ABX Pentra 80 RAB108BA User Manual Download Page 14

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Pentra

1–2

Pentra

80 - User Manual - RAB108EA

Section1: Introduction

This section provides important information to get you started with

Pentra 80

1. Warning and precautions,

page 1-2

2. Labels,

page 1-5

3. Operational conditions,

page 1-8

4. Software overview,

page 1-13

5. Workflow overview,

page 1-21

6. Printer,

page 1-28

1. Warning and precautions

User manual must be enterely read and personnel trained by

ABX Diagnostics

before attempt-

ing to operate instrument. The user always operates with full knowledge and appreciation of
instrument warnings, alarms and flags.

Always refer to labeling and

ABX Diagnostics

instructions in order to avoid to compromise

system integrity.

The

Pentra 80

responds to the Standards and directives named in the Declaration of Confor-

mity added at the beginning of this manual.

◆

The reagents and accessoiries stipulated by

ABX Diagnostics

have been vali-

dated in accordance with the European Directive for in-vitro medical devices
(98/79/CE).

◆

The 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 nor for the results rendered.

◆

Disposal gloves, eyes protection and lab coat must be worn by the operator.
Local or national regulations must be applied in all the operations

◆

Portable/mobile telephones should not be used in proximity of the instrument.

◆

All peripheral devices should be IEC compatible.

1.1. Limited guarantee

The duration of guarantee is stipulated in the Sales conditions associated with the purchase
of this instrument. To validate the guarantee, ensure the following is adhered to:

1 - The system is operated under the instructions of this manual.

2 - Only software or hardware specified by

ABX Diagnostics

is installed on the instrument.

This software must be the original copyrighted version.

3 - Services and repairs are provided by an

ABX Diagnostics

authorized technician, using only

ABX Diagnostics

approved spare parts.

4 - The electrical supply of the laboratory follows the national regulations.

5 - Specimens are collected and stored in normal conditions.

Summary of Contents for Pentra 80 RAB108BA

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 prove to be extremely hazardous to either the operator or the environment or both Emphasizes an operating procedure that must be followed to avoid possible damage to the instrument or erroneous test re...

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 overview 1 13 4 1 Generic toolbar description 1 14 4 2 Contextual toolbar description 1 15 4 3 Main Menu description 1 16 4 4 Miscellaneous 1 17 5 Workflow overview 1 21 5 1 Order overview 1 21 5 2 ...

Page 4: ...2 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 4 Results 2 13 4 1 Printing a result series 2 13 4 2 Unmatched results 2 14 5 Archives 2 15 5 1 Searching results by day 2 15 5 2 Searching results by patient 2 15 6 Instrument Shutdown 2 16 6 1 Manu...

Page 5: ...B 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 3 25 4 1 Accessing the Calibration Main Menu 3 25 4 2 Target values 3 26 4 3 Running calibration 3 27 5 Logs 3 32 5 1 Access to Logs function 3 32 5 2 Calibration logs 3 34 5 3 Quality control logs ...

Page 6: ...orklist 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 4 Running specimens 4 25 5 Run results and associated Flags 4 26 5 1 Printer output format 4 26 5 2 Result screen 4 27 5 3 Flags 4 29 6 Order sample run association 4 47 6 1 Reviewing sample results...

Page 7: ...of 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 5 17 5 2 Local settings 5 17 5 3 Communication 5 19 5 4 Printer 5 21 5 5 Cycle option 5 25 6 Save and restore 5 26 6 1 Access to Save Restore screen 5 26 6 2 Configuration 5 26 6 3 Dump database 5 27...

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: ...View 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 6 9 3 2 CBC detection principles 6 11 3 3 WBC and differential count 6 15 ...

Page 10: ...7 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 3 Others 7 35 6 Troubleshooting 7 36 6 1 Instrument operation mode 7 37 6 2 Results 7 38 6 3 Flags 7 40 7 Hydraulic Diagram 7 42 8 Error messages 7 43 8 1 Analyzer error types and help messages 7 44...

Page 11: ...tion 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 Reproducibility 8 7 3 2 Precision Repeatability 8 8 3 3 Linearity 8 9 3 4 Carryover 8 10 3 5 Normal Ranges 8 11 3 6 Accuracy 8 11 3 7 Leukocyte differential count 8 12 3 8 Sample stability study 8 12 3 9 Waste h...

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

Page 13: ...emperature 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 Racks 1 12 4 Software overview 1 13 4 1 Generic toolbar description 1 14 4 2 Contextual toolbar description 1 15 4 3 Main Menu description 1 16 4 4 Miscellaneous 1 17 5 Workflow overview 1 21 5 1 Ord...

Page 14: ...The 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 nor for the results rendered Disposal gloves eyes protection and lab coat must be worn by the operator Local or national regulations must be applied in all the operations Portable mobile telephones s...

Page 15: ...ery 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 disable sensors as it may cause operator injuries Protection covers must not be opened during instrument operations 1 2 2 Biological risks Consider all Specimens Reagents Calibrators Controls etc that...

Page 16: ...EC 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 limitation Batch code Catalogue number Use by Consult Instructions for Use Calibrator Control Content All graphics including screens and printouts photographs are for illustrations purpose only and are not co...

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: ...tion 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 Label 1 RS 232 output LIS Laboratory Information System connection 2 Printer connection Do not connect any printer which has not been recommended by an ABX Diagnostics qualified engineer ...

Page 19: ...ntroduction 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 connections ...

Page 20: ...Diagnostics 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 table or workbench Please note that the Pentra 80 and printer weigh approximately 55 kilograms 121 lbs Avoid exposure to sunlight Place your instrument where it is not exposed to water or vapor Place ...

Page 21: ...efore 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 conformity with its destination allowing the cor rect operation of other instruments also in conformity with their destination In case of suspected electromagnetic noise check that the instrument has...

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 list table Part Number Qty Designation XEA709A 1 Installation kit Pentra 80 HAX0023 1 Rack label type 1 1 to 20 HAX0024 1 Rack label type 2 1 to 20 XBA453A 1 Barcode reader GBL072A 4 Lifting handles GBL...

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 Keyboard 4 LAN 5 2 X USB 6 Printer 7 COM3 External Bar Code Reader 8 COM2 Labo Link 9 COM1 To Mother Board 10 Power 8 9 1 6 2 3 4 5 7 10 ...

Page 24: ...ks 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 Front side Fig 1 9 Rack Identification Number Back side ...

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 screen Startup and Shutdown operation keys are also featured in the center portion of the touch screen Fig 1 10 Main Menu A Status Bar is also located at the bottom of the screen which indicates the Date ...

Page 26: ...1 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 Edits Modifies data OK Validation Validates an action Cancel Cancel Cancels an action Delete Delete Deletes data Print Print Prints data Return Return Quits the current menu Quit Quit Quits the ASP02 s...

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 Worklist page 4 14 Start Rack Runs the automatic mode See Section 2 3 Running specimen page 2 9 Stat Runs the manual mode See Section 2 3 Running specimen page 2 9 Results Opens results menu Displays the...

