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Ug 003 DX 2 2 1 en v02 Pannoramic 250 Flash III DX Digital Scanner

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0% found this document useful (0 votes)
196 views101 pages

Ug 003 DX 2 2 1 en v02 Pannoramic 250 Flash III DX Digital Scanner

Uploaded by

AwalJefri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH

PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1


USER’S GUIDE

April 26, 2023 – v02


PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
WITH PANNORAMIC DIAGNOSTIC SCANNER TABLE OF CONTENTS
SOFTWARE 2.2.1

Table of Contents
Table of Contents 1
Disclaimer 4
Declaration of Conformity and Compliance 6
Notes on Warranty 7
About This Manual 8
1 Introduction 9
1.1 About the Product 9
1.2 Intended Use 10
1.3 Labeling Limitations 11
1.4 Compatibility 11
1.4.1 Services and Maintenance 11
1.5 Compliance 12
1.6 Required Training 12
1.7 Contact Information 12
2 Operational Safety 13
2.1 Safety Instructions 13
2.2 Emergency Procedure 15
2.3 Electrical Safety 15
2.4 Transportation Safety 17
2.5 Mechanical Safety 18
2.6 Fire and Combustion Safety 19
2.7 Electromagnetic Compatibility 19
2.8 Biohazard Safety 19
2.9 Cleaning Safety 20
2.10 Liquids and Safety 20
2.11 Security 21
2.12 Vigilance 21
2.13 Labels and Symbols on the Scanner 22
2.13.1 Labels 22
2.13.2 Symbols 23
3 PANNORAMIC® 250 Flash III DX Digital Scanner System Overview 25

UG-003-DX-2_2_1-EN-V02 1
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
TABLE OF CONTENTS
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

3.1 About PANNORAMIC® 250 Flash III DX Digital Scanner and PANNORAMIC® Diagnostic
Scanner Software 25
3.2 System Configuration 27
3.3 Hardware Configuration 27
3.4 Accessories 28
4 User Interface 29
4.1 Starting PANNORAMIC® Diagnostic Scanner Software 29
4.2 Exiting PANNORAMIC® Diagnostic Scanner Software 30
4.3 Logging in 30
4.4 Description 31
4.4.1 Magazine View 32
4.4.2 Slide View 35
4.4.3 Slide Processing 39
4.4.4 Scanning History 41
4.4.5 Settings 43
4.4.6 Program settings 47
5 Operation 62
5.1 Introduction 62
5.1.1 Safety 62
5.1.2 Image quality 62
5.2 Scanner On/Off 63
5.2.1 Connecting the Scanner 63
5.2.2 Switching the Scanner on 63
5.2.3 Switching the Scanner off 64
5.2.4 Emergency shutdown 64
5.2.5 Power failure 64
5.3 Loading the Scanner 64
5.3.1 Preparation of glass slides 64
5.3.2 Placing slides in the glass slide magazines 70
5.3.3 Placing glass slide magazines in the Scanner 72
5.4 Initiating the Scanning Process 74
5.5 Aborting the Scanning Process 75
5.6 Unloading the Scanner 75
5.6.1 Removing Magazines from the Scanner 75

2 UG-003-DX-2_2_1-EN-V02
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
WITH PANNORAMIC DIAGNOSTIC SCANNER TABLE OF CONTENTS
SOFTWARE 2.2.1

5.7 Checking the Scan Results 76


5.8 Checking the Status of the Scanner 76
6 Troubleshooting 78
6.1 Introduction 78
6.2 Event Logging 78
6.3 Failed to log in 78
6.4 If the Scanner Cannot Read the Barcode on the Label Area 79
6.5 If the Scanner Shuts Down Automatically Before All Slides Have Been Scanned 79
6.6 If a Warning or Error Message Appears on the User Interface 80
6.7 If Interaction with the User Interface is Unavailable 80
7 Maintenance 81
7.1 Introduction 81
7.2 Planned Maintenance 82
7.3 Routine User Checks Program 82
7.4 How to Access Logged Events 83
7.5 Cleaning 86
7.5.1 Preparation 86
7.5.2 Tools for Cleaning 86
7.5.3 Cleaning the Covers 87
7.5.4 Cleaning the Loader Unit 87
7.5.5 Removing and Cleaning of Air Filters 88
7.5.6 Replacing Fuses 88
8 Transporting 90
9 Product Disposal 92
9.1 Introduction 92
9.2 Passing the Scanner on to Another User 92
9.3 Final Disposal of the Scanner 92
10 Technical Data 93
Glossary of Terms and Abbreviations 100

UG-003-DX-2_2_1-EN-V02 3
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
DISCLAIMER
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

Disclaimer
Copyright © 2001-2023 3DHISTECH Kft.
All rights reserved.

Intellectual property related to the 3DHISTECH products are as follows:

• P1300124; PCT/HU2014/000020; EP 14745228.8.; US 14/771.380


• P0700404; PCT/HU2008/000065; EP 08762668.5.; US 12/663.537
• P1700279; PCT/HU2018/050030
• P1700483
• P1500394; PCT/HU2016/050039; EP 16840280.8.; US 15/756.370
• P0700409; US 2008/0306964
• P0800181; PCT/HU2009/000027; EP 09721248.4.
• P0600435; PCT/HU2007/000047; EP 2024772; US 12/301.781
• P0600177; PCT/HU2007/000018; EP 1.994.398; US 12/281.566
• P0900741; PCT/HU2010/000130; EP 10812989.1.
• P0900142; PCT/HU2010/000027; EP 10726183.6
• P101036; PCT/IB2005/050351; EP 1789831; US 7.663.078
• P0301911; PCT/HU04/00019; EP 1644767; US 7327515

The above-mentioned granted patents, granted utility model, registered trademarks, pending
international and national patent applications and the other corresponding IP are the sole
properties of the 3DHISTECH Kft.
3DHISTECH Kft. is not liable for damage of whatever nature (including, but not limited to,
general or specific damage, indirect damage, consequential damage or incidental damage,
including the results of the analysis of the digitized slides, for example, change of health status
related to erroneous diagnosis from the digitized slide(s)) that stems from or is associated with
use of Product, digitized slides, quality of staining, quality of stained slides, quality of used
method of staining. 3DHISTECH Kft. assumes no responsibility for the functionality and fault-
free condition of your “application programs” (Workflows, VBA macros, Commander scripts).

CAUTION
This product has not been approved or cleared as a medical device by the U.S. Food and Drug
Administration.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these may interfere with the proper operation.

4 UG-003-DX-2_2_1-EN-V02
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
WITH PANNORAMIC DIAGNOSTIC SCANNER DISCLAIMER
SOFTWARE 2.2.1

Third-party disclaimer
3DHISTECH Kft. is not liable for damage of whatever nature (including, but not limited to, general
or specific damage, indirect damage, consequential damage or incidental damage, including
damage resulting from lost profits, interruption of business, loss of business information,
pecuniary loss or similar damage) that stems from or is associated with the incorporated part of
this Product that is made by a third-party company.
THE SOFTWARE IS PROVIDED “AS IS” AND WITHOUT WARRANTY OF ANY KIND, EXPRESSED,
IMPLIED OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Further Information
For the latest information on 3DHISTECH products and services, please visit our website at the
following URL: https://www.3dhistech.com.

Company Address
Öv utca 3.
1141 Budapest – HUNGARY

UG-003-DX-2_2_1-EN-V02 5
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
DISCLAIMER
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

Declaration of Conformity and Compliance

Product name: PANNORAMIC 250 Flash III DX Digital Scanner


Basic UDI-DI code: 5999571470266JC / GS1
Risk class: Class A

The product complies with relevant international and national standards and laws.
3DHISTECH Kft. declares that the product PANNORAMIC® 250 Flash III DX Digital Scanner is
designed and produced with consideration of specified requirements according to the ISO 13485
Medical devices – Quality management systems – Requirements for regulatory purposes (ISO
13485:2016) and 2017/746 EU Regulation on In vitro diagnostic medical devices (IVDR).

IEC 61010-1:2010 – “Safety requirements for electrical equipment for measurement, control and
laboratory use – Part 1: General requirements”
IEC 61010-2-081:2015 – “Safety requirements for electrical equipment for measurement, control
and laboratory use – Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes”
IEC 61010-2-101:2017, “Safety requirements for electrical equipment for measurement, control,
and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment”
IEC 61326-2-6:2013, “Electrical equipment for measurement, control and laboratory use - EMC
requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment.”
There is no further operator (user) action required in case of residual risks.
Professional use only.
Further information may be obtained from the manufacturer:
[email protected]

6 UG-003-DX-2_2_1-EN-V02
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
WITH PANNORAMIC DIAGNOSTIC SCANNER DISCLAIMER
SOFTWARE 2.2.1

Notes on Warranty

3DHISTECH Kft. – as the Product Manufacturer – warrants PANNORAMIC® 250 Flash III DX Digital
Scanner to be free from faults in material and workmanship at the moment of installation.
Defects must be notified immediately on identification and maximum efforts must be undertaken
in order to the amount of damage as small as possible. On receiving notice of a fault, the Product
Manufacturer will be under obligation to remove the fault, at his own option, either by providing
adequate repair services or by delivering a faultless product for replacement. No warranty will be
accepted in cases of natural wear (notably, wear and tear parts) or improper product handling.

The Product Manufacturer will refuse any liability in the event of damage resulting from faulty
operation, negligence or unauthorized intervention into the product, notably, from the
replacement of product parts or the usage of accessory parts from other manufacturers. Any
such case will void the user’s claim for warranty.

Except for action which is explicitly described in this manual, you are prohibited from performing
any kind of maintenance or repair work at PANNORAMIC® 250 Flash III DX Digital Scanner. Only
3DHISTECH Service personnel or specifically authorized representatives are allowed to handle
repair work. In case of malfunction, contact the 3DHISTECH Service Support first at
[email protected].

UG-003-DX-2_2_1-EN-V02 7
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
ABOUT THIS MANUAL
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

About This Manual

The purpose of this manual is to assist users in the safe and reliable operation of PANNORAMIC®
250 Flash III DX Digital Scanner. Before operating the Scanner, you must read this manual, and
adhere to all Warning! and Caution! notices. The manual must be kept in the immediate vicinity of
the Scanner so that it is accessible at any time.

The following character formats and symbols call your attention in this manual:
Example (text in bold)
Words or characters that appear on the screen. These include field names, screen and window
titles, push-button and menu names, paths or options. Keys on the keyboard. For example,
function keys (such as F11) or the Ctrl+S hotkey.
Example (text in bold and italics)
Cross-references within this document or to other documents.

Warning!
Can cause irreversible damage or harm to the user of the product or the product itself if this
instruction is not followed.

Caution!
Can cause the product to not work properly if this instruction is not followed and alerts to a
potentially critical situation.

Notice:
Calls attention to some important information or feature.

Special attention should be paid to all information provided and the procedures described in
chapter Safety Instructions.

