ADVIA® 120

ADVIA® 2120
ADVIA® 2120i
Hematology Systems

ADVIA® 120 / 2120 / 2120i Hematology Systems

Supplemental Information
Research Use Only (RUO)

11220948 Rev. A, 2016-10

© 2016 Siemens Healthcare Diagnostics. All rights reserved.
No part of this operator’s guide or the products it describes may be reproduced by
any means or in any form without prior consent in writing from
Siemens Healthcare Diagnostics.
ADVIA is a trademark of Siemens Healthcare Diagnostics.
All other trademarks are property of their respective owners.

The information in this operator’s guide was correct at the time of printing.
However, Siemens continues to improve products and reserves the right to change
specifications, equipment, and maintenance procedures at any time without notice.
If the system is used in a manner differently than specified by Siemens, the
protection provided by the equipment may be impaired. See warning and hazard
statements.
Contents
CONTENTS ...................................................................................................................... I

RESEARCH USE ONLY PARAMETERS ................................................................... 1

INTRODUCTION ............................................................................................................... 2
SUMMARY ...................................................................................................................... 2
BASOPHIL / LOBULARITY METHOD ................................................................................ 3
CSF METHOD ................................................................................................................. 8
HEMOGLOBIN METHOD ................................................................................................ 10
PEROXIDASE METHOD .................................................................................................. 11
RBC / PLATELET METHOD ........................................................................................... 16
NRBC METHOD ........................................................................................................... 22
RETICULOCYTE METHOD ............................................................................................. 23
LEGAL INFORMATION........................................................................................... A-1
LIMITED INSTRUMENT WARRANTY AND SERVICE DELIVERY POLICY ........................ A-2
WARRANTY AND SERVICE EXCLUSIONS ..................................................................... A-4
CONTACT INFORMATION ............................................................................................ A-5
SIEMENS AUTHORIZED REPRESENTATIVE .................................................................. A-5
WARNINGS AND SAFETY INFORMATION ........................................................ B-1
WARNINGS ................................................................................................................. B-2
SAFETY INFORMATION ............................................................................................... B-3
REGULATORY COMPLIANCE ....................................................................................... B-3
DOCUMENTATION ...................................................................................................... B-4
SYSTEM SYMBOLS ...................................................................................................... B-4
INTERPRETATION OF RESULTS .................................................................................... B-9
EXPLANATION OF THE WARNING LABELS ON THE AC POWER BOX ............................B-10
EXPLANATION OF THE WARNING LABELS ON THE MANUAL
CLOSED-TUBE SAMPLER.............................................................................................B-11
PROTECTING YOURSELF FROM LASERS ......................................................................B-12

Contents i
ii Contents
Research Use Only Parameters
INTRODUCTION ........................................................................................................... 2

SUMMARY ...................................................................................................................... 2

BASOPHIL / LOBULARITY METHOD...................................................................... 3

CALCULATING PARAMETERS .......................................................................................... 4
CSF METHOD................................................................................................................. 8
MEASUREMENT .............................................................................................................. 8
CSF SCATTER/SCATTER CYTOGRAM ............................................................................. 8
CSF SCATTER/ABSORPTION CYTOGRAM ....................................................................... 8
CALCULATING PARAMETERS .......................................................................................... 8
HEMOGLOBIN METHOD.......................................................................................... 10
CALCULATING PARAMETERS ........................................................................................ 10
PEROXIDASE METHOD ............................................................................................ 11
PEROX CYTOGRAM .................................................................................................... 11
ABNORMAL CELL LOCATIONS ...................................................................................... 11
CALCULATING PARAMETERS ........................................................................................ 13
RBC / PLATELET METHOD...................................................................................... 16
CALCULATING RBC PARAMETERS ............................................................................... 18
CALCULATING PLATELET PARAMETERS ....................................................................... 20
NRBC METHOD........................................................................................................... 22

RETICULOCYTE METHOD ...................................................................................... 23

RETICULOCYTE METHOD NOMENCLATURE .................................................................. 23
RETIC HC HISTOGRAM ............................................................................................... 24
RETIC CH HISTOGRAM ............................................................................................... 25
CALCULATING RETIC PARAMETERS ............................................................................. 26

Research Use Only Parameters 1

Introduction
This Research Use Only (RUO) supplemental information manual provides
information on Research Use Only (RUO) parameters. RUO parameters are not
FDA cleared and are not to be used for the reporting of patient results in
any form or for any clinical or diagnostic purposes. They are provided as an
aid for laboratory personnel to alert them to suspected sample abnormalities.
For routine operation and for reporting of results the ADVIA® 2120/2120i
Operator’s Manual is to be used.

Summary
This RUO manual provides information on Research Use Only (RUO)
parameters. It is used by laboratory personnel to alert them to suspected sample
abnormalities through the combined use of morphology and quantitative flags
(high and low). ADVIA 2120/2120i morphology flags are derived from a series
of complex algorithms. These algorithms are based on the identification of
conditions surrounding the presence of abnormalities.
The ADVIA 2120/2120i system does not enumerate abnormal cells. Despite a
high degree of sensitivity and specificity in detecting conditions consistent with
the presence of abnormal cells, test results produced by the ADVIA 2120/2120i
system are intended for laboratory use only. Whenever morphology or
quantitative flags are triggered, the laboratory, before reporting patient results,
must validate the results and take the appropriate action in accordance with
established standard operating procedures.
All general method and bibliographical information can be referenced in the
ADVIA 2120/2120i Operator’s Manual.

2 Research Use Only Parameters

Basophil / Lobularity Method
Location of Atypical Lymphocytes on the BASO Cytogram
Atypical Lymphocytes
appear within the
mononuclear (MN) area (1)
on the BASO cytogram.

Location of Immature Granulocytes on the BASO Cytogram

Immature Granulocytes
appear within the MN area
on the BASO cytogram.

Location of Bands on the BASO Cytogram

Bands appear between the

mononuclear (MN) and
polymorphonuclear (PMN)
populations.

Research Use Only Parameters 3

 Calculating Parameters

Additional Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

%BASO Suspect 100 x (BASO Suspect ÷ BASO PHA Cells )

%BLAST 100 x (Blasts ÷ BASO PHA Cells )

%MN 100 x (MN ÷ BASO PHA Cells )

%PMN 100 x (PMN ÷ BASO PHA Cells )

%PMN Ratio %PMN ÷ (%NEUTS + %EOS)

BASO % Dead Time 100 x FracDT

BASO % Noise 100 x (Noise ÷ BASO PHA Cells )

BASO % Saturation 100 x (BASO Saturation ÷ BASO PHA

Cells )

BASO Flatness Sum of theSquared Differences

9 × Mean Cell Counting Rate

LI PMNx ÷ MNx
MNx Peak X channel of Mononuclear cluster

MNy Peak Y channel of Mononuclear cluster

PMNx Peak X channel of Polymorphonuclear

cluster

Parameter Key
% BASO Suspect
Percent of events from Baso Suspect area
% MN
Percent of events from Mononuclear area
% PMN
Percent of events from Polymorphonuclear area
% PMN Ratio
Ratio of the percent of the Polymorphonuclear events to the percent of NEUTS
and EOS obtained from the peroxidase method
BASO % Dead Time
Percent of analysis time when the channel is busy and cannot detect flowcell
events

4 Research Use Only Parameters

 BASO % Noise
Percent of events from Noise area
BASO % Saturation
Percent of events from Saturation area
LI
Lobularity Index
% Blast
Percent of events from Blast area
BASO PHA Cells (B-acq)
The total number of events in the BASO cytogram excluding the Noise area.
BASO PHA Total (B-tot)
The total number of events in the BASO Cytogram including the Noise area.
BASO Valid Cells (B-vc)
The number of valid electronic pulse signals detected from flowcell events.
BASO Saturation
The number of events in the Saturation area (1) of the BASO cytogram.

