Biomerieux Previ Color Gram User Manual
USER’S MANUAL
4501 - 1689 - en
IVD
bioMérieux S.A. 69280 Marcy l'Etoile / France
Tel. 33 (0)4 78 87 20 00 - Fax 33 (0)4 78 87 20 90
http://www.biomerieux.com
Printed in France / 673 620 399 RCS Lyon
© 2008. bioMérieux, S.A.
REF
29675
version B
03/2009
The performance characteristics and the results of the products presented are subject to a proper and skilled use of the product in strict
conformance with the User’s Manual.
Photo and illustration credit: bioMérieux.
bioMérieux, the blue logo and PREVI are used, pending and/or registered trademarks belonging to bioMérieux S.A. or one of its subsidiaries.
Revisions
The list of revisions below summarizes replacements or additional pages in your User’s Manual.
Version Date of printing Modifications Pages modified
A 09/2008
B 03/2009 Addendum # 4501-1842 insert P 2-6
Creation All
Table of Contents
1. How to use this manual 1-1
Warnings ...............................................................................................................................................................1-1
Specific warnings...................................................................................................................................................1-1
2. General 2-1
Functional description............................................................................................................................................2-1
Key features ..........................................................................................................................................................2-1
Intended use..........................................................................................................................................................2-1
Specifications ........................................................................................................................................................2-2
General ............................................................................................................................................................2-2
Performance ....................................................................................................................................................2-2
Run timing sequence and reagent consumption - General references ............................................................2-3
References ............................................................................................................................................................2-3
Description.............................................................................................................................................................2-4
Front panel and keypad description .................................................................................................................2-4
Back panel .......................................................................................................................................................2-5
Bowl .................................................................................................................................................................2-5
Maintenance kit................................................................................................................................................2-5
Nozzle..............................................................................................................................................................2-6
Nozzle cleaning solution ..................................................................................................................................2-6
Other parts.......................................................................................................................................................2-6
3. Installing the PREVI™Color Gram 3-1
Unpacking procedure ............................................................................................................................................3-1
Installation procedure ............................................................................................................................................3-2
Installing waste tubing......................................................................................................................................3-2
Connecting power............................................................................................................................................3-3
Installing reagent bottles ..................................................................................................................................3-4
Preparation procedure...........................................................................................................................................3-5
Nozzle checking...............................................................................................................................................3-5
Pattern and volume testing ..............................................................................................................................3-6
4. Operating the PREVI™ Color Gram 4-1
CLEAN reprime stage............................................................................................................................................4-2
Pattern test ............................................................................................................................................................4-3
Loading slides........................................................................................................................................................4-5
Starting a staining cycle.........................................................................................................................................4-8
Unloading slides ....................................................................................................................................................4-9
CLEAN alcohol purge stage ................................................................................................................................4-10
Alcohol fixation (ethanol or methanol) .................................................................................................................4-11
Monitoring reagent level ......................................................................................................................................4-12
Replacing a reagent bottle .............................................................................................................................4-12
Emptying the waste container ........................................................................................................................4-13
Other settings ......................................................................................................................................................4-13
Decolorizer setting .........................................................................................................................................4-13
Stain adjustment ............................................................................................................................................4-15
PREVI™Color Gram User’s Manual I-1
Table of Contents
5. Maintenance and cleaning 5-1
Preventive maintenance plan ................................................................................................................................5-1
Preventive maintenance chart..........................................................................................................................5-1
DAILY maintenance .........................................................................................................................................5-2
WEEKLY maintenance ....................................................................................................................................5-2
MONTHLY maintenance..................................................................................................................................5-3
YEARLY maintenance .....................................................................................................................................5-3
Nozzle handling .....................................................................................................................................................5-4
Disassembly.....................................................................................................................................................5-4
Cleaning...........................................................................................................................................................5-5
Reassembly .....................................................................................................................................................5-6
Unclogging the tubing ......................................................................................................................................5-8
Volume test..........................................................................................................................................................5-10
B line flushing procedure .....................................................................................................................................5-13
Priming all lines simultaneously...........................................................................................................................5-16
Long-term storage ...............................................................................................................................................5-16
Cleaning ..............................................................................................................................................................5-18
Cleaning the instrument and the carousel......................................................................................................5-18
Liquid spills ....................................................................................................................................................5-18
Preventing injury..................................................................................................................................................5-18
Disinfecting and/or sterilizing...............................................................................................................................5-19
Disinfection solutions .....................................................................................................................................5-19
Disinfection procedure ...................................................................................................................................5-20
Instrument shipment ............................................................................................................................................5-22
Disinfection declaration..................................................................................................................................5-22
Fuse replacement................................................................................................................................................5-23
6. Troubleshooting 6-1
Error messages and Troubleshooting Table..........................................................................................................6-1
7. Preventive maintenance chart 7-1
Note: Screenshots, figures, and messages are given for information purposes only.
