IMAGE PLORER Macro Array Diagnostics Instructions
- June 11, 2024
- IMAGE PLORER
Table of Contents
INSTRUCTION FOR USE
PLORER Macro Array Diagnostics
DISCLAIMER
MacroArray Diagnostics has validated the provided instructions, reagents,
instrument, software, and customizable features for this analyser to optimize
product performance and meet product specifications. User defined
modifications are not supported by MacroArray Diagnostics as they may affect
performance of the analyser and test results. It is the responsibility of the
user to validate any modifications made to these instructions, instruments,
reagents, or software provided by MacroArray Diagnostics.
Please consult the relevant instructions for use of ALEX² and FOX tests before
processing!
LIABILITY STATEMENT
This guide was checked for correctness. The instructions and descriptions for
the ImageXplorer were correct at the time this guide was written. Subsequent
guides may be
changed without prior notice; however, MacroArray Diagnostics assumes no
liability for harm caused directly or indirectly by errors from the guide. The
ImageXplorer is an in-vitro diagnostic devices that is intended to be used by
trained laboratory personnel only.
This guide and the software described are protected by copyright. No part of
this guide or of the software described may be duplicated, reproduced, or
copied to an electronic medium or machine-readable format without prior
written permission from MacroArray Diagnostics.
TERMS AND DEFINITIONS
Damage| Physical injury or damage to human health, damage to goods or the
environment.
---|---
Intended Operation| Operation, including readiness for operation, in
accordance with the operating instructions or the intended use.
Intended Use| Use of a product, method, or service in accordance with the
specifications and instructions defined by Macro Array Diagnostics (MADx).
Obvious damage| Damage that can be recognized with the naked eye alone by
careful observation of the analyser or its component, or by monitoring
available displays, signals, or transmitted data.
Operator| Individual or group responsible for the usage and maintenance of the
device. The operator makes sure the users have been appropriately instructed
about how to operate the device.
Process| Resources and activities that interact to convert inputs into
results.
Trained personnel| Employees who have completed a recognized education program
for the task that has been assigned to them, who are familiar with the special
aspects and hazards of their work environment and who continue their education
with regular training sessions about changes and developments (such as
standards and guidelines) that are relevant to their education and their work.
User| Person using the device in accordance with the specifications.
Validation| Confirmation by providing objective evidence that the requirements
for a specifically intended use or specifically intended application have been
fulfilled.
Verification| Confirmation by providing objective evidence that defined
requirements have been fulfilled.
INTENDED USE FOR IMAGEXPLORER
The ImageXplorer is an instrument and intended as accessory to ALEX
technology-based products.
The IVD medical product acquires pictures of the ALEX technology-based arrays
and is used by trained laboratory personnel and medical professionals in a
medical laboratory.
MANUFACTURER AND LABELING
V.1 MANUFACTURER
The ImageXplorer is manufactured by MacroArray Diagnostics (MADx)
MacroArray Diagnostics
Lemböckgasse 59/Top 4
A-1230 Vienna, Austria
V.2 IDENTIFICATION OF THE DEVICES
An identification label is placed at the rear side of the ImageXplorer.
VI. PERFORMANCE DATA
VI.1 ASSAY CALIBRATION
For the Assay Calibration refer to the respective IFU of the ALEX² or FOX
test.
VI.2 MEASURING RANGE
For the Measuring Range refer to the respective IFU of the ALEX² or FOX test.
VI.3 QUALITY CONTROL
Record keeping for each assay:
According to good laboratory practice it is recommended to record the lot
numbers of all reagents used. Lot numbers of all reagents are saved for each
run and the information can be retrieved retrospectively for each Run ID via
RAPTOR SERVER Analysis Software.
Control Specimens:
According to good laboratory practice it is recommended that quality control
samples are included within defined intervals. MacroArray Diagnostics provides
acceptance ranges for the most recent batches of Lyphochek® sIgE Control Panel
A. These values are stored in RAPTOR SERVER and cannot be edited by the user.
VI.4 DATA ANALYSIS
ALEX² and FOX images are automatically analysed using MADx’s RAPTOR SERVER and
a report is generated summarizing the results for the user.
