Alarm levels Fig 3 11 Control expiration date Use the scrolling box key to open a calendar and select the expiration date Modify or...

Page 69: ...and close the door to the backwards position When the analysis is complete the QC results will automatically be saved in the QC menu for that specific lot 1 7 2 Running in Rack mode With barcode labe...

Page 70: ...y Reject and or DIL flags and an RBC and HCT result within the clinical life sustaining categories which have neither reject nor DIL flag a RBC result higher than 100 103 mm3 and HCT higher than 0 7 a...

Page 71: ...2 XB keys Key Name Function Details Switches from LJ Graph to Data Grid screen see 2 3 XB Data Grid screen page 3 17 Target Access to XB limit modifying screen see 2 5 XB limits page 3 19 XB Displays...

Page 72: ...e the Print Transmit key to print out XB graphs 60 total points Use the Parameter Tab keys to select between parameter groups For the XB limit values the Red line indicates the Maximum limit the Green...

Page 73: ...number The running date and limit values are also included The Statistical data includes the mean of all the batches Standard deviation and Coefficients of variation When the Batch values and or Means...

Page 74: ...ts Fig 3 16 XB Batch content A Maximum of 5 results may be de selected from the last batch only Select the Check Box es to de select results to be excluded from the statistical calculations The number...

Page 75: ...cal function flags page 4 46 If the printer is selected a message XB is printed out This flag can also be transmitted via the data output if it has been activated from the RS output format If a printe...

Page 76: ...lyses of the same blood sample Sections detailed in Within Run 3 1 Accessing the Within Run Data Grid page 3 20 3 2 Closed tube sample setting page 3 22 3 3 Running cycles page 3 22 3 1 Accessing the...

Page 77: ...Delete Deletes Unselected Selected or All results see 3 3 4 Print Transmit or delete Results page 3 23 Print Transmit Prints selected or all results or Statistics only Sends selected or all results se...

Page 78: ...1 15 Once the STAT key has been selected the tube holder door opens Place the sample tube in the appropriate position of the tube holder Close the tube holder on the rear position the analysis cycle b...

Page 79: ...ariation will be displayed in red if it is greater than the upper limit established by the operator Section 5 3 4 Coefficients of variation ranges page 5 12 Results can be excluded from the statistica...

Page 80: ...Fig 3 21 Print Send Within run results Delete results Open the Within Run Data Grid screen Using the Delete key see Tab 3 3 Within Run keys page 3 21 discard the unselected selected or all results fro...

Page 81: ...n close tolerances of known target values and limits Coefficients of variation and percent difference recovery must be within their specified limits Sections detailed in Calibration 4 1 Accessing the...

Page 82: ...g 3 24 Editing the target values Select the Edit key to edit the target fields Read the barcode label on the calibrator with the external Barcode Reader or type in all the calibrator information using...

Page 83: ...needs to be entered into the system follow the procedure as described in 4 2 Target values page 3 26 Open the Calibration Grid as described in Accessing the Calibration Main Menu page 3 25 Select the...

Page 84: ...he statistical calculation select the check box see Fig 3 25 page 3 28 to remove the mark To remove Parameters from the Coefficient calculations select the check box see Fig 3 25 page 3 28 to remove t...

Page 85: ...e shall request confirmation to continue When running calibration a warning message appears on the screen stating a Forced cal ibration has been detected another message will appear asking you if you...

Page 86: ...culations by selection of the Check Boxes in the Calibration Results Grid see Fig 3 27 page 3 30 Press the Print key of the Contextual Toolbar to open it Fig 3 27 Print and send windows Fig 3 28 Calib...

Page 87: ...Quality Assurance Calibration Pentra 80 User Manual RAB108EA 3 31 Fig 3 29 Delete options...

Page 88: ...ctions are described in 5 1 Access to Logs function page 3 32 5 2 Calibration logs page 3 34 5 3 Quality control logs page 3 34 5 4 Reagent logs page 3 35 5 5 Settings logs page 3 35 5 6 Maintenance l...

Page 89: ...Reagent Launches Reagent log screen see 5 4 Reagent logs page 3 35 Settings Launches settings log screen see 5 5 Settings logs page 3 35 Maintenance Launches Maintenance log screen see 5 6 Maintenanc...

Page 90: ...hange a notification is done For every rejected analysis in calibration a notification is done When an analysis is launched with an expirated calibrator a notification is done 5 3 Quality control logs...

Page 91: ...ost logs Each time a file from the Host is rejected a notification is done This rejection is generated in the software rather than the raster when for example An order is pending a ReRun The rack on w...

Page 92: ...done When exception is generated because of the mismatch of the rack position of the sample and the order Section 4 1 7 Exception management page 4 11 a notification is done When the user match an or...

Page 93: ...1 9 Patient file management 4 13 1 10 Loading Worklist from the LIS 4 13 2 Worklist 4 14 2 1 Overview 4 14 2 2 Accessing the Worklist function 4 14 2 3 Worklist grid 4 15 2 3 1 Creating an order 4 16...

Page 94: ...the Result list 4 47 6 1 2 Result list function keys 4 47 6 1 3 Result Grid information 4 48 6 1 4 Sorting out 4 49 6 1 5 Result Filters 4 49 6 1 6 Result display 4 50 6 1 7 Result display keys 4 50...

Page 95: ...ge 4 3 1 2 Workflow page 4 4 1 3 Worklist page 4 4 1 4 Sample identification page 4 5 1 5 Barcode Identification page 4 5 1 6 Sample identification on Rack position page 4 8 1 7 Exception management p...

Page 96: ...tion of a sample tube selection of the test to be performed CBC or DIFF Selection parameter ranges according to the specific blood types i e Male Female Child etc the creation of a patient file and pa...

Page 97: ...cess Orders are deleted once the sample analysis is complete 3 modes of sample identification are available Barcode identification see 1 5 Barcode Identification page 4 5 Rack Position identification...

