PerkinElmer Panthera-Puncher 9 User manual

2081-0010 INSTRUMENT MANUAL
Panthera-Puncher™ 9
Dried Blood Spot Punching Device

Contents
General information...................................................................................1
Changes from previous manual version....................................................................................................................... 1
Trademarks..................................................................................................................................................................... 1
Intended purpose...........................................................................................................................................................1
Instrument overview......................................................................................................................................................1
Safety information..................................................................................... 3
Conventions.................................................................................................................................................................... 3
Notice regarding serious incidents............................................................................................................................... 3
Warnings and precautions.............................................................................................................................................3
Safety requirements.......................................................................................................................................................3
Installation instructions............................................................................ 5
Functional description............................................................................... 6
The plate track................................................................................................................................................................ 6
The punch head module................................................................................................................................................ 6
The camera..................................................................................................................................................................... 6
The punching platform.................................................................................................................................................. 6
The touch screen............................................................................................................................................................ 7
The ionizer...................................................................................................................................................................... 7
Disk detector...................................................................................................................................................................7
Information about user instructions and warnings.................................8
On screen........................................................................................................................................................................8
The User Manual............................................................................................................................................................ 8
Routine maintenance..................................................................................................................................................... 8
Decontamination............................................................................................................................................................8
Symbols...........................................................................................................................................................................8
Moving the instrument..............................................................................9
Specifications............................................................................................10
Capacity of plates......................................................................................................................................................... 10
Punch sizes................................................................................................................................................................... 10
Barcodes....................................................................................................................................................................... 10
Sample barcodes.............................................................................................................................................10
Plate barcodes.................................................................................................................................................10
Loading......................................................................................................................................................................... 10
Analytes.........................................................................................................................................................................11
Physical dimensions..................................................................................................................................................... 11
Power requirements.....................................................................................................................................................11
Environmental conditions............................................................................................................................................11
EMC............................................................................................................................................................................... 11
Packaging, storage, and transportation requirements..............................................................................................11
Conformance to EU directives..................................................................................................................................... 11
Connectors on the instrument.................................................................................................................................... 12
Licensed third-party software components................................................................................................................13
i

WEEE Instructions for PerkinElmer Products..........................................14
Warranty................................................................................................... 15
Index......................................................................................................... 17
ii

General information
WARNING
THIS EQUIPMENT MUST BE INSTALLED AND USED IN ACCORDANCE WITH THE MANUFACTURER'S
RECOMMENDATIONS. INSTALLATION AND SERVICE MUST BE PERFORMED BY PERSONNEL PROPERLY TRAINED
AND AUTHORIZED BY PERKINELMER.
FAILURE TO FOLLOW THESE INSTRUCTIONS MAY INVALIDATE YOUR WARRANTY AND/OR IMPAIR THE SAFE
FUNCTIONING OF YOUR EQUIPMENT.
TRADEMARKS
PerkinElmer, Specimen Gate and Specimen Gate Laboratory are registered trademarks, and Panthera-Puncher is a
trademark of PerkinElmer, Inc.
Windows 7 and Windows 10 are registered trademarks of Microsoft, Inc.
Changes from previous manual version
Changes made to this manual are marked with underlined text.
Trademarks
PerkinElmer®, Specimen Gate®, and Specimen Gate Laboratory® are registered trademarks of PerkinElmer, Inc.
Panthera-Puncher™ is a trademark 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 a 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 of the
sample to the plate. The instrument is semi-automatic and intended for use by trained laboratory personnel.
Instrument overview
The Panthera-Puncher 9 is a semi-automatic puncher for DBS and other similar samples that are dried on a filter paper
media. The instrument is equipped with a punch head and a plate tray for nine sample plates. The punch head punches
the disks and drops them into the plate wells. The Panthera-Puncher 9 is fitted with a digital camera and imaging
software capable of detecting blood spots and ID information (barcode) from the sample cassettes or other sample
formats.
The system contains an embedded user interface that serves various purposes: punching operations, instrument and
analyte settings configuration. The same graphical environment is used whether the instrument is in stand-alone mode
or connected to Specimen Gate Laboratory®.
The Panthera Manager software runs on a computer running Windows® 7 (32-bit) or Windows® 7 (64-bit). The system is
provided with a keyboard and a mouse, which are not necessary for operation.