VI.5 RESULTS
ALEX² is a quantitative method for specific IgE and a semi-quantitative method
for total IgE determination. Allergen- specific IgE antibodies are expressed
as IgE response units (kUA/L), total IgE results as kU/L. MADx’s RAPTOR SERVER
Analysis Software automatically calculates and reports sIgE results
(quantitatively) and tIgE results (semi- quantitatively).
FOX is a semi-quantitative method for specific IgG determination. Specific IgG
antibodies are expressed as IgG response units (µg/ml). MADx’s RAPTOR SERVER
Analysis Software automatically calculates and reports sIgG results semi-
quantitatively as classes (low, intermediate, and highly elevated).
VI.6 LIMITATION OF THE PROCEDURE
For the Limitation of the procedure refer to the respective IFU of the ALEX²
test or FOX test.
VI.7 EXPECTED VALUES
For the expected values refer to the respective IFU of the ALEX² test or FOX
test.
VI.8 PERFORMANCE CHARACTERISTICS
ALEX² test:
Precision:
For the precision, we refer to the section performance characteristics in the
IFU of the ALEX² test.
Repeatability (within-run precision):
In the repeatability study, multi-sensitized samples were tested 10 times by
the same operator on different days. The study comprised 319 allergens per
sample combinations
covering 165 individual allergens at 3 different levels (>10 kUA/L, 1-10 kUA/L
and 0.3-1 kUA/L).
| Concentration – kUA/L | Total CV % |
|---|---|
| ≥ 0.3 – < 1.0 | 25.6 |
| ≥ 1 – < 10 | 13.8 |
| ≥ 10 | 10.7 |
| ≥ 1 | 13.5 |
Analytical Sensitivity:
For the Limit of Detection, we refer to the section performance
characteristics in the IFU of the ALEX² test.
Analytical Specificity:
For the Analytical Specificity, we refer to the section performance
characteristics in the IFU of the ALEX² test.
Interference:
For the interference with other substances, we refer to the section
performance characteristics in the IFU of the ALEX² test.
FOX test
Precision (lot-lot variation):
The lot-to-lot variation was determined on 3 cartridge lots in three separate
runs. Multisensitized samples were included in the study. The study comprised
867 allergen/sample combinations covering 121 individual allergens over the
entire measuring range.
| Concentration – µg/ml | Intra CV % | Inter CV % | Total CV % |
|---|---|---|---|
| 10.0 – 19.9 | 6.9 | 11.2 | 9.1 |
| ≥ 20 | 3.1 | 5.5 | 4.3 |
| ≥ 10 | 4.8 | 7.9 | 6.3 |
Repeatability (within-run precision):
In the repeatability study, multi-sensitized samples were tested 10 times by
the same operation on different days. The study comprised 862 antigen/sample
combinations covering 115 individual antigens over the entire measuring range.
| Concentration – µg/ml | Total CV % |
|---|---|
| 10.0 – 19.9 | 11.3 |
| ≥ 20 | 5.4 |
| ≥ 10 | 7.2 |
Analytical Sensitivity:
For the Limit of Detection, we refer to the section performance
characteristics in the IFU of the FOX test.
Interference:
For the interference with other substances, we refer to the section
performance characteristics in the IFU of the FOX test.
VII. PRINCIPLE OF THE PROCEDURE
VII.1 ALEX² TEST PRINCIPLE
ALEX² is a solid-phase immunoassay. Allergen extracts or molecular allergens,
which are coupled to nanoparticles, 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’s sample.
After incubation, non-specific IgE is washed off. The procedure continues by
adding an enzyme labelled anti-human 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 assay procedure is
followed by an automated image acquisition and analysis which is integrated in
the ImageXplorer. The test results are analysed with MADx’s RAPTOR SERVER
Analysis Software and reported in IgE response units (kUA/L). Total IgE
results are also reported in IgE response units (kU/L).
VII.2 FOX TEST PRINCIPLE
FOX is a solid-phase immunoassay. Food extracts, which are coupled to
nanoparticles, are deposited in a systematic fashion onto a solid phase
forming a macroscopic array. First, the particle bound proteins react with
specific IgG that is present in the patient’s sample. After incubation, non-
specific IgG is washed off. The procedure continues by adding an enzyme
labelled anti-human IgG detection antibody which forms a complex with the
particle bound specific IgG. 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 IgG in the patient sample. The lab test procedure is followed by an
automated image acquisition and analysis which is integrated in the
ImageXplorer. The test results are analysed with MADx’s RAPTOR SERVER Analysis
Software and reported in µg/ml and in IgG classes.
