RAL instruments STAINER User manual

The RAL Automated staining system
User Guide
RAL STAINER
The RAL Automated staining s
y
ste
m
Use
r
Guide
Ref:12060-V05 / EN

RAL STAINER
2 RAL STAINER User guide
Before use, please read the user guide carefully in order to be able to use the equipment correctly.
The user guide must be kept in the immediate vicinity in order to be available for reference at all
times.
All rights reserved. The reproduction, modification or use of any part of this document in any form is prohibited
without the written permission of RAL Instruments.
RAL DIAGNOSTICS - Site Montesquieu - 33650 Martillac - FRANCE
E-mail: [email protected]
Tel: [phone] - Fax: [phone]
www.ral-instruments.com
History of changes to the user guide
Revision Date Section Software Version
1 03/2012 2.43
2 07/2012 6 2.55
3 08/2012 12 2.55
4 02/2013 - 2.60
5 07/2013 - 2.63
Updates available on www.ral-instruments.com.

RAL STAINER
3 RAL STAINER User guide
1 INTRODUCTION.....................................5
1.1 RESPONSIBILITY...................................5
2 SYMBOLS.........................................6
2.1 SYMBOLS USED IN THIS GUIDE ........................6
2.2 DESCRIPTION OF THE SYMBOLS ON THE APPLIANCE .........6
3 WARRANTY AND WARRANTY LIMITS .....................7
4 SAFETY INSTRUCTIONS...............................8
4.1 COMPLIANT USE...................................8
4.2 WARNINGS.......................................8
4.3 WASTE..........................................9
4.3.1 ELECTRONIC WASTE ..............................9
4.3.2 BACTERIOLOGICAL AND CHEMICAL WASTE...............9
5 DESCRIPTION OF THE APPLIANCE ......................10
5.1 OPERATING PRINCIPLES ............................13
5.2 PERFORMANCE...................................13
5.3 SAFETY ........................................13
5.4 SIZE ..........................................13
5.5 ELECTRIC SPECIFICATIONS ..........................13
5.6 ENVIRONMENTAL LIMITS FOR USE .....................14
5.7 ENVIRONMENTAL LIMITS FOR TRANSPORTATION AND STORAGE 14
6 STAINING REAGENTS ...............................15
7 INSTALLATION .................................... 16
7.1 PACKAGING LIST..................................16
7.2 INSTALLATION ENVIRONMENT ........................17
7.3 SETTING UP .....................................17
7.4 CONNECTION OF THE INSTRUMENT TO THE MAINS POWER SUPPLY
7.5 HYDRAULIC CONNECTIONS ..........................18
8 SCREEN DESCRIPTIONS ............................. 19
8.1 MEANINGS OF THE SYMBOLS ........................19
8.2 PAGE DESCRIPTIONS ..............................20
8.2.1 STAINING PAGE .................................20
8.2.2 SETTINGS PAGE.................................21
8.2.3 CHANGE SESSION PAGE...........................23
8.2.4 INFORMATION PAGE ..............................24
8.2.5 ALPHANUMERIC AND NUMBER KEYBOARD..............25
9 INITIALISATION .................................... 26
9.1 USER CREATION AND RIGHTS MANAGEMENT .............26
10USE...........................................29
10.1 STARTING UP ...................................29
10.2 INSTALLING REAGENTS ............................29
10.2.1 STAINING KIT..................................29
10.2.2 RINSING SOLUTION ............................. 30
CONTENTS