Blasts
The number of events in the Blasts area (1) of the BASO cytogram.

Research Use Only Parameters 5

 PMN
The number of events in the PMN area (1) of the BASO cytogram.

MN
The number of events in the MN area (1) of the BASO cytogram.

Noise
The number of events in the Noise area (1) of the BASO cytogram.

6 Research Use Only Parameters

 BASO Suspect
The number of events in the Baso Suspect area (1) of the BASO cytogram.

RawWBC
BASO Valid Cells x (BASO PHA Cells ÷ BASO PHA Total)
BasoCalFactor
The sampler-specific calibration factor:
BasoCalFactor = BASO WBC (AS) x 0.0012475
BasoCalFactor = BASO WBC (MCTS) x 0.0012475
BasoCalFactor = BASO WBC (OTS) x 0.0012475
To view the BASO WBC calibration factors, click Cal/Gain Logs on the System
Logs menu.
FracDT
The fraction of time that the channel is busy processing flowcell events. While
the Baso channel is busy identifying a particular flowcell event, it is unable to
process any additional events that might occur. By measuring this "dead time,"
the analyzer can compensate for these events.

Research Use Only Parameters 7

CSF Method

Measurement
A research-use-only eosinophil count and percent ( %) is provided.

CSF Scatter/Scatter Cytogram

The CSF Scatter/Scatter Cytogram is a 100 x 100-channel, two-dimensional,
pulse height distribution of the scatter high and scatter low data for WBC, RBC,
and noise, where the X-axis is high-angle scatter and the Y-axis is low angle
scatter. A fixed mask is used to set thresholds for Neutrophil, Lymphocyte,
Monocyte and RBC regions. Eosinophils fall within the Neutrophil region in this
cytogram. The number of eosinophils is determined from the Scatter/Absorption
cytogram and is subtracted from the number of cells in the Neutrophil region
prior to calculating WBC and Neutrophil parameters. Eosinophil data is for
research purposes only and is non-reportable.

CSF Scatter/Absorption Cytogram

The CSF Scatter/Absorption Cytogram is a 100 x 100-channel, two-dimensional,
pulse height distribution of the scatter high and absorption data for WBC, RBC,
and noise, where the X-axis is absorption and the Y-axis is high angle scatter. A
fixed mask is used to set the threshold for eosinophil analysis. Because of their
higher absorption, eosinophils fall to the right of the neutrophil population in this
cytogram and are thus able to be separated from the neutrophil population. The
number of eosinophils is subtracted from the number of cells falling in the
neutrophil region of the Scatter/Scatter cytogram before calculating WBC and
Neutrophil parameters.

Calculating Parameters

Additional Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

%CSF Eos %CSF Eos = 100 x CSF Eos / CSF WBC

#CSF Eos #CSF Eos/μL = (CSF PHA Eos / CSF PHA
Total x CSF PHA Cells) / (1-Fractional Dead
Time) x Perox Nominal Factor

CSF PHA Total The total number of cells displayed in the CSF
Scatter/Scatter cytogram including the noise
region.

CSF PHA Cells The total number of cells displayed in the CSF
Scatter/Scatter cytogram excluding the noise
region.

8 Research Use Only Parameters

 Parameter Explanation

CSF %Noise The percentage of cells that are located in the

noise region of the CSF Scatter/Scatter
cytogram.

CSF PHA WBC The number of cells falling into the WBC
regions of the CSF Scatter/Scatter cytogram.
CSF PHA Eos The number of cells falling in the Eosinophil
Region of the CSF Scatter/Absorption
cytogram.

CSF PHA Lymphs The number of cells falling in the Lymphocyte

Region of the CSF Scatter/Scatter cytogram.

CSF PHA Monos CSF PHA Monos is the number of cells falling
in the Monocyte Region of the CSF
Scatter/Scatter cytogram.
CSF PHA Neuts The number of neutrophils falling in the
Neutrophil Region of the CSF Scatter/Scatter
cytogram. Due to their scatter/scatter properties,
both neutrophils and eosinophils fall in this
region of the CSF Scatter/Scatter cytogram. The
number of CSF PHA Eos is identified in the
Eosinophil Region of the CSF
Scatter/Absorption cytogram and subtracted
from the number of cells in the Neutrophil
Region of the CSF Scatter/Scatter cytogram to
determine the CSF PHA Neuts.

CSF PHA Neuts = # cells in Neutrophil Region

(CSF Scatter/Scatter Cytogram) – CSF PHA
Eos (CSF Scatter/Absorption Cytogram)

CSF R Count The number of cells falling in the Red Cell

Region of the CSF Scatter/Scatter cytogram.

Parameter Key
%CSF Eos
The research-only CSF differential percentage eosinophil cell count.
#CSF Eos
The research-only CSF absolute eosinophil cell count.

Research Use Only Parameters 9

Hemoglobin Method

Calculating Parameters

Additional Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

Delta HGB HGB - Calculated HGB

HGB Baseline Transmission Baseline Mean x 3.05194E-4

HGB Sample Transmission Sample Mean x 3.05194E-4

HGB Baseline Flatness Maximum Baseline Value -

Minimum Baseline Value

HGB Sample Flatness Maximum Sample Value -

Minimum Sample Value

10 Research Use Only Parameters

Peroxidase Method

PEROX Cytogram

Abnormal Cell Locations

If abnormal cells are present, their size and peroxidase activity determine their
location on the PEROX cytogram.

Location of Atypical Lymphocytes

on PEROX Cytogram
Atypical
lymphocytes are
large cells with no
peroxidase activity
that can appear in
the LUC area (1).

Location of Blasts on PEROX Cytogram

Similarly, blasts
and other large
abnormal cells
with no peroxidase
activity also appear
in the LUC area
(1).

Research Use Only Parameters 11

 Location of Immature Granulocytes on PEROX Cytogram
Immature Granulocytes
are large cells with high
peroxidase activity that can
appear in the neutrophil area
(1) and the saturation area
(2).

Location of Bands on PEROX Cytogram

Bands appear within the the

Neutrophil population (1)
due to their similar size and
degree of peroxidase
staining.

Location of Platelet Clumps on PEROX Cytogram

Platelet Clumps form a

separate cluster (1) that
originates in the Noise area
on the PEROX cytogram.

12 Research Use Only Parameters

 Location of Unlysed RBCs on PEROX Cytogram

Unlysed RBCs with no

peroxidase activity appear
along the left side of the
PEROX cytogram.

