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HELMED® IFA Processor

for IFA Software version 3.1

INSTRUCTION MANUAL

HELMED® Standard Edition

HELMED® HTC-Humidity and Temperature Controlled Edition

37oC INCUBATOR MODULE

© Unless expressly authorized, forwarding and duplication of this document is not permitted. All rights reserved.

Table of Contents

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Table of Contents

1 HELMED® INSTALLATION ................................................................................ 6

1.1 Introduction __________________________________________________________ 6

1.2 Theory of Operation ___________________________________________________ 6

1.2.1 Installation requirements _________________________________________________ 7 1.2.2 Unpacking the HELMED® ________________________________________________ 7

1.3 Installing the HELMED® _______________________________________________ 11

1.3.2 Connecting the HELMED® Equipment / Warning labels ________________________ 12

2 HELMED® SOFTWARE .................................................................................... 14

2.1 PC Requirements ____________________________________________________ 14

2.2 Software Installation v3.1 _____________________________________________ 14

2.3 Uninstall from IFA v1.0/v2.0 ____________________________________________ 15

2.4 Languages __________________________________________________________ 16

3 ACCESSORIES ................................................................................................ 17

3.1 IFA Module _________________________________________________________ 17

3.2 Sample Tube Racks __________________________________________________ 17

4 SOFTWARE OVERVIEW .................................................................................. 18

4.1 File ________________________________________________________________ 20

4.2 Tools ______________________________________________________________ 20

4.3 Help _______________________________________________________________ 21

5 SLIDE AND TEST DESIGNER ......................................................................... 22

5.1 Slide Designer _______________________________________________________ 22

5.1.1 Tools: Well Designer ___________________________________________________ 22 5.1.2 Slide ________________________________________________________________ 24

5.2 Test Designer _______________________________________________________ 28

5.2.1 Tools: Control Designer _________________________________________________ 28 5.2.2 Test ________________________________________________________________ 29

6 RUN A WORKLIST ........................................................................................... 38

7 37OC INCUBATOR MODULE ........................................................................... 44

7.1 Introduction _________________________________________________________ 44

7.2 Instrument Description _______________________________________________ 44

7.2.1 General description ____________________________________________________ 44 7.2.2 Purpose and application ________________________________________________ 44 7.2.3 Parts list _____________________________________________________________ 44

7.3 Setup / Installation Incubator Ring ______________________________________ 45

7.4 Instructions for use __________________________________________________ 45

Table of Contents

HELMED® Instruction Manual 4 / 52

7.5 Disposable Sponge Inlay ______________________________________________ 46

7.6 Maintenance instructions _____________________________________________ 46

7.6.1 After usage ___________________________________________________________ 46 7.6.2 Reuse _______________________________________________________________ 46

8 HELMED® HTC EDITION .................................................................................. 47

9 MAINTENANCE ................................................................................................ 48

9.1 Daily Shutdown ______________________________________________________ 48

9.2 Weekly maintenance _________________________________________________ 49

10 CALIBRATION .................................................................................................. 50

11 GENERAL AND TECHNICAL SPECIFICATIONS............................................ 51

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1 HELMED® Installation

1.1 Introduction

The HELMED® IFA module is the software application for the HELMED® system. It provides

programming options for the processing of IFA slides. The system requires the addition of the supplied

slide carousel, the reagent rack and the sample rack to accommodate IFA kit components.

To run the IFA module, a complete HELMED® system is required. The HELMED® System consists of

the following: the HELMED® workstation, a computer (not provided), a monitor (not provided), and a

printer (not provided).

Up to ten HELMED® workstations may be connected to a single computer.

The system automates the processing of IFA slides.

The HELMED® IFA software contains AESKU IFA test files, but also allows the user to define slides

types and test files for other IFA Kits. Since the HELMED® is evaluated on AESKU IFA Kits

AESKU.SYSTEMS GmbH & Co.KG cannot take responsibility for processing IFA kits of other

manufacturers.

A fluorescence microscope (not provided) is required in order to read the slides processed by the

HELMED® workstation. Please follow the instructions supplied with the selected IVD kit.

1.2 Theory of Operation

The detection of antibodies is based on the principle of indirect immunofluorescence assay (IIFA).

Glass microscope slides are coated with tissue sections or cells (for example Hep-2-cells [ANA],

granulocytes [ANCA] or Crithidia luciliae [nDNA]). If the patient’s serum contains specific antibodies to

these coated cells, then they will bind during the first incubation. Washing steps will remove any

unbound material. The bound antibodies are detected by fluorescein conjugated anti-human

immunoglobulins during a second incubation. A specific green fluorescent staining of the antigen-

antibody-complex can be visualized by the use of a fluorescence microscope.

The HELMED® IFA software automates the processing of IFA slides.

For in vitro diagnostic use only.

In addition to the main software there are four additional software modules: well designer, control

designer, slide designer and test designer.

The well designer module is used to define the well on a slide (size [diameter], type (shape

[rectangle]).

The control designer is used to define the controls which can be run with a test.

The slide designer module is used to define the positions of the wells, along with the surfaces, texts,

and substrates affixed on the slide to be processed.

The test designer module is used to define how a slide should be processed during a run. Defined

here are the dilution factors for screening or titration, the positions of controls and samples on the

slide, and the steps required for processing.

Test steps include: the volumes needed for transfer to the slide, incubation times, number of wash

cycles, volume of wash buffer(s), counterstain (optional), and mounting medium dispensing (optional).

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1.2.1 Installation requirements

The requirements for the site where the equipment is to be installed are the following:

Do not place the equipment out of doors.

Do not place the equipment on a surface of flammable material.

Do not place the equipment so that it is difficult to access for maintenance or servicing.

Do not block air openings.

Do not place the equipment where it could get wet.

Do not position the equipment so that it is difficult to operate the mains disconnection

switch.

Do not let the equipment or its flexible cord come into contact with surfaces that are too hot

to touch.

Check that the nominal voltage shown on the equipment matches the supply voltage.

Check for a horizontal work surface.

Avoid contact with, or jolting of, the instrument during operation.

