PerkinElmer chemagic 360-D User manual

2024-0010 INSTRUMENT MANUAL
chemagic 360-D

Contents
General information...................................................................................1
Changes from previous manual version....................................................................................................................... 1
Trademarks..................................................................................................................................................................... 1
Intended purpose...........................................................................................................................................................2
Table of symbols............................................................................................................................................................. 2
Principles of operation...................................................................................................................................................3
Safety information..................................................................................... 4
Conventions.................................................................................................................................................................... 4
Warnings and precautions.............................................................................................................................................4
Electrical safety precautions.............................................................................................................................5
Biological safety precautions............................................................................................................................5
Computer precautions...................................................................................................................................... 5
Electromagnetic information and precautions................................................................................................5
Safety when using the equipment................................................................................................................... 6
Notice regarding serious incidents............................................................................................................................... 6
Installation and calibration....................................................................... 7
The chemagic Software..............................................................................8
Installing the chemagic Software..................................................................................................................................8
Starting the chemagic Software.................................................................................................................................... 8
Logging into the system................................................................................................................................................ 8
Login and Rod Head Selection.......................................................................................................................................9
The main program window............................................................................................................................................9
Loading and unloading the chemagic 360-D instrument with racks and/or consumables.....................................10
Switching off procedure...............................................................................................................................................11
Starting a protocol with the chemagic 12 Rod Head.............................. 12
Running a protocol with the chemagic Dispenser installed...................................................................................... 12
Running a protocol without the chemagic Dispenser installed.................................................................................14
Entering Sample IDs (chemagic 12 Rod Head)...........................................................................................................14
Reading IDs from a file.................................................................................................................................................16
Entering Elution IDs..................................................................................................................................................... 16
Assigning IDs to the Tube Racks..................................................................................................................................17
Starting the Isolation Procedure................................................................................................................................. 18
Starting a protocol with the chemagic 24 Rod Head.............................. 21
Running a protocol with the chemagic Dispenser installed...................................................................................... 21
Running a protocol without the chemagic Dispenser installed.................................................................................24
Entering Sample IDs (chemagic 24 Rod Head)...........................................................................................................24
Reading IDs from a file.................................................................................................................................................25
Entering Elution IDs..................................................................................................................................................... 25
Assigning IDs to the Plates or Tube Racks.................................................................................................................. 26
Starting the Isolation Procedure................................................................................................................................. 26
Starting a protocol with the chemagic 96 Rod Head.............................. 29
Running a protocol with the chemagic Dispenser installed...................................................................................... 29
Running a protocol without the chemagic Dispenser installed.................................................................................31
Entering Sample IDs (chemagic 96 Rod Head)...........................................................................................................31
Reading IDs from a File................................................................................................................................................32
i

Entering Elution IDs..................................................................................................................................................... 32
Assigning IDs to the Plates.......................................................................................................................................... 33
Starting the Isolation Procedure................................................................................................................................. 34
System Settings........................................................................................ 36
Edit user settings..........................................................................................................................................................37
Display Log Files........................................................................................................................................................... 38
Service and maintenance.........................................................................40
Cleaning of the chemagic Dispenser...........................................................................................................................40
Displaying the version number of the chemagic Software........................................................................................40
Changing the chemagic Rod Heads............................................................................................................................ 41
End-user maintenance and controls........................................................................................................................... 41
Checking and priming of the dispenser manifolds.................................................................................................... 42
Cleaning and disinfection of the chemagic 360-D instrument.................................................................................. 42
Cleaning of the chemagic Rod Heads......................................................................................................................... 42
Cleaning of the drop cover.......................................................................................................................................... 43
Moving the instrument................................................................................................................................................ 43
Specifications............................................................................................44
Technical specifications................................................................................................................................................44
Performance specifications......................................................................................................................................... 44
Environmental conditions............................................................................................................................................44
Operator........................................................................................................................................................................44
Error messages......................................................................................... 45
Troubleshooting....................................................................................... 52
Warranty................................................................................................... 53
WEEE instructions for PerkinElmer products.......................................... 54
Index......................................................................................................... 55
ii

General information
The chemagic 360-D system can be used with broad variety of sample material and sample volumes.
Figure 1: Overview of the chemagic 360-D instrument and its main components
1. panel with monitor and power switch
2. chemagic Rod Head
3. x-axis (sample carrier)
4. z-axis
5. electromagnet
6. drop cover
7. chemagic dispenser
8. PC
9. electronic cabinet
Changes from previous manual version
Changes made to this manual are marked with underlined text.
Trademarks
Copyright © 2017-2022, PerkinElmer, Inc. All rights reserved. PerkinElmer®, Chemagen®, and chemagic 360-D® are
registered trademarks of PerkinElmer, Inc.
All other trademarks are the property of their respective owners.
chemagic 360-D
General information
1

