User Manual CVR 909 - bio-optica.it · Bio‐Optica S.p.A. has approved all accessories for...

User Manual

CVR 909

Automatic Coverslipper

BIO‐OPTICA S.p.A. EN 11/10/2018 Ed.03

Keep close to the device at all times. Read carefully before start‐up.

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Bio‐Optica Milano S.p.A. Via San Faustino 58 ‐ 20134 Milano Phone +39 02.21.27.13.1 ‐ Fax Italia +39 02.21.53.000 ‐ Fax Export +39 02.21.54.155

www.bio‐optica.it – info@bio‐optica.it – claims@bio‐optica.it

Date of publication: 11/10/2018Rev. 03

ATTENTION

The information, figures, notes and estimates inthis documentation represent the most advanced stage of science and technology and are the result of in‐depth research. We are not obliged to update this manual regularly in response to new technical developments, or send revised versions, updates, etc. for this manual to our clientele. We accept no liability for any errors in data, notes, technical illustrations etc. in this manual, in line with current Italian legislation. In particular, we are not liable in any way for any damage to property or other indirect damage arising from failure to comply with instructions or specific information provided in this manual. Instructions, drawings, illustrations and any other technical or general information in this user manual are not binding with regard to our products.

The provisions of the contract agreed between our company and the customer prevail in all cases. Bio‐Optica reserves the right to make changes to technical specifications or the production process without notice. This is necessary to allow constant progress in production and technology. This document is protected by copyright. All copyright is held by Bio‐Optica S.p.A. Even partial reproduction of the text or illustrations by printing, photocopying, microfilm, Web Cam or other methods ‐ including all electronic instruments and systems ‐ is only permitted with the prior written authorization of Bio‐Optica S.p.A. The serial number and year of manufacture are provided on the nameplate affixed to the rear of the device.

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TABLE OF CONTENTS

TABLE OF CONTENTS ....................................................................................................................................................... 5 1 Important Notes ..................................................................................................................................................... 7

1.1 Symbols AND their meanings ....................................................................................................................... 7 1.2 User group ................................................................................................................................................... 10 1.3 Intended Use ............................................................................................................................................... 10 1.4 Type of device ............................................................................................................................................. 10

2 Safety .................................................................................................................................................................. 11 2.1 Safety precautions ....................................................................................................................................... 11 2.2 Danger warnings ......................................................................................................................................... 11

3 Components and specifications ............................................................................................................................. 15 3.1 General view ............................................................................................................................................... 15 3.2 Technical data ............................................................................................................................................. 18 3.3 Standard supply package ............................................................................................................................ 19

4 Commissioning ..................................................................................................................................................... 20 4.1 Installation location requirements ................................................................................................................ 20 4.2 Unpacking the CVR 909 .............................................................................................................................. 21

4.2.1 Assembling the CVR 909 ............................................................................................................................ 22 4.2.2 Removing or fitting the transport fixtures ................................................................................................... 23

4.3 Setting the device horizontal ....................................................................................................................... 24 4.4 Fitting the accessories ................................................................................................................................. 25 4.5 Connecting the power supply ...................................................................................................................... 26 4.6 Preparing and installing the device ............................................................................................................. 26

4.6.1 Switching on the device ............................................................................................................................. 26 4.6.2 At first start‐up ......................................................................................................................................... 26 4.6.3 At each coverslipper restart, before starting a program ............................................................................... 27 4.6.4 When switching off the coverslipper .......................................................................................................... 27

4.7 Filling up with consumables ........................................................................................................................ 27 5 Parts of the device ................................................................................................................................................ 29

5.1 Baskets input ............................................................................................................................................... 29 5.2 Mounting unit ............................................................................................................................................... 30 5.3 Tray containment system ............................................................................................................................ 32 5.4 Basket unloading chutes ............................................................................................................................. 33 5.5 Display ......................................................................................................................................................... 34 5.6 Fume extraction system .............................................................................................................................. 34

6 Operation ............................................................................................................................................................ 36 6.1 Control panel functions ................................................................................................................................ 36 6.2 Switching the device on or off ..................................................................................................................... 37 6.3 Device operating button functions ............................................................................................................... 37 6.4 Short check before starting the coverslip application process .................................................................... 38 6.5 Coverslip application process ..................................................................................................................... 39 6.6 Process of glass-slides reading .................................................................................................................. 42 6.7 Maintenance menu ...................................................................................................................................... 43 6.8 Setup Menu ................................................................................................................................................. 43 6.9 Service Menu .............................................................................................................................................. 43

7 Operation as workstation ...................................................................................................................................... 44 7.1 Removal of the cover to allow operation as workstation ............................................................................. 44 7.2 Integrated operation as HPC 940 workstation ............................................................................................ 44 7.3 Integrated operation as HPC 940 workstation ............................................................................................ 44 7.4 Stopping operation as workstation .............................................................................................................. 44

8 Cleaning and maintenance .................................................................................................................................... 46

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8.1 Cleaning and maintenance instructions ...................................................................................................... 46 8.2 Daily cleaning and maintenance - Overview ............................................................................................... 48 8.3 Weekly cleaning and maintenance ............................................................................................................. 48 8.4 Unplanned cleaning and maintenance ........................................................................................................ 48 8.5 Description of daily cleaning procedures .................................................................................................... 49

8.5.1 Nozzle‐Cleaner ......................................................................................................................................... 49 8.5.2 Loading container ..................................................................................................................................... 49 8.5.3 Nozzle ...................................................................................................................................................... 49 8.5.4 Coverslip loader ........................................................................................................................................ 49 8.5.5 Cleaning and replacing the suction cups ..................................................................................................... 50

8.6 Description of weekly cleaning procedures ................................................................................................. 50 8.6.1 Dispenser unit .......................................................................................................................................... 50 8.6.2 Nozzle‐Cleaner ......................................................................................................................................... 50 8.6.3 Slide holders, gripper and exit chutes ......................................................................................................... 50

8.7 Unplanned maintenance ............................................................................................................................. 50 8.7.1 Charcoal filter ........................................................................................................................................... 50

8.8 Mounting medium replacement procedure .................................................................................................. 50 8.8.1 Xylene‐based mounting medium ................................................................................................................ 51 8.8.2 Mounting medium circulation line cleaning procedure ................................................................................ 51

9 Troubleshooting and dealing with errors ................................................................................................................ 52 9.1 Error codes .................................................................................................................................................. 52 9.2 Troubleshooting and dealing with errors ..................................................................................................... 59

10 Warranty and after‐sales service ............................................................................................................................ 65 11 Annex A Information and recommendations related to the application .................................................................... 66

11.1 A1.1 Bio-Optica plastic slide holders, trays and coverslips ................................................................... 66 11.2 A1.2 Slide holders produced by other manufacturers ............................................................................ 66 11.3 A1.3 Slides and gripper mechanism ...................................................................................................... 66 11.4 A1.4 CVR 909 - Approved, recommended slides .................................................................................. 67 11.5 A1.5 Coverslips ...................................................................................................................................... 67

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1 Important Notes

1.1 Symbols AND their meanings

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Visual inspection necessary.

Use of tools required.

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1.2 User group

The CVR 909 may only be operated by trained technical staff.

No one must use the device without first reading this user manual carefully and familiarizing themselves with the device's specific technical details.

1.3 Intended Use The CVR 909 is an automatic coverslipper which applies glass coverslips to tissue sections, cells or swabs mounted on slides, with the aid of mounting medium. Bio‐Optica S.p.A. has approved all accessories for operation of the device.

1.4 Type of device All information in this user manual refers solely to the type of device specified on the front cover. A nameplate with the serial number is affixed to the rear of the device. (The serial number is also marked above the loading door on the front of the device). An identification plate with the serial number is placed on the side of the appliance in the position shown in the picture.

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2 Safety

2.1 Safety precautions

This manual contains important instructions and information for the device's operating safety and maintenance. It is an essential part of the device, must be read carefully before it is put into service and used, and must be kept in the vicinity of the device.

This unit has been produced and tested in accordance with the safety regulations for measuring, control and calibration instruments and laboratory equipment. In order to maintain this status and ensure risk‐free operation, the operator must comply with the safety warnings and symbols included in this user manual.

