Clinitek Advantus-Operator's Guide
Clinitek Advantus-Operator's Guide
Analyzer
Operator's Guide
2
Using this Guide
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1 Introduction
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Hardware Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Testing and Printing Areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Connections and Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Operating Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2 Operating the System
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Preparing for a Run . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Select a Urine Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Enter Strip Lot and Expiration Information . . . . . . . . . . . . . . . . . . 22
Check the Strip Loading Station. . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Change the Starting Sequence Number . . . . . . . . . . . . . . . . . . . . 23
Change the Technician Identification . . . . . . . . . . . . . . . . . . . . . . 24
Print Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Run Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Auto-Checks: Detect Urine Strip Humidity Over-Exposure . . . . . . 24
Testing Routine Specimens . . . . . . . . . . . . . . . . . . . . . . . . . 25
Testing Without a Specimen ID or Loadlist. . . . . . . . . . . . . . . . . . . . 25
Using the Specimen ID Without a Loadlist. . . . . . . . . . . . . . . . . . . 27
Using Loadlists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Entering a Loadlist from the Display or Computer Keyboard . . . . 28
Editing a Loadlist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Entering a Loadlist from a Host or Laboratory/Hospital System . . 29
Performing a STAT Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Cancelling a Run. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Managing Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
End-of-Run Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Editing Results in the Confirmatory Reports . . . . . . . . . . . . . . . 32
Merging Data from Microscopic Testing . . . . . . . . . . . . . . . . . . 33
Recalling Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Printing and Transmitting Results . . . . . . . . . . . . . . . . . . . . . . . . . 35
Printing Records from Memory . . . . . . . . . . . . . . . . . . . . . . . . . 35
Resending Records from Memory . . . . . . . . . . . . . . . . . . . . . . . 36
Deleting Results from Memory . . . . . . . . . . . . . . . . . . . . . . . . . 37
Appendix G: Symbols
System and Packaging. . . . . . . . . . . . . . . . . . . . . . . . . . . . 217
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Appendix H: Performance Results
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
symbol conventions:
Convention Description
Biohazard statements alert you to
BIOHAZARD potentially biohazardous conditions.
Intended Use
Introduction
The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench
top analyzer. It is designed to read Siemens Healthcare Diagnostics
Reagent Strips for Urinalysis, such as Multistix® 10 SG and
Multistix PRO®Reagent Strips.
This analyzer is intended for the measurement of the following:
Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes,
Nitrite, pH, Protein, Protein-to-Creatinine ratio, specific gravity, and
Urobilinogen.
These measurements are used to assist diagnosis in the following
areas:
• Kidney function
• Urinary tract infections
• Metabolic disorders, such as diabetes mellitus
• Liver function
Tests performed using the CLINITEK Advantus urinalysis analyzer are
intended for in vitro diagnostic use.
As with all diagnostic tests, a definitive clinical diagnosis should not be
based on the results of a single test, and should only be made by the
physician after all clinical and laboratory findings have been evaluated.
The analyzer is for professional use in centralized laboratory settings.
Overview
The analyzer is a reflectance spectrophotometer that analyzes the
color and intensity of the light reflected from the reagent area and
reports the results in clinically meaningful units. The analyzer can
determine and report the color of the urine. You can enter clarity for
each specimen. You are not required to make any calculations.
Calibration is performed automatically each time a urine strip is
analyzed.
Hardware Overview
User Interface
By default, interaction with the CLINITEK Advantus analyzer is via an
integrated touch screen. Messages, options, and requests for
information display, and responses are made by touching the
appropriate key symbol on the screen.
CAUTION
Do not use anything hard or pointed on the touch screen. It
may damage the screen.
Introduction
incubation/read station, where they are tested. When testing is
complete, the strips drop into the waste bin.
When testing is complete, an internal thermal printer prints the test
results.
1. Display
2. Printer
3. Waste bin
4. Fixed platform
5. Incubation/read station
6. Strip loading station
7. Push bar
Memory
The analyzer software is stored in internal flash memory. When
necessary, you can update the software using an electronic memory
card located on the back of the interactive touch display.
The analyzer stores the operating parameters, including those selected
by the user, and up to 500 patient results and 200 quality control
results. This information is in a RAM with a battery backup, and is held
in memory regardless of whether the analyzer power is on or off.
Introduction
1. Memory card slot
2. Cooling fan
3. Power switch
4. Line cord receptacle
5. Ethernet interface connector
6. Serial interface connector
7. Printer interface connector
8. Keyboard and barcode reader interface connector
When the analyzer is not in use, the screen saver or the Ready/Run
screen displays. If the screen saver displays, touch the screen to access
the Ready/Run screen. You can access all tests through the Ready/Run
screen. You can also navigate from this screen to any point in the
software.
Introduction
options are available. Each time you select the key, a different option
displays for the selection.
If an option is active, the key symbol is fully lit. If it is not active, it is
dimmed, and a tone will sound when you touch the key.
The system status area displays only on the Ready/Run screen. It shows
the current date and time, and the Technician ID, if Technician IDs are
active on your system.
1. Numeric keypad
2. Information and instructions area
3. Return to Ready/Run screen key
4. Reset QC Lot ID key
5. Move Left key
6. Alphabet key
7. Enter key
Operating Sequence
If specimen IDs are not used and color/clarity results are reported and
displayed, the analyzer automatically enters the Run mode when you
place a strip on the fixed platform. A sensor detects the strip's presence
and activates the strip movement and reading cycle.
If the push bar is positioned at the left side of the loading station, the
analyzer is ready to accept placement of a strip. If the bar is positioned
to the right, the analyzer is not ready and ignores any strip placed on
the platform.
If the analyzer is already in the Run mode and you place a strip on the
platform, there may be delay of up to 7 seconds before the push bar
moves. The amount of delay depends on the status of the timing cycle
for the strips currently being analyzed.
The push bar moves the strip along the loading station to the read
area. The sequence number increments. A series of pins move the strip
across the platform at a rate of about 1.3 cm (1/2 inch) every 7
seconds.
Two readheads, located inside the read area, scan the length of each
urine strip at a specific time in the incubation cycle. The first readhead
reads the reagent areas requiring shorter incubation times. The second
reads those requiring longer incubation times.
Overview
You can test without a loadlist or specimen ID. Put a strip on the
analyzer. The analyzer automatically assigns a Sequence Number and
begins testing.
You can manually assign specimen IDs to tests. You can enter
CAUTION
Only use Siemens brand urine strips. Use of other strips may
cause erroneous results.
2. If required, select the cycle key next to Choose Strip to use the
alternate strip.
3. If the primary and alternate strip types selected for your analyzer
Operating the System
do not correspond to the strip types you are using, change the
selected strips before beginning testing.
Select the new strip types through the Setup Routine.
See Section 8, System Configuration for more information.
Note If you enable automatic color detection and use one of the
following reagent strips for urinalysis, no result for color is reported:
• Multistix
• Multistix SG
• Uro-Hema-CombistixTM
• Uro-LabstixTM
• Hema-Combistix® - LONG
Print Information
Use this procedure to print information:
1. At the Ready/Run screen, select Menu.
2. Select Print to print:
• The ID list if a loadlist exists in memory
• Confirmation of the last calibration
• A report of the setup parameters
Run Controls
At the Set options menu, select QC to run controls before processing
patient samples. See Section 4, Quality Control, for more information.
CAUTION
Only use Siemens brand urine strips. Use of other strips may
cause erroneous results.
2. If you are entering color or clarity, use the cycle key to set color
and clarity for each specimen.
You can also enter the color and clarity by scanning the barcoded
symbols provided with the handheld barcode reader.
Note If Use default COL/CLA during run is set to on, the default
values of YELLOW and CLEAR display.
Enter the color and clarity of each specimen before dipping the
urine strip.
You can change the color and clarity until the strip moves.
3. Completely immerse all of the reagent pads on a Siemens urine
Strip in fresh, well-mixed, uncentrifuged urine.
4. Immediately remove the urine strip.
5. While removing the strip, run the edge against the side of the
container.
This removes excess liquid.
CAUTION
Do not blot the edge of the strip. This could affect results.
CAUTION
Improper placement may cause the analyzer to jam or the strip
to incorrectly align under the readheads.
Using Loadlists
You can enter a loadlist of up to 200 specimen IDs before starting the
run. You can enter the IDs from the analyzer display, a computer
keyboard, a host computer, or Laboratory or Hospital Information
System (LIS/HIS).
Note You can use loadlists only if Enter Sample IDs is On. See Enter
Sample IDs‚ page 127 for information on this setting.
Editing a Loadlist
Use this procedure to make changes to the loadlist when initial entry is
complete:
1. Use Move Up and Move Down to select the record to edit.
2. Edit the ID number.
Note You cannot change or delete the ID number during Run
mode. Make any changes while the analyzer is in the Ready mode.