Page 98: ...this mode it is impossible to allocate a position for the tube in the worklist Fig 4 2 Barcode Manual match OFF The P80 tab Settings Soft parameters General tab barcode option is set as shown Section...

Page 99: ...l match ON The P80 tab Settings Soft parameters General tab barcode option is set as shown Section 5 2 2 5 Identification option page 5 7 Barcode reading Problem Matching screen Identification re done...

Page 100: ...in the rack The Sample ID field is now available for manual entry but it is not mandatory to do so If the sample tube position in the rack was indicated the final results will contain sample identifi...

Page 101: ...position Manual match ON The P80 tab Settings Soft parameters General tab barcode option is set as shown Section 5 2 2 5 Identification option page 5 7 Result identification Rack x Position y Auto Nu...

Page 102: ...ig 4 5 Rack position Manual match ON Result identification Rack x Position y Order and sample Matching screen Matched with an order Worklist sample identification P80 analysis process matched Sample d...

Page 103: ...or when a barcode label cannot be read Fig 4 6 Order result workflow Setting the exceptions criteria must be performed in the configuration of the Setting func tion Manual match on Exception Section 5...

Page 104: ...rrespond to the order position 1 1 which is identified 124 This tube is analyzed in the instrument default test The result and the order must be manually matched 1 7 2 Identification with barcode with...

Page 105: ...s followed AUTO_PID_xxx This mode will create limitations for sample pro cessing It is highly recommended that you use the Patient ID field to create a single Patient ID for each patient sample This f...

Page 106: ...from the worklist The orders are also removed from the worklist when the operator manually matches them to a result see 6 2 3 Results orders matching page 4 54 Orders can be entered into the Worklist...

Page 107: ...play of hidden information on the orders The right part aloows the creation modification of the orders in the Edit mode The Worklist patient file management depends on the specific working method for...

Page 108: ...e order details are displayed on the right hand side of the screen Fig 4 9 Sorting out by title clicked Select a column description or title to sort out the items within One click for ascending order...

Page 109: ...erun Indicates that order is a Rerun checked box Clinical information Department Department requesting the order Section 5 2 3 Department Physicians tab page 5 8 Selection list or cap ture enabled 20...

Page 110: ...g typed the Grid refreshes and displays the Sample list that corresponds to the characters entered When a specific Sample ID is located select the OK key to exit the screen and return to the Worklist...

Page 111: ...ig 4 12 Worklist printout window A Full printing and Light printing mode are available Full printing Order informations are printed out in the grid mode Patient clinical sample see Fig 4 13 page 4 19...

Page 112: ...key Fig 4 15 Capture of the rack number Read the Rack Number with the External Barcode reader to display the Rack graphics screen This Rack View will display the order information and test type reque...

Page 113: ...med on the sample Note the color of the indicators DIFF in Green CBC in Yellow If a test type is not selected an instrument Default test is performed DIFF The cursor automatically moves to the next ra...

Page 114: ...functions The operator is able to select an Empty tube to directly enter a new order specifically to this position If a rack is currently being processed order entry is not allowed If the tube positio...

Page 115: ...al RAB108EA 4 23 2 4 4 Printing the rack view From the rack view screen Select the Print send key Fig 4 18 Rack view print out The rack view printout ticket shows the patient informations the sample i...

Page 116: ...be itself Any incorrectly measured blood sample collections will show a possible variation in the results 3 1 Recommended anticoagulant The recommended anticoagulant is K3EDTA with the proper proporti...

Page 117: ...Workflow Running specimens Pentra 80 User Manual RAB108EA 4 25 4 Running specimens See Section 2 3 Running specimen page 2 9...

Page 118: ...e 4 26 5 2 Result screen page 4 27 5 3 Flags page 4 29 run results are displayed and printed out A result function allows the operator to review the run results of the day 5 1 Printer output format Th...

Page 119: ...alysis are automatically displayed as shown Flags appear on a tree view mode based on five categories Morphology Flags Analyzer Alarms Suspected Pathologies Quality Assurance Flags Remarks These flags...

Page 120: ...Zoom in feature A zoom feature is available for each parameter graphic RBC PLT BAS LMNE by selecting the histogram or matrix representation see Fig 4 20 page 4 28 Fig 4 20 Result display zoom Select t...

Page 121: ...s 5 3 2 Results exceeding Linear ranges of the instrument page 4 30 5 3 3 Analysis reject page 4 31 Flags linked to an abnormal morphology in the blood cell populations 5 3 4 LMNE matrix flags page 4...

Page 122: ...h D Dilution Parameter value may be replaced with D Tab 4 5 Results exceeding linear ranges The instrument must have been configured by an ABX DIAGNOSTICS approved technician Parameters Conditions Con...

Page 123: ...pre defined value in Settings Type Parametering Alarms and Curves Threshold Tab Alarm Level Grid HGB parameter absolute value Section 5 8 3 1 Alarm levels page 5 37 A suspect flag is generated if the...

Page 124: ...r Alarms area on the screen and the printout Fig 4 21 No flag Standard value for NO 100 120 Section 5 8 3 Alarms Curve thresholds page 5 37 Meaning Background NOise This flag occurs when the number of...

Page 125: ...C LIC Fig 4 23 LL1 flag Standard value for LL1 5 45 Section 5 8 3 Alarms Curve thresholds page 5 37 Meaning Left Lymphocytes 1 Presence of a significantly large population of cells on the left hand si...

Page 126: ...d value for MN 100 120 Section 5 8 3 Alarms Curve thresholds page 5 37 Meaning Mono Neutro Presence of a significantly large population of cells located in the separation threshold area between monocy...

Page 127: ...Section 5 8 3 Alarms Curve thresholds page 5 37 Meaning Neutro Eosino Presence of a significantly large population of cells located in the separation area between neutrophils and eosinophils be cause...

Page 128: ...Section 5 8 3 Alarms Curve thresholds page 5 37 Meaning Right Neutro Presence of a significantly large population of cells located on the right hand side of the neutrophil area high LIC This flag occ...

