autoclart plus User Manualmedicalsolutionme.com/.../uploads/product/brochure/...CLART, CLART-Strip and SAICLART are brands registered by GENOMICA. For greater detail in relation to

autoclart® plus User Manual Version 2, September 2016

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USER MANUAL

autoclart® plus – User Manual


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autoclart® plus

CLART, CLART-Strip and SAICLART are brands registered by GENOMICA.

For greater detail in relation to the information set forth in this manual please access the

following website: www.genomica.com

GENOMICA, S.A.U.

Parque Empresarial Alvento, Edificio B

Calle Vía de los Poblados, 1 – 1ª planta

28033 Madrid, Spain

www.genomica.com

Version 2

September 2016


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1. TABLE OF CONTENTS

1. TABLE OF CONTENTS ................................................................................................... 3

2. PRINCIPLE OF THE ASSAY ............................................................................................. 6

3. INTENDED PURPOSE ................................................................................................... 8

4. USE8

5. CLASSIFICATION ........................................................................................................... 9

6. PRODUCT TRADE NAME AND REFERENCES ..................................................................... 9

7. DESCRIPTION ............................................................................................................. 10

8. COMPONENTS / CONSUMABLES .................................................................................. 11

8.1 COMPONENTS ................................................................................................... 11

8.2 CONSUMABLES. ................................................................................................. 12

9. ACCESSORIES. ............................................................................................................ 13

10. CHARACTERISTICS. ................................................................................................... 15

11. UNPACKING, STORAGE AND PACKING. ....................................................................... 16

11.1. UNPACKING. ................................................................................................... 16

11.2. STORING THE PACKAGING. ............................................................................... 17

11.3. STORING THE EQUIPMENT. ............................................................................... 18

11.4. TRANSFER / TRANSPORTATION. ........................................................................ 18

11.5. PACKING. ........................................................................................................ 18

12. ENVIRONMENTAL CONDITIONS .................................................................................. 19

12.1. VENTILATION. ................................................................................................. 19

12.2 - ENVIRONMENTAL CONDITIONS. ........................................................................ 19


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13. PRECAUTIONS OF USE ............................................................................................... 21

14. PREPARATION OF THE FACILITY PRIOR TO INSTALLATION .............................................. 23

15. INSTALLATION .......................................................................................................... 24

16. TURNING THE EQUIPMENT ON AND OFF ..................................................................... 26

16.1. ON ................................................................................................................. 26

16.2. OFF ................................................................................................................ 27

17. START OF THE ANALYSIS ............................................................................................ 28

17.1. ENTRY OF THE TYPE OF ASSAY ........................................................................... 30

17.2. ENTRY OF THE SAMPLE REFERENCES .................................................................. 31

17.3. WORK LIST ...................................................................................................... 33

17.4. ANALYSIS SETTINGS. ........................................................................................ 34

18. ANALYSIS ADDING THE SAMPLE AUTOMATICALLY ........................................................ 34

19. ANALYSIS ADDING THE SAMPLE MANUALLY ................................................................ 43

20. READING ONLY ANALYSIS .......................................................................................... 45

21. READING ................................................................................................................. 45

22. RESULTS .................................................................................................................. 46

23. REANALYSIS OF THE SAMPLE ..................................................................................... 49

24. MAIN MENU RECORDS ............................................................................................. 52

22.1. SEARCH BY RUN. .............................................................................................. 52

22.2. SEARCH BY SAMPLE. ........................................................................................ 54

25. MAIN MENU SETTINGS ............................................................................................. 54

22.3. INSTALLING / UPDATING A PROGRAM. ............................................................... 55

22.4. SYSTEM .......................................................................................................... 56


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22.5. BACK-UP / EXPORT .......................................................................................... 57

22.6. SERVICE .......................................................................................................... 58

DECONTAMINATION PROGRAM ......................................................................................... 59

CLEANING PROGRAM .......................................................................................................... 60

26. MAINTENANCE / CALIBRATION .................................................................................. 61

27. CLEANING ............................................................................................................... 61

28. CARING FOR THE EQUIPMENT AFTER USE ................................................................... 63

29. FAQ ........................................................................................................................ 64

29.1 UPDATING AND INSTALLATION OF SOFTWARE ...................................................... 64

30. TECHNICAL ASSISTANCE SERVICE ............................................................................... 65

APPENDIX A. TABLE OF FREQUENT ERRORS AND RESPECTIVE SOLUTIONS ........................... 66

APPENDIX B. DECLARATION OF CE CONFORMITY .............................................................. 69

Declaration of CE Conformity ...................................................................................... 69

APPENDIX C. ABBREVIATIONS USED ................................................................................ 70

APPENDIX D. WARNING SYMBOLS AND SIGNS. ................................................................. 71

APPENDIX E. DECONTAMINATION CERTIFICATE. ............................................................... 73


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2. PRINCIPLE OF THE ASSAY

autoclart® plus has been developed for the automation of both viewing and reading and

interpreting the results of the in vitro diagnostic kit manufactured by GENOMICA.

The technique is based on:

1. The viewing of a specific reaction through the precipitation of an insoluble

product in microarray areas in which the amplified products have undergone

hybridization.

2. The capacity to associate the tip pattern generated in the array with a specific

diagnostic. This is conducted using an image capturing and processing system and a

specific algorithm for each kit. The technique is based on a system designed to

capture and process the images obtained in the microarray, which will result in the

automatic generation of a single report for each sample analysed. The algorithms used

in each kit are comprehensively validated during the process involving the evaluation of

the performance of the product.

The results obtained by CAR® are automatically displayed on the touch screen and can

be printed out or exported to the LIMS system or a memory unit using the USB

connection.

The image capture device includes a LED light source, a diffusor (to homogenize the

light) and a CCD camera to capture the image.


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Furthermore, the device is equipped with an automatic positioning system to ensure the

plate is in the correct place.

The analysis of the microarray image is conducted using the SAICLART® software

developed by GENOMICA for the interpretation of microarrays. The analysis of the

image is fully automatic, preventing subjectivity and the interaction of the user, thereby

ensuring accurate results in a rapid and repeatable manner.

