PerkinElmer Panthera-Puncher 9 User manual

2081-0010 USER MANUAL
Panthera-Puncher™ 9
Software version 1.8
Dried Blood Spot Punching Device

Contents
General information...................................................................................1
Changes from previous manual version....................................................................................................................... 1
Trademarks..................................................................................................................................................................... 1
Intended purpose...........................................................................................................................................................1
General notes................................................................................................................................................................. 1
Table of symbols............................................................................................................................................................. 1
Safety information..................................................................................... 3
Conventions.................................................................................................................................................................... 3
Warnings and precautions.............................................................................................................................................3
Notice regarding serious incidents............................................................................................................................... 4
Installation................................................................................................. 5
Main features............................................................................................. 6
Touch screen...................................................................................................................................................................6
General page layout.......................................................................................................................................................6
On-screen keyboard....................................................................................................................................................... 6
Intellipunch™.................................................................................................................................................................. 6
Punch sizes......................................................................................................................................................................6
Error situations............................................................................................................................................................... 6
Routine operation...................................................................................... 8
Startup and shutdown................................................................................................................................................... 8
Loading and setting up the plates.................................................................................................................................9
Unloading the plates from the instrument.................................................................................................................10
Plate edit view...............................................................................................................................................................10
Operations in detail..................................................................................12
Punching and sample queries..................................................................................................................................... 12
Sample identification...................................................................................................................................... 13
Detection of punch areas................................................................................................................................13
Punching priority.............................................................................................................................................14
Punching patterns...........................................................................................................................................14
The Retest mode (Stand-alone)................................................................................................................................... 14
Packing partial plates...................................................................................................................................................15
Check plate functionality..............................................................................................................................................15
Repunch mode................................................................................................................................................ 15
Maintenance and shutdown.................................................................... 16
Punch head maintenance............................................................................................................................................ 16
Hard disk cleanup (only available to Service and Panthera Admin level users)....................................................... 16
System information......................................................................................................................................................16
Instrument cleaning.....................................................................................................................................................17
Removing and cleaning the punch heads...................................................................................................................17
Settings..................................................................................................... 24
Touch area.....................................................................................................................................................................24
Automatic Sample ID generation................................................................................................................................ 24
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Barcode rule for samples.............................................................................................................................................24
External barcode reader (optional)............................................................................................................................. 25
SG Connection.............................................................................................................................................................. 25
Loading templates........................................................................................................................................................25
Analytes.........................................................................................................................................................................25
Punching..........................................................................................................................................................26
Punches per well............................................................................................................................................. 26
Card barcode rules..........................................................................................................................................27
Plate................................................................................................................................................................. 27
Exporting......................................................................................................................................................... 27
Plate maps....................................................................................................................................................... 28
Barcode rule notation..................................................................................................................................... 28
Storing of the sample card image........................................................... 30
Log files.....................................................................................................31
Troubleshooting....................................................................................... 32
Contact information.................................................................................33
Multilingual versions............................................................................... 34
Index......................................................................................................... 35
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General information
This section contains general information about the Panthera-Puncher 9.
Changes from previous manual version
Changes made to this manual are marked with underlined text.
Trademarks
Copyright © 2014-2022, PerkinElmer, Inc. All rights reserved.
PerkinElmer® is a registered trademark of PerkinElmer, Inc.
Panthera-Puncher™ and Intellipunch™ are trademarks of PerkinElmer, Inc.
All other trademarks are the property of their respective owners.
Intended purpose
The Panthera-Puncher 9 is an accessory for IVD assays (for example, neonatal screening assays) where the sample
type is dried blood spot and the sample size is supported by the Panthera-Puncher 9. The Panthera-Puncher 9 cuts the
sample from the dried blood spot, deposits it to a microtiter plate, and documents the traceability of the sample to the
plate. The instrument is semi-automatic and it is intended for use by trained laboratory personnel.
General notes
The user interface is available in several languages, which may be selected from the service software. Please note that
changing the language from the service software will not change the keyboard layout. If you need a language-specific
keyboard layout, you can add it from the Keyboards and Languages tab of the Windows Region and Language
dialog.