RAL STAINER
4 RAL STAINER User guide
10.3 STAINING PROTOCOL ............................. 30
10.3.1 PROTOCOL MODIFICATION ........................31
10.3.2 CHANGING THE PROTOCOL........................ 33
10.4 INSTALLING THE SLIDES ...........................33
10.4.1 LOADING THE SLIDE HOLDER ......................33
10.4.2 PLACE THE SLIDE HOLDER IN THE APPLIANCE ..........33
10.5 STAINING ......................................34
10.6 CHANGING THE STAINING KIT OR DRAINING .............34
10.6.1 CHANGING THE STAINING KIT ......................34
10.6.2 DRAINING ....................................35
10.7 STAND-BY .....................................35
10.8 POWERING OFF..................................35
11 TRACEABILITY ................................... 36
11.2 LOADING THE TRACEABILITY FILE .....................36
12 CLEANING ......................................37
12.1 CLEANING .....................................37
12.2 HYDRAULIC SYSTEM CLEANING ......................37
12.3 ACTIVATED CARBON FILTER .........................38
12.4 DECONTAMINATION............................... 39
13 CONSUMABLES AND OPTION EQUIPMENT ...............40
13.1 CONSUMABLES .................................40
13.2 OPTIONAL EQUIPMENT ............................40
14 MAINTENANCE ...................................41
15 AFTER-SALES SERVICES ............................41
16 TROUBLESHOOTING ...............................42
16.1 ERROR MESSAGES ...............................42
16.2 WHAT TO DO WHEN ...?............................43
17 SUMMARY OF TIPS................................ 45
18 INDUSTRIAL PROPERTY ............................46
19 EC DECLARATION .................................47
20 INDEX .........................................48

RAL STAINER
5 RAL STAINER User guide
Thank you for having chosen RAL Stainer.
RAL Stainer is intended for the staining of haematological or bacteriological smears.
It can be used to autonomously stain 20 slides and returns the slides ready for observation.
It recognises the staining kits installed and recommends the protocol to use as well as the renewal of the
reagents.
It can trace staining carried out using an RFID system.
It ensures the complete safety of the user: the user loads and unloads the biological samples without
opening the appliance, the residual stain emanations are retained by an activated carbon filter.
1.1 RESPONSIBILITY
Even if the greatest care has been given to the drafting of this guide, RAL Instruments cannot be held liable
by any party in the event of damages caused, or supposed to have been caused, either directly or indirectly, by
the failure to carry out the instructions contained in this guide or by the non compliant use of the equipment
described below.
1 INTRODUCTION

RAL STAINER
6 RAL STAINER User guide
2 SYMBOLS
2.1 SYMBOLS USED IN THIS GUIDE
RAL Stainer is designed in order to ensure the maximum safety of the user. However, it is necessary to follow
the instructions described in this guide and indicated by the following symbols:
Attention : Failure to respect the information preceded by this symbol can be dangerous for the
user or for the environment ; or cause major damage to the appliance.
Warning: This symbol precedes all information covering the correct use of the appliance and a
quality diagnosis.
Biological risks
Information: This symbol precedes information that may be useful to a user operating the appliance.
Tips: This symbol precedes useful advice.
2.2 DESCRIPTION OF THE SYMBOLS ON THE APPLIANCE
Biological Risks
REF Appliance Reference
SN Appliance Serial Number
Manufacturer's Address
Fabrication Date
Operating relative humidity limits
Operating temperature limits
Recycling of the instrument or return to the distributor
Pollution Control
Attention, see User Guide
Consult the User Guide
Medical In Vitro Diagnosis System
Security Certification
European Compliance
Back sideFront side

RAL STAINER
7 RAL STAINER User guide
3 WARRANTY AND WARRANTY LIMITS
The duration of the warranty for equipment and manufacturing faults is indicated on your warranty contract.
The warranty period starts on the day your RAL Instruments representative commissions the equipment.
Failure to respect the safety instructions below or a use which is not compliant with this user guide may use
cause the cancelling of the warranty.
The warranty does not cover wear parts.