Calculating Parameters

Additional Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

%HPX 100 x (HPX ÷ PHA Cells )

Clumps Count Number of events in the Platelet Clumps area of the

PEROX cytogram

Valley Count Number of events in the NRBC area of the

PEROX cytogram

Lymph Mode Mode channel of the Lymphocyte cluster

MPXI ( X Mean of Sample Neut - Expected staining index) * 100

Expected staining index

NEUT X Mean X channel for neutrophil cluster

NEUT Y Mean Y channel for neutrophil cluster

Noise/Lymph Valley Valley channel between Noise and Lymph clusters

Perox d/D Lymph Mode Count - Noise / Lymph Valley Count

Lymph Mode Count

PEROX % Dead Time 100 x FracDT

PEROX % Noise 100 x (Noise ÷ PHA Cells )

PEROX % Saturation 100 x (Perox Saturation ÷ PHA Cells )

PEROX Flatness Sum of theSquared Differences

9 × Mean Cell Counting Rate

Research Use Only Parameters 13

 Parameter Key
RawWBC
Perox Valid Cells x (PHA Cells ÷ PHA Total)
PeroxCalFactor
The sampler-specific calibration factor:
PeroxCalFactor = PEROX WBC (AS) x 0.001248
PeroxCalFactor = PEROX WBC (MCTS) x 0.001248
PeroxCalFactor = PEROX WBC (OTS) x 0.001248
To view the PEROX WBC calibration factors, select Cal/Gain Logs at the
System Logs menu.
FracDT
The fraction of time that the channel is busy processing flowcell events. While
the perox channel is busy identifying a particular flowcell event, it is unable to
process any additional events that might occur. By measuring this "dead time,"
the analyzer can compensate for these events.
MPXI
The mean peroxidase activity index or staining intensity of the neutrophil
population relative to the archetype.
PEROX PHA Cells (P-acq)
The total number of events in the PEROX cytogram excluding the Noise area.
NOTE: nRBC and PLT Clump events are components of Perox Noise. Therefore,
they are not included in the PEROX PHA Cells.
PEROX PHA Total (P-tot)
The total number of events in the PEROX cytogram including the Noise area.
Perox Valid Cells (P-vc)
The number of valid electronic pulse signals detected from flowcell events.
HPX
The number of events with absorption values greater than 1.4 times the X
channel mean of the neutrophil cluster.
Clumps Count
The number of events in the
Platelet Clumps area (1) of
the PEROX cytogram.

14 Research Use Only Parameters

 Valley Count
The number of events in the
NRBC area (1) of the
PEROX cytogram.

Perox Noise

The number of events in the

Noise area (1) of the
PEROX cytogram.

Perox Saturation
The number of events in the
Saturation area (1) of the
PEROX cytogram.

Research Use Only Parameters 15

RBC / Platelet Method

RBC Volume histogram (microcytic sample)

1 Microcytic region
2 Normocytic region
3 Macrocytic region
4 60 fL marker
5 120 fL marker

In samples with increased numbers of microcytic red blood cells, the histogram
curve shifts to the left, indicating an increase in the percentage of the cells with
volumes less than 60 fL.

RBC Volume histogram (macrocytic sample)

1 Microcytic region
2 Normocytic region
3 Macrocytic region
4 60 fL marker
5 120 fL marker

In samples with increased numbers of macrocytic red blood cells, the histogram
curve shifts to the right, indicating an increase in the percentage of the cells with
volumes greater than 120 fL.

RBC Volume histogram (anisocytosis)

1 Microcytic region
2 Normocytic region
3 Macrocytic region
4 60 fL marker
5 120 fL marker

RDW is monitored as an indication of anisocytosis, and the results are flagged if

the RDW exceeds 16%. Note that two specimens with the same RDW value can
have different degrees of microcytosis and macrocytosis.

16 Research Use Only Parameters

 RBC HC histogram (hypochromic sample)
1 Hypochromic region
2 Normochromic region
3 Hyperchromic region
4 28 g/dL marker
5 41 g/dL marker

In samples with increased numbers of hypochromic RBCs, the histogram curve

shifts to the left, indicating an increase in the percentage of the cells with
hemoglobin concentrations less than 28 g/dL.

RBC HC histogram (hyperchromic sample)

1 Hypochromic region
2 Normochromic region
3 Hyperchromic region
4 28 g/dL marker
5 41 g/dL marker

In samples with increased numbers of hyperchromic RBCs, the histogram curve

shifts to the right, indicating an increase in the percentage of the cells with
hemoglobin concentrations greater than 41 g/dL.

RBC HC histogram (Hgb variance sample)

1 Hypochromic region
2 Normochromic region
3 Hyperchromic region
4 28 g/dL marker
5 41 g/dL marker

HDW provides an indication of Hgb concentration variance, and the results are
flagged if the HDW exceeds 3.4 g/dL. Note that two specimens with the same
HDW value can have different degrees of hypochromia and hyperchromia.
Since the histogram analysis uses calibration factors that are not applied to the
RBC V/HC cytogram, there can be a discrepancy between the RBC matrix values
and the corresponding %Micro, %Macro, %Hypo, and %Hyper values obtained
from the histograms based on the value of the calibration factors. The closer the
MCV and CHCM calibration factors are to 1.0, the smaller the discrepancies are.

Research Use Only Parameters 17

 Calculating RBC Parameters

Additional Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

CHDW SD of RBC CH histogram

RBC Flatness Sum of theSquared Differences

9 × Mean Cell Counting Rate

RBC % Dead 100 x (Measured Dead Time ÷ Measured Sample

Time Time)
RBC Coin Number of coincidence events to be trimmed
Level

RBC Coin Coincidence Count in RBC Scatter cytogram

Count
RBC R Number of RBCs in RBC Scatter cytogram
Count
RBC P Count Number of platelets in RBC Scatter cytogram

RBC Valid Number of Valid Signals Obtained from Flowcell

Cells Events

#MICRO Cell Count (30 fL to 60 fL) in RBC Volume histogram

%MACRO Cell Count in RBC Volume histogram > 120 fL

100 ×
Total Cell Count in RBC Volume histogram

%MICRO Cell Count in RBC Volume histogram < 60 fL

100 ×
Total Cell Count in RBC Volume histogram

%HYPER Cell Count in RBC HC histogram > 41g/dL

100 ×
Total Cell Count in RBC HC histogram

%HYPO Cell Count in RBC HC histogram < 28g/dL

100 ×
Total Cell Count in RBC HC histogram

%MICRO/ %MICRO ÷ %HYPO

%HYPO
RATIO

18 Research Use Only Parameters

 Parameter Key
CHDW
Cell Hemoglobin Distribution Width
RBC % Dead Time
Percent of analysis time when the channel is busy and cannot detect flowcell
events
RBC Coin Level
RBC Coincidence Level
RBC Coin Count
RBC Coincidence Count
RBC R Count
Raw red blood cell count from the RBC method
RBC P Count
Raw platelet count from the RBC method
% MACRO
Percent of macrocytic red blood cells
% MICRO
Percent of microcytic red blood cells
# MICRO
Number of microcytic red blood cells
% HYPER
Percent of hyperchromic red blood cells
% HYPO
Percent of hypochromic red blood cells
%Micro / %Hypo Ratio
This parameter is reported to be of use in differentiating two types of microcytic
anemia.

