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Summary of Contents for ThermoFisher Scientific KingFisher Apex Dx
- Page 1 KingFisher Apex Dx Purification Instrument ™ User Guide | Research Use Only Workflow Catalog Number B5400900P Publication Number MAN0029203 Revision A.0 For Research Use Only. Not for use in diagnostic procedures.
- Page 2 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 12 July 2023 New document for KingFisher Apex Dx Purification Instrument.
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Page 3: Table Of Contents
Contents ■ CHAPTER 1 Product information ..........6 Product description ... - Page 4 Contents ■ CHAPTER 2 Methods ............. 24 Protocol access overview .
- Page 5 Contents ■ APPENDIX B Maintenance ............52 Regular and preventive maintenance .
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Page 6: Chapter 1 Product Information
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. -
Page 7: Product Overview
Chapter 1 Product information Product overview (continued) Cat. no. Cat. no. Cat. no. Cat. no. Details Cat. no. B5400910 B5400920 B5400930 B5400940 Magnetic heads KingFisher Apex Dx 96 PCR Head B24079910 — — — ™ KingFisher Apex Dx 96 Combi Head B24079920 —... - Page 8 Chapter 1 Product information Product overview Figure 2 KingFisher Apex Dx Purification Instrument rear view ™ Power switch Power inlet Ethernet/LAN port USB port (Host) × 2 RS-232 serial port USB port (Device) Internal layout The process chamber of the KingFisher Apex Dx Purification Instrument consists of a turntable with ™...
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Page 9: User Interface Overview
Chapter 1 Product information Product overview Figure 3 Process chamber layout Turntable with plate stations (1–8) Processing position Loading position Tip comb holder Magnetic head holder Shield plate Barcode reader UV light clip × 2 UV light socket × 2 User interface overview Symbol Function Notifications screen (For more details, see “Home screen”... -
Page 10: Upon Receiving The Device
Chapter 1 Product information Upon receiving the device (continued) Symbol Function Home screen (For more details, see “Home screen” page 34) Select Home Gives access to the following items: • Home • Import/Export • Protocol editor • Settings • Protocol library • Instrument •... -
Page 11: Precautions For Use
Chapter 1 Product information Upon receiving the device 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. -
Page 12: Guidelines For Unpacking The Instrument
Chapter 1 Product information First time instrument setup 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. -
Page 13: Install The Uv Light Bulbs
Chapter 1 Product information First time instrument setup 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. Power on the instrument 1. Turn on the power switch at the rear of the instrument. 2. -
Page 14: Install Heating Block
Chapter 1 Product information First time instrument setup 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. -
Page 15: Install Magnetic Head
Chapter 1 Product information First time instrument setup 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. -
Page 16: Instrument Components And Plastic Compatibility
Chapter 1 Product information Instrument components and plastic compatibility 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. - Page 17 Chapter 1 Product information Instrument components and plastic compatibility (continued) Heating block Plate KingFisher Apex PCR Heating Block, barcoded PCR plate (10–80 µL), skirted (Cat. No. AB2396 ™ (Cat. No. 24075910) KingFisher Apex 96 Storage Tube Heating Block, 96 Storage Tube (Nunc 374086), 30–200 µL ™...
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Page 18: Magnetic Heads
Chapter 1 Product information Instrument components and plastic compatibility (continued) Heating block Plate Adapter KingFisher Apex 96 PCR Semiskirted Plate Adapter (Cat. No. N21446) or semi-skirted (Cat. No. AB2496 ™ The fill volume depends on the type of tip comb being used. Recommended PCR plate Magnetic heads Magnetic head... - Page 19 Chapter 1 Product information Instrument components and plastic compatibility (continued) Magnetic head Tip comb KingFisher Apex Dx 96 Combi Head, barcoded KingFisher 96 Combi Tip Comb, barcoded (Cat. ™ ™ (Cat. No. B24079920) No. 97002570) KingFisher Apex Dx 24 Combi Head, barcoded KingFisher 24 Deep Well Tip Comb, barcoded (Cat.