8 UG-003-DX-2_2_1-EN-V02
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
WITH PANNORAMIC DIAGNOSTIC SCANNER INTRODUCTION
SOFTWARE 2.2.1

1 Introduction
1.1 About the Product
PANNORAMIC® 250 Flash III DX Digital Scanner as a diagnostic scanner in the whole slide
imaging (WSI) system can be used as an aid to the pathologist to create, review and interpret
digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded
(FFPE) tissue, cytology smear/specimen, peripheral blood smear, HE (hematoxylin eosin
stained) tissue, IHC labeled tissue, or frozen section. The WSI consist of a Scanner, an image
management system (that is able to create digital slides on SlideCenter where patient data is
not stored, and to view, and analyze images), and a monitor. This system utilizes optical,
mechanical, electronic, and software elements to scan FFPE tissue, cytology specimen, or
frozen section mounted on glass slides at a resolution of at least 0.125 μm per pixel to create
digital whole slide images. The system is designed to be connected over a network within a
hospital/clinic in which the Scanner, image management system, and monitor can be in
separate locations if desired. The pathologist workstation with access to the IMS and Monitor
will either be in the pathology lab or in the pathologist office.

Figure 1: PANNORAMIC® Whole Slide Imaging System including the Scanner, IMS, and Monitor

Notice:
This user’s guide only describes the operation and technical data of PANNORAMIC® 250
Flash III DX Digital Scanner. Some sections briefly describe the use the Scanner in correlation
to the IMS/Monitor, but the user should reference to the Monitor and PANNORAMIC® Image
Management System for additional details.

UG-003-DX-2_2_1-EN-V02 9
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
INTRODUCTION
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

Notice:
The product can only be installed and repaired by a Service Technician or Engineer approved
by 3DHISTECH.

1.2 Intended Use


The scanner is a digital slide microscope that automatically creates a digital image of the inserted
glass slides. The digital microscope can be part of the diagnostic Pathology Management System,
it uses barcode-based slide recognition and communication to identify the slides (with the
CaseManager DX report inventory system).
The Pathology Management System is intended to be used to analyze and evaluate pathological
specimens, and this product assists the pathologist in reviewing and interpreting digital images of
a surgical pathology (histology) study that includes PANNORAMIC® 250 Flash III DX Digital
Scanner. Digital slides can be displayed, reviewed and analyzed using the slide viewer and image
analysis module of CaseManager DX.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards
to assure the validity of the interpretation of images obtained using the system.

Warning!
Use of this product for purposes other than those intended by the manufacturer, as well as
incorrect use or operation, may relieve the manufacturer from all or some responsibility for
resultant non-compliance, damage, or injury. This shall also apply to service or repair work of
any kind, which is performed by other than authorized service personnel. All claims for
warranty and warranty services will be null and void in any such case.

Warning!
PANNORAMIC® 250 Flash III DX Digital Scanner must be operated by a properly trained
person only. Operating personnel must be fully aware of the potential dangers which a
particular field of application involves. PANNORAMIC® 250 Flash III DX Digital Scanner is a
precision instrument which may suffer a significant reduction in operational functions or
even physical destruction following intervention performed in any nonconforming manner.

10 UG-003-DX-2_2_1-EN-V02
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WITH PANNORAMIC DIAGNOSTIC SCANNER INTRODUCTION
SOFTWARE 2.2.1

1.3 Labeling Limitations


• PANNORAMIC® scanner systems allow pathologist to perform diagnosis on digital images
of scanned glass slides, provided PANNORAMIC® 250 Flash III DX Digital Scanner, IMS, and
Monitor are used with a user managed network with connectivity of at least 100 Mbps.
• Clinical performance of the device was not evaluated for all possible tissues and
diagnoses.
• There are pre-analytical factors such as tissue thickness, tissue folds, staining quality and
intensity, etc. that have effect on image quality. If the quality of the images causes the
pathologist to have uncertainty about the accuracy of a diagnosis, then the pathologist should
examine the corresponding glass slide by conventional methods before rendering a diagnosis.

1.4 Compatibility
Ancillary equipment, accessories, and components may only be used with PANNORAMIC® WSI
system that are recognized by 3DHISTECH as compatible.

Warning!
Any modification to a hardware or software component of the PC will highly affect the
functionality of the Scanner program.

Warning!
Do NOT install any other application on the control computer of PANNORAMIC® 250 Flash
III DX Digital Scanner other than the Scanner control software and its auxiliary drivers.

Warning!
The use of third-party antivirus programs is NOT recommended and can affect the operation
of the Scanner and software.

1.4.1 Services and Maintenance


Modifications, parts replacements, or repairs to PANNORAMIC® 250 Flash III DX Digital
Scanner must be performed only by service technicians authorized by 3DHISTECH, a
contracted third-party company, or distributor. Service technicians must have the proper

UG-003-DX-2_2_1-EN-V02 11
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
INTRODUCTION
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

training to carry out the necessary modification/servicing of the device. Modifications


and/or additions to the system must be performed in accordance with applicable laws
and regulations (as legally required by the relevant jurisdictions) and in compliance with
best engineering practices.

In the event of any non-conforming type of use, including non-conforming use of


assemblies or single parts, no liability will be assumed by the Manufacturer. This shall
also apply to service or repair work of any kind, which is performed by other than
authorized service personnel. All claims for warranty and warranty services will be null
and void in any such case.

Modifications and/or additions to the device made by persons without proper training
and/or the use of unapproved parts will void the warranty. As this device being a
complex technical equipment, maintenance by unqualified personnel and/or the use of
unapproved parts can pose a serious risk of equipment damage and personal injury.

1.5 Compliance
The product complies with relevant international and national standards and laws. Conformity
information can be provided by 3DHISTECH or your local 3DHISTECH representative upon
request (refer to section Contact Information for details.)

1.6 Required Training


It is the responsibility of the owner (individual, group, company) of PANNORAMIC® 250 Flash
III DX Digital Scanner to ensure that all users of the equipment are properly trained in
accordance with local laws or regulations before using the system. Please, contact 3DHISTECH
or your local 3DHISTECH representative for more information on training.

1.7 Contact Information


3DHISTECH Kft.

Öv u. 3 – 1141 Budapest

HUNGARY

www.3dhistech.com

E−mail: [email protected]

12 UG-003-DX-2_2_1-EN-V02
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
WITH PANNORAMIC DIAGNOSTIC SCANNER OPERATIONAL SAFETY
SOFTWARE 2.2.1

2 Operational Safety
2.1 Safety Instructions
The below chapter of this user’s guide contains information and warnings of a kind that must
be followed by owner/operator personnel to maintain the safe use and solid performance of
the device.

PANNORAMIC® 250 Flash III DX Digital Scanner, including any of its original accessory
components, should not be operated in any other way than described in chapter Intended Use.
Any of the following notes and warning symbols used on PANNORAMIC® 250 Flash III DX
Digital Scanner must be strictly observed:

Warning!
Image quality and performance
It is strictly prohibited to operate the device other than specified by the manufacturer;
otherwise, if operating the device by not observing warnings, cautions and instructions, the
level of safety, the quality of the acquired image, and the performance of the Scanner will
decrease.

Warning!
Maintenance and Errors
If any part of the Scanner is found or likely to be defective or maladjusted, it is forbidden to
use the Scanner until the necessary repairs have been made, otherwise, operating the
Scanner with defective or misaligned components can cause fatal or other serious personal
injury or lead to clinical misdiagnosis or mistreatment.

Warning!
Safety awareness
The Scanner can be operated only if you have read, and understood all of the safety
information, safety procedures, and emergency procedures detailed in this section. Using
the Scanner without proper knowledge of its safe use can result in death or other serious
personal injury, and can also lead to clinical misdiagnosis or mistreatment.

UG-003-DX-2_2_1-EN-V02 13
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
OPERATIONAL SAFETY
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

Warning!
Safety components
The safety components (locking mechanisms and locks) are essential parts of the Scanner,
and it is strictly prohibited to override, alter, or remove such components. Using the Scanner
without safety components can result in death or other serious personal injury, and can also
lead to clinical misdiagnosis or mistreatment.

Warning!
Intended use and compatibility
It is strictly prohibited to use the Scanner for any purpose other than for which it is
intended, and with any device or equipment other than those 3DHISTECH recognizes as
compatible. If the Scanner is used for unintended purposes, or it is used with incompatible
device or equipment, can result in death or other serious personal injury, and can also lead
to clinical misdiagnosis or mistreatment.

Warning!
PANNORAMIC® 250 Flash III DX Digital Scanner does not include any special devices for
protection against samples that are corrosive, potentially infectious, toxic, radioactive or
otherwise harmful to health. When handling such samples, you are required to comply with
all currently binding legislation, namely national accident prevention regulations.

Warning!
A defective PANNORAMIC® 250 Flash III DX Digital Scanner is not classified as domestic
waste. It must be properly disposed in accordance with currently valid legal requirements.

Caution!
PANNORAMIC® 250 Flash III DX Digital Scanner must be positioned that it is easy to access,
operate, and disconnect the device if necessary.

14 UG-003-DX-2_2_1-EN-V02
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
WITH PANNORAMIC DIAGNOSTIC SCANNER OPERATIONAL SAFETY
SOFTWARE 2.2.1

Notice:
The safety level of the equipment after servicing will be identical with level of the original
equipment.

2.2 Emergency Procedure


In case of emergency, the power cord should be unplugged from the power outlet.

Warning!
The power outlet and plugs should be easily accessible at all times.

2.3 Electrical Safety

Warning!
Cables, fuses and covers
Remove cables, or fuses and/or open the housing only if you are instructed to do so by
PANNORAMIC® Diagnostic Scanner Software or it is required during a service, cleaning or
maintenance task (performed according to this user’s guide). The removal of cables, or
opening the housing can be performed only by trained, qualified, and authorized personnel.
Only compatible cables can be used to the Scanner. See chapter Technical data for more
details on specifications.

Warning!
Check cables, plugs and connections before operation, and if defective or cannot be
replaced, contact 3DHISTECH Service for support.

Warning!
Check that your local line voltage is compatible with PANNORAMIC® 250 Flash III DX Digital
Scanner specifications before you turn power on. The device can operate at line voltages
100V to 240V and 50/60 Hz.

UG-003-DX-2_2_1-EN-V02 15
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
OPERATIONAL SAFETY
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

Warning!
Only plug the device in a socket with protective grounding (earth) contact. PANNORAMIC®
250 Flash III DX Digital Scanner has a built-in protection which must not be rendered
ineffective by extension cables without protective (earth-ground) conductor.

Warning!
If protective devices are found to be ineffective, PANNORAMIC® 250 Flash III DX Digital
Scanner must be shut down and precautions must be taken to prevent unintended usage.
For necessary repair work or work to restore proper operating condition, you should
contact the 3DHISTECH Service.

Warning!
Preparing for servicing, cleaning, and maintenance

Disconnect plug!
Remember to unplug the power cord before opening the housing of PANNORAMIC® 250
Flash III DX Digital Scanner in case servicing, cleaning and/or maintenance tasks must be
performed.

Warning!
Only connect external devices that are safety extra low voltage rated to the instrument to
avoid the risk of electrical shock.

Warning!
Use of this instrument in an environment where air humidity is below 35%, especially if
synthetic materials are present (synthetic clothing, carpets, etc.) may cause damaging
electrostatic discharges that may cause erroneous results.

