cytiva NanoAssemblr Ignite Operating Instructions Manual

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NanoAssemblr™ Ignite™ and

Ignite+™

Operating Instructions

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Summary of Contents for cytiva NanoAssemblr Ignite

Page 1 NanoAssemblr™ Ignite™ and Ignite+™ Operating Instructions Original instructions cytiva.com...
Page 2: Table Of Contents
Parameters ............................... 56 5.1.1 Syringe selection ............................57 5.1.2 Mixing parameters ............................59 5.1.3 Waste parameters ............................62 5.1.4 Parameter validation ..........................67 Recipes ................................68 Settings ................................72 Replace sample arm ............................. 73 NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 3 China .................................. 123 9.4.6 South Korea ..............................126 9.4.7 General regulatory statements ......................127 9.4.8 Other regulations and standards ......................128 Ordering information ........................... 130 Health and Safety Declaration Form ...................... 131 NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 4: Introduction
This chapter contains information about this manual and associated user documenta- tion, important user information and intended use of the product. In this chapter Section See page Important user information About this manual Associated documentation NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 5: Important User Information
Intended use of the product NanoAssemblr™ Ignite™ and NanoAssemblr Ignite+™ are intended for the production of nanoparticle formulations for research purposes. The products are intended to be used by trained laboratory staff members in research laboratories within academia and industry.
Page 6: About This Manual
This manual provides information needed to install, operate and maintain the product in a safe way. Scope of this manual This manual is valid for the NanoAssemblr Ignite and Ignite+ systems, and covers the Ignite and Ignite+ instruments, embedded software, and accessories. Notes and tips...
Page 7: Associated Documentation
Introduction This section describes the user documentation that is delivered with the product, and how to find related literature that can be downloaded or ordered from Cytiva. User documentation for Ignite The user documentation is listed in the table below.
Page 8: Safety Instructions
All users must read and understand the entire contents of this general safety chapter, and the specific safety precau- tions information in each subsequent chapter of this manual to become aware of the hazards involved. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 9: Safety Precautions
WARNING Do not operate the product in any other way than as described in the user documentation. WARNING Only properly trained personnel are allowed to operate and main- tain the product. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 10 Some of the chemicals used with the system can be flammable under certain conditions. Make sure to use chemicals only under conditions where they are not flammable. Refer to local and/or national classifications of flammable liquids. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 11 WARNING Explosion hazard. To avoid building an explosive atmosphere when using flammable liquids, make sure that the room ventilation meets the local requirements. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 12: Labels And Symbols
Description Warning! Risk of danger. Consult the user documenta- tion. Proceed with caution. Warning! Hot surface. Do not touch. Warning! Crush hazard. Keep hands clear from moving parts to avoid pinch injuries. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 13 Warning! Biological hazard. Materials used can be biological hazards. Indicated hazards are dependent on the materials selected by the user. Refer to SDS and take appropriate precautions for the materials used. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 14: Emergency Procedures
2.3 Emergency procedures Emergency procedures Introduction This section describes how to shut down NanoAssemblr Ignite or Ignite+ instrument in an emergency situation, and the result in the event of power failure. The section also describes the procedure for restarting the instrument.