In addition to the end-user software, the system also has service software that is used during the instrument
manufacturing, maintenance and service.
Panthera-Puncher™ 9 Instrument Manual
General information
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The instrument can hold up to two different sized punch heads simultaneously, and up to 9 microtiter plates (height 14
mm - 16.1 mm). Alternatively, 3 of the available plate positions may be occupied by deep well plates, with max. height
44.5 mm, leaving 6 plate positions free for standard plates.
1. Touch screen
2. Punching platform
3. Plate tray
4. Camera
5. Punch head assembly
6. Frame
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General information
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Safety information
This section contains the safety information for the Panthera-Puncher 9.
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.
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]
Warnings and precautions
Please counsult the Warnings and precautions section in the Panthera-Puncher® 9 User Manual.
Warning: Make sure the instrument is switched off before opening the side panels! Both side panels are fastened
with a screw to ensure maximum safety.
Warning: The electromagnetic environment should be evaluated prior to operation of the device. Do not use this
device in close proximity to sources of strong electromagnetic radiation (e.g. unshielded intentional RF sources), as
these can interfere with the proper operation.
Caution: 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.
Safety requirements
The instrument is designed to meet the following safety standards.
• CAN/CSA-C22.2 61010-1
• UL 61010-1
• EN 61326:1
• EN IEC 61326-2-6
• EN 61010-1
• EN IEC 61010-2-101
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• EN 62366-1
Every attempt has been made to minimize the risk of the user touching moving parts.
Make sure you leave a gap of at least 5 cm between the wall and the back of the instrument.
The instrument must be connected to a mains supply having a protective earth.
Make sure the instrument is grounded. A protective grounding screw (marked with the ground symbol) is located
beside the power supply connector on the back of the instrument.
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Safety information
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Installation instructions
Installation instructions are not included in this documentation because installation is only to be performed by
personnel trained and authorized by PerkinElmer.
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Installation instructions
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Functional description
The Panthera-Puncher 9 consists of:
• two main modules
• the plate track
•the punch head
• three functional units
• the camera
• the punching platform
• the touch screen.
The plate track
The plate track consists of the plate tray and the mechanics that move it. The plate tray can hold up to 9 plates
simultaneously, of which a maximum of 3 plates can be deep well microtiter plates. When required, the instrument will
bring out the plate tray so that the user can load plates in all positions simultaneously. When all the plates have been
loaded, the instrument brings the tray back inside and starts to read barcodes from the plates that are present. If no
plate is present, the instrument will know that position is empty.
During the punching operations, the plate track moves in such a way that the target well is placed under the punch
head. Once it is positioned, the instrument punches the disk, which falls into its assigned well.
The punch head module
The punch head module consists of the punch head mover and the punch head itself. The punch head makes the
punching movement that cuts the disk from the sample card. The punch head mover is responsible for two actions: it
can switch between two punch heads of different sizes, and it brings the punch head to the exact location where the
disk needs to be punched. The instrument can contain 2 punch heads at the same time, and these can be of 5 different
sizes: 1.5, 3.2, 3.8, 4.7 and 6 mm.
The camera
The CCD camera is located above the punching platform. It provides the image used to display the sample card on
the screen. The software analyses the sample card image and allows real time blood detection. Together with the
intelligent punching location algorithm, it offers great benefits to the users: the sample card blood spot is used in the
most efficient way. The camera is also able to read the barcode of the sample card in the punching area. For Quality
Assurance (QA) purposes, the system can also save the camera blood card image every time the punch command has
been given. The blood card image will include the dots indicating the planned punches, their numbers and the image
meta-data will contain the assay information. The default folder for storing these pictures is c:/users/public/public
documents/Panthera, and it can be accessed easily from the Documents library shortcut in the Windows file explorer.
The pictures are organized by date with the Panthera folder containing one sub-folder for each year. Each year folder
contains one sub-folder for each month, and each month folder contains one sub-folder for each day. Each blood
card image file name contains the card barcode (or ID) and a timestamp. The file metadata holds information on the
punches, i.e. which disk was punched into which well of which plate.