VIII. SERVICE
MacroArray Diagnostics or its local distributors are available to repair the
device during normal local office hours. In case a service is required at any
other time, contact the MacroArray Diagnostics service
(support@macroarraydx.com) or your local
distributor. The scope of agreed service is included in your service contract.
IX. WARRANTY
MacroArray Diagnostics and its local distributors guarantee that the
ImageXplorer will show no defects during operation if it is installed and
operated according to this manual by qualified and trained personnel. For
further information about warranty, contact the MacroArray Diagnostics service
or its distributors. The warranty is not valid for damage that occurs because
of non-compliance with this manual, whereby repairs and servicing must only be
carried out by persons trained and certified by MacroArray Diagnostics.
Maintenance needs to be performed as described in this manual. Improper
interventions on the device void the warranty and can result in service
charges. Only use the device as intended. If the device is not used as
intended, MacroArray Diagnostics disclaims all liability for damage to the
analyser.
ORDERING INFORMATION
Use only consumables, accessories and spare parts provided by or recommended
by MacroArray Diagnostics. Order these items only from MacroArray Diagnostics
or local
distributors. For ordering information, see the MacroArray Diagnostics
brochure for our ImageXplorer contact the MacroArray Diagnostics team at
orders@macroarraydx.com or your local
distributor.
The MADx article number (REF) for the ImageXplorer is 11-0000-01.
XI. SAFE HANDLING
The analyser has been inspected for technical safety before shipment. To
maintain this status and to ensure hazard-free operation:
- Always follow the instructions in this manual.
- Always follow good laboratory practice.
In addition, MacroArray Diagnostics clearly states that using the analyser in a manner not specified by this manual or elsewhere by MacroArray Diagnostics may affect the safety measures implemented by the manufacturer and may also result in a hazardous situation or lead to wrong test results.
XI.1 OPERATOR QUALIFICATION
The ImageXplorer 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 Analysis software,
the operator should:
- Read these Instructions for Use carefully
- Be aware of all relevant laboratory procedures
- Be aware of all relevant safety rules and regulations
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 Macro Array Diagnostics or
its local distributors.
XI.2 OPERATIONAL SAFETY
As with any mechanical system, certain precautions must be taken when
operating the imager.
Do NOT load humid or wet cartridges!
Any liquid spilled on the instrument may result in the malfunction of the system. If liquid is spilled on the instrument, wipe it off immediately and contact technical support.
XI.3 DECONTAMINATION
For safety reasons, the ImageXplorer must be disinfected/decontaminated before
repairs and service work are performed. Make sure you follow the instructions
for decontaminating the analyser. Before decontamination and/or disinfection,
disconnect the analyser from the power supply (pull the plug). The operator is
solely responsible for the effectiveness of the disinfection and
decontamination methods used and their validation.
XII. GLOSSARY OF SYMBOLS
| **** | Consult instruction for use |
|---|---|
| In vitro diagnostic medical device | |
| **** | CE mark |
| Manufacturer | |
| Serial number | |
| **** | Waste electrical and electronic equipment |
| Caution |
XIII. SAFETY MESSAGES
All safety messages must be observed to avoid hazardous situations which may
result in death, injury, or damage to the equipment.
Indicates a hazardous situation which, if not avoided, will result in death, serious or minor injury.
XIV. LEGAL REQUIREMENTS
XIV.1 INTERNATIONAL STANDARDS
The ImageXplorer has been developed, tested, and manufactured in accordance
with
EN ISO 13485, EN IEC 61010-2-101, EN ISO 14971, EN IEC 61326-2-6, EN ISO 62304
and EN ISO 62366.
XIV.2 CE CONFORMITY
The ImageXplorer hold a CE mark which certifies that the devices meet the
essential requirements of the following European directives:
- In Vitro Diagnostic Medical Devices Directive 98/79/EC
- Directive on Waste Electrical and Electronic Equipment 2012/19/EU
- Directive on Restriction of Hazardous Substances 2011/65/EC
XIV.3 ELECTROMAGNETIC COMPATIBILITY (EMC), RADIO INTERFERENCE SUPPRESSION
AND IMMUNITY TO INTERFERENCE
The ImageXplorer has been tested in accordance with EN IEC 61326-2-6 and
correspond to CISPR 11 Class B.
