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Software Version 2.5
CYTOfast SA – User Manual
CYTOfast SA
CYI000002
USER MANUAL 1.4
Software Version 2.5
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CYTOfast SA – User Manual
INDEX
2. INSTALLATION PROCEDURE...............................................................................2-13
2.1. UNPACKING ............................................................................................................................... 2-13
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4. SETUP.....................................................................................................................4-26
4.1. SELECT READING ..................................................................................................................... 4-26
5. RESET.....................................................................................................................5-33
8. TROUBLESHOOTING ............................................................................................8-38
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INDEX OF PICTURES
Picture 1 CYTOfast SA ................................................................................................................................. 1-10
Picture 2 CYTOfast SA instrument ............................................................................................................... 2-13
Picture 3 Initialization .................................................................................................................................... 2-14
Picture 4 Main Screen .................................................................................................................................. 2-15
Picture 5 Proper vial ..................................................................................................................................... 2-16
Picture 6 Vial's dimension and label placing ................................................................................................ 2-16
Picture 7 Main menu ..................................................................................................................................... 3-18
Picture 8 Start menu ..................................................................................................................................... 3-18
Picture 9 Prepare all six sample ................................................................................................................... 3-19
Picture 10 Samples selection ....................................................................................................................... 3-19
Picture 11 Pre-Shake.................................................................................................................................... 3-20
Picture 12 Empty containers ......................................................................................................................... 3-21
Picture 13 Full containers ............................................................................................................................. 3-21
Picture 14 Tips needed and positioning ....................................................................................................... 3-22
Picture 15 Sample positioning ...................................................................................................................... 3-22
Picture 16 Work cycle screen ....................................................................................................................... 3-23
Picture 17 Stopped Cycle ............................................................................................................................. 3-24
Picture 18 Results Screen ............................................................................................................................ 3-25
Picture 19 Setup menu ................................................................................................................................. 4-26
Picture 20 Start read screen ......................................................................................................................... 4-26
Picture 21 Select reading screen .................................................................................................................. 4-27
Picture 22 Password screen ......................................................................................................................... 4-27
Picture 23 Insert calibrator screen ................................................................................................................ 4-27
Picture 24 Calibration end screen ................................................................................................................ 4-28
Picture 25 Stress screen............................................................................................................................... 4-29
Picture 26 Settings screen ............................................................................................................................ 4-29
Picture 27 Language screen ......................................................................................................................... 4-30
Picture 28 Mixing screen .............................................................................................................................. 4-30
Picture 29 Balancing screen ......................................................................................................................... 4-31
Picture 30 +/- Class screen .......................................................................................................................... 4-32
Picture 31 Shut-down screen ....................................................................................................................... 6-34
Picture 32 Shut-down ................................................................................................................................... 6-34
Picture 33 Luer Connector and Waste lock .................................................................................................. 7-36
Picture 34 Waste lock screw ........................................................................................................................ 7-37
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I. RESPONSABILITY DECLARATION
Our Company declines all responsibility for damage due to any type of modifications made
on the Hardware and Software due to connection to other instruments not carried out by
our personnel or not previously authorized by our firm.
In case the apparatus is damaged do not switch it on until it has been repaired by a
technician from our company's Service Department.
Any type of electric operation required to install or repair the instrument must be carried
out by our staff; do not install in any other way.
The instrument should be used under the environment conditions and according to safety
norms given in points II and III of the following chapter, in order to guarantee that the
results obtained by the instrument are equivalent to those given in the technical
specifications.
.
Although CYTOfast SA does not entail any particular risk for the operator, instrument has
to be used only by appropriately trained personnel, and only for the use as intended.
The indications for use must be applied simultaneously to respect the laws in force in
the country where the instrument is installed, about risk prevention and environmental
protection.
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explosive materials;
materials which, in contact with others, can react by releasing large amounts
of energy.
• The safe working CYTOfast SA and its operational reliability are guaranteed only if:
any checking and repair are carried out by personnel authorized by the
manufacturer;
WARNING:
Guarantee will be not applicable on instruments for which previous indications have
been not respected.