Compared to classic microarray systems, this system significantly simplifies the

hybridization and viewing processes, allowing for the simultaneous detection of multiple

molecular markers for diagnostic use, while providing the controls required to

guarantee the reliability of the results.


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3. INTENDED PURPOSE

The equipment will be used exclusively by personnel from accredited laboratories and

using GENOMICA S.A.U. in vitro diagnostic kits, illustrated on the website

www.genomica.com

Any use other than that specified may undermine the performance of the equipment.

4. USE

IN VITRO DIAGNOSTIC HEALTH PRODUCT

autoclart® plus is for exclusive use with the reagents supplied by

GENOMICA.

Follow the instructions carefully. We suggest you read these instructions

before putting them aside. They contain useful information on the correct

and efficient management of the equipment.

This apparatus should not be used by people without the appropriate

experience or knowledge, unless under the surveillance of someone

responsible for their safety or who has been given instructions on the use

of the apparatus.

The use of autoclart® plus in a manner other than that specified in this

manual will result in the loss of the guarantee provided.


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5. CLASSIFICATION

autoclart® plus complies with the provisions of Council Directive 98/79 / CE on in vitro

diagnostic health products, in accordance with Spanish law pursuant to Royal Decree

1662/2000 of 29 September 2000, and is classified under “other products” in Appendix

III of the Directive.

Moreover, GENOMICA S.A.U. declares that the autoclart® plus equipment has been

manufactured in accordance with the following safety and quality standards and

requirements in force (EN ISO 13485, EN 61010-2-101 and EN 61326-2-6).

6. PRODUCT TRADE NAME AND REFERENCES

autoclart® plus

Reference: ACP


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7. DESCRIPTION

Figure 1. autoclart® plus.

autoclart® plus is a fully automated system for processing plate format assays.

The tool is designed for processing the sample, the addition of reagents, the removal of

liquids, heating, cooling, agitating the incubation plate and scanning the plate at the end

of the assay.

As such, it is equipped with a Peltier system capable of maintaining precise control over

the temperature during the assay, an incubation agitation system and a system to

transfer the plate to the core of the equipment where the camera for capturing images

and analysis is located.

autoclart® plus features an X/Y/Z axis mechanism for adding and removing samples and

reagents. It also features a system for disposable tips, as well as an independent 4-

needle reagent suction system connected to a peristaltic pump.

The control of volumes during the addition of samples is conducted by piston pumps

driven by “micro-step” type motors controlled by software. autoclart® plus is equipped

with a computer which operates by means of a touch screen and an interface designed


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specifically for the equipment.

The user can use the touch screen to view the number of samples and the assay to be

executed, whereby it is possible to process a minimum of 4 and a maximum of 96

samples per assay.

The equipment will conduct the analysis, reading and the interpretation of the results

automatically.

8. COMPONENTS / CONSUMABLES

8.1 COMPONENTS

The different components of autoclart® plus are illustrated in the diagram below:

Figure 2. Components of autoclart® plus.


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The instructions for the assembly of the different components of the equipment are set

forth in the table below.

Remember that most of the components need to be placed in a specific position.

8.2 CONSUMABLES.

1. Distilled water bottle

holder

Place the holder on the markers in the position

marked 1.

Remember it will only fit in one position.

2. Distilled water bottle

Screw on the cap. Place the bottle in the holder in

the position marked 2. Connect the tube from the

piston pumps to the top of the bottle.

3. Tip rack holder Place the holder on the markers in the position

marked 3.

4. TL trough Place the TL trough on the markers in the position

marked 4.

5. SH trough Place the SH trough on the markers in the position

marked 5.

6. CJ and RE troughs

Place both troughs on the markers in the position

marked 6. The troughs are labeled and only fit in

one position.

7. Liquid waste trough

Place the trough on the markers in the position

marked 7. Connect the tube from the peristaltic

pump.

8. Tip waste trough

Place the trough on the markers in the position

marked 8.


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Disposable tips will need to be used in addition to the GENOMICA diagnostic kit.

The equipment has been designed to be used with a specific disposable tip model.

Please contact our local distributor for more information.

Do not attempt to use any other type of tip. This may cause the equipment to

malfunction or result in a breakdown which is not covered by the guarantee.

9. ACCESSORIES.

The equipment comes with the following accessories.

ACCESSORY 1: SOFTWARE.

The analysis of the images and the interpretation of the results are conducted by

specific software for each kit, designed and implemented by GENOMICA.

GENOMICA distributes this software to its clients in accordance with the diagnostic kits

it provides.

Take particular care to ensure the USB device used both for updating software

and exporting data is not infected with a virus. GENOMICA will not be held liable

for removing a virus which has infected the system as a result of improper use

by the user.

In the event the user selects the wrong software, an error message appears

in the results report. Please review the analysis you wish to conduct and

select the correct software.


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ACCESSORY 2: A/C POWER CABLE.

Used to connect the equipment to the power mains with a plug.

autoclart® plus has been designed for use with GENOMICA diagnostic kits, and ,

as such, no other type of tube, vial or material should be used. The use of

autoclart® plus in a manner other than that specified in this manual will result

in the loss of the guarantee provided.

Do NOT use any accessory which has not been supplied by GENOMICA.

GENOMICA will not be held liable for the use of materials not supplied

by the manufacturer.

All the accessories required for the correct use of the equipment will be

supplied by the manufacturer.

In the event any of these components is missing or damaged, please

contact GENOMICA or a sales representative immediately.


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10. CHARACTERISTICS.

Type of instrument Table equipment

Processing capacity 4 to 96 samples per assay

Processing time Normally less than 3 hours for 96 samples

Temperature control. PID control

Processing volume 3 L to 100 L

Dispensing and tolerance system

Piston pumps:

3-10 µL ±10%

100 µL +0% / -5%

+0% / -5%

Software Integrated software

Network voltage and frequency 100 to 240 VAC with 5A grounding

50/60 Hz

Fuses 5A UL Approved – Ø5x20 mm - T5AL250VAC

Dimensions 620(H) x 650(D) x 800(W) mm / (W = 1150 mm with the screen)

Weight 80 kg

Power 500 W (max)

Noise level (dB) ~ 60 dB

Electromagnetic compatibility Classes A 30 MHz to 1000 MHz


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Electromagnetic susceptibility

10 V/m 80 MHz to 1000 MHz

3V/m 1.4 GHz to 2 GHz

1V/m 2 GHz to 2.7 GHz

UV lamp T8 15W UVC G13 (GEMICIDA)

11. UNPACKING, STORAGE AND PACKING.

We suggest you read the entire manual before unpacking and installing the equipment

or using it. Pay attention to all the hazard alerts and warnings. Failure to do so may

result in serious injury to the user or damage to the equipment. In order to ensure the

protection this equipment provides is not damaged, do not use or install it in a manner

other than that specified in this manual.

