b30328rev10 auto-lipa 48 · auto-lipa 48 part no.: 30005203 revision no.: 1.9 (b30328 rev 10) 3/77...

Instructions for Use for

Auto-LiPA 48

Document Part No.: 30005203 2011-05

Document Revision No.: 1.9 (B30328 rev 10)

Auto-LiPA 48 Part No.: 30005203 Revision No.: 1.9 (B30328 rev 10) 2/77

Innogenetics Customer Support Manufactured by INNOGENETICS N.V. Technologiepark 6 9052 Gent Belgium

+32-9 329 13 29 BTW BE 0427.550.660 RPR Gent E-mail: [email protected] Distributed by

INNOGENETICS N.V. Technologiepark 6 9052 Gent Belgium

+32-9 329 13 29

Innogenetics Diagnostica Iberia, S.L.U. Calle Tarragona 161, Planta 14 08014 Barcelona Spain

+34-93 270 53 00

Innogenetics Inc. 4500 McGinnis Ferry Road Alpharetta, GA, 30005 USA

+1-678 393 1672

Innogenetics S.r.l. Via Vaccareccia 39/A 00040 Pomezia (Roma) Italy

+39-06 965 28 700

Innogenetics GmbH Hans-Böckler-Allee 20 30173Hannover Germany

+49-511 857 3931

Innogenetics s.a.r.l. Les Conquérants, Bât. Le Kilimandjaro 8/10 Avenue des Tropiques 91840 Les Ulis France

+33-1 69 07 48 34


WARNING CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED

IN THIS DOCUMENT BEFORE OPERATING THE INSTRUMENT.

Manufacturer Innogenetics NV

Technologiepark 6 9052 Gent Belgium Tel.: +32-9 329 13 29 Fax: +32-9 329 19 11 [email protected] Declaration for EU Certificate See the last page of these Instructions for Use.

Area of Application – Intended Use See chapter 2.2 Area of Application – Intended Use

About the Instructions for Use Original instructions. These instructions for use will describe • General information • Installation of the instrument • Operation of the instrument • Defining and running programs • Cleaning and maintenance procedures


Warning, Cautions and Notes The following types of notices are used in this publication and highlight important information or warn the user of a potentially dangerous situation:

Note Gives helpful information.

Caution Indicates a possibility of instrument damage or data loss if

instructions are not followed.

WARNING INDICATES THE POSSIBILITY OF SEVERE PERSONAL INJURY,

LOSS OF LIFE OR EQUIPMENT DAMAGE IF THE INSTRUCTIONS ARE NOT FOLLOWED.

WARNING THIS SYMBOL INDICATES THE POSSIBLE PRESENCE OF

BIOLOGICALLY HAZARDOUS MATERIAL. PROPER LABORATORY SAFETY PRECAUTIONS MUST BE

OBSERVED.

ATTENTION NEGATIVE ENVIRONMENTAL IMPACTS ASSOCIATED WITH THE

TREATMENT OF WASTE. DO NOT TREAT ELECTRICAL AND ELECTRONIC EQUIPMENT

AS UNSORTED MUNICIPAL WASTE. COLLECT WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT

SEPARATELY.

WARNING RISK OF FIRE AND EXPLOSION!

ETHANOL IS FLAMMABLE AND WHEN IMPROPERLY HANDLED CAN LEAD TO EXPLOSIONS. PROPER LABORATORY SAFETY

PRECAUTIONS MUST BE OBSERVED.


Symbols

Manufactured by

Date of Manufacturing

In vitro diagnostic medical device

Indicates the possible presence of biologically hazardous material.

Conformité Européenne

Toxic

Attention hot

Use by

Single use only

USB label


Abbreviations The following abbreviations are provided as a reference and may appear in the Instructions for Use.

Abbreviation

A Ampere

°C Degrees Celsius

CE Conformité Européenne

cm Centimeter

CV Coefficient of Variation

ELISA Enzyme-Linked ImmunoSorbent Assay

EN European Norm: a voluntary European standard of the European Committee for Standardization or Comité Européen de Normalisation (CEN)

°F Degrees Fahrenheit

hPa Hectopascal

Hz Hertz

IEC International Electrotechnical Commission

IFU Instructions for Use

in. Inch

inHg Inches of mercury

IVD In vitro diagnostics

IVD-D In vitro diagnostics Directive

kg Kilogram

l; L Liter

LiPA Line probe assay

LOT LOT number

m Meter

mBar Millibar

ml Milliliter

mm Millimeter

mS Millisiemens

µl Microliter

PCR Polymerase Chain Reaction

ppm Parts per million

QC Quality Control

REF Reference number/ Order number

s Second

SN Serial number

T Träge (Slow Blow Fuse)

torr Torr – millimeter of mercury (mmHg)


Abbreviation

TYPE Name and type of instrument

USB Universal Serial Bus

V Volt

VA Volt ampere

WEEE Waste electrical and electronic equipment


Table of Contents 1. Safety ..................................................................................................10

1.1 Instrument Safety.................................................................................10 2. General................................................................................................11

2.1 Introduction ..........................................................................................11 2.2 Area of Application – Intended Use....................................................12 2.3 User Profile ...........................................................................................12

2.3.1 Professional User - Administrator Level ...................................12 2.3.2 End User or Routine User ........................................................12 2.3.3 Service Technician ...................................................................12

2.4 Validation ..............................................................................................13 2.5 Instrument Specifications ...................................................................14 2.6 Instrument Description........................................................................15

2.6.1 Aspirating and Dispensing Head ..............................................17 2.6.2 Aspirating and Dispensing Pumps ...........................................18 2.6.3 Tray Heating Lid .......................................................................19

3. Installation Procedure........................................................................20 3.1 Introduction ..........................................................................................20 3.2 Packing List ..........................................................................................20 3.3 Unpacking Procedure and Inspection................................................21 3.4 Power Requirements............................................................................21 3.5 Environmental Requirements .............................................................21 3.6 Instrument Installation Procedure ......................................................22

3.6.1 First Use ...................................................................................22 4. Operating Instructions.......................................................................23

4.1 Introduction ..........................................................................................23 4.2 Switching ON the Instrument ..............................................................23

4.2.1 Setup for a Test Run ................................................................25 4.2.2 Menu Overview ........................................................................27

4.3 Positioning the Heating Lid.................................................................28 4.4 Positioning the Tray.............................................................................29 4.5 Removing the Tray...............................................................................31 4.6 Disposal of the Tray (and the Instrument) .........................................32 4.7 Cleaning and Shut Down Procedures ................................................32

4.7.1 After Each Run .........................................................................32 4.7.2 Daily Cleaning Procedures.......................................................33

5. Main Programming Procedures ........................................................34 5.1 Define Program.....................................................................................35

5.1.1 Aspirate Step (ASP) .................................................................36 5.1.2 Dispense Step (DISP) ..............................................................37 5.1.3 Wash Step (WASH)..................................................................38 5.1.4 Incubate Step (INC)..................................................................39 5.1.5 Insert Program (INSPROG)......................................................40


5.1.6 Insert Step (INS).......................................................................41 5.1.7 Delete Step (DEL) ....................................................................42 5.1.8 Temp Step (TEMP) ..................................................................42 Cool Step (COOL) ..................................................................................43 5.1.9 Drying Step (DRYING) .............................................................43 5.1.10 Pause Step (PAUSE) ...............................................................44 5.1.11 End Step (END)........................................................................45 5.1.12 Edit Procedure for a Defined Program .....................................45 5.1.13 Change Defined Steps .............................................................45

5.2 Run Program.........................................................................................46 5.3 Show Program Submenu.....................................................................48 5.4 Liquid Preparation Submenu ..............................................................49

5.4.1 Clean ........................................................................................50 5.4.2 Pump Back ...............................................................................51 5.4.3 Auto Clean................................................................................51 5.4.4 Pump Calibration......................................................................53 5.4.5 Adjust Tub Volume ...................................................................55 5.4.6 Fill System................................................................................57

5.5 Define Password ..................................................................................58 5.6 Define User Password .........................................................................59

6. Cleaning and Maintenance ................................................................60 6.1 Introduction ..........................................................................................60 6.2 Cleaning the Instrument ......................................................................60 6.3 Cleaning Pumps and Tubes ................................................................61 6.4 Cleaning Waste Bottles .......................................................................61 6.5 Fuse Replacement................................................................................62 6.6 Maintenance Plan.................................................................................63

6.6.1 Daily .........................................................................................63 6.6.2 Weekly......................................................................................63 6.6.3 Every Three Months .................................................................63 6.6.4 Yearly .......................................................................................64

6.7 Instrument Disinfection .......................................................................65 6.7.1 Disinfection Procedure .............................................................65

6.8 Disinfection Certificate ........................................................................67 6.9 Disposal ................................................................................................68

6.9.1 Introduction...............................................................................68 6.9.2 Disposal of Packing Material ....................................................68 6.9.3 Disposal of Operating Material .................................................69 6.9.4 Disposal of the Auto-LiPA 48 Instrument .................................69

7. Error Messages ..................................................................................70 7.1 Introduction ..........................................................................................70 7.2 Messages ..............................................................................................70

Index ..........................................................................................................77


1. Safety

1.1 Instrument Safety • The responsible body must ensure that appropriate decontamination is

carried out if hazard material is spilt onto or into the equipment. • The responsible body must ensure that the manufacturer or his agent is

consulted if there is any doubt about the compatibility of decontamination or cleaning agents with parts of the equipment or with material contained in it.

• The equipment must not be used in hazardous atmospheres or with hazardous materials for which it is not designed.

• The protection provided by the equipment may be impaired if the equipment is used with accessories not provided or recommended by the manufacturer, or used in a manner not specified by the manufacturer.

WARNING IF THE Auto-LIPA 48 OR THE FIRMWARE IS MODIFIED IN ANY WAY, THE PERFORMANCE OF THE INSTRUMENT MAY BE NEGATIVELY

AFFECTED, THE WARRANTY WILL NO LONGER BE VALID AND THE

INSTRUMENT WILL NOT BE CE CONFORM.

WARNING THE INSTRUMENT COMPLIES WITH THE EMISSION AND IMMUNITY

REQUIREMENTS DESCRIBED IN IEC 61326-2-6; HOWEVER, THE ELECTROMAGNETIC ENVIRONMENT SHOULD BE EVALUATED

PRIOR TO THE OPERATION OF THE INSTRUMENT. IT IS THE OPERATOR'S RESPONSIBILITY TO ENSURE THAT A COMPATIBLE ELECTROMAGNETIC ENVIRONMENT FOR THE INSTRUMENT IS MAINTAINED, SO THAT THE INSTRUMENT

PERFORMS AS INTENDED. DO NOT OPERATE THE INSTRUMENT IN CLOSE PROXIMITY TO SOURCES OF STRONG ELECTROMAGNETIC RADIATION (E.G.