Page 129: ...hils Fig 4 31 ALY flag Meaning Atypical Lymphocytes Presence of a significantly large population of cells located on the right hand side of the Lymphocytes area This flag occurs when the number of par...

Page 130: ...ed from the LMNE Matrix populations and a will be dis played instead of the BAS and BAS This alarm appears in the Analyzer Alarms area on the screen and on the printout Fig 4 32 WBC histogram Standard...

Page 131: ...acrocytic area MAC compared to the total number of RBCs are above the set limits for both MIC and MAC percentages set up by the user RBC1 and RBC2 thresholds define the microcytic and macrocytic areas...

Page 132: ...C flag will be generated The PLT results are not reliable Verify the result using a Platelet Rich Plasma PRP or a manual platelet count Fig 4 35 PLT Flags If the mobile threshold cannot be po sitioned...

Page 133: ...e generated If the WBC LMNE count is 20 lower than the WBC BASO count a LMNE flag will be generated WBC count is higher than 8000 If the WBC LMNE count is 15 higher than the WBC BASO count a LMNE flag...

Page 134: ...a surement and the Optical measurement as they pass through the LMNE flowcell If the cell measurements between the resistive and optical are less than 50 a CO flag will be indicated Suspected abnormal...

Page 135: ...es Tab 4 6 WBC pathology messages H extreme high limit L extreme low limit indicates that the pathology is detected on the high and low absolute values of the pa rameter in question Message Condition...

Page 136: ...tion Anemia HGB HGB L Anisocytosis RDW RDW H Microcyte MIC Microcyte MIC 10 Microcyte MIC 15 Macrocyte on Mac Flag Hypochromia MCHC MCHC L Cold Agglutinin MCHC MCHC H and WBC 91 3x103 mm3 Microcytosis...

Page 137: ...all cells at the beginning of the Platelet curve Platelets Aggregate condition 1 PLT 150x103 mm3 WBC reject or NO PDW 20 or NO MPV 10 or NO PLT 150x103 mm3or NO WBC reject or L1 or LL1 PDW 20 or L1 or...

Page 138: ...3 19 Selecting and Deselecting an analysis can activate the XB alarm The user has the option of enabling or disabling the XB alarm in the Instrument Settings functions Section 5 3 2 XB options page 5...

Page 139: ...6 1 2 Result list function keys Tab 4 10 Function Keys Heading Key Name Action Function Association key Launches the Result Association View see 6 2 Result order association page 4 53 Disabled if a cy...

Page 140: ...indicators DANEPT D means Defect analysis see 5 3 Flags page 4 29 displayed for 1 Results exceeding parameter linear capacity 2 Reject on one or several parameters 3 Incorrect HGB blank reference 4 C...

Page 141: ...s Filters based on DANEPT indicators see 6 1 3 Result Grid information page 4 48 can be applied to the result list as defined below Fig 4 38 Result filters Default Select this box to display the resul...

Page 142: ...play Function Keys Heading Key Name Function Left arrow Displays the previous result in a full screen mode Right arrow Displays the next result in a full screen mode Rerun Rerun request generates a ne...

Page 143: ...as described in Section 2 3 Running specimen page 2 9 to run the analysis on this new order The Rerun key is disabled if the results are unmatched see 6 2 Result order as sociation page 4 53 or if a...

Page 144: ...4 52 Pentra 80 User Manual RAB108EA Fig 4 42 Selected rows printout Sending options Fig 4 43 Sending options screen Send last result to the host Send selected results to the host Send all results to...

Page 145: ...ssociation grid This screen will show 2 lists Worklist orders not matched to results as it has been defined in the Worklist sample ID patient ID etc Results with Rack Position of the tubes or and Barc...

Page 146: ...is added to the instrument logs If the order type is different from the results one the results will be recomputed with the new type settings thresholds limits The recomputed results will be flagged...

Page 147: ...en configured as described in Section 2 1 Instrument Startup page 2 2 Reviewing the Results Archives is accessible by two modes By date Daily results see 7 2 Daily result Description page 4 56 By pati...

Page 148: ...include the Sample ID the Rack number and position of the tube the Patient ID first name the Test CBC DIFF and the sample type given to the sample Select a date that you want to review by using the s...

Page 149: ...typed in Delete enables the deletion of all unselected or selected analyses Select all Checks all the results lines of the list column Selected Unselect all Unchecks all the result lines in the list c...

Page 150: ...ographics of the patient If the Patient ID is known follow the steps as indicated From the Daily results grid select the Patient Result key see Tab 4 14 Patient result function Keys page 4 59 Fig 4 49...

Page 151: ...sts in the Archives function it will be displayed on a single line along with the rest of patient information Patient ID First name Birthday Gender etc Heading Key Name Function Daily result Displays...

Page 152: ...t and left arrows To return to the Patient Result screen select the Return key in the full screen mode 7 4 2 Daily Result screen From the Daily Result screen see Fig 4 47 page 4 56 select the line of...

Page 153: ...Number of calibration runs 5 11 3 4 Coefficients of variation ranges 5 11 4 Rules 5 12 4 1 Accessing the Rules screen 5 12 4 2 Rerun conditions 5 12 4 2 1 Rerun on alarms 5 13 4 2 2 Rerun by paramete...

Page 154: ...3 Creating a new User profile 5 30 8 Sample Types 5 32 8 1 Accessing the Types parameters menu 5 32 8 1 1 Functions keys 5 33 8 1 2 Creating a new blood sample type 5 33 8 1 3 Modifying limit Alarm v...

Page 155: ...uding 1 Menu Settings overview page 5 3 2 Soft parameters page 5 5 3 Quality assurance settings page 5 11 4 Rules page 5 13 5 System page 5 17 6 Save and restore page 5 26 7 User profiles page 5 30 8...

Page 156: ...e set here Rules Opens management screens to define criteria for printing sending to Host and rerun conditions see 4 Rules page 5 13 System Opens management screens for specific system options date an...