Page 15: Power Failure
Press the power switch to the I position to restart the instrument. Result: Upon restart, all of the system components return to their home positions. Remove any syringes or collection tubes. The instrument is ready to start a new formulation. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 16: System Description
About this chapter This chapter gives an overview of Ignite, and a brief description of its function and the software. In this chapter Section See page System overview Instrument Microfluidic cartridges User interface Accessories NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 17: System Overview
Section 5.1.2 Mixing parameters, on page Illustration of the system The illustrations below show the Ignite and Ignite+ instruments and the accessories delivered with the system. Ignite Ignite+ Part Description Main instrument Power supply Sample arms NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 18 3 System description 3.1 System overview Part Description Cartridge adapters Power cord Ignite: Two black sample arms; Ignite+: Three grey sample arms NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 19: Instrument
Tubes for collecting the sample and the waste from the tubes formulation. Status indicator When lit, the instrument is powered on. Right (R) pusher Syringe pushers press the syringe pistons at independ- ently controlled rates. Center (C) pusher Left (L) pusher NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 20 See above section adapter Sample arm Sample arms with different sized holders to hold the collection tubes. Note: The sample arms supplied with the system differ between the Ignite and Ignite+ systems. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 21 An optional heating block to maintain the temperature of preheated reagents and syringes above the ambient temperature. Note: The heating block is not a default part of the system and must be requested and installed separately. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 22: Microfluidic Cartridges
3.3 Microfluidic cartridges Microfluidic cartridges Introduction This sections describes the microfluidic cartridges available for Ignite and Ignite+ systems. In this section Section See page 3.3.1 Introduction 3.3.2 Two-inlet cartridges 3.3.3 Three-inlet cartridges NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 23: Introduction
50 mL/min to 200 mL/min (pre- dilution) NxGen 500D Clinical develop- Ignite+ ment and commercial production from 50 mL/min to 200 mL/min (pre- dilution) Note: Recommended shelf life for all cartridges is 1 year. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 24: Two-Inlet Cartridges
Illustration of two-inlet cartridge front The illustrations below show the locations and gives brief descriptions of the parts on the front of the cartridge. Part Description Cartridge inlets Mixer geometry Cartridge outlet NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 25 The illustration below shows the locations and gives brief descriptions of the parts on the back of the cartridge. Part Description Cartridge inlets with Luer fittings to connect to syringes Cartridge outlet NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 26: Three-Inlet Cartridges
Illustration of three-inlet cartridge front The illustrations below show the locations and gives brief descriptions of the parts on the front of each cartridge. NxGen Dilution NxGen 500D Part Description Cartridge inlets NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 27 3 System description 3.3 Microfluidic cartridges 3.3.3 Three-inlet cartridges Part Description Mixer geometry Cartridge outlet NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 28: User Interface
This section describes the user interface for Ignite and Ignite+ instrument. In this section Section See page 3.4.1 Main menu Recipes menu 3.4.2 Quick run 3.4.3 History menu 3.4.4 Settings menu 3.4.5 NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 29: Main Menu
Heater control icon Shows the status of the cartridge in the instru- Cartridge indicator ment Recipes Enables user to create, edit, and store formula- tions providing convenient access to frequently used formulations NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 30 Red background with no present because both border heaters are off. The red background remains until both heaters are below 45°C. Cartridge indicator states The following table gives the meaning of each cartridge indicator symbol. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 31 • The cartridge is the wrong type for the current run • The cartridge has been used previously Note: This state is only displayed when viewing or editing parameters for a run Cartridge is acceptable for the current run NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 32: Recipes Menu
User input recipe name and summary or key parameters Edit button Opens the parameters menu for the user to edit the parameters of the recipe Run button Runs the selected recipe Delete button Deletes the selected recipe NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 33: Quick Run
3.4.3 Quick run The user can directly enter run parameters on the Quick run screen. See Quick run, for instructions on how to initiate a run with Quick run. on page 88 NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 34: History Menu
Description Function Quick run or recipe Shows Quick run or user-input recipe name name Run parameters Shows key run parameters Time and date of Shows time and date the run was performed NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 35 STOP, by an error detected throughout the run, or by a power failure to the instrument. Cartridge type Shows the cartridge type used during the run Navigation arrows Navigates between pages NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 36: Settings Menu
Opens the menu to change the date and time Syringes Shows a list of compatible syringe brands and sizes. Software version Shows the current software version Note: Cytiva might ask for the software version when providing technical support. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 37: Accessories
