ThermoFisher Scientific KingFisher Apex Dx User manual

For Research Use Only. Not for use in diagnostic procedures.
KingFisher™Apex Dx Purification Instrument
User Guide | Research Use Only Workflow
Catalog NumberB5400900P
Publication Number MAN0029203
Revision A.0

Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256
For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition.
Revision history:Pub.No. MAN0029203
Revision Date Description
A.0 12 July 2023 New document for KingFisher™Apex Dx Purification Instrument.
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE
LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR
ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these
products, you accept the terms and conditions of all applicable Limited Use Label Licenses.
NOTICE TO PURCHASER: DISCLAIMER OF LICENSE: Purchase of this software product alone does not imply any license under any
process, instrument or other apparatus, system, composition, reagent or kit rights under patent claims owned or otherwise controlled by
Thermo Fisher Scientific, either expressly, or by estoppel.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
©2023 Thermo Fisher Scientific Inc. All rights reserved.

Contents
■CHAPTER1Productinformation .................................................. 6
Product description ............................................................. 6
Orderingconfigurations .......................................................... 6
Product overview ............................................................... 7
Instrument overview ......................................................... 7
User interface overview ...................................................... 9
Upon receiving thedevice ....................................................... 10
Precautions for use ........................................................ 11
Magneticheads ........................................................... 11
Guidelines for unpacking theinstrument ...................................... 12
First time instrumentsetup ...................................................... 12
Install the UV lightbulbs .................................................... 13
Power on theinstrument .................................................... 13
Log in to KingFisher™Apex Dx Purification Instrument for first time
as administrator ......................................................... 13
Install heatingblock ........................................................ 14
Install magnetichead ...................................................... 15
Instrument components and plasticcompatibility .................................. 16
Heating block ............................................................. 16
Magneticheads ........................................................... 18
Tip comb and platecompatibility ............................................ 20
General login functionalitydescription ............................................ 21
About Thermo Fisher™ConnectPlatform .......................................... 21
Create a Connectaccount .................................................. 22
Connect the instrument to the internet ........................................ 22
Create a PINnumber ....................................................... 22
Generate a link code from theinstrument ..................................... 22
Add an instrument to your Connectaccount .................................. 23
Set up new administrator ................................................... 23
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 3

■CHAPTER2Methods ............................................................. 24
Protocol access overview ....................................................... 24
Download protocols through theinstrument ................................... 24
Download protocols from Connect ........................................... 24
Change password .............................................................. 25
Create, edit, or deleteusers ..................................................... 25
Access RUO protocols ......................................................... 25
Run purificationkit ............................................................. 26
Abortrun ..................................................................... 28
Turn o theinstrument .......................................................... 28
Change heat block/magnetichead ............................................... 28
Unload heatingblock ....................................................... 29
Unload magnetichead ..................................................... 29
■CHAPTER3Softwareapplications .............................................. 31
About the user interface ........................................................ 31
Users and roles ............................................................ 31
Diomni™and SAE integration ................................................ 31
RUO mode(local) .......................................................... 33
Run the instrument with computer control .................................... 33
Overview of user interface controls ............................................... 34
Home screen .............................................................. 34
Protocol editor screen ...................................................... 37
Protocol library screen ...................................................... 38
Run history overview ....................................................... 38
Import/Export overview ..................................................... 39
Settings screen ............................................................ 41
Usersettings .............................................................. 42
Protocolsettings .......................................................... 43
Soundsettings ............................................................ 44
About .................................................................... 44
Instrument screen ......................................................... 46
Protocol overview .......................................................... 47
Telemetrydata ............................................................ 47
■APPENDIXATroubleshooting .................................................... 49
Troubleshootingguide .......................................................... 49
Contents
4KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