Intended purpose
The chemagic 360-D is an IVD instrument intended to be used for DNA and RNA extraction. The instrument is
automated and intended to be used by trained laboratory personnel.
The instrument can be used in combination with an IVD assay if the instrument is listed as a compatible device in
the instructions for use of that particular assay. The function, specific disorder, condition, risk factor to be identified,
the product's quantitative and qualitative properties, the specimen type, and the testing population are based on and
described within the intended purpose of the applicable assay.
Table of symbols
Symbol Description
CE conformity marking
Manufacturer
Date of manufacture
Biological risks
Powerful electromagnet included
Hot surface
Caution, consult instructions for use
Persons wearing a pacemaker must keep a safe distance
of at least two meters from the instrument
In vitro diagnostic medical device
Catalogue number
chemagic 360-D
General information
2

Symbol Description
Serial number
Consult instructions for use
Certificate from SGS testing laboratory
This way up
Fragile, handle with care
Keep dry
WEEE, follow local guidelines when disposing of the
instrument
Principles of operation
The instrument is used in combination with various chemagic Kits delivering high yield of pure DNA/RNA. Protocols can
be added to the system by loading the appropriate protocol in to the PC controlling the instrument.
The magnetic separation is achieved by metal rods, magnetized by an electromagnet. Resuspension of once separated
magnetic particles in to liquid is accomplished by rotation of demagnetized metal rods.
chemagic 360-D
General information
3

Safety information
This section describes the main safety precautions (electrical, mechanical and biological) to be taken while operating
the chemagic 360-D instrument as well as the main hazards involved. Please read this section very carefully before
using the chemagic 360-D instrument and ensure that you understand the described topics.
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
Caution: The chemagic 360-D instrument should only be used by adequately trained personnel.
Caution: Any interruption of power during an extraction run can cause the loss of your sample material. If this is
unacceptable, use an uninterruptible power supply (make sure the power supply can provide the required overall
capacity).
Caution: When operating the chemagic 360-D instrument, always wear appropriate protective equipment,
consisting of a laboratory coat, protective gloves and safety glasses. Do not touch the lab ware with unprotected
hands to avoid direct contact with potentially hazardous substances and to prevent any cross contamination of the
hardware.
Caution: For a safe and reliable operation of the chemagic 360-D instrument, it is a prerequisite to follow the
cleaning and maintenance intervals as described in Service and maintenance on page 40. Do not use aggressive
cleaning agents such as acetone or hypochlorite solutions (or similar) to clean and disinfect the system.
Caution: The chemagic 360-D instrument includes a powerful electromagnet that is activated during the extraction
process.
Warning: Persons wearing a pacemaker must keep a safe distance of at least two meters from the instrument.
Warning: To build up and maintain a sufficient magnetic field the electromagnet is charged with a high electrical
current, which generates a significant amount of heat. Thus the magnet's housing can be very hot during and also
after operation. Do not touch it and do not cover the ventilation outlets of the system.
Caution: Always operate the system with the door closed. While the chemagic 360-D instrument is running do not
place your hands in the way of any moving part - keep your head and hands away from the deck, the magnet, the
chemagic Rod Heads and all other parts and areas of the system. Unless explicitly prompted, do not manipulate any
lab ware during a running extraction procedure.
Caution: Always use disposable sleeves according to the positions of your samples in extraction runs. Failure to do
so results in contamination of the system and will require immediate disinfection and cleaning of the instrument (see
section Cleaning and disinfection of the chemagic 360-D instrument on page 42).
Caution: Switch off the power during maintenance, service and cleaning of the chemagic 360-D instrument and
when the system is not used.
Caution: Never disable or override any safety measure of the system.
Caution: At the end of an extraction run and prior to setting up a new one, ensure that no disposable sleeves are left
on the metal rods of the chemagic Rod Head.
chemagic 360-D
Safety information
4