I-2 PREVI™Color Gram User’s Manual
1. How to use this manual
This manual provides the appropriate instructions to install, operate and maintain the
PREVI™ Color Gram instrument.
Warnings
Different types of warnings are used throughout the manual:
• for safety reasons (DANGER!),
• to ensure that the instruments are maintained in good working condition (CAUTION!),
• for regulatory reasons (WARNING!) or,
• for optimum performance of operations, procedures, etc. (IMPORTANT!).
Before using your instrument, please also read the "General safety and regulatory
information" booklet, provided with the instrument, and the above mentioned warnings.
Specific warnings
DANGER! The PREVI™ Color Gram must be installed in a well ventilated area.
If power is lost while the stainer is running, do not open the lid until carousel rotation
ceases. Check the amber rotation light on the front panel and listen for the sound of
carousel rotation to cease.
The anhydrous alcohol used in the instrument is highly flammable. A break or
malfunction in the reagent delivery system has the potential of releasing up to 500 ml
of alcohol in and around the instrument. If this occurs, carefully shut off the power to
the stainer and consult the safety sheet for information in handling alcohol spills.
Do not use the instrument again until any leaks are repaired.
Regarding the PREVI™ Color Cytocentrifuge Rotor, lid and rotor gaskets and related
components are intended to be part of biosafety systems such as are specified in
international and national biosafety guidelines, and cannot be relied on as the only
means of safeguarding workers and the environment when handling pathogenic
micro-organisms.
bioMérieux recommends distilled water for reagent D and ethanol for reagent E.
Methanol can also be used for reagent E, nevertheless its use is subject to specific
safety precautions and requires the instrument to be placed under a safety hood.
CAUTION! To avoid serious instrument damage, never use reagents other than those supplied by
bioMérieux.
Except for both reagent mentioned above, using reagents not supplied by bioMérieux
may seriously damage the stainer and may void your warranty.
PREVI™Color Gram User’s Manual 1-1
How to use this manual
Specific warnings
IMPORTANT! Please read this manual carefully before using the PREVI™ Color Gram.
In all cases of maintenance and repair, work should only be undertaken by a skilled
technician. Untrained personnel should not attempt to dismantle the instrument.
Only spare parts supplied or specified by bioMérieux should be used. Fitting of non-
approved parts may affect the performance and safety features designed into the
instrument.
If the equipment is used in a manner not specified in the instructions for use provided
by bioMérieux, the protection provided by the equipment may be impaired.
If in doubt, contact your bioMérieux representative.
1-2 PREVI™Color Gram User’s Manual
2. General
Functional description
The PREVI™ Color Gram is designed to Gram stain specimen smears on microscope slides.
A Gram stain aids in the presumptive diagnosis of the illness, and it gives preliminary
classification of the causative agent.
This microprocessor-controlled slide stainer is dual purpose. Additionally, the
PREVI™ Color Cytocentrifuge Rotor allows to quickly sediment sample cells onto
microscope slides for staining or other purposes.
The chemical mechanism of Gram differentiation is based on the differential cell wall
permeability to the Crystal Violet-Iodine complex. The Gram stain yields a specimen in which
the Gram-positive organisms are purple to black and the Gram-negative organisms are pink
to red.
Key features
Intended use
PREVI™ Color Gram’s features are:
• minimized reagent consumption
• fast staining
• high volume staining productivity (12 or 30 slides at a time)
• CLEAN cycle to purge each spray nozzle with ethanol or methanol
• 9 operator-selected decolorizer cycles*
• separate reservoir, delivery tube, pump and spray nozzle for each reagent
• operator-selectable ethanol or methanol fixation function to fix samples.