2.2 Danger warnings The protective features installed on this device by the constructor are only the basis for accident prevention. The main responsibility for accident‐free operation lies first and foremost with the person in charge of the processing center in which the device is used, and with the people designated by the former to operate, maintain or repair the device. To guarantee perfect operation of the device, the following warnings and precautions must be complied with. N.B.: Direct or indirect contact with the CVR 909 could cause electrostatic discharges.

Danger warnings ‐ transport and installation

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The device must only be transported in the vertical position (use transport anchors!).The device must be lifted and transported by two people! The CVR 909R 909 is only intended for use indoors. Only operate the device with the power cable supplied. This power cable may not be replaced with another one. If the power supply cable provided does not fit perfectly into the socket in the installation location, notify the competent Bio‐Optica After‐Sales Service. The device must only be connected to a power supply socket with ground connection. The effect of the protection must not be eliminated by using an extension with no ground wire. The device automatically recognizes the voltage/frequency present. The installation location must be well ventilated and free from ignition sources. The chemicals for use in the CVR 909 are both highly flammable and harmful to health. Use in environments with explosion risk is forbidden. In the event of extreme differences in temperature between the storage and installation locations, and if humidity is high, condensate may form. In this case, wait at least two hours before activating the device. Failure to comply with this waiting time may cause damage to the device. The device must be perfectly leveled horizontally before it is put into operation (see point 4.4 "Setting the device horizontal").

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Danger warnings ‐ working with the device

Danger warnings‐ handling reagents

The device may only be used by skilled, trained laboratory staff.It may only be used in accordance with the intended use and with the instructions provided in this user manual. In an emergency, turn off the master switch and remove the plug. When working with reagents, wear suitable protective clothing (lab coat, gloves, goggles). Avoid direct contact between solvents or mounting media and the skin. Take care to dose solutions correctly. Surplus mounting medium might drip from the slide onto the working surface and container feeder conveyor belt, obstructing the movement of device components (also see point 7 ‐ "Cleaning and maintenance"). During operation, do not obstruct motor‐driven components by tampering with them or inserting other objects. Risk of injury due to broken glass! The placing movement of the transfer module (coverslip mounting) cannot be carried out manually! Comply with the warnings provided in point 4.7.1. Never leave the device unattended for a long period of time. Especially in the event of a power blackout, it is important to ensure that the fabric sections do not dry out. After stopping, all glass parts or other objects must be removed from the CVR 909's working area. The start button cannot be pressed until this has been done.

If necessary, operate the device with connection by means of the optional fume extractionmanifold to the laboratory extraction system or a Bio‐Optica Tech series hood. Use the charcoal filter as backup. Since the device is designed for use with solvents, there is a fire hazard when working with naked flames (e.g. Bunsen burner) in its immediate vicinity. During operation, no liquid must come into contact with the electronic components.

Take care when handling solvents and mounting media!• When handling the chemicals used in this device, always wear gloves, lab coat and protective goggles. • The reagents used may be toxic and/or flammable. • Dispose of the reagents used in compliance with the local regulations in force and your company or laboratory's disposal procedures.

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Danger warnings ‐ maintenance and cleaning

It is advisable to check that consumables are used before the expiry date shown on the package.

The safety technical data sheets of the reagents are available on request from the producer of the chemicals. Otherwise, the safety data sheets for the materials can be downloaded from: http://www.bio‐optica.it

Before all maintenance work, remove the loading container and slide holder basket fromthe device, switch it off and disconnect the power supply plug. The device may only be opened for maintenance or repair work by authorized After‐Sales Service engineers. When using cleaning products, comply with the producer's safety warnings and current laboratory regulations. Never use abrasive products, or solvents which contain acetone, chlorine or xylene, for cleaning the surfaces of the device. Clean the housing and seats with ordinary commercial delicate, neutral pH cleaners. Painted surfaces may be damaged by aggressive cleaners and solvents! During cleaning, no liquid must come into contact with the electronic components.

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3 Components and specifications

3.1 General view The CVR 909 is an automatic coverslipper for use in histology laboratories (Fig. 1). The CVR 909 is unique of its kind because the mounted slides are placed in a 10‐position tray. The tray just filled with mounted slides is automatically ejected from the output slot and can be collected by the technician. This eliminates all handling of the slides just mounted and, after drying if necessary, the tray can be collected by the laboratory technician, who in the event of anomalies can immediately adjust the mounting medium and coverslip positioning settings on the device. The output station is able to accommodate up to 90 slides. (9 trays of 10 slides each). The tray on which the slide is placed has been optimized in terms of:

Preventing slides from sticking to the surface

Simplifying the handling of slides, if slides have to be moved around in order to group them together (e.g. by patient, by tissue type, etc.)

Stackability Operation of the device: The device's operating cycle comprises 6 phases, as follows:

Loading of the slide holder basket

Positioning and collection of the slide

Dispensing and application of the mounting medium

Mounting of the slide

Placing of the mounted slide in the output trays

Unloading of the empty basket Loading of the slide holder basket The CVR 909 coverslipper is able to accommodate up to 60 slides for mounting in the loading station (2 baskets of 30 slides each). When the cycle start command is given, the device moves the loading cradle and the basket containing the slides is scanned by a sensor. Positioning and collection of the slide When the slide's presence is detected, the loading cradle stops and the handling system comes into operation, picking up the slide by means of a gripper. Dispensing and application of the mounting medium The slide held by the gripper is conveyed underneath the dispensing station, which delivers the dose of mounting medium, and at the same time the handling system moves the slide to create a uniform line of medium. Mounting of the slide Once application of the mounting medium is complete, the handling system moves the slide to the mounting station, where the selected coverslip, already collected by two suction cups, is placed on the slide. The suction cups are operated in a sequence which allows the coverslip to be correctly mounted on the slide. Placing of the mounted slide in the output trays The mounted slide is transferred to one of the trays in the output station, and placed in one of the 10 positions on the

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tray. The 9 slots in the station have sensors, and the device can therefore check before placing a mounted slide that at least one free tray is present. Unloading of the empty basket When a basket in the loading station is emptied, meaning that it no longer contains slides, the handling system collects it and unloads it down one of the 2 ejection chutes. This frees the input station, ready to accommodate a new basket. Mounting unit As already mentioned, the mounting unit:

1. Collects the coverslip from one of the 2 slots by means of 2 suction cups operated by the suction pump. 2. Dispenses mounting medium by means of a diaphragm pump 3. Places the coverslip on the slide and presses it into place

The loading station is able to process 3 types of coverslips (40‐50 60 mm), placed in 2 separate slots. The type of coverslip to be used (60‐50‐40 or none) can be assigned to each slot. Operations 1 and 2 described above are performed with the handling system still in operation. In other words, at the end of the mounting phase, while the slide is being conveyed to the output station, the mounting unit is already preparing for the next mounting cycle. The mounting unit uses sensors to check that the suction cups have actually picked up the coverslip by testing the seal on the suction cups and also checking that the coverslip is no longer in the slot. Consent to dispense the mounting medium onto the slide is not given until the coverslip is actually present on the suction cup. The entire instrument is monitored and programmed by means of a 7"LCD color monitor with touch screen. The operator interface is simple and user‐friendly and all control and programming functions are accessible from a menu. Main mounting phase settings:

Adjustment of alignment of positioning of the coverslip on the slide (Central ‐ Edge)

Adjustment of positioning of the coverslip on the slide (+‐ 3mm)

Adjustment of mounting medium dosage

Adjustment of the mounting medium dispensing start point The device is designed to mount slides with dimensions approved under the ISO 8037‐1 standard: We recommend the use of Bio‐Optica slides for reliable results. The coverslips used should be quality articles supplied by Bio‐Optica:

Length: 60 mm ‐ 50 mm ‐ 40 mm

Width: 24 mm

Thickness: 0.13‐0.16 mm

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The left side panel

Figure 4 The following are located on the instrument's left side panel: MAIN POWER = Master Switch and Socket for connection to the electrical mains. FUSES = Protective fuses (see table at back of manual for ratings) RS232 = Three RS‐232 serial ports RESET = Reset button (switch off the device and switch it back on again, holding this button down until the MAIN MENU appears) USB = Four USB ports for the connection of various peripherals (keyboard, mouse, UPS, printer, touch screen) USB = One USB port for the connection with the reporting system LIS, to read the data coming from the barcode reader. VGA = LCS video connector TS‐POWER = Touch Screen power supply (+12V) REMOTE ALARM = ‐ No alarm:contacts 1‐2 closed, contacts 1‐3 open. ‐ Alarm active: contacts 1‐2 open, contacts 1‐3 closed There are no electrical voltages of any kind on these contacts and they are isolated from the rest of the device; they can therefore be used to control external alarm devices (e.g. our Auto Dialer device which dials telephone numbers and sends alarm messages) Maximum permitted voltage 48V ac/dc; Maximum current 1A. ETHERNET = Two ports for connection to Internet or Intranet