Electrical safety precautions
Caution: Before opening the electric cabinet of the chemagic 360-D instrument or removing any electrical or
mechanical parts, the instrument has to be switched off and disconnected from the electrical power supply.
Warning: All servicing of the instrument is to be performed by qualified PerkinElmer personnel.
Note: The instrument must be connected to a grounded electrical outlet.
Note: Ensure clear access to the rear of the instrument so that the power cord may be disconnected easily if needed.
Biological safety precautions
Caution: The chemagic 360-D instrument maybe used with a broad variety of sample materials. These can include
potentially biohazardous substances. If the chemagic 360-D instrument becomes contaminated with any sample
material it has to be disinfected and cleaned as soon as possible. Please follow the instructions in Cleaning and
disinfection of the chemagic 360-D instrument on page 42.
Caution: Treat all samples and waste as potentially infectious. Wear protective clothing and gloves and use safety
glasses. For instructions on reagent handling, refer to the corresponding kit insert. Treat all waste as potentially
infectious and dispose of it according to your local guidelines.
Computer precautions
Caution: Only the PC that is delivered with the chemagic 360-D instrument including the original chemagic Software
may be used to control the chemagic 360-D instrument. The chemagic Software also needs to be licensed for the use
in combination with a liquid handling system. Extraction protocols must not be changed by operators or anyone else
who has not been trained and authorized in these matters by PerkinElmer.
Caution: Power saving and screensaver functions are configured to be disabled on the PC controlling the chemagic
360-D instrument and they must remain so. If enabled, one of these functions may activate while the instrument is
running, which will result in the interruption of the instrument control, leading to a run failure.
Electromagnetic information and precautions
The chemagic 360-D instrument electromagnetic compatibility complies with IEC/EN 61326-2-6.
This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio
interference, in which case, you may need to take measures to mitigate the interference.
The electromagnetic environment should be evaluated prior to operation of the device.
Caution: Biological hazard. Treat all samples and waste as if they were infectious. Wear adequate protective gloves
and clothing and use safety glasses
Warning: Moving parts. Keep your hands, head and other body parts away from the moving parts while the
instrument is in operation.
Warning: Electrical current. Do not touch electrical parts, cables or wires while the instrument is powered up.
Warning: Hot parts. Do not touch hot parts in the instrument. Give them time to cool down before you handle them.
Warning: Strong magnetic field.
Warning: Persons wearing a pacemaker must keep a safe distance of at least two meters from the instrument.
Caution: Hot surface. Do not touch. Allow for cooling before service.
chemagic 360-D
Safety information
5

Safety when using the equipment
Caution: When operating inside the instrument, wear safety goggles, protective clothing, and gloves.
Warning: Touching hot parts may lead to severe injuries.
Warning: Serious injury may occur if body parts get pinched between moving parts.
Caution: When power is switched on, do not open the instrument's cover.
Caution: The instrument is very heavy. Do not attempt to lift the instrument.
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]
chemagic 360-D
Safety information
6

Installation and calibration
The chemagic 360-D instrument installation and calibration is only to be performed by personnel trained and
authorized by PerkinElmer.
Note: Instrument needs to be connected to grounded electrical outlet.
Note: The instrument needs to placed on clean, dry, level, and stable surface able to bear the weight of 140kg.
Note: Ensure clear access to the rear of the instrument so that the power cord may be cdisconnected easily if needed.
Note: The instrument should not be positioned within two meters of instruments that may be effected by magnetic
field.
chemagic 360-D
Installation and calibration
7

The chemagic Software
The chemagic Software offers advanced features for quality assurance purposes. To have these functions available
you have to obtain a license key that has to be entered in the "License for Enhanced Functions" area of the System
Settings.
This manual describes the setup and use of the chemagic Software with Enhanced Functions enabled. For instructions
on using the chemagic Software without features please refer to the respective manual.
Installing the chemagic Software
The chemagic 360-D system is delivered with a PC on which the chemagic Software has been preinstalled.
By default a folder "chemagic_360" exists in the root directory of the operating system. In this folder a file
"ChemagicModule_360.exe must be present. This is the executable for the chemagic Software. In addition the
files "Parameter_S1.msm", "Settings_S1.msm" and "User_Settings_S1.msm" have to be in the same folder. Three
subdirectories in the chemagic 360-D folder are needed for the software to run: "Logfiles, Protocols and Parameter".
Starting the chemagic Software
Before you start ensure that all software components are installed according to the instructions given in the previous
section of this manual.
Switch on the chemagic 360-D before double-clicking the desktop icon to start the chemagic Software. A splash
screen appears, giving information about the software version and the type of license. This window will disappear after
5 seconds or on clicking the OK button.
Figure 2: Splash screen with software information
Logging into the system
Access to the chemagic 360-D instrument user interface is restricted to users with login credentials. The credentials are
system-wide.
Important: The temporary password provided by your administrator cannot be used to log into the system. Before
logging in for the first time, you need to log into the LifeCycle program using the temporary password provided by the
administrator and then create your own password. After creating your own password, you can log into the chemagic
360-D system.
chemagic 360-D
The chemagic Software
8