Page 28: ...he 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 Quality Assurance access key page 3 3 Run in Progress Launches the Run in Progress menu Section 2 3 4 Run in progress page 2 12 Status Launches the reagent Status menu Section 2 1 4 Status page 2 5 Se...

Page 29: ...are 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 arborescence and Hints 4 4 2 Tabs description Tabs are used to group similar functions that pertain to a specific menu Press a Tab or click one with the mouse to access that specific function Menu Enab...

Page 30: ...ter 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 Placing a Check Mark within the box will enable the option Removing a Check Mark from the box will disable the option The Edit key must be selected to modify the Checked Box ...

Page 31: ...selected 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 Name Date Time etc Some fields have predefined formats Date Number Text etc These data fields may be modified when they appear in WHITE Use the Tab key to move the cursor from one field to the next ...

Page 32: ...16 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 arrows to move through all the data Fig 1 17 Sliders ...

Page 33: ...ew 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 analytical process The order includes 3 data areas of intervention as followed The patient information Patient ID Patient name Birthdate Sex The sample information Sample Id barcode or other Sample ty...

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 can be manually entered into the worklist without an order association if nec essary order 1 order 2 order 3 order n Sample ID1 Sample ID 2 Sample ID3 Sample ID n Worklist Analytical Process ...

Page 36: ...ts 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 Section 4 6 Order sample run association page 4 47 Fig 1 20 Runs Results Runs RBC Runs PLT Runs WBC Runs DIFF Results ...

Page 37: ...sults 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 Archives page 4 55 Sample Id1 Sample Id2 Sample Id3 Sample Id4 Patient Id1 Patient Id2 Patient Id3 Patient Id4 Runs results ...

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: ...d 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 Idn Worklist Analytical process Runs results Archives Patient 1 Patient 2 Patient 3 Patient n No order Sample Id1 Worklist Analytical process Runs results Archives Operator Operator ...

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 barcode reader 2 10 3 3 Stat mode 2 12 3 4 Run in progress 2 13 4 Results 2 14 4 1 Printing a result series 2 14 4 2 Unmatched results 2 15 5 Archives 2 16 5 1 Searching results by day 2 16 5 2 Searc...

Page 42: ...2 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 7 2 1 3 Waste container replacement page 7 11 1 2 Printer start up Check to see if the printer has enough paper for daily operations If not replace the printer paper according to the Printer User s ...

Page 43: ...er 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 to enter into the opera ting program of the analyzer Enter the User login password See Section 5 7 User profiles page 5 30 1 3 1 Automatic startup When the daily automatic Startup has been program me...

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 is within its limits values as indicated Instrument default values WBC 0 3 103 mm3 RBC 0 03 106 mm3 HGB 0 3 g dl PLT 7 103 mm3 LMNE 0 30 A ...

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 Section 7 2 1 Reagent replacement page 7 5 ...

Page 46: ...material 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 etc Position the control vial in any cassette as indica ted in the picture barcode label facing out and to the front Load the cassette into the rack loader Press the START RACK key When the analysis o...

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 material again Exit the Quality Assurance screen Select the Quality Assurance Quality Control QC grid Select the control lot number and verify its iden tification scrolling list When a control name or lot...

Page 48: ...er 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 control lot scrolling list If they do not match perform a control identification procedure See Section 3 1 6 New blood control setup page 3 10 2 Rerun the control material 3 Perform a concentrated clea...

Page 49: ...der 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 the rack loader Press the START RACK key Select the WORKLIST key Then the RACK VIEW key With use of the external barcode reader select the rack identification label and press the ENTER key once the lab...

Page 50: ...owed 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 for the next position Place the rack into the Rack loader Press the START RACK key ...

Page 51: ...ck 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 already been identified or use the External Barcode reader to a barcode label from that tube Collecting date Sample Type Male female child etc Test CBC or DIFF ...

Page 52: ...he 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 Remove the tube Press the START RACK key to continue analysis on the rack that was interrupted by the STAT entry At any time during the rack analysis the previous sam ples processed can be reviewed ...

Page 53: ...age 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 the Selected column of each result to be printed Selcet the PRINT SEND key of the Contextual toolbar and select a printing option ...

Page 54: ...ra 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 key ...

Page 55: ...eric 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 type in the patient name or first identification characters Press the OK key to display the results associated with the patient selected Once the results have been reviewed or printed press the DAILY R...

Page 56: ...performed 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 Menu screen press the SHUTDOWN key to perform a complete instrument enzymatic cleaning with ABX CLEANER When the Shutdown cycle is complete select Stop win dows to turn off the instrument ...

Page 57: ...raphs 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 22 3 3 1 Manual mode 3 22 3 3 2 Rack mode 3 22 3 3 3 Results 3 23 3 3 4 Print Transmit or delete Results 3 23 4 Calibration 3 25 4 1 Accessing the Calibration Main Menu 3 25 4 2 Target values 3 26 4 ...

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 Quality Control XB page 3 14 Within Run see 3 Within run page 3 20 Calibration see 4 Calibration page 3 25 Logs are described in 5 Logs page 3 32 ...

Page 60: ...e 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 Graphs page 3 6 1 3 QC data screen grid page 3 7 1 4 Graphics screen page 3 8 1 5 Print send or delete results page 3 9 1 6 New blood control setup page 3 10 1 7 Running control blood page 3 13 1 1 ...

Page 61: ...in 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 from CBC target display to DIFF target display Print Transmit In Data screen Grid Selected or all results or statistics only see Print send or delete results page 3 9 Send to the host selected or all r...

Page 62: ...he 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 which is indicated by the cursor 1 Indicates the target value shown by the centerline in the parameter field 2 Indicates the Maximum Target value shown by the upper line in the parameter field 3 Indicat...

Page 63: ...mits 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 Control parameter is out of range a QC alarm is activated See Section 4 5 3 11 Statistical function flags page 4 46 1 Check boxes select deselect QC data 2 Operator that processed the control runs 3 Date...

Page 64: ...rol 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 Section 4 5 3 Flags page 4 29 Entering a comment Comments can be entered into the Comment field when in the QC Graphics screen A Max imum of 50 characters may be entered Select the Comment field and ...

Page 65: ...en 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 When in this screen select the data to be printed then select the Print Send key 1 5 2 Sending results to the LIS Enter into the Data Grid screen see Fig 3 4 page 3 7 Select the Print Send key and c...

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 and select the control you would like to modify From 1 to 12 reserved to CBC control from 13 to 24 reserved to DIFF If you need to modify the target values or lot proceed as described in Target initi...

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 blood with a barcode label make sure that the reserved box has been checked see Fig 3 11 page 3 12 Fig 3 8 Floppy access key Insert the floppy disk into the drive Select the Edit key then the Floppy d...

Page 68: ...lue 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 enter target values by selecting the area in which you want to replace the value ...

Page 69: ...n 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 label identification Verify that the lot of control blood has been entered as described in 1 6 New blood control setup page 3 10 Prepare the Blood control according to the specific instructions detailed ...

Page 70: ...ny 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 are archived with their flags When a total of 20 results are archived an XB batch is computed The batch data commutated is the mean result for all 20 analyses contained in that specific batch The date...

