Operator's Guide: Advia [PDF]

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ADVIA® 360

Hematology System

ADVIA® 360 Hematology System

Operator’s Guide

11170855 Rev. A, 2015-03

© 2015 Siemens Healthcare Diagnostics. All rights reserved. No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Siemens Healthcare Diagnostics Inc. ADVIA is a trademark of Siemens Healthcare Diagnostics Inc. All other trademarks are the property of their respective owners.

The information in this manual 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 ADVIA 360 Hematology system is used in a manner differently than specified by Siemens, the protection provided by the equipment may be impaired. Observe all warning and hazard statements.

ADVIA 360 Hematology System Operator’s Guide

Contents

Contents 1

Overview Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Back Panel Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagent Connectors on the Back Panel . . . . . . . . . . . . . . . . . . . . . Left Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Built-in Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 3 4 4 5

Principles of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Measured Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Measurement Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Photometric Light Absorbance Method . . . . . . . . . . . . . . . . . . . . . 9 Volumetric Impedance Method . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3-Part Differential Analysis Method . . . . . . . . . . . . . . . . . . . . . . . 10 Measurement Sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2 System Operation Powering-on the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 Powering-off the System . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 To power-off the ADVIA 360 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15 Using the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Entering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Logging-In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 User Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Automatic Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 User Types. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Changing the User Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

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Contents

ADVIA 360 Hematology System Operator’s Guide

3 Sample Measurements Sample Tubes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Supported Sample Tube Types . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Sample Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Sample Collection and Handling . . . . . . . . . . . . . . . . . . . . . 21 Sample Types and Sample Modes . . . . . . . . . . . . . . . . . . . . 22 Sample Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Preparing to Run Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 24 When to Run a Blank Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Running a Patient Sample . . . . . . . . . . . . . . . . . . . . . . . . . . 25 To run a sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Remote Work List (EMR) Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Interpretation of Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 The Measure Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4 Quality Control New QC Material Controls Lot . . . . . . . . . . . . . . . . . . . . . . . 33 To enter a new lot of QC material . . . . . . . . . . . . . . . . . . . . . . . . 33 To view, print, or export control lot data files . . . . . . . . . . . . . . . 34

Levey-Jennings QC chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 To view a Levey-Jennings chart . . . . . . . . . . . . . . . . . . . . . . . . . . 34 To show the Reference Values for a Lot . . . . . . . . . . . . . . . . . . . . 35

Database View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 To display the QC measurement results in database (table) view 35

5

Maintenance Parts that Can or Cannot be Serviced by Operators. . . . . . 37 User-accessible Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Before Daily Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 11170855 Rev. A

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Contents

After Daily Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Preventative Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Cleaning the ADVIA 360 System . . . . . . . . . . . . . . . . . . . . . .41 Cleaning Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43 Viewing or modifying calibration factors . . . . . . . . . . . . . . . . . . . 43 Preparing to run a calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Viewing Calibration History and Calibration Database . . . . . . . . 44

Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45 Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . To replace reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Liquid Sensors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Reagent Log History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

46 47 49 50

6 Troubleshooting Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 Mechanical Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 Failures of the Sample Rotor . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dilutor Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Priming Problems – Reagent Warnings . . . . . . . . . . . . . . . . . . . . Touchscreen Not Working . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . System Does Not Power-on . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

52 54 55 55 55

Problems Related to Measurement Results. . . . . . . . . . . . .55 Fluctuating PLT Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

7 Data Management Database Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57 Database Navigation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Viewing Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Calculating Statistics for Selected Records. . . . . . . . . . . . . . . . . . Viewing Database Records Details . . . . . . . . . . . . . . . . . . . . . . . . Managing Selected Records in the Database . . . . . . . . . . . . . . . .

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57 57 59 59 60

Contents

ADVIA 360 Hematology System Operator’s Guide

8 System Configuration Settings General Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Communication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Peer Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Measurement Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 Printer Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Date and Time Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Appendix A: Safety Information Emergency Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 General Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 Reagent Warnings and Precautions. . . . . . . . . . . . . . . . . . . 73

Appendix B: Warranty and Support Information Siemens Authorized Representative in the EU. . . . . . . . . . 75 Service and Technical Information . . . . . . . . . . . . . . . . . . . 75

Appendix C: Orderable Supplies Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Optional Reagent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Approved Controls and Calibrator . . . . . . . . . . . . . . . . . . . . 79

Appendix D: Specifications System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Reagent Consumption of the ADVIA 360 . . . . . . . . . . . . . . 83 Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . 83 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Waste Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 11170855 Rev. A

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Contents

Known Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . .85 Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85 Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86 Linearity and Reportable Ranges . . . . . . . . . . . . . . . . . . . . .86 Carry-over and Reportable Ranges . . . . . . . . . . . . . . . . . . . .86 Sample Stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87 Reference Ranges. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87 Interfering Substances. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88

Appendix E: Symbols

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Contents

ADVIA 360 Hematology System Operator’s Guide

11170855 Rev. A

ADVIA 360 Hematology System Operator’s Guide

1

Overview

Overview The ADVIA® 360 Hematology system is a quantitative, fully-automated, multi-parameter, bench-top hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The ADVIA 360 system provides these hematology parameters: GRA% GRA# HCT HGB LYM% LYM# MCV MCH

MCHC MID% MID# MPV PLT RBC WBC

PCT* PDW–SD* PDW–CV* P–LCR* P–LCC* RDW–CV* RDW–SD* * non-USA parameters

See Table 1 on page 6 for full names and description of the above parameters. The system can process up to 100 µL of K2 or K3–EDTA anti-coagulated whole blood from an open or closed sample vial. CAUTION If system operation is different from the manufacturer’s specifications, the protection provided by the equipment may be diminished. Accuracy and precision may also be impaired. Similarly, misuse of the equipment or use other than that for which it is designed, invalidate the warranty. The ADVIA 360 Hematology system supports external printers via USB connectors.

11170855 Rev. A

•

The internal database is capable of storing 10,000 patient results, separate Quality Control (QC) and calibration result records including flags and graphical histograms.

•

The system software is field-upgradable via a USB storage device to ensure up-to-date operation.

•

The system features advanced Ethernet LIS connectivity via the HL7 protocol in addition to a standard serial interfaces.

1

Overview

ADVIA 360 Hematology System Operator’s Guide

Hardware Overview Front Panel Figure 1:

2

Front Panel

1

Touch-screen

2

Built-in Printer

3

Side Door Lock

4

Sample Rotor Station

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ADVIA 360 Hematology System Operator’s Guide

Overview

Back Panel Connectors Figure 2:

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Back Panel Connectors

1

Reagent and Waste Connectors

2

Grounding Screw

3

Power Switch

4

Power Connector

5

USB (A) Port 1

6

USB (A) Port 2

7

LAN / Ethernet Port

8

USB-B Port

3

Overview

ADVIA 360 Hematology System Operator’s Guide

Reagent Connectors on the Back Panel Figure 3:

Reagent Connectors

1

Reagent Connector Diluent

2

Reagent Connector Lyse

3

Reagent Connector Cleaner

4

Waste Outlet Connector 1

5

Waste Outlet Connector 2

Left Side Figure 4:

4

2 USB Ports

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ADVIA 360 Hematology System Operator’s Guide

Overview

Built-in Printer The optional built-in thermal printer prints on 58-mm-wide thermal paper. The printer has a LED status indicator: •

If lit, the printer is ready to use.

•

If blinking, the printer requires more paper.

Loading Paper into the Built-in Printer 1. Open the paper lid by pulling it upwards by the handle. 2. Remove the plastic roller of the old paper roll. 3. Unwind a new paper roll, with the leading edge of the paper facing you from the bottom of the roll. 4. Gently drop the new roll into the holder of the printer, hold the leading edge of the paper with your hand, ensure that the paper emerges from the front of the printer. Figure 5:

Loading New Roll of Paper

5. Close the lid, making sure that the paper is captured between the lid and the printer mechanics, and that it is securely closed. Note The button on the front, right of the printer advances the paper.

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5

Overview

ADVIA 360 Hematology System Operator’s Guide

Principles of Operation •

Impedance measurement technology is used to measure leukocytes (WBC), erythrocytes (RBC), and platelet (PLT) concentrations.

•

A differential lyse reagent is used in measuring the 3-part WBC differential (LYM, MID, GRA).

•

Photometric technology is used to measure the hemoglobin (HGB) concentration of red blood cells.

Measured Parameters The ADVIA 360 Hematology system measures the hematology parameters (including the 3-part WBC differential) shown in the table below. The system samples 100 µL of whole blood from a closed or open sample vial placed in the sample rotor. Measurement cycle time is 60 seconds. Table 1:

Parameter WBC

RBC

HGB

Parameters Measured

Description

Unit 9/L

White Blood Cell x10 count or x103/L

Calculation Method Number of leukocytes WBC = WBC cal x counted WBC

Red Blood Cell count

x1012/L or 106/L

Number of erythrocytes

Hemoglobin concentration

g/dL, g/L, mmol/L

Measured photometrically at 540 nm; in each cycle blank measurement is performed on diluent.

RBC = RBC cal x counted RBC

HGB = HGB cal x (HGB measured – HGB blank) MCV

Mean Corpuscular Volume

fL

Average volume of individual erythrocytes derived from the RBC histogram.

HCT

Hematocrit

percentage, Calculated from the RBC and MCV values. absolute HCT percentage = RBC x MCV / 10 HCT absolute = HCT percentage / 100

6

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ADVIA 360 Hematology System Operator’s Guide

Overview

Parameter

Description

Unit

MCH

Mean Corpuscular Hemoglobin

pg, fmol Average hemoglobin concentration of depends on erythrocytes, calculated from RBC and HGB unit HGB values. selected MCH = HGB / RBC

Mean Corpuscular Hemoglobin Concentration

g/dL, g/L, mmol/L equal to HGB unit selected

Calculated from the HGB and HCT values.

RDW–SD

Red Cell Distribution Width–SD

fL

Distribution width of the erythrocyte or platelet population derived from the histogram at 20% of peak

PDW–SD

Platelet Distribution Width–SD

RDW–CV

Red Cell Distribution Width–CV

%

Platelet Distribution Width–CV

%

MCHC

PDW–CV

PLT

PCT

Platelet count

Thrombocrit

fL

Calculation Method

MCHC = HGB / HCT absolute

xDW–SD = RDW cal x (P2 - P1) (fL)

xDW–CV = RDW cal x 0.56 x (P2 - P1) / (P2 + P1) by the factor of 0.56 CV is corrected to the 60% cut

x109/L or x103/L

Number of thrombocytes (platelets)

percentage absolute

Calculated from the PLT and MPV values

PLT = PLT cal x counted PLT

PCT percentage = PLT x MPV /10.000 PCT absolute = PLT percentage /100

MPV

Mean Platelet Volume

fL

Mean volume of platelets derived from PLT histogram MPV has its own calibration factor.