Login and Rod Head Selection
Subsequent to the splash screen a login window will open. After selecting your user name from the drop-down list,
information about your user level is shown and you can enter your password. Clicking the OK button or hitting Enter
opens a window for selection of the chemagic Rod Head of your choice.
Figure 3: Login screen and Rod Head selection
Just click on the chemagic Rod Head you want to use and the Main Program Window will open. In case you have
already installed a chemagic Rod Head before starting the software it will be detected automatically and the selection
menu will be skipped.
The main program window
Subsequent to the selection/detection of the chemagic Rod Head the main program window will open and both
axes of the chemagic 360-D instrument will move into their reference positions. If this process finishes without any
complications, the red lights in the "Instrument Status" panel next to the X- and Z-axis become green and the text
changes from "Failure" to "OK" (A). In case of any errors a message box will appear.
The main window is separated into 4 different panels:
chemagic 360-D
The chemagic Software
9

Figure 4: The main program window
Panel A shows the status of the instrument and its single components. Bright green lights indicate active components,
dark green lights indicate inactive components and a red light shows a possible error situation or - in case of the axes
- indicates a running calibration process. The lower part of [Panel A] gives information about the position of the axes,
the installed chemagic Rod Head, the currently logged in user and the availability of the enhanced functions.
Panel B contains a drop-down menu for the selection of the protocols - each protocol is stored in a single file that can
be found in the "Protocols" folder within the installation directory.
For your information: only protocols that are configured for the use with the selected chemagic Rod Head will be
listed.
Panel C shows the status of the currently running protocol - e.g. it monitors the elapsed time and the time remaining
for the run. In the event of using "external steps" the computer monitors the estimated time until the next external
step has to be carried out. During external steps the chemagic 360-D instrument will pause the running protocol e.g.
allowing you to access the rack carrier to add a buffer, take out a rack for a heating step etc. Some protocols require an
external step.
Panel D comprises of different buttons to start an automated isolation protocol, to edit the Sample IDs, to access the
system settings, to turn the table in the tracking system or control the drop cover. To exit the chemagic Software click
the Close Program button.
Loading and unloading the chemagic 360-D instrument with racks
and/or consumables
Loading: For the automated extraction protocol racks for disposable tips and reaction tubes and/or deep well plates
need to be placed on the tracking system (x-axis, Figure 1: Overview of the chemagic 360-D instrument and its main
components on page 1). The racks must be loaded to the tracking system before starting the protocol run if the
enhanced functions are not activated or if the sample and elution IDs are read from a file. When the enhanced
functions are activated, the loading sequence and the positions are given by explicit commands of the chemagic
Software according to the selected protocol. Open the front door and follow the single command step given by the
chemagic Software.
chemagic 360-D
The chemagic Software
10

Unloading: After the finished extraction protocol the before placed items need to be removed from the tracking system.
Open the door and press the Turn Table button to have access to any position on the tracking system (Figure 4: The
main program window on page 10) for unloading.
Caution: Do not turn the x-axis by hand. Doing so may damage the equipment.
Switching off procedure
To power the instrument down, first close the software, then switch off the PC, and then switch off the instrument itself.
chemagic 360-D
The chemagic Software
11

Starting a protocol with the chemagic 12 Rod Head
With the chemagic 12 Rod Head installed or after selecting the chemagic 12 Rod Head during the startup of the
software a warning window will open reminding you to ensure that the correct drop cover is installed. As the tips will
automatically be removed during the isolation process it is absolutely necessary to have the right drop cover for the
chemagic 12 Rod Head installed.
Figure 5: Reminder for installing the Drop Cover
To run an automated isolation procedure, select the protocol of your choice from the drop-down menu from the Main
Program Window and click the green Insert IDs button.
Figure 6: Instructions for connecting the buers
Depending on the individual configuration of your chemagic 360-D system, you will have different setup steps to
follow:
Running a protocol with the chemagic Dispenser installed
Note: If you do not have the chemagic Dispenser installed, please refer to section Running a protocol without the
chemagic Dispenser installed on page 14.
Clicking the Insert IDs button opens an information window with instructions for connecting the buffers to the
different valves of the chemagic Dispenser.
chemagic 360-D
Starting a protocol with the chemagic 12 Rod Head
12