RAL STAINER
8 RAL STAINER User guide
4.1 COMPLIANT USE
r3"-4UBJOFSJTintended for the staining of haematological or bacteriological smears. It operates using RAL
Stainer kits from RAL Diagnostics. It is not designed for any other use and cannot be operated using other
reagents than those from RAL Diagnostics.
r5IFTNFBSTXJMMCFNBEFPOTUBOEBSETMJEFT
r3"-4UBJOFSJTTUSJDUMZSFTFSWFEGPSJOUFSJPSVTF
r5IFVTFPGUIFBQQMJBODFNVTUDPNQMZXJUIUIFJOTUSVDUJPOTHJWFOJOUIJTHVJEF
r5IFDPOEJUJPOTPGDPNQMJBOUVTFBMTPJODMVEFUIFSFHVMBSDMFBOJOHPGUIFBQQMJBODFBOEUIFDBSSZJOHPVUPG
maintenance operations.
r5IFVOQBDLJOHJOTUBMMBUJPOBOESFQBJSPQFSBUJPOTNVTUCFDBSSJFEPVUCZBOBVUIPSJTFEUFDIOJDJBO
rThe reservoir tank must be always in place. See section 7.3.
r5IJTEFWJDFDPNQMJFTXJUI1BSUPGUIF'$$3VMFT0QFSBUJPOJTTVCKFDUUPUIFGPMMPXJOHUXPDPOEJUJPOT
this device may not cause harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
4.2 WARNINGS
r Failure to respect the safety instructions and the use instructions may compromise the user safety .
r/FWFS DPOOFDU UIF BQQMJBODF UP B NBJOT QPXFS PVUMFU TVQQMZJOH B WPMUBHF EJGGFSFOU UIBO UIBU
indicated on the rear of the appliance. The main supply must not exceed ± 10% of the specified
voltage (100-240V). Failure to follow this instruction can cause a fire or an electric shock.
r"WPJEDBVTJOHEBNBHFUPUIFQPXFSTVQQMZDBCMF%POPUQMBDFBOZBQQMJBODFTPOJU%POPUUVH
on the cable (to disconnect the appliance for example). Failure to follow these instructions can
cause a short circuit or a disconnection that could, in turn, cause a fire or an electric shock.
r
Before connecting the product to the mains, check that the electrical installation of the building
complies with national installation regulations.
r Do not use a power cable of a length greater than 3m .
r/FWFSUPVDIUIFFMFDUSJDDJSDVJUTPSPUIFSQBSUTMPDBUFEJOTJEFUIFBQQMJBODF5IFSFJTBSJTLPG
electric shock, especially with damp hands.
r5IFMJUIJVNCBUUFSZDPOUBJOFEJOUIFFMFDUSPOJDDBSEMPDBUFEJOUIFMFGUSFBHFOUESBXFSPGUIFEFWJDF
can be replaced by a battery with the same characteristics (CR1220 3v). If not, it may cause an
explosion. Throwing away used batteries according to your laboratory practises.
r*OUIFFWFOUPGVOVTVBMTNPLFCFJOHFNJUUFECZUIFBQQMJBODFJNNFEJBUFMZTXJUDIJUPGGVTJOHUIF
main switch and unplug the mains power supply cable. Contact the RAL Instruments post-sales
service.
r*UJTQSPIJCJUFEUPGPSDFUIFDPWFSPQFOJOHTUIFTMJEFESBXFSTPSUIFSFBHFOUESBXFSTCPUIXIFO
operating and when not operational.
r*UJTQSPIJCJUFEUPGPSDFUIFSPUBUJOHBSNCPUIXIFOPQFSBUJOHBOEXIFOOPUPQFSBUJPOBM
r8FBS MBCPSBUPSZ HMPWFTBOE BMBCPSBUPSZDPBU XIFO VTJOHUIF BQQMJBODF BOEJUTSFBHFOUT 5IF
dangers relative to each reagent are indicated on their respective packaging or see section 6. In
the event of an accident, refer to the relevant safety data sheets.
rAll biological samples, all effluents and all used consumables should be considered to be
potentially dangerous. Once the appliance is no longer used, the user should disinfect and
wash his/her hands.
rThe contact between contaminated hands and the appliance can cause the contamination of
the appliance. In this case, decontaminate the appliance according to current laboratory best
practises. See also section 12.2.
r(FOFSBMMZNBLFTVSFUIBUDVSSFOUMBCPSBUPSZCFTUQSBDUJTFTBSF used.
The guarantee is not responsible for any changes or modifications not expressly approved by the
party responsible for compliance. Such modifications could avoid the user's authority to operate
the equipment.
4 SAFETY INSTRUCTIONS

RAL STAINER
9 RAL STAINER User guide
4.3 WASTE
4.3.1 ELECTRONIC WASTE
This symbol is applicable in European countries.
It indicates, in compliance with the 2003/108/EC directive relating to electric and electronic waste,
that electric and electronic objects are subject to selective waste collection by the company that
brought them onto the territory. Contact your RAL Instruments representative.
Outside the European Union, refer to current local or national regulations.
4.3.2 BACTERIOLOGICAL AND CHEMICAL WASTE
Before disposing of biological samples and/or chemical reagents, consult the reagent safety instructions.
Generally, make sure that current laboratory best practises are used.