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3.2 Technical data

Rated voltage: 115‐230 V AC, ±10 % Rated Frequency: 50‐60 Hz Approvals CE, CSA C/US Fuse: 2 automatic fuses, T5 A Power: 650 W Dimensions (W x H x D): 860 x 780 x 770 mm (with clear cover closed and

without extraction manifold) Weight (device only) 80kg approx Weight (including packaging) 130 kg approx. Operating temperature range +15 °C ‐ +35 °C Storage temperature: –19 °C ‐ +40 °C Transport temperature range: –19 °C ‐ +40 °C Air relative humidity: Max. 75 % (without condensation) Classification under IEC 1010: Protection class 1 Operating altitude Up to max 2000m above sea level Weighted sound pressure level A: <65 dB(A), measured at distance of 1m

Heat conduction: 100 J/s Fume extraction: On left‐hand side, with filtered air discharged

into room by means of accessories to ducting pipe diameter 100 mm for discharge outdoors.

Fume extraction quantity 38,5 m3/h

GENERAL INFORMATION

Device Type: Automatic coverslipper for histology and cytology

Model: Bio‐Optica CVR909

Product code: 40‐500‐000

Manufacturer: Bio‐Optica Milano S.p.A.

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3.3 Standard supply package

Ordering information:

Consumables supplied with the device – starter kit CODE DESCRIPTION Q.TY

05‐BMHM500 BioMount HM, mounting medium 500 ml. 1

06‐1304E Xylene – histological grade 2,5 lt. 1

09‐2040PZ Coverslips 24x40 (100 pcs) 1



09‐1030PZ Slides with white band and ground edges (50 pcs) 6

Accessories supplied with the device

CODE DESCRIPTION Q.TY

8C1835‐B Coverslip Holder (24x40 mm), capacity 100 coverslips 2



40‐400‐253 Charcoal filter (about 600 working hours, equivalent to about 4 months) 1

7RMF12 Vapor filter for mounting medium bottle (about 6 months) 1

8C1238‐G Tray to take 10 slides 30

7AD001 Metal mounting medium dispensing nozzle (type G17) 1

8C1838‐F Nozzle cleaning holder (2 positions – 60 slides) 1

40‐400‐252 Slide basket holder (capacity 30 slides) 3

7EV998 Power supply cable – 16A 115‐230V 1

8C1260‐A Input slot 2

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4 Commissioning

4.1 Installation location requirements The installation location of the Bio‐Optica CVR 909 automatic coverslipper must meet the following requirements:

The device requires a supporting surface of about 860 x 760 mm. • The worktop must have sufficient load capacity and be rigid enough to support the weight of the device. • The device is for indoor use only. • The power supply connection point must be within the radius of the length of the power supply cable. No use of extension cables is permitted. • The device MUST be connected to a socket with ground connection. • Only the use of the cables supplied, rated for the local power supply, is permitted. • The device may not be installed underneath an air‐conditioning system. • Knocks, exposure to direct light and wide variations in electrical current levels must be avoided. • The chemicals used in the device are both highly flammable and harmful to health. • All the device's connections are described in the user manual. • The coverslipper should be operated with the extraction hood (optional component) connected to the laboratory system, or underneath a Bio‐Optica TECH series extraction hood. The device must not be operated without the relative activated charcoal filter.

• The installation location must be well ventilated and free from all kinds of ignition sources.• The chemicals for use in the Bio‐Optica CVR 909 are easily flammable and harmful to health. • Use of the device in environments with explosion risk is forbidden. • In the event of extreme differences in temperature between the storage and installation locations and if humidity is high, condensate may form. In this case, wait at least two hours before activating the device. • Failure to comply with this waiting time may lead to damage to the device. • Troublefree operation is only guaranteed if a gap of at least 10 cm is left between the rear and right‐hand side of the device and walls and furniture. A gap of 25 cm must be left between the left‐hand side of the device and furnishings, to ensure unimpeded access to the maintenance door. • Install the device in such a way that the mains electrical connection on the rear and the power supply plug are accessible at all times. • The installation location must be protected from electrostatic discharges.

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The device's manager must ensure that ESD protection measures are complied with. The device's manager must comply with and document the local limit values for workplaces. He must also ensure that there is sufficient ventilation and replace the charcoal filters at the recommended interval. The device's manager is responsible for compliance with workplace limit values and the measures necessary to ensure this, including documentation.

4.2 Unpacking the CVR 909

Opening the packaging (See below): ∙ Undo the screws on the side of the wooden crate and loosen the lid. ∙ Carefully lift the lid off the wooden crate. ∙ Take out the screws and remove the sides ∙ Remove the protective bag ∙ Remove the film.

On delivery of the device, check that the crate is horizontal.Inspect the materials received for damage and report any problems to Bio‐Optica. The device may only be unpacked and installed by authorized staff.

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4.2.1 Assembling the CVR 909

Open the bottom drawer and the clear cover; they contain the accessories supplied. ∙ Check against the order that all the accessories are present. ∙ Take the 4 handles provided and screw them on to the sides. ∙ The device (which weighs about 80kg) can be picked up by the handles and placed on the intended stable supporting surface. ∙ Check that it is resting on all four feet. ∙ Before connecting and switching on the device, remove the axis fixing strap (point 4.2.2)

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4.2.2 Removing or fitting the transport fixtures

Warning: before switching on the device, operate the red lever (no tools required) to remove the Axis Fixing Strap fitted across the axes of the manipulator on the right‐hand side of the device.

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4.3 Setting the device horizontal Position the device, preferably on a single stable surface; adjust by turning the 4 feet, checking with a spirit level.

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4.4 Fitting the accessories

# CODE DESCRIPTION

1 8C1835‐B Coverslip Holder (24x40 mm), up to 100 coverslips



4 8C1238‐G Plateau for 10 slides

5 8C1838‐F Holder for needle cleaning system

1

2

34

5

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4.5 Connecting the power supply

Connect the power supply cable on the left‐hand side.

4.6 Preparing and installing the device Check‐list for use of the device:

4.6.1 Switching on the device _ Press the master switch on the right‐hand side of the device. _ Wait about 60 sec. _ After this time, the device will start up and the display will show the system diagram screen requesting confirmation for the axis reset. _ Make sure that the cover is closed. _ Press the START button; the handling system will perform the axis reset procedure, moving to the LH side and then to the HOME position.

4.6.2 At first start‐up _ Check the system date and time. _ Program and/or check the SETUP parameters. _ Install the charcoal filter and set its use limits. _ Fit the 3 supports on the cradle underneath the suction cups. Coverslip slot 1 ‐ Coverslip slot 2 ‐ Mounting support.

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_ Fit a new bottle of mounting medium, checking that the intake tube reaches down to the bottom. _ Fit a waste container underneath the glue dispenser nozzle _ Use the MOUNTANT LINE ‐ FILL function in the “SERVICE BASE” submenu to fill the circuit which delivers the mounting medium to the dispenser nozzle. (During this operation the medium pump will perform about 30 cycles – duration 7 minutes.) On completion of the function, make sure that whole tube is full of medium and there are no air bubbles. Otherwise, repeat if necessary. _ Remove the waste container. _ Fit the support, with the bottle full of xylene, underneath the mounting medium dispenser nozzle. _ Fill the loading container with xylene or an equivalent reagent, up to the level shown on the rim.

_ Place at least 2 trays in the output station.

4.6.3 At each coverslipper restart, before starting a program _ Check that the xylene bottle is full. _ Check the xylene level in the loading container. _ Check that the trays in the output station are empty. _ Check that the basket output chutes are clean _ Check that the needle is clean from old medium.

4.6.4 When switching off the coverslipper

_ Wait for the coverslipper to complete the basket and for the basket to reach the exit chute. _ The handling arm must be in the HOME position. _ Make sure that the mounting medium dispenser nozzle is immersed in the bottle of xylene. _ Press the master switch. _ Remove any full trays from the output station.