chemagic 360-D
Starting a protocol with the chemagic 12 Rod Head
13

Figure 7: Setting up the chemagic Dispenser for the chemagic 12 Rod Head
Please read these instructions carefully and make sure that all buffer containers contain sufficient amounts of buffer.
To continue click the OK button. A new window opens, allowing you to select the sample positions to be automatically
filled by the chemagic Dispenser (A). By default all 12 tube positions are preselected and therefore green.
If you have less than 12 samples, you can select the exact number of samples from the drop-down menu (B). Please
keep in mind that due to its design the chemagic Dispenser always fills entire rows i.e. manifolds of 4. Positions
without samples in partially filled rows will be marked in orange to indicate that those positions will be filled with
buffer. Make sure to place empty tubes into those positions to avoid any spillage.
After entering the sample positions for automated buffer dispensing click OK and a new input window opens asking
you to enter the lot number of the kit to be used during the isolation run. By default this window shows the last entered
kit lot number. The easiest way to enter the data is by using the barcode scanner, but you can also enter the number
manually. After entering the lot number of the kit and confirming with OK a new window for the registration of your
samples will open.
A detailed instruction of how to register your samples is given in section Entering Sample IDs (chemagic 12 Rod Head)
on page 14, so please continue reading there.
Running a protocol without the chemagic Dispenser installed
Without the chemagic Dispenser you have to pipette the buffers manually into their respective tubes on the different
racks. Please refer to the individual protocol of the kit you are using for detailed information about the pipetting
scheme.
After clicking the Insert IDs button you can enter the lot number of the kit before you can continue with registering the
IDs of your samples (see section below).
Entering Sample IDs (chemagic 12 Rod Head)
The chemagic Software offers a feature to register the IDs of your samples and their respective eluates which will be
stored in the log files generated during the isolation process. In addition you can register the IDs of the racks used for
buffers, eluates and tips.
chemagic 360-D
Starting a protocol with the chemagic 12 Rod Head
14

Figure 8: Entering the Sample IDs (chemagic 12 Rod Head)
The process of sample registration is started subsequently to entering the lot number of the kit to be used. A new
window which is separated into 4 different areas will open.
Panel A gives a schematic overview of the rack and allows you to allocate the positions of your samples.
Panel B comprises of 3 buttons to cancel the protocol, read the Sample IDs from a file and an OK button to finish the
registration process.
Panel C gives a schematic overview of the elution rack and the positions of the eluates and allows assigning IDs to the
elution tubes.
Panel D shows the positions of the racks containing the tips and tubes for samples , buffers, eluates and magnetic
beads on the Tracking System x-axis and allows you to assign individual IDs to them.
chemagic 360-D
Starting a protocol with the chemagic 12 Rod Head
15

Figure 9: Entering the Sample IDs
To enter the Sample IDs click on the sample position you want to start with. A new window will open with the sample
position preselected (A). Alternatively you can click on the Enter Sample IDs button which will open the window
mentioned above, but without preselection of the first sample position.
You can easily enter your Sample IDs with the barcode scanner or by typing them into the provided input field (B).
After entering the Sample ID (and clicking ID entered or hitting Enter for the manual input) the color changes from
red to green and the ID appears in the adjacent text field. The next sample position is automatically selected - either
horizontally or vertically - depending on the settings. Repeat this procedure until all Sample IDs are entered.
Once the registration of the samples is completed you can print the list (C) as a template for pipetting or for archiving
purposes. Click OK to return to the previous screen.
Reading IDs from a file
Instead of entering the Sample IDs one by one you can prepare the sample sheets in advance and load them from a file
into the program. The file has to be saved in the *.txt format and the Sample IDs have to be entered one per row. To
read the IDs from a file click the Read IDs from File button (Figure 8: Entering the Sample IDs (chemagic 12 Rod Head)
on page 15). A dialogue window will open allowing you to select the file you have prepared earlier. After the selection
of the file a window opens from which you can directly start the isolation procedure (Figure 12: Final instructions before
starting the run on page 18).
Entering Elution IDs
After entering the Sample IDs, continue by clicking the Finished button. A small window opens and you can choose
whether the Elution IDs are identical to the Sample IDs.
chemagic 360-D
Starting a protocol with the chemagic 12 Rod Head
16