UNSHIELDED INTENTIONAL RF SOURCES) AS THIS MAY INTERFERE WITH THE PROPER FUNCTION OF THE

INSTRUMENT AND MAY ALSO LEAD TO INCORRECT RESULTS.


2. General

2.1 Introduction The Auto-LiPA 48 offers automated processing of INNO-LiPA and INNO-LIA™ tests from sample preparation to color development. The Auto-LiPA48 can also be used for automated processing of INNO-LIA tests from sample preparation to colour development provided only wells 1 till 24 are used. The instrument is designed for professional use only and should only be operated by trained personnel.

Instrument features

Walk-Away Processing

• Loads up to 48 strips • Fully automated reagent addition and aspiration • Overnight processing • Built-in failure detection

Performance

• Up to 20 defined programs, permanently stored • Up to 59 process steps possible for each program • 6 different reagent channels (channel 7 optional) • 3 built-in aspirating pumps to remove the liquids • Automatic clean function • Manual clean function • Pump calibration • Incubation with programmable heating and cooling for the tray (heated by

an internal element) • Reagent incubator for 2 reagents with magnetic stirrers

Important If the operating directions given in these Instructions for Use are not correctly followed, the instrument may be damaged or the procedure may not be correctly performed and the safety of the operator cannot

be guaranteed.

Any in vitro procedures for diagnostic purposes that are performed on the instrument must be validated.


2.2 Area of Application – Intended Use The Auto-LiPA 48 is a wash and incubation device for up to 48 strips for processing biological samples according to the specifications described in this manual. The instrument is intended for professional in-vitro diagnostic use in Europe, applying test systems such as • INNO-LiPA strips • INNO-LIA strips • southern blot strips, e.g. oncology testing, forensic medicine • western blot strips, e.g. infectious diseases, autoimmune diagnostic,

allergy screening (according to temperature specification of the instrument) which must be validated according to the European IVD directive 98/79/EC or other relevant regulations. The waste can be biohazardous or toxic.

2.3 User Profile 2.3.1 Professional User - Administrator Level

The administrator is a person who has suitable technical training and corresponding skills and experiences. If the product is used as intended, the person is able to recognize and avoid dangers. The administrator has extensive skills and is able to instruct the end user or the routine user in assay protocols in connection with a Tecan product within the bounds of the intended use. Computer application skills and good English skills are required.

2.3.2 End User or Routine User The end user or routine user is a person who has suitable technical training and corresponding skills and experiences. If the product is used as intended, the person is able to recognize and avoid dangers. Computer application skills and good language skills for the respective national language at the installation site and English are required.

2.3.3 Service Technician The service technician is a person who has suitable technical training and corresponding skills and experiences. If the product needs to be serviced or maintained, the person is able to recognize and avoid dangers. Computer application skills and good English skills are required.


2.4 Validation The Auto-LiPA 48 has been validated for representative applications (see above). The validation shows the general ability of Auto-LiPA 48 to using the above mentioned methods.

Note If the Auto-LiPA 48, software or firmware are modified in any way the

instrument loses its guarantee and will no longer be IVD compliant for Europe.

Note The operating authority must use only CE-labeled test kits for clinical

diagnostic applications.

The operating authority must assure that the combination of a particular CE-labeled test kit used with the CE-labeled Auto-LiPA 48 has been validated according to IVD directive for Europe or to other relevant

national or local regulations.


2.5 Instrument Specifications The table below lists the physical specifications of the instrument.

Parameters Characteristics

General

Display unit: Liquid Crystal Display with 2 rows of 16 digits

Keyboard: 4-key membrane keyboard

Number of dispensing channels: 6 (7th optional)

Capacity of bottles: 4 x 250 mL 2 x 500 mL

1 x 1000 mL 1 x 2000 mL

1 x 2500 mL 1 x 3000 mL

Computer Interface: Serial RS 232 C, ,USB (9600 Baud)

Incubation temperature: Adjustable between 35°C and 65°C

Temperature accuracy: ± 1°C

Volume of reagent dispensed: 250 - 3000 µL in 250 µL steps

Dispensing accuracy: 2000 µl: less than or equal to 10% 250 µl: +25% to -20%

Cooling: Temperature < 30°C within 6 min

Power

Supply: Auto-sensing for the settings

100 - 120 Volt and 220 - 240 Volt

50 or 60 Hz

Mains fuses: 2 x T 8A / 250V (Slow Blow)

Consumption: Max. 900 VA

Physical Closed Open

External dimensions: Width : 804 mm/ 31’’ 804.0 mm/ 31’’

Height: 460 mm/ 18’’ 671.4 mm/ 26’’

Depth : 459 mm/ 18’’ 510.6 mm/ 20’’

Weight: 47 kg

Refer to chapter 3.5 Environmental Requirements for environmental parameters.


2.6 Instrument Description The illustrations below show the main components of the instrument.

Front View

Rear Panel

All connected devices must be approved and listed as per IEC 60950-1 Information technology equipment – Safety or equivalent local standards.

Aspirating and dispensing tubes

Reagent bottles

Front cover

Calibration tub

Waste bottle

Heat transfer shell

Toxic waste bottle

Heating block/ stirrer

Display with 4 keys48 Strip tray

Pumps

Bottles with insulation jacket

RS232 and USB port

Labels

ON / OFF Switch


RS232 USB


2.6.1 Aspirating and Dispensing Head The aspirating and dispensing head contains the aspirating needles and the reagent dispensing tubes.

Note Ensure that the aspirating tubes run left and right of the dispensing tubes.

The aspirating and dispensing head can be used for 48-strip trays and contains: 3 aspirating needles (3 wells are aspirated simultaneously). 3 dispensing tubes for reagent 2 (3 wells are filled simultaneously). 3 dispensing tubes for reagent 3 (3 wells are filled simultaneously). 1 dispensing tube for reagent 1. 1 dispensing tube for reagent 4. 1 dispensing tube for reagent 5. 1 dispensing tube for reagent 6. 1 dispensing tube for reagent 7 (optional).

Reagent Tube

1 A (green)

2 A,B,C (blue)

3 A,B,C (orange)

4 A (red)

5 A (white)

6 A (yellow)

7 A (brown)

Aspirating tubesAspirating tubes

CORRECT! WRONG!


2.6.2 Aspirating and Dispensing Pumps The instrument is fitted with 3 aspirating and 10 dispensing pumps (11 for option with 7 channels). The dispensing pumps are arranged as follows: Reagent 1 1 pump (green) Reagent 2 3 pumps (blue) Reagent 3 3 pumps (orange) Reagent 4 1 pump (red) Reagent 5 1 pump (white) Reagent 6 1 pump (yellow) Reagent 7 1 pump (brown, optional)

3A1 63C3B

2C 4 5 7

2B 2A


2.6.3 Tray Heating Lid To prevent condensation, which could cause crossover contamination from one strip to another, the heating lid contains a low-voltage heating element.

Only remove for scanning or cleaning

Make sure the lid screws are in the correct position in order to fasten the heating foil (Open – Closed).

Tray

Tray heating lid


3. Installation Procedure

3.1 Introduction This chapter contains the necessary information for installing the instrument. The installation procedures involve unpacking, environmental requirements, power requirements, and connection of the reagent bottles.

3.2 Packing List

Note The Auto-LiPA 48 is a very heavy instrument (47 kg). At least two people

must carefully lift the instrument from the box.

The complete package includes: • The Auto-LiPA 48 instrument • Power cable • 2 spare fuses • Instructions for Use • 4 x 250 mL bottles (optional 5 for the 7th channel) • 1 x 2500 mL bottle (marked black and labeled “biohazardous waste”) • 1 x 2000 mL bottles (marked red for hot water) • 1 x 3000 mL bottle (marked blue for cold water) • 1 x 1000 mL bottles (for reagent channel 3) • 1 x 500 mL bottle + lid (for toxic waste, channel 6) • 1 x 500 mL bottle + lid (for reagent channel 2) • 3 x insulated containers (plastic jackets) for 500 mL, 2000 mL and 3000 mL

bottles • 3 magnetic stirrers • 2 heat transfer shells (250 mL, 500 mL) • 5 trays • 4 sieves • Computer connection cable RS232 • USB cable • Certificate of conformity to final QC procedures • Out of Box quality report • BlotWare software (CD-ROM)


3.3 Unpacking Procedure and Inspection 1. Visually inspect the container for damage before opening. Report any damage immediately on the installation report. 2. Place the carton in an upright position and open it. 3. Remove the carton and set apart the packed accessories. 4. Lift the instrument from the pallet and place it on a flat surface, free from

dust, vibration, and away from direct sunlight. 5. Visually inspect the instrument for loose, bent or broken parts. Report any damage immediately. 6. Compare the serial number on the rear panel of the instrument with the

serial number on the delivery (shipping) note. 7. Check the instrument accessories with the delivery (shipping) note. 8. Save all packing materials as they may be required for later transportation.

3.4 Power Requirements The instrument is auto-sensing, so does not have to be set to the correct voltage. Connect the instrument only to an electricity supply system with protective earth.


TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY BE REPLACED WITH THE SAME TYPE AND RATING OF FUSE.

In case of an electric black out, a power failure occurs.

3.5 Environmental Requirements The instrument should be placed on a level surface that is free from dust, solvents and acidic vapors. Vibration and direct sunlight must be avoided to ensure correct results.

Environmental Parameters Temperature

Operation: +15°C to +30°C (59°F to 86°F)

Non-operation: -10°C to +50°C (14°F to 122°F)

Relative humidity

Operation: 20% to 90%, no condensing

Over voltage category: II

Pollution degree: 2

Method of disposal: Toxic waste


3.6 Instrument Installation Procedure 3.6.1 First Use

CAUTION Before the instrument is installed and switched on, it should be left to

stand for at least 3 hours so there is no possibility of condensation causing a short circuit.

The following procedure describes the necessary steps to be followed when installing the instrument. 1. Place the instrument on a level surface.

Ensure that the distance between the back panel of the instrument and the wall is at least 10 cm.

2. Open the front cover of the instrument. 3. For transportation, the instrument's hot and cold water circulation system is

filled with distilled water and the tubes are tied together with a red cable tie. Place a container under the water tubes (hot and cold) and remove the red cable tie from the water tubes. Please Note: Some of the distilled water will run out!

4. Plug the power cable into the mains power socket on the back panel of the instrument.

5. Switch the instrument ON using the ON/OFF switch on the back panel.

6. On the display the following header appears: 7. When the instrument is switched ON for the first time or after the hot and

cold water circulation system has been filled with distilled water (refer to chapter 5.4.6 Fill System), a procedure to empty the water circulation system is started. Pressing any key at the message “empty water bath, press any key”. 'Empty water bath in progress' appears on the display. At the end of the procedure the instrument returns to the standby mode (Run Program).