3. Select Delete to delete an item from the loadlist.
You can delete only the ID number being displayed or all IDs in
memory.
4. Edit the color and clarity.
5. Select Enter to accept the new number, color, and clarity.
You can also print the ID list from the Ready/Run screen.
a. At the Ready/Run screen, select Menu.
b. Select Print.
c. Select ID list.
Note You must make changes to the loadlist before starting
testing. To edit remaining IDs in the loadlist, enter a loadlist from
the analyzer display or a computer keyboard and then cancel the
run. Add new IDs when the run is complete.
5. Test each specimen.
The Ready/Run screen displays each ID number and the
color/clarity descriptions in the same order as they were entered
into the loadlist.
a. Check that the ID number, color, and clarity descriptions are
correct for the specimen you are about to test.
b. Edit the color and clarity, if necessary.
c. Dip and place a urine strip.
When the strip for the last loadlisted specimen is moved to the read
area, you are not allowed to place any additional strips on the table.
The push bar stays at the right side and the analyzer completes the
run.
CAUTION
Only use Siemens brand urine strips. Use of other strips may
cause erroneous results.
Cancelling a Run
Select Stop Run if you need to stop the run before all readings are
complete.
You can cancel the entire run or only the last strip placed on the
platform.
If the you cancel the entire run, all strips on the platform are moved
immediately to the waste bin. No results are reported. No SEQ # is
assigned for any strip that was not read at both readheads before Stop
Run was selected. You must retest all the specimens for all cancelled
strips.
If only the last strip is cancelled, the run continues and you can test a
new strip using the same SEQ #.
Recalling Results
Up to 500 patient records and 200 quality control records are stored in
memory. Use the following procedure to recall 1 or more records:
1. At the Ready/Run screen, select Menu.
2. Select Memory.
3. Recall a group of records.
• All patient records
• All QC records
To Select
Print the record Print only this result
displayed The SEQ # and ID of that record continues to
display on the print option menu.
Specify the beginning Print a group of results
and ending records to 1. Use the movement keys to specify the
print start record to print.
2. Select Enter to select the end record to
print.
Operating the System
To Select
Send the record Send only this result
displayed The SEQ # and ID of that record continues to
display on the sent option menu.
Specify the start and Send a group of results
end records to resend 1. Use the movement keys to specify the
start and end records to resend.
2. Select Enter to begin resending.
All records in the sequential group are sent.
Form Printer. Do not select Reprint last result on the analyzer display.
1. Select Reprint last result.
As long as the checkmark displays in the selection key, the last set
of results are reprinted each time a form is inserted into the
printer.
2. Insert a new form into the Form Printer.
Do not insert the form before selecting Reprint last result or the
last set of results is lost.
3. When the report is printed correctly, select Reprint last result
again to remove the checkmark.
4. Insert a new form to print the next set of results.
Thermal Printing
Thermal print from the internal printer fades with time, especially
when exposed to light. The print also fades if covered with transparent
tape or when exposed to extremes in temperature or humidity.
Overview
Calibration
Calibration is performed at each readhead immediately before each
urine strip is read. The fixed platform contains 2 white calibration bars,
positioned directly under each readhead. As a strip comes into position
under a readhead, the analyzer reads the calibration bar and calibrates
for that scanning cycle. The analyzer then scans the urine strip and
stores the data in memory.
Confirming a Calibration
Use the following procedure to print a report of the most recent
successful calibration:
1. At the Ready/Run screen, select Menu.
2. Select Print.
3. Select Calibration confirmation.
The date and time of the latest successful calibration prints.
CAUTION
Only use Siemens brand urine strips. Use of other strips may
cause erroneous results.
CAUTION
Do not blot the edge of the strip. This could affect results.
10. Place the urine strip onto the supports of the strip loading station,
with the reagent pads facing up.
Place the strip to the right of and parallel to the push bar. Ensure
that the end of the strip is against the back wall of the platform
and that it is not touching the bottom of the strip loading station.
CAUTION
Improper placement may cause the analyzer to jam or the strip
to incorrectly align under the readheads.
Quality Control
General Cleaning
Maintenance
Keep the exterior of the CLINITEK Advantus analyzer free of dust at all
times. Clean the exterior using a damp cloth and a mild detergent.
CAUTION
Do not use any type of solvent, oil, grease, or silicone spray
on any part of the analyzer. Harsh chemicals can damage the
platform components.
Maintenance
Figure 5-2: Remove the Fixed Platform
Note You must remove the holddown plate for proper cleaning.
1. Tab
CAUTION
Do not use any type of solvent to clean the analyzer. Harsh
chemicals can damage the platform components.
9. Clean the push bar, the platform, the holddown plate, and the
table with warm water and mild detergent.
CAUTION
When cleaning the platform, avoid wiping across the 2 white
calibration bars. Use a cotton-tipped swab, wetted with plain
water, to clean the bars. Cleaning solution can damage the
calibration bars.
Maintenance
Use care when drying around the pins on the moving table.
13. Allow the calibration bars on the platform to air dry.
14. After cleaning, inspect the calibration bars for scratches, marks, or
discoloration.
If you cannot clean the bars, discard the current platform and
replace it with a new one.
15. Disinfect the parts, if required. See Performing a Decontamination‚
page 55.
Note Do not disinfect the liner. Discard it into an appropriate
container and use a new liner.
16. Reinstall the moving table:
a. Hold the table with the small rectangular tab facing to the
back.
b. Align the 2 grooves on the bottom of the table with the edges
of the platform on which the table rests.
c. Gently push the table in until you hear the tab latch into the
hold position.
d. Check that the table is secure.
17. Reinstall the holddown plate:
a. Position the holddown plate with the arrow side facing up and
the arrow pointing to the back.
b. Place the pin on the front of the holddown plate into the hole
at the front of the fixed platform.
c. Align the tab at the back of the holddown plate with the slot at
the back of the platform.
d. Snap the holddown plate into place. Listen for a loud click,
indicating proper installation.
e. Ensure that the white calibration bars are visible.
CAUTION
Do not force the platform. Ensure that the moving table is
correctly positioned before you attempt to reinstall the fixed
platform. If you force the platform, you may damage the
moving table or fixed platform.
CAUTION
Do not use bleach to clean the display. Do not spray or pour
the glass cleaner directly onto the screen. Do not use
laboratory wipes, such as Kimwipes, because they may scratch
the screen.
Maintenance
plate, the fixed platform, the moving table, and the display screen. You
can also use this procedure when taking the analyzer out of service.
See the labeling accompanying the disinfection products for complete
instructions on their use.
1. Remove, clean, and dry the push bar, the fixed platform, the
holddown plate, and the moving table. See Performing the Daily
Cleaning‚ page 49.
Note Do not disinfect the liner. Discard it into an appropriate
container and use a new liner.
2. Prepare 1 of the following solutions:
• Household Bleach (5% sodium hypochlorite) – use either full
strength or dilute to as much as a 1:20 dilution. To make a
1:20 dilution, add 5 mL of bleach to a container and add
95 mL of water, for a total volume of 100 mL. To make a 1:10
dilution, combine 10 mL of bleach and 90 mL of water.
• Cidex and Theracide1 – you can use these products, or their
equivalents, in general disinfection. Prepare and use the
solution according to the directions that come with the
product.
Note Repeated or prolonged soaks over a long period of time with
glutaraldehyde solutions may cause a slight fading or discoloration
of the platform and table, and a cloudy appearance to the push
bar. These changes do not affect performance.
CAUTION
Do not soak analyzer components in solution for more than
10 minutes once a day.
Do not use isopropyl alcohol or any product containing phenol,
such as Amphyl. These cause damage to the calibration bars.
Use care when drying around the pins on the moving table.
6. Allow the calibration bars on the platform to air dry.
7. Reinstall the pieces. See Performing the Daily Cleaning‚ page 49.
8. Disinfect the display screen, if needed.
Use either Cidex or Theracide solution, or their equivalents, only.
CAUTION
Do not use bleach to clean the display. Do not spray or pour
the disinfectant directly onto the screen. Do not use laboratory
wipes, such as Kimwipes, because they may scratch the
screen.
Maintenance
the push bar to move erratically.
An initial tube of Lubriplate lubricant is supplied with your
analyzer. See Appendix C, Orderable Supplies, for information on
obtaining additional tubes.
8. Move the slide arm several times to spread the lubrication.
9. Reinstall the pieces. See Performing the Daily Cleaning‚ page 49.
10. Reconnect the power cord.
11. Turn analyzer power on.
WARNING
Be careful when touching the printer. It may be hot.
CAUTION
Do not touch the printer without observing precautions for
handling electrostatic sensitive devices. A risk of electrostatic
discharge to the analyzer exists when touching the printer.
Maintenance
Figure 5-6: Printer Release Lever
Maintenance
Be careful when touching the printer. It may be hot.