Research Use Only Parameters 19

 Calculating Platelet Parameters

Additional Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

Large PLT Platelets with volumes greater than

20 fL

MPC Mean of Platelet PC histogram

MPM Mean of Platelet PM histogram

PCDW SD of Platelet PC histogram

P Count - 2D Raw cell count for platelets and large

platelets from 2D-platelet analysis

PCT (PLT x MPV) ÷ 10,000

PDW 100 x (SD of Platelet VOL histogram

÷ MPV)
PLT N Mean of refractive index values for
platelets only

PLT X Mean of high-angle, high-gain values

for platelets only

PLT Y Mean of low-angle, high-gain values

for platelets only

PMDW SD of Platelet PM histogram

R Count - 2D Raw cell count for RBCs, RBC

ghosts, and RBC fragments from 2D-
platelet analysis

RBC - 2D Count Number of Red Cells-2D from 2D-

platelet analysis x RBC Cal Factor x
Dilution Factor x Coincidence-
correction Factor

RBC Fragments Count of RBC Fragments

RBC Ghosts Count of RBC Ghosts

20 Research Use Only Parameters

 Parameter Key
Large PLT
The count of platelets with volumes greater than 20 fL is derived from the
Platelet Volume histogram based on Integrated Analysis.
Large Platelet Count is in the same units selected for PLT on the Unit Set
Configuration window of the System Setup tab.
RBC Fragments
This count includes events in the RBC Fragment area of the PLT Scatter
cytogram that have volumes less than 30fL and refractive indexes greater than
1.400.
1 RBC Ghost area
2 Platelet area
3 RBC Fragment area

The RBC Fragments Count is in the same units selected for RBC on the Unit Set
Configuration window of the System Setup tab.
RBC Ghosts
This count includes events in the RBC Ghost area of the PLT Scatter cytogram
that have refractive indexes lower than 1.350.
1 RBC Ghost area
2 Platelet area
3 RBC Fragment area

The RBC Ghosts Count is in the same units selected for RBC on the Unit Set
Configuration window of the System Setup tab.
MPC
Mean Platelet Component Concentration
MPM
Mean Platelet Dry Mass
PCDW
Platelet Component Distribution Width

Research Use Only Parameters 21

 PDW
Platelet Volume Distribution Width
PMDW
Platelet Dry Mass Distribution Width
PCT
Platelet Crit
RBC Fractional Dead Time
The fraction of time that the channel is busy processing flowcell events. While
the RBC/Plt channel is busy identifying a particular flowcell event, it is unable to
process any additional events that might occur. By measuring this "dead time,"
the analyzer can compensate for the missed events.
Note that the RBC / Plt channel dead time has RBC and platelet components.
Corrected Platelet Count
The corrected platelet count is calculated using the P Count-2D , R Count-2D
RBC Fractional Dead Time, and RBC Valid Cells.
P Count-2D
The number of cells identified as platelets and large platelets. The platelets are
obtained from the PLT Scatter cytogram, and the large platelets are obtained
from the integrated analysis.
R Count-2D
The count of RBCs, RBC ghosts, and RBC fragments that is obtained from the
integrated analysis.
Number of red cells-2D
(R Count-2D x RBC Valid Cells) ÷ (R Count-2D + P Count-2D)
NRBC Method

Calculating Reported NRBC Parameters

The system corrects the reported WBC count when nRBCs are detected.
Histo, Residual, or WBCu
Gaussian Count % NRBC
1+
100

Barox Count ⎛ % Neut + % Eos ⎞ ⎛ % MN + % Baso ⎞

WBCB − ⎜WBCP x ⎟ + ⎜WBCB x ⎟
⎝ 100 ⎠ ⎝ 100 ⎠

22 Research Use Only Parameters

Reticulocyte Method

Reticulocyte Method Nomenclature

Mature (m),
The lowercase letter m, is commonly used in the reticulocyte parameters to
identify a specific population.
For example: MCVm, refers to the mean cell volume for the mature RBC.

Immature Reticulocyte Fraction

Immature Reticulocyte Fraction (IRF) is a descriptive term recommended in
NCCLS Document H44-A "Methods for Reticulocyte Counting: Flow Cytometry
and Supravital Dyes; Approved Guideline" to replace a previously-used term,
Reticulocyte Maturation Index (RMI).
Two IRF parameters are calculated: IRF-H and IRF-H+M.

RETIC Volume Histogram Parameters

%MACROm Percentage of mature RBC population with cell
volumes greater than 120 fL
%MICROr Percentage of reticulocyte population with cell
volumes less than 60 fL
%MICROm Percentage of mature RBC population with cell
volumes less than 60 fL
%MICROg Percentage of gated cell population with cell
volumes less than 60 fL
MCVm Mean Corpuscular Volume is the mean of the
RETIC Volume histogram for the mature RBC
population.
MCV Delta MCVr - MCVm
RDWr Red cell Distribution Width is the coefficient of
variation (CV) of the RETIC Volume histogram
(channels 15 to 99) for the reticulocyte population.
RDWm Red cell Distribution Width is the coefficient of
variation (CV) of the RETIC Volume histogram
(channels 15 to 99) for the mature RBC population.
RDWg Red cell Distribution Width is the coefficient of
variation (CV) of the RETIC Volume histogram
(channels 15 to 99) for the gated cells.
RDW Delta RDWr - RDWm

Research Use Only Parameters 23

 RETIC HC Histogram
The RETIC hemoglobin concentration (RETIC HC) histogram represents the
overlaid distributions of mature RBCs and reticulocytes by cellular hemoglobin
concentration only. The histogram has a range from 0 g/dL to 50 g/dL. The
displayed data includes the CHCMg calibration factor.
Mature RBC population
(red)
Reticulocyte population
(blue)

RETIC HC Histogram Parameters

%HYPERr Percentage of reticulocyte population with cellular
hemoglobin concentration greater than 41 g/dL
%HYPERm Percentage of mature RBC population with cellular
hemoglobin concentration greater than 41 g/dL
%HYPERg Percentage of gated cell population with cellular
hemoglobin concentration greater than 41 g/dL
%HYPOr Percentage of reticulocyte population with cellular
hemoglobin concentration less than
28 g/dL
%HYPOm Percentage of mature RBC population with cellular
hemoglobin concentration less than
28 g/dL
%HYPOg Percentage of gated cell population with cellular
hemoglobin concentration less than 28 g/dL
CHCMm Cellular Hemoglobin Concentration Mean is the
mean of the RETIC HC histogram for the mature
RBC population.
CHCM Delta CHCMr - CHCMm
HDWr Hemoglobin Distribution Width is the standard
deviation (SD) of the RETIC HC histogram for the
reticulocyte population.
HDWm Hemoglobin Distribution Width is the standard
deviation (SD) of the RETIC HC histogram for the
mature RBC population.
HDWg Hemoglobin Distribution Width is the standard
deviation (SD) of the RETIC HC histogram for the
gated cells.
HDW Delta HDWr - HDWm

24 Research Use Only Parameters

 RETIC CH Histogram
The RETIC cellular hemoglobin (RETIC CH) histogram represents the overlaid
distributions of mature RBCs and reticulocytes by the actual weight or mass of
hemoglobin present in each cell. The histogram has a range from 0 pg to 100 pg.
Mature RBC population
(red)
Reticulocyte population
(blue)

