Horiba ABX Pentra 60 C+ User manual

ABX Pentra 60 C

HAN 616A

Explore the future

User Manual

P/n: RAB092IEN

Instrument User Manual Update

RAM227AEN

ABX Pentra 60 C+

User Manual Update for Electrical Standard Certification

Please, take note of the modifications on next pages. Please, cross out the appropriate sections in the user manual prior to inserting this addendum at the beginning of the user manual.

FORM 0860 - rev 1

Date: 28/7/08

Contents RAM227AEN

Contents ................................................................. 2

Update chart ........................................................... 3

Updates .................................................................. 4

Manufacturer ..................................................................4

Logo modification ..........................................................4

Revisions .......................................................................4

Warnings .......................................................................4

Graphic and symbols .......................................................5

Pentra 60 C+ back side ...................................................5

Waste levels ...................................................................6

NE flag ..........................................................................6

Verification after a reagent replacement ..........................6

2/6

Update chart RAM227AEN

Update chart

Tab.1-1: Concerned sections of the Pentra 60 C+ user manual:

Section Page Paragraph Item change

Front page I Manufacturer

Introduction II Copyright

Introduction III Revisions

Introduction IV 1.1. Warnings

Introduction VIII 1.6. Graphics and Symbols

Description & Technology

Specimen Run & Results

Maintenance & Troubleshooting

2.3 1.2. Pentra 60 C+ back side

3-2 1.1. Waste levels

3-34 NE flag

5.2 1.1. Reagent replacement

Telephone and fax number addition.

See “1. Manufacturer, page 4”

Modification of Manufacturer logo. See “2. Logo modification, page 4”

Modification of Copyright.

See “3. Copyright, page 4”

Modification of paper documents updates.

See “4. Revisions, page 4”

Peripheral devices compliance sentence modification.

See “5. Warnings, page 4”

Modification of Manufacturer logo and addition of new RoHS logos.

See “6. Graphic and symbols, page 5”

New Serial Number Label. See “7. Pentra 60 C+ back side, page 5”

Addition of precautions about waste.

See “8. Waste levels, page 6”

Ne flag information.

See “9. NE flag, page 6”

Addition of verification after reagent replacement.

See “10. Verification after a reagent replacement, page 6”

3/6

Updates RAM227AEN

Updates

1. Manufacturer

Telephone and fax numbers:

◆ Phone: + 33 (0)4.67.14.15.16

◆ Fax: + 33 (0)4.67.14.15.17

2. Logo modification

New Manufacturer logo.

3. Copyright

4. Revisions

Index Technical note Revision Section Date

A RAH774AA V1.50 All 26/06/200

B RAH792AA V1.61 All 20/02/2001

C RAH873AA V2.2 ALL 14/01/2002

D RAH986AA V2.2.9 All 24/09/2003

E RAN179A V2.3.0 (RAM146AEN) 1, 3 16/11/2005

RAB092FEN /

RAB092GEN RAN321A

RAB092HEN RAN321B V2.4.X (RAM215BEN) 3, 4, 5 30/11/2007

RAB092IEN / Electrical standard certification (RAM227AEN) Intro, 2, 3, 5 21/05/2008

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 ABX. To update a paper document, please contact your local HORIBA ABX representative.

Instrument default settings (RAM200AEN) User manual update (RAM205AEN)

Platelet interferences (RAM210BEN) V2.4.0 (RAM215AEN)

4 Intro, 1, 2, 3

2 3, 4, 5

10/10/2006

08/06/2007

5. Warnings

4/6

◆ All peripheral devices should comply with relevant standards.

Updates RAM227AEN

6. Graphic and symbols

Manufacturer

Packaging recycling mark

Notice of environment-friendly use period

7. Pentra 60 C+ back side

Diluent input

Waste output

Serial number label

Barcode reader (not used on Pentra 60C+)

Printer (not used on Pentra 60C

RS 232 output

Main supply cable

)

5/6

Updates RAM227AEN

8. Waste levels

At the beginning of each day, before startup, check if the waste container needs to be emptied. During the operation, do not remove the reagent tubes and the waste liquid tube under any condition.

9. NE flag

Meaning: Neutro/Eosino. Presence of a significantly large population of cells located in the separation area between neutrophils and eosinophils because of a superimposition of the 2 populations. This flag occurs when the number of particles counted in this area is higher than the limit setup in NE# or when the number of particules counted regarding the total number of WBC is above the NE% limit. Standard values for NE: % 1.1 / # 60

Suspected abnormalities:

◆ Young eosinophils

◆ Giant hypersegmented neutrophils

◆ Eosinophils with low intracytoplasmic material

◆ Immature cells

◆ Neutrophils with cytotoxic granulations

This flag is associated with an (!) on LIC % and LIC # and replaces NEU %, NEU #, EOS %, EOS # by ----.