11.1. UNPACKING.

BEWARE, HEAVY EQUIPMENT!

At least 2 persons are required to move the equipment. The packed equipment

weighs around 110 kg.

The use of gloves is recommended when handling the equipment as some of

the components of the container may have sharp edges.

On receiving the equipment check the packaging is not damaged; if it is, please notify

GENOMICA immediately.


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Follow the steps below to open the packaging:

1. Place the box in a vertical position to open it.

2. Open the box and remove the user manual; continue in accordance with the

instructions set forth in the manual.

3. Remove the flaps and the lid.

4. Pull off the outer wooden cover and remove the protective bubble paper.

5. Lift the equipment to one side and remove the side foam at the same time. Repeat

this procedure on both sides.Two persons are required to take the equipment out

of the container, one in front of it and one behind it.

7. Inspect the equipment to check for any clear signs of damage during

transportation. Report any damage to your local representative

immediately.Check the serial number and the number on the delivery note match.

9. Open the door to the equipment and remove the box of accessories from inside.

Para in order to prevent any kind of damage to autoclart® during delivery, the

internal mobile components are held in place using fastening systems

which need to be removed prior to use.

autoclart® plus features a safety screw to protect the optical system from

damage while being transported. This screw must be removed prior to

using autoclart® plus.

11.2. STORING THE PACKAGING.

Fold the wooden box in order to store the packaging correctly.


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Keep the original packaging materials!

Equipment returned for repair should be dispatched in the

original packaging material in order to protect it from damage

during transportation.

11.3. STORING THE EQUIPMENT.

If the equipment is temporarily stored on the ground or an uneven surface, the

appropriate measures should be taken to protect it.

The equipment features delicate components which operate in a vertical position, and

care should be taken not to twist the structure of the equipment while it is being stored.

This manual should be kept close at hand for everyday

reference!

In the event of transfer, ensure the manual is kept together with

the equipment to provide the new owner with the instructions

of use and the respective warnings.

11.4. TRANSFER / TRANSPORTATION.

In the event the equipment needs to be transported after use in the laboratory, it will

need to be cleaned and decontaminated. Moreover, a certificate of decontamination

should be issued.

In the event the equipment needs to be moved to another location, it should be lifted

and transported. It should never be pushed or dragged.

11.5. PACKING.

The safety screw and the three new fastening straps must be in place when transporting

the equipment. Follow the respective instructions below:


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1. Turn off the equipment completely. Unplug the equipment from all power

sources.Place the safety screw in its housing located on the lower right-hand side

in the rear of the working area and screw it in. Move the robot arm fully to the left

and put the safety straps in place.

12. ENVIRONMENTAL CONDITIONS

12.1. VENTILATION.

Take the following recommendations into account:

Do not place the equipment in areas in which there are currents of air.

Moreover, the equipment does not require specific ventilation.

Place the equipment at least 100 mm away from walls and equipment.

12.2 - ENVIRONMENTAL CONDITIONS. Take the following recommendations into

account:

The equipment is for exclusive use indoors and should not be exposed to major

variations in temperature and humidity. It has been designed for use in normal

laboratory conditions.

Keep the equipment away from solvents and acidic vapours.Avoid vibrations and

direct sunlight to ensure accurate results.

Altitude Up to 2000 m.

Temperature Ambient temperature: 18 °C – 24 °C.

Humidity Maximum relative humidity of 80% for temperatures of up to 31 °C

decreasing linearly to around 50% for 40 °C.

Network voltage 100 to 240 VAC – 5A 50/60 Hz with variations of up to ± 10 %.


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Transport and

storage conditions From 5 °C to 50 °C.

Once the equipment has been assembled wait for 1 hour before turning it

on to avoid potential problems caused by condensation. All waste liquid is

stored in the equipment until the end of the test, and, as such, it does not

need to be drained.

Do not use this equipment in the vicinity of powerful electromagnetic

radiation as this may affect its performance.

The user is responsible for guaranteeing an electromagnetic environment

which is compatible with the equipment to ensure the device operates

correctly.

When working in a magnetic environment the user should check the device

is performing correctly prior to routine use.


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13. PRECAUTIONS OF USE

Please read the following warnings carefully.

All the precautions contained on this page should be strictly complied

with in order to prevent harm to individuals and/or damage to the

equipment.

In the event of a malfunction, contact the technical support service and

do not attempt to deal with the problem using your own means.

Please acknowledge and comply with all the warning signs on the equipment and its

accessories.

CAUTION

Do not operate

instrument with

cover open -

Risk of injury

CAUTION

Risk of trapping

fingers during

instrument

operation

CAUTIONHot Surface

Both the lower and upper microplate heaters may reach temperatures of up

to 65 °C during the assay. Make sure you do not touch these surfaces when

the assay has been paused.

Avoid touching the equipment with wet hands. Do NOT touch the internal

components of the equipment. You could suffer an electric shock. Any

such harm or damage would not be covered under the guarantee.


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The equipment will turn itself off automatically when the door is opened.

Do not handle the equipment´s safety components. Never touch the

equipment during an assay.

The equipment may be used with infectious / or hazardous substances.

We recommend wearing a laboratory coat and protective gloves when

handling the equipment and reagents. If a reagent should come into

contact with the skin or the eyes, wash with plenty of water.

Avoiding looking into the UV light when the UV decontamination

procedure is underway.

Do not open the door or touch the door sensor during the UV

decontamination procedure.

Take special care with the electrical components. Comply with safety

measures at all times. Repairs to the electrical system may only be

conducted by qualified personnel.

Do not touch any of the equipment´s electronic components. In the event

of breakage or failure contact the GENOMICA technical support service.

