ADVIA® 360 Hematology System
PEP to Go
Answers for life.
© Siemens Healthcare Diagnostics Inc. 2015 All rights reserved.
© Siemens Healthcare Diagnostics Inc. 2015 All rights reserved.
Page 1
2014-07-22
HILS# 00001401 Effective date 04/09/2015
Global Product Education
Table of Contents
1. System Overview
2. Daily Setup
3. Sample Processing
4. Technologies
5. Calibration
6. Quality Control
7. Maintenance
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Global Product Education
System Overview
Front, Top, and Right Side External Panel
Components:
2
1. LCD Capacitance Touch-screen
2. On-board Printer (Prints to 58mm wide
thermal paper)
5
1
3. Right Side Door Lock
4. Sample Rotor Station
5. Status light – Green (Ready), Red (Busy),
Orange (Standby)
6. Barcode scanner (Scans sample and control
barcodes and product and IFU reagent
barcodes)
6
4
3
Note: The 2D barcode reader/scanner that
ships with the system can be connected
via one of the USB (A) ports.
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System Overview
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System Overview
Back Panel and Reagent Connectors:
1. Reagent Connectors
2. Waste Connectors
3. Power Switch
4. Power Connector
3
5. USB (A) Port 1 and 2
6. LAN/Ethernet Port
4
7. USB-B Port
5
6
7
1
2
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System Overview
Reagent Connectors and Waste Outlets:
1. Diluent
2. Lyse
3. Cleaner
4. Waste Outlet Connector 1
1
5. Waste Outlet Connector 2
2
3
4
5
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System Overview
Left Side External Components:
1. USB (A) Port 1
2. USB (A) Port 2
Note: The 2D barcode reader/scanner that ships
with the system can be connected via
one of these USB (A) ports.
Note: You may connect an external USB
keyboard and/or a USB mouse to the
system, but these do not ship with the
system.
1
2
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System Overview
Right Side Internal Components:
1. Needle Chamber / Drain Chamber
2. Mixing Chamber
5
3. RBC Chamber
4. X-Y Sampling Unit with Piercing Needle
4
7
6
5. Sampler Head
6. Reagent Sensors
7. Vacuum Receiver
8
8. Sample micro-dilutor
9. Lyse Dilutor
10. Dilutors
9
10
1
2
3
12
11
11. Valves
12. WBC Aperture Assembly Chamber and HGB
Head
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System Overview
Home Screen Components:
1. Measure – New Sample, Re-run, Print, Discard
2. Database – Details, Print, Filter, Statistics,
Manage
3. Maintenance – Cleaning, Calibration,
Diagnostics, Reagent Status
1
2
4. Exit – Shutdown, Preparing for Shipment,
Logout Admin, User Management
5. Settings – General, Communication,
Measurement, Printer, Date and Time
6
3
6. Quality Control – New Lot, Delete, Print,
Export, Monthly View
5
4
Note: The Header at the top of the screen
displays warning messages, the title of
the Menu or function and the current
time
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Daily Setup
Power On/Start Up the System:
 Turn on all external and peripheral devices
prior to powering on the system
 Press the Main power switch located on the
back of the system above the DC power input
connector
 During startup, the ADVIA 360 screen appears,
followed by the Home screen
 The system automatically runs a priming cycle
if the fluidic system requires additional liquid
and the fluid sensors are turned on
Caution: Wait 5 minutes before initiating any
measuring processes after turning on the
power to allow the instrument to warm
up.
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Daily Setup
Check/Empty Waste:
 Check the contents of the waste tank
 If the level is above 80% full, empty the tank
 After disposing of the waste contents,
navigate to:
1. Home
2. Maintenance
3. Reagent status
4. Empty Waste (located within the
Waste box)

Selecting Empty waste resets the waste
counter to 0%

The waste level % calculation is based on the
setting of the tank capacity
Note: If your system empties directly into a
drain, the Waste tracking setting will be
set to OFF, and you will not need to track
the waste level.
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Daily Setup
Check/Replace Reagents:
 To check reagents navigate to:
1. Home
2. Maintenance
3. Reagent status
 Check if the there is sufficient reagent for the
expected number of daily measurements.
 The reagent level % calculation is based on the
setting of the tank capacity
 To replace reagents navigate to:
1. Home
2. Maintenance
3. Reagent status
4. Replace
5. Reagent type
6. Scan the reagent barcode
7. Accept