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Page 20: Tip Comb And Plate Compatibility
Chapter 1 Product information Instrument components and plastic compatibility Tip comb and plate compatibility Tip comb Compatible plates KingFisher 96 Tip Comb for Deep Well Magnets KingFisher 96 Deep Well plate (Cat. No. ™ ™ (Cat. No. 97002534B) 95040450B) KingFisher 96-Well Microplate (Cat. No. ™... -
Page 21: General Login Functionality Description
Chapter 1 Product information General login functionality description General login functionality description The KingFisher Apex Dx Purification Instrument has a login functionality. The user can log in to ™ the instrument locally or via Security, Auditing, and E-Signature (SAE) server (if Applied Biosystems ™... -
Page 22: Create A Connect Account
Chapter 1 Product information About Thermo Fisher Connect Platform ™ • Automatically or manually upload run report from the instrument to the signed-in user's Connect account. • Manage multiple KingFisher Apex instruments remotely from a web-based dashboard. ™ • Upgrade instrument software automatically, without hardware or manual updates. Create a Connect account 1. -
Page 23: Add An Instrument To Your Connect Account
Chapter 1 Product information About Thermo Fisher Connect Platform ™ Add an instrument to your Connect account Connect supports access to the KingFisher Apex Dx Purification Instrument with the ™ InstrumentConnect application on your mobile device or through https://apps.thermofisher.com. When the instrument is connected, real-time instrument status can be viewed from the InstrumentConnect application. -
Page 24: Chapter 2 Methods
Methods Protocol access overview There are several ways to access KingFisher protocols. ™ • Download protocols from the KingFisher Apex Protocol Library directly from the instrument ™ (requires an internet connection, but does not require setting up a Connect account). •... -
Page 25: Change Password
Chapter 2 Methods Change password Change password 1. Select User Settings from Menu. 2. Click the Change the password tab. 3. Enter your current password, then enter the new password twice. 4. Click Confirm or exit without changing the password. Create, edit, or delete users To create a new user, you must be logged in as Administrator.. -
Page 26: Run Purification Kit
Chapter 2 Methods Run purification kit Run purification kit 1. Prepare reagents and samples and place them in the appropriate plates according to the instructions for your kit of choice. 2. Select a protocol and press on the Home screen. Note: A new window will open. 3. - Page 27 Chapter 2 Methods Run purification kit 6. Load the appropriate plates into the instrument on the lighted loading position as prompted by the instructions displayed on the touch screen. IMPORTANT! When loading plates, ensure that the A1 position of plate aligns with the A1 position indicated on the plate stations of the turntable in the instrument.
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Page 28: Abort Run
Chapter 2 Methods Abort run Abort run Icon Function Abort a protocol that is in progress. If the user ends the run, the Protocol aborted window appears: If the user selects , the Tools view appears. Turn off the instrument 1. On the Home screen, select User Settings, then click Logout to log off from the instrument. 2. -
Page 29: Unload Heating Block
Chapter 2 Methods Change heat block/magnetic head Unload heating block 1. Select Menu4Instrument. 2. Select Unload for the position (1 or 2) you want to remove the heating block from and wait for the instrument to present the heating platform with the heating block.. WARNING! The heating block surface may be hot during operation. - Page 30 Chapter 2 Methods Change heat block/magnetic head 4. Lift the magnetic head from the holder. Note: Select Information for details on magnetic head removal. 5. Select KingFisher Apex Dx Purification Instrument (Research Use Only Workflow) User Guide ™...
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Page 31: Chapter 3 Software Applications
Software applications About the user interface The KingFisher Apex Dx Purification Instrument has a login functionality. You can log in to the ™ instrument locally or via SAE server (if Applied Biosystems Diomni Software and SAE integration ™ ™ is enabled). When the instrument is used after logged in locally, the user (with scientist or administrator privileges) can run, import, and customize RUO protocols. - Page 32 Chapter 3 Software applications About the user interface 3. If required, enter the SMB username and password for accessing base directory. 4. Click Test to initiate verification that the instrument has the required permissions to the base folder. Note: If any test ends in an error, the verification fails. An error report is displayed. 5.