The dimensions of the instrument, and then the space required for its placement, are
shown in the technical specifications.
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FUSE: None
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SYMBOLS TABLE
1 Alternate current
2 Ground terminal
3 ON (power)
4 OFF (power)
5 Fuse
11 CE mark
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1. GENERAL DESCRIPTION
1.1. INTRODUCTION
CYTOfast SA instrument is part of the whole system for liquid based cytology (LBC),
named CYTOfast system, produced by HOSPITEX INTERNATIONAL SRL.
CYTOfast SA is used for the optical density determination of samples collected in
CYTOfast preservative liquid, and the subsequent preparation of related cytological slides.
.
Picture 1 CYTOfast SA
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MODEL CYTOfast SA
CODE CYI000002
POWER CONSUMPTION 15 W
FUSES None
WEIGHT 22 kg
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Packaging contains:
ETHERNET CABLE PC 1
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2. INSTALLATION PROCEDURE
2.1. UNPACKING
W
T
S
C
S: Stickeur tank
C: CYTOfast tank
T: Tip rack
W: Waste
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During the initialisation phase, the mechanical arm and all others devices find their home
positions. The steps of the initialisation are visualized on the display by 7 blue circles, one
for each check (Picture 3).
Picture 3 Initialization
- nephelometer movement.
If each item is properly initialized (seven blue circles at the bottom of the display), after a
few seconds, it shows the home (Picture 4).
Otherwise, instrument tries to initialize the blocked item again.
If the item is still blocked or it is not working, display shows “INIT FAILED” message.
Then, a message with the name of blocked item appears.
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In the first case (home picture is shown by the display), it is possible to proceed starting a
new work cycle or manage the instrument settings.
In the second case (one resource is blocked) it is recommended a new initialization
procedure by pressing RESET, if problem persists the operator must call technical
assistance.
From this section user can start a new work cycle (see Section 3.5) by pressing START,
manage the instruments settings (see Section 4) by pressing SETUP or perform a RESET
(see Section 5).
The software release version is indicated in the lower left corner.
.
Uncap the two containers on the instrument, marked with C and S.
Fill the container marked with C with preservative solution CYTOfast; fill the container
marked with S with fixative solution Stickeur.
Replace caps on the two containers.
From this moment, hydraulic circuits of CYTOfast and Stickeur solution are filled.
Check the presence of the proper container in the place where used tips will be
discharged.
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2.4. VIAL
Dimensions and the proper way to stick on the label are shown in the pictures below
(Picture 6).
It is very important that the label is into the correct position: incorrect positions compromise
nephelometric reading.
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3. OPERATIVE PROCEDURES
Instrument shows main menu (Picture 7). Use touch screen for scrolling the menu.
Select START for starting work.
The other functions selectable from main menu are SETUP (Section 4) and RESET
(Section 5).
By selecting START, instrument shows a new menu where operator can choose how
many samples set up during the working cycle (Picture 8).
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By selecting PREPARE ALL, the operator chooses to set up six samples, simultaneously.
This working method as to be considered as the standard: it allows to obtaining the
maximum productivity of the instrument, coupled with highest productivity of cytocentrifuge
(Picture 9).
Please note that the cytocentrifuge cannot manage a single sample, or 5 samples, while it
can manage simultaneously 2, 4 samples (placing them on opposite sides), 3 samples
(placing them as a triangle) and 6 samples of course.
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3.2.3. PRE-SHAKE
In the same screen of samples selection, option PRE-SHAKE is displayed (Picture 11).
Picture 11 Pre-Shake
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After selecting PREPARE ALL or SELECT SAMPLE instrument shows the screen where is
possible to check the levels of the two solutions CYTOfast and Stickeur.
If the two levels, or one of them, are visualized in red, add solutions in the correspondent
containers because it is not possible to realize a work cycle (Picture 12).
If the two levels are visualized in green, the work cycle can start (Picture 13).
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After the containers level’s check the instrument displays the number of tips and their
positioning needed for selected work cycle (Picture 14).
If less than 6 samples have been selected, operator can prepare a number of tips equal to
the number of samples selected: the position of the sample on the plate has to match
the position of the tip, plus the tip in position 7, which always has to be prepared.