16 UG-003-DX-2_2_1-EN-V02
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER
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SOFTWARE 2.2.1

Warning!

This equipment is not intended for use in residential environments and may not provide
adequate protection to radio reception in such environments.

Warning!

This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY


ENVIRONMENT. It is likely to perform incorrectly if used in a HOME HEALTHCARE
ENVIRONMENT. If it is suspected that performance is affected by electromagnetic
interference, correct operation may be restored by increasing the distance between the
equipment and the source of the interference.

Warning!

The electromagnetic environment should be evaluated prior to operation of the device.

Warning!

Do not use this device in proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these can interfere with proper operation.

2.4 Transportation Safety

Warning!
The Scanner should not be moved after installation. Contact 3DHISTECH Service if the
Scanner must be moved to another location.

UG-003-DX-2_2_1-EN-V02 17
PANNORAMIC® 250 FLASH III DX DIGITAL SCANNER WITH
OPERATIONAL SAFETY
PANNORAMIC DIAGNOSTIC SCANNER SOFTWARE 2.2.1

2.5 Mechanical Safety

Warning!
Covers
The housing of the Scanner can be opened only by a properly trained operator or
3DHISTECH service technicians.

Warning!
Sharp edges
Whenever you are handling magazines during loading and removing from the Scanner, or
you are instructed to open the housing to remove a glass slide from the Scanner, always
make sure that the necessary precautions are taken. Those areas and units of the Scanner
where you must operate cautiously are marked with the following stickers:

Pinch point hazard area

Operate with care


Watch out for pinch points or areas and sharp edges to prevent injury, cuts or bruises. Glass
splinters of broken slides can be present in the Scanner – be careful when removing
splinters, and always wear protective gloves.

Caution!

Precision instrument
PANNORAMIC® 250 Flash III DX Digital Scanner is a precision medical device that must be
operated with care and in accordance with the instructions in this user’s guide. Avoid
external shocks and vibrations and accidental influences to a maximum possible degree, as
such phenomena can affect and reduce performance and the expected lifespan of the
Scanner. Dirt or dust may adversely impact the operating capability of the Scanner. For this

18 UG-003-DX-2_2_1-EN-V02
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SOFTWARE 2.2.1

reason, measures must be taken to eliminate such influences to a maximum possible


degree. During periods of non-use, PANNORAMIC® 250 Flash III DX Digital Scanner must be
protected with a dust cover. Check that power is turned off before you put the cover on.

2.6 Fire and Combustion Safety

Warning!
The operation of the instrument in explosion-risk environments is not allowed. Do not use
flammable or potentially explosive cleaning sprays, as the resulting vapor may ignite,
causing fatal or other serious personal injury and/or equipment damage.

Warning!
Location-specific fire regulations must be observed and applied. It is required to install fire
extinguishers in the location in accordance with the regulations. Operators and users of this
Scanner must be fully aware of the necessary steps that must be taken and how to use fire
extinguishers in case of fire.
Do NOT use water, other fluids or materials to extinguish electrical fire, as it could lead to
fatal or serious injuries or death.

2.7 Electromagnetic Compatibility


PANNORAMIC® 250 Flash III DX Digital Scanner is tested and complies with the standard
IEC61010.

2.8 Biohazard Safety

Warning!
Do not use the Scanner for slides with biohazardous materials.

Warning!

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Slides that are not used any longer do not classify as domestic waste and must be treated as
hazardous materials and disposed in compliance with the currently valid legal requirements.

2.9 Cleaning Safety

Warning!
Switch the power off before performing cleaning tasks.

The cleaning procedures described in chapter 10 Maintenance should be followed.

2.10 Liquids and Safety

Warning!
Prior to cleaning the Scanner, the power cord should be unplugged. Only use a dry or lightly
damped lint-free cotton cloth to clean the Scanner. Isopropanol is recommended as a
cleaning agent to clean greasy or dirty surfaces. Make sure that the affected area is
completely dry before switching the device on and operating the system again.

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2.11 Security
Access control

User name and Password on the user interface must be entered to access and enable full
functionality of PANNORAMIC® Diagnostic Scanner Software.

Caution!

PANNORAMIC® 250 Flash III DX Digital Scanner cannot be operated without user
authentication during login to PANNORAMIC® Diagnostic Scanner Software.

Caution!

The automatic logout function of PANNORAMIC® 250 Flash III DX Digital Scanner software
prevents the device from unwanted access by logging the user out automatically after the
specified time of inactivity.

Patient and data security

Warning!
Take extra care when labeling or inserting slides into the magazines as such mistakes can
result in skipped slides or unidentified slides in CaseManager DX, or lead to patient data mix-
up. For proper labeling of glass slides, the instructions in chapter Operation must be
followed.

Warning!
it is the System Administrator/IT's responsibility to prevent any DDOS attacks of medical
devices using public or private network.

2.12 Vigilance
Report immediately or as soon as possible any vigilance and vigilance suspect cases, serious
incidents, any unexpected event or accident which may endanger the life of the user of the

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device, or which may lead or could have led to a serious deterioration in the user's health to local
distributor and 3DHISTECH Service Support at [email protected].

2.13 Labels and Symbols on the Scanner


2.13.1 Labels
The sticker on the rear panel of PANNORAMIC® 250 Flash III DX Digital Scanner includes
the following information:

Logo and name of manufacturer IVD symbol


Scanner type – PANNORAMIC® 250FLASH III DX Digital Scanner
“Read
SN symbol / Serial P250FYYMDDXX Date of YYYY-MM instructions”
number Production symbol
symbol
AC symbol / Input Voltage, frequency, power consumption
voltage
QR code
REF symbol / e.g.: PFLMBADCO00A001O001
Article number
UDI symbol e.g.: (01)0599957147xxxx(21)P250FYYMMDDXX(11)YYMMDD CE symbol
Data Matrix code Manufacturer Name and address of “WEEE”
symbol manufacturer symbol

Made in Hungary Label identifier


LBL112101

Table 1: Scanner label

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2.13.2 Symbols

Symbol Description

Serial number
Indicates the manufacturer's serial number so that a specific medical device
can be identified.
NF EN ISO 15223-1, symbol #5.1.7

Alternating current.
IEC 61010-1, symbol #2

Catalogue number
Indicates the manufacturer’s catalogue number so that the medical device can
be identified.
NF EN ISO 15223-1, symbol #5.1.6

Manufacturer
Indicates the medical device manufacturer, as defined in EU Directives
90/385/EEC, 93/42/EEC and 98/79/EC.
NF EN ISO 15223-1, symbol #5.1.1

Date of manufacture
Indicates the date when the medical device was manufactured.
NF EN ISO 15223-1, symbol #5.1.3

In vitro diagnostic medical device


Indicates a medical device that is intended to be used as an in vitro diagnostic
medical device.
NF EN ISO 15223-1, symbol #5.5.1

Indicates the conformity of the medical device with the provisions of this
Directive to enable it to move freely within the Community and to be put into
service in accordance with its intended purpose.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic
medical devices

Consult user’s guide.


Indicates the need for the user to consult the user’s guide.
NF EN ISO 15223-1, symbol #5.4.3

Separate collection: do not discard with other waste.


See chapter Product Disposal for additional information.
Directive 2012/19/EU (WEEE recast)

This symbol indicates pinch point hazard area. Keep fingers or skin away from
such areas.

This symbol indicates areas where you must operate with care when reaching
into the device. Keep your fingers or skin away from sharp edges.

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Table 2: Symbols on the Scanner

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SYSTEM OVERVIEW
SOFTWARE 2.2.1

3 PANNORAMIC® 250 Flash III DX Digital Scanner


System Overview
3.1 About PANNORAMIC® 250 Flash III DX Digital Scanner and
PANNORAMIC® Diagnostic Scanner Software
The key features are:

Hardware
• A maximum loading capacity of up to 300 slides within a single session
• Fully automatic loading and scanning
• Up to 54 slides per hour – whole-slide scanning, with a 20×/0.8 NA objective (41×
optical equivalent magnification) in 0.24 μm/pixel, and a 40×/0.95 NA objective
(82× optical equivalent magnification) in 0.19 μm/pixel resolution, 15×15 mm
scanned area in single layer
• Innovative hardware design
o Cameras inside the unit
o Built-in power supply
• Anti-vibration components in the structure for maximum stability and image
quality
• Robust construction for heavy duty use
• Automated slide handling
• Rapid loading
• High-resolution imaging
Software
• PANNORAMIC® Diagnostic Scanner Software developed for PANNORAMIC®
Diagnostic Scanners
• Direct scanning to CaseManager DX server
• Direct scanning to SlideCenter server – automatic name assignment based on
barcode information
• Objective and scanning path selection per magazine
• Motorized Objective changer for two objectives (0.8 NA and 0.95 NA)
• Multiple file formats (MRXS / DICOM)
• Automated tissue detection and coverslip detection
• 1D and 2D type barcode reading and parsing

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• Advanced operational information management:


• User management and authentication
• Different user levels
• Remote access and control via Central Log Service
• Adaptive focusing
• Self-calibration
• Event history logging
• Automatic saving of scanning settings
• Running in Windows 10 OS
Main parts of PANNORAMIC® 250 Flash III DX Digital Scanner

The following figure shows the main outer parts of the Scanner.

Figure 2: Main outer parts of PANNORAMIC® 250 Flash III DX Digital Scanner

1. Protective lid

2. Magazine feeder unit

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3. Power supply switch

4. Cover release hole

5. USB port

6. Fuse box

7. Main power switch

8. Power supply cable connector

3.2 System Configuration


PANNORAMIC® 250 Flash III DX WSI system

The main components of PANNORAMIC® 250 Flash III DX WSI system are the following:

1. PANNORAMIC® 250 Flash III DX Digital Scanner


2. Monitor
3. Mouse
4. Control computer
5. Keyboard

3.3 Hardware Configuration


Camera

1 CMOS camera for high-quality brightfield applications allowing ultra-fast scanning up to 180
fps.

Warning!
The replacement or reinstallation of the camera in PANNORAMIC® 250 Flash III DX Digital
Scanner can be carried out by 3DHISTECH service technicians only.

Camera adapters

1.0× or higher

Objectives

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20×/NA 0.8
40×/NA 0.95

3.4 Accessories
PANNORAMIC® 250 Flash III DX system is delivered including the following accessories for the
Scanner:

• Control computer (minimum 6240 Xeon Gold CPU, 96 GB RAM, 256 GB SSD, min
2.1 TB SSD or a functionally similar equivalent)
• Monitor (Fujitsu UHD 27” or a functionally similar equivalent)
• PANNORAMIC® Slide Magazines
• Cables:
o Control – USB cable (between Scanner and control computer)
o Preview camera – USB cable (between Scanner and control computer)
o Scan camera cables (between scan camera and control computer)
o Video cable (between monitor and control computer)
o Power supply cable (between 230V/110V outlet and monitor)
o Power supply cable (between 230V/110V outlet and control computer)
o Power supply cable (between 230V/110V outlet and Scanner)

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4 User Interface
4.1 Starting PANNORAMIC® Diagnostic Scanner Software
Make sure that the Scanner is switched on.