If you are replacing the lyse reagent, insert
the reagent hardware key into the key slot
on the back of the system.
Note: Run a Priming cycle and a Blank cycle
after the replacement of any reagents.
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Daily Setup
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Daily Setup
Reagents:
1. ADVIA 360 Lyse 3P Diff 1L:
 Color code – Yellow
 Creates hemolysate for 3-part WBC
differential, WBC count and HGB
determination
 Reagent key is attached to the bottle
2. ADVIA 360/560 Dil 20L:
 Color code – Green
 Dilutes whole blood samples
 Rinses the fluidic system between
measuring cycles
3. ADVIA 360 Cleaner 1L:
 Color code – Dark Blue
 Cleans the tubing, counting chambers,
and apertures
1
2
3
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Daily Setup
More Reagents:
4. ADVIA 360/560 Hypoclean CC 100mL:
 Color code – Black
 Used for the Hard Cleaning procedure
to remove protein and lipids from
sample tubes, chambers, and
apertures
 1mL should be dispensed into a 5mL
sample tube and run before a Hard
cleaning is started
4
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Daily Setup
Reagent Lock System/Hardware (HW) Key
 Each ADVIA 360 Lyse 3P Diff reagent comes
with a hardware key containing 900
measurement credits.
 When the number of measurement credits
reaches zero (0), the system can no longer
perform a measurement, and Error 6003
displays:
 Hardware key not found, or is not
suitable for this device! Please
connect a proper hardware key!
 Each measurement cycle decreases the
number of measurement credits by one,
except for initialization, standby, and wakeup cycles which do not affect the credits
 To restore measurement credits, obtain a new
reagent hardware key, remove the depleted
key, and insert it into the HW Key reagent slot
 To display the number of measurement
credits:
 Navigate to Home > Maintenance >
Reagent status > Measurement
credits
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Global Product Education
Daily Setup
Perform a Blank Measurement:
 To ensures the cleanliness of the system
 Prior to running patients, controls, or
calibrations on the system
 At the beginning of each shift and before
sample analysis
 If reagents are replaced and/or maintenance is
performed
 If the system has not been used for more than
3 hours
 Navigate to:
1. Home > Measure > New Sample
2. If a Blank measurement was not
performed before running a sample, a
message appears: “There is no valid
blank measurement”. Select OK to
continue with the Blank measurement
3. Otherwise, select Blank
 After one minute, the system displays the
blank values.
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Daily Setup
Perform a Blank Measurement Continued:
 If the Blank values are within the acceptable
ranges, select Accept

If one or more parameters are out of range,
re-run the blank by selecting Re-blank

