FCC ID: RWI405000 Tag Reader

RAL STAINER The RAL Automated staining system The RAL Automated staining system User Guide User Guide Ref:12060-V05 / EN 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. History of changes to the user guide Revision 1 2 3 4 5 Date 03/2012 07/2012 08/2012 02/2013 07/2013 Section Software Version 6 12

2.43 2.55 2.55 2.60 2.63 Updates available on www.ral-instruments.com. R E N I A T S L A R RAL DIAGNOSTICS - Site Montesquieu - 33650 Martillac - FRANCE E-mail: commercial@ral-diagnostics.fr Tel: +33 (0) 557 960 404 - Fax: +33 (0) 557 960 405 www.ral-instruments.com 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.

2 RAL STAINER User guide R E N I A T S L A R CONTENTS 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 10 USE . 29 10.1 STARTING UP . 29 10.2 INSTALLING REAGENTS . 29 10.2.1 STAINING KIT . 29 10.2.2 RINSING SOLUTION . 30

3 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 R E N I A T S L A R

4 RAL STAINER User guide 1 INTRODUCTION 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. R E N I A T S L A R

5 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 Front side Back side 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 R E N I A T S L A R Pollution Control Attention, see User Guide Consult the User Guide Medical In Vitro Diagnosis System Security Certification European Compliance

6 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. R E N I A T S L A R

7 RAL STAINER User guide R E N I A T S L A R 4 SAFETY INSTRUCTIONS 4.1 COMPLIANT USE

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.

maintenance operations.

The reservoir tank must be always in place. See section 7.3.

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

Failure to respect the safety instructions and the use instructions may compromise the user safety.

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.

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.

Before connecting the product to the mains, check that the electrical installation of the building complies with national installation regulations.

Do not use a power cable of a length greater than 3m.

electric shock, especially with damp hands.

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.

main switch and unplug the mains power supply cable. Contact the RAL Instruments post-sales service.

operating and when not operational.

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.

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.

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.

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

8 the equipment. 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. R E N I A T S L A R

9 RAL STAINER User guide 5 DESCRIPTION OF THE APPLIANCE Open front face view Left view Right view R E N I A T S L A R Side view with drawers open Top view with drawers open

10 RAL STAINER User guide Touch screen interface Draining nozzle 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) Standby button Protective cover Staining arm Staining stations with sealed lid (x4) Reagent loading drawers R E N I A T S L A R

11 RAL STAINER User guide USB port for downloading traceability information R E N I A T S L A R Connections for the rinsing level and the waste outlet level Connections for the rinsing liquid and the waste outlet Peristaltic pump for effluent suction

12 RAL STAINER User guide Activated carbon filter On/Off or 0/1 switch Power supply input 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

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.

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.

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 R E N I A T S L A R 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

13 RAL STAINER User guide 5.6 ENVIRONMENTAL LIMITS FOR USE Temperature: from 18 to 30C 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 55C Humidity: from 5 to 85%

R E N I A T S L A R

14 RAL STAINER User guide 6 STAINING REAGENTS Only RAL Diagnostics staining reagents can be used in the RAL Stainer. Staining kits available:

Field of activity Kit description Use Reference Number of reusable slides Number of days after opening =

BBD Expiry Danger Haematology Kit RAL Stainer MCDh Staining kit for blood and bone marrow smears 360200-0000 500 slides 21 days 18 months Xi Ethylic Alcohol, Isopropanol Bacteriology Kit RAL Stainer Gram-Hucker Bacteriology Kit RAL Stainer Gram-Nicolle Bacteriology Kit RAL Stainer 555 Staining kit for Gram + and Gram - bacteria Staining kit for Gram + and Gram - bacteria Fast staining kit for cytobacteriology 360210-0000 500 slides 14 days 24 months F, Xn Ethylic Alcohol, Crystal Violet 360220-0000 500 slides 14 days 24 months 360250-0000 300 slides 14 days 24 months Bacteriology Kit RAL Stainer Fluo-RAL Bacteriology Kit RAL Stainer Cold ZN Auramine staining kit for mycobacterium tests Cold fuchsine staining kit for mycobacterium tests 360230-0000 300 slides 7 days 12 months 360240-0000 500 slides 14 days 12 months F Ethylic Alcohol F, T Methanol F, C Ethanol, Phnol F, C Ethanol, Phnol 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. R E N I A T S L A R

15 RAL STAINER User guide 7 INSTALLATION 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:

R E N I A T S L A R Description RAL Stainer Power supply (L=2m) RAL Stainer 10 L Jerrycan Hydraulic cane for effluents Hydraulic cane for rinsing liquid Reservoir tank Pack of Slide-holder RAL Stainer (x3) Rinsing Station RAL Stainer Filter Cartridge RAL Stainer Stylus RAL Stainer CD RAL Stainer Quick Start Label sheets RAL Stainer USB Stick Quantity 1 1 2 1 1 1 1 1 2 1 1 1 20 1 If one of the items is damaged or missing, contact your RAL Instruments representative.