6/6

10. Verification after a reagent replacement

Make sure that a blank cycle and Control run will be carried out after the change of a reagent in the course of day.

Instrument User Manual Update

RAM215BEN

ABX Pentra 60 C+

Update for instrument version V2.4.X

Please, take note of the modifications on next pages. Please, cross out the appropriate sections in the user manual prior to inserting this addendum at the beginning of the user manual.

FORM 0860 - rev 1

Date: 30/11/07

Update for instrument version V2.4.X RAM215BEN

Update for instrument version V2.4.X

Tab.1-1: Concerned sections of the manual

Section Page Paragraph Item change

Specimen run & Results

Maintenance & Troubleshouting

Instrument configuration

Index History:

From RAM215AEN to RAM215BEN: V2.4.0 replaced by V2.4.X and modification of conditions on platelets.

3-24 7.4. Flags

3-45 7.5.3. Plt messages

5-2 1.1. Reagent replacement

4-2 1. Control

Addition of paragraph “Suspicion flags”

See “1. Suspicion flag, page 2”

Addition of message condition in “PLT Aggregate (1)”

See “2. Plt messages, page 3”

Addition of ABX Diluent 10L

See “3. ABX Diluent 10L, page 3”

Addition of Export QC

See “4. Export QC, page 3”

1. Suspicion flag

1.1. PLT

Conditions Triggered flag Consequences

If PLT < 120x103/mm3 (in CBC mode only)

If PLT < 120x103/mm3 + PDW > 20 (in CBC and DIFF mode)

(!) on PLT and on PDW, MPV, PCT

1.2. WBC

◆ If a flag LMNE+ or LMNE- or BASO+ is triggered, then a suspicion flag «!» on WBC parameter is generated too.

See “7.4.7. WBC balance”.

◆ If a suspicion flag «!» on WBC occurs, then «!» is also generated on BAS#, BAS%, LYM#, LYM%, MON#, MON%,

EOS#, EOS%, NEU#, NEU%, ALY#, ALY%, LIC#, LIC% parameter results.

◆ A suspicion flag «!» is generated on the BAS#, BAS%, LYM#, LYM%, MON#, MON%, NEU#, NEU% and EOS#, EOS%

parameter results if Hgb > 17,5 g/dl or invalid «---».

PLT result needs to be confirmed according to Good Laboratory Working Practices

2/5

Update for instrument version V2.4.X RAM215BEN

2. Plt messages

"H": high extreme limit "L": low extreme limit

Message Triggering conditions

Thrombocytosis PLT > PLT H

Thrombocytopenia PLT < PLT L

Microcytosis Schizocyte Small Cell

PLT Aggregate (1)

Erythroblasts(2)

Erythroblasts PLT Aggregate

Macroplatelets MPV > 11

See triggering conditions for these flags in paragraph ”7.4.5.Flags on RBC histogram“.

PLT < 150x103/mm3 + WBC Reject or NO + PDW > 20 or NO + MPV > 10 or NO + PLT < 150x10 NO + WBC Reject or (L1 or LL1) + PDW > 20 or (L1 or LL1) + MPV > 10 or (L1 or LL1) + PLT < 150x10

PDW > 20 + PLT < 120x103/mm3 (in CBC mode only)*

LL or WBC reject + L1 or WBC reject + LL1

If conditions 1 and 2 are not satisfied and if L1 or LL1 or WBC reject

/mm3 or

/mm

* New condition

3. ABX Diluent 10L

A 10 liters container of ABX Diluent is available under the part number: 0901010.

Software version v2.4.X introduces 10L or 20L volumes management (barcode identification, capacity, level, expiration date, etc.).

4. Export QC

Software version v2.4.X allows backup of QC results and statistics on floppy disk. This backup file is registered on a «.csv» format in order to be reused on a spreadsheet type software.

4.1. Saved QC data

◆ Only one «.csv» file is generated for each control lot number.

◆ Each «.csv» file has a unique name and is generated in the current language and units. File name is saved on

the following model : «xxx_AAAAMMJJ.csv» where xxx is the lot# and AAAAMMJJ the file creation date.

4.2. Limitations

RUO (for Research Use Only) parameters (PCT, PDW, ALY, LIC) are not saved on the Export QC file.

3/5

Update for instrument version V2.4.X RAM215BEN

4.3. Export QC file content

Each file includes the following fields: Header

Instrument name / Lab ID Instrument serial number Lot number File creation date time Start period for lot use End period for lot use Expiration date Comment User lot comment Unit used

CBC data (Minotrol) 3 parts for Low, Normal and High levels

Results detailed by parameters Statistics results lot target values

DIFF data (Difftrol) 3 parts for Low, Normal and High levels

Results detailed by parameters Statistics results lot target values

See “Tab.1-1: DIF example” in the following page.