The punching platform
The punching platform not only provides the support for the sample card while punching, but it also helps the software
detect a sample card thanks to 4 "hot spots" on the dark background. When some of these hot spots' color intensity
changes, it means that a card has been placed in the punching area. The punching area is also equipped with sensors
and the gripper. The sensors enable the user to trigger the punching operation by tapping the platform. The gripper
holds the card in place during punching.
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Functional description
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The touch screen
The instrument user interface has been developed for use with a touch screen. There is therefore no need for a mouse
or a keyboard. Whenever required, the user interface will show the on-screen keyboard for manual data entry. All
needed functions are available through the user interface in a clear and easy way using the touch screen. During
punching operations, the screen displays the camera image of the platform, so that the user does not need to lean
forward to see where the punch will be done.
The ionizer
Under the punching platform, there is an ionizer that reduces static electricity by releasing ions into the air.
Disk detector
Dropping of the punched disk is verified with sensors in the lower end of the chute. If a disk is not detected, due to e.g.
the disk sticking to the punch head, the operation is stopped and an error message is displayed.
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Functional description
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Information about user instructions and warnings
There are several forms of user instructions in addition to this Instrument Manual:
On screen
The user interface provides context sensitive instructions that guide the user operating the instrument.
The User Manual
This Instrument Manual provides a general presentation of the system and some technical specifications. The User
Manual focuses on describing how to operate the instrument using the Panthera Manager software. The CD on the
back cover of the User Manual contains translations of the User Manual in pdf format.
Routine maintenance
Routine maintenance comprises the tasks intended for performance by the user and these are described in the User
Manual. All other maintenance tasks must be performed by personnel trained and authorized by PerkinElmer.
Decontamination
For the purpose of decontamination of the punch heads or other instrument parts, clean the parts to be
decontaminated with water, followed by ethanol (max. 70%).
Symbols
The symbols that appear on the instrument, the package or other labelling material are explained in the Panthera-
Puncher® 9 User Manual.
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Information about user instructions and warnings
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Moving the instrument
If for some reason the instrument must be moved, we recommend that two people lift it by supporting the instrument
from the lifting areas indicated in the image below. Be careful not to tilt the puncher too much while moving it.
Rotated bottom view:
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Moving the instrument
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Specifications
This section includes the specifications of the Panthera-Puncher 9 instrument.
Capacity of plates
The instrument can use 96-well microtiter plates (ANSI SBS 1-4 standards).
9 plates can be loaded in the instrument at the same time, of which up to 3 can be deep well plates.
Normal plate height: 14 - 16.1 mm
Deep well plate height: max. 44.5 mm
Punch sizes
2 punch head sizes from the following can be installed simultaneously in the instrument:
• 1.5 mm (~1/16 in)
• 3.2 mm (~1/8 in)
• 4.7 mm (~3/16 in)
• 6 mm (~1/4 in)
Barcodes
Below are the barcode types supported by the Panthera-Puncher 9.
Sample barcodes
The following barcode types are supported:
• Code 128
• IL 2/5
• Code 39
0.191 mm is the minimum bar width that can be used for barcodes.
The sample ID length has to be 2-20 characters. By default, the sample ID can contain numbers, letters and special
characters - and /.
Plate barcodes
The following barcode types are supported:
• Code 128
• IL 2/5
0.191 mm is the minimum bar width that can be used for barcodes.
The plate barcode has to be 4-20 characters, including the check digits. By default, the plate barcode can contain
numbers and letters.
Loading
The instrument offers continuous sample, calibrator and control loading as well as continuous plate loading.
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Specifications
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Analytes
The stand-alone mode has several predefined assays.
The other assays can be added and defined with the help of your local PerkinElmer representative.
Physical dimensions
Height: 300 mm (~11.81 in)
Width: 876 mm (~34.49 in)
Depth: 740 mm (~29.13 in)
Weight: 45 kg (~99.21 lbs)
These dimensions are excluding the PC and screen. The touch screen can be placed on the top of the instrument.
Power requirements
Power consumption: 70 VA
Mains Voltage: 100-240 V, 50-60 Hz
Environmental conditions
The Panthera-Puncher 9 is a benchtop instrument designed to be used in a normal laboratory environment. It should
be laid on a flat surface, such as a table or a workbench, and if possible, keep it away from direct sunlight as extraneous
light can interfere with barcode reading. Under such circumstances, the lights of the Panthera-Puncher 9 might need to
be adjusted.