1.2.1.1 Accessories

1 x HELMED® (Unit)

1 x Power Cord e.g. Schuko for Germany

1 x Fuse Power switch

1 x USB Cable

1 x Wash # 1 (Bottle with Tube)

1 x Wash # 2 (Bottle with Tube)

1 x Waste (Bottle with Tube)

1 x Reagent Rack Standard

2 x Sample Racks (1-50 and 51-100)

3 x Silicone tube

1 x Cleaning tool for the needles

1 x Calibration Tube

1 x Starter Kit; includes: 50 x 4 ml empty vials + caps

50 x 20 ml empty vials + caps

5 x Uncoated Nunc MTP

Also included:

Software CD with latest Software version.

Printed Version of the Instruction manual.

The additional part list for HELMED® HTC edition and the 37°C incubator module can be found

under 7.2.3.

1.2.2 Unpacking the HELMED®

The HELMED® equipment is normally shipped in an industrial strength cardboard box set

on a pallet.

Remove the upper part of the cardboard box.

Remove all boxes with accessories.

Place the instrument in its designated area.

Open the green cover and carefully remove the cardboard protectors.

If there are any signs of damage to the cardboard box and/or the instrument please contact your local

distributor.


1.2.2.1 Description of the HELMED® Equipment parts

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Detailed view on HELMED® parts

The Z-assembly includes the Z-motor

for moving the needles up and down

The two syringes 1ml and 50µl

The needle assembly

Third needle motor

Wash cup

Peristaltic wash pump

Dispensing needle

Aspirating needle

Middle needle (third needle)


Connections (Power and Fluids)

Electrical connections Quick connections

USB port

Power connection

Power switch

Fuse

Wash #1

Wash #2

Waste

Incubator block

The incubator block is below the MTP-holder ring.

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1.2.2.2 Placing the HELMED® in its designated area

Two persons, one on each side of the instrument, are required to move it once it has been unpacked.

One hand holds the bottom front of the instrument. The other hand holds the bottom back of the

instrument. This method prevents any tendency for the instrument to tip. It should be lifted equally by

the two individuals, and set on the designated table.

1.3 Installing the HELMED®

First installation should be performed by trained people only following the instructions

in the Service Manual!

1.3.1.1 Connectors on the instrument

1. Fluid lines

On the rear of the instrument you have quick connectors for the wash solutions and for the waste

bottle. See bottle installation.

2. Mains power inlet

The power inlet is located at the back of the instrument. Plug the instrument power cord into this.

3. USB Port

The instrument is connected to the PC via a USB cable. The USB port necessary for this connection is

located at the back of the instrument.

4. Bottle Installation

The bottles are labeled as follows:

WASH # 1 blue

WASH # 2 red

WASTE black

The tubing is correspondingly color-coded. The quick connectors for the bottles are located at the

back of the instrument.

5. USB Connection

Please connect the system after you have installed the HELMED IFA Software with the USB-cable

provided.


1.3.2 Connecting the HELMED® Equipment / Warning labels

1.3.2.1 Connecting to the main electrical supply

The HELMED® equipment is connected via the socket on the back of the instrument, using the power

cord supplied.

Warning!

Electromagnetic compatibility and electrical safety tests have been performed using the cord

supplied by the manufacturer. However, if it is necessary to use another cord, ensure that the

new cord meets the following specifications:

Cable type: flexible cable with insulation and PVC cover with 3 conductors (neutral,

live and earth). Cord length: 2m

Connector type: For IEC inlet. Connector for class I appliances.

Plug type: Plug type used in the country where the equipment is installed and with

earthed connection.

Connector, cable and plug must comply with the electrical safety requirements

applicable in your country.

It should be remembered that the equipment uses a switched power supply, which

automatically adapts to the main electrical supply voltage, and therefore does not

require any type of switching (consult the specifications in order to check the

operating margins).

DANGER!

Using cables other than those specified may result in degraded electromagnetic compatibility

of the equipment.

DANGER!

To avoid the risk of electric shock, this equipment must be connected to the main earthed

electrical supply.

1.3.2.2 Warning labels

CAUTION!

In case of a malfunction of the incubator, the labeled Microtiter Plate Holder may be hot!

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CAUTION!

Do not open the waste container peristaltic pump cover, while the pump is rotating. The

cylinders of the rotating pump may crush your fingers or cause other injury!

CAUTION!

The waste solution in the two liter waste bottle may contain infectious material. Please follow

your internal guidelines for biohazard/infectious waste disposal!

CAUTION!

According to WEEE 2002/96/EG for orderly disposal of the instrument you have to follow local

regulations or return the instrument to the manufacturer.

1.3.2.3 Replacing the fuse in the main cable inlet

DANGER!

If you need to replace the fuse (T4A / 250V; 5x20mm) be sure that the power supply cord is

unplugged, before opening the fuse cover! Do not plug in the power supply cord, when the

cover for the fuse is open! Plug in the power supply cord, only after first replacing the fuse and

closing the fuse cover!

THIS PRODUCT IS FOR IN VITRO DIAGNOSTIC USE ONLY.

Only trained staff, specially skilled in methods of in vitro diagnostic testing, may operate the

instrument. Although this instrument is not considered toxic or dangerous in conditions of

normal use, refer to the following for maximum safety.

Recommendations and precautions.

We recommend avoiding contact with eyes and skin, and wearing disposable gloves, when you

are working with human specimens!


2 HELMED® Software

2.1 PC Requirements

Windows XP, Windows 7 (32 bit/64 bit)

Older systems should meet the following specifications. 4 GB RAM for XP and Win7

min. 80 GB Hard Disk Drive

Monitor must support a minimum resolution of 1280 x 1024

CPU: best available technology

Important:

Do not use USB hubs when working with the HELMED®! Use of USB hubs is not recommended by

AESKU.SYSTEMS GmbH & Co.KG.

Power supply for each port can be interrupted when too many USB accessories are plugged in.

Please use all available ports of your computer instead of a USB Hub.

2.2 Software Installation v3.1

Installing the HELMED® software.

NOTE: To uninstall the IFA version 1.0 or 2.0, please see Chapter 2.3.

The work list structure has been changed in version 3.1. Old work lists cannot be read in the

new version. HELPS+ Versions up to 1.3 are not compatible with the IFA Version 3.1.