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 the content of results of the selected batch see 2 4 Batch content page 3 18 Print Transmit In XB Data grid prints a list of Batch see Printing XB Data grid page 3 17 In XB graphs mode prints graphs ...

Page 72: ...se 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 line indicates the Target value and the Blue line indicates the Minimum limit The Yellow cursor can be positioned by the opera tor to select a specific batch Parameter values of a se lected batch ar...

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 are not within their specific limits see 2 5 XB limits page 3 19 they will be displayed in Red if they are greater than their upper limit in Blue if they are lower than their lower limit Select the ...

Page 74: ...nts 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 of analyses included in the batch values is shown in the square located to the right of Selected Analysis When results are de selected from the batch the statistical val ues are automatically re cal...

Page 75: ...ical 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 printer is configured with the system a message stating XB will be noted on the print out The XB flag can also be transmitted to a host computer if it has been selected in the RS232 Output Format This alar...

Page 76: ...alyses 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 Within Run Data Grid From the Quality Assurance Menu see Fig 3 1 page 3 3 select the Within Run key Fig 3 18 Within Run Data Grid ...

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 see 3 3 4 Print Transmit or delete Results page 3 23 CBC DIFF Switches from CBC to DIFF test see 3 3 Running cycles page 3 22 ...

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 begins Rerun the sample several times The Within Run is complete once the operator exits the Within Run Data Grid screen 3 3 2 Rack mode Position the tube in any rack If there is more than one sample ...

Page 79: ...variation 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 statistical data by using the check boxes to de select the analyses 3 3 4 Print Transmit or delete Results Print or Transmit Open the Within Run Data Grid screen Using the Print Transmit key see Tab 3 3 Within...

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 from the grid Fig 3 22 Delete Within Run Results ...

Page 81: ...in 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 Calibration Main Menu page 3 25 4 2 Target values page 3 26 4 3 Running calibration page 3 27 4 1 Accessing the Calibration Main Menu From the Quality Assurance Menu see Fig 3 1 page 3 3 select the C...

Page 82: ...ig 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 the calibrator Assay sheet that comes with the calibrator kit Once all entries have been made select the OK key to save the information Key Name Function Automatic Calculation Runs an automatic calc...

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 Stat Mode key Gently mix the calibrator and place it into the appropriate position in the tube holder Now close the tube holder door to run the analysis When the tube holder door opens remove and rec...

Page 84: ...the 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 the mark When a Coefficient of variation is displayed in Red it is above its limit and that parameter will fail calibration 4 3 1 Calibration passed There are only 2 passing criteria for calibration 1...

Page 85: ...ge 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 wish to continue the calibration You have the option of continuing or rejecting the calibration at this time 4 3 3 Coefficients of calibration ranges Check that the coefficients of calibration are wi...

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 Calibration printout Deleting calibration results For deleting results from the Calibration Results Grid select the Check Boxes to select or de select results and parameters then select the Delete key fro...

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

Page 88: ...nctions 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 logs page 3 35 5 7 Error logs page 3 35 5 8 Host logs page 3 35 5 9 Blank cycle logs page 3 35 5 10 Patient logs page 3 36 5 1 Access to Logs function Fig 3 30 Logs main screen Press the Logs key of t...

Page 89: ...4 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 Maintenance logs page 3 35 Error Launches error log screen see 5 7 Error logs page 3 35 Host Launches Host log screen see 5 8 Host logs page 3 35 Blank cycle Launches Blank cycle log screen see 5 9 Blank cycle...

Page 90: ...change 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 Every time that the QC targets are changed a notification is done Key Name Function Add comments Opens a comment window The user can enter a com ment to associate to the Logs entry on which he is po...

Page 91: ...Host 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 which the tube is found is in progress of an analysis 5 9 Blank cycle logs For every Startup analysis performed a notification is done A Startup has passed if the cycle is launched and the WBC RBC HGB...

Page 92: ...s 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 order and a result in the association screen a notification is done If a recomputing of the result is done the notification shall contain this information ...

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 2 3 2 Contextual toolbar keys 4 16 2 3 3 Grid functions 4 16 2 3 4 Order information fields 4 17 2 3 5 Searching by sample ID 4 18 2 3 6 Searching by patient name 4 18 2 3 7 Printing out the worklist...

Page 94: ...g 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 6 1 8 Rerunning sample manually 4 51 6 1 9 Printout or Transmit Result list 4 51 6 2 Result order association 4 53 6 2 1 Association grid description 4 53 6 2 2 Association grid keys 4 54 6 2 3 Resul...

Page 95: ...age 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 page 4 11 1 8 Sample tube and order association page 4 13 1 9 Patient file management page 4 13 1 10 Loading Worklist from the LIS page 4 13 PENTRA 80 enhances the system operations form sample analys...

Page 96: ...ation 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 patient demographics Matching orders to specific patient files When creating orders there are only 2 modes available 1 A graphics screen see 2 4 Rack view page 4 20 that simulates a rack view with samp...

Page 97: ...ocess 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 see 1 6 Sample identification on Rack position page 4 8 Automatic numbering by the instrument 1 5 Barcode Identification The Barcode Identification mode is the most recommended mode on the ABX PENTRA...

Page 98: ...n 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 5 2 2 5 Identification option page 5 7 OK Problem on reading Matching screen Identification re done Barcode Id 123 Barcode reading Result id 123 ...

Page 99: ...al 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 Barcode Id 123 Worklist check Worklist matched Worklist unmatched OK OK Worklist check Result id 123 on reading ...

Page 100: ...n 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 identification If not the instrument assigns an auto numbering AUTO_SID_xxx to ensure that the final results for this sample contains a single identification 1 6 1 Setting Rack position Manual match OFF The ...

Page 101: ...k 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 Numbering Auto_SIDxx No order Worklist sample identification P80 analysis process Sample detected on position 3 ...

Page 102: ...Fig 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 detected on position 3 Auto Numbering Auto_SIDxx ...

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 2 2 5 Identification option page 5 7 defines a specific treatment of expectations Results obtained for each specific expectation condition are saved in a specific screen which allows the matching of...

Page 104: ...orrespond 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 without order However PENTRA 80 does not generate an exception in this case provided that the rack po sition of this tube has not been reserved for an order in the worklist Example This tube is analyzed ...

Page 105: ...as 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 field is highly necessary to create patient files that can be archived and easily associated with searching on Patient ID criteria in order Patient demographical data can only be modified when it is M...

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 as followed Manually from the Worklist see 2 3 1 Creating an order page 4 16 or from the Re sults screen if you are requesting a Rerun see 6 1 8 Rerunning sample manually page 4 51 Automatically from...

Page 107: ...splay 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 sample identification in your laboratory see 1 Workflow page 4 3 Fig 4 8 Worklist grid Heading Key Name Function Grid view key Displays the worklist grid view see 2 3 Worklist grid page 4 15 Rack vie...

Page 108: ...he 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 Two clicks for descending order Three clicks to restore the initial order Multiple selections are not allow at this time Only one selection at a time Heading Key Name Function Edit Modification of an...

