AliFax Roller 20 Manual GB

Table of Contents
Table of Contents
1 - Introduction ...................................................... 5
Intended Use ..............................................................................................................................5
How to Use the Operator’s Manual .............................................................................................5
Accessing a Section Using the Bookmark Navigation Pane ..................................................6
Following a Link inside the Manual ........................................................................................6
Warnings and Precautions: Symbols – Definitions ......................................................................7
Notes ....................................................................................................................................7
Cautions ................................................................................................................................7
Warnings ...............................................................................................................................7
Biological Warnings ...............................................................................................................7
Symbols ......................................................................................................................................8
Manufacturer ...............................................................................................................................9
Beckman Coulter Contact Information .........................................................................................9
Terminology ..............................................................................................................................10
Warnings...................................................................................................................................11
2 – System Description ........................................ 13

Theory of Operation ..................................................................................................................13
Internal Automated Mode ....................................................................................................13
Manual Mode ......................................................................................................................13
Front View ...........................................................................................................................14
Rear View ...........................................................................................................................15
Internal Components ...........................................................................................................16
Rotor with 20 Positions ..................................................................................................16
Wash Tank ....................................................................................................................16
External Retractable Probe............................................................................................16
Smart Card ...............................................................................................................................17
Starting the Instrument ..............................................................................................................18
Software....................................................................................................................................19
Levels of Access .................................................................................................................19
Main Menu ..........................................................................................................................20
Setup Menu .........................................................................................................................20
Availability Menu .................................................................................................................21
Warning Level ...............................................................................................................21
Display Availability .........................................................................................................22
Comm Menu .......................................................................................................................22
Tech Menu ..........................................................................................................................22
Installation.................................................................................................................................23
Location ..............................................................................................................................23
Installation Requirements ....................................................................................................23
Technical Specifications............................................................................................................24
301-4331-English Rev AA 06/2013 Operator’s Manual 1

Table of Contents
3 - Configuration ................................................. 25
Setup Menu ..............................................................................................................................25
Log In ..................................................................................................................................26
Date and Time Menu.................................................................................................................27
Changing the Date ..............................................................................................................27
Changing the Time ..............................................................................................................28
FL Menu ..............................................................................................................................28
Settings Menu ...........................................................................................................................29
Software Version .................................................................................................................30
Print in Run .........................................................................................................................31
Print Expanded....................................................................................................................32
Language Setup ..................................................................................................................33
Wash Time ..........................................................................................................................34
4 – Specimen Processing ................................... 35

Sample Requirements...............................................................................................................35
Automatic Sampling ............................................................................................................35
Manual Sampling ................................................................................................................35
Tube Requirements ..................................................................................................................36
Tube Dimensions ................................................................................................................36
Tube Volume .......................................................................................................................36
Tube Caps ..........................................................................................................................36
Sample Mixing.....................................................................................................................36
Switching the Instrument ON.....................................................................................................37
Perform a Wash Cycle ........................................................................................................37
Internal Wash ................................................................................................................38
Manual Wash ................................................................................................................39
Running Samples......................................................................................................................40
Sample Processing Flowchart .............................................................................................40
Selecting the Type of Measure Mode ..................................................................................41
Internal Measurement....................................................................................................41
External Measurement ..................................................................................................41
External Measurement without Mixing ...........................................................................41
Entering the Patient Identification ........................................................................................42
External Barcode Reader Patient ID ..............................................................................42
Manual Patient ID Entry .................................................................................................43
Autogenerated Patient ID ..............................................................................................44
Verifying the Patient Identification .......................................................................................45
Internal Sampling ......................................................................................................................46
Loading the Samples on the Rotor ......................................................................................46
Manual Sampling ......................................................................................................................48
Internal Sample Mixing ........................................................................................................48
Manual Priming Procedure ..................................................................................................48
Manual Sampling Procedure ...............................................................................................50
Cleaning the External Probe................................................................................................51
Manual Sampling Completion..............................................................................................51
Emptying the Roller ...................................................................................................................52

Table of Contents
Switching the Instrument Off .....................................................................................................53
5 – Quality Control .............................................. 54

Quality Control ..........................................................................................................................54
Control Material.........................................................................................................................54
Control Frequency ...............................................................................................................55
Handling Control Material ....................................................................................................55
Shelf Life .......................................................................................................................55
Storage conditions .........................................................................................................55
Running QC on the Rotor ..........................................................................................................56
Internal Wash with 0.5% Bleach Solution before Controls ...................................................56
Entering Control ID and Loading Latex QC Tubes on the Rotor .......................................... 58
Entering the Control Identification ..................................................................................59
Loading the Tubes on the Rotor ....................................................................................60
Running Latex QC on the External Probe .................................................................................61
Latex Priming – Sampling Procedures ...........................................................................61
QC Results ...............................................................................................................................62
Reviewing QC Results ........................................................................................................63
Latex Individual Control Printout ..........................................................................................64
QC Statistics .............................................................................................................................65
QC Screen Selections .........................................................................................................66
QC Statistics from Samples ......................................................................................................67
Average Statistics from Samples .........................................................................................67
Average Printout from Normal Samples Range .............................................................68
Global Average Printout from Samples ..........................................................................69
Cumulative Distribution from Samples .................................................................................69
Cumulative Distribution Printout from Normal Samples .................................................70
Global Cumulative Distribution Printout from Samples ...................................................70
Daily Distribution from Samples ..........................................................................................71
Daily Distribution Printout from Normal Samples ...........................................................72
Global Daily Distribution Printout from Samples ............................................................72
QC Statistics from Latex Controls Distribution .....................................................................73
Latex Statistic Report ....................................................................................................74
Wash Distribution Quality Control Printout ...........................................................................75
Average Printout from Wash Distribution .......................................................................76
6 - Results ............................................................. 77
Analysis Results........................................................................................................................77
Display ................................................................................................................................77
Printout................................................................................................................................77
Statistical Results Printouts .......................................................................................................78
QC Screen Selections .........................................................................................................78

Table of Contents
7 – Maintenance and Service............................ 79

Maintenance .............................................................................................................................79
Daily Maintenance ...............................................................................................................79
Consumable Replenishment ...............................................................................................79
Daily Maintenance ....................................................................................................................80
Wash Procedures .....................................................................................................................80
Wash Options......................................................................................................................81
Wash Menu .........................................................................................................................81
Internal Wash ................................................................................................................82
Automatic Wash ............................................................................................................83
Manual Wash ................................................................................................................83
Wash Procedure with 0.5% Diluted Bleach Solution ............................................................84
Internal Wash with Bleach .............................................................................................84
Manual Wash with Bleach .............................................................................................88
Run Controls .......................................................................................................................90
Clean Instrument Surfaces ..................................................................................................91
Perform a Wash and Sleep Procedure ................................................................................91
Manual Wash and Sleep ...............................................................................................91
Internal Wash and Sleep ...............................................................................................93
As Needed Maintenance ...........................................................................................................97
Refill the Wash Tank ...........................................................................................................97
Empty the Waste Tank ........................................................................................................99
Replace the Printer Paper .................................................................................................101
Tallies -FL (Flag) Menu .....................................................................................................102
Troubleshooting ......................................................................................................................106
Before Calling for Service ..................................................................................................106
Hardware issues ..........................................................................................................106
Instrument applications issues .....................................................................................106
Washing Errors .................................................................................................................107
Photometer Not OK .....................................................................................................107
Error Messages .................................................................................................................108
Service ....................................................................................................................................111
Probe Replacement...........................................................................................................111
Fuse Replacement ............................................................................................................116
Sanitation Procedure .........................................................................................................117
Sanitation Form ...........................................................................................................118
Maintenance Log ....................................................................................................................119
8 - Appendix ..................................................... 120

Limitations...............................................................................................................................120
References .............................................................................................................................122

1 - Introduction
1 - Introduction
Intended Use
For professional in vitro diagnostic use only.
The Roller 20PN is an automated Erythrocyte Sedimentation Rate analyzer;

classified as a Class I device and exempt from the premarket notification
requirement.
The Roller 20PN is a fully automated analyzer for the determination of the
Erythrocyte Sedimentation Rate (ESR) in human blood, and provides results in
thirty-five (35) seconds after an initial pre-mix by measuring red blood cell
aggregation; overcoming the variables and limitations of the Westergren method.
The analyzer is equipped with a hand-held barcode reader for specimen

identification, internal mixing system, automated closed vial cap pierce and
aspiration, external probe for manual mode open vial sampling for small
specimens, automatic wash, and on-board quality control for latex controls and
patient samples.
How to Use the Operator’s Manual

Use the Operator's Manual as a guide to daily operations, maintenance and
quality control as well as a reference for system components, and
troubleshooting. This document is provided electronically on a CD with the Roller
20PN system.
It is intended to explain the instrument operations in detail, to be a training guide

for new operators and to be a troubleshooting reference resource.

1 - Introduction
Accessing a Section Using the Bookmark Navigation Pane

The Bookmark navigation pane, located on the left side of the screen, can be
used as a “linked” table of contents.
Click on a bookmark to go automatically to the starting page of the selected

section.
1. To expand the selection, click on the + sign located next to the bookmark.
2. To collapse the selection, click on the - sign located next to the bookmark.
Following a Link inside the Manual

In order to avoid searching for a specific section, links have been created to jump
to other locations and to give immediate access to the related information. Links
are indicated in the following manner: the text is displayed in blue and bold
italics. Example: see Beckman Coulter Contact Information.
1. Select the hand tool .

2. Position the pointer over the linked area on the page until the pointer changes
to the hand with a pointing finger .
3. Click the link, the destination screen is displayed.
4. To return to the previous section, click the Go to Previous View button.

1 - Introduction
Warnings and Precautions: Symbols – Definitions

The Operators Manual includes information and warnings that must be observed
by the operator to ensure safe operation of the system.
There are four types of messages.
Notes
NOTE: Highlights important facts, gives helpful information and tips, and clarifies
procedures.
Cautions
CAUTION: Identifies electrical caution! Unplug before handling.
CAUTION: International symbol for “Attention, see instructions for use” or

“Caution, consult accompanying documents.”
Warnings
WARNING: Identifies potentially hazardous situations that could result in serious

injury to laboratory personnel.
Biological Warnings
WARNING: Identifies potential biological hazards.

1 - Introduction
Symbols
The following is a list of symbols used on the product labeling and their meaning:
Symbol Meaning
Caution Consult Accompanying Documents
Consult Operating Instructions
Control
Manufacturer
Date of Manufacture
Reference Number
In Vitro Diagnostic
Serial Number
Caution: Laser Radiation
Caution: Moving Parts Inside
Caution: Sharp Objects Inside
Ground terminal plug on the equipment
Compliant with Waste Electrical and Electronic Equipment (WEEE)

directive

1 - Introduction
Manufacturer
Alifax S.P.A
SIRE Analytical Systems s.r.l
Via Bella 121/3
33100 Udine, Italy
ISO 9001:2000 certified by TÜV Italia (n. 50 100 6107/A)

ISO 13485:2003 certified by TÜV Italia (n. 50 100 6107/B)
Distributed by Beckman Coulter

www.beckmancoulter.com
250 Kraemer Blvd.
Bread CA 92821
All trademarks are property of their respective owners.