Install NET Framework 3.5 before installing the new software. Insert the HELMED® program

installation stick into the usb port. Run the installation program with the file

“HelMed®IFASetup_3.1.exe” on the stick. Accept the default options and follow the instructions as they

are displayed.

A HELMED® icon will be installed on the desktop:

HELMED® IFA Software 3.1

After installation of the HELMED® IFA Software

3.1 find the following folders under “Program

Files”.

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2.3 Uninstall from IFA v1.0/v2.0

All data files from software version 1.0 or 2.0 reside in the folder AESKU.DIAGNOSTICS IFA

Software. AESKU.SYSTEMS GmbH & Co.KG recommends that you first back-up all data in the data

files folder.

To creat a back-up file select “My documents\AESKU.DIAGNOSTICS IFA Software” by clicking the

righthand mouse button- on folder “1.0.0.0” or “2.0”. Select option “Copy” and paste the copied folder

e.g. to the Desktop with a traceable name e.g. “Back-up-folder 1.0.0.0_year-month-date”.

The software version 1.0 or 2.0 must be deinstalled following the instructions for deinstallation of the

software from the computer: Select START – settings - control panel – software – CLICK on

HELMED® IFA Software 1.0.0.0 or 2.0 to deinstall HELMED® IFA Software 1.0.0.0 or 2.0.

After deinstallation of the HELMED® IFA Software 1.0 or 2.0, the data files folder of version 1.0 or 2.0

in “My documents” can be deleted as well.

Generally, it is recommended to uninstall all old versions before installing the new software

version.

If the old version needs to be retained the data should be saved in a separate folder.

After installation of the HELMED® IFA

Software 3.1 the following folders can be

found in “My documents”.

The control panel of the computer will show

the following screen.

NOTE: Please be aware that the folder

“Racks” is hidden. In a standard installation

of Windows you are not able to see this

folder. Go to “Control Panel – Folder

Options”. Check the box “Show hidden

files, folders and drives”.

If you have problems with this step contact

your system administrator.


2.4 Languages

The following languages are available:

ENGLISH en

By default the installation of this software version will be installed in the same language as your windows operative system. If you would like to change the language to any of the listed, you can do so by right clicking the HELMED® IFA Software shortcut and editing the target of your shortcut. You have to write i.e. /lang:es for Spanish or /lang:fr for French. Please make sure to add a blank space after the last quotation mark.

RUSSIAN ru

HEBREW he

GREEK el

GERMAN de

SPANISH es

ITALIAN it

HUNGARIAN hu

FRENCH fr

PORTUGUESE pt

CZECH cs

POLISH pl

For example, for French use “fr”

(…\HelmedRackSelect.exe" /lang:fr)

For example, for Spanish use “es”

(…\HelmedRackSelect.exe" /lang:es)

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3 Accessories

3.1 IFA Module

Software

HELMED® System IFA Software at least version 1.0 or higher

Hardware

Slide Carousel

MTP Carousel

Reagent Rack

Sample Racks

Bottles and Tubings

WASH # 1 red (including the tubing which is correspondingly color-coded)

WASH # 2 blue (including the tubing which is correspondingly color-coded)

WASTE black (including the tubing which is correspondingly color-coded)

3.2 Sample Tube Racks

The following sample tube racks have been programmed for your instrument.

These racks are barcoded and when they are placed in the instrument the scanner will read the

necessary information. There is no need to call the technical service; users can change the racks, just

follow the Scan Rack Layout function as described in section 4, Software Overview.


4 Software Overview

When starting the application the following screen will appear:

RCKR 8

Select this reagent rack to take full advantage of the AESKUSLIDES® kits.

RCKR1

Use one of the following options depending on your test requirements:

A. Large - 20ml vial (see blue large bottle in diagram above)

• More than 20 slides per vial - Ideal for large screening with a single test

NOTE: Only one large conjugate bottle is available. (If two tests are selected only

the first test can use the large bottle, the second test however must use the small

bottle.)

B. Standard - 4ml vial (see green small bottles in diagram above)

• Up to 10 slides per vial - Ideal for combining multiple tests

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If the device is connected to the PC the name of the

instrument appears in the white field of the window.

Select an instrument and click „Start” to work with the

instrument.

If you click on the "Demo Mode", you can use the software without the device and familiarise with the operating methods.

IFA Software Main Screen

There are three options along the top of the screen:

1. File Contains options for creating a new work list, to open an existing work list, to close

one/all work list(s), to print the preview, to save the work list, export a worklist to

HELPS or HELPS+ (must be installed) and to exit the program.

2. Tools Contains the modules for the slide designer and the test designer. It also contains the

order to: prime the instrument, scan the rack layout, change the name of the

instrument, switch on/off the barcode reader and the backlight, and the function to

"scan rack layout before run". The reagent loading wizard can be enabled as can the

function that the software will request more sample if the volume in the appropriate

tube is insufficient.

3. Help Contains information on the IFA software version, contact details of the manufacturer

and a digital version of the manual.


4.1 File

There are nine options given in the file menu:

New:

Allows the user to create a new work list for a run.

Open:

Allows the user to open a previously saved work list file of

a run.

Close:

To close one/all work list(s).

Save/Save as:

To save a programmed work list file and / or give it a

name.

Export to HELPS / HELPS+:

If the HELPS / HELPS+ Software is installed this option

exports an active worklist to HELPS / HELPS+.

NOTE: HELPS+ Versions up to 1.3 are not compatible

with the IFA Version 3.1.

Print/Print Preview:

To print the work list of the programmed run.

EXIT:

To leave the HELMED® IFA program.

4.2 Tools

There are eleven options listed in the tools menu:

Slide designer:

Open the Slide Designer screen. This contains the Well Designer Module. Refer to section 4.2.1 for

details of the Slide Designer screen.

Test designer:

Open the Test Designer screen. This contains the Control Designer Module. Refer to section 5 for

details of the Test Designer screen.

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LIS Settings:

Connect the IFA Software with the LIS. For further information please contact your local distributor.

Prime Instrument:

Manually primes the Instrument with the connected solution on Wash #1 or Wash #2.

Change Rack Layout:

Scans the position of each rack.

