PerkinElmer Migele User manual

2118-0010 User Manual
Migele®
Gel Electrophoresis Unit

Contents
General information...................................................................................1
Changes from previous manual version....................................................................................................................... 1
Trademarks..................................................................................................................................................................... 1
Rx only.............................................................................................................................................................................1
Intended purpose...........................................................................................................................................................1
Table of symbols............................................................................................................................................................. 1
Safety information..................................................................................... 3
Conventions.................................................................................................................................................................... 3
Warnings and precautions.............................................................................................................................................3
Notice regarding serious incidents............................................................................................................................... 3
Contents of the package............................................................................ 5
Materials required but not provided with this package...............................................................................................5
Instrument overview................................................................................. 6
Description of parts....................................................................................8
Components in the system............................................................................................................................................ 8
Cooling plate...................................................................................................................................................................8
Lid with electrodes......................................................................................................................................................... 9
Installation............................................................................................... 11
Connecting the cooling system (single unit).............................................................................................................. 13
Levelling the instrument..............................................................................................................................................14
Setting the lid ...............................................................................................................................................................17
Connecting the power supply......................................................................................................................................17
Connecting the cooling system (multiple units).........................................................................................................18
Stacking several GEUs ................................................................................................................................................. 18
Operation..................................................................................................21
Cooler setting............................................................................................................................................................... 21
Power setting................................................................................................................................................................21
Electrode setting...........................................................................................................................................................21
Placing gel.....................................................................................................................................................................22
Closing the unit............................................................................................................................................................ 22
Starting the run............................................................................................................................................................ 23
Ending the run..............................................................................................................................................................23
IQ/OQ for Migele Gel Electrophoresis Unit............................................. 25
Maintenance.............................................................................................26
Daily maintenance........................................................................................................................................................26
Cleaning the cooling plate..............................................................................................................................26
Lid.....................................................................................................................................................................26
Electrodes........................................................................................................................................................ 27
Monthly maintenance.................................................................................................................................................. 27
Replacing the lid .............................................................................................................................................27
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Decontamination information.....................................................................................................................................28
Technical specifications........................................................................... 29
Troubleshooting....................................................................................... 30
Contact addresses.................................................................................... 32
WEEE Instructions for PerkinElmer Products..........................................33
Warranty................................................................................................... 34
Index......................................................................................................... 35
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General information
This equipment must be installed and used in accordance with the manufacturer's recommendations.
Failure to follow these instructions may invalidate your warranty and/or impair the safe functioning of your equipment.
Changes from previous manual version
Changes made to this manual are marked with underlined text.
Trademarks
Copyright © 2018-2022, PerkinElmer, Inc. All rights reserved.
PerkinElmer® and Migele® are registered trademarks of PerkinElmer, Inc. All other trademarks are the property of
their respective owners.
Rx only
Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner (applicable only to the
United States and its territories).
Intended purpose
The Migele® Gel Electrophoresis Unit is intended to be used together with the RESOLVE™ Hemoglobin Kit in screening
neonatal hemoglobinopathies and as an aid in the diagnosis of adult hemobloginopathies. It is used together with
a power supply and a circulating water bath for qualitative separation of hemoglobin variants in whole blood, cord
blood or dried blood spot specimen applied in the isoelectric focusing (IEF) gels. The Migele Gel Electrophoresis Unit is
intended to be used by trained laboratory personnel.
Table of symbols
The following table contains symbols that identify important information and alert you to hazards. These symbols can
appear in this manual, on the product or on its package.
Symbol Description
CE conformity marking self-declaration
Manufacturer
Date of manufacture
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
General information
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Symbol Description
(Label)
Caution, consult instructions for use
(Instrument)
Consult instructions for use
In vitro diagnostic medical device
Catalogue number
Serial number
This way up
Fragile, handle with care
Keep dry
Certification mark from testing laboratory
Follow national guidelines when disposing of the
equipment
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
General information
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Safety information
Read the instructions of this manual carefully before using the instrument. The instrument can only be used
by personnel adequately trained in isoelectric gel electrophoresis. The provided instructions should be followed
accordingly.