4.7 Filling up with consumables Use mounting medium for mounting the coverslips and xylene for filling the slide container and for the nozzle cleaning bottle. Put the coverslips in the containers provided for each size.

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Mounting medium Order number 05‐BMHM500

Xylene Order number 06‐1304E

Coverslips Order number 09‐2040 09‐2050 09‐2060

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5 Parts of the device

5.1 Baskets input The CVR 909 can receive as input up to 60 slides to be mounted: the input point is made of 2 removable slots, each receiving one basket with 30 slides. Working in normal conditions the input slots must be filled with xylene until the proper level is reached, as shown in the following picture.

To work in the proper way please always check the level and the quality of xylene into the slots, everytime the CVR is started. The loading tanks are designed so that they can be removed individually. This allows to change or top up easily the xylene within.

Starting the mounting cycle, the input chassis is moved so that the basket with the slides can be scanned with a proper sensor.

Make sure that the input tanks are correctly placed until the end of the supports as shown in the following picture:

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When the sensor gets the presence of a slide, the claw starts moving to grab the slide and to take it to the next station. In case the CVR 909 is used together with the AUS 240 you must leave the input slots free: the AUS 240 will bring the baskets into the slots.

5.2 Mounting unit

Mounting unit is the delivery unit, where a proper needle places the selected medium dose onto the slide, while the handling system moves the slide backwards so that the medium is placed in a uniform stripe. During every mounting cycle, the needle stays clean because it is dipped into xylene in the needle‐cleaning bottle, passing through a proper slot. Please check the xylene level into that bottle is good enough to avoid the needle to get dried.

Before starting a new cycle it is always necessary to check that the needle is correctly dipped into xylene.

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Once application of the mounting medium is complete, the handling system moves the slide to the mounting station, where the selected coverslip, already collected by two suction cups, is placed on the slide. The suction cups are operated in a sequence which allows the coverslip to be correctly mounted on the slide. In case the CVR mounts a barcode reader, it is placed at the end of the mounting unit and it allows to read the barcodes printed onto the mounted slides. To be able to read the barcodes read by the sensor, it is necessary to connect a PC to the dedicated USB port. It will need to access the LIS software to read the data linked to each barcode.

ATTENTION: Setting the nozzle height in relation to the slide exit point

The ideal gap is 0.75‐0.8 mm. The nozzle height set can be checked visually from the front of the device.

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This gap must be set by skilled staff.

5.3 Tray containment system

The grippers arrange the mounted slides tidily in special removal trays, made from a non‐stick, solvent‐resistant technical material. Each tray is monitored by a presence sensor, so the CVR checks is there is at least one available tray before going to store the mounted slide. The slides are arranged in rows of 10; each completed tray is pushed forwards towards the operator ready for collection.

Each time the CVR is turned on, please remove every tray which has been filled with some slides. Please use empty trays only.

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5.4 Basket unloading chutes

When a basket in the loading station is emptied, meaning that it no longer contains slides, the handling system collects it and unloads it down one of the 2 ejection chutes. This frees the input station, ready to accommodate a new basket. The chutes can receive up to 6 baskets, this will be notified by an acoustic and graphic alarm.

Take care when the gripper is in motion; do not place fingers in the slide placing zone. Bio‐Optica advises users to wait for the tray to be pushed forward and for the display to show that all the slides have actually been mounted (colored green).

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5.5 Display

Mediante un monitor a colori LCD da 7"" con touch screen viene monitorato e programmato l'intero strumento. L'interfaccia operatore è semplice e di facile utilizzo e tutte le funzioni di controllo e programmazione sono accessibili da un menu principale. Principali regolazioni nella fase di montaggio:

Regolazione allineamento della posa del coprioggetto sul vetrino (Centrato ‐ Bordo)

Regolazione del posizionamento del coprioggetto sul vetrino (+‐ 3mm)

Regolazione del dosaggio del collante

Regolazione del punto di inizio erogazione colla

5.6 Fume extraction system

The coverslipper must be connected to an external laboratory fume extraction system or toa suitable fume extraction hood (Bio‐Optica TECH line). The device must not be operated without the relative activated charcoal filter. The charcoal filters must be changed every three months. Note that the charcoal filter, if used alone, is only able to filter harmful vapors (e.g. xylene). Installation locations may vary widely with regard to contamination with solvents, ventilation, room temperature, size, etc. If in doubt, the laboratory's owner/manager may have local measurements made to guarantee that the legally enforced thresholds for solvent vapors are not exceeded.

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Charcoal filter compartment

To replace the filter element, remove the grille on the inside left of the coverslipper.

Figure 5

Connection to the extraction system (see

accessories)

Mainfold diameter 100mm

Figure 6

N.B.: If the device is connected to a fume extraction system, its own extraction fans must be deactivated.

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6 Operation

6.1 Control panel functions

Main Menu

Coverslip management

Maintenance

Setup

Service

Extended Service

Coverslip load

Filling xylene tube

Purge mountant unit

Charcoal Filter

Password

Time‐Date

User parameters

Alarms File

Axle Init

Mountant Line

Touch Screen

Remote Control

Version Management

Test I/O – Watch Dog

Axle Board

Calibration Position

Test Mountant Line

System

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6.2 Switching the device on or off Use the green button on the side of the device to switch it on or off.

6.3 Device operating button functions

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6.4 Short check before starting the coverslip application process In the Coverslip Control function, the following can be set for Stack 1 and Stack 2:

Type of coverslip assigned to Stack 1 and Stack 2 (C40‐C50‐C60 ‐ None):

Press the arrow button at the bottom next to the coverslip type or open a drop‐down menu for selection of the type of coverslip. The type of coverslip chosen is highlighted and is also illustrated in graphic form.

Working stack in use:

The working stack can be chosen by pressing the corresponding icon. The stack in use appears with the slide on a blue background.

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6.5 Coverslip application process Function: COVERSLIP POSITION SELECTION: Used to select the alignment of the coverslip on the slide CX= Centered in relation to the specimen space of LH= on the left, aligned with the edge opposite the band. COVERSLIP ALIGNMENT OFFSET (mm) Allows the alignment of the coverslip with the LH side of the slide to be adjusted in relation to the default setting. To adjust, simply press the "‐" and "+" buttons (Max. setting +‐ 3 mm) MEDIUM DISPENSING START POINT OFFSET (mm) Allows the mounting medium dispensing start point to be adjusted in relation to the default setting. To adjust, simply press the "‐" and "+" buttons (Max. setting +‐ 3 mm) MEDIUM DOSAGE OFFSET (ul) Allows the mounting medium dose to be adjusted in relation to the default setting. To adjust, simply press the "‐" and "+" buttons (Min. setting 0 ul, Max. setting 100ul) For the best setting, it is advisable to adjust one parameter at a time and perform the TEST after each change. The "TEST" function allows the user to check that the changes made are correct and meet requirements. Before pressing the "TEST" button, check that the loading station contains a basket of unused slides and that the tray number 1 is present and empty. At the end of the TEST function, if the settings are correct, press the "SAVE" button to save the parameters in a specific file; the new parameters will now become operational.

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Use the EXIT button to quit this function. If changes have been made to the settings without pressing the "SAVE" button, the changes will be lost. For each coverslip dimension you can manage 3 different mountant doses: STANDARD, CITOLOGIC, HYSTOLOGIC. There is a drop‐down menu to choose which kind of dose will be used.

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Coverslip Test

CORRECTION 1

CORRECTION 2

CORRECTION 3

Did you achieve

the result? YES

START

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6.6 Process of glass‐slides reading The coverslipper is equipped with an innovative system of glass-slides reading through a high performance 2D scanner that through a led pointer allows the traceability of the histological slide during the coloring and assembly process. Main features:

• Scan Method: CMOS, 752 x 480 pixels • Scan Speed: until 60 fps • Image Format: Windows Bitmap, JPEG, TIFF • Graduation: 256, 16, 2 • 2D Image output mode: 4 resolution (full, 1/2, 1/3, 1/4), 2 ranges (horizontal, vertical) • 2D Curvature: R>16 mm (10‐digit Codabar), R>20 mm (12‐digit UPC) • Min. Resolution: a PCS 0.9 0.169 mm / 7 mil at PDF417, 0.212 mm / 8 mil at QR Code and DataMatrix • Min. PCS: value 0.3 • Field of view: horizontal 40.6º, vertical 26.4º • Depth of Field: At Code 39, 85 ‐ 125 mm / 3.35 ‐ 4.92 in (0.127 mm / 5 mil), 65 ‐ 205 mm / 2.56 ‐ 8.07 in (0.254 mm / 10 mil), 60 ‐ 295 mm / 2.36 ‐ 11.61 in (0.508 mm / 20 mil), at QR Code, 90 ‐ 115 mm / 3.54 ‐ 4.53 in (0.212 mm / 8.4 mil), 55 ‐ 195 mm / 2.17 7.68 in (0.381 mm / 15 mil • Protection against liquids and solids: IP 65 • Supply: 6V +/‐ 5%, max. 200mA • Dimension: (w x h x d) 41.1 x 33 x 24 mm

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6.7 Maintenance menu

This menu allows performing the main maintenance operations safely. 1. Coverslip load: to load new coverslip if the slots are empty or if you need to change scoverslip size.