Always unplug autoclart® plus when performing work involving the use of

liquids or when conducting maintenance on the electrical system or the

equipment´s internal parts.

In the event the power supply in the laboratory is cut off or surges, we

recommend the use of an uninterrupted power supply (UPS) source.

Do not attempt to open or force the outer protective housing of the

apparatus. Avoid vibration or any sudden movement of the equipment

during the reading and analysis process.


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Gloves should always be worn when handling potentially infectious

substances (such as human samples and reagents) and which may come

into contact with the skin.

The user should take care not to contaminate the inside or outside of the

equipment with biological samples.

14. PREPARATION OF THE FACILITY PRIOR TO INSTALLATION

Follow the detailed instructions below carefully for the correct preparation of the facility

prior to installation:


Always place the equipment on a firm, flat surface. The assembly surface should be

level in all directions to ensure the equipment functions correctly. Make sure

autoclart® plus is installed on a totally horizontal, stable surface.The minimum

surface area required is 1200 mm in length by 700 mm in depth. The equipment

measures 800 mm in length, but requires an additional 350 mm for the installation of

the touch screen.The equipment should not be placed more than one metre away

from the power socket.

The equipment opens vertically and it is 1000 mm in height when fully open. Make

sure you clear the top of the equipment before opening it.The autoclart® plus main

switch is located on the left hand side panel of the equipment. Place the equipment

where it can be easily accessed.


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Before connecting the equipment to the power mains, check that the

voltage is 110-230 V (AC) and 50/60 Hz and that the system is

earthed.

Do not install autoclart® plus near a source of light, intense heat or

external vibrations.

Never touch the switches with wet hands.

Turn the equipment off completely before unplugging it from the

mains.

15. INSTALLATION

Follow the detailed instructions below carefully for the correct installation of

the equipment.


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15.1. INSTALLATION OF THE TOUCH SCREEN

Follow the steps detailed below carefully:

Figure 3. M6 x 80 screw.

1. Check the device is on a level surface.

2. Fasten the arm of the screen by

tightening the rear clamp using the M6 x

80 screw.

3. Insert the M4 screw on the other side to

limit the inclination of the touch screen.

We recommend requesting the assistance of a second person from this point on.

Figure 4. The yellow circle highlights the M5

screws for the bracket. The red circle highlights

the screen cable.

4. Ensure the screen is in the correct position and

fasten it by tightening the two M5 screws in the

bracket.

5. Once it is in place, check the screen cannot be

moved.

6. Connect the screen cable to the equipment and the

USB cable to one of the equipment´s USB ports.


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16. TURNING THE EQUIPMENT ON AND OFF

16.1. ON

Follow the steps detailed below carefully:

Connect the power cable to the panel on the side of the equipment and plug it into the

mains (connecting the equipment to the mains automatically ensures the connection to

earth). Press the ON button.

Figure 5. Power cable and ON switch.

Once it has been turned on, autoclart® plus will take a few seconds to start up. During this

time the device will conduct a series of internal checks on both the hardware and software,

and both the axes and the Peltier plate will be placed in their original position.

If the equipment door is open the message “please close the door” will appear on the

screen. Please close the door to continue.

Whilst on the screen, the progress bar will expand.


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Figure 6. Starting up the equipment

The main screen will appear once the equipment start up has concluded.

16.2. OFF

1. Remove the microplate from the equipment if you have not done so already.Remove

the deionized water bottle from its bracket.

3. Remove the waste troughs (liquids and solids) and dispose of the waste in accordance

with local and state provisions.

4. Remove the reagents troughs and dispose of the waste in accordance with local and

state provisions.

5. Clean the reagent troughs with water (see the cleaning section) and put the

accessories back in the equipment.

6. Clean the waste troughs with bleach diluted to 4% (see the cleaning section) and

rinse. Put the accessories back in the equipment.Close the door to the equipment.

8. Return to the main screen and press the OFF button. When the screen darkens, turn

off the switch on the side of the equipment.


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Figure 7. The main menu. The OFF button is highlighted in red.

9. We recommend disconnecting the equipment completely for long periods of

inactivity.

17. START OF THE ANALYSIS

The reading and analysis of a sample is a simple sequential process consisting of a series of

menus from which to select the different options involved in the process.

Press the “new analysis” option on the main menu, which appears automatically when the

equipment is turned on.

Figure 8. “New Analysis”, highlighted in red

A new screen will appear featuring a diagram of a 96-well microplate.


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Figure 9. Diagram of a microplate on the “New Analysis” menu.

This is the application´s most important menu, as it enables the user to establish:

The number of samples to be analysed. The assay reference number.

The sample reference number.


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17.1. ENTRY OF THE TYPE OF ASSAY

Automatic method:

A bar code reader needs to be connected to autoclart® plus in order to select the assay

automatically.

Press the “auto assays” button located on the lower left-hand side of the screen and read

the assay code provided by GENOMICA.

All the CS will appear in light-grey in the microplate diagram, indicating that the assay has

not been selected.

Then, read the specific bar code for the test provided by GENOMICA and the CS in which

the assay has been defined will automatically change to the specific colour of the same.

Once the process has been concluded press the tick.

Figure 9. Selection of “auto assays”.

Manual method:

Select the CS number to be used in the assay. Press the X at the top of the specific position

and then press the wells. Unselecting all the wells will unselect the entire CS.

CLART® HPV4 will be assigned to all CS by default; to change the software press the edit

symbol above the selected CS.

A drop-down menu will appear enabling you to change only the CS selected or all the CS

selected as of this time appear with the software chosen on selecting “auto select”.


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Figure 11. Selection of the bands to be processed

Figure 12. Manual entry of the assay references.

N.B: Remember that if you intend to conduct the same assay in all the bands, press “AUTO SEL”

after selecting the assay. The symbol “A” will appear alongside the assay selected.

17.2. ENTRY OF THE SAMPLE REFERENCES

In the same manner as the previous sections, the sample references can be entered

automatically by installing a bar code reader, or manually.


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Automatic entry of sample references

A bar code reader needs to be connected to autoclart® plus in order to enter the sample

references automatically.

Select “samples” on the lower right-hand side of the screen and a sub-menu will appear

featuring a list of the positions.