Page 109: ...Rerun 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 characters max Physician Physician requesting the order Section 5 2 3 Department Physicians tab page 5 8 Selection list or cap ture enabled 20 characters max Collecting date Date and time of the spec...

Page 110: ...ng 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 2 3 6 Searching by patient name The operator has the ability to select a specific Patient file from the Patient Name field Just select the Search Patient key see Tab 4 3 Order fields page 4 17 Once t...

Page 111: ...Fig 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 Fig 4 13 Worklist grid printout Light printing A light printout of the Worklist one order by line is also available Select the Light printing option and press the OK button see Fig 4 14 page 4 19 Fig...

Page 112: ...w 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 requested for each position on the rack Fig 4 16 Rack view screen Select one empty position to enter a new sample tube Fill in the order field information see Tab 4 3 Order fields page 4 17 Sample Informa...

Page 113: ...rmed 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 rack position If no positions are available the cursor then moves to the next rack number ...

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 position is not empty sample results and patient information are displayed Heading Key Name Function Edit Modification of an order for a position already filled except if the rack is in the process of being...

Page 115: ...ual 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 informations the clinical informations ...

Page 116: ...ube 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 proportion of blood to anticoag ulant as specified by the tube manufacturer K2EDTA is an acceptable alternative as long as the sample collection is made in normal con ditions Otherwise blood clots may be pos...

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: ...ge 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 The operator can modify the Printer output format by selecting the Settings function key Section 5 5 4 Printer page 5 21 Header RBC Flags Legend WBC DIFF PLT Order ...

Page 119: ...nalysis 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 are listed in 5 3 Flags page 4 29 Results can be reviewed by selecting the Results function see 6 1 Reviewing sample re sults page 4 47 Order 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 the Return key to return the display to normal ...

Page 121: ...is 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 32 5 3 5 Flags on WBC BAS histogram page 4 38 5 3 7 Flags on PLT histograms page 4 39 5 3 10 Pathology messages page 4 43 Analyzer alarms 5 3 9 Analyzer alarms page 4 42 Flags linked to statistical f...

Page 122: ...th 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 Consequences WBC 0 1x103 mm3 and RBC 0 01x106 mm3 120x103 mm3 150X103 mm3 WBC forced to 0 WBC replaced by D diff results replaced by RBC 0 01x106 mm3 8x106 mm3 18x106 mm3 RBC replaced by RBC value D RBC...

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 three Hemoglobin measurements are different from the pre defined value in Settings Type Parameterising Alarms and Curves Threshold Tab Alarm Level Grid HGB parameter percent value Section 5 8 3 1 Ala...

Page 124: ...er 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 parti cles counted in the background noise area is higher than the limit set up in NO or when the number of counted particles ver sus the total number of WBC is above the NO limit Suspected abnormal...

Page 125: ...IC 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 side of the lym phocytes area This flag occurs when the number of particles counted is higher than the limit set up in LL1 and when the number of particles counted in LL regar ding the total number of ...

Page 126: ...rd 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 monocytes and neutrophils This flag occurs when the number of parti cles counted in this area is higher than the limit set up in MN or the number of particles counted in MN versus the total number of WBC i...

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 of a superimposition of the 2 populations This flag occurs when the number of particles counted in this area is higher than the limit setup in NE or when the number of particules counted regar ding t...

Page 128: ...9 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 occurs when the number of particles coun ted in this area is higher than the limit setup in RN or when the number of parti cles counted regarding the total number of WBC is above the RN limit Suspected ...

Page 129: ...phils 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 particles counted in this area is higher than the limit setup in ALY or when the number of particles counted regarding the total number of WBC is above the ALY limit Section 5 8 2 Pathological limits pa...

Page 130: ...ved 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 value for L1 3 200 Section 5 8 3 Alarms Curve thresholds page 5 37 L1 flag is established according to the ratio of the cells counted be tween the 0 channel and BA1 L1 indicates the presence of an a...

Page 131: ...macrocytic 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 and are calculated according to the MCV and the RDW from the RBC histogram Fig 4 34 PLT histogram The PLT histogram contains 256 channels between 2fL and 30fL A mobile threshold at 25 fL by de fault...

Page 132: ...IC 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 no valley between the PLT and RBC histograms the SCH Schizo cytes flag will be generated Suspected abnormalities Presence of schizocytes Presence of PLT aggregates Verify this abnormality by viewing...

Page 133: ...be 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 will be generated If the WBC LMNE count is 15 lower than the WBC BASO count a LMNE flag will be generated The WBC BAS channel is considered as a reference and is used to calibrate the WBC LMNE chann...

Page 134: ...ea 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 abnormalities Stroma interfering with the measurement Strong pollution Incorrect adjustment of the optical bench Others From LMNE Matrix NO flag From WBC Balance LMNE LMNE From WBC BAS Histogram BASO ...

Page 135: ...ges 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 Leukocytosis WBC WBC H Leukopenia WBC WBC L Lymphocytosis LYM LYM H or if LYM LYM H Lymphopenia LYM LYM L or if LYM LYM L Neutrophilia NEU NEU H or if NEU NEU H Neutropenia NEU NEU L or if NEU NEU L ...

Page 136: ...ition 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 MCV MCV L Macrocytosis MCV MCV H Erythrocytosis RBC RBC H Interpretation Not possible RBC 0 01x106 mm3 or RBC reject or RBC 0 03 during Startup ...

Page 137: ...mall 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 LL1 MPV 10 or L1 or LL1 PLT 150x103 mm3 Erythroblasts Condition 2 LL or WBC reject L1 or WBC reject LL1 Platelets Aggregate Erythroblasts If conditions 1 and 2 are not satisfied and if L1 or LL1 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 11 The XB alarm can stop the instrument operations if the user has selected the XB alarm con ditions in the Instrument Settings functions Section 5 2 2 General tab page 5 6 QC failed This flag will a...

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 cycle is in progress or if there is no unmatched result Select all Checks all the result lines in the list column Selected Unselect all Unchecks all the result lines in the list column Selected Print S...

Page 140: ...g 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 CO alarm A means Pathology Alarms see 5 3 Flags page 4 29 displayed for 1 Flags involving distribution curves 2 Flags involving LMNE matrix thresholds 3 MIC PLA SCL SCH alarms N the result is outside ...

Page 141: ...rs 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 results with the D indicator only Alarmed select this box to display the results with the A indicator only Normal Default values select this box to display the results with the N indicator only Extreme De...

Page 142: ...splay 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 new entry in the worklist having the same order see 6 1 8 Rerunning sample manually page 4 51 Result comment Allows the operator to add a comment to results Result i j Result i j i j number of displayi...

Page 143: ...d 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 Rerun for this order is already in the Worklist 6 1 9 Printout or Transmit Result list Several printing and result transmission options are available from the results grid Press the Print Send key th...

Page 144: ...0 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 the host ...

Page 145: ...Association 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 Barcode Identification of the sample as the instrument has read it On the right hand side of the screen Running date Rack Position fields associated to the selected Results Other fields of the order in g...

Page 146: ...n 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 in the Remarks flags see 5 2 Result screen page 4 27 If the order test differs from the results test then the test of the matched results CBC When the user validates the association and no order is s...