P–LCC

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Large PLT Count x109/L or x103/L

Number of platelets larger than 12 fL

7

Overview

ADVIA 360 Hematology System Operator’s Guide

Parameter

Description

Unit

Calculation Method

P–LCR

Large PLT percentage

%

Percentage of platelets larger than 12 fL in size P–LCR = P–LCC/PLT

LYM LYM%

MID MID%

GRA GRA%

8

White blood cell x109/L 3-part or differential: 3 count and % of x10 /L lymphocyte cells

Count and % of medium size cells Count and % of granulocyte cells

Absolute values counted in the channels determined by the three WBC discriminators

Percentages calculated from the absolute WBC value LYM = LYM% x WBC MID = MID% x WBC GRA = GRA% x WBC

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ADVIA 360 Hematology System Operator’s Guide

Overview

Measurement Methods The ADVIA 360 Hematology system uses 3 methods to determine measurement results: Method

Description

Photometric Light Absorbance Method

Measures the WBC dilution to determine the hemoglobin (HGB) concentration of erythrocytes (RBC).

Volumetric Impedance Method

Measures the cellular concentrations and volume distributions of erythrocytes (RBC), and platelets (PLT) from so-called RBC dilution. The volumetric impedance method is also used with a lytic reagent to determine the distribution of leukocytes (WBC), and their three sub-populations (LYM, MID, GRA).

Part Differential Analysis Method

Counts and simultaneously sizedifferentiates the white blood cells by using a WBC lytic process.

Photometric Light Absorbance Method A lysed blood sample (WBC) dilution is analyzed for hemoglobin (HGB) concentration based on its stable chromogen content. The lyse reagent causes the red blood cells to release cellular hemoglobin. The hemoglobin concentration is measured by taking a photometric reading across the ADVIA 360 Hematology WBC chamber. The HGB result is calculated as the difference between a blank and a sample measurement with, and without, illumination to reduce the effect of liquid refraction and incident light.

Volumetric Impedance Method The volumetric impedance method determines cellular concentrations and volume distributions of cells. The ADVIA 360 Hematology system detects and measures changes in electrical impedance when particles that are suspended in a conductive liquid pass through a small aperture. A constant direct current flows between the electrodes on both sides of the aperture. Each cell passing through the aperture causes a change in the electrical impedance of the conductive blood cell suspension (diluted blood). This impedance change is detected by the system electronics and the change is converted to an electrical voltage pulse. The number of pulses therefore, is proportional to the number of particles in the diluted sample. 11170855 Rev. A

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Overview

ADVIA 360 Hematology System Operator’s Guide

Intensity (amplitude) of each voltage pulse is proportional to the volume of the particle. The volume distribution diagrams of the particles are displayed as the WBC, RBC, and PLT histograms measured in femtoliter (fL, µm3) units. Electronic discrimination by size allows separation of platelets (PLT) and erythrocytes (RBC), and leucocytes (WBC). Discriminators are indicated by dotted vertical lines on the histograms.

3-Part Differential Analysis Method The ADVIA 360 is a 3-part WBC differential hematology analyzer. The WBC lytic process allows the system to simultaneously count and sizedifferentiate the white blood cells. Three elements determine where the different cell types fall in the WBC histogram: Element

Description

Chemical formulation and concentration of the lytic reagent

The lytic reagent controls how different WBC types are differentially lysed. Concentration of the lytic reagent controls the rate of the lysing (shrinking) process, and the time of incubation.

Type and maturation of the cells present for analysis

Different WBC types and grades of maturation have different sensitivities to the lytic reagent.

3-part WBC differential analysis: LYM, MID, GRA

Different WBC types lyse at different rates: •

Lymphocytes are the most sensitive type.

•

Band neutrophils and segmented neutrophils are the least sensitive types.

Eosinophils, basophils, immature granulocytes and blasts have a cell membrane that is sensitive to the lytic process which classifies them as mid-size cells, for the lytic process at the time these cells are counted and sized. Time window in the lytic process

10

During the time window the cells are counted and sized. As the lytic process is a dynamic reaction, the count and sizing-time window used during the lytic process has been optimized for performance.

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ADVIA 360 Hematology System Operator’s Guide

Overview

Particle data is used to present a size-distribution histogram of the WBC populations. Since size distribution is the only data available for the WBC histogram, the resolution is not high enough to accurately differentiate more than three distinct WBC populations. Consequently, all possible normal and abnormal WBC cell types fall into one of the three histogram populations. Therefore, when abnormal WBC populations are present in the sample, resolution is not high enough to accurately generate specific morphological flags. This is a well-recognized limitation of all 3-part differential WBC cell counter systems in the market today.

Measurement Sequence Table 2 show the stages or sequences of the system’s analysis process: Table 2:

Stage 1

Sample Preparation Process

Description The sampling needle moves into the sample vial, and aspirates 100 µL of EDTA anti-coagulated venous whole blood sample. A precise amount of 25 µL of this sample is separated in the sampler head. Remaining blood is disposed of through the sampling needle into a dedicated washing chamber.

2

The 25 µL of whole blood sample is transported to the mixing chamber through the sampling needle with an addition of 4 mL diluent, to form 1:160 primary dilution. 25 µL of this diluted sample is aspirated into the sampler head, and then mixed with another 4 mL of diluent dispensed into the RBC chamber. This forms a 1:25,600 overall RBC dilution.

3

Remaining mix dilution is moved into the WBC chamber where 0.9 mL of lysing reagent is added. The ADVIA 360 Hematology system uses bubbles for mixing lyse with the mix dilution. This lytic dilution of 1:196 is suitable for photometric measurement and WBC counting.

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4

WBC cell counting is performed. HGB is measured at the end of the WBC counting process.

5

RBC and PLT counting is performed.

6

The system drains and cleans measuring chambers and related tubing, and prepares for the next blood sample. Apertures are cleaned with high-voltage burning pulses.

11

Overview

ADVIA 360 Hematology System Operator’s Guide

Nominal dilution rates used in the ADVIA 360 Hematology system: • Primary dilution 1:160 • Total RBC dilution 1:25,600 • WBC dilution 1:196 Measuring times: • WBC count (adaptive) 2–6 seconds • HGB measurement 2 seconds • RBC/PLT count 8 seconds

12

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ADVIA 360 Hematology System Operator’s Guide

System Operation

2 System Operation Powering-on the System Before powering-on the ADVIA 360 Hematology system, power-on all external and peripheral devices, such as the printer and host computer. To power-on the ADVIA 360 press the main power switch on the back above the DC power input connector. The power-on position is marked on the switch by the symbol, I. CAUTION After power on, wait 5 minutes before initiating any measuring process to allow the instrument to reach optimal working temperature. During start up, the ADVIA 360 screen appears for a few seconds, then the system Home screen is displayed. Figure 6:

System Home Screen

The ADVIA 360 Hematology system automatically runs a priming cycle if the fluidic system requires additional liquid and the fluid sensors are turned on. 11170855 Rev. A

13

System Operation

ADVIA 360 Hematology System Operator’s Guide

Run a priming cycle in these circumstances: •

After installation

•

After an extended unused period

•

After the replacement of any component related to the fluidic system

•

After the replacement of any reagents

Powering-off the System WARNING Do not turn off the instrument by flipping the power switch on the rear panel. Doing so may result in erroneous operating, loss of data, or a prolonged start-up cycle during subsequent use. A power-off must be initiated from the Home screen because it performs this crucial sequence: •

Saves data, settings, closes the databases. (If the power is cut before all data items are securely saved, data might be lost.)

•

Cleans and flushes debris from the system to prevent clogs and contamination. Note Without a proper shut-down, a blood sample could remain inside the system thereby increasing the risk of contamination. If a blood sample dried in the system, it could permanently block the sample path.

•

The system moves mechanical parts (sample needle, syringe pumps, valves) into their safe, home positions.

To power-off the ADVIA 360 1. On the Home screen, tap Exit. 2. On the Exit screen, tap Shutdown. It is safe to power-off the system when a warning message is displayed and the system emits a sustained tone. 3. Power-off the instrument using the power switch on the rear panel. The off position is marked by the O symbol.

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System Operation

User Interface Interact with the system by using the touchscreen and the virtual onscreen keypad, or by using an external keyboard and a mouse.

Using the Touchscreen •

Operate the touchscreen with a finger or a conductive stylus designed for touchscreens. The screen is not pressure-sensitive.

•

The touchscreen supports simple operations, but multi-touch gestures and multiple tapping are not supported.

•

If the screen is dirty it may not work reliably. Clean the screen with a lint-free tissue damp with 5% bleach solution. Make sure that the system is off before cleaning the screen.

Entering Information The ADVIA 360 Hematology system often requires the operator to enter information such as sample ID or patient data. To enter information into a data field, tap its data entry field. •

An enabled data entry field is white.

•

When you tap an enabled field its border changes color indicating that the field is active and data can be entered.

•

If a data entry field is disabled or unavailable it appears darker or shaded.

Enter information using the on-screen keyboard or keypad or with an external keyboard and mouse. Data is not saved until you tap Enter, Save, or Accept, depending on the particular screen. Tap Cancel to discard changes and return to previous screen.

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ADVIA 360 Hematology System Operator’s Guide

Logging-In An operator must enter a password at log-in time in order to use the system. Only an individual with Administrator (Admin) access to the system can set-up new users. 1. Navigate to Home > Exit. 2. Tap Log in. CAUTION The default Admin password is 0. Siemens strongly recommends that you change this Admin password, so that no one can change user privileges without authorization. 3. Tap the Login name field and select from available users. 4. Type the password and tap Enter in the on-screen virtual keypad When logged in as Admin, the User management screens are available.

User Management The User Management screen is available to Administrators to set-up users and modify permissions. To navigate to the User Management screen: Home > Exit > User Management. Task

Action

To set up a new user account.

Tap new

To delete an existing user account.

Tap Remove user

To modify an existing user account or remove a user.

Tap Edit user

To set up automatic login.

Tap Automatic login set

Automatic Login To have the system automatically log in a particular user upon startup, set the automatic log-in feature. 1. Navigate to Home > Exit > User Management > Automatic login set. 2. Tap the Login name field and select the user account for automatic login. 3. Tap Accept. To turn-off this feature tap the Login name field and select Automatic login off and Accept. 16

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User Types The lab manager, as the system administrator, controls access to the ADVIA 360 Hematology system to ensure that only authorized users operate the system, by setting a User Type for each operator. The system offers three user types: User Type

Description

Admin

Administrator users have access to all system functions and can create new Admin users.

Advanced

Advanced users can access all functions, except for settingup users. For example, Advanced users have the authority to perform critical system functions, such as maintenance and calibration.

Basic

Basic users can run samples, but cannot perform calibration or change system settings.

Changing the User Type User Types are set when a New User profile is created.

To change the User Type for an exiting user 1. Navigate to Home > Exit > User Management > Edit user. 2. Tap the Login name field, select the user name and tap Accept. 3. In the Edit User screen that is displayed, tap the User type field, select the new User Type, then tap Accept.

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Sample Measurement and Interpretation of Results

3 Sample Measurement and Interpretation of Results Sample Tubes Supported Sample Tube Types The ADVIA 360 Hematology system supports K2- or K3-EDTA, 13 x 75-mm sample tubes: • • •

Becton Dickinson (BD) Vacutainer Terumo Venosafe Sarstedt Monovette (in open mode only)

Sample tubes supplied by other vendors must meet these conditions: •

The tube is mechanically compatible (13 x 75-mm family) with the sample rotor and adapter.