Scan the codes of the samples to be analysed. The number of samples to be analysed will

depend on the number of references added, which will always occupy consecutive

positions.

Once all the references have been added press the tick to return to the previous menu.

Figure 13. Entry of samples.

Manual entry of sample references

Select “samples” on the lower right-hand side of the screen and a sub-menu will appear

featuring a list of the positions.

Type the sample references into the selected positions.

Once all the references have been added press the tick to return to the previous menu.

In the event no specific reference is assigned to the sample, the software

will assign each sample a consecutive number from 1 to 96, starting with

the sample located in position 1A.


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Figure 14. Entry of samples. Positions sub-menu.

Automatic entry of sample references from files

To enter references automatically from files, first contact the GENOMICA product specialist.

17.3. WORK LIST The work list will enable us to check all the data entered up to now is

correct.

If you should need to correct any data, select “Back” (left blue arrow) to edit the test or

reference, as explained in the previous sections.

If all the information is correct, press “continue” (right blue arrow) to start the analysis.


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Figure 14. Work list

17.4. ANALYSIS SETTINGS.

The equipment can be used in three different settings:

To add samples automatically.To add samples manually.For reading only.

Select the desired option on the touch screen.

Figure 15. Analysis settings

18. ANALYSIS ADDING THE SAMPLE AUTOMATICALLY

Select the “add samples automatically” option.

Check the following list of steps which appears on the touch screen.

Press the blue arrow (“next step”) to move on to the next step.


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STEP 1/11: LOAD COMPLETE NEW TIP RACKS

Figure 16. Loading tip racks.

Place the tip racks in their holder, taking

into account there is only one possible

position.

1 ml tip racks at the back of the

holder (red rack).

10 μl tip racks at the front of the

holder (white racks).

Ensure the racks are full. Remember that

the consumption of 1 ml tips is the same

for all assays regardless of the number of

samples analysed.

Press down on the four corners of the

racks to ensure they are properly in place

and close the fastening clamps (highlighted

in yellow circles),

Figure 17. Tip racks


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Step 2/11: LOADING THE MICROPLATE

Figure 18. Loading the Microplate

Raise the microplate holder cover and insert the

plate with as many CS as required for the analysis of

the samples, as illustrated in the image on the right.

Ensure position A1 is in the top left corner.

Figure 19. Position of the microplate

Ensure the CS adaptor is correctly inserted and press

it firmly downwards.

Close the cover and turn the lock.

Figure 20. Closing the cover, highlighted in

yellow.


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Step 3/11: CHECK THE USED TIP

TROUGH IS IN PLACE AND EMPTY.

Figure 21. Empty tip trough

Step 4/11: CHECK THE WASTE TROUGH

IS IN PLACE AND EMPTY.

Figure 22. Empty waste trough

Step 5/11: CONNECT THE TUBE TO THE

WASTE TROUGH.

Figure 23 a. Connecting the tube


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Place the waste trough in its

position.

Attach the connecting tube to the

waste trough and put on the cover

as illustrated in the image on the

right.

Figure 23 b. Connecting the tube to the waste trough, as highlighted in

yellow.

Step 6/11: LOAD THE WATER BOTTLE

WITH 250 ML OF DISTILLED WATER.

Figure 24 a. Bottle of distilled water


39

Fill the bottle with 250 ml of distilled water and place

it in its holder.

Take into account that the consumption of water is

the same regardless of the number of samples

processed. The bottle should be refilled prior to each

assay.

Close the bottle with the red cap and insert the pump

tube through the cap as illustrated in the image on

the right.

Figure 24 b. Bottle of distilled water. Tube

inserted through the red cap.

REMEMBER THAT REAGENTS AND THE AMPLIFICATION PLATE SHOULD NOT BE ADDED UNTIL

THE TROUGHS HAVE COOLED DOWN.

Figure 25. autoclart® plus audio signal highlighted in red.

The equipment will emit an audio signal when the troughs have been prepared.

This audio signal indicates that the troughs have cooled down and the assay may continue.

Touch the audio symbol to turn it off.

The equipment automatically calculates the volume of reagents required for viewing in

accordance with the number of samples to be processed. Refer to the kit manual used at

the time of preparing the assay reagents.


40

Take note that the viewing reagent troughs only fit in the correct position.

TL SH Troughs

CJ RE Troughs

Figure 26. Position of the viewing reagent troughs

Step 7/11. PLACE THE SPECIFIED

VOLUME OF WASH BUFFER IN THE

TANK.

Figure 27. Wash buffer volume.


41


VOLUME OF HYBRIDISATION SOLUTION

IN THE TANK.

Figure 28. Volume of hybridisation solution.

Step 9/11 – PLACE THE SPECIFIED

VOLUME OF DILUTED CONJUGATE IN THE

TANK.

Figure 29. Volume of conjugate


VOLUME OF DEVELOPER IN THE TANK.

Figure 30. Volume of developer


42

Step 11/11 – LOAD THE AMPLIFICATION

PLATE.

Figure 30 a. Load PCR plate.

Open the cover and place the PCR

plate in the holder.

Check the PCR plate is in the correct

position and position A1 is in the top

left corner and press it firmly

downwards.

Figure 30 b. Loading the PCR plate. Position in the holder.

Close the cover and turn the lock as

illustrated in the image on the right.

Figure 30 c. Loading the PCR plate. Locking the PCR plate.


43

Once all these steps have been completed, close the cover to the equipment and press the

continue button (white arrow) to start the analysis. The screen will show the estimated

time of the end of the assay, the processing phase (which will change throughout the assay)

and the warning not to open the door to the equipment.

Figure 31. Countdown of the time remaining.

19. ANALYSIS ADDING THE SAMPLE MANUALLY

Select the “add samples manually” option.


44

Check the following list of steps (as explained in item 2 of the previous section) on the

touch screen. Press the blue arrow (“next step”) to move on to the next step.

Figure 32. Manual addition of the samples.

Once all these steps have been completed, close the cover to the equipment and press the

continue button (white arrow) to start the analysis.

When the equipment reaches the sample addition step it will emit an audio signal and the

message “load samples” will appear on the screen.

Figure 33. Loading samples

Remove the autoclart® plus microplate and add the denatured PCR product to each of the

CS.