RETIC CH Histogram Parameters

%HIGH CHr Percentage of reticulocyte population with
cellular hemoglobin greater than 31 pg
%HIGH CHm Percentage of mature RBC population with
cellular hemoglobin greater than 31 pg
%HIGH CHg Percentage of gated cell population with cellular
hemoglobin greater than 31 pg
%LOW CHr Percentage of reticulocyte population with
cellular hemoglobin less than 27 pg
%LOW CHm Percentage of mature RBC population with
cellular hemoglobin less than 27 pg
%LOW CHg Percentage of gated cell population with cellular
hemoglobin less than 27 pg
CHm Cellular Hemoglobin Mean is the mean of the
RETIC CH histogram for the mature RBC
population.
CH Delta CHr - CHm
CHDWr Cellular Hemoglobin Distribution Width is the
standard deviation (SD) of the RETIC CH
histogram for the reticulocyte population.
CHDWm Cellular Hemoglobin Distribution Width is the
standard deviation (SD) of the RETIC CH
histogram for the mature RBC population.
CHDWg Cellular Hemoglobin Distribution Width is the
standard deviation (SD) of the RETIC CH
histogram for the gated cells.
CHDW Delta CHDWr - CHDWm

Research Use Only Parameters 25

 Calculating Retic Parameters

System Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

RTC RBC RBC Count

RTC Flatness Sum of theSquared Differences

9 × Mean Cell Counting Rate

RTC % Dead Time 100 x (Measured Dead Time ÷

Measured Sample Time)
RTC % Noise 100 x (Outlier Cells ÷ #RTC Cells
Analyzed)
Mean Absorption Mean of the RETIC Abs histogram for
the reticulocyte population
ABS Low Cell Count Counts in x axis channels 1 to 3 of the
RETIC Scatter Abs cytogram
ABS Mode Mode channel of the Absorption
population
RTC Valid Cells Number of Valid Signals Obtained
from Flowcell Events

Additional Parameters
The following parameters are for research or laboratory use only and are not for
patient reporting:
Parameter Explanation

MCVm Mean of the RETIC Volume histogram

for the mature population
#Neg RBC Number of mature RBCs

%Neg RBC 100 x (#Neg RBC ÷ #RTC Gated Cells)

Retic Count Number of reticulocyte events

#LRetic Number of low absorption reticulocytes

%LRetic 100 x (#LRetic ÷ RETIC Count)

#MRetic Number of medium absorption

reticulocytes
%MRetic 100 x (#MRetic ÷ RETIC Count)

26 Research Use Only Parameters

 Parameter Explanation

#HRetic Number of high absorption

reticulocytes
%HRetic 100 x (#HRetic ÷ RETIC Count)

IRF-H 100 x (#HRetic ÷ RETIC Count)

IRF-M+H 100 x ([#HRetic + #MRetic] ÷ RETIC

Count)
RTC Mean X Mean x channel of the RETIC Scatter
cytogram
RTC Mean Y Mean y channel of the RETIC Scatter
cytogram
#RTC Cells Acquired Number of Valid Signals Obtained
#RTC Cells Analyzed Cells on RTC Scatter cytogram with
nonzero volume and hemoglobin
values, and are not in channel 99
#RTC Gated Cells #Neg RBC + Retic Count within
threshold limits
Slope Negative Cells Slope of the negative (mature RBC)
population relative to y axis of the
RETIC Scatter ABS cytogram

Parameter Key
MCVm
Mean Cell Volume of mature population
RTC RBC
Red blood cell count from the Reticulocyte method. The RTC RBC count is
calculated in the same manner as the RBC count from the RBC / Platelet Method.
RTC % Dead Time
Percent of analysis time when the channel is busy and cannot detect flowcell
events
RTC % Noise
Percent of events from the outlier areas

Research Use Only Parameters 27

 Outlier Cells

The outlier cell count

includes cells with high-
scatter values less than the
RTC Platelet threshold, and
cells with high-scatter values
greater than the RTC
Coincidence threshold.

RTC Gated Cells

The number of cells between

the RTC platelet and RTC
coincidence thresholds in the
Retic Scatter Abs cytogram
excluding channel 99.

Neg RBC

The number of cells in the

mature RBC area (1) of the
Retic Scatter Abs cytogram.

# Neg RBC
Count of mature red blood cells
% Neg RBC
Percent of mature red blood cells

28 Research Use Only Parameters

 Number of Low Absorption Reticulocytes

The number of gated cells

(1) between the RTC and
Low/Medium RTC
thresholds of the Retic
Scatter Abs cytogram.

#LRetic
Count of low absorption reticulocytes
%LRetic
Percent of low absorption reticulocytes
Number of Medium Absorption Reticulocytes

The number of gated cells

(1) between the
Low/Medium RTC and
Medium/High RTC
thresholds of the Retic
Scatter Abs cytogram.

#MRetic
Count of medium absorption reticulocytes

Research Use Only Parameters 29

 %MRetic
Percent of medium absorption reticulocytes
Number of High Absorption Reticulocytes

The number of gated cells

(1) to the right of the
Medium/High RTC
threshold of the Retic
Scatter Abs cytogram.

#HRetic
Count of high absorption reticulocytes
%HRetic
Percent of high absorption reticulocytes

30 Research Use Only Parameters

Legal Information
LIMITED INSTRUMENT WARRANTY AND SERVICE DELIVERY POLICY .. 2
WARRANTY PERIOD ....................................................................................................... 2
ADDITIONAL SERVICE PERIOD ....................................................................................... 2
SERVICE DURING NORMAL HOURS ................................................................................ 3
EXTENT OF A SERVICE CALL .......................................................................................... 3
SERVICE OUTSIDE NORMAL HOURS ............................................................................... 3
REPLACEMENT OF PARTS ............................................................................................... 3
DESIGN CHANGES AND RETROFITTING OF INSTRUMENTS............................................... 3
KEY OPERATOR DESIGNATION ....................................................................................... 4
OSHA REQUIREMENTS (US ONLY) ................................................................................ 4
WARRANTY AND SERVICE EXCLUSIONS ............................................................ 4

CONTACT INFORMATION......................................................................................... 5

SIEMENS AUTHORIZED REPRESENTATIVE........................................................ 5

ADDRESSES .................................................................................................................... 6

Legal Information A-1

 This section provides the following information:
• address of the Siemens authorized representative, which is the Siemens
contact within the European community
• addresses for obtaining service and technical information and for ordering
supplies
• system warranty and service delivery policy information

Limited Instrument Warranty and Service Delivery Policy

Siemens and its authorized distributors may provide customers who acquire new
Siemens instruments with a limited warranty either in a specific agreement or in
standard language on their invoices. This limited warranty is designed to protect
customers from the cost associated with repairing instruments that exhibit
malfunctions due to defects in materials and/or workmanship during the warranty
period.
Siemens, at its election, provides warranty service either by providing repair
service of the instrument on site, or by exchanging the defective instrument or
component, subject to the limitations and exclusions set forth in Replacement of
Parts and Warranty and Service Exclusions below. Repairs, replacements or
exchanges of instruments or components provided during the warranty or any
additional service period, does not extend the warranty or service period beyond
the initially agreed upon period.
When the customer calls for service, the Siemens representative or authorized
distributor informs the customer of the type of service available for the
customer’s instrument, and instructs the customer as to how to obtain that
service.