Page 157: ...the Settings window select the soft parameters key This will bring up the Soft pa rameters general menu Fig 5 2 Soft parameters General menu There are three tabs available from this menu General see 2...

Page 158: ...ALY and LIC are for research use only his message will also be printed out and or transmitted to a host computer Select the Edit key and then place a Check mark in the Visible or Invisible box Now sel...

Page 159: ...3 page 5 7 Fig 5 3 Comments dialog box From the Soft parameters screen select the Edit key then select the appropriate boxes for your applications Once your selections have been made select the OK ke...

Page 160: ...tab To prevent manual entering of clinical information for each order this tab provides fields to enter Department names and Physician names that are requesting the analysis of the samples Section 4...

Page 161: ...department 20 characters maximum Insert Addition of new department Physician if the focus is on the department list the software allows the addition of a department 20 charac ters maximum Delete Dele...

Page 162: ...Pentra 80 5 10 Pentra 80 User Manual RAB108EA Fig 5 6 Units tab...

Page 163: ...Calibration QC and XB coefficient values see 3 4 Coefficients of variation ranges page 5 12 3 2 XB options The XB function Section 3 2 Patient Quality Control XB page 3 14 is based on a BULL method an...

Page 164: ...highlight the number in the field Modify the number to the number of runs requested for calibration Remember the Minimum is 5 Now select the OK key to confirm your entry 3 4 Coefficients of variation...

Page 165: ...s see 4 4 Transmit conditions page 5 16 4 2 Rerun conditions In this tab the user has the option of establishing the criteria for sample rerun conditions The re sampling of sample tubes will be based...

Page 166: ...confirm your choice of re sampling conditions Fig 5 12 Rerun by parameters From the Rerun screen scroll the Types list and select a type to configure Select the EDIT key Choose the limits Panic Norma...

Page 167: ...inted result from the Results screen Unconditionnal All results will be printed Selected criteria the result must respond to one or several of the following conditions to be printed 1 one of the check...

Page 168: ...transmitted result from the Results screen Unconditionnal All results will be transmitted Selected criteria the result will not be transmitted to the host if one of the following con ditions is verifi...

Page 169: ...munication see 5 3 Communication page 5 19 Printer see 5 4 Printer page 5 21 Cycle option see 5 5 Cycle option page 5 25 5 2 Local settings This tab allows the date time format modification see 5 2 1...

Page 170: ...ish Portuguese From the Local Settings screen select the Edit key then select language that is appro priate for your operations Now select the OK key to confirm your selection Fig 5 17 Language format...

Page 171: ...5 3 Communication Fig 5 19 System Communication tab The System Communication menu settings affects what information is sent to and receive from the LIS This information has been configured in your sys...

Page 172: ...gs tab page 5 20 Heading key Function Default value Bauds speed selection 9600 Parity parity selection None Protocol Protocol selection Xon Xoff Format Selection of protocol format between P80 host AB...

Page 173: ...Selected hematology paramaters sent to the host Flags Flags Section 4 5 3 Flags page 4 29 associated to the selected parameters sent to the host Pathology Pathologies Section 4 5 3 Flags page 4 29 ass...

Page 174: ...the default printer Delete Printer The printer displayed into the printer list is removed Enable Range Normal limits are printed out when checked see Fig 5 21 page 5 23 Raw Raw counts are printed out...

Page 175: ...Settings System Pentra 80 User Manual RAB108EA 5 23 5 4 1 Printout example Fig 5 21 Result printout 1 Report header 2 Range 3 Manual entry grid 4 Raw counts 5 Suspected pathologies...

Page 176: ...Pentra 80 5 24 Pentra 80 User Manual RAB108EA 5 4 2 Printer properties Fig 5 22 Printer properties window...

Page 177: ...ng key Function Default value Autoclean Frequency Number of analyses performed to trigger the autoclean cycles 100 Startup Startup cycle is automatic at begin of day if checked Checked Shutdown Shutdo...

Page 178: ...6 3 Dump database page 5 27 6 2 Configuration 6 2 1 Analyzer setting functions Tab 5 9 Analyzer save restore Heading key Function Save settings on hard disk Opens a dialogue window in order to save t...

Page 179: ...disk Opens a dialogue window in order to select one of the save settings Save setting on floppy Opens a dialogue window in order to select the save path of the current configuration on a disk If the...

Page 180: ...inting and reviewing operations It also includes last update of the Help on line file This one can be easily installed on your Pentra 80 using the key Help Update as follows Fig 5 26 Save and restore...

Page 181: ...lowing screen appears Fig 5 28 Accessing the Help on line or user manual The Pdf key opens the user manual in Acrobat reader software in order to be read or printed The HTML key opens the Help on line...

Page 182: ...ABX certified technician The TrainedUsers software profile which which allows access to Service menus useful for instrument maintenance operations It also allows access to Instrument settings and Cal...

Page 183: ...de field and enter your code Once all information requested has been completely filled in on the User screen select the OK key to confirm your entries Your profile will now be added to one of the prof...

Page 184: ...tra 80 User Manual RAB108EA When the Login window appears all the users are displayed Double click the user Enter the password then press the Validate button see Fig 5 31 User password page 5 32 Fig 5...

Page 185: ...page 5 36 Alarm levels curve thresholds see 8 3 Alarms Curve thresholds page 5 37 8 1 Accessing the Types parameters menu From the Settings window select the Type key Fig 5 32 Type parameters Alarms c...

Page 186: ...ifying limit Alarm values page 5 34 8 1 3 Modifying limit Alarm values From the Pathological limits tab or Alarms curves Thresholds tab select the Edit key Click the figure you want to modify and ente...

Page 187: ...r is created or captured in the worklist this one is used to provide results Sample with no type The default type see Tab 5 13 Types function Keys page 5 34 is automatically as sociated to provide res...

Page 188: ...d Child5 are Factory Default values The Standard Type values are set values and cannot be modified by the user Man Woman Child1 Child2 Child3 Child4 and Child5 Factory Default values can be modi fied...