Then place the microplate back in autoclart® plus and turn the lock. Close the equipment

and press the white arrow to continue.


45

20. READING ONLY ANALYSIS

Select the “reading” option.

Figure 34. Analysis reading settings.

Load the microplate with the desired number of CS to be read and turn the lock.

Close the equipment and press the white arrow to continue.

21. READING

When the test has been concluded the equipment will automatically read the microplate for

the purpose of analysis. A progress bar will appear when the analysis begins, indicating the

status of the process.


46

Figure 35. Reading progress bar

Figure 36. End of the reading

When the progress bar reaches 100% the test has been completed and the results can be viewed,

exported and/or printed out.

22. RESULTS

22.1. VIEWING RESULTS

Press “report” to view the results of the complete run. The work list will reappear, which

will now include the information on the results.


47

In order to view the results in an individual manner press the corresponding will in the

image of the microplate. This will access the specific report on the sample.

Figure 37. Individual results.

The following information is available on this sub-menu:

- Raw data: Provides access to the numeric, raw and standarised values obtained from

the analysis of the arrays.Image: Provides access to the image of the array taken by

autoclart® plus. This image may be exported or printed out individually.

FIgure 38. Image of a result.

- Export: Enables the user to export the information to an external server, LIMS or mass

data storage system established as an export route beforehand.


48

22.2. OTHER OPTIONS.

The following options appear on the results menu:

Export:

Enables the user to export the complete assay, reports and results to an external server,

LIMS or mass data storage system established as an export route beforehand.

On selecting Export a list will appear of all the assay samples from which to select the

results you wish to export.

Select the samples you wish to export. This can be conducted individually or by selecting

the entire assay by pressing “select all”. If you wish to delete what you have selected press

“Delete selection”. If you wish to close the export menu click on “Close”.

Press “send” to export the results. A new window will then appear with the message

“Please wait, exporting”. Do not close the window until the process has ended.

Once the assays have been exported a new window will appear with the message “export

concluded”. Press “Ok”.

Figure 39. Selecting the test to export to LIMS

Figure 40. Export concluded.

Reports:

Once the analysis of the samples has ended autoclart® plus will generate two types of

report. A report with the results of the complete assay (work list) and individual reports for

each of the samples (see item 22.1.).


49

The work list includes the following information:

- Date and time of the process

- Position of the sample in the microplate

- The code of the analysis conductedThe type of analysis

conductedThe sample referenceThe results

Figure 41. Report on the assay work list. The print option is highlighted in red.

The work list can be printed out. To do so connect a printer to autoclart® plus and press

the printer icon.

23. REANALYSIS OF THE SAMPLE

If, after having analysed the plate, a sample is colored red, this means the grid could not be

aligned automatically by the software. However, the user may reanalyse the sample, or in

other words, align the gird manually.

In order to reanalyse a sample press the same and the “Reanalysis” option menu will

appear on the screen automatically.

Only wells which CAR® was unable to analyse will be available for reanalysis.


50

Figure 42. Initial menu of the reanalysis option. Change of assay reference.

First of all, check the assay selected is the correct one, and if not, change it. To do so press

the drop-down menu located in the middle of the screen.

Selecting “Start reanalysis” will access the application, in which the user can use a zoom

device to help align the grid correctly.

The correct alignment consists of placing the top left marker of the grid in the correct

position, and then doing the same with the bottom right marker. The latter marker enables

the user to increase or reduce the size of the grid. Once both markers are in position, select

“Reanalysis”.

Figure 43. Procedure for the manual alignment of the grid.

To put the markers in place, simply press on them on the screen and drag them into their

final position.


51

Once the markers are in position the software provides a general view of how the grid

would fit on the array. If the grid is in the correct position, press “Accept” in order to

continue with the reanalysis.

Figure 44. Position of the grid on the array.

Aligning the grid manually implies the intervention of the user in the results, which will be

registered in the final report generated in the form of the following message.

The image has been reanalysed by the user.

Figure 45. Message on the manual alignment of the samples.


52

24. MAIN MENU RECORDS

The “records” option on the main menu provides a results search tool.

Figure 46. The main menu. Access to assay records.

This results search tool can be used for an analysis or run or a sample.

22.1. SEARCH BY RUN.

Fig 47. Search by run.

This search should be conducted using:


53

1. Two dates established by the user, one for the start and one for the end of the

search.

2. Search parameter: There are three different search parameters to choose from: run

ID, assay and plate.

Figure 48. Search parameters.

Once the parameters have been established, a list will appear with all the assays

which comply with the search parameters defined. Select the assay in question and

press “Next” to access the desired results.

Figure 49. List of analyses displayed.


54

22.2. SEARCH BY SAMPLE.

Figure 50. Search by sample.

On selecting “Search by sample” a sub-menu will appear as in the “Search by run”

procedure, which will enable the user to set the parameters by date, run ID, assay ID,

plate ID, and particularly, sample ID.

Once the parameters have been established, a list will appear with all the samples which

comply with the search parameters defined. Select the sample in question and press

“Next” to access the desired results.

25. MAIN MENU SETTINGS


55

Figure 51. Settings.

Press the “Settings” option to access a sub-menu with a number of options for

configuring autoclart® plus.

Figure 52. Settings sub-menu

22.3. INSTALLING / UPDATING A PROGRAM.

Select the “install / update” option to access a sub-menu containing a list of all the

programs currently installed in the equipment and version of the same.

Selecting a specific program and pressing “delete” will enable you to remove that program.

The “install” options provides access to a search menu from which to select the external

memory device connected to autoclart® plus containing the new software to be installed.


56

Select the .Zip file provided by GENOMICA to install the program. The installation is

automatic.

Figure 53. Assay install / update menu.

22.4. SYSTEM

The “System” option provides the user with information on the software, hardware

and the serial number of the equipment.

Figure 54. System information screen.

This option also provides:


57

- Export: Select the export route. Pressing the “…” symbol will access a browser tab

from which to select the external memory or LIMS network you wish to use to export

results.Back-up: Select the back-up route. Pressing the “…” symbol will access a

browser tab from which to select the external memory you wish to use for the back-

up of the assays stored in the equipment (see item 24.3). Language: change the

language used on the equipment.

- By default: select the program which appears in a new run by default.