3 System description 3.5 Accessories Accessories Introduction This section describes the accessories available for Ignite and Ignite+ systems. In this section Section See page 3.5.1 Heating insert 3.5.2 Syringe extenders NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 38: Heating Insert
5 mL - T 5 mL 5 mL 5 mL 10 mL 10 mL 10 mL 10 mL 10 mL 10 mL 10 mL 10 mL X: Syringe not supported by Ignite instrument NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 39 10 mL 20 mL 20 mL 20 mL 20 mL 20 mL ✓ ✓ ✓ 30 mL X: Syringe not supported by Ignite+ instrument ✓: No insert is needed for the specified syringe NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 40: Syringe Extenders
Syringe extenders must be used with the following syringe manufacturers and sizes: • B Braun Injekt syringes, 2 mL • Terumo syringes, 2.5 mL Section 9.5 Ordering information, on page 130 for more information. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 41: Installation
This chapter provides required information to enable users and service personnel to unpack, install, move and transport the Ignite or Ignite+ system. In this chapter Section See page Site preparation Installing the system Moving the system Electrical connections NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 42: Site Preparation
This section describes the site planning and preparation that should be performed before the product is installed. In this section Section See page 4.1.1 Delivery, storage and unpacking 4.1.2 Room requirements 4.1.3 Site environmental requirements 4.1.4 Power requirements NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 43: Delivery, Storage And Unpacking
25% to 65%, non-condensing Transportation The following equipment is recommended for handling the delivery boxes: Equipment Specifications Cart for transporting the Dimensioned to accommodate the size and instrument to the lab weight of the instrument NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 44: Unpacking The Instrument
Save all the original packing material. If the system has to be repacked, for transporta- tion or otherwise, it is important that the system can be safely packed using the orig- inal packing material. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 45: Room Requirements
Access to power cord. Do not block access to the power cord. The power cord must always be easy to disconnect. CAUTION Make sure that the system is placed on a stable, level bench with adequate space for ventilation. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 46 40 x 44 x 73 cm (15.7 x 17.3 x 28.7 in) instrument (W x D x H) Load capacity Enough to support instrument and any other accessories on the laboratory bench Inclination of bench surface Horizontal ±2° NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 47: Site Environmental Requirements
The heat output data is listed in the table below. The heat output data is valid when the syringe heaters are installed and on. Component Heat output Syringe heaters on the Ignite or Ignite+ Maximum output per heater: 35 W instrument Total Maximum: 70 W NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 48: Electrical Power Requirements
The mains power supply must be stable and conform to specifications at all times to ensure reliable operation of the instrument. Avoid transient or slow changes in average voltage outside the limits specified above. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 49: Installing The System
Place the instrument on the bench (see Space requirements, on page 45 for space requirements). Lift the instrument from the base. It is recommended to use two people to lift the instrument. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 50: Step Action
Step Action Lift the lid of the instrument. Remove the protective insulation from the pushers. Make sure that the paddles attached to the pushers are in the horizontal orientation. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 51 Hold the applicable sample arm with the tube holders on the left top side. Align the body of the sample arm with the holder on the instrument. Push the sample arm into the holder horizontally. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 52: Moving The System
For transport over longer distances, pack the instrument securely in a protective box. Use the original packing material if possible. Contact Cytiva for information on moving the system over longer distances. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 53: Electrical Connections
Connect power to the instrument Follow the instructions below to connect power to the NanoAssemblr Ignite or Ignite+ instrument. WARNING Protective ground. To reduce the risk of electric shock, this equipment must always be connected to a grounded power outlet.
Page 54 4 Installation 4.4 Electrical connections Step Action Connect the power supply to the port at the rear of the NanoAssemblr Ignite or Ignite+ instrument. Note: To remove the power supply from the instrument, slide the sheath of the connector backwards while pulling the connector out.
Page 55: Preparation
About this chapter This chapter gives instructions on how to set up a run with the Ignite or Ignite+ system. In this chapter Section See page Parameters Recipes Settings Replace sample arm NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 56: Parameters
Run parameters may be entered and saved in a recipe from the Recipes screen, or entered on the Quick run screen prior to starting a run. In this section Section See page 5.1.1 Syringe selection 5.1.2 Mixing parameters 5.1.3 Waste parameters 5.1.4 Parameter validation NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 57: Syringe Selection
Result: A list of compatible syringe brands and sizes are displayed. The syringes are grouped by brand. Each syringe is identified by a two-letter code for the brand and the syringe volume. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 58 Tap the blue box next to a syringe name to remove the syringe type from the list of available syringes. Tap the back arrow at the top left of the screen to apply the settings. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 59: Mixing Parameters