Change Instrument Name:

The name of the instrument can be changed.

Scan Sample Barcodes:

If this function is enabled, the sample barcodes will be scanned before a run.

Scan Rack Layout:

If this function is enabled, the rack layout will be scanned before a run.

Enable Back Light:

If this function is enabled, the green Backlight will be turned on during a run

Start Loading Wizard Before Run:

If this function is enabled, you will be guided when loading the instrument.

Prompt Sample refill if insufficient volume:

The system alarm will be activated when sample level is too low offering the option to:

A. Refill sample

B. Skip sample –automatically skips to next sample if unattended for > 10 mins.

4.3 Help

There are two options listed in the Help menu:

User manual:

Contains the user manual as a pdf file.

About:

Provides information on the software version and includes

the manufacturer contact details.


5 Slide and Test Designer

5.1 Slide Designer

First, select the Tools option at the top of the

HELMED® IFA main screen. Second, select Slide

designer, from the drop down menu, to open the

Slide Designer screen.

NOTE: This function is password protected. If you

want to change settings here please contact your

local distributor.

The slide must be designed before creating a new test design. The HELMED® IFA software is pre-

programmed for AESKU IFA slides, but is open to allow the user to define slide types from any

manufacturer.

There are two options along the top of the screen:

Slide:

Contains options for creating a new slide or to open an existing

slide.

Tools:

Contains the well designer module for creating a new well or for opening an existing well.

5.1.1 Tools: Well Designer

There are five options listed in the well designer menu:

New:

To create a new well type.

Open:

To open an existing well type.

Save:

To quick save a programmed well.

Save as:

To save a programmed well as a named well.

Close:

To close the well designer and return to the slide designer.

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Create a new well by filling in the information about type and size (X- & Y- Size) of a well.

Measure the size of a circular or rectangular well:

For circular wells, measure the diameter across the center of the well.

For rectangular wells, measure the width and the height of the wells.

All measurements are in millimetres.

Multiply the result by 10 and enter the value into the X-Coord- and the Y-Coord- field

(X-Coord & Y-Coord must be the same for a circular well).

It is possible to set multiple dispensing points in this module (recommended for slides with large wells).

Press the plus (+) – button to add dispensing points. You can move the dispensing points on the well by

entering the X- and Y-Coord. You can delete dispensing points by pressing the cross (x) – button.


5.1.2 Slide

The Slide Designer is used to modify an existing slide layout or to define new slides for additional

assays that will be run using the HELMED® IFA Module

NOTE: AESKU slides are pre-programmed and should not be edited.

The Slide Designer has the flexibility to program most IFA slides. It is the responsibility of the user to

make proper adjustments, if needed, and to verify the slide designer settings prior to use.

This section will describe how to design a new slide.

NOTE: The Slide Designer Main Screen will open a default slide file. This slide has to be changed.

There are three Info fields listed in the Slide Designer:

Slide Info:

Contains options to select the

manufacturer, color, thickness

and width of a slide.

Text Info:

The text option can be used to

place text on a slide.

Well Info:

Contains the options to define the

number of wells and their

positions on the slide. Select the

well (created in the well designer),

color (optional), function (optional)

and the substrate.

5.1.2.1 Slide Info

Select a manufacturer by

using the drop down menu

in the manufacturer line. To

add a manufacturer, right

click the mouse on the

arrow. A window will open.

Press the plus (+)- button. You will get an untitled line in which the name of the manufacturer can be

added.To delete a manufacturer, follow the same procedure but select the manufacturer to delete with

a mouse click and press the cross (x) - button. The manufacturer will be deleted.

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Use the color button to select

the color of the slide. The

thickness of the slide can be

adjusted using the thickness

field. Set the width of the slide

by selecting 25mm or 26 mm

option.

5.1.2.2 Text Info

The X and Y positions define the upper, left position where the text begins. Enter the

text in the field.

Measure the distance from the left edge of the slide to the right edge of the text in

millimetres. Multiply by 10 and enter the value in the X-Coord (1/10mm) position.

Measure the distance from the upper front edge of the slide to the top edge of the

text in millimetres. Multiply by 10 and enter the value in the Y-Coord position

(1/10mm).

Texts can be placed left to right, bottom to top, top to bottom (Orientation field).


5.1.2.3 Well Info

Numbers of wells are defined by clicking the plus (+) - button in the Well Info field. Complete the

“Caption” - column by numbering the wells continuously.

Wells can also be removed by clicking the cross (x)- button.

Well positions are defined by measuring from the designated front

and left edges of the slide to the center of the well. A ruler, for X and

Y positioning, is shown on the screen. The 0 / 0 axis is in the upper,

left corner.

Measure the X position of the first well, in millimetres, using a metric

ruler. The X position is the distance from the left edge of the slide to

the center of the well. Multiply the distance measured by 10. Enter

the value into the X-COORD (1/10 mm) field.

Measure the Y position of the first well, in millimetres, using a metric

ruler. The Y position is the distance from the upper front edge of the

slide to the centre of the well. Multiply the distance measured by 10.

Enter the value into the Y-COORD (1/10 mm) field.

Repeat these steps for all other wells on the slide.

Select a well using the drop down menu in the well column. The Well has

been defined and previously saved in the Well Designer. Refer to section

4.2.2 for further information.

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Using the color column, the well can be colored.

The menu “function” has to be “undefined” for the settings and should never be

changed!

Select a substrate by using the drop down menu in the substrate column.

Substrates can be added by a right mouse click on the arrow. A window will open.

Press the plus (+) button to get an untitled line in which the name of an additional

substrate can be added.

Saving the slide design

Once the slide is defined with all information needed, it has to be saved.

1. Select Slide from the Slide Designer screen

2. Select “Save as” from the drop down menu

3. Enter a slide name and select “Save”. The slide will be saved in the HELMED® IFA

Software.


5.2 Test Designer

The Test Designer is used to create a new test or to change settings of an existing test if required.

Refer to section 4.2.1 for details on creating a new slide.

NOTE: AESKU tests are pre-programmed and should not be edited.

The Test designer has the flexibility to program most IFA assays. The parameters of these assays

should be based on the instruction manual contained within the kit.

