1. （待機画面）
© 2007 HORIBA, Ltd. All rights reserved.

2. Pentra ES 60 Haematology Analyzer

3. TABLE OF CONTENTS I- Introduction II- Main Features III- Dimensions
IV- Reagents
V- Maintenance
VI- Parameters
VII- Tubes handling and Micro-sampling
VIII- Reliable Results with Proven Technologies
IX- Software Overview
X- Summary
XI- Conclusion

4. I- Introduction

5. 5 DIFF & 60 tests/hour Analyzers
ABX Pentra 60
Open Tube
Pentra ES 60: New!
Open Tube
Dedicated Workstation
ABX Pentra 60C+
Closed Tube
Dedicated Workstation
With this new comer, the 5 DIFF, 60 tests/hour family has grown from 2 products to 3 products:

6. Hematology IVD Market Segmentation
The Pentra ES 60 is dedicated to the Middle segment (medium size analyzers) with CBC and 5 Part Differential and a throughput less than 80 samples per hour.
The Pentra ES 60 is suitable for laboratories requiring:
Simple operation
Cost effective systems
Small size instruments
Standardization of data and instrument performance
Windows environment
The Pentra ES 60 can be used as:
Stand alone analyzer in small/medium laboratories
Back-up of 5 DIFF analyzers (especially for ABX Pentra 120 customers who want the same powerful technology and can accept the open tube feature).

7. II- Main Features

8. Main Features 26 Parameters 60 tests / hour Reagents compartment
4 onboard
Colour screen
Memory: results + graphs
Open tube
The Pentra ES 60 is a compact, open tube, 5 part differential hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The Pentra ES 60 delivers the performance a laboratory needs from a hematology analyzer :
60 tests per hour
26 Parameters: CBC (12), DIFF (14)
Micro-sampling on whole blood: 30 μL in CBC mode and 53 μL in CBC+DIFF mode
Dedicated Workstation : color user interface with memory: results + graphs, QC and traceability of results
Compatible with ABX Pentra ML (Multilink System) to centralize hematology operations and to enhance the data management capabilities.
60 tests / hour
26 Parameters

9. III- Dimensions

10. Dimensions Compact bench top system
48 cm
51.5cm
15 inches
Dimensions
Height Width Depth
51.5cm 44.5cm 48 cm
20.3 in 17.5 in 19 in
Weight
35 kg = 77 lb
44.5cm
Compact bench top system
Ideal for laboratories where the table-top space available is limited.

11. IV- Reagents

12. Reagents ONLY 5 REAGENTS Small volumes
Bar codes (batch number, expiry date)
Cyanide free lyse (ABX Lysebio)
Waste level sensor
4 internal reagents
ABX Cleaner (1L)
ABX Eosinofix (1L)
ABX Basolyse II (1L)
ABX Lysebio (0.4 L)
1 external reagent
ABX Diluent (10L or 20L)
Reagent level control
Logs
ONLY 5 REAGENTS

13. VI- Parameters

14. Parameters
Access to CBC or CBC+DIFF mode through one click on the mouse.

15. VII- Tubes handling and Micro-sampling

16. 30 µl in CBC and 53 µl in CBC+DIFF
Tubes handling
Bar code identification with external bar code reader.
Whole blood Micro-sampling with Multi-Distribution Sampling System (MDSS) :
30 µl in CBC and 53 µl in CBC+DIFF

17. Micro-sampling MDSS (Multi-Distribution Sampling System)
30 μL in CBC mode and 53 μL in CBC+DIFF mode are aspired
Ideal for pediatric, oncology or geriatric sample types or whenever a small sample volume is required
The remaining volume may be used for additional analysis such as sedimentation rate, smear…It will avoid to puncture again the patient
Blood split into precise aliquots
Aliquots distributed directly into pre-heated analysis chambers with a synchronized tangential flow of diluent for appropriate dilutions without viscosity problem
Perfect mixing and homogenization of blood with reagents.
The needle is positioned near the chamber cavity and injects the aliquot of blood in the reagent tangential flow.
The needle is then cleaned internally and externally.
No sampling shear-valve to distribute blood sample in all appropriate chambers: No maintenance, no clogging
Immediate CBC+DIFF test selection without a cleaning cycle in between.
HORIBA Medical Patent

18. VIII- Reliable Results with Proven Technologies

19. RBC and PLT count Electronic Impedance Variation Principle
In the chamber, the sample is diluted with ABX DILUENT reagent (current conducting), mixed, then pushed into a calibrated aperture.
Two electrodes are placed on either side of the aperture and electric current continuously passes between the two electrodes.
As the cells pass through the aperture, they create resistance (impedance) in the electronic field between the two electrodes.
The voltage is proportional to the volume of the cell: the larger the cell is, the «more» resistance it has. The smaller the cell is, the «less» resistance it has.
The pulses are amplified, channeled according to volume and threshold, grouped and then mathematically calculated along with the calibration coefficients to give a final numerical value.
Result = Nb of cells counted per volume unit x calibration coef.