Page 147: ...een 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 patient Patient results see 7 3 Patient Result page 4 58 7 1 Accessing the Results Archives Select the Archives key from the generic toolbar Fig 4 46 Archives access When the Archives function is opened ...

Page 148: ...h 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 scrolling icon to move through the list Deleting results from the Archives screen is notified in the Data handling logs see Fig 4 48 Data handling logs page 4 56 Fig 4 48 Data handling logs ...

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 column Selected Print Send Printing or sending options all the lines or selected lines only Click a line Click a line Displays the results in full screen mode see 7 4 Reviewing a result in full screen...

Page 150: ...mographics 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 Patient result screen The Slider icon can be used to display all the results that are associated with this patient ...

Page 151: ...ists 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 the search by date screen see 7 2 Daily result Description page 4 56 Patient ID When a patient is selected Results are displayed on the right hand side Search patient Button Launches the search patie...

Page 152: ...ht 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 the result that you want to display in full screen see Fig 4 51 page 4 60 Other results of the day can be displayed by using the right and left arrows To return to the Daily Result screen select the ...

Page 153: ...3 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 parameters 5 13 4 3 Print conditions 5 14 4 4 Transmit conditions 5 15 5 System 5 16 5 1 Accessing the System screen 5 16 5 2 Local settings 5 16 5 2 1 Date and time format 5 16 5 2 2 Languages options 5 17 ...

Page 154: ...7 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 values 5 33 8 1 4 Sample Type copying 5 34 8 1 5 Type automatic association 5 34 8 2 Pathological limits 5 35 8 3 Alarms Curve thresholds 5 36 8 3 1 Alarm levels 5 36 8 3 2 5DIFF Matrix thresholds 5 3...

Page 155: ...luding 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 Sample Types page 5 33 1 Menu Settings overview 1 1 Accessing the Settings menu Select the SETTINGS key on the Main screen Fig 5 1 Settings menu access key ...

Page 156: ...be 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 and time RS 232 printer see 5 System page 5 17 Save Restore Configuration Opens management screen for saving restoring the software config uration see 6 Save and restore page 5 26 Users Opens managemen...

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 2 General tab page 5 6 Department Physicians see 2 3 Department Physicians tab page 5 8 Units see 2 4 Units tab page 5 9 ...

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 select the OK key to confirm your choice Key Heading Name Function Auto Numbering Auto Numbering Defines the initial value of the autonumbered Sample ID see 2 2 2 Automatic numbering page 5 6 RUO parame...

Page 159: ...5 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 key to confirm your selections 2 2 5 Identification option Fig 5 4 Identification option This option must be setup according to the specific working order of the laboratory opera tions Section 4 1 Work...

Page 160: ...s 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 2 Worklist page 4 14 From the Soft Parameters menu select the Department Physicians tab Fig 5 5 Department Physicians tab Use the following function keys to insert delete or modify a department Physi...

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 Deletion of department or Physician if the focus is on the department list the software allows the deletion of a department UNITS WBC RBC HGB HCT PLT MCV STD 103 mm3 106 mm3 g dl 103 mm3 µm3 SI 109 l 1012 ...

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 and includes a calculation on 3 or on 9 extended parameters The 3 parameters include MCV MCH MCHC The 9 parameters include WBC RBC HGB HCT MCV MCH MCHC RDW PLT This function allows the operator to sele...

Page 164: ...d 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 ranges Coefficients of variation CV applied on statistical calculations as calibration Section 3 4 3 1 Calibration passed page 3 28 QC Section 3 1 3 QC data screen grid page 3 7 and within run grids...

Page 165: ...ns 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 on these criteria Re sampling will be required if a hematological results trigger alarm conditions L1 LL1 MB These criteria are de fined for all types of blood see 4 2 1 Rerun on alarms page 5 14 b h...

Page 166: ...o 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 Normal set by the user or rejected parameters that will trigger a rerun Select or De select the boxes to trigger or not trig ger a rerun on parameter limits If you want a rerun for any parameter that is o...

Page 167: ...rinted 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 checked flags has been triggered 2 a rejected result occurs on one of the checked parameters 3 the results are out of panic or normal limits on one of the checked parameters To select or de select criteri...

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 verified 4 one of the checked flags has been triggered 5 a rejected result occurs on one of the checked parameters 6 the results are out of panic or normal limits on one of the checked parameters To select...

Page 169: ...mmunication 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 Date and time format page 5 17 and language modification see 5 2 2 Languages options page 5 18 5 2 1 Date and time format Fig 5 16 date time format Select the Edit key then scroll through the Date or...

Page 170: ...nish 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 5 2 3 Change date and time From the Local settings tab see Fig 5 15 page 5 17 select the Edit key Then select Change Date Time key Change the date and time so that the computer can become updated wi...

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 system by a qualified technician using the LIS Output Format documentation P N RAA024 ...

Page 172: ...ngs 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 ABX format or ASTM format None Mode communications in both directions or from the P80 to the host ABX BIDIR Max time time out in seconds before automatic deconnection 80 Response time time out in secon...

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 associated to the selected parameters sent to the host General flags Section 4 5 3 Flags page 4 29 Patient File Selected fields sent to the host Section 4 2 Worklist page 4 14 Histograms and thresholds ...

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 when checked see Fig 5 21 page 5 23 Manual entry grid Manual formula are printed out when checked see Fig 5 21 page 5 23 Suspected pathologies Pathologies are printed out if checked see Fig 5 21 page...

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: ...ing 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 Shutdown cycle is automatic at the programmed time if checked Checked Daily workload Workflow notion approximate number of DIF CBC analyses per day Used to warn the operator if reagent level is too short f...

Page 178: ...e 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 the current configuration Restore setting from hard 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 save the current...

Page 179: ...d 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 floppy is unformatted the software then invites the user to format it Restore settings from floppy Opens a dialogue window in order to select one of the save settings on the disk Heading key Function...

Page 180: ...rinting 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 screen Insert the CDROM into the instrument CD drive Open the Settings Save and Restore settings screen Press the Update help key to access to User manual screen The contents of this CDROM can be rev...

Page 181: ...llowing 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 recorded on the CDROM The Install key will install the new Help on line from the CDROM on your instrument and erase the previous one ...

Page 182: ...n 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 Cali bration functions The Users profile wich allows access to daily working operations User profiles sections 7 1 Accessing the User screen page 5 30 7 2 User menu function keys page 5 31 7 3 Creating ...

Page 183: ...ode 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 profile lists A user can edit insert delete a login of the same level or a lower level but not at a higher level Entering the name of the user is done in the login windows Section 2 1 3 Pentra 80 Startup...

Page 184: ...ntra 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 31 User password ...

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 curves thresholdsTab From this menu the operator will have the ability to Create a new blood type see 8 1 2 Creating a new blood sample type page 5 34 Modify Pathological limits see 8 1 3 Modifying li...

Page 186: ...difying 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 enter a new value Once all entries have been made select the OK key to confirm your modifications Key Heading Name Function Insert Allows to define a new blood type see 8 1 2 Creating a new blood sample ...

Page 187: ...er 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 results When the Standard type is captured in the order or defined as default type an auto matic search on Department Date of birth or Gender field is performed 1 if a type name has been entered in the ...