ON/OFF switch

Main power cable socket

Fuse holder

Auto-LiPA 48 V X.x

empty water bath press any key

empty water bath in progress

MAIN FW-Run


4. Operating Instructions

4.1 Introduction The topics covered in this chapter are: 1. Switching ON the Instrument This section contains the instructions on how to switch the instrument ON and the description of the menu. 2. Operating Instructions This section includes the necessary instructions for operating the instrument. 3. Cleaning and switching OFF Procedures This section includes the instructions on how to perform the 'Automatic Cleaning' procedure and how to switch the instrument OFF.

4.2 Switching ON the Instrument Make sure the instrument has been correctly installed and the power cable is connected to the power cable socket in the back panel of the instrument. Switch the instrument ON, using the ON/OFF switch in the back panel of the instrument.

Note When the instrument is switched on for the first time, or after it has not

been used for some time, the hot and cold water circulation system is filled with distilled water and must be emptied.

The procedure to empty the water circulation system is started by pressing any key on the display at the message “empty water bath in progress – press any key”. Place containers under the hot and cold water tubes to

collect the water.

The instrument then starts the initialization procedure and displays the following message: Auto-LiPA 48 is the displayed starting header for the instrument and V X.x is the instrument's software version. The instrument then performs the following self-check procedures: • Software version check • Programs check • Memory check • Initialization (tray drive, needle drive ). If an error is detected the instrument displays an error message. (See chapter 7 Error Messages for further details ).

Auto-LiPA 48 V X.x


After the self-check procedures have been completed, the instrument proceeds to the MAIN mode and displays the message: Press the FW-Run key (4th key ↵) to enter the Standby mode (Run Program is displayed). The instrument is in the Run Program menu (Standby mode). Press the < key (1st key), to go a step backwards in the menu. Press the > key (2nd key), to go a step forward in the menu. Pressing the Main key (3rd red key), leads to the Main mode.

Note Connection to the PC is only possible when the instrument is in the

Main mode. BlotWare software must be started after the instrument is in Main mode otherwise the instrument is not recognized.

Pressing the yes key (4th key ↵), confirms the selection of the displayed menu, in this case Run Program (see chapter 5.2 Run Program).

Main FW-RUN

POWER

< >

Run Program Main yes

POWER

< >


4.2.1 Setup for a Test Run

Cold water bottle …with cover …with insulation jacket

Hot water bottle …with cover …with insulation jacket

Fill the hot water bottle (marked red) up to the upper edge of the red marker with d i s t i l l e d water (approx. 1.6 L). Fill the cold water bottle (marked blue) up to the upper edge of the blue marker with d i s t i l l e d water (approx. 2.5 L).

Note Check the water level before each run and refill (up to the markers) if

necessary. The water has to be replaced weekly. Ensure that the sieves in the hot and cold water tubes (marked with HW1,

HW3, CW1, CW3) are clear.

1. Insert the hot and cold water bottles into the insulation jackets and place

them in the instrument. 2. Insert the hot water tubes (marked red) into the hot water bottle (also

marked red) and the cold water tubes (marked blue) into the cold water bottle (also marked blue). Put the lids on the insulation containers.

3. Check that the sieves in the hot and cold water tubes (marked with HW1, HW3, CW1, CW3) are clean.

4. Place the reagent bottles in the instrument (on the correspondingly colored circles) and connect to the appropriate color-coded reagent tubes.


Please note: Channels 2 and 3 have 3 tubes for each channel.

Heat transfer shell – 250 ml Heat transfer shell – 500 ml

5. Place reagent bottles in the heat transfer shells, place the magnet in the bottles and then place them onto the incubator unit.

6. Place the tube for biohazardous waste (marked with a black strip) into the large bottle (marked black and labeled 'biohazardous waste'). The tube is located on the left side of the instrument.

7. Place the tube for toxic waste into the 500 mL bottle marked ‘toxic waste’. The tube is located on the left side of the instrument.

Caution Never open the cover of the instrument while a test run is being

performed.

We recommend to load the tray with all the strips showing in the same direction and with the coated surface on top. Maximal dimension of a strip is approximately 9 cm x 0,3 cm (3.54’’ x 0.12’’). For further details on the strips refer to the manual of the corresponding kit.

Caution When the instrument is connected via USB to the PC and a test is running, never switch off the PC. The run will stop immediately.


4.2.2 Menu Overview

Main < > FW Run

Run Program < > Main yes

Liquid Prep < > yes

Define Program< > yes

Show Program < > yes

Service < > yes

Define User PW< > yes

Runs a defined program. See 5.2 Run Program

See 5.4 Liquid Preparation Submenu Clean Pump Back Auto Clean Pump Calibration Adjust Tub Volume

Procedure for defining programs. See 5.1 Define Program

Show defined parameters for programs. See 5.3 Show Program Submenu

Procedure for defining a user password. See 5.6 Define User Password

Connection to the PC is only possible when the instrument is in Main mode

For service technician only (password protected)

Define Password< > yes

Procedure for defining a password. See 5.5 Define Password

Main mode

Standby mode


4.3 Positioning the Heating Lid

1. Install the heating lid and carefully fasten the two screws of the heating lid. 2. Make sure that the heating lid is correctly positioned with the heating

contacts connected.

Note If the message “Lid heat error” is displayed, make sure that the heating lid

and tray clamp-bar are correctly fitted, and that the heating lid contacts and tray clamp-bar contacts are clean (see chapter 7 Error Messages).

Remove the heating lid by turning left the screws. The heating lid can be stored under the bottom plate of the instrument.

Heating contact


4.4 Positioning the Tray

CAUTION ONLY ORIGINAL TRAYS HAVE TO BE USED AS THEY HAVE BEEN DESIGNED TO MEET THE EUROPEAN IVD DIRECTIVE

98/79/EC. TRAYS ARE FOR SINGLE USE ONLY.

Note The tray can only be loaded when the instrument is in standby mode.

During preparation procedure INSERT TRAY is displayed; the pumps and valves for the tray heating and water cooling are deactivated.

(During preparation procedure, the instrument brings the hot and cold water to temperature).

Do not open the tray support when a program is being performed.

1. Open the front cover of the instrument. 2. Make sure that the 3 tray clamp-bar clips are turned to the left, so that the

tray support movement is blocked. Then lift the tray clamp-bar.

Use by (date) Single use only

Clamp-bar clip

Tray heating lid

Tray clamp-bar

Tray

Tray clamp-bar

Clamp-bar clip Clamp-bar clip


3. Make sure that the bottom of the tray is not damaged or dusty. Insert the

tray under the clamp-bar and position it as described in the following procedure.

IMPORTANT

Each tray must be used only once to avoid the risk of cross-contamination.

Note Trays not used immediately must be kept in the original packaging.

4. Position the tray in such a way that the clamp-bar clips are fitted into the

slots of the tray.

The tray has to fit exactly on the tub. Positioning pin

5. When the two slots at the front of the tray fit around the positioning pin, the

tray is positioned correctly. 6. Lower the clamp-bar, press it down and turn the clamp-bar clips to the right

so that the tray is locked into place.

CORRECT! WRONG!


4.5 Removing the Tray

WARNING THE TRAY CAN BE REMOVED WHEN THE INSTRUMENT IS IN

STANDBY MODE (RUN PROGRAM IS DISPLAYED) AND THE PUMPS AND VALVES FOR THE TRAY HEATING AND COOLING WATER HAVE STOPPED. DO NOT OPEN THE TRAY SUPPORT WHILE A PROGRAM

IS BEING PERFORMED.

1. Open the front cover of the instrument. 2. Make sure the 3 tray clamp-bar clips are turned to the left and then raise

the tray clamp-bar. 3. Remove the tray from the tray support. 4. Make sure that the tray clamp-bar remains open while removing the tray. If another program is to be performed, insert and position the next tray. 5. Press the clamp-bar down and turn the clamp-bar clips to the right so that

the clamp-bar locks the tray into place. 6. Close the front cover of the instrument. The instrument is now ready to perform another program.

WARNING IF THE TRAY IS TO BE UNLOADED DURING A PROGRAM FOR ANY REASON, THE PROCEDURE MUST FIRST BE ABORTED AND THE

INSTRUMENT RETURNED TO THE STANDBY MODE. IF THE INSTRUMENT IS NOT RETURNED TO THE STANDBY MODE, THERE IS A FIRE HAZARD FROM THE WATER-HEATING SYSTEM.


4.6 Disposal of the Tray (and the Instrument) Follow the required procedures for biohazardous or toxic waste disposal. E.g.:

Method of disposal Toxic / biohazardous waste

Pollution degree 2 ( IEC / EN 61010-1 )

WARNING TOXIC AND BIOHAZARDOUS WASTE CAN BE ASSOCIATED WITH THE

TRAY FROM THE PROCESS RUN ON THE AUTO-LIPA 48. TREAT THESE SUBSTANCES AND THE DISPOSABLE TRAY IN

ACCORDANCE WITH GOOD LABORATORY PRACTICE GUIDELINES. INQUIRE ABOUT APPROPRIATE COLLECTING POINTS AND

APPROVED METHODS OF DISPOSAL IN YOUR COUNTRY, STATE OR REGION.

WHEN DISPOSING OF OPERATING MATERIAL OF THE AUTO-LIPA 48, THE RELEVANT NATIONAL AND REGIONAL LAWS, DIRECTIVES AND

RECOMMENDATIONS MUST BE FOLLOWED.

See chapter 6.9 Disposal for further details.

4.7 Cleaning and Shut Down Procedures

WARNING IT IS ADVISABLE TO WEAR DISPOSABLE POWDER-FREE GLOVES

AND PROTECTIVE GLASSES AND CLOTHING WHEN CLEANING THE INSTRUMENT.

4.7.1 After Each Run The cleaning procedure is the most important maintenance procedure for the instrument. After each run, and before the instrument is switched off, the dispensing system should be thoroughly rinsed with preheated distilled water.

Important The cleaning procedure must be carried out after each run and before an extended period of disuse (one week or longer). This prevents the

formation of crystals from the reagent solutions in the dispensing system. If this occurs, the instrument will malfunction and may require

expensive repair.


The instrument has two rinsing modes: Auto Clean

Automatic cleaning procedure for all 6 (7th optional) channels (see chapter 5.4.3 Auto Clean). Liquid volume used for each channel: 10 mL

Clean Cleaning procedure for selected channels using a defined volume of solution. Liquid volume can be selected from 2 mL to 10 mL, the default is 3 mL.

Note Before starting the rinsing procedures, decide whether the reagent in the dispensing system is to be pumped back into the reagent bottles or not.

