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Pentra ML

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0% found this document useful (0 votes)
45 views152 pages

Pentra ML

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 152

ABX Pentra ML

User manual
P/n: RAB236DEN

HORIBA ABX SAS


BP 7290
34184 MONTPELLIER Cedex 4 - FRANCE
ABX pentra ML

Pentra ML
Introduction

Revisions

Index P/n revision Software revision Section Date


A RAN172B V3.0.0 All 15/10/2005
B RAN172G V4.0.x All 02/07/2007
See 5. Modifications for v5.0.x
C RAN172H V5.0.x 26/03/2008
software release, page 11
See 6. Modifications for v6.0.x
D RAN172I V6.0.x 01/10/2008
software release, page 13

◆ This document applies to the latest software listed and higher versions.
◆ When a subsequent software version changes the information in this document, a new electronic
issue (CD-ROM and/or online help) will be released and supplied by HORIBA Medical. To update a
paper document, please contact your local HORIBA Medical representative.

Notice of liability
The Information in this manual is distributed on an «As Is» basis, without warranty. While every
precaution has been taken in the preparation of this manual, HORIBA Medical will not assume any
liability to any persons or entities with respect to loss or damage, caused or alleged to be caused
directly or indirectly by not following the instructions contained in this manual, or by using the
computer software and hardware products described herein in a manner inconsistent with our
product labeling.

Trademarks
◆ Microsoft and Windows are registered trademarks of Microsoft Corporation
◆ Other product names mentioned within this publication may be trademarks or registered
trademarks of other companies.

Graphics
All graphics including screens and printouts, photographs are for illustrations purposes only and are
not contractual.

Copyright ® 2007 by HORIBA Medical


All rights reserved. No part of this book may be reproduced or transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written
permission of HORIBA Medical.

HORIBA ABX SAS


B.P. 7290
34184 MONTPELLIER Cedex 4 - FRANCE
Phone: + 33 (0)4.67.14.15.16
Fax: + 33 (0)4.67.14.15.17

2 - ABX pentra ML - User Manual - RAB236DEN


Introduction

Potential hazards
To alert the operator of potentially hazardous conditions, one of the bold captioned headings which
are described below is provided wherever necessary throughout this text.

WARNING: Flags a procedure that if not followed properly, can prove to be


extremely hazardous to either the operator or the environment or both.

CAUTION: Emphasizes an operating procedure that must be followed to avoid


possible damage to the system or erroneous test results.

NOTA: Emphasizes the important information especially helpful to the


operator before, during or after a specific operational function.

ABX pentra ML - User Manual - RAB236DEN - 3


ABX pentra ML

1. Warning and precautions


Work safety reliability and general characteristics are guaranteed by HORIBA Medical under the
following conditions:
◆ ABX pentra ML and connected HORIBA Medical Analyser, user manuals must be entirely read and
personnel trained by HORIBA Medical before attempting to operate the system.
◆ All results calculated, modified or entered manually are done under the responsability of the user.
◆ The user always operates with full knowledge and appreciation of system warnings, alarms and
flags.
◆ The ABX pentra ML system must be operated as instructed in the user manual. Any other use might
compromise system integrity and might be hazardous for the operator.
◆ The ABX pentra ML responds to the Standards and directives named in the Declaration of
Conformity. The latest version of the CE declaration of conformity for this system is available on
www.horiba-abx.com.

All peripheral devices should comply with relevant standards.

1.1. Limited guarantee


The duration of guarantee is stipulated in the Sales conditions associated with the purchase of this
system. 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 HORIBA Medical is installed on the system. This software
must be the original copyrighted version.
3- Services and repairs are provided by an HORIBA Medical authorized technician, using only HORIBA
Medical approved spare parts.
4- The electrical supply of the laboratory adheres to national or international regulations.
5- The system is operated according to HORIBA Medical recommendations.

If this system has been supplied to you by anyone other than HORIBA Medical
or an authorised representative, HORIBA Medical cannot guarantee this
product in terms of specification, latest revision and latest documentation.
Further information may be obtained from your authorised representative.

4 - ABX pentra ML - User Manual - RAB236DEN


Introduction

1.2. Graphics and symbols

Switch off position Switch on position

Alternating current Manufacturer

This product conforms to the EC


In Vitro Diagnostic Medical Device Directives named in the
Declaration of Conformity.

Caution, consult accompanying


Biological risks
documents

This product should be disposed


of and recycled at the end of the
Up
usefullife in accordance with the
WEEE Directive (2002/96/CE)

Fragile, handle with care Keep dry

Do not stack Temperature limitation

Batch code Catalogue number

Use by Consult Instructions for Use

Calibrator Control

Content Use no hooks

ABX pentra ML - User Manual - RAB236DEN - 5


ABX pentra ML

2. Operational conditions
2.1. Environment
◆ The operation of the ABX pentra ML should be restricted to indoor location use only.

2.2. Location
◆ The ABX pentra ML should be placed on a clean and leveled table or workbench.
◆ Please note that the ABX pentra ML and printer weigh approximately: Depends on the computer
model (See computer’s manual).
◆ Avoid exposure to sunlight.
◆ Place your system where it is not exposed to water or vapor.
◆ Place your system where it is free from vibration or shock.
◆ Place your system where an independent power receptacle can be used.
◆ Provide a space of at least 20 cm (8 inches) at the back and on the front of the system for
arranging the power cable and connections (see computer’s manual).

The Power switch and Input voltage supply connection should always be
accessible. When positioning the system for operational use, leave the
required amount of space for easy accessibility to these items

2.3. Grounding
◆ Proper grounding is required when installing the system. Check the wall outlet ground (Earth) for
proper grounding to the facilities electrical ground. If you are unsure of the outlet grounding,
contact your facilities engineer to verify the proper outlet ground.

2.4. Humidity/Temperature conditions


◆ Limited in accordance with associated HORIBA Medical Analyser.

2.5. Electromagnetic environment check


◆ The ABX pentra ML produces less than the accepted level of electromagnetic interference in order
to operate in conformity with its destination, allowing the correct operation of other instruments
also in conformity with their destination.
◆ In case of suspected electromagnetic noise, check that the system has not been placed in the
proximity of electromagnetic fields or short wave emissions, (i. e. Radar, X-rays, Scanners, Cell
phones, etc...).

2.6. Main supply


◆ ABX pentra ML connections to supply are done by an HORIBA Medical representative.
◆ Grounding is required. Check that earth wall-plug is correctly connected to the laboratory
grounding system. If there is no such system a ground stake should be used.
◆ Use only main supply cable delivered with the system.
◆ Main supply voltage fluctuations must not exceed +/-10% of the nominal voltage.

6 - ABX pentra ML - User Manual - RAB236DEN


Introduction
Physical specifications

2.7. Environmental protection

In accordance with the European Directive (2002/96/CE, known also as


W.E.E.E) instruments having this symbol, and sold into a European country by
HORIBA Medical or an authorised representative must be disposed of and
recycled correctly at the end of its useful life. Due to the local changing
regulations in each country, please contact your local representative for
detailed and upto date information on how to appropriately dispose of the
instrument.

2.8. Transportation and storage conditions


◆ Before moving the system call an HORIBA Medical representative for information.

Prior to the shipping of an instrument by transporter, whatever the


destination, an external decontamination of the system must be carried out.

◆ Condition for storage and transportation: Depends on the computer model (See computer’s
manual).

2.9. Installation
◆ An HORIBA Medical representative will install your system.
◆ Verify that all of the parts from the packages are present.

2.10. Fuse replacement


◆ All fuses must not be exchanged by the operator.

3. Physical specifications
3.1. Power requirements
◆ Power supply: From 100Vac to 240Vac (+/-10%) 50 to 60Hz (See computer’s manual)
◆ Heat output: Max 1638 Btu/h (1728Kjoules/h)
◆ Power consumption: Depends on the computer model (See computer’s manual)
◆ Printer: Depends on the printer model (See printer’s manual)

3.2. Dimension and weight


◆ System dimension: Depends on the computer model (See computer’s manual)
◆ System weight: Depends on the computer model (See computer’s manual)

ABX pentra ML - User Manual - RAB236DEN - 7


ABX pentra ML

8 - ABX pentra ML - User Manual - RAB236DEN


Introduction
Modifications for V4.0.0 software release

4. Modifications for V4.0.0 software release

Information for user manual update ................................... Chap Introd.- Page 2


Heat output addition ....................................................... Chap Introd.- Page 7
Connection setting standards ............................................ Chap 1- Page 3
Deletion of "Software version" in the status bar ................... Chap 1- Page 4
Pevious and Next Report keys inversed in the chart .............. Chap 1- Page 5
Number of items in the list title bars .................................. Chap 2- Page 5
wk Sample flag remove ..................................................... Chap 2- Page 6
Worklist popup menu modification ..................................... Chap 2- Page 6
Worklist filters ................................................................ Chap 2- Page 7
Number of items in the list title bars .................................. Chap 2- Page 10
Filters report modified ...................................................... Chap 2- Page 14
New order window header is modified ................................. Chap 2- Page 17
Stat in the patient demographics fields .............................. Chap 2- Page 18
Create new order procedure modification ............................ Chap 2- Page 19
Result window modification .............................................. Chap 2- Page 23
zoom on the messages window .......................................... Chap 2- Page 24
Unrerun popup menu ........................................................ Chap 2- Page 28
Report popup menu modification ....................................... Chap 2- Page 30
Correction Delta check flags .............................................. Chap 2- Page 30
Played Rules screen shot modification ................................ Chap 2- Page 31
Manual match description addition .................................... Chap 2- Page 32
Report printing window modification .................................. Chap 2- Page 33
update of Comments description ........................................ Chap 2- Page 36
Rules: documented in the Setup section .............................. Chap 2- Page 41
archive description update ................................................ Chap 2- Page 42
General setting window modification .................................. Chap 3- Page 3
Parameter definition recommendation (creation, units, sample nature and Type) :
should not be used. ......................................................... Chap 3- Page 5
Delta Check flags ............................................................. Chap 3- Page 6
Default Pathological Limits values update ........................... Chap 3- Page 9
Comments procedure layout .............................................. Chap 3- Page 15
Note on parameters rules .................................................. Chap 3- Page 18
Rules description addition ................................................ Chap 3- Page 19
Control Run quick guide .................................................... Chap 4- Page 6
Control Run .................................................................... Chap 4- Page 6
EQC Control Protocol window modification .......................... Chap 4- Page 18
Statistics window modifications ......................................... Chap 4- Page 20
Results by Run window modification ................................... Chap 4- Page 22

ABX pentra ML - User Manual - RAB236DEN - 9


ABX pentra ML

Date to date statistics window modification ........................ Chap 4- Page 28


restore EQC warning message addition ................................ Chap 4- Page 31
XB applied on 9 parameters .............................................. Chap 4- Page 38

10 - ABX pentra ML - User Manual - RAB236DEN


Introduction
Modifications for v5.0.x software release

5. Modifications for v5.0.x software release

Revision table update ....................................................... Chap Introd.- Page 2


dmd H_SYS_0441: "All peripheral devices..." modification .... Chap Introd.- Page 4
Analyser addition : ABX P120 Retic, Micros 60 ............................. Chap 1- Page 3
"Quick parameter input" function deletion ................................ Chap 2- Page 21
Report display is modified (limits and deltacheck) ...................... Chap 2- Page 23
"Hematovision" key addition in the extended Diff window .......... Chap 2- Page 25
Cellcount: when the number of cells is reached a sound is triggered. Chap 2- Page 26
Cellcount:Overcount checked ................................................... Chap 2- Page 26
Report screen details (delta check and limits) are changed .......... Chap 2- Page 27
Validation procedure reviewed ................................................. Chap 2- Page 29
"Results flags" chart is modified with delta check and limits ........ Chap 2- Page 29
Print options have changed ..................................................... Chap 2- Page 33
Report printout example ......................................................... Chap 2- Page 35
"delete report" section is modified ........................................... Chap 2- Page 38
Archiving after transmittingt or after printing ........................... Chap 2- Page 44
General settings window update ................................................ Chap 3- Page 3
Prefix in the Unknown patient ID field ........................................ Chap 3- Page 4
Delta Check flag is modified ...................................................... Chap 3- Page 6
Pathological limits defined according age ................................... Chap 3- Page 9
New Upload Rules description .................................................. Chap 3- Page 20
Evaluation on interpretation Rules ........................................... Chap 3- Page 25
"Creating a new Rule" reserved to Horiba abx ............................ Chap 3- Page 26
EQC Software overview description ............................................. Chap 4- Page 4
level L, N, H replaced by 1,2,3 ................................................... Chap 4- Page 6
Modification "rejected points" window becomes "Last control runs to be reviewed"
window ................................................................................ Chap 4- Page 10
New window "Edit Run Comment " ........................................... Chap 4- Page 10
"Control Protocol" window has moved to "Setup" menu ............... Chap 4- Page 14
"Event Log" Window is moved to "file" menu ............................. Chap 4- Page 20
"Statistics" becomes "Statistics by Period" ................................ Chap 4- Page 20
Results by Parameter accessible only double clicking parameter .... Chap 4- Page 20
"Results by Run" window is modified ....................................... Chap 4- Page 22
User defined Chart is modified ................................................. Chap 4- Page 27
Last collected results window modification ................................ Chap 4- Page 28
Report window modification .................................................... Chap 4- Page 29
"Validation Blocked" description addition ................................. Chap 4- Page 29
Creation menu "Database" ...................................................... Chap 4- Page 30
Database Statistics addition .................................................... Chap 4- Page 31

ABX pentra ML - User Manual - RAB236DEN - 11


ABX pentra ML

12 - ABX pentra ML - User Manual - RAB236DEN


Introduction
Modifications for v6.0.x software release

6. Modifications for v6.0.x software release

Modification Logo Company ......................................................... Chap Introd.-Page 1

Revision table update for v6.0.x ................................................... Chap Introd.-Page 2

Company name becomes HORIBA Medical....................................... Chap Introd.-Page 2

(H_SYS_0456) CE symbol description correction.............................. Chap Introd.-Page 5

Search engine modification ......................................................... Chap 2-Page 40

set the search window ................................................................ Chap 2-Page 41

new menu "file\qcp export" ......................................................... Chap 4-Page 4

"Results by run" screen modification (targets, statistics, print) ........ Chap 4-Page 22

Results by run printing setup addition........................................... Chap 4-Page 23

Results by run printout report ...................................................... Chap 4-Page 25

Quality Control Program (QCP)...................................................... Chap 4-Page 34

ABX pentra ML - User Manual - RAB236DEN - 13


ABX pentra ML

14 - ABX pentra ML - User Manual - RAB236DEN


User Manual Contents

User Manual contents

Introduction ............................................................................Introd.-2
1. Warning and precautions...................................................................... Introd.-4
2. Operational conditions ......................................................................... Introd.-6
3. Physical specifications .......................................................................... Introd.-7
4. Modifications for V4.0.0 software release ............................................. Introd.-9
5. Modifications for v5.0.x software release ............................................ Introd.-11
6. Modifications for v6.0.x software release .....................................................1-13

Specifications .................................................................................. 1-3


1. ABX pentra ML general Information...............................................................1-3
2. Software overview .........................................................................................1-4

Workflow ........................................................................................ 2-5


1. Worklist ........................................................................................................2-5
2. Report List ...................................................................................................2-10
3. Alarms .........................................................................................................2-15
4. Populating the Worklist ...............................................................................2-17
5. Result view ..................................................................................................2-23
6. Printing........................................................................................................2-33
7. Comments ...................................................................................................2-36
8. Deleting a Report or an order ......................................................................2-38
9. Manual LIS Transmission .............................................................................2-39
10. File Search.................................................................................................2-40
11. Archive......................................................................................................2-42

Pentra ML Setup .............................................................................. 3-3


1. Introduction...................................................................................................3-3
2. Parameter Definition......................................................................................3-5
3. Pathological Limits ........................................................................................3-8
4. Departments/Physicians...............................................................................3-14
5. Comments definition ...................................................................................3-15
6. Printer Setup ................................................................................................3-16
7. Format Codes ..............................................................................................3-17
8. Rules ...........................................................................................................3-18
9. Users Setting................................................................................................3-27
10. Lock the ABX pentra ML ............................................................................3-34

ABX pentra ML - User Manual - RAB236DEN - 15


ABX pentra ML

EQC ................................................................................................ 4-3


1. Introduction .................................................................................................. 4-3
2. Software overview ......................................................................................... 4-4
3. Control Run................................................................................................... 4-6
4. Managing control materials .........................................................................4-11
5. Managing patient data ................................................................................. 4-18
6. Common options.........................................................................................4-20
7. Advanced options ....................................................................................... 4-30
8. Quality Control Program (QCP) ................................................................... 4-34
9. Appendix .................................................................................................... 4-38

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Specifications

Contents
1. ABX pentra ML general Information...................................................................1-3
1.1. Intended Use ..............................................................................................1-3
1.2. System Components ...................................................................................1-3
2. Software overview..............................................................................................1-4
2.1. Main Application Window .........................................................................1-4
2.2. Menus ........................................................................................................1-5
2.3. Toolbar Icons (shortcuts).............................................................................1-5
2.4. Toolbar Icons description ...........................................................................1-5
2.5. Keyboard Shortcuts (ABX pentra ML) ..........................................................1-6
2.6. Working with Menus ..................................................................................1-6
2.6.1. Open a Menu .....................................................................................1-6
2.6.2. Select a Menu Item.............................................................................1-7
2.6.3. Open a Submenu ...............................................................................1-7
2.6.4. Popup Menus .....................................................................................1-7
2.7. Working with MDI Windows......................................................................1-7
2.7.1. Introduction........................................................................................1-7
2.7.2. MDI Windows....................................................................................1-7
2.8. Dialog Box Windows..................................................................................1-8
2.8.1. Moving a Window..............................................................................1-9
2.8.2. Data Fields .........................................................................................1-9

ABX pentra ML - User Manual - RAB236DEN - 1


ABX pentra ML

2 - ABX pentra ML - User Manual - RAB236DEN


Specifications

Specifications

1. ABX pentra ML general Information


1.1. Intended Use
The ABX pentra ML collects and manages data from a HORIBA Medical Analyser, offering the
possibility of connection to a LIS system.
The ABX pentra ML provides data management capabilities such as automatic results validation, delta
checking, reflex testing, quality control, results editing and archiving and restoring of patient
results.

HORIBA Medical Analyser corresponds to:


◆ ABX pentra DX 120 (V2.0.0 and above)
◆ ABX pentra DF 120 (V2.0.0 and above)
◆ ABX pentra XL 80 (V1.4.0 and above)
◆ ABX pentra 80 (V1.5.0 and above)
◆ ABX pentra 60C+ (V2.2.9 and above)
◆ ABX pentra 60 (V2.1.6 and above)
◆ ABX pentra 120/120 Retic (V4.7.2 and above)
◆ ABX Micros 60 (V1.7.0 and above)

Connection setting standards:


3 Workstations maximum,
3 Analyzers maximum
Data processing: up to 2000 sample per day (depends on LIS capacity)

1.2. System Components


ABX pentra ML includes the following components:
◆ CPU (central processing unit) with software loaded
◆ Security Kit
◆ Keyboard
◆ Mouse
◆ Cables

The following software is loaded on the CPU:


◆ Microsoft Windows XP Operating System software
◆ Microsoft SQL Server 2000 database operation software
◆ Application software

ABX pentra ML kit includes documentation, software, and software licenses for the Microsoft
Windows XP Operating System software and the Microsoft SQL Server 2000 database software.

ABX pentra ML - User Manual - RAB236DEN - 3


ABX pentra ML

2. Software overview
2.1. Main Application Window
The following window is the main application window.
1
2

3b

3a
4

1- Title Bar
2- Menu Bar
3- Toolbar (3a and 3b)
4- Status Bar

The following table describes the elements of the main application window:

Name Functions
Title bar contains the following elements:
Title Bar The control menu button
The application name, minimize, maximize and close buttons
Menu Bar The menu bar contains application menus.
Tool Bar The toolbar contains application icons.
The status bar contains the following elements:
status or required action
Status Bar
name of the user connected
date and time

4 - ABX pentra ML - User Manual - RAB236DEN


Specifications
Software overview

2.2. Menus
The following table lists the software menus. Refer to the chapter listed in the table for detailed
information on the menu functions.

Menu Description
The Settings menu contains setup functions for peripherals (instrument, LIS, etc.),
Settings
maintenance functions, parameter settings, ...
The Archives menu contains functions for archiving current reports and other archive
Archives functions. Archived reports are available for viewing, printing, and comparing to current
reports, but cannot be modified.
Window The Window menu allows you to arrange displayed window or to switch to a specific one.
The Help menu contains information on the keyboard, the help function and information
Help
on the software version, copyright, etc.

2.3. Toolbar Icons (shortcuts)

Toolbar Icon Function Keyboard Shortcut


Open the help file [F1]

Open the Alarm window [Ctrl]+[L]

Open the Worklist [F7]

Open the Report List [F8]

Access to patient history [CTRL]+[A]

Access to the search function [CTRL]+[F]

Create a new Order [CTRL]+[N]

View previous report in the Report List [F9]

View next report in the Report List [F10]

Access to the EQC functions [CTRL]+[Q]

Open Hematovision software

2.4. Toolbar Icons description

Toolbar Icon Function Keyboard Shortcut


Access the About window

Create a new item (on active window) [F4]

Save the selected item (on active window) [F2]

Validate current report(s) [F12]

Unvalidate current report(s)

Delete the selected item (on active window) [F3]

Print the current report(s) [F5]

ABX pentra ML - User Manual - RAB236DEN - 5


ABX pentra ML

Toolbar Icon Function Keyboard Shortcut


Transfer current report to the LIS [F6]

2.5. Keyboard Shortcuts (ABX pentra ML)

Keyboard
Function Menu Equivalent
Shortcut
[Alt]+[F4] Exit Settings Menu+ Exit
[Ctrl]+[A] View archived report(s)
[Ctrl]+[B] Lock the station Setting Menu + Lock Station
[Ctrl]+[F] Search
[Ctrl]+[L] Open Alarm list
[Ctrl]+[N] Create new order
[Ctrl]+[Q] Access to the QC
Settings Menu + Soft parameters + Departments/
[Ctrl]+[S] Define Department/Physicians
Physicians
[F1] Help Help Menu + Help
[F2] Save Help Menu + Keyboard + Save
[F3] Delete Help Menu + Keyboard + Delete
[F4] Create new item Help Menu + Keyboard + New
[F5] Print report(s) Help Menu + Keyboard + Print
[F6] Send report(s) Help Menu + Keyboard + Send
[F7] Worklist Help Menu + Keyboard + Worklist
[F8] Report List Help Menu + Keyboard + Report List
[F9] Previous report Help Menu + Keyboard + Previous Report
[F10] Next report Help Menu + Keyboard + Next Report
[F11] Validate all Help Menu + Keyboard + Validate All
[F12] Validate Current Report Select report + Validate key

2.6. Working with Menus


2.6.1. Open a Menu
Use one of the following options to open a menu from the menu bar:
◆ Click the menu with the left mouse button.
◆ Press the [Alt] key, then use the right and left arrow keys to highlight the menu. Use the up or
down arrow key to open the menu.

1- Use the mouse or the up and down arrow keys to highlight a menu item.
2- A black arrow on the far right indicates a submenu.
3- Keyboard shortcuts are listed on the far right.