16 RAL STAINER User guide 7.2 INSTALLATION ENVIRONMENT

water connection option.

the appliance installation, use and maintenance. m m 4 2 6 m m 0 6 4 424 mm m m 0 5 2 m m 1 2 4 Rayon vrai 200 mm 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. pplied container with the To eliminate any risk of error in the use of the appliance, mark each supplied container with the CC ntainer and Rinsing liquid supplied labels in order to assign a function to each one: Effluent Container and Rinsing liquid container. ibib dd ii wwidd dd 3 1 0 2

9 0 R E N I A T S L A R ee The standard containers supplied with the RAL Stainer can be replaced by autoclave Rinse label 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 r fffffffffffffff the container as it is not certain that the supplied cover fits your container. RAL STAINER

. v R

4 0 V 4 9 0 2 1

. f R 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 Waste label 3 1 0 2

9 0

. v R

4 0 V 4 9 0 2 1

. f R

17 RAL STAINER User guide 7.4 CONNECTION OF THE INSTRUMENT TO THE MAINS POWER SUPPLY Only use the power supply supplied with the appliance. R E N I A T S L A R power outlet 120/240V, 50-60Hz 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. Rinsing container tube Waste container tube Rinsing level and waste level connections

18 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 Cancel Validate Go to page w wwww Staining Settings Change session Information Unlock the slide drawer Launch staining Halt staining Soak Rinse Mix Dry Drain R E N I A T S L A R

19 RAL STAINER User guide 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. RAL STAINER Name of the staining kit Name of the staining protocol used Error or information message area Number of staining cycles remaining Drawer status Control panel of the two work zone Remaining staining time Progress of staining Drying in progress Staining in progress Available zone R E N I A T S L A R To return to this page, press the button

20 RAL STAINER User guide 8.2.2 SETTINGS PAGE 9 functions RAL STAINER ADJUST PROTOCOL SET PROTOCOL LOAD/CHANGE REAGENTS EMPTY REAGENTS USER RIGHTS MANAGEMENT LANGUAGE DATE / HOUR MAINTENANCE OPEN COVER LID To access this page, Presentation of the functions:

Name ADJUST PROTOCOL RAL STAINER 1 Reagent name 2 Reagent name 3 Reagent name 4 Reagent name min:sec Screen Function to access the Used protocol modification page and record up to 9 modified protocols modified from standard protocols min:sec yes 1 no R E N I A T S L A R

21 RAL STAINER User guide Name SET PROTOCOL RAL STAINER Screen Function Used to access the list of recorded protocols and switch from one to the next. LOAD/CHANGE REAGENTS No specific screen, PLC action Used to open the sealed lids of the staining stations and the reagent loading side doors in order load a new staining kit or replace a staining kit. to EMPTY REAGENTS RAL STAINER EMPTY REAGENTS to drain in order Used the reagents to remove the containers in complete safety when the staining kit has expired or is out of service, or when the user requires. OPEN COVER LID No specific screen, PLC action USER RIGHTS MANAGEMENT RAL STAINER Used to open the cover for a weekly interior clean. Used to record the users with a level of rights to be selected. UTILISATEUR USER EXPERT ADMINISTRATOR INSTALLER R E N I A T S L A R

22 RAL STAINER User guide Name Screen Function LANGUAGE RAL STAINER Franais English Deutsch

Portugus

Espaol Italiano Used operating French, German. to select the language;

or English R E N I A T S L A R DATE / TIME RAL STAINER to update Used the date and time on the machine for use with the traceability monitoring. 0 1 2 3 4 5 6 7 8 9 MAINTENANCE

H2O T1 T2 T3 T4 C1 C2 6 C3 C4 L1 L2 V R Only accessible to authorised persons. Used to check the appliance's operating steps and to operate the hydraulic system. NS erase trace erase mem 8.2.3 CHANGE SESSION PAGE The Change session page is used to change users while operating.