■APPENDIXBMaintenance ....................................................... 52
Regular and preventive maintenance ............................................. 52
Store transportlock ............................................................ 52
Magnetic head maintenance ..................................................... 53
Decontamination procedure ..................................................... 53
Decontaminateinstrument .................................................. 53
UV decontamination procedure .................................................. 54
UV treat processchamber .................................................. 54
Prepare instrument for transport ................................................. 54
Refit the transportlock ..................................................... 54
■APPENDIXCSpecifications ...................................................... 56
Physicaldimensions ............................................................ 56
Instrumentspecifications ....................................................... 56
Performancespecifications ...................................................... 57
■APPENDIXDOrderinginformation .............................................. 59
Orderingconfigurations ......................................................... 59
■APPENDIXESafety ............................................................... 61
Safetycompliance ............................................................. 61
■APPENDIXFSymbols on thisinstrument ....................................... 62
Standard safetysymbols ........................................................ 62
■APPENDIXGElectromagnetic compatibility (EMC) standards ................ 63
EMCcompliance ............................................................... 63
Physical injury ................................................................. 64
Electricalsafety ................................................................ 64
Chemicalsafety ................................................................ 66
Biological hazardsafety ......................................................... 67
■APPENDIXHSeriousincidents .................................................. 68
■APPENDIXIDocumentation and support ....................................... 69
Customer and technical support ................................................. 69
Limited product warranty ........................................................ 69
Contents
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 5

Product information
Product description
The Thermo Scientific™KingFisher™Apex Dx Purification Instrument is intended for automated transfer
and processing of magnetic particles in a microplate format. The instrument utilizes magnetic heads
covered with a disposable, specially designed tip comb, and plates. The instrument functions without
any dispensing or aspiration parts or devices. Before the run, samples and reagents (including magnetic
particles) are dispensed into the plate according to research use only (RUO) protocols.
When the system is used when logged in locally, the user can work with RUO protocols in RUO mode.
RUO protocols can be created and customized with the instrument.
For the product information sheet on the magnetic heads or the quick reference card on instrument
installation see the following documents:
•KingFisher™Apex Dx Heads Product Information Sheet (Pub. No. MAN0029197)
•KingFisher™Apex Dx Purification Instrument Quick Reference (Pub. Part No. 100109527)
Ordering configurations
The KingFisher™Apex Dx Purification Instrument is intended to automate the process of isolation and
purification of nucleic acids, proteins and cells for RUO procedures in combination with a purification
kit.
Details Cat. no. Cat. no.
B5400910
Cat. no.
B5400920
Cat. no.
B5400930
Cat. no.
B5400940
Instrument
KingFisher™Apex Dx Purification Instrument B5400900P 1 1 1 1
Components of instrument
UV lamp N21447 2 2 2 2
3-mm flat-tip driver MLS 1 1 1 1
Heatings blocks
PCR Heating Block 24075910 1 — — —
96 Heating Block 24075920 1 1 1 —
96 Deep Well Heating Block 24075930 — 1 1 —
24 Deep Well Heating Block 24075940 — — — 1
1
6KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

(continued)
Details Cat. no. Cat. no.
B5400910
Cat. no.
B5400920
Cat. no.
B5400930
Cat. no.
B5400940
Magnetic heads
KingFisher™Apex Dx 96 PCR Head B24079910 1 — — —
KingFisher™Apex Dx 96 Combi Head B24079920 — 1 — —
KingFisher™Apex Dx 96 Deep Well Head B24079930 — — 1 —
KingFisher™Apex Dx 24 Combi Head B24079940 — — — 1
Product overview
Instrument overview
The KingFisher™Apex Dx Purification Instrument consists of a touch screen control and a process
chamber with lid to protect specimens and processing plates against environmental contamination.
Figure1KingFisher™Apex Dx Purification Instrument front view
1Front lid
2Touch screen
3On/o button
4USB port × 3 (Host)
Chapter1Product information
Product overview 1
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 7