Beckman Coulter, the stylized logo are trademarks of Beckman Coulter, Inc. and
are registered with the USPTO
Beckman Coulter Contact Information

Attention Clinical Support
9172 Eton Avenue
Chatsworth, CA 91311
USA
Telephone:
From U.S. locations +1-800-776-4747 Option 2
Fax: +1-800-239-2864
E-mail: clinsupport@beckman.com

1 - Introduction
Terminology
Term Meaning
Automatic Wash Wash performed with DI water directly from the Wash
Tank
BCR External Barcode Reader
ESR Erythrocyte Sedimentation Rate
Manual Wash Wash performed using tubes filled with DI water
presented manually to the external probe
FIFO First In First Out
Internal Wash Wash performed using tubes filled with DI water loaded
on the rotor
Sensor 1 Internal Sensor
Sensor 2 External Sensor
Smart Card A pre-programmed card used to load available tests onto
the instrument.
Standard Select this option to run Latex Control Materials on the
instrument
Wash and Sleep Wash procedure performed at the end of a working day.
Wash Tank Container located inside the front door filled with DI
water for automatic wash
Waste Tank Container located inside the front filled with discarded
blood, latex, and DI water

1 - Introduction
Warnings
The manufacturer does not assume any responsibility for eventual damages to
persons or things due to improper use of the instrument, installation by
unauthorized person(s), use of the instrument while safety interlocks and sensors
are defeated, use of the instrument in a manner other than specified and
operation by untrained individuals.
WARNING risk of operator injury if:

• all doors and covers are not secured in place prior to and during
operation
• integrity of safety interlocks and sensors are compromised
• contact with moving or broken parts
Report any broken parts to your Iris representative. Use the tools provided with
the system for troubleshooting
Operate the instrument as instructed in the Operator's Manual.
The instrument is designed for indoor use only
Check that the instrument is connected to a ground outlet before use.
Switch OFF the instrument before connecting to any external peripheral, external
barcode reader, and/or RS232 serial cables.
Check the waste tank level before operation; empty the waste tank if filled to
security level. Follow the Laboratory standard safety procedures.
The blood samples must remain capped. Do not uncap and recap them which
could affect the instrument’s performances except if analyzed using the external
manual sampling probe.
Never mix Bleach with Blood in the system. Always run DI water before and after
Bleach.
Always follow the Wash Maintenance procedure to ensure instrument

performance.
Use only original spare parts supplied by the manufacturer.
The instrument can be exposed to potential infective materials. Therefore, it is

required to follow all precautions and necessary warnings, in accordance with
Federal and State laws.

1 - Introduction
Keep away from the instrument any kind of objects, liquids, or substances not
required for the instrument’s use.
Do not remove the instrument panels or tamper with the reading sensor. The
service operations must be carried out only by technical personnel authorized by
the manufacturer.
Avoid the use of the instrument near electromagnetic sources, such as cellular
phones, CB’s, radio transmitting units and similar.
In order to avoid possible mistakes with the Query-Host communication and/or

the transmission of patient ID to the Host computer, use the barcode
identification "check digit" option to ensure correct transmission of specimen
identification.

2 – System Description
Theory of Operation
The Roller 20PN uses stopped flow kinetic analysis with capillary photometry to
measure the optical density of red blood cell aggregation.
The Roller 20PN has two specimen sampling modes - manual and automated, each
equipped with a sample probe, micro capillary tube and blood aspiration pump.
The instrument is first primed before sample analysis can be performed. Priming
is accomplished by aspirating additional volume of specimen from tubes in
position one and two in the rotor. Once primed, the system will then aspirate a
second time from tube one for the analysis cycle. Each sample is separated by
an air bubble. After analysis, the sample is discarded into the waste tank.
If the internal sampling is selected, up to twenty (20) sample tubes can be loaded
on the rotor. The system performs the measurements automatically.
If the external probe is selected, sample tubes are presented individually for
sampling.
Internal Automated Mode

• Minimum volume requirement is 1.3 mL
• Priming specimen volume is 116 μL whole blood from tubes one and two
• Analysis specimen volume is 175 μL for the first tube and all subsequent
tubes loaded in the rotor
The first result is available after 7 minutes. Thereafter, results are available every
35 seconds per sample. Up to sixty (60) samples can be processed in one hour,
twenty (20) samples in 20 minutes.
Manual Mode
• Priming specimen volume is 100 μL from the first tube
• Analysis specimen volume is 100 μL from the first and all subsequent
tubes
After priming, the first result is available in 35 seconds (analysis). Mixing of the
manual mode sample can be accomplished either internally following the display
screen instructions, or externally by hand, or on a separate mixer.
If the specimen is short for analysis in the manual mode, then priming should be
completed with an alternative available specimen volume before proceeding.

Front View
2 1
3
5
Legend: 1 – Smart Card Slot

2 – Sample Loading Door
3 – Touchscreen LCD
4 – Internal Thermal Printer
5 - Stylus

Rear View
3 2 1
4
6
7
Legend: 1 – Power Cord Plug

2 – Fuses Box
3 – Main Power Switch
4 – Power Supply Fan Intakes
5 – Instrument Cooling Fan
6 – Instrument Cooling Fan Intake
7 – External Barcode Reader Serial Port
8 – Host Computer (LIS) Serial Port
9 – USB Port (for future applications)

Internal Components
Rotor with 20 Positions
Located underneath the Sample Loading Door, one (1) rotor allows for a total of
20 tubes to be loaded on the instrument.
Wash Tank
Located inside the front door on the instrument, the Wash Tank is filled with DI
water to perform the manual or automated wash procedures. Following a wash
and latex control procedure, the system checks the photometer and displays its
status. The maximum Washing Tank capacity is 500 mL.
External Retractable Probe

Located next to the Touchscreen LCD, the External Probe is used for manual
mode sampling from uncapped tubes. This option is useful for low volume or
pediatric specimens.

Smart Card
The Smart Card is loaded into the slot located on the top right of the instrument.
Each smart card contains a specified number of tests from 1,000 to 20,000. Any
number of smart cards can be loaded. The system will display the number of
tests available to run. When a smart card is loaded, all the tests on the card will
be downloaded to the instrument. If required, Service can move all the tests from
one instrument to another.
If the instrument runs out of tests while processing, the current batch can be
completed in the automated mode. The number of tests in deficit will be deducted
when a new smart card of tests is loaded.
To ensure adequate tests are always available, the system has a threshold alarm
that will display a warning message when reached. It is possible to adjust the
threshold level via the Availability > Warning Level screen. The Threshold can be
set between 3 and 30,000 remaining tests. When the warning message occurs,
check or order a new smart card. See Display Availability.
Conform to ISO 7816-1 specifications – 85.6 x 54 x 0.8 mm

Coded using SIRE Analytical Systems / Alifax Group proprietary algorithm.
Four different cards are available:
Part Number Number of Tests

700-2011 1,000
700-2012 4,000
700-2013 10,000
700-2014 20,000

Starting the Instrument

Press the Main Power Switch located on the upper rear side of the instrument.
The analyzer automatically starts the internal checkup, and then displays the
Main Menu screen.

Software
This instrument is controlled using the Touch Screen. Each option, function,
process is activated/deactivated by touching the corresponding button.
Button Function
Main Used to access the common functions: measure, wash, empty roller,
and mixer.
Setup Accessible only to Admin level 2 users or technical service.
Used to access some common configuration functions, and specific
functions protected by password.
Availability Used to set the test credit warning alarm, and to display/print the
credits availability.
Comm Accessible only to technical service.

Tech Accessible only to technical service.
More Information lists manufacturer’s phone numbers.
For use inside the USA contact Beckman Coulter.
+1-800-776-4747
or email clinsupport@beckman.com
Last Session
Print last session results
The Start Up screen displays four (4) touchscreen options allowing the operator
to access directly specific functions:
• Measure
• Wash
• Empty Roller
• Mixer
Levels of Access
Not all the functions inside the menus are freely accessible. The instrument has
three levels of access:
Level Access
Level 1 - OPERATOR No password required. Allows access only to the basic
functions
Level 2 – ADMIN LEVEL Password required.
Allows access to the basic setup functions. When the
instrument is switched off, the instrument is reset to Level 1
Operator.
Level 3 – TECH LEVEL Password required.
This level is reserved only for Iris Technical Service
Personnel.

Main Menu
From the Main Screen, press Main to displays the following options:
Setup Menu
From the Main Screen, press Setup to displays the following options:

Availability Menu
From the Main Screen, press Availability to display the following options:
Warning Level
This function is used to setup the number of tests available remaining at which
the instrument will issue a warning. The tests are loaded on the instrument, see
Smart Card. The instrument will stop running samples when the number of tests
remaining is 0.

Display Availability
This function is used to display and print the number of tests available on the
currently used Smart Card.
Comm Menu
NOTE: This function is password protected and is reserved only for Technical
Service Personnel.
Tech Menu
NOTE: This function is password protected and is reserved only for Technical
Service Personnel.

Installation
The Roller 20PN will be installed by a Beckman Coulter trained representative. If
the installation is performed by other personnel, then the warranty will be void.
Location
The Roller 20PN weighs about 35 pounds and should be installed on a stable
bench with four inches of clearance around all sides to allow for connection of
cables, including hand held bar code reader, power cord and RS232 interface
cable.
Installation Requirements
The instrument should be located in a dry moisture free area away from direct
sunlight to increase operational reliability. Sunlight can interfere with the door
sensor.
Avoid using extension leads and while a dedicated outlet is not required it is
preferable that the system does not share an outlet with devices that create a
voltage imbalance such as centrifuges or refrigerators.
As reported in the technical specifications, the instrument uses alternating

current from 85 VAC to 256 VAC; therefore it is not necessary to use a voltage
selector.

Technical Specifications
Specimen Processing Barcode or manual entry of ID
Up to 20 EDTA whole blood tubes per run
Closed and open tube sampling
Specimen Tubes 13 x 75 mm 4 mL EDTA tubes
Specimen Volume Auto Mode: 1 mL up to 60% of total tube volume
External Mode / Manual mode: 100 μL of blood
Auto Mode Sampling 175 μL closed tube
Measurement Principle Measures the kinetics of red blood cell aggregation by
capillary photometry
Reportable Range 2 – 120 mm/hr
Result Storage 6,000 (First In First Out) used for statistics only
Result Time 35 seconds

Throughput Up to 60 samples/hour
QC Data Storage 30 days
Correlation to Modified r => 0.94
Westergren
Quality Control Tri-level latex control
Reproducibility CV=5.1% from 2-210 mm/hour
Stability 4°C 24 hours r=>0.980
4°C 48 hrs r=>0.95
20-25°C 24 hours r=>0.917
Communication 2 serial RS232 ports
Optional CCD Barcode Reader
LIS Interface Bi-directional
Electrical Power Req. 115 - 230 VAC 50/60 Hz
Power Consumption 115 VA
Dimensions 10” W x 15” D x 18’ H

Weight 35 lbs.
Fluid Waste Waste is pumped from the instrument into a Waste Tank
Ambient Temperature Temperature control 37°C
Control, Relative Ambient temperature must be 50° - 86° F (10° - 30°C)
Humidity, and Heat Relative humidity must be between 15% and 85% non-
Output condensing.
Heat output approximately 230 British Thermal Units or BTUs
Maximum Rated Altitude 9840 feet - 3000 meters alignment signal locator (ASL)

3 – Configuration
3 - Configuration
Setup Menu
NOTE: Only a Level 2 Administrator can modify the user-defined settings. Any
user can view the settings. See Levels of Access.
From the Main Menu, press Setup. The following screen is displayed.