23 RAL STAINER User guide Fill in the code RAL STAINER CODE :

0 1 2 3 4 5 6 7 8 9 A B C D E F G H I G H II J K L M N O P Q R S T U V W X Y Z FF GG HH

e c a p S and press on or

. Four authorisation levels are defined: Installer, Administrator, Expert and User. To access this page, press 8.2.4 INFORMATION PAGE The information page gives access to:

- The information on the staining kit being used: Kit batch number and remaining number of cycles;

- The information about your staining appliance: serial number and software version (GUI software version/

Motor software version/ RFID software version)

- Access to information on the activated carbon filter: the remaining time of use

- Information on the user currently working and the list of all users. To access this page, press RAL STAINER REAGENT KIT INFORMATION Loaded kit : ---

Remaining cycles : 0 MACHINE INFORMATIONS Serial number: 0000 20/02/2012 15:09:31 Software version : 02:41 / 02:14 / V305 Filter autonomy : 61h PROFILES Current session : XXX INFO INIT PROFILES This information can be useful when you contact your RAL Instruments representative for questions about the use of your RAL Stainer appliance or your RAL Stainer staining kit. R E N I A T S L A R

24 RAL STAINER User guide 8.2.5 ALPHANUMERIC AND NUMBER KEYBOARD RAL STAINER RAL STAINER 0 1 2 3 4 5 6 7 8 9 A B C D E F G H I G H II J K L M N O P Q R S T U V W X Y Z FF GG HH

e c a p S 0 1 2 3 4 5 6 7 8 9 These dialogue pages are used in several parts of the interface. They are used to enter numbers from 1 to 9, letters, add a space [Space] or a hyphen [-]. The key is used to cancel entered characters. On the number page, the cursor passes automatically from minutes to seconds. Then press :

or

. R E N I A T S L A R

25 RAL STAINER User guide 9 INITIALISATION 9.1 USER CREATION AND RIGHTS MANAGEMENT Turn on the appliance using the 0/1 switch located behind the instrument. RAL STAINER CODE :

0 1 2 3 4 5 6 7 8 9 A B C D E F G H I G H II J K L M N O P Q R S T U V W X Y Z FF GG HH

e c a p S Enter the user code created with your RAL Instruments representative during the installation, On first use, you must record the users and assign them access rights. The user code will then suffice to start up the machine. Four authorisation levels can be used:

Type USER RAL STAINER Screen Rights User level ADJADJADJADJUSTUSTUSTUST PROPROTOCTOCOLOL SET PROTOCOL LOAD/CHANGE REAGENTS EMPTY REAGENTS OPEN COVER LID EXPERT RAL STAINER ADJUST PROTOCOL SET PROTOCOL LOAD/CHANGE REAGENTS EMPTY REAGENTS OPEN COVER LID USEUSEUSEUSER RR RR RR RIGHIGHIGHIGHTSTSTSTS MANMANAGEAGEMENMENTT LANGUAGE LANLANLANGUAGUAGUAGEGEGE DATE / HOUR DATDATE /E / HOHOURUR MAINTENANCE MAIMAIMAINTENTENTENANNANNANCECECE USEUSEUSEUSER RR RR RR RIGHIGHIGHIGHTSTSTSTS MANMANAGEAGEMENMENTT LANGUAGE LANLANLANGUAGUAGUAGEGEGE DATE / HOUR DATDATE /E / HOHOURUR MAINTENANCE MAIMAIMAINTENTENTENANNANNANCECECE level makes to use to it This the possible machine and load protocols that have been defined by an Expert or Administrator user. User level + creation and modification of staining protocols. to use level makes it This possible the machine and to modify the a protocol or to create a new protocol. settings for R E N I A T S L A R

26 RAL STAINER User guide Type Screen Rights ADMINISTRATOR RAL STAINER ADJUST PROTOCOL SET PROTOCOL LOAD/CHANGE REAGENTS EMPTY REAGENTS USER RIGHTS MANAGEMENT LANGUAGE DATE / HOUR MAINTENANCE OPEN COVER LID Expert level + Rights management + some functions of maintenance screen an This level gives access to all settings except for the Maintenance page. Only Administrator can create a new user and define his/her rights. Authorized functions on the maintenance screen:

operating arm movements, activation of water pump pump and for effluents, file erasing. peristaltic trace INSTALLER RAL STAINER ADJUST PROTOCOL SET PROTOCOL LOAD/CHANGE REAGENTS EMPTY REAGENTS OPEN COVER LID Administrator

+ a c c e s s t o maintenance page level t h e This level gives access to all the functions of the machine. It is reserved for persons authorised RAL Instruments. by USER RIGHTS MANAGEMENT LANGUAGE DATE / HOUR MAINTENANCE a. On the settings menu , press USER RIGHTS MANAGEMENT The user list page appears. b. Select a location. 10 users can be defined. RAL STAINER If you use a location that is already in use, the new record will overwrite the previous record. R E N I A T S L A R

27 RAL STAINER User guide c. Enter the user name and validate RAL STAINER NAME :

0 1 2 3 4 5 6 7 8 9 A B C D E F G H I G H II J K L M N O P Q R S T U V W X Y Z FF GG HH

e c a p S d. Enter the user identification code and validate RAL STAINER CODE :