Page 189: ...tered in the percentage and or an abso lute value field of the parameter The flags are triggered by values exceeding these set numbers Fig 5 36 Standard alarm levels Section 4 5 3 Flags page 4 29 Defa...

Page 190: ...The threshold adjustments are expressed in channels Fig 5 37 Matrix thresholds There are only 3 basic reasons to adjust the matrix thresholds see 8 1 3 Modifying limit Alarm values page 5 34 a To imp...

Page 191: ...L Separation between Left Lympho Lympho 30 NOL AL LN Separation between Neutro Left Neutro 35 NON LMN NOE Separation between Noise Eosino 48 NON Cha 127 LMN Intersec dot between Lympho Mono Neutro are...

Page 192: ...80 5 40 Pentra 80 User Manual RAB108EA Tab 5 17 BAS thresholds Threshold Purpose STD BA1 Separation between L1 counting area and WBC 35 BA2 Separation between WBC BAS 110 BA3 End of the BAS Counting a...

Page 193: ...is tab will allow the user to define limits between pediatric areas The child type range is displayed in purple The low range of a child n 1 begins at the high range of child n 1 day The date format o...

Page 194: ...Pentra 80 5 42 Pentra 80 User Manual RAB108EA...

Page 195: ...ribution sampling sytem MDSS 6 9 3 1 1 CBC mode 6 9 3 1 2 Diff Mode 6 9 3 1 3 Sample distribution 6 10 3 2 CBC detection principles 6 11 3 2 1 RBC PLT 6 11 3 2 2 HGB Measurement 6 12 3 2 3 HCT Measure...

Page 196: ...ver to repla ce empty bottles LMNE Syringe assembly Ensures the correct proportioning of the stop diluent in the LMNE chamber Injects the specimen into the flowcell Injects the interior and exterior s...

Page 197: ...of portions of the specimen into the dilution chambers Aspirates the sample from the first dilution and distributes it into the RBC PLT chamber Count Assembly Receives the different rinsings and dilu...

Page 198: ...usy sampling When the Red LED is lit instrument is in operation Sampling position 1 For 5ml tubes Sampling position 2 For 3ml tubes Sampling position 3 For Controls Calibra tors Latex material Fig 6 4...

Page 199: ...mechanism which allows the mixing and sampling of each tube within the rack Micro switches allow detection of the racks when placed in the loading tray Fig 6 6 Tube height detection and correction Th...

Page 200: ...rk in conjunction with the tube sampling The first tube grabber grabs the number 1 tube and mixes it for 30 seconds The tube is then placed back into the rack The same process applies for the second t...

Page 201: ...mode principles Pentra 80 User Manual RAB108EA 6 7 Sample tube identification An internal Barcode reader identifies both racks and sample tubes to ensure true identifica tion and security of results F...

Page 202: ...e sample volume at a very small amount approximately 60ml ABX DIA GNOSTICS utilizes a Double needle sample probe This probe consists of an external piercing needle with narrow internal sampling probe...

Page 203: ...nt distribution in CBC mode 3 1 2 Diff Mode While in the DIFF Mode 53 l of whole blood is aspirated then delivered with into the following chambers as indicated One segment of sample for the Dilution...

Page 204: ...ple is distributed into the chambers by means of a Tan gential flow of reagent This flow allows for perfect mixing of each dilution and avoids any viscosity problems This tan gential flow process is p...

Page 205: ...is the more resistance it has The smaller the cell is the less resistance it has These electronic voltages vary in pulse size as the cells pass through the aper ture The pulses are amplified channeled...

Page 206: ...h Absorbance value obtained from the sample x coeffi cient of calibration Technical characteristics of the RED BLOOD CELL and PLATELET counts Initial blood volume 10 l Method Impedance Vol ABX DILUENT...

Page 207: ...from the RBC histogram Calculations are as followed RDW K X SD MCV With K system constant SD Standard Deviation according to statistical studies on cell distribution within the RBC histogram MCV Mean...

Page 208: ...t Distribution Width is calculated from the PLT histogram The PDW is represented by the width of the curve between 15 of the number of plate lets starting from 2 fl S1 and 15 of the number of pla tele...

Page 209: ...ibration BAS The number of cells counted within a specified amount of time per volume x the WBC calibration coefficient in a percentage as to the total number of leukocytes Basophils and WBC nuclei Th...

Page 210: ...of whole blood is delivered into the LMNE chamber in a tan gential flow of EOSINOFIX This reagent lyses the RBC s stabilizes WBC s in their native forms and stains the Eosinophil nuclei with a specifi...

Page 211: ...iples Pentra 80 User Manual RAB108EA 6 17 No cell in the flowcell Baseline Poorly stained agranular cell in the flowcell Low absorbance Hyper segmented with complex gra nularity and staining Fig 6 19...

Page 212: ...ause of their small size The far left side of the lymphocyte zone LL should normally be empty Any detection of cells in the LL zone will indicate Small lymphocytes Platelet aggregates NRBC s Nucleated...

Page 213: ...ls are detected by their larger volumes and by the increased gran ules which allow more light to pass through the cells and increase the intensity of scattered light Therefore cells such as metamyeloc...

Page 214: ...Pentra 80 6 20 Pentra 80 User Manual RAB108EA...

Page 215: ...obe replacement 7 13 2 4 Rinse chamber filter cleaning 7 15 2 5 Instrument Rinse 7 16 2 5 1 Instrument rinse 7 16 2 5 2 Syringes and carriage park 7 17 3 Instrument panels cover Removals 7 18 3 1 Left...

Page 216: ...error types and help messages 7 44 8 2 Transfer error types and help messages 7 45 8 3 STAT mode error type and help message 7 46 8 4 Environment Error Types and Help Messages 7 46 8 5 User Error Type...

Page 217: ...maintenance functions are available on the system for the user to clean and check the instrument The frequency of maintenance cycles depends upon the number of analysis cycles per day Perform the inst...