3 – Configuration
Log In
The Log In screen is used to access administrator settings as well as by
technical service functions.
Level Access
Level 1 - OPERATOR No password required. Allows access only to the basic
functions
Level 2 – ADMIN LEVEL Password required. Enter 1010, left arrow
Allows access to Date / Time setting and Wash Time option.
When the instrument is switched off, the instrument is reset
to Level 1 Operator.
Level 3 – TECH LEVEL Password required.
This level is reserved only for Iris Technical Service
Personnel.
1. From the Setup Menu, press LOGIN. The numerical keyboard is displayed.
2. Enter 1010 password to access the Admin Level, and then press .
3. Press Back to return to the Main Menu.
4. On the Main screen, the logged in user level will be displayed.

3 – Configuration
Date and Time Menu

From the Setup Menu, select Date time. The following screen is displayed.
If the Admin Password has been entered into the Log in screen then the display
below will be visible to set the date/time.
Changing the Date

1. Press the SET option, the numerical keyboard is displayed.
2. The instrument prompts to modify in the following order: Year,
Month and Day
3. Enter the appropriate value, and then press to validate the
entry and update the Date on the screen.

3 – Configuration
Changing the Time

1. Press the SET option, the numerical keyboard is displayed.
2. The instrument prompts to modify in the following order: Hour
and Minutes.
3. Enter the appropriate value, and then press to validate the
entry and update the Time on the screen.
FL Menu (Flag List)

This option is used to print tallies of instrument runs, and test availability.

3 – Configuration
Settings Menu
From the Setup Menu, select Settings. The following screen is displayed.

3 – Configuration
Software Version
This function is used to display the instrument software version, and the
processors software versions. The instrument uses five (5) different processors
and not all of them may have the same version installed.
1. From the Setup Menu, select SW version. The following screen is displayed.
2. Press Back to return to the Settings menu.

3 – Configuration
Print in Run
If this function is enabled, the instrument will print the IDs and ESR results after
the completion of each sample analysis. If this function is disabled, the
instrument will print the IDs and ESR results after completion of all sample
analyses.
1. From the Setup Menu, select Print in Run. The following screen is
displayed.
2. Select YES to enable the function.

3. Select NO to disable the function.
3. Press Back to validate the change and return to the Settings menu.

3 – Configuration
Print Expanded
If this function is enabled, the instrument will print the IDs and ESR results with
enlarged (expanded) text. If this function is disabled, the instrument will print the
IDs and ESR results with the default size text.
1. From the Setup Menu, select Print Expanded. The following screen is
displayed.
2. Select YES to enable the function.

3. Select NO to disable the function.

3 – Configuration
Language Setup
This function allows the user to select the language for displaying messages and
warnings on the instrument screen.
The available languages are:

English Italian Spanish
French Russian
1. From the Setup Menu, select Language. The following screen is displayed.
2. Select the desired language.


3 – Configuration
Wash Time
CAUTION: This option must be used to avoid residual blood clotting inside
the capillary after completion of the analysis cycle. The recommended time
is 15 minutes.
This option allows setting up the time delay, in minutes, after which an automatic
wash procedure is performed. The countdown starts at the end of the analysis
cycle. This will be set on installation.
NOTE: Log in as the Admin to access the menu to change the washing time.
1. From the Setup Menu, select Login.

2. Enter the password 1010, press
3. From the Setup Menu, select Wash Time. The keyboard screen is displayed.
4. Type the new time delay in minutes, and then press to validate the
change.
5. Press Back to return to the Settings menu.

4 – Specimen Processing
Sample Requirements
Automatic Sampling
• The sample must be of whole blood collected in EDTA anti-coagulant.
• The blood sample must be neither coagulated nor hemolyzed.
• It is recommended to test the sample within 4-6 hours from venipuncture or
within 48 hours if kept at +4 / +8 °C, allowing it to return to room temperature
before testing.
• The minimum blood volume for the sampling (dead volume) is 1.3 mL.
• The minimum blood working volume required for the analysis is about 175
microliters. When running a batch or single run, the first two samples required
an additional 116 microliters withdrawn for priming. In total, 232 microliters
are withdrawn from the first two samples. If there is only one sample, the
amount withdrawn is around 232 microliters.
• Samples separation inside the capillary are performed using air bubble.
Manual Sampling
• The minimum blood volume required for the analysis is about 100 microliters;
except for the first sample after a wash from which supplementary 100
microliters are withdrawn for priming.
• Samples separation inside the capillary is performed using air bubble.

Tube Requirements
Tube Dimensions
Test-tubes 13x75 mm like BD Vacutainer® or Greiner Bio-one or with 13 mm
diameter and from 75 to 83 mm high, cap included (like for example the Sarstedt
tubes that measure 11.5x66 mm without cap).
Tube Volume
The sample volume must not exceed 50-60% of the total volume of the test tube.
Tube Caps
Optional Terumo® cap adapter for Terumo Venojet II® tubes
Optional Sarstedt® cap adapter for Sarstedt Monovette® tubes
Sample Mixing
Sample mixing can be programmed in three speeds (60, 32, and 24 RPM) and in
number of rotations from 2 to 1,000 rotations
The system is pre-programmed at the recommended setting of 32 RPM at 200

rotations, about 6 minutes of mixing time.

Switching the Instrument ON

1. Turn on the instrument using the power switch located on the top back panel
2. Remove any Wash and Sleep Tube loaded previously from the rotor.
3. Check the Waste container and empty if needed.
4. Check the Wash tank and fill if needed.
5. Check the printer paper roll and replace if needed.
6. Perform a wash cycle.
Perform a Wash Cycle

1. From the Main Menu or the Main Screen, press Wash.
2. The instrument prompts to select the wash option.

3. Select the appropriate wash option. The instrument will activate the
corresponding procedure.
Internal Wash
1. After selecting Internal, the instrument will prompt to insert washing tube on
the rotor.
2. Load two (2) wash tubes filled to 3/4 volume with DI water in positions 1 and 2
of the rotor.
3. At the end of the wash cycle, the instrument will display and print a report
indicating the photometer parameters.
4. When a wash procedure is not successful, the instrument will generate a
PHOTOMETER NOT OK error and the washing procedure must be repeated.

Manual Wash
1. After selecting External, the instrument moves the external probe to the
sampling position.
2. Insert the external probe inside the DI water wash tube, and then press Start.
3. Repeat the procedure with a second tube filled to 3/4 volume with DI water.
indicating the photometer status, OK or Not OK. When a wash procedure is
not successful, the instrument will generate a PHOTOMETER NOT OK error
and the washing procedure must be repeated.

Running Samples
Sample Processing Flowchart
From Main Menu,

Select Measure
Type of Measure
Mode? Select
External with External

Internal
Internal Mixing without Mixing
Barcode Label
on the tube?
YES YES NO
Select Auto.
Scan the barcode Select Manual ID.
Enter the
label using the Enter the Patient
Patient ID using
external Barcode ID from Barcode
autogenerated
Reader Label
values
Measure Selected
External
External with
without
Internal Internal
Internal
Mixing
Mixing
Load all the

Load all the Present the
sample tubes on
sample sample tube
the rotor for
tubes on for external
mixing. Press
the rotor sampling
Measure
Remove individual
tube from the rotor
Press Measure position as
requested
Present the sample

tube for external
sampling

Selecting the Type of Measure Mode
From the Main menu, press Measure. The following screen is displayed.
Internal Measurement
The tube will be loaded on the rotor for automatic sampling with mixing.
From the Measure screen, press Internal.
External Measurement
The tube will be loaded on the rotor for mixing, and then will be presented to the
external probe for sampling, press External.
External Measurement without Mixing

The tube will be presented to the external probe for sampling without mixing.
From the Measure screen, press External without mixing.
NOTE: This measure must be selected if the sample tubes are uncapped, or
when measuring short samples.
From the Measure screen, press External without mixing.

After selecting the type of measurement, the instrument checks the
following:
• The position of the rotor,
• The level of the waste tank,
• The availability of test credits.
NOTE: If the waste tank is full, it must be emptied before starting a new session.
If not, the instrument remains in standby mode until when the waste tank is
emptied.
Proceed with the Patient Identification. See Entering the Patient Identification.
Entering the Patient Identification

If a barcode label has been applied to the sample tube, the following options are
available:
• The Patient identification is entered automatically by scanning the
barcode label using the external CCD barcode reader.
• If an external barcode reader is not available, the sample ID can be
entered using the keyboard.
If the sample is not identified by manual input or with a barcode label, a unique
autogenerated ID will be assigned.
External Barcode Reader Patient ID

1. After selecting type of measurement, the instrument displays the following
screen.

2. Scan the barcode on the sample tube using the external scanner. The
instrument will display the patient ID number in the ID field.
Manual Patient ID Entry

1. After selecting type of measurement, the instrument displays the following
screen.
2. Press the Manual ID button. The instrument will display the keyboard.
3. Enter the Patient ID, and then press .
4. The instrument will display the patient ID number in the ID field.

Autogenerated Patient ID
The autogenerated code is composed of a numeric sequence made by the
following series of numbers:
• The cycle number,

• The serial number of Roller 20,
• The wheel number,
• The position of tube in the rack (1-10).
Example: 0307920106
1. After selecting the type of measurement, the instrument displays the following
screen.
2. Press the Auto button.

3. The instrument will display the keyboard.
4. Enter the Patient ID, and then press .

Verifying the Patient Identification

1. After the Patient Identification has been entered, the instrument will display
the patient ID number in the ID field.
2. Verify the patient ID with the number on the barcode label or the
autogenerated number. If the wrong patient ID is displayed, press Delete to
erase the ID and re-enter the patient ID using the barcode reader, manual
entry option, or the autogenerated option.
3. If the correct ID is displayed, press OK. The following screen is displayed.
4. Proceed with specimen processing. See Loading the Sample on the Rotor
or Manual Withdrawal Sampling .

Internal Sampling
Loading the Samples on the Rotor
The samples must be loaded on the Rotor when the following measurements are
selected:
• Internal
• Manual with internal mixing
1. Open the tilting door, and then insert the tube in the next available tube
holder according to the screen display.
2. The instrument is equipped with two sensors to detect the presence of the
tube’s cap, and the presence of fingers. If after few seconds the external
sensor still detects the fingers, the instrument will display the following
message: “Remove hands from the instrument”.
3. After loading the sample, the instrument displays the Measure button.