0 1 2 3 4 5 6 7 8 9 A B C D E F G H I G H II J K L M N O P Q R S T U V W X Y Z FF GG HH

e c a p S It is recommended to choose a mnemonic type code, the appliance cannot remind the user of the code. e. Choose the level of rights to associate to the user RAL STAINER UTILISATEUR USER EXPERT ADMINISTRATOR INSTALLER At all times it is possible to change users by clicking on the icon See section 8.2.3. A strict use of this tool makes it possible to enrich traceability related to the use of the machine. R E N I A T S L A R

28 RAL STAINER User guide 10 USE 10.1 STARTING UP Turn on the appliance using the 0/1 switch located behind the instrument. The following page is displayed:

RAL STAINER CODE :

0 1 2 3 4 5 6 7 8 9 A B C D E F G H I G H II J K L M N O P Q R S T U V W X Y Z FF GG HH

e c a p S Enter the user code. Validate 10.2 INSTALLING REAGENTS 10.2.1 STAINING KIT If, on start-up, the appliance does not detect a staining kit, it will request one to be inserted. 1. Press on page LOAD/CHANGE REAGENTS 2. The appliance opens the lids on the reagent housings and the reagent loading doors. 3. Break the protection seal and place the closed containers from your staining kit using the numbers on the labels to place them at the corresponding location within the instrument. Carefully remove the container caps and keep them. Take off the tamper-proof seal. Special precautions for bottle 1:

Bottle 1 contains the RFID chip. This chip must be opposite the RFID reader (located to the left of the left reagent drawer) in order to be read. If we consider that the front face of the bottle is the labelled, curved face, this face must be placed opposite you, thus the chip will be correctly read by the appliance. In the event of an error, the "Tag error" message will be displayed. This can be corrected by turning bottle 1. Front face bottle R E N I A T S L A R

29 RAL STAINER User guide RFID chip RFID Reader R E N I A T S L A R Removing the caps from the bottles once they have been placed in the appliance avoids any dangerous handling such as the spilling of the reagent. If the kit is new, turn the caps a quarter turn to break the seals. 4. Then gently close the reagent loading drawers until you hear a "click"as they lock. It is important that the necks of the bottles be free from reagent so that the level sensor can adjust the soaking height of the slides in the reagents. Remove the tamper-proof seal, the can disturb the arm movement. 5. The appliance closes the covers of the reagent housings. RAL STAINER RFID Reading RAL Stainer identifies the staining kit that was placed in the appliance and proposes a "Standard" protocol. It is possible to vary the protocol settings (time, mixing, rinsing). See section 10.3. This function LOAD/CHANGE REAGENTS can also be used to change staining kits during their use. 10.2.2 RINSING SOLUTION Fill the container reserved for this use with the adequate rinsing liquid for the stain being used. Refer to the staining kit instructions. Adapt the cap with the suction cane to the rinsing container. In the case of a low consumption of rinsing water, RAL Instruments recommends the regular replacement of rinsing water in order to prevent the proliferation of bacteria and to clean the rinsing liquid container weekly. See section 12. RAL Stainer permanently checks the level of the rinsing liquid and notifies you when the level becomes critical. 10.3 STAINING PROTOCOL 10 protocols can be memorised by the appliance. The protocols proposed by default are protocols optimised by RAL Diagnostic in collaboration with expert laboratories. Due to the complex actions of the stainers, it is necessary to establish standard staining conditions to ensure good staining quality and reproduction. We therefore advise to test and assess the protocols tested by RAL Diagnostics before making any changes to the protocol settings.

30 RAL STAINER User guide 10.3.1 PROTOCOL MODIFICATION RAL Stainer identifies the staining kit that was placed in the appliance and proposes a Standard protocol. It is, however, possible to vary the protocol settings (time, mixing, rinsing). On page ADJUST PROTOCOL

, This function is only accessible to Administrator and Expert users. See section 9.1. Main settings RAL STAINER Loaded reagents 1 Reagent name 2 Reagent name 3 Reagent name 4 Reagent name min:sec min:sec yes 1 no Rinsing station draining Number of rinsing Slides shaking Dipping time Drying time To modify a setting,

. min:sec yes 1 no Press the time bar to change the soaking time in tank. A single push on the key is used to switch from yes to no. Select "Yes" if you wish to agitate the slides in reagent. If you select

"No" the slide holder will not move during soaking. this Indicate the number of rinses after each tank. Pressing key displays another screen used the rinsing parameters. See next section. to define Indicate whether you wish to drain the rinsing liquid after each rinse. A single push on the key is used to switch from yes to no. R E N I A T S L A R In the event of an error, returns to the previous screen.