Page 218: ...irty surfaces Stainless steel parts Slightly wet a sponge with disinfectant product and wipe the dirty surfaces Dry with a soft cloth Products having the following microbiological properties Bacterici...

Page 219: ...page 7 5 an optical bench lamp see 2 2 Optical bench lamp replacement page 7 11 the sampling probe see 2 3 Sampling probe replacement page 7 13 2 1 Reagent replacement 2 1 1 Reagent locations and conn...

Page 220: ...replacement During instrument startup the user compares the remaining quantity of each reagent to the daily workload setup If one or more reagents reach a Low Level during the working day an alarm oc...

Page 221: ...Pentra 80 User Manual RAB108EA 7 7 Fig 7 2 Reagent low level alarm When a Reagent Low Level alarm appears on the screen select the Check key see Fig 7 2 page 7 7 to display the Reagent Status window...

Page 222: ...reagent status window select the reagent you want to replace Once you select the reagent the following screen will be displayed see Fig 7 3 page 7 7 Now select the Edit key to modify any reagent spec...

Page 223: ...eld and then use the Barcode reader to update some of the reagent specifications Lot number Expiration date see Fig 7 5 page 7 9 The reagent level is set to an automatic default level Verify this leve...

Page 224: ...RAB108EA Fig 7 6 Reagent Level Select the OK key to accept the changes see Fig 7 7 page 7 10 Fig 7 7 Reagent replacement validation Once the OK key has been selected the instrument automatically prim...

Page 225: ...ainer with the cap and dispose of waste liquids according to your lo cal national organizations 2 2 Optical bench lamp replacement 2 2 1 Lamp replacement Wait for the lamp to cool down before handling...

Page 226: ...nect the lamp connector see Fig 7 10 page 7 12 Fig 7 10 Optical bench lamp disconnection Loosen the lamp holding bracket screws a few turns see Fig 7 11 page 7 12 Fig 7 11 Lamp fixation screws Turn th...

Page 227: ...fy that the Optical Bench lamp is lit If the lamp is illuminated wait until the instrument startup is complete then power off the instrument and re install the covers and panels 1 If the lamp is not i...

Page 228: ...block screws Lift the locker top retaining bracket to free the sample probe see Fig 7 14 page 7 14 Fig 7 14 Probe locker Gently disconnect the tubing connected to the top of the sample probe and remo...

Page 229: ...e are no fluid leaks during startup Re install the right hand side panel 2 4 Rinse chamber filter cleaning 1 This filter has to be cleaned once a month as follows 2 Dismantle the Right hand side panel...

Page 230: ...an empty bottle 3 Remove straw from Diluent cubitainer and plunge it into the empty bottle 4 Enter Service Super User Menu Hydraulic Unprime Cycle then click the All button See Unprime cycle screen p...

Page 231: ...See Unprime cycle screen page 16 to drain the instrument 2 5 2 Syringes and carriage park Move the syringes and the carriage in a safe position 1 Enter Service Super User Menu Others and press the Run...

Page 232: ...front door removal page 7 19 3 3 Right hand side panel removal page 7 19 3 4 Left hand side panel removal page 7 20 Power off the instrument Disconnect the power supply cable 3 1 Left front door remov...

Page 233: ...out to remove it as indi cated in 2 see Fig 7 23 page 7 19 Fig 7 23 Right front cover 3 3 Right hand side panel removal Locate the 2 locking screws at the top of the right side panel Place a flat tipp...

Page 234: ...artment cover to expose the 2 retaining screws on the rear of the left side panel Remove Left Panel by unscrewing 2x CHC M4X6 at the front and loosening 2x CHC M4X6 at the rear see Fig 7 25 page 7 20...

Page 235: ...u screen 3 Maintenance Hydraulical cycles are available on this menu Miniclean short rinsing sequence of the counting chambers Concentrated Cleaning Thorough cleaning of the chambers with a bleach sol...

Page 236: ...the user enters the Super User Menu screen the following menus will be available to the user 3 menus are available to the user for maintenance intervention on the instrument 5 1 Mechanical menu page 7...

Page 237: ...ate for the Auto sampler Sampling probe sample Carriage Syringes etc This is also termed as a mechanical homing for all assemblies to their ready position 5 1 2 Check motors This menu will allow the u...

Page 238: ...mooth and complete movement of Rack Loader 7 Transfer Mechanism Check for smooth and complete movement of the rack transfer mechanism 8 Mixer Mechanism Check for smooth and complete rotational movemen...

Page 239: ...raight and regular Fig 7 30 Super User Mechanical Check Valves 1 Valves 1 to 12 Verify the correct operation of these valves 2 Valves 13 to 19 Verify the correct operation of these valves 3 Valves 20...

Page 240: ...hnical Support Representative for further instructions 5 1 5 Sampler test Obtain a Sample tube rack and place some tubes in position and leave 2 or 3 empty spaces rom the Main screen select the Super...

Page 241: ...nual RAB108EA 7 27 Fig 7 32 Super User Mechanical Sampler Test 5 1 6 Sample tube Holder adjustment The Sample tube holder and sampling needle positions has been factory adjusted Do not at tempt to mod...

Page 242: ...d Level fields Run key This key allows the acceptance of the number of steps from the Sample probe Home position to the top flat surface of the tube holder The obtained value is returned into Position...

Page 243: ...ubleshooting Super User menu description Pentra 80 User Manual RAB108EA 7 29 Accept Values key This key is used to accept any changes made to the Depth and Level fields Fig 7 34 Super User Mechanical...

Page 244: ...s the LMNE chamber 4 RBC PLT Drains the RBC PLT chamber 5 WBC BASO Drains the WBC BASO chamber 6 All Drains all the chambers 5 2 2 Prime cycles This menu will allow the user to prime reagents into the...