6 - ABX pentra ML - User Manual - RAB236DEN


Specifications
Software overview

2.6.2. Select a Menu Item


Use one of the following options to select a menu (or submenu) item:
◆ Click the menu item with the left mouse button.
◆ Use the up and down arrow keys to highlight the menu item, then press the [Enter] key.
◆ Press the letter key for the underlined letter in the menu item.

2.6.3. Open a Submenu


Submenus are indicated by a black arrow to the right of a menu item. Use one of the following
options to open a submenu:
◆ Click the menu item with the left mouse button.
◆ Use the up or down arrow keys to highlight the menu item. Use the right arrow key to open the
submenu. Use the left arrow key to close the submenu.
◆ Press the letter key for the underlined letter in the menu item.

2.6.4. Popup Menus


Some software windows (Report List window, Worklist window, Report sheet, etc...) have additional
functions which are accessible through a popup menu. Use one of the following options to open a
popup menu:
◆ click the right mouse button anywhere inside the window
◆ Popup menu items are selected in the same way as other menu items.

2.7. Working with MDI Windows


2.7.1. Introduction
This section describes the two types of windows used in software (MDI and Dialog Box) and types
of data entry fields.

2.7.2. MDI Windows


The following is an example of an MDI (Multiple Document Interface) window:

Characteristics of this type of window are:


◆ An MDI window can be minimized, maximized (some windows), or closed by clicking on the
following icon in the title bar.

Minimized Maximized Closed

◆ These functions are also available in the title bar control menu (icon on left side of title bar for
each window).

ABX pentra ML - User Manual - RAB236DEN - 7


ABX pentra ML

◆ Multiple MDI windows can be open at the same time. Only one window is active at a time (dark
title bar). To move between windows, either click anywhere inside a window with the left mouse
button or press [Alt]+[Tab].
◆ Active toolbar icons (save, delete, etc...) are accessible in these windows.
When an MDI window is minimized, it is displayed as a box at the bottom of the client zone:

To restore the window, click the icon.


To save information entered in an MDI window, select the Save icon from the toolbar or press [F2]
before exiting the window.
Use one of the following options to close an MDI window:

◆ Click the icon in the title bar.


◆ Press the [Esc] key.
◆ Select Close in the control menu.
◆ Press the [Ctrl]+[F4] keys.

2.8. Dialog Box Windows


The following is an example of a dialog box window:

Characteristics of this type of window are:


◆ The dialog box window cannot be minimized or maximized from the title bar. The title bar control
menu is accessed by clicking the left mouse button in the title bar.
◆ Only one dialog box window can be opened at a time. No other windows can be accessed until the
dialog box is exited.
◆ Toolbar icons (save, delete, etc...) are not accessible in dialog box windows.
◆ Dialog box windows always require some action. An action is performed by selecting a button in
the window. Selecting a button will execute a function, exit the window, or both. In the example
above, selecting the <OK> button will reset communication for the selected instruments and exit
the window.

8 - ABX pentra ML - User Manual - RAB236DEN


Specifications
Software overview

Use one of the following options to close a dialog box window without selecting a button in the
window:

◆ Click the icon in the title bar.


◆ Press the [Esc] key.
◆ Select Close in the control menu.
◆ Press the [Alt]+[F4] keys.

2.8.1. Moving a Window


Use one of the following options to move a window:
◆ Click and drag on the title bar with the left mouse button.
◆ Select Move from the control menu. Use the arrow keys to move the window, then press the
[Enter] key.

2.8.2. Data Fields


The following table describes the different types of data fields in a window:

Field Type Example Description


Input Text Box Type in the appropriate information.
Input Text Box with Type in information or select an
Drop down Menu option from the drop down menu.
Data entry not allowed. Select an
Drop down Menu
option from the drop down menu.
Select or deselect one or more
Check Box
options.
Toggle between options. Only one
Radio Buttons
option allowed in a field.

Select an item in the list. In some


Selection Box cases more than one item may be
selected.

Select a table cell. Type the


Table appropriate information in the data
entry field at the top of the table.

Use one of the following options to select fields for data entry:
◆ Click the field or option with the left mouse button.
◆ Press the [Tab] key to move to the next field or press the [Shift]+[Tab] keys to move to the
previous field. Use the arrow keys to make selections in a field.
In a table, press the [Tab] key to move right or the [Shift]+[Tab] keys to move left. Press the
[Enter] key or down arrow key to move down. Press the up arrow key to move up.

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Contents
1. Worklist ............................................................................................................2-5
1.1. Introduction................................................................................................2-5
1.2. Worklist Window .......................................................................................2-5
1.2.1. Access ................................................................................................2-5
1.2.2. Description.........................................................................................2-5
1.2.3. Status..................................................................................................2-6
1.2.4. Sorting................................................................................................2-6
1.2.5. Columns Size .....................................................................................2-6
1.2.6. Columns order....................................................................................2-6
1.2.7. Display Filters.....................................................................................2-7
1.2.8. Manual Match ....................................................................................2-8
1.2.9. Assign to an Instrument ......................................................................2-8
1.2.10. Assign + Download ..........................................................................2-8
1.2.11. Download ........................................................................................2-8
1.2.12. Stat ...................................................................................................2-8
1.2.13. Routine.............................................................................................2-9
1.3. Manual samples download .........................................................................2-9
1.3.1. Introduction........................................................................................2-9
1.3.2. Download from the Worklist ..............................................................2-9

2. Report List........................................................................................................2-10
2.1. Introduction..............................................................................................2-10
2.2. Report List Window ..................................................................................2-10
2.2.1. Access ..............................................................................................2-10
2.2.2. Description.......................................................................................2-10
2.2.3. Status................................................................................................2-11
2.2.4. Flags.................................................................................................2-11
2.2.5. Sorting..............................................................................................2-11
2.2.6. Column size .....................................................................................2-11
2.2.7. Column order ...................................................................................2-12
2.2.8. To validate, Validated.......................................................................2-12
2.2.9. To validate: SLIDE pending, RET pending .........................................2-12
2.2.10. Report List Popup Menu .................................................................2-13
2.3. Report list display filters............................................................................2-13
2.3.1. Introduction......................................................................................2-13
2.3.2. Display report window .....................................................................2-13

3. Alarms..............................................................................................................2-15
3.1. Introduction..............................................................................................2-15
3.2. List of alarms ............................................................................................2-15
3.2.1. Alarm popup menu ..........................................................................2-15
3.2.2. Alarms filters window.......................................................................2-15

4. Populating the Worklist....................................................................................2-17


4.1. Introduction..............................................................................................2-17
4.2. New order window...................................................................................2-17
4.2.1. Description.......................................................................................2-17
4.2.2. Sample information fields .................................................................2-18
4.2.3. Creating a new order ........................................................................2-18
4.2.4. Create a New Order for an Existing Patient.......................................2-19
4.3. Create a New Order for an Unknown Patient ...........................................2-20

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4.4. Testing - Parameters/Profiles windows ...................................................... 2-20


4.4.1. Sample ID window...........................................................................2-21

5. Result view....................................................................................................... 2-23


5.1. Introduction ............................................................................................. 2-23
5.2. Result window .........................................................................................2-23
5.2.1. Graphic for the selected run ............................................................. 2-24
5.2.2. Messages for selected run................................................................. 2-24
5.2.3. Patient comments............................................................................. 2-24
5.3. Extended Diff ........................................................................................... 2-25
5.3.1. Cellcount (Option) ...........................................................................2-25
5.4. Report ......................................................................................................2-27
5.5. Manual results entry ................................................................................. 2-27
5.6. Results color code .................................................................................... 2-27
5.7. Add manual run ....................................................................................... 2-28
5.8. Set Slide Done.......................................................................................... 2-28
5.9. Results validation .....................................................................................2-29
5.10. Result flags ............................................................................................. 2-29
5.11. Result error codes................................................................................... 2-30
5.12. Report popup menu ...............................................................................2-30
5.13. Rerun window........................................................................................2-30
5.14. Played rules............................................................................................2-31
5.15. Manual Match ........................................................................................2-32

6. Printing ............................................................................................................2-33
6.1. Introduction ............................................................................................. 2-33
6.2. Patient reports .......................................................................................... 2-33
6.3. Report printing window............................................................................2-33
6.4. Procedure................................................................................................. 2-34
6.5. Report printout example ...........................................................................2-35

7. Comments........................................................................................................ 2-36
7.1. Introduction ............................................................................................. 2-36
7.2. Comments window ..................................................................................2-36
7.3. Procedure................................................................................................. 2-36
7.4. Enter a predefined comment.....................................................................2-36
7.5. Selecting pre defined comments ...............................................................2-37

8. Deleting a Report or an order .......................................................................... 2-38


8.1. Introduction ............................................................................................. 2-38
8.2. Delete results ........................................................................................... 2-38
8.3. Delete a Run ............................................................................................2-38
8.4. Delete a Report ........................................................................................2-38
8.5. Delete an order ........................................................................................2-38

9. Manual LIS Transmission..................................................................................2-39


9.1. Introduction ............................................................................................. 2-39
9.2. Procedure................................................................................................. 2-39

10. File Search .....................................................................................................2-40


10.1. Introduction ........................................................................................... 2-40
10.2. Access .................................................................................................... 2-40
10.3. Procedure...............................................................................................2-40
10.4. Set the search window............................................................................2-41

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11. Archive...........................................................................................................2-42
11.1. View Archived Reports ...........................................................................2-42
11.1.1. Introduction....................................................................................2-42
11.1.2. Anteriority window.........................................................................2-42
11.1.3. Archive information........................................................................2-42
11.1.4. Toolbar functions ...........................................................................2-43
11.1.5. Anteriority search ...........................................................................2-43
11.1.6. Other previous reports....................................................................2-43
11.2. Archiving current reports ........................................................................2-44
11.2.1. Introduction....................................................................................2-44
11.2.2. Procedure.......................................................................................2-44
11.2.3. Reports archiving window ..............................................................2-45
11.3. Save archives..........................................................................................2-45
11.3.1. Introduction....................................................................................2-45
11.3.2. Save archives window ....................................................................2-45
11.3.3. Extract Archived Patients ................................................................2-46
11.3.4. Delete Archived Patient Reports .....................................................2-47
11.3.5. Save Archives .................................................................................2-47
11.3.6. Restore Archives .............................................................................2-49

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Worklist

Workflow

1. Worklist
1.1. Introduction
The Worklist window gives a concise overview of all current (non-archived) samples.

1.2. Worklist Window


1.2.1. Access
To open the Worklist window, select the appropriate icon from the Tool bar (shortcut: [F7]).

1- The Worklist window is resizable and its position is memorized when the window is
closed; this allows you to customize the working area.
2- By default, the Worklist shows the most recent report.
3- See “1.2.6. Columns order”, page 6 to move right or left one of the column of the
worklist chart.

1.2.2. Description
The Worklist contains the following information:
◆ Title bar
Name of the List
Number of items in the list
◆ Columns
Sample ID
Patient ID
Patient Name
First Name
CBC
DIF
RET
NRBC
SLIDE
Request Creation Date
Instrument
Rack
Pos.
Stat
Rack
Pos.

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1.2.3. Status

Tab. 2–1 CBC, DIF, RET, NRBC and SLIDE column status
CBC, DIF, RET, NRBC
and SLIDE column Description
status
The test has not been programmed

The test has been done

The test has been programmed and Workstation is waiting for the result

Tab. 2–2 Stat column status


Stat column status Description
The order has been requested in routine mode

The order has been requested in «stat» mode (See “1.2.12. Stat”, page 8)

1.2.4. Sorting
Click left a column in order to sort the list out. The list will be sorted based on this information.

◆ On the right side of the column title, an arrow is displayed, indicating that the Worklist is sorted
with this column, and that the order is ascending.
◆ In order to sort the Worklist descending, left click again the column’s title.

1.2.5. Columns Size


Columns size can be customized. Move the mouse cursor between two columns, and it will change
into a double arrow. Click and drag the line between both columns in order to change their size.

1.2.6. Columns order


Columns order can be customized. Right click the Report List; a popup menu will be displayed.

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Worklist

Select the «Columns Settings» menu by clicking it. A new window will be displayed, allowing the
user to define the columns order, and the default type of sort for dates.

To move a column in the list, left click the column’s name, and then left click the Up or Down button
to move the selected column in the list.
The Default button allows the user to reset the columns settings to their original configuration.

1.2.7. Display Filters


Select the «Filters» menu. A new window will be displayed, allowing the user to define the worklist
display preferences based on the status of the order

Tab. 2–3
Option Function
To Download Will display orders «To download» to the selected instruments
Received Will display orders «Received» from the selected instruments
Downloaded Will display orders «Downloaded» to the selected instruments
Rerun Will display orders that have been «Rerun» only on the selected instruments
To Rerun Will display orders «To Rerun» on the selected instruments
Stat Will display «Stat» orders on the selected instruments

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◆ Select the option of the «Display Samples» : to be displayed, an order must meet the requirements
of all the selected options.
◆ Select <OK> to save and exit the window. Select <Cancel> to cancel and exit the window.

1.2.8. Manual Match


Allows the user to manually associate an order to results without Sample ID
See “5.15. Manual Match”, page 32

1.2.9. Assign to an Instrument


Right click the Report List; a popup menu will be displayed.

«Assign» to an Instrument allows the user to assign a selected sample to an instrument.

1.2.10. Assign + Download


Right click the Report List; a popup menu will be displayed.

«Assign + Download» combines the Assign to an Instrument and Download options into one step.

1.2.11. Download
Right click the Report List; a popup menu will be displayed.

This option downloads the selected samples to their assigned instruments.

1.2.12. Stat
It is possible to define from the Worklist a sample as urgent proceeding as follows:
Select an order
Right click; a popup menu will be displayed.

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Workflow
Worklist

This option will assign the Stat flag to the selected order(s).

1.2.13. Routine
Right click the WorkList; a popup menu will be displayed.

This option will remove the Stat flag to the selected order(s).

1.3. Manual samples download


1.3.1. Introduction
Samples can be manually downloaded to the instrument from the Worklist.

1.3.2. Download from the Worklist


To download from the Worklist window, samples must first be assigned to an instrument. Follow the
steps below to download samples from the Worklist window.

Tab. 2–4
Step Action
1 Open the Worklist window.
2 Select one or more samples to download.
3 Open the Worklist popup menu.
4 Select Download from the popup menu. This will download the selected samples.

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2. Report List
2.1. Introduction
The Report List window gives a concise overview of all current (non-archived) patient reports.

2.2. Report List Window


2.2.1. Access
To open the Report List window, use the appropriate icon in the Tool bar (shortcut: [F8]).

1- The Report list window is resizable and its position is memorized when the window is
closed; this allows you to customize the working area.
2- By default, the Report list shows the most recent report.
3- See “2.2.7. Column order”, page 12 to move right or left one of the columns of the
Report list chart.

2.2.2. Description
The Report list contains the following information:
◆ Title bar
Name of the List
Number of items «to validate» or «validated» according to the tabs which is displayed (See
“2.2.8. To validate, Validated”, page 12)

◆ Columns

Stat Flags
Sample ID Department
Patient Name Physician
First Name Gender
Patient ID Birth date
Rack Age
Pos. Instrument
Run Date
Number of runs
CBC
DIF
RET
NRBC
SLIDE

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Report List

2.2.3. Status

Tab. 2–5 CBC, DIF, RET, NRBC and SLIDE column status
CBC, DIF, RET, NRBC and
Description
SLIDE column status
The test has not been programmed

The test has been done


The test has been programmed and workstation is waiting for the
result

Tab. 2–6 Stat column status


Stat column status Description
The report has been requested in routine mode

The report has been requested in «stat» mode

2.2.4. Flags
This column can list up to seven flags. The following table describes the different patient flags.

Tab. 2–7 Flag column


Flag Description Detailed Description
O Out of Pathological Limits At least one result is out of the pathological limits defined.
P Pending The order is pending one or more results.
C Complete The report is complete.
R Received Results have been received but not yet viewed.
I Printed The report has been printed.
V Validated The report is complete and validated.
H Host All results for the report have been sent to the LIS.

2.2.5. Sorting
Click left a column in order to sort the list out. The list will be sorted based on this information.

◆ On the right side of the column title, an arrow is displayed, indicating that the Report List is
sorted with this column, and that the order is ascending.
◆ In order to sort the Report List descending, left click again the column’s title.

2.2.6. Column size


Columns size can be customized. Move the mouse cursor between two columns, and it will change
into a double arrow. Click and drag the line between the two columns in order to change their size.

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2.2.7. Column order


Columns order can be customized. Right click the Report List; a popup menu will be displayed.

Select the «Columns Settings» menu by clicking it, then a new window will be displayed, allowing
the user to define the columns order.

◆ To move a column in the list, left click the column’s name, and then left click the Up or Down
button to move the selected column in the list.
◆ The Default button allows the user to reset the columns settings to their original configuration.

2.2.8. To validate, Validated

◆ Two tabs are displayed on top of the Report List: To validate, and Validated. Clicking on a tab
will refresh the Report List in order to display the list of the non-validated reports, or the list of
the already validated reports.
◆ By default, the To validate tab is activated.

2.2.9. To validate: SLIDE pending, RET pending


◆ The To validate list allow the user to filter the Report List with two options: SLIDE pending and
RET pending. The user has to check the selected option in order to activate the filter.

◆ By default, the To validate tab is activated, and SLIDE pending and RET pending are not checked.

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Report List

2.2.10. Report List Popup Menu


◆ To open the Report List popup menu, click with the right mouse button anywhere in the Report
List window.

◆ The following table describes the options in the Report List popup menu.

Tab. 2–8
Option Function
Columns settings See “2.2.7. Column order”, page 12
This option allows the user to select display filters for the report list See “2.3.
Filters
Report list display filters”, page 13
Manual match See “5.15. Manual Match”, page 32
Archive This option will archive directly the current report selected in the report list
Stat TThis option will assign the Stat flag to the selected report(s).
Routine This option will remove the Stat flag from the selected report(s).

2.3. Report list display filters


2.3.1. Introduction
The «Display Report» window is used to modify the report list filters. These filters allow the user to
determine which patient reports are displayed in the Report List window.

2.3.2. Display report window


◆ Open the Report List window [F8]
◆ then open the Report List popup menu (click right).
◆ Select Filters from the popup menu. The window below shows the default options, which would
display all reports.

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The following table describes each of the fields in the Display Reports window.

Tab. 2–9
Field Function
Select one or more of the following options:

Select... to display reports that...


To Print have not been printed.
To Validate Not available
Display Reports
To Upload to LIS have not been upload to the LIS.
(upper left)
Out of Panic Limits have results that are out of Panic Limits.

To be displayed, a report must only meet the requirements of one of the selected
options.
Select one or more of the following options:

Select... to display only reports that...


Validated have been validated.
Stat are Stat.
Display only Completed are completed
reports Received (R) have been received but not yet viewed.
Not Complete are pending one or more results.
are downloaded and pending one or more
Pending
results.

To be displayed, a report must meet the requirements of all the selected options.
◆ Select <OK> to save and exit the window. Select <Cancel> to cancel and exit the window.

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Workflow
Alarms

3. Alarms
3.1. Introduction
The Alarm window gives a concise overview of all Alarms created by Rules for all current (non
archived) reports.

3.2. List of alarms


To open the Alarm Window, select the icon from the Tool bar or use the appropriate shortcut
[Ctrl] + [L]

The Alarm window is resizable and its position is memorized when the window is closed;
this allows you to customize the working area.

The Alarm window contains the following information:


◆ Two flags can be displayed: «R»: To be reviewed, or «-»: has been reviewed.
◆ Sample ID
◆ The parameter that generates the message
◆ Message

3.2.1. Alarm popup menu


◆ To open the Alarm popup menu, click with the right mouse button anywhere in the Alarm window.
.

◆ The option 'Filters' allows the user to select display filters to the message list.

3.2.2. Alarms filters window


◆ The Alarm filters window is used to modify the message filters. These filters allow the user to
determine which messages are displayed in the message list window:

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«Show only messages not reviewed»: Check this option to display the messages for reports that have
not been reviewed (messages will then disappear after you review the report).

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Populating the Worklist

4. Populating the Worklist


4.1. Introduction
Patient orders can be downloaded from the LIS, uploaded from the instrument, or created on the
Workstation. The «New Order» window is used to create a new order.

Patient IDs must be unique. If the LIS downloads an order with a patient ID
that already exists in a demographics record on the instrument, then the
instrument will create the order using the existing instrument demographics
record, not the demographics downloaded from the LIS. If more than one
patient is assigned the same Patient ID by the LIS, test orders and results
may be assigned to the wrong patient.

4.2. New order window


4.2.1. Description
◆ To open the New Order window, select the New Order icon from the toolbar (or
[ctrl]+[N]).

◆ Patient Demographics fields are stored in the patient demographics record. When a new order is
created for an existing patient, demographic fields do not need to be re-entered.

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The following table describes the demographics fields:

Tab. 2–10
Field Function
Patient ID Enter a patient ID (up to 15 alphanumeric characters).
Patient Name Enter a last name (up to 20 alphanumeric characters).
First Name Enter a first name (up to 20 alphanumeric characters).
Middle Name Enter a middle name (up to 20 alphanumeric characters).
Date of Birth Enter a date of birth. The date format is MM/DD/YYYY.
Department Select a department from the drop down menu.
Physician Select a physician from the drop down menu.
Comment Enter a patient comment (up to 20 alphanumeric characters).
Address Enter an address (up to 75 alphanumeric characters).
Gender Select the patient's gender from the drop down menu (male, female, or unknown).
Enter the patient's age (1 - 9999). Select days, months, or years from the drop
Age down menu. If a date of birth is entered in the <Date of Birth> field, the age is
automatically calculated.
Select this option to tag the patient. This tag is archived with the patient
Patient Tag demographics, and can be used to select tagged patients for viewing, deletion,
or backup in the archive database.
Stat Select this option to define the order as urgent: «Stat»

◆ If the instrument or LIS interface uses a 2 digits year (MMDDYY) to


transmit the data of birth, YOU MUST ENTER AN AGE, or else the date of birth
will be ignored by instrument.
◆ If a demographics field is entered that is longer than the instrument or
LIS interface will allow, the demographics will be truncated when transmitted
to the instrument or LIS.

4.2.2. Sample information fields


Sample information fields are specific to the order, and are not saved in the patient demographics
record. The following table describes the sample information fields in the Report window.

Tab. 2–11
Field Function
Enter a sample collection time in hours and minutes (hh:mm time
Sample Collection Time
format).
Sample Collection Date Enter a sample collection date (MM/DD/YYYY date format).

Instrument demographics records cannot be updated electronically from the LIS. Changes
to existing instrument demographics records must be made at the workstation.

4.2.3. Creating a new order


◆ Follow the steps below to create a new order.

Tab. 2–12
Step Action
Enter the Patient ID and/or Last Name in the New Order window. Use the [Tab] key or the
1
mouse to move between fields.

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Populating the Worklist

Tab. 2–12
Step Action (...)
After entering the Patient ID and/or Last Name, press the [Enter] key. The following
window will open:

Select <Yes> to create a new patient and return to the New Order window. Select <No> to
3 cancel and return to the New Order window. You can continue entering demographics at
this time (use the [Tab] key or the mouse to move between fields), or continue to Step 4.
Press the [Enter] key. This will save the demographics and open the Testing - Parameters
4
window. Select the desired parameter(s), then select <OK> to exit the window.
The Sample ID window will open when the Testing - Parameters window is exited. Review
5
and/or edit the instrument assigned Sample ID, then select <OK> to exit the window.
Save the new order by selecting the save icon from the toolbar or by pressing the [F2] key.
6
This will close the order window and open a blank New Order sheet.