Warranty Period
The limited warranty period generally commences upon installation of the
original instrument at the customer’s location and extends for a period of 1 year
thereafter, unless otherwise specifically agreed to by and between Siemens (or its
authorized distributors) and customer in a writing signed by duly authorized
representatives of both parties (sales representatives are generally not authorized
representatives of Siemens for these purposes).

Additional Service Period

The customers, with some exceptions, may purchase additional service coverage
beyond any initial warranty period as part of the original instrument acquisition
for second or subsequent years beyond the original installation date. The
customer’s original Purchase Invoice or appropriate Agreement Addendum must
indicate the term in months for additional service coverage.

A-2 Legal Information

 Service During Normal Hours
The customer may obtain service for instruments during normal business hours
by contacting the nearest Siemens location or authorized distributor. Refer to the
list of Siemens locations in this section.

Extent of a Service Call

Warranty or service calls generally include onsite repair or exchange of
instruments or components, travel to the location of the instrument, and onsite
labor during normal business hours. A warranty or service call is initiated by the
customer by following the instructions on how to obtain service for the
customer’s instrument. The service call is considered complete when any defects
in material or workmanship have been corrected by repair or replacement and the
instrument conforms to the applicable specifications. When service is complete,
the customer receives a copy of the documentation detailing all work performed
by the Siemens representative or authorized distributor.

Service Outside Normal Hours

Customers, with some exceptions, may also request service to be delivered or an
exchange to be initiated outside normal business hours, including evenings,
weekend days, or nationally observed holidays, by contacting the nearest
Siemens location or authorized distributor. Service performed outside normal
hours is subject to a surcharge unless the customer has in place a service product
option that provides service at the time requested.

Replacement of Parts
In performing service, Siemens or its authorized distributors provide appropriate
parts to repair the instrument, or arranges for the exchange of the instrument or
affected parts, at no charge with the exception of certain parts or subassemblies
that are considered Customer Maintenance Items. Customer Maintenance Items
include, but are not limited to, the following items: lamps, electrodes or sensors
(which are covered by a separate warranty), reagents, calibrators, controls, paper,
and pens. Consult the appropriate system operator’s manuals for a complete list
of Customer Maintenance Items for any specific model of instrument.

Design Changes and Retrofitting of Instruments

Siemens reserves the right to change the design or construction of specific
models of instruments at any time without incurring any obligation to make such
changes available to individual customers or instruments. If Siemens notifies
customers of a change that improves the performance or reliability of their
instrument, and requests to retrofit that instrument, the customer must agree to
allow Siemens or an authorized distributor, at Siemens’ expense, to retrofit
components or make design changes, which does not adversely affect the
instrument’s performance characteristics.

Legal Information A-3

 Key Operator Designation
Each customer designates a key operator who is available to Siemens
representatives to describe instrument malfunctions by telephone and/or to
perform simple adjustments and corrections as requested. If a key operator is not
designated or is unavailable when the customer requests service, the delivery of
service may be delayed.

OSHA Requirements (US only)

When service is required at a customer location, the customer must provide the
Siemens representative with adequate facilities that comply with the regulations
of the Secretary of Labor under the Occupational Safety and Health Act (OSHA)
of 1970, as amended.

Warranty and Service Exclusions

The following exclusions are in addition to any exclusions provided for in any
written warranty or service agreement.
IF ANY OF THE FOLLOWING EVENTS OCCUR, THE WARRANTY OR
SERVICE PROVISIONS DO NOT APPLY:

1. Repairs or modifications have been made to the instrument by someone other

than an authorized Siemens representative.
2. The instrument has been operated using accessories and supplies other than
Siemens brand accessories, or consumable supplies and/or reagents not
having the same grade, quality, and composition as defined in the system
operator’s manuals.
3. Siemens has notified customers of a change that improves the performance or
reliability of their instrument and customer has not agreed to retrofit or make
design changes to the instrument.
4. Customer did not purchase the instrument from Siemens or one of its
authorized distributors.
5. The instrument has not been installed within 90 days of shipment to the
customer’s facility unless otherwise specified.
6. The customer has not performed appropriate customer maintenance
procedures, as outlined in the system operator’s manuals.
7. The instrument has been misused or used for a purpose for which it was not
intended.
8. The instrument has been damaged in transit to the customer or damaged by
the customer while moving or relocating it without supervision by a Siemens
representative.
9. Damage was caused by floods, earthquakes, tornados, hurricanes, or other
natural or man-made disasters.
10. Damage was caused by Acts of War, vandalism, sabotage, arson, or civil
commotion.

A-4 Legal Information

 11. Damage was caused by electrical surges or voltages exceeding the tolerances
outlined in the system operator’s manuals.
12. Damage was caused by water from any source external to the instrument.
13. The customer has purchased an alternative agreement whose terms of
warranty or service supersede these provisions.
Siemens or its authorized distributors can invoice customers, at current standard
labor and parts rates, for instruments repaired to correct damage or malfunctions
due to any of the reasons listed above.
OTHER THAN AS STATED ABOVE, THERE ARE NO OTHER
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE
INSTRUMENT, ITS SALE TO THE CUSTOMER, ITS LEASE TO THE
CUSTOMER, OR THE SALE OF THE INSTRUMENT TO THE CUSTOMER
AT THE EXPIRATION OR TERMINATION OF THE LEASE AGREEMENT.
SIEMENS HEALTHCARE DIAGNOSTICS SPECIFICALLY DISCLAIMS
ANY AND ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR USE OR PURPOSE.
SIEMENS HEALTHCARE DIAGNOSTICS’ LIABILITY FOR BREACH OF
ANY WARRANTY OR SERVICE AGREEMENT SHALL BE LIMITED
ONLY TO THE REPAIR OR REPLACEMENT OF DEFECTIVE
EQUIPMENT AND SHALL NOT INCLUDE ANY DAMAGES OF ANY
KIND, WHETHER DIRECT, INDIRECT, INCIDENTAL, CONTINGENT, OR
CONSEQUENTIAL. SIEMENS SHALL NOT BE LIABLE FOR DELAY
FROM ANY CAUSE IN PROVIDING REPAIR OR EXCHANGE SERVICE.
ANY LIMITATIONS OR OTHER PROVISIONS NOT CONSISTENT WITH
APPLICABLE LAW IN PARTICULAR JURISDICTIONS OR A SPECIFIC
WRITTEN AGREEMENT DO NOT APPLY TO CUSTOMERS IN THOSE
JURISDICTIONS OR SUBJECT TO THOSE AGREEMENTS.

Information for Technical Assistance

Refer to the procedures in this appendix to provide system information that you
may need when you call for technical assistance.

Contact Information
This section provides the following information:
• the address of the Siemens authorized representative, which is the Siemens
contact within the European community
• the Siemens addresses for obtaining service and technical information and
for ordering supplies

Siemens Authorized Representative

Siemens Healthcare Diagnostics Ltd.
Sir William Siemens Sq., Frimley, Camberley, UK GU16 8QD.