Page 245: ...r User Hydraulical Prime Cycles 1 ABX Diluent Primes ABX Diluent reagent 2 ABX Cleaner Primes ABX Cleaner reagent 3 ABX Eosinofix Primes ABX Eosinofix reagent 4 ABX Basolyse 2 Primes ABX Basolyse 2 re...

Page 246: ...0 7 32 Pentra 80 User Manual RAB108EA 5 2 3 Unprime cycle Fig 7 37 Super User Hydraulical Unprime Cycle 1 Diluent reservoir Drains the diluent reservoir 2 All Unprimes all the reagents from the instru...

Page 247: ...NE flowcell with ABX Diluent to rid the counting area of air bubbles and or blockage To perform a concentrated cleaning remove the right hand side panel see 3 Instrument panels cover Removals page 7 1...

Page 248: ...ig 7 40 Concentrated cleaning pour Minoclair Fig 7 41 Pour Minoclair Select Validate key once Minoclair has been distributed into all the chambers Wait for the instrument to complete the cleaning Conc...

Page 249: ...sport from one location to another 3 Run Maintenance Carriage Pos This key allows the user to automatically move the Sample Carriage over the chamber area for sample probe replacement and or other mai...

Page 250: ...ed on Paper feed Bottle Level control OK Proc 1 Replacement Expiration date Waste level control Empty Main supply connected Connect On Off Proc 3 Section 3 switch Switched on Startup passed Temperatur...

Page 251: ...g see 5 2 4 Clean Cycles page 7 33 Temperature not reached a Wait for five minutes to reach the operating temperature b If temperature is not reached call your ABX representative service department Ca...

Page 252: ...the specimen have been di luted Fig 7 44 Chambers Drain and rinse a Check chambers are drained and rinsed b If operations are faulty identify the source of the malfunction when possible and call your...

Page 253: ...2 4 Clean Cycles page 7 33 d If all these operations appear to be correct call your ABX Diagnostics representative department Calibration a Perform a calibration of the instrument see Calibration page...

Page 254: ...closing during cycle If defective replace the valve d If this does not correct the WBC results call your ABX Diagnostics representative de partment RBC PLT a Perform a concentrated cleaning see 5 2 4...

Page 255: ...Diagnostics representative de partment Differential LMNE a Check optical bench lamp is lit when instrument is on If not replace the lamp see 2 2 Optical bench lamp replacement page 7 11 b Run a Cytome...

Page 256: ...Pentra 80 7 42 Pentra 80 User Manual RAB108EA 7 Hydraulic Diagram See Hydraulic diagram on next page...

Page 257: ...7 43 Check the type of error and follow the instruction from the Alarm screen Fig 7 46 Alarm key Fig 7 47 Alarm screen Error messages in this section 8 1 Analyzer error types and help messages page 7...

Page 258: ...ailure DRAIN 2 Syringe Motor home switch always detected Run an Auto Clean Check Motor in Service Menu DRAIN 2 syringe mechanism not reaching home DRAIN 2 Syringe Motor Mecha nism initialization faile...

Page 259: ...ampler Loading Motor Run an initialization Check motor in Service Menu Sampler Transfer mechanism not reaching home Sampler Transfer Motor Mechanism initialization failed Run an initialization Check m...

Page 260: ...lp Message Tube holder mechanism failure Door not open No message Alarm Error Type Help Message d Incoherent s Result s for s Incoherent Results Run an initialization Communication With Analyzer Cut O...

Page 261: ...ow to run a analasys Out of Reagent Check reagent and restart auto matic cycle Reagent level too low to run a rack Out of Reagent Check reagent and restart auto matic cycle Result not stored Software...

Page 262: ...Unknown cycle Run an Initialization Error on cycle d Run an Initialization Error on start internal chrono Run an Initialization HGB Blank Error Management HGB blank cycle incorrect Run an Autoclean Ho...

Page 263: ...ect pos motor sampling d Min d Max d Sampling motor bad position Run an Initialization Incorrect pos motor tranfer d Min d Max d Translation motor bad position Run an Initialization Internal Barcode E...

Page 264: ...Pentra 80 7 50 Pentra 80 User Manual RAB108EA...

Page 265: ...2 4 Minimum specimen volume 8 5 2 5 dilution ratios 8 5 2 6 HGB measurement 8 5 2 7 Counting aperture diameters 8 5 2 8 Reagent consumption ml 8 6 2 9 Recommended Anticoagulant 8 6 3 Summary of perfor...

Page 266: ...o diagnostic testing of whole blood specimen 1 1 Parameters Tab 8 1 CBC Parameters PCT PDW ALY and LIC have not been established as indications for this product in the United States The use of PCT PDW...

Page 267: ...2 Throughput Analyses 80 samples per hour WBC White Blood Cell LYM Lymphocytes and MON Monocytes and NEU Neutrophils and EOS Eosinophils and BAS Basophils and LIC Large Immature Cell and ALY Atypical...

Page 268: ...ternal Computer Capacity 10 000 results graphics Color LCD touch screen 12 inches Industrial PC board Windows NT 4 0 Processor frequency Celeron 433 MHz Memory capacity 128 Mo Hard drive 4 5 Go mini F...

Page 269: ...humidity 80 for temperature up to 31 C 88 F decreasing linearly to 50 relative humidity at 40 C 104 F 2 3 Dimension and weight Dimensions 82 x 57 x 54 cm 34 1 x 23 3 x 22 in Weight 55 Kg 122 lbs 2 4 M...

Page 270: ...acceptable alternative Cycles Estimated duration s Diluent ml Eosinofix ml Basolyse II ml Cleaner ml Lyse ml CBC DIFF 0 45 27 4 1 0 2 0 1 0 0 45 CBC 0 45 24 4 2 0 1 0 0 45 Prime DILUENT 3 00 44 Prime...

Page 271: ...0 11 0 1 0 12 0 16 PX052 Low 0 06 0 04 0 04 0 07 RBC PX052 High 0 06 0 04 0 05 0 07 PX052 Normal 0 06 0 04 0 04 0 06 PX052 Low 0 03 0 02 0 03 0 04 HGB PX052 High 0 12 0 07 0 09 0 13 PX052 Normal 0 08...