Instrument uses one tip each sample, plus tip in position 7 which is used for CYTOfast
(balancing solution) and Stickeur (fixative solution) addiction, in all the samples prepared.
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4. Place on the right side of each vial its corresponding slide, previously assembled
(Picture 15).
Some precaution is required during insertion of those vials containing the brush.
Make sure the brush is not blocked by the walls of the vial, but free to float.
Place the vial so that the tip of the brush is facing the center of the preparation
plate, to ensure a better floating the brush inside the vial.
Select (“start” key) in the menu in which number of samples has been selected.
Instrument starts to prepare the 6 samples, following this work sequence:
1. mechanical arm takes tip 1, inserts it in vial 1, then it resuspends sample by
performing 3 cycles of aspiration/dispensation (see Section 4.4.2, for alternative
configurations);
2. sample 1 is read by the nephelometer, then tip aspirates the sample quantity
determinated by the nephelometric reading and dispenses it on the assembled
slide;
3. mechanical arm discharges tip 1 in the proper container, then it takes tip 2.
In the same way the other 5 samples are processed.
During this preparation cycle, display shows following screen (Picture 16).
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After 3 cycles of aspiration/dispensation nephelometer reads sample class and the result
is written under “QTY[ul]” label (see Section 2.5).
If the option “Prepare all” has been selected, all six vials have a class number.
If the option “Select sample” has been selected, the empty positions show the message
“Sample not in use”.
In the “VOL[ul]” line, the indication of balancing with CYTOfast solution will appear (see
Section 3.5.1).
If the operator wants to stop the work cycle can press STOP button.
By pressing STOP, the instrument can interrupt work cycle but according to the action
started: the instrument interrupts itself only before to catch the tip or before sample
aspiration. By pressing STOP “Wait...” message will appear and, when instrument is
stopped this label is replaced with two different choices: RESTART and ABORT (Picture
17).
By pressing RESTART the instrument resumes and finishes the work cycle whereas, by
pressing ABORT, the cycle is aborted: possible tip caught is released and the instrument
performs the initialization procedure.
After the 6 samples preparation, mechanical arm takes the seventh tip and aspirates by
the valve corresponding to CYTOfast solution, adding a volume of it of 5 ml, less aspirated
sample volume.
This operation needs to balance all the samples to the same volume, before centrifugation.
Being 5 ml the highest sample addiction foreseen by the nephelometric reading (sample
with the lowest cellularity) all samples are balanced to that volume (see Section 4.4.3, for
alternative configuration).
In case of samples of class 1, from which a volume of 5 ml has been aspirated,
instrument does not add liquid CYTOfast.
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With the seventh tip again, instrument dispenses 1.5 ml (fix quantity) of fixative solution,
named Stickeur, on each slide.
Final volume on each slide during centrifugation will be 6.5 ml (5 ml of sample + CYTOfast
solution and 1.5 ml of Stickeur solution).
Fixative solution allows, together with centrifuge force and polysined slides use, the perfect
adhesion of cellular material on the slide.
After the addiction of fixative solution in the sixth sample, mechanical arm discharges the
seventh tip and find it home position again.
If less than 6 samples have been selected at the beginning, the work cycle will be the
same, for the number of selected samples. In this case, the number of tips to be placed on
the instrument and the number of assembled slides have to match the
number of samples to be processed.
It is always necessary to place the seventh tip, in order to realize samples balancing
and fixative solution addiction.
At the end of a work cycle, display shows aspirated quantities of just prepared samples,
and performed balancing (Picture 18).
By selecting (home) it is possible to return to the main menu and eventually start a
new work cycle if requested.
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4. SETUP
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4.2. CALIBRATION
It is possible to realize a new instrument calibration if the previous one works not properly.
The operator needs a password and the Hospitex International calibration kit. Display
shows next image (Picture 22).
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Insert first calibrator and press OK. Display shows an image (Picture 23), but it will ask to
insert the second calibrator. Insert it and press OK. The same procedure is for third and
fourth calibrator. At any time, by pressing CANCEL the instrument stops calibration
procedure and goes back to the setup menu.