If Blank values are consistently high for any of
the parameters, run a Cleaning by selecting
Maintenance > Cleaning > Cleaning
 Repeat Blank once Cleaning is complete
 If Blank measurement continues to be out of
range after performing a Cleaning, perform a
Hard Cleaning on the system:
1. Put 1mL of ADVIA Hypoclean CC
reagent in a 5mL sample tube
2. Place sample tube in the sample rotor
3. Select Maintenance > Cleaning >
Hard Cleaning > OK
4. When complete, repeat Blank
measurement and select Accept if
Blank is in range
5. If the Blank measurement is still out of
range call the Customer Care Center –
Technical Solutions for assistance
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Global Product Education
Daily Setup
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
 To prime the reagent, navigate to:
1. Home
2. Maintenance
3. Reagent status
4. Prime (located within each individual
reagent box) or Prime all (located at
the bottom of the screen)
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Daily Setup
Perform a Daily Shutdown / Cleaning:
 Initiate a Shutdown of the system from the
Home screen by selecting Exit > Shutdown
 Turn off the power via the power switch when
the system displays a warning and emits a
sustained tone
 During a shutdown, the system:
1. First, saves data and settings, and
closes the databases
2. Then, automatically cleans and
flushes debris from the system to
prevent clogs and contamination
3. Lastly, moves mechanical parts
(sample needle, syringe pumps, and
valves) into their home positions
Warning: Do not turn off the instrument by
flipping the power switch on the back
panel. Doing so may result in erroneous
operating, loss of data, or a prolonged
start-up cycle during later use.
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Sample Processing
Run a Patient Sample (Barcoded and NonBarcoded)
1. Mix sample gently by inverting 8 – 11 times
2. Navigate to Home > Measure > New Sample
3. Select a sample type (Human, Male, Female,
Profile 1 – 7)
4. Identify the sample (Sample ID) by scanning
the sample barcode or manually entering
Sample ID
5. Insert the sample tube into the Sample rotor
6. Select Run
7. During this time the status light turns red, the
sample rotor rotates the sample into the
system for aspiration (100µL). After a few
seconds, the sample rotor rotates back out to
its original position
8. When sampling is complete, the status light
turns green indicating that the system is ready
for the next sample
Important: If QC was not performed, perform QC
prior to running a patient sample.
Note: If a Blank was not performed before running a sample, a
message appears: “There is no valid blank
measurement. Press OK to measure a blank first”.
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Sample Processing
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Sample Processing
Interpret Patient Results:
 Results display in the Measure screen (Home >
Measure)
 Results are divided into three categories:
1. Parameters
2. Normal Ranges
3. Tech Details
 The ID header displays:
 PID – Patient ID, date and time of
sample run
 SID – Sample ID and sample Type
 Warning flags when appropriate
 Results screen – Parameters
 Values within normal range are white
 Values outside of the normal range are
red and flag as L or H
 Histograms display graphical
information about volume distribution
of WBC, RBC, PLT
 Discriminators are indicated by vertical
lines that separate different cell
populations
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Sample Processing
Review Patient Results:
 Results screen – Normal Ranges
 Normal ranges display in a graphical
format on the right of the screen
 Each value is indicated by a downwardpointing white arrowhead within the
normal range graphics
 Low and high limits of the normal
range display on either side of the
range line
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Sample Processing
Review Patient Results:
 Results screen – Tech Details
 Probe voltage: shows electrode
voltages for WBC and RBC counts
 WBC lyse volume: default value = 0.9
 Diagnostic flags: shows evaluations
made by the system based on results
 Warning flags display for the
measurement
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Sample Processing
Review Patient Results:
 Flags
 Out of Normal Range Flags
• Parameters are highlighted in
red and display an L flag if under
the normal range, and an H flag
if above the normal range
 Measurement Condition Flags
• If the system cannot interpret
measurements, condition flags
are attached to the result and
display in the header of the
Measure screen with a Warning,
and in the Tech Details screen
with a brief explanation.
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Sample Processing
Review Patient Results:
 Flags
 Blank Cycle Flagging
• The system flags parameter
values if a high Blank has been
accepted
• Associated value is
displayed but flagged
with an asterisk (*)
• Associated value is
dashed out (---) and
flagged by an E flag
Note: Refer to the tables titled Flagging on WBC and HGB
channels, Flagging on RBC/PLT channel, and Warning
Flags of Differential Parameters in the Sample
Measurement and Interpretations of Results section
of the Operator’s Guide, for more information
regarding flag symbols, their meaning, and explanation
and recommended actions.
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Technologies
Measurement Methods:
 Photometric Light Absorbance Method
 Measures the WBC dilution to
determine the hemoglobin (HGB)
concentration of the erythrocytes (RBC)
 Volumetric Impedance Method
 Measures the cellular concentrations
and volume distributions of RBCs and
PLTs from RBC dilution
 A lytic reagent is used to determine the
distribution of leukocytes (WBC), and
their three sub-populations (LYM, MID,
GRA)
 3-Part Differential Analysis Method
 Counts and simultaneously sizedifferentiates the white blood cells by
using a WBC lytic process
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Technologies
Global Product Education
Technologies
Measurement Sequence:
1. The sampling needle moves into the sample
vial and aspirates 100µL of EDTA anticoagulated whole blood sample
2. 25µL of this sample is separated in the
sampler head while the remaining 75µL is
disposed of through the sampling needle into
a dedicated washing chamber
6. The WBC cell counting is performed, followed
by an HGB measurement
7. Then an RBC and PLT counting is performed
8. The system drains and cleans the measuring
chambers and related tubing, and prepares for
the next blood sample. Apertures are cleaned
with high-voltage burning pulses
3. The 25µL whole blood sample is transported
to the mixing chamber through the sampling
needle with an addition of 4mL of diluent to
make a 1:160 primary dilution
4. 25µL of the diluted sample is aspirated into
the sampler head and then mixed with
another 4mL of diluent which is dispensed
into the RBC chamber forming a 1:25,000
overall RBC dilution
5. The remaining mix dilution is moved to the
WBC chamber where 0.9mL of lysing reagent
is added. Bubbles are used to mix the lyse and
the mix dilution. This creates a dilution of
1:196 which is suitable for photometric
measurement and WBC counting
Note: Measuring times:
WBC count (adaptive) 2 – 6 seconds
HGB measurement 2 seconds
RBC/PLT count 8 seconds
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Calibration
Prepare and Perform a Calibration:
1. Prior to performing a Calibration, run a Selftest and a Blank measurement:

To perform a Self-test navigate to:
1. Home
2. Maintenance
3. Diagnostics
4. Self Test
5. Start
2. Run a Blank measurement (Refer to the
section titled Daily Startup in this
documentation for instructions)
3. To perform a calibration navigate to:
1. Home
2. Maintenance
3. Calibration
4. Calibration with measurement
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Calibration
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Maintenance
Global Product Education
Calibration
Prepare and Perform a Calibration:
4. If using a new lot of calibrator, scan the
barcode on the assay sheet to upload the lot
number, expiration date, and target values for
the calibrator
5. Select the number of runs desired: 3 or 7 and
select Accept
6. Mix the calibrator material, insert the tube into
the sample adaptor, and select Run
1. The system rotates the sample for
aspiration and begins measuring
(Status light turns red)
2. The system rotates the sample to the
original position once aspiration is
complete
7. If the results look good, and there are no
warning flags, run Calibration with
Measurement again until you reach the
required number of runs: 3 or 7
8. If a warning flag is displayed (C or c, clogging)
select Discard to delete that particular
calibration run, then run Calibration with
measurement again
Note: Mix the calibrator sample thoroughly in
between runs
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Maintenance
Global Product Education
Calibration
Review and Interpret Calibration Results:

After performing all the runs, the results
display showing statistical evaluation of
calibration runs

Each calibration factor must be within 1.00 +/0.20 limits

If a calibration is outside this range, it is
highlighted in red

The left part of the screen displays: Target
values, Mean Values of Runs, CV%, and the
newly calculated calibration factors

If the CV% values and the new factors are
satisfactory, select Evaluate > Accept

If the results are not acceptable, select Cancel.

Repeat the calibration process using a new vial
of calibration material
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Maintenance
Global Product Education
Calibration
View Calibration History and Database

To view the history of calibration events by
factors, navigate to:
1. Home
2. Maintenance
3. Calibration
4. History

The Calibration History screen shows the
calibration factors that were generated by
each calibration
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Maintenance
Global Product Education
Calibration
View Calibration History and Database

To view the calibration database, navigate to:
1. Home
2. Maintenance
3. Calibration
4. Database

The calibration database screen shows the
details of each calibration run
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Maintenance
Global Product Education
Quality Control
Enter a New Lot of QC Material:
1. Navigate to Home > Quality control > New
Lot
2. Scan the QR code located on the Assay sheet
shipped with your control materials, to load
the Lot information, expiration date, and
target and range values
3. Allow time for the prompt “Do you want to
install controls…?” to appear
4. Select Yes
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Quality Control
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Maintenance
Global Product Education
Quality Control
View QC Reference Values:
1. Select Quality control
2. Select > next to the expiration date for that
control
3. Select References
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Quality Control
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Maintenance
Global Product Education
Quality Control
Run a Quality Control Sample
1. To measure QC (all levels), navigate to:
1. Quality control
2. Select the check box in front of the Lot
number and level of QC you wish to run
3. Select > next to the expiration date for
that control
4. Select Measure
5. Mix the control material, insert the tube
into the sample adaptor, and select Run
6. The system rotates the sample for
aspiration and begins the QC
measurement (Status light turns orange
and then red)
7. The system rotates the sample to the
original position once aspiration is
complete
8. The QC results display and the system
beeps when the measurement is
complete
9. Select Run to rerun QC, Discard to
discard the QC results, and Print to
print the results
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Important: Verify that a valid Blank has been
performed and accepted prior to running QC.
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Maintenance
Global Product Education
Quality Control
Review and Interpret QC Results

Results display in the QC screen (Home >
Quality control)