Page 272: ...27 0 79 1 02 1 47 PX052 Normal 1 2 0 93 0 87 1 38 PX052 Low 1 38 0 88 1 16 1 64 HGB PX052 High 0 76 0 42 0 56 0 83 PX052 Normal 0 59 0 57 0 55 0 8 PX052 Low 0 81 0 73 0 61 0 99 HCT PX052 High 1 67 1 3...

Page 273: ...This Visible range is outside Manufacturer s range Linearity kits Linearity was tested using available Low Range and Full Range Linearity Test kits The Test kits were analyzed and data was computed ac...

Page 274: ...eticulocyte counting and cell marker applications ISLH 14 January 1994 Carry over Claims Tab 8 10 Carry over claims Parameters Linearity Range Linearity Limits Visible range Difference Which ever is g...

Page 275: ...erformance was proven by comparing the Pentra 80 with a recognised com parison instrument using 200 patient whole blood specimens operating within the instrument normal functioning range Parameters Ma...

Page 276: ...stability study In accordance with the ICSH guidance 10 samples were collected from the routine laboratory workload 5 normal samples and 5 abnormal samples The samples were divided into 2 ali quots o...

Page 277: ...or biohazard waste dis posal If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste Dispose of the waste container accor...

Page 278: ...that exceed the linearity limits of the system will require dilution of the blood sample Leukemia sample followed by a leukopenia Re assaying the diluted sample will help to obtain the correct assay...

Page 279: ...dity and fol low the appropriate method below High WBC An extremely high WBC will cause excessive light scatter In these cases use reference manual methods The diluted sample should be centrifuged and...

Page 280: ...cause high RDW results due to iron and or cobalamin and or folate deficiency PLT Platelets Very small erythrocytes microcytes erythrocyte fragments schizocytes and WBC frag ments may interfere with t...

Page 281: ...e post collection and storage temperature LYM Lymphocyte count absolute value LYM Lymphocyte percentage The Lymphocyte count is derived from the WBC count The presence of erythroblasts cer tain parasi...

Page 282: ...er to the packaging of each reagent concerned to establish the approval method Waste handling precautions When disposing of waste protective clothing must be worn lab coat gloves eye pro tection etc F...

Page 283: ...piration Storage conditions Room temperature between 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label 3 Measurements principles results Directions for use see Se...

Page 284: ......

Page 285: ...n Storage conditions Stored at 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label 3 Measurements principles results Directions for use see Section Maintenance Trou...

Page 286: ......

Page 287: ...expiration Storage conditions Stored at 15 C 59 F to 30 C 86 F away from light Expiration date refer to expiration date reagent packaging label 3 Measurements principles results Directions for use see...

Page 288: ......

Page 289: ...tion date reagent packaging label 3 Measurements principles results Directions for use see Section Maintenance Troubleshooting Reagent Location and connection in the instrument User Manual This reagen...

Page 290: ......

Page 291: ...in the instrument User Manual 2 Conservation expiration Storage conditions Stored at 18 to 25 C and away from the light Expiration date refer to expiration date reagent packaging label 3 Measurements...

Page 292: ......

Page 293: ...conditions Room temperature between 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label 3 Measurements principles results Directions for use see Section Maintenanc...

Page 294: ......

Page 295: ...s principles results Directions for use see Section Reagent Location and connection in the instrument User Manual Measuring Principles see Section Technology in the instrument User Manual Results Refe...

Page 296: ......

Page 297: ...Index Glossary Pentra 80 User Manual RAB108EA 9 1 Contents 1 Glossary 9 2 2 Index 9 4 Section9 Glossary...

Page 298: ...l used for dailyinstrument quality control characteristics See performance characteristics coefficient of variation An expression in percent of data SD spread related to the mean CV SD mean x100 contr...

Page 299: ...RBC population Quality control QC A comprehensive set of of procedures a laboratory establishes to ensure that the instrument is working accurately and precisly reproductibility This procedure checks...

Page 300: ...t Chap 4 58 Association grid Chap 4 52 Automatic numbering Chap 4 22 Chap 5 5 B BASO WBC Count Chap 6 14 Batch Chap 3 18 C Carryover Chap 8 6 Clean Cycles Chap 7 26 Consumption power consumption Chap...

Page 301: ...NL flag Chap 4 34 NO flag Chap 4 32 Normal and panic ranges Chap 4 30 Pathology messages Chap 4 43 QC failed Chap 4 45 reject Chap 4 31 Results exceeding instrument capacity Chap 4 30 RM flag Chap 4...

Page 302: ...C and differential Chap 6 14 Mixing Chap 4 24 MPV Measurement Chap 6 12 N Normal and panic ranges Chap 4 30 O Optical bench Chap 6 2 Optical bench lamp replacement Chap 7 9 Order overview Chap 1 16 Or...

Page 303: ...Chap 3 13 screen grid Chap 3 7 Send results Chap 3 10 Targets Chap 3 10 R Rack Chap 1 7 Identification Number Chap 1 7 RDW calculation Chap 6 12 Reagent Chap 6 2 Chap 8 3 consumption Chap 8 5 cover Ch...

Page 304: ...ap 1 11 Chap 2 12 Soft parameters Chap 5 4 Software Chap 1 8 arborescence and Hints Chap 1 12 overview Chap 1 8 Specifications Chap 8 2 Parameters Chap 8 2 Physical Chap 8 4 Reagent Chap 8 7 technical...

Page 305: ...ccess Chap 3 20 Key Chap 3 20 Run Chap 3 21 Workflow Chap 4 4 association Chap 4 14 Barcode Identification Chap 4 6 Exception management Chap 4 12 Rack position Chap 4 9 Sample ID Chap 4 4 Chap 4 6 Wo...

Page 306: ...Pentra 80 9 10 Pentra 80 User Manual RAB108EA Z Zoom Chap 4 28...

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