CAUTION
Do not touch the printer without observing precautions for
handling electrostatic sensitive devices. A risk of electrostatic
discharge to the analyzer exists when touching the printer.
Maintenance
a. Press the bottom of the shield on the right-hand side toward
the touch screen.
b. Lift to release the 2 clips located on either side at the bottom
of the shield.
1. Clip
2. Hooks
Maintenance
7. Gently pull the interface cable from the connector.
You may need to wiggle the cable slightly to loosen it.
Maintenance
touched:
1. Turn analyzer power off.
2. Wait several seconds.
3. Turn analyzer power on.
4. When the title screen displays, touch the screen anywhere.
The display prompts Touch the top left corner and an X displays in
the corner.
5. Touch the screen at the center of the X.
6. Repeat when the prompt changes to Touch the bottom right
corner.
When the touch screen is calibrated, the display automatically
continues in the normal sequence of screens.
General Information
If an operational or analyzer problem occurs, an error number may
display on the analyzer screen with an explanation of the problem. This
section of the guide lists the various errors and messages, along with
probable causes and corrective actions. If the problem persists, record
the error number being displayed and contact your local technical
service provider for assistance.
If you think Siemens Reagent Strips for Urinalysis are causing the
problem, consult the product insert that comes with the urine strips for
Troubleshooting
troubleshooting information.
If you turn the analyzer off, you must retest all samples in process
when the error occurs. The normal end-of-run reports for samples
processed prior to the error display when the analyzer is turned back
on.
With some errors, the analyzer continues to run while the error
displays. Select Return to Ready/Run to return to the Ready/Run
screen before attempting to correct the error. If another error occurs
while the previous error is being displayed, the new error displays in its
place.
Troubleshooting
moving table is rotated into the correct position.
3. Turn analyzer power off.
4. Install the fixed platform. See Performing the Daily Cleaning‚
page 49.
5. Turn analyzer power on.
Troubleshooting
provider.
Printout Missing reports are When the run is complete,
does not flagged for a review and edit the list of
contain all Confirmatory Report, flagged reports.
reports and Edit flagged When you exit the End-of-Run
results is On Report screens, the reports
are printed.
Push bar Other strips are being Allow up to 7 seconds to
does not moved along the elapse prior to movement of
move to the platform the push bar. The time lapse
right after a depends upon the timing
strip is cycle for movement of the
placed onto strips across the platform.
the platform
Strip sensor problem 1. Ensure that the run is
complete, and the
analyzer is at the
Ready/Run screen.
2. Turn analyzer power off.
3. Wait several seconds.
4. Turn analyzer power on.
5. If the problem continues,
contact your local
technical support
provider.
Troubleshooting
6. If the problem continues,
contact your local
technical support
provider.
Test results Internal printer is set Set the internal printer to On
are not to off through the Setup Routine.
being
printed by
the internal
printer.
No paper installed in Install a new roll of paper.
printer
Paper is misfed, 1. Open the printer cover
accompanied by an and check the paper
unusual noise path.
2. Reinstall if necessary.
The print head is not Latch the printhead.
latched correctly
Loose electrical Carefully remove and reinstall
connection to the the interface cable to the
printer printer.
Defective printer 1. Run the Printer test.
2. Contact your local
technical support
provider if it does not
print correctly.
Hospital
Information
System
The data for transfer Ensure that the loadlist has at
has less than 1 ID or least 1, and no more than
more than 200 IDs 200 IDs.
The list contains an ID Ensure that the loadlist
that has more than 13 contains no IDs with more
characters than 13 characters.
The data includes Ensure that the loadlist uses
characters that cannot only characters that can be
be transferred. The transferred.
characters that can be
transferred are those
within ASCII code
range 0032 to 0126,
with the exception of
these characters: & \ ^|
A run is in progress or Allow all tests in the current
the analyzer is not run to complete and the
displaying the analyzer to return to the
Ready/Run screen Ready/Run screen.
when the loadlist is
downloaded
Troubleshooting
Error 05
Error 06-2 A urine strip detected 1. Select Return to
at the first readhead is Ready/Run to cancel the
not detected at the run and return to the
second readhead Ready/Run screen.
2. Turn analyzer power off.
3. Remove the fixed
platform to locate the
strip.
4. Check the pins on the
moving table to ensure
that none are bent or
broken.
5. Perform the Performing
the Daily Cleaning‚
page 49.
6. Check your printout of
results, or the Results
Error Report to determine
the specimen(s) for
which no results exist.
7. Retest those specimens.
Troubleshooting
4. Retest those specimens.
5. Ensure that the end of
the strips are placed
against the back wall of
the platform, and are not
touching the bottom of
the strip loading station.
6. If the error repeats,
remove and clean the
moving table, the fixed
platform, the push bar,
and holddown plate.
7. Check the moving table
to ensure that no pins are
bent or broken.
8. Reinstall the parts.
9. Ensure that the fixed
platform is fully pushed
in on both sides.
Troubleshooting
lowest position. Another
error displays.
5. Turn analyzer power off.
6. Reinstall the moving
table.
7. Ensure it is pushed in
completely.
8. Reinstall the fixed
platform, and push bar.
9. Turn analyzer power on.
Analyzer mechanical Contact your local technical
error support provider.
Error 24 Fixed platform is 1. Turn analyzer power off.
Error 25 misaligned or push bar 2. Inspect the analyzer for
is misaligned or upside any obvious signs of
down misalignment or incorrect
installation of the push
bar, the fixed platform, or
the holddown plate.
3. Remove and reinstall, if
needed.
4. Ensure the feet on the
push bar are on the
bottom, nearest the
platform.
5. Turn analyzer power on.
Troubleshooting
3. Do not place your hand
or other objects on the
strip loading station.
These can be mistaken
for a urine strip.
If the error occurs repeatedly:
1. Turn analyzer power off.
2. Wait several seconds
3. Turn analyzer power on.
This will recalibrate the
strip sensor.
If a strip was present:
1. Remove and clean the
moving table, fixed
platform, and the
holddown plate.
Error 29 Shipping foam is still in 1. Turn analyzer power off.
place. 2. Remove the foam.
This occurs the first 3. Turn analyzer power on.
time the analyzer is
powered on. It is
accompanied by a loud
noise.
Troubleshooting
Causes for this error
include:
• The load list
contains an
invalid character.
Use an ASCII
code range 0032
to 0126
excepting these
characters: &\^|
• The load list
contains more
than 200 records.
• The load list
contains less
than 1 record.
• A Patient ID in
the load list has
no characters.
• A Patient ID in
the load list
contains only
space characters.
A Patient ID in the load
list contains more than
13 characters
Troubleshooting
Error 46 The analyzer’s print For internal printer:
Error 47 memory is full. Error 1. Ensure the printer is set
46/47 only display to ON
after E42/43 errors are 2. Ensure the internal
reported and not printer has paper
resolved. Testing
3. Check the printer flex
cannot continue until
cable connection
you print the results.
For external printer
Error 46 displays when
using an internal 1. Ensure the printer power
printer. is on
Error 47 displays when 2. Ensure the printer has
using an external paper
printer. 3. Ensure cable connections
are secure
4. Replace the printer or
connect to a different
printer
If the issue can not be
resolved, contact your local
technical service
representative.
Troubleshooting
3. Ensure that the setup
parameters for the
computer interface are
correct.
4. Transfer at least some of
the records.
5. If unable to transfer
records, contact your
local technical support
provider.
Error 53 The analyzer’s memory 1. Ensure the host PC or
Error 54 has reached the LIS/HIS power is on
maximum storage of 2. Ensure cable connections
200 quality control are secure
results or 500 patient If the issue can not be
results, and the LIS or resolved, contact your local
printer is not available. technical service
Testing cannot representative.
continue until you
transfer or delete the
results.
Error 53 displays when
the analyzer’s quality
control memory is full.
Error 54 displays when
the analyzer’s patient
memory is full.
File Management
The analyzer stores the operating parameters, including those selected
by the user, and up to 500 patient results and 200 quality control
results. The analyzer automatically overwrites the oldest results when
it exceeds capacity.
If you connect the analyzer to a computer, it automatically transfers
results at the end of a run. See Section 8, System Configuration for
information on connecting to a computer.
If your analyzer is connected to a computer, or if you accidentally set
Computer port to Computer port, Ethernet port, or Both, the computer
expects an acknowledgement after it attempts to send results. If it
does not receive the acknowledgement, it continues to hold results in
memory instead of overwriting them. The analyzer generates an error
when the memory nears capacity. See Section 6, Troubleshooting for
error message details, and suggested corrective actions.
Installation
Overview
This section provides detailed installation instructions for the
CLINITEK Advantus analyzer. You must follow the installation steps
correctly to ensure proper installation, operation, and service.