20. HGB measurement Spectrophotometry
ABX Lysebio : cyanide-free !
The newest developed reagent for RBC lysis and determination of HGB.
Advantage
It does not contain cyanide.
It could be thrown with the regular wastes (depending of the national regulations).
How does it work ?
By action of lysis agent, contained in the reagent, hemoglobin is released.
All the heme iron is oxidized and stabilized.
Oxidation resulting complexes are measured through the optical part of the first dilution chamber by spectrophotometry at a wavelength of 550nm.
Result = Absorbency value x coef. of calibration.

21. RDW, MCV, MCH, MCHC, MPV, PCT, PDW: Calculation HCT: Numeric Integration
Erythrocyte abnormalities linked to Anisocytosis. RDW is a calculation from the RBC histogram :
RDW = (K X SD) / MCV
K = System constant
SD = according to statistical studies on cell distribution within the RBC histogram.
MCV = Mean Corpuscular Volume
MCV, MCH, MCHC
MCV is directly calculated from the RBC histogram.
MCH (pg) = HGB/RBC x 10
MCHC (g/dL) = HGB/HCT x 100
HCT
Numeric integration of the MCV
PCT
PCT% = PLT (103 / mm3) x MPV (μm3) / 10000
PDW
PDW is directly calculated from the PLT histogram.
MPV
MPV is directly derived from the analysis of the platelet distribution curve.

22. WBC and DIFFERENTIAL count
WBC count is carried out twice by two different analysis methods which utilize the total WBC count in both areas :
1- In WBC/BAS count chamber during the BAS/WBC count.
WBC reference count
2- In the OPTICAL CHAMBER during the LMNE count.

23. WBC and DIFFERENTIAL count WBC/BAS count
Electronic Impedance Variation Principle
Differentiation between the BAS and the other WBC is obtained by the use of the ABX BASOLYSE II reagent with it specific lysing action.
Nucleus of WBC populations are counted between the electronic thresholds from 0 to <BA2>.
BAS are counted between the electronic thresholds <BA2> and <BA3>.
Results
WBC = Number of cells counted within a specified amount of time per volume x WBC calibration coefficient.
BAS = Number of cells counted within a specified amount of time per volume x WBC calibration coefficient in a percentage as the total number of leukocytes (BAS and WBC nuclei).

24. WBC and DIFFERENTIAL count LMNE count
Step 1: Cytochemistry
25 μL of whole blood is delivered into the LMNE chamber in a tangential flow of the reagent ABX Eosinofix.
The blood sample is incubated at a regulated temperature with ABX Eosinofix during 12 seconds.
- It lyses RBC
- It stains EOS cytoplasm, granules and nuclei with a specific dye agent : Chlorazol Black
- It stabilizes WBC in their original state : 48 hour post-draw stability
Then, the sample is diluted in a current conductor diluent.

25. WBC and DIFFERENTIAL count LMNE count
Step 2: Flow cytometry
The prepared sample is injected through the flow cytometer: DHSS : Double Hydrodynamic Sequential System
1 - Focused flow for impedance measurement
Cell volume measurement:
The dilution is aspirated through a calibrated aperture.
Two electrodes are placed on each side of the aperture.
Electric current passes through the electrodes continuously.
When a cell passes through the aperture, electric resistance (or impedance) between the 2
electrodes increases proportionately with cell volume.
2- Focused flow for optical detection
Analysis of the internal cellular structure by measuring light absorbency of cells.

26. WBC and DIFFERENTIAL count LMNE count
Step 3: Results are obtained and displayed in LMNE matrix
LMNE matrix is obtained from:
- IMPEDANCE measurement
- OPTICAL detection
4 sub-populations are perfectly separated because of the high definition system:
Lymphocytes
Monocytes
Neutrophils
Eosinophils
The quality of the resolution allows the counting of 2 additional sub-populations:
Large Immature Cells (LIC) : myelocytes, promyelocytes, large blasts.
Atypical Lymphocytes (ALY) : large lymphocytes, activated lymphocytes, blasts.
BAS are removed in proportion to LMN populations.

27. WBC and DIFFERENTIAL count Advantages
A sequential system (timing device) is applied between 2 measurements. The impulse generated by the first passage of the cell through the aperture system for volume measurement crosses the halogen light beam in less than 200 microseconds time period. This timing prevents from counting bubbles and will give a perfect differentiation of the WBC sub-populations.
48 hour post-draw stability : During 48 hours following the moment of taking the blood sample from the patient, it is possible to run the sample and to have reliable and coherent results. No need to puncture again the patient. It is a real comfort for the patient.
ALY and LIC flags give information about these abnormal sub-populations and allow a better diagnostic, enable early detection of lymphocytes pathology and the follow-up of patients in the intensive care units, in oncology and in pediatrics.
The compact optical chamber and the flow cell technology guarantees accuracy, stability and repeatability of the results.