•

The tube can be pierced or used in open vial mode.

•

Sample tubes contain anticoagulants, K2- or K3-EDTA.

CAUTION Although these sample tube types are designed for multiple piercing, Siemens recommends removing the cap after 3–4 piercing cycles. Rubber pieces from the cap can clog or contaminate the sample, adversely affecting the performance of the system.

Sample Adapters The ADVIA 360 Hematology system can process both open and closed sample tubes in the sample rotor. Before placing a tube into the sample rotor place the tube into the appropriate sample adapter:

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•

Standard

•

Microtainer

•

Small Control

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ADVIA 360 Hematology System Operator’s Guide

Standard Sample Adapter The standard adapter is used for piercing vacutainer tubes of 13 x 75 mm, and tall control vials. Figure 7:

Standard Adapter

1

Vacutainer with cap removed

2

Vacutainer with cap

3

5 mL Control Vial with screw-cap removed

Microtainer Adapter Three types of microtainers are used in microtainer adapters: Figure 8:

20

Microtainer Adapters

1

Remove cap from microtainer

2

Remove cap from microtainer

3

Rotate the vial so that the micriotainer’s open cap lid is close to the rotor wall

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Small Control Adapter The correct application of the small control adapter: Figure 9:

Small Control Adapter

Away remove the cap when using in the open mode.

Sample Collection and Handling •

Blood samples must be analyzed within seven hours of collection.

•

The blood and anticoagulant must be properly mixed by inverting the tube at least eight times. Do not shake the sample as this could damage blood cells and cause micro bubbles.

•

A minimum of 30 minutes must elapse between taking the blood sample and running it on the ADVIA 360 Hematology system. This period ensures that the blood and anticoagulant have fully stabilized. Check the data sheet of the sample tube for exact time requirement.

•

Samples must be room temperature when analyzed.

BIOHAZARD Handle all blood samples as potentially infectious material that represent a biohazard.

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Sample Types and Sample Modes The ADVIA 360 Hematology system processes 3 sample types: •

Whole human venous blood (Male, Female, Profiles 1–7)

•

Calibrator

•

Quality Control (same as Control but with a different menu and database)

QC materials are artificially modified human or animal blood samples with known parameter values. QC samples can be stored for the period of time indicated on the control insert. The sample mode must be selected before a measurement starts. The ADVIA 360 Hematology system offers three Sample Modes: Sample Mode

Description

Blank Mode

No sample has to be presented to run a blank. Blank mode checks that the measuring system is operating correctly.

Control (QC) Mode

The hematological parameters of QC and control materials are known prior to analysis. Controls are used to check the long-term stability of the ADVIA 360 Hematology system.

Human Blood Mode

Ten human blood profiles are available: Human, Male, Female, and Profiles 1–7. Each mode has a unique set of normal ranges associated with it. For Profiles 1–7 the name of profile can be changed and the normal ranges can be redefined by the operator.

Note Calibration with calibrator material is not one of the ADVIA 360 Hematology sample modes. Calibration is a separate and specific procedure (Home > Maintenance > Calibration).

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Sample Identification CAUTION Be careful when manually entering sample ID or patient ID information as misidentification of sample results can have serious consequences. Sample identifiers are used to distinguish each sample. Sample Identifiers

Description

Sample Mode

Blank, Control, Human, Male, Female, and Profiles 1–7.

Time of measurement

Assigned automatically—time-stamped in 60 second increments—by the system software

Sample ID

The Sample ID is not applicable for Blank mode runs. Sample ID can be submitted by any of these three methods: •

Manual typing

•

Manual barcode reader

•

Automatically assigned by the ADVIA 360 Hematology software

The sample ID need not be unique. Patient ID

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Assigned by the operator via a keyboard. Note Patient ID is not applicable for Blank, QC, or Control runs.

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ADVIA 360 Hematology System Operator’s Guide

Preparing to Run Samples After powering-up the ADVIA 360 Hematology system, ensure that these conditions are met: •

All reagents and the waste receptacle are properly connected.

•

Blank cycle has been run and accepted (see When to Run a Blank Cycle in the next section).

•

Quality Control materials have been tested and produced acceptable results, so that calibration of the system is valid. (see Chapter 4, Quality Control.)

•

The sample is ready to use, well-mixed, and is within the recommended time frame for measurement (see Sample Collection and Handling in this chapter).

When to Run a Blank Cycle A blank cycle is a cycle that is run without a sample in order to ensure the cleanliness of the system. •

An acceptable blank cycle must be run before running patient samples, controls, or calibrators.

•

An acceptable blank cycle must be run before sample analysis starts, and at the beginning of every shift

•

An acceptable blank cycle must be run if the system has not been used for more than 3 hours.

•

An acceptable blank cycle must be run after any reagent replacement or maintenance operation

To Run a Blank Cycle 1. Navigate to Home > Measure > New Sample. 2. Tap Blank. After one minute, the system displays blank values. Acceptable blank ranges: Parameter

Acceptable Range

HGB

0–1 g/dL

WBC

0–0.5 x 103 /µL

PLT

0–25 x 103 /µL

RBC

0–0.05 x 106 /µL

3. If the blank values are within acceptable ranges, tap Accept. 24

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Sample Measurement and Interpretation of Results

If one or more parameters are out of range, run a blank cycle two or three more times, by tapping the Re-blank. If blank values are consistently high for any parameters, run Cleaning or Hard cleaning. (See Chapter 5, Cleaning the ADVIA 360 System.)

Running a Patient Sample Note An accepted blank cycle must be performed before running samples See When to Run a Blank Cycle in this chapter.

To run a sample 1. Mix the sample gently but thoroughly by inverting the sample tube 8–11 times. See Sample Collection and Handling in this chapter. 2. Navigate to Home > Measure > New Sample. 3. Insert the appropriate tube adapter into the sample rotor. 4. Open the tube if necessary. 5. Put the sample tube into the adapter. 6. Select a sample Type (Human, Male, Female, Profile 1-7). 7. Identify the sample (Sample ID) either manually or by scanning the barcode. See Sample Identification, in this chapter. 8. Tap Run. The sample rotor turns-in and the needle aspirates 100 µl of sample from the tube. The sampling needle is then retracted, and its surface is automatically rinsed with diluent. After a few seconds, the sample rotor turns-out.

WARNING Do not reach inside the instrument during piercing as the needle can cause injury.

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9. Remove the sample tube from the adapter. After one minute the system displays the results. See Interpretation of Results in this chapter for result interpretation. If a blank cycle was not performed before the sample run, this message is displayed. There is no valid blank measurement. Press OK to measure a blank first.

Remote Work List (EMR) Mode If a work list was sent to the ADVIA 360 Hematology system from an LIS (Laboratory Information System), the list is available in the Measure screen. 1. Navigate to Home > Measure > New Sample. 2. In the New Sample screen that is displayed, tap EMR(LIS) to show the list of samples to be measured. 3. Tap Sample ID to select a sample, or scan the barcode of a sample from the list to automatically set its Sample ID. 4. Tap Run.

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Interpretation of Results This section helps you understand results and flags.

The Measure Screen The Results of a sample are displayed in the Measure screen (Home > Measure) in three categories: •

Parameters

•

Normal Ranges

•

Tech(nical) Details

The ID header at the top of the screen remains the same for each category of results and displays this information: •

PID – Patient ID, date and time of sample run

•

SID – Sample ID and sample Type

•

Warning flags when appropriate

Results Screen: Parameters •

Values within the normal range are displayed in white.

•

Values outside the normal range are displayed in red, and are flagged Low or High.

•

Histograms display graphical information about volume distribution of WBC, RBC, and PLT. Histograms indicate discriminators by vertical lines that separate different cell populations.

Results Screen: Normal Ranges •

Normal ranges are displayed in a graphical format on the right of the screen. Each value is indicated by a downward-pointing white arrowhead within the normal range graphics.

•

Low and high limits of the normal range are displayed on either side of the range line. If the value is out of normal range, the line is red, otherwise it is green.

If a normal range has not been defined for a particular parameter, a normal range graphics does not appear.

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Results Screen: Technical Details •

Probe voltage: Shows electrode voltages for counting WBC and RBC. The min. and max. values are shown for service purposes only.

•

WBC lyse volume: The default value is 0.9.

•

Diagnostic flags: Shows evaluations made by the system based on the results. Numerous diagnostic flags may appear here.

•

Warning flags are displayed for the measurement.

Flags This section describes diagnostic and warning flags.

Out-of-Normal-Range Flags •

The first flagging method is an evaluation against the normal ranges.

•

Out-of-Range parameters are highlighted in red and display an L flag if under the normal range and an H flag if over the normal range.

•

The operator can establish normal ranges for each Profile provided by the software. (See Chapter 8, To set normal ranges for measured parameters.)

Note If a 0 (zero) value is set for range limit of a parameter, it cannot be verified, and no normal range graphics is generated.

Measurement Condition Flags If the ADVIA 360 cannot interpret measurements appropriately, condition flags are attached to the result. These flags are displayed in the header section of the Measure screen, indicated by a Warning. These condition flags also appear in the Tech Details screen with a short explanation.

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Sample Measurement and Interpretation of Results

Flagging on WBC and HGB channels Uppercase letters — WBC or HGB flags. Flag

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Meaning

Explanation & Recommended Action

E

No WBC 3-part differential

Possibly lyse problem, or sample was inadequate. May also occur in pathological lymphocytosis. Rerun sample, making sure it is enough.

W

3-part differential warning

Possibly lyse problem, or the sample is more than 7 hours old. Run prime lyse, and rerun sample.

G

HGB blank is high, Repeat a blank cycle. If HGB blank is still not or no HGB blank stable, there are probably bubbles in the WBC chamber. Run prime lyse, run cleaning, and run blank again. Close the side door if open during measurement.

B

WBC blank is high, Possibly lyse contamination or noise problem. or no WBC blank Repeat blank cycle, or run prime lyse and try blank cycle again.

C

WBC clogging

Aperture clogged. Perform cleaning or hard cleaning and rerun sample. If this flag persists contact your technical support provider or distributor representative. Low temperature reagent may also cause this flag (mainly diluent), in that case, you must wait until it warms to room temperature.

M

WBC coincidence is too high. Linearity error.

Rerun sample after manual pre-dilution and correct the proportional results

D

WBC/RBC threshold Interference

The RBC–WBC discriminator is over 45 fL on the histogram. Rerun sample with a higher lyse volume setting.

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ADVIA 360 Hematology System Operator’s Guide

Flagging on RBC/PLT channel Lowercase letters — RBC/PLT flags.

30

Flag

Meaning

Recommended Action

p

PLT blank is high, or no PLT Run cleaning or Hard cleaning and blank repeat a blank cycle. Diluent or system cleanliness problem. Check for bubbles at reagent inlets, and prime diluent. If it is stable high, replace the diluent.

b

RBC blank is high, or no RBC blank

Same action as in case of warning flag p.

c

RBC/PLT clogging

See remedial action above described in case of warning flag C.

m

RBC/PLT coincidence is too high. Linearity error.