CAUTION
Do not drop the analyzer or handle it roughly. This can disturb
internal calibrated optics and electronics or cause other
damage. Always handle the analyzer with care. The
CLINITEK Advantus analyzer is a precision instrument and
must be handled accordingly.
2. Push bar
3. Moving table
The serial number is found inside the analyzer near the front left
corner.
1. Serial number
position.
4. Check that the table is secure.
1. Tab
CAUTION
Do not force the platform. Ensure that the moving table is
correctly positioned before you attempt to reinstall the fixed
System Configuration
System Configuration
Installing Connections
Figure 8-9: Analyzer Connections
System Configuration
Connect to a Printer
You can use most 80-column, continuous feed printers or the CLINITEK
Form Printer with the CLINITEK Advantus analyzer.
Some printers include an interface cable that can connect to the
printer port on the back of the analyzer. If not, you need to obtain the
cable separately. See Appendix F, Computer and Printer Interface, for
the pin specifications for the male connector. The requirements for the
other end of the cable depend on the printer. Appropriate cables are
available at most retail computer stores.
1. Connect the appropriate end of the interface cable to the 25-pin
printer port on the CLINITEK Advantus analyzer.
2. Connect the other end to the printer.
3. Carefully read the operator’s guide that accompanies the printer
and become familiar with its operation before using.
Connect to a Computer
System Configuration
CAUTION
Only use Siemens brand urine strips. Use of other strips may
cause erroneous results.
4. Completely immerse all of the reagent pads on a Siemens Reagent
Strip for Urinalysis in negative control solution, such as Chek-Stix
Negative Control solution.
CAUTION
Do not blot the edge of the strip. This could affect results.
7. Place the urine strip onto the supports of the strip loading station,
with the reagent pads facing up.
Place the strip to the right of and parallel to the push bar. Ensure
that the end of the strip is against the back wall of the platform
and that it is not touching the bottom of the strip loading station.
CAUTION
Improper placement may cause the analyzer to jam or the strip
to incorrectly align under the readheads.
The push bar moves almost immediately, pushing the strip into the
read area. Most of the keys on the display become inactive.
System Configuration
After the strip is read, the internal printer prints the test results.
The analyzer produces a result for each reagent pad that is within
the limits given in the package insert for the control solution.
8. If the analyzer does not perform as expected, or if the printed
results do not agree with the expected values, see Section 6,
Troubleshooting.
With satisfactory completion of the initial analyzer check, the
CLINITEK Advantus analyzer is ready for routine testing.
9. At the Ready/Run screen, select Menu.
10. Select Setup.
11. Use the information in Setup Information to customize the
software for your laboratory.
System Configuration
Setup Information
Use Set Options to customize the analyzer for use in your laboratory.
1. At the Ready/Run screen, select Menu.
2. Select Setup to display the first setup options menu.
Setup Menu 1
Use the first Setup menu to change the date and time, turn the
computer port on or off, set printer options, and adjust the display
contrast.
Select the key symbol that displays next to the option to change the
option. Each option is described below.
Date
Use this option to set the current date.
You can change the Date Format and Separator using Setup Menu 3.
System Configuration
1. Select Date.
The display changes to show the current date and the numeric
keypad.
Time
Use this option to set the current time.
You can change the Time Format and Separator using Setup Menu 3.
1. Select Time.
The display changes to show the current time and the numeric
keypad.
2. Enter the time.
Select the Move Left and Move Right keys to move the cursor to
the digit to change and enter the correct number.
The message changes as you move from 1 part of the time to the
next, showing the prompts Enter hour and Enter minutes. Enter
the leading 0 where needed.
3. If the time format is 12 Hour, select the AM/PM cycle key to set the
time to AM or PM.
The AM/PM cycle key is only active if the time format is 12 Hour.
4. Select Enter.
System Configuration
To Select
use no computer Off
transfer selected results to a Computer port
computer Ethernet port
Both
The specifications for the computer port are selected using Setup
Menu 8.
Printer
Select Printer to set several printer options.
Internal
The internal printer is used to print patient results.
Use the Internal cycle key to set the internal printer.
To Select
stop the internal printer Off
turn the printer on On, 2 blank lines between
patient result sets
On, 6 blank lines between
patient result sets
On, 12 blank lines between
patient result sets
System Configuration
Custom Header
Use this procedure to set the custom report header.
If you select 12 blank lines between patient result sets for the internal
printer, it prints a header at the end of each printed report. The default
header is MICROSCOPICS. You can customize the header or set it to
contain all blanks if you do not want a header.
External
You can attach and configure an external printer. This printer can be a
form or 80-column, continuous-page printer.
Use the External cycle key to set an external printer.
To Use Select
No external printer Off
80-column printer On, 80 column
Printer Products Form Printer, On, Form printer 1
80-column printer printing single
record on each page
CLINITEK Form Printera On, Form printer 2
Star Form Printer On, Form printer 3
a. If you are using the CLINITEK Form Printer, set the Mode Switches on the
printer to Computer (both DS1-1 and DS1-2 switches down).
Display Contrast
Use this procedure to adjust the contrast of the analyzer display.
1. Select Display contrast.
Setup Menu 2
Use the second Setup menu to select the Language, Result Units, and
Test Strips.
1. At the first Setup menu, select Next Screen to access the second
Setup menu.
2. If password protection is set, enter the password.
3. Select Enter.
Language
Use the Language cycle key to select the language for the user
interface. All screens display in the language selected.
Key Options
Language English
Français
Deutsch
System Configuration
Italiano
Kanji (Japanese)
Español
Português
Chinese
Svenska
Result Units
Several of the languages have options for the units in which results
display. See Tables of Results‚ page 151 for the results that display and
print for each option. As with Language, the default selection for
several other options may change, depending upon the result units
selected.
Use the Result units cycle key to set the Result Units.
Key Options
Result units Conventional
S.I.a
Nordicb
JCCLSc
a. Not available in Japanese
b. English and Swedish only
c. Japanese only
Plus System
Use the Plus system cycle key to display and print results in the Plus
system, which uses + symbols, rather than in clinical units, such as
mg/dL.
Key Options
Plus system Off
On
System Configuration
Strip
Siemens urine strips have identification (ID) bands, which can be white
or colored. When using these strips, this procedure is not required
unless you want to identify strip lot information.
Key Options
Stripa MULTISTIX 10 SG (default)b
MULTISTIX 9 SG
MULTISTIX 8 SGb
MULTISTIX SG
MULTISTIX SG L
MULTISTIX
NEPHROSTIX L
URO-HEMA-COMBISTIX SG L
URO-LABSTIX SG L
MULTISTIX 9
URO-HEMA-COMBISTIX
HEMA-COMBISTIX-LONG
URO-LABSTIX
LIFESTIX
MULTISTIX PRO 11b
MULTISTIX PRO 10LSb
N-MULTISTIX SG L
CLINITEK MICROALBUMIN 9b
a. Not all urine strips are available in all countries.
System Configuration
b. Alternate strip option available only when one of these strip configurations is
selected as a Primary strip.
Alternate Strip
When testing patient samples, you can select the alternate urine strip
type without re-accessing the Setup menu.
Use the Alternate strip cycle key to select the alternate urine strip.
This feature is available only with select Primary strip configurations.
Choose different primary and alternate urine strips to enable switching
between tests. When Alternate strip is selected, only a single Alternate
strip can be tested. To test additional Alternate strips, you must select
Alternate strip for each one.
Siemens urine strips have identification (ID) bands, which can be white
or colored. When using these strips, this procedure is not required
unless you want to identify strip lot information.
Ensure the urine strip selected agrees with the name of the Siemens
Reagent Strip for Urinalysis used as the alternate urine strip.
Key Options
a
Alternate strip None
MULTISTIX 10 SG
MULTISTIX 8 SG
MULTISTIX PRO 11
MULTISTIX PRO 10LS
CLINITEK MICROALBUMIN 9
a. Not all urine strips are available in all countries.
System Configuration
Key Options
Date format Month/Day/Year
Day/Month/Year
Year/Month/Day
Date separator - (default)
.
/
Time format 12 Hour
24 Hour
Time separator : (default)
,
.
System Configuration
Setup Menu 4
Use the fourth setup menu to select tests to report and their order,
mark positives, set positive levels for tests, and set normal ranges for
SG, pH, and CRE.
The primary urine strip you selected determines the options available.
The analyzer uses the same settings for the alternate urine strip, if they
are relevant to the urine strip selected.
System Configuration
To Then
retain the existing tests and select Previous Screen.
their order
select tests to report, their 1. At the first position you want to
order, and the position of change, use the cycle key to select
color and clarity a test, color or clarity.
Any tests not already listed display
first. Then a blank displays and all
tests from that position are erased
and must be re-entered.
As each test is selected, the next
test in the list is the first test
displayed for the following
position.
2. Select a test for each of the
remaining positions.
3. When finished, select Previous
Screen.