XV. LIFE CYCLE
This section describes the stages the ImageXplorer goes through, beginning
from delivery to disposal, and the requirements involved for the operator
within each stage.
XV.1 DELIVERY
XV.1.1 DAMAGES DURING TRANSPORT
The outer packaging of the ImageXplorer ensures the best possible protection
against transport damage. Nevertheless, please check each shipment immediately
upon receipt for visible transport damage. If you receive an incomplete or
damaged shipment, please directly contact MacroArray Diagnostics or your local
distributor. Please notify the carrier about apparent damage.
XV.1.2 SCOPE OF DELIVERY
Included Items
1x ImageXplorer
1x ImageXplorer Carriage
1x Connecting cable (PC to ImageXplorer)
Table 1 List of items available for delivery
For the operation of the device, an ALEX² (50x: REF 02-5001-01 or 20x: REF 02-2001-01) or FOX (REF 80-5001-01) assay kit is required, which is not included in the shipment of the ImageXplorer and must be ordered separately.
XV.2 DISPOSAL
In the European Union, disposal of the analyser is regulated by Directive
2012/19/EU on waste electrical and electronic equipment (WEEE) and
corresponding national transpositions.
MacroArray Diagnostics is committed to take back and recycle electrical and
electronic equipment in areas where the above-mentioned directive is enforced.
In areas where the above-mentioned directive is not enforced, contact the
MacroArray Diagnostics service or a local distributor regarding disposal of
the analyser.
Depending on the applications, parts of the analyser may be contaminated with
biohazardous or hazardous chemical material.
Treat contaminated material according to national and local standards and
regulations. Before transport or disposal, disinfect parts of the analyser
that may be contaminated according to national and local standards and
regulations. If you need assistance, contact MacroArray Diagnostics or a local
distributor.
Do not treat electrical and electronic equipment as unsorted municipal waste
and check with your local waste disposal contractor for specific requirements
regarding disposal. Please collect waste electrical and electronic equipment
separately and return them to MacroArray Diagnostics or a local distributor in
areas where the above-mentioned directive is enforced.
XV.3 DATA BACKUP
When using RAPTOR SERVER Analysis Software, all analytical and patient 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 on-premise version, please
consult with your local IT administrator.
XVI. DESCRIPTION
A: chassis
B: slider
C: carriage
The relevant system components of the ImageXplorer are:
- CCD (charge-coupled device) Camera for image acquisition
- Custom LED light circuit board
- Carriage for inserting cartridges
- Stage for sliding the cartridge holder
- USB 2.0 or USB 3.0 cable
XVI.1 CONNECTING THE IMAGEXPLORER TO THE PC
The ImageXplorer is not a standalone device and must always be used in
combination with RAPTOR SERVER Analysis Software. The ImageXplorer is plugged
into a computer via the provided USB 2.0or USB 3.0 cable, and both the
connection and the power supply are managed through the computer’s USB 3.0
port by the provided USB cable.
Note: The device can also be used on an USB 2.0 port, but the analysis
will require longer time because of lower data transmission rates.
XVI.2 RAPTOR SERVER SOFTWARE SETUP
Google Chrome is recommended as a browser for using the RAPTOR SERVER. The
graphical user interface of RAPTOR SERVER can be accessed on the website:
https://www.raptor-server.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. If measurements should be transferred from one tenant to another one,
it has to be done actively in the RAPTOR SERVER Analysis Software.
For further information on the RAPTOR SERVER please refer to the corresponding
Instructions for Use.
XVI.3 DOWNLOAD OF THE IMAGEXPLORER AGENT SOFTWARE AND IMAGEXPLORER
DEFINITION
To set up an ImageXplorer for your tenant, go to the Tenant Admin area and
click “Manage ImageXplorers”. 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 shall download the ImageXplorer Agent software.
Carry out the installation of the ImageXplorer agent, as a regular
installation process.
NOTE: The use of the ImageXplorer requires the presence of the software
“Pylon Runtime 6.1.1, by Basler. If you install the “full” version of the
ImageXplorer Agent, the software is included. If you already have this
software, it is enough to install the “slim” version of the Software.
NOTE: It is suggested to remove any other Pylon software from the PC
before installing the ImageXplorer Agent, such as previous versions of the
Pylon Runtime.