RAL STAINER
10 RAL STAINER User guide
5 DESCRIPTION OF THE APPLIANCE
Open front face view
Left view Right view
Side view with
drawers open
Top view with
drawers open

RAL STAINER
11 RAL STAINER User guide
Touch screen interface
Standby button
Staining arm
Connectors
liquid with level
detection
Waste outlet
and rinsing
liquid
Slide loading/unloading drawers
And drying zone (x2)
Autonomy of 1 to 20 slides
(2 ten-slide slide holders)
Staining stations
with sealed lid (x4)
Reagent loading
drawers
Protective cover
Draining nozzle

RAL STAINER
12 RAL STAINER User guide
On/Off or
0/1 switch
Activated
carbon filter
Peristaltic pump
for effluent suction
Power supply input
Connections for the rinsing
liquid and the waste outlet
Connections for
the rinsing level
and the waste
outlet level
USB port for
downloading
traceability
information

RAL STAINER
13 RAL STAINER User guide
5.1 OPERATING PRINCIPLES
RAL Stainer is an automatic bath staining appliance.
A arm which follows a circular and vertical path successively:
- Hooks the slide holder installed by the user;
- Brings the slide holder into each staining tank and then into the rinsing tank depending on the recorded
protocol;
- Returns the slide holder to its initial position.
- The slides are then dried.
Staining is complete.
5.2 PERFORMANCE
r-$%UPVDITDSFFO
r$BQBDJUZYTMJEFT
rTUBJOJOHTUBUJPOT
rSJOTJOHTUBUJPO
rMPBEJOHVOMPBEJOHESBXFSTGPSUPTMJEFTFBDIXJUIBWFOUJMBUPSUPESZUIFTMJEFTBUUIFFOEPGUIFDZDMF
r6QUPTUBJOJOHQSPHSBNNFTJONFNPSZ
rVTFSTUIBUDBOCFQBSBNFUFSFEGPVSMFWFMTPGBVUIPSJTBUJPO"ENJOJTUSBUPS&YQFSU6TFSBOE.BJOUFOBODF
r3'*%4ZTUFN
Automatic recognition of kits and corresponding staining protocol optimised by RAL Diagnostics.
Control of the batch, the expiry date, the staining kit autonomy and the activated carbon filter replacement.
r1PMZWBMFOUVTF
It is possible to switch from one kit to the other, from one application to another: RAL Stainer keeps the data
about all the kits being used in memory.
r4UBJOJOHUSBDFBCJMJUZø
It is possible to print a report giving the correlation of work dates, users, staining and the product batch used.
5.3 SAFETY
Vapour emanation is limited because the loading/unloading of the reagents and slides is carried out using
drawers.
Each tank is closed using a sealed lid inside the appliance.
The cover need not be opened other than for cleaning operations.
RAL Stainer has a ventilation system which uses an activated carbon filter to evacuate all possible residual
vapour (Warning when the filter needs to be changed).
The arm is fitted with a level sensor which adjusts the slide immersion height depending on the liquid
remaining in the containers.
The draining of the solutions is carried out by the appliance itself thanks to a peristaltic pump which directs
towards the waste bin (10 L), thus avoiding dangerous handling.
The waste bin level will be automatically detected in order to avoid any overflow.
The level of rinsing liquid will be automatically detected to avoid launching staining without rinsing liquid.
Drainage holes and a reservoir tank can collect liquids in case of leak.
5.4 SIZE
Weight: 28 kg
Diameter: 42.5 cm
Height: 62.4 cm
5.5 ELECTRIC SPECIFICATIONS
Voltage: 100-240V/ ~ 50-60Hz. Overvoltage category 2
Operating power: 150 VA