With UP the axles free the coverslip slots unit, with DOWN the axles go in the Home position. 2. Filling Xylene tube: to drive up and down the dispensing needle to check the xylene level into the

needle‐cleaning bottle and to replace it in case it is needed. 3. Purge mountant needle: to execute a purge cycle in case the mountant dose on the slides should be

erratic. Please follow the exact instructions shown on the display. 4. Charcoal Filter: to monitor and replace the charcoal filter.

6.8 Setup Menu

His menu allows adjusting the settings of the instrument as language, time, date, password, basket dripping function, fan filtration.

6.9 Service Menu This menu allows performing basic technical interventions. This menu must be used only by specialist and authorized staff under the guidance of Bio‐Optica technicians.

1. Alarms file: to monitor the alarms that occured during the operation of the coverslipper. 2. Axle init: to execute the axles initialization. 3. Mountant Line: to clean and full the mountant circuit. Please follow carefully the instructions shown on

the display. 4. Touch screen: to calibrate the touch screen. 5. Remote control: to share the screen through Teamviewer.

The Extended service menu is protected by password. Bio‐Optica technicians only (or authorized technicians) can access this menu

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7 Operation as workstation

7.1 Removal of the cover to allow operation as workstation Remove the right‐hand cover of the coverslipper to connect the two machines together using the bolts provided on the left‐hand side of the stainer; this operation must be performed on a suitable study worktop of appropriate size.

7.2 Integrated operation as HPC 940 workstation

7.3 Integrated operation as HPC 940 workstation

7.4 Stopping operation as workstation

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In general terms, the functions of the PAUSE and STOP buttons are as described in point 5.6.

• If the mounting procedure is stopped by pressing the STOP button, the coverslipper

will have to be initialized. To do this, press the START button.

• After halting the mounting process using the STOP button, once the slide holder

(basket) still inside the device has been completed, it must be collected from the loading

tank by hand, because in this case it is not automatically conveyed to the transfer station.

In the event of a power blackout or device switch‐off, the slide holders may be left in different positions. Therefore, in the event of an error the following positions must be checked: ‐ transfer station, with all transfer possibilities ‐ coverslipper loading container • These slide holders must be removed by hand to prevent collisions after the restart of operation in workstation mode. • For the next process, the slide holders which had been left in the automatic coverslipper must be inserted by hand, and collected again after processing.

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8 Cleaning and maintenance

8.1 Cleaning and maintenance instructions The device should be switched off before cleaning. Cleaning the structure.

CLEANING THE STRUCTURE

Part Substances to be used Personal protective

equipment to be worn

Plexiglass cover Water – Degreasing cleaner Gloves

Painted structure Trichloroethylene ‐ Degreasing cleaner Gloves + Face mask

Steel parts Steel cleaner Gloves + Face mask

Aluminum parts Aluminum cleaner Gloves

Touch screen Water and glass cleaner Gloves

Mounting medium circuit

Xylene Gloves + Face mask

CLEANING REMOVABLE PARTS

Part Substances to be used Personal protective

equipment to be worn

Loading container Xylene Gloves + face mask

Slide holder Water Gloves

Mounted slides trays Xylene Gloves + Face mask

Mounting support Xylene Gloves + Face mask

Xylene bottle support Xylene Gloves + Face mask

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Coverslip holders Xylene Gloves + Face mask

• The device must always be cleaned at the end of use, BEFORE it is switched off. • Maintenance must be performed at regular intervals. • NEVER open the gripper by hand! During the necessary cleaning procedures inside the device, no modification or manipulation of the slide gripper mechanism is permitted. Make sure that the grippers are never widened, pressed or bent by hand. • When using cleaning products, comply with the producer's safety warnings and current laboratory regulations. • The device's outside surfaces must never be cleaned using solvents (e.g. alcohol, acetone, xylene, toluene or similar) or cleaners which contain solvents. • Clean housings and seats with ordinary commercial delicate, neutral pH cleaners. Painted surfaces are only partially resistant to solvents! • During cleaning and maintenance, do not allow liquids to enter the device or its electrical contacts. • If solvents are left in the device after it is switched off, vapors may be generated. • Dispose of the solvents used in compliance with the local regulations in force and your company or laboratory's disposal procedures. • The device must be switched off in the case of lengthy stoppages and at the end of the working day. • Remove any mounting medium which has dripped onto or into the device (e.g. during the mounting medium preparation cycle) immediately with a thread‐free cloth. • Take care to ensure that large amounts of solvent are not spilled into the device (electronic system!). In the event of solvent spills, the liquid must be removed at once with an absorbent cloth. • Before all maintenance work, remove the loading container and slide holder from the device, switch it off and disconnect the power supply plug.

Clean housings and seats with ordinary commercial delicate, neutral pH cleaners. Paintedsurfaces are only partially resistant to solvents! • Clean the sensors, suction cups and shoes of the transfer module, the conveyor chain, slide holder and trays with a thread‐free cloth dipped in a compatible solvent. • Never leave accessories in solvent or water for too long (e.g. overnight) as this can cause damage.

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8.2 Daily cleaning and maintenance ‐ Overview More details in chapter 8.5. A Check that there are no broken glass fragments or mounting medium residues in the loading

container or anywhere in the working area. If necessary, remove them with care (see point 7.5.1). B Check the plastic nozzle‐cleaner container and add max. 5 ml of xylene if necessary.

C Fill the loading container with sufficient solvent (see point 7.5.4).

D If no drops or only one drop comes out of the nozzle, it is blocked and must be replaced with a new nozzle of the same type (see point 7.5.5). Place the fouled nozzle in xylene to clear the blockage.

E Check the coverslip mounting area (see point 7.5.6) and the coverslip loading area(see point 7.5.7): • broken glass fragments • all loaders in correct position. If necessary, fill the coverslip loader.

F Check the suction cups (see point 7.5.9), ensuring that they are free from:• mounting medium residues • broken glass fragments If necessary replace the suction cups with new ones and clean and lubricate the moving rods.

G Check that there are no mounting medium residues at the slide exit point; if necessary, clean with a cloth dipped in a compatible solvent (see point 7.5.11).

H Clean the output basket chutes with Xylene.

8.3 Weekly cleaning and maintenance More details in chapter 8.6.

A If necessary, completely change the solvent in the loading container.Check that there are no broken glass fragments in the loading container and loading drawer.

B Wash the dispenser unit with solvent (see point 9.6.1)

C Check that the nozzle cleaner is free from mounting medium residues and also check that the bottle is not full of medium.

P Check the 2 exit chutes and clean them with solvent if necessary; check that the baskets slide smoothly, and otherwise clean again. Take care to perform this operation slowly to avoid the risk of bruises • Clean the nozzle with suitable, compatible solvent and then clean gently with a thread‐free cloth (see point 7.6.2). • Clean the gripper gently with a thread‐free cloth dipped in a suitable solvent. • Clean the slide holders and trays only with a thread‐free cloth dipped in a compatible solvent (see point 7.6.3). Never leave them to soak in the solvent overnight!

8.4 Unplanned cleaning and maintenance

More details in chapter 8.7.

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A Mounting medium line:• At the end of the working day and in general, do not add mounting medium, to prevent bubbles from forming during filling • If necessary, clean the thread inside the cap of the bottle (blue) to remove mounting medium residues.

B If necessary, when the device indicates that this is required, replace the charcoal filter, which must be changed at least every three months (see point 8.7.1).

