Jan 14th 2021

RAPTOR SERVER INSTRUCTIONS FOR USE

The following links are provided for convenience to jump directly into important chapters of this IFU:

The herein described procedure is only for using the RAPTOR SERVER Analysis Software in combination with the ImageXplorer. For using the RAPTOR SERVER Analysis Software with the MAX 45k refer to the Instruction for Use for MAX 45k.


1. ABBREVIATIONS


IVD In-vitro diagnostic medical device
GD Guide dots - special allergen spots at the corners of the cartridge. Used for plausability checks by RAPTOR SERVER Analysis Software.
QC Quality control
IFU Instruction for use
IgE Immunoglobulin E
RUO Research Use only

2. INTENDED USE

ImageXplorer

The ImageXplorer is an imaging device to be used in combination with the RAPTOR SERVER Analysis Software to acquire images of ALEX technology-based arrays after they have been processed by the laboratory user or medical professional.

RAPTOR SERVER Analysis Software

The RAPTOR SERVER Analysis Software (RAPTOR SERVER) is intended for in vitro diagnostic (IVD) use in combination with the ALEX technology-based test kits. The cloud-based RAPTOR SERVER performs a quantitative analysis for allergen-specific IgE (sIgE) and semiquantitative analysis for total IgE (tIgE) of processed arrays and offers basic interpretation and decision support comments. The testing system is an aid in the clinical diagnosis of patients with allergies in conjunction with other clinical and laboratory findings. The software is to be used in clinical laboratories by trained operators or medical professionals. The software can either be used in conjunction with ImageXplorer or MAX 45k, as an analysis tool and for sharing results with other users/referring physicians.

Currently available kits:


3. SUMMARY AND EXPLANATION

RAPTOR SERVER Analysis Software is an alternative, web-based approach to Raptor Analysis Software. RAPTOR SERVER is a web-based application and is operated via the browser. The RAPTOR SERVER is a software for the acquisition and analysis of medical device images taken by the ImageXplorer device from the already processed ALEX technology-based cartridge. RAPTOR SERVER is developed as a standalone solution which also performs the storage of data and creation of reports of the diagnostic lab results.

The software consists of

The software was especially developed for analysing and reporting of results obtained with ALEX or similar MADx products.

Operation

Ideally, the operation of RAPTOR SERVER should be centralized, in the form of a cloud-based SaaS (Software as a Service) application. However, a purely local operation on a single PC or operation within a customer-owned data center ("on-premise" = RAPTOR SERVER Desktop) is also possible.

IMPORTANT USER INFORMATION:

For the correct use of the ImageXplorer and the RAPTOR SERVER software, it is necessary for the user to carefully read and follow these instructions for use. The manufacturer assumes no liability for any use of this test system which is not described in this document or for modifications by the user of the test system.

This version of the IFU is valid from the RAPTOR SERVER Version 1.2 on.


4. PRINCIPLE OF PROCEDURE

ALEX technology-based tests are solid-phase immunoassays. Allergen extracts or molecular allergens, which are coupled to nano-particles, are deposited in a systematic fashion onto a solid phase forming a macroscopic array.

First, the particle bound allergens react with specific IgE that is present in the patient sample. After incubation, non-specific IgE is washed off. The procedure continues by adding an enzyme labelled antihuman IgE detection antibody which forms a complex with the particle bound specific IgE. After a second washing step, substrate is added which is converted to an insoluble, coloured precipitate by the antibody-bound enzyme. Finally, the enzyme-substrate reaction is stopped by adding a blocking reagent. The amount of precipitate is proportional to the concentration of specific IgE in the patient sample.

The lab test procedure is followed by image acquisition and analysis using the ImageXplorer. The test results are analysed with MADx’s RAPTOR SERVER and reported in allergen specific IgE units (kUA/L). Total IgE results are also reported in IgE units (kU/L).


5. ENVIRONMENTAL CONDITIONS AND SHIPMENT

Environmental Conditions for the ImageXplorer

To ensure trouble-free operations of the ImageXplorer, it is important to locate the instrument in an appropriate environment.