4.4. Procedure to export QC data

◆ Insert a Windows formatted Floppy disk into the drive.

◆ Open the «QC & Calibration» Tab (See “Fig.1-1: «QC & Calibration» tab, page 4”).

◆ Select the lot to export (Fig.1-1-A).

◆ Click the «Export QC» button (Fig.1-1-B).

4/5

Fig.1-1: «QC & Calibration» tab

Update for instrument version V2.4.X RAM215BEN

◆ Accept when the following message is displayed «Do you confirm QC export?»

◆The use of Export QC function will copy all levels results of the selected lot on the floppy

disk at the same time.

◆Lot barcode identification must not be modified to allow QC exportation on floppy disk.

◆Statistical calculation results displayed in .csv file on the floppy disc are based on the

raw values determined by the instrument, and not by the rounded values of control runs

displayed in this .csv file.

5/5

LIC#

ALY#

BAS#

EOS#

NEU#

MON#

LYM #

LIC%

ALY%

BAS%

EOS%

NEU%

MON%

LYM %

PDW

PCT

MPV

PLT

RDW

MCHC

MCH

MCV

HCT

HGB

RBC

WBC

alarm

LIC#

alarm

LIC#

ALY#

alarm

ALY#

BAS#

alarm

BAS#

EOS#

alarm

EOS#

NEU#

alarm

NEU#

MON#

alarm

MON#

LYM #

alarm

LYM #

LIC%

alarm

LIC%

ALY%

alarm

ALY%

BAS%

alarm

BAS%

EOS%

alarm

EOS%

NEU%

alarm

NEU%

MON%

alarm

MON%

LYM %

alarm

LYM %

PDW

alarm

PDW

PCT

alarm

PCT

MPV

alarm

MPV

PLT

alarm

PLT

RDW

alarm

RDW

MCHC

alarm

MCHC

MCH

alarm

MCH

MCV

alarm

MCV

HCT

alarm

HCT

HGB

alarm

HGB

RBC

alarm

RBC

WBC

alarm

WBC RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW LYM% MON% NEU% EOS% BAS% ALY% LIC% LYM# MON# NEU# EOS# BAS# ALY# LIC#

WBC

LIC#

ALY#

BAS#

EOS#

NEU#

MON#

LYM #

LIC%

ALY%

BAS%

EOS%

NEU%

MON%

LYM %

PDW

PCT

MPV

PLT

RDW

MCHC

MCH

MCV

HCT

HGB

RBC

WBC

alarm

LIC#

alarm

LIC#

ALY#

alarm

ALY#

BAS#

alarm

BAS#

EOS#

alarm

EOS#

NEU#

alarm

NEU#

MON#

alarm

MON#

LYM #

alarm

LYM #

LIC%

alarm

LIC%

ALY%

alarm

ALY%

BAS%

alarm

BAS%

EOS%

alarm

EOS%

NEU%

alarm

NEU%

MON%

alarm

MON%

LYM %

alarm

LYM %

PDW

alarm

PDW

PCT

alarm

PCT

MPV

alarm

MPV

PLT

alarm

PLT

RDW

alarm

RDW

MCHC

alarm

MCHC

MCH

alarm

MCH

MCV

alarm

MCV

HCT

alarm

HCT

HGB

alarm

HGB

RBC

alarm

RBC

WBC

alarm

WBC RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW LYM% MON% NEU% EOS% BAS% ALY% LIC% LYM# MON# NEU# EOS# BAS# ALY# LIC#

WBC

LIC#

ALY#

BAS#

EOS#

NEU#

MON#

LYM #

LIC%

ALY%

BAS%

EOS%

NEU%

MON%

LYM %

PDW

PCT

MPV

PLT

RDW

MCHC

MCH

MCV

HCT

HGB

RBC

WBC

alarm

LIC#

alarm

LIC#

ALY#

alarm

ALY#

BAS#

alarm

BAS#

EOS#

alarm

EOS#

NEU#

alarm

NEU#

MON#

alarm

MON#

LYM #

alarm

LYM #

LIC%

alarm

LIC%

ALY%

alarm

ALY%

BAS%

alarm

BAS%

EOS%

alarm

EOS%

NEU%

alarm

NEU%

MON%

alarm

MON%

LYM %

alarm

LYM %

PDW

alarm

PDW

PCT

alarm

PCT

MPV

alarm

MPV

PLT

alarm

PLT

RDW

alarm

RDW

MCHC

alarm

MCHC

MCH

alarm

MCH

MCV

alarm

MCV

HCT

alarm

HCT

HGB

alarm

HGB

RBC

alarm

RBC

WBC

alarm

WBC RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW LYM% NEU% EOS% BAS% ALY% LIC% LYM# MON# NEU# EOS# BAS# ALY# LIC#