NOTE: It is the responsibility of the user to make proper adjustments and then validate the test

before use.

Select the Tools option at the top of the HELMED® IFA

main screen.

Select Test Designer from the drop down menu to open

the Test Designer screen.

NOTE: This function is password protected. If you want

to

change settings here please contact your local

distributor.

There are two options along the top of the screen:

Test:

Contains options for creating a new test or to open an

existing test.

Tools:

Contains the module of the control designer for creating

a new control or to open an existing control.

5.2.1 Tools: Control Designer

There are five options listed in the control designer menu

New:

To create a new control.

Open:

To open an existing control.

Save:

To quick save a programmed control.

Save as:

To save a programmed control as a named control.

Close:

To close the control designer and return to the test designer.

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Define the Controls:

Edit the name of the control. Select a dilution if

needed (default setting 1/1 for ready-to-use

controls). Select between controls dispensed

before first patient and/or controls dispensed on

every slide.

If you define a new control and you click “Save”

you will be prompted to enter a name for the

control. If you opened an existing control the

changes will be saved.

5.2.2 Test

5.2.2.1 Settings for Test Info

Select the manufacturer, substrate, well, slide and wash type that should be used in the test by using

the drop down menu on every line. The function “Allow Well Pooling” is for using different conjugates

on one slide. For IFA assays requiring incubation(s) higher than room temperature (23°C-25°C), the

Test Run Temperature can be adjusted. However, the specialized carousel with the heating unit must

be used. The standard HELMED® does not have a heating unit and is therefore not suitable.

Refer to section 7 for additional information. NOTE: The Test Designer main screen will open with default settings Test Info. These settings

have to be changed before starting with the Step selection.

Select a manufacturer by using the drop down menu in the manufacturer line. A manufacturer’s name

can be added by a right mouse click on the arrow. A window will open. Click the plus (+) button to get

an Untitled line in which the name of an additional manufacturer can be added.

If a manufacturer should be deleted, then select the manufacturer to delete with a mouse click and

press the cross (x) button. The manufacturer will be deleted.


Select a substrate by using the drop down menu in the Substrate line. Substrates are defined in the

Slide Designer. For further information refer to Selection 4.2.6.

Select a well by using the drop down menu in the Well line. Wells are defined in the Well Designer

(Slide Designer – Tools). For further information refer to Selection 4.2.2.

Select a slide by using the drop down menu in the Slide line. Slides are defined in the Slide Designer.

For further information refer to Selection 4.2.1.

Select a wash type by using the drop down menu in the Wash type line. Wash types can be added by

a right mouse click on the arrow. A window will open. Click the plus (+) button to get an Untitled line

in which the name of an additional wash buffer can be added.

If a wash buffer should be deleted, then select the one to delete with a mouse click, and click the cross

(x) button. The wash buffer will be deleted.

Selecting “Allow Well Pooling” enables use of different conjugates on one well.

Run Test Temperature can be increased for a special test (a special heater carousel is needed –

available on request).

5.2.2.2 Settings for Steps

Select from the list on the right of the screen the steps that should

be processed in a test. Seven options are available: Dilution,

Incubation, Wash, Conjugate Addition, Counterstain Addition,

Mounting Medium Addition and Composite.

The steps to process slides must be defined. Select Test Steps on the right of the screen as described

in the manufacturer’s instruction manual.

NOTE: All step files will open with default settings. These settings have to be changed before

adding to the step.

AESKU test steps are pre-programmed and should not be edited.

The following instructions for creating test steps are an example only, and refer to the AESKU

IFA Kit instruction manual.

31 / 52 009: 2013-05-14

Step 1

Select “Dilution” on the right of the screen (double-click or add–button). A window will open in order to

define samples, controls, diluent, dispensing (transfer to the slide) and additional needle wash.

Define the screening dilutions for the samples.

This dilution will be used for all patient samples. The

titration dilutions of interest for the samples can also

be defined. The titration dilutions are added by

clicking the Add button.

Select the controls:

Add the controls needed with the plus (+) button.

Then select the control you have designed in the

control designer. Please see chapter 5.2 for

information on the control designer.

Select the diluent by using the drop down menu

of the dilution medium line:

Select between Wash Solution and Diluent. If Wash

Solution is selected the wash buffer of the test will be

used. If Diluent is selected the Diluent line will be

enabled and the test diluent will be used. A diluent

can be selected by using the drop down menu.

Diluent types can be added by a right mouse click on

the arrow. A window will open. Click the plus (+)

button to open an untitled line in which the name of

an additional diluent can be added as well as its

manufacturer.


Define the dispensing settings for the transfer to

the slide:

These settings are divided by Dispensing Volume,

Dispensing Height and Dispensing Speed. The

volume needed to cover the entire well depends on

the well size (i.e. Round 50x50 = 30µl; Round 80x80

= 80µl). The Dispensing Height is the dispensing

needle height above the slide when dispensing fluid.

The Dispensing Speed is arbitrary and relates to the

revolutions per minute of the volumetric pump during

dispensing. These parameters must be verified and

validated for the slides.

Number of needle wash cycles during dilution:

You can increase the needle wash cycles (up to 10)

between each sample when creating the dilution in

the MTP.

Number of needle wash cycles during transfer:

You can increase the needle wash cycles (up to 10)

between each sample during the transfer to the

slide.

The standard value is 1.

After these settings are entered press OK. The first test step appears under Step

on the left side of the screen.

Step 2

Select incubation

Click on the add button

on the right of the screen

(or double-click on

Incubation and define

the incubation time

needed for the first

incubation. Then click

OK.

Incubation step appears under Steps on the left of the screen.

33 / 52 009: 2013-05-14

Step 3

Select Wash

Double-click Wash or

click add–button on the

right of the screen ().

Enter the number of

required wash cycles.

Volume, dispensing

height, dispensing speed

and aspiration height

settings must be verified

and validated.

The volume needed to cover the entire well depends on the size of the well. The Dispense Height is

the height of the dispensing needle above the slide when dispensing fluid. The Dispense Speed is

arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing. The

Aspirate Height is the height of the aspiration needle when aspirating the fluid from the slide.