Click on the desktop to run PANNORAMIC® Diagnostic Scanner Software.


Once the control software of the Scanner is launched the splash screen is visible on the monitor
during initialization.

Figure 3: Splash screen

After initialization, the main screen of the user interface appears.

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Figure 4: Main screen

4.2 Exiting PANNORAMIC® Diagnostic Scanner Software


1. Make sure that all the scanning processes are completed and there is no slide in
queue to be scanned. On how to abort scanning process, refer to section Aborting
the Scanning Process.
2. Click X at the top right corner of the window.
3. Confirm exit from the control software by clicking Yes in the confirmation
window, or No to cancel exit.

4.3 Logging in
The users of PANNORAMIC® 250 Flash III DX Digital Scanner must give their user credentials prior
to performing any operation through the GUI (Graphic User Interface) of PANNORAMIC®
Diagnostic Scanner Software. Registered users can access the control software only, by entering
either their user name and password or a 4-digit PIN code.

Click at the right of the main menu bar to log in to PANNORAMIC® Diagnostic Scanner
Software. There are three user levels according to which different colors are assigned – blue for
Administrator, yellow for General, and white for the Service user.

Figure 5: Login screen

Caution!

PANNORAMIC® Diagnostic Scanner Software of PANNORAMIC® 250 Flash III DX Digital


Scanner cannot be accessed without logging in if user authentication is required.

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4.4 Description
The GUI (Graphic User Interface) of the PANNORAMIC® Diagnostic Scanner Software can be
divided into the following view panels:

Figure 6: GUI of PANNORAMIC® Diagnostic Scanner Software

1 – Magazine view (see section Magazine View)


2 – Slide view (see section Slide view)
3 – Slide processing queue (see section Slide Processing)
4 – Scanning history (see section Scanning History)

At the rest of the menu bar there are additional function buttons available:
5 – Scanning properties (see section Settings)
6 – Stop/start scanning process
7 – Log out
8 – Program settings (see section Settings)
9 – Help

The name of the user currently logged in and the remaining access time is displayed at the left
of the button.

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4.4.1 Magazine View

Figure 7: Magazine view

This panel displays the magazines added to the scanning queue as thumbnails. The thumbnail
images give exact information on the specific magazine properties and its status. If a slide is
loaded and involved in a process, the magazine thumbnail image is highlighted.

Toolbar of Magazine View

Figure 8: Toolbar of Magazine View

1. Settings card selector – Assign a predefined parameter set before selecting a


magazine. The setting of parameters of a profile can be managed after opening
the Scanning properties panel. For more information on Scanning properties, see
section Scanning properties.

Notice:
On the magazine thumbnail, the scanning profile assigned for the magazine is indicated by
an icon at the corner, and the objective type is presented with a bar of the same color as the
icon at the selector.

2. Objective selector – Assign an objective type (20×/40×) for the selected magazine.

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3. Scanning mode – Switch between Single layer or Multilayer mode for scanning.
Toggle this switch before selecting a magazine. The selected mode is presented
by color strip on the thumbnail image:

marks that the magazine have been selected for scanning in Single layer, and

marks scanning in Multilayer mode.

The arrow at the right of the switch opens the Multilayer settings window in
which the Number of layers, and Motor step size can be set in the corresponding
value boxes. Select Use extended focus if required. Click OK to apply the set
values.
4. Add a magazine to the scanning queue – After selecting a magazine or magazines
that are not involved in a process yet, click to add selected magazines to the
processing queue.
Remove a magazine from the scanning queue – Select a magazine that is already
added to be processed first, then click the button to remove it from the
processing queue.
5. Unload magazine – Click this button to unload the magazine that is being
processed in the scanning queue. The actual process is interrupted first, the slide
that is loaded will be inserted back into the magazine, only then will the magazine
be unloaded.

Magazine status indication

Indicator Description
Magazine is processed, scanning of slides in magazine
is completed

Some kind of error was detected during processing this


magazine

Magazine is not processed yet / slides are waiting in the


queue to be scanned

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Magazine is being processed / a slide is being scanned

Magazine was processed and is being unloaded

Magazine position is empty

Table 3: Magazine status indicators

Slide Preview

The preview image of the slide that is actually scanned is displayed in the Slide Preview
panel at the right side of the screen in this view. The steps of the ongoing process are
listed at the bottom of the preview panel and the progress is indicated with a progress
bar (with percentage of completion).

Figure 9: Progress list and bar (example)

Completed magazines

This panel in the Magazine View contains magazines that have already been processed.
When you click a magazine thumbnail, it shows the first slide with a recorded preview
image in the preview panel on the right. Use the arrows to switch between images of
other slides stored in the selected magazine.

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Figure 10: Completed magazines panel in Magazine View

Switch to Slide View

Upon double-clicking a magazine thumbnail in this view, the program GUI switches to
Slide View, in which all the information and the set parameters of the slides contained in
the magazine are listed.

4.4.2 Slide View

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Figure 11: Slide view

In Slide View the slides in the selected magazine are listed, and the slide information bar includes
their position in the magazine, thumbnail images, slide name, and a message/information.

The slide preview section displays the preview or thumbnail image and the label area of the
selected slide. This section includes a progress indicator, as well.

If the selected slide is currently being scanned, the preview and label area images are adaptive
and information are displayed in the following order:

• No information is displayed until the preview image of the slide is taken.


• Preview image of the slide until the slide is fully scanned.
• Thumbnail image of the slide if the slide has been fully scanned.
• The label area displays nothing until the barcode image is taken.
• The label area displays the barcode image once it was recorded.
• If the slide has already been scanned the preview always displays the thumbnail
image of the slide instead of the preview image.

• If scanning is in progress, the progress bar displays the process of the scanning
dynamically, regardless of whether selecting a different slide in the list (that will
become displayed in the preview area) or not. Otherwise, if scanning has not
started yet, this area contains a '-' character in the middle and no progress
indication is displayed.
• If no slide is selected, the 'No slide selected' text is displayed instead of the
preview image.

Note, that a green scanner bar appears above the slide thumbnails of the
currently processed slides, either it is being scanned, or if preview image is taken
of it, or it is involved in a conversion process.

Slide toolbar
You can switch between the already processed magazines with the following buttons on the
interface, so that their contents and slide information are displayed. The time of completion is
displayed next to the magazine number.

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Slide information bar


Scanning status of a slide is visible in the information bar of the slide. Any event (change in
status/warning/error/malfunction) that occurred during the scanning process is promptly
displayed at the right end of the slide information bar. For example, if the scanning of slide was
stopped, “Scanning has been stopped” can be read.
The slide information bar has the following structure and contains the following information:

Figure 12: Slide information bar

1 – Scan status indicator


Indicates the actual status of the slide. The following table lists the possible indicator
statuses:

Indicator Description

The slide is not yet processed.

Indicates that the slide has successfully been loaded and


further processes are being performed.
Slide scanning is finished.

MRXS slide processing is finished.

DICOM slide processing is finished.

Preview image is recorded.

Waiting in scanning queue (lilac), and scanning without


processing is already performed (green).
Slide was scanned successfully, but with warning. For
instance, the focus quality did not match the expected
result.
Slide scanning is failed. The error message is displayed at
the end of the bar.
The slide was scanned successfully.

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Table 4: Slide status indicators

2 – Slide index
Index of the slide within the magazine – displayed after the slide was loaded; otherwise,
this area is empty.
3 – Preview image / progress indicator
This area is empty until the preview image is taken. If there is no slide at the position, the
"NO SLIDE" text is displayed. The preview image is displayed in landscape orientation.
During scanning, an indeterminate progress bar is displayed above the preview image.
4 – Barcode
Empty until the barcode has been parsed. After parsing, the barcode that has been read is
displayed.
5 – Slide name
Displays the slide name generated / entered for the slide.
6 – Objective type
The icon of the objective selected for scanning (applicable for the slides within the
magazine).
7 – Scanning mode
Presents that the slide has been scanned in Single layer or Multilayer mode.
8 – Profile indicator
Displays the selected profile (applicable for the slides within the magazine).
9 – Messages
If an error or warning event has occurred during processing, the related message is
displayed here. Error messages are displayed in red; warning messages are displayed in
orange.

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4.4.3 Slide Processing


During slide processing, the ongoing task / operations and the actual status of slides can be
tracked. In this view, the actual slide processing statuses related to conversions are traceable.

In Magazine View, the actual conversion statuses are traceable at the bottom bar of the magazine
thumbnail.

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The following table lists the possible slide conversion indicator statuses:

Indicator Description

Conversion to MRXS format is completed

Conversion to DICOM format is completed

Not selected for conversion

Selected for conversion

Error has occurred during conversion

Scanning with warning / conversion is completed

Scanning with warning / conversion is could not be


performed successfully
Slide is being scanned / Conversion is progress
(alternating colors)

Table 5: Slide conversiuon status indicators

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4.4.4 Scanning History


The Scanning History panel lists scanning events occurred during the last session, but any specific
date on which scanning was performed can be selected with a calendar tool (see Filter for
interval function). The following slide scanning events (Scanning statuses) are logged:
• Scanning started
• Scanning finished
• Process was cancelled
• Duration time of the whole scanning process
• Errors – if there were any

Figure 13: Scanning history

Slide scanning events are grouped into processes on the list. A process item can be expanded (so
the view of scanned magazines and slides that are listed).
When a list item is expandable, the button is visible at the right end of the row, and by clicking
this button an additional sub-list is displayed in the tree. The list includes time data (such as
Process started, Process ended, Duration) related to slide scanning events and event statuses
sorted into columns.
A detailed scanning process-related information of a slide can be listed upon double-clicking on its
information bar. Once a slide row is expanded, process-related information that is more detailed
and specific for the selected slide is displayed in the window. These data include the slide number,
slide name, time when the preview image was taken, or the barcode grabbing was performed,

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and slide naming has taken place, the time when scanning was started and finished, duration of
scanning, FOV count, and the slide path.
Filter for interval

Once clicked the icon, a date panel is opened where a range can be set, and all the scanning
processes performed within this interval will be automatically listed. Set a starting- and an end-
date to defined the date interval.

Figure 14: Filter for interval

Filter for user

Click to list all the events initiated by the user selected from the drop-down list. The events
list is automatically updated.

Figure 15: Filter for user

Refresh

Click to refresh the Scanning History list.


Log Export

Click to export logged events into a CSV file (available for Administrator users only).

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4.4.5 Settings
4.4.5.1 Scanning properties

Click to open the Slide Save Settings panel on which the destination of scanning,
barcode parsing, and conversion settings can be performed (both for scanning to a local
folder or to a designated server). You can create up to 5 different profiles (marked with
different colors) that are selectable on the left side of the panel.

Figure 16: Scanning properties – Scan to Local / Scan to Server

• Scan to Local – location on a local storage (optional – requires license)


OR

Scan to Server – location on a server


• Server settings (available only if Scan to Server is selected)
The following must be defined to establish a server connection:
• Server – Select a server from the list or select Add new item at the bottom of
the list to create a new connection.