The value of the parameter Total volume gives the amount of liquid that is formulated before dilution during the procedure. The table below gives the range of possible values. Instrument Total volume Ignite 1 mL to 20 mL Ignite+ 1 mL to 60 mL NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 60 • 3:1 flow rate ratio , • and BD syringes, the minimum syringe sizes that can be used are: • one 10 mL syringe (at 150 mL/min), • and one 3 mL syringe (at 50 mL/min). NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 61 The dilution flow rate is calculated automatically by the instrument based on the other parameter settings. Instrument Dilution flow rate Ignite 0.1 to 48 mL/min Ignite+ 0.1 to 435 mL/min NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 62: Waste Parameters
If using dilution, add the value from the column Dilution syringe. If using same size syringes for both channels, skip to the second table for calculation recommendations. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 63 Contact us for further help with parameter optimization. See Contact information for support, on page 119. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 64 Values used to calculate Start waste for same sized syringes (mL) Syringe size (mL) Same size syringes Dilution syringe 0.20 0.20 0.30 0.25 0.50 0.35 0.80 0.50 1.60 0.65 2.70 0.65 NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 65 Values used to calculate Start waste for different sized Syringe size syringes (mL) (mL) Smaller syringe Larger syringe Dilution syringe 0.10 0.20 0.15 0.35 0.25 0.50 0.20 0.35 0.30 0.80 0.50 0.65 0.65 NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 66 A value of 0.05 mL is recommended for the parameter End waste for all syringe combi- nations and flow rates. Note: For some formulations, no collection of end waste is required. In this case, the value of End waste can be set to 0 mL. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 67: Parameter Validation
If errors are present, adjust the run parameters to within the flow rate and volume limi- tations. See Section 5.1.2 Mixing parameters, on page 59 for the range of acceptable flow rates and volumes. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 68: Recipes
Follow the instructions below to create or edit a recipe. Step Action From the main menu, tap Recipes. Tap the edit button next to the recipe. Result: The recipe parameters are shown. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 69 Note: Enter values for Dilution ratio, L : (C+R) only for recipes that use a NxGen Dilution or NxGen500D cartridge. For all other cartridges, leave this field blank. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 70 Tap Save in the bottom right corner of the screen. Result: The screen returns to the Recipes menu. Delete a recipe Follow the instructions below to delete a recipe. Step Action From the main menu, tap Recipes. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 71 Tap Yes to proceed with the deletion. Tap No to cancel the deletion and return to the Recipes menu. Result: The screen returns to the Recipes menu. The recipe slot where the recipe was previously stored is now empty. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 72: Settings
If applicable, check the PM box. Tap Save to apply the settings. Result: The date and time are immediately updated in the Date & Time menu and in the information bar at the top of the screen. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 73: Replace Sample Arm
Pull the sample arm horizontally out of the holder. Hold the new sample arm with the tube holders on the left top side. Align the body of the sample arm with the holder on the instrument. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 74 5 Preparation 5.4 Replace sample arm Step Action Push the sample arm into the holder horizontally. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 75: Operation
About this chapter This chapter gives instructions on how to operate Ignite and Ignite+ in a safe way. In this chapter Section See page Safety precautions Start-up and shutdown Run a procedure NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 76: Safety Precautions
Hot surface. Avoid direct contact with the heating block and the top surface of the rotating block during or after heating. Contact with hot surfaces during or directly after a procedure in which the heaters are on can cause burns. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 77: Start-Up And Shutdown
When the instrument starts, the following occurs: • The user interface and status indicator are illuminated. • When the system is ready to use, the user interface displays the main menu. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 78: Shut Down The Instrument
6 Operation 6.2 Start-up and shutdown Shut down the instrument To shut down the instrument, press the power switch on the back of the instrument to the O position. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 79: Run A Procedure
Prerequisites and required materials 6.3.3 Optional: Preheat the system 6.3.4 Initiate a run 6.3.5 Prepare the cartridge 6.3.6 Load syringes and collection tubes 6.3.7 Start the formulation 6.3.8 Monitor the formulation 6.3.9 End a run NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 80: Workflow
The steps in this phase depend on whether the heaters are used. Start the formulation After formulation is complete, remove the sample and waste tubes Disconnect and dispose of used cartridge and syringes NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 81: Prerequisites And Required Materials
The Ignite or Ignite+ must be installed by trained personnel. If syringe heating is used, the heating block must be installed by authorized Cytiva personnel. The correct size of sample arm must be installed prior to running a procedure. See Section 5.4 Replace sample arm, on page 73...