4. If more samples need to be processed, repeat the procedure for the next
tube.
5. When all tubes have been loaded on the rotor, press the Measure button to
proceed with the analysis or the internal mixing.
6. When the analysis is completed, the instrument displays the sample results.
Based on the printer setup, the individual results are printed immediately or
delayed until the end of the analysis cycle.

Manual Sampling
WARNING: When using the manual sampling procedure, it is mandatory to use
protective gloves and all others protective tools, precautions and warnings
necessary in order to avoid the contact with biohazardous material in accordance
with Federal, State, and local regulations.
Internal Sample Mixing

If the selected measurement is external sampling with internal mixing, the
instrument will prompt to load the samples on the rotor and will mix them. See
Loading the Samples on the Rotor.
For the priming procedure, the instrument will mix the blood loaded on the rotor
for half of the total mixing cycles. The minimum number of mixing cycles is not
less than 10.
After the mixing cycle has been completed, the instrument will prompt to remove
the first sample from the rotor for manual priming. See Manual Priming
Procedure.
Manual Priming Procedure
NOTE: The instrument will start a Priming procedure only if the analysis is
performed after a Washing procedure.
NOTE: If pediatric samples are measured, since they contain a small quantity of
blood, the aspiration for the priming can be performed using a previously
analyzed blood sample or blood sample belonging to an adult.
1. After the internal sample mixing is completed, the instrument prompts to

remove the tube from position 1.
2. The external probe moves out for access, and the Mixing is displayed.
3. Remove the tube, and then uncap the tube from position 1.
4. Insert the external probe inside the tube all the way down.

5. From the Priming screen, press START .

6. The instrument aspirates a small quantity of blood from the tube to prepare
the capillary to receive the blood.
7. When three (3) beeps sound, remove the tube, recap and clean the probe.
8. The instrument prompts to reload the tube on the rotor in position 1; close the
door and the mixing procedure continues until the programmed mixing cycles
are completed.

Manual Sampling Procedure

1. After the internal sample mixing is completed, the instrument prompts to
remove the tube from position 1.
2. The external probe moves out for access, and the Sample screen is
displayed.
3. Remove the tube, and then uncap the tube from position 1.
4. Insert the external probe inside the tube all the way down.
5. From the Sample screen, press START.

6. The instrument aspirates a small quantity of blood from the tube for
measurement.
7. When three (3) beeps sound, remove and then recap the tube.
8. The tube can be reloaded on the rotor or left outside the instrument (external
rack) for other analysis.
9. When the analysis is completed, the instrument displays the sample results.
Based on the printer setup, the individual results are printed immediately or
delayed until the end of the analysis cycle.
10. From the Result screen, press Back . The instrument prompts to clean the
external probe. See Cleaning the External Probe.

Cleaning the External Probe
1. To clean the external probe, use a dry lint free tissue.

2. Gently, wipe the probe from the top to the bottom.
3. When the probe has been cleaned, from the Wipe Probe screen, press OK .
CAUTION: To avoid damaging the probe, do not pull on the probe.
4. The instrument will move the rotor to the next position and will ask to remove
the next sample to be analyzed. See Manual Sampling Procedure.
Manual Sampling Completion

When all samples have been processed on the manual mode, perform a Manual
wash, see Manual Wash.

Emptying the Roller

1. From the Main Menu, press Empty Roller.
2. Open the tilting door, and then remove all the loaded tubes. The instrument
checks as the tubes are removed from the rotor.

Switching the Instrument Off

Before switching OFF the instrument, it is mandatory to perform the Wash and
Sleep procedure. See Perform a Wash and Sleep Procedure.
When the Washing procedure is completed, the instrument can be switched OFF
using the main power switch located on the back.

5 – Quality Control
Quality Control
The Quality Control program is used to collect QC data and display QC reports
and statistics. These functions are used to obtain data, verify and monitor the
proper system operation.
Quality Control Tools

The Roller 20PN System has a series of tools to enable monitoring of instrument
performance. These include:
• Latex Quality Control material and monitoring of daily and cumulative
values versus reference value.
• Patient Population daily average, cumulative average ESR values and
Cumulative distribution of ESR ranges.
• Photometer value monitoring during daily wash procedures.
Control Material
The Latex Controls kit is used to verify system function. The results of the control
simulate three ESR values, one low level (≅5 mm/h), one medium level (≅20
mm/h) and one high level (≅60mm/h).
By comparing the results obtained from the analyzer with those reported on the
kit package, it is very easy to verify that the instrument is reporting reliable
results.
Part Number Kit Tubes

800-2007 Latex Control Kit 6 tests Greiner tubes 13x75 mm
800-2008 Latex Control Kit 30 tests Greiner tubes 13x75 mm
Latex Control Kit 6 tests Latex Control Kit 30 tests

Control Frequency
All controls should be run at least once every 24 hours or as specified in the
Laboratory’s QC Procedure manual. Beckman Coulter recommends running the
controls at the beginning of the day.
Handling Control Material

Refer to the control material package insert for more information.
Shelf Life
From production: 6 months.
From the first piercing: 6 weeks.
Storage conditions
Before use: between 4 to 25°C
From the first piercing: keep refrigerated between 2° to 8°C.
Refrigerated control material should be returned to room temperature before
running on the instrument.

Running QC on the Rotor

NOTE: Since the system is equipped with two reading circuits, the Rotor and the
External Probe, controls must be run on both circuits.
It is recommended to first run the Control Material on the Rotor, and then run the
same Control Material using the External Probe.
Before running the latex controls, run one (1) wash procedure using 2 wash
tubes of DI water, followed by one (1) wash procedure with one tube of 0.5%
Diluted Bleach and the 2nd filled with DI water.
Internal Wash with 0.5% Bleach Solution before Controls
NOTE: Wash tubes must be single use only and should not be refilled and re-
used. Only use Beckman Coulter provided Wash tubes.
NOTE: Starting with a 5% solution of household bleach, dilute the bleach solution
1:10 (one part Bleach and nine parts DI Water) to obtain a final working dilution
of 0.5%.

2. The instrument will check the rotor status, prompting to remove any tube
present on the rotor.

4. Select Internal, the instrument will prompt to insert the washing tubes on the
rotor.
5. Load one (1) wash tube filled to ¾ volume with 0.5% diluted Bleach in
position 1 of the rotor. Load one (1) wash tube filled to ¾ volume with DI
water in position 2 of the rotor.
6. Close the door; the instrument will start the wash automatically.
indicating the status of the photometer parameters.
8. Continue with latex QC only if Photometer OK is displayed. Otherwise refer
to Washing Errors.

Entering Control ID and Loading Latex QC Tubes on the Rotor

1. From the Main Menu or the Main Screen, press Standard.
NOTE: Standard menu is for running latex control. The QC menu is for
displaying QC statistics.
3. The instrument prompts to select the measurement mode. Select Internal.
4. The system prompts to load the tubes on the rotor. Open the rotor door.
5. The tubes must be loaded in the following order:

Position Tube
1 Wash tube filled to ¾ volume with DI water
2 Low level control tube
3 Medium level control tube
4 High level control tube
Entering the Control Identification
NOTE: The Control Identification located on the Barcode Label must match the 3
Latex Levels. The numbers 2, 3, and 4 indicate the tube position on the rotor.
1. Before loading the Control Tubes, the instrument prompts to enter each
Control Identification printed on the barcode label attached on the tube.
2. Using the Barcode Reader:
a. Scan the barcode label on the tube. The ID is displayed inside the ID
field.
b. Verify the ID.
3. Manual entry using the keyboard:
a. Select the Manual option. The screen displays the keyboard.
b. Enter the Latex ID, and then press .
c. Verify the ID.
4. Recall a tri-level ID stored in the database.
a. Select the Memo option. The screen displays the stored Latex ID.
b. If the correct Latex ID is displayed, press OK.

Loading the Tubes on the Rotor

1. Load a wash Tube willed to ¾ volume with DI water in position 1 on the rotor.
2. Load the Low Level Control in position 2 on the rotor.
3. Load the Medium Level Control in position 3 on the rotor.
4. Load the High Level Control in position 4 on the rotor.
5. Load a wash Tube filled to ¾ volume with DI water in position 5.
6. Load a wash Tube filled to ¾ volume with DI water in position 6.
7. Close the rotor door.
8. The system will check the following:
• Latex expiration date: if the controls are expired, the screen prompt will
appear – latex control lot expired, cannot run.
• The three tubes belong to the same kit: if not, will prompt that the codes
are inconsistent. Press Clear. The instrument will prompt to remove the
tubes from the rotor.
• Always discard all 3 sequestered tubes and do not mix tubes.

Running Latex QC on the External Probe

1. After mixing, the external probe will move down, and the instrument will
display the following screen.
2. Wipe the probe from top to bottom using a dry lint free tissue.
3. Open the rotor door, and then remove the tube in position 1.
4. Close the rotor door, and then insert the external probe all the way inside the
tube.
5. The screen displays Wash. Press Start .
5. The instrument performs a washing procedure. When three (3) beeps sound,
remove and then recap the tube.
Latex Priming – Sampling Procedures

2. Open the rotor door, and then remove the low level control in position 2.
3. Insert the external probe all the way inside the tube.
4. Close the door.
5. The screen displays Priming. Press Start .
6. The instrument performs a priming procedure using the latex control. When
three (3) beeps sound, remove the tube.
8. Insert the external probe all the way inside the tube.
9. The screen displays Latex. Press Start .
10. The instrument performs a sampling procedure using the latex control. When
three (3) beeps sound, remove the tube.

12. Repeat the procedure for the two remaining Latex controls.
13. Repeat the wash procedure for the two remaining tubes filled with DI water.
QC Results
After the Quality Control measurements are completed, the instrument displays
the obtained values and the expected ranges.
From the Latex Absolute Levels screen, select OK . The Reference values
screen is displayed.

Reviewing QC Results
The printout displayed on the next page is an example of a report after a Latex
Control.
At the end of the procedure, compare the printed results with the expected range
printed in Table 2 on the latex control kit box.
If the results obtained by the analyzer are within the expected range, the
analyzer is correctly calibrated.
If one or more results are not within the expected range printed on the latex
control kit box, re-run the controls. If the results are still out of range, then contact
Customer Service.

Latex Individual Control Printout

Printout Section Meaning
Latex Lot number and Kit number.
Values before and after washing.
Washing Sequence water tubes

Tube 1 (before Latex Control)
Tube 5 (after Latex Control)
Tube 6 (after Latex Control)
Report photometer status (OK – not OK)
Operating parameters
Results obtained after the Control procedure
Level = Measured values (expected range)
Sensor 1 Measured Value 1

Sensor 2 Measured Value 2

QC Statistics
Results obtained during the latex control procedure are stored by the instrument
for 30 days.
Up to 6,000 ESR sample results are included in the QC statistics. When the total
of stored results reaches 6,000 the first 1,000 are removed from the internal
memory (First In First Out).
1. From the Main Menu or the Main Screen, press Q.C..
2. The QC screen is displayed.