If the reagent is to be pumped back into the reagent bottles, use the Pump Back submenu in the Liquid Preparation menu to pump the reagent back into the bottles (see section 5.4.2 Pump Back for details). Before the instrument is switched OFF, the dispensing system should be thoroughly rinsed with at least distilled water.

4.7.2 Daily Cleaning Procedures 1. Remove the reagent bottles and place ALL the reagent tubes (including

tubes of unused channels) into a bottle containing distilled water or a suitable cleaning solution (2% SDS and 0.1% Tween 20 in distilled water, heated to +60°C before use). The tubes must then be thoroughly rinsed with distilled water.

Note Do not forget to rinse with distilled water after using a cleaning liquid.

2. Use the Auto Clean procedure to clean ALL channels (in the Liquid

Preparation Submenu). Use the Clean procedure to clean selected channels. The channel number(s) and rinsing volume must be entered manually.

3. When the Auto Clean procedure has been completed, the calibration tub will be filled with water. Press any key to empty.

4. Leave the distilled water in the pumps and tubes by selecting Exit at the Remove water command.

5. If the instrument is to be switched off for a week or longer, place a tray in the instrument and fill the hot and cold water circulation system with distilled water (refer to chapter 5.4.6 Fill System, for further information). When the instrument is switched on again, the water circulation system is emptied by pressing any key at the message “empty water bath, press any key”.

6. Switch off the instrument.


5. Main Programming Procedures This chapter gives instructions on how to define the programs for the instrument. The submenu Show Program for displaying the programmed parameters will be explained. The instrument can store up to 20 programs. Each program can contain up to 59 process steps. Programs can be defined by the user (see chapter 5.1 Define Program). The following processing steps are available:

ASP Aspiration of liquid.

DISP Dispense liquid (250 - 3000 µl in 250 µl steps)

WASH Aspirate and immediately dispense liquid

INC Incubation of the tray (1 - 999 min)

INSPROG Insert a defined program at the desired program step

INS Insert a new step at this point

DEL Delete the displayed step

TEMP Switch the heating system ON to heat the tray (35°C to 65°C)

COOL Switch the heating system OFF to cool the tray

DRYING Procedure for drying

PAUSE Pause the procedure at this point

END End of the program definition procedure

The defined programming steps are performed on all the wells before the next step is performed.

Note If an incubation step is programmed after a step that dispenses reagent,

the incubation time is started after the first well has been dispensed.

If a COOL step is programmed after an ASP or WASH program step, the cooling procedure is started at the beginning of the ASP or WASH step.

The COOL step stops when the next INCUBATION step is performed.


5.1 Define Program

Main FW Run

Define Program < > yes

Press yes to enter Define Program procedure


Prog XX — + exit yes

Use the – / + keys to scroll through programs 1 to 20 and select program number to be defined by pressing yes

Name: XX 890 , , ABCDE

Enter a name for the program (up to 8 characters) 1,2,3,4,5,6,7,8,9,0 and A-Z. At least one character has to be entered in order to proceed. To enter a name use the < or > key to position a character between the commas. Confirm the selection with the ↵ key. To delete the last character use the sign. When a name is complete move the ↵ between the commas and confirm with the ↵ key. Proc. 01 ASP

— + other yes

Use other to scroll through the program steps: see 5.1 sub menus Aspirate Step (ASP), Dispense Step (DISP), Wash Step (WASH), Insert Step (INS), Delete Step (DEL), Pause Step (PAUSE), End Step (END). (up to 59 steps including the end step can be defined).

Standby Mode. Use arrow keys to scroll to Define Program submenu

Main mode

Password:xxxx0 — + exit yes

Enter password (protects programs 1 to 15; see 5.5 Define Password) or user password (protects programs 16 to 20; see 5.6 Define User Password).

Proc. End exit yes

Insert End step to end the program. Press yes to confirm and menu returns to standby mode


5.1.1 Aspirate Step (ASP) The Aspirate step is used to aspirate reagents from the wells.

Note If the final program step is an ASP step and if for the Final Aspirate step the option NO was selected, then the ASP step is interrupted by a Pause

step.

Proc. 01 ASP — + other yes

Proc. X+1 ASP — + other yes

Press yes to enter Aspirate procedure into the program at the chosen step number

Use – / + keys to move to next program step number. Continue defining or editing the program by scrolling through the program steps using other. Select the step by pressing yes.


Main mode

Use arrow keys to scroll to Define Program submenu. Follow procedure for entering password, choosing program number and naming the program as described in chapter 5.1 Define Program.

Proc. End exit yes

Insert End step to end the program. Press yes to confirm and menu returns to standby mode

Main FW Run


5.1.2 Dispense Step (DISP) The Dispense step is used to dispense liquid into the wells. From the Standby mode use the arrow keys < or > to scroll to Define Program submenu. Follow procedure for entering password, choosing program number and naming the program as described in chapter 5.1 Define Program.

Proc. X ASP — + other yes

Proc. X DISP — + other yes

Use other to select Dispense step

Press yes to confirm Dispense step

Channel: 0 — + exit yes

Use – / + keys to select required channel (1–6, 7th optional); default is channel 0. If different reagents have to be used for different strips, select channel 0. When channel 0 is selected, the Start Pos. and the No. of strips have to be entered separately. The instrument requests the Start Pos. and the No. of Strips before each test run.

Channel 1-6 selected

Channel: 1 — + exit yes Select required channel X (1–6, 7th optional)

(Note: channel selection is requested twice)

Volume 2000μl — + exit yes

Select required volume (250–3000 μl in 250 μl steps); default is 2000 μl

Start Pos: 0 < > exit yes

Nr. of Strips < > exit yes

Select required number of strips for dispensing reagents from the respective channel; strips from 1 to 48 or 0 can be selected. When No. of Strips: 0 is selected, the instrument requests the No. of Strips for this step before each test run. (No. of Strips: Y Ch Z X Y=step Z=channel X=no. of strips) ‘End = takes the number of strips defined at the start of the test)

Select required starting position for dispensing reagents with this channel. When Start Pos: 0 is selected, the instrument requests the Start Pos for this step before each test run. (StPos: Y Ch Z X Y=step Z=channel X=start position)


Select next program step to continue defining/ editing the program

Channel 0 selected

Channel: X — + exit yes Use the – / + keys to select a channel from 1 to 6 / 7.

Press yes to confirm



Use - / + keys to move to next program step number. Continue defining or editing the program by scrolling through the program steps using other. Select the step by pressing yes.



Every channel is automatically primed before its first use. If a channel is used for different reagents, the reagents can be changed and the tubes primed during a Pause step.

5.1.3 Wash Step (WASH) The Wash step is used to aspirate and dispense liquid (three wells are washed simultaneously). From the standby mode use the arrow keys < or > to scroll to Define Program submenu. Follow procedures for entering password, choosing program number and naming the program as described in 5.1 Define Program.


Proc. X WASH — + other yes

Use other to select Wash step

Press yes to confirm Wash step

Channel: X — + exit yes

Select required channel X (1–6, 7th optional)

Channel 1-6 selected


Select required channel X (1–6, 7th optional) (Note: channel selection is requested twice). If different reagents have to be used for different strips, select channel 0.



Start Pos: 0 < > exit yes

No. of Strips < > exit yes

Proc. X+1 ASP — + other yes Select next process step to continue defining/ editing

the program

Select required number of strips for dispensing reagents from the respective channel; strips from 1 to 48 or 0 can be selected. When No. of Strips: 0 is selected, the instrument requests the No. of Strips for this step before each test run. (No. of Strips: Y Ch Z X Y=step Z=channel X=no. of strips) ‘End = takes the number of strips defined at the start of the test)

Select required starting position for dispensing reagents with this channel. When Start Pos: 0 is selected, the instrument requests the Start Pos for this step before each test run. (StPos: Y Ch Z X Y=step Z=channel X=start position)

Channel 0 selected


Use the – / + keys to select a channel from 1 to 6 / 7. Press yes to confirm






5.1.4 Incubate Step (INC) The Incubate step is used to define the incubation time.

If Low appears the actual temperature is at least 1°C lower than incubation temperature. This usually appears at the start of a program when the tray support is still cold. This message will disappear after incubation temperature is reached. In order to avoid this message, a short additional incubation step is recommended before starting a program.

Note The incubation time starts when liquid is dispensed in the first well.

If incubation temperature is not achieved within a test run, a Test Temperature Low (Test Temp. Low) error appears (refer to chapter 7 Error Messages for further details).


Proc. X INC — + other yes

Use other to select Incubate step

Confirm Incubate step

Inc. Time manual other yes

An incubation time (in minutes) can be entered if necessary The incubation procedure can only be stopped manually

Inc. Time: 1 min — + exit yes

Select required incubation time (1 – 999 min in steps of 1 min)

Shake Speed: X — + exit yes

Select required shake speed (1 – 5)


Select next process step to continue defining/ editing the program


5.1.5 Insert Program (INSPROG) The Insert Program step is used to insert a previously defined program into another program.

Note It is not possible to insert a program while the instrument is in operation.

This command overwrites the program steps of the original program; e.g. a program consists of 30 steps; if a program of 5 steps is inserted at step 20 of the original program, step 26 to 30 are deleted.


Proc. X INSPROGR — + other yes

Use other to select Insert Program step

Press yes to confirm Insert Program step

Prog: XX — + exit yes

Use – / + keys to select program to be inserted

Program too big! yes

Selected program contains too many steps to be performed

Proc. XX END — + other yes

Last step of inserted program Use other to switch to the next type of process step, or press yes to confirm the end of the programming procedure.



Not enough space to insert program

Enough space to insert program

Proc. END Exit yes



5.1.6 Insert Step (INS) The Insert step is used when editing a defined program, to insert a new step at any position of the program. The position number of all steps after this inserted step are then automatically increased.

Note It is not possible to insert a program step while the instrument is in

operation.



Proc. X INS — + other yes

Use other to select Insert Step

Press yes to confirm Insert Step

Use – / + keys to select step to be inserted: ASP, DISP, WASH, INC, INSPROG, PAUSE, DEL

Program too big! yes

Selected program contains too many steps to be inserted

Programming procedure for selected step


Not enough space to insert step

Enough space to insert step

Insert: xx YYYY — + exit yes

Last step of inserted program Use other to switch to the next type of program step, or press yes to confirm the end of the programming procedure


5.1.7 Delete Step (DEL) The Delete step is used to delete a defined program step from any position of the program. The position numbers of all steps after this deleted step are then automatically decreased.

5.1.8 Temp Step (TEMP) The Temp step is used to activate the heating system pumps and valves so that heating water circulates under the tray.


Proc. X TEMP— + other yes

Use other to select Temp step

Confirm Temp step

Temp: 65.0— + exit yes

Select required temperature 35.0°C – 65.0°C in 0.1°C steps




Proc. X DEL— + other yes

Use other to select Delete step

Press yes to confirm Delete step

Delete: YY XXXX no yes

Press yes to delete the selected step




Cool Step (COOL) The Cool step de-activates the tray heating system and activates the tray cooling system so that the tray is cooled down to below 30°C).