Page 82 A collection tube that is large enough to hold the start and end waste, and that is chemically compatible with the reagents. See Collection tube compatibility, on page 113 for compatible tubes. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 83: Optional: Preheat The System
Only C and R channels can be used with heating. Step Action Open the lid of the instrument. Rotate the rotating block upwards so that the underside of the cartridge is visible. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 84 If using Ignite+ heating inserts, the three arrows on the insert must point in the direction of the fluid flow. Result: The heating inserts snap into place magnetically. Rotate the rotating block down into the default position. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 85 The setpoint or setpoints chosen are shown in the top row of the heating control indicator. The heating block immediately begins to heat the syringe heaters. The actual temperature of each heater is displayed in the bottom row of the heating control indicator. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 86 Proceed to the next section to start a run. Tip: Preheat the reagents in a wet or dry bath while you wait for the syringe heaters to reach the setpoint temperature. Make sure to heat the empty or filled syringes. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 87: Initiate A Run
The formulation screen is shown. The recipe name is shown in the informa- tion bar at the top of the screen. The chosen parameters and next steps are also displayed on the screen. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 88 If any validation errors are present, the errors are listed in red at the bottom of the screen. See Section 5.1.4 Parameter validation, on page 67 for more information. Tap Next at the bottom right of the screen. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 89 Proceed to the following sections to load the cartridge, syringes, and collection tubes. Refer to the formulation screen while preparing these items, as the syringes and required volumes are displayed in the formulation summary in the top half of the screen. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 90: Prepare The Cartridge
• Single-use cartridges remove the risk of cross-contamination from prior runs. • Cartridges are manufactured using a highly automated process in a cleanroom environment, minimizing the potential for leaks, blockages, and debris. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 91 Fill syringes with the priming solvents. At least 6 mm (¼ inch) of fluid must be added to each syringe. Open the lid of the instrument. Rotate the rotating block upwards so that the underside of the cartridge is visible. Result: NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 92 Tap PRIME at the bottom left of the user interface. Result: The syringe pushers travel approximately 6 mm after detecting a syringe, which is equivalent to: • approximately 0.1 mL when using a 1 mL syringe, or NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 93 • approximately 1 mL when using a 10 mL syringe. Open the lid and remove the syringes. Proceed to the following sections to load the syringes with the reagents for the run. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 94: Load Syringes And Collection Tubes
To prevent excess fluid from collecting in the Luer fitting, hold a lint-free labo- ratory tissue near the tip of the syringe when expelling air bubbles. Rotate the rotating block upwards so that the underside of the cartridge is visible. Result: NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 95 Syringes without Luer fittings: Push the syringe until you meet resist- ance. NOTICE Do not insert the syringe too far. Inserting the syringe too far can damage the syringe and the cartridge. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 96 Make sure the lip of the 100 mL sample tube is pressed downwards to sit as low as possible on the top edge of the tube holder. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 97 To change the sample arm, see Section 5.4 Replace sample arm, on page Follow the steps below to preheat the syringes, load the reagents and syringes, and load the collection tubes. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 98 To prevent excess fluid from collecting in the Luer fitting, hold a lint-free labo- ratory tissue near the tip of the syringe when expelling air bubbles. Insert the R and C syringes into the heating inserts in the right and center channels, respectively. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 99 Make sure the lip of the 100 mL sample tube is pressed downwards to sit as low as possible on the top edge of the tube holder. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 100 Do not wait longer than 3 minutes between inserting the syringes and starting the formulation. Leaving the heating block on with the syringes inserted can cause ignitable vapor to form inside the instrument. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 101: Start The Formulation
If there are any errors listed in red on the screen, the errors must be corrected before proceeding with the formulation. See Error messages and suggested corrective actions, on page 110 for troubleshooting. Tap START. Result: The formulation begins. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 102: Monitor The Formulation
During the formulation, the user can interrupt the formulation at any time. If the lid of the instrument its opened at any time during the formulation, the formulation is also interrupted. Follow the steps below to interrupt the formulation. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 103 Tap STOP, or open the lid. Result: The instrument stops all actions immediately. Tap RESET to return all system components to their home positions. Collect any sample already in the sample tube and start a new procedure. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 104: End A Run
When running a procedure on the Ignite+ instrument, some spillage is expected during the procedure due to the high flow rates. The spillage is minimized as much as possible by the system. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 105: Maintenance
This chapter provides information about maintenance that should be performed by users of Ignite and Ignite+. To ensure that the system works according to specifications, planned maintenance should be performed annually by a Cytiva service engineer, or service personnel authorized by Cytiva. In this chapter...
Page 106: Safety Precautions
Safety precautions WARNING Disconnect power. Always disconnect power from the instru- ment before performing any maintenance task. WARNING Always use appropriate Personal Protective Equipment (PPE) during operation and maintenance of this product. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 107: Service And Preventive Maintenance
Service agreements Contact your Cytiva representative for information about frequency of service require- ments to suit individual process needs and for details of the Cytiva service agreement options available for each instrument. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 108: Cleaning Before Planned Service
Health and safety declaration forms Health and safety declaration forms are available for copying or printing in the Refer- ence information chapter of this manual, or on digital media supplied with the user documentation. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 109: Routine Cleaning
• Warm water and a mild non-abrasive detergent • Ethanol • Isopropyl alcohol The lid should be wiped with a soft cloth to avoid scratches that could impact visibility. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 110: Troubleshooting
If the suggested actions in this guide do not solve the problem, or if the problem is not covered by this guide, contact your Cytiva representative for advice. Error messages and suggested...