For continued protection against electrical hazards, this device must be used according to the manufacturer's
instructions.
The instrument is designed for indoor use only. The instrument is used under the specified operating conditions,
temperature +18 - +30 °C and relative humidity below 80 %.
The instrument cannot be used in high humidity (above 80% RH). When the instrument is delivered from a cool
environment to a warm environment, it is important that the instrument is equilibrated to ambient temperature before
operating. Ensure that the operating environment and laboratory practice will not cause excess condensation.
Do not store liquids on top of the instrument, and ensure that the environment of the instrument is clean and dry.
Wear suitable protective clothing, gloves and eye protection. All waste should be disposed of in accordance with local
regulations.
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: This instrument requires high voltage in operation.
Warning: Do not attach the Migele Gel Electrophoresis Unit to the portable power supply if you identify any damage
on either of them. Also monitor wires. If you identify any damage, do not use the wires.
Warning: Always disconnect the Migele Gel Electrophoresis Unit from the external power supply before cleaning or
servicing the unit.
Warning: Only use water as a coolant in the Circulating Water Bath.
Warning: The cooling plate's pressure should not exceed 0.5 bar.
Warning: To ensure electrical safety, only use cables and adapters provided with the GEU.
Caution: Maximum voltage (2000 V), current (0.1 A), and power (100 W), should not be exceeded.
Caution: Always connect the cables to the instrument first and then to the power supply before turning the power
supply on.
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
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
Safety information
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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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Safety information
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Contents of the package
• Migele Gel Electrophoresis Unit (2118-0010)
• Migele Gel Electrophoresis Unit User Manual (2118-9010)
• Electric safety routine test report
•Quality control certificate
• Installation kit (61012727)
Materials required but not provided with this package
The following items are required and are available from Wallac Oy or PerkinElmer, Inc. and its distributors:
•Programmable Power Supply (CWP-2000)
• Circulating Water Bath (1023-0010, 1023-0020)
• Resolve Hemoglobin Kit (FR-9120), FR-9360), FR-9400)
• Resolve Hb FASC Control Kit (3412-0010).
In addition, the following installation tools are required but not provided with this package:
•16 mm wrench for attaching tubing to Circulating Water Bath
• screw driver (slot head) for attaching tubing to Circulating Water Bath.
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Contents of the package
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Instrument overview
The Migele Gel Electrophoresis Unit is used together with the programmable power supply (CWP-2000 or equivalent)
and the circulating water bath (1023-0010, 1023-0020) or equivalent. The instrument can run gels of different sizes. For
example, 240 × 203 mm (FR-9400, FR-9360) and 203 × 127 mm (FR-9120).
Additional equipment required but not supplied with the instrument:
• Programmable power supply CWP-2000 or equivalent
Voltage at least 1500 V
Power at least 80 W
Current at least 200 mA
• Circulating water bath (1023-0010, 1023-0020) or equivalent
Temperature setting +10 - +15 °C
Flow rate at least 5 l/min
Maximum pressure below 0.5 bar
Cooling power at least 160 W at +10 - +15 °C
Figure 1: Migele Gel Electrophoresis Unit
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
Instrument overview
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Figure 2: Migele Gel Electrophoresis Unit connections
Water tubing is shown on the right, and the power supply connections are shown on the left part of the instrument.
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Instrument overview
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Description of parts
Two to four 2118-0010 Migele Gel Electrophoresis Units can be attached to series with one circulating water bath (for
example, 1023-0010, 1023-0020 or equivalent).
Two to four 2118-0010 Migele Gel Electrophoresis Units can be attached to one programmable power supply (e.g.
CWP-2000 or equivalent) depending on the model of the power supply.
Components in the system
This section describes the components in the Migele Gel Electrophoresis Unit system.
Cooling plate
Ceramic (aluminium oxide) cooling plate measures 260 x 260 mm, supports the gel, and provides uniform temperature
control. Aluminium oxide is an excellent heat conductor and electrical insulating material.
To facilitate the correct positioning of electrophoresis gels, the surface of the cooling plate is screened with a grid
measuring 240 x 240 mm.
Figure 3: Grid
Warning: Do not use the Migele Gel Electrophoresis Unit at above 2000 V.