Note If English is the selected
language and S.I. is the selected
Results units, color is automatically
included as the last test. You can also
add it manually to the end of the list.
You can also choose to include visually
determined clarity as a reported
System Configuration
result.
remove a test from the Select the tests to report and leave a
reporting order blank description in the final position.
To Select
mark positives On
leave positives unmarked Off
Note If Mark Positives is Off, you are unable to set several other
options.
Urinalysis.
Setup Menu 5
At the fourth Setup menu, select Next Screen to access the fifth Setup
menu.
Color
Use the Color cycle key to have the analyzer determine color, or allow
visual determination.
To Select
have the analyzer determine color Determined by analyzer
automatically
System Configuration
Color Choices
If the color option is Entered by tech, you can specify up to 7 specimen
colors. Use this procedure to customize descriptions and remove
defaults from the reporting list.
You can select this option only if COL is selected on the Tests to report
and their order screen
1. Select Color choices.
2. Edit the first 4 default colors.
3. Select Next Screen to display and edit the last 3 default colors.
The default colors are Yellow, Orange, Red, Green, Blue, Brown,
and Other.
4. Remove default options from the reporting list.
The colors included on the list are designated by a check mark.
a. Select the check mark to remove it, and delete the option from
the list.
The first option is always selected and cannot be made
inactive.
5. Change the color description:
a. Select the word describing the color to change the color.
An alphabetic keypad displays.
System Configuration
To Select
display no default value Off
set the first listed value for color and On
clarity as the default
Setup Menu 6
At the fifth Setup menu, select Next Screen to access the sixth Setup
menu.
computer.
You can select this option only if COL or CLA is selected on the Tests to
report and their order screen
1. Select Positive levels for COL/CLA.
The lowest level considered positive for color and clarity displays.
The available choices are those set earlier.
Set QC Options
You can set the entry of QC expiration information and the QC interval.
1. Select Set QC Options.
Set QC Expiration
You can enter QC Lot and Expiration information from a computer
keyboard, or scan it from a barcoded label using the handheld barcode
reader.
Note The analyzer requires entry of QC lot information.
Use the QC expiration date cycle key to set this option.
To Select
disable entry of QC expiration Off
information
System Configuration
Set QC Interval
Use this procedure to set prompting for regular QC testing. You can set
the interval between QC tests from 1 hour to 99 days.
To Select
not set a QC interval No regular QC test
prompt when a QC test is due Prompted regular QC test
prevent testing of patient samples Compulsory regular QC test
when a QC test is due
Setup Menu 7
At the sixth Setup menu, select Next Screen to access the seventh
Setup menu.
To Select
disable entry of strip lot and Off
expiration information
force entry of strip lot and On
expiration information
Microscopics Setup
Enable entry of microscopics results.
1. Select Microscopics setup.
The display shows where to select 5 headings and their associated
units. The sixth selection enables you to enter custom data and
units.
2. Use the first 5 cycle keys to select headings and associated units
for microscopic results.
Key Options
Cycle keys 1 to 5 RBC /µL PATH CASTS /HPF
RBC /HPF PATH CASTS /LPF
RBC /LPF CRYSTALS
WBC /µL CRYSTALS /HPF
WBC /HPF CRYSTALS /LPF
WBC /LPF YEAST
EC /µL YEAST /HPF
EC /HPF YEAST /LPF
EC /LPF SPERM
BACT /µL SRC
System Configuration
Key Options
Cycle key 6 /µL
/HPF
/LPF
mS/cm
NONE
c. Select Enter.
4. When finished, select Previous Screen.
To Select
disable editing Off
allow editing of confirmatory On
reports
specimen.
To Select
disable entry of specimen Off
identification numbers
force entry of specimen On
identification numbers
Tech ID
Identify the technician performing the tests. The Tech ID displays on
the Ready/Run screen, and on QC results only, or on both patient and
QC results.
Use the Tech ID cycle key to set display of the Tech ID.
To Select
disable display of the Tech ID Off
display the Tech ID on QC results On, control results only
display the Tech ID on QC and On, both patient and control
patient results results
Setup Menu 8
At the seventh Setup menu, select Next Screen to access the eighth
Setup menu.
To Select
allow unrestricted access to all Off
setup menus
require a password to access most On
setup menus
Key Options
Port Off
Computer Port
Ethernet Port
Both
Baud 1200
2400
4800
9600
19200
Data, Parity 8/None
7/Even
7/Odd
7/None
Key Options
Output format CCS
CT200+
CT200
Checksuma On
Off
Handshakea On
Off
a. Not available in CCS format.
The CT200+ and CT200 formats transmit 2 stop bits. The CCS
format transmits 1 stop bit.
5. Select CCS to transmit results in the CLINITEK Advantus format.
The parameters for this format are available from your local
technical support provider.
Note You must set the computer port to CSS to download loadlists
from a computer or LIS.
6. Select CT200+ or CT200 to transmit results in the same format as a
CLINITEK 200+ or CLINITEK 200 Urine Chemistry Analyzer.
Results are not printed in the selected format.
If you are using a CLINITEK 200+ or CLINITEK 200 analyzer in your
laboratory, you must:
• Set identical parameters for CLINITEK Advantus analyzer and
the CLINITEK 200 analyzer or CLINITEK 200+ analyzer. This
helps ensure that the data is transferred in the same format by
System Configuration
all analyzers.
• Use checksum and handshake. See your computer
specification for the requirements.
Network Settings
Specify network settings to send results to a local computer network.
1. Select Network settings.
2. Use the IP configuration cycle key to set the configuration.
To Select
use dynamically assigned IP DHCP
addresses
use a static IP address Static
Key Options
Subnet mask 255.255.255.000
255.255.000.000
255.000.000.000
To Select
not use a gateway address No
make the gateway address active Yes
Setup Menu 9
At the eighth Setup menu, select Next Screen to access the ninth
Setup menu. This is the final setup menu.
To Select
to reset to the defaults Yes, return to original
settings (This will delete all
results and all IDs.)
retain your custom settings No, do not change settings
Strip Sensor
Use this test to determine if the strip sensor is functioning properly:
1. Select Strip sensor.
2. When prompted, place a test strip.
If the strip sensor detects the presence of a strip placed on the
table, the message Strip detected displays.
3. Select Previous Screen.
System Configuration
Touch Screen
Use this test to determine if the touch screen is functioning properly:
1. Select Touch screen.
A screen displays that is filled with small boxes.
2. Select the center of each box.
As each box is selected, a check mark should display. It disappears
when the same box is selected again.
3. Select Previous Screen key when finished.
Barcode Reader
System Configuration
Display
Use this test to ensure that all the lighted elements on the display are
lit and turned off properly:
1. Select Display.
The entire screen is lit for several seconds, then becomes blank.
This series is repeated twice more before returning to the previous
menu.
2. If numerous faulty pixels exist, or if they are located in critical
areas, call your local technical support provider to replace the
display.
Printer
Use this test to ensure that the internal or 80-column external printer
prints all characters correctly:
1. If you are using an external printer, ensure that it is turned on.
2. Select Printer.
3. Follow the directions on the screen.
4. Examine the printout for its readability.
The display automatically returns to the previous menu.
Completing Setup
System Configuration
Safety Information
Protecting Yourself from Biohazards
This information summarizes the established guidelines for handling
laboratory biohazards. This summary is based on the guidelines
developed by the Centers for Disease Control, the Clinical and
Laboratory Standards Institute, and the Occupational Safety and
Health Administration.
Use this summary for general information only. It is not intended to
replace or supplement your laboratory or hospital biohazard control
procedures.
By definition, a biohazardous condition is a situation involving
infectious agents biological in nature, such as the hepatitis B virus, the
human immunodeficiency virus, and the tuberculosis bacterium. These
infectious agents may be present in human blood and blood products
and in other body fluids.
The following are the major sources of contamination when handling
potentially infectious agents:
• Needlesticks
• Hand-to-mouth contact
• Hand-to-eye contact
• Direct contact with superficial cuts, open wounds, and other skin
conditions that may permit absorption into subcutaneous skin
layers
• Splashes or aerosol contact with skin and eyes
To prevent accidental contamination in a clinical laboratory, strictly
adhere to the following procedures:
• Wear gloves while servicing parts of the system that have contact
with body fluids such as serum, plasma, urine, or whole blood.
• Wash your hands before going from a contaminated area to a
noncontaminated area, or when you remove or change gloves.
• Perform procedures carefully to minimize aerosol formation.
References
1. Centers for Disease Control. Update: Universal precautions for
prevention of transmission of human immunodeficiency virus,
hepatitis B virus and other bloodborne pathogens in healthcare
settings. 1988. MMWR, 37:377–382, 387, 388.