The default user and administrator user names and corresponding passwords are provided in a separate document.
If the network connection is lost while network folders are mapped, the software experiences a slow-down during
start-up and while refreshing the folder browser. This is caused by the software waiting for Windows timeouts when
trying to locate the mapped network folders.
A few words on positive vs negative identification of samples
The positive identification of a sample means that the laboratory set up ensures a continuous and automatic follow
up of all sample data, from the moment the disks are punched into the wells, until their measurement results are
known. This means that the worklists are either automatically created and transferred to the measurement instrument
and connected to the results, or that the data transfer occurs through the LIMS automatically with no need for human
intervention.
Note: When removing plates from the instrument, visually inspect all wells in every plate.
Table of symbols
The following table contains symbols that identify particularly important information and alert you to the presence of
hazards. These symbols may appear in this manual, the product or the package.
Symbol Description
CE compliance mark
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Symbol Description
Manufacturer
Date of manufacture
Caution, consult instructions for use
Warning! Beware of moving parts in the instrument
This way up
Fragile, handle with care
Keep dry
Certification mark from testing laboratory
In vitro diagnostic medical device
Catalogue number
Battery recycle
WEEE, follow local guidelines when disposing of the
equipment
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General information
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Safety information
This section contains the safety information for the product.
Conventions
The following conventions are used in all system documentation:
Warning: A warning indicates a hazardous situation or operation that, if not avoided, could result in serious personal
injury or death to the operator or the patient. Follow all stated precautions.
Caution: A caution indicates an operation that could cause damage to the instrument or loss of data, or personal
injury to the operator or the patient if correct procedures are not followed.
Note: A note emphasizes significant information in a procedure or description, and alerts users to key points of interest
not related to personal injury.
In cases where a specific hazard or warning has been identified – such as an electrical or burn hazard – that symbol is
added to the cautions and warnings.
Warnings and precautions
Warning: To ensure data security, log off from the computer when you leave it.
Warning: Do not open the side covers unless the instrument is switched off.
Warning: The specimens are human dried blood spots. The dust that is created by punching should be cleaned
regularly.
Warning: The humidity levels of the air and the materials used affect the build-up of static electricity and thus the
punching performance. With low humidity, there is a higher possibility of pumching errors than with high humidity.
These effects increase as the punch size decreases. Be careful when working in conditions which are at the lower end
of the humidity specifications.
Warning: Always check the number of disks in the well in error or repunch situations. Incorrect number of disks may
lead to a false result.
Warning: Installing the instrument in a location where sunlight reaches the sample plane may cause issues with
barcode reading and sample identification.
Warning: Using glossy paper for sample barcodes can cause barcode reading to fail.
Warning: Under some lighting conditions, the top light intensity may have to be decreased to ensure the
best performance in barcode reading. To adjust the top light intensity, please contact your local PerkinElmer
representative.
Warning: To minimize the risk of a partially read sample barcode, the barcode rule for patient samples should be
activated. To activate the barcode rule, and for any other barcode-related issues, contact your local PerkinElmer
representative.
Warning: When punching a calibrator or a control sample, it is your responsibility to select the correct level spot for
punching. The instrument cannot recognize the markings below the blood spots. The level queried can be seen on
the left side of the screen.
Warning: The information of a partially punched well is not transferred to Specimen Gate, worklists or recovery files.
The wells appear as empty wells.
Warning: The Panthera-Puncher 9 is equipped with an ionizer to counteract static charges from microplates. When
working with assays which are developed in-house using coated microplates, ensure that the homogeneity of the
assay plates after they have been exposed to the ionizer. Exposure to the ionizer has been minimized and does not
impact PerkinElmer DBS assays.
Caution: Keep your fingers and other body parts away from the instrument's moving parts.
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Caution: This software is intended to be installed in a local network and isolated from the public internet with
a firewall. If a remote connection is needed, then a VPN connection is the preferred method to enable secure
connectivity.