28. IX- Software Overview

29. Secured Access
Log in the application with your user name and password.
1. Select a user name from the Operator drop-down list.
2. Type your password in the Password field.
3. Click OK.

30. Reagents’ Management
Check the level of each reagent. The percentage indicates the remaining level.
Check the expiration date of each reagent in the Expiration fields.
At instrument start-up, the remaining quantity of each bottle is compared to the daily workload set up by the user.
If a low level is expected during the working day, a dialog box appears.
You can click OK and go on running specimen until the dialog box appears again. Then, the bottle must be changed.

31. Worklist 1/2
Green: This routine analysis has been done.
Pink: This Analysis such as QC, Calibration, Repeatability or blank has been done already.
Blue: This Analysis such as QC, Calibration, Repeatability or blank is pending.
Blank: This routine analysis is pending.
Red: This analysis is currently running.
The worklist provides the list of orders to perform, those currently in analysis and those already run.
New orders can be created from this menu.
These ones include all the patient data and the test to carry out.

32. Worklist 2/2 Two views are available:
one is a list with one analysis by line (slide before). You can print your list of orders to prepare your series of analyses.
one is a detailed view of each field of the patient: Order Entry.

33. Run a sample 1- Click the Worklist tab
4- Plunge the sampling needle into the specimen tube and press the start bar.
2- To select one order: click the order holding Ctrl key.
3- Enter Run tab.
5- Remove the tube when the light indicator stops flashing..
6- Recap the specimen tube.
In the worklist, the order in progress is highlighted in red
When the LED turns to green again, the instrument is ready for the next analysis.
7- You can now review the results of the analysis.
The next specimen to run is shown in the Next field.

34. Results Display Review Results in full screen mode
Results status indicator:
White: not validated yet
Red: pending for rerun
Green: validated
Suspected Pathology
Review Results in full screen mode
Full diagnostic access to the hematological status of the patient with 26 parameters including a complete 5 part differential analysis with Atypical Lymphocytes (ALY) and Large Immature Cells (LIC) in percentage and absolute value.
3 histograms for RBC, WBC/BAS and PLT together with the LMNE Matrix.
Analyzer Alarms
Patient file
Morphology Flags
CBC and DIFF results, histograms and matrix

35. Results Printing Line Mode Printout Ticket Printout
Print your Results on request
From the “All the Results” tab, it is possible to select
- List to print in a Line Mode
- Ticket to print in a full page with histograms and matrix

36. Printing Flexibility Header
Each printout includes header in two lines that can be defined in the six Header fields (in the settings)
Printing options

37. To Search Patients Results
Search results for a known patient in current worklist or archived worklists.
You need to know Patient Number or Patient Name or Sample ID.

38. Quality Control and Calibration 1/6
Controls
Control's runs results
Controls
A maximum of 12 control lots can be created.
For each control lot, 400 results can be archived in the database.
Three control levels are available for each test (Low, Normal, High).
The three controls can be simultaneously active allowing QC on three levels.
Current target
This area provides information about the control lot selected in the QC lot numbers list.
Control's runs results
The results displayed in this area are those of the control lot selected in the QC lot numbers list. It is possible to select or unselect a result. For example, clear the first checkbox to discard the first result.
Results which are out of the limits defined in the Target Values window are blue (too low) or red (too high).
Parameters statistics
This area provides statistics calculated from the selected results. If you select / unselect results, the statistics are automatically recalculated.
If a variation coefficient (in %) is out of the limits set by the user the value's background turns to red.
Parameters statistics
Current target

39. Quality Control and Calibration 2/6
QC Export
The Quality Control Results may be exported from the instrument to a floppy disk in CSV format.
QC results displayed in a spreadsheet (statistical calculation or any other use...)

40. Quality Control and Calibration 3/6
Levey-Jennings Graph
The Levey-Jennings Graph is a graphical representation of quality control data.
It is based on the daily value for each control parameter, its target value and range that are plotted on a graph for a periodic review.
For each parameter, a curve is displayed.
A point on a curve represents a control blood analysis.
It is possible to move the marker (black vertical line) to switch from one analysis to another. This changes the number in the Seq.# field and the results on the right.
Each parameter has a normal value (in black), a high limit (in red) and a low limit (in blue).
If a mean value of a result is higher or lower than the limit set up by the user, the points of the curve then turn to red or blue.