Rerun sample after manual predilution and correct the proportional results.

d

RBC/PLT threshold interference

The analytical software could not separate RBCs from PLTs because of a population overlap. Possibly clumped PLTs.

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Warning Flags of Differential Parameters Flag

Parameter

Flag Type

Flag Description

Possible Indication

LYM%

LYM cell population > 46%

GRA%

LYM cell Distributional population < 11% GRA cell population > 81%

The following sample-related causes may not contain all conditions that could cause these flags. • Hemolysis • Cryoglobulins

H L H L

GRA cell population < 44%

• • •

Chylomicrons Pyropoikilocytosis Lipemia

Multiple occurrences of these flags, especially for consecutive samples, can indicate a system problem. However, isolated instances of this flag are usually sample-related. H

MID%

Distributional MID cell population > 17%

Abnormal WBC cell types; immature granulocytes; blasts; basophilia, monocytosis, eosinophilia; region interference flag.

D

N/A

Region Interference

Interference between PLT and WBC population

WBC fragments; RBC agglutination

d

N/A

Region Interference

Interference between PLT and RBC population

Nucleated RBCs; Giant platelets; Platelet clumps

•

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Perform a cleaning cycle then run a blank cycle to correct blank cycle measurement flags.

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Blank Cycle Flagging Parameters are flagged if the operator has accepted a high blank value. In some cases the associated parameter is flagged, but in other cases it is dashed out. Parameter HGB

Value is displayed but flagged by an asterisk (*).

Value is dashed-out (---) and flagged by an E (error) flag.

1–2.5 g/dL

> 2.5 g/dL 3

WBC

0.6– 1.0 x 10 /µL

> 1.0 x 103 /µL

PLT

26–50 x 103 /µL

> 50 x 103 /µL

RBC

0.06–0.5 x 106 /µL

> 0.5 x 106 /µL

•

Perform a cleaning cycle then run a blank cycle to correct blank cycle measurement flags.

Known Limitations in WBC Differentials

32

•

Each laboratory is responsible for establishing its own protocols for addressing flags. The ADVIA 360 Hematology system classifies cells based only on size differentiation. The system cannot flag specimens with morphologic abnormalities of any particular cell type.

•

Due to the limited performance characteristics of the system, some abnormal cell types that are present at low frequencies are not likely to be identified.

•

The ADVIA 360 system does not have the resolution to differentiate atypical or abnormal lymphocytes from normal ones based strictly on size alone.

•

Nucleated red blood cells are not classified or flagged by the ADVIA 360 system.

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Quality Control

4 Quality Control Quality Control allows the operator to monitor and maintain the day-to-day consistency and accuracy of the ADVIA 360 Hematology system.

New QC Material Controls Lot Before you perform any QC measurements, you must enter target values and tolerance ranges for each parameter of the QC material (control blood) being used. Enter the information for a new lot of control materials in 2 different ways: • Scanning the barcode •

Manually entering data

The assay sheet that comes with the QC material contains the target values and tolerance ranges for that particular lot. CAUTION Target values and tolerance ranges of the control material are set once for each lot. When target values and tolerance ranges are reset, the previous QC results are deleted. Similarly, any change made to the QC control setting also deletes the previous QC results. Siemens recommends printing QC results before entering new values.

To enter a new lot of QC material 1. Navigate to Home > Quality Control > New Lot option. 2. Use the barcode reader to scan-in target and range values from the ADVIA 360 Hematology assay sheet. To enter the data manually, tap the LOT field, type the lot number of the control material, then tap Enter. 3. Tap the Level field and select Normal, Low, or High. 4. Type in the correct expiration date in the appropriate format for your system. 5. Tap Enter. 6. Enter the Target values and Tolerance ranges manually. 7. Tap Accept.

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ADVIA 360 Hematology System Operator’s Guide

To view, print, or export control lot data files 1. Navigate to Home > Quality Control. 2. Tap-select the check box to the left of the Lot name that you want to examine. 3. Tap Monthly view at the bottom of the screen. 4. Navigate through the months using the arrows at the top of the screen on either side of the header, QC lots that were measured mm/yyyy. 5. Tap Print or Export for the selected file/s. Export writes the selected records as an ASCII file (.txt) to the USB storage device if you have one in the USB slot, otherwise the system requests that you insert one.

Levey-Jennings QC chart The QC database contains the results of QC measurements in LeveyJennings format and in a database table format.

To view a Levey-Jennings chart 1. Navigate to Home > Quality Control. 2. Tap the check box in front of the Lot name. 3. Tap the greater-than control (>) to the right of the expiration date. The Levey-Jennings chart is displayed. • • •

The mean and the specified range are displayed on the right of each parameter. Measurement points are indicated by a white o. Out-of-range points are indicated by a red x.

To navigate through the Levey-Jennings chart to view the different parameters of the results •

34

Tap the Up/Down arrows near the bottom of the screen.

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Quality Control

To display the Results for a Specific Measurement Point 1. Tap the left/right arrows on either side of the View option to move the white triangle pointer to the specific measurement you want to view. 2. Tap View. The record details screen that is displayed shows the parameter measurements. 3. Tap Normal ranges and Tech Details to view those results for that particular measurement.

To show the Reference Values for a Lot 1. Navigate to Home > Quality Control. 2. Tap the greater-than control (>) to the right of the expiration date. 3. Tap References. The fields are grayed-out because they are not writable— cannot be changed.

Database View To display the QC measurement results in database (table) view 1. Navigate to Home > Quality Control. 2. Tap the check box in front of the Lot name. 3. Tap the greater-than control (>) to the right of the selected lot information 4. Tap Database at the bottom of the screen. In the Database table that is displayed, navigate through all parameters by tapping the left/right arrows at the bottom of the screen. View subsequent and previous samples in the database by tapping the Up/Down arrows. See Chapter 7, Data Management, for information on database options.

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Quality Control

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5

Maintenance

Maintenance

Parts that Can or Cannot be Serviced by Operators Operators are allowed to access, maintain, and check the parts that are located behind the side door of the ADVIA 360 Hematology system: •

Tubing and chambers

•

Wash head on the X-Y needle mechanics

WARNING Operators must not open or service the following parts: • •

Power supply Instrument housing and electronic boards

User-accessible Parts The door on the right side of the system allows the operator to access the fluidic system and mechanical parts for Maintenance.

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Maintenance

ADVIA 360 Hematology System Operator’s Guide

Figure 10:

38

Inside the Right Side Door of the ADVIA 360 Hematology System

1

Needle Chamber / Drain Chamber

2

Mixing Chamber

3

RBC Chamber

4

X-Y Sampling Unit with Piercing Needle

5

Sampler Head

6

Reagent Sensors

7

Vacuum Receiver

8

Sample micro-dilutor

9

Lyse Dilutor

10

Dilutors

11

Valves

12

HGB Head

13

WBC Aperture Assembly Chamber

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Maintenance

Maintenance Schedule Before Daily Operation CAUTION A waste tank that is 80% full can be heavy for some individuals to lift. Empty the waste tank before it becomes 80% full if weight is a concern.

Task

Instruction

1. Check reagent condition

Navigate to Home > Maintenance > Reagent status. Check if the liquid amount in reagent containers is sufficient for the expected number of daily measurements.

2. Check the contents of the waste tank

If the level is above 80% full, empty the tank.

3. Check for air bubbles

Inspect the rear reagent liquid connectors and syringes (except waste line). If you see bubbles, prime the reagent and perform a blank run.

4. Run blank measurement

If the results of the blank run are within range, tap Accept and proceed with your routine.

5. Run QC samples

Run QC samples according to established laboratory protocols before patient samples.

After Daily Operation •

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At the end of the work day, navigate to Home > Maintenance > Cleaning and run the daily cleaning.

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ADVIA 360 Hematology System Operator’s Guide

Weekly Maintenance Maintenance Task

Instruction

Perform Hard Cleaning

Put 1 mL of ADVIA Hypoclean solution into a sampling tube and run the Hard Cleaning function. (Home > Maintenance > Cleaning > Hard Cleaning)

Check Tubing System

Open the side door and look for any liquid leakage. Contact an authorized technician if there is leakage.

Clean the Needle Wash Head

1. Run the shut-down procedure, and powerdown the system. (Home > Exit > Shutdown) 2. Open the side door. 3. Use a moistened cotton swab to remove salt and blood residuals from the bottom of the wash head.

BIOHAZARD All products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting infectious diseases. Wear facial protection, gloves, and protective clothing. Refer to Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline–3rd edition, (2005), Document M29-A3, promulgated by the Clinical and Laboratory Standards Institute (CLSI), for information about user protections when working with biohazardous material.

WARNING The sharp tip of the piercing needle can cause injury. Always use rubber gloves and a cotton swab to clean the wash head to avoid injury to fingers.

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Figure 11:

Maintenance

The Needle Wash Head

Preventative Maintenance •

Certified service personnel should perform service maintenance on the ADVIA 360 Hematology system every 10,000 measurements a year.

Cleaning the ADVIA 360 System WARNING Disconnect the ADVIA 360 Hematology system power supply from the electric network before cleaning the chassis of the analyzer and front cover.

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Clean the system on the outside only, using a lint-free tissue damp with a 5% bleach solution.

•

Do not allow liquids inside the unit or near the electrical connectors.

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Maintenance

ADVIA 360 Hematology System Operator’s Guide

Cleaning Tasks Tasks

Description

Cleaning

Home > Maintenance > Cleaning > Cleaning Starts a wash cycle using the cleaning reagent connected to cleaner input. A cleaning cycle is automatically performed during a start up and a shutdown procedure.

Hard cleaning

Home > Maintenance > Cleaning > Hard Cleaning Must be performed weekly as part of routine maintenance. Clogging errors or high PLT blank values indicate the need for additional hard cleaning. The software prompts for insertion of the cleaning solution into the sample rotor using a sample vial.

Drain Chamber

Home > Maintenance > Cleaning > Drain Chamber Used only during troubleshooting or component replacement. Drain Chamber should be run before removal or replacement of parts related to the measuring chambers or apertures (service personnel task).

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Maintenance

Calibration Calibration is required whenever the control values are out of range.

Viewing or modifying calibration factors 1. Navigate to Home > Maintenance > Calibration > Factors. 2. Tap the field of a factor and manually enter a new value using the keypad. 3. After all calibration factors are entered tap Accept. The system stores the new factors and generates a new event in the calibration history log, with the current date and time. See Viewing Calibration History and Calibration Database in this chapter.

Preparing to run a calibration Prior to running a Calibration, run a Self-test and a blank measurement with acceptable results: 1. Home > Maintenance > Diagnostics > Self Test 2. Home > Measure > New Sample > Blank

To run a calibration 1. Navigate to Home > Maintenance > Calibration > Calibration with measurement. 2. Scan the barcode on the assay sheet of the calibrator to upload the lot number, expiration date, and target values for the calibrator material. In the absence of a barcode reader, type the values manually. 3. Select the Number of runs desired 3 or 7. Note The Type is Normal Sampling, which cannot be changed. 4. Tap Accept. 5. Mix the calibrator material, insert the tube into the sample adapter and tap Run. 6. If the results look good, and no warning flags are displayed, run Calibration with Measurement again until you reach the required number of runs, 3 or 7. Note Between runs, mix the sample thoroughly.