5.1.9 Drying Step (DRYING)

Note The DRYING step has to be a program on its own and has always to be

combined with an INC step. Before starting the drying procedure, remove the heating lid.


Proc. X COOL— + other yes

Use other to select Cool step

Confirm Cool step. Select an appropriate incubation time (INC step); otherwise the Cool step will not be performed properly (only the water bottle will be emptied)




Proc. X DRY— + other yes

Use other to select Dry step

Confirm Dry step (35°C - 65°C)

Temp: 65°C< > exit yes

The drying temperature can be entered




5.1.10 Pause Step (PAUSE) The Pause step is used to hold the program at the current step (e.g. for manual dispensing of samples). The program is continued when the Cont key is pressed.

When a selected program has been defined with a Pause step, the instrument operates up to the Pause step, then the alarm sounds and the following message appears on the display:

Note Each channel is primed automatically before the first usage. If a channel is used with more than one reagent during a program, the channel must be

primed manually during a pause step (the 4th key = prime).


Proc. X PAUSE— + other yes

Use other to select Pause step

Confirm Pause step



PAUSE cont. prime

Volume 3mL — + exit yes

Channel X — + exit yes

Volume 3mL

Channel X — + exit yes

Press cont. to continue according to program definition. Press prime to select the channel to be primed


Select required volume



5.1.11 End Step (END) The End step finishes the programming procedure for the current program.

5.1.12 Edit Procedure for a Defined Program To edit a defined program, proceed as described in chapter 5 Main Programming Procedures and edit the parameters as required. If the programs are password protected, enter the correct password (for programs 1 to 15) or user password (for programs 16 to 20).

5.1.13 Change Defined Steps To change the type of a defined step, use the – and + keys to scroll to the required step number that is to be altered. When the step number is displayed, press the other (3rd key) to scroll the program step types across the display. When the required program step is displayed, press the yes key (4th key) to confirm the selection. The instrument then enters the programming procedure for the selected program step. When the parameters have been entered, press the yes key (4th key) to confirm each parameter, until the end step has been confirmed. The instrument then saves the parameters and displays the next program step.

Note If an existing process step has been changed to END, all previously

defined steps after END will be deleted.


Proc. X END— + other yes

Use other to select End step

Press yes to confirm End step

Proc. End — + exit yes

Press yes to confirm programming procedure to be stopped



5.2 Run Program This section gives the instructions on how to perform a test run (see also chapter 4.2.1 Setup for a Test Run).

Note Before starting a program, the wells on the tray where the run is to be

performed, must be selected. The selection is done by entering the start position and the number of strips. The default start position is 1.

Note The instrument automatically primes the dispensing channels with the

required solution when the dispensing channel is selected in the program for the first time.

Before starting the procedure make sure that the heating and cooling water bottles contain enough d i s t i l l e d water. Fill the hot water bottle to the upper edge of the red marker with approx. 1.6 L. Fill the cold water bottle to the upper edge of the blue marker with approx. 2.5 L. Cold water should have a temperature of approx. 20°C. Make sure that the sieves in the hot and cold water tubes (marked HW1, HW3, CW1, CW3) are clean. To guarantee that the reagents fully dissolve, do not forget to use the magnetic stirrers, the heat transfer shells, and the insulation containers must be used. The reagents to be placed on the stirrer unit must have a temperature between 10°C and 15°C and not above incubation temperature. Place all reagent bottles in the correct position and insert the tubings (color-coded). Be sure that the tubing reaches at the bottom of the bottles. If 'Low' appears, the current temperature in the tray is at least 1°C lower than incubation temperature. This usually appears at the start of a test when the tray support is still cold. This message will disappear after a short incubation time. In order to avoid this, it is recommended to perform an additional incubation step before starting a test. Performing a program on the Auto-LiPA 48 consumes more reagent than a manual test. Therefore prepare larger volumes of solutions; for example, enough for a full tray plus 5 wells.

Note

The test program can be aborted at any time by pressing and holding the 3rd RED key until the current process step has been completed and

the alarm sounds.

The instrument then displays the message

Confirm Stop no yes

Press the 'no' key, to return and continue the test program. Press the 'yes' key, to confirm abortion of the test program and the instrument then returns to the standby mode.

Note After abortion, the test program cannot be continued.


When heating system at required temperature

Run: XX + — exit yes

WASTE BOTTLE OK? exit yes

Temp: xx°C exit yes

Preparing xx°C yy°C zz°C

INSERT TRAY ! press any key

CHECK SIEVES! exit yes

StPos Strip: XX exit yes

No of Strips XX exit yes

Last Aspiration no yes

Proc.: 01 Yyyy exit yes

Main < > FW Run


Step: xx Yyyy exit

Step: xx Zzzz XX.X°C exit

Test done ! Please wait

you should cleanpress any key

Set temperature displayed (only if the program contains a TEMP step)

Message to ensure that the waste bottles are empty

Heating system being prepared; this takes up to 45 min (depending on required temperature) xx = temperature cold water yy = temperature hot water zz = temperature reagent incubator

Insert tray into tray support and close front cover

Select the position of the strip where the program is supposed to start; default is StPos 1

Select required number of strips to be processed; default is 48

Does the program contain an ASP step as last step? Press yes or no.

Select program step where the procedure is to be started

Instrument displays information about the step that is being performed

If previous step is TEMP or COOL, the instrument displays the temperature

Test program completed

Message displayed as a reminder to clean the liquid system, e.g. with distilled water

Last Aspiration Cont.

Main mode. Press FW Run to move to standby mode

Standby mode

Use the - / + keys to select required program to be run. Press yes to confirm selection


5.3 Show Program Submenu This procedure is used to check the defined parameters of a program. In this submenu the defined parameter settings cannot be altered.

Main < > FW Run

Show Program< > yes

Select Show Program menu


Show XX — + exit yes

Select required program to be shown

Proc. 01 XXX — + exit yes

YYYYYYY: XXXXXXX yes

ZZZZZZZ: XXXXXXX yes

Proc. NN XXX — + exit yes

Proc. NN END exit yes

Procedure repeated for all defined steps


Select required step using – and + keys

Parameters for selected step displayed

Select required step using – and + keys

Menu


5.4 Liquid Preparation Submenu This chapter describes the use of the Liquid Preparation submenu which has the following options:

Clean Cleaning procedure for individual channels

Pump Back Procedure to pump back the solutions into the original bottle

Auto Clean Procedure to clean all channels automatically

Pump Calibration Pump Calibration procedure

Adjust Tub Volume Calibration Tub Volume Adjustment procedure

Fill System Procedure to be performed when the instrument will not be used for some time.

Main < > FW Run

Liquid Prep.< > yes

Use arrows to scroll to Liquid Prep. menu. Press yes to enter menu.


Clean < > exit yes

Cleaning procedure (confirming EXIT takes you back to the Standby mode)

Pump Back < > exit yes

Auto Clean < > exit yes

Pump Calibration< > exit yes

Adjust Tub Vol. < > exit yes

Fill System < > exit yes

Pump Back procedure

Auto Cleaning procedure for ALL channels

Pump Calibration procedure for ALL channels

Adjust Tub Volume procedure

Fill System procedure

Main mode


5.4.1 Clean This option is used to clean a selected dispensing channel.

Note The minimum volume required for cleaning the pump and tubing is 3 mL.

Liquid Prep. < > yes

Clean < > exit yes

Confirm selection of Clean option

Channel: X – + exit yes

Volume: 3 mL – + exit yes

Volume: 3 mL


Select required channel

Select required volume using < and > keys (2 – 10 mL in 1 mL steps; default is 3 mL)

Cleaning procedure performed on selected channel

Select next required channel or exit



5.4.2 Pump Back This option is used to pump back the solution from the dispensing system into the reagent bottle.

5.4.3 Auto Clean This option is used to automatically clean ALL the dispensing channels with a preheated cleaning liquid (e.g. 2% SDS and 0.1% Tween 20 in distilled water, heated to +60°C before use). Volumes required: 250 mL cleaning solution. 250 mL distilled water

Note It is recommended to rinse with distilled water at the end of each working

day and after using cleaning liquid.


Pump Back < > exit yes

Confirm selection of Pump Back option

All Pumps ? no yes



Select yes if reagents from ALL channels are to be pumped back. Select no if only liquids from selected channels are to be pumped back

Pump Back procedure performed on selected channels

Select next required channel or exit


Pump Back procedure performed on all channels

Channel: X

Select the channel to be pumped back


Automatic cleaning procedure performed (X = channel being cleaned, one after the other) When channel 1-5/7 is selected, the biohazardous waste tube is cleaned



Confirm selection of Auto Clean option (performed with 10 mL liquid)

CLEAN LIQUID ? exit yes

Auto Clean Channel: X

DISTILLED WATER ? exit yes

All reagent tubes placed in a bottle containing cleaning liquid (250 mL)


All reagent tubes placed in a bottle containing distilled water (250 mL)

Auto Clean Channel: X

Automatic cleaning procedure performed (X = channel being cleaned) When channel 6 is selected, the toxic waste tube is cleaned

After all channels cleaned, calibration tub filled with water

Tub Cleaning press any key!

Tub cleaning procedure When complete, press any key

REMOVE WATER exit yes

Remove tubes from distilled water

Empty Tubes Channel: X

Tubes are being emptied X = selected channel being emptied, one after the other

After all channels are emptied


Cleaning procedure completed


5.4.4 Pump Calibration To be carried out when the three month pump volume check fails and if dispensing faults occur

This option is used for calibration of the dispensing pumps, to ensure that the pumps are dispensing the correct volume of solution. Calibration Liquid: Make a 10 x stock solution

Dissolve 1 tablet Phosphate buffered saline + 0.5mL Tween 20 in 1 liter of distilled water. Do NOT dilute this solution with distilled water!

Alternatively, dissolve 1g NaCl and 0.05ml Tween 20 in 1 liter of distilled water. (Use 1g NaCl instead of 0.5g NaCl!)

Caution Never replace the calibration liquid with distilled water.

When this procedure is in operation the instrument must not be knocked or moved in any way and it must be level.

(The location of the instrument should not be changed between the Adjust Tub Vol. and Pump Calibration procedures).

Note Always perform an Auto Clean procedure before a Pump Calibration

procedure.




LIQUID ? – + exit yes

All Pumps ? – + no yes

Pump CalibrationPump: X

Put ALL reagent tubes in a bottle containing enough calibration liquid for the procedure


Automatic Pump Calibration procedure performedX = pump being calibrated (1 – 10, 11 optional)

DISTILLED WATER?press any key

Tub Cleaning press any key


Tub cleaning procedure; when complete press any key

After calibration completed

Calibration tub filled with water

Place ALL reagent tubes in a bottle containing distilled water

All Pumps ? – + no yesPump: 1

– + exit yes

Use - / + keys followed by yes to move to and select Liquid Prep. menu. Use arrow keys to scroll through to the option Pump Calibration.