Page 188: ...nd 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 by the user Results exceeding the Normal Ranges limits are marked with the following flags h for results above the normal upper limit l for results below the normal lower limit Results exceeding the ...

Page 189: ...ntered 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 Default values have been incremented for the 8 types Standard man woman child1 child2 child3 child4 and child5 see 8 1 3 Modifying limit Alarm values page 5 34 ...

Page 190: ...n 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 improve the separation between different cell populations which may vary according to the selection of anti coagulant for blood sample collection or minor internal instru ment adjustments b To modify th...

Page 191: ...LL 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 area 70 LN LMU AL Separation between Lympho Left Lympho 68 LL LMU LMU Upper dot of the separation slope ALY Mono 78 AL LMD LMD Lower dot of the separation slope ALY Mono 90 LMU RM MN Upper dot of the se...

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 area 240 ...

Page 193: ...his 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 of the range is as followed xx year xx month xx day To modify the range of one child select the Edit key Move left right the cursor of the child type to display the wished high range Select the OK key...

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

Page 195: ...tribution 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 Measurement 6 13 3 2 4 RDW calculation 6 13 3 2 5 MCV MCH MCHC calculation 6 13 3 2 6 MPV Measurement 6 13 3 2 7 Pct Calculation 6 13 3 2 8 PDW calculation 6 14 3 3 WBC and differential count 6 15 3 3 1 Gen...

Page 196: ...over 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 sheath flow into the flowcell Floppy and CD drivers Fig 6 2 PENTRA 80 left side view Optical bench Ensures the support and ad justment of the flowcell lamp and optical and electro nic elements Reagent...

Page 197: ...n 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 dilutions Regulates the tempera ture of dilutions Provides the dilutions for WBC BAS RBC PLT and HGB Fig 6 3 PENTRA 80 right side view Mother board Amplifies proces ses and counts the following signals R...

Page 198: ...busy 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 Stat tube holder Sampling position 4 For microtainer Diluent and waste connections Serial number label Main power sup ply inlet Fig 6 5 Rear View Host computer connection Printer connection ...

Page 199: ...a 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 The Sample tube is detected and the tube height is adjusted by the presence of 2 rolling de tectors within the mechanism see Fig 6 6 page 6 5 Sensors are also present within the mechanism to index the ...

Page 200: ...ork 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 tube in the rack Then both tubes numbered 1 and 3 are grabbed and mixed at the same time for another 30 seconds more The tubes are placed back into the rack and then tubes numbered 2 and 4 are taken a...

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 Fig 6 8 Sample tube identification ...

Page 202: ...he 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 that aspirates the sample while the cap is being pierced Fig 6 9 Sample Cap piercing ...

Page 203: ...ent distribution in CBC mode 3 1 2 Diff Mode While in the DIFF Mode 53µl of whole blood is aspirated then delivered with into the following chambers as indicated One segment of sample for the Dilution chamber which is used for the RBC PLT dilution and the Hemoglobin measurement The second segment of sample is used for the WBC BASO count The last segment of sample is used for the LMNE chamber from ...

Page 204: ...mple 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 patented by ABX DIAGNOSTICS Fig 6 12 Sample distribution in a tangential flow Reagent Input ...

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 according to size and thres hold grouped and then mathematically calculated along with the calibration coefficients to give a final numerical va lue for both RBC s and PLT s Results Number of cells ...

Page 206: ...sorbance value obtained from the sample x coeffi cient of calibration Technical characteristics of the RED BLOOD CELL and PLATELET counts Initial blood volume 10 µl Method Impedance Vol ABX DILUENT 2500 µl Aperture diameter 50 µm Final dilution rate 1 10000 Count vacuum 200 mb Temperature of reaction 35 C Count period 2 X 6 seconds Two successive dilutions are carried out Primary Dilution for RBC ...

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 Corpuscular Volume of erythrocytes 3 2 5 MCV MCH MCHC calculation MCV Mean Cell Volume is calculated directly from the entire RBC histogram MCH Mean Cell Hemoglobin is calculated from the HGB value a...

Page 208: ...et 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 telets beginning with the variable top threshold S2 Fig 6 16 PDW calculation S1 S2 ...

Page 209: ...bration 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 The measurement principle is exactly the same as the RBC PLT measurement The Differentiation between the BASO s and the other leukocytes is obtained by the use of the ABX BASOLYSE II reagent with it spec...

Page 210: ...f 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 specific coloration for there measu rement in the matrix The solution is then stabilized with Diluent and transferred into the LMNE flowcell Each cell is mea sured in absorbance cytochemistry and resistive vo...

Page 211: ...ciples 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 Absorbance measurement High absorbance ...

Page 212: ...cause 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 Red Blood Cells and improperly adjusted flowcell alignment Background noise may also be detected in this zone if the interference is great MONOCYTES The Monocytes are a very large irregular shaped c...

Page 213: ...lls 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 metamyelocytes will be found to the right of the neutrophils and almost at the same level Myelocytes and promyelocytes will be found on the far right of the matrix in the saturation position The metamyelocytes...

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

Page 215: ...robe 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 front door removal 7 18 3 2 Right front door removal 7 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...

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 Types and Help Messages 7 49 8 6 Expiration Date Error Types and Help Messages 7 49 8 7 Analyzer Internal Error Types and Help Messages 7 49 ...

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 instrument maintenance according to the chart table 1 2 Maintenance procedures Maintenance Sample output Analyses per Day Cycles 100 100 Startup 1 per day 1 per day Shut down 1 per day 1 per day Concentr...

Page 218: ...dirty 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 Bactericidal Fungicidal Active on Aspergillus fumigatus Active on Mycobacterium tuberculosis B K Antiviral VIH HBV and rotavirus Product Example validated by ABX Diagnostics ANIOS detergent disinfectant WIP A...

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 connections When installing the Diluent on the system it is most important to maintain the depth of the container no lower than 80 cm 31 5 in below the instrument If the depth limit is exceeded erroneous...

Page 220: ...r 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 occurs and the following alarm window will appear indicating the following message see Fig 7 2 page 7 7 1 2 3 4 5 6 ...

Page 221: ...s 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 see Fig 7 3 page 7 7 Fig 7 3 Reagent status window ...

Page 222: ...e 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 specifications see Fig 7 4 page 7 8 Fig 7 4 Reagent edit ...

Page 223: ...ield 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 level and or change it to the correct level in milliliters if necessary Select the Level field and edit if necessary see Fig 7 6 page 7 10 ...

Page 224: ...l 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 primes the reagent see Fig 7 8 page 7 11 ...

Page 225: ...tainer 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 it Power off the instrument Open the instrument left hand and right hand side panels lift the top cover of the instrument as well see 3 Instrument panels cover Removals page 7 18 Locate the Optical ...

Page 226: ...nnect 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 the lamp bracket from the loosened screws and remove the lamp see Fig 7 12 page 7 13 ...

Page 227: ...ify 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 illuminated 2 Verify that the lamp connection is connected properly 3 Remove the lamp and verify that the lamp filament is not damaged 4 Try another lamp if available 5 If all these simple remedies do...