At the end of calibration procedure, display shows picture below.
4.3. STRESS
Due to stress function, the instrument starts uninterrupted work cycle. The instrument is
never stopped. During the uninterrupted cycle display shows the initialization image
(Picture 25). It is necessary turn OFF the instrument to stop the stress procedure.
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4.4. SETTINGS
From this menu it is possible to reach to different instrument settings (Picture 26).
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4.4.1. LANGUAGE
4.4.2. MIXING
This option allows selecting the number of sample mixings that instrument performs before
nephelometric reading (Picture 28).
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4.4.3. BALANCING
In practice:
1. if, after nephelometric reading, from sample 1 a quantity lower than 2 ml has been
taken, and also from sample 4 a quantity lower than 2 ml has been taken, this
couple of samples will be balanced to 2 ml, by adding CYTOfast liquid in order to
reach the volume of 2 ml in both samples (regardless of the balancing for couples
2-5 and 3-6);
2. if, after nephelometric reading, from sample 1 quantity lower than 2 ml has been
taken, but from sample 4 quantity higher than 2 ml has been taken, this
couple of samples will be balanced to 5 ml, by adding CYTOfast liquid in order to
reach the volume of 5 ml in both samples (regardless of the balancing for
couples 2-5 and 3-6).
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This function allows to increase or decrease the amount of cellular material on the slide
(Picture 30).
It is possible to increase or decrease the amount of cellular material of 50%. This function
has some limitation:
Class 10 ignore decreasing (minimum volume for the sample is 100 µl).
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5. RESET
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At the end of working session, operator can switch off instrument by pressing the red key,
in the main menu.
Instrument asks if “SHUT DOWN” has to be performed (Picture 31).
.
Picture 32 Shut-down
Then switch off the instrument using the power switch on the rear panel.
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This section provides the user recommendations for a proper maintenance and cleaning of
the instrument. The producer reminds again the user that the periodic visual inspection of
the instrument is the first and easier way to guarantee the best performance of the
instrument itself. Please remember to switch off the instrument before any cleaning and
maintenance procedure.
WARNING: Vials and theirs contents may present a hazard for the operator. Follow
standard laboratory procedures for protection from hazards when performing
maintenance and troubleshooting procedures.
Note that the instrument must be installed in a dry and clean area, as specified in a “safety
precaution” section.
Make sure that the samples plate is clean; otherwise clean it with a soft cloth that doesn’t
leave any residues and a common detergent.
If during the work session the plate enters in contact with biological liquid, immediately
wipe it with a soft cloth that doesn’t leave any residues and a disinfectant liquid.
Preparation plate is easily removable, not screwed.
Every instrument surface, included touch screen surface, must be cleaned with a soft
cloth, that doesn’t leave any residues and not aggressive detergent. Such cleaning
procedure does not ensure that all the viruses and micro-organisms are inactivated and
the instrument is sterilized, although it reduces the risk at a minimum level.
To empty the tanks: packaging contains two discharging pipes with Luer connectors; insert
these into the correct instrument connections under the tanks (as shown in following
pictures). Above each of these there is the respective waste lock.
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1. Insert discharging pipes with Luer in the proper connectors on the instrument
(Picture 33).
2. Insert the other end of the pipes in the proper discharge containers, or in CYTOfast
solution and Stickeur tanks (respectively) if the liquid can be used again.
Waste Lock
Luer Connector
3. Place the discharge container at a lower level than the instrument; otherwise the
liquid can’t to come out of the tank (waste tank at least 30 cm under the instrument).
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Stickeur
Waste Lock
and Luer CYTOfast
Waste Lock
and Luer
6. Fill the tank with distilled water and let it soak for about 15 minutes.
WARNING: It is possible that at first filling the presence of eventual air bubbles in the
circuit doesn’t allow the aspiration of liquid by the tip. In this case, loosen a bit the screw
related to the tank then fix it again.
WARNING: Remember to empty and clean the tanks before moving the instrument to
another location or before shipping.
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8. TROUBLESHOOTING
Slides with too much or not enough cellular 2. Use +/- Class function to adjust the
material amount of cellular material.
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