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Page 33: Ruo Mode (Local)
Chapter 3 Software applications About the user interface 4. Click OK to confirm. Click Cancel to modify the settings. Note: After the confirmation you are logged out and cannot modify the settings RUO mode (local) When RUO mode is used while logged in locally, the user can work with RUO protocols. This includes running protocols, editing protocols, using the protocol library, viewing the run history, using import/export, and modifying settings. -
Page 34: Overview Of User Interface Controls
Chapter 3 Software applications Overview of user interface controls Download and install software from the Thermo Fisher Scientific website 1. Go to thermofisher.com/kingfisher. 2. Select Software and protocols. 3. Select the BindIx tab and download the software. ™ 4. Run the .exe file to install the software. Download and install software from the Microsoft Store ™... - Page 35 Chapter 3 Software applications Overview of user interface controls Smith Smith Figure 4 Toolbar Return to Home screen. Access Protocol editor Access Protocol library Access Run history screen Access Import/Export screen Access Instrument screen Access Settings screen Access User name screen KingFisher Apex Dx Purification Instrument (Research Use Only Workflow) User Guide ™...
- Page 36 Chapter 3 Software applications Overview of user interface controls Figure 5 Run protocol window KingFisher Apex Dx Purification Instrument (Research Use Only Workflow) User Guide ™...
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Page 37: Protocol Editor Screen
Chapter 3 Software applications Overview of user interface controls Protocol editor screen The protocol editor screen is used to create a new protocol, open an existing protocol, or search for a protocol by manually entering a catalog number or using the barcode reader. The scientist and administrator users can create new protocols. -
Page 38: Protocol Library Screen
Chapter 3 Software applications Overview of user interface controls Protocol library screen Users can search and select the available protocols in the Protocol library. Users can also arrange protocols in different orders by selecting either the Name, Application, or Kit SKUs icons. Run history overview The Run history tab shows the recent protocol runs, also the protocols that were aborted or stopped because of an error occurred. -
Page 39: Import/Export Overview
Chapter 3 Software applications Overview of user interface controls Run history screen The Run history screen shows the recent successful protocol runs, as well as the protocols that were aborted by the user or stopped because of an error. The following tasks can be performed in the Run history screen: •... - Page 40 Chapter 3 Software applications Overview of user interface controls Import protocol from a USB memory device 1. Insert a USB memory device containing your protocol into a USB port on the instrument. 2. Select the protocol that you want to import to the instrument. 3.
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Page 41: Settings Screen
Chapter 3 Software applications Overview of user interface controls Settings screen The Settings screen is used to set or change instrument settings, enable network sharing, and view information about the instrument. Localization settings The administrator and the scientist user can modify these settings: •... -
Page 42: User Settings
Chapter 3 Software applications Overview of user interface controls Set date and time 1. Select (Change) under Date and time 2. Scroll through the numerical menus to select the time and date. 3. Select Set time zone 1. Select the Time zone field to open the drop down menu. 2. -
Page 43: Protocol Settings
Chapter 3 Software applications Overview of user interface controls Protocol settings Set default magnetic head type 1. Select the Default magnet head type field to open the drop down menu. 2. Select the desired magnetic head (96 DW, 96 Combi, 24 Combi, 96 PCR). 3. -
Page 44: Sound Settings
Chapter 3 Software applications Overview of user interface controls Sound settings About About ( ) displays instrument information, including instrument serial number, software versions, and usage information. All users can change the instrument settings. KingFisher Apex Dx Purification Instrument (Research Use Only Workflow) User Guide ™... - Page 45 Chapter 3 Software applications Overview of user interface controls Set instrument name 1. Select the Instrument name field to access the keyboard. 2. Enter a name for the instrument. 3. Select Reset factory settings Performing a reset will restore all setting parameters to the factory defaults. All Connect user and instrument links are removed, but locally stored protocols and run reports are retained.