22.5. BACK-UP / EXPORT

This option enables the user to copy or copy and delete only. The

latter option will also remove these assays from the equipment´s

memory.

The final destination should be specified prior to exporting or backing up data.

The information contained in autoclart® plus may be stored on any external memory

device with a USB connection or exported to the laboratory´s LIMS network, provided the

user has selected the export route (see item 24.2).

Select “back-up” on the “settings” menu and press continue (tick). Select the data you wish

to copy in accordance with the date, run ID and / or assay ID.

There are two back-up options once these parameters have been defined:

- Copy: The results are copied on the defined back-up route.

- Move: The results are copied on the defined back-up route and deleted from the

autoclart® plus memory. This ensures a result cannot be deleted unless it has been

copied first. Select the option in question and the process will be conducted

automatically, returning to the settings” menu once it has been completed.


58

Figure 55. The back-up process.

22.6. SERVICE

Press “Service” in the settings menu where you will find three protocols for the

maintenance of the equipment.

- Decontamination: This program decontaminates the equipment using UV

light.Cleaning: This program cleans the equipment´s tubing and pump

system.Technical Assistance: This menu is for the exclusive use of specialised

technical assistance personnel. It is protected with a password and users have no

access.

Figure 56. Service menu.


59

DECONTAMINATION PROGRAM

Select the “decontamination” program on the “services” menu.

Then complete the following 6 steps displayed on the touch screen:

1. Put the empty tip holders in place.

2. Load the empty used tip trough.

3. Put the empty sand dry waste trough in place.

4. Put the empty reagent troughs in place.

5. Load the empty hybridisation solution trough.

6. Ensure neither the PCR plate nor the CS microplate has been loaded.

7. Close the equipment door.

Once completed press continue. Up to this point the user may reverse the process by

pressing the cancel button (X), which will take you back to the “services” menu.

The decontamination process will begin and a countdown will appear on the screen.

Ensure the cover to the equipment remains closed throughout this process.

Avoiding looking into the UV light when the UV decontamination procedure is

underway.

Do not open the door during the UV decontamination process.


60

Figure 57. The decontamination process.

An audio signal will indicate the end of the decontamination process.

CLEANING PROGRAM

Select the “cleaning” program on the “services” menu and follow the instructions which

appear on the touch screen.

1. Fill the bottle with disinfectant: Fill the extra bottle with bleach diluted at 4% or

another disinfectant whenever no foam is formed. Avoid all soapy solutions.Check

the waste trough is present and empty.

Once completed press continue. Up to this point the user may reverse the process by

pressing the cancel button (X), which will take you back to the “services” menu.

A countdown will appear to determine when the user needs to intervene. Once the process

has finished autoclart® plus will flash and a message will appear on the touch screen to

replace the clean bottle with the full bottle of distilled water.

Once the cleaning program has ended the equipment will emit an audio signal once again.


61

26. MAINTENANCE /

CALIBRATION

Both the maintenance and the calibration of the equipment should be

conducted by qualified personnel. In the event of an incident contact

your GENOMICA technical assistance department or your retailer.

Only change the fuses when they blow. Following these steps to do so:

1. Remove the fuse box by pressing the upper and lower tabs.

2. Replace the blown fuses and put the fuse box back in place by pressing down firmly

on the middle of the same.

3. The type of fuse is indicated on the autoclart® plus label: T5A 250V (5 X 20 MM).

27. CLEANING

The equipment should be cleaned on a regular basis.

Only the top and outer surface of the equipment should be cleaned, using towels soaked

in alcohol or patented decontaminants*, followed by water and appropriate detergent*.

This exterior cleaning process should be accompanied by the execution of the program for

cleaning the inside of the equipment (see item 25.4).


- Do not attempt to remove the panels with the aim of cleaning the inside of the

equipment, as this involves the risk of injury and may damage the device.

- Always put on protective gloves before cleaning the equipment.


62

- Use an appropriate detergent to clean the surrounding surfaces.

- Use a damp cloth and detergent to clean all the areas around the base and the reagent

area.

- Use the same technique to wash all the parts which might come into contact with an accidental spill.

- Clean all the reagent trays at the end of each run and ensure the waste trough has been

emptied.

- We recommend the use of UV goggles as a precautionary measure when conducting the

UV decontamination.

* The user is responsible for not using cleaning or decontamination products which might

represent a hazard as a result of the reaction with parts of the equipment or the

material comprising the same.

In the event of doubt in relation to the compatibility of the decontamination or cleaning

agents, please contact your local agent or the GENOMICA technical assistance

department.


63

28. CARING FOR THE EQUIPMENT AFTER USE

The device

This equipment should not be disposed of using public waste

systems. In compliance with domestic and local European legal

regulations (EU Directive 2002/96/CE), the users of European

electrical equipment are required to return old equipment and

whose life cycle has expired to the manufacturer.

N.B: With regard to recycling, please contact GENOMICA or the

supplier of the equipment for instructions on how to return

equipment whose life cycle has ended for appropriate disposal.

Packaging

Please keep the packaging material throughout the service life of the

equipment.

The packaging components (wood, cardboard, polyethylene, etc.) are

products comparable with normal urban solid waste and can be

disposed of easily. However, we suggest disposing of these products

separately (selective collection) in accordance with the requirements

in force in relation to correct recycling. DO NOT THROW THE

PACKAGING PRODUCTS AWAY INTO THE ENVIRONMENT.


64

29. FAQ

29.1 UPDATING AND INSTALLATION OF SOFTWARE

Figure 58. USB memory with installation files.

1. Connect the external memory to a free USB port in the equipment.

2. Access the “Settings” menu.

3. Press the “Install / Update” button.

4. You should see unit C:\ of autoclart® plus and its external memory on the browser,

which is normally identified with the letter D:\.

5. autoclart® plus may take a few minutes to recognise the memory. Return to the main

menu, wait for a moment and try again.Access the USB memory by pressing the box

Take particular care to ensure USB device used both for updating

software and exporting data is not infected with a virus.

GENOMICA will not be held liable for removing a virus which has

infected the system as a result of improper use by the user.


65

with the icon. You will now see the compressed files required for the

installation.Select the kit you wish to install and press “Install”.

8. The installation ends with a window indicating that the process has been successfully

concluded.