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• User name – Type your user name registered for your account on the server.
• Password – Enter your password registered for your account on the server.
• Use server scan mode – Select to enable automatic slide scanning based on
settings set on the server.
Click Connect to establish connection to server, and Disconnect to interrupt
server connection.
How to add a new connection
• Select Add new item at the bottom of the Server list to open the Server
Profile Settings window

• Click New
• Enter Display name, Host name, then select the Protocol type
• Click Save to create connection
How to delete a connection
• Click the icon of the connection you want to delete
• Click Yes in the pop-up window

• Slide naming
Slide name can be defined manually or automatically.
• Barcode parsing – Select the type of barcode profile from the drop-down list
for slide naming though parsing the barcode string. By using Default barcode
profile, the barcode of the slide is being matched with all the barcode types.
Click at the left of a list item to open the Barcode Profile Settings window
in which the parsing settings of the selected profile can be edited.

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If you click Add new item ... on the list, blank input fields will be displayed.

▪ Define/modify profile name in the Name input field, select barcode


type from the Type drop-down list.
▪ Define/modify ranges within the barcode string when Range is
selected at Parsing mode to extract necessary information (Slide
name, Profile, Case, Block, Root folder), for example slide name is
extracted from sting based on the range of 1 to 4, profile from 2 to 4,
etc.
▪ If the option Separator is selected at Parsing mode, the character (for
example: / or *) used as a separator in the selected barcode type can
be defined in the Separator input field.

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▪ Enable Parsing subfolders to make it available to create subfolders


when parsing data from the barcode. Type name of the subfolder in
the Folder1, Folder2, etc. fields depending on the depth you want to
define.
Click to delete range values set for the corresponding field.
▪ Click Save to apply settings.
• Server-side barcode parsing (available only if Scan to Server is selected) – The
barcode read by the software is being identified, and the predefined location
of that specific case on the server is automatically selected as scanning
destination based on the CaseID (containing slide and patient data stored on
HIS/LIS). Therefore, Folder, Case, Block, and Slide name field data cannot be
modified, only a profile can be selected.
Select All Types from the drop-down list to analyze all barcode types when
parsing.
• Generate – Activate this option to create slide name automatically based on
the criteria defined in the configuration file.
• Manual naming – Activate this option to name slides manually.
• Slide file format
• Change file format
• PACS server DICOM
• Keep original MRXS file
• Output file format: MRXS or DICOM
• Specify a folder for storing converted files
Profile marker icons indicate the scanning location and the conversion type, for
example:

• Scanning to server / No conversion

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• Scanning to local storage / Conversion to DICOM format

• Automatic scanning to server / Conversion depending on server


settings
• PACS server data
• Local Application Entity Title
• Remote address/IP
• Remote Application Entity Title
• Remote Port
• Sending Thread Limit

4.4.6 Program settings

Click at the main toolbar to open the Settings panel, that consists of the following
tabs:

• User management
• Scanner settings
• Maintenance
• General settings
• Barcode settings

I. User management

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Figure 17: User management

This tab is available for Administrators only, who have administrator authorization rights
to access and modify specific settings. On this panel the Administrator can perform
administration settings grouped into the following separate sections:

• User list panel (User / Authentication / Level) with settings


• Login type
• Automatic logout
• User engagement
There are three different levels of user authentication, which are marked by a specific
number of shields (1, 2, or 3, depending on the set of access rights):

General user can perform scanning, calibration, change magazine priority,


and initiate shutdown.
Service user is allowed to scan, calibrate, perform maintenance tasks,
change magazine priority, and initiate shutdown.
Administrator user, in addition to the access rights of service user, is
allowed to export software log into file, perform user management tasks,
and change login type.

Notice:

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The user privileges are listed in the Engagements of users per level panel at the right side of
the window. Each user has granted one user engagement level only.

• Login type – Set the type of access (generally applicable setting).


• User authentication – This login type is an authentication method that
requires password or PIN code entered by the user to access the software.
• No authentication – Authentication is not required for the user to access the
software (can be set by Administrator user only).
• Automatic logout – Set the time of user inactivity after which the software
initiates automatic logout (generally applicable setting). The options are:
• None
• 5 mins
• 20 mins
• 50 mins

Warning!
The Scanner will become accessible if the option None is selected. To prevent unauthorized
access to the Scanner, either the security of the room or location must be ensured by an
access control or security system, or the control computer must be locked by the user.

How to Add a User

1) Select Settings panel / User management tab.


2) Click at the top of the left panel.

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Figure 18: Create User

3) Enter User name, set User level, then set Generate Initial Password or fill in
Password and Confirm password fields. Upon selecting the Generate Initial
Password option, a random password string is generated with which the user can
access the software at the first logon. This initial password then must be changed
by the user at the first logon.

Notice:
User name, Password and Confirm password fields are case-sensitive.

4) Click Create User when finished. The initial password is now generated if selected.

Figure 19: Create User

5) Click Close to exit the Create User window.

Notice:
The length of PIN code must be not less than 4 digits, and cannot start with 0. Duplicate
name or PIN is not allowed.

How to Edit a User’s Name

The name of a registered user cannot be modified. The administrator though can delete the
user first, then create another account for the new user name. See section How to Remove a
User on deleting a user from the list.

How to Edit a User’s Password

1. Select Settings panel / User management tab.


2. Select the user from the list.
3. Click at the top of the user list panel.

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4. Click Reset password, then copy and share the generated new password with the user.
5. Click Close to exit the Edit User window.

How to Edit Rights for Users

1. Select Settings panel / User management tab.


2. Select the user from the list.
3. Click at the top of the user list panel.
4. Set User level, and click Close to exit the window.

How to Remove a User

1. Select Settings panel / User management tab.


2. Select the user from the list.
3. Click at the top of the user list panel.
4. Click Yes in the message window to permanently delete the user, otherwise, click No.

Figure 20: Delete User

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How to Adjust the Login Procedure

1. Select Settings panel / User management tab.


2. Set Login type option User authentication or No authentication.
3. Click Apply to save changes.

How to Adjust the Automatic Logout Setting

1. Select Settings panel / User management tab.


2. Set Automatic logout (None, 5 mins, 20 mins, or 50 mins).
3. Click Apply to save changes.

II. Scanner settings

Figure 21: Scanner settings

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The Scanner settings panel lists various information about the Scanner and its settings.
The information is grouped into the following separate sections:
• Scanner information
• Focus quality settings
• Self-calibration
• Authentication
• Central Log Service settings
• Slide Storage settings

III. Maintenance

On this panel the following information related to Scanner maintenance is included:

Figure 22: Maintenance panel

▪ Maintenance data
o Total number of scanned slides
o Next maintenance in (slides)
o Next maintenance due date
▪ CLS client cache data
o Total number of cached records
o Caching is active (enabled / disabled)

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Notice:
For maintenance tasks and procedures, read chapter 8 Maintenance.

(Available to Administrator users only)

• Click Modify to modify number of scanned slides remaining before the


scheduled maintenance, and/or the due date.

• Click Clear cache to clear data from cache.

IV. General settings

Figure 23: General settings – image 1

This tab includes general settings related to the following functions:


• Language – select the language of the user interface from the list.
• The skin of the GUI can be set from the Theme drop-down list – select Classic
or Flat.

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• ICC Profile – Available for Administrator and Service users only.


Select an applicable preset color profile to be used for Brightfield scanning
from the drop-down menu. Settings according to the profile has effect on the
color set, color temperature, and gamma value of the scanned image.
Preset profiles are the following:

▪ Calibrated Linear: Color scheme is defined by calibration (Gamma


value is not included)

▪ sRGB standard: Color scheme is defined by calibration (standard


Gamma value -2.2- is applied)

▪ sRGB standard Microscope-like: Color scheme is defined by


calibration (standard Gamma value / White Point: D50)

▪ Custom: parameters are freely customizable as follows:


▪ Color Scheme

▪ Calibrated: scheme is defined by the color calibration slide

▪ Raw: the color information of the recorded raw image is


applied

▪ Custom: White Point, Gamma, and Color Matrix can be


set for your own requirements
▪ White Point

▪ D65: color temperature according to a standard illuminant


D65 white point value is applied (6500K / daylight)

▪ D50: color temperature according to a standard illuminant


D50 white point value is applied (5000K / horizontal daylight)
▪ Gamma

▪ Standard: a value of 2.2 is used

▪ Medium: a value of 1.8 is used

▪ Off: a value of 1.0 is used


• Global Settings

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Figure 24: General settings – Image 2

▪ Unload at exit: Unload slide when exiting the control software.


▪ Minimum empty slide size: The minimum size of disk space can be
determined in MB (Administrator user can modify this value).
▪ Use External Profiles: If enabled, the user has the option to use an
external profile instead of the automatic scanning profile, which the
program will use from the following location (from the subfolder
according to the microscope type): C:\Program
Files\3DHISTECH\PANNORAMIC Diagnostic Scanner Software\Profiles
▪ Scanner SWAP location: Path of the SWAP folder required for
scanning.
▪ Use AI Preview Image Segmentation: Use of an AI-based preview
evaluation module. If disabled, the program will use the legacy
evaluation (sample detection from the preview image).
▪ DICOM Viewer path: The path of the viewer application that the user
wants to use to open DICOM slides with. Default setting is
SlideViewer.
▪ Compensation image number: Define the number of compensation
images the software should take from the slide before scanning.
Default value is 10.
▪ Use main camera in ROI mode: This function that can be used for the
25 MP camera. If enabled, the software will digitize the slide at the
same FOV resolution that the 12 MP camera is capable of.
▪ Show native magnification: In the case of objective magnification, you
can choose whether the native resolution or the nominal resolution is
displayed on the interface, except for the display does not affect
scanning. The default value is the nominal magnification.
▪ Scan continuously: If it is enabled and there is a magazine in the input
column of the scanner, it will be added to the scanning queue during
scanning at the unload of the currently scanned magazine. The

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settings card and scanning properties will be based on the last


scanned magazine.

Figure 25: General settings – image 3

• Log Service Settings


Settings of the Central Log Service connection.
• Authentication Service Settings
Settings of the AuthServer client.
• Focus Quality Settings
If the quality of the digital slide is below the acceptable level and the focus
quality value does not reach the desired one, the slide will be automatically re-
scanned before creating the final digital slide.
By default, the slide is re-scanned three times maximum by taking several
focus points into account to determine the focus plane more properly. For the
third run, a 3-layer scanning is performed, and if the quality is still below the
acceptable level, then an exclamation mark is displayed on the slide thumbnail
image. This event is logged and presented on the Event History panel and in
the Central Log Service as well.
Set the number of re-scanning at the Re-scan counter value box.
• Self-Calibration Settings

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Figure 26: General settings – image 4

• Whole Slide Settings


If activated, the system performs whole slide scanning, but here you can modify
the size of that area.
• Focusing Settings

Figure 27: General settings – image 5

• E-mail Settings

Figure 28: General settings – image 6

If an error occurs during operation, a mail is sent to the defined address


(available for Administrator user only).
▪ User name
▪ Password
▪ Secure Connection
▪ Port
▪ Recipient address

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▪ Sender address
▪ SMTP server

Figure 29: General settings – image 7

• Slide Label Settings


▪ Exclude Barcode CDV
▪ Barcode orientation
• Normal
• Up-side down
• Post Processing Settings
▪ Temp folder
▪ Thread count
• Slide Naming Settings

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V. Barcode settings
This tab includes barcodes that are selectable for identification. Click Select/Clear
all to select/deselect all types.