Press yes to enter Pump Calibration procedure

Press yes to select all pumps. Calibration will start immediately. Press no to select single individual pumps

Use – or + keys to scroll through the 10 (or 11) pumps and select pump to calibrate.

Press exit to return to standby mode.


5.4.5 Adjust Tub Volume To be carried out during yearly maintenance

This option is used to adjust the volume of the calibration tub. Calibration Liquid: • Make a 10 x stock solution

Dissolve 1 tablet Phosphate buffered saline + 0.5mL Tween 20 in 1 liter of distilled water. Do NOT dilute this solution with distilled water!

• Alternatively, dissolve 1g NaCl and 0.05ml Tween 20 in 1 liter of distilled water. (Use 1g NaCl instead of 0.5g NaCl!)

Caution Never replace the calibration liquid with distilled water.

When this procedure is in operation the instrument must not be knocked or moved in any way and it must be level.

(The location of the instrument should not be changed between the Adjust Tub Vol. and Pump Calibration procedures).

Note Always perform an Auto Clean procedure before an Adjust Tub Volume

procedure.



Adjust Tub Vol.< > exit yes

Press yes to enter Liquid Prep. submenu. Use arrow keys to scroll to Adjust Tub Volume.

LIQUID ? – + exit yes

Tara: – + exit yes

Weigh Liquid ? – + exit yes

Insert reagent tube 1A (green) into a bottle containing calibration liquid

Remove and weigh bottle and set balance to zero.When balance is set to 0, insert reagent tube 1A into bottle


Remove and weigh bottle, record weight of liquid dispensed

Dist.: XXXX μl – + exit yes

Use – and + keys to enter the weight of the liquid dispensed. Weight is changed in steps equivalent to 10 μl. XXXX μl: last given number

If pump calibration is to be performed, place ALL reagent tubes in a bottle with enough calibration liquid for the procedure

Pump CalibrationPump: X

Remove tubes from distilled water

DISTILLED WATER?press any key

Automatic Pump Calibration procedure performed X = pump being calibrated

Pump Calibration– + no yes

After calibration completed

Calibration tub filled with water

Tub Cleaning press any key

All reagent tubes placed in a bottle containing distilled water

Adjust Tub Vol. < > exit yes

Tub cleaning procedure When complete press any key

after 3 times 2 times more

Press yes to enter Adjust Tub Volume procedure


5.4.6 Fill System

Note This procedure is to be performed when the instrument is not going to be

used for a week or longer and is switched OFF.

Place a tray in the instrument and fill the hot and cold water circulation system with distilled water.

When the filling procedure has been performed the instrument can be switched OFF. In case the Fill System procedure is stopped for some reason – e.g. a power failure – switch on the instrument and restart the procedure. When the instrument is switched ON again, the hot and cold water circulation system is automatically emptied (see chapter 3.6.1 First Use). Place containers under the hot and cold water tubes to collect the water. As soon as the water circulation system has been completely emptied and the procedure is finished, the tray can be replaced by a new one. See chapter 3 Installation Procedure and chapter 4.7.2 Daily Cleaning Procedures for further details.

Use arrow keys to scroll to Fill System procedure

Press yes to enter Liquid Prep. menu Liquid Prep. < > yes


INSERT TRAY ! – + exit yes

Fill System in progress

Insert a tray

The water circulation system is filled




5.5 Define Password This option is used to define the password for the instrument. The password is active by default and defined as 0000. The password code can be redefined if desired to a 4 numbered code of choice (use numbers only). The password protects programs 1 to 15 from editing. Once the password is entered it opens programs 1 to 20 which can then be edited or defined. The password can be deactivated in the service menu by a service technician.

Caution It is the responsibility of the user:

• to ensure that the password remains secret • to follow the SOP which ensures that the password is not lost

• to contact the service technician if the password is lost.

Note If a false password is entered an error message will be displayed. See 7.2

Error Messages

Press yes to enter Define Password procedure

Password: 0000 exit yes

Password: xxxx 0 — + exit yes


Press yes to re-define a new password. Press exit to return to standby mode.

Use the – / + keys followed by yes to enter each of the 4 digits of the new password code. It is automatically accepted on entering the last 4th digit.

Menu returns to standby mode and the new password has been defined

Define Password < > yes

Enter the current password by scrolling through the digits using the – / + keys and press yes to enter each one. On entering the final digit the password is automatically entered and displayed. Press exit to return to standby mode.

Password: xxxx 0 - + exit yes


Use arrow keys to scroll to Define Password submenu


5.6 Define User Password This option is used to define the user password for the instrument. The user password is active by default and defined as “0000”. This factory setting is the same code as for the password (see 5.5 Define Password). The user password code can be redefined if desired to a 4 numbered code of choice (use numbers only). The user can choose to define it to be the same as the password in chapter 5.5 or give it a unique code. The user password protects programs 16 to 20 from editing and can open programs 16 to 20 which can then be edited or defined.

Caution It is the responsibility of the user:

• to ensure that the user password remains secret • to follow the SOP which ensures that the password is not lost

• to contact the service technician if the password is lost.

Enter the current user password by scrolling through the digits using the – / + keys and press yes to enter each one. On entering the final digit the password is automatically entered and displayed. Press exit to return to standby mode.

Press yes to enter Define User Password procedure

Password: 0000 exit yes

Password: xxxx 0 — + exit yes


The user password is displayed. Press yes to re-define a new user password. Press exit to return to standby mode.

Use the – / + keys followed by yes to enter each of the 4 digits of the new user password code. It is automatically accepted on entering the last 4th digit.

Menu returns to standby mode and the new user password has been defined.

Define User PW < > yes

Password: xxxx 0 - + exit yes


Use arrow keys to scroll to Define User Password submenu


6. Cleaning and Maintenance

6.1 Introduction This chapter gives instructions on how to clean and disinfect the instrument and on how to replace the main fuses.



6.2 Cleaning the Instrument This is a precision instrument and requires regular cleaning to ensure continued precision.

Display Window Cover The display window cover on the alphanumeric display may be cleaned periodically, using a lint free tissue moistened with a mild detergent.

Front Cover The front cover may be cleaned periodically, using a lint free tissue moistened with a mild detergent. Never use alcohol or acetone for cleaning the cover.

Note Never use acetone or alcohol, to clean the cover.

Tray Seal Clean the tray seal using a lint free tissue moistened with a mild detergent.


6.3 Cleaning Pumps and Tubes This cleaning procedure is the most important maintenance procedure for the instrument, because it prevents blocking the needles caused by crystallization of solutions.

CAUTION It is mandatory that the procedure is performed at the end of each working day or when the instrument will not be used for a week or

longer.

IMPORTANT IF THE DISPENSING SYSTEMS BECOME BLOCKED WITH CRYSTALS, THE INSTRUMENT WILL NOT DISPENSE CORRECTLY AND MAY NEED

EXTENSIVE REPAIRS.

For more details on cleaning, refer to chapter 5.4.1 Clean and chapter 5.4.3 Auto Clean.

6.4 Cleaning Waste Bottles

WARNING BEFORE CLEANING THE WASTE BOTTLES EMPTY THEM

ACCORDING TO DISPOSAL REGULATIONS (SEE CHAPTER 6.9.3 DISPOSAL OF OPERATING MATERIAL).

THE BOTTLES MUST BE CLEANED REGULARLY DEPENDING ON THE APPLICATIONS, USING A MILD DETERGENT.




6.5 Fuse Replacement

WARNING TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY BE

REPLACED WITH THE SAME TYPE AND RATING OF FUSE.

The following steps must be performed to replace the fuse, which is located under the power cable connection, in the rear panel of the instrument. 1. Switch off the instrument and unplug the power cable. 2. Open the plastic cover of the fuse holder by inserting a screwdriver into the

slot on top of the cover and pushing the cover out. 3. The fuse holder is located above the ON/OFF switch.

4. Pull the fuse holders out and replace the defective fuses with new fuses. Make sure that the fuses have the correct rating.

100 – 120 Volt and 220 - 240 Volt: T 8.0 / 250 V (Slow Blow)

Fuse label: 5 Replace the fuses and close the plastic cover on the fuse holder. 6. Reconnect the power cable and switch on the instrument.

WARNING IF THE FUSES CONTINUE TO BLOW, PLEASE CALL FOR SERVICE.

ON/OFF switch

Main power cable socket

Fuse holder


6.6 Maintenance Plan This procedure describes the necessary steps which must be performed regularly to guarantee the correct performance of the instrument.

6.6.1 Daily Auto Clean procedure: Remove all reagent containers from the instrument. Place all dispensing tubes in a bottle filled with distilled water and perform the Auto Clean procedure. To save the reagents, the Pump Back step can be used prior to the Auto Clean procedure (see chapter 5.4.3 Auto Clean). Clean the tray seal using a lint free tissue moistened with a mild detergent.

6.6.2 Weekly Perform the Auto Clean procedure using distilled water or Perform the Auto Clean procedure using the following cleaning solution: 2% SDS and 0.1% Tween 20 in distilled water, heated to +60°C before use.

WARNING BE CAREFUL WHEN HANDLING THE HEATED SOLUTION TO

PREVENT BURNS AND SCALDS!

To remove all traces of the detergent, perform three complete Auto Clean cycles using only distilled water. Clean the display, cover, and the bottle compartment with a mild detergent.

Caution Never use Acetone, it will damage the cover or display window.

6.6.3 Every Three Months Check the volume of all dispensing pumps. Use the Clean cycle (see 5.4.1 Clean) to dispense 2 mL per channel. Measure the dispensed volume with on a calibrated balance. The variation per pump must not exceed ±10%. Calibrate the dispensing pumps that don’t meet the specifications. For more information about the dispensing pumps (see chapter 5.4.4 Pump Calibration).


6.6.4 Yearly

Caution Only trained Service Technicians are authorized to perform the yearly

maintenance.

• Replace all dispensing pumps and tubes

• Check and clean calibration system (clean tube needles).

• Adjust tub volume and calibrate all dispensing pumps (see 5.4.5 Adjust Tub Volume)

• Adjust the pressure pin for the tray support.

• Clean the guide bars of the dispensing head and lubricate with silicone oil.

• Check Adjust positions.

• Check the silicone seal in the tray support and tighten all hinge-screws in the metal frame if necessary.

• Make sure that the temperature control system tubes are properly secured.

• Replace the sieves in the silicone tubes which lead into the hot and cold water bottles if necessary.

• Clean all water channels inside the tray support to remove dust or other particles.