◆ Only the patient ID and/or last name are required to complete a new order. The remaining patient
demographics can be entered later.

4.2.4. Create a New Order for an Existing Patient


◆ Follow the steps below to create a new order with an existing patient demographics record.

Tab. 2–13
Step Action
To search for an existing patient demography record in the New Order window,
◆ type in the Patient ID or Last Name, or
◆ type in a partial entry in the Patient ID or Last Name fields using wildcard symbols.
1
An * (asterisk) is a wildcard for all following characters, and a ? (question mark) is
a wildcard for a single character.
Example:
Search for the name Adams by entering Ad* or Ad??s in the Last Name field.
Press [Enter] after entering the search criteria. The «Search Patient» window will open.

3 Select a patient demographic record from the list in the «Search Patient» window.
Select <OK> to confirm the selection. Select <New> to return to the New Order window
4 to enter a new patient. Select <Cancel> to cancel the search and return to the New Order
Sheet window.
If you select <OK> in the «Search Patient» window, the «Testing - Profiles» window will
5 open (See “4.4. Testing - Parameters/Profiles windows”, page 20). Select one or several
profiles (CBC, DIF, RET, ERB) and/or SLIDE, then select <OK> to exit the window.

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Tab. 2–13
Step Action (...)
The Sample ID window will open when the «Testing - Parameters» window is exited.
6 Review and/or edit the instrument assigned Sample ID, then select <OK> to exit the
window.
Save the New Order by selecting the save icon from the toolbar or by pressing the [F2]
7
key. This will close the order window and open a blank New Order sheet.

4.3. Create a New Order for an Unknown Patient


◆ Creating a new order with unknown patient demographics allows rapid entry of patient
programming using only a Sample ID as the identifier. Follow the steps below to create a new
order with unknown demographics.

Tab. 2–14
Step Action
1 Open the New Order window. The cursor should be in the Patient ID or Last Name field.
Press the [Enter] key without entering any information in the Patient ID or Last Name
2
fields.
Instrument will automatically assign a Patient ID of '000000' and a Last Name of
3 'UNKNOWN' (depends on the settings. Can assign a patient ID with an automatic prefix
(see 1.2. General Setup Options, page 3-3)
Then The «Testing - Profiles» window will open (See “4.4. Testing - Parameters/Profiles
4 windows”, page 20). Select one or several profiles (CBC, DIF, RET, ERB) and/or SLIDE, then
select <OK> to exit the window.
The «Testing - Parameters» window will open (See “4.4. Testing - Parameters/Profiles
5 windows”, page 20). Select the desired parameter(s), then select <OK> to exit the
window.
The Sample ID window will open when the «Testing - Parameters» window is exited. Review
6
and/or edit the Instrument assigned Sample ID, then select <OK> to exit the window.
Save the New Order by selecting the save icon from the toolbar or by pressing the [F2]
7
key. This will close the order window and open a blank New Order sheet.
◆ New patient demographics can be entered later by selecting Other Demographics from the Report
window popup menu.

4.4. Testing - Parameters/Profiles windows


◆ The «Testing - Parameters» window opens automatically when the [Enter] key is pressed while
entering demographics in a new order window (See “4.2. New order window”, page 17).
◆ The window includes the list of profiles available on the instrument. A button is available to
switch from the profile’s list to the parameter’s list. Left click the Testing – Parameters button
in order to display the list of parameters (see 1 in the screen below)
◆ The window includes the list of parameters available on the instrument. Click the Testing –
Profiles (see 2 in the screen below) button in order to display the list of profiles.
◆ In any of these lists, the user is able to click any item to select or deselect it.
◆ Left click the OK button validates the user’s choice.
◆ The Testing – Profiles window can also be opened from the Report window, if the user left click
the Add profiles / Parameters button, which is bellow the patient’s demography.

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Workflow
Populating the Worklist

4.4.1. Sample ID window


◆ The Sample ID window will open automatically when the Testing - Parameters window is exited
while creating a new order:
.

◆ This field defaults to an instrument assigned Sample ID. If desired, enter a new Sample ID (up to
15 alphanumeric characters).

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If you enter a Sample ID that is longer than the instrument will allow, the Sample ID will
be truncated when it is downloaded to the instrument. When these results are uploaded
from the instrument, they will be assigned to an «unknown» patient report.

Sample IDs for current orders must be unique. If an instrument uploads


results with a Sample ID that already exists in a current orders on the
instrument, then the results will be merged into that order.

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Workflow
Result view

5. Result view
5.1. Introduction
The result window is used to view and edit existing patient demographics, reports and results,
manually validate results and print reports. The result window could also include some graphical
information (Curves and matrix) as well as comments.

5.2. Result window


Use one of the following options to open the Order window for an existing patient:
◆ Double click a report in the Report List window.

◆ Select the Previous Report or Next Report icon from the toolbar. .

◆ Select the Search icon from the toolbar.

2 7
8 9

4 5 6

The following list describes the elements of the Order Sheet window:
1- Title bar: By default contains Department, Physician, collection date and time.
2- Patient and Graphics area:
Graphics for selected run: Instruments received histograms and/or matrix are displayed in
this area. Clicking «Patient» tab changes the left area of the window, in order to display the
demographics for the selected run.
Patient: Clicking this tab changes the left area of the window, in order to display the patient
demographics (’See “4.2. New order window”, page 17)
3- Messages: This area is displayed only when the «graphics for selected run» tab is selected.

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Double click the messages area displays a window that contains all the messages.
4- Patient Comments: Clicking this button displays the patient comments window.
5- Technical Comments: Clicking this button displays automatic and technical comments window.
6- Extended Diff: Clicking this button displays the Extended Diff windows.
7- Result area: This area contains the report of the order, every results for every runs of the sample,
and archived results.
8- Report: This area contains the report. The report contains the most recent validated results for a
sample consolidated with the values validated from the runs.
9- Runs: This area contains the results given by the analyzers.

5.2.1. Graphic for the selected run


Double click a curve or on the matrix displays a window that contains the magnified graphic (twice
the original size).

5.2.2. Messages for selected run


Double click the message list (Graphics for selected run tab) will display a a bigger window where
all messages can be reviewed.

5.2.3. Patient comments


◆ Left click the Patient comments button displays the Patient Comments window:

◆ The user can view, edit or add patient comments in this window.

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Workflow
Result view

5.3. Extended Diff


◆ This window allows the user to do a manual Diff from the ABX pentra ML application.
◆ Left click the Extended diff button to display the Extended Diff window:

◆ The Button allows to run the «Hematovision» software from the Extended Diff window.

5.3.1. Cellcount (Option)


◆ From the Extended Diff window, a left click on the DIFFPAD button activates the Cellcount
column.

To enable the «DIFFPAD» key option, it is necessary to install it with the software version.
This must be done by an approved HORIBA Medical technician.

◆ Using the Cellcount, press the key corresponding to the cell or to the comment (Cellcount’s Shift
key allows to toggle between the 2 layouts: cells/comments).

◆ The following button allows to cancel the last action.

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Overcount checkbox blank


◆ When the number of cells is reached (setup to «100» by default*), a sound is triggered (this one
can be modified*), the number of cell to be counted turns green, the count is stopped and can
not continue over the defined value. Press OK button to calculate the ratio for each type of cell.

*Adjustment must be done by an HORIBA Medical representative

When the number of cells to count is not reached, pressing OK button will ask the operator
to validate before ratio calculation. Press OK button to validate or Cancel to continue the
counting.

Overcount checked
◆ The «Overcount» checkbox can be selected for a slide count (blank by default): when the number
of cells is reached, a sound is triggered, the number of cell to be counted turns green, but the
count can continue over the defined value. Press OK button to calculate the ratio for each type
of cell.

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Workflow
Result view

5.4. Report
The report is on the left side of the Results area. The report contains the most recent validated
results for a sample.

1 2

◆ Values in the report are the ones that will be sent and archived for this order. The report is empty
by default. Each time a result is validated, the report is updated.
◆ The report is complete, when all parameters are validated and no parameters are pending. When
complete, the report can be automatically sent to the host (automatic and partial transmission
can be defined).

Result Area Interface


1- Profiles: Profiles rows may be extended or reduced, if the user left clicks the marked button (1).
2- Report and Runs: Report and Runs columns may be extended or reduced, if the user left clicks
the marked button (2). By default, the report is closed when no parameter is validated yet. As soon
as a Run or a parameter has been validated the Report is «open».

5.5. Manual results entry


Results can be uploaded from an instrument or manually entered in the Report window. To manually
enter see 5.7. Add manual run, page 2-28. Validated results cannot be edited.

5.6. Results color code


On the display, results have color code to indicate how they compare to panic limits and normal
limits. The following table lists the results color codes.

Tab. 2–15
Code Font Color Description
Panic Low Blue / Bold Out of panic limit low.
Normal Low Blue Out of normal low, inside panic limit.
Normal Black Inside normal limits
Normal High Red Out of normal high, inside panic limit.
Panic High Red / Bold Out of panic limit high.

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◆ To view the pathological limits for a parameter in the Report window, double click the table cell
containing the result. This will open the Pathological window for the selected result/parameter:

In the example above:


◆ The panic limits for WBC are from 3.0 to 13.0
◆ The normal limits are from 4.0 to 10.0

The «Pathological limits» screen displays «Standard» limits only but not the
limits related to sex and age.

5.7. Add manual run


Right click the Report List; a popup menu will be displayed.

◆ «Add manual run» allows the user to create a run for which the results will be entered manually.
◆ Some parameters are not available for manual entry: Calculated parameters, RDW, PDW, PCT, RETL,
RETH, RETM, MFI, and CRC.

5.8. Set Slide Done


Right click the Report List: a popup menu will be displayed.

◆ «Set SLIDE done» allows the user to set manually a SLIDE to the «Done» state.

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Workflow
Result view

A SLIDE may also be set to «Done» when the user closes the Extended Diff window after a
manual entry.

5.9. Results validation


Results can be validated automatically or manually. Automatic Validation is setup in the parameter
definition, and can be dependent on rules (Which could use limits, delta checking method,...).
Manual validation is done in the Report window.
The following manual validation options are available in the Report window:

◆ When there is a single Run in the Report, select the Validate icon in the toolbar (or [F12]
key).
The report is validated and the next report to validate is displayed.

If calculated parameters of the Report (example: MCHC, MCH, MCV... ) have been obtained
from different Runs and are out of ranges, you will need to validate one more time these
«out of ranges» parameters or this Report.

◆ When there are more than one Run in the report,


select the Run to validate by clicking on the result (all the Run cell will be highlighted),then
select the Validate icon in the toolbar
or select the parameters (the cell will be highlighted) to validate, ,then select the Validate
icon in the toolbar

◆ To remove the validation results from the validated report, select the Unvalidate icon in
the toolbar
select the Run to unvalidate by clicking on the result (all the Run cell will be
highlighted),then select the Unvalidate icon
or select the parameters (the cell will be highlighted),then select the Unvalidate icon

You may select multiple results to validate or unvalidate by holding the [Ctrl] key while
clicking the parameters. The name of the person who validates manually the results is
memorized.

5.10. Result flags


◆ Result flags are listed in columns besides each parameter (See “5.4. Report”, page 27). The
following table describes the different Result flags.

Tab. 2–16
Printout
Display flag Description
Flag
H Red & Bold parameter Result is above panic limit high
h Red parameter Result is between normal and panic limit high
l Blue parameter Result is between normal and panic limit low
L Blue & Bold parameter Result is below panic limit low
V V Result validated automatically
v v Result validated manually
M M Result manually entered or edited
C C Calculated result

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Tab. 2–16
Printout
Display flag Description
Flag
Red triangle Results failed Delta Check
none
Green triangle Results passed Delta Check
H H Result sent to the LIS
There are also some 3 flags that can be displayed on the right side of the result (these flags
represents alarms from the instruments, refer to Instrument User Manual):
* : Rejected
! : Suspect
D : Dilution

5.11. Result error codes


If the instrument sends an error code instead of a result, the error code will appear in the results
table and displayed with a black/italic/underlined font.

5.12. Report popup menu


To open the Report popup menu, click with the right mouse button anywhere in the Report window.

The following table describes the options in the Report popup menu.

Tab. 2–17
Option Function
This option allows the user to program one or more selected parameter(s)
Rerun
for rerun.
This option allows the user to cancel a rerun for selected parameter(s). The
P (Pending) flag is removed.
Unrerun
Note: the Unrerun functionality does not work for the Slide or parameter
without results.
This option allows the user to add parameters or profiles.
Note: If you wish to add parameters to a completed sample in addition to
Add Parameters
rerunning one or more parameters, you must select the Rerun option first,
then the Add Parameters option.
Add manual run See “5.7. Add manual run”, page 28
Set Slide done See “5.8. Set Slide Done”, page 28
This option allows the user to access, for the selected parameter, to the rules
Played Rules that were played, and for each of these to know the status and action
performed.
Manual Match See “5.15. Manual Match”, page 32
This option clears most of the demographics information. The user can enter
Other Demographics new demographics or select existing demographics. This is usefull for
entering new patient demographics for an «unknown» patient.

5.13. Rerun window


Follow the steps below to rerun one or more parameters.

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Workflow
Result view

Tab. 2–18
Step Action
First select one or more parameters in the Report window to rerun by clicking the parameter
in the results table (the row will be highlighted).
1 Note: All parameters to be rerun in a sample must be selected before selecting the Rerun
option. To select multiple parameters, hold the [Ctrl] key while clicking the parameters in
the results table. You may only select parameter(s) from one sample at a time for rerun.
Open the Report window popup menu. Select Rerun from the popup menu. This will open
the Rerun window.

3 The <Sample ID> field defaults to the assigned Sample ID.


Select <OK> to save and exit the screen. The rerun will automatically be downloaded to the
4
instrument. Select <Cancel> to cancel the rerun and exit the screen.

If a rerun is downloaded from the LIS, a window will open notifying the user of the rerun. The rerun
will be automatically downloaded to the instrument.

5.14. Played rules


To access to the played rules, select from the Report window the contextual menu 'Played Rules'. You
obtain a new screen with the trace of the played rules on the report on the left part:
◆ The rules which failed appear in red.
◆ The rules which generate an action appear in green with the status 'ok'.

The right part of the screen contains:


◆ The display criteria (in order to display or not some types of rules)
◆ The played rule (when a line indicating a parameter is selected in the grid)

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◆ The values used for the evaluation of the rule (when a rule is selected)

You can obtain a direct access to the rule definition by selecting a line in the grid (for a specific
parameter) and then by selecting the button 'Rule Definition' Select 'Close' to exit the 'Played Rules'
window and return to the report window.
Also See Section 3, 8. Rules, page 3-18

The trace corresponding to rules played may disappear if you change the rules definition
for rules already evaluated.

5.15. Manual Match


When Sample ID is missing for a report (barcode label can not be read), this function allows the user
to manually associate an order to results without Sample ID:
◆ Select the report without sample ID (or open directly this report).
◆ Right click to open the Report Popup menu and select «Manual Match» (See “2.2. Report List
Window”, page 10). The following menu will be displayed:

◆ Associate the selected «Report without Sample ID» (listed in the lower tab) with the order
corresponding to the sample demographics (upper table, click the order).
◆ Click «Match»
◆ The message «Do you want to match the order xxx with the result of the tube yyyy?» is displayed.
Click «Yes» to confirm.
◆ Verify in the report that the Sample ID and demographics have been well associated to the reports.

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Workflow
Printing

6. Printing
6.1. Introduction
This option allows the user to print reports or runs. Information present in the report will be printed
too.

6.2. Patient reports


The following table describes each of the patient reports available in the instrument.

Tab. 2–19
Report Description
Includes all the runs of the report(s) with complete demographics, units,
Run
normal limits and flags, anteriority, and last archived results.
Includes all the runs of the report(s) in a line mode with demographics and
Runs in line
results.
Prints the validated Report(s) with a graphic profile, and includes complete
Report
demographics.
Prints Runs with a graphic profile, and includes complete demographics. This
Graphic Runs
is used to print non validated results. A «Manual diff» chart is added.

6.3. Report printing window


To open the Report Printing window, select the Print icon from the toolbar. The Report Printing
window can be opened from the following windows:
◆ The Report window for a selected patient
◆ The Report List window after selecting a patient or several.

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6.4. Procedure
Follow the steps below to print a report:

Tab. 2–20
Step Action
1 Select a report type from the drop down menu.
Select one of the following print options:
Select... to print...
All Reports All current Reports.
All Reports Not Printed and Not All current Reports which have not been printed
Validated and have not been validated.
2 Only the selected patient reports. This option is
Selected Reports available if the Report Printing window is
opened from the Report List Window.
Print only pending reports. The user is
Reports pending able to select for which profiles the reports must
be printed (CBC, DIF, RET, NRBC and SLIDE).
3 Select <OK> to initiate the print. Select <Cancel> to cancel and exit the window.

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Workflow
Printing

6.5. Report printout example

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7. Comments
7.1. Introduction
This option allows the user to enter, edit or review technical notes and results interpretations for a
current patient Report.

7.2. Comments window


The Comments window can be opened from the Report. Two kinds of comments windows are
available:

◆ Patient comments:

◆ Sample comments:

Example of Sample Comments window:

7.3. Procedure
◆ Enter the appropriate information in the <Tube Comments> field.
◆ Select <OK> to save and exit the window, or <Cancel> to cancel and exit the field.
◆ Once a comment has been entered the corresponding icon of the comment turns to red color:

7.4. Enter a predefined comment


◆ The user can enter a predefined comment in either the <Tube Comments> field or the <Patient
comment> field of both Comments windows. To enter a predefined comment in either field, type
an & (ampersand) followed by the predefined comment abbreviation, as shown in the example
below.

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Workflow
Comments

◆ Select <OK> to save and exit the window. When the Comments window is opened again, the
defined comment has been entered into the field, as shown in the example below.

7.5. Selecting pre defined comments


◆ You can instead of entering manually the comments, select them in a list by selecting the button
Choose....

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8. Deleting a Report or an order


8.1. Introduction
◆ The user can delete an entire patient report/order or specific results or runs within a patient
report.

Deletion is irreversible. Deleted patient report or results cannot be recovered.

8.2. Delete results


To delete results in a report/order, open the Report window
click the parameter results of the Report to delete

select the Delete icon from the toolbar.

Then select the option «selected results» or «selected parameters»

8.3. Delete a Run


To delete a Run, open the Report window
Select the Run of the Report

select the Delete icon from the toolbar.

Confirm the deletion clicking the «Yes» key

8.4. Delete a Report


Report can be deleted from the following windows:
◆ The Report window for a selected patient report

select the Delete icon from the toolbar

in that case all the runs must be deleted one by one, then the demographics too.

◆ The Report List window after selecting one or more patient reports

select the Delete icon from the toolbar

Confirm the deletion clicking the «Yes» key

8.5. Delete an order


◆ To delete an order in the Worklist window:
select one or more orders

then select the Delete icon from the toolbar.

Confirm the deletion clicking the «Yes» key

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Workflow
Manual LIS Transmission

9. Manual LIS Transmission


9.1. Introduction
This option allows the user to manually upload results to the LIS.
Results can be manually uploaded to the LIS from one of the following windows:
◆ The Report window for a selected patient report
◆ The Report List window after selecting one or more reports
◆ The Worklist window after selecting one or more Samples

9.2. Procedure
◆ To manually upload the selected results, select the LIS Transmission icon from the Toolbar or the
appropriate function key. Selected results will be uploaded.

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10. File Search


10.1. Introduction
◆ This option allows the user to search the current file for a specific patient.

10.2. Access
To open the Search window:

◆ Select the Search icon from the Toolbar or [Ctrl] + [F].

10.3. Procedure
◆ To search for a patient report, enter your search criteria in one or more of the search fields (Sample
ID, Patient ID and Name, Rack, Position).
◆ Select the folder to search for: «Current» for non archived reports or «Archive» or both.
◆ You may type in a partial entry in any of the search fields using wildcard symbols. An * (asterisk)
is a wildcard for all following characters, and a ? (question mark) is a wildcard for a single
character.

Example:
◆ Search for Sample ID beginning by «70» entering «70*» in the «Sample ID» field, and having
Patient Name which includes «Anton» by entering «*Anton*» in the field «Patient Name».
◆ Select <OK> to initiate the search. Select <Cancel> to cancel the search and exit the window.
◆ If your search criteria matches only one patient report, the Report window for that report will
open.
◆ If more than one patient report matches your search criteria, a list will open up in the Report
Search window, as shown in the example window above.
◆ If your search criteria matches more than 5000 results (value by default), a message is displayed
to warn about the oversizing. Nevertheless a «Show all» key allows to display the results.

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Workflow
File Search

◆ To open the Report window for a patient, double click that patient in the list.

10.4. Set the search window


Sorting out
◆ You can sort the results out by clicking the column headers.
◆ You can also change the column order using «Drag and Drop» on the column header.

Set the color


For more convenience, you can separate «Archive» and «Current» results setting two different colors:
◆ Right click on one of both checkboxes «Archive» or «Current»
◆ Select between «Archive record color» or «Current record color» in the popup menu
◆ Then choose your color in the pallet.
◆ Press «OK» key to enable the display of this color for the selected folder.

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11. Archive
11.1. View Archived Reports
11.1.1. Introduction
This option allows you to view and print archived reports.

11.1.2. Anteriority window


Use one of the following options to open the Anteriority window to view archived patient reports:
◆ Open the Report Sheet window for a patient.

◆ Select the Anteriority icon from the toolbar to view archived reports for that patient.

◆ Open the Anteriority Search window. This option is described later in this section (see 11.1.5.
Anteriority search, page 2-43).

The results table in the Anteriority window contains the following information:
◆ Archived reports are listed in columns. Use the right and left arrows to view additional reports.
◆ The header for each column is the date the report was archived.
◆ The top row of each report indicates whether a technical comment or interpretation was entered
for the report (Yes or No).
◆ The remaining rows list the parameter results for each report. Use the up and down arrows to view
additional results for each report.
◆ Results which fell outside the panic limits are indicated by an * (asterisk) next to the result.
◆ The result window may also display some graphical information (curves and matrix if available and
archived).
◆ To see them, select a column (by clicking on the column header, or date information). The window
resizes automatically in order to display the graphics and comments.

11.1.3. Archive information


To view additional information stored with each result, double click the table cell containing the
result. This will open the Archive Information window for the selected result.

The following table describes each of the items in the Archive Information window.

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Workflow
Archive

Tab. 2–21
Field Value Description
Sample ID xxx Sample ID of result
Sample modification M Sample ID was manually entered
Stat S Stat order
Validation V Result validated automatically
(result flag) v Result validated manually
Result Flag M Result manually entered or edited
(result flag) C Calculated result
Delta check D Result passed delta check
(result flag) X Result failed delta-check
Send to host
H Result sent to the LIS
(result flag)
Number of results — Number of results
Instrument — Instrument the result was run on
Person who validated manually this results (name of the user who
Validated by —
was logged on)

Select <OK> to exit the Archive Information window.