Warning: Use water in the circulating water bath. The maximum pressure is 0.5 bar.
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
Description of parts
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Lid with electrodes
The lid contains a fixed cathode electrode in the middle and two anodes at both sides of the cathode. Anode positions
can be modified and positioned correctly in accordance with the grid and gel requirements.
The instrument can be run with two or one anode electrode modes. The lid contains three electrodes, but one anode
electrode can be disabled with the levers if not in use. See the pictures below for more details.
Figure 4: Disabling anode electrode with the levers
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Description of parts
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Figure 5: Electrodes seen through top window. Cathode positioned in the middle and two anodes at the both sides of
the cathode.
The two anode electrodes can be adjusted by clamping nuts located at each end of the electrode. The distance from the
cathode electrode can be varied from 6 cm to 10 cm
One of the anode electrodes can be lifted to remove it from operation, if the instrument requires to be operated in two
electrode mode (small gel, e.g. FR-9120 kit).
The lid can be left in the "idle" position to protect the electrodes and ventilate the cooling plate.
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Description of parts
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Installation
For all products, check the unassembled parts against the Packing List for the respective product to ensure that all
items have been included.
Tools needed (included)
• 10 mm wrench for feet adjustment
• 3 mm hex key for lid replacement
Tools needed (not included)
• 16 mm wrench for attaching tubing to circulating water bath
• screw driver (slot head) for attaching tubing to circulating water bath
Figure 6: Installation kit contents
For IQ/OQ, the FR-9120/FR-9400/FR-9360 RESOLVE Hemoglobin kit and the 3412-0010 Resolve Hb FASC Control kit or
equivalent controls are needed (not included). Use the same kit and gel that you are planning to use for the samples.
As the Migele Gel Electrophoresis Unit is intended to control the gel processing condition, avoid warm exhaust air
from other instruments when placing the instrument. Leave sufficient space behind the instrument for tubing and
ventilation.
Remove the transport protection from the top of the lid and the protective plastic sheet from the cooling plate. For
more details, see the pictures below.
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
Installation
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Figure 7: Removing transport protection
Figure 8: Removing protective plastic sheet
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Installation
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Connecting the cooling system (single unit)
The Migele Gel Electrophoresis Unit contains connectors on both inlet and outlet tubing (male and female) (see Figure
9: Connecting tubing on page 13). The package contains tubing with the corresponding connectors to be used with
the circulating water bath. Install the connectorsto the circulating water bath using the clamp supplied with the water
bath. Ensure that direction of the flow is correct (circulator out to unit in) (see Figure 10: Tubing for the water bath on
page 14).
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
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Figure 9: Connecting tubing
To lock the connectors, insert the male connector into the female until it clicks. Used connectors are non-spill type (to
allow disconnection without leaking).
Figure 10: Tubing for the water bath
For efficient cooling, it is vital to remove any air from the cooling plate. Switch on and leave the circulator running until
all the air in the connecting tubing is removed, and this may take several minutes. Then refill the circulator reservoir
with cooling liquid (water)
Caution: Ensure that tubing is not bent too severely (kinked). This blocks the coolant flow, and gel run may be
affected.
Note: Using HI setting in the circulator pump speed is recommended.
Levelling the instrument
When the Migele Gel Electrophoresis Unit is in the final bench location, place a spirit level on the cooling plate (see
Figure 11: Spirit level to monitor that the instrument is levelled correctly on page 15) (in inward position) and adjust
the unit foot until the unit is levelled (see Figure 12: Adjust the unit with the levelling feet on page 15).
2118-0010 - Migele® Gel Electrophoresis Unit User Manual
Installation
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Figure 11: Spirit level to monitor that the instrument is levelled correctly
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Installation
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Figure 12: Adjust the unit with the levelling feet
Use 10 mm wrench to tighten the nut to lock the foot position.
You can turn the device on the side to get better access to loosen the locking nuts. Adjust first the back feet to get the
device on level sideways. Then adjust front feet to get the device on level front to back. Then adjust the other front feet
to get the device to sit firmly on the table. You can turn the device on the side to get better access to tighten the locking
nuts.
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