• Inspect mounting of Peltier elements and remove dust from all cooling fans (heat exchanger and power supply unit).

• Check real temp. insert value.

• Check pump speed values: Circ. 1 (tray pump) and Circ. 2 (preparation pump).

• Check if air-in tube is not blocked.

• Check and calibrate the temperature system.


6.7 Instrument Disinfection The responsible body must ensure that the appropriate decontamination is carried out if hazard material is spilt onto or into the equipment.


AND PROTECTIVE GLASSES AND CLOTHING WHEN OPERATING THE INSTRUMENT AND MAKING ADJUSTMENTS.

It is very important that the instrument is thoroughly disinfected before it is removed from the laboratory or any servicing is performed on it. Before the instrument is returned to the distributor for servicing, it must be disinfected and a disinfection certificate completed. If a disinfection certificate is not supplied, the instrument may not be accepted by the servicing center or it may be withheld by the customs authorities.

6.7.1 Disinfection Procedure The responsible body must ensure that the manufacturer or his agent is consulted if there is any doubt about the compatibility or decontamination or cleaning agents with parts of the equipment or with material contained in it.


ETHANOL IS FLAMMABLE AND WHEN IMPROPERLY HANDLED CAN LEAD TO EXPLOSIONS. PROPER LABORATORY SAFETY

PRECAUTIONS MUST BE OBSERVED.

Note Never use acetone or alcohol, to clean the cover.

WARNING THE DISINFECTION PROCEDURE SHOULD BE PERFORMED BY

AUTHORISED TRAINED PERSONNEL IN A WELL VENTILATED ROOM WEARING DISPOSABLE POWDERFREE GLOVES, PROTECTIVE

GLASSES AND CLOTHING. THE DISINFECTION PROCEDURE SHOULD BE PERFORMED

ACCORDING TO NATIONAL AND LOCAL REGULATIONS.

Caution Please note that the disinfectant can influence the performance of the

instrument if it is applied inside the instrument.


The following procedure should be used to disinfect the instrument. Disinfection of the Dispensing System

1. Wear protective powder-free gloves, protective glasses and protective clothing.

2. Prepare an autoclavable bag for all disposables used during the disinfection procedure and label it with autoclave tape.

3. Disinfection of the Dispensing System To disinfect the dispensing system, prepare four liters of Aseptisol or

approved alternative. 4. Fill the reagent bottles with this disinfecting solution, switch on the

instrument and perform the 'Clean' (10 mL) procedure for each channel so that the dispensing system is filled with the solution. The cleaning procedure should be repeated for at least four cycles for each channel; the instrument should then be left to stand for at least five hours. The disinfecting solution should then be removed from the reagent bottles. These bottles should be thoroughly rinsed with distilled water.

5. The reagent bottles should then be filled with distilled water, the instrument reconnected and switched on, and the rinsing procedure (10 mL) should be performed for at least five and to up to ten cycles.

6. The rinsing procedure should be performed very thoroughly, as residual disinfecting solution may affect the results obtained.

Disinfection of the Aspirating System In case the aspirating system breaks down during a test run, leaving infectious material in the channels, a disinfection of the instrument is no more possible. Call your local customer support to have a service technician repair the defect in the field.

Exterior Disinfection 1. Switch off the instrument and disconnect it from the mains power supply. 2. Disconnect the instrument from any accessories that are used i.e.

computer, cartridge etc. Accessories which are to be shipped together with the instrument must be included in the disinfection procedure.

3. Carefully spray the disinfectant solution (or use a disposable soft tissue paper towel soaked in the disinfectant) on all outer surfaces of the instrument.

4. After a minimum contact time of ten minutes, repeat the previous step of this procedure.

5 After a contact time of five hours wipe the instrument using a soft paper towel and a mild detergent or distilled water to remove all traces of the disinfectant.

6. Wipe dry the outer surfaces of the instrument. 7. Pack the instrument and its accessories. 8. Disinfect your hands and clean them with a mild detergent. 9. Complete a disinfection certificate and attach it to the outside of the

box so that it is clearly visible. See below for an example of a disinfection certificate.


6.8 Disinfection Certificate The following label MUST be completed and attached to the top of the package in which the instrument is returned, before sending it to the servicing center for service or repair. The instrument has to be disinfected by the user at the operating authority’s site.

I declare that the instrument in this package has been decontaminated or disinfected to remove or inactivate any biological material, which could be dangerous to the service personnel, or that it has never been exposed to any hazardous biological material.

Contact person.....................................................................................................

Company:.............................................................................................................

Function: ..............................................................................................................

.............................................................................................................................

Phone/Fax:...........................................................................................................

E-mail: .................................................................................................................

Date of decontamination: .....................................................................................

Method of decontamination applied: .................................................................

.............................................................................................................................

Date: ....................................................................................................................

Signature:.............................................................................................................

--------------------------------------------------------------------------------------------------------

I declare that the instrument in this package has been decontaminated or disinfected to remove or inactivate any biological material, which could be dangerous to the service personnel, or that it has never been exposed to any hazardous biological material.

Contact person.....................................................................................................

Company:.............................................................................................................

Function: ..............................................................................................................

.............................................................................................................................

Phone/Fax:...........................................................................................................

E-mail: .................................................................................................................

Date of decontamination: .....................................................................................

Method of decontamination applied: .................................................................

.............................................................................................................................

Date: ....................................................................................................................

Signature:.............................................................................................................


6.9 Disposal 6.9.1 Introduction

Follow laboratory procedures for biohazardous waste disposal, according to national and local regulations. This gives instructions on how to lawfully dispose of waste material accumulating in connection with the instrument.

WARNING OBSERVE ALL FEDERAL, NATIONAL AND LOCAL ENVIRONMENTAL

REGULATIONS.

ATTENTION Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)

Negative environmental impacts associated with the treatment of WEEE

• Do not treat electrical and electronic equipment as unsorted municipal waste.

• Waste of electrical and electronic equipment must be collected separately.

6.9.2 Disposal of Packing Material According to Directive 94/62/EC on packaging and packaging waste, the manufacturer is responsible for the disposal of packing material.

Returning Packing Material If you do not intend to keep the packing material for future use, e.g. for transport and storage purposes, return the packaging of the product, spare parts and options via the field service engineer to the manufacturer.


6.9.3 Disposal of Operating Material

WARNING TOXIC AND BIOHAZARDOUS WASTE CAN BE ASSOCIATED WITH THE WASTE MATERIAL FROM THE PROCESS RUN ON THE AUTO-

LIPA 48. TREAT THESE SUBSTANCES AND DISPOSABLES, SUCH AS TRAYS, SYSTEM LIQUID, ETC. IN ACCORDANCE WITH GOOD LABORATORY

PRACTICE GUIDELINES. INQUIRE ABOUT APPROPRIATE COLLECTING POINTS AND

APPROVED METHODS OF DISPOSAL IN YOUR COUNTRY, STATE OR REGION.

6.9.4 Disposal of the Auto-LiPA 48 Instrument Please contact your local Innogenetics Service representative before disposing of the instrument.

Caution Always disinfect the instrument before disposal.

Pollution degree 2 (IEC/EN 61010-1)

Method of Disposal Contaminated Waste

WARNING DEPENDING ON THE APPLICATIONS, PARTS OF THE AUTO-LIPA 48 MAY HAVE BEEN IN CONTACT WITH BIOHAZARDOUS MATERIAL.

• MAKE SURE TO TREAT THIS MATERIAL ACCORDING TO THE APPLICABLE SAFETY STANDARDS AND REGULATIONS.

• ALWAYS DECONTAMINATE ALL PARTS BEFORE DISPOSAL.


7. Error Messages

7.1 Introduction This chapter gives instructions on the appropriate actions to take when error messages are displayed.

7.2 Messages Preparation Error (Prep. Error )

This error message is displayed if the required hot water temperature has not been reached during the 45 minutes preparation procedure. Possible causes: Starting temperature of the water too low Heating element or controller defective Hot water temperature sensor defective Action: Repeat the preparation procedure, if the error continues contact the service technician.

Low Temperature Error (Low Temp. Error) This error message is displayed if the hot or cold water or the reagent incubator temperature sensors show a temperature below 5°C. Possible causes: • Cold water bottle empty • Cold water tubing bent or blocked • Cold water tube sieves blocked • Temperature sensors defective • Processor defective • Pump defective Action: Make sure that the cold water bottle contains enough water and that the tubes are immersed and are not bent or blocked. The sieves in the cold water tubes must be clear. Repeat the preparation procedure; if the error continues contact the service technician.

High Temperature Error (High Temp. Error) This error message is displayed if the hot water or the reagent incubator temperature sensors show a temperature above 85°C or if the temperature increases too quickly during preparation. Possible causes: • Hot water bottle empty • Hot water tubing bent or blocked • Hot water tube sieves blocked • Pump defective • Controller for reagent incubator heater defective • Temperature sensors defective • Processor defective


Action: Make sure that the hot water bottle contains enough water and that the tubes are immersed and not bent or blocked. Be sure that the sieves in the hot water tubes are clear. Repeat the preparation procedure, if the error continues please contact the service technician.

Temperature too High (Temp. too high) This message is displayed when a new test procedure is started with a lower temperature than the previously used test and the water temperature is too high. Action: • Reduce the temperature of the water in the hot water bottle (add cold

distilled water). • Wait until the hot water has cooled down to the required temperature.

Power Failure This message is displayed, when the power to the instrument has been interrupted for any reason (e.g. instrument switched off or mains power failure) while it was performing a test program.

POWER FAILURE Press any key!

Press any key and the instrument displays the step at which the power failure occurred e.g.

Step: 25 XXXX Strip: XX

Note The program cannot be continued.

Press any key to close the error message and return to the standby mode. The instrument then displays the message:


Steploss This message is displayed when the instrument detects steploss in the tubing transport mechanism. Possible causes: • Tubing transport mechanism blocked or difficult to move • Dispensing /aspirating head is blocked • Defective 'Home Position' sensor • Defective steploss sensor • Defective motor Action: Make sure that the tubing transport mechanism is not blocked and that it is free to move. If the error continues, contact the service technician. Make sure that the aspirating tubes are fitted so that they run left and right of the dispensing tubes.


Note The program cannot be continued.

Shake Error

This message is displayed when the instrument does not detect the 'Home Position' for the tray shaking motor during shaking. Possible causes: • Tray shaking mechanism blocked • Defective 'Home Position' sensor • Defective motor Action: Make sure that the tray shaking mechanism is not blocked and that it can be moved easily (tray clamp-bar clips correctly positioned). If the error continues, contact the service technician.