11.1.4. Toolbar functions


Some toolbar functions are available in the Anteriority window. To use these functions, a report must
first be selected by clicking on the column header (date report was run). This will highlight the
column you selected. The following toolbar functions is available:

Print: To print a patient report for the selected report, select the Print icon from the toolbar. The
report type is selected in the <Print> option field on the left side of the Anteriority window.

11.1.5. Anteriority search


To search for an archived patient without first opening the Report window, select the Anteriority
icon. This will open the Anteriority window (blank Anteriority window in which you can search for
a patient).
Follow the steps below to search for archived patient reports in the Anteriority Search window.

Tab. 2–22
Step Action
To search for archived patient reports in the Anteriority Search window,
type in the Patient ID or Last Name,
or
type in a partial entry in the Patient ID or Last Name fields using wildcard symbols. An *
1
(asterisk) is a wildcard for all following characters, and a ? (question mark) is a wildcard
for a single character.
Example:
Search for the name Adams by entering Ad* or Ad??s in the Last Name field.
Press [Enter] after entering the search criteria. The Demographics Search window will
2
open.
3 Select a patient from the list in the Demographics Search window.
Select <OK> to confirm the selection. Select <Cancel> to cancel the search and return to
4
the Anteriority window.

11.1.6. Other previous reports


If you wish to view archived reports for another patient without exiting the Anteriority window, click
the right mouse key and select others anteriorities.

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Select Other Anteriorities to clear the Anteriority window. This allows you to enter new search
criteria.

11.2. Archiving current reports


11.2.1. Introduction
Current reports should be archived on a regular basis (at least once a day is recommended). Too many
current reports may cause performance issues. Also, delta checks are performed against the last
archived reports.
◆ If you are connected to an LIS, you have the option to automatically archive reports after all
results have been sent to the LIS (menu Settings\Communication\Host settings ; option:
«Transmit conditions\Archives after Upload»).
◆ You can choose to automatically archive reports after printing has been performed (Menu
Settings\Soft parameters; option: «Archive after print»; see 1.2. General Setup Options, page 3-3)

11.2.2. Procedure

Tab. 2–23
Step Action
1 Select the Archives menu, then select Archive Report(s). This will open a message window.
2 Select <Yes> to open the Reports Archiving window. Select <No> to cancel and exit.
If you have selected <Yes>, the Reports Archiving window will open

Select one of the following options:

Select... To archive...
4 All all current reports.
one or more reports selected in the Report List
Selected
window.

Enter a date range to archive. The default date range is from the last archive date to the
5
current date. The date format is MM/DD/YYYY.

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Workflow
Archive

Tab. 2–23
Step Action
Optional: Select one or both of the following options:

Select... If...
Archive Only Validated you wish to only archive reports with all results
6
Reports validated.
you do not want to archive any reports that has not
Archive Only Viewed Reports
been viewed.

Optional: If you are connected to LIS, deselect the <Archive Only Recalled Reports>
option if you wish to archive reports even if one or more results have not been sent to the
7
LIS.
Archived reports cannot be uploaded to the LIS.
Archive Graphs:
8
Select this option if you want to archive curves and matrix when archiving reports.
9 Select «Pentra» from the list.
Select <OK> to initiate the archive, select <Cancel> to cancel the archive and exit the
10
screen.
If you selected <OK>, a Reports Archiving log window opens.
11 Note: If none of the current Reports fit the criteria selected in the Reports Archiving
window, the Reports Archiving log window will not open, and nothing will be archived.

11.2.3. Reports archiving window


The status (archived or not archived) of each of the reports selected for archive is displayed in the
Reports Archiving log window. If the report is not archived, the reason will be listed. The following
report will not be archived:
◆ Reports with no results.
◆ Reports with "Unknown" demographics.
◆ Reports not uploaded to LIS (Reports not recalled).

11.3. Save archives


11.3.1. Introduction
The Save Archives window is used to save or delete archived reports. Old archive and demographics
records should be deleted on a regular basis to prevent performance issues (every 7 to 60 days is
recommended). The user has the option of first saving archived reports data to a backup file.
◆ Archiving capacity: 25000 reports with graphs; 100 000 reports without graphs. Deleted archived
data cannot be recovered

The instrument can be set up to automatically overwrite the oldest archived patient reports
after a specified number of days.

11.3.2. Save archives window


To open the Save Archives window, select the Archives menu, then select Save.

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The following functions can be done in the Save Archives window:


◆ Extract: Extract patients for backup or deletion
◆ Delete: Once extracted, delete one or more extracted patients
◆ Save: Once extracted, save one or more extracted patients to a backup file

11.3.3. Extract Archived Patients


Follow the steps below to extract archived patients for backup or deletion.

Tab. 2–24
Step Action
Enter criteria in one or more of the following fields:
<Patient Name>
<Patient ID>
<Sample ID>
1 You may type in a partial entry in any of the search fields using wildcard symbols. An *
(asterisk) is a wildcard for all following characters, and a ? (question mark) is a wildcard
for a single character.
Example:
Search for the name Adams by entering Ad* or Ad??s in the <Patient Name> field.
2 Enter a date range in the <From> and <To> fields (format: MM/DD/YYYY)
3 Select the <Tagged Patient> to extract only tagged patients.
Select <Extract> to extract the archived patients which match the criteria selected in
4
Steps 1 to 3.
Extracted archived patients are listed on the right side of the window. The following information is
listed for each patient:
◆ Current Report Flag: an * (asterisk) if the patient has current (non-archived) reports
◆ Patient Tag Flag: M if the patient is tagged.
◆ Last name
◆ First Name
◆ Gender: M for male, F for female, ? for unknown

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Workflow
Archive

Patients with current (non-archived) reports cannot be deleted or saved to a backup file.

To view archived reports for an extracted patient, double click the patient in the list.

11.3.4. Delete Archived Patient Reports


Follow the steps below to delete selected archived patients in the Patient Records Management
window.

Tab. 2–25
Step Action
1 Extract patients in the «Save Archive» window.
Select one or more patients from the extracted patients list, or click <Select All> to select
2
all extracted patients. Patients with current (non-archived) results will not be deleted.
3 Select <Delete> to initiate the deletion. A message window will open.
Select <Yes> to delete all results for the selected patients. Select <No> to cancel the
4
results deletion and return to the Save Archives window.
If you selected <Yes> in Step 3, another message window will open.
Select <Yes> to delete demographics for all patients which have no results.
5 OR
Select <No> to cancel the demographics record deletion and return to the Patient Records
Management window.

Deletion is irreversible. Deleted patient records cannot be recovered.

11.3.5. Save Archives


Follow the steps below to save selected archived patients to a backup file in the Save Archives
window.

Tab. 2–26
Step Action
1 Insert a formatted 3.5" floppy disk into the A:\ drive.
Select one or more patients from the extracted patients list, or click <Select All> to select
2
all extracted patients.

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ABX pentra ML

Tab. 2–26
Step Action
Click <Backup> to open the Save As window.
Note: If you do not have a floppy disk inserted in the A:\ drive, an error message will
appear. Insert a floppy disk and select <Retry>, or select <Cancel> to open the Save As
window in a different drive.

In the Save As window, enter a file name for the backup file in the <File name> field. The
default file name is BACKUP00. The file extension is always .TXT. The default backup drive
4
is the A:\ drive, but you can save the file in a different drive or directory by using the <Save
In> drop down menu.
Select <Save> to continue the backup procedure. Select <Cancel> to cancel the backup
5
procedure and return to the Save Archives window.
If you selected <Save> in Step 5, the selected patients will be saved to the backup file and
deleted from the archive database, and a window will open. Select <Yes> to delete the
6
backed up records on the instrument. Select <No> to cancel the deletion and return to the
Save Archives window.
If you selected <Yes> in Step 6, a second window will open. Select <Yes> to delete the
7 demographics for all patients that have no results. Select <No> to cancel the demographics
record deletion and return to the Save Archives window.
You can also choose to save these records in another location (C: or D: for the hard drive, or other
backup device if available).

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Workflow
Archive

11.3.6. Restore Archives


◆ This option allows the user to restore archives from backup file(s) to the archive database.
.

Tab. 2–27
Step Action
If the backup is stored on 3,5'' floppy disk, insert the appropriate floppy disk into the A:
1
drive
2 Open the Restore Archive Window (menu Archives - Restore)
Enter your search criteria in one or more of the following fields:
Patient Name
3 Patient ID
Sample ID
Select <Extract>

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ABX pentra ML

Tab. 2–27
Step Action
Select the type of extraction from:

from a file

from a directory (scan of all files in a specified directory)

Select OPEN or OK to continue to restore. All the patients saved in the backup file that
5
correspond to your criteria are displayed in the list.
Select the list of archived reports you want to restore or <Select All> of them. Select the
6
<Restore> button to proceed
Select the <CLOSE> button to validate the restore
7 Caution: if you Cancel or if you close the screen, the previously selected patient reports
won't be restored

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Workstation setup

Contents
1. Introduction .......................................................................................................3-3
1.1. General Setting window .............................................................................3-3
1.2. General Setup Options ...............................................................................3-3
1.3. Patient Fields Setup Window ......................................................................3-4

2. Parameter Definition..........................................................................................3-5
2.1. Introduction................................................................................................3-5
2.2. Parameter Definition window .....................................................................3-5
2.3. Procedure ...................................................................................................3-5
2.4. Delta Check...............................................................................................3-6
2.4.1. Principle.............................................................................................3-6

3. Pathological Limits .............................................................................................3-8


3.1. Introduction................................................................................................3-8
3.2. Pathological Limits Window .......................................................................3-8
3.3. Procedure ...................................................................................................3-8
3.4. Default Pathological Limits values ..............................................................3-9
3.5. Delete Pathological Limits ........................................................................3-13

4. Departments/Physicians...................................................................................3-14
4.1. Introduction..............................................................................................3-14
4.2. Departments/Physicians Window .............................................................3-14
4.3. Procedure .................................................................................................3-14

5. Comments definition ........................................................................................3-15


5.1. Introduction..............................................................................................3-15
5.2. Comments definition window...................................................................3-15
5.3. Procedure .................................................................................................3-15

6. Printer Setup ....................................................................................................3-16


6.1. Introduction..............................................................................................3-16
6.2. Printer configuration .................................................................................3-16
6.3. Report header setting ................................................................................3-16

7. Format Codes ...................................................................................................3-17


7.1. Introduction..............................................................................................3-17
7.2. Format codes window ..............................................................................3-17
7.3. Definitions................................................................................................3-17
7.4. Procedure .................................................................................................3-17

8. Rules ................................................................................................................3-18
8.1. Introduction..............................................................................................3-18
8.2. Parameter rules.........................................................................................3-18
8.3. Download rules ........................................................................................3-19
8.4. Upload rules.............................................................................................3-19
8.4.1. Description.......................................................................................3-19
8.4.2. Upload rules of the default setting ....................................................3-20
8.4.3. Principle of the automatic validation ................................................3-24
8.5. Evaluation on interpretation Rules ............................................................3-25
8.6. Creating a new Rule .................................................................................3-26

9. Users Setting ....................................................................................................3-27

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ABX pentra ML

9.1. Introduction ............................................................................................. 3-27


9.2. Users Setting Window .............................................................................. 3-27
9.3. Define a new user .................................................................................... 3-27
9.4. Delete a user ............................................................................................3-27
9.5. Change a user password ...........................................................................3-27
9.6. Assign user privileges ...............................................................................3-27
9.7. Save .........................................................................................................3-28
9.8. End........................................................................................................... 3-28
9.9. Password ..................................................................................................3-28
9.10. Database maintenance functions ............................................................3-28
9.11. Statistics ................................................................................................. 3-30
9.12. Print settings ........................................................................................... 3-30
9.13. Print parameters/rules ............................................................................. 3-31
9.14. Save settings ........................................................................................... 3-32
9.15. Restore settings....................................................................................... 3-33

10. Lock the ABX pentra ML ................................................................................ 3-34

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Setup

Pentra ML Setup

1. Introduction
The General Setting window is used to customize the instrument environment.

1.1. General Setting window


To open the General Setting window, select the Settings\Soft Parameters menu, then select
General.

1.2. General Setup Options


The following table describes each option of the General Setup window.

Tab. 3–1
Field Function
Select this option to automatically print validated report
Print Report
(associated to «Default Report» option)
Select this option to automatically delete report after print
Delete After Print
(associated to «Default Report» option)
Select this option to automatically archive report after print
Archive After Print
(associated to «Default Report» option)
Select a default format for automatic printing from the drop
down menu. Options are:
Runs: prints all the runs associated to report
Default Report Runs in line: prints all the runs associated to report in line
Graphic runs: prints all the runs associated to report with
graphics
Report: prints the report only
Select this option if you want the Pentra ML workstation to
Instrument: Manage control tubes manage the control results and statistics through EQC
function.
Select this option if you want the instrument to recall results
Host: Manage control tubes to the LIS with the flag «control» (if controls are managed at
the LIS).

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ABX pentra ML

Tab. 3–1
Field Function
This option allows to assign a prefix to patients with unknown
Patient ID. Reports with «Unknown» patient ID can not be
Create patient instead of unknown
archived. When the demographics is not received from the
with prefix
host, it is recommanded to use this prefix on patient ID. This
will be incremented automatically.
Select this option to automatically assign a sample to the
Assign automatically (if entered
instrument if the order is entered manually at the instrument
manually)
console.
Select this option to automatically download a sample if the
Download automatically (if order is entered manually at the instrument console. The
entered manually) <Assign automatically (if entered manually)> option must also
be selected.
Untagged patients archive:*
Enter the number of days to keep archived data before
automatically overwriting the oldest data. The recommended
settings are 7 to 60 days. More than 90 days is not
Number of archived days to keep recommended.
(Archiving capacity: 25000 reports with graphs; 100 000
reports without graphs). Deleted archived data cannot be
recovered.
Keep graphs Select this option to archive graphs with reports.
Tagged patients archive:*
Enter the number of days to keep archived data before
automatically overwriting the oldest data. The recommended
settings are 7 to 60 days. More than 90 days is not
Number of archived days to keep recommended.
(Archiving capacity: 25000 reports with graphs; 100 000
reports without graphs). Deleted archived data cannot be
recovered.
Keep graphs Select this option to archive graphs with reports.
If you specify a number of days different than 0, the current
Delete current reports after
reports will be deleted automatically after that delay.
Select this option to archive reports automaticallly everyday
at the same time.
«Automatically Archive»: enter the archive time starting
Automatically archive
«Reports created for more than xx hours»: if xx=0 all the
reports are archives. HORIBA Medical recommends xx=12
hours.
* To tag a patient click the check box «Patient Tag» from the demography tab See Section 2, 4.2.
New order window, page 2-17.

Save before exiting the window.

1.3. Patient Fields Setup Window


◆ The Patient Fields Setup window allows the user to select which demographics input fields to
display on the patient Report window.
◆ To open the Patient Fields Setup window from the General Setup window, click the button at the
bottom of the window.

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Setup
Parameter Definition

◆ Select or deselect the demographics input fields to display on the patient report window. Select
<OK> to save and exit to the General Setup screen. Select <Cancel> to cancel changes and exit
to the General Setup screen.

2. Parameter Definition
2.1. Introduction
The Parameter Definition window is used to edit (or define) parameters.

Definition of a new parameter is an exceptional procedure which may place


at risk the performance of the instrument. HORIBA Medical does not
recommend to modify parameter definition without approval of your HORIBA
Medical representative.

2.2. Parameter Definition window


To open the Parameter Definition window, select the Settings menu, then select Soft Parameters,
then select Parameter Definition.

2.3. Procedure
Follow the steps below to edit parameter definition:

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ABX pentra ML

Tab. 3–2
Step Action
Select an existing parameter code from the drop down menu. The parameter code is
displayed in the software and printed in most reports, but is not downloaded to the
instruments. Parameter information is transmitted between the ABX pentra ML and the
1
instrument or LIS using format codes.
Note: The parameter code is used by instrument to identify the parameter, and should be
unique for each parameter.
Parameter abbreviation (up to 10 alphanumeric characters). The parameter abbreviation is
2
displayed and printed in some printout (must not be modified)
Parameter name (up to 20 alphanumeric characters). The parameter name is printed on the
3
full report (must not be modified)
4 Select a unit from the drop down menu (must not be modified)
Select a number of decimal places from the drop down menu (0 - 4). Parameter results will
5
be reported with the selected number of digits after the decimal point.
6 Select «blood» as the sample type from the drop down menu (must not be modified)
Select «Hematology» as the sample nature from the drop down menu (must not be
7
modified)
8 Delta Check fomula (See ”2.4. Delta Check”, page 3-6) for each parameter
Validity: displays Delta check validity period in number of days (See ”2.4. Delta Check”,
9
page 3-6)
10 Pathological limits edition (See ”3. Pathological Limits”, page 3-8)
11 Rules on parameter edition (See ”8. Rules”, page 3-18)

2.4. Delta Check


2.4.1. Principle
Current analysis is compared to history (when it does exist) parameter by parameter.
This comparison is applied on hematologic parameters and when the difference between history and
current results are not within operator defined limits, following flags should appear:

Tab. 3–3
Delta check Flag Interpretation
▲ Result passed Delta check and the new result is higher than the history result
▼ Result passed Delta check and the new result is lower than the history result
▲ Result failed Delta check and the new result is higher than the history result
▼ Result failed Delta check and the new result is lower than the history result

The user can enter a Delta check formula to compare a current result to the last archived result. The
Delta check will not compare the current result to a result that has not been archived.
The following fields are used for entering Delta check information:

Tab. 3–4
Field Function
Enter a Delta check formula.
In the example above, the absolute difference between the current result (R1) and
Formula
the last archived result (R2), must be less than 25 (in selected units) to pass the
Delta check.

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Setup
Parameter Definition

Tab. 3–4
Field Function
Enter the number of days (1 to 10,000) between the current and last archived result
Validity
that the Delta check is valid.

Example 1
ABS(R1-R2) < 25
In this example, the Delta check will fail if the difference between the current result and the last
archived result is 25 or greater.

Example 2
((ABS(R1-R2))/R2)*100<5
In this example, the Delta check will fail if the difference between the current result and the last
archived result is 5% or greater.
If the Delta check passes, the result will be flagged with a green triangle. If it fails, the result will
be flagged with a red triangle.

Example 3
((ABS(R1-R2)<10) AND (R1<120)) OR ((ABS(R1-R2)<(5*R1/100)) AND (R1>=120))
In this example, are combined 2 different Delta check formulas for two ranges.
If the result if <120, then the difference between the result and the previous one should be within
10.
But if the result is >=120, then the difference should be within 5 percent.

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ABX pentra ML

3. Pathological Limits
3.1. Introduction
The Pathological Limits window is used to enter both panic and normal limits for a parameter.
The user can enter default normal limits, default panic limits, and specific pathological based on
patient age, gender, and also department.

3.2. Pathological Limits Window


To open the Pathological Limits window from the Parameter Definition Window, click the button
labeled <Pathological Limits> (menu «Settings\Soft Parameters\Parameters Definition»). This
button is only active after the parameter definition has been saved once.

3.3. Procedure
Follow the steps below to enter pathological limits.

Tab. 3–5
Step Action
Enter the following default normal limits information:
1
Low. and High. (limits): Enter the default lower and upper limits.
2 Enter an age minimum for each normal range.
3 Enter an age maximum for each normal range.
4 Enter age units for each normal range. Options are D (day), M (month), or Y (year).
5 Enter a Gender for each normal range. Options are M (male), F (female), or B (both).
6 Enter a low panic limit for each
7 Enter a high panic limit for each
8 Specify a Department (if needed)
Select <Cancel> to cancel the changes and exit to the Parameter Definition window. Select
9
<OK> to save the changes and exit to the Parameter Definition Window.

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Setup
Pathological Limits

3.4. Default Pathological Limits values


Tab. 3–6 Default limit values for Man or Woman > 144 month and < 50000 month (Standard units)
Man Woman
Parameter Extremely Extremely Extremely Extremely
Normal low Normal high Normal low Normal high
low high low high
WBC 3 4 10 13 3 4 10 13
NEU% 0 0 99.9 99.9 0 0 99.9 99.9
LYM% 0 0 99.9 99.9 0 0 99.9 99.9
MON% 0 0 99.9 99.9 0 0 99.9 99.9
EOS% 0 0 99.9 99.9 0 0 99.9 99.9
BAS% 0 0 99.9 99.9 0 0 99.9 99.9
NEU# 1.7 2 7.5 8 1.7 2 7.5 8
LYM# 1 1 4 5 1 1 4 5
MON# 0 0.2 1 1.5 0 0.2 1 1.5
EOS# 0 0 0.5 0.7 0 0 0.5 0.7
BAS# 0 0 0.2 0.25 0 0 0.2 0.25
RBC 3.5 4.5 6.5 6.5 3.5 3.8 5.8 6
HGB 11 13 17 18 9.5 11.5 16 17
HCT 37 40 54 54 34 37 47 50
MCV 70 80 100 110 70 80 100 110
MCH 25 27 32 34 25 27 32 34
MCHC 32 32 36 36 32 32 36 36
RDW 10 11 16 17 10 11 16 17
PLT 100 150 500 550 100 150 500 550
MPV 6 6 11 12 6 6 11 12
PCT 0 0.15 0.5 1 0 0.15 0.5 1
RET# 0 0.02 0.1 0.15 0 0.02 0.1 0.15
RET% 0 0.5 2.5 3.5 0 0.5 2.5 3.5
Blasts% 0 0 999 999 0 0 999 999
ERB% 0 0 999 999 0 0 999 999
Myelocytes% 0 0 999 999 0 0 999 999
Blasts# 0 0 999 999 0 0 999 999
Myelocytes# 0 0 999 999 0 0 999 999
ERB# 0 0 999 999 0 0 999 999
PDW 7 11 18 20 7 11 18 20
ALY# 0 0 0.25 0.25 0 0 0.25 0.25
ALY% 0 0 2.5 2.5 0 0 2.5 2.5
IML# 0 0 0.25 0.25 0 0 0.25 0.25
IML% 0 0 2.5 2.5 0 0 2.5 2.5
IMM# 0 0 0.11 0.11 0 0 0.11 0.11
IMM% 0 0 1.1 1.1 0 0 1.1 1.1
IMG# 0 0 0.25 0.25 0 0 0.25 0.25
IMG% 0 0 2.5 2.5 0 0 2.5 2.5
RETH% 0 0 10 15 0 0 10 15
RETM% 0 0 40 50 0 0 40 50
RETL% 0 65 97 99 0 65 97 99
MFI 0 5 30 40 0 5 30 40
CRC 0 0.75 2.3 3 0 0.75 2.3 3
RET_IMM 0 0 0.5 1.5 0 0 0.5 1.5
CWBC 0 0 999 999 0 0 999 999
Bands# 0 0 999 999 0 0 999 999
Bands% 0 0 999 999 0 0 999 999
MetaMyelo# 0 0 999 999 0 0 999 999
MetaMyelo% 0 0 999 999 0 0 999 999
LIC# 0 0 0.3 0.3 0 0 0.3 0.3
LIC% 0 0 3 3 0 0 3 3
MRV 0 0 9999 9999 0 0 9999 9999
ProMyelo% 0 0 999 999 0 0 999 999
ProMyelo# 0 0 999 999 0 0 999 999
PIC 0 0 999 999 0 0 999 999
IRF 0 0 999 999 0 0 999 999
Other# 0 0 999 999 0 0 999 999
Other% 0 0 999 999 0 0 999 999
Plasmocytes# 0 0 999 999 0 0 999 999
Plasmocytes% 0 0 999 999 0 0 999 999
ProLympho# 0 0 999 999 0 0 999 999
ProLympho% 0 0 999 999 0 0 999 999
Lym.Hypbas# 0 0 999 999 0 0 999 999
Lym.Hypbas% 0 0 999 999 0 0 999 999
LYMAT# 0 0 999 999 0 0 999 999
LYMAT% 0 0 999 999 0 0 999 999
ProMono# 0 0 999 999 0 0 999 999
ProMono% 0 0 999 999 0 0 999 999