Results are divided into three categories:
1. Parameters
2. Normal Ranges
3. Tech Details
 The Lot number, date and time of run, sample
ID and sample type display in the header
 Results screen – Parameters
 Values within normal range are white
 Values outside of the normal range are
red and flag as L or H
 Histograms display graphical
information about volume distribution
of WBC, RBC, PLT
 Discriminators are indicated by vertical
lines that separate different cell
populations
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2014-07-22
Maintenance
Global Product Education
Quality Control
Review and Interpret QC Results
 Results screen – Normal Ranges
 Normal ranges display in a graphical
format on the right of the screen
 Each value is indicated by a downwardpointing white arrowhead within the
normal range graphics
 Low and high limits of the normal range
display on either side of the range line
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2014-07-22
Maintenance
Global Product Education
Quality Control
Review and Interpret QC Results
 Results screen – Tech Details
 Probe voltage: shows electrode
voltages for WBC and RBC counts
 WBC lyse volume: default value = 0.9
 Diagnostic flags: shows evaluations
made by the system based on results
 Warning flags display for the
measurement
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2014-07-22
Maintenance
Global Product Education
Quality Control
To Display QC Results in Database (Table) View:
1. Select Quality control
2. Select the check box to the left of the Lot file
that you wish to view
3. Select > next to the expiration date for that
control
4. Select Database at the bottom of the screen
5. Navigate through all the parameters by
selecting the left/right arrows at the bottom of
the screen
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Maintenance
Global Product Education
Quality Control
View, Print, or Export Control Lot Data Files
1. Navigate to Home > Quality Control
2. Select the check box to the left of the Lot file
that you wish to view
3. Select Monthly View at the bottom of the
screen
4. Navigate through the months (mm/yyyy)
using the arrows at the top of the screen
5. Select Print or Export for the selected file(s)
Important: Selecting Export writes the selected
records as an ASCII file (.txt) to the USB storage
device if a USB device is present in the USB port,
otherwise the system requests that the USB
device be inserted.
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Maintenance
Global Product Education
Quality Control
View a Levey-Jennings Chat
1. Navigate to Home > Quality Control
2. Select the check box to the left of the Lot file
that you wish to view
3. Select > to the right of the expiration date so
that the Levey-Jennings chart displays
4. To navigate through the chart to view the
results for the different parameters, select the
up and down arrows towards the bottom of
the screen
5. To display results for a specific measurement
point, select the Left/Right arrows on either
side of the View option, to move the white
triangle pointer to the specific measurement
you wish to view
6. Select View
7. Select Normal ranges and Tech Details to
view those results for that particular
measurement
Important: Any QC that has been measured via the
Measure screen will not be included in the
statistical data.
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Maintenance
Global Product Education
Maintenance
Daily Maintenance:

Perform a Daily Shutdown / Cleaning:
1. To shut down the system select Exit >
Shutdown
•
The software initiates a Cleaning
sequence
2. When the system displays a warning
message and emits a sustained tone, it
is safe to turn off the power
3. Power off the system by pressing the
Power switch

Perform a Daily Startup:
1. Power on all external devices (Printer) if
installed
2. Power on the system by pressing the
Power switch (Wait 5 minutes before
initiating any measuring processes to
allow system to warm up)
3. Follow Startup as per laboratory policy
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Maintenance
Global Product Education
Maintenance
Weekly Maintenance:

Perform a Hard Cleaning
 Put 1 mL of the ADVIA Hypoclean
solution into a sample tube
 Run the Hard Cleaning function by
navigating to:
1. Home
2. Maintenance
3. Cleaning
4. Hard Cleaning
 Repeat blank and select Accept if in
range

Check Tubing System
 Open the side door and check for any
leaks
Warning: The sharp tip of the piercing needle can
cause injury. Always use rubber gloves and a
cotton swab to clean the wash head.
© Siemens Healthcare Diagnostics Inc. 2015 All rights reserved.
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Global Product Education
Maintenance
Weekly Maintenance:

Clean the Needle Wash Head
1. Run the shut-down procedure and
power down the system
2. Open the side door
3. Use a moistened cotton swab with
deionized water to remove salt and
blood residuals from the bottom of the
wash head
4. Power on the system by pressing the
Power switch
5. Follow Startup as per laboratory policy
Warning: The sharp tip of the piercing needle can
cause injury. Always use rubber gloves and a
cotton swab to clean the wash head.
© Siemens Healthcare Diagnostics Inc. 2015 All rights reserved.
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Global Product Education
Note: This document is for supplemental use only, and not
meant to be used in place of primary technical materials.
© 2015 Siemens Healthcare Diagnostics Inc. All rights reserved.
This guide and the software described within, are copyrighted.
No part of this may be copied, reproduced, translated, or
reduced to any electronic medium or machine-readable form
without the prior written consent of Siemens Healthcare
Diagnostics.
ADVIA is a trademark of Siemens Healthcare Diagnostics Inc. or
its affiliates. Other trademarks used herein are the property of
the respective owners.
Global Siemens Headquarters
Siemens AG
Wittelsbacherplatz 2
80333 Muenchen
Germany
Global Siemens Healthcare Headquarters
Siemens AG
Healthcare Sector
Henkestrasse 127
91052 Erlangen
Germany
Global Division
Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591-5005
USA
www.siemens.com/diagnostics
© Siemens Healthcare Diagnostics Inc. 2015 All rights reserved.
Page 44
2014-07-22
Global Product Education