WBC

04/24/2007 13:17 2.5 2.48 6.9 22.7 H 92 H 27.7 30.2 L 12.5 46 L 4.8 L 24.1 0.9 57.7 14.0 3.3 0.61 0.02 1.46 0.35 0.08

04/24/2007 13:24 2.6 2.50 6.7 22.9 H 91 H 26.7 29.2 L 12.8 56 4.4 L 25.0 0.7 58.1 12.9 3.3 0.64 0.02 1.49 0.33 0.08

04/24/2007 13:26 2.5 2.49 6.8 22.8 H 92 H 27.4 29.9 L 13.0 71 4.3 L 24.8 0.5 55.9 15.6 3.2 0.63 0.01 1.41 0.39 0.08

Lower limits 2.0 2.40 6.3 18.4 75 24.6 30.7 10.0 46 6.7 19.0 --- 48.0 3.0 1.5 0.43 --- 1.12 0.04 0.03

Target values 2.4 2.52 6.7 19.9 79 26.6 33.7 14.0 66 8.7 27.0 1.5 58.0 10.0 3.5 0.65 0.04 1.39 0.24 0.08

Upper limits 2.8 2.64 7.1 21.4 83 28.6 36.7 18.0 86 10.7 35.0 3.0 68.0 17.0 5.5 0.87 0 .08 1.66 0.44 0.13

Mean 2.5 2.49 6.8 22.8 92 27.3 29.8 12.8 57 4.5 24.6 0.7 57.2 14.2 3.3 0.63 0.02 1.45 0.36 0.08

Mean/target diff. 0.1 0.03 0.1 2.9 13 0.7 3.9 1.2 9 4.2 2.4 0.8 0.8 4.2 0.2 0.02 0.02 0.06 0.12 0.00

Standard deviation 0.02 0.01 0.1 0.07 0.07 0.49 0.52 0.27 12.72 0.27 0.47 0.2 1.17 1.36 0.06 0.01 0.01 0.04 0.03 0.00

Variation Coeff. 0.65 0.37 1.46 0.29 0.08 1.81 1.74 2.08 22.17 H 5.92 1.92 28.57 2.05 9.58 1.77 2.26 28.67 2.62 8.97 2.29

DIF Normal

Run date WBC

04/24/2007 13:10 8.0 4.44 L 13.2 L 44.5 H 100 H 29.7 29.7 L 11.4 229 4.1 L 25.9 0.6 64.8 5.5 3.2 H 2.08 0.05 5.21 0.44 0.26

04/24/2007 13:12 7.3 4.35 L 13.4 L 43.7 H 100 H 30.9 30.8 L 11.8 218 4.1 L 27.3 0.6 63.4 5.3 3.4 H 2.00 0.04 4.65 0.39 0.25

04/24/2007 13:13 7.2 4.41 L 13.4 L 44.3 H 101 H 30.5 30.3 L 11.3 219 4.1 L 25.2 0.6 65.6 5.3 3.3 H 1.81 0.04 4.70 0.38 0.24

Lower limits 6.3 4.54 13.5 38.8 83 27.9 31.3 8.5 205 6.2 20.5 --- 53.0 --- 0.0 1.45 --- 3.82 --- 0.04

Target values 7.3 4.69 14.0 40.8 87 29.9 34.3 12.5 235 8.2 28.5 1.5 63.0 3.5 0.3 2.08 0.11 4.60 0.26 0.26

Upper limits 8.3 4.84 14.5 42.8 91 31.9 37.3 16.5 265 10.2 36.5 3.0 73.0 7.0 0.5 2.71 0.22 5.38 0.52 0.48

Mean 7.5 4.40 13.4 44.1 100 30.4 30.3 11.5 222 4.1 26.1 0.6 64.6 5.4 3.3 1.96 0.05 4.85 0.40 0.25

Mean/target diff. 0.2 0.29 0.6 3.3 13 0.5 4.0 1.0 13 4.1 2.4 0.9 1.6 1.9 3.0 0.12 0.06 0.25 0.14 0.01

Standard deviation 0.46 0.05 0.13 0.44 0.2 0.61 0.56 0.25 6.04 --- 1.07 --- 1.11 0.12 0.1 0.14 0.00 0.31 0.03 0.01

Variation Coeff. 6.18 1.09 1.01 0.99 0.2 2.0 1.86 2.19 2.72 --- 4.09 --- 1.72 2.15 3.03 7.24 6.18 6.4 8.38 4.24

DIF High

Run date WBC

04/24/2007 13:38 28.1 H 5.14 16.6 53.6 H 104 32.3 31.0 L 10.3 450 3.8 L 13.8 1.1 75.4 5.5 4.2 3.88 0.31 21.21 H 1.55 1.18