1
346
5
2
Figure2KingFisher™Apex Dx Purification Instrument rear view
1Power switch
2Power inlet
3Ethernet/LAN port
4USB port (Host) × 2
5RS-232 serial port
6USB port (Device)
Internal layout
The process chamber of the KingFisher™Apex Dx Purification Instrument consists of a turntable with
eight plate stations. The loading position has an illuminated display, while the processing position is
situated over the heating block and underneath the processing head. There are two heating block
stations under the turntable (not shown on picture) that can be selected for applying to the processing
position.
The processing head consists of two vertically moving platforms—the magnetic head holder, and the
tip comb holder. The magnetic head holder is used to attach up to two magnetic heads composed of
24 or 96 magnetic rods, while the tip comb holder is used to hold plastic tip combs with 24 or 96 tips.
Chapter1Product information
Product overview
1
8KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

Figure3Process chamber layout
1Turntable with plate stations (1–8)
2Processing position
3Loading position
4Tip comb holder
5Magnetic head holder
6Shield plate
7Barcode reader
8UV light clip × 2
9UV light socket × 2
User interface overview
Symbol Function
Notifications screen (For more details, see “Home screen” on page34)
Swipe down from the top of the touch screen
Displays the following information:
•Notifications
•Internet status
•Storage devices
Chapter1Product information
Product overview 1
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 9

(continued)
Symbol Function
Home screen (For more details, see “Home screen” on page34)
Select Home
Gives access to the following items:
•Home
•Protocol editor
•Protocol library
•Run history
•Import/Export
•Settings
•Instrument
•User management
Settings screen (For more details, see “Settings screen” on page41)
Select Home4Settings
Gives access to the following items:
•Localization
•Protocols
•Sound
•Loading position display
•Connect
•Network share
•About
•Reset factory settings
•Troubleshoot
•View EULA
Instrument screen (For more details, see “Instrument screen” on page46)
Select Home4Settings
Gives access to the following items:
•Tools
•Magnets
•Heating blocks
Upon receiving the device
• Visually inspect the transport package, the instrument and the accessories for any damage
incurred during transit.
• If the carton has been damaged in transit, it is particularly important that you retain it for inspection
by the carrier in case there has also been damage to the instrument.
• Any damage claims must be filed with the carrier. Neither the manufacturer nor its agents can be
held responsible for any damage incurred in transit. Upon receipt of the carrier's inspection report,
arrangements will be made for repair or replacement.
Chapter1Product information
Upon receiving the device
1
10 KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

Precautions for use
CAUTION! PHYSICAL INJURY HAZARD. Do not remove the instrument cover. There are no
components inside the instrument that you can safely service yourself. If you suspect a problem,
contact technical support.
CAUTION! PHYSICAL INJURY HAZARD. The instrument weighs 56 kg (123 lbs) and requires at
least two people to lift. Use the proper precautions when lifting the instrument to avoid injury.
CAUTION! PHYSICAL INJURY HAZARD. During instrument operation, the heating block
temperature can reach 100°C. Allow it to cool to room temperature before handling.
CAUTION! Before using a cleaning or decontamination method other than those recommended by
Thermo Fisher Scientific, confirm with Thermo Fisher Scientific that the proposed method will not
damage the instrument. See “Decontaminate instrument” on page53.
Magnetic heads
WARNING! This product contains very strong permanent magnets. People wearing a pacemaker
or metallic prosthesis should not use this product. A pacemaker or prosthesis may be aected or
damaged if it comes in close contact with a strong magnetic field.
There are four kinds of interchangeable magnetic heads with corresponding disposable plastic tip
combs available for the instrument. The magnetic head holder has two positions that can be used to
hold dierent types of magnetic heads.
IMPORTANT! Keep magnetic heads away from each other and other magnets at all times. Clashing of
the magnets can cause serious damage to the magnets.
•Do not place the magnetic head on top of the instrument or on any metal surfaces.
•Do not use metal tools when handling magnetic heads.
•Do not place the magnetic head in close proximity to magnetic tapes, computer discs or other
magnetic storage systems, such as credit cards, as damage can occur due to the strong magnetic
field of the magnetic heads.
•Do not place the magnetic heads near a PC display, as this may cause damage to the display.
•When not in use, keep the magnetic heads in their respective storage boxes.
•For details on changing a magnetic head, see “Change heat block/magnetic head” on page28.
Chapter1Product information
Upon receiving the device 1
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 11