Legal Information A-5

 Addresses
For technical assistance contact your local technical support provider. For
customer service or additional information contact your local technical support
distributor.

www.siemens.com/diagnostics

A-6 Legal Information

Warnings and Safety Information
WARNINGS ..................................................................................................................... 2

SAFETY INFORMATION ............................................................................................. 3

REGULATORY COMPLIANCE .................................................................................. 3

STANDARDS OR REGULATIONS ....................................................................................... 3
CE MARK REQUIREMENTS .............................................................................................. 3
NOISE-LIMIT REQUIREMENT ........................................................................................... 4
DOCUMENTATION....................................................................................................... 4

SYSTEM SYMBOLS....................................................................................................... 4

INTERPRETATION OF RESULTS.............................................................................. 9

EXPLANATION OF THE WARNING LABELS ON THE AC POWER BOX...... 10

EXPLANATION OF THE WARNING LABELS ON THE MANUAL

CLOSED-TUBE SAMPLER ........................................................................................ 11

PROTECTING YOURSELF FROM LASERS .......................................................... 12

RBC LASER OPTICAL ASSEMBLY .................................................................................. 12
AUTOSAMPLER BARCODE READER .............................................................................. 13

Warnings and Safety Information B-1

Warnings

ELECTRICAL WARNING

To avoid exposure to shock hazards and/or damage to the instrument while

performing this procedure, power off the analyzer before proceeding.

BIOHAZARD

All products or objects that come in contact with human or animal body fluids
should be handled, before and after cleaning, as if capable of transmitting
infectious diseases. Wear facial protection, gloves, and protective clothing.
The operator should follow the recommendations to prevent the transmission of
infectious agents in health-care settings as recommended by the Clinical and
Laboratory Standards Institute (formerly NCCLS) in Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved Guideline - Third
Edition. 2005. CLSI Document M29-A3. This document contains complete
information on user protection and it can be used as reference material for
instructions on laboratory safety.

LASER WARNING

To avoid damage to the eyes, never look directly at the laser beam or at its
reflection from a shiny surface. All field service procedures must be followed
precisely. Only Siemens-trained field service personnel should perform
procedures related to laser assemblies.
For more safety information and laser specifications, refer to Safety
Information, Protecting yourself from lasers.

WARNING

Regular strength household bleach is 5% sodium hypochlorite. Extra-strength

household bleach is 6% sodium hypochlorite. Either strength may be used with
the ADVIA 2120/2120i Hematology System. When using or handling ADVIA
EZ KLEEN / EZ WASH, bleach, any cleaning or antiviral agent, or any other
potentially hazardous liquids, wear protective clothing, gloves, and safety
glasses. Siemens further recommends the use of face shields with safety
glasses whenever using or handling these materials to provide optimal
safety. These materials are harmful if swallowed and may cause eye or skin
irritation.
Use household bleach that is free of heavy metals, such as Clorox.

B-2 Warnings and Safety Information

 To prepare a 25% solution of household bleach, dilute one part of bleach with
three parts of clean distilled water, or clean deionized water. The prepared
solution is stable for one week when stored at room temperature.

Safety Information
Safety features have been incorporated into the ADVIA 2120/2120i system to
protect the operator from injury, the analyzer from damage, and the test results
from inaccuracies.

Regulatory Compliance

Standards or Regulations
The ADVIA 2120/2120i conforms to the following safety standards or
regulations:
EN61010-1: 1993 Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use; Part 1
EN60825-1 Safety of Laser Products; Part 1
UL 3101-1 Electrical Equipment for Laboratory Use; Part 1:
General Requirements.
CAN/CSA C22.2 No. Safety requirements for Electrical Equipment for
1010.1 - 92 Measurement, Control, and Laboratory Use; Part 1:
General Requirements
CFR 47: Chapt. 1 This equipment has been tested and found to comply
FCC Subpart B with the limits of a Class A digital device, pursuant to
Part 15.103 part 15 of the FCC Rules. These limits are designed to
Exempted Devices (C) provide reasonable protection against harmful
Part 15.105 (A) interference when equipment is operated in a
commercial environment. This equipment generates,
uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction
manual, may cause harmful interference to radio
communications. Operation of this equipment in a
residential area is likely to cause harmful interference,
in which case the user will be required to correct the
interference at his own expense.

CE Mark Requirements
The ADVIA 2120/2120i conforms to the following standard. It therefore meets
the EMC conformity requirements for “CE” marking according to the European
IVDD Directive 98/79 EC.
EN 61326-1 1997+ Electrical Equipment for measurement, control, and
A1:1998 + A2:2001 laboratory use - EMC requirements
(Class "A")

Warnings and Safety Information B-3

 Noise-limit Requirement
The ADVIA 2120/2120i conforms to the following noise-limit requirement:
EN27779: 1989 Measurement of Airborne Noise Emitted By Computer and
Business Equipment (61 dBA)

Documentation
In the printed and online documentation, all hazards (except those associated
with reagents) are categorized as follows:
WARNING Indicates the risk of personal injury or loss of life if operating
procedures and practices are not correctly followed.
CAUTION Indicates the possibility of damage to or destruction of
equipment if operating procedures and practices are not strictly
observed.
IMPORTANT Indicates that system functions, including test results, may be
adversely affected if operating procedures and practices are not
correctly followed.
Hazards associated with the presence, handling, or use of required reagents are
categorized as follows:
CAUTION ! Indicates a hazard that could cause illness, burns, skin reactions,
and so on. Substances such as diluted acids, mild caustics,
minor skin irritants, and combustible materials are assigned to
this category.
ATTENTION Indicates that a specific risk exists to the user or performance.
Refer to the labels on the reagent containers and to the Material Safety Data
Sheets for information about the hazards and precautions associated with the
reagents.

System Symbols
This section describes the symbols that can appear on the exterior of the ADVIA
2120/2120i system or on the system packaging. The symbols on the system
provide you with the location of certain components and with warnings for
proper operation. The symbols on the system packaging provide you with other
important information.

B-4 Warnings and Safety Information

 Warnings and Cautions

• A Warning indicates the risk of personal

injury or loss of life if operating procedures
and practices are not correctly followed.
• A Caution indicates the possibility of loss of
data or damage to or destruction of
equipment if operating procedures and
practices are not strictly observed.

When this symbol appears on the system without

additional information, you must consult the
instructions for use.

Biohazard
The biohazard warning label mounted on the
front of the analyzer alerts you to the possibility
of exposure to a biohazard during the sampling
process or through contamination of the analyzer.
This symbol identifies a product that may contain
an infectious agent.
This symbol alerts you to a potentially harmful
substance.
These symbols together alert you to a waste
biohazard.

Laser hazard

Electrical hazard

This symbol indicates an in vitro diagnostic device

or an in vitro diagnostic medical device.
This symbol indicates that you should consult the
operating instructions for necessary information.

Warnings and Safety Information B-5

 This symbol indicates the number used for ordering
a part or product.
This symbol indicates the serial number of a part or
product.
This symbol indicates the batch code for a product.