Initialization Error: Tray (Init Err.: Tray) This message is displayed when the instrument does not detect the 'Home Position' for the tray shaking motor during start-up and before each 'DISP', 'WASH' or 'ASP' step. Possible causes: • Tray shaking mechanism blocked • Defective 'Home Position' sensor • Defective motor Action: Be sure that the tray shaking mechanism is not blocked and that it can be moved easily (tray clamp-bar clips correctly positioned). If the error continues, contact the service technician.

Initialization Error: Needle (Init Err.: Needle) This message is displayed when the instrument does not detect the 'Home Position' for the tubing transport motor. Possible causes: • Defective 'Home Position' sensor • Defective transport • Steploss error

Steploss ! Step: X exit

Steploss exit

Confirm Stop no yes



Action: Make sure the 'Home Position' sensor and the flag are mounted on the transport mechanism. If the error continues, contact the service technician.

Aspirating Error (Asp. Error) This message is displayed when the aspirating needles are not lowered or raised. Possible causes: • Aspirating needles stuck in tray (possible with wrong positioning) • Aspirating needle mechanism blocked or dirty • Sensor defective • Solenoid defective Action: Make sure that the aspirating needles are not stuck in the tray and the mechanism is free to move up and down. If the error continues please contact the service technician. Be sure that the aspirating tubes run left and right of the dispensing tubes

Note The duration of this error cannot be given. The user must decide whether

to continue the run (select repeat) or to stop.

Cover Open This message is displayed when the instrument cover is open when a test program is started. When the cover is closed, the instrument automatically proceeds with the procedure. If the instrument does not proceed, the sensor is defective. Contact the service technician.

Cover Was Open This message is displayed at the end of a procedure when the cover was opened during a run. The instrument delivers an alarm if the cover is opened during the procedure.

ASP Error ! repeat exit

Confirm Stop no yes


Continues aspirate step


Lid Heat Error

This message is displayed when the instrument does not detect a current flow through the heating lid. Possible causes: • Heating lid not fitted or incorrectly fitted • Heating lid contacts dirty • Heating lid defective • Heating lid heater controller defective • Heating lid heater fuse blown Action: Be sure that the heating lid is correctly fitted and that the contacts are clean. If the error continues, contact the service technician.

Calibration Error (Cal. Error) This message is displayed when the contacts for the volume calibration are not detected, during the pump calibration or tube volume calibration procedures. Possible causes: • Not enough calibration liquid in bottle • Tubes not in bottle • The liquid is not aspirated • Processor for cables defective • Pump defective Action: Make sure that the bottle contains enough calibration liquid and that all the pump tubes are inserted into the bottle. Be sure that the solution is being aspirated and that the aspirating needles are not blocked. Repeat 'Pump Calibration' or 'Adjust Tub Volume', if the error continues, contact the service technician.

Tub Calibration Error (Tub Calibr. Err) This message is displayed when the 3 measured calibration tub volumes differ by more than 2%. Possible causes: • Not enough calibration liquid in bottle • Tube not in bottle • Instrument has been knocked or moved • The liquid has not been aspirated • Pump malfunction • Liquid is foaming Action: Make sure that the correct calibration liquid is used. The calibration liquid must not foam. Be sure that the solution is being aspirated and that the aspirating needles are not blocked. Repeat tub calibration procedure 'Adjust Tub Volume' in 'Liquid Preparation' menu. If the error continues, contact the service technician.


Error Pump: XX (Err Pump: XX )

XX = Pump number This message is displayed when the pump calibration volume is out of range, (± 10 % of the previously measured pump calibration value). Possible causes: • Not enough calibration liquid in bottle • Tubes not in bottle • The liquid is not aspirated • Instrument has been knocked or moved • Pump malfunction • Liquid is foaming Action: Make sure that the bottle contains enough calibration liquid and that all the pump tubes are inserted into the bottle. Check that the solution is being aspirated and that the aspirating needles are not blocked. Repeat 'Pump Calibration', if the error continues contact the service technician.

Pump:X Out of Range (Pump:X O. o. R.) This message is displayed when the pump calibration volume is out of range. X = Pump number. Possible causes: • Not enough calibration liquid in bottle • Tubes not in bottle • Instrument has been knocked or moved • The liquid is aspirated • Pump malfunction • Liquid is foaming Action: Check that the bottle contains enough calibration liquid and that all the pump tubes are inserted into the bottle. Check that the solution is being aspirated and that the aspirating needles are not blocked. Repeat 'Pump Calibration', if the error continues contact the service technician.

Too Many Strips This error message is displayed at the start of a test program if the number of strips selected is higher than the number of wells after the selected starting position.

Checksum Error This error is displayed if the program parameters have been cleared or overwritten. Possible causes: • Instrument has been switched off while in 'Define Program' Action: Return to 'Define Program' and then leave the setting by pressing 'Exit'. The checksum is then recreated. The program parameters should then be checked in 'Show Program'. If the error continues contact the service technician.


Test Temperature Low (Test Temp. Low) This error is displayed if the set incubation temperature is not reached. Possible causes: • Water tube sieves are blocked • Temperature sensor in tray defective Action: Be sure that the sieves in the cold water tubes are clear. If the error continues contact the service technician. Have the temperature sensor changed by the service technician.

Tray Sensor Error (Tray Sens. Error) This error is displayed if the temperature sensor in the tray is defective. Action: Have the temperature sensor changed by the service technician.

Pass-Err. Cont? This error message is displayed if the password or the user password has been entered incorrectly. Action: Enter correct password or user password.

Cool Temp High This message is displayed when a cool step is defined in a program and the instrument didn’t reach a lower temperature value then 30°C within 10 minutes. Action: • Check in the service menu the temperature of the sensors. • Check the complete liquid system if sieves are blocked or if there is

something inside the tray or tubing of the temperature system so that the liquid is not able to flow.

• The pump voltages of the Tray- and Preperation -Pump has to be checked • Check the voltages of the peltier elements and if they are lubricated

enough. • Check the Real Temp. Value.


Index Numbers refer to pages.

A

Adjust Tub Volume ............................................... 55 Apirate.................................................................... 36 Aspirating Error..................................................... 73 Auto Clean....................................................... 33, 51

C

Calibration pump.................................................................. 53

Calibration Error ................................................... 74 calibration tub ......................................................... 33 Changing the Type of Defined Step .................. 45 Checksum Error.................................................... 75 Clean ................................................................ 33, 50 Cleaning and Maintenance...................................... 60 Cleaning Pumps and Tubes ............................... 61 Cleaning the Instrument ...................................... 60 Cool ........................................................................ 43 Cover Open ........................................................... 73 Cover Was Open .................................................. 73

D

Define Program..................................................... 35 Define User Password ......................................... 59 Delete Step............................................................ 42 Disinfection Certificate ......................................... 67 Disinfection Procedure ........................................ 65 Dispense................................................................ 37 Display Window Cover ........................................ 60 Disposal

of operating material .................................... 32, 69 of the instrument .......................................... 32, 68 of the tray ..................................................... 32, 68

Drying ..................................................................... 43

E

Edit Procedure for a Defined Program .............. 45 Error Messages........................................................ 70 Error Pump: ........................................................... 75

F

Fill System ............................................................. 57 Front Cover ........................................................... 60 Fuse Replacement ............................................... 62

H

High Temperature Error ...................................... 70

I

Incubate ................................................................. 39 incubation temperature.......................... 14, 39, 46, 76 Initialization Error: Needle ................................... 72 Initialization Error: Tray........................................ 72 Insert Program ...................................................... 40 Insert Step ............................................................. 41

Instrument disposal............................................................... 32

Instrument Disinfection ........................................ 65

L

Lid Heat Error........................................................ 74 Liquid Preparation ................................................ 49 Low Temperature Error ....................................... 70

M

Maintenance.......................................................... 63

P

Packing Material Returning .......................................................... 68

password ........................................................... 58, 59 Pause ..................................................................... 44 Positioning the Heating Lid ................................. 28 Positioning the Tray ............................................. 29 Power Failure ........................................................ 71 Preparation Error .................................................. 70 Pump Back ...................................................... 51, 63 Pump Calibration ............................................ 53, 55 Pump:X Out of Range.......................................... 75

R

Run Program ......................................................... 46

S

self-check .......................................................... 23, 24 Shake Error ........................................................... 72 Show Program ...................................................... 48 Steploss ................................................................. 71

T

Temp ...................................................................... 42 temperature ............................................................. 64 Temperature too high........................................... 71 Test Temperature Low ...................................... 39, 76 Too Many Strips.................................................... 75 Tray

disposal............................................................... 32 positioning.......................................................... 29 removing ............................................................ 31

Tray Heating Lid ................................................. See tray seal ................................................................... 60 Tray Sensor Error ................................................. 76 Tub Calibration Error............................................ 74

U

user password.......................................................... 59

W

Wash ...................................................................... 38

INNOGENETICS N.V. • Technologiepark 6 • B-9052 ZWIJNAARDE, BELGIUM TEL.: +32 9 329 13 29 • FAX +32 9 329 19 11 • E-MAIL [email protected] •

WWW.INNOGENETICS.COM BTW BE 0427.550.660 • RPR Gent • KBC 440-0117601-12 • IBAN : BE19 4400 1176 0112 • BIC : KREDBEBB

EC Declaration of conformity We, Innogenetics N.V. Technologiepark 6 B-9052 Gent, Belgium declare under our sole responsibility that the product(s)

Auto-LiPA 48 (Ref.80628)/Auto-LIA 48 (Ref.80629)

meet(s) the provisions of the following EC Directive(s)

Directive 98/79/EC for in vitro Diagnostic Medical Devices The conformity with the requirements of the Directive has been assessed following procedure(s) outlined in Annex III of the Directive.

Directive 2006/42/EC on Machinery

Relevant sections of the following (harmonized) standards apply:

⋅ EN 591:2001 Instruction for use for in vitro diagnostic instruments for professional use.

⋅ EN 980:2008 Graphical symbols for use in labelling of Medical Devices. ⋅ EN/ISO 13485:2003/AC:2009 Quality System for Medical Devices. ⋅ EN/ISO 14971:2009 Application of risk management to Medical Devices. ⋅ EN/ISO 14121-1:2007 Safety of machinery – Risk assessment – Part 1: Principles ⋅ EN 61010-1:2001 Safety requirements for electrical equipment for

measurement, control and laboratory use – Part 1: General requirements.

⋅ EN 61010-2-81/A1:2003 Part 2-081: Particular requirements for automatic and semiautomatic laboratory equipment for analysis and other purposes.

⋅ EN 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.

⋅ EN 61326-1:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 1: General Requirements.

⋅ EN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment.

⋅ EN 62304:2006 Medical device software – Software life-cycle processes. ⋅ EN 62366:2008 Medical devices – Application of usability engineering to

medical devices The manufacturer retains all supporting documentation.

b30328rev10 auto-lipa 48 · auto-lipa 48 part no.: 30005203 revision no.: 1.9 (b30328 rev 10) 3/77...

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