The correct accessory must be used for each function.
The PREVI™ Color Cytocentrifuge Rotor is available from bioMérieux as an option offering
additional features.
* program no. 2 and 3 recommended by bioMérieux.
The PREVI™ Color Gram is an in vitro diagnostic medical device for professional use only.
The PREVI™ Color Gram has been designed to perform automated Gram staining of human
sample micro-organisms for in vitro diagnostics with bioMérieux reagents only.
The PREVI™ Color Gram has been qualified with the following cell suspensions:
• blood
• bronchoalveolar liquid (BAL)
• cerebrospinal fluid (CSF)
• feces
• sputum
• vaginal swab
• urine.
WARNING! bioMérieux disclaims any responsibility for the use of the PREVI™ Color Gram with
biological cell suspensions other than those mentioned above.
PREVI™ Color Gram User’s Manual 2-1
General
Specifications
Specifications
General
PARAMETERS CHARACTERISTICS
Main power input
Power Consumption
Fuse rating
Outside dimensions
Width
Depth
Height - Lid open
Height - Lid closed
Weight
Ambient temperature
Operation
Storage
Relative humidity
Altitude
Pollution degree
100 – 240 V~ / 50 - 60 Hz
The power setting is indicated on the back panel.
85 W max
2A-250V ~ IEC TYPE T
5x20 mm (0.2x7.9 inches)
560 mm (22 inches)
530 mm (21 inches)
580 mm (23 inches)
240 mm (9.5 inches)
16.8 kg (37 lbs)
15 °C to 30 °C (59 °F to 95 °F)
- 20 °C to 60 °C (- 4 °F to 140 °F)
maximum 80% at up to 31 °C
≤ 2000 m
2
Performance
* Not provided by bioMerieux. Since distilled water and ethanol or methanol are not available
** Ethanol or methanol should be 99.8% pure.
Over-voltage category
II
PARAMETERS CHARACTERISTICS
Reagent spray nozzles
Reagent channel
Carousel capacity
Run
Rotor speeds
from bioMérieux, it must be obtained locally. Water should be filtered (0.2 micron inline filter)
to remove bacteria and particulates.
Each reagent has a separate spray nozzle
to dispense the correct amount of reagent.
A - Fuchsin or Safranin (with or without acetone)
B - Iodine
C - Crystal Violet
D - Distilled water *
E - Ethanol or methanol **
12 slides
30 slides
9 operator-selected decolorizer cycles
(Program no.2 and no.3 validated by bioMérieux)
20 rpm for staining (rpm - revolutions per minute)
950 rpm for drying
2-2 PREVI™ Color Gram User’s Manual
Run timing sequence and reagent consumption - General references
The following table includes the general references for a staining cycle at DECOLORIZER 3.
Slides carousel
Phases PUMP
Time
sec
12 30
Volume
ml
Time
sec
General
References
Volume
ml
* Option for ethanol or methanol fixation.
References
(0) FIXATION* (E)
1 CRYSTAL VIOLET C
2 WASH D
3 IODINE B
4 WASH D
5 DECOLORIZER A
6 WASH D
7 HIGH SPEED DRY -
Total without alcohol fixation
Total with alcohol fixation
(70) (3.0) (82) (3.5)
35 4.5 43 5.5
25 17.3 34 23.5
30 4.5 38 5.7
33 22.8 69 47.8
39 6.0 47 7.2
20 13.8 34 23.5
55 - 55 -
237
4 min
307
5.1 min
69
144
320
5.3 min
402
6.7 min
PRODUCTS REFERENCES
PREVI™Color Gram CD Rom
PREVI™Color Gram User’s Manual
PREVI™Color Cytocentrifuge Rotor User’s Manual
General Safety and Regulatory Information
• fr, en, de, es, it, pt, el, sv, da, pl, hu, sk
• et, lt, lv, ru, ja, tr, na, zh, ko, th
REAGENTS
• Acetone safranin-A
• Safranin-A
• Acetone fuchsin-A
• Fuchsin-A
• Iodine-B
• Crystal violet-C
Nozzles * 2
Nozzle o-ring
Nozzle wire
Nozzle cleaning solution
Slide carousel : 12 / 30
D&E empty bottle
D&E 5-Liter empty bottle
Waste tubing
Waste container
Maintenance kit
See your
bioMérieux
representative
113.3
116.8
PREVI™ Color Gram User’s Manual 2-3
General
Description
Description
Lid
with safety lock
Carousel 30
or
Carousel 12
Bowl
(see page 2-5)
Front panel
(see page 2-4)
The PREVI™ Color Gram consists of:
Right side panel with
5 prime buttons for 5
reagent channels :
Fuchsin or
safranin (with or
without acetone)
Iodine
Crystal Violet
Distilled water
Ethanol or
methanol
Front panel and keypad description
Indicators
Cytocentrifuge mode selection
Access to PATTERN and VOLUME tests
(see "Pattern and volume testing", page 3-6)
Power Rotation
Cleaning process
Run a staining process
Program the staining setting
Abort any operation or Exit
Digital display
Numeric keys (programs)
Control keys
2-4 PREVI™ Color Gram User’s Manual
Back panel
Bowl
General
Description
Volume button:
(signal tone setting)
Exhaust vent
Power switch:
On Off
Fuse door; alternative
current
(see "Specifications", page 2-2).