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Page 46: Instrument Screen
Chapter 3 Software applications Overview of user interface controls Instrument screen The Instrument screen is the main control panel for manual operation of the instrument. Move the turntable counterclockwise. Insert magnetic head (See “Install magnetic head” page 15). Move the turntable clockwise. Unload heating block (See “Unload heating block” Perform check to ensure that tip combs are properly page 29). -
Page 47: Protocol Overview
Chapter 3 Software applications Overview of user interface controls Protocol overview A protocol is a set of instructions that the instrument uses to perform a sample processing procedure. The protocol is a collection of information regarding the layout of with reagent data and procedure steps done in a session as well as the instrument used. - Page 48 Chapter 3 Software applications Overview of user interface controls – 24 combi tip comb – 96 PCR tip comb • Export count of run report files [integer] – to USB – to network share – to Connect • Export count of protocol files [integer] –...
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Page 49: Appendix A Troubleshooting
Troubleshooting Troubleshooting guide Table 1 Actions taken against error messages and warnings Code Error message Action Switch the instrument OFF and ON, then try Head position error again. If the error appears during initialization or is otherwise repeated, contact service. Switch the instrument OFF and ON, then try Magnets position error again. - Page 50 Appendix A Troubleshooting Troubleshooting guide Table 1 Actions taken against error messages and warnings (continued) Code Error message Action Switch the instrument OFF and ON, then try Tip shield position error again. If the error appears during initialization or is otherwise repeated, contact service. Switch the instrument OFF and ON, then try Lock position error again.
- Page 51 Appendix A Troubleshooting Troubleshooting guide Table 1 Actions taken against error messages and warnings (continued) Code Error message Action Switch the instrument OFF and ON, then try Heater 1 Temperature is not changing again. If the error appears during initialization or is otherwise repeated, contact service. Switch the instrument OFF and ON, then try Heater 1 Heater not working again.
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Page 52: Appendix B Maintenance
Maintenance Regular and preventive maintenance • Keep the instrument free of dust and liquid spills. • Immediately wipe away spilled saline solutions, solvents, acids or alkaline solutions from outer surfaces to prevent damage. • Use a mild sterilizing solution to clean any surfaces are contaminated with biohazardous material. •... -
Page 53: Magnetic Head Maintenance
Appendix B Maintenance Magnetic head maintenance Magnetic head maintenance If necessary, wipe the magnetic rods using a soft cloth or tissue paper soaked in a mild detergent solution (SDS), soap solution, or alcohol. Decontamination procedure WARNING! The decontamination procedure should be performed by authorized trained personnel in a well-ventilated room wearing disposable gloves, protective glasses and clothing. -
Page 54: Uv Decontamination Procedure
Appendix B Maintenance UV decontamination procedure 6. Place a cloth soaked in the prepared glutaradlehyde solution into the bag. Ensure that the cloth does not make contact with the instrument. 7. Close the bag firmly and leave the instrument in the bag for at least 24 hours. 8. - Page 55 Appendix B Maintenance Prepare instrument for transport 5. Place the upper transport lock plate over the tip comb holder and fasten the screws to hold the plates together. 6. Lower the magnetic head holder to the upper transport lock plate and fasten the magnetic head holder to the transport lock with the screw.
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Page 56: Appendix C Specifications
Specifications Physical dimensions Parameter Instrument Transport package Width 79 cm (31 in) 99 cm (39 in) Depth 59 cm (23 in) 77.5 cm (30.5 in) Height 45 cm (18 in) 83.5 cm (33 in) Weight 56 kg (123 lb) 58 kg (128 lbs) Addition of +/-0.5 cm tolerance to the Width, Depth, and Height of the instrument dimensions. Weight including instrument. -
Page 57: Performance Specifications
Appendix C Specifications Performance specifications (continued) Technical specifications Internal barcode reader Altitude Located between sea level and 2,000 m (6,500 ft) above sea level Pollution degree Pollution Degree II – Install the instrument in an environment with only non- conductive pollutants (e.g., dust particles or wood chips). Typical environments with a Pollution Degree II rating are laboratories and sales or commercial areas. - Page 58 Appendix C Specifications Performance specifications Table 2 Performance specifications (continued) Performance specifications Heating/Cooling From 4°C to 100°C, instrument at room temperature temperature range Heating block accuracy ±2°C (min 4°C), ±2°C (max 80°C), ±3°C (min 81°C to 100°C), instrument at room temperature Processing volume KingFisher Apex Dx Purification Instrument (Research Use Only Workflow) User Guide ™...