C Check that the mounting stations are not dirty with splashed medium and clean with a suitable solvent if necessary

8.5 Description of daily cleaning procedures

8.5.1 Nozzle‐Cleaner

Fill the nozzle‐cleaner with about 5 ml of solvent. Check the slotted cap. If it is badly splashed with medium or is stiff, replace it with a new nozzle‐cleaner. 8.5.2 Loading container

Device loading container:

Check the loading container for broken glass fragments and remove any found, with care. There is a risk of injuries due to cutting during this cleaning operation. Therefore, proceed with the necessary caution. Wear protective clothing!

Mounting medium residues can be removed with a thread‐free cloth dipped in a compatible solvent. Glass fragments or dust which do not stick to it can be removed with an ordinary vacuum cleaner.

Refill the loading container with sufficient solvent.

8.5.3 Nozzle

Before starting the device or the preparation cycle, check that the nozzle is airtight and free from mounting medium residues. Check that the nozzle is securely fitted and not bent (also see point 4.6).

8.5.4 Coverslip loader

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8.5.5 Cleaning and replacing the suction cups If suction cup travel is impaired by sticking around the spring, lubricate with a suitable oil from the oilcan with spout (code 08‐1721), applying one drop to the spring. Repeat the operation on both suction cups. If coverslips are not picked up correctly and the device often signals a "no coverslips" error when they are in fact present, medium and glass dust have probably accumulated on the suction cups. This reduces pickup effectiveness by preventing correct application of the vacuum. Clean the suction cups with solvent and try again. If this does not solve the problem, contact the after‐sales service, since the suction cups, complete with support, will have to be changed.

8.6 Description of weekly cleaning procedures

8.6.1 Dispenser unit Check that there are no air bubbles in the tubes and bleed them if necessary.

8.6.2 Nozzle‐Cleaner Check that xylene is always present to prevent the nozzle from drying out and becoming blocked.

8.6.3 Slide holders, gripper and exit chutes Check that the slide holders are free from damage and clean them, or replace them in the event of serious deposits which interfere with slide insertion. Warning: clean the gripper gently, only if necessary, with a cloth. Check that the chutes are not dirty with residues of glass or medium which prevent the output baskets from sliding down them. Clean them to restore correct operation.

8.7 Unplanned maintenance

8.7.1 Charcoal filter

Replace the charcoal filter with a new one; as described in point 4.5, the device indicates when this is necessary.

8.8 Mounting medium replacement procedure

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This procedure can be performed in two ways:

Fast procedure with tested effects: replace the mounting medium with a new one

without bubble formation or long waiting times (method recommended by Bio‐Optica BIO MOUNT HM) (see next point).

Slow procedure with possible unwanted side‐effects: fill an empty bottle (see accessories) and pour in the mounting medium slowly to prevent bubble formation, then wait about 12 hours before proceeding.

Warning: special precautions and tests on the actual dosing quality are required with mounting media not produced by Bio‐Optica. Setup operations with another mounting medium will not be guaranteed by Bio‐Optica.

8.8.1 Xylene‐based mounting medium

Remove the bottle of mounting medium, unscrewing the top complete with tubes.

Fit the new bottle, screwing the cap back into place, taking care that the tubes do not turn with it.

Perform a filling preparation cycle (see point 7.3 B). Press the FILL button and the various cycles will be activated; they are required to ensure that the hose is completely free from air bubbles and full of mounting medium. If this is not sufficient, press FILL again.

8.8.2 Mounting medium circulation line cleaning procedure

Remove the bottle of mounting medium, unscrewing the top complete with tubes.

Insert the tube into a container of about 200ml suitable for xylene.

Perform a cleaning preparation cycle (see point 7.3 B).Press the CLEAN button and the various cycles will be activated; they are required to ensure that the hose is completely free from mounting medium. If they are not sufficient, press CLEAN again.

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9 Troubleshooting and dealing with errors

9.1 Error codes

01 – Wrong password

EXPLANATION/CAUSE – The password has been typed incorrectly more than three times; the alert is savedin the alarm database so that this event remains in the memory.

SOLUTION – Type the correct password. If you have forgotten the password, the after‐sales service will haveto be called to unlock the system.

02 – Watch dog test failed

EXPLANATION – This alarm is generated when the Watch Dog test is failed (function: WATCH DOG TEST).

CAUSE – Hardware malfunction between CPU and IOB.

SOLUTION – It is important to restore this function at once because in the event of a failure on the communication line between CPU and IOB, the Watch‐Dog resets the IOB board, effectively disabling all the outputs.

03 – Language dictionary absent

EXPLANATION – The dictionary file in use has been deleted from the memory.

CAUSE – File corrupted and/or deleted by mistake

SOLUTION – Ask the after‐sales service for help. Work can be continued by selecting another dictionary.

04 – Aggiornamento software ‐ File non trovato

EXPLANATION – During the software update procedure (function: SW UPDATE) the program has not foundthe executable file on the USB stick.

CAUSE – File not present or incorrectly named.

SOLUTION – Check that the file is on the USB stick and if present check that its name is correct.

05 – File indispensabile non trovato

EXPLANATION ‐ A file essential for the computer's operation is corrupt or cannot be found; the error recoverysystems have found a solution to the file's absence.

CAUSE ‐ Computer memory malfunction.

SOLUTION ‐ There are NO solutions for the operator to adopt; call the after‐sales service, but very probablythe device can be used successfully in the meantime.

07 – File not found

EXPLANATION ‐ A file essential for the computer's operation is corrupt or cannot be found; the error recoverysystems have found a solution to the file's absence.

CAUSE ‐ Computer memory malfunction.

SOLUTION ‐ There are NO solutions for the operator to adopt; call the after‐sales service, but very probablythe device can be used successfully in the meantime.

08 ‐ Init axes not executed

EXPLANATION – The operator has not performed the axis home procedure required whenever the device isswitched on.

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CAUSE ‐ The control system generates this alarm because the axes have not been reset

SOLUTION – Confirm axis initialization from the system diagram screen or service menu.

09 ‐ Driver Not found

EXPLANATION ‐

CAUSE ‐

SOLUTION – contact the after‐sales service

10 ‐ Time‐out axis movement

EXPLANATION – last movement took too long.

CAUSE – malfunctioning in the communication between axles.

SOLUTION – If the cycle can’t be restarted, turn off the coverslipper and turn it on after some seconds. If the error repeats itself, contact the after‐sales service.

11 ‐ Axle X error ‐ position not reached

EXPLANATION ‐

CAUSE ‐

SOLUTION ‐– Check for any impediments, then switch the device off and back on after a few seconds.

12 ‐ Axle Z error ‐ position not reached

EXPLANATION ‐

CAUSE ‐


13 ‐ Axle Y error ‐ position not reached

EXPLANATION ‐

CAUSE ‐


14 ‐ Rotary table error ‐ rotation not compete

EXPLANATION ‐

CAUSE ‐

SOLUTION ‐ – Check for any impediments, then switch the device off and back on after a few seconds.

15 ‐ Gripper error ‐ opening/closing

EXPLANATION ‐

CAUSE ‐


16 ‐ Home position not reached

EXPLANATION ‐ The home position is a checkpoint, controlled by sensors, used to check that the XZYAT axes are correctly aligned after performance of a home procedure.

CAUSE Control sensor not operating or incorrectly positioned, or axis home procedure failed because of blockage on one or more axes,

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SOLUTION ‐ Repeat the axis home position procedure from the "Service Base" menu.If the error recurs, the alarm on the screen can be overridden to proceed; before confirming, make sure that the axes are positioned as shown in the diagram.

17 ‐ Slide absence on gripper

EXPLANATION ‐ The gripper is unable to pick up the slide from the basket or the gripper has dropped the slide after picking.

CAUSE ‐ Slide dimensions not to specifications or problems of slide alignment in the loading basket. Gripperpositioning error. Errore di posizionamento della pinza.

SOLUTION ‐ If the error is recurrent, contact the authorized after‐sales service.

18 ‐ Basket absence on gripper

EXPLANATION ‐ The gripper is unable to pick up the basket from the loading station or the gripper has dropped the basket during handling.

CAUSE ‐ Basket not correctly positioned in loading station or gripper positioning error

SOLUTION ‐ If the error is recurrent, contact the Authorized After‐Sales Service

19 ‐ Axle Z error ‐ brake doesn't work

EXPLANATION ‐

CAUSE ‐

SOLUTION ‐ – Check for any impediments, then switch the device off and back on after a few seconds

20 ‐ Slide on gripper

EXPLANATION – The gripper is closed, so it can potentially be holding a slide.