Waste tubing
Power cord
Maintenance kit
DR E C
B
A
D
Spray nozzle orifices:
DR - Distilled water Rear
E - Ethanol or methanol
C - Crystal Violet
B - Iodine
F
A -- Fuchsin or Safranin
(with / without
acetone)
D
- Distilled water Front
F
Drive hub
6 nozzle tubes
6 volume test tubes
1 nozzle tool
1 cleaning wire
1 unclogging tool
1 nozzle disassembly tool
2 nozzles
4 nozzle O-ring
Grease (silicon lubricant)
PREVI™ Color Gram User’s Manual 2-5
General
Description
Nozzle
Nozzle cleaning solution
The nozzle cleaning solution is used for the PREVI™ Color Gram maintenance operations.
The 2.5 L concentrated nozzle cleaning solution (reference 29525) is contained in a 5-liter
bottle. The concentrate is composed of 25.2 g of Oxalic Acid Dihydrate per liter of deionized
water.
It contains at least 1% of Oxalic Acid Dihydrate (the Material Safety Data sheet is available
on request).
The nozzle cleaning solution must be reconstituted before use by adding
2.5 liters of ethanol (C
This instruction is symbolized on the bottle label by the following mention:
“--> + 2.5 L (C
The reagents required but not provided (ethanol or methanol) may present a chemical risk
and should be handled with care. Reconstituted Nozzle Cleaning Solution with ethanol or
methanol, can be hazardous and should be handled with the same care.
The concentrated nozzle cleaning solution must be stored at 15-25°C until the expiry date
indicated on the bottle label.
After reconstitution, the solution must be stored at 15-25°C until the expiry date.
For practical reasons, the solution can be transferred into a 500 mL or a 1-liter bottle.
In this case, it is important to record the expiry date on the bottle.
Please refer to “Maintenance and cleaning” section, page 5-4.
Waste disposal: the Nozzle Cleaning Solution effluents must be treated in the same
manner as the reagents, see warning page 5-3.
O) or methanol (CH4O) (99.8%) to the 5 L bottle.
2H6
O or CH4O)”.
2H6
Note: The nozzle cleaning solution is available separately.
Please contact your bioMérieux representative.
Compression screw
Nozzle housing
Swirl cone
O-ring
Other parts
Since the following parts are not available from bioMérieux, they must be obtained locally:
• ethanol or methanol more than 99.8 % pure
• distilled water.
Empty bottles can be provided by bioMérieux (see "References", page 2-3).
WARNING! ETHANOL OR METHANOL are not provided by bioMérieux.
The customer should purchase them locally and observe the recommendations, in
terms of safety and chemical risk.
2-6 PREVI™ Color Gram User’s Manual
3. Installing the PREVI™Color Gram
CAUTION! If you observe any damage on the packaging or equipment, please contact your
bioMérieux representative before installing the instrument.
Place the instrument with at least 30 cm (12 inches) clearance from obstructions
or hazardous materials.
Unpacking procedure
Open the 2 boxes and
remove the protection
(foam packaging).
Check the contents
according to the
packing lists included
in the 2 boxes
(instrument and
accessories).
Lift the stainer out of
the box.