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ABX pentra ML

Tab. 3–6 Default limit values for Man or Woman > 144 month and < 50000 month (Standard units)
Man Woman
Parameter Extremely Extremely Extremely Extremely
Normal low Normal high Normal low Normal high
low high low high
Sezary# 0 0 999 999 0 0 999 999
Sezary% 0 0 999 999 0 0 999 999

Tab. 3–7 Default limits values for Child < 1 month and Child >1 month and <12 month (Standard units)
Child (<1 month) Child (>1 month and <12 month)
Parameter Extremely Extremely Extremely Extremely
Normal low Normal high Normal low Normal high
low high low high
WBC 10 10 26 30 10 10 26 30
NEU% 0 0 99.9 99.9 0 0 99.9 99.9
LYM% 0 0 99.9 99.9 0 0 99.9 99.9
MON% 0 0 99.9 99.9 0 0 99.9 99.9
EOS% 0 0 99.9 99.9 0 0 99.9 99.9
BAS% 0 0 99.9 99.9 0 0 99.9 99.9
NEU# 6 6 26 26 6 6 26 26
LYM# 2 2 11 11 2 2 11 11
MON# 0.4 0.4 3.1 3.1 0.4 0.4 3.1 3.1
EOS# 0 0 0.85 0.85 0 0 0.85 0.85
BAS# 0 0 0.65 0.65 0 0 0.65 0.65
RBC 4 4 6 6 4 4 6 6
HGB 13.5 13.5 19.5 19.5 13.5 13.5 19.5 19.5
HCT 44 44 64 64 44 44 64 64
MCV 98 100 112 114 98 100 112 114
MCH 30 30 38 38 30 30 38 38
MCHC 32 32 36 36 32 32 36 36
RDW 10 11 16 17 10 11 16 17
PLT 150 200 400 450 150 200 400 450
MPV 6 6 11 12 6 6 11 12
PCT 0 0.15 0.5 1 0 0.15 0.5 1
RET# 0 0.02 0.1 0.15 0 0.02 0.1 0.15
RET% 0 0.5 2.5 3.5 0 0.5 2.5 3.5
Blasts% 0 0 999 999 0 0 999 999
ERB% 0 0 999 999 0 0 999 999
Myelocytes% 0 0 999 999 0 0 999 999
Blasts# 0 0 999 999 0 0 999 999
Myelocytes# 0 0 999 999 0 0 999 999
ERB# 0 0 999 999 0 0 999 999
PDW 7 11 18 20 7 11 18 20
ALY# 0 0 0.35 0.35 0 0 0.35 0.35
ALY% 0 0 2.5 2.5 0 0 2.5 2.5
IML# 0 0 0.25 0.25 0 0 0.25 0.25
IML% 0 0 2.5 2.5 0 0 2.5 2.5
IMM# 0 0 0.11 0.11 0 0 0.11 0.11
IMM% 0 0 1.1 1.1 0 0 1.1 1.1
IMG# 0 0 0.25 0.25 0 0 0.25 0.25
IMG% 0 0 2.5 2.5 0 0 2.5 2.5
RETH% 0 0 10 15 0 0 10 15
RETM% 0 0 40 50 0 0 40 50
RETL% 0 65 97 99 0 65 97 99
MFI 0 5 30 40 0 5 30 40
CRC 0 0.75 2.3 3 0 0.75 2.3 3
RET_IMM 0 0 0.5 1.5 0 0 0.5 1.5
CWBC 0 0 999 999 0 0 999 999
Bands# 0 0 999 999 0 0 999 999
Bands% 0 0 999 999 0 0 999 999
MetaMyelo# 0 0 999 999 0 0 999 999
MetaMyelo% 0 0 999 999 0 0 999 999
LIC# 0 0 0.35 0.35 0 0 0.35 0.35
LIC% 0 0 3 3 0 0 3 3
MRV 0 0 9999 9999 0 0 9999 9999
ProMyelo% 0 0 999 999 0 0 999 999
ProMyelo# 0 0 999 999 0 0 999 999
PIC 0 0 999 999 0 0 999 999
IRF 0 0 999 999 0 0 999 999
Other# 0 0 999 999 0 0 999 999
Other% 0 0 999 999 0 0 999 999
Plasmocytes# 0 0 999 999 0 0 999 999
Plasmocytes% 0 0 999 999 0 0 999 999
ProLympho# 0 0 999 999 0 0 999 999
ProLympho% 0 0 999 999 0 0 999 999

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Setup
Pathological Limits

Tab. 3–7 Default limits values for Child < 1 month and Child >1 month and <12 month (Standard units)
Child (<1 month) Child (>1 month and <12 month)
Parameter Extremely Extremely Extremely Extremely
Normal low Normal high Normal low Normal high
low high low high
Lym.Hypbas# 0 0 999 999 0 0 999 999
Lym.Hypbas% 0 0 999 999 0 0 999 999
LYMAT# 0 0 999 999 0 0 999 999
LYMAT% 0 0 999 999 0 0 999 999
ProMono# 0 0 999 999 0 0 999 999
ProMono% 0 0 999 999 0 0 999 999
Sezary# 0 0 999 999 0 0 999 999
Sezary% 0 0 999 999 0 0 999 999

Tab. 3–8 Default limits values for Child >12 month & <72 month and Child >72 month & <120 month
(Standard units)
Child (>12 month and <72 month) Child (>72 month and <120 month)
Parameters Extremely Extremely Extremely Extremely
Normal low Normal high Normal low Normal high
low high low high
WBC 5 5 15 17 4.5 4.5 13.5 15
NEU% 0 0 99.9 99.9 0 0 99.9 99.9
LYM% 0 0 99.9 99.9 0 0 99.9 99.9
MON% 0 0 99.9 99.9 0 0 99.9 99.9
EOS% 0 0 99.9 99.9 0 0 99.9 99.9
BAS% 0 0 99.9 99.9 0 0 99.9 99.9
NEU# 1.5 1.5 8.5 8.5 1.8 1.8 8 8
LYM# 2 2 8 8 1.5 1.5 6.5 6.5
MON# 0 0 0.8 0.8 0 0 0.8 0.8
EOS# 0 0 0.65 0.65 0 0 0.6 0.6
BAS# 0 0 0.2 0.3 0 0 0.2 0.3
RBC 4.1 4.1 5.5 5.5 4 4 5.4 5.4
HGB 11.5 12 14 14.5 11 11.5 14.5 15
HCT 36 36 44 44 37 37 45 45
MCV 71 73 89 91 75 77 91 93
MCH 24 24 30 30 24 24 30 30
MCHC 32 32 36 36 32 32 36 36
RDW 10 11 16 17 10 11 16 17
PLT 150 200 400 450 150 200 400 450
MPV 6 6 11 12 6 6 11 12
PCT 0 0.15 0.5 1 0 0.15 0.5 1
RET# 0 0.02 0.1 0.15 0 0.02 0.1 0.15
RET% 0 0.5 2.5 3.5 0 0.5 2.5 3.5
Blasts% 0 0 999 999 0 0 999 999
ERB% 0 0 999 999 0 0 999 999
Myelocytes% 0 0 999 999 0 0 999 999
Blasts# 0 0 999 999 0 0 999 999
Myelocytes# 0 0 999 999 0 0 999 999
ERB# 0 0 999 999 0 0 999 999
PDW 7 11 18 20 7 11 18 20
ALY# 0 0 0.35 0.35 0 0 0.25 0.25
ALY% 0 0 2.5 2.5 0 0 2.5 2.5
IML# 0 0 0.25 0.25 0 0 0.25 0.25
IML% 0 0 2.5 2.5 0 0 2.5 2.5
IMM# 0 0 0.11 0.11 0 0 0.11 0.11
IMM% 0 0 1.1 1.1 0 0 1.1 1.1
IMG# 0 0 0.25 0.25 0 0 0.25 0.25
IMG% 0 0 2.5 2.5 0 0 2.5 2.5
RETH% 0 0 10 15 0 0 10 15
RETM% 0 0 40 50 0 0 40 50
RETL% 0 65 97 99 0 65 97 99
MFI 0 5 30 40 0 5 30 40
CRC 0 0.75 2.3 3 0 0.75 2.3 3
RET_IMM 0 0 0.5 1.5 0 0 0.5 1.5
CWBC 0 0 999 999 0 0 999 999
Bands# 0 0 999 999 0 0 999 999
Bands% 0 0 999 999 0 0 999 999
MetaMyelo# 0 0 999 999 0 0 999 999
MetaMyelo% 0 0 999 999 0 0 999 999
LIC# 0 0 0.35 0.35 0 0 0.3 0.3
LIC% 0 0 3 3 0 0 3 3
MRV 0 0 9999 9999 0 0 9999 9999
ProMyelo% 0 0 999 999 0 0 999 999
ProMyelo# 0 0 999 999 0 0 999 999
PIC 0 0 999 999 0 0 999 999

ABX pentra ML - User Manual - RAB236DEN - 11


ABX pentra ML

Tab. 3–8 Default limits values for Child >12 month & <72 month and Child >72 month & <120 month
(Standard units)
Child (>12 month and <72 month) Child (>72 month and <120 month)
Parameters Extremely Extremely Extremely Extremely
Normal low Normal high Normal low Normal high
low high low high
IRF 0 0 999 999 0 0 999 999
Other# 0 0 999 999 0 0 999 999
Other% 0 0 999 999 0 0 999 999
Plasmocytes# 0 0 999 999 0 0 999 999
Plasmocytes% 0 0 999 999 0 0 999 999
ProLympho# 0 0 999 999 0 0 999 999
ProLympho% 0 0 999 999 0 0 999 999
Lym.Hypbas# 0 0 999 999 0 0 999 999
Lym.Hypbas% 0 0 999 999 0 0 999 999
LYMAT# 0 0 999 999 0 0 999 999
LYMAT% 0 0 999 999 0 0 999 999
ProMono# 0 0 999 999 0 0 999 999
ProMono% 0 0 999 999 0 0 999 999
Sezary# 0 0 999 999 0 0 999 999
Sezary% 0 0 999 999 0 0 999 999

Tab. 3–9 Default limits values for Child >120 month and <144 month (Standard units
Child (>120 month and <144 month)
Parameter
Extremely low Normal low Normal high Extremely high
WBC 4.5 4.5 13.5 15
NEU% 0 0 99.9 99.9
LYM% 0 0 99.9 99.9
MON% 0 0 99.9 99.9
EOS% 0 0 99.9 99.9
BAS% 0 0 99.9 99.9
NEU# 1.8 1.8 8 8
LYM# 1.5 1.5 6.5 6.5
MON# 0 0 0.8 0.8
EOS# 0 0 0.6 0.6
BAS# 0 0 0.2 0.3
RBC 4 4 5.4 5.4
HGB 11 11.5 14.5 15
HCT 37 37 45 45
MCV 75 77 91 93
MCH 24 24 30 30
MCHC 32 32 36 36
RDW 10 11 16 17
PLT 150 200 400 450
MPV 6 6 11 12
PCT 0 0.15 0.5 1
RET# 0 0.02 0.1 0.15
RET% 0 0.5 2.5 3.5
Blasts% 0 0 999 999
ERB% 0 0 999 999
Myelocytes% 0 0 999 999
Blasts# 0 0 999 999
Myelocytes# 0 0 999 999
ERB# 0 0 999 999
PDW 7 11 18 20
ALY# 0 0 0.25 0.25
ALY% 0 0 2.5 2.5
IML# 0 0 0.25 0.25
IML% 0 0 2.5 2.5
IMM# 0 0 0.11 0.11
IMM% 0 0 1.1 1.1
IMG# 0 0 0.25 0.25
IMG% 0 0 2.5 2.5
RETH% 0 0 10 15
RETM% 0 0 40 50
RETL% 0 65 97 99
MFI 0 5 30 40
CRC 0 0.75 2.3 3
RET_IMM 0 0 0.5 1.5
CWBC 0 0 999 999
Bands# 0 0 999 999
Bands% 0 0 999 999
MetaMyelo# 0 0 999 999
MetaMyelo% 0 0 999 999

12 - ABX pentra ML - User Manual - RAB236DEN


Setup
Pathological Limits

Tab. 3–9 Default limits values for Child >120 month and <144 month (Standard units
Child (>120 month and <144 month)
Parameter
Extremely low Normal low Normal high Extremely high
LIC# 0 0 0.3 0.3
LIC% 0 0 3 3
MRV 0 0 9999 9999
ProMyelo% 0 0 999 999
ProMyelo# 0 0 999 999
PIC 0 0 999 999
IRF 0 0 999 999
Other# 0 0 999 999
Other% 0 0 999 999
Plasmocytes# 0 0 999 999
Plasmocytes% 0 0 999 999
ProLympho# 0 0 999 999
ProLympho% 0 0 999 999
Lym.Hypbas# 0 0 999 999
Lym.Hypbas% 0 0 999 999
LYMAT# 0 0 999 999
LYMAT% 0 0 999 999
ProMono# 0 0 999 999
ProMono% 0 0 999 999
Sezary# 0 0 999 999
Sezary% 0 0 999 999

3.5. Delete Pathological Limits


To delete limits in the table, first select one or more pathological limits by clicking on the row
number. This will highlight the row or rows you have selected. Then select <Delete>. The selected
pathological limits will be deleted.

ABX pentra ML - User Manual - RAB236DEN - 13


ABX pentra ML

4. Departments/Physicians
4.1. Introduction
The Departments/Physicians Definition window is used to define or edit physicians or departments.

4.2. Departments/Physicians Window


To open the Departments/Physicians Definition window, select the Settings menu, then select
Software Parameters, then select Departments/Physicians.

4.3. Procedure
The following table describes each field in the Departments/Physicians Definition window.

Tab. 3–10
Step Action
Enter a code for the department or physician (up to 10 alphanumeric characters) or select
1
a code from the drop down menu.
2 Enter a name for the department or physician (up to 80 alphanumeric characters).
3 Enter a fax number (up to 15 alphanumeric characters).
4 Select this option if the entry is not a physician or department.
◆ Departments and physicians are selected from drop down menus in the Report window - Panel
«Patient».
◆ If you are connected to an LIS, department or physicians names can be downloaded with the order
from the LIS.
◆ These department or physicians names are automatically assigned with an incremental
department/physicians code by the instrument. You may modify the department/physicians code
and enter extra information in the Departments/Physicians Definition window.

14 - ABX pentra ML - User Manual - RAB236DEN


Setup
Comments definition

5. Comments definition
5.1. Introduction
This option allows the user to pre-define technical comments or interpretations.

5.2. Comments definition window


To open the Comments Definition window, select the Settings menu, then select Soft Parameters,
then select Comments Definition.

5.3. Procedure
Enter abbreviations for the comments in the <Abbrev.> column. Enter technical comments or
interpretations in the <Name> column. Save before exiting the window.
The comment abbreviation can be used as a shortcut to enter one or more Sample or Patient
comments in the Comments window for a report.

ABX pentra ML - User Manual - RAB236DEN - 15


ABX pentra ML

6. Printer Setup
6.1. Introduction
The Printer submenu allows the user to set up the following report options:

Tab. 3–11
Options Function
Printer Configuration Change printer settings.
Enter header information for patient and quality control
Report Header
reports.

6.2. Printer configuration


The instrument printer is the default printer in the Windows XP print configuration program. The
printer configuration option allows the user to change printer settings without having to exit the
application.
To open the printer configuration window, select the Settings menu, then select System, then select
Printer, then select Printer Configuration.
The main item to check in the printer configuration window is paper size (generally Letter or A4).

6.3. Report header setting


To open the Report Header Setting window, select the Settings menu, then select System, then
select Printer, then select Report Header.

Follow the steps below to report header information.

Tab. 3–12
Step Action
Type the appropriate information in the five fields.
1 Note: The following reports have headers that contain only the first two header lines:
line (summary) report
2 Select <OK> to save and exit the window. Select <Cancel> to exit without saving.

16 - ABX pentra ML - User Manual - RAB236DEN


Setup
Format Codes

7. Format Codes
7.1. Introduction
Instrument parameters must have instrument codes defined for each instrument and LIS connected
to the ABX pentra ML, in order to send or receive programming or results. The format Codes window
is used to enter, modify or delete instrument codes.

Definition of Format Codes is an exceptional procedure which may place at


risk the performance of the instrument. HORIBA Medical does not recommend
to modify these definitions without approval of your HORIBA Medical
representative.

7.2. Format codes window


To open the Instrument Codes window, select the Settings menu, then select System, then select
Communication, then select Format Codes.

7.3. Definitions
Format: Type of interface (either instrument interface or LIS interface).
Codes: Codes used to transmit parameter information between the instrument and/or the LIS and
analyzer. These codes are also referred to as parameter codes or test codes.

7.4. Procedure
Follow the steps below to enter format codes.

Tab. 3–13
Step Action
1 Select a format type (type of interface) from the drop down menu.
Type a code for each parameter configured for the selected format.
2 Instrument: Refer to the specific instrument manual or LIS specification for a list of codes.
LIS: The code must be the same on instrument and the LIS.
3 Save before exiting or selecting another instrument or LIS to modify.

ABX pentra ML - User Manual - RAB236DEN - 17


ABX pentra ML

8. Rules

Any creation or modification of default rules is under the entire


responsability of the user ; these should be verified and validated prior to
their use.

8.1. Introduction
The rule is the standard mecanism to trigger a set of actions based on complex formulas.
3 types of rules are available:
◆ Parameter rules: These rules defines a parameter: See ”8.2. Parameter rules”, page 3-18
◆ Upload rules: Concern results of the Run. They are evaluated when the Run results are received.
See ”8.4. Upload rules”, page 3-19
◆ Download rules: Concern data transmission from the LIS. These rules are evaluated when the
order is received from the LIS. See ”8.3. Download rules”, page 3-19

The user should enable or disable the rules in each group. When they are disabled, they are displayed
between brackets in the settings menu.

The rules follow:


1- IF condition(s) THEN action(s)
2- IF condition(s) THEN action(s) ELSE action(s)

Depending of the type of rule, the condition can involve any parameter, normal limits, panic limits,
delta check, patient age or gender, physician or location, comments, etc...
The formula evaluated can include one or several conditions attached with the operators AND or OR.
After evaluation, the formula can trigger (or not) one or several actions (validation, comments,
messages,...)

8.2. Parameter rules


From the screen Parameter definition, select the parameter you want and press the button Rules
to get access to the definition and selection of individual rules for the corresponding parameter.

Parameter rules are used for calculated parameters (MCHC, MCH...) and units
only. Validation rules included in this set of rules concern also the calculated
parameters.

18 - ABX pentra ML - User Manual - RAB236DEN


Setup
Rules

From this screen, you can create new rules, modify existing rules or arrange the rules defined in the
right order.
The rules for a specific parameter are evaluated (one after the other, in definition order) once a
result is received for this specific parameter.
They can be used to do validation based on specific limits, add comments to the report or warn the
user of something abnormal by displaying messages.

8.3. Download rules


Select the menu Settings - Rules - Download Rules to have access to the following screen:

The download rules are evaluated once a new run is received from the LIS.
They can be used to add automatically new tests to a received run, delete some other tests, or warn
the user that something special is to review on that report.

8.4. Upload rules


8.4.1. Description
They can be used to do reflex rerun or add other instrument tests (reflex testing). The upload rules
are evaluated once a set of results is received from the instrument.
By default 9 groups of rules are set on ABX pentra ML and played chronologically (from the top to
the bottom). The user chooses to enable or disable each of them (disabled, they are displayed
between brackets)

When they are verified, the following actions will be triggered:


1- Pathologies: a comment on the suspected pathology is displayed

ABX pentra ML - User Manual - RAB236DEN - 19


ABX pentra ML

2- Sample ID (technical comment; reserved to HORIBA Medical use)


3- Rerun on Incorrect Sampling: Displays a «Reflex» comment
4- Rerun on Reject: Displays a «Rerun» comment
5- ReFlex: Displays a «Reflex» comment
6- Profiles: Checks comment of the 3, 4 and 5. Requests an analysis for parameters according to the
comment displayed in 3, 4 and/or 5.
7- Slides: Add comment «Slide---» if new profiles are required. Requests an analysis for a slide.
8- Download: sends previous request to the instrument which sent the result
9- Validation: According to parameter, this one will be validated automatically if Delta Check has
been successfull, if there is no alarm on matrix, if there is no reject (See ”8.4.3. Principle of the
automatic validation”, page 3-24)

8.4.2. Upload rules of the default setting


h and l are respectively the high and low normal limits (see 3. Pathological Limits, page 3-8)
H and L are respectively the High and Low panic Limits (see 3. Pathological Limits, page 3-8)

Tab. 3–14
Upload Rules
Rules name Conditions (Standard units) Comment or results
group
Large Immature CellsLIC# > LIC# h or LIC% > LIC% h Large Immature Cells
Atypical LymphocytesALY# > ALY# h or ALY% > ALY% h Atypical Lymphocytes
Pancytopenia WBC < WBC l and RBC < RBC l and PLT < PLT l Pancytopenia
Leucocytosis WBC> WBC h Leucocytosis
Leucopenia WBC < WBC l Leucopenia
Lymphocytosis LYM# > LYM# h or LYM% > LYM% h Lymphocytosis
Lymphopenia LYM# < LYM# l or LYM% < LYM% l Lymphopenia
Neutrophilia NEU > NEU h Neutrophilia
Neutropenia NEU < NEU l Neutropenia
Eosinophilia EOS# > EOS# h or EOS% > EOS% h Eosinophilia
Myelemia NEU% > NEU% h and LIC# > LIC# h Myelemia
Monocytosis MON# > MON# h or MON% > MON% h Monocytosis
Basophilia BAS# > BAS# h or BAS%> BAS% h Basophilia
BAS# > BAS# h and LIC# > LIC# h and «Rm»
Blasts Blasts
flag
Anemia HGB < HGB l and RBC > 0.1 Anemia
Microcytosis MCV < MCV l and RBC > 0.1 Microcytosis
Macrocytosis MCV > MCV h and RBC > 0.1 Macrocytosis
Erythrocytosis RBC > RBC h and RBC > 0.1 Erythrocytosis
Cold Agglutinins MCHC > MCHC H and WBC < 85 and RBC > 0.1 Cold Agglutinins
Thrombocytosis PLT > PLT h Thrombocytosis
Pathologies Thrombocytopenia PLT < PLT l Thrombocytopenia
Imm Reticulocytes IMR > IMR h Imm Reticulocytes
Reticulocytosis RET# > RET# h and RET% > RET% h Reticulocytosis
Reticulopenia RET# < RET# l and RET% < RET% l Reticulopenia
Hypochromia MCHC < MCHC l Hypochromia
(MCHC > MCHC h or MCHC < MCHC l)
Poikylocytosis Poikylocytosis
and RDW > RDW h
Blast 1 NEU# <1.2 Blast 1
Blast 2 «Ln» flag and «Atypical Lymphocytes» Blast 2
Immature Granulocyt IMG# > IMG# h Immature Granulocyt
Immature Monocytes IMM# > IMM# h Immature Monocytes
Immature
IML# > IML# h Immature Lymphocytes
Lymphocytes
ERB suspicion? ERB% > 0 and ERB% < 2.1 ERB suspicion?
Small Lymphocytes «Scw» flag Small Lymphocytes
PLT interference «Ptn» flag PLT interference
Nuclee cells H fluo «Imn» flag Nuclee cells H fluo
ERB interference «Bgn» flag ERB interference
Ne «Ne» flag Reflex DIF Ne
Reject analysis Reject «*» on ERB Reject analysis
ERB low count «Lon» flag ERB low count