Please close the window by pressing the tab in the top right corner.

If you wish to install more programs, repeat the operation from step 4. When you have

finished return to the main menu and reboot the equipment. In the event error messages

appear, please contact your technical assistance department. Remember to quote these

messages in your request for assistance.

30. TECHNICAL ASSISTANCE SERVICE

Remember that only GENOMICA SAU technical service personnel or associates may

conduct authorised repairs and services.

You may contact the GENOMICA, S.A.U. technical assistance department on:

Tel: + 34 91 674 89 90

Fax: + 34 91 674 89 91

E-mail: [email protected]

mailto:[email protected]


66

APPENDIX A. TABLE OF FREQUENT ERRORS AND RESPECTIVE SOLUTIONS

N.B: the correct working order of this equipment should be checked after all maintenance,

servicing or repair operations.

Dealing with simple problems

Visual inspection

A comprehensive visual inspection of the equipment prior to using it will often reveal real or

potential problems. Conducting the following checks will help to determine the state of the device.

Check for any signs of evident damage. With the equipment turned off, open the lid and inspect the

base of the device for any spills or obstruction. Remove the obstruction and clean up the spill where

applicable.

Mechanics

Ensure the tip picking / removal system is in the initial position, move the X and Y axes by hand to

check for obstructions. In the event of obstructions, look for mechanical impediments such as loose

screws.

Check the suction probe needles are clean and in good condition. Gently clean each probe with

cotton wool soaked in alcohol. The tips should be straight – if for some reason they are bent, a

qualified technician should replace them accordingly.

Ensure nothing is blocking the path of the reagent plate.

Fluids

Check the tubes are not damaged and ensure there are no visible folds along the 'Y' and the "X" axis

which might affect the processing of the sample. Pay particular attention to the tip picking /

ejection mechanism connections.

Any problem detected during the visual inspection needs to be dealt with before turning the

equipment on, and failure to do so may cause even more damage to the device.

Start-up


67

The specific functions of the equipment should be checked during the start-up process.

The table below provides details of the start-up process:

Step Action Comment Possible cause Consequence Solution

Pass

1

Master Controller

constant load, check

modules and the

compatibility of

firmware

Immediately if

functioning

correctly

Corrupt data

Incorrect firmware

Module disconnected

Error code

Check BUS cables

Check modules

Contact the technical assistance

department

2 Start-up of module C Home sensor not

detected Error code


department

3 Start-up of module AZ Home sensor not

detected Error code


department

4 Start-up of module Z Home sensor not

detected Error code


department

5 Start-up of module XY Home sensor not

detected Error code


department

6 Start-up of module T Home sensor not

detected Error code


department

7 Start-up of module RP Home sensor not

detected Error code


department

8 Ejection of tips Home sensor not

detected Error code


department

9 Check of pumps Home sensor not

detected Error code


department

Error codes


68

The equipment features an error management mechanism with parameters which can be

monitored in real time.

In the event of an error the device will stop immediately and an error code will appear on the touch

screen.

The error codes are stored in a register. ALL CASES of error codes (S) should be reported to the

service provider immediately for analysis, stating in which phase of the assay the error occurred.

New measures

If the error persists or the solution fails to DEAL WITH the error please contact the Authorised

Technical Assistance Department.


69

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718

APPENDIX B. DECLARATION OF CE CONFORMITY

Declaration of CE Conformity

Manufacturer: GENOMICA, S.A.U.

Parque Empresarial Alvento

Edificio B.Vía de los Poblados, 1 -1ª planta.

28033 Madrid

Product: Autoclart® Plus

Classification: Other products

References: ACP

Evaluation procedure: Appendix III to Directive 98/79/CE (Declaration of

CE Conformity).

Classification Class A. Rule 5. Appendix VII.

Genomica, S.A.U. hereby declares that the product autoclart ®Plus complies with the

requirements of Directive 98/79/CE of 27 October on health products for in vitro

diagnostic, registered in Spanish law under Royal Decree 1662/2000 of 29 September

2000.

Quality standards applied EN ISO 13485. EN ISO 14971. EN 980, EN 13612. EN

ISO 18113-3, EN 62304. EN 61010-2-101. EN

61326-2-6

Entity Notified Not applicable

CE certificate nº Not applicable

Validity of the certificate: Not applicable

Cargo: Directora General


70

APPENDIX C. ABBREVIATIONS USED

CS: CLART-strip®

Fig: Figure

PCR: Polymerase Chain Reaction

PDF: Portable Document Format generated by Adobe.

LIMS: Laboratory Information Management System

USB: Universal Serial Bus


71

APPENDIX D. WARNING SYMBOLS AND SIGNS.

This symbol indicates the danger of harm being caused to both the operator

and the robot.

This symbol warns of the possible damage or harm the operator may suffer in

the event the normal robot function is interrupted.

This symbol warns of the danger of possible damage or harm caused by the

high voltage of the equipment.

This symbol refers to important information on autoclart® plus. Please read

the attached instructions carefully.

Refer to the instruction for use.

Manufacturer

Manufacture sheet

Indicates that the equipment is used as an in vitro diagnostic product

Expiration date

Serial number

Batch code

Catalogue number


72

CE marking

Fuses 2 x T4H250 V (5 x 20 mm)

Electrical and electronic products, do not mix with standard waste

Symbol Colour Standard Description Location

Symbol and

Border:

Black

IEC 60417 –5032 Alternate Current

A/C

Identifying label on

the

equipment

Symbol and

Border:

White

IEC 60417 –5007 ON On switch with

filter

Symbol and

Border:

White

IEC 60417 –5008 OFF On switch with

filter

Rear: Yellow

Symbol and

Border: Black

IEC 60417 –5032 Danger: Hot

Surface On the heated area

Rear: Yellow

Symbol and

Border: Black

IEC 60417 –5007 Danger: risk of

damage

Junto a etiquetas de advertencia

Rear: Yellow

Symbol and

Border: Black

- Danger: UV light On the warning

label


73

APPENDIX E. DECONTAMINATION CERTIFICATE.

Decontamination Certificate

This equipment:

Model: ____________

Serial number: ____________

Has not been in contact with biological samples of an infectious nature.

Date:

Signature:

Documents

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