Operating temperature: 15-30 ºC
Relative humidity: 20-80 % for punches of 3.2 mm or greater, 40 - 80 % (not condensed) for 1.5 mm punches
When operating at less than 20% relative humidity, static electricity increases the probability of disks jumping out of the
wells.
EMC
Electromagnetic compatibility according to IEC/EN 61326-2-6. Emissions according to Class B limit values.
Packaging, storage, and transportation requirements
Temperature
Storage: -20 to 50º C
Transportation: -20 to 50º C
Relative humidity (not condensed)
Storage: 5% to 90%
Transportation: 5% to 90%
Conformance to EU directives
The CE mark conforms to the following EU directives:
• 2014/30/EU (Electromagnetic Compatibility Directive)
• 2014/35/EU (Low Voltage Directive)
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Specifications
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• 98/79/EEC (In-vitro diagnostic medical devices)
Connectors on the instrument
All the instrument connectors are found on the back panel.
When facing the back panel, there are three connectors on the left. These are clearly indicated (as shown on the picture
below):
• The camera connector to be connected to one of the PC's USB ports.
• The CAN IN connector to be connected to the PC's CAN port. It allows the control of all mechanical parts by the
software running on the computer.
• The pedal connector to be connected to the optional external pedal.
The right side of the back panel hosts the mains inlet connector, the grounding screw and the main power switch (see
picture below).
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Specifications
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Licensed third-party software components
• DTK Software (DTKSOFT)
• DTKBarReader.dll
• uEye camera driver provided by IDS imaging Development Systems GmbH
• DSCameraDriver.dll
• FPS On-Screen virtual keyboard
• FPS.Shared.dll
• FPS.VirtualKeyboard.dll
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Specifications
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WEEE Instructions for PerkinElmer Products
or
A label with a crossed-out wheeled bin symbol and a rectangular bar indicates that the product is covered by the Waste
Electrical and Electronic Equipment (WEEE) Directive and is not to be disposed of as unsorted municipal waste. Any
products marked with this symbol must be collected separately, according to the regulatory guidelines in your area.
The objectives of this program are to preserve, protect and improve the quality of the environment, protect human
health, and utilize natural resources prudently and rationally. Specific treatment of WEEE is indispensable in order to
avoid the dispersion of pollutants into the recycled material or waste stream. Such treatment is the most effective
means of protecting the customer’s environment.
Requirements for waste collection, reuse, recycling, and recovery programs vary by regulatory authority at your
location. Contact your local responsible body (e.g. your laboratory manager) or authorized representative for
information regarding applicable disposal regulations. Contact PerkinElmer at the website listed below for information
specific to PerkinElmer products.
Website:
www.perkinelmer.com/WEEE
Europe: follow the link provided above to access instructions on WEEE handling specific to different European countries
Customer Care USA: call 1-800-762-4000
Customer Care Rest of the World: call ([phone]
Products from other manufacturers may also form a part of your PerkinElmer system. These other producers are
directly responsible for the collection and processing of their own waste products under the terms of the WEEE
Directive. Please contact these producers directly before discarding any of their products.
Consult the PerkinElmer web site (above) for producer names and web addresses.
Panthera-Puncher™ 9 Instrument Manual
WEEE Instructions for PerkinElmer Products
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Warranty
The enclosed instrument comes with a limited warranty (the “Warranty”) from Wallac Oy (“Wallac”), a PerkinElmer
company. This is only a summary of the warranty on the enclosed instrument and shall not be deemed to alter or
amend the terms of the Warranty. Consult the terms and conditions, and rental or purchase agreement for a full
explanation of the Warranty.
In general, for a period of twelve (12) months from the date of installation, or fifteen (15) months from the date of
shipment (the “Instrument Warranty Period”), whichever comes earlier, Wallac warrants that this instrument is free
from defects in materials and workmanship.
During the Instrument Warranty Period, Wallac will provide parts and labor to repair defects in materials and
workmanship.
Note: The warranty on this instrument does not cover required Periodic Maintenance (“PM”), if any, the cost
and expense of which must be borne by the purchaser or renter. Failure to perform required PM shall void the
Warranty. PerkinElmer and authorized representatives are available to perform PM. Please contact your PerkinElmer
representative for additional information on PM.
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Warranty
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Warranty
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