31 RAL STAINER User guide Rinsing 3 parameters :

RAL STAINER Define whether you require movement during rinsing. Min Sec 0 1 2 3 4 5 6 7 8 9 Number of rinses Define rinsing time with the numeric keypad. Define the number of i rinses by pressing on the left and right arrows. Draining Drying RAL Stainer makes it possible to limit the volume of your effluents. You choose whether to drain the rinsing liquid after each dip. If you choose never to drain the rinsing liquid during a cycle, RAL Stainer will request the draining frequency by the question :

"How many cycles before draining rising water?" Enter the value. RAL Instruments recommends draining the rinsing tank after each soaking in order to optimise the quality of the staining. 00min 00s Select the drying time with the numeric keypad. When all the settings are correct,

. RAL STAINER PROTOCOL NAME :

0 1 2 3 4 5 6 7 8 9 A B C D E F G H I G H II J K L M N O P Q R S T U V W X Y Z FF GG HH

e c a p S Give a name to the defined protocol,

. RAL STAINER R E N I A T S L A R Select a location to which to save your new protocol on the protocol list page. The selection of a location that has already been used will overwrite the protocol that was previously at this location. It is impossible to record a new protocol in location 1 which is reserved for the protocol proposed by RAL Diagnostics. It is possible to return to this protocol at any time.

32 RAL STAINER User guide 10.3.2 CHANGING THE PROTOCOL On page SET PROTOCOL

, RAL STAINER This function is available to all users. See section 9.1. The parametered protocol list is displayed, press on the protocol to be changed to load it. The last used protocol remains the active protocol after all appliance off/on operations. 10.4 INSTALLING THE SLIDES 10.4.1 LOADING THE SLIDE HOLDER Place from 1 to 10 slides in the slide holder. 1. Turn the slide holder and free the jaw by placing the knob on the O "Open" position. 2. Place up to ten slides

(identification maintained). 3. Block the jaw by moving the knob to the C "Close" position. Always make sure that the slides are correctly placed and aligned. 10.4.2 PLACE THE SLIDE HOLDER IN THE APPLIANCE On page

, for unlocking the slide loading drawer. Place the slide holder correctly on its support in the drawer(s). Close the drawer(s) until the "click" indicates they are locked. R E N I A T S L A R During staining, it is possible to load a second slide holder or to remove an awaiting slide holder to add or change a slide.

33 RAL STAINER User guide 10.5 STAINING Staining is launched from the staining page, gives access to this page from any other page. Once the protocol has been selected and the slides placed, to launch the staining. The appliance moves into action, the arm picks up the slide holder. Staining begins. RAL STAINER Name of the staining kit Name of the staining protocol used Error or information message area Number of staining cycles remaining Drawer status Control panel of the two work zone Remaining staining time Progress of staining To halt an ongoing staining,

. Available zone Staining in progress Drying in progress At the end of a cycle, unlock the drawer. Your slides are ready to be examined. If two stainings are launched, the arm will begin the second staining after having dropped the first slide holder back to its initial position. Before the second cycle begins, you can retrieve an awaiting slide holder to add or change a slide by pressing on the lock button. You can retrieve the first batch of slides after drying while the second batch is being stained. The slide holder can be retrieved while drying is in progress. 10.6 CHANGING THE STAINING KIT OR DRAINING 10.6.1 CHANGING THE STAINING KIT This is a useful function if you wish to use the appliance for several staining operations. Press LOAD/CHANGE REAGENTS on page

. The arm opens the lids, the reagent drawers open. R E N I A T S L A R Put the caps back onto the bottles before removing them. Remember to store the bottles away from light. Then insert the bottles for the new staining kit and close the reagent drawers. The appliance is ready to operate using the new staining kit, no cleaning cycle is required.

34 RAL STAINER User guide The appliance can manage several staining kits in parallel, it keeps the data for each kit in memory: the autonomy and the customised protocols for this kit reference. 10.6.2 DRAINING The RAL Stainer will systematically drain the reagents being used if:

- the kit has expired,

- the autonomy (cycles or slides) has been exceeded,

- the level of one reagent is lower. EMPTY REAGENTS The effluents are rejected into the appliance's waste container, the reagent drawers are opened to allow to remove the empty bottles. The bottles must be disposed of using the decontaminated waste channel. If the expiry date after opening is passed, the RAL Stainer will advise you to drain the staining kit with the message: "Warning BBD expired". On page

, EMPTY REAGENTS

. These safety mechanisms have been included for quality assurance reasons. We advise you to follow the RAL Stainer recommendations. 10.7 STAND-BY At the end of your working session, simply place the appliance on standby by using the standby button on the top of the machine. g y Standby button The RAL Stainer can be restarted by simply pressing the same button again. 10.8 POWERING OFF When a long period of inactivity is foreseen, prefer powering off the machine to placing it on standby. In this case press the O/1 switch at the back of the appliance. R E N I A T S L A R On/Off or 0/1 switch

35 RAL STAINER User guide 11 TRACEABILITY The traceability file will indicate:

- Dates of each cycle

- User

- Staining kit name and batch

- Dyeing compliant Yes/No with error message. See section 16.1.