Caution: To protect the system from cybersecurity attacks, the operating system updates should be installed as soon
as possible and the operating system antivirus services should be turned on. Third-party antivirus software can be
used, but their compatibility has not been verified by PerkinElmer.
Caution: Use protective gloves when cleaning or otherwise manipulating punch heads.
Caution: When cleaning the punch heads, ensure that parts from different punch heads do not become
interchanged. This may cause the punch head to become unusable, the disk to not have space to fall, or the punch
head size to be wrongly identifed.
Notice regarding serious incidents
For a patient/user/third party in the European Union and in countries with an identical regulatory regime (IVDR; EU
2017/746/EU); if, during the use of this device or as a result of its use, a serious incident has occurred, please report
it to the manufacturer and to your national authority. The contact information for the manufacturer of this device to
report a serious incident is:
Wallac Oy
Mustionkatu 6, FI-20750 Turku, Finland
http://www.perkinelmer.com
Phone: [phone]
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Installation
The Panthera-Puncher 9 is delivered with a computer on which the Panthera user interface is pre-installed, and no
other software installation is required. Updates to the Panthera Manager software are carried out by PerkinElmer
service personnel.
All the adjustments to the Panthera-Puncher 9 are factory set and the system should be ready for use once installed.
However, the service personnel in charge of the installation will check the adjustment of the camera, the punch head
and the plate track to ensure they work properly.
If you wish to add Panthera users, please contact your local PerkinElmer representative. These users are based on
Windows user accounts, but these accounts need to be added to certain user groups in order to have access rights
to the Panthera software. User groups in question are Puncher Users or Puncher Administrators, depending on what
functions the users need. Puncher Users have access to functions related to the routine operation of the instrument,
whereas the Puncher Administrators have rights to change assay and system configuration parameters. For more on
user configuration, please refer to Startup and shutdown on page 8.
If anti-virus software is installed on the Panthera PC, it needs to be configured so that it does not scan for viruses
while the Panthera-Puncher 9 instrument is being used. Real-time virus scans are not allowed. To prevent errors, only
use scheduled virus scans. External software accessing the CPU resources may cause errors in the functioning of the
Panthera-Puncher 9.
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Main features
The following section describes the main features of the Panthera-Puncher 9.
Touch screen
The Panthera Manager user interface software is designed to be used with a touch screen instead of a mouse and
keyboard.
General page layout
The upper part of the user interface screen can be assimilated to a task bar. This area is always visible and contains,
from left to right:
• The navigation buttons to the Plates, Punch, and Maintenance views
• The date and time and the name of the currently displayed view
• Three small icons and their related information, respectively
• the communication settings (stand-alone or SG connectivity)
• the humidity of the punching area
• the user name of the user currently logged in
• The navigation button to the Settings view.
The rest of the screen is dedicated to displaying the content of the selected view.
On-screen keyboard
When pressing an editable field on the screen or whenever manual text input is needed (e.g. for writing a note to be
assigned to a sample), the on-screen keyboard is displayed.
Intellipunch™
Intellipunch™ is a function that allows the software to maximize the number of disks that can be punched from each
blood spot. Intellipunch detects the blood areas on the sample card based on the card surface color and automatically
optimizes the punch locations for the current blood spot. This provides the most economical usage of blood spots that
are not symmetrical.
The program also offers the possibility to use static punch patterns. There are numerous predefined punch patterns
that can be used with or without automatic blood detection. When choosing a punch pattern, the maximum punch size
that can be used in the pattern is shown next to it. The software will only show you punch patterns available for the
punch heads currently installed on the instrument.
Punch sizes
The instrument can contain two different punch head sizes simultaneously. The possible punch head sizes are 1.5 mm,
3.2 mm, 3.8 mm, 4.7 mm and 6 mm. If the instrument does not contain a suitably sized punch head for a loaded
analyte, it displays a warning message and disables the plate.
1.5 mm disks can sometimes cause issues, especially in a very dry environment. Please refer to Troubleshooting on
page 32 for more details on this.
Error situations
If the instrument encounters an error situation, it will inform you through the user interface by means of an error
message, which will also instruct you on how to proceed.
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