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Note If a warning flag is displayed (C or c, clogging), tap Discard to delete that particular calibration run, then run Calibration with Measurement again. After performing all the runs, the results are displayed showing a statistical evaluation of calibration results. •

Each calibration factor must be within 1.00 ± 0.20 limits.

•

If a calibration factor is outside this range, it is highlighted in red.

•

The left part of the screen displays: Target values, Mean Values of Runs, CV% (coefficient of variance), and the newly calculated calibration factors.

7. If CV% values and the new factors are satisfactory, tap Accept. •

If results are not acceptable, tap Cancel to discard the unacceptable calibration factors.

•

Repeat the calibration process using a new vial of calibrator material.

•

If results still are not acceptable, contact your local technical support provider or distributor.

Viewing Calibration History and Calibration Database

44

•

To view the history of calibration events by factors, navigate to Home > Maintenance > Calibration > History. The Calibration History screen shows the calibration factors that were generated by each calibration.

•

To view the calibration database, navigate to Home > Maintenance > Calibration > Database. The calibration database screen shows the details of each calibration run.

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Maintenance

Diagnostics •

Navigate to Home > Maintenance > Diagnostics and tap the desired option.

Option

Description

Device Information

Shows the Model, Serial Number, Software version, PIC version, and software compilation date.

Statistics

Shows the device statistics for measurement cycles, errors, and other information for use by service personnel.

Self test

Run Self-test at these times: • • • •

After installation After replacing any component After extended time not in use When you suspect that the system is not giving reliable results.

When Self-test is finished, the system displays a summary of the results. The results must fall within the ranges specified by the min. and max. values. To save the results, insert a USB storage device and tap Save. Note If any of the self-test parameters fail, contact your support provider or distributor representative.

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Reagents The reagent status screen allows you to monitor reagent levels, set-up reagent tanks, set-up lot numbers, and calibrate sensors. •

Navigate to Home > Maintenance > Reagent status and tap the option desired:

Reagent option

Description

Prime

The prime option for each reagent, initiates a priming for that particular reagent.

Prime all

The Prime all option at the bottom of the screen primes all three reagents.

Waste

After you dispose of the contents of waste container, tap Empty Waste to reset the waste counter to 0%. The waste and reagent level % calculation is based on the setting of the tank capacity.

Waste tracking ON/OFF

• •

If your system empties directly into a drain, set this to OFF. If your system empties into a waste container set this to ON.

Empty Waste

Resets the waste counter if waste tracking is ON.

Replace

Use this option when you are replacing Reagents. Note The waste and reagent level% calculation is based on the setting of the tank capacity.

View log

Shows reagent replacement history.

Measurement credits

Shows the measurement credit counter. For more information see, To display the number of measurement credits in this chapter.

If a sensor error message appears, run Calibrate Sensors.

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Maintenance

To replace reagents 1. Navigate to Home > Maintenance > Reagent Status. 2. Tap Replace at the bottom of the screen. 3. Tap the Reagent Type field, and select the reagent to be replaced from the drop-down list. 4. Type the Lot number and the Expiration date. Note If you are replacing ADVIA 360 Lyse 3P Diff (1L) insert the reagent hardware key into the key slot on the back of the system. 5. Tap Accept to complete the replacement. 6. Repeat the above procedure for the all reagents to be replaced.

Reagent Lock System and the HW Key The ADVIA 360 Hematology system is equipped with a Reagent Lock System to prevent use of incompatible or poor quality reagents. When the number of measurement credits reaches 0 (zero), the system cannot perform measurements, and displays an error message Error 6003 Hardware key not found, or is not suitable for this device! Please connect a proper hardware key! Note Each measurement cycle decreases the number of measurement credits by one, except for initialization, standby, and wake-up cycles which do not affect the measurement credits. To restore measurement credits, you must obtain a new reagent hardware key and insert it into the HW Key reagent slot. Figure 12:

Reagent Hardware Key

Each ADVIA 360 Lyse 3P Diff (1L) reagent comes with a hardware key containing 900 measurement credits.

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To display the number of measurement credits 1. Navigate to Home > Maintenance > Reagent status. 2. Tap Measurement credits. The measurement credits on the system and on the reagent hardware key are displayed.

To load measurement credits from a hardware key 1. Remove the hardware key from the zip bag of a new ADVIA 360 Lyse 3P Diff (1L) reagent. 2. Insert the hardware key into the key connector on the back of the ADVIA 360 Hematology system in the way indicated as shown in Figure 13, Installing the Hardware (HW) Key. The gold contacts of the key face downwards. Figure 13:

Installing the Hardware (HW) Key

CAUTION Do not insert the hardware key into a USB port. The ADVIA 360 System cannot read it in a USB port. Use only the reagent lock connector on the back of the system. 3. Navigate to Home > Maintenance > Reagent Status. 4. Tap Replace at the bottom of the screen. 5. In the Reagent Type field, select Lyse-DIFF. 6. Tap Accept. All measurement credits are moved to the ADVIA 360, and the credits are deleted from the hardware key.

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Maintenance

7. Remove the hardware key from the reagent lock connector.

CAUTION The hardware key cannot be used again. The maximum number of measurement credits allowable on the system is 950. Do not load measurement credits from more than one reagent hardware key at a time. If you attempt to do so, credits above 950 will be lost, and the number of credits on the hardware key will be deleted. If you do not insert a key when the system reaches zero credits, or if a used key is inserted, or a key that is not compatible with your particular system, this error message is displayed: Error 6003 Hardware key not found, or is not suitable for this device! Please connect a proper hardware key! If this error message is displayed, insert a good key and tap Retry. Credit counting is linked to lyse reagent in the system; however, a small amount lyse remains in the reagent container when the counter gets to 0 to ensure that enough is available if extra maintenance is required.

Liquid Sensors The ADVIA 360 Hematology system is equipped with four liquid sensors.

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•

Diluent

•

Lyse

•

Cleaner reagent

•

The fourth sensor is built into the sampling head and checks aspiration of the blood sample. If this sensor detects bubbles during sampling, an error message is displayed after measurement.

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Troubleshooting Sensors The two most common sensor problems are micro-bubbles and blockages. Trouble

Maintenance Operation

Micro-bubbles in the tubing

Check the tubing connections at the reagent container connections and the pick-up tubes and at the back of the unit. Reconnect the tubing if necessary.

Dried or accumulated contamination in a position that blocks the sensor.

When this kind of block occurs a sensor incorrectly detects liquid. 1. Perform a hard cleaning to remove the blockage. 2. Run a calibration.

Reagent Log History To view or save the reagent log history 1. Navigate to Home > Maintenance > Reagent status. 2. Tap View log at the bottom of the screen. 3. Tap Filter and select which reagents to display in the log. 4. Tap Export to save the Reagent change log on a USB storage device as a file named, reagent_tracking.csv, in ASCII format. (This file can be opened in Excel.)

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Troubleshooting

6 Troubleshooting The ADVIA 360 Hematology system provides all the maintenance functions required to keep the system running ally. The system may encounter problems that require operator intervention. The system displays error messages when a condition exists that requires attention.

Error Messages Error message codes help you identify the cause of an error. These codes are important for service personnel who can interpret the codes and take necessary actions. If an error messages with a numerical code is displayed, write it down and describe what the system was doing before the error appeared in order to help the service engineer diagnose the problem. The system stores and displays every error message, but it cannot describe the operation you were performing when the error occurred. When an error occurs, the software usually offers a solution and asks for a retry of the operation. If this recovery process fails, or if the problem reoccurs, contact your support provider or distributor representative.

Mechanical Problems The system is designed to be error-tolerant and recover from minor problems. However, some physical obstructions and extreme operating conditions can cause a mechanical part to behave unexpectedly. In such cases the system displays an error message. Problems caused by severe blockages are often accompanied by a grinding noise. The noise is a generally a motor unsuccessfully attempting to turn, but this does not usually result in mechanical damage to moving parts.

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Failures of the Sample Rotor

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Failure

Solution

Sample vial is too tall causing it to hit the front cover or incorrect sample adapter is used.

Replace and Retry operation.

The opening on the front is not aligned with the sample rotor door.

Open the door and check the wash head for contamination (blood and/ or salt) as excessive salt build up can prevent the wash head from lifting up effectively and the sample rotor door can get stuck. Perform wash head cleaning. See Weekly Maintenance in this chapter

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Troubleshooting

Needle Mechanics, Vertical Motor (MVert) Problems WARNING Do not turn off the instrument by flipping the power switch on the rear panel. Doing so may result in erroneous operating, loss of data, or prolonged start-up cycle during later use.

BIOHAZARD All products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting infectious diseases. Wear facial protection, gloves, and protective clothing. Refer to Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline–3rd edition, (2005), Document M29-A3, promulgated by the Clinical and Laboratory Standards Institute (CLSI), for information about user protections when working with biohazardous material.

Problem

Solution

Sampling depth is not set up See Supported Sample Tube Types, correctly for the sample tube used. page 19. Salt build-up, or thick salt layer at Perform wash head cleaning. the bottom or on the inside can See Weekly Maintenance in this block the movement of the needle chapter. in the wash head. Conversely, such a build-up can block the movement of the wash head around the needle. The piercing needle is bent or the needle is not set/misaligned.

Call your technical support provider or distributor representative.

The vertical rod holding the needle Try removing the part that causes carriage is blocked by something. the block or call your technical support provider or distributor representative.

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Needle Mechanics, Horizontal Motor (MHori) Problems WARNING Do not turn off the instrument by flipping the power switch on the rear panel. Doing so may result in erroneous operating, loss of data, or prolonged start-up cycle during later use.

BIOHAZARD All products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting infectious diseases. Wear facial protection, gloves, and protective clothing. Refer to Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline–3rd edition, (2005), Document M29-A3, promulgated by the Clinical and Laboratory Standards Institute (CLSI), for information about user protections when working with biohazardous material.

Problem

Solution

The piercing needle is bent or the needle is not set/misaligned.

Call your technical support provider or distributor representative.

The horizontal driving rod holding the needle carriage is blocked by something.

Try removing the part that causes the block or call your technical support provider or distributor representative.

Dilutor Errors

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Problem

Solution

Pinched or clogged tube around the dilutor or at the rear reagent tubes

Check for free flow of reagents.

Physical obstruction (foreign material) present in the tubing.

Remove obstruction.

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Troubleshooting

Priming Problems – Reagent Warnings Problem

Solution

Out of reagent

Replace reagent.

Tubing coming from a reagent container has fallen off.

Reattach the tube.

Tubing coming from a reagent container is kinked.

Remove the blockage or replace the tube.

Tubing coming from a reagent container has a leak or is broken.

Cut-off a piece from the end, and reconnect reagent lines or replace the tubes.

A tube inside the system is disconnected.

Open side door and look for the open tube. Reconnect it to the valve or tubing connection.

A tube inside the system is damaged.