This symbol indicates the name and location of the

product manufacturer.
This symbol indicates the date of manufacture of
the product.
This symbol indicates the manufacturer’s
authorized representative within the European
community.
This symbol indicates that the product complies
with the applicable directives of the European
Union.
This symbol indicates that the product was IEC
61010-1 safety tested by TUV for conformity to
global markets including Canada, US, and EU.
This symbol indicates that the colorimeter
conforms with DIN standard 58 960 developed by
the Working Committee on Photometers of the
Standards Committee on Medicine (NAMed) in the
DIN Deutsches Institute für Normung e.V.
This symbol indicates that the product is a Class 1
laser product, with no laser exposure during normal
operation.
This symbol indicates that the product is a Class 2
laser product, with potential exposure to a laser
beam.

This is the On symbol.

B-6 Warnings and Safety Information

 This is the Off symbol.

This is the Start symbol.

This is the Standby symbol.

This symbol indicates the switch position for normal

system operation of the waste container.

This symbol indicates the switch position for

emptying the waste container.

This symbol indicates the need to empty the waste

container.

This symbol indicates the open and closed positions

for a spigot.

This symbol indicates liquid waste.

This symbol indicates pressure. In this example, the

symbol indicates 20 PSI.

This symbol indicates vacuum. In this example, the

symbol indicates a vacuum of 20" Hg.
}
This symbol indicates the manual open-tube
sampler.

This symbol indicates the manual closed-tube

sampler.

This symbol indicates that there is a rack in the

sampler.

Warnings and Safety Information B-7

 This is the eject rack symbol.

This is the network symbol.

This is the monitor symbol.

This symbol indicates the maximum level.

This is the knob symbol.

This is the fuse symbol.

This is the filter symbol.

This is the vacushield symbol.

This is the CPU symbol.

This symbol indicates a protective terminal.

This is the barcode scanner symbol.

This symbol indicates that moving the component

can cause injury.

This symbol identifies a product that contains

recyclable material.
This symbol indicates the top of the package.

This symbol indicates the acceptable temperature

range for storage of the product.

This symbol identifies the date by which the product

should be used.

This is the Setpoint Calibrator symbol.

B-8 Warnings and Safety Information

 This is the TESTpoint 3-in-1 Hematology Control
Abnormal 1 symbol.
This is the TESTpoint 3-in-1 Hematology Control
Abnormal 2 symbol.
This is the TESTpoint 3-in-1 Hematology Control
Normal symbol.
This is the TESTpoint High Control symbol.

This is the TESTpoint Low Control symbol.

This is the TESTpoint Normal Control symbol.

This is the CSF Control 1 symbol.

This is the CSF Control 2 symbol.

This is the ADVIA RETIC High Control symbol.

This is the ADVIA RETIC Low Control symbol.
This is the DEFOAMER symbol.

This is the EZ KLEEN symbol.

This is the BASO Reagent symbol.

This is the CSF Reagent symbol.

This is the HGB Reagent symbol.

This is the CN-FREE HGB Reagent symbol.

This is the PEROX 1 Reagent symbol.

This is the PEROX 2 Reagent symbol.

This is the PEROX 3 Reagent symbol.

This is the PEROX SHEATH symbol.

This is the RBC/PLT Reagent symbol.

This is the SHEATH/RINSE symbol.

Interpretation of Results
System operators and laboratory supervisors are responsible for operating and
maintaining Siemens products in accordance with the procedures described in the
applicable Product Labeling (online documentation, package inserts, bulletins),
and for determining that product performance conforms to the applicable claims.

Warnings and Safety Information B-9

 If, under these prescribed conditions of operation and maintenance, an aberrant
or abnormal result, as defined by the laboratory protocol, occurs, laboratory
personnel should first make certain that the system is performing and is being
operated in accordance with the Product Labeling; then follow the laboratory
protocol for advising the clinician of a result that appears to have deviated from
the norms established by the laboratory.
Siemens products do not make diagnoses on patients. Siemens intends its
diagnostic products (systems, reagents, software, hardware) to be used to collect
data reflecting the patient’s chemical, hematological, or immunological status at
a certain point in time. Such data must be used in conjunction with other
diagnostic information and with the attending physician’s evaluation of the
patient’s condition to arrive at a diagnosis and a clinical course of treatment.
Any malfunction of a Siemens diagnostic product (for example, failure to meet a
performance specification or to perform as intended) should be appropriately
addressed by laboratory personnel. Various sections of the Product Labeling
address malfunctions and their possible effect on results.

Explanation of the Warning Labels on the AC Power Box

1. The AC power box must be opened by

qualified personnel only. The only
operator serviceable parts in the AC
power box are fuses F1 through F7, which
are replaced without opening the module.

2. The two electrical outlets on the side of

the AC power box are intended only for
the computer and monitor supplied with
the system. These outlets are designed to
ensure proper operation of the system
devices and to maintain the system safety AC power box location
certifications. Do not connect other
devices to them.
3. Since electrical power is still applied to some system components even
after the power switch is turned off, you must unplug the main power
before servicing the system (for example, when replacing fuses).

4. Always replace fuses F1 and F2 at the same time. Any high-current event
that causes one of these fuses to fail can damage the other one and
shorten its service life.
5. Always replace a fuse with one of the same type and rating. If the fuse
label is missing or illegible, refer to the fuse information table. Be sure to
select the fuse requirements appropriate for your system’s input voltage.

B-10 Warnings and Safety Information

Explanation of the Warning Labels on the Manual Closed-Tube Sampler
Sampler Door Manual Closed-Tube Sampler

Never put your finger into the To avoid injury when removing
manual closed-tube sampler or replacing the manual closed-
centering collar. tube sampler needle or centering
collar, the system must be off.
You must place a protective
cover over the needle
immediately after removing the
centering collar.

Warnings and Safety Information B-11

Protecting Yourself from Lasers
The ADVIA 2120/2120i Hematology System is classified as a Class I laser
product as defined by the National Center for Devices and Radiological Health
(CDRH) regulations 21 CFR 1040 and by EN-60825.

RBC Laser Optical Assembly

The RBC laser optical assembly is classified as a Class II laser device which has
a maximum power output of 800 μW at 670 nm (nominally) and a continuous
wave output. The RBC laser assembly is set internally to have a maximum output
of 290 ±58 μW. The laser beam path is enclosed in a series of non-interlocked
protective housings that prevent human access to laser radiation during operation
and maintenance of the laser product.

1 Laser Aperture

B-12 Warnings and Safety Information

 Autosampler Barcode Reader
The autosampler barcode reader is classified as a Class II laser device. It has a
maximum power output of 1 mW at a wavelength of 670 nm, a pulse duration of
90 ns, and 3.6 mr units of beam divergence.

1 Laser aperture in back of barcode reader

LASER WARNING

Some field service procedures require the removal of the protective housings that
prevent human access to the laser radiation. All field service procedures must be
followed precisely to prevent possible eye injury from the laser radiation. Only
Siemens-trained field service personnel should perform procedures related to the
ADVIA 2120/2120i laser optics bench.

Laser Hazard Precautions

The following list of precautions must be observed when servicing the ADVIA
2120/2120i laser optics:
• Remove all jewelry from hands and wrists.
• Do not look directly at the laser beam.
• Do not look at specular reflections from the laser beam.
• Do not place reflective objects, such as screwdrivers or jewelry, into the
beam path.
• Always ensure that the laser beam is terminated with a beam stop.

Warnings and Safety Information B-13

B-14 Warnings and Safety Information