If using MIL for barcode reading, you can select the following barcode types:

Linear

• Codabar
• Code11
• Code128
• Code39
• Code93
• EAN13
• EAN8
• IATA2of5
• Interleaved2of5
• Matrix2of5
• MSI
• Patch Code
• Pharmacode
• RSS14

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• RSSExpanded
• RSSLimited
• Standard2of5
• Telepen
• UPCA
• UPCE
Stacked linear
• Code16K
• RSS14Stacked
• RSSExpandedStacked
Postal

• AustralianPost
• DutchKIX
• IntelligentMail
• Mailmark4StateC
• Mailmark4StateL
• Planet
• Postnet
• RoyalMail
Two-dimensional

• Aztec
• DataMatrix
• HanXinCode
• MaxiCode

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5 Operation
5.1 Introduction
This chapter includes detailed information on how the control software of PANNORAMIC® 250
Flash III DX Digital Scanner works, what features are available and how it should be operated by
the user.

5.1.1 Safety

Warning!

Before operating PANNORAMIC® 250 Flash III DX Digital Scanner, the user must strictly
observe all the safety procedures that are described in chapter 3 Safety. These instructions
must be followed during operation. If the user operates PANNORAMIC® 250 Flash III DX
Digital Scanner without fully understanding the operating instructions and safety
procedures, the risk of causing harm will become so high, that it can lead to serious or fatal
injury to the person and to false results.

Warning!

Before operating PANNORAMIC® 250 Flash III DX Digital Scanner, the user must check that
the periodic maintenance tasks have been performed. For more information on these tasks,
refer to chapter 10 Maintenance.

5.1.2 Image quality


The overall quality of the created digital image as the result of scanning is affected by
several components, such as condition of the sample/tissue, the properness of slide
preparation, and the settings used for scanning.

Warning!

In all cases, the user must always ensure that the quality (and the aspects such as average
focus, contrast, stain color, tissue area) of the generated image is adequate for obtaining a
final result.

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Warning!

PANNORAMIC® 250 Flash III DX Digital Scanner is capable of scanning glass slides with the
specified dimensions. For the specific slide types and dimensions, see section Slide
preparation. If slide types other than specified are used with PANNORAMIC® 250 Flash III DX
Digital Scanner, it can lead to damage or cause the Scanner to malfunction.

Warning!

The Scanner has been carefully and thoroughly tested, but sometimes parts of certain
images may be out of focus. This phenomenon occurs when the tissue sample in the
scanned area (within the FOV) is not of uniform thickness.

5.2 Scanner On/Off


5.2.1 Connecting the Scanner
PANNORAMIC® 250 Flash III DX Digital Scanner system is installed, assembled, and
connected to the main power supply by a 3DHISTECH service technician on-site.

5.2.2 Switching the Scanner on

Caution!

Before turning the Scanner on, the user must switch the control computer and the monitor
on.

To switch PANNORAMIC® 250 Flash III DX Digital Scanner on, push the 1 side down of
power rocker switch at the back of the Scanner. Once the Scanner is switched on, the
Scanner initialization is launched (hardware components, assembly statuses are checked
by the sensors).

If the Scanner won’t turn on, check the state of the mains power rocker switch. See
Figure 4 for the exact location of the mains power switch.

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5.2.3 Switching the Scanner off


To switch PANNORAMIC® 250 Flash III DX Digital Scanner off, push the 0 side down of
the mains power switch at the back of the Scanner. See Figure 2 for the exact location of
the mains power switch.

Warning!

Before switching the Scanner off, the user must assure that digitization process is
completely finished, and there is no slide in the scanning queue waiting to be scanned.

5.2.4 Emergency shutdown


In case of emergency, press the 0 side down of the main power rocker switch to turn off
the Scanner immediately.

5.2.5 Power failure


After an emergency shutdown or power failure (if no UPS is used), upon restarting the
control software and the Scanner, the actual status at the time of the shutdown can be
restored.

5.3 Loading the Scanner


This section includes detailed information on how to prepare, load and insert slides into
magazines and magazines into the Scanner.

5.3.1 Preparation of glass slides

Warning!

Always wear personal protective equipment (safety goggles, gloves and coat) when
working with bio-hazardous material or slides.

Warning!

Do not use a slide when it is broken or its edges are not properly cut or grounded. Using
such slides can lead to injury.

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Warning!

Ensure that edges of the mounted coverslip and the label do not stick out of the slide. Both
the coverslip and the label must be placed flat on the glass slide.

Use slides with completely dried embedding medium only. Otherwise, the coverslip can be
shifted that makes slide insertion less reliable. Not completely dried embedding might also
influence the operation of objectives and other device parts.

Caution!

Do NOT scratch any circular marker onto the glass surface of a slide, use a soft tip pen
instead for marking area of interest.

You can use standard slides and coverslips only that meet the following specifications:

Definition Slide Coverslip

Length 75.0 to 76.0 mm max. 50 mm

Width 25.0 to 26.0 mm max. 24 mm


(standard slide) (recommended: 22 mm)

Thickness 0.90 to 1.2 mm No. 1 and No. 1.5 (0.13 to 0.16


mm and 0.16 to 0.19 mm)

Corners 45° beveled corners N/A

Edges Ground or cut N/A

Table 6: Slide and coverslip specifications

Preparation of tissue and the glass slide

Caution!

The quality of tissue and slide preparation highly affects the quality of the final digital image.
Laboratory instructions and protocol must always be followed during tissue preparation.

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The tissue after the preparation must not be damaged in any way (torn, bubbled, wrinkled,
folded, over exposed, poorly- or over-stained) and has uniform thickness).

During preparation make sure to take these key criteria into account so that the final glass will
meet the expected quality:
• When cutting the tissue with microtome, the thickness must be set between 3-
5μm. Use sharp blades only for cutting, and cut slowly, so the uniform thickness is
ensured.
• Tissue is properly stained.
• Use clean glass slides.
• Place the tissue on the glass slide avoiding wrinkles or folds, keeping at least 3mm
distance between the tissue and the slide edges.
• The tissue is wet-mounted (permanent) on the glass slide.

Figure 30: Correct and incorrect tissue placement

• If the tissue has elongated shape, avoid placing the tissue diagonally, on the slide
to shorten scanning time.

Figure 31: Preferred tissue orientation

• Use coverslips as specified above (see Table 5: Slide and coverslip specifications).
• When placing the coverslip, leave a 5mm gap between the tissue and the label
area, and a 1mm gap along the edges of the slide.
• Make sure that there are no air bubbles underneath the coverslip.
• Clean mounting media residue from the slide.

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Figure 32: Placing the coverslip

• As the final step of slide preparation, check that the surfaces of the glass slide are
clean (free from residue of mounting media, fingerprints and markers), and the
mounting media is dried so the coverslip is fixed.

Figure 33: Check slide quality

Affixing Barcode Labels to Slides


This section describes how to affix barcode labels to slides.

Caution!

Barcodes must be placed on the frosted end (label area) of each slide as case identifiers to
enable virtual slide identification.

Caution!

Ensure that a marginal space of 1-2 mm remains on all sides between the label and the label
area outer limits. It is vital for barcode identification. Do not let barcode label protrude from
slide edges, or stick on the coverslip surface. The thickness of the barcode label on the slide
must not exceed 0.4 mm and the overall thickness must be kept below 1.65 mm (including
the barcodes and the slide).

The following criteria must be taken into account to ensure safe barcode reading and case
identification:

• Barcode label is printed correctly

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• There are no smears, scratches, markers, stain or dirt on the label

• Label orientation is horizontal to the shorter edge of the glass slide

• Label is placed firmly on the label area (on the upper surface, at the frosted end of
the glass slide)

• Keep the required distances between the coverslip and edges when placing the
barcode label

Figure 34: Standard format slide with barcode label

The label area (1) is recorded by the preview camera, and can be displayed by the control and
viewer software. To affix barcode labels to slides, do the following:
1. Peel off the barcode label (2) from the roll.
2. Stick it on the label area (1) of the slide, on the specimen side.

The following barcode types can be used on the label:


1D barcode types
• *Code 39

• Code 128

• Code 16K

• *Interleaved 2 of 5

• Standard 2 of 5

• IATA 2 of 5

• Matrix 2 of 5

• Telepen

• Code 93

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• Code 11

• MSI

• Codabar

• Patch Code

• Pharmacode

• EAN-13

• EAN-8

• UPC-A

• UPC-E

2D barcode types
• Aztec

• Data Matrix

• PDF417/Compact

• Micro PDF417

• QR

• Micro QR

• MaxiCode

Labeling Recommendations and Restrictions


It is highly important to affix labels to glass slides appropriately. The user must always make sure
that the barcode label is readable and identifiable by the Scanner, thus preventing erroneous or
incorrect identification, or patient data mix-up.

There are some recommendations and restrictions on how and how not to perform affixing
barcode labels to glass slides:
• Code orientation

• Not superimposed

• Not oversized

• Not folded

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• No markings

• No scratches

• Use only one label

• Use barcode labels

Figure 35: Examples of incorrect barcode labels

Figure 36: Example of a correct barcode label

Notice:

Case ID is stored in the barcode, and is identified by the control software.

5.3.2 Placing slides in the glass slide magazines


The capacity of a magazine is 25 slides each. PANNORAMIC® 250 Flash III DX Digital
Scanner magazines are designed to receive slides of standard format only.

Caution!

To avoid jamming or breaking slides, always make sure that the slide is correctly inserted in
the magazine. Incorrect slide insertion may break the glass. The edge of the broken area of
the slide is sharp and its removal can lead to injury and contagion! Broken slide can be
removed only by a well-trained person!

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Figure 37: Inserting a standard format glass slide in the magazine

1. Hold the magazine (Figure 37 – 4) in hand or on the surface of the table where you insert
slides into your magazines.

Warning!

The symbol on the side of the magazine demonstrates the proper way of inserting slides.

Incorrectly positioned glass slides will not be identified and scanned by PANNORAMIC® 250
Flash III DX Digital Scanner.

Caution!

The slide magazine must be free clean and in perfect condition.

Insert slides (Figure 37 – 1) into the magazine by gripping them gently and so that the label area
(Figure 37 – 2) of the glass slide should be facing the back (closed end) of the magazine, with the
label area pointing to the right during insertion. You should insert several slides into a magazine
without empty slots. Begin the insertion on position 1 of the magazine.
When all the slides have been inserted into the magazines you want to digitize, you can load them
into their dedicated slots in the magazine compartment area of the Scanner. See section Placing
Slide Magazines in the Scanner.

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5.3.3 Placing glass slide magazines in the Scanner

Notice:

PANNORAMIC® 250 Flash III DX Digital Scanner is capable of receiving a total of 300 slides
(12 magazines, 25 slides each).

The magazine and its proper insertion are identified by a sensor in the main unit upon
actuating it by the magnet in the side of the magazine (Figure 37 – 3).