Look for leakage, or salt traces of liquid. Contact your support provider or distributor representative.

Touchscreen Not Working 1. Moisture on the glass may interfere with touch operation. Check if the screen is wet. 2. If it is wet, power-off the system and clean the screen with a lint-free tissue, damp with 5% bleach solution. 3. Wipe the screen completely dry. 4. Power-off and power-on the system and retry the touchscreen.

System Does Not Power-on 1. Check all power connections: the wall outlet, the power supply, and the unit itself. 2. Check the state of the power switch at the rear of the system.

Problems Related to Measurement Results See Chapter 3, for details and remedy actions in connection with warning flags.

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Fluctuating PLT Background Problem

Solution

Blank PLT values are not consistent, or increasing unexpectedly

Perform a Hard cleaning function using Siemens ADVIA 360 Hypoclean 100 mL reagent as described in Cleaning Tasks in Chapter 5 and then measure blank several times to ensure that the system is clean and stable.

Stable but high PLT blank

Reagents may be contaminated. Use a new tank of diluent and see if PLT blank becomes low and acceptable. When replacing reagent, avoid contamination to the tubes. Flush them with tap water. Clean (wipe) the outer surface of the tubes with a lint-free cloth, damp with 5% bleach solution, before putting them into the new reagent, otherwise crosscontamination may occur.

PLT blank fluctuates

Check if there is a device nearby that radiates electromagnetic noise. Relocate the system if you suspect that electronic interference is causing a high PLT blank. Note Proper electrical grounding is essential for stable, backgroundfree operation.

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Data Management

7 Data Management Database Operations Patient results are stored in system memory, and can be viewed in the database at any time. Memory capacity is 10,000 patient records, including all parameters, histograms, flags, sample ID, and date/time of measurement. If storage space is full, the latest record overwrites the oldest record in the database.

Database Navigation To select all of the records in database, tap the check box at the top of the screen—the check box to the immediate left of words, Patient ID. This special check box is a toggle—it also un-checks (deselects) any record that is currently selected, even one that is off-screen (scrolled out of sight). The top check box is checked if at least one record is selected. As you scroll through a large database this check box remains selected even if you have only one record selected.

Viewing Records To view records in the database 1. Navigate to Home > Database. 2. In the Database screen, tap the check box of the record(s) to view. 3. Tap Details. 4. Tap the option you want to see: Parameters, Normal Ranges, or Tech Details.

To filter and view database records by specific criteria 1. Navigate to Home > Database. 2. Tap Filter.

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3. On the Results filter screen, type the data criteria by which you want to filter. Filter by

Action

Date from

The default setting for the date is the current date. The date must be in the format setup by the system’s administrator. The system automatically adds the forward slash (/) to separate the days, month, and years. Tap Enter on the keypad.

Date to Patient ID

Type and tap Enter on the keypad.

Sample ID Type

Select one of the 10 profile types, or Control, or Blank, or All.

Records

Siemens recommends selecting Selected, otherwise the filter runs against the entire database, giving too many results.

To restore default settings or delete all dates, tap Clear. 4. Tap Filter. The screen displays only those records that match your criteria. 5. To filter the initial results tap Filter again and select (or type) further criteria. To select records from the filtered results, tap the check box next to the Patient ID of the wanted record(s). The Statistics option and Print option are enabled to view stats or print filtered, selected records.

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Data Management

Calculating Statistics for Selected Records They system can calculate statistics — SD, CV, Levey-Jennings chart, mean values and so on — for a set (2 or more) of selected records. (If you do not select 2 or more records the Statistics option is grayed-out.) 1. Navigate to Home > Database. 2. Tap the check box next to the records for which you want to calculate statistics. 3. Tap Statistics. The Levey-Jennings charts for the selected records are displayed. 4. Navigate through the charts and data points using the arrows on either side of the View option. 5. Tap View to see the Parameters, Normal Ranges and Tech Details for those records.

Viewing Database Records Details 1. To view Details of records, navigate to Home > Database. 2. Tap the check boxes next to the records you want to view. 3. Tap the Details. 4. To view the details for Parameters, Normal ranges, and Tech, tap that particular option.

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Managing Selected Records in the Database 1. Navigate to Home > Database. 2. Tap the check box next to the selected records. 3. Tap Manage and select from the options: Option

Function

Delete

Since deleted records cannot be restored, the system asks for confirmation.

Send .

If hardware connection exist between the system and the external PC or network, transmits selected records to external computer or laboratory information system (LIS). •

PC to transmit selected records to a PC via ethernet channel

•

EMR to upload the selected record to a PC or LIS connected via ethernet port

•

USB-Serial to use PC link via the USB-B port connection, and serial communication protocol.

Note A screen is displayed, in which you can select the method by which records are transmitted (even if the connection type has not yet been configured in case the options to send are active in Settings. See Chapter 8, System Configuration Settings Backup

Opens back-up options screen. The records that you selected can be saved in different file formats onto USB storage device connected to the system.

To Backup selected records 1. Before proceeding with backup function, insert a USB storage device into one of the USB ports. 2. Navigate to Home > Database. 3. Tap the check box for the selected record. 4. Tap Manage then Backup.

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Data Management

5. Tap the Backup option you want: Backup option

Function

Save

Saves selected records in.db format. Data saved in this format can be viewed using Backup view. Note Wait until the save operation is completed (progress bar is finished). Also wait until the USB storage device is no longer flashing, then remove the drive from USB port to avoid data loss.

Export

Exports selected records as an ASCII file (.txt). In this format, data can be easily imported into Microsoft Excel and other programs. See Chapter 8, System Configuration Settings to learn about setting up the format of the text exported to file.

Backup view

Opens a .db format data files previously saved onto a USB storage device. See the Backup View function for details.

Backup one day

Allows you to backup data records of a specific day (.db format).

To view backed-up records 1. Insert the USB storage device containing saved data records (.db file format). 2. Navigate to Home > Database > Manage > Backup > Backup view. 3. Select the database file you want to view and tap OK. 4. To view individual records tap Details. Records loaded from the USB storage device can be viewed, printed, transmitted filtered, managed, and so on, just as for normal database records. See Chapter 7, Data Management for details on database functions.

To print records of a single day (Backup one day) 1. Navigate to Home > Database. 2. Tap the check boxes next to the records. 3. Tap Print.

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Print Option

Function

Result by result

Prints normal report format

Table format

Prints a summary of records without histograms 61

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Handling Print Job Errors If a print job has started but did not finish because of an error (for example, the connection to the printer was lost or the printer is out of paper), the system displays an error icon (an exclamation mark) in the header. •

Tap the error icon (exclamation point) in the screen header. The print jobs screen displays the printer status and print job that are pending:

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Backup option

Function

Abort

Cancels the current printing.

Abort all

Deletes all print jobs from the queue.

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System Configuration Settings

8 System Configuration Settings General Settings 1. Navigate to Home > Settings > General Settings. 2. Tap the setting. Field Setting

Description

Sound

Turns on/off system beeps and other notification sounds.

Language

User interface Language. Opens a popup to select the appropriate language.

Export format

Select the format of the system’s data transmission. • Simple text: Results only

Barcode

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•

Advanced text: Results and ranges only

•

Extended text: Results with histograms and ranges

•

Select Disabled if a barcode reader is not connected to the system.

•

Select Patient ID if a barcode reader is used only for patient IDs.

•

Select Sample ID if a barcode reader is used only for sample IDs.

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Communication Settings To set up networking for the ADVIA 360 system 1. Navigate to Home > Settings > Communication > Device Communication. Note Current settings are displayed in grayed-out fields. 2. Tap a white field to change its setting. Field Setting

Description

DHCP

If Enabled, the master device on thelocal network will assign an IP address for the system. If Enabled, keep the IP address at its default, 0.0.0.0.

IP address

If DHCP is Disabled, enter a valid IP address. Contact the network administrator for a valid IP address in your facility.

Subnet mask

Typically set to 255.255.255.0 If DHCP is Disabled, contact the network administrator for the subnet mask at your facility.

Gateway

Typically set to 0.0.0.0

DNS

Typically set to 0.0.0.0

Peer Communication To set up peer networking for the ADVIA 360 system 1. Navigate to Home > Settings > Communication > Peer Communication. 2. Tap a field to change its setting.

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System Configuration Settings

Note Contact your technical support provider or the LIS administrator for more information on these settings. Field Setting

Description

PC

If a PC is connected to the system, select Active.

PC remote IP address

If PC setting is Active, enter a valid network address so the system can send data to an LIS. Note The interface allows you to enter an IP address here even if the PC setting is set to Inactive. This enables you to “store” a valid IP address here for later use, if you set the PC to Active at a later time.

EMR

Set to Active if the system must receive work lists.

EMR remote IP address

If EMR setting is Active, enter a valid network address otherwise the system cannot send or receive work lists.

EMR local port

Enter the local port number on which the system will receive work lists from a local device.

USB-Serial link

If a PC is connected via the USB-B port, this setting must be Enabled.

USB-Serial Baud Rate

To connect a PC via a USB-B emulated serial link, set the baud rate to that of the connected PC serial baud rate.

Automatic send

After a measurement is completed, the data record is sent automatically if you select one of the ports here: • PC only: Records sent to a PC connected via the LAN port •

EMR (LIS) only: Records sent to LIS address via a LAN

•

PC and EMR(LIS): Records sent to both addresses via the LAN (Ethernet) port

•

USB-Serial: Records sent via the USB-B port to a PC.

The default, Disabled, means that no records will be automatically transmitted.

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Measurement Settings To set the units of measured parameters 1. Navigate to Home > Settings > Measurement > Units 2. Select the unit type for Count and HGB. Unit

Measurement Type

Count

Tap to select: • cells/L •

HGB

cells/L

Tap to select: • g/dL •

mmol/L

To set normal ranges for measured parameters Normal ranges can be set up for Human, Male, Female, and all other Profiles. 1. Navigate to Home > Settings > Communication > Measurement > Normal ranges. 2. Tap the field for which you want to enter or change data.

To rename a profile (1–7) 1. Navigate to Home > Settings > Communication > Measurement > Normal ranges. 2. Tap the Type field and tap the Profile to rename. 3. Tap Rename. 4. Type a new name and tap Enter.

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System Configuration Settings

Printer Settings To select printer and paper setting •

Navigate to Home > Settings > Printer > Device.

Field Printer

Setting Select the way your printer is connected: • USB port •

Built-in

Mode

Black & White or Color

Paper

A4 or Letter (North America)

Top margin

Enter the distance from edge of paper that you want printing to begin.

Automatic printing

If enabled, the ADVIA 360 automatically prints all results after each run.

To modify what is printed in the body of reports •

Navigate to Home > Settings > Printer Setting > Format.

Field

If Enabled

Limits

Normal ranges are printed

Warnings

Warning flags are printed

Technical information

Lyse volume and probe voltages are printed

Diagnostic flags

Diagnostic flags are printed

Logo

ADVIA 360 Hematology Logo appears on printout.