If the option “Enforce Timing” is selected, then the

incubation time of the step prior to washing will be

strictly adhered to.

After entering the settings press OK. The washing step appears under “Steps” on

the left side of the screen.

If “Enforce Timing” was selected for the incubation time, the Wash Step appears in

red.

Step 4

Select Conjugate

Addition

From the right side of

the screen (double-

click or add–button).

Select a conjugate

using the drop down

menu in Conjugate

line.


Conjugates can be added by a right mouse click on the arrow. A window will open. Click the plus (+)

button to obtain an untitled line in which the name of an additional conjugate can be added, as well as

its manufacturer. Define the settings for Conjugate Addition, Dispense Height, Dispense Speed and

Aspirate Height. These settings must be verified and validated.

If it is necessary to first wash the wells with conjugate,

then the number of cycles must be defined. Up to three

cycles are possible.

For every cycle edit the volume needed to cover the

entire well.

If there is no need for more than one cycle of conjugate addition, then only enter the µl’s needed for

Volume #1. After these settings are entered press OK.

The Conjugate Addition step appears under “Steps” on the left of the

screen.

Step 3 and Step 4 can be combined in a composite step. The function of this step is to immediately

add conjugate to each well after it is washed.

Select Composite

on the right of the screen. Composite appears

under “Steps” on the left of the screen when

this step is enabled. On the right of the screen

there are now three different steps available:

Wash, Conjugate Addition and Counterstain

Addition.

Select Wash

and follow the instructions in step 3. The Wash appears under Composite

on the left of the screen. Then select Conjugate Addition and follow the

instructions in step 4. Conjugate Addition appears under Composite on the

left of the screen. To continue defining steps click once on “Steps” on the

left of the screen.

35 / 52 009: 2013-05-14

Step 5

Select Incubation on the right of the screen (double-click or add–button) and define the incubation

time needed for conjugate incubation. Then click OK.

Incubation step appears under “Steps” on the left of the screen.

Step 6

Select Wash from the right of the screen (double-click or add–button). Define how many cycles a well

is required to be washed. Settings such as Volume, Dispense Height, Dispense Speed, Aspirate

Height have to be verified and validated. The volume needed to cover the entire well depends on the

size of the well. The Dispense Height is the height of the dispensing needle above the slide when

dispensing fluid. The Dispense Speed is arbitrary and relates to the revolutions per minute of the

volumetric pump during dispensing. The Aspirate Height is the height of the aspiration needle above

the slide when aspirating the fluid. If the option Enforce Timing is selected, then the incubation time of

the step before the washing will be strictly adhered to.

After these settings are entered, press OK. The Washing Step appears under

“Steps” on the left of the screen.

If Enforce Timing has been selected, the incubation time will be strictly adhered to

and the Wash Step appears in red fonts.

Step 7 As an optional step for IFA, you may select Counterstain Addition on the right of the screen (double-

click or add–button). Define the Volume needed to cover the entire well. The Dispense Height is the

height of the dispensing needle above the slide when dispensing fluid. The Dispense Speed is

arbitrary and relates to the revolutions per minute of the volumetric pump during dispensing. The

Aspirate Height is the height of the aspiration needle above the slide when aspirating the fluid.

Settings, such as Volume, Dispense Height, Dispense Speed, and Aspirate Height must be verified

and validated.

Step 6 and Step 7 can be combined in a composite step. The function of this step is to immediately

add counterstain to each well after it is washed.

Select Composite on the right of the screen.

Composite appears under Steps on the left of

the screen when this step is enabled. On the

right of the screen, there are now three different

steps available: Wash, Conjugate Addition and

Counterstain Addition. Select Wash and follow

the instructions in step 3 / 6.


Wash appears under Composite on the left of the screen. Now select

Counterstain Addition and follow the instructions in step 7. Counterstain

Addition appears under Composite on the left of the screen. To continue

defining steps click once on Step on the left of the screen.

Step 8

Select Incubation on the right of the screen (double-click or add–button) and define the incubation

time needed for counterstain incubation. Then click OK. Incubation step appears under “Steps” on the

left side of the screen.

Step 9

Select Wash on the right of the screen (double-click or add–button). Define how many wash cycles

are required. Settings as Volume, Dispense Height, Dispense Speed, Aspirate Height have to be

verified and validated. The volume needed to cover the entire well depends on the size of the well.

The Dispense Height is the height of the dispensing needle above the slide when dispensing fluid. The

Dispense Speed is arbitrary and relates to the revolutions per minute of the volumetric pump during

dispensing. The Aspirate Height is the height of the aspiration needle above the slide when aspirating

the fluid.

It is recommended to select Enforce Timing for the Counterstain Incubation.

By doing so, the incubation time will be strictly adhered to. Then click OK.

Wash step appears under “Steps” on the left of the screen.

Step 10

Select Mounting Medium Addition on

the right of the screen (double-click or

add–button). Define the settings of the

Mounting Medium Addition Volume,

Dispense Height,

Dispense Speed, and Aspirate Height. These settings have to be verified and validated. After these

settings are programmed click OK.

The Mounting Medium Addition step appears under “Steps” on the left of the

screen.

37 / 52 009: 2013-05-14

Select Counterstain Addition as an optional step for IFA in a Composite

step, see left.

Saving the Test:

Once all test steps are defined the test has to be saved.

1. Select Test from the Test Designer Screen

2. Select Save from the drop down menu

3. Enter a test name and select Save. The test will be saved in the HELMED® IFA Software.


6 Run a Worklist

Up to four different tests with four different substrates and four different conjugates maybe run on one

HELMED® Workstation. Select the HELMED® IFA Software icon on the desktop to open the main

screen.

Select the File option at the top of the HELMED® IFA main

screen. Selecting New from the drop down menu enables

user to create a new worklist. Selecting Open from the drop

down menu allows the user to open a previously saved

work list file of a run.

NOTE: Only one large conjugate bottle is available. (If

two tests are selected only the first test can use the

large bottle, the second test must use the small bottle.)

The following instructions for creating a worklist are an example only, and refer to the AESKU IFA

ANA_Hep2_12w_51.100 Kit.