2. Clinical and Laboratory Standards Institute (formerly NCCLS).
Protection of Laboratory Workers from Occupationally Acquired
Infections; Approved Guideline - Third Edition. Wayne, PA: Clinical
and Laboratory Standards Institute; 2005. CLSI Document M29-A3.
[ISBN 1-56238-567-4].
3. Federal Occupational Safety and Health Administration.
Bloodborne Pathogens Standard. 29 CFR 1910. 1030.
Information
Legal Information
To contact the legal representative for Siemens within the European
community, contact the Siemens Authorized Representative. For
service, contact your local technical support provider.
Warranty Information
Installation Details
Please record the following information and keep this sheet in the your
laboratory for future reference.
Date of Installation:
Serial Number:
Disclaimer of Warranties
This warranty is expressly made in lieu of any and all other warranties
express or implied (either in fact or by operation of law) including the
warranties of merchantability and fitness for use which are expressly
excluded, and is the only warranty given by Siemens.
Limitations of Liability
In no event shall Siemens be liable for indirect, special or
consequential damages, even if Siemens has been advised of the
possibility of such damages.
For warranty service, contact the local Siemens office for assistance
and/ or instructions for obtaining repair/ replacement of this
instrument.
Support Information
Call for assistance:
• If the error message continues to be displayed after performing
the steps described on the screen and in the Troubleshooting
Chart
• If additional assistance is required concerning an analyzer problem
• If the problem is beyond the scope of this guide
• If the problem cannot be solved and an analyzer failure is apparent
Our local technical support providers are available to help you. Before
calling, please complete the Pre-service Checklist‚ page 143. Make a
photocopy of the checklist first. This information helps your local
technical support provider to identify the probable cause of the
problem.
Information
Date of Installation:
Serial Number:
If NO:
Have you performed the Touch Screen test using the
procedure in Perform Hardware Tests‚ page 135?
Have you calibrated the touch screen using the procedure
in Calibrating the Touch Screen‚ page 67?
3. Does the analyzer proceed properly while analyzing urine
strips?
4. Is the printer functioning properly? Are the appropriate
messages and patient results being printed?
If NO:
Is the internal or an external printer turned on using the
procedure in Printer‚ page 108?
Is there paper in the printer?
expiration dating?
Is the bottle of Control Strips within its expiration dating
Information
If so, what are they? List the error description and any
numbers that display.
8. Have you performed the appropriate steps suggested on
the display for the error being displayed?
If an external device is being used:
9. Is the printer or host computer/LIS connected and turned
on?
10. Have the correct parameters for transmission been
selected through the Setup menus?
11. Is the external printer properly printing the test results?
Orderable Supplies
List of Supplies and Optional Equipment
The supplies and optional equipment available for the
CLINITEK Advantus analyzer are listed below.
Catalog Number Description
* Siemens Reagent Strips for Urinalysis
1364 Chek-Stix Combo Pak Control Strips for
Urinalysis
1360 Chek-Stix Positive Control Strips for Urinalysis
1421 CLINITEK Advantus Handheld Barcode Reader
5773 Thermal Printer Paper (5 rolls)
6472 CLINITEK Advantus Waste Bin Liners (5 liners)
RC200P STAR Form Printer Ribbon Cassette
5256 CLINITEK Form Printer Ribbon Cartridge
5163A CLINITEK 3-Copy Forms (10 x 100)
50336008 Lubriplate Lubricant
insert and on the bottle label, and test results that should be obtained
are listed in the package insert.
Note Chek-Stix Control Strips are not suitable for use with
Multistix PRO Reagent Strips for Urinalysis.
The Control Strips are available as a Combo Pak, which contains 1
bottle each of the Positive Control Strips and Negative Control Strips
(25 strips/bottle). The Positive Control Strips are also available as a
separate product (1 bottle of 25 strips).
Orderable Supplies
This is a list of the replacement parts available for your
CLINITEK Advantus analyzer. Contact your local technical support
representative to order.
• AC power cord
• CLINITEK Advantus Operator’s Guide
• CLINITEK Advantus Operator’s Guide CD
• Color/Clarity Card (for use with the handheld barcode reader)
• Fixed Platform and Holddown Plate
• Holddown Plate
• Loopback Connector
• Moving Table
• Printer
• Printer Cover
• Push Bar
System Specifications
This section summarizes the design specifications for the
CLINITEK Advantus analyzer.
Safety Certifications
See the DECLARATION OF CONFORMITY shipped with the
CLINITEK Advantus analyzer.
Analyzer Dimensions
Dimension Value
Depth 35 cm (13.75 in)
Height 32 cm (12.75 in)
Width 39 cm (15.75 in)
Weight 7.2 kg (16 lbs)
Environmental Specifications
Specification Value
Ambient Operating 18° to 30°C (64° to 86°F).
Temperature At temperatures under 22°C (72°F),
urobilinogen and leukocyte results may be
decreased, and at temperatures above 26°C
(79°F), increased.
Optimum Operating 22° to 26°C (72° to 79°F).
Temperature
Relative Humidity 20 to 80%, non-condensing, actively
controlled
Optimum Relative 35 to 55%
Humidity
Indoor Use Only
Electrical Requirements
Requirement Value
Electrical Rating 100 to 240 VAC ± 10%
Power Requirements 50 to 60 Hz
Maximum Power 72 VA
Input
Fuse Rating 2 A, 250 V, 2 AG, SB(T)
Line Leakage Current < 0.5 mA in normal condition
< 3.5 mA in single fault condition
d. Determined visually. Reported results are default descriptions that can be changed by the user.
Table D-2: English and Chinese, Units—International (SI)
154
ORANGE BLUE
RED BROWN
d
Clarity CLA CLEAR TURBID No Difference
SL CLOUDY OTHER
CLOUDY
a. These tests and results are only available when using Multistix PRO Reagent Strips for Urinalysis.
b. Specimen is too dilute to accurately determine ratio result. Repeat test on new specimen.
c. Color may be preceded with LT or DK when determined by the analyzer. If determined visually, default descriptions can be changed by the user.
Other can also be reported.
d. Determined visually. Reported results are default descriptions that can be changed by the user.
Table D-3: English Nordic, Units—Nordic Plus System
CLINITEK Advantus Operator’s Guide
d. Determined visually. Reported results are default descriptions that can be changed by the user.
Table D-4: German, Units—Conventional
160
ORANGE BLAU
ROT BRAUN
d
Klarheit CLA KLAR TRUEB gleich
FLOCKIG ANDERS
S. FLOCKIG
a. Diese Tests und Ergebnisse stehen nur bei Verwendung von Multistix Pro Teststreifen zur Verfügung.
b. Probe ist zu stark verdünnt, um den Quotienten genau zu bestimmen. Test an neuer Probe wiederholen.
c. Vor der Farbe kann HELL oder DUNK stehen, wenn die Auswertung durch das System erfolgt. Bei visueller Bestimmung können die vom System
vorgegebenen Farben vom Bediener verändert werden. "ANDERS" kann auch angegeben werden.
d. Wird visuell bestimmt. Die angegebenen Ergebnisse sind Standardbeschreibungen, die vom Benutzer geändert werden können.
Table D-5: German, Units—International (SI)
CLINITEK Advantus Operator’s Guide
d. Wird visuell bestimmt. Die angegebenen Ergebnisse sind Standardbeschreibungen, die vom Benutzer geändert werden können.
Table D-6: French, Units—Conventional
166
ROUGE MARRON
Aspectd ASP LIMPIDE OPAQUE Identique
LEG TROUBLE AUTRE
TROUBLE
a. Ces analyses et résultats sont disponibles uniquement lors de l'utilisation de bandelettes réactives Multistix PRO.
b. L'échantillon est trop dilué pour permettre de déterminer avec précision le résultat du rapport. L'analyse doit être effectuée sur un nouvel
échantillon.
c. La couleur peut être précédée de la mention CLR. ou FONC. en cas de définition par l'analyseur. En cas de détermination visuelle, les descriptions
par défaut peuvent être modifiées par l'utilisateur. La mention Autre peut également être indiquée.
d. Détermination visuelle. Les résultats rapportés sont des descriptions par défaut qui peuvent être modifiées par l'utilisateur.
Table D-7: French, Units—International (SI)
CLINITEK Advantus Operator’s Guide
ARANCIONE AZZURO
ROSSO MARRONE
d
Aspetto ASP LIMPIDA MOL. TORB. Uguale
LEGG. TORBIDA ALTRO
TORBIDA
a. Queste analisi e risultati sono disponibili solo quando si utilizzano le strisce reattive Multistix Pro.
b. Il campione è troppo diluito per determinare con precisione un risultato accurato. Ripetere l’analisi con un nuovo campione.
c. Il colore può essere accompagnato da "LT" (Chiaro) o "DK" (Scuro) quando è determinato dallo strumento. Se si determina visivamente, le
descrizioni di default possono essere cambiate dall’utente; i risultati possono refertare anche "ALTRO".
d. Determinato a vista. I risultati riportati sono le descrizioni predefinite modificabili dall'utente.