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Page 59: Appendix D Ordering Information
Ordering information Ordering configurations IMPORTANT! The customer is responsible for validation of all consumables before use, and for compliance with regulatory requirements that pertain to the procedures and uses with the instrument. Details Cat. No. Instrument KingFisher Apex Dx Purification Instrument B5400900P ™... - Page 60 Appendix D Ordering information Ordering configurations (continued) Details Cat. No. Plastics for 96 deep well format KingFisher 96 Combi Tip Comb 97002570 ™ KingFisher 96 Deep Well Plate 95040450B ™ KingFisher 96 Deep Well Plate, sterile 95040460B ™ KingFisher 96 Tip Comb for Deep Well Magnets 97002534B ™...
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Page 61: Appendix E Safety
Safety WARNING! GENERAL SAFETY. Using this product in a manner not specified in the user documentation may result in personal injury or damage to the instrument or device. Ensure that anyone using this product has received instructions in general safety practices for laboratories and the safety information provided in this document. -
Page 62: Appendix F Symbols On This Instrument
Symbols on this instrument Symbols may be found on the instrument to warn against potential hazards or convey important safety information. In this document, the hazard symbol is used along with one of the following user attention words. • CAUTION!—Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury. -
Page 63: Appendix G Electromagnetic Compatibility (Emc) Standards
Electromagnetic compatibility (EMC) standards EMC compliance Reference Description Directive 2014/30/EU European Union “EMC Directive” IEC 61326-1 Class B Electrical Equipment for Measurement, Control and Laboratory Use – EMC Requirements – Part 1: EN 61326-1 Class B General Requirements The equipment is intended for use in a basic electromagnetic environment. -
Page 64: Physical Injury
Appendix G Electromagnetic compatibility (EMC) standards Physical injury Physical injury CAUTION! Moving and Lifting Injury. Improper lifting can cause painful and permanent back injury. Things to consider before lifting or moving the instrument or accessories: · Depending on the weight, moving or lifting may require two or more persons. ·... - Page 65 Appendix G Electromagnetic compatibility (EMC) standards Electrical safety • Do not insert the plug into sockets that are dusty or dirty. Insert the plug firmly and all the way into the socket. Otherwise, sparks that result in fire and/or injuries may occur. •...
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Page 66: Chemical Safety
Appendix G Electromagnetic compatibility (EMC) standards Chemical safety Chemical safety WARNING! GENERAL CHEMICAL HANDLING. To minimize hazards, ensure laboratory personnel read and practice the general safety guidelines for chemical usage, storage, and waste provided below. Consult the relevant SDS for specific precautions and instructions: ·... -
Page 67: Biological Hazard Safety
Appendix G Electromagnetic compatibility (EMC) standards Biological hazard safety Biological hazard safety WARNING! Potential Biohazard. Depending on the samples used on this instrument, the surface may be considered a biohazard. Use appropriate decontamination methods when working with biohazards. WARNING! BIOHAZARD. Biological samples such as tissues, body fluids, infectious agents, and blood of humans and other animals have the potential to transmit infectious diseases. -
Page 68: Appendix H Serious Incidents
Serious incidents Any serious incident that has occurred in relation to the device shall be reported to the manufacturer and the relevant regulatory authority in which the user and/or the patient is established. KingFisher Apex Dx Purification Instrument (Research Use Only Workflow) User Guide ™... -
Page 69: Appendix I Documentation And Support
Documentation and support Customer and technical support Visit thermofisher.com/support for the latest service and support information. • Worldwide contact telephone numbers • Product support information – Product FAQs – Software, patches, and updates – Training for many applications and instruments •... - Page 70 KingFisher Apex Dx Purification Instrument_RUO_UG_MAN0029203-v2- GUID-9EE69F04-91EB-4FD3-8F56-7458B70382DC-2023/05/17 20:37:41 en 18:16:48.868+01:00 thermofisher.com/support | thermofisher.com/askaquestion thermofisher.com 12 July 2023...
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