41. Quality Control and Calibration 4/6XB
The (XB) Patient Quality Control is used to detect any deviation in the quality of results, using patient data only.
This data monitoring is based on a BULL method and can be applied to a set of:
- 9 parameters (WBC, RBC, HGB, HCT, RDW, PLT, MCV, MCH, MCHC)
- 3 parameters (MCV, MCH, and MCHC).
This quality control does not require any intervention from the operator, nor the running of any specific controls.
The statistical calculation includes all patient results that do not contain analysis default.
When 20 results have been archived, a batch is calculated.
A batch is the mean result for 20 analyses contained in that specific batch.
The XB alarm occurs when the calculation of the last batch shows a point located outside of the limits set by the operator.
60 batches can be recorded. After 60 batches, each new batch overwrites the oldest one.

42. Quality Control and Calibration 5/6
Repeatability
The repeatability is based on results obtained from consecutive analyses of the same fresh human normal blood sample.
CBC or DIFF tests can be done with a limit of 35 results per test.
If a variation coefficient (in %) is out of the limits set by the user, the value's background turns to red.

43. Quality Control and Calibration 6/6
The calibration function is used to determine the precision and accuracy of the analyzer, with use of a specifically formulated product, to recover each parameter within close tolerances of known target values and limits.
The calibration is an exceptional procedure which must be carried out, particularly after certain technical interventions (installation, maintenance, service intervention).
The calibration should not be carried out to compensate a drift on a result due, for example, to a clogging of the instrument.
If the frequency of re-calibration is too important, it may be the sign of the beginning of a problem (technical, reagents, etc.)
Current target
This area provides information about the calibrator lot selected in the Lot Number list
Calibrator's runs results
The results displayed in this area are those of the calibrator lot selected in the Lot Number list. It is possible to select or unselect a result.
For example, clear the first checkbox to discard the first result.
Results which are out of the limits defined in the Target Values window are blue (too low) or red (too high).
Parameters statistics
This area provides statistics calculated from the selected results. If you select / unselect results, the statistics are automatically recalculated.
If a variation coefficient (in %) is out of the limits set by the user, the value's background turns to red.
Current target
Calibrator's runs results
Parameters statistics

44. Logs The logs list events of your instrument for the following:
Reagent: information about a reagent replacement
Calibration: information about the parameters coefficients
Users: comments after a maintenance for users
Technicians: comments after a maintenance for technicians
Errors: description of system errors
Startup: instrument startup results

45. Archives
The Archives include the list of all archived worklist and the total number of analyses.
Open the Archives window.
Select the date and the worklist you want to display.
Click OK.

46. X- Summary

47. Summary Efficient cytology platform 60 tests per hour
Qualification and quantification of ALY and LIC in DIFF mode.
26 parameters : CBC (12), DIFF (14)
Micro-sampling on whole blood with the patented MDSS technology :
30 μL in CBC mode and 53 μL in CBC+DIFF mode.

48. Summary
DHSS and MDSS  technologies (HORIBA Medical Patents) give accurate and reliable results
DHSS (Double Hydrodynamic Sequential System)
Cytochemistry
Best cell marking
48 hours post-draw stability
Flow Cytometry
Best cell focalization (Focused flow for impedance measurement + Focused flow for optical detection)
MDSS (Multi-Distribution Sampling System)
Complete homogenization of blood samples with reagents.
Only 30 μL in CBC mode and 53 μL in CBC+DIFF mode are extracted.
No shear-valve to distribute blood sample in the chambers : No maintenance, no clogging.
48 hours post-draw stability : No need to puncture again the patient. It is a real comfort for the patient. During 48 hours following the moment of taking the blood sample from the patient, it is possible to run the sample and to have reliable results. This is possible with the reagent ABX Eosinofix which prevents the volume of the cells from being modified, cells are stabilized in their native conditions.

49. Summary Secured and efficient information management
Powerful Data Management
Memory : patient results
Precise patient reports: test results, demographics, graphs, flags and suspected pathologies
Quality assurance
3 active control levels identified by barcode scanner
Control results displayed in charts and Levey-Jennings graphs
XB results and graphs available from 60 files (20 results per file)
Repeatability test management
Full traceability of reagents
Access to all information logs concerning instrument status (calibration, reagents, maintenance…)

50. Summary Comfort & Ergonomic
Space saving : compact with integrated reagents
Easy-to-use with practical and extremely intuitive user interface
Results are available after 45 seconds and transferred to print and to the data management
Only one automatic start-up and one automatic shut-down per day
Only 4 reagents (internal) and 1 diluent (external), with bar-code for automatic management
Small volumes of reagents. 2 volumes of diluent: 20 L or 10 L (easy to handle for safety and comfort)
Reliable (no shear valve, no compressor)
Reduced noise volume: less that 60 dBa

51. XI- Conclusion

52. Conclusion
With the Pentra ES 60, you will receive the most reliable technology available with the benefit of the powerful user friendly data management interface!

53. Thank you !