20 - ABX pentra ML - User Manual - RAB236DEN


Setup
Rules

Tab. 3–14
Upload Rules
Rules name Conditions (Standard units) Comment or results
group
RBC Interpret 1 HGB < 13 and MCV < 80 and RDW > 20 Double population suspicion
IDA (Iron Deficiency Anemia) or
RBC Interpret 2 HGB < 13 and MCV < 80 and RDW < 20
Thalassemia suspicion
RBC Interpret 3 13 < HGB < 17 and MCV < 80 and RDW < 20 Thalassemia suspicion
Inflammatory Normocytic Anemia or
RBC Interpret 4 HGB <13 and 80< MCV < 100 and RDW < 20 ACD (Anemia Chronic Disease or Bleed
suspicion
RBC Interpret 5 HGB < 13 and 80< MCV < 100 and RDW > 20 Double Population Suspicion
13 < HGB < 17 and MCV < 80
RBC Interpret 6 and 32< MCHC < 36 and 0.2 < RET# < 1 and Thalassemia suspicion
RBC > 5.8 and RDW < 20
RBC Interpret 7 HGB < 13 and MCV > 100 and RET% > 2.5 Hemolytic Anemia Suspicion
Liver Disease or Alcohol Abuse or
Cytostatic Treatment or Hematology
RBC Interpret 8 HGB < 13 and MCV > 100 and RET% < 0.5
Disease or Megaloblastic Anemia
suspicion
Cold agglutinins or Spherocytosis
RBC Interpret 9 MCHC > 36
suspicion
RBC Interpret 9 bis MCHC > 36 and RET% > 2.5 Spherocytosis
HGB < 13 and RET% > 2.5 and PLT < 100 and Hemolytic Microangiopatic Anemia
RBC Interpret 10
MCV > 80 suspicion
Hemolytic Microangiopatic Anemia
RBC Interpret 10 bis HGB < 13 and RET% > 2.5 and «Sch» flag
suspicion
HGB < 13 and RET% > 2.5 and PLT < 100 and Thrombocytic Thrombocytopenic
RBC Interpret 10 ter
«Sch» flag Purpura suspicion
RBC Interpret 11 «Sch» flag Schistocytes suspicion
PLT Interpret 12 (PLT < 100 or PLT «*» reject ) and MCV < 75 Microcytosis interference suspicion
Pathologies PLT Interpret 13 130 < PLT < 400 and MPV > 11 MDS (Myelodysplasia) suspicion
(Interpretation ITP (Idiopathic Thrombocytopenia
rules see 8.5. PLT Interpret 14 PLT < 100 and MPV > 11 and MCV > 80
Purpura) or Chemotherapy suspicion
Evaluation on Chemotherapy or liver disease or
interpretation PLT < 100 and 6 < MPV < 11 and
PLT Interpret 15 infection or Hematological disease
Rules, page 3-25) 80 < MCV < 100
suspicion
Macroplatelets and/or Microcytic RBC
Intrepretation PLT Interpret 16 PLT «*» reject and («Mic» or «Sch» flag)
suspicion. Check PLT result
Rules*
PLT Interpret 17 MPV > 11 and no reject «*» on PLT Macroplatelets suspicion
Primary or secondary thrombocytosis
PLT Interpret 18 PLT > 600
suspicion
Bacterial infection or Surgery or
WBC Interpret 19 IMG% > 2 Hematological disease or others
suspicion
Bacterial infection or Surgery or
WBC Interpret 20 No «Nl» flag and «Mn» flag Hematological disease or others
suspicion
Dilute and rerun the sample. If flag is
WBC Interpret 21 «Nl» flag and no «Mn» flag confirmed, then hematological disease
suspicion
Bacterial infection or Surgery or
WBC Interpret 22 NEU# > 15 Hematological disease or others
suspicion
WBC Interpret 23 «Nl» flag and «Mn» flag MDS (Myelodysplasia) suspicion
Viral infection or Hematological disease
WBC Interpret 24 ALY% > 3 and AGE > 12 years
suspicion
WBC Interpret 25 IML% > 2 Hematological disease suspicion
WBC Interpret 26 IMM% > 2 Hematological disease suspicion
Intestinal Parasitemia or allergic
WBC Interpret 27 EOS# > 1.5 disease (asthma) or hematological
disease suspicion
LYM# > 4.5 and AGE > 12 years Lymphoproliferative disorder or viral
WBC Interpret 28
and IML% < 2 and ALY% < 2.5 infection suspicion
MON# > 1.5 and IMM% < 2 and no «Mn» flag
WBC Interpret 29 Hematological disorder suspicion
and ALY% < 2.5
Other instrument than ABX pentra DX 120 or
No_IML_IMM_IMG no parameter IML, IMM, IMG
ABX pentra DF 120
Sample Id SampleID (technical comment; reserved to HORIBA Medical use)
Rerun I.S. CBC Incorrect sampling in CBC mode Reflex CBC incorrect sampling
Rerun I.S. DIF Incorrect sampling in DIF mode Reflex DIF incorrect sampling
Rerun On Rerun I.S. RET Incorrect sampling in RET mode Reflex RET incorrect sampling
incorrect Rerun I.S. CBR Incorrect sampling in CBR mode Reflex CBR incorrect sampling
Sampling Rerun I.S. DIR Incorrect sampling in DIR mode Reflex DIR incorrect sampling
Rerun I.S. ERB Incorrect sampling in ERB mode Reflex ERB incorrect sampling
Rerun I.S. CBE Incorrect sampling in CBE mode Reflex CBE incorrect sampling

ABX pentra ML - User Manual - RAB236DEN - 21


ABX pentra ML

Tab. 3–14
Upload Rules
Rules name Conditions (Standard units) Comment or results
group
Rerun CBC Rej. WBC Reject «*» on WBC in CBC mode Reflex CBC Reject WBC
Rerun CBC Rej. RBC Reject «*» on RBC in CBC mode Reflex CBC Reject RBC
Rerun CBC Rej. HGB Reject «*» on HGB in CBC mode Reflex CBC Reject HGB
Rerun CBC Rej. HCT Reject «*» on HCT in CBC mode Reflex CBC Reject HCT
Rerun CBC Rej. PLT Reject «*» on PLT in CBC mode Reflex CBC Reject PLT
Rerun CBC Rej. PDW Reject «*» on PDW in CBC mode Reflex CBC Reject PDW
Rerun DIF Rej. WBC Reject «*» on WBC in DIF mode Reflex DIF Reject WBC
Rerun DIF Rej. RBC Reject «*» on RBC in DIF mode Reflex DIF Reject RBC
Rerun DIF Rej. HGB Reject «*» on HGB in DIF mode Reflex DIF Reject HGB
Rerun DIF Rej. HCT Reject «*» on HCT in DIF mode Reflex DIF Reject HCT
Rerun DIF Rej. PLT Reject «*» on PLT in DIF mode Reflex DIF Reject PLT
Rerun DIF Rej. PDW Reject «*» on PDW in DIF mode Reflex DIF Reject PDW
Rerun RET Rej. RBC Reject «*» on RBC in RET mode Reflex RET Reject RBC
Rerun RET Rej. RET% Reject «*» on RET% in RET mode Reflex RET Reject RET%
Rerun CBR Rej. WBC Reject «*» on WBC in CBR mode Reflex CBR Reject WBC
Rerun CBR Rej. RBC Reject «*» on RBC in CBR mode Reflex CBR Reject RBC
Rerun CBR Rej. HGB Reject «*» on HGB in CBR mode Reflex CBR Reject HGB
Rerun CBR Rej. HCT Reject «*» on HCT in CBR mode Reflex CBR Reject HCT
Rerun on
Rerun CBR Rej. PLT Reject «*» on PLT in CBR mode Reflex CBR Reject PLT
Reject
Rerun CBR Rej. PDW Reject «*» on PDW in CBR mode Reflex CBR Reject PDW
Rerun CBR Rej. RET% Reject «*» on RET% in CBR mode Reflex CBR Reject RET%
Rerun DIR Rej. WBC Reject «*» on WBC in DIR mode Reflex DIR Reject WBC
Rerun DIR Rej. RBC Reject «*» on RBC in DIR mode Reflex DIR Reject RBC
Rerun DIR Rej. HGB Reject «*» on HGB in DIR mode Reflex DIR Reject HGB
Rerun DIR Rej. HCT Reject «*» on HCT in DIR mode Reflex DIR Reject HCT
Rerun DIR Rej. PLT Reject «*» on PLT in DIR mode Reflex DIR Reject PLT
Rerun DIR Rej. PDW Reject «*» on PDW in DIR mode Reflex DIR Reject PDW
Rerun DIR Rej. RET% Reject «*» on RET% in DIR mode Reflex DIR Reject RET%
Rerun ERB Rej. WBC Reject «*» on WBC in ERB mode Reflex ERB Reject WBC
Rerun ERB Rej. ERB% Reject «*» on ERB% in ERB mode Reflex ERB Reject ERB%
Rerun CBE Rej. WBC Reject «*» on WBC in CBE mode Reflex CBE Reject WBC
Rerun CBE Rej. RBC Reject «*» on RBC in CBE mode Reflex CBE Reject RBC
Rerun CBE Rej. HGB Reject «*» on HGB in CBE mode Reflex CBE Reject HGB
Rerun CBE Rej. HCT Reject «*» on HCT in CBE mode Reflex CBE Reject HCT
Rerun CBE Rej. PLT Reject «*» on PLT in CBE mode Reflex CBE Reject PLT
Rerun CBE Rej. PDW Reject «*» on PDW in CBE mode Reflex CBE Reject PDW
Rerun CBE Rej. ERB% Reject «*» on ERB% in CBE mode Reflex CBE Reject ERB%
ERB analysis has not been requested yet
Reflex ERB «NRBC» flag or RBC > RBC H Reflex ERB
and PDW, PLT, MPV are within normal ranges
RET analysis has not been requested yet
Reflex Reflex RET and HGB < HGB l (DeltaCheck not verified or Reflex RET
no anteriority) and RBC > 0.1
DIF analysis has not been requested yet
Reflex DIF and WBC > WBC h (DeltaCheck not verified or Reflex DIF
no anteriority)

22 - ABX pentra ML - User Manual - RAB236DEN


Setup
Rules

Tab. 3–14
Upload Rules
Rules name Conditions (Standard units) Comment or results
group
SPS LIC LIC# > LIC# h and no SLIDE has been done Reflex SPS LIC ; SLIDE is requested
SPS ALY ALY# > ALY# h and no SLIDE has been done Reflex SPS ALY ; SLIDE is requested
SPS IMM IMM# > IMM# h and no SLIDE has been done Reflex SPS IMM ; SLIDE is requested
SPS IMG IMG# > IMG# h and no SLIDE has been done Reflex SPS IMG ; SLIDE is requested
SPS IML IML# > IML# h and no SLIDE has been done Reflex SPS IML ; SLIDE is requested
Reflex SPS Blast Susp'n ; SLIDE is
SPS Blast Susp’n «Blasts» alarm
requested
«Platelet Aggregates» flag and no SLIDE has Reflex SPS PLT agg 1 ; SLIDE is
SPS PLT agg 1
Profiles been done requested
PLT < PLT l and (PDW > PDW h or MPV > MPV Reflex SPS PLT agg 2 ; SLIDE is
SPS PLT agg 2
h) and no SLIDE has been done requested
«Macro Platelets» flag and no SLIDE has Reflex SPS PLT abn morph ; SLIDE is
SPS PLT abn morph
been done requested
«Microcytes ++» flag or «Macrocytes ++» and Reflex SPS RBC ab morph1 ; SLIDE is
SPS RBC ab morph1
no SLIDE has been done requested
«Anisocytosis ++» and no SLIDE has been Reflex SPS RBC ab morph2 ; SLIDE is
SPS RBC ab morph2
done requested
AUTOCOMMENT Contains «Reflex CBC» or
AUTOCOMMENT Contains «Reflex DIF» or
CBC AUTOCOMMENT Contains «Reflex CBR» or a CBC analysis is requested
AUTOCOMMENT Contains «Reflex DIR» or
AUTOCOMMENT Contains «Reflex CBE»
AUTOCOMMENT Contains «Reflex DIF» or
DIF a DIF analysis is requested
AUTOCOMMENT Contains «Reflex DIR»
Slides AUTOCOMMENT Contains «Reflex DIF» or
EXT DIF AUTOCOMMENT Contains «Reflex DIR» and a DIF analysis is requested
Instrument = «PDX» or «PDF»
AUTOCOMMENT Contains «Reflex RET» or
RET AUTOCOMMENT Contains «Reflex CBR»or a RET analysis is requested
AUTOCOMMENT Contains «Reflex DIR»
AUTOCOMMENT Contains «Reflex ERB» or
ERB a ERB analysis is requested
AUTOCOMMENT Contains «Reflex CBE»
Download Download AUTOCOMMENT Contains «Reflex» «DOWNLOAD ; STOP»
Valid_WBC
Valid_NEU%
Valid_LYM%
Valid_MON%
Valid_EOS%
Valid_BAS%
Valid_RBC
Valid_HGB
Valid_HCT
Valid_RDW
Valid_PLT
Valid_PCT
Valid_RET%
Validation Valid_PDW See 8.4.3. Principle of the automatic validation, page 3-24
Valid_ALY%
Valid_IML%
Valid_IMM%
Valid_IMG%
Valid_RETH%
Valid_RETM%
Valid_RETL%
Valid_MFI
Valid_CRC
Valid_RET_IMM
Valid_MRV
Valid_PIC
Valid_IRF

Intrepretation Rules* : these rules are disabled by default on the workstation.

Rules that does not concern common profiles performed on the instrument
must be disabled to prevent from slowing down the workstation process. For
example, if CBR analysis is never performed on instrument, it is important to
disable all the «CBR rerun» rules...

ABX pentra ML - User Manual - RAB236DEN - 23


ABX pentra ML

As Parameter Rules and Download Rules, from this screen you can define new rules, modify rules
delete and reorder them.
Select the menu Settings - Rules - Upload Rules to access to the following screen:

Pathologies

8.4.3. Principle of the automatic validation

Example for PLT :


Default Rule is
((DeltaCheck_else_Norm(PLT)) AND (SUSPECT = NULL) AND (NOT (PLT.Flag Contains '!')) AND (NOT
(PLT.Flag Contains '*')) AND (PLT.Value > 1.000 * 60) AND (DeltaCheck_else_Norm(MPV))) OR
(IsManual(PLT))

In this case the automatic validation occurs if:


◆ «Delta check and Normal ranges» rule on PLT parameter is verified (See ” «Delta
Check_else_Norm(PLT)» rule principle”, page 3-24)
◆ There is no alarm on PLT histogram
◆ There is no suspicion on PLT parameter
◆ There is no reject on PLT parameter
◆ The PLT value is > 60 103/mm3
◆ « Delta check and Normal ranges» rule on PDW parameter is verified
◆ The PLT value has been manually entered.

«Delta Check_else_Norm(PLT)» rule principle


Delta Check evaluation has the priority on Pathology Limits:
◆ If Delta check rule is:
((ABS(R1-R2)<10)
R1 is the last archived result for the patient and concerned parameter
R2 is the result of the day
If Normal ranges for PLT are as follows: 150 - 500 103/mm3

Tab. 3–15
ABS value Normal Ranges Automatic
Platelet results DeltaCheck
(R1-R2) for R2 validation
R1= 350 R2= 410 60 yes No False
R1= 120 R2= 130 10 No Yes True

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Setup
Rules

Tab. 3–15
ABS value Normal Ranges Automatic
Platelet results DeltaCheck
(R1-R2) for R2 validation
R1= 140 R2= 190 50 No No False
R1= no value
R2= 150 - Yes No False
or out of date

8.5. Evaluation on interpretation Rules


Results Interpretation Rules on the ABX pentra DX 120 Hematology Analyser
A.H. Roderick – Department of Haematology, University Hospital of Wales, Cardiff. UK
J.M. Jou – Servei d’Hemoterapia, Hospital Clinic, Barcelona. Spain
R. Ayala - Servicio de Hematología, Hospital Universitario, Madrid. Spain

presentation ISLH 2007, Miami


ref : Evaluations ABX Pentra DX 120, book Horiba ABX publish nov2007, ref HAN 710 AEN.

Tab. 3–16 : RBC population


N of Sam- False False True True
Rules Comment
ples Tested Positives Negatives Positives Negatives
1 Double population suspicion 1557 3 0 42 1512
0,19% 0,00% 2,70% 97,11%
2 IDA or Thalassemia suspicion 1657 0 2 39 1616
0,00% 0,12% 2,35% 97,53%
3 Thalassemia suspicion 1657 2 0 30 1625
0,12% 0,00% 1,81% 98,07%
Inflammatory Normocytic Anemia or
4 ACD (Anemia Chronic Disease) or 1657 5 10 388 1254
Bleed
0,30% 0,60% 23,42% 75,68%
5 Double Population Suspicion 1557 0 0 12 1545
0,00% 0,00% 0,77% 99,23%
6 Thalassemia 452 0 0 2 450
0,00% 0,00% 0,44% 99,56%
6 bis Thalassemia 452 0 0 2 450
0,00% 0,00% 0,44% 99,56%
7 Hemolytic Anemia Suspicion 558 1 1 11 545
0,18% 0,18% 1,97% 97,67%
Liver Disease or Alcohol Abuse or
8 Cytostatic Treatment or Hematology 475 1 9 29 436
Disease or Megaloblastic Anemia
0,21% 1,89% 6,11% 91,79%
9 Cold agglutinins or Spherocytosis 1657 0 0 14 1643
0,00% 0,00% 0,84% 99,16%
9 bis Spherocytosis 451 0 0 1 450
0,00% 0,00% 0,22% 99,78%
10 Hemolytic Microangiopatic Anemia 561 9 1 3 548
1,60% 0,18% 0,53% 97,68%
11 Schistocytes ? 2110 2 0 22 2086
0,00% 0,00% 2,69% 97,31%
0,09% 0,09% 6,72% 93,09%

Tab. 3–17 : Platelet population


N of Sam- False False True True
Rules Comment
ples Tested Positives Negatives Positives Negatives
12 Microcytosis interference 1557 2 0 10 1545
0,13% 0,00% 0,64% 99,23%
13 MDS 557 1 0 2 554
0,18% 0,00% 0,36% 99,46%
14 ITP or Chemotherapy 1557 1 0 5 1551
0,06% 0,00% 0,32% 99,61%
Chemotherapy or liver disease or
15 infection or Hematological disease or 1557 21 1 87 1448
surgery (mainly cardiac surgery)
1,35% 0,06% 5,59% 93,00%
Macroplatelets and/or Microcytic RBC.
16 557 0 0 15 542
Check PLT result.
0,00% 0,00% 2,69% 97,31%

ABX pentra ML - User Manual - RAB236DEN - 25


ABX pentra ML

Tab. 3–17 : Platelet population


N of Sam- False False True True
Rules Comment
ples Tested Positives Negatives Positives Negatives
17 Macroplatelets 1557 1 0 11 1545
0,06% 0,00% 0,71% 99,23%
18 Primary or secondary thrombocytosis 1557 0 0 38 1519
0,00% 0,00% 2,44% 97,56%

Tab. 3–18 : WBC Population


N of Sam- False False True True
Rules Comment
ples Tested Positives Negatives Positives Negatives
Bacterial infection or Surgery or
19 1057 1 0 48 1008
Hematological disease or others
0,09% 0,00% 4,54% 95,36%
Bacterial infection or Surgery or
20 1057 6 0 27 1024
Hematological disease or others
0,57% 0,00% 2,55% 96,88%
Rerun the sample (and dilute). If flag
21 is confirmed, then hematological 1057 11 0 24 1022
disease
1,04% 0,00% 2,27% 96,69%
Bacterial infection or Surgery or
22 1057 1 1 71 984
Hematological disease or others
0,09% 0,09% 6,72% 93,09%
23 MDS 1057 2 0 3 1052
0,19% 0,00% 0,28% 99,53%

8.6. Creating a new Rule

Definition of a «new rule» is an exceptional procedure which may place at


risk the performance of the instrument. Please contact your HORIBA Medical
representative before attempting to define a rule.

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Setup
Users Setting

9. Users Setting
9.1. Introduction
Different levels of access (validation, configuration, patient records deletion, etc...) can be defined
for different individual users.

All the access allowed are under the reponsability of the user, except for the
«administrator» level, that remains under HORIBA Medical responsability.

9.2. Users Setting Window


The Users Setting window is used to define, modify, and delete users and user privileges.
To open the Users Settings window, select the Settings menu, then select Users, then select Access
Rights.

To edit a user, select that user in the Users field.

9.3. Define a new user


Select <New> to define a new user. In the window that opens, enter the SYSADM password, a user
name, a new password (up to 25 alphanumeric characters), and confirm the new password. Select
<OK> to save and exit. Select <Cancel> to exit without saving.

9.4. Delete a user


Select <Delete> to delete the selected user.

9.5. Change a user password


Select <Password> to change the password of the selected user. In the window that opens, enter
the SYSADM password, the new password (up to 25 alphanumeric characters), and confirm the new
password. Select <OK> to save and exit. Select <Cancel> to exit without saving.

9.6. Assign user privileges


The Access Allowed and Access Denied lists are used to assign user privileges for the selected user.
To move an access privilege from one list to another, click the item.

A user with Administrator privileges can define and edit users and access
rights, delete current reports from the Settings - Database menu and delete
all archived report from the Settings menu.

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ABX pentra ML

9.7. Save
Select <Save> to save the current settings.

9.8. End
Select <End> to exit the Users window. Be sure to save before exiting.

9.9. Password
Introduction
This option allows users to change their password.

Password Window
To open the password window, select the Settings menu, then select Users, then select Password.

Procedure
Follow the steps below to change a password.

Tab. 3–19
Step Action
1 Enter your current password in the Current Password field.
Enter your new password (up to 25 alphanumeric characters) in the first New Password
2
field.
3 Retype your new password in the second New Password field for confirmation.
4 Select <OK> to save and exit the window. Select <Cancel> to cancel and exit the window.

Passwords are case sensitive.

9.10. Database maintenance functions


Introduction
The following database maintenance functions are available in the Settings, Database menu.

Tab. 3–20
Menu Option Function
Delete Orders/Reports Delete current (non-archived) patient orders and reports.
Delete All Archives Delete all reports from the archive database.
Delete Patients with No
Delete patient demographics with no results.
Records
Statistics Provides statistics on current and archived reports.

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Setup
Users Setting

Delete Orders/Reports
◆ Follow the steps below to delete current orders / reports from the Settings - Database menu.

Tab. 3–21
Step Action
Select the Settings menu, then select Database, then select Delete Orders/Reports.
This will open the Delete Orders/Reports window.