Environmental conditions Specifications
Operating Temperature: 15 to 30 °C
Humidity: 30 - 85%, non-condensing
Power supply: The device is powered by a +5V USB 3.0 or USB 2.0 cable from either a personal computer or a USB power supply. No additional power supply is needed.
Weight and dimensions of work place: The device fits on a normal work bench or desk, weight and dimension do not require special support structures
Dust: Dust-free environment recommended
Operating system: Windows 10

6. WASTE DISPOSAL

Waste disposal of the ImageXplorer has to be performed in accordance with local guidelines.


7. GLOSSARY OF SYMBOLS

Symbol Description
CE Mark
In vitro diagnostic medical device - Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.
Consult instructions for use - Indicates the need for the user to consult the instructions for use.
Serial number - Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Manufacturer - Indicates the medical device manufacturer
Symbol for the marking of EEE
Important Note

8. CONTENTS OF IMAGEXPLORER PACKAGE

Equipment REF Quantity
ImageXplorer 11-0000-01 1
ImageXplorer carriage - 1
Connecting cable (PC - ImageXplorer) - 1
RAPTOR SERVER Analysis Software 22-0000-01 1
USB Power Hub for constant +5V supply - optional

9. SAFETY INSTRUCTIONS

Operator qualification

The ImageXplorer and the RAPTOR SERVER should be operated by or under the supervision of a technician or operator who is sufficiently qualified for laboratory work. Before operating the ImageXplorer and the RAPTOR SERVER the operator should:

Carefully follow the procedure specified in these Instructions for Use for the operation and maintenance of the system. Maintenance which is not described in the Instructions for Use should be left to qualified service engineers.


DO NOT open the instrument housing!


Electronic equipment can be a source of electric shocks!

Service and Repair should only be carried out by authorised and qualified personnel of the manufacturer!

Data backup

When using RAPTOR SERVER, all analytical and person related data are stored according to the MadX Terms of Service Agreement in the Microsoft Azure Online Portal. Please also refer to the Online Services Terms (OST) of Microsoft available, at https://www.microsoft.com/en-us/licensing/product-licensing/products. For the RAPTOR SERVER Desktop version, please consult with your local IT administrator.

Electromagnetic Compatibility

The ImageXplorer fulfils the requirements of Electromagnetic Compatibility (EMC) according to EN 61326 (Electrical equipment for measurement, control and laboratory use).

Electromagnetic devices: Devices that emit electromagnetic waves may affect measurement data or cause the instrument to malfunction.


10. SYSTEM COMPONENTS

ImageXplorer


A: chassis
B: slider
C: carriage

The relevant system components are:


11. WORKFLOW


  1. Connect ImageXplorer to computer
  2. Go to www.allergy-explorer.com
  3. Log into your tenant account
  4. Start measurement
  5. Enter patient information
  6. Analyse and verify result, then approve results
  7. Export the data

12. INSTRUCTIONS

Connecting the ImageXplorer to the PC

The ImageXplorer is not a standalone device and always has to be used in combination with RAPTOR SERVER. The ImageXplorer is plugged into a computer via the provided USB cable and both, connection and power supply, are managed through the computers USB 3.0 port by the provided USB cable. The thicker USB plug (USB B) is attached to the back of the ImageXplorer, whereas the thinner USB port (USB A) is attached to the computer.

Note: The device can also be used on USB 2.0 port, but the analysis will require longer time because of lower data transmission rates.



RAPTOR SERVER Software setup

Google Chrome is recommended as a browser for using the RAPTOR SERVER. The RAPTOR SERVER can be accessed by the website: https://www.allergy-explorer.com.

The RAPTOR SERVER instance is designed for SaaS operation and therefore supports multiple independent tenants. Each tenant is logically differentiated from all other tenants and no exchange of data between tenants is possible in any way.


Log-In

Tenant: Single laboratory within the RAPTOR SERVER. This tenant is created by MADx

Access to RAPTOR SERVER will only be available to users with a valid username and password or external directory service (Office 365/Azure Active Directory). The users can not register themselves but must be entered and released by the RAPTOR SERVER administrator.


After a successful login, the user has access to his tenant. A password can also be reset if forgotten. If you click on the following icon and select Tenant Admin, you will be directed to the Tenant Admin area, where you can set the preferences for your tenant.