Figure 38: Inserting a magazine into the Scanner

1. Open the protective lid of the magazine feeder area by moving it backwards and
lay it down to the upper cover of the Scanner.

2. Place a magazine into the input stack (Figure 38 – 1) of the feeder unit. The back
side of the magazine must contact with the guide rails, with its open side
towards the scanner.

Warning!

To insert or remove a filled magazine from the device, slightly tilt it to its closed end to
prevent the slides from accidentally falling out. Magazines should always be kept clean from
dust, broken glass and other mounting media residues. Slide loader will only operate safely
and properly, if magazines are clean.

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Warning!

ALWAYS be cautious when handling (removing, replacing or loading) a magazine and avoid
contact with areas marked with and inside the Scanner.

3. Slide down the magazine on the input guide rails until it rests on the gear wheels
(Figure 39 – 1) or on an already inserted magazine.

Figure 39: Inserting a magazine into the Scanner

Notice:

PANNORAMIC® 250 Flash III DX Digital Scanner has two pairs of guide rails both at the
loading and unloading side of the magazine feeder area. The guide rails have built-in sensors
that detect whether there are magazines inserted in the input stack, or whether the output
stack is full. If the system does not detect the inserted magazine in the input stack, check
whether you have inserted it correctly. If the magazine is placed correctly, there may be a
problem with the sensor. In this case, contact 3DHISTECH Service Support.

Warning!

Make sure that the magazines are properly placed between the rails, because it can cause
serious damages in the feeding mechanism.

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Figure 40: Misplaced magazine

Notice:

The input stack can be filled with a maximum of 11 magazines in addition to the one in the
magazine loader. Do NOT place magazines into the output stack (Figure 31 – 2) or remove
magazines with already digitized slides from there during the digitization process. Only
remove magazines from the output stack when you have finished digitization of all slides.

4. Once you have finished with loading/removing the magazines, you can close the
protective lid.

5.4 Initiating the Scanning Process

Warning!

The protective lid must always be closed while the microscope is loading and/or scanning!

1) Click to add the magazine to the processing queue. After selecting a


magazine or magazines that are not involved in a process yet, set its scanning
parameters and select the objective with which you want to scan the contained
slides.

2) Select a magazine that is already added to be processed first, then click the
button to remove it from the processing queue.

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3) Click at the function bar of the Scanner PANNORAMIC® Diagnostic


Scanner Software to launch scanning process. The scanning of slides in the first
magazine is being performed after initiating the scanning process.

5.5 Aborting the Scanning Process

Click at the function bar of PANNORAMIC® Diagnostic Scanner Software to stop the
scanning process. Note, that the actual slide is being scanned, but the rest of the slides in the
queue will not be.

The scanning process can be continued by clicking again.

5.6 Unloading the Scanner

Warning!

NEVER remove a single slide from a magazine that is already loaded into the device (except
in cases when the software instructs you to do so), as it can lead to patient data mix-up.
Remove complete magazines only.

5.6.1 Removing Magazines from the Scanner


Remove the loaded magazine(s) from the output stack of the magazine feeder unit.
Make sure to grab magazines firmly and raise them slowly. Hold the magazine tilted to
its back side and in a way that your palm prevents slides from falling out of the magazine
while removing and putting it away.

Warning!

ALWAYS be cautious when handling (removing, replacing or loading) a magazine and avoid
contact with areas marked with and inside the Scanner.

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5.7 Checking the Scan Results

Warning!

It is ALWAYS the user’s responsibility to validate scanning results by comparing the digital
slide with the macro image of the histological section or the tissue/sample on the glass slide.

Note, that there can be differences between the digital image of the slide and the macro
image.

Follow these steps to view the digitized image of the slide:

1. Select magazine, then Slide View in PANNORAMIC® Diagnostic Scanner Software, or


double-click the magazine thumbnail in the Magazine View.
2. Select the slide in the magazine first, then double-click the thumbnail image at the left of
the slide information bar to open the digital slide in the Viewer program.
3. Make sure that the digital slide includes all the tissue area selected for scanning.

Notice:

If the quality of the digital slide is below the acceptable level and the focus quality value
does not reach the desired one, the slide will be automatically re-scanned before creating
the final digital slide. The slide is re-scanned three times maximum by taking several focus
points into account to determine the focus plane more properly. For the third run, a 3-layer
scanning is performed, and if the quality is still below the acceptable level, then an
exclamation mark is displayed on the slide thumbnail image. This event is logged and
presented on the Event History panel and in the Central Log Service as well.

5.8 Checking the Status of the Scanner


Magazine statuses are indicated on PANNORAMIC® Diagnostic Scanner Software
interface.

Notice:

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Magazine statuses are presented real-time in the Magazine View, and Slide statuses on the
Slide View of PANNORAMIC® Diagnostic Scanner Software marking magazine thumbnails
with colors indicated in Table 3 and Table 4). If an error has occurred during the scanning
process, always make sure to read information displayed on the interface before removing a
magazine that is involved in a faulty or failure event.

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6 Troubleshooting
6.1 Introduction
Some type of errors, malfunctions or problems can occur during the operation of the Scanner, but
most of these issues can be solved by following the actions listed in this section. If a problem
persists or it can be solved only by a 3DHISTECH service technician, please contact us at:
[email protected] or +36 (1) 467-5600

6.2 Event Logging

Notice:
Due to cybersecurity reasons, the logged events are accessible only through the Central Log
Service tool and in the Scanning History view of the control software.

Notice:
Each software operation or task performed by the Scanner is logged in a database. This
database can be accessed through the Central Log Service web application, and logged
events can be retrieved only by Local IT and Maintenance users. If your user status is
General, you won’t have the permission to access the Central Log Service web application.

6.3 Failed to log in


The following windows appear if the login has failed:

Figure 41: “Login failed” panels

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• Possible cause: Typing error

• Solution: Make sure that User name and Password strings or the PIN code are all
entered correctly and Caps Lock is off, as these fields are case-sensitive.

Notice:

Upon unsuccessful login despite entering credentials/PIN correctly, contact your system
administrator.

6.4 If the Scanner Cannot Read the Barcode on the Label Area
• Possible cause: The barcode printed on the label is scratched, damaged, and
therefore, unreadable. Check the following:

• Only one barcode is visible on the label area

• Solution: The glass slide must be identified with one single barcode only

• There is no dirt, smear, bleaching, or staining on the label area

• Solution: Clean the label surface or print a new one

• Label orientation or location is not correct – See chapter Preparation of Glass


Slides for more information on how labels can be affixed on slides

• Solution: Remove label, then print and stick a new label in accordance with
the steps described in section Preparation of Glass Slides

• Incorrect barcode type is used

• Solution: See section Preparation of Glass Slides for the barcode types that
can be identified by the software. Remove the label if it includes a barcode
that is not recognized by the software, and print a new label that includes a
barcode that is identifiable by the software

6.5 If the Scanner Shuts Down Automatically Before All Slides Have
Been Scanned
If the Scanner shuts down due to power failure and can be turned on again, and the built-in auto
recovery feature of the software resumes the last session, and the process will resume where it
left off.

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6.6 If a Warning or Error Message Appears on the User Interface


• Solution: Perform action(s) accordingly, follow steps described in the message
box

6.7 If Interaction with the User Interface is Unavailable


• Possible cause: Unknown software malfunction

• Solution: Restart PANNORAMIC® Diagnostic Scanner Software

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7 Maintenance
7.1 Introduction
This chapter describes the most common maintenance solutions that can be performed by the
user of the Scanner. For maintenance solutions not described in this manual, contact your
3DHISTECH service technician.
PANNORAMIC® 250 Flash III DX Digital Scanner is a precision device that must be operated
properly, and maintenance procedures must be performed in specified intervals. For the safe and
reliable operation of the Scanner, it must be used as intended and kept maintained and serviced.
It is recommended to perform the following procedures:
• Keep the Scanner clean (see section Cleaning for more details)

• The user must visually inspect certain units of the Scanner

Warning!

It is legally required that PANNORAMIC® 250 Flash III DX Digital Scanner is serviced in
specified intervals, and servicing must be carried out by 3DHISTECH service technicians or
contracted personnel only.

PANNORAMIC® Diagnostic Scanner Software does NOT instruct you to perform a cleaning
task or maintenance procedure, or to contact 3DHISTECH for servicing, so it is mandatory
that you act in accordance with the regularly scheduled inspections, maintenance and
cleaning tasks, otherwise the performance characteristics, the image quality, or reliability of
the Scanner may decrease, that may lead to a possible misdiagnosis by the pathologist.

Warning!

If you find that the Scanner does not operate or cannot be operated as intended, contact
3DHISTECH or the local distributor for servicing. If a component or unit is defective, it must
be replaced by an original replacement part or unit.

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7.2 Planned Maintenance


Throughout the entire life cycle of the Scanner, some of its components must be periodically
inspected, serviced or replaced in order to maintain proper operation and ensure image quality.

Warning!

The servicing and service maintenance of the Scanner must be performed by qualified and
trained Service Technicians only (and NOT by the user).

Routine user checks are necessary if PANNORAMIC® Diagnostic Scanner Software instructs
you to do so. These tasks are simple, but can be performed by trained users only.

Repair and maintenance service provided by 3DHISTECH is always carried out in accordance with
the contractual agreement. 3DHISTECH service technicians are qualified and holding a license,
therefore, are authorized to perform any maintenance and repair tasks on the Scanner.

7.3 Routine User Checks Program

Warning!

Under the contract with the manufacturer / distributor, the owner of the equipment is
obliged to provide users with adequate training and to make sure that the equipment is
used properly. It is the owner’s responsibility to ensure that routine user checks and
maintenance tasks are performed in time / on a timely basis.

If during the operation a possible defect or malfunction of the Scanner is suspected, the
user must immediately contact 3DHISTECH for service, and the Scanner must be switched
off and cannot be further operated. The Scanner can only be used further once the Service
technician eliminated the problem, or has performed the necessary repair, otherwise, using
the Scanner although it has not been repaired or checked may lead to misdiagnosis or
mistreatment.

Routine inspection tasks on a timely basis must be performed by the user. Such tasks are the
following:

• Monthly – Clean inner surfaces


• Yearly – Overall maintenance

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Warning!
PANNORAMIC® 250 Flash III DX Digital Scanner must be powered off first before performing
any routine inspection task on the device.

7.4 How to Access Logged Events


Accessing a list of logged events can be necessary when contacting the Service to include an
operational background data when giving specific details of a defective operational symptom
or incident.

Notice:
The database of logged events is NOT accessible for General users. You can log into Central
Log Service only if you are a Local IT user, or Maintenance user.

1. Launch Central Log Service web application in your browser.

2. Enter your user credentials (User Name and Password) in the Log in window.

3. Click Log in to continue.

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Click Clients to display different clients registered in the database. Client types can be selected
from the drop-down list at the top right corner of the Clients panel.

Select the client of which you want to list the event log data, then the list is automatically
displayed.

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Click to modify start and end date of event logging in the Interval section. Also, the Scanner
device of the same type for which the events are logged is selectable from the Microscope drop-
down list.

Browse for the event on the list, see details of the event, and contact support if necessary,
specifying the symptom (details of a possible malfunction).