- Staining protocol 11.1 USING THE TRACEABILITY SOFTWARE Insert the supplied CD into your computer. Execute the file "Trace.exe" Follow the instructions. The CD will install software which will enable you to decrypt the traceability file that can be retrieved from the RAL Stainer. 11.2 LOADING THE TRACEABILITY FILE 1. Create a new file on the supplied USB stick called "TRACE.txt" (capital letters) using the windows Notepad. 2. Turn off the appliance and insert the USB stick supplied with the appliance in its location. 3. Turn the machine back on:

- the diode flashes.

- 3 Beeps indicate the end of the download. R E N I A T S L A R 4. Open the file on the USB stick named "TRACE.txt" using your traceability software "Trace.exe" on your computer.

36 RAL STAINER User guide R E N I A T S L A R 12 CLEANING 12.1 CLEANING On page

, OPEN COVER LID gives access to the inside of the machine. Basic weekly surface cleaning is sufficient with a wet cloth. You can use for exemple Ethanol 70. Clean:

- The slide drawers

- The slide holders

- The inside and outside surfaces

- The rinsing tank Procedure of rinsing station release RAL STAINER ADJUST PROTOCOL SET PROTOCOL LOAD/CHANGE REAGENTS EMPTY REAGENTS USER RIGHTS MANAGEMENT LANGUAGE DATE / HOUR MAINTENANCE MAINMAINMAINTENATENATENANCENCENCE OPEN COVER LID 1. Free the rinsing tray by giving a quarter turn to the screw 2. Lift the rinsing nozzle and pivot it lightly 3. Remove the rinsing nozzle 4. Remove the rinsing tank Never pour liquid onto the appliance, it could damage the electronic components. Do not use solvents on the screen and the cover lid. In the event of accidental spillage of reagents, turn off the appliance as quickly as possible and clean using a cloth and the appropriate solvent. In all cases limit the dose of solvent. 12.2 HYDRAULIC SYSTEM CLEANING This procedure should be done weekly in order to prevent the bacteria proliferation. Equipment must be switched on. Rinsing and draining circuits must be connected to the equipment. Decontamination solution advised :

- Bleaching water with 2,6 % of active chlorine (available in commerce)

- Solutions like Stereanios of the Laboratoires Anios or Elusept of Pierre Fabre Sant a. Clean the rinsing liquid container with a decontamination solution in order to prevent the proliferation of bacteria on the container bottom. b. Fill the rinsing liquid container with approximatively 500 ml of decontamination solution. c. Deep the rinsing cane in the container filled with the disinfectant solution.

37 RAL STAINER User guide d. On page

, MAINTENANCE

. e. Switch on the rinsing pump in order to decontaminate the rinsing circuit : H2O . Switch off the rinsing pump by pressing H2O again. Be careful, pump doesnt stop automatically. Fill the rinsing tank until to have the level at 1 cm from the rim.

H2O T1 T2 T3 T4 C1 C2 6 C3 C4 L1 L2 V R NS erase trace erase mem f. Clean the waste circuit by switching on the draining pump, is empty in order to switch off the pump.

, and press again this touch when the tank Repeat at least 3 times steps e and f in order to decontaminate perfectly the waste circuit. g. Rinse the rinsing liquid container with your rinsing solution. h. Deep now the rinsing cane in the rinsing solution. Repeat again by 3 times (at least) steps e and f with the rinsing solution of staining in order to eliminate the disinfectant solution previously used. 12.3 ACTIVATED CARBON FILTER The RAL Stainer recommends the changes of the activated carbon filter cartridges. The life span is calculated using the RAL Stainer operating times. RAL Stainer will give you an advertising message before the necessity of the filter-cartridge change: "The activated carbon filter has expired: have you replaced it?"

The filter-cartridges are housed on the left of the machine. 1. Open the cover lid 2. Unscrew the two screws by a quarter turn 3. Remove the used filter cartridge 4. Fit a new filter-cartridge 5. Re-screw the two screws by a quarter turn 6. On page

, set the cartridge life span counter to zero by pressing RAZ RAL STAINER REAGENT KIT INFORMATION Loaded kit : ---

Remaining cycles : 0 MACHINE INFORMATIONS Serial number: 0000 20/02/2012 15:09:31 Software version : 02:41 / 02:14 / V305 Filter autonomy : 61h PROFILES Current session : XXX INFO INIT PROFILES R E N I A T S L A R

38 RAL Stainer filter cartridges are available from your RAL Diagnostics reseller. RAL STAINER User guide 12.4 DECONTAMINATION All biological samples should be considered to be potentially dangerous. The contact between contaminated hands and the appliance can cause the contamination of the appliance. Before operation of decontamination, unplug the mains power supply cable. Use the adapted personal protective equipment : laboratory gloves, laboratory glasses and a laboratory coat. Decontamination solution advised:

- Bleaching water with 2,6% of active Chlorine (available in the commerce)

- Solutions like Stereanios of the Laboratoires Anios or Elusept of Pierre Fabre Sant If your laboratory procedures require it:

- the reagent bottles can be decontaminated before being disposed of;

- the appliance itself and its accessories (slide-holder, rinsing station) can be decontaminated using air or manual cleaning. Use a decontamination solution and scrub using a clean cloth soaked in the disinfecting

12.2.