Select one of the available tests shown in the next

window. ´New Worklist – Step 1 of 4´ by clicking

the Add button and then the Next button

New Worklist – Step 2 of 4 shows the selected

test.

Selected test is shown. The slide that belongs to

the selected test is shown in the drop down menu.

Use the drop down menu in the Mode line to

select between screening or titration of the

samples.

When you click “Traceability” a window pops up.

Here you can provide additional information e.g.:

the operator name or the Lot Numbers.

NOTE: Check the information on a regular

basis to ensure it is up to date!

Clicking the “Add Another Test” button returns the

user to the ´New worklist – Step 1 of 4´ in order to

add additional tests.

Press Next.

39 / 52 009: 2013-05-14

When using barcode labeled samples the barcode

reader must be enabled before creating a new

worklist. Select Tools from the HELMED® IFA

main screen. Enable the barcode reader in the

drop down menu. The barcodes of the samples

and of the racks will be scanned into New Worklist

– Step 3 of 4.

Standard sample tubes are:

5 ml tube Ø13 x 75mm

Scanned barcodes will be shown in the window of

“New Worklist – Step 3 of 4”.

New worklist – Step 4 of 4

This lists the instrument name and the test(s)

selected for the worklist that will be configured.

Press Finish to advance to the layout screen.

The worklist layout will open by default. This has an Info field on the right of the screen containing Test

Info, Wash Solution Info, Reagent Rack Info and Slide Info.


There are four options listed at the top of the worklist screen:

Layout

The Layout screen shows where to put the reagents, controls, samples and slides. After all samples

slots are occupied and selected (refer to 2. Sample Data) by ticking, the layout default screen becomes

the real layout screen where the number of slides needed will be shown.

If samples are added or removed using the sample data tab, the layout screen will be automatically

updated.

41 / 52 009: 2013-05-14

Sample Data

Sample Data has to be defined. Select the plus (+) button to add samples when not using the barcode

reader. Sample ID has to be defined before selection. The “Add Samples” option enables the user to

enter the number of samples to be processed. Auto Sample ID names will be generated. All samples

and the appropriate dilutions for processing during a run must to be selected. The list maybe

supplemented with remarks and patient names.

By right clicking on a specific titration 3 options are revealed:

“Select all”: all available samples of this column will be checked

“Unselect All”: all available samples of this column will be unchecked

“Select Number”: Enter the required number of samples for the specific column. The “Select Number”

function always starts with the first sample of the column.

Sample Selection blockwise:

To select samples blockwise click on the last sample of the required block using the left mouse button.

Depress and hold down the right mouse button on this position and move the mouse up to the

designated sample position. Release the right mouse button at that position. Samples will be selected.

NOTE: This function will only work if the mouse is moved upwards within the Rack Position, not

downwards!


MTP

MTP shows how many strips are needed for

the pre-dilution steps.

Status

Status provides the progress status.

By clicking “Start” the HELMED® will process

the defined worklist.

After all slides, reagents, controls and samples are loaded, return to the Status option on the top of the

Worklist screen and press START. After „Start“ the instrument lock mechanism will lock the green

cover. If you selected the option "Start Loading Wizard Before Run", the device will remain unlocked

and the loading assistant starts. Here you can check if you have loaded the device properly. You will

also be advised to fill the system bottles and empty the liquid waste bottle. You will then be prompted

to close the lid of the device. The instrument starts with the initialization.

First the z-axis will rise and the middle needle moves up and down.

The R-motor moves to the home position and the three rings begin to turn. Each ring is searching for

its home sensor and stays in this position when found.

If the instrument passes the initialization procedure without an error message, the instrument is ready

for use.

If an error message appears during initialization, please contact your distributor’s technical service.

43 / 52 009: 2013-05-14

While running the software shows two clocks. The large clock shows the remaining time of the entire run,

while the small clock shows the remaining time of the actual action currently in progress.

If needed, it is possible to pause the run using the PAUSE button.

The system is then unlocked, e.g. the samples may be removed. Press CONTINUE and the run will

resume.

If any reagent is missing from the reagents rack (e.g. buffers, controls, conjugates) the instrument will give

off an alarm beep and a visual red alarm will light up. The system will be unlocked during this time and the

run is paused. The carousel will rotate to the position where the reagent is missing. After refilling the

reagent bottle, the cover has to be closed. Press OK to continue with the run. The ERROR report is shown

in the status option.


7 37oC Incubator Module

7.1 Introduction

This portion of the instruction manual is for the incubator module which is used with the HELMED® IFA Processor with IFA software version 2.0 or above. In order to ensure optimum performance and for safety reasons please familiarize yourself with the contents of this manual before operating the system.

The specifications listed in this manual are subject to change.

WARNING If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. The incubator module and the original accessories are intended to be used only for the purposes described in this manual. AESKU.SYSTEMS GmbH & Co.KG cannot be held responsible for any different use other than what is described in this manual.

7.2 Instrument Description

7.2.1 General description

The IFA (Immunofluorescence) Incubator module is used in conjunction with the HELMED® IFA

Processor in order to perform IFA slide incubations at temperatures above 30ºC. This specially

designed module performs incubations at optimal humidity levels at a maximum temperature of 37ºC.

7.2.2 Purpose and application

This module is suitable for automatically processing standard IFA slides with incubation temperatures

of 37ºC. The range of application includes all IFA methods that use standard slide dimensions and

have an incubation range between room temperature and 37ºC. Examples of applications are

autoimmunity IFA methods and infectious serology IFA methods. This module is also suitable for IFA

veterinary tests.

7.2.3 Parts list

HEL-3511 1x Incubator slide holder ring, 1x IFA SW V. 2.0 and 1x disposable incubator ring sponge

pack (HEL-3514)

HEL-3514 Disposable sponge for the incubator ring (5 pieces / pack)

HEL-3561 Foam, spoiler inlay (5 pieces / pack)

45 / 52 009: 2013-05-14

7.3 Setup / Installation Incubator Ring

i. Please ensure that HELMED® software version 2.0 or above is installed. Otherwise follow the

instructions for installation on the CD provided with the Incubator module.

ii. Remove the reagents and sample racks from the instrument.