To modify what appears in the header of printed reports 1. Navigate to Home > Settings > Printer Setting > Format. 2. Locate the Laboratory headers section. 3. In the Laboratory header fields enter any text to be printed in the headers of each report sheet of paper. For example, Header lines 1–2 can contain the name of the lab and the address. Header lines 2–4 contain a contact person’s name and telephone number.

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Date and Time Settings To Change the system Date, Time, and their formats •

Navigate to Home > Settings > Communication > Measurement > Date and time.

Setting

Description

Date

Enter current date in the Date format.

Time

Enter current time, and tap Enter.

Date format

•

Day/Month/Year

•

Month/Day/Year

•

Year/Month/Day

Time format

68

12-hour mode or 24-hour mode.

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Appendix A:

Safety Information

Safety Information

Emergency Situations Always follow all applicable laws and regulations regarding emergency situations. An emergency shutdown of the system may sometimes be required: •

When there is a risk of personal injury

•

If there is a fire or flood in the laboratory

•

If the wrong reagent is connected to the system

•

When there is a risk of high voltage on the electric grid such as in a lightening storm

In emergency situation, cut-off the power by disconnecting the power mains cable, or by turning off the main switch. In case of an electrical risk, cut-off the power from the external power supply unit — do not use the main switch. Use a fire extinguisher if necessary. WARNING In case of fire, do not use water to extinguish the fire unless the ADVIA 360 Hematology is disconnected from the electrical power network.

WARNING After an emergency power-off, be cautious when reaching into the unit through the side door, since the sampling needle may be in a position that it can cause injury.

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General Precautions Read this section carefully before operating the ADVIA 360 Hematology system. BIOHAZARD All products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting infectious diseases. Wear facial protection, gloves, and protective clothing. BIOHAZARD The sampling needle and other components inside the system may cause injury, or can get damaged if handled incorrectly. Only certified personnel should open the covers. Running samples with opened cover is not recommended due to the risk of possible injury. Always wear safety gloves while performing maintenance actions. CAUTION The system should be moved holding the system in an upright position. CAUTION Make sure to retain the original packaging material for safe transportation and storage in the future. CAUTION To prepare the system for shipping, storage or extended periods of inactivity, drain the reagents and repackage it in its original packaging. Do not expose the ADVIA 360 Hematology to direct sunlight, extreme temperature or humidity over 85%. WARNING The system operates with chemically and biologically active reagents. Physical contact with these reagents should be avoided. Read reagent descriptions and MSDS carefully for possible emergency actions.

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Safety Information

WARNING To ensure reliable operation and reliable results: •

Only human blood samples should be analyzed.

•

Only Siemens reagents should be used.

•

Required maintenance should be performed as detailed in this manual.

•

Only Siemens certified service personnel should perform service actions.

•

Only Siemens service materials and spare parts should be used.

CAUTION Only Siemens certified service personnel that have successfully completed the Siemens Service Training program are qualified to service the ADVIA 360 Hematology . CAUTION Before operating the ADVIA 360 Hematology system, all operators should complete an ADVIA 360 Hematology Operator Training program. This program is offered by your distributor or local service provider. BIOHAZARD Waste contains poisonous substances (because of chemical content) and human origin substances meaning biohazard. These substances are representing potential danger to environment. For this reason, safe handling of the waste liquid is very important. BIOHAZARD Replacement materials or spare parts (tubes, valves, etc.) which might have been in contact with human blood or reagents should be handled as a potentially biologically hazardous and chemically dangerous material. All local laws and regulations must be observed in the handling and disposal of these materials. CAUTION The ADVIA 360 Hematology system is designed for laboratory operation. Mobile operation is not supported. Operate it within the ambient temperature range described in Chapter D, Specifications. CAUTION This IVD equipment complies with the emission and immunity requirements described in relevant part of the IEC 61326 series.

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CAUTION This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. WARNING Electromagnetic environment should be evaluated prior to operation of the device. WARNING This system contains electronic components. Handle electronic waste adhering to local or federal regulations. BIOHAZARD Waste contains poisonous substances (because of chemical content) and human origin substances meaning biohazard. These substances are representing potential danger to environment. For this reason, safe handling of the waste liquid is very important.

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Safety Information

Reagent Warnings and Precautions When working with Siemens reagents follow the warnings and precautions associated with that particular reagent. Reagent and Ordering Code ADVIA 360/560 Dil 20L SMN 11170845

Symbol

GHS Codes

Description

H317

Warning! May cause an allergic skin reaction. Wear protective gloves/protective clothing/eye protection/face protection.

P280 P272 P302+P352 P333+P313 P501

IF ON SKIN: Wash with plenty of soap and water. If skin irritation or rash occurs, get medical attention. Dispose of contents and container in accordance with all local, regional, national, and international regulations. Do not allow contaminated work clothing out of the workplace. Contains 5-chloro-2-methyl-3(2h)isothiazolone mixture with 2-methyl3(2h)-isothiazolone

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Safety Information

Reagent and Ordering Code ADVIA 360,560 Hypoclean 1L, Hypochlorite solution

ADVIA 360 Hematology Operator’s Guide

Symbol

GHS Codes

Description

H319

Warning!

H315

Causes serious eye irritation. Causes skin irritation. Wear protective gloves/protective clothing/eye protection/face protection. Wash hands thoroughly after handling.

P280 SMN 11170850

P264

P305+P351+ P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do so. Continue rinsing. Contains sodium hydroxide ADVIA 360/560 Hypoclean CC 100 mL emergency cleaner

H319

Warning!

H315

Causes serious eye irritation. Causes skin irritation. Wear protective gloves/protective clothing/eye protection/face protection. Wash hands thoroughly after handling.

P280 SMN 11170851

P264

P305+P351+ P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do so. Continue rinsing. Contains sodium hydroxide

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Appendix B:

Warranty and Support Information

Warranty and Support Information

Siemens Authorized Representative in the EU Address of the Siemens Healthcare Diagnostics authorized representative, which is the Siemens contact within the European community:

Service and Technical Information For technical assistance contact your local technical support provider. For customer service or additional information contact your local support provider or distributor representative.

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Appendix C:

Orderable Supplies

Orderable Supplies

Reagents For operating the ADVIA 360 Hematology system, use only the reagents listed in Table 3. All these reagents are for in vitro use only. Open bottle stability for these reagents is 120 days. •

ADVIA 360 Lyse 3P Diff

•

ADVIA 360/560 Dil

•

ADVIA 360/560 Hypoclean

Reagent storage temperature: 15–30°C (59–86°F°F).

WARNING If eyes or skin contact any reagent, flush abundantly with water. If a large quantity is ingested, drink water immediately and contact a doctor. Performance and lifespan of the ADVIA 360 Hematology system are guaranteed only if reagents supplied by the manufacturer are used.

Table 3:

ADVIA 360 Hematology System Reagents

Reagent Type and Ordering Code

Color Code & Shelf Life

Description

ADVIA 360/560 Dil 20L

Green

Ann isotonic, filtered saline solution, used to dilute whole blood samples and rinse the fluidic system between measuring cycles. It is connected to a dedicated diluent input at the rear of the system.

3 years SMN 11170845 ADVIA 360 Lyse 3P Diff 1L Comes with a reagent key attached to the bottle in a plastic zipbag.

Yellow 4 years

Lyse reagent is connected to the rear reagent input. The Lyse reagent creates hemolysate for 3-part WBC differential, total WBC count and HGB determination. The reagent key attached to the bottle contains 900 measurement credits.

SMN11170848

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Reagent Type and Ordering Code

Color Code & Shelf Life

Description

ADVIA 360 Cleaner 1L

Dark Blue

Cleaning solution of the fluidics, connected to the dedicated rear reagent input.

4 years SMN 11170849 ADVIA 360/560 Hypoclean CC 100 mL emergency cleaner

Black 15 months

The system uses this reagent from time to time, to clean the tubing, counting chambers and apertures. Used for Hard Cleaning procedure to remove protein and lipids from sample tubes, chambers and apertures. This reagent should be dispensed into a sample vial, and run before a Hard cleaning is started.

SMN 11170851

Optional Reagent The reagent below is optional for cleaning use. Table 4:

ADVIA 360 Hematology System Optional Reagent

Reagent Type

Color Code Shelf Life

Description

ADVIA 360,560 Hypoclean 1L Hypochlorite solution

Purple

Used for service maintenance for removing debris from tubing and chambers.

2 years

SMN 11170850 For reagent consumption information, see Appendix D, Reagent Consumption of the ADVIA 360.

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Orderable Supplies

Approved Controls and Calibrator Hematology controls and optional calibrator are used to check precision, accuracy and to calibrate the system. ADVIA control and calibrator materials are the al products to use with the ADVIA 360 Hematology system: Table 5:

Approved Controls and Calibrator

Material

Purpose

Reagent Type and Ordering Code

Control material (low, Checking performance of ADVIA 360 Control normal, high levels) the ADVIA 360 Set Hematology system SMN 11170853 Calibrator material (optional)

Performing calibration of the ADVIA 360 Hematology system

ADVIA 360/560 Calibrator SMN 11170852

The package insert contain useful information on these products in the assay sheets.

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Appendix D:

Specifications

Specifications

System Specifications Item

Description

Operating conditions

Temperature: 15–30°C (59–86°F) Optimal temperature is 20–25°C (68–77°F) Relative humidity: 45–85% non-condensing Analyzer operation at altitudes above 3000 meters (9800 feet) is not guaranteed.

Storage conditions

Temperature: 5–35°C (41–95°F) Relative humidity: 15–90% non-condensing

Power supply unit

External, auto-ranging power supply unit. Input: 90-240 VAC, 47–63 Hz Maximum input current: 6A at 90VAC, 3A at 240 VAC. Output: 12 VDC, max. 8.3 A, max. 100 W

User interface

Easy-to-use, user interface with a touchscreen

Languages available

English, Bulgarian, French, Greek, German, Indonesian, Italian, Polish, Portuguese, Romanian, Russian, Slovakian, Spanish, and Turkish

Data storage capacity

10,000 results with RBC, PLT, and 3-part diff. WBC histograms

Host computer interface

USB-B port (direct connection to host computer via USB port) PC, LAN: Ethernet port on the back

Data back-up method

USB storage device up to 16 Gbyte size Send data to LIS (Laboratory Information System)

Printer interface

USB with support for most HP printer languages (DeskJet, LaserJet, PCL3, PS, LIDIL)

Built-in printer

Optional 58 mm thermal printer, monochrome printout with histograms

Display

8” (173 x 104 mm), LED backlit, color graphics LCD

External keyboard

Optional, via USB connection

Software upgrade method

Via USB port using USB storage device (max. 16 Gbytes)

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Item

Description

Sampling volume

100 μl of whole blood

Chambers

3 chambers for diluting whole blood and counting; MIX, RBC, WBC +1 needle-washing/draining chamber

Reagent system

Isotonic diluent, Lyse, Cleaner

Aperture diameter

80 μm (RBC/PLT), 100 μm (WBC)

Throughput

up to 60 tests/hour

Sampling method

Open tube or closed tube system with automatic sample rotor

Specimen types supported

Human whole blood, Control blood

Recommended sample collection K2- or K3-EDTA primary blood sample tubes, method venipuncture Sample identification method

Individual sample ID entered by operator. Barcode with external manual barcode reader

Sample types

Control, Human, Male, Female (built-in reference ranges), and Profiles 1–7 for additional operatordefined ranges.