CAUSE – This error can occur at the turn on in case the systems should find the the gripper is closed. This can happen if previously the coverslipper has been turned off while the gripper was closed.

SOLUTION ‐ – Check for any slide hold by the gripper and eventually remove it. Confirm the action on the display to let the initialization go on.

21 ‐ Axle S1 error ‐ position not reached

EXPLANATION ‐

CAUSE –

SOLUTION ‐ – Check for any impediments, then switch the device off and back on after a few seconds

22 ‐ Error ‐ basket absent

EXPLANATION ‐

CAUSE –

SOLUTION ‐ – A new basket with slides is needed as input.

23 ‐ Slide sensor alignment error

EXPLANATION ‐

CAUSE ‐


31 ‐ Mountant low level

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EXPLANATION ‐ The sensor in the mounting medium container slot is detecting a low level

CAUSE ‐ Mounting medium level too low, mounting medium container not fitted in slot

SOLUTION ‐ Check the mounting medium level and make sure that the container is fitted in the slot correctly.

32 ‐ Slot 1 coverslips ‐ empty

EXPLANATION ‐ The coverslips in slot 1 have run out

CAUSE ‐

SOLUTION‐ Place coverslips in slot 1

33 ‐ Slot 2 coverslips ‐ empty

EXPLANATION ‐ The coverslips in slot 2 have run out

CAUSE ‐

SOLUTION ‐ Place coverslips in slot 2

34 ‐ Slot 1 and 2 coverslips ‐ empty

EXPLANATION ‐ The coverslips have run out in both slots

CAUSE ‐

SOLUTION ‐ Place coverslips in slot 1 or 2 or both

35 ‐ Picking error coverslip ‐ Absence vacuum on sucker 1

EXPLANATION ‐ Suction cup 1 (see image ..) is unable to suck up the coverslip..

CAUSE – This may be due to various causes. Leak on air line 1 from fittings, suction cup, hose. Malfunction ofsolenoid valve 1, suction cup worn or with lips stuck together, or suction cup obstructed by glass fragments / dirt

SOLUTION ‐ Clean the suction cup and make sure that the contact lip is intact. Check that the vacuum pumpstarts up. If these checks do not provide a solution to the problem, the Authorized After‐Sales Service must be called.

36 ‐ Picking error coverslip ‐ Absence vacuum on sucker 2

EXPLANATION ‐ Suction cup 2 (see image ..) is unable to suck up the coverslip..

CAUSE – This may be due to various causes. Leak on air line 2 from fittings, suction cup, hose. Malfunction ofsolenoid valve 2, suction cup worn or with lips stuck together, or suction cup obstructed by glass fragments / dirt

SOLUTION ‐ Clean the suction cup and make sure that the contact lip is intact. Check that the vacuum pumpstarts up. If these checks do not provide a solution to the problem, the Authorized After‐Sales Service must be called.

37 ‐ Picking error coverslip ‐ Absence vacuum on sucker 1 and 2

EXPLANATION ‐ Neither suction cup is working.

CAUSE ‐ This fault is due to leaks in the air circuit / a pump malfunction

SOLUTION ‐ Contact the Authorized After‐Sales Service

38 ‐ Error ‐ lost coverslip

EXPLANATION – problem with faulty coverslip or dirty suction cups

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CAUSE ‐

SOLUTION – check the coverslips and suction cups.

39 ‐ Axle S2 error ‐ On Sled movement ‐ Slots coverslips

EXPLANATION ‐

CAUSE ‐

SOLUTION – Check for any impediments, then switch the device off and back on after a few seconds.

40 ‐ S3 error ‐ On Sled movement ‐ Positioning Suchers/Mountant Nozzle

EXPLANATION ‐

CAUSE ‐

SOLUTION – Check for any impediments, then switch the device off and back on after a few seconds.

41 ‐ Mountant pump failure

EXPLANATION ‐

CAUSE ‐


42 ‐ Refill and check xylene tube

EXPLANATION ‐

CAUSE ‐

SOLUTION – Change the xylene bottle or top up using the pipette provided

51 ‐ Absence ‐ tray slide holder

EXPLANATION ‐

CAUSE ‐

SOLUTION ‐ trays have run out; add more to restart the device

52 ‐ Has been removed, an incomplete tray slide holder, from storage

EXPLANATION ‐

CAUSE ‐

SOLUTION ‐ trays have run out; add more to restart the device

53 ‐ Photocell (1‐9) failure

EXPLANATION ‐

CAUSE ‐

SOLUTION‐ contact the after‐sales service

54 ‐ Slide not complete put in storage

EXPLANATION – suction cup failure or broken coverslip

CAUSE ‐

SOLUTION ‐ check and remove the broken coverslips

55 ‐ Tray slide holder not ejected n. ...

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EXPLANATION –

CAUSE ‐

SOLUTION ‐ remove the completed tray

56 ‐ Remove tray slide holder not ejected n. ...

EXPLANATION – all the trays are full

CAUSE ‐

SOLUTION ‐ remove the full trays and place empty trays

61 ‐ Chute full

EXPLANATION – unloading ramp full

CAUSE ‐

SOLUTION – remove the 6 baskets from the chutes

62 ‐ Basket absence

EXPLANATION ‐

CAUSE ‐

SOLUTION – insert a basket of slides

71 – Cover opened

EXPLANATION – The device must operate with the cover closed, to contain the reagent vapors and to prevent injury to the operator due to collisions with the handling system. However, to prevent a device stoppage, if this alarm occurs the handling system operates at reduced speed..

CAUSE – The cover may have been left open, but it may be caused by a sensor malfunction.

SOLUTION – Close the cover and if the alarm persists call the After‐Sales Service.

72 – Drawer opened

EXPLANATION – If the drawer is open, the manipulator arm is unable to access it to pick up and/or place slides.

CAUSE – If may just be open, or if this alarm occurs with the drawer closed, it is due to a sensor malfunction

SOLUTION – Close the drawer and if the alarm persists call the After‐Sales Service

73 ‐ Charcoal filter waste

EXPLANATION ‐

CAUSE ‐

SOLUTION – end of filter lifetime; replace it

74 ‐ Replace Needle‐Clean

EXPLANATION – The needle‐clean bottle has been used for too many cycles.

CAUSE ‐

SOLUTION – replace the xylene bottle with a new full one.

79 ‐ Axis communication failure

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EXPLANATION ‐

CAUSE ‐

SOLUTION – Switch the device off and back on

81‐ CPU‐AXIS communication line error

EXPLANATION ‐

CAUSE ‐

SOLUTION ‐ contact the after‐sales service

82‐ CPU‐PUMP communication line error

EXPLANATION ‐

CAUSE ‐


xx – Touch screen driver not found

EXPLANATION – Since the program cannot find the touch screen driver, it is unable to receive commandsfrom the operator.

CAUSE – Possible touch screen malfunction or loss of driver files.

SOLUTION – Try switching the device off and back on and if the error persists call the After‐Sales Service. The device can be used without the touch screen by connecting a keyboard and a mouse to the USB ports on its right‐hand side.

xx – Axis ## board error

EXPLANATION – Problem related to operation of the handling system. In other words, the axes are unable toreach the programmed position and/or have been moved by hand during the process.

CAUSE ‐ The handling system is unable to locate correctly (physical impediment preventing movement) orthe axes have been moved with the device in operation.

SOLUTION – Check and remove any impediments which may obstruct the axes and try switching the deviceoff and back on. If the problem persists, call the After‐Sales Service.

xx – Pump error

EXPLANATION ‐

CAUSE ‐

SOLUTION – contact after sales assistance

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9.2 Troubleshooting and dealing with errors Histology and Cytology Artifacts:

∙ Coverslip mounting errors ∙ Use of coverslips which are too small ∙ Incorrect slide positioning ∙ Air bubbles trapped ∙ Too much mounting medium ∙ Too little mounting medium

Fit a new nozzle of the same size, and perform a sufficiently long preparation cycle before the next application process. When replacing the nozzle, the nozzle height must always be checked. Check the nozzle‐cleaner: top up with sufficient solvent every day.