RAL STAINER
14 RAL STAINER User guide
5.6 ENVIRONMENTAL LIMITS FOR USE
Temperature: from 18 to 30°C
Humidity: from 20 to 85%
RAL Stainer is strictly reserved for interior use. It is not recommended to use this device in a location with
an altitude more than 3 000 meters and in an environment having a pollution degree superior than 2.
5.7 ENVIRONMENTAL LIMITS FOR TRANSPORTATION AND STORAGE
Temperature: from -10 to 55°C
Humidity: from 5 to 85%

RAL STAINER
15 RAL STAINER User guide
Only RAL Diagnostics staining reagents can be used in the RAL Stainer.
Staining kits available:
Some reagents may occur a danger. Refer to the staining kit packaging and reagents MSDS.
Refer to the staining protocol for the use of each staining kit, for the attempt performances, for the quality
control and the standard staining protocol.
6 STAINING REAGENTS
Field of
activity Kit description Use Reference
Number of
reusable
slides
Number of days
after opening =
BBD
Expiry
Haematology
Bacteriology
Bacteriology
Bacteriology
Kit RAL Stainer MCDh
Kit RAL Stainer Gram-Hucker
Kit RAL Stainer Gram-Nicolle
Kit RAL Stainer 555
Staining kit for
blood and bone marrow smears
Staining kit for
Gram + and Gram - bacteria
Staining kit for
Gram + and Gram - bacteria
Fast staining kit
for cytobacteriology
360200-0000
360210-0000
360220-0000
360250-0000
500 slides
500 slides
500 slides
300 slides
21 days
14 days
14 days
14 days
18
months
24 months
24 months
24 months
Xi
Ethylic Alcohol, Isopropanol
F, Xn
Ethylic Alcohol, Crystal Violet
F
Ethylic Alcohol
F, T
Methanol
Danger
Bacteriology
Bacteriology
Kit RAL Stainer Fluo-RAL
Kit RAL Stainer Cold ZN
Auramine staining kit
for mycobacterium tests
Cold fuchsine staining kit
for mycobacterium tests
360230-0000
360240-0000
300 slides
500 slides
7 days
14 days
12 months
12 months
F, C
Ethanol, Phénol
F, C
Ethanol, Phénol

RAL STAINER
16 RAL STAINER User guide
The RAL Stainer must be installed by a technician approved by RAL Instruments.
7.1 PACKAGING LIST
Check that all the items below are contained in the RAL Stainer package:
Description Quantity
RAL Stainer 1
Power supply (L=2m) 1
RAL Stainer 10 L Jerrycan 2
Hydraulic cane for effluents 1
Hydraulic cane for rinsing liquid 1
Reservoir tank 1
Pack of Slide-holder RAL Stainer (x3) 1
Rinsing Station RAL Stainer 1
Filter Cartridge RAL Stainer 2
Stylus 1
RAL Stainer CD 1
RAL Stainer Quick Start 1
Label sheets 20
RAL Stainer USB Stick 1
If one of the items is damaged or missing, contact your RAL Instruments representative.
7 INSTALLATION