Select one of the following options in the Delete Current Orders/Reports window.

Select... to delete...
All all current reports.
current order and/or reports with Unknown as the
patient name (the Unknown patient name is
2 Unknown orders/reports
automatically assigned when no patient demographics
were entered).
Complete reports current reports with a status of complete.
Pending orders all current orders that are pending.
Incomplete reports all current reports that are incomplete.

Enter beginning and ending dates into date field to delete reports in that date range. To
3
delete all selected reports, leave the date fields empty.
4 Select <OK> to continue. Select <Cancel> to cancel the deletion and exit the window.
If you selected <OK> in Step 4, a message window will open. Select <Yes> to delete the
5
selected reports. Select <No> to cancel the deletion.

This action is irreversible. The patient orders / reports selected for deletion
cannot be recovered.

Delete All Archives


To delete all results from the archive database (patient demographics are not deleted), select the
Settings menu, then select Database, then select Delete all Archives. This will open a message
window. Select <Yes> to initiate the deletion. Select <No> to cancel the deletion.

Patient demographics are not deleted by this procedure.

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ABX pentra ML

This action is irreversible. The deleted archived patient reports cannot be


recovered.

Delete Patients With No Records


To delete patient demographics with no results from the archive database, select the Settings menu,
then select Database, then select Delete Patients With No Records. This will open a message
window. Select <Yes> to initiate the deletion. Select <No> to cancel the deletion.

This action is irreversible. The deleted patient demographics cannot be


recovered.

9.11. Statistics
Introduction
This option calculates database statistics (number of reports, number of samples, etc.) for current
reports and anteriorities.

Procedure
◆ To calculate database statistics, select the Settings menu, then select Database, then select
Statistics. This will open a message window. Select <Yes> to initiate the statistics calculation.
Select <No> to cancel.
◆ If you selected <Yes>, the instrument will calculate the statistics and display them in the
Database Statistics window.

◆ Select <OK> to exit the window.

9.12. Print settings


Introduction
This option allows the user to print out the complete settings of the system. This printout contains
the following information:
◆ connected instrument
◆ connected LIS
◆ modules
◆ software configuration
◆ pentra.ini

30 - ABX pentra ML - User Manual - RAB236DEN


Setup
Users Setting

Procedure
◆ To print the instrument setup, select the Settings menu, then select Print, then select Print
Settings. The following window will appear:

Select <Yes> to initiate the print. Select <No> to cancel the print.

9.13. Print parameters/rules


Introduction
◆ This option allows the user to print out reports of the settings.

Tab. 3–22
Report Description
This report prints one parameter per page, and includes all parameter values,
Parameters
including formulas and limits.
This report prints a list of parameters, including parameter code, unit,
Reduce Param.
precision, and panic limits.
Instrument Codes This report prints a list of instrument codes defined for each format.
This report prints all the rules defined for each parameters in addition of
Rules
Upload Rules and Download Rules.

Print parameters/Rules window


◆ To open the Print Parameters/Rules window, select the Settings menu, then select Print, then
select Print Parameters/Rules.

Procedure
◆ Follow the steps below to print a configuration report.

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ABX pentra ML

Tab. 3–23
Step Action
1 Select a report to print from the list on the upper right side of the window.
Select one or more parameters from the list on the left hand side of the window, or click
2
<Select all>.
3 Select <OK> to initiate the print. Select <Cancel> to cancel the print.

9.14. Save settings


Introduction
This option allows the user to save their current settings. The following settings and definitions are
saved by this procedure:
◆ Parameter
◆ Departments/physicians
◆ Comments
◆ Units
◆ Instrument setting
◆ LIS setting
◆ Users setup
◆ Download rules
◆ Upload rules
◆ The following settings are not saved:
◆ General setup

Procedure
◆ Follow the steps below to save the current settings.
.

Tab. 3–24
Step Action
To open the Save As window, select the Settings menu, then select Save.

Enter a file name for the settings in the <File name> field. The default file name is the
2
current date (YYYYMMDD). The file extension is always .DIC.
The default directory is the C:\pentra directory, but you can save the file in a different drive
3
or directory by using the <Save In> drop down menu.
4 Select <Save> to save the settings. Select <Cancel> to cancel the save and exit the window.

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Setup
Users Setting

9.15. Restore settings


Introduction
◆ This option allows the user to load a saved settings. Refer to the previous section for a list of
configuration settings that were saved.

Procedure
◆ Follow the steps below to load a saved settings.

Tab. 3–25
Step Action
Select the Settings menu, then select Restore.
1
Select <Yes> to continue. Select <No> to cancel the load and exit the window.
If you selected <Yes> the Open window will open.

In the Open window, select a settings file to load. If the settings file is not in the default
3 drive or directory, you can search in other drives or directories by using the <Look In> drop
down menu.
Select <Open> to load the selected settings file. Select <Cancel> to cancel the load and
4
exit the window.

Current settings will be overwritten by this procedure. It is recommended


that current settings be saved before loading a saved settings file.

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ABX pentra ML

10. Lock the ABX pentra ML


◆ In order to avoid usage of the validation console while you are not in front of it, you can lock the
ABX pentra ML by using the menu «Lock Station».
◆ The connection window will be displayed.
◆ To unlock the ABX pentra ML, you may enter your own password, or type in a new user name/
password.

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EQC

Contents
1. Introduction .......................................................................................................4-3

2. Software overview..............................................................................................4-4
2.1. Launching EQC application ........................................................................4-4
2.2. Main EQC window .....................................................................................4-4
2.3. Software tree...............................................................................................4-4

3. Control Run........................................................................................................4-6
3.1. Loading a control lot...................................................................................4-6
3.1.1. Creating and activating a lot ...............................................................4-6
3.1.2. Loading a lot by floppy.......................................................................4-6
3.1.3. Manual loading ..................................................................................4-7
3.2. Control running ..........................................................................................4-9
3.2.1. On instruments...................................................................................4-9
3.2.2. On ABX pentra ML .............................................................................4-9
3.2.3. Control Runs to be reviewed ............................................................4-10

4. Managing control materials..............................................................................4-11


4.1. Control .....................................................................................................4-11
4.1.1. Definition .........................................................................................4-11
4.1.2. Creating a control.............................................................................4-11
4.1.3. Duplicate a lot..................................................................................4-12
4.1.4. Lots activated on the system .............................................................4-12
4.2. Control Protocols......................................................................................4-12
4.2.1. Default protocols set on EQC application .........................................4-12
4.2.2. Creating a control protocol...............................................................4-14
4.2.3. Protocol types...................................................................................4-14
4.2.4. Learning mode .................................................................................4-16
4.2.5. Managing User Defined charts .........................................................4-16
4.2.6. Duplicating control protocols ...........................................................4-17
4.2.7. Compacting periods .........................................................................4-17
4.2.8. Managing periods.............................................................................4-17
4.3. Collection of data .....................................................................................4-17

5. Managing patient data......................................................................................4-18


5.1. Creating a control protocol .......................................................................4-18
5.2. Methods available ....................................................................................4-19
5.3. Learning mode..........................................................................................4-19
5.4. Managing User Defined charts..................................................................4-19
5.5. Duplicating control protocols ...................................................................4-19
5.6. Managing periods .....................................................................................4-19

6. Common options..............................................................................................4-20
6.1. Reviewing statistics by Period ...................................................................4-20
6.2. Reviewing Results by Parameter ..............................................................4-20
6.3. Reviewing Results by Run.........................................................................4-22
6.3.1. Main screen......................................................................................4-22
6.3.2. Printing setup ...................................................................................4-23
6.3.3. Printout report ..................................................................................4-25
6.4. Charts .......................................................................................................4-26
6.5. User Defined charts ..................................................................................4-27
6.6. Last collected results.................................................................................4-28

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ABX pentra ML

6.7. Reviewing date to date statistics ...............................................................4-28


6.8. Reports .....................................................................................................4-29
6.9. Validation Blocked ................................................................................... 4-29

7. Advanced options ............................................................................................4-30


7.1. Creating User Defined charts.................................................................... 4-30
7.2. Database menu ........................................................................................4-30
7.2.1. Backup / Restore QC data ................................................................ 4-30
7.2.2. Database Statistics............................................................................4-31
7.2.3. Delete all data..................................................................................4-32
7.3. EQC setup ................................................................................................ 4-32
7.4. Access rights and permissions................................................................... 4-32
7.5. Parameters configuration .......................................................................... 4-32
7.6. Lock the EQC software ............................................................................. 4-32
7.7. Exit the EQC software ...............................................................................4-33

8. Quality Control Program (QCP)....................................................................... 4-34


8.1. Overview ................................................................................................. 4-34
8.2. «QCP export» function description...........................................................4-34
8.2.1. Procedure to export QC results......................................................... 4-34
8.2.2. History of exportation....................................................................... 4-36
8.2.3. «QCP export» setting........................................................................4-36

9. Appendix.......................................................................................................... 4-38
9.1. Ranges rules ............................................................................................. 4-38
9.1.1. Definition.........................................................................................4-38
9.1.2. Learning mode ................................................................................. 4-38
9.2. Xb ............................................................................................................4-38
9.2.1. Definition.........................................................................................4-38
9.2.2. Implementation of Xb in EQC...........................................................4-39

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EQC

EQC

1. Introduction
2 EQC softwares are available: EQC Standard and EQC Extended*.

The EQC Standard software provides the following functionalities:

◆ Manages control materials with the following rules:


Rules based on ranges (out ranges, warning ranges, error ranges)
Manage lots of control bloods

◆ Manages «patient based qc» (statistics on patient results) with the following rules:
Xb

◆ Different types of graphics:


Levey jenning
Shewart
Distribution charts
Possibility to overlay graphics for an easy comparison
Detailed statistics by period (day, week, month or manually selected)

◆ Interacts with the instrument software with the following actions selectable (based on abnormal
results):
Display specific + predefined errors
Display specific + predefined warning
Accept data from the instrument

◆ The EQC Extended software provides following further functionalities:


Result validation blocking
Multi-instruments Quality control
Extended multi-levels control blood management

*EQC Extended is optional, contact your HORIBA Medical representative.

ABX pentra ML - User Manual - RAB236DEN - 3


ABX pentra ML

2. Software overview
2.1. Launching EQC application
From ABX pentra ML application, open EQC module clicking the icon (or from
Settings\Quality Control\Switch to EQC)

2.2. Main EQC window


The main EQC window presents the following toolbar:

1 2 3 4 5 6 7 8

1- Open «Control runs to be reviewed» window (3.2.3. Control Runs to be reviewed, page 4-10)
- If results are out ranges, the key is red. Control Runs need to be reviewed.
- If all results are within ranges, the key is green
2- Open the «Lots» window (3.1. Loading a control lot, page 4-6)
3- Open «Results by Run» window (6.3. Reviewing Results by Run, page 4-22)
4- Open the «Statistics by Period» window (6.1. Reviewing statistics by Period, page 4-20)
5- Open the graph view: «User Defined Charts» (6.5. User Defined charts, page 4-27)
6- Allows to zoom in the results charts (active only when 7 has been selected previously)
7- Save current result charts (Levey jenning, Shewart, Distribution) in a pdf file format.
8- Allows to switch to ABX Pentra ML application.

2.3. Software tree


◆ File ....... ......... QCP Export ...... ......... 8. Quality Control Program (QCP), page 4-34
.......... ......... Print (see above)
.......... ......... Event Log
.......... ......... Lock Station
.......... ......... Exit

◆ Setup .... ......... Control Definition ...... 4.1. Control, page 4-11
.......... ......... Lots definition. ......... 3.1. Loading a control lot, page 4-6
.......... ......... Control Protocols ....... 4.2. Control Protocols, page 4-12
.......... ......... New Period for all protocols
.......... ......... User Chart definition . 7.1. Creating User Defined charts, page 4-30

◆ Results .. ......... Results by run . ......... 6.3. Reviewing Results by Run, page 4-22
.......... ......... Last collected results.. 6.6. Last collected results, page 4-28
.......... ......... Manual collect
.......... ......... Last Control Run Result (Not available)
.......... ......... User defined chart ..... 6.5. User Defined charts, page 4-27
.......... ......... Statistics by period .... 6.1. Reviewing statistics by Period, page 4-20
.......... ......... Date to date Statistics 6.7. Reviewing date to date statistics, page 4-28
.......... ......... Report............. ......... 6.8. Reports, page 4-29
.......... ......... Blocked parameters

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EQC
Software overview

◆ Database ..........Backup QC Data and config


.......... ..........Backup QC config only
.......... ..........Restore QC data and config
.......... ..........Delete all data
.......... ..........Database Statistics

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ABX pentra ML

3. Control Run
3.1. Loading a control lot
Open the list of available control lots by clicking the following key or menu: Setup\Lots
Definition (shortcut: CTRL+T)

All the controls used on ABX pentra ML connected instruments are displayed in this window (active
lots and/or expirated ones).
They are classified according to control type (Minotrol, Difftrol, Minotrol Retic, Erytrol), analyzer
range (ABX pentra DX 120, ABX pentra DF 120, ABX pentra XL 80, ABX pentra 80, ABX pentra 60C+,
ABX pentra 60) and levels (1, 2, 3).

3.1.1. Creating and activating a lot


In order to load new number, select the appropriate lot by double clicking the corresponding line:
then the «Control Lot setup» window is opened (See 3.1.3. Manual loading, page 7).

3.1.2. Loading a lot by floppy

The loading of target values with floppy is available only with Difftrol,
Minotrol Retic and Erytrol.

◆ Insert the corresponding blood control floppy into the floppy drive of the ABX pentra ML.
◆ Click the button "Floppy" to open the browser
◆ With the following screen, search (on the floppy drive A:) and open the file containing lot
information (file named QCTGETXX.CSV).

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EQC
Control Run

◆ Once selected, the EQC review the type of file, display it and ask you for the system unit in use
(values on the floppy are usually in Standard System unit). Once accepted, the conversion will
apply to target and tolerances.
◆ Using EQC Standard you must select the control level you are registering: Low, Normal or High

◆ Using EQC Extended all control levels are loaded at the same time: Low, Normal and High.

3.1.3. Manual loading


From the «Control lot setup» (access: «Setup\Lots» then double click on a lot) window:

For ABX Minotrol and for instrument other than ABX pentra DX/DF, target
values must be loaded manually.

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ABX pentra ML

◆ Modify the target values for each parameter by the values given with the blood control.
◆ Modify the standard deviation (SD) for each parameter as follows:
SD = Control parameter tolerances / 3

◆ Modify the value of High/Low limit warning as follows:


High limit warning = Target values + (2/3 x tolerances)
Low limit warning = Target values - (2/3 x tolerances)

◆ Change the value of High/Low limit error as follows:


High Limit error = Target values + tolerances
Low limit error = Target values - tolerances
Those values are used to set statistic values, to trigger QC error messages and set control graphics.
◆ Enter the lot number, Sample ID (which will identify the control tube) and Lot# for each level
(Example for Difftrol lot number PX037 level N it must be PX037N)
◆ Modify the reception and expiration dates
◆ If this new lot has to be used immediately, select the «Activate This Lot» button; only one
activated lot should exist for each of the control created. Automatically, all control protocols that
use this lot will be impacted (and a new period of data will be created).

EQC Extended (optional) will display the 3 Levels in the same control lot
setup window, click over the tabs to select between Control blood
- Level 1: Low level
- Level 2: Normal level
- Level 3: High level

◆ Once all the information is correct, select the «Save» button.

Compute ranges
◆ The low and high warning and error ranges can be computed automatically by using the option
«Compute ranges».

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Control Run

3.2. Control running


3.2.1. On instruments
◆ Refer to instrument’s User manual to perform the loading and identification of the control.
◆ Refer to instrument’s User manual to run the control blood.

3.2.2. On ABX pentra ML


Once the Control blood samples have been run on the instrument, results are sent automatically to
the ABX pentra ML:

◆ If at least the result of one parameter is out of its ranges, a message box is displayed on the ABX
pentra ML advising of the problem regarding the control. All following control would be blocked
until an action is taken on the defective control. From this box it is possible to access directly to
EQC application:

◆ Press «Open rejected list» (see See “3.2.3.Control Runs to be reviewed, page 10”)

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3.2.3. Control Runs to be reviewed


◆ You can access this window by clicking the following key

All the quality control results blocked are displayed in this list.
Red Lines shows parameters which are out of the ranges.
Pink lines shows parameter which the result is within the ranges but belongs to a tube where some
parameters are out of the ranges.

By selecting a red line different options will be available on the bottom of the window:
◆ Accept Run: This force the selected Run to be accepted. The results is taken into account in the
calculation of statistics and will appear in the graphs
◆ Reject Run: This will reject the selected Run
◆ Add comment: Select this option to add a comment to the selected Run:

◆ Once the comment has been entered, select between «Accept Run» or «Reject Run»

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Managing control materials

4. Managing control materials


To proceed with the analyze of control material define the following:
◆ 4.1. Control, page 4-11: definition of the control material (name, manufacturer, number of levels,
and parameters)
◆ 3.1. Loading a control lot, page 4-6: identification of a new material used to run control series.
◆ 4.2. Control Protocols, page 4-12: method applied to the control results

Controls that are usable on the instrument are all preconfigured, as well as
the protocols. it is just necessary to register the lot to be used.

4.1. Control
4.1.1. Definition
The Control (accessed by the menu Setup\Control Definition) represents the definition of the
control material you will use to verify your instrument.

4.1.2. Creating a control


It is needed to fill, at least, the following information: Control Name, manufacturer, and a list of
parameters that can be evaluated with the considered control material.

«Add Level» button is not active due to limitation of the EQC used with the
system (controls are all single levels).

For each of these levels add more information: Number of decimals to keep, SampleId and instrument
code that will be used when you run the tubes on the instrument. The Following screen gives you
all the details of the control definition.

Once the control has been defined, you can Save it, and then Create the Lot which corresponds to
the package received. You can also Duplicate that control if there is one similar to setup (another
level for example).

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4.1.3. Duplicate a lot


◆ You can duplicate a lot in order to create a new lot. In this case, all values of the initial lot are
copied in the new lot (except the lot number).
◆ To duplicate a lot, use the Duplicate button in the Control Lot Setup window.

4.1.4. Lots activated on the system


◆ You can access a list of all defined controls by selecting the menu Setup\Lots Definition:

◆ This list gives you a summary of all lots defined on your system (You can Show active lots only if
the list is too long). To view details or modify the lot, select it and use the Open Lot button (or
double click).
◆ You can also Print one or more lots that you have selected.

4.2. Control Protocols


◆ A Control Protocol corresponds to an analysis method applied to the control results. A Control
Protocol is dedicated to one instrument. It is possible to define one or several Control Protocols
for a specific control material (control\lot). Note that this possibility may not be accessible for
the EQC used with the instrument (limitation).
◆ For example, it is possible to define two «Range» protocols (internal and external verification may
be required by some regulation) for the same control tube. In this case, each protocol will have
a specific answer (reaction) when control results are collected by EQC. It can be advantageous to
setup several protocols for a targeted sample to catch different potential problems or to manage
statistics based on the manufacturer definition and statistics based on an internal definition or
even to evaluate the same control material (control + lot) on different instruments.

4.2.1. Default protocols set on EQC application

Tab. 4–1: Default protocols set on EQC monolevel


Name Instrument
ABX Minotrol 8 P60 Low ABX pentra 60/ pentra 60C+
ABX Minotrol 8 P60 Normal ABX pentra 60/ pentra 60C+
ABX Minotrol 8 P60 High ABX pentra 60/ pentra 60C+
ABX Minotrol 8 P80 Low ABX pentra 80/pentra XL80
ABX Minotrol 8 P80 Normal ABX pentra 80/pentra XL80
ABX Minotrol 8 P80 High ABX pentra 80/pentra XL80
ABX Minotrol 8 PDX Low ABX pentra DX120/ pentra DF120

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Managing control materials

Tab. 4–1: Default protocols set on EQC monolevel


Name Instrument
ABX Minotrol 8 PDX Normal ABX pentra DX120/ pentra DF120
ABX Minotrol 8 PDX High ABX pentra DX120/ pentra DF120
ABX Difftrol P60 Low ABX pentra 60/pentra 60C+
ABX Difftrol P60 Normal ABX pentra 60/pentra 60C+
ABX Difftrol P60 High ABX pentra 60/pentra 60C+
ABX Difftrol P80 Low ABX pentra P80/pentra XL80
ABX Difftrol P80 Normal ABX pentra P80/pentra XL80
ABX Difftrol P80 High ABX pentra P80/pentra XL80
ABX Difftrol PDX Low ABX pentra DX120/ pentra DF120
ABX Difftrol PDX Normal ABX pentra DX120/ pentra DF120
ABX Difftrol PDX High ABX pentra DX120/ pentra DF120
ABX Minotrol Retic PDX 1 ABX pentra DX120
ABX Minotrol Retic PDX 2 ABX pentra DX120
ABX Minotrol Retic PDX 3 ABX pentra DX120
ABX Erytrol PDX 1 ABX pentra DX120
ABX Erytrol PDX 2 ABX pentra DX120
ABX Erytrol PDX 3 ABX pentra DX120
Xb ABX pentra DX120/ pentra DF120

Tab. 4–2: Default protocols set on EQC multilevel


Name Instrument
ABX Minotrol 8 P60 ABX pentra 60 / pentra 60C+
ABX Minotrol 8 P80 ABX pentra 80/pentra XL80
ABX Minotrol 8 PDX ABX pentra DX120/ pentra DF120
ABX Difftrol P60 ABX pentra 60/pentra 60C+
ABX Difftrol P80 ABX pentra P80/pentra XL80
ABX Difftrol PDX ABX pentra DX120/ pentra DF120
ABX Minotrol Retic PDX ABX pentra DX120
ABX Erytrol PDX ABX pentra DX120
Xb ABX pentra DX120/ pentra DF120

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4.2.2. Creating a control protocol


◆ You can access to the definition of the protocols by selecting the menu Setup\Control Protocols:

◆ When you create a New protocol, you have to enter, at minimum, the following information:
Protocol Name, Protocol type (one of the methods available), corresponding instrument and then
to link to a previously defined control (button Add Control).

◆ Once this is done, the list of parameters defined for the active lot appears (for each level), and
for each of them the Target and SD associated to the lot (if you defined them).
◆ To be able to Save the protocol, the SampleId and Instrument code are mandatory (for each level).
◆ To be able to collect and manage the statistics for the results sent by the instrument, do not forget
to select the option «The protocol is enable».

4.2.3. Protocol types


For the analysis of control materials, the protocol type to select is:
◆ Ranges

Ranges method
For the control protocol considered, you can access the Rules available for the Protocol type
selected. The EQC software implements the following Ranges rules:

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Managing control materials

◆ Failure if outside the warning ranges defined: 2xSD by default


◆ Failure if outside the error ranges defined: 3xSD by default

◆ Each rule can be enabled individually. For each rule activated, you can select one or more actions
to trigger in case of failure:
- displaying a warning (with or without specific message)
- displaying an error (with or without specific message)

displaying a warning
◆ Once a result collected by the EQC software fails a selected rule, you can decide which type of
action to trigger:
◆ Displaying a Warning: a predefined message and a Specific message will pop up to the operator:

◆ A similar warning message will pop up at the EQC to warn the EQC operator:

◆ The result(s) will be collected and included into the statistics.

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Activating an error
◆ Activating an Error: a predefined message and a Specific message will pop up to the operator.