Page 111: Reference Information
In this chapter Section See page Specifications Chemical resistance Recycling information Regulatory information Ordering information Health and Safety Declaration Form NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 112: Specifications
KOVAX syringes 1 mL * Not compatible with heating accessories. Must be used with syringe extenders for optimal performance in all other cases Consult the manufacturer of the syringes for chemical compatibility. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 113 The table below describes the environmental requirements for Ignite and Ignite+ system. Parameter Requirement Allowed location Indoor use only Ambient temperature 15°C to 35°C Relative humidity 25% to 65%, non-condensing Pressure 70 to 106 kPa Altitude Up to 2000 m NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 114 9 Reference information 9.1 Specifications Parameter Requirement Pollution degree of the intended envi- Pollution degree 2 ronment NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 115: Chemical Resistance
Solvent Methyl cellosolve Solvent Methyl phenyl silicon oil Polyethylene glycol 50% (PEG4000S) Aqueous solution Saline Aqueous solution Aqueous solution Sodium hydroxide, NaOH Sulfuric acid 95% Aqueous solution Aqueous solution Tween 20 10% NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 116 9 Reference information 9.2 Chemical resistance Chemical Usage Aqueous solution Tween 80 10% Aqueous solution Urea 50% NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 117: Recycling Information
Waste electrical and electronic equipment must not be disposed of as unsorted munic- ipal waste and must be collected separately. Contact an authorized representative of the manufacturer for information concerning the decommissioning of the equipment. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 118: Regulatory Information
See page 9.4.1 Contact information 9.4.2 European Union and European Economic Area 9.4.3 Great Britain 9.4.4 North America 9.4.5 China 9.4.6 South Korea 9.4.7 General regulatory statements 9.4.8 Other regulations and standards NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 119: Contact Information
The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Global Life Sciences Solutions Canada ULC 4560 Tillicum St Burnaby, BC, V5J 5L4 Canada Telephone number of manufacturer +1 604 453 8660 NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 120: European Union And European Economic Area
• used according to the Operating Instructions or user manuals, and • used in the same state as it was delivered, except for alterations described in the Operating Instructions or user manuals. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 121: Great Britain
• used according to the Operating Instructions or user manuals, and • used in the same state as it was delivered, except for alterations described in the Operating Instructions or user manuals. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 122: North America
Note: The user is cautioned that any changes or modifications not expressly approved by Cytiva could void the user’s authority to operate the equip- ment. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.
Page 123: China
Declaration of Hazardous Substances (DoHS) 根据 SJ/T11364-2014《电子电气产品有害物质限制使用标识要求》特提供如下有关污染控制方面的信息。 The following product pollution control information is provided according to SJ/ T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 124 EFUP shall be done in accordance with the Product Maintenance Procedures. This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 125 Indicates that this hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB/T 26572 • Data listed in the table represents best information available at the time of publication. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 126: South Korea
When used in a residential environment, there is a concern of radio interference. 유의사항 A급 기기 (업무용 방송통신 기자재) 이 기기는 업무용환경에서 사용할 목적으로 적합성평가를 받 은 기기 로서 가정용 환경에서 사용하는 경우 전파간섭의 우려가 있습 니다. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 127: General Regulatory Statements
EMC emission, CISPR 11: Group 1, Class A statement NOTICE This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 128: Other Regulations And Standards
The following marking appears on the product to indicate compliance with radio-emis- sion regulations in the respective regions. Singapore Complies with IMDA Standards DA103787 The dealer licence number for Ignite and Ignite+ is DA103787. South Africa TA -2023/0699 Approved NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 129 The said legal communications means radio communica- tions is operated in compliance with the Telecommunications Management Act. The low power radio-frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 130: Ordering Information
Action Navigate to cytiva.com. Search for the product name or product category. Navigate to the relevant product page. Scroll to Product Specifications to find the product names, codes, and other ordering information. NanoAssemblr Ignite and Ignite+ Operating Instructions NIN1134 AA...
Page 131: Health And Safety Declaration Form
Service Ticket #: To make the mutual protection and safety of Cytiva service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, complete this checklist and present it to the Service Engineer upon arrival.
Page 132 To make sure the mutual protection and safety of Cytiva personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to Cytiva. To avoid delays in the processing of your equipment, complete this checklist and include it with your return.
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Page 134 QR code. cytiva.com Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corporation or an affiliate doing business as Cytiva. Ignite, Ignite+, NanoAssemblr, and NxGen are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.

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