Place the instrument
on a flat surface, free
from dust and
vibration and away
from direct sunlight.
PREVI™ Color Gram User’s Manual 3-1
Installing the PREVI™Color Gram
Installation procedure
Installation procedure
CAUTION! Ensure that the distance between the back panel of the PREVI™Color Gram and
the wall is at least 30 cm (12 inches).
Before the PREVI™ Color Gram is installed and switched ON it should be left to
stand for at least three hours so that there is no possibility of condensation
causing a hazardous situation.
Keep the waste container tube straight and as short as possible:
2 meters (79 inches) maximum.
The waste container tube should be positioned at a lower level than the table.
If possible, bioMérieux recommends you to install the instrument at an extremity
of the bench top.
Installing waste tubing
Clip the waste tubing
into the PREVI™Color
Gram and push until
you hear a "click".
Click
Adjust the tube length
(L < 2m).
Connect the waste
tubing to the waste
container.
Install the waste
container into a drip
tray to prevent from
spilling any liquid.
Drip tray
3-2 PREVI™ Color Gram User’s Manual
Connecting power
Make certain the
switch is OFF (O).
Check that the voltage
label complies with
the power supply.
Installing the PREVI™Color Gram
Installation procedure
Insert the electric
cord into the power
socket.
Plug the power cord
into the mains
(AC power).
Turn the power
switch ON ( I ).
…
bioMérieux
PREVI Color Gram
Version X.X
…
After 2 seconds the
digital display will
show:
X: firmware version.
PREVI™ Color Gram User’s Manual 3-3
Installing the PREVI™Color Gram
Installation procedure
Installing reagent bottles
DANGER! Reagents used in the PREVI™ Color Gram contain moderately hazardous
chemicals that require care in handling. Always use appropriate safety
measures including gloves and eye protection when handling reagents.
Fill the E bottle with
ethanol or methanol
99.8% pure and the
D bottle with distilled
water.
Place each bottle in
the appropriate
position.
Right side panel with 5
prime buttons for 5
reagent channels :
Fuchsin or
Safranin (with
or without
acetone)
Iodine
Crystal Violet
Distilled water
Ethanol or
methanol
Open the new bottle,
record the letter on the
cap and keep it for
future use (e.g. long
term storage).
Insert the dip tube “E”
into the reagent bottle
“E” and screw on the
ring cap.
Repeat step 3 for
bottles D,C,B,A.
Note: For frequent use
5-L bottles D & E are
available,
see "References"
page 2-3.
To install the bottles,
cut the tubing just
above the dip tube.
Install the bottles in a
drip tray.
3-4 PREVI™ Color Gram User’s Manual
Installing the PREVI™Color Gram
Preparation procedure
Preparation procedure
IMPORTANT! To obtain optimum performance, thoroughly purge and prime each reagent
delivery line using the following instructions.
CAUTION! This procedure must be applied before the 1st use of the instrument.
WARNING! Never operate a dry pump for more than 10 seconds.
Nozzle checking
Remove each spray
nozzle with the nozzle
tool by turning the
counter clockwise.
Note the location of
each nozzle so you
can return it to the
original location.
Hold a sheet of white
paper in front of
the nozzle A.
Press and hold each
prime button.
Stain should appear
within 5 seconds.
If this is the case:
go to step 6.
If not, immediately
stop the procedure
and
see "Unclogging the
tubing", page 5-8.
PREVI™ Color Gram User’s Manual 3-5
Installing the PREVI™Color Gram
Preparation procedure
Flush with distilled
water and wipe dry
the bowl and the
nozzles.
Replace each spray
nozzle by hand and
then with the nozzle
tool by turning
clockwise.
Pattern and volume testing
For first use, please refer to both of the following tests:
•
•
The "Pattern test", page 4-3
Then the "Volume test", page 5-10.
IMPORTANT! After this preparation procedure, follow the ROUTINE use described in
"Operating the PREVI™ Color Gram", page 4-1.
3-6 PREVI™ Color Gram User’s Manual
4. Operating the PREVI™ Color Gram
PREVI™ Color Gram routine process
This routine process flow diagram describes the necessary stages for the routine use of the instrument.
Details are given in the following sections.
PREVI™ Color Gram User’s Manual 4-1
Key
Orange line: run process
Blue line: maintenance process
Grey elements: optional part
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