Clog prevention

High-voltage pulse on apertures in each analysis cycle; chemical cleaning; high-pressure back flush of apertures.

Cleaning procedure

High-voltage burst of the apertures, high-pressure back-flush, chemical cleaning of the apertures.

Quality control

max. 24 QC levels, QC parameters including: number of runs, mean, ± range, SD and CV for all measured and calculated parameters, Levey-Jennings charts, separate QC database.

Calibration

Automatic with 3 or 7 measurements, or manual (factorial) calibration of WBC, HGB, RBC, RDWc, PLT, MCV and MPV.

Dimensions (WxDxH)

316 x 492 x 360 mm

Net weight

17.8 kg

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Specifications

Reagent Consumption of the ADVIA 360 Reagent Consumption (mL)

Function

ADVIA 360, Dil 20L SMN 11170845

ADVIA 360 Lyse 3P Diff 1L SMN 11170848

ADVIA 360 Cleaner 1L SMN 11170849

Startup (init + wake up)

114.0

3.0

6.5

Shutdown

054.0

0.0

4.6

Measure Blank

040.2

1.1

0.0

Measure Human

041.0

1.1

0.0

Measure Calibration

040.9

1.1

0.0

Measure QC

040.9

1.1

0.0

Prime Diluent

036.0

0.0

0.0

Prime Lyse

014.8

2.4

0.0

Prime Cleaner

019.3

0.0

2.0

Prime All

029.2

2.1

1.9

Standby

013.5

0.0

0.0

Wake up

000.9

0.0

0.0

Clean

049.8

0.0

4.6

Hard clean*

076.5

0.0

0.0

Self-test

011.4

0.0

0.0

*Hard cleaning cycle: 0.4 mL of ADVIA 360 Cleaner 1L SMN 11170849

Environmental Requirements Operate the ADVIA 360 Hematology system within the ambient temperature range of 15–30° C (59–86 °F) and a relative humidity range of 45–85%. Optimum operating temperature is between 20–25°C (68–77° F). The ADVIA 360 Hematology system should be stored within the temperature range of 5–35°C (41–95°F). Avoid exposing it to direct sunlight or to extreme high or low temperatures. If the system was subjected to extreme temperatures during shipment or storage, it must be placed for at least one hour in a room whose temperature is within the operational range before installation or use. Reagents should be stored at a temperature range of 15–30°C (59–86°F). Reagents can tolerate temperature range of 5–35°C (41–95°F) for a maximum of 3 days.

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Electrical Requirements The system should only be operated from a wall outlet meeting these power input requirements: •

The system MUST be operated from its power supply module.

•

Input voltage: 100–240VAC; 47Hz to 63Hz, max. 100 VA

•

The system must be earth-grounded

The ADVIA 360 Hematology system comes with a power cord appropriate for your power system. Use of the appropriate power cord ensures adequate grounding of the system. If the power is not reliable, contact your representative for options such as installation of an external UPS (uninterruptible power supply) module. WARNING Failure to properly ground the ADVIA 360 Hematology system bypasses important safety features and may result in electrical hazard. The instrument should not be placed near potentially interfering devices capable of emitting radio frequencies (for example, radio or television transmitters, radars, centrifuges, X-ray devices, fans, and so forth.). The ADVIA 360 Hematology is designed to be safe for transient voltages to Installation Category II and Pollution Degree 2.

Waste Disposal The ADVIA 360 Hematology system waste contains human blood and reagents that are chemically and biologically active, and should be considered to be potential infection and biohazard threat. Safe laboratory practices must be followed including the use of personal protective when operating the ADVIA 360 Hematology system and handling blood, reagents, and waste.

BIOHAZARD System waste contains poisonous substances (chemical content) and substances of human origin that must be handled as a biohazard. These substances represent an environmental danger that must be handled with all the standard precautions and safeguards required by loacal laws, regulations, and good laboratory practices.

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Known Limitations The ADVIA 360 Hematology system is not intended for analysis of animal blood samples. Anti-coagulated and homogenized (well-mixed) human blood samples must be free from contamination and clots. Blood samples should be analyzed within 7 hours of venipuncture, otherwise precision is not guaranteed, especially on WBC 3-part differential parameters.

Performance Characteristics Performance characteristics of the ADVIA 360 Hematology system are listed sections below: •

Accuracy

•

Precision

•

Linearity

•

Carry-over

•

Sample Stability

•

Reference ranges

•

Interfering Substances

Accuracy Difference Criteria Parameter

Absolute

Percent

Low Range

WBC (103/µL)

0.30

6.00%

0.00

85.00

GRA% (%)

3.00

10.00%

0.00

100.00

LYM% (%)

3.00

10.00%

0.00

100.00

MID% (%)

3.00

10.00%

0.00

40.00

RBC (10 /µL)

0.15

6.00%

0.00

8.00

HGB (g/dL)

0.30

6.00%

1.00

25.00

MCV (fl)

1.00

6.00%

50.00

120.00

RDW (%)

0.50

6.00%

8.00

20.00

15.00

8.00%

0.00

1000.00

0.50

10.00%

5.00

30.00

6

PLT

(103/µL)

MPV (fl)

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Specifications

ADVIA 360 Hematology Operator’s Guide

Precision Repeatability Parameter

WBC

SD

(103/µL)

Within-Device Precision

CV%

SD

CV%

< 0.18

< 2.7%

< 0.40

< 4.0%

GRA% (%)

< 3.5

< 8.0%

< 3.5

< 8.0%

LYM% (%)

< 3.1

< 8.0%

< 3.1

< 8.0%

MID% (%)

< 2.0

< 17.0%

< 2.0

< 17.0%

< 0.11

< 1.7%

< 0.15

< 2.5%

HGB (g/dL)

< 0.20

< 2.0%

< 0.22

< 2.4%

MCV (fl)

< 1.0

< 1.7%

< 1.20

< 2.0%

RDW (%)

< 0.4

< 2.5%

< 0.45

< 3.0%

3

< 23

< 6.0%

< 27

< 7.0%

< 0.45

< 8.7%

< 0.5

< 10.0%

RBC

(106/µL)

PLT (10 /µL) MPV (fl)

Linearity and Reportable Ranges Param.

Determination (R2)

Nonlinearity absolute error

Nonlinearity relative error

Reportable Low

Reportable High

WBC (103/µL)

> 0.95

< 0.80

< 3.0%

0.0

85.0

HGB (g/dL)

> 0.95

< 0.27

< 3.0%

1.0

25.0

6

> 0.95

< 0.20

< 3.0%

0.00

08.00

3

> 0.95

< 35

< 3.0%

0

1000

RBC (10 /µL) PLT (10 /µL)

Carry-over and Reportable Ranges Parameter

Reportable Low

Reportable High

WBC (103/µL)

< 1.0%

0.2

83.0

HGB (g/dL)

< 0.8%

1.0

23.0

6

< 0.5%

0.40

7.70

3

< 1.0%

11

975

RBC (10 /µL) PLT (10 /µL)

86

Maximum Carryover (%)

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Specifications

Sample Stability Long-term sample stability studies on blood specimens drawn in K2- and K3EDTA collection tubes at room temperature showed no significant clinical variation for all parameters between 30 minutes and 7 hours post phlebotomy. MPV results can show instability in the first 2 hours but are stable afterwards.

Reference Ranges Male

Female

Human

Units

Parameter

Low

High

Low

High

Low

High

WBC

4.0

11.7

4.0

11.7

4.0

11.7

(103 /µL)

LYM%

7.1

43.1

7.1

43.1

7.1

43.1

%

MID%

0.0

18.8

0.0

18.8

0.0

18.8

%

GRA%

44.4

86.4

44.4

86.4

44.4

86.4

%

LYM

0.6

3.1

0.6

3.1

0.6

3.1

(103

MID

0.2

1.8

0.2

1.8

0.2

1.8

(103 /µL)

GRA

2.4

9.2

2.4

9.2

2.4

9.2

(103 /µL)

RBC

3.26

5.73

2.75

5.59

2.75

5.73

(103 /µL)

HGB

10.1

16.5

8.8

15.5

8.8

16.5

g/dL

HCT

30.6

49.6

26.1

47.4

26.1

49.6

%

MCV

76.4

102.0

76.4

102.0

76.4

102.0

fL

MCH

23.3

36.1

23.3

36.1

23.3

36.1

pg

MCHC

29.7

36.7

29.7

36.7

29.7

36.7

g/dL

RDW

12.2

16.6

12.2

16.6

12.2

16.6

PLT

97

390

97

390

97

390

MPV

7.1

10.9

7.1

10.9

7.1

10.9

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/µL)

% (103

/µL)

fL

87

Specifications

ADVIA 360 Hematology Operator’s Guide

Interfering Substances The substances below can interfere with parameter measurement and alternate measurement procedures may be required.

88

Parameter

Interference

WBC

> 5 NRBCs/100 WBCs, PLT clumps/large PLTs

RBC

WBC Count > 50.0 x 103/µL

MCV

WBC Count > 50.0 x 103/µL

PLT

PLT clumps/large PLTs (Abnormal histogram)

HGB

WBC count > 50.0 x 103/µL, Lipids > 270 mg/dL

Differential

> 5 NRBCs/100 WBCs, PLT clumps/large PLTs (Abnormal histogram)

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Appendix E:

Symbols

Symbols

This section describes the symbols that can appear on the exterior of the ADVIA 360 Hematology 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. For information on the symbols that can display on the automation reagent packaging and labelling, see the related assay instruction for use. Symbol

Description This symbol is used for both 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. This symbol alerts you to a biohazard.

This symbol alerts you to the risk of exposure to lasers.

This symbol alerts you to a potential electrical hazard.

This symbol alerts you to the risk of corrosive materials

This symbol identifies the location of a protective earth (GND) conductor terminal. This symbol indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive. It must be recycled or disposed of in accordance with applicable local requirements. 11170855 Rev. A

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Symbols

ADVIA 360 Hematology System Operator’s Guide

Symbol

Description This symbol indicates that the main power supply is on. This symbol indicates that the power switch is off.

This symbol indicates that the product has a temperature limitation. In this example, the product must be stored at 5° to 25 ° C. This symbol indicates that you should consult instructions for use. 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 revision letter of a part or product. This symbol indicates an in vitro diagnostic device or an in vitro medical device.11170855 Rev. A 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 Diluent connection.

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Symbol

Symbols

Description This symbol indicates a Lyse connection.

This symbol indicates a waste line connection.

This symbol indicates a cleaning line connection.

This symbol indicates the batch code for a product.

This symbol indicates that the product complies with the applicable directives of the European Union. This symbol indicates that the product complies with Canadian Safety Standards (CAN/CSA C22.2 No. 61010-1 2nd edition). This symbol indicates compliance with the restriction of hazardous substances used in electrical or electronic equipment. This symbol indicates that the input electricity is direct current. This symbol indicates a USB port.

This symbol indicates the location of an Ethernet connection.

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