Remove the original slide holder ring.

iii. Place the IFA incubator ring (ref. 3511) on the HELMED® Processor

Please look for the designated, colored (two white and one black) support pillars when you

install the ring. Ensure the ring is completely flush with the base.

iv. Your incubator module is ready to use

7.4 Instructions for use

If the incubator ring is not installed in the HELMED® please follow the instructions described in 3.ii and 3.iii

Place a new inlay sponge (ref. HEL-3514) inside the ring as shown in the picture below:

Soak the inlayed sponge in the incubator ring with 800 – 1.000 ml of warm distilled water (about

37ºC). Carefully pour the water into the ring and ensure that the water is fully absorbedby the sponge.

Prepare your worklist and the HELMED® is ready to process your slides

ATTENTION: Do not overfill the sponge (i.e. water should l be completely absorbed by the sponge). Ensure

that the water is distributed around the entire sponge as evenly as possible.

For optimal results use warm distilled water to soak the sponge.

In the case of 37° C incubation steps it is essential that the cover remains closed throughout

the entire incubation period in order to maintain the humidity and temperature levels inside the

HELMED® chamber. Please ensure that the maintenance procedures are followed after each

use.


7.5 Disposable Sponge Inlay

7.6 Maintenance instructions

7.6.1 After usage

To remove the sponge, please first remove the complete incubator ring from the instrument and place

near a sink. The sponge will drip when removed!

Wring-out the sponge and let it dry.

Please wipe the inside of the incubator ring where the foam was positioned using a tissue to ensure

this is dry.

Leave the HELMED® cover open for a few minutes to enable any remaining condensate to evaporate.

7.6.2 Reuse

Following the recommendations described in section 4.1.1 you should be able to use the sponge up to

five times

If you will have any doubts regarding contamination of the sponge please insert a new one.

Please check for proper fit after insertion.

IMPORTANT NOTICE: The continuous use of the incubator module might reduce the maximum life time of some HELMED® components. Make regular visual inspections of the system parts to look for signs of degradation/rust. Please contact your technical service representative if signs of degradation/rust are present. Aesku recommends a minimum of 3 yearly technical service visits to assure optimal performance of the HELMED® analyzer together with the incubator module.

The sponge inlay is a natural

sponge with a thickness of

25mm.

47 / 52 009: 2013-05-14

8 HELMED® HTC Edition

The HELMED® HTC Edition is a separately produced instrument which assures the highest possible

humidity during a temperature controlled assay.

Special sealing around the green cover guarantees a humidity level for longer incubation times. This

helps to keep tissue covered throughout processing.

Unique to the HTC model, we have added a spoiler containing a foam seal around the front of the

instrument.. This special construction (spoiler) provides a tight seal with the green cover.

Aesku.Systems GmbH & Co.KG recommends replacing this foam on a two monthly basis. If the foam

comes into contact with hazardous material, please replace it immediately for your safety!

The foam can be easily removed and replaced by insertion into the spoiler. The foam expands and

remains in position.

When the incubation temperature rises above 32oC the internal humidity ring will move every 10

seconds (18 degrees) so as to ensure a homogeneous heat/humidity distribution throughout the entire

ring.


9 Maintenance

Daily maintenance is important for proper operation of the instrument. The following procedure is

recommended.

9.1 Daily Shutdown

After processing a worklist the instrument has to be primed with distilled water. For this purpose,

replace wash solution with distilled water.

This keeps the fluid lines in good condition and avoids particles clogging the needles and tubing.

Wipe the outside of the needles with a tissue and 70% ethanol.

Replace wash solution with distilled water.

Empty the wash bottle #1 and rinse the bottle with distilled water. Fill it with distilled water or

disconnect the quick connector on the bottle top and replace with a new bottle containing distilled

water.

Prime the instrument

Select Tools from the IFA main screen. Then

select Prime Instrument.

Select the Wash bottle Number and enter

the number of cycles. We recommend

priming the instrument 1-3 times, 9 cycles

each with distilled water.

49 / 52 009: 2013-05-14

9.2 Weekly maintenance

Prime the instrument once a week with 0.3 % sodium hypochlorite (NaOCl) solution or alternatively 70

% ethanol. Follow the steps from 9.1 to prime instrument. Let it incubate for at least 15 minutes. Prime

the instrument with distilled water three times 9 cycles each.

Attention: After cleaning the instrument with sodium hypochlorite (NaOCl) solution it is essential to

prime the instrument with distilled water. The decontamination solution must not contain any kind of

tenside as these are very persistent and can affect the needle level detection behaviour. Follow

procedure 9.1 to prime instrument.


10 Calibration

We recommend calibrating the carousels during the yearly maintenance.

To calibrate the peristaltic wash pump please contact your local distributor.

Only trained personnel are allowed to calibrate the carousels and the peristaltic wash pump!

For calibrating the wash pump you need the special calibration tube Part No HEL-3522

Detailed procedures can be found in the service manual.

51 / 52 009: 2013-05-14

11 General and technical specifications

Sample capacity:

With barcode, IFA: up to 190.

Dilution capacity:

IFA: 192 positions.

1/1 to 1/160: one step (one well).

1/161 to 1/25600: two step (two wells).

Pumps:

One peristaltic pump for aspiration of fluids.

One peristaltic pump for slide well and MTP well washing.

1 x 50 uL syringe.

1 x 1 mL syringe.

Plates:

96 wells, F-bottom

Plate washer:

1 channel.

Power consumption:

210 W

Fuse

T4A / 250V; 5x20mm Ceramic!

breaking capacity 1.500 V

Voltage range

Input: 115 / 240 Volt, 50-60 Hz.

Output: 24 Volt DC./ 5 Volt DC.

Operating temperature

20° - 35°C

Humidity

10% - 90%, non-conducting

Weight:

28 Kg

GmbH & Co. KG, Mikroforum Ring 3, 55234 Wendelsheim, Germany

Telephone:+49-6734-9622-0

Fax:+49-6734-9622-3222

www.aesku-systems.com

For technical inquiries please contact us at [email protected]

For inquiries about products and services please contact us at [email protected] © Unless expressly authorized, forwarding and duplication of this document is not permitted.

All rights reserved.

http://www.aesku-systems.com/

mailto:[email protected]

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