QC Screen Selections
The options AVERAGE, CUMULATIVE, and DAILY, allow the user to print the
corresponding distribution of ESR sample results obtained by the instrument.
Option Selection Function

Normal (1-1) Average distribution of the normal result range
(2 to 30)
AVERAGE
Global (1-2) Average distribution of the global result range
(2 to 120)
Normal (2-1) Cumulative distribution of the normal result range
(2 to 30)
CUMULATIVE
Global (2-2) Cumulative distribution of the global result range (2
to 120)
DAILY Normal (3-1) Daily distribution of the normal result range
(2 to 30)
Global (1-2) Daily distribution of the global result range
(2 to 120)
LATEX Print (4-1) Print the Latex QC results from the last 30 days
WASH Print (5-1) Print the Wash

QC Statistics from Patient Samples

Results from a reference population are used as statistical daily controls. There
are four different printouts, see QC Screen Selections.
Average Statistics from Samples

Select this option to print the statistical data relative to the ESR population
average:
• average of the “Normal” range (ESR from 2 to 30)
• average of the “Global” range (ESR from 2 to 120)
From the Main Menu, press QC. From the QC Menu, press Normal (1-1) or
press Global (1-2).
Assuming a constant patient population, the average ESR value will remain
relatively constant. As more data points are added each day so the cumulative
average ESR value becomes more statistically significant. Based on population
variances the average ESR value of the laboratories normal range being more
stable than the average ESR value of the reportable or global range.
Daily variations in instrument performance can be evaluated by comparing the

daily ESR average value to the cumulative average ESR value. A normal in
control value is one that oscillates around the cumulative average value. A daily
average ESR value that shows directional change over time indicates a systemic
instrument drift. The percentage of pathological samples varies day to day and
influences the daily average, however the cumulative average over time is
unaffected.

Average Printout from Normal Samples Range
 Indicates a cumulative average.
o Indicates a daily average
Number of today samples results inside the

normal range
Lower and Upper values for the normal range
8.88  cumulative average

4.11  day 1 average
6.69  cumulative average (day 1 + day 2)
7.14  cumulative average (day 1 + day 2 +
day 3)
Data for today’s analysis
Daily SD average - # of samples analyzed during

the day
SD cumulative average - # of samples analyzed
during the last 30 days
>5 and <10 Limits of the cumulative CV%
This graphical printout represents the last 30 days of analysis, and an anomalous
tendency of the daily average with respect to the cumulative average, can be
easily spotted. The data are printed from oldest (top of the graph) to most recent
(bottom of the graph).
Consider the number of daily sample results. The cumulative average line
becomes stable after more than 100 samples, and the daily average moves
around the cumulative trend line. This way, a problem could be immediately
evidenced by a rapid deflection of the trend line of daily and cumulative
averages.
The instrument is able to store 6,000 sample results to calculate the average, so
a large variation on daily statistics will not change in determinant way the
cumulative average. As soon as the instrument reaches 6,000 sample results, it
will discard the first 1,000 (using the First In First Out rule), conserving 5,000
sample results. This prevents the range around the cumulative mean from being
too tight.

Global Average Printout from Samples
The meaning and display of the printout is identical to the Average Normal
Printout. The only difference is that the sample results used to generate the
printout are within the global ESR range from 2 to 120.
Cumulative Distribution from Samples

This option prints out the statistical data relative to the cumulative distribution of
ESR values.
press Global (2-2).
The cumulative distribution is defined by the percentage and number of data

points for each defined ESR interval.

Cumulative Distribution Printout from Normal Samples

Total Number of samples, inside the normal

range
Mean and SD values
ESR results are redistributed in intervals.
Each interval indicates:
ESR range of interval

Percentage of samples inside each interval
Number of samples results belonging to the
interval
Global Cumulative Distribution Printout from Samples

The meaning and display of the printout is identical to the Cumulative Normal
Printout. The only difference is that the sample results used to generate the
printout are within a global ESR range from 2 to 120.

Daily Distribution from Samples

This option prints out the statistical data relative to the daily ESR distribution
values.
press Global (3-2).
Assuming a constant patient population, the distribution of ESR values within the
normal range will remain relatively constant. As more data points are added each
day so the cumulative average ESR value becomes more statistically significant.
The variation in the graphical printout can be due to a casual variation in the
number of pathological samples.
The distribution in the medium to high ESR value ranges can vary, while the
distribution within the normal range is constant.
As a general rule, the higher the number of samples, the lower the variations
compared to the cumulative parameters.

Daily Distribution Printout from Normal Samples
Total Number of samples, inside the normal

range
Mean and SD values
ESR results are redistributed in intervals.
Each interval indicates:
ESR range of the interval

Percentage of samples inside each interval
Number of samples results belonging to the
interval
Global Daily Distribution Printout from Samples

The meaning and display of the printout is identical to the Daily Normal ESR
Distribution Printout. The only difference is that the sample results used to
generate the printout are within a global ESR range from 2 to 120.

QC Statistics from Latex Controls Distribution
From the Main Menu, press QC. From the QC Menu, press Print (4-1).
Using the QC printout, the user can identify instrument trends requiring attention.
The control values are compared to reference values printed on the Latex kit. Up
to 30 days of control results are stored and printed with the most recent at the top
of the printout.

Latex Statistic Report

In order to better understand the meaning of the
printed results, we assume that a series of three
controls with reference values of 5, 20 and 60 mm/h
are run on the instrument.
After running the controls, if the results are identical

to the reference values (5, 20 and 60), this indicates
no shift (y=1.00*x). The shift is indicated on the left
side of the printout and the dots are printed directly
below the number 1, see the second row on the
graph above.
If the results are 6, 22 and 64 mm/h, the shift is

+5,36% (y=1.0536*x). The shift is indicated on the
left side of the printout and the dots are printed in the
column between1 and +10%, see the first row in the
graph above.
The Standard Deviation (SD), and the Percentage

Coefficient of Variation (CV %) are printed at the end
of the printout.
A CV% within +/- 10% indicates that the analyzer is

performing efficiently. A CV% exceeding +/- 10%
indicates that the analyzer may need to be calibrated.
Call Technical Services.

Wash Distribution Quality Control Printout

This function prints statistical data about the photometer measurement during
the wash procedures (Internal, Manual, or Automatic) performed on the
instrument.
This printout allows the user to estimate the photometer efficiency. Normally, the
instruments are regulated automatically around an absolute value of 3800 during
the wash with DI water. This value tends to move down with time, due to residue
buildup inside the capillary.
From the Main Menu, press QC. From the QC Menu, press Print (5-1).

Average Printout from Wash Distribution

Key to sensors:
1 – Sensor 1 
2 – Sensor 2 
Stop sensor ∗
Lower and Upper limits of DI water range, ideal

reference value is 3800
No line on the left column indicates that the
instrument has been switched ON, not used and
then switched OFF
N indicates that the instrument has been switched
ON, not used and then switched OFF without
having been washed or every time Photometer
Not OK is issued
the instrument has been washed and the three
sensors report DI water values within the lower
and higher limits:
sensor 1: 3774
sensor 2: 3791
stop sensor: 3782
Statistical data about the last 30 days.

The average and the SD of each sensor for the
last 30 days.
Each average should remain as close as possible
to the reference value of 3800.
If the photometer signals fall below 3600 or increases above 4000, the
instrument will generate “PHOTOMETER NOT OK” error and will prompt to retry
the washing procedure. In this cases, if is recommended to perform a Wash
Bleach Maintenance, see Wash Maintenance with Bleach.
If the value does not return inside the normal range, call the Technical Services.

6 – Results
6 - Results
Analysis Results
Display
After the sample analysis is completed, the instrument displays the results.
Printout
Based on the printer setup, a printout of results is generated either after each
single analysis, or globally at the end of the analysis cycle. See Print in Run.
An example of the printout is displayed on the

right.
For each session:

Date and time of analysis
Session number (01 = first session of the day)
For each sample, the tube position inside the

rotor, patient ID, and the ESR results
expressed in (mm/h).
, in this case all 6 parameter’s result are displayed, if (as
explained in chapter 7 Increase Availability Test Using Smart
Card) one or more specific parameters are not available, the
instrument will printout only the results for the available
parameters.

6 – Results
Statistical Results Printouts

Up to 6,000 ESR results are stored by the instrument for statistics, and cannot be
recalled individually. When the total of stored results reaches 6,000 the first
1,000 are removed from internal memory (First In First Out).
Since these results are used as “controls” for statistical purposes, the printouts
can be accessed from the QC Menu.
QC Screen Selections
The options AVERAGE, CUMULATIVE, and DAILY, allow the user to print the
corresponding distribution of ESR sample results obtained by the instrument.
Option Selection Function

Normal (1-1) Average distribution of the normal result range
(2 to 30)
AVERAGE
Global (1-2) Average distribution of the global result range
(2 to 120)
Normal (2-1) Cumulative distribution of the normal result range
(2 to 30)
CUMULATIVE
Global (2-2) Cumulative distribution of the global result range (2
to 120)
DAILY Normal (3-1) Daily distribution of the normal result range
(2 to 30)
Global (1-2) Daily distribution of the global result range
(2 to 120)
LATEX Print (4-1) Print the Latex QC results from the last 30 days
WASH Print (5-1) Print the Wash/photometer
See Average Statistics from Samples, Cumulative Distribution from

Samples, and Daily Distribution from Samples for more information.

7 – Maintenance and Service

Maintenance
WARNING: Wear protective gloves and all necessary protective gear to prevent
exposure to pathogens. Discard contaminated materials according to applicable
regulations.
Daily Maintenance
Items Suggested Intervals
Wash Procedure Daily at the beginning of the day
Clean Instrument Surfaces Daily
Wash Procedure with 0.5% Bleach Before running Latex Controls

Solution before running Latex Controls
Run Controls Daily
Perform a Wash and Sleep Procedure Daily at the end of the day
with DI water and 0.5% Bleach Solution
Consumable Replenishment
Items Suggested Intervals
Refill the Wash Tank As needed
Empty the Waste Tank When indicated by the instrument
Replace the Printer Paper As needed

Daily Maintenance
Wash Procedures
These procedures are designed to ensure that the capillary and the hydraulic
circuitries are maintained clean and free of blood residue.
Since the instrument uses Teflon tubing in which blood, water and latex flows, it
is normal that the internal walls of the capillary tend to become opaque over time.
To ensure the capillary lasts, the instrument provides three different washing
options: Wash with DI, Wash with 0.5% Bleach Solution and Wash and Sleep.
When a wash procedure is not successful, the instrument will generate a
PHOTOMETER NOT OK error and the wash procedure must be repeated.
NOTE: Wash tubes used on the internal mode must be single use only and
should not be refilled and reused.

Wash Options
NOTE: Wash tubes used on the internal mode must be single use only and
should not be refilled and reused.
Wash Option Procedure

Internal Two (2) wash tubes loaded on the rotor.
Automatic Uses DI water from the internal Wash Tank
External A wash tube is presented manually to the external probe.
Wash Menu
NOTE: Wash tubes must be single use only and should not be refilled and re-
used.

NOTE: If the waste tank is full, the system will prompt to empty the waste tank.
The instrument will remain in standby until the Waste Tank is emptied. See
Emptying the Waste Tank.