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.raptor-
server.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.
If the Log in was successful, the homepage of the RAPTOR SERVER Analysis
Software shows up with the dashboard, which includes new and approved
measurement results from previous ALEX² and FOX assay runs on the
ImageXplorer. and the date of the last ConfigXplorer scan and/or monthly
maintenance (for MAX devices only).
XVI.4 ADJUSTING THE IMAGEXPLORER SETTINGS
Each ImageXplorer has unique image settings that need to be calibrated using
the ConfigXplorer during the first installation and then every 60 days.
Upon the first installation or upon starting the new RAPTOR SERVER version for
the first time, no measurement can be made with the ImageXplorer without a
ConfigXplorer scan.
Every new ImageXplorer system will include a calibration ConfigXplorer with a
special barcode starting with the digits “30” on the label (e.g., 30AAF267).
The calibration array is delivered in a resealable pouch and should always be
stored in a dark place at room temperature.
After clicking “Configure” in the menu “Manage ImageXplorers” you are directed
to the area where you can run a ConfigXplorer Scan.
By clicking on “Start new ConfigXplorer scan”, the calibration of the setting- adjustments starts (takes about 1-2 minutes).
This calibration measurement will identify and adjust 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 ConfigXplorer Scan is displayed. The
user shall apply the new ImageXplorer settings by clicking “Apply detected
settings.”
NOTE: If the calibration ConfigXplorer Scan gets stuck and does not
update the state for a couple of minutes, click on abort. On the configure
page of the ImageXplorer, click “Start ConfigXplorer scan” again. If this
problem occurs in the long term, check your connections, as described in
chapter XVI.10.
Running the ConfigXplorer Scan on a regular basis will ensure that the ImageXplorer uses the optimal configuration. Therefore, after 60 days a message will appear, which prompts you to repeat the ImageXplorer ConfigXplorer Scan 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 QR-Code
is not recognized during the ConfigXplorer Scan, the standard “QR-Code
Exposure” of 3.000 can be increased.
Configure “Neuer Ⅸ
The Calibration configuration is set by default to “Use automatic exposure”,
which stays for an exposure of 2500. However, it can be set to “Use manual
exposure”. With this mode, the exposure can be corrected up or down. 
XVI.5
IMAGING AND ANALYSIS OF MEASUREMENTS
XVI.5.1 INSERTING A CARTRIDGE INTO THE IMAGEXPLORER
The ImageXplorer has an insertion mechanism for loading one processed
cartridge at a timinto the device. Carefully take the cartridge (do not touch
the membrane of the cartridge) aninsert it by facing the QR-Code to the MADx
logo on the ImageXplorer into the carriage.
Make sure that the cartridge is completely inserted into the carriage and
neither in front norin 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
XVI.5.2 IMAGE ACQUISITION, QR-CODE READING AND GRID FINDING
On the overview page you will find a tab “New measurements”, a tab “Approved
measurements”, a button for “Start measurement with ImageXplorer” and a button
for MAX devices. 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 will start immediately. If several ImageXplorers are connected to the tenant on RAPTOR SERVER, the user must first select which ImageXplorer they want to use. RAPTOR SERVER automatically recognizes the QRCode, which is the basis of all further processing and assigns the identified QR-Code to the new measurement.
Attention: Be aware of which ImageXplorer you are using, to have the correct test results for a given patient!
The QR-Code on each cartridge contains the following information:- type of test array (ALEX2 / FOX)
- corresponding allergen layout
- QC information
- Lot number of cartridge
For further information on the features of the RAPTOR SERVER Analysis Software such as customizing reports and approving / exporting measurements please refer to he corresponding Instructions for Use.
XVI.6 INTERNAL QUALITY CONTROL
ALEX² and FOX cartridges have an inbuilt assay run control, represented by so
called “Guide Dots” (GD) at 3 corners on the cartridge surface.
ALEX²cartridges work with 4 Guide
Dots, while FOX cartridges work with 3 Guide Dots, in the positions as
depicted below 
During the image acquisition of an ALEX² or FOX cartridge, RAPTOR SERVER
evaluates the signal of all Guide Dots as well as the background signal of the
membrane surface. If all quality criteria are fulfilled, the “automatic QC”
field under the image is set to “OK”. Please consult the RAPTOR SERVER
Analysis Software Instructions for Use for further information about QC
attached to the cartridge. If QC criteria are not fulfilled, please contact
MADx support or your local distributor. 