Guidelines for unpacking the instrument
• To prevent condensation, the instrument should be left in its protective, antistatic plastic wrapping
until the ambient temperature has been reached.
• Retain the original packaging and packing material for future transportation. The packaging is
designed to assure safe transport and minimize transit damage. Use of alternative packaging
materials may invalidate the warranty. Also retain all instrument-related documentation provided by
the manufacturer for future use.
First time instrument setup
The initial installation qualification and operational qualification (IQ/OQ) must be performed by field
service engineers (FSEs). Content should be retained for the instances where there is an emergency by
the end user.
1. Connect the power supply cable to the power inlet.
The instrument operates at voltages of 100–240 VAC and the frequency range of 50/60 Hz. Ensure
that the local supply voltage in the laboratory conforms to that specified on the type label on the
back of the instrument
2. Remove the transport lock screw from the magnet holder.
3. Remove the transport lock screws from the transport lock plate over the tip comb holder.
3
2
4. Remove the upper transport lock plate, then lift the tip comb holder and remove the lower
transport lock plate.
Do not discard the parts of the transport lock. The lock is required in case of future transportation
of the instrument (see “Store transport lock” on page52).
Chapter1Product information
First time instrument setup
1
12 KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

Install the UV light bulbs
1. Insert the UV light bulb into the light clip.
2. Slide the light bulb back and into the light socket.
1
2
Power on the instrument
1. Turn on the power switch at the rear of the instrument.
2. Press the on/o button to turn on the instrument.
Log in to KingFisher™Apex Dx Purification Instrument for first time as
administrator
1. At initial login, create username and password for administrator local user profile.
Note: Create a username and password that contains at least six characters, and may contain
upper- and lower-case letters, numbers, and special characters. Not all characters are supported.
IMPORTANT! Only the administrator can create and modify the other user roles.
2. Read the license agreement, then select accept.
3. Choose region.
4. Set date, time, and other selectable options.
IMPORTANT! The time set here will be applied in the logging and reporting functions.
Chapter1Product information
First time instrument setup 1
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 13

5. On the Mode selection screen, select RUO mode.
Note: After RUO mode is selected, the RUO Home should open.
Install heating block
1. Select Menu4Instrument.
2. In the Heating blocks section, select Insert for the position (1 or 2). The system will present the
heating block station to allow the user to install the heating block.
3. Scan the heating block to be installed by facing the heating block barcode sticker approximately
8–10 cm from the barcode reader inside the process chamber.
Note: Alternatively, select the heating block to be installed manually from the list shown on the
screen menu.
4. Place the heating block on the heating block station. Fit the pins on the block into the slots of the
station. Press the block down until it clicks properly into position.
Note: Select Information for details on heating block installation.
5. Select .
Chapter1Product information
First time instrument setup
1
14 KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

Install magnetic head
1. Select Menu4Instrument.
2. Select Insert for the position (1 or 2) to install the magnet.
3. Scan the magnetic head to be installed with the barcode reader or perform manual selection with
the menu.
4. Place the magnetic head onto the holder. Fit the pins on the head into the slots in the holder.
5. Turn the handle to lock the magnet in place.
Note: Select Information for details on magnetic head installation.
5
4
6. Select .
Chapter1Product information
First time instrument setup 1
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 15