Download of ImageXplorer Agent software and ImageXplorer definition

To set up an ImageXplorer for your tenant, go to the Tenant Admin area and click “Manage ImageXplorer”. To add a new ImageXplorer, please select "Add new ImageXplorer" and assign a name to it. An ImageXplorer key will be generated automatically.




After clicking on "Save" you will return to the overview page of the respective ImageXplorer. Here you have to download the ImageXplorer Agent software.


To activate the agent and connect it to ImageXplorer and RAPTOR SERVER, please go to Settings and type in the RAPTOR SERVER URL: https://www.allergy-explorer.com and your ImageXplorer Key and click “Continue”.


A: Connection to RAPTOR SERVER
B: Connection to ImageXplorer

If a connection to both the RAPTOR SERVER and the ImageXplorer is established, both fields are highlighted in green. If one connection fails, refer to the troubleshooting section for further instructions. link


Adjusting the ImageXplorer Settings

Each ImageXplorer has unique image settings that need to be adjusted during the first installation and then every 6 weeks.

Upon the first installation or upon starting the new RAPTOR SERVER version for the first time (and if an ImageXplorer is connected to the computer) no measurement can be made without an ImageXplorer test array run.


Every new ImageXplorer system will include a test array with a special barcode starting with the digits "30" on the label (e.g. 30AAF267). The test array is delivered in a resealable pouch and should always be stored in a dark place at room temperature. The test array must be analysed with an ImageXplorer.

After clicking "Configure" in the menu "Manage ImageXplorer" you are directed to the area where you can run a test array.


By clicking on “Start new test array scan”, the settings-adjustment starts (takes about 2-3 minutes).


This measurement will identify the optimal settings for x, y, width and height of the array edges and the optimal exposure. After the calculation is finished, a report of the test array run is displayed. The user has to apply the new ImageXplorer settings by clicking “Apply detected settings”.


Running the test array on a regular base will ensure that the ImageXplorer uses the optimal configuration. Therefore, after 60 days a message will appear, which prompts you to repeat the ImageXplorer test array run within 30 days.


If you do not repeat the ImageXplorer test, no new measurements will be possible after 90 days. Previous results will be accessible as before.

The current ImageXplorer settings are to be found in the “Tenant Administration” area --> “Manage ImageXplorers” --> “Configure”

If the barcode is not recognized during the test array run, the "automatic exposure" under calibration configuration can be changed to --> "manual exposure". The Calibration Exposure is set to 2500 by default. However, it can be corrected a little bit up or down.




Personal settings

In "Personal Settings" you can select the user language, the culture (e.g. English (UK)) and the time zone. ALEX2 contains 5 Research Use Only (RUO) allergen spots. These are deactivated by default. To make the RUO spots visible, the user can select “show research spots” in the drop-down menu. In addition, the display language can be selected, once it is translated into the required language.



Insert a cartridge into the ImageXplorer

The ImageXplorer has an insertion mechanism for loading one processed cartridge at a time into the device. Carefully take the cartridge (don’t touch the membrane of the cartridge) and insert it by facing the barcode to the MADx logo on the ImageXplorer into the carriage. Take care that the cartridge is completely inserted into the carriage and neither in front nor in the back raised up (see pictures below). After inserting a cartridge, close the slider by moving it forward gently until it stops.


A: slider
B: carriage

Image acquisition, barcode reading and grid finding

On the overview page you will find a tab "New measurements", a tab "Approved measurements", a button for "Start measurements" and if there is a MAX 45k (automated processing unit), a button for Automat. The tab "New measurements" contains all new and unapproved measurements, the tab "approved measurements" contains all hitherto approved measurements.

Click on “Start Measurement” in the RAPTOR SERVER browser window to acquire an image and start the analytic sequence.


If only one ImageXplorer is connected, the analysis is started immediately. If several ImageXplorers are connected to the RAPTOR SERVER in one tenant, the user must first select which ImageXplorer he wants to use. RAPTOR SERVER automatically recognises the barcode, which is the basis of all further processing and assigns the identified barcode to the new measurement.

Attention: Make sure to know which ImageXplorer you are using for entering the correct patient information!