04/24/2007 13:39 28.2 H 5.15 16.7 53.7 H 104 32.4 31.0 L 10.7 459 3.7 L 13.7 1.1 76.0 5.0 4.2 3.86 0.31 21.41 H 1.41 1.18

04/24/2007 13:41 27.9 H 5.11 16.6 53.2 H 104 32.5 31.2 L 10.5 453 3.8 L 13.5 1.3 75.5 5.5 4.2 3.77 0.36 21.06 H 1.53 1.17

Lower limits 15.5 4.95 16.0 45.4 79 29.7 31.7 7.8 450 5.3 5.5 MON% 65.5 1.0 1.0 1.09 --- 11.56 0.17 0.13

Target values 17.7 5.15 16.6 47.9 93 32.2 34.7 11.8 500 7.3 13.5 --- 75.5 5.5 4.0 2.69 0.27 13.36 0.97 0.71

Upper limits 19.9 5.35 17.2 50.4 107 34.7 37.7 15.8 550 9.3 21.5 1.5 85.5 10.0 7.0 4.29 0.54 15.16 1.77 1.29

Mean 28.1 5.13 16.6 53.5 104 32.4 31.1 10.5 454 3.8 13.7 1.2 75.6 5.3 4.2 3.84 0.33 21.23 1.50 1.18

Mean/target diff. 10.4 0.02 0.0 5.6 11 0.2 3.6 1.3 46 3.5 0.2 0.3 0.1 0.2 0.2 1.15 0.06 7.87 0.53 0.47

Standard deviation 0.15 0.02 0.03 0.25 0.05 0.11 0.12 0.17 4.46 0.04 0.15 0.12 0.32 0.29 --- 0.06 0.03 0.18 0.08 0.01

Tab.1-1: DIF example

Instrument name/Lab ID Pentra60C+/ABX Parc Euro

Instrument serial number 454548887

Lot Number PX017

File creation date time 04/24/2007 13:43

Start period for lot use

End period for lot use

Expiration Date 2/6/07

Comment Calculation results displayed on this floppy are based on the raw values determined by the instrument and not by the rounded value

User lot comment

Unit used STD

DIF Difftrol

DIF Low

Run date WBC

Variation Coeff. 0.53 0.43 0.17 0.47 0.04 0.34 0.38 1.62 0.98 0.98 1.12 9.9 0.43 5.41 --- 1.61 9.34 0.83 5.12 0.53

Instrument User Manual Update

RAM210BEN

ABX Pentra 60/60 C+

Platelet interferences

Please, take note of the modifications on next pages. Please, cross out the appropriate sections in the user manual prior to inserting this addendum at the beginning of the user manual.

FORM 0860 - rev 1

Date: 6/4/07

Platelet interferences RAM210BEN

Platelet interferences

1. ABX Pentra 60

Tab.1-1: Concerned sections of the manual

Section Paragraph Item change

Specifications 5.3. Known interfering substances

1.1. Plt (Platelets)

◆ Elevated lipids and/or cholesterol: may interfere with correct platelet counting.

From patients undergoing parenteral treatment with intralipids brought, it is noted an over-estimate of the platelet counting which can mask a thrombopenia in DIFF mode. In this case, sample re-run should be done in CBC mode.

Modification of information about interference in the platelet results

See “1.1. Plt (Platelets), page 2”

◆ Elevated bilirubine : may interfere with correct platelet counting.

From patients with severe hepatic disorder, liver transplant…It is noted an over-estimate of the platelet counting which can mask a thrombopenia.

2. ABX Pentra 60 C+

Tab.1-2: Concerned sections of the manual

Section Paragraph Item change

Specifications 5.3. Known interfering substances

2.1. Plt (Platelets)

◆ Elevated lipids and/or cholesterol: may interfere with correct platelet counting.

◆ Elevated bilirubine : may interfere with correct platelet counting.

From patients with severe hepatic disorder, liver transplant…It is noted an over-estimate of the platelet counting which can mask a thrombopenia.

Modification of information about interference in the platelet results

See “2.1. Plt (Platelets), page 2”

2/2

Instrument User Manual Update

RAM205AEN

ABX Pentra 60 C+

User manual update

Please, take note of the modifications on next pages. Please, cross out the appropriate sections in the user manual prior to inserting this addendum at the beginning of the user manual.