- The effluents and their containers are to be eliminated and/or decontaminated in compliance with current laboratory best practises. The procedure will depend on the type of effluent container you are using. RAL Stainer 10L jerrycan: decontamination using air or manual cleaning Autoclave compatible container: resists up to 135C In all cases respect the laboratory best practises applied by your laboratory. The use of organic solvents is under the responsibility of the user and may cause the discolouring of certain parts of the appliance as well as the alteration of some plastic parts. R E N I A T S L A R

39 RAL STAINER User guide 13 CONSUMABLES AND OPTION EQUIPMENT 13.1 CONSUMABLES Consumable name Pack of slide-holder RAL Stainer (x3 Filter cartridge RAL Stainer Rinse station RAL Stainer RAL Stainer 10L jerrycan 13.2 OPTIONAL EQUIPMENT Consumable name Autoclavable 10L jerrycan Connection system to the mains water networ R E N I A T S L A R

40 RAL STAINER User guide 14 MAINTENANCE Maintenance must be carried out by a technician approved by RAL Instruments. For the first year following the purchase of your appliance, the maintenance is ensured by your RAL Instruments representative. Beyond this period you can subscribe to a maintenance contract. Contact your RAL Instruments representative. 15 AFTER-SALES SERVICES If your RAL Stainer should be return to your RAL Instrument representative workshop, it must be decontaminated. The decontamination declaration joined with your apparatus should be well filled in and added to the equipment for the acceptation in the workshop. R E N I A T S L A R

41 RAL STAINER User guide 16 TROUBLESHOOTING 16.1 ERROR MESSAGES Message Diagnosis Solution Warning BBD expired Best Before Date expired Change the Staining Kit The activated carbon filter has expired Carbon filter expired Change the activated carbon filter Tag error Bad tag position SID tag incorrect The tag on your Staining Kit is defective. Motor unit card error Rinsing Station filling fault Turn off the appliance and then turn it back on Slide-holder incorrectly placed in the drawer Slide incorrectly placed on its support Drainage nozzle incorrectly placed on its support This can occur when detection could not be carried out. the level Step loss on Theta Code 200 Step loss on Z Code 1+tank number+1 =

Loss of Z step when lowering to tank X Examples :

Code 131 : Loss of Z step when lowering to tank 3 Code 1A1 : Loss of Z step when lowering to rinsing tank Code 1B1 : Loss of Z step when picking up or dropping off basket Code 1+tank number+2 =

Liquid missing in tank X Example :

Code 142 : Liquid missing in tank 4 Call a maintenance technician Check that bottle 1 is correctly placed as per the operating instructions in section 10.2.1 Change the staining kit or Contact your RAL Diagnostics representative. Contact your RAL Instruments representative. Check that the hydraulic circuit is not disconnected at some point. Turn off the appliance and then turn it back on. If the system is not restored, contact your RAL Instruments representative. Check that the arm is operating correctly by simulating a staining kit change. If the system is not restored, contact your RAL Instruments representative. Check that the necks of the bottles are not dirtied. If so, clean them. Turn off the appliance and then turn it back on. Check that the arm is operating correctly by simulating a staining kit change. If the system is not restored, contact your RAL Instruments representative. Contact your RAL Instruments representative. R E N I A T S L A R

42 RAL STAINER User guide 16.2 WHAT TO DO WHEN ...?

Problem encountered Diagnosis Solution Screen off when powering on The green and blue diodes visible on the USB be port are on?

If yes ON/OFF too fast?

Is the machine on standby?

Press the standby button. If not The machine does not turn on?

Is the green diode that is visible inside the machine when the arm is in the soaking position in tank 3 on?