The barcode on each cartridge contains the following information:

After imaging and analysing, a detailed overview of the measurement is displayed with the patient information fields and sample information fields on the left, an analytic image of the array on the right and a detailed result view of allergens below.


A: Patient and sample information fields
B: Analytic image
C: Result view

In addition, date of analysis, serial number of the ImageXplorer, QC and possibly also an error log are displayed below the analytical image.

Additional sample and patient information can be added manually:


If you click on "Save" the entered information will be saved.

The array of the measurement with grid is displayed in the analytical image area. The software automatically identifies the position of the array in the image data based on the guide dots. There are 4 guide dots on ALEX2.


B: ALEX2 - 4 guide dots

To enter the image processing mode, click on the image.



If the automatic position finding fails, the user will be alerted and the measurement quality control (QC) will be set to FAIL. In this case, the user can try to manually position the array by resetting the grid by pressing “R” or go to “Manual Analysis --> Reset Grid”. After resetting, you can move the whole grid with the mouse by additionally pressing "Shift", or by setting a check mark at "edit entire grid". The grid can also be found automatically by selecting "Manual Analysis --> “Find grid" or by pressing "W". To turn the grid clockwise, click the buttons "A" or "B" according to the picture above. The position of the grid can be confirmed by pressing “P” or “Manual Analysis --> Process”.

Press "R" or "Manual Analysis --> Reset Grid"
Press "W" or "Manual Analysis --> Find Grid" or manually move the whole grid
Press "P" or "Manual Analysis --> Process"

If the image is reset manually, or with the button "Reset everything and reprocess", a button "Show analysis & QC logs" appears.

If you click on this button, an area will open with the explanation for QC fail or QC OK. For ALEX2 the background must be within a certain range and all 4 guide dots must reach a special value.

Image Analysis

The analytic image of the selected ALEX technology-based array is displayed in a false colour code to allow a clear visualisation. The false colour intensity can be adjusted in three steps. Go to “Image” and select one of the 3 levels (low color correction, medium color correction or high color correction).


Pictures above from left to right: High colour correction (default) - Medium color correction - Low color correction

By clicking inside one spot, name, x and y coordinates of the image, raw and result value of the spot and the signal-to-noise ratio (SNR) are displayed.


Each allergen is surrounded by a circle. The graphic depiction of the circle represents the automatic interpretation by the software or the modification by the user:

  1. Circle with dotted line: not yet analysed or below cut-off
  2. Circle with a solid thin line: positive spot automatically found
  3. Circle with solid thick line: spot set to good by user
  4. Circle with a solid thin line and an X in the center: spot set to bad by the user
  5. Circle with a thick dashed orange line: Spots to be inspected by the user with poor signal-to-noise ratio but a quantitative result above the system cut-off. Those spots should be set to “good” or “bad” by the user.
  6. Research Use Only Spots (RUO) are marked with a “R” inside of the circle and will not be displayed in the PDF report, but are exported in the CSV, EXCEL or ASTM file. The RUO spots can be displayed by changes in the personal settings.


Spots are editable by the user:

The last two features can also be used by selecting “Grid” --> “show or hide grid” and “show or hide names”.



Short-Cut Summary:

Short Cut Execution
R Reset analysis
W Find grid
P Process
G Set feature to good
B Set feature to bad
N Annotate allergen features
H Hide/unhide grid
SHIFT Select all measurements

Orange marked spots needs to be inspected and set to Good or Bad by the user. Otherwise they will be marked by an orange triangle with an exclamation mark in the report. If the spot was set to “good” or “bad”, this will not be displayed.


It is also possible to open an image of the barcode, an image of the unprocessed or the processed array. To do this, go to "More" and select the desired image. A complete reset is also possible by pressing the "Reset everything and reprocess" button.


If the user changes the position or the interpretation of the spot or the whole grid, the analytic data will be erased, and the QC set to NA. After the analysis, press “Apply Changes” to save the modifications.


To return to the detail page of the measurement, press "Back to measurement". You can also click "Next/Previous" to go to the editing page of the following image.



Analytical results

In the detailed results list, below the patient information and the analytic image, the results of the selected measurement will be displayed. The analytic result will display a list containing the following information:


By clicking on the drop-down menu “All allergens/Only positive allergens”, the information to be displayed in the analytic results window can be selected. This is independent of those results that are displayed in the PDF report.