Page 228: ...g 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 remove the probe see Fig 7 15 page 7 14 Fig 7 15 Probe replacement ...

Page 229: ...re 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 as described in 3 Instrument panels cover Removals page 7 18 in order to access to dilution chambers Fig 7 16 Rinse chamber filter location 3 Locate the filter below the rinse chamber 4 Remove the f...

Page 230: ...o 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 page 16 Fig 7 18 Unprime cycle screen 5 Press the Validate button then repeat this cycle a second time 6 Dry the straws using absorbant paper 7 Plunge the straws in a bottle full of distilled water 8 ...

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 park syringe position button See Park screen page 17 Fig 7 20 Park screen 2 Before the transport of the instrument press the Run maintenance carriage position button 3 Block the carriage using the P...

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 removal Pull the Left Front cover down as indicated in 1 and then pull out to remove it as indi cated in 2 see Fig 7 22 page 7 18 Fig 7 22 Left Front cover 2 1 ...

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 tipped screwdriver into the screw slots and turn counter clockwise to unlock the screws see Fig 7 24 page 7 19 Fig 7 24 Righthand side panel Lift the panel up and out of its placement slot 2 1 ...

Page 234: ...partment 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 Fig 7 25 Lefthand side panel Now slide the left side panel forward and lift it out of the instrument ...

Page 235: ...nu 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 solution see Clean Cycles page 7 33 Autoclean Automatic Cleaning cycle This can be automatically run every n analysis cy cles see 5 5 Cycle option page 5 25 as well as a Super User sub menu see 5 Super ...

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 23 5 2 Hydraulical menu page 7 30 5 3 Others page 7 35 Fig 7 27 Super User menu ...

Page 237: ...tate 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 user to check the operation of all the motor driven assemblies independently Power off the instrument Open the instrument right and left front doors and remove the right hand and left hand side panels...

Page 238: ...smooth 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 movement of the sample tube mixer 9 Sampling Needle Check for smooth and complete movement of the sample probe 10 Carriage Motor Right hand side of the instrument Check for smooth and complete movement of t...

Page 239: ...traight 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 to 23 Verify the correct operation of these valves 4 Valves 24 to 30 Verify the correct operation of these valves 5 Valves 31 to 35 Verify the correct operation of these valves 5 1 4 Check Sensors Ve...

Page 240: ...chnical 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 User Menu and then Mechanical Sampler Test Now select the Start Rack key and verify that the rack identification and all the tubes in the rack have been detected Rack number Type of rack CBC or DIFF ...

Page 241: ...anual 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 modify them unless instructed to do so by an ABX DIAGNOSTICS Representative ...

Page 242: ...nd 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 id field Holder Open Time key This key allows the instrument to calculate the amount of time it takes for the tube holder to completely open This value will be entered into the Time field 5 1 7 Rack...

Page 243: ...oubleshooting 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 Rack Adjustment ...

Page 244: ...ns 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 instrument Run this procedure after service has been performed on the instrument This function allows only the priming of reagents into the instrument It does not set the reagent quantities to 100 4...

Page 245: ...er 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 reagent 5 ABX Lyse Primes ABX Lyse reagent 6 All reagents Primes all reagents at the same time 4 5 6 1 2 3 ...

Page 246: ...80 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 instrument 1 2 ...

Page 247: ...MNE 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 18 to access to the chambers Select Concentrated Cleaning key then press Validate key in the following window to con firm the cycle see Fig 7 39 page 7 33 Fig 7 39 Concentrated cleaning confirmation T...

Page 248: ...Fig 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 Concentrated cleaning cycle duration is around 4min ...

Page 249: ...nsport 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 maintenance procedures that may require the movement of the sample carriage 4 Each Calibration Coefficient can be forced to a value Enter the value you want to modify in the Calibration coefficients gri...

Page 250: ...hed 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 Temperature reached Calibration verification No No Failed No poor See error messages Technical operations Temperature reagents printout transmit Probe Proc 3 Proc 4 Proc 5 Blood aspiration Probe motion sample ...

Page 251: ...ng 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 Calibration verification out of acceptable limits a Clean the system see 5 2 4 Clean Cycles page 7 33 and re run the control b Run a new vial c Calibrate the instrument Section 3 4 Calibration page 3 2...

Page 252: ...e 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 ABX Diagnostics representative department 6 2 Results Procedure 6 All parameters Repeatability According to the CV specifications Section 8 3 2 Precision Repeatability page 8 8 Is the instrument non...

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 7 39 Procedure 8 HGB Repeatability If HGB is non repeatable a Run an analysis cycle b Check dilution colour in the chamber 2 Milky when sample is first delivered to the chamber then brown transparen...

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 Clean Cycles page 7 33 b Re run the specimen c Check the operation of liquid valve 14 Opening and closing during cycle If defec tive replace the valve d If this does not correct the RBC PLT results c...

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 Cytometer rinse see 5 2 4 Clean Cycles page 7 33 c Re run the specimen d If this does not correct the WBC results call your ABX Diagnostics representative de partment ...

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

Page 257: ...e 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 44 8 2 Transfer error types and help messages page 7 45 8 3 STAT mode error type and help message page 7 46 8 4 Environment Error Types and Help Messages page 7 46 8 5 User Error Types and Help Mess...

Page 258: ...failure 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 failed Run an Auto Clean Check Motor in Service Menu Drain sensor sensor number 1 2 or 3 time out Drain Sensor Run an Auto Clean Injection syringe motor failure Injection Syringe Motor home switch always ...

Page 259: ...Sampler 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 motor in Service Menu Sampler Transfer motor failure Sampler Transfer Motor home sen sor always detected Run an initialization Check motor in Service Menu Stop rack Transfer switch not detected Sample...

Page 260: ...elp 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 Off System Run an initialization Communication With Analyzer Failed System Run an initialization End Sampler Transfer Sensor Error Sensor state Run an initialization Error on raw results sending Resul...

Page 261: ...low 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 Run an autoclean RS232 alarm RS232 external problem Check host connection Sample ID d already in progress Software No message LIS communication module closed Software No message Tube Detection Sensor...

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 Home Motor d error Run an Initialization Incorrect pos motor carriage d Min d Max d Carriage motor bad position Run an Initialization Incorrect pos motor counting d Min d Max d Incor rect pos motor PRE...

Page 263: ...rect 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 Error Barcode internal connection problem Run an Initialization Internal synchronization failed System stop due to synchroniza tion problem Run an Autoclean Motor d is busy Run an Initialization Run a...

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 performance data 8 7 3 1 Precision Reproducibility 8 7 3 2 Precision Repeatability 8 8 3 3 Linearity 8 9 3 4 Carryover 8 10 3 5 Normal Ranges 8 11 3 6 Accuracy 8 11 3 7 Leukocyte differential count 8 12 3 ...

Page 266: ...ro 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...

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 Lymphocytes and RBC Red Blood Cell HGB Hemoglobin Concentration HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Distr...

Page 268: ...nternal 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 Floppy disck CD ROM drive RS 232C Keyboard Mouse 1 6 Measurements and computation Impedance for WBC PLT RBC BAS Photometry for HGB Impedance and light scattering for LYM MON NEU EOS ALY and LIC Comput...