4. Select the appropriate wash option. The instrument will activate the
corresponding procedure.
Internal Wash
1. After selecting Internal, the instrument will prompt to insert washing tube on
the rotor.
2. Load two (2) wash tubes filled to 3/4 volume with DI water in positions 1 and 2
of the rotor.
When a wash procedure is not successful, the instrument will generate a

PHOTOMETER NOT OK error and the washing procedure must be repeated.

Automatic Wash
1. After selecting Automatic, the instrument aspirates DI water directly from the
Wash Tank. The screen will display “Washing”.
Manual Wash
1. After selecting External, the instrument moves the external probe to the
sampling position.
2. Insert the external probe inside the DI water wash tube, and then press Start.
3. Repeat the procedure with a second tube filled to 3/4 volume with DI water.
indicating the photometer status OK or Not OK. When a wash procedure is

Wash Procedure with 0.5% Diluted Bleach Solution
CAUTION: The first wash must be DI water. Do not start the wash
procedure by placing a tube with Bleach Solution in first position.
To maintain the instrument, use a 5% solution of commercial grade Bleach

diluted 1:10 to provide a final working concentration of 0.5%: One (1) part 5%
Bleach to nine (9) parts DI water) at the beginning of the day, immediately before
running controls.
NOTE: This procedure can be performed also if the capillary and/or the probe
are obstructed.
Internal Wash with Bleach
of 0.5%.
Items required: Three (3) wash tubes filled ¾ volume with DI water, and 1 wash
tube filled ¾ volume with 0.5% diluted Bleach solution.
NOTE: Wash tubes used on the internal sampling mode must be single use only
and should not be refilled and re-used.
First Wash
2. The instrument checks the rotor position, prompting to remove any tube

4. Select Internal , the instrument prompts to insert two (2) wash tubes filled to
¾ volume with DI water in positions 1 and 2 of the rotor.

5. Close the door; the instrument starts the wash automatically.

6. At the end of the wash cycle, the instrument displays and prints a report
indicating the photometer status OK or Not OK. When a wash procedure is
Second Wash
2. The instrument checks the rotor position, prompting to remove any tube

4. Select Internal, the instrument prompts to insert washing tube on the rotor.
5. Load one (1) wash tube filled to ¾ volume 0.5% Bleach in position 1 of the
rotor. Load one (1) wash tube filled to ¾ volume with DI water in position 2 of
the rotor.
6. Close the door; the instrument will start the wash automatically.
indicating photometer status OK or Not OK.

Manual Wash with Bleach
of 0.5%.
Items required: Three (3) wash tubes filled to ¾ volume with DI water, and 1
wash tube filled to ¾ volume with 0.5% diluted Bleach solution.
First Wash Tube


3. After selecting External, the external probe moves to the sampling position.
4. Insert the external probe inside the wash tube, and then press Start .
Second Wash Tube

Repeat the first wash with the second tube filled with DI water.
Third Wash Tube

Repeat the first wash with the tube filled with 0.5 % Bleach solution.
Fourth Wash Tube

Repeat the first wash with the third tube filled with DI water.
At the end of the wash cycle, the instrument will display and print a report
indicating the photometer status OK or Not OK.

Run Controls
This procedure should be performed at least once daily at the beginning of the
working day on both internal and external circuits.
NOTE: Always perform a wash with 0.5% bleach solution before running Latex
controls. See Running QC.

Clean Instrument Surfaces

Items required: Alcohol, paper towels, and protective gloves
1. Clean the instrument using a paper towel moistened with alcohol.

2. Wipe again using DI water; and then dry.
WARNING: Clean any blood spills immediately.
Perform a Wash and Sleep Procedure
of 0.5%.
This option must be performed at the end of the working day to keep the
capillary moist overnight. All the hydraulic circuitry remains filled with DI water.
Manual Wash and Sleep

Items required: Three 3 wash tubes. Tube 1 filled to ¾ volume with DI water,
Tube 2 tube filled to ¾ volume with 0.5% Bleach solution, Tube 3 filled to ¾
volume with DI water.
1. From the Main Menu, press Wash and sleep.

3. After selecting External, the external probe moves to the sampling position.
4. Insert the external probe inside the first wash tube of DI water, and then
press Start .

5. Repeat with the second tube filled with 0.5% Bleach solution.
6. Repeat the third tube filled with DI water.
7. The system aspirates approximately 1/3 of the tube content, and then stops
the pump.
8. The external probe retracts inside the instrument.
9. From the Wash screen, press Back.
10. The next time the instrument is switched ON, the liquid remaining in the
external capillary is discarded to the Waste Tank.
11. The system is ready for operation.
Internal Wash and Sleep
of 0.5%.
Items required: Three 3 wash tubes. Tube 1 filled to ¾ volume with DI water,
Tube 2 tube filled to ¾ volume with 0.5% Bleach solution, Tube 3 filled to ¾
volume with DI water.
NOTE: Wash tubes used in the internal mode must be single use only and
should not be refilled and re-used.
1. From the Main Menu, press Wash and sleep.

2. The instrument will check the rotor position, prompting to remove any tube

4. After selecting Internal, the instrument will prompt to insert the first two wash
tubes on the rotor.
5. Load one (1) wash tube in positions 1 and one (1) tube filled with 0.5%
Bleach solution in position 2 of the rotor.

indicating the photometer status OK or Not OK.
7. The instrument prompts to remove the two wash tubes loaded in the rotor.
8. The instrument then prompts to insert the third DI water wash tube in position
1 of the rotor.
9. Load the last wash tube in position 1 of the rotor
10. The system aspirates approximately 1/3 of the tube content, and then stops
the pump, keeping the internal probe inside the tube.
11. The system prompts to switch OFF the instrument.
12. The next time the instrument is switched ON, the liquid remaining in the
internal capillary is discarded to the Waste Tank.
13. The system prompts to remove the tube from the rotor.
14. The system is ready for operation.

1. Repeat the procedure with a second tube filled to ¾ volume with DI water.

As Needed Maintenance
Refill the Wash Tank
NOTE: The Washing Tank does not have any liquid level control. It is suggested
to check the level of DI water inside the tank at least once per day, before
running samples.
1. Press the left side of the door where indicated on the picture below, and then
pull the front door until it clicks in open position.
2. The Wash Tank is located inside the front door.

Wash
Tank
3. Remove the cap from the top of the Wash Tank.

4. Remove the Wash Tank from inside the instrument.
5. Refill the Wash Tank using DI water only, up to the 500 mL mark.
6. Replace the Wash Tank inside the instrument door.
7. Replace the tubing connection plate on top of the Wash Tank.
8. Close the front door until it clicks in the closed position.
9. Document in the Maintenance Log.

Empty the Waste Tank

Item required: 0.5% Bleach solution, paper towels, and protective gloves
of 0.5%.
The system is equipped with an internal sensor to automatically check the level
in the waste tank:
• When the instrument is switched ON,
• At the beginning of each washing procedure,
• At the beginning of every analysis cycle.
When the system detects that the waste tank is full, a prompt is displayed
indicating that the waste tank must be emptied or replaced.

2. The Waste Tank is located inside the front door.
Waste
Tank
3. Remove the tubing connection plate from the top of the Waste Tank.
4. Remove the Waste Tank from inside the instrument.
5. Empty the contents of the Waste Tank.
WARNING: Discard the contents of the Waste Tank according to Federal, State
and local procedures for disposal of Biohazardous Materials.
6. Clean the Waste Tank using 0.5% Bleach solution.

7. Rinse the Waste Tank with tap water.
8. Replace the Waste Tank inside the instrument door.
9. Replace the tubing connection plate on top of the Waste Tank.
10. Close the front door until it clicks in the closed position.
11. Document in the Maintenance Log.
CAUTION: Do not remove or cut the Waste Tank discharge tube. The length is
designed specifically to measure safely the waste level. The safe length must be
at least 45 mm.

Replace the Printer Paper

Item Required: PN B36600 - Thermal roller paper 58 +0/-1 mm x Max 32 mm
external diameter
1. Open the printer door located on the bottom of the instrument door.
2. Remove the empty cardboard roll.
1. Discard the first 10" - 12" of the paper roll to prevent printer jamming due to
the glue.
2. Place the paper inside the printer with the outside face of the paper upward.
3. Press the [>>] key until the paper advances through the opening at the top of
the printer.
4. Document the Maintenance Log.

Test Metering -FL (Flag List) Menu

This option is used to print test availability, and test used for metering.
1. From the Main Menu, press Setup. The following screen is displayed.
2. From the Setup Menu, press FL. The instrument prints all parameters. Next
is a sample of a FL printout.

PRINTOUT SECTIONS MEANING
UNIT INTERFACE
For technical services only
AVAILABILITY
Test availability for the ESR
ESR counter of executed tests
Alarm threshold for tests
MOTOR PCB

INTERNAL CPS
EXTERNAL CPS

COMMUNICATION PARAMETERS

Troubleshooting
Before Calling for Service
• Refer to the troubleshooting section at the end of this chapter.
NOTE: Before calling for Service, please make a note of any error messages
displayed.
After completing the above, contact Beckman Coulter for assistance.
Hardware issues
Technical Services - Call the phone number indicated below, and then enter the
Field Service extension number printed on the card affixed to the front of the
instrument
Instrument applications issues

Clinical support - Call the phone number indicated below, and then enter number
2, or contact clinical support via email at support@beckman.com.
Telephone
From U.S. and Canada locations 1-800-776-4747
1-818-709-1244
Fax 1-800-239-2864
Stay close to the system and be prepared to explain the nature of the problem.
Provide:
• Your name
• Account name
• Telephone number with area code
• Roller 20PN serial number
Describe:
• Error messages
• Operation in process
• Problem

Washing Errors
Photometer Not OK
If after completion of the washing procedure, the instrument displays:

Photometer not OK, it indicates that the washing cycle has not been performed
correctly or that abnormal conditions have been detected by the system.
Causes Remedies
An empty wash tube was inserted. Repeat the procedure with a wash tube
filled to ¾ volume with DI water.
One or both tubes are missing. Repeat the procedure making sure that
both tubes are loaded on the rotor.
The washing reference level is lower Repeat the procedure.
than 2500.
The washing reference level is inside Repeat the procedure.
the reference range (2500-4000), but
not detected on the sample.
The washing reference level is Repeat the procedure.
higher than 4000.
Air bubbles detected during the Repeat the procedure.
washing procedure.
The Wash Tank is empty. See Refill the Wash Tank.

Error Messages
Errors Code Cause Remedy

EXXRESET Internal error. Switch off the instrument,
wait 10 seconds and switch
ELAHHHHH on again.
If the problem persists,
EEXHHHHH contact Technical Services.
ENDHHHHH
E00HHHHH
Rotor’s home sensor not Contact Technical Services.
E01HHHHH
detected.
Syringe’s home sensor not Contact Technical Services.
E02HHHHH
detected.
Carriage home sensor not Contact Technical Services.
E03HHHHH
detected.
Home sensor not detected Contact Technical Services.
E04HHHHH for peristaltic pump after
three complete rotations.
Home sensor not detected Contact Technical Services.
E05HHHHH
for external probe.
Carriage position 1 sensor Contact Technical Services.
E06HHHHH
not detected.
Carriage position 2 sensor Contact Technical Services.
E07HHHHH
not detected.
Not detected out sensor for Contact Technical Services.
E09HHHHH
external probe.
CPS. Internal Serial Switch off the instrument,
Communication Protocol wait 10 seconds and switch
E14----- error. on again.
contact Technical Services.
EXT EEprom. Error during Switch off the instrument,
external Eeprom access. wait 10 seconds and switch
E15----- on again.