Table D-9: Italian, Units—International (SI)
CLINITEK Advantus Operator’s Guide
NARANJA AZUL
ROJO MARRON
d
Aspecto ASP CLARO MUY TURBIO Ninguna Diferencia
LIG. TURBIO OTROS
TURBIO
a. Estas pruebas y resultados sólo estarán disponibles si se utilizan tiras reactivas MULTISTIX PRO.
b. La muestra está demasiado diluida para determinar de forma exacta el resultado del cociente. Repetir la prueba con una muestra nueva.
c. El color puede ir precedido de CL. u OSC. cuando es determinado por el analizador. Si se determina visualmente, el usuario puede modificar las
descripciones predeterminadas. El resultado también puede ser “Otros”.
d. Determinado visualmente. Los resultados comunicados son descripciones predeterminadas que el usuario puede modificar.
Table D-11: Spanish, Units—International (SI)
CLINITEK Advantus Operator’s Guide
d. Determinado visualmente. Los resultados comunicados son descripciones predeterminadas que el usuario puede modificar.
Table D-12: Portuguese, Units—Conventional
184
VERMELHO MARROM
Aspectod ASP CLARO TURVO Sem diferenças
POUCO OUTROS
NEBULOSO
NEBULOSO
a. Esses testes e resultados estão disponíveis apenas usando as tiras reagentes Multistix Pro.
b. A amostra está muito diluída para determinar um resultado de relação com precisão. Repita o teste em uma nova amostra.
c. A coloração pode ser precedida por CL. ou ES. quando determinada pelo analisador. Se forem determinadas visualmente, as descrições padrão
poderão ser mudadas pelo usuário. Outras descrições também podem ser informadas.
d. Determinado visualmente. Os resultados informados são descrições padrão que podem ser mudadas pelo usuário.
Table D-13: Portuguese, Units—International (SI)
CLINITEK Advantus Operator’s Guide
ORANGE BLAA
ROED BRUN
d
Klarhet CLA KLAR GRUMLIG Ingen skillnad
ANINGEN OKLAR ANNAT
OKLAR
a. De här testerna och resultaten finns endast om du använder Multistix-Pro reagensstickor.
b. Det går inte att bestämma rätt kvotresultat eftersom proverna är för utspädda. Upprepa testet med ett nytt prov.
c. Färg kan föregås av CL eller DK när den bestäms med analysinstrumentet. Om färgen bestäms med ögat kan standardbeskrivningar ändras av
användaren. Även annat kan rapporteras.
d. Bestämd med ögat. Rapporterade resultat är standardbeskrivningar som kan ändras av användaren.
Table D-15: Swedish, Units—International (SI)
CLINITEK Advantus Operator’s Guide
d. Bestämd med ögat. Rapporterade resultat är standardbeskrivningar som kan ändras av användaren.
Table D-16: Swedish, Units—Nordic Plus System
196
ROED BRUN
Klarhetd CLA KLAR GRUMLIG Ingen skillnad
ANINGEN ANNAT
OKLAR
OKLAR
a. De här testerna och resultaten finns endast om du använder Multistix-Pro reagensstickor.
b. Det går inte att bestämma rätt kvotresultat eftersom proverna är för utspädda. Upprepa testet med ett nytt prov.
c. Färg kan föregås av CL eller DK när den bestäms med analysinstrumentet. Om färgen bestäms med ögat kan standardbeskrivningar ändras av
användaren. Även annat kan rapporteras.
d. Bestämd med ögat. Rapporterade resultat är standardbeskrivningar som kan ändras av användaren.
Table D-17: Japanese, Units—Conventional
CLINITEK Advantus Operator’s Guide
検査 印刷 単位 報告された結果
標準システム プラスシステム
Glucose GLU g/dL - 0.5 - 2+
(ブドウ糖) 0.1 >=1.0 +/- 3+
0.25 1+
Bilirubin BIL - 2+ 同左
(ビリルビン) 1+ 3+
Ketone KET - 2+ 同左
(ケトン体) +/- 3+
1+
Specific Gravity SG <=1.005 1.020 同左
(比重) 1.010 1.025
(屈折率 - 0.005 選択単位)
1.015 >=1.030
Occult Blood OB - 1+ 同左
(潜血) +/- LYSED 2+
+/- INTACT 3+
199
200
検査 印刷 単位 報告された結果
標準システム プラスシステム
pH pH 5.0 7.5 同左
5.5 8.0
6.0 8.5
6.5 >=9.0
7.0
Protein PRO mg/dL - 100 - 2+
(蛋白質) +/- (15a ) >=300 (300a) +/-(LOWa) 3+
30 1+
Urobilinogen URO E.U./dL 0.1 4.0 同左
(ウロビリノーゲン) 1.0 >=8.0
CLINITEK Advantus Operator’s Guide
2.0
Nitrite NIT - + 同左
(亜硝酸塩)
Leukocytes WBC - 2+ 同左
(白血球) +/- 3+
1+
CLINITEK Advantus Operator’s Guide
検査 印刷 単位 報告された結果
標準システム プラスシステム
Creatinine CRE mg/dL 10 200 同左
(クレアチニン)a 50 300
100
Protein-to-Creatinine Ratio P:C mg/g NORMAL DILUTEb 同左
(蛋白 / クレアチニン比)a NORMAL 300 ABNORMAL
150 ABNORMAL >500 ABNORMAL
Color COL YELLOW GREEN 同左
(色調)c ORANGE BLUE
RED BROWN
Clarity CLA - 2+ 同左
(混濁)d +/- OTHER
1+
a. MULTISTIX PRO 試験紙を使用した場合のみ、これらの検査を実施して結果を得ることができます。
b. 尿検体が希薄すぎます。正確な結果を得ることができません。新たに採取した検体 (早朝第一尿が望ましい)で再検査してください。
c. 色調を尿分析器で測定する場合、”LT.” (Light)または ”DK.” (Dark)を表示することがあります。
見た目で判断する場合、ユーザーが初期設定の説明を変更することができます。”OTHER” もレポートできます。
d. 目視判定します。目視判定する場合、ユーザーが初期設定の表示値を変更することができます。
201
Table D-18: Japanese, Units—JCCLS
202
検査 印刷 単位 報告された結果
標準システム プラスシステム
Glucose GLU mg/dL - 500 - 3+
(ブドウ糖) 100 >=1000 1+ 4+
250 2+
Bilirubin BIL - 2+ 同左
(ビリルビン) 1+ 3+
Ketone KET - 2+ 同左
(ケトン体) +/- 3+
1+
Specific Gravity SG <=1.005 1.020 同左
CLINITEK Advantus Operator’s Guide
検査 印刷 単位 報告された結果
標準システム プラスシステム
pH pH 5.0 7.5 同左
5.5 8.0
6.0 8.5
6.5 >=9.0
7.0
Protein PRO mg/dL - 100 - 2+
(蛋白質) +/- (15a ) >=300(300a) +/-(LOWa) 3+
30 1+
Urobilinogen URO E.U./dL 0.1 4.0 同左
(ウロビリノーゲン) 1.0 >=8.0
2.0
Nitrite NIT - + 同左
(亜硝酸塩)
Leukocytes WBC - 2+ 同左
(白血球) +/- 3+
1+
203
204
検査 印刷 単位 報告された結果
標準システム プラスシステム
Creatinine CRE mg/dL 10 200 同左
(クレアチニン)a 50 300
100
Protein-to-Creatinine Ratio P:C mg/g NORMAL DILUTEb 同左
(蛋白 / クレアチニン比)a NORMAL
150 ABNORMAL
300 ABNORMAL
>500 ABNORMAL
Color COL YELLOW GREEN 同左
(色調)c ORANGE BLUE
CLINITEK Advantus Operator’s Guide
RED BROWN
Clarity CLA - 2+ 同左
(混濁)d +/- OTHER
1+
a. MULTISTIX PRO 試験紙を使用した場合のみ、これらの検査を実施して結果を得ることができます。
b. 尿検体が希薄すぎます。正確な結果を得ることができません。新たに採取した検体 (早朝第一尿が望ましい)で再検査してください。
c. 色調を尿分析器で測定する場合、”LT.” (Light)または ”DK.” (Dark)を表示することがあります。
見た目で判断する場合、ユーザーが初期設定の説明を変更することができます。”OTHER” もレポートできます。
d. 目視判定します。目視判定する場合、ユーザーが初期設定の表示値を変更することができます。
Appendix E: Barcode Reader
Barcode Reader
General Information
You can use the optional CLINITEK Advantus handheld barcode reader
to:
• scan barcoded labels that are adhered to the specimen tubes,
• scan the color and clarity barcodes from the special card that is
included with the reader
• enter lot and expiration information
• enter patient and operator IDs.