Additionally, it is recommended to run at least one negative and one positive
quality control sample with every assay run. RAPTOR SERVER contains a basic QC
module which can monitor QC performance with the commercial quality control
sample “Lyphochek® sIgE Control, Panel A” from the company Bio-Rad. Please
consult the Instruction for Use from the manufacturer on how to use this
control material. Currently, the QC module in RAPTOR SERVER is only available
for ALEX², not for FOX.
MacroArray Diagnostics provides acceptance ranges for the most recent batch of
Lyphochek® sIgE Control Panel A. These values are stored in RAPTOR SERVER and
cannot be edited by the user. In order to use Lyphochek® sIgE Control Panel A
as an internal quality control during an analysis with ImageXplorer, use the
lot number with the proceeding product ID “32” of the control as the barcode
for the sample, for example “3222630” for Lyphochek® sIgE Control Panel A lot
22640. RAPTOR SERVER will recognize this barcode as a QC sample.
For lot #22640, the following allergens and acceptance limits have been
predefined in RAPTOR SERVER analysis software:
| Feature Name | Min Threshold | Max Threshold |
|---|---|---|
| Ara h 9 | 0.3 | 1.63 |
| Bet v 1 | 0.5 | 3.36 |
| Der p 1 | 1.92 | 7.76 |
| FeI d 1 | 3.98 | 12.33 |
| Phl p 1 | 1.61 | 7.36 |
QC results can be obtained from the ImageXplorer settings page (“System Admin”
→Manage QC Lots”).
Additionally, the results of the ConfigXplorer scan can be found at the
ImageXplorer settings page (“Tenant Admin” → “Manage ImageXplorers” →
“Configure”).
XVI.7 TECHNICAL SUPPORT
If you have any questions, experiences or difficulties concerning the
ImageXplorer or RAPTOR SERVER Analysis Software, please contact your local
distributor.
XVI.8 TECHNICAL DATA AND REQUIREMENTS
| Features | Parameters |
|---|---|
| Compatible Test Formats | ALEX² or FOX 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 |
| 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 |
| Features | Parameters |
| --- | --- |
| Power supply | The device is powered either by the supplied +5V USB 2.0 cable |
or an USB 3.0. No additional power supply is needed.
Size (W x D x H)| 160 x 180 x 180 mm
Weight| 1.2 kg
Barcode Identification| QR-Code
Operating System| PC with MS Windows® 10 or higher
Required software (Incl. with the full version of the Agent installer)| Pylon
Runtime v6.1.1
Connection| USB 2.0 or higher
Temperature Range| Room Temperature (15 – 30°C)
Humidity| 30 – 85%, non-condensing
Dust| Dust-free environment recommended
XVI.9 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!
XVI.10 TROUBLESHOOTING
The following errors are the most common ones and therefore explained here in
more detail.
Server Connection to www.raptor-server.com
failed (Agent flags connection in red colour)
Possible Solutions:
- Check internet connection
- Click settings and check if RAPTOR SERVER URL (www.raptor-server.com is correct
- Click settings and check if ImageXplorer key is correct and corresponds to the one specified for the Tenant on RAPTOR SERVER
ImageXplorer Connection failed (Agent flags connection in red colour):
Possible Solutions:
- Check if ImageXplorer is connected to the computer
- Reconnect ImageXplorer to the computer (pull out and plug in the USB cable again).
- Click settings and check if the ImageXplorer key is correct and the same as on RAPTOR SERVER
Start Measurement is not possible:
Possible Solutions:
- Check if ImageXplorer is connected
- Check if the last required ConfigXplorer Scan has been performed
If you still experience problems or have any other questions to the products and services of MacroArray Diagnostics, please contact your local distributor.
©Copyright by MacroArray Diagnostics
MacroArray Diagnostics (MADx)
Lemböckgasse 59/Top 4
1230 Vienna, Austria
+43 (0)1 865 2573
www.macroarraydx.com
Version number: 11-IFU-01-EN-14
Date of Issue: 2022-12
MacroArray Diagnostics
• Lemböckgasse 59/Top 4
• 1230 Vienna
• macroarraydx.com
• CRN 448974 g
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>