FORM 0860 - rev 1

Date: 10/10/06

User manual update RAM205AEN

User manual update

Tab.1-1: Concerned sections of the manual

Section Page Paragraph Item change

Introduction II Notice of liability

Introduction III Revisions

Introduction VI 1.4. Biological risks

Introduction VIII 1.6. Graphics and symbols

Introduction IX 2.1. Environment

Introduction X 2.6. Environment protection

Specifications 1-6 2.1. Power requirements

Specifications 1-8 2. Physical specifications

Specifications 1-15 4.1. Reagent specifications

Specifications 1-17

Specifications 1-19

Specifications 1-20

Description & Technology

Specimen run & Results

5.3. Known interfering substances

2-11 2.3. Hgb measurement

3. Calibration verification

3-5

(control blood sampling)

3-14 6. Running specimen

7.4.4. Flags on WBC/BASO

3-39

histogram

3-43 7.4.7. WBC balance

Paragraph correction

See “1. Notice of liability, page 3”

Addition of internet link to Declaration of conformity

See “2. Declaration of conformity, page 3”

Recommendations addition

See “3. Biological risks, page 3”

WEEE Directive symbol addition

See “4. Graphics and symbols, page 3”

“Safety requirements” Standard evolution

See “5. Environment, page 3”

WEEE Directive addition

See “6. Environment protection, page 3”

Heat output addition

See “7. Power requirements, page 3”

Addition of “2.9. Compatible tube list” paragraph

See “8. Compatible tube list, page 4”

A.F.S.S.A.P.S reference deletion and Reagent leaflets update

See “9. Reagent specifications, page 6”

Modification of known interferences due to Chemotherapy

See “10.1. White Blood Cells (Leukocytes), page 6”

Modification of interference in the platelet result information

See “10.2. Plt (Platelets), page 6”

Addition of interferences in the basophil count information

See “10.3. BAS# (Basophil cell count absolute), BAS% (Basophil percentage), page 6”

Addition of measuring principle with Lysebio

See “11. Hgb measurement, page 7”

Addition of calibration general information See “12. Calibration

verification (control blood sampling), page 7”

Addition of recommendations on the analysis mode selection

See “13. Running specimen, page 8”

Addition of recommendations on CBC mode: L1 flag

See “14. Flags on WBC/BASO histogram, page 8”

Addition of CBC mode limitations

See “15. WBC balance, page 8”

2/8

User manual update RAM205AEN

1. 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 ABX 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.

2. Declaration of conformity

Latest version of the CE declaration of conformity for this instrument is available on www.horiba-abx.com.

3. Biological risks

Consider all instrument accessible surfaces as potentially contaminated with blood. Use protective gloves to operate instrument.

4. Graphics and symbols

This product should be disposed of and recycled at the end of the useful life in accordance with the WEEE Directive (2002/96/CE)

5. Environment

The instrument is designed for safety from voltages surges according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2 (IEC 61010-1).

6. Environment protection

◆ European Legislation:

In accordance with the European Directive (2002/96/CE, known also as W.E.E.E) instruments having the above symbol, and sold into a European country by HORIBA ABX or an authorised representative must 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.

7. Power requirements

◆ Heat output....... ......... Max 1440 Kjoules/h (1365 BTU/h)

3/8

User manual update RAM205AEN

8. Compatible tube list

8.1. Compatible tube list for Tube holder

Tube lists given in the tables below are not exhaustive. If the tubes in use in your laboratory does not match with this lists, please contact your HORIBA ABX service representative.

On microsampling tubes, the 100µl volume can only be use in the following conditions:

- The tube must be held always in vertical position

- Blood mixing must be obtained by slight tapping on the tube Do not rotate the tube for mixing, otherwise the blood will be spread on the tube side, and the minimum required level will be lost.

◆ Legend:

- MAN: Manufacturer

- BC: Barcode

◆ Tube holder position:

- GBG214AS Standard tube holder positions: Position 1, position 2, position 3, position 4

- GBG215AS Optional tube holder positions: Position 1, position 3, position 5, position 6