The software in the barcode reader automatically distinguishes
between barcode formats.
Note You must configure the barcode prior to use.
7. Test your barcode reader, and select the correct parameters for the
labels used in your laboratory. See Barcode Reader Options‚
page 133, in this guide for more information.
8. Attach the backing included with the reader bracket to the bracket.
9. Set the bracket near the analyzer.
Barcode Reader
Reading errors may occur if any of the following conditions exist:
• The narrow bar width is too small
• The barcode length too great
• The height too small
• The reader is held too far from the label
• The background reflection too high or low
The test labels included with the barcode reader can be used to verify
the operation of the reader. Two sheets of labels are provided. Each
sheet contains 2 labels in each of the 6 symbology and check digit
combinations. These test labels are of a known quality, printed within
the barcode reader specifications.
If the reader is not able to consistently read your labels, apply a test
label of the format being used to a new specimen tube and perform
the Barcode Test. If the reader is able to read the test label, the quality
of your labels may be suspect. If the test label cannot be read, the
reader itself is suspect.
If you have problems that cannot be resolved, contact your local
technical support provider for assistance.
Specifications
Barcode Formats
The CLINITEK Advantus barcode reader meets the requirements of
ASTM E1466-92, “Standard Specification for Use of Bar Codes on
Specimen Tubes in the Clinical Laboratory” (available from ASTM, 100
Barr Harbor Dr., West Conshohocken, PA 19428).
This measurement effects both the symbol length and how far away
from the label you can hold the handheld barcode reader. If the narrow
bar width is at the minimum, the symbol length can be no greater than
90 mm (3.5 in), including quiet zones, and the reader can be held no
more than 75 mm (3 in) away.
Narrow to Wide Ratio: Must be within the specifications for the
format being used. This is generally 2.0 to 3.0.
Symbol Length: Variable. See Narrow Bar Width for more information.
Quiet Zone: Minimum of ten times the narrow bar width at each end
of the symbol.
Symbol Height: Minimum of 10 mm (0.40 in).
Total Size of Label: May be greater than the size of the symbol to
allow for printing of human readable information. Printing of the
specimen ID number in alphanumeric digits is strongly recommended.
Symbol grade: Minimum grade of “C” as defined by ANSI X3.182-1990
(available from American National Standards Institute, 1430
Broadway, New York, NY 10018).
Wavelength of Light: 630 nm (visible red LED).
CAUTION
Do not submerge the reader in water. The reader’s housing is
not water-tight.
Do not use laboratory wipes, such as Kimwipes, because they
may scratch the window.
Do not use any type of solvent to clean the reader. Harsh
chemicals can damage the finish or the window.
Interface
General Information
You can connect the CLINITEK Advantus analyzer to a host computer or
Laboratory Information System (LIS). You can also connect an 80-
column or form printer. This appendix contains the specifications
needed for the interface cables required. Contact your local technical
support provider for additional information on programs to interface
the analyzer to a computer or LIS.
Interface
TXD Transmit Data This output sends test data,
control characters, and analyzer
information.
RXD Receive Data This input receives control
characters for software
handshaking and data for IDs.
RTS Request to Send This output line, when high,
indicates to the computer that it
may send data.
CTS Clear to Send This input is checked before
sending each character, and, if
high, the next character is sent. If
it is not supplied by the
computer, jumper pin 7 to pin 8.
DSR Data Set Ready The computer must raise this line
whenever it is ready to receive
data. If it is not supplied by the
computer, jumper pin 4 to pin 6.
DTR Data Terminal This signal is on whenever the
Ready analyzer IO is configured for a
computer and the computer is
on.
You can use any standard 80-column printer with a Centronics style
interface.
• Set the External Printer option to On, 80-column. See Printer‚
page 108 for more information.
• Ensure that the interface cable contains a DB-25 male connector.
This is the standard IBM configuration.
The analyzer also generates data suitable for use with the following 3
types of form printers.
Printer Products Form Printer – Set the external printer option to On,
Form Printer 1. This format adds 9 spaces to the beginning of each
line, so that the results are in the proper location on the CLINITEK
Report Form.
CLINITEK Form Printer – Set the external printer option to On, Form
Printer 2. This format does not add additional spaces to the front of
the line.
Star Form Printer or another simple form printer – Set the external
printer option to On, Form Printer 3. This format does not add
additional spaces to the front of the line. This format also includes
commands to the printer preventing it from printing a record until a
form is in place, and ejecting the form when printing is complete.
If any of the form printer formats are used, the display includes a
Reprint key that you can use if a record needs reprinting.
To determine the best format, print a record using each of the Form
Printer options.
Interface
Number Name
1 STROBE-L Data Strobe 1 CLINITEK Advantus
2 Data 1 Parallel Data CLINITEK Advantus
Line
3 Data 2 Parallel Data CLINITEK Advantus
Line
4 Data 3 Parallel Data CLINITEK Advantus
Line
5 Data 4 Parallel Data CLINITEK Advantus
Line
6 Data 5 Parallel Data CLINITEK Advantus
Line
7 Data 6 Parallel Data CLINITEK Advantus
Line
8 Data 7 Parallel Data CLINITEK Advantus
Line
9 Data 8 Parallel Data CLINITEK Advantus
Line
11 BUSY Busy Line Printer
12 PRINTER Printer Out Printer
OUT Line
18 SIG GND Signal Ground 2 N/A
Notes
Signal Function Description
Name
1 STROBE-L Data Strobe -L indicates active low signal
2 SIG GND Signal Pins 19 through 25 are also connected
Ground to the signal ground.
Symbols
This section describes the symbols that can display in the analyzer
documentation, the exterior of the CLINITEK Advantus analyzer, or on
the analyzer packaging. The symbols on the analyzer provide you with
the location of certain components and with warnings for proper
operation. The symbols on the analyzer packaging provide you with
other important information. For information on the symbols that can
display on the CLINITEK Advantus reagent packaging and labeling, see
the related assay instruction for use.
Symbol Description
This symbol is used for both Warnings and Cautions.
• A Warning indicates the risk of personal injury or
loss of life if operating procedures and practices are
not correctly followed.
• A Caution indicates the possibility of loss of data or
damage to or destruction of equipment if operating
procedures and practices are not strictly observed.
This symbol alerts you to a biohazard.
Symbols
This symbol indicates that the instrument is type B
equipment, which provides a particular degree of
protection against electric shock.
This symbol indicates to follow the appropriate
procedures for disposal of electrical and electronic
equipment.
User Interface
This section describes the symbols that display on the analyzer user
interface.
Symbols
platform are immediately moved to the
waste bin and no results are reported for
them.
This key displays on the Ready/Run screen
and becomes active as soon as the first strip
in a run is detected.
Help Select this key to display a Help screen with
information about the screen.
Select Previous Screen from the Help screen
to return to the previous screen.
Help is not available on all screens.
Next Screen Select this key to display the next screen in a
series.
This key displays only if additional screens
exist.
Previous Select this key to change the display back to
Screen the previous screen in a series.
This key displays only if previous screens
exist.
Enter Select this key to accept data you enter, such
as ID and sequence numbers, date, and time.
If you exit the screen without selecting
Enter, the analyzer does not save the newly
entered data and retains any data in
memory.
Move Right Select this key to move the cursor one space
to the right.
If the cursor is at its right-most position,
selecting this key has no effect. Moving the
cursor does not erase any characters and
new characters can be entered directly over
the incorrect characters.
Symbols
Cancel Print Select this key to cancel printing.
Performance Results
analyzer).
Each site tested between 390–400 urine specimens, using protocol
guidelines to assure collecting a sufficient number of specimens at
each clinical level.
The study results are summarized in Table H-19 and Table H-20 below.
Table H-19 shows the example results for sensitivity and specificity,
assuming that the comparative method was 100% sensitive and
specific. For example, for bilirubin with the comparative method
CLINITEK 500 analyzer, this table can be read as follows:
• Sensitivity: For bilirubin, the CLINITEK 500 analyzer reported 204
(N) results as positive. Of these 204 positive results on the
CLINITEK 500 analyzer, the CLINITEK Advantus analyzer showed a
positive result 86.8% of the time (the observed rate of agreement).
The one-sided 95% upper confidence bound (UCB) for this
agreement rate is 90.5%.
• Specificity: For bilirubin the CLINITEK 500 analyzer reported 2140
(N) results as negative. Of these 2140 negative results on the
CLINITEK 500 analyzer, the CLINITEK Advantus analyzer showed a
negative result 97.3% of the time (the observed rate of
agreement). The one-sided 95% upper confidence bound (UCB) for
this agreement rate is 97.9%.
For the CLINITEK Advantus analyzer, sensitivity and specificity rates
were ≥ 85% for all tests; and in most cases, sensitivity and specificity
were well over 90%. See Table H-19.