RTC – Error during internal Switch off the instrument,
communication. wait 10 seconds and switch
E16----- on again.
UI (Unit Interface) – error Switch off the instrument,
during writing process on wait 10 seconds and switch
E17----- Unit Interface flash memory. on again.
COMM. Error during internal Switch off the instrument,
data transmission. wait 10 seconds and switch
E18----- on again.
COMM. Error in the internal Switch off the instrument,
protocol. wait 10 seconds and switch
E19----- on again.
Internal motor error. Switch off the instrument,
E20----- on again.
Internal carriage motor error. Switch off the instrument,
E21----- on again.
Internal syringe motor error. Switch off the instrument,
E22----- on again.
Internal syringe motor error. Switch off the instrument,
E23----- on again.

Internal manual syringe Switch off the instrument,
motor error. wait 10 seconds and switch
E24----- on again.
Missing ACK of performed Contact Technical Services.
E25----- command from Hydraulic
Selection Board
Internal motor error. Switch off the instrument,
E26----- on again.
No flow. Repeat the run; check the
NF
integrity of the sample.
Not reliable Repeat the run; check the
NR
integrity of the sample.
The Smart Card has already
been loaded on the
Not Valid Card
instrument and cannot be
loaded twice.
The Smart Card has a Use a new Smart Card.
number of tests outside the
OUT STD error
normal range: 1000 – 4000 –
10000 – 20000.
OUT STD 24384 The Smart Card has not
been inserted correctly.

Service
Probe Replacement
The syringe assembly, like the carriage assembly, moves on “self-lubricating „
sliding guides it is not therefore necessary to lubricate or to add to any kind of oil
or grease to the guides.
WARNING: When replacing the probe, it is mandatory to use protective gloves

and all others protective tools, precautions and warnings necessary in order to
avoid the contact with biohazardous material in accordance with Federal, State,
and local regulations.
WARNING: DO NOT touch the top of the syringe piston, a light pressure could
allow the probe to become loose. The tip of the probe could pierce the glove and
the skin. Operate with extreme caution.
1. Turn the instrument OFF using the power switch located on the back of the
instrument.

3. Locate the piston assembly, see picture below.
4. Turning counterclockwise, unscrew the fixing screw located on the left of the
bracket. See picture below.

5. Tilt the piston assembly 45° away from the instrument. See picture below.
6. Turning counterclockwise, remove the cap of the piston to access the inside
of the piston. See picture below.

7. Insert the green tool (supplied) inside the piston. Turn the tool
counterclockwise to unscrew the probe, and then remove it.
8. Discard the old probe.
WARNING: Discard the old probe according to Federal, State and local
procedures for disposal of Biohazardous Materials.
9. Remove the transparent cap protecting the new probe. Insert the new probe
inside the green tool. See picture below.
10. Insert the green tool (supplied) inside the piston. Turn the tool clockwise to
attach the new probe. Do not overnight the probe to avoid damaging the
thread.
11. Remove the green tool from the piston, and reserve for future use.
12. Turning clockwise, attach the cap of the

piston. See picture on the right.

13. Tilt the piston assembly 45° towards the instrument. See picture below.
14. Turning clockwise, secure the piston with

the fixing screw located on the left of the
bracket. See picture on the right.
15. Close the front door until it clicks in the

closed position.
16. Turn the instrument ON using the power

switch located on the back of the instrument.

Fuse Replacement
The fuse box is located on the back of the instrument, next to the Main switch.
1. Using a flat screwdriver, push down the small tab that

keeps the box inside the switch block and pull it out using
small pliers (if necessary).
2. Remove completely the fuse box.
3. Replace BOTH fuses with 115 Vac fuse 5.0 Amp.
4. Replace the fuse box inside the Main Switch block.
5. Press firmly to assure the box’s tab fits on the hook.

Decontamination Procedure
The following procedure must be performed before:
• Collection/shipment of the instrument from the laboratory after a demo or

for replacement/reparations.
• Technical service repair or check inside the instrument.
Item required:
• Protective glasses.
• Protective gloves.
• Absorbing paper towels.
• Biohazard bag for waste disposal.
The Decontamination Form MUST be filled up and accompany the instrument.
In case the decontamination cannot be performed due to a failure of the washing

system, contact Customer Services.
NOTE: Make a copy of the Decontamination Form for each usage. Fill the form
according to the procedure.

Decontamination Form
This form must be filled by the Laboratory before shipping the instrument.
This document MUST be attached to the instrument.
Description of the decontamination procedure to be performed by the Laboratory:
Not
OK
OK
Switch the instrument ON.
Perform an Internal washing procedure
1. Perform a first wash using two tubes filled with DI water.
2. Perform a second wash using one tube filled with water and one tube
filled with 0.5% diluted Bleach solution.
Perform a Manual washing procedure
1. Perform a first wash using two tubes filled with DI water.
2. Perform a second wash using one tube filled with DI water and one tube
filled with 0.5% diluted Bleach solution.
Empty and thoroughly clean the Waste tank
To avoid leaving any blood residual inside the tank.
WARNING: Discard the contents of the Waste Tank according to
Federal, State and local procedures for disposal of Biohazardous
Materials.
Notes:
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
DATE
NAME
SIGNATURE

Maintenance Log

8 – Appendix
8 - Appendix
Limitations
1. The erythrocyte sedimentation rate is a phenomenon confined to fresh blood
and transient(2), not a hematic matrix component (at corpuscular / molecular
level). The procedures used to determine the ESR cannot be calibrated as
they are susceptible to a variety of errors (temperature, hematocrit,
erythrocyte mean corpuscular volume, plasma viscosity, etc.)(2). Based on the
acquired experience, TEST1 family instruments (TEST1, Roller 20PN), are
limitedly affected by these variables. For this reason it is possible to observe
instrument performances deviations compared to other procedures if the
above variables are not taken into account.
2. Erythrocyte sedimentation remains an only partly understood

phenomenon….is a nonspecific reaction (from a clinical point of view)… (2)
that is affected by several technical aspects (3).
International guidelines for diagnosis and management of multiple myeloma

do not mention the Erythrocyte Sedimentation Rate (4). It is then necessary to
point out that even though TEST1 analytical performances have been
confirmed in patients affected by multiple myeloma (5,6), there have been
some cases of patients affected by multiple myeloma in which TEST1
has reported clinically negative ESR values in comparison to other
methods. Based on this experience there could be cases in which Roller
gives low ESR results likewise TEST1 in presence of Multiple Myeloma.
It is then highly recommended to perform other tests together with the ESR in
the diagnosis of cancer since a normal ESR value is not enough to exclude
that the patient is not affected by this pathology.
Furthermore in presence of this disease it is possible to observe deviations

from other methods since other phenomena in addition to the rouleaux
formation can contribute to the sedimentation like for example amorphous
aggregates formation (crystallization of paraproteins or mineral materials like
calcium) resulting from bone tissue alteration.
3. Sample mixing is programmed at the beginning of the analysis with the

purpose of disaggregating erythrocytes. An inefficient disaggregation or
micro-clots presence can affect the result given by the instrument that in fact
measures erythrocytes aggregation kinetics.
4. The above instrument performances have been obtained using test tubes
with a capacity of 3 ml and 13x75 mm size with K3EDTA anticoagulant. The

8 – Appendix
use of such tubes optimizes the mixing phase and consequently the results
reproducibility.

8 – Appendix
References
1. E. Heverin (Galway-Mayo Institute of Technology, Ireland): ”Comparison of
the Westergren method versus the TEST1 technique for determining the
Erythrocyte Sedimentation Rate”, May 2002, private communication
2. NCCLS “Reference and Selected procedure for the Erythrocyte

Sedimentation rate (ESR) Test; Approved Standard-Fourth Edition”, Vol. 20
No. 27
3. Sox HC, Liang MH: “The Erythrocyte Sedimentation Rate”, Annals of Internal
Medicine 1986; 105:515-523.
4. NCCN (National Comprehensive Cancer Network) Clinical Practice

Guidelines in Oncology “Multiple Myeloma” (V.I.2007)
5. Ajubi et al.: “Determination of the length of sedimentation reaction in blood

using the TEST1 system: comparison with the Sedimatic 100 method,
turbidimetric fibrinogen levels, and the influence of M-proteins”, Clin Chem
Lab Med 2006; 44 (7): 904-906
6. Mercurio S. et al.: “Comparison between two methods for ESR measure in

patients affected by myeloma”, 37° SIBioC National Congress, 11-14 October
2005 Rome.

Index
Index
Cumulative Distribution Printout from Normal Samples
A ............................................................................ 74
D
Access
Levels ...................................................................... 21
Accessing a Section ....................................................7
Daily Distribution from Samples ............................. 75
Agreement .............................................................124
Daily Distribution Printout from Normal Samples .. 76
Analysis Results .......................................................81
Daily Maintenance .................................................. 83
Analytical performances ........................................124
Date
As Needed Maintenance .......................................101
Changing ................................................................. 29
Autogenerated Patient ID ........................................43
Date and Time Menu .............................................. 29
Automatic Sampling.................................................36
Definitions ................................................................. 8
Automatic Wash ......................................................99
Display
Availability
Results .................................................................... 81
Display .................................................................... 24
Display Availability .................................................. 24
Availability Menu .....................................................23
Distributor for the United States ............................ 10
Average Printout from Normal Samples ..................72
Average Printout from Wash Procedures ................80
Average Statistics from Samples .............................71 E
B
Empty the Waste Tank .......................................... 103
Emptying the Roller ................................................ 51
Entering Control ID ................................................. 61
Barcode Reader Patient ID ......................................41
Entering Control ID XE "Loading Latex QC Tubes on the
Before Calling for Service.......................................110
Rotor" ................................................................ 56
Biological Warnings ...................................................8
Entering the Control Identification ................... 57, 62
Bookmark Pane ..........................................................7
Entering the Patient Identification ......................... 41
Error Messages ..................................................... 112
C Errors
Washing ................................................................ 111
Card External Barcode Reader Patient ID ........................ 41
Smart ...................................................................... 19 External Probe
Cautions .....................................................................8 Running QC ............................................................. 60
Changing the Date ...................................................29 External Retractable Probe ..................................... 18
Changing the Time ...................................................29
F
Clean Instrument Surfaces.......................................90
Cleaning the External Probe ....................................50
Comm Menu ............................................................24
FL Menu .......................................................... 29, 106
Consumable Replenishment ....................................83
Following a Link......................................................... 7
Contact Information ................................................10
Frequency
Control
Control .................................................................... 53
Handling ................................................................. 54
Front View ............................................................... 16
Control Frequency ...................................................53
Fuse Replacement ................................................. 120
Control Identification
Entering ............................................................ 57, 62
Control Material ......................................................53
Control Run ..............................................................90
Cumulative Distribution from Samples....................73