8.2. Tube holder position 1

Tab.1-2: Compatible tube position 1

Manufact Model Part number Additive Vol Vacuum Stickers

Becton D Vacutainer 368452 K3-EDTA 5ml MAN+BC With cap

Becton D Vacutainer 367651 K3-EDTA 5ml 2ml MAN+BC With cap Hemogard

Becton D Vacutainer 367856 K3-EDTA 5ml 3ml MAN+BC With cap Hemogard

Becton D Vacutainer 367652 K3-EDTA 5ml 3ml MAN+BC With cap Hemogard

Becton D Vacutainer 367654 K3-EDTA 5ml 4,5ml MAN+BC With cap Hemogard

Terumo Venoject II VP-053SDK K3-EDTA 5ml 3ml MAN With cap UltraSeal

Terumo Venoject VT-050STK K3-EDTA 5ml 5ml MAN With cap

Terumo Venoject VT-053STK K3-EDTA 5ml 3ml MAN With cap

CML ABX 3004002 TH5C0C K3-EDTA 5ml 4ml MAN+BC With cap

Greiner Vacuette 454087 K3-EDTA 5ml 2ml MAN+BC With cap Hemogard

Greiner Vacuette 454086 K3-EDTA 5ml 3ml MAN+BC With cap Hemogard

Greiner Vacuette 454036 K3-EDTA 5ml 4ml MAN+BC With cap Hemogard

Greiner Vacuette 454223 K3-EDTA 5ml 4,5ml MAN+BC With cap Hemogard

LDM Paris EDTAKE 5ml 4,5ml MAN+BC With cap Hemogard

Pirecing condition

Type of cap

Rubber with groove

Rubber strongly not advisable

4/8

User manual update RAM205AEN

8.3. Tube holder position 2

Tab.1-3: Compatible tube position 2

Manufact Model Part number Additive Vol Vacuum Stickers

Becton D Vacutainer 6385 K3-EDTA 3ml MAN *Without cap

Terumo Venoject VT-03STK K3-EDTA 3ml 3ml MAN With cap

Greiner Minicollect** 450403 K3-EDTA 1ml With cap With valve

*Because of the cap thickness and the lack of space between the holder and the top of the tube, the tube holder may not open correctly.

**Requires an additional adjustment procedure: in the Menu «Service\Mechanical Systems\Sampling needle Ad- justment», adjust the «Level» on «Position 2» to «8.0» instead of «3.0» (See Section 5: Maintenance & Troubleshooting, 2.3.4. Sampling needle adjustment)

Pirecing condition

Type of cap

Rubber strongly not advisable

8.4. Tube holder position 3

Tab.1-4: Compatible tube position 3

Manufact Model Part number Additive Vol Vacuum Stickers

Comar R&D Systems TX2B 18533IF 5ml 2,2ml Without cap With thread

Pirecing condition

Type of cap

8.5. Tube holder position 4

Tab.1-5: Compatible tube position 4

Manufact Model Part number Additive Vo l Vacuum Stickers

Sarstedt 901091 0,5ml

KABE ABX 3001001 0777008RED 0,5ml

*The tube accepts a small sticker (not supplied by the manufacturer).

*Out of format

8.6. Tube holder position 5

Tab.1-6: Compatible tube position 5

Manufact Model Part number Additive Vol Vacuum Stickers

Becton D Microtainer 365975 0,5ml

*The tube accepts a small sticker (not supplied by the manufacturer). **Cap fitted with an adaptor (require another probe adjustment).

*Out of format

Pirecing condition

Without cap Unlostable

With cap Unlostable

Pirecing condition

Without cap **Microgard

Type of cap

5/8

User manual update RAM205AEN

8.7. Tube holder position 6

Tab.1-7: Compatible tube position 6

Manufact Model Part number Additive Vol Vacuum Stickers

Becton D Microtainer 365973 0,5ml

*The tube accepts a small sticker (not supplied by the manufacturer).

*Out of format

Pirecing condition

Without cap

Type of cap

9. Reagent specifications

The HORIBA ABX reagents specified for this instrument have been approved in accordance with the European Directive 98/79/CE (Annex III) for in-vitro medical devices.

◆ The CD ROM RAX055 delivered with your instrument provided Reagents, Controls and Calibrators leaflets/msds.

Latest versions of these documents are available on www.horiba-abx.com/documentation.

10. Known interfering substances

10.1. White Blood Cells (Leukocytes)

Chemotherapy - Cytotoxic and immunosuppressive drugs may increase the fragility of the leukocyte membranes which may cause low WBC counts. In these particular cases, CBC mode must not be used as WBC balance alarm (See Section 3: Specimen run & Results, 7.4.7. WBC balance) is disabled. It is recommended to run these samples in DIFF mode.

10.2. Plt (Platelets)

Interference in the Platelet result may occur for samples from Patients undergoing parenteral treatment with injection of lipid emulsion.

10.3. BAS# (Basophil cell count absolute), BAS% (Basophil percentage)

◆ Over evaluation in the Basophil count:

Excessive number of leukocytes (leukocytosis) can cause artificial rise in the number of counted basophils due to the shifting of the leukocytes population in the zone of the basophil ones.

Monocytes and Blasts show large granules and may shift on the basophil counting area. This may interfere with an accurate count.

An abnormally of leukocytes (leukopenia) may increase too the basophil results. The elements present in the zone of basophil are brought back on a small total quantity of leukocytes, which increases the statistical error and may cause variabilities in the percentage.

The weakness of leukocyte cells shown in certain diseases (Chronic Lymphocytic Leukomia) or during anti-cancer treatment (chemotherapy) can be translated on the basophilic channel by under evaluation of the leukocytes because of their destruction and thus cause a statistical increase in the basophil ones.

6/8

User manual update RAM205AEN

◆ Under evaluation in the Basophil count:

During leukomia, basophils may lose their cytochemical characters and react abnormally with the reagent. The destruction of the basophil cytoplasms prevents their differentiation with the other leukocytes.