Overview of measurements

New and unapproved measurements can be displayed in the “New Measurements” overview.


Clicking on the barcode or the analysis date takes you to the detail area of the measurement. Patient information and tags can also be entered in the overview page. To do this, simply click in the corresponding field of the measurement and insert it. With "TAB" you automatically enter the next field and your entry will be saved.


In the search field, measurements can be searched for by according barcode, patient name, sample code or tag.


It is possible to duplicate the barcode and the measurement data in the data repository if a cartridge is acquired several times. However, this is indicated by a triangle with a exclamation mark during measurement.



Approving and exporting measurements

After analysis and careful revision of the results, the measurements can be approved by two ways:

  1. One or more measurements can be selected by ticking and then approved in the drop-down menu together:

    Unapproved measurements can also be downloaded as CSV or EXCEL.

  2. A measurement can also be approved on the detail page of a measurement. Simply click on "Save and approve".

If the QC of a measurement is "ok", the measurement simply moves to the "Approved Measurements" tab. If the QC of a measurement is "Failed", the user will get a notification that the “Measurement QC is not OK”. In addition, it will also be stated on the report that the internal QC (plausibility check for GD and background signal) was not successful.


Approved measurements are stored in the “Approved measurements” tab. No patient information can be changed or added . The details of a measurement can be displayed by clicking on a measurement.


Selected measurements in the approved measurements tab can be downloaded as PDF report, as EXCL, CSV or ASTM file.


Report Settings

In the “Tenant Admin” and “Manage report templates” the report settings can be selected.



The following settings can be selected:


After the change, the report template can be saved by clicking the “Save” Button.

The following languages are available:

To define your “default” template that is used as standard template you need to have “basic tenant” rights.

If you go to "Configure Tenant" in the Tenant Admin area, you can select your default language and template.


A report of an unapproved measurement can be displayed by clicking on one measurement from the “New measurement” tab and selecting “Report”


Then you see a preview of the report, where you can select a report template (default or customized) and set the default language. However, it is not possible to download this PDF report. For this purpose, it is necessary to approve the measurement first.

Version 2

Approved measurements can either be downloaded together or individually. To download measurements together, first go to the "Approved measurements" tab and select the measurements you want to download. Then select PDF Report from the drop-down menu and a zip folder containing the PDF Reports will be saved locally on your computer.


If you click on a measurement, you get to the detail area of this measurement. From there, you can also display a preview of the report and change the settings for the header and language of this report. You can then download the report directly from there.




Requesting Interpretation Guidance

A special software module has been implemented to support the interpretation of ALEX technology-based results: RAVEN interpretation guidance (currently available for ALEX2)

For using this service, a license key has to be requested by your local distributor or by sending a request to support@macroarraydx.com.

The license key received must be entered in the Tenant Admin area under "Configure Tenant". To add a licence key, full company details, a data processing agreement document and a term of service document has to be uploaded.


An interpretation query with RAVEN is possible for both - approved and unapproved - measurements. The report can only be downloaded for approved measurements. Select a measurement for an interpretation query to get to the detail page of a measurement, then click on the icon and select "View interpretation".


This opens a window in which the settings (language) specific patient information (such as age, gender and environment) and patient symptoms can be entered.


After entering these, the query can be started with the button "Request interpretation".


The interpretation is automatically inserted at the end of the report and is also displayed in a preview window. Measurements which have already received an interpretation query are indicated by the following symbol:

In addition, several queries can also be queried in batch. If you select several measurements on the overview page (of both unapproved and approved measurements) and click with the mouse on the 3 lines in the upper left corner, you can select "Update Interpretation" to perform the query in batch.

Multiplex on Demand (NEUE Überschrift so wie Deleting measurements)

Selecting Multiplex on Demand

The user can select which analytical parameters should be considered for the analysis. In the detail window of a measurement, a global predefined panel can be selected. If a panel is selected, the software will only display the allergen spots and results of the selected panel.

After approval of the measurements, the unselected allergen results will be deleted from both image and data. The unselected allergens are then listed in the report as “-“. To reset the selection, select "no panel".