Click to view a statistical analysis including the number of daily scanning, scanning duration,
and a day-by-day breakdown of scanning tendencies.

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7.5 Cleaning

Warning!
Dust, specks and humidity may decrease or harm the operating capability of the device.
Protect it with dust cover when not in use. Switch the power off before covering it.
Before performing any cleaning task, switch off the device and pull the plug out of the
power outlet/socket. Do NOT use any liquid substance when cleaning the Scanner, as it can
cause short-circuits and other electrical problems. You can only use a cloth pre-moistened
with tap water for cleaning the outer surface of the Scanner.
To clean greasy surfaces, it is recommended to apply Isopropanol on a piece of lint-free
cotton cloth and gently rub the surface. The use of any other types of substance (for
example, abrasive polishes, cleaning agents, solvents, etc.) must be strictly avoided.

Regardless of the number of scanned slides / scans (daily or within other operating intervals)
the Scanner must be cleaned on a monthly basis.

• Daily – Check and clean magazines if necessary

7.5.1 Preparation
1. Turn off the Scanner

2. Open the protective lid covering the magazine feeder unit.

7.5.2 Tools for Cleaning


The following tools are required to perform this task:

• Optical cleaning brush

• Lint-free cotton cloth

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• Tweezers

7.5.3 Cleaning the Covers


• To clean liquid from the device, use a lint-free cotton cloth. You can moisten
the cloth with water.
• To clean greasy surfaces, it is recommended to apply Isopropanol on a piece
of lint-free cotton cloth and gently rub the surface.

7.5.4 Cleaning the Loader Unit


Tools you will need:

• Optical cleaning brush


• Soft lint-free cloth

Follow these steps to clean the loader unit:

1. Open the protective lid of the magazine feeder area.


2. Remove dust and specks or glass debris from the loader tray by brushing
sideways. Remove larger specks of glass with tweezers. Be careful not to drop
them into the gears.

Figure 42: Loader unit

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3. Clean the guiding rails of the feeder area with the cloth.

7.5.5 Removing and Cleaning of Air Filters


Air filters are located at the back of the Scanner, and must be cleaned in every six
months.

Follow these steps to remove and clean the air filters:

1) Grab and pull the upper part of outer frame of the filter housing.

2) Pull out the filter from the frame, and shake or blow from the inside to remove
dust from its outer surface.
3) Insert filter back to the frame, then reattach to the base.

7.5.6 Replacing Fuses


Follow these steps to replace fuses of the main power switch:

1. Switch off the main power supply and disconnect the power supply cable

2. The fuse compartment is located above the main power supply switch at the back
side of PANNORAMIC® 250 Flash III DX Digital Scanner

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3. Release lock (2) by pushing the lever upwards, so the insert (1) can be pulled out

Figure 43: Fuse compartment

4) Remove insert from the compartment.

Figure 44: Removing the fuse insert

5) Replace fuses, put the insert back into its seating, and push it inwards until you
hear a snap, so the lever locks.

Figure 45: Replacing the fuses

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8 Transporting
The following procedure shows how to transport Pannoramic® 250 FLASH III DX Digital Scanner.

Figure 46. Transporting handles

Caution!

Do not use the protective cover (2) to raise, shift or transport Pannoramic® 250 FLASH III DX
Digital Scanner!

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Notice:

The base unit has four carrying handles for transporting. Two or four people can carry the
base unit using these carrying handles. To determine the appropriate number of transporter
people, observe the laws of your country regarding load carrying capacity limitations. You
can find the weight data of the base unit in chapter Technical Data.

To transport Pannoramic® 250 FLASH III DX Digital Scanner, do the following:


4. Switch power supply off (see chapter Main parts of the base unit) and detach all other
cables.
5. Pull carrying handles out (1) until mechanical stop position (A).
6. Turn carrying handles by 90° (B) towards the base unit to secure them.
7. Now you can transport Pannoramic® 250 FLASH III DX Digital Scanner with the help of
another person.
8. After finishing transportation, push carrying handles back into normal position (C).

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9 Product Disposal
9.1 Introduction
PANNORAMIC® 250 Flash III DX Digital Scanner is designed and manufactured to comply with the
relevant guidelines for environmental protection. If the device is disposed improperly, it presents
environmental risk. As an electric device, PANNORAMIC® 250 Flash III DX Digital Scanner consists
of components that can be recycled (e.g. aluminum, steel) and other components that contain
rubber, plastic that cannot be recycled.
Before disposing of this device, please refer to local environmental guidelines on the proper
method of disposing electronic (medical) devices.

9.2 Passing the Scanner on to Another User


If the owner of the Scanner wants to pass or donate the Scanner on to another user, and if the
purchase contract includes a clause describing the owner’s liabilities, they must act accordingly.

9.3 Final Disposal of the Scanner

Warning!

When the Scanner cannot be longer used for its intended purposes, and the owner wants to
dispose of PANNORAMIC® 250 Flash III DX Digital Scanner, it must be considered that the
Scanner is not classified as domestic waste, but it must be properly disposed in accordance
with currently valid legal requirements.

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10 Technical Data

Weight and Dimensions

Measurement Value

Weight 103lb (47 kg)

Width 28.77 inches (680 mm)

Depth 29.52 inches (750 mm)

Height 22.83 inches (580 mm)

Table 7: Weight and dimension specifications

Environmental Conditions
Transportation / Shipment (packed)

Permissible ambient temperature -40°F to 158°F (-40°C to +70°C)

Storage

Permissible ambient temperature 32°F to 140°F (0°C to +60°C)

Permissible relative air humidity (non-condensing) Max. 75% at 95°F (35°C)

Operation

Permissible ambient temperature 50°F to 95°F (+10°C to +35°C)

Permissible relative air humidity Max. 75% at 95°F (35°C)

Altitude at installation site max. 6561ft (2000m)

Atmospheric pressure 500 hPa to 1060 hPa

Ventilations

Gap area Specification

Side panels 10 inches (254 mm)

Back panel 10 inches (254 mm)

Table 8: Necessary space for ventilation

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PANNORAMIC® 250 Flash III DX Digital Scanner General Performance


Throughput – 60 slides/hour (scanning time of a 15×15mm benchmark tissue size with 20×
objective at 40× equivalence is ~35 seconds, with adaptive focus point algorithm, single layer local
scanning)
Tissue detection – AI-based

Glass Slide Magazines


Type – PANNORAMIC® Slide Magazine

Glass Slides

Definition Slide Coverslip

Length 75.0 to 76.0 mm max. 50 mm

Width (standard slide) 25.0 to 26.0 mm max. 24 mm


(recommended: 22 mm)

Thickness 0.90 to 1.2 mm No. 1 and No. 1.5 (0.13 to 0.16 mm and 0.16 to 0.19 mm)

Corners 45° beveled corners N/A

Edges Ground or cut N/A

Table 9: Glass slide specifications

Digital Slide Images

Definition Specification

Pixel size (using 20× objective and 0.24µm


1.6× C-mount adapter)

Pixel size (using 40× objective and 0.12µm


1.6× C-mount adapter)

Default image compression level 80%

Output formats Lossless/RAW, DICOM

Label image format JPG

Table 10: Digital slide images specifications

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Operating data

Intended site closed room facilities

Electrical protection class I

Internal protection degree IP 20 (*)

Electrical safety in compliance with DIN EN 61010-1:2001, DIN EN 61010-2-


101:2002 (IEC 61010-1:2001, IEC 61010-2-101:2002)

Degree of pollution 2

Over-voltage category II

Radio interference suppression in accordance with EN 55011 class B

Noise immunity in accordance with EN 61326-2-6:2012

Power consumption of the complete device max 350W

Fuses 2x T3.15A L, 250V

* NOTE: If the housing is open, IP20 compliance is only achieved when the device is switched off.

Power Supply

Definition Specification

Mains type Single phase load (hot, service neutral, separate ground)

Input voltage range 100-240 Vac ±

Range 10%

Frequency 50/60 Hz

Max freq. deviation ±1 Hz

Cable length 1.5 m

Capacity 1200 W

Table 11: Power supply specifications

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Notice:
Wall outlets must have a ground connection. The power mains must be hospital grade in the
United States and Canada. In other countries, the connector must be approved by the
relevant local safety regulations for this application.

Fuses

Definition Specification

Type Schurter - 0034.3122

Voltage 250V, Capacity 3.15A, Size 5×20mm

Approvals Approval Reference Type: FST 5×20


VDE Certificate Number: 40016601
UL File Number: E41599

Power Consumption ~200 W


(during operation)

Table 12: Fuse specifications

Electromagnetic Compatibility
The Scanner is intended for use in the electromagnetic environment specified below. The owner
of the Scanner must assure that it is used in such environment.
RF emissions - Group1 – The Scanner RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment. Class B

Network and other Connections


The Scanner / control computer supports the following connections:
• Connection to network/server – 10 Gb/s Ethernet cable class CAT6A with RJ45
connector

• Control – USB cable (between Scanner and control computer)

• Preview camera – USB cable (between Scanner and control computer)

• Scan camera cables (between scan camera and control computer)

• Video cable (between monitor and control computer)

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• Power supply cable (between 230V/110V outlet and monitor)

• Power supply cable (between 230V/110V outlet and control computer)

• Power supply cable (between 230V/110V outlet and Scanner)

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Light sources

Brightfield illumination Precision-Aligned Pulsed Xenon Light Source

Average service life 1 x 109 flashes

Preview camera

Preview camera VRmagic VRmC-8+ PRO

Sensor CMOS, rolling shutter

Sensor size ½”

Resolution 2056×1544

Pixel size 3.2 um x 3.2 um

Max. frame rate 13 Hz

Bit depth 8/10 bit

Scan camera

Global Shutter CMOS

Pixel size 5.5µm × 5.5µm

Camera resolution 4096 (H) × 3072 (W) pixels

Max frame rate (with 40x objective) 180 fps

Bit-depth 8-bit

Pixel resolution with 20x objective and 1.6x C-mount adapter 0.24µm

Pixel resolution with 40x objective and 1.6x C-mount adapter 0.12µm

Connection type CoaXPress – 4 lanes

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Control computer, minimum system requirements

Operating System Microsoft Windows 10 Professional 64-bit EN

CPU Intel Xeon Gold 5120

RAM 96 GB DDR4

Hard disk 3 TB

Optical drive DVD-RW

Display 96 dpi

Graphics SXGA (1280×1024, True color)

Input devices Keyboard, mouse

Ports 1x CoaXPress Quad; 1x Double CameraLink port; 1x FireWire (1394 A); 4 × USB 2.0

Network connection 1 Gb/s Ethernet cable class CAT6A with Rj45 connector

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Glossary of Terms and Abbreviations

Term Description

Digital Slide / A digital image of a thin glass plate on which specimens are mounted for
Slide microscopic study:

a dynamic, interactive image that you can manage, save, magnify, zoom,
name, evaluate, annotate, mark and comment, send to a colleague
electronically for co-operation or advice, and so on.

Thumbnail A static preview image on the GUI of a PANNORAMIC® Slide or a


magazine loaded into the Scanner.

FOV Field of View

NA Numerical Aperture

WSI Whole Slide Imaging

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