Index
G M
Global Average Printout from Samples ...................72 Main Menu.............................................................. 22
Global Daily Distribution Printout from Samples....76 Maintenance
As needed ............................................................. 101
H
Maintenance Log .................................................. 123
Maintenance, Daily ................................................. 83
Manual ...................................................................... 7
Handling Control Material .......................................54
Manual Patient ID Entry .......................................... 42
Hardware issues ....................................................110
Manual Sampling .................................................... 36
How to Use the Operator’s Manual...........................6
Manual Mode.......................................................... 15
Manual Measurement ............................................ 40
I Manual Measurement without Mixing ................... 40
Manual Priming Procedure ..................................... 47
Installation ...............................................................25 Manual Sampling .................................................... 47
Installation Requirements .......................................25 Manual Sampling Completion ................................. 50
Instrument applications issues ..............................110 Manual Sampling Procedure ................................... 49
Instrument, Clean Surfaces......................................90 Manual Wash .......................................................... 99
Intended Use .............................................................6 Manual Wash and Sleep ......................................... 90
Internal Automated Mode .......................................15 Manual Wash with Bleach ...................................... 88
Internal Components ...............................................18 Manual Wash with Bleach Solution before Controls60
Internal Measurement.............................................40 Manufacturer .......................................................... 10
Internal Sample Mixing ............................................47 Material
Internal Sampling .....................................................45 Control .................................................................... 53
Internal Wash ..........................................................98 Measure mode
Internal Wash and Sleep ..........................................92 Selecting ................................................................. 40
Internal Wash with Bleach .......................................84 Measurement
Internal Wash with Bleach Solution before Controls55 Manual.................................................................... 40
Iris Diagnostics .........................................................10 Internal ................................................................... 40
Issues, Hardware ...................................................110 Measuring Range .................................................. 124
Issues, instrument application ...............................110 Menu
Availability .............................................................. 23
L Comm ..................................................................... 24
Date and Time ........................................................ 29
FL 29, 106
Language Setup .......................................................34
Main........................................................................ 22
Latex Controls
Setup....................................................................... 22
QC statistics ............................................................ 77
Tech ........................................................................ 24
Latex Individual Control Printout.............................68
Mixing
Latex Priming ...........................................................65
Internal Sample ...................................................... 47
Latex Statistic Report ...............................................78
Sample .................................................................... 37
Levels of Access .......................................................21
Limitation of Liability ...............................................14
Limitations .............................................................124
Link ............................................................................7
N
Loading Latex QC Tubes on the Rotor ............... 56, 61 Normal Samples
Loading the Samples on the Rotor ..........................45 Average printout .................................................... 72
Loading the Tubes on the Rotor ........................ 58, 63 Cumulative distribution printout ............................ 74
Location ...................................................................25 Daily distribution printout ...................................... 76
Log In ................................................................. 28, 38 Notes ......................................................................... 8

Index
O R
Operator’s Manual Rear View ................................................................ 17
How to Use ............................................................... 6 References ............................................................ 126
Refill the Wash Tank ............................................. 101
P
Repeatability ......................................................... 124
Replace the Printer Paper ..................................... 105
Replacement
Patient ID
Fuse ...................................................................... 120
Autogenerated ....................................................... 43
Probe .................................................................... 115
Manual Entry .......................................................... 42
Replenishment, Consumable .................................. 83
with external barcode reader................................. 41
Report
Patient Identification
Latex Statistic .......................................................... 78
Entering .................................................................. 41
Reproducibility ...................................................... 124
Verifying ................................................................. 44
Requirements
Perform a Wash and Sleep Procedure .....................90
Installation .............................................................. 25
Photometer Not OK ...............................................111
Sample .................................................................... 36
Precautions
Tube ........................................................................ 37
and Warnings ........................................................... 8
Results
Priming
Analysis ................................................................... 81
Manual ................................................................... 47
Display .................................................................... 81
Latex ....................................................................... 65
Printout................................................................... 81
Print Expanded ........................................................33
QC ........................................................................... 66
Print in Run ..............................................................32
Reviewing QC .......................................................... 67
Printer Paper
Results Printouts
Replace ................................................................. 105
Statistical ................................................................ 82
Printout
Reviewing QC Results.............................................. 67
Latex Individual control .......................................... 68
Roller
Results .................................................................... 81
Emptying ................................................................. 51
Printouts
Rotor
Statistical results .................................................... 82
Loading tubes ......................................................... 63
Probe
Loading tubes on the ........................................ 45, 58
Cleaning the external ............................................. 50
Rotor with 20 Positions ........................................... 18
External .................................................................. 18
Running Latex QC on the External Probe ................ 64
Probe Replacement ...............................................115
Running QC on the Rotor ........................................ 54
Running QC using the External Probe ..................... 60
Q Running Samples ..................................................... 39
S
QC
Reviewing Results ................................................... 67
Running Latex on external probe ........................... 64
Sample Mixing......................................................... 37
Running on the Rotor ............................................. 54
Sample Requirements ............................................. 36
using the external probe ........................................ 60
Samples
QC Results ................................................................66
Average statistic ..................................................... 71
QC Screen Selections ...............................................70
Cumulative distribution .......................................... 73
QC Statistics .............................................................69
Daily distribution .................................................... 75
from samples .......................................................... 71
Global average printout.......................................... 72
QC Statistics from Latex Controls ............................77
Global daily distribution printout ........................... 76
Quality Control ........................................................53
Sampling
Quality Control Printout
Automatic ............................................................... 36
Wash procedures ................................................... 79

Index
Manual ................................................................... 49 Terminology ............................................................ 11
Internal ................................................................... 45 Theory of Operation ............................................... 15
Manual ................................................................... 36 Time
Sanitation Form .....................................................122 Changing the ........................................................... 29
Sanitation Procedure .............................................121 Troubleshooting .................................................... 110
Selecting the Type of Measure mode ......................40 Tube Caps ................................................................ 37
Selections Tube Dimensions .................................................... 37
QC screen ............................................................... 70 Tube Requirements................................................. 37
Service ...................................................................115 Tube Volume ........................................................... 37
Service, Before calling for ......................................110
V
Settings Menu ..........................................................30
Setup
Language ................................................................ 34
Verifying the Patient Identification ......................... 44
Setup Menu ....................................................... 22, 27
Shelf Life
Control.................................................................... 54
Smart Card ...............................................................19
W
Software ..................................................................21 Warning Level ......................................................... 23
Software Version .....................................................31 Warnings ............................................................. 8, 12
Stability of Samples ...............................................124 Warnings and Precautions ........................................ 8
Starting the Instrument ...........................................20 Warranty ................................................................. 14
Statistical Results Printouts .....................................82 Wash
Statistics Automatic ............................................................... 99
QC ........................................................................... 69 Manual.................................................................... 99
Storage conditions Internal ................................................................... 98
Control.................................................................... 54 Wash and Sleep
Surfaces, Clean Instrument......................................90 Manual.................................................................... 90
Switching the Instrument Off ..................................52 Internal ................................................................... 92
Switching the Instrument ON ..................................38 Perform................................................................... 90
Symbols.................................................................. 8, 9 Wash Procedures .................................................... 95
Average printout .................................................... 80
T
Wash Procedures Quality Control Printout ............ 79
Wash Tank............................................................... 18
Refill ...................................................................... 101
Tallies .....................................................................106
Wash Time .............................................................. 35
Tank
Washing Errors ...................................................... 111
Wash....................................................................... 18
Waste Tank ............................................................. 18
Waste ..................................................................... 18
Empty.................................................................... 103
Tech Menu ...............................................................24
Technical Specifications ...........................................26

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Table of Contents

2 – System Description ........................................ 13

301-4331-English Rev AA 06/2013 Operator’s Manual 1

4 – Specimen Processing ................................... 35

301-4331-English Rev AA 06/2013 Operator’s Manual 2

5 – Quality Control .............................................. 54

301-4331-English Rev AA 06/2013 Operator’s Manual 3

7 – Maintenance and Service............................ 79

8 - Appendix ..................................................... 120

301-4331-English Rev AA 06/2013 Operator’s Manual 4

The Roller 20PN is an automated Erythrocyte Sedimentation Rate analyzer;

The analyzer is equipped with a hand-held barcode reader for specimen

How to Use the Operator’s Manual

It is intended to explain the instrument operations in detail, to be a training guide

301-4331-English Rev AA 06/2013 Operator’s Manual 5

Accessing a Section Using the Bookmark Navigation Pane

Click on a bookmark to go automatically to the starting page of the selected

Following a Link inside the Manual

1. Select the hand tool .

301-4331-English Rev AA 06/2013 Operator’s Manual 6

Warnings and Precautions: Symbols – Definitions

There are four types of messages.

CAUTION: Identifies electrical caution! Unplug before handling.

CAUTION: International symbol for “Attention, see instructions for use” or

WARNING: Identifies potentially hazardous situations that could result in serious

WARNING: Identifies potential biological hazards.

301-4331-English Rev AA 06/2013 Operator’s Manual 7

Caution Consult Accompanying Documents

Consult Operating Instructions

Caution: Laser Radiation

Caution: Moving Parts Inside

Caution: Sharp Objects Inside

Ground terminal plug on the equipment

Compliant with Waste Electrical and Electronic Equipment (WEEE)

301-4331-English Rev AA 06/2013 Operator’s Manual 8

ISO 9001:2000 certified by TÜV Italia (n. 50 100 6107/A)

Distributed by Beckman Coulter

All trademarks are property of their respective owners.

Beckman Coulter Contact Information

301-4331-English Rev AA 06/2013 Operator’s Manual 9

301-4331-English Rev AA 06/2013 Operator’s Manual 10

WARNING risk of operator injury if:

Operate the instrument as instructed in the Operator's Manual.

The instrument is designed for indoor use only

Check that the instrument is connected to a ground outlet before use.

Always follow the Wash Maintenance procedure to ensure instrument

Use only original spare parts supplied by the manufacturer.

The instrument can be exposed to potential infective materials. Therefore, it is

301-4331-English Rev AA 06/2013 Operator’s Manual 11

In order to avoid possible mistakes with the Query-Host communication and/or

301-4331-English Rev AA 06/2013 Operator’s Manual 12

Internal Automated Mode

301-4331-English Rev AA 06/2013 Operator’s Manual 13

Legend: 1 – Smart Card Slot

301-4331-English Rev AA 06/2013 Operator’s Manual 14

Legend: 1 – Power Cord Plug

301-4331-English Rev AA 06/2013 Operator’s Manual 15

External Retractable Probe

301-4331-English Rev AA 06/2013 Operator’s Manual 16

Conform to ISO 7816-1 specifications – 85.6 x 54 x 0.8 mm

Four different cards are available:

Part Number Number of Tests

301-4331-English Rev AA 06/2013 Operator’s Manual 17

Starting the Instrument