Instrument components and plastic compatibility
Heating block
The instrument uses specially designed barcoded plates for optimal processing. Use of other types of
plates may damage the instrument and compromise the warranty, as well as result in below optimal
performance.
The heating blocks are specifically designed for the plates listed in the following table to ensure even
heating during sample processing.
For details on changing a heating block, see “Change heat block/magnetic head” on page28.
Heating block Plate
KingFisher™Apex 24 Deep Well Heating Block,
barcoded (Cat. No. 24075940)
KingFisher™24 Deep Well Plate, barcoded (30 µL to
5mL [1], Cat. No. 95040470B)
KingFisher™Apex 96 Deep Well Heating Block,
barcoded (Cat. No. 24075930)
KingFisher™96 Deep-Well Plate, barcoded (15–
1000 µL, Cat. No. 95040450B)
KingFisher™Apex 96 KF Heating Block, barcoded
(Cat. No. 24075920)
KingFisher™96-Well Microplate, barcoded (15–
200 µL, Cat. No. 97002540B)
Chapter1Product information
Instrument components and plastic compatibility
1
16 KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

(continued)
Heating block Plate
KingFisher™Apex PCR Heating Block, barcoded
(Cat. No. 24075910)
PCR plate (10–80 µL), skirted (Cat. No. AB2396 [2])
KingFisher™Apex 96 Storage Tube Heating Block,
barcoded (24075950)
96 Storage Tube (Nunc™374086), 30–200µL
KingFisher™Apex 24 Storage Tube Heating Block,
barcoded (24075960)
24 Storage Tube (Nunc™364323), 200–1000µL
Chapter1Product information
Instrument components and plastic compatibility 1
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 17

(continued)
Heating block Plate
Adapter
KingFisher™Apex 96 PCR Semiskirted Plate Adapter (Cat. No. N21446) or semi-skirted (Cat. No. AB2496 )
[1] The fill volume depends on the type of tip comb being used.
[2] Recommended PCR plate
Magnetic heads
Magnetic head Tip comb
KingFisher™Apex Dx 96 PCR Head, barcoded (Cat.
No. B24079910)
KingFisher™96 PCR Tip Comb, barcoded (Cat. No.
97002560)
KingFisher™Apex Dx 96 Deep Well Head, barcoded
(Cat. No. B24079930)
KingFisher™96 Tip Comb for Deep Well Magnets,
barcoded (Cat. No. 97002534B)
Chapter1Product information
Instrument components and plastic compatibility
1
18 KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide

(continued)
Magnetic head Tip comb
KingFisher™Apex Dx 96 Combi Head, barcoded
(Cat. No. B24079920)
KingFisher™96 Combi Tip Comb, barcoded (Cat.
No. 97002570)
KingFisher™Apex Dx 24 Combi Head, barcoded
(Cat. No. B24079940)
KingFisher™24 Deep Well Tip Comb, barcoded (Cat.
No. 95040470B)
(also KingFisher™24 Combi Tip Comb, barcoded )
Chapter1Product information
Instrument components and plastic compatibility 1
KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide 19

Tip comb and plate compatibility
Tip comb Compatible plates
KingFisher™96 Tip Comb for Deep Well Magnets
(Cat. No. 97002534B)
KingFisher™96 Deep Well plate (Cat. No.
95040450B)
KingFisher™96-Well Microplate (Cat. No.
97002540B)
KingFisher™96 Combi Tip Comb (Cat. No.
97002570)
KingFisher™96 Deep Well plate (Cat. No.
95040450B)
KingFisher™96-Well Microplate (Cat. No.
97002540B)
96 storage tube
KingFisher™24 Deep Well Tip Comb (Cat. No.
97002610B)
KingFisher™24 Deep Well plate (Cat. No.
95040470B)
KingFisher™24 Combi Tip Comb (Cat. No.
97002580)
24 storage tube
KingFisher™24 Deep Well plate (Cat. No.
95040470B)
KingFisher™96 PCR Tip Comb (Cat. No. 97002560) PCR plate, skirted (Cat. No. AB2396)
PCR plate, semi-skirted (Cat. No. AB2496)
KingFisher™96-well Microplate (Cat. No. 97002540)
Chapter1Product information
Instrument components and plastic compatibility
1
20 KingFisher™Apex Dx Purification Instrument (Research Use Only Workflow) User Guide