If yes Turn off the appliance and then turn it back on. If the system is not restored, contact your RAL Instruments representative. Contact your RAL Instruments representative. Contact your RAL Instruments representative. If not You must changed the power supply or the fuse. Contact your RAL Instruments representative. No reaction of the touch screen No beep when pressing impossible to enter the code. Incorrect reaction on the touch screen The codes do not allow to go to the codes page Data loss The machine does not Memory problem keep the codes in memory Turn off the appliance and turn it back on. If the system is not restored, contact your RAL Instruments representative. Contact your RAL Instruments representative Fill in the code to initialise If the system restored, contact your RAL Instruments representative. the machine. is not There is an SD card in the RFID card located in the left reagent loading door. Check that the SD card is in the machine. If necessary, remove it and replace it after having cleaned the connections. Tag reading impossible

"Tag reading" very long

(greater than 10 seconds) info page whether the RFID software contact your RAL Check whether the blue diode is on the RFID card and check on the is present. If the diode is on, try another tag. If it persists impossible, Instruments representative. If the diode is off, contact your RAL Instruments representative. R E N I A T S L A R

43 RAL STAINER User guide Problem encountered Diagnosis Solution Staining begins, but slides are found on the machine plate. one of the positioning settings is to be adjusted. Contact your RAL Instruments representative. The slides are incorrectly rinsed Rinsing is carried out using soiled water. The rinsing tray overflows Variation of the soaking of the slides Check that there is no liquid on the neck thread. Drain the rinsing container more often or change the rinsing water in your container. If the fault persists there may be a fault on the draining pump. Contact your RAL Instruments representative. Contact your RAL Instruments representative. Wipe the bottle necks. If the fault persists, Contact your RAL Instruments representative to adjust the settings on the level sensor. The arm opens the lids either too far or too little. The arm positions have become offset. Contact your RAL Instruments representative. Major oscillation of the slide holders during Z movements Too much space between the hooks and the slide holders Slightly tighten the hooks Systematic message

"Z step loss"

Reagent levels low?

Check the level of the liquid in the containers. If necessary, if the arm is more than one year old, re-grease the Z axis. If persists, contact your RAL Instruments representative. problem the On installation the arm moves a few mm, groans and stops moving The machine has been taken out of its packing. The cold tightens the i.e. at room temperature Use the "Load/Change the the gaps and fixes the grease staining kit"

on the Z axis. times to make the arm operate. Wait 1 Hour function several The loading drawer refuses to shut Bad adjustment of the switch or electro-magnetic bearing. Contact your RAL Instruments representative. Impossible to load the traceability programme Wrong USB stick Use the USB stick supplied with your instrument or try to format your USB stick for FAT16. Other USB sticks are available on demand. R E N I A T S L A R

44 RAL STAINER User guide 17 SUMMARY OF TIPS At all times it is possible to change users by clicking on the icon See section 8.2.3. A strict use of this tool makes it possible to enrich traceability related to the use of the machine. RAL Stainer permanently checks the level of the rinsing liquid and notifies you when the level becomes critical. RAL Stainer makes it possible to limit the volume of your effluents. You choose whether to drain the rinsing liquid after each dip. If you choose never to drain the rinsing liquid during a cycle, RAL Stainer will request the draining frequency by the question :

"How many cycles before draining rising water?" Enter the value. If two stainings are launched, the arm will begin the second staining after having dropped the first slide holder back to its initial position. Before the second cycle begins, you can retrieve an awaiting slide holder to add or change a slide by pressing on the lock button. You can retrieve the first batch of slides after drying while the second batch is being stained. The slide holder can be retrieved while drying is in progress. R E N I A T S L A R

45 RAL STAINER User guide 18 INDUSTRIAL PROPERTY The RAL Stainer model is a community model registered under the n 001733361-001. It is prohibited, unless explicitly authorised by RAL Instruments in writing, to manufacture, propose, put on the market, import, export, use or possess a product including the model for the same purposes. R E N I A T S L A R

46 RAL STAINER User guide 19 EC DECLARATION R E N I A T S L A R

47 RAL STAINER User guide 20 INDEX A Activated carbon filter . 39 C Cleaning . 39 D Decontamination . 40 Description . 11 Draining . 34 Drying . 34 H Hydraulic . 21 I Installation . 19 Interface . 22 M Main settings . 33 Maintenance . 42 P Power cable . 21 Power supply . 21 R Rights management . 28 Rinsing . 34 Rinsing solution . 32 S Settings page . 23 Setting up . 20 Slides . 35 Smears . 9 Staining . 36 Staining reagents . 16 Standards . 9 Symbols . 7 T Traceability . 38 Troubleshooting . 43 U User safety . 10 W Warnings . 9 Warranty . 8 Waste . 10 R E N I A T S L A R

48 RAL STAINER User guide Leader in stains for microscopy since 1916 HAEMATOLOGY BACTERIOLOGY MYCO-PARASITOLOGY CYTOLOGY HISTOLOGY RAL INSTRUMENTS is a brand of RAL DIAGNOSTICS RAL DIAGNOSTICS - Site Montesquieu - 33650 Martillac - FRANCE E-mail: commercial@ral-diagnostics.fr Tel: +33 (0) 557 960 404 - Fax: +33 (0) 557 960 405 www.ral-instruments.com