The basophils with very small sizes (following treatments) may interfere with leukocyte counts, as cell sizes cannot be distinguished.

The abnormal basophils (degranulation following allergies) may interfere with leukocyte counts, because cell sizes cannot be distinguished and because they may lose their characteristic intracytoplasmic material.

11. Hgb measurement

◆ Lysebio

Reagent for erythrocyte lysis and cyanide-free determination of hemoglobin. By addition of agent of lysis, hemoglobin is released. All the heme iron is oxidized and stabilized. Oxidation resulting complexes are quantified by spectrophotometry at a wavelength of 550nm.

12. Calibration verification (control blood sampling)

The calibration on HORIBA ABX instruments is an exceptional procedure, which must be carried out particularly in case of certain technical interventions (installation, maintenance, service intervention). The calibration should not be carried out to compensate a drift on a results due for example to a clogging of the instrument.

Before carrying out a calibration, it is essential to make sure that the instrument is in perfect condition of operation, and to follow the steps below:

1- Carry out a Concentrated cleaning procedure (refer to Section 5: Maintenance & Troubleshooting).

2- Perform two blank cycles to check the cleanliness of the instrument (if the blank measurement is not correct,

please contact your HORIBA ABX representative).

3- Check the repeatability of the instrument by running 6 times a normal human blood without taking account of

the first result (if the repeatability is not correct, please contact your HORIBA ABX representative).

4- Calculate the CV obtained out on the other 5 results. The values of CV must be lower than: WBC: 2%, RBC: 2%,

HGB: 1%, HCT: 1%, PLA: 5%.

5- Run a control blood and check that the values are within the acceptable limits. If not, run a new control blood.

If the instrument is clean (blank cycles in conformity with the values given in the manual), the repeatability is correct (acceptable CV values) and the values of control are not within the acceptable limits, then it is possible to carry out the calibration:

6- Run at least 4 times Calibrator without taking the values of the first result into account.

7- Calibrate the instrument on the average of the last 3 results according to indications of the manual. Take care

to respect the minimum and maximum calibration coefficient values given in the manual. Run 3 times again Calibrator to check the values.

8- Confirm the calibration while passing a control blood, the values have to be returned within acceptable limits.

9- After about thirty analyses of the day, check that values of MCV, MCH and MCHC are in conformity with the usual

values of the laboratory.

7/8

User manual update RAM205AEN

13. Running specimen

◆ Recommendations on the analysis mode selection (CBC or DIFF)

When selecting CBC analysis, there is no control mode on WBC erroneous countings that may be caused by specific treatments on patients (See Section 1: Specifications, 5.3. Known interfering substances) and WBC balance (See Section 3: Specimen run & Results, 7.4.7. WBC balance).

14. Flags on WBC/BASO histogram

CBC and DIFF mode

In certain cases, the L1 flag will not be triggered off because of the poor sensitivity of this flag (large platelet aggregates and/or erythroblasts that are beyond the electronic treshold). This happens in CBC mode only. Two additional flags LL and LL1 are available in DIFF mode and provide more reliability in anomaly detection. This mode should be recommended.

15. WBC balance

CBC mode Limitations The WBC balance flag will indicate an instrument defect or it can also highlight a known interference (See Section 1: Specifications, 5.3. Known interfering substances). In the case of pathology whose treatments weaken the leukocytic membranes, the agent of lysis of WBC channel can damaged the cells and give a lower leukocytes counting. The LMNE+ flag will then be triggered off and a suspicion will be integrated to the WBC results. We thus recommend not to disable WBC balance flag and to work in DIFF mode for all the samples which can present this possible interference. Selecting the CBC mode will disable this control mode. It is thus recommended to use this mode for patient not presenting this type of interference.

8/8

Instrument User Manual Update

RAM200AEN

ABX Pentra 60 C+

Instrument default settings

Please, take note of the modifications on next pages. Please, cross out the appropriate sections in the user manual prior to inserting this addendum at the beginning of the user manual.

FORM 0860 - rev 1

Date: 10/10/06

Instrument default settings RAM200AEN

Instrument default settings

Tab.1-1: Concerned sections of the manual

Section Page Paragraph Item change

Instrument Configuration

Type parametering

Addition of Instrument Default parametering charts

1. General information

Type parametering:

- The following values are the software default values for pathological limits & thresholds (See “2.Pathological

limits and thresholds, page 2”), Alarm levels (“3.Alarms levels, page 5”), Matrix thresholds (See “4.Matrix thresholds, page 8”), classified by types (standard, man, woman, Child 1,2,3).

Other modifications

- Default values for XB limits ( See “6.XB limits, page 11”).

- Default values for Quality Control coefficients (“5.QC Variation Coefficients, page 11” ).