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Accessories for the use of consumables

Nozzle‐cleaner, complete Nozzle‐cleaner, comprising:

∙ Nozzle cleaning system holder (complete with bottle). We advise the use of a disposable plastic pipette for top‐ups Order no. 8C1838‐F

(not included)

Xylene Order no. 06‐1304E Loader for coverslips of 24X40 (for 100 coverslips) Order no. 8C1835‐B

Coverslips 24X40 Order no. 09‐2040 Loader for coverslips of 24X50 (for 100 coverslips) Order no. 8C1836‐B

Coverslips 24X50 Order no. 09‐2050

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Loader for coverslips of 24X60 (for 100 coverslips) Order no. 8C1837‐B

Coverslips 24X60 Order no. 09‐2060 Slide holder tray Order no. 8C1238‐G

30‐position slide holder basket Order no. 40‐400‐252

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Metal nozzle, G17 Order no. 7AD001

Vapor filter for mounting medium bottle Order no. 7RMF12

Charcoal filter Order no. 40‐400‐253

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Vapor discharge manifold Diameter 100 mm Order no. 40‐500‐061

Suction cups with flanges (pack of 2 pieces) Order no. –

Lubricating oil 100 ml Order no. 08‐1721

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Loading container lid Order no. 8C1260‐A

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10 Warranty and after‐sales service

Warranty

Bio‐Optica S.p.A. guarantees that the product delivered as per the contract has undergone complete

control of its quality in accordance with the internal control criteria, that the product is free from defects,

and that it has all the technical specifications guaranteed and/or characteristics agreed.

The warranty's duration depends on the contract negotiated. The only binding warranty conditions are

those of the competent Bio‐Optica distribution company or the company from which the contract product

was purchased.

After‐Sales Service Information

If after‐sales service or spare parts are required, contact your local Bio‐Optica office or the Bio‐Optica

distributor where the device was purchased.

In this case, the following information about the device must be provided:

• The model name and device serial number.

• The device's location and the name of a contact.

• The reason for the after‐sales service request.

• The delivery date.

In case of replacement or return of the instrument due to anomalies of serious malfunction, it is necessary

to clean and empty the machine from any chemical liquid such as xylene or derivative, pack it with the

initial packaging.

It is possible to refer for this operation to paragraph 4.2.

Decommissioning and disposal The device or its components must be disposed of in accordance with the relevant legislation

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11 Annex A Information and recommendations related to the application 11.1 A1.1 Bio‐Optica plastic slide holders, trays and coverslips

Bio‐Optica plastic accessories are produced using a special material, designed to be durable in service. Various factors, such as material‐based aging, material fatigue due to wear, heat and splashing may cause modifications to plastics. Therefore, Bio‐Optica slide holders and trays are amongst the components available for purchase at a later date, and are listed amongst the optional accessories (see point 9). To guarantee trouble‐free performance from the trays take care that the sides of the trays do not become deformed: • The trays must not be soaked in a solvent for hours at a time (e.g. overnight) (see point 7.1) • They must not be dried after contact with solvent or water at temperatures over 100°C for a lengthy period of time (overnight).

11.2 A1.2 Slide holders produced by other manufacturers

Bio‐Optica does not accept any liability for, or guarantee the operation and performance in the device of slide holders produced by other manufacturers. The device's user is personally responsible for the use of slide holders produced by other manufacturers. • For the use of slide holders produced by other manufacturers special container inserts, listed amongst the optional accessories, are required. • It is important to check regularly that the slide holders produced by other manufacturers are not damaged, dirty or misshapen. These factors, combined with the specific way in which the slide holders produced by other manufacturers are made, may interfere with the device's operation. It is therefore necessary to check, in particular, that the slide holders produced by other manufacturers are in perfect condition at the time of use.

11.3 A1.3 Slides and gripper mechanism

The gripper mechanism is suitable for all slides produced in accordance with the ISO 8037‐1:1986 standard, with the following types of edges:

ground 90° (with 90° or 45° bevel)

ground 45°

cut

Warning! During the necessary cleaning procedures inside the device, no modification ormanipulation of the slide gripper mechanism is permitted. Make sure that the jaws are never widened, pressed or bent by hand.

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11.4 A1.4 CVR 909 ‐ Approved, recommended slides

The following slides are approved for use with the gripper from serial number 001

Code Producer Description

09‐1000MB Bio‐Optica 90° ground ege with frosted band

09‐1000 Bio‐Optica 90° ground ege with pink band

09‐1010 Bio‐Optica 90° ground ege with blue band

09‐1020 Bio‐Optica 90° ground ege with green band

09‐1030 Bio‐Optica 90° ground ege with white band

09‐1040 Bio‐Optica 90° ground ege with yellow band

09‐1050 Bio‐Optica 90° ground ege with orange band

09‐2000 Bio‐Optica 90° ground edge with positive charge and white band

11.5 A1.5 Coverslips For the Bio‐Optica CVR909 automatic coverslipper, coverslips specifically developed for use in this automatic application should be used. They are designed to make the mounting together of several coverslips unlikely or impossible. Bio‐Optica recommends the use of the following articles: 09‐2040 (24X40) vacuum series with silica gel 09‐2050 (24X50) vacuum series with silica gel 09‐2060 (24X60) vacuum series with silica gel In general, coverslips should be stored in a dry place. High air humidity levels may cause the coverslips to stick together, interfering with the mounting process.

Bio‐Optica does not accept any liability for, or guarantee the operation and performance inthe device of, slides produced by other manufacturers. The device's user is personally responsible for the use of slides produced by other manufacturers. Before use, Bio‐Optica recommends testing of slides produced by other manufacturers in the device.

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Bio‐Optica Milano S.p.A. Via San Faustino 58 ‐ 20134 Milano


DICHIARAZIONE DI CONFORMITA’ DECLARATION OF CONFORMITY KONFORMITÄTSERKLÄRUNG DECLARATION DE CONFORMITÉ DECLARACIÓN DE CONFORMIDAD

Nome e indirizzo del fabbricante

Name and address of manufacturer Name und adresse der Firma

Nom et adresse de l’entreprise Nombre y dirección de la empresa

Bio‐Optica Milano S.p.A. Via San Faustino 58 20134 Milano Italy

Dichiariamo sotto la nostra responsabilità che il dispositivo medico – diagnostico in vitro

We declare on our own responsability that the in vitro diagnostic medical device Erklären in alleiniger Verantwortung, dass das Medizinprodukt für die In‐Vitro‐Diagnostik

Nous déclarons sous notre propre responsabilité que le dispositif medical de diagnostic in vitro Declaramos bajo nuestra única responsabilidad que el producto médico de diagnóstico in vitro

Nome Name Name Nom

Nombre

Montavetrini automatico CVR909 Automatic coverslipper CVR909 Glas‐Eindecker CVR909 Colleuse de lamelles CVR909 Montador automático CVR909

Della classe

Of class Der klasse

De la classe De la clase

Altro dispositivo Other device Sonstiges Produkt Autre dispositif Otro dispositivo

Soddisfa tutte le disposizioni della Direttiva 98/79/CE relative ai Dispositivi medici diagnostici in vitro che lo riguardano

Meets all the provisions of the 98/79/CE Directive on in vitro diagnostic medical devices which apply to it Allen Anforderungen der Richtlinie über In‐Vitro‐Diagnostika 98/79/EG entspricht, die anwendbar sind

Remplit toutes les exigences de la directive relative aux dispositifs médicaux de diagnostic in vitro 98/79/EC qui le concernent Cumple todos los requisites de la directive sobre los productos medicos de diagnóstico in vitro 98/79/CE que le conciemen

Procedura di valutazione della conformità

Conformity assessment procedure Konformitätsbewertungsverfahren

Procédure d’évaluation de la conformité Procedimiento de evaluación de la conformidad

DIRETTIVA 98/79/CE, Allegato III, ad esclusione del paragrafo 6 DIRECTIVE 98/79/EC, Annex III, except paragraph 6 RICHTLINIE 98/79/EG, Anhang III, ausgenommen Absatz 6 DIRECTIVE 98/79/CE, Annexe III, avec exception du paragraphe 6 DIRECTIVA 98/79/CE, Anexo III, ecepto el párrafo 6

Luogo, data Place, date Ort, datum Lieu, date

Lugar, fecha

Milano, 28/03/2018

Nome, funzione Name, function Name, funktion Nom, fonction

Nombre, función

______________________________________________ CARLO SBONA Legale Rappresentante

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