◆ A similar error message will pop up at the EQC to warn the EQC operator.

◆ The result(s) will be collected but will not be included into the statistics.

4.2.4. Learning mode


◆ In some cases, it would be interesting to define a protocol to verify the control material with
different target, SD or ranges than the one provided by the manufacturer.
◆ EQC can be programmed to Compute the target and SD automatically after a certain number of
results.

4.2.5. Managing User Defined charts


For each protocol created, you can automatically generate a User defined Chart which includes
several types of information that can be displayed simultaneously:
◆ A Defined chart for each parameter and for each level
◆ A Defined chart per level with all parameters
◆ A Defined chart including all levels and all parameters (the chart could be overlaid for easy
viewing):

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Managing control materials

4.2.6. Duplicating control protocols


◆ If you have several instruments of the same type and you have to run the same control tube on
each of these instruments, you have to create one control protocol for each instrument. Once a
control protocol is defined on instrument 1, you can Duplicate it, rename it, and assign it to
instrument 2.
◆ This option may not be available for an EQC attached to the system.

4.2.7. Compacting periods


By default, all values are kept in the database (statistics AND values). If you want to keep only the
statistics (to free some space in the database) and delete the values, select the button Compact
Period from the Quality Control Protocol screen.

4.2.8. Managing periods


The periods can be automatically managed by the system (which means that the system will manage
statistics for each of the periods); you can select the Period duration from day, week or month. If
this does not correspond to your period management, you can activate the change of period
manually (select manual as the period duration, and use the button Start a new period to force the
calculation of new statistics).

If, for any reason, you made a mistake or simply if you don't want to keep all results as part of the
database, you can Delete a Period.

4.3. Collection of data


Usually, the data are collected automatically (this for all control tubes or patient tubes ran at the
instrument). If some control tubes created at the instrument contain results entered manually, then
you have to force the data collection at the EQC. To do this, select the menu Results\Manual
Collect. This may display error or warning messages (depending of the rules selected).

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5. Managing patient data


Compare to the analysis of control materials, the analysis based on patient data is easier. To proceed
to an analysis of patient data (statistics), you have to only define a control protocol.

Defining protocols
A Control Protocol corresponds to an analysis method applied to patient's results. A Control Protocol
could reference a specific instrument, but more generally it is assigned to All instruments. It is
possible to define one or several Control Protocols for statistics on patient data.

5.1. Creating a control protocol


You can access to the definition of the protocols by selecting the menu Setup\Control protocols:

◆ When you create a New protocol, you have to enter the following information: Protocol Name,
Protocol type (one of the methods available) and the instrument (All instruments or a specific
one).
◆ Once this is done, you can Add Parameters. You can select the parameters from the list available
on the system. For multiple parameters use the CTRL key to highlight your selection.

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Managing patient data

◆ Once this is completed, you can Save the control protocol.


◆ To be able to collect and manage the statistics for the results sent by the instrument, do not forget
to select the option The protocol is enable.

For Xb, the parameters are automatically selected.

5.2. Methods available


Xb
For the Xb, you can setup the Number of batches you want to keep by choosing Rules for the protocol
type selected.

Actions available
Once a result collected by the EQC software fails one of the selected rules, you can decide the type
of actions to trigger. Refer to the Chapter Control materials - actions available.

5.3. Learning mode


If you are not familiar with the population normality, targets and SDs, you can use the learning mode
(highly recommended). Refer to the chapter 4.2.4. Learning mode, page 4-16.

5.4. Managing User Defined charts


Refer to the chapter 4.2.5. Managing User Defined charts, page 4-16.

5.5. Duplicating control protocols


Refer to the chapter 4.2.6. Duplicating control protocols, page 4-17.

5.6. Managing periods


Refer to the chapter 4.2.8. Managing periods, page 4-17.

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6. Common options
6.1. Reviewing statistics by Period
A complete statistics is available clicking the following key or via the menu
Results\Statistics by Period. It displays per protocol and per period, for each parameter and per
level, a series of statistics (values expected, values calculated and Bias).

◆ This is true for control materials and for patient data.


◆ You can double click a parameter row to open the «Control values» window (see 6.2. Reviewing
Results by Parameter, page 4-20

Last period that has been reviewed in this menu, is memorized when the
menu is open once again.

6.2. Reviewing Results by Parameter


◆ Individual results can be accessed directly from the previous screen (Statistics) by selecting a
parameter and double clicking the line.
◆ It displays per protocol, period, parameter, and the list of values that were used to calculate the
statistics.

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Common options

◆ Results Values are tagged with different colours to show the status of each value

Tab. 4–3: QC Run status


Status Meaning
Run that contains at least one rejected parameter, waiting to be manually
«Rejected»
accepted or rejected.
Run that has not been automatically accepted, which has been afterwards
«Manually rejected»
rejected manually by the operator.
«Accepted» Run automatically accepted
Run that has not been automatically accepted, which has been afterwards
«Manually accepted»
accepted manually by the operator.
Runs that are pending because previous rejected run has not been accepted
«Blocked»
or rejected yet by the operator.
«Out» Run out of ranges.

◆ A complete Report for all the levels can be saved in a pdf file, clicking the «print» key. Status are
reported on the pdf file.

Adding a comment to a particular value


◆ You can add a comment on any result. In the «Control values» window, double-click any result.
The Comment window appears, and you can enter or modify the comment for the value.

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The previous comment is logged in the trace.log.

6.3. Reviewing Results by Run


You can also review results per run, this for each protocol defined on the system on each period.

6.3.1. Main screen


◆ This screen is accessible, clicking the following key or via the menu Results\Results by
Run.
◆ Three tabs allows to display runs for each level in the selected protocol (XB also available on this
window).

1 2 3 4 5
6

The following table describes each option of the «Results by run» window.

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Common options

Tab. 4–4
Option Function
1- «Protocol» dropdown list Allows to choose the Protocol
2- «Period» dropdown list Allows to choose the Period in the selected Protocol
3- «Control target» checkbox Check this option to display control lot target data (target
values, SD, low and high error and warning limits) on the
higher part of the chart.
4- «Statistics» checkbox Check this option to display Statistics on the chosen level
(Means, SD, Min and Max values, CV and number of values
included in the statistics results).
5- «Print» key Opens the «Results by run print setup» menu in order to select
the printing configuration (see 6.3.2. Printing setup, page 4-
23)
6- «Level» tab Allows to choose between Level 1, 2, 3 or all in the selected
Period
7- Double click a parameter row Opens the «Control values» window (see 6.2. Reviewing
Results by Parameter, page 4-20)

◆When the tab «All» is selected, the target values and statistics parts of the
window is not displayed.
◆In XB Charts, the statistics part is automatically disabled.
◆Last tab that has been accessed in this menu, is memorized when the menu
is open once again.

6.3.2. Printing setup


This screen allows to configure the printing options of the «Results by run» charts:

3
4

The following table describes each option of the «Results by run» window.

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Tab. 4–5 Printing options


Option Function
Prints the protocol lot values (charts with targets and
«Print what I see»
statistics) which are displayed in the «Results by run»
checkbox
window (see 6.3.1. Main screen, page 4-22)
Allows to select protocols, periods and lots for printing
individually and successively (results charts with
targets and statistics).
1- Checkboxes «Print
◆In the left part of the «Results by Run print
What I see» or «Print
setup» window, select items (protocol, period,
selected items» «Print selected level) to print in the «Protocols» tree. This one
items» can be expanded or collapsed using the +/-
◆Transfer the selected items to the right window by
means of the «>>» key.
◆Press «OK» key: selected items in the list are
printed successively.
Allows to valid the selection of the items and to transfer
«>>» key
2- Arrow keys them to the right window.
«<<» key Cancels the entire selection and empties the right list.
Check this box to allow the printing of the target values
«Print control
(target, SD, low and high error and warning limits) on
target»
each page of the printout report.
Check this box to allow the printing of the statistics
3- Control data
«Print statistics» (Means, SD, Min and Max results, CV, number of result
values) on the last page of the printout report.
Check this box to allow the printing of the Comments on
«Print Comment»
the last page of the printout report.
Check this box to allow the printing of the «Rejected»
Runs (checked by default).
On the printout, a «RJT» indicator shows the
«Rejected»
parameter(s) that has been rejected.
«RRJ» indicator shows the run rejected, which one
contains rejected parameter(s) («RJT»).
Check this box to allow the printing of «Manually
«Manually rejected» rejected» results. The chart cell is coloured in black.
4- Selection of the Checked by default.
Status of the QC runs
Check this box to allow the printing of the «Accepted»
«Accepted»
results. Checked by default.
Check this box to allow the printing of the «Manually
«Manually
Accepted» results. The chart cell is coloured in green.
accepted»
Checked by default.
Check this box to allow the printing of the «Blocked»
«Blocked» results. A «BLK» indicator is shown on the printout.
Checked by default.

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Common options

6.3.3. Printout report

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6.4. Charts
◆ A graphical chronological representation of the results is also available.
◆ The menu Results\Chart proposes several graphical representations.

After you selected the control protocol, parameter, period and level, you can choose the number of
values to display (per parameter) and the type of chart:
◆ Moving Average, Shewart and distribution charts are available for patients based protocols,
◆ Levey Jenning, Shewart and distribution charts are available for control material protocols.
◆ This option displays only single charts (no overlay, no comparison possible…).

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Common options

6.5. User Defined charts


◆ You can also access the User Defined charts clicking the following key or via the menu
Results\User Defined charts.

◆ You just need to select the type of Defined chart and the period to get access to a complete list
of charts (for an easy review).
◆ This is true for control materials and for patient data.
◆ Refer to the chapter 7.1. Creating User Defined charts, page 4-30 for further information.

By default 60 points are displayed on this page but it will be full screen for
30 points (see «Max points» options of the toolbar).

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6.6. Last collected results


◆ To review the last results received and managed at the EQC, you can access the menu Results\Last
collected results.

◆ All controls material results are displayed in that screen; if you want, you can also include patients
protocols.
◆ You can double click on a parameter results row to open the «Control values» window (see 6.2.
Reviewing Results by Parameter, page 4-20)

6.7. Reviewing date to date statistics


Date to date Statistics are available via the menu Results\Date to date Statistics.
It displays per protocol, for each parameter and per level, a series of statistics (Mean, SD, CV%, Mini
and Maxi values and Bias) over several chosen periods.
◆ Press Compute once the protocol, periods and levels have been chosen.
◆ The Print key will print out a complete report of this Statistics chart.

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Common options

6.8. Reports
◆ The menu Results\Report shows the following screen:

The report that will be previewed (and then printed) contains, for each protocol selected, one or
more information:
◆ The protocol definition (control/lot/protocol OR protocol only).
◆ The statistics.
◆ For the selected period: all results, results with error or warning, or none.

6.9. Validation Blocked


The menu Results\Blocked parameters provides the following charts:
◆ One list that shows non validated parameters: if a control, that has been run during series of
analyses, has parameters out of ranges then all the parameters that follows in the sample runs
can not been automatically validated. This list shows these «blocked» parameters.
◆ A second list that shows Runs that have not been requested to the instrument(s) due to a quality
control problem.

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7. Advanced options
7.1. Creating User Defined charts
If every time you verify the same parameters, in the same order by using the same type of chart, or
if you want to overlay charts, you can define your own «defined» charts. Via the menu Setup\User
Chart definition you obtain the following screen:

◆ First, you should name the Defined chart you are creating, and add to it a comment to be able to
Save it. Once this is done, you can Add Chart by selecting a control protocol, a level, the parameter
and the type of chart expected (from Levey Jenning, Shewart, moving average or distribution).
Several charts can be added and will be displayed one after another (in the order of the
definition).
◆ If you want to display several levels on the same graphic (up to 6) or several instruments results
together, use the Overlay option (so it overlays the selected graphic to the one previously
defined).

7.2. Database menu


The following functionalities are accessible with access rights: «Modif. QC» (see 7.4. Access rights
and permissions, page 4-32).

7.2.1. Backup / Restore QC data


From the menu Database\Backup QC data and Config, you can save all EQC data (definition, values,
and statistics). You obtain the following screen (SAVE window) in which you just have to enter the
file name of the destination backup file (the extension .EQC is added automatically):

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Advanced options

◆ From the menu Database\Backup QC Config Only, you can save only the QC configuration
(definitions of controls, lot, protocols). You obtain the same screen (SAVE window)
◆ From the menu Database\Restore QC data and Config, you can restore all the EQC data
(definition, values, and statistics). You obtain the following screen (OPEN window) in which you
just have to enter the file name (or select it into the list), and then click the Open button:

This will overwrite all the information contained in the EQC database. It may
conclude to a loss of EQC settings and/or data. A «Backup QC data and
Config» procedure should be proceeded previously to restoring. Warning
messages inform the operator.

7.2.2. Database Statistics


From the menu Database\Database Statistics, you can display the following information:
◆ Number of lots (see 3.1. Loading a control lot, page 4-6)
◆ Number of protocols (see 4.2. Control Protocols, page 4-12)

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◆ Number of periods (see 4.2.8. Managing periods, page 4-17)


◆ Number of accepted values (see 3.2. Control running, page 4-9)
◆ Number of rejected values (see 3.2. Control running, page 4-9)

7.2.3. Delete all data


From the menu Database\Delete all data, you can destroy all EQC data (definition, values and
statistics). This action is irreversible and should be used carefully. If you answer YES to the following
message, everything is deleted from the database!

7.3. EQC setup


◆ When the EQC installs, the program group (Start + Programs + EQC) contains 2 icons: one to launch
the EQC software and one to setup the connection with the instrument database:

From this screen, you can configure:


◆ The EQC Server which corresponds to the database used. By default, local host which means it is
using a local database.
◆ If the option enable EQC is checked, the instrument will use this EQC software.

7.4. Access rights and permissions


The access right to the EQC program is given by the administrator of the system from the menu
Settings\Users\Access Rights. To have full access to the EQC configuration, the user must have the
following right: «Modif. QC» (see 9.6. Assign user privileges, page 3-27)

7.5. Parameters configuration


Since the EQC software is fully compatible with the system, the setup of the parameters used by the
quality control has to be made at the instrument from the menu Settings\Soft
Parameters\Parameters Definition.

7.6. Lock the EQC software


If you are not using the software for a period (even for a short moment), it is recommended to lock
the access. This can be done with the menu File + Lock ABX pentra ML. The connection screen will
be displayed (you have to re enter your password or log in as a different user to be able to access
data again).

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Advanced options

7.7. Exit the EQC software


To quit the EQC software, you just have to use the menu File\Exit, or the combination of keys
ALT+F4. Even if you disconnect the EQC software, all the QC data are still evaluated, collected…

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8. Quality Control Program (QCP)


8.1. Overview
Quality Control Program or QCP is an Online Interlaboratory Comparison dedicated to all Hematology
and Clinical Chemistry analyzers of HORIBA Medical

By submitting Internal Quality Control results online to QCP, a participating laboratory can obtain
real time peer group statistical reports.

◆ The QCP website address is «http://qcp.horiba-abx.com/».


◆ Participation in QCP requires the exclusive use of HORIBA Medical
instruments, reagents and control products.
◆ For enrollment fees and conditions of participation, please contact your
Local HORIBA Medical Representative.

On Pentra ML workstation, a function is dedicated to QCP, which allows to export Quality Control
results in an uploadable format for the online program (which is .xml).

8.2. «QCP export» function description


The QCP export menu is accessible by means of the «File\QCP Export»
The following window is opened:

8.2.1. Procedure to export QC results


◆ Active and unactive lots by instrument including results to export. Active lots are displayed in
white, unactive ones are grey.
◆ Each line is a new lot. You can click the lot field (in the «Lot» column) to open the «Control lot
setup» window (see 3.1.3. Manual loading, page 4-7)
◆ Click «Start date» field to open the «Set start date time» window.

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Quality Control Program (QCP)

By default this one includes:

Reception date of the lot (if this one has not been exported yet) or date of the last export
operation on this lot.
Expiration date
Export begin date: Beginning of the period of the Runs exportation on this lot

◆ Click «End date» field to open the «Set End date time» window. By default this one includes:
Export end date: End of the period of Runs exportation on this lot (or expiration date of
the lot, if this one has never been exported)

◆ Check the checkbox «Show previous lots» to display all the unactive lots that have been already
exported.
◆ Click the column «His.» to open the History of exportation of one lot (see 8.2.2. History of
exportation, page 4-36)
◆ Select the lot(s) to export by means of the checkbox(es) in the column «To export». The control
types and instruments serial numbers must have been first entered (see 8.2.3. «QCP export»
setting, page 4-36)
◆ If the QC results are exported to an USB key, connect it to the Workstation (See 8.2.3. «QCP
export» setting, page 4-36 to set the export location).
◆ Click «Export» key and wait for the message «....export done.»

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8.2.2. History of exportation


In the «QCP Export» main menu, click the «His.» column

This window shows the list of Exportations for one control Lot with:
- Date & time of the Exportation procedure
- Beginning of the period of the Runs exportation on this lot
- End of the period of the Runs exportation on this lot
- Numbers of Runs exported,
- Name of the exported file
- User that has run the Exportation

If the time is not displayed, then this one is 00: 00: 00

8.2.3. «QCP export» setting


«QCP Export setup» menu is accessible only for authorized users pressing the «Config» key of the
«QCP Export» main menu.

The access right to this menu is given by the administrator of the system from
the menu Settings\Users\Access Rights (see 9.6. Assign user privileges, page
3-27).

8.2.3.1. General setup

Default export folder: the Export folder by default is «d:\qcpexports». To export the QC files to an
external media, click the «...» key and select the media or the folder. Press «OK» to confirm.

Export history number: this gives the maximum number of lots in the «History» menu.
When it is changed to 0, the history list will never be overwrited.

8.2.3.2. Instruments

The instruments serial numbers must be indicated to enable the export QC operation.
◆ Enter the serial numbers in column «Serial number» in front of the displayed instruments.

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Quality Control Program (QCP)

8.2.3.3. Controls

«Control type» must be indicated in front of the defined Control Names.


◆ Double click in the «Type» column to open the list of the Control types.
◆ Double click the matching control Type.

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9. Appendix
9.1. Ranges rules
9.1.1. Definition
With this protocol, the user can specify error and warning limits. When you setup a Range QC
Protocol, you can specify, for one or more parameters, the target, and four limits:

Tab. 4–6
Error low A value below this limit will generate an «Error» event
Warning low A value below this limit will generate an «Warning» event
Warning high A result above this limit will generate an «Warning» event
Error high A result above this limit will generate an «Error» event

9.1.2. Learning mode


To setup the learning mode, the user must specify the number of runs (NR) needed to compute the
target value and the SD. In this case, the protocol begins by collect NR results and computes the
mean M and the SD of these populations. Finally the limits are computed by:

Tab. 4–7
Error low M - 3 * SD
Warning low M - 2 * SD
Warning high M + 2 * SD
Error high M + 3 * SD

9.2. Xb
9.2.1. Definition
The Xb protocol is dedicated to 9 parameters: MCV, MCH and MCHC.
The Xb protocol is based on series (batch) of 20 values for the 9 parameters considered, and
calculates the average for each of them. It is not a moving average method, but a batch average for
every 20 values (N=20).
For the parameter each Xb parameter (X), the calculation of the average (BM=Batch Mean) is as
follow:

N
BM i =BM i−1+SGN{∑SGN(x j −BM i−1)* |x j −BM i−1|}*Fi−1
j =1

With:
BMi = Average for batch i.
xj = is the value j in the current batch for the parameter X.

N
{∑ SGN [ x j − BM i −1 ] * x j ,i − BM i −1 }2
j =1
Fi −1 =
N2
SGN(u): Sign (+1,-1,0) of u.

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Appendix

9.2.2. Implementation of Xb in EQC

Creation of an Xb protocol
◆ When defining your Xb protocol, you can not choose your parameters; when selecting the type,
the parameters are automatically selected.
◆ You can add Target values and tolerances for each of the parameters. Tolerances means warning
and error limits, like for other types of protocols. «Out» limits could be considered and used by
the protocol. The learning mode is also available for that type of protocol.
◆ Actions available for the protocol are the same than for the other types of protocols.
◆ The system will keep the last 20 batches. The older batches will be automatically deleted for the
current period (20 batches of 20 results are kept).

Statistics
3 lines of statistics are mandatory for each batch (one for each parameters).
For each line, we display: the parameter, the target, tolerance, the BMi value, the min. and max
values for the batch, the %Diff calculated as follow:

BatchMean
%Diff = - 1 *100
TargetMean

Graphics
Levey-Jennings charts could be used, not displaying each values, but BMi.

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Index

A Lock 32
Alarms Ranges rules 38
Window 15 Restore QC data 30
Anteriority 42 Run a lot 6
Search 43 Setup 32
Archive 42 Software 4
Current reports 44 Software overview 4
Delete Reports 47 Standard 3
Extract 46 toolbar 4
Restore 49 User Defined charts 27
Save 45 User defined charts 27
Assign to an Instrument 8 EQC window 4
Extended Diff 25

C
Cellcount 25 F
Charts 26 Filters 7
Column settings 7 Format Codes 17
Comment
Predefined 36
Comments
I
Definition 15
Interpretation rules 21
Control
Definition 11
Duplicate a lot 12
Protocols 12 K
Running 9 Keyboard Shortcuts 6

D L
Database LIS Transmission
Maintenance functions 28 Manual 39
Statistics 30
Delete
Results 38
Run or Report 38 M
Delta Check 6 Main supply 6
Principle 6 Manual Match 32
Demographics Manual results entry 27
New 19 Manual samples download 9
Departments/Physicians 14

O
E Order 17
EQC creating a new order 18
Backup QC Data 30
Control Protocols 12
control runs to be reviewed 10
Control values 21 P
Creating a control 11 Parameter Definition 5
Date to date statistics 28 Password
Exit 33 Change a user password 27
Extended 3 Pathological Limits 8
Introduction 3 Defaults values 9
launching 4 Patient data 18
Loading a lot 6 Patient demographics 23

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Print 33 Patient fields 4


Example 35 Window 3
Printer Setup 16 shortcuts 5
Slide
Set Slide Done 28
Software
R Keyboard shortcuts 6
Report 27 Menu bar 4
Assign 8 Menus 5
Comments 36 Toolbar 4, 5
Deleting 38 Software overview 4
Download 8 Specifications
Flags 11 Data processing 3
List sorting 11 System components 3
Patient 33 Stat 8
Played rules 31 Statistics 20
Popup Menu 13
Popup menu 30
Print Patient 33
Search 40 T
Slide Pending 12 Temperature conditions 6
Validate 12 Testing
View archive 42 Parameters/Profiles 20
Report List 10 Toolbar
Columns settings 12 Icons description 5
Display filters 13 shortcuts 5
Status 11
Rerun
Window 30
Rerun option 31 U
Result 23 Upload rules
Window 23 Default setting 20
Results User
Flags 29 Define a new user 27
Validated 45 Delete a user 27
Results validation 29 Settings 27
Rules
Download rules 19
Parameter rules 18
Pathologies 21
V
Played 31 Validation
Principle 18 Principle of the automatic validation 24
Printing 31
Reflex 22
Rerun 22 W
Slides 23
Worklist
Upload rules 19
Sorting 6
Run
Stat 5
Add manual Run 28
Window 5

S X
Sample
Xb 19, 38
Deleting 38
Set Slide Done 28
Set the search window 41
Setting
Delta Check 6

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