Predefined MODs

The following allergen panels can be selected:

Defining new MOD Panels

Each tenant can define his own MOD panels. To do this, go to "Tenant Admin" --> click on "Manage MODs" and create a tenant-specific MOD panel by clicking on "Add new MOD".


Enter a name of the panel, the type (only specified allergens, or all allergens except the specified ones), and the allergens you would like to include in the panel.


Deleting measurements

Non-approved measurements can be deleted by selecting the measurement that should be deleted and select in the drop-down menu “delete”. Before a measurement is permanently deleted, a warning appears that has to be approved. Deleted measurements will be permanently erased and cannot be restored.


Importing the patient information from a file

Patient information corresponding to a certain sample barcode can be added in an Import-Template.csv file. To download this file, go to the Tenant Admin area and click on "Manage Measurement Data Completion" under "Measurement data completion".


After downloading the Template CSV file, you can type in patient information for the corresponding barcode, save it on your computer as CSV, upload the document again and click “Apply Changes”.


After uploading this file, the entered information is displayed. This information can be edited again and changes can be applied.


If an image is acquired and the corresponding sample barcode with the information was uploaded before, the patient information is automatically imported into the software.

User Portal

Measurements can be shared with a physician or other user. To do this, you must first create a physician or user. To create a physician or user, go to "Tenant Admin --> User Portal", click on “Manage Users” and add a new doctor or user.


Enter the user information and send an E-mail to create a password. Alternatively, you can define the password for the user.


Only already approved measurements can be shared. For this purpose, please go to the tab "Approved measurements", click on the detail page of a measurement, go to the icon and select "View Shares".


Then select the user with whom you want to share the measurement and click “Share”. After that you can either send a link by E-mail, with which the user can access this measurement. Or the user can log in with his access data on the following website (https://doctorportal.allergy-explorer.com/) and see the measurement shared with him.



After log in, the user can view the patient details of the shared measurements and open the report. However, the user cannot change anything.


Measurements that have been shared are marked with the following symbol. Measurements that have been shared can also be withdrawn by a tenant:


Log-out

To log out of the RAPTOR SERVER, click on "Log out" and close the window.



Technical support

If you have any questions, experiences or difficulties concerning the ImageXplorer or the RAPTOR SERVER, please contact your local service contact or Macro Array Diagnostics GmbH via support@macroarraydx.com.


Technical data

This chapter summarises the specifications of the ImageXplorer.

Features Parameters
Compatible Test Formats ALEX technology-based cartridges
Cartridge Dimensions (W x D x H) 53 x 18 x 7 mm
Maximum Scan Area /W x D) 50 x 30 mm
Light Source White light LED
Applicable Dyes Colorimetric Dyes
Scan Resolution Up to 600 dpi
Sensitivity ≤ 0.3 kUA/L
Scan Speed CPU dependent, < 5 s per cartridge
Dynamic Range 2.5 logs
Repeatability R2 ≥ 99 %, CV ≤ 5 %
Focus Distance 80 ± 10 mm
Image File Format BMP 16 Bit
Voltage 5 V USB
Power < 5 Watts
Size (W x D x H) 160 x 180 x 180 mm
Weight 1.2 kg
Barcode Identification QR Barcode
Operating System PC with MS Windows® 10
Connection USB 2.0 or higher
Temperature Range Room Temperature

Maintenance

The ImageXplorer is a sensitive imaging device and should be handled carefully. For accurate results, it is essential that the instrument be maintained dust-free state as much as possible. To this end, the external ImageXplorer housing must be regularly cleaned with a lint-free cloth. Do not use any detergents for cleaning. The carriage which holds the cartridges can be separately cleaned if necessary, using mild detergents or alcoholic solutions.


DO NOT open the instrument chassis!


Troubleshooting

The following errors are the most common ones and therefore explained here in more detail.


If you have questions to or problems with products from Macro Array Diagnostics, please contact:


MacroArray Diagnostics GmbH
Lemböckgasse 59/Top 4
A-1230 Vienna
Tel: +43(0) 1 865 25 73
E-mail: support@macroarraydx.com


Version: 22-IFU-01-EN-02