RAL STAINER
17 RAL STAINER User guide
7.2 INSTALLATION ENVIRONMENT
r4UPSFUIFJOTUSVNFOUJOBMPDBUJPOXJUIJOUIFFOWJSPONFOUBMPQFSBUJOHMJNJUT
r5IFBQQMJBODFNVTUCFQMBDFEPOBTUBCMFGMBUBOEDMFBOUBCMF"WPJETIPDLTBOEWJCSBUJPOT
r$POTJEFSJOHUIFXFJHIUPGUIF3"-4UBJOFSLHVTFBTVGGJDJFOUMZTPMJEUBCMF
r1MBDFUIFBQQMJBODFDMPTFUPBNBJOTQPXFSPVUMFUBOEBSVOOJOHXBUFSUBQJGZPVIBWFTFMFDUFEUIFSVOOJOH
water connection option.
r$POTJEFSJOHUIFTJ[FPGUIF3"-4UBJOFSDN)DNQMBOUPVTFBTQBDFPGYDNGPS
the appliance installation, use and maintenance.
Avoid placing the appliance behind a window in order to limit the heating of the reagents under the
sun's rays.
If the appliance has been stored at temperatures outside the environmental usage limits, it must
remain at room temperature for 1 hour before powering up.
Avoid using the appliance in close proximity to a chemical reagent storage area or in an atmosphere
containing emanations of dangerous gases.
Make sure the on/off switch and the mains power
outlet remain accessible.
If you have to move the instrument, handle it carefully
by lifting it up by the bottom, like showing the opposite
picture
7.3 SETTING UP
Place the RAL Stainer on a flat and stable surface, in a sufficiently wide space, as described in
section 7.2.
Place the two supplied containers beneath the table.
To eliminate any risk of error in the use of the appliance, mark each supplied container with the
supplied labels in order to assign a function to each one: Effluent Container and Rinsing liquid
container.
The standard containers supplied with the RAL Stainer can be replaced by autoclave
compatible containers. Contact your RAL Instruments representative.
The supplied containers can also be replaced using your usual containers. However take care over the sealing of
the container as it is not certain that the supplied cover fits your container.
Rayon vrai 200 mm
424 mm
250 mm
421 mm
624 mm
460 mm
w
wi
d
d
d
d
ib
ib
d
d
i
i
pplied container with the
C
C
ntainer and Rinsing liquid
e
e
Réf.: 12094-V04 Rév.: 09/2013
RAL STAINER
r
f
f
f
f
f
f
f
f
f
f
ff
f
f
f
Réf.: 12094-V04 Rév.: 09/2013
RAL STAINER
Rinse label
Waste label
Slide the reservoir tank below the machine on the back until
it is blocked.
The reservoir tank must always be empty. If it is full,
because of the flammability hazard of some
products, remove it by sliding it gently, then empty it
and call your service engineer.

RAL STAINER
18 RAL STAINER User guide
7.4 CONNECTION OF THE INSTRUMENT TO THE MAINS POWER SUPPLY
Only use the power supply supplied with the appliance.
Using the supplied power cable, connect the RAL Stainer to an alternating current power outlet nearby.
The appliance operates in the voltage range 100V to 240V, 50-60Hz
7.5 HYDRAULIC CONNECTIONS
Connect the Effluent container and the rinsing liquid container to the right hand part of the appliance.
1. Introduce the tube and the level sensor connected to the red cover into the waste container and screw the
cover to hermetically seal the container.
2. Introduce the tube and the level sensor connected to the blue cover
into the rinsing container and screw the cover to hermetically seal
the container.
3. Connect the tubes to the corresponding couplers on the appliance
taking care to respect the colour codes:
Blue: Connection of the rinsing liquid container
Yellow: Connection of the effluent container
4. Connect the electric cables using the male jack connectors to the
appliance's female male connectors in any order. The level sensors
do not have any specific connectors.
power outlet
120/240V, 50-60Hz
Rinsing container
tube
Rinsing level
and waste level
connections
Waste container
tube

RAL STAINER
19 RAL STAINER User guide
8 SCREEN DESCRIPTIONS
RAL Stainer has a simple and user friendly interface, and a touch screen.
8.1 MEANINGS OF THE SYMBOLS
Validate Cancel
Go to page
w
Staining Settings Change session Information
Unlock the slide drawer Launch staining Halt staining
Soak Rinse Mix Dry Drain
w
w
w
w

RAL STAINER
20 RAL STAINER User guide
RAL STAINER
Progress of staining
Staining in progress
Drying in progress
Available zone
Name of the staining
protocol used
Name of the
staining kit
Control panel of the two work
zone
Error or information
message area
Remaining staining time
Number of staining
cycles remaining
Drawer status
To return to this page, press the button
8.2 PAGE DESCRIPTIONS
8.2.1 STAINING PAGE
The Staining page is the page that is always displayed by default. Staining is launched from this page.