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 Minimum specimen volume CBC Mode CBC 30µl CBC 5DIFF Mode DIF 53µl 2 5 dilution ratios WBC BAS 1 200 LMNE 1 80 RBC PLT 1 10000 HGB 1 250 2 6 HGB measurement HGB chamber LED 555 nm Modified Drabkin meth...

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 EOSINOFIX 1 34 1 6 23 7 Prime BASOLYSE 2 1 25 1 7 23 7 1 0 Prime CLEANER 1 24 1 7 24 7 Prime LYSE 1 31 2 7 8 4 Prime ALL 7 13 50 7 24 0 24 0 25 0 8 4 STARTUP 1 blank cycle 2 28 55 2 2 0 3 0 2 0 0 95 ...

Page 271: ...l 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 0 08 0 07 0 11 PX052 Low 0 05 0 05 0 04 0 06 HCT PX052 High 0 76 0 61 0 65 0 95 PX052 Normal 0 62 0 62 0 62 0 88 PX052 Low 0 28 0 34 0 37 0 48 PLT PX052 High 16 29 8 32 10 6 16 72 PX052 Normal 9 01 ...

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 35 1 44 2 09 PX052 Normal 1 58 1 57 1 58 2 23 PX052 Low 1 54 1 83 2 02 2 63 PLT PX052 High 3 29 1 68 2 14 3 38 PX052 Normal 3 34 1 93 3 2 4 2 PX052 Low 4 94 5 3 6 42 8 22 Neutro PX052 High 3 2 07 2 32...

Page 273: ...his 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 according to the Manufacturer s instructions Human Blood Linearity was also obtained on human blood using a minimum of 5 dilution points The re sults of this study are as followed Parameters Manual CV Op...

Page 274: ...reticulocyte 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 greater WBC 103 mm3 0 45 124 0 120 120 150 0 3 7 RBC 106 mm3 0 22 8 9 0 8 0 8 0 18 0 0 07 2 HGB g dl 1 3 26 0 24 24 30 0 3 2 HCT 1 9 72 0 67 67 80 2 0 3 PLT 103 mm3 for HGB 2 g dL RBC 0 5x106 mm3 7 20...

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 Male Female WBC 103 mm3 4 10 4 10 RBC 106 mm3 4 50 6 50 3 80 5 80 HGB g dl 13 0 17 0 11 5 16 0 HCT 40 0 54 0 37 0 47 0 MCV µm3 80 100 80 100 MCH pg 27 0 32 0 27 0 32 0 MCHC g dl 32 0 36 0 32 0 36 0 RDW ...

Page 276: ...e 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 one of which was stored at room temperature and one at 4 degrees centigrade Sample stability was assessed over a 72 hour period The following results were obtained Parameter R Comparison of means Accu...

Page 277: ...for 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 according to the local or national regulatory requirements Room Temperature 4 Celsius 0 hrs 24 hrs 48 hrs 72 hrs 0 hrs 24 hrs 48 hrs 72 hrs Deviation WBC 0 1 44 1 85 7 19 0 0 41 0 1 9 87 Deviation RBC 0 1...

Page 278: ...s 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 value Unlysed Red Cells In some rare instances the erythrocytes in the blood sample may not be completely lysed These non lysed red blood cells may be detected on the WBC histo gram with an L1 alarm ...

Page 279: ...idity 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 the superna tant fluid measured with a spectrophotometer High lipid concentration A high concentration of lipids in the blood sample will give the plasma a milky appearance This condition can occur ...

Page 280: ...y 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 the proper counting of platelets and cause elevated PLT counts Agglutinated erythrocytes May trap platelets causing an erroneously low platelet count The presence of agglutinated erythrocytes may be d...

Page 281: ...me 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 parasites and erythrocytes that are resistant to lysis may interfere with an accurate LYM count Limitations listed for the WBC count pertain to the LYM and counts as well MON mononuclear cell count absolut...

Page 282: ...efer 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 Follow your local and or national guidelines for biohazard waste dis posal If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposin...

Page 283: ...on expiration 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 Section Maintenance Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description technology in the instrument User Manual Results see S...

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Page 285: ...xpiration 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 Troubleshooting Reagent Location and connexion in the instrument User Manual Measuring Principles see Section Description technology in the instrument User Manual Results see Section Workflow in t...

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Page 287: ...ervation 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 Section Maintenance Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description technology in the instrument User Manual Result...

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Page 289: ...to expiration 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 reagent is for professional in vitro diagnostic use only Measuring Principles see Section Description technology in the instrument User Manual Results see Section Workflow in the instrument User Ma...

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Page 291: ...ications 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 principles results Directions for use see Section Maintenance Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description techno...

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Page 293: ... 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 Section Maintenance Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description technology in the instrument User Manual Results see Section Workfl...

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Page 295: ...surements 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 Refer to the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative 4 Composition Han...

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

Page 298: ...al 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 control A substance used for monitoring the performance of an analitycal process or instrument CV See Coefficient of variation default An original factory setting expiration date The last day that you can...

Page 299: ...c 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 that the system gives similar results within estab lished limits every time it measures the same sample SD A measure of variation within a group samples or within a population standard deviation Shu...

Page 300: ...nt 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 8 4 Contextual toolbar Chap 1 8 Chap 1 9 Cycle option Chap 5 23 D DANEPT Chap 4 47 Date and time Chap 5 15 Drain chambers Chap 7 23 Dump database Chap 5 25 E Error messages Chap 7 34 F Flags Chap 4 2...

Page 301: ...6 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 35 RN flag Chap 4 36 SCH Chap 4 40 SCL Chap 4 40 Suspiscion Chap 4 32 XB flag Chap 4 45 Front View Chap 6 2 G generic toolbar Chap 1 8 H Host connector Chap 6 4 I Identification option Chap 5 6 L L J...

Page 302: ...BC 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 Order runs association Chap 4 46 P Panels cover dismantling Chap 7 13 Pathological limits Chap 5 31 Pathology messages Chap 4 43 Pct Calculation Chap 6 12 PDW calculation Chap 6 13 Prime cycles Chap 7 ...

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 Chap 6 2 Diluent and waste connections Chap 6 4 replacement Chap 7 4 Reagent Syringe Chap 6 2 Repeatability Chap 8 6 Rerun conditions Chap 5 11 Result display Chap 4 49 Result screen Chap 4 27 Results ...

Page 304: ...hap 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 Chap 8 2 Startup Chap 1 11 Chap 2 2 automatic Chap 2 3 Stat mode Chap 2 8 Status Chap 1 17 Super User menu Chap 7 16 Check motors Chap 7 17 Check Sensors Chap 7 19 Check valves Chap 7 18 Holder adju...

Page 305: ...access 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 Worklist Chap 4 5 Worklist Chap 4 15 access key Chap 4 15 Auto Numbering Chap 4 22 grid Chap 4 16 order Chap 4 17 Rack view Chap 4 20 search patient Chap 4 19 search sample Chap 4 19 X XB Chap 3 14 acc...

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

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