Symbols and abbreviations ........................13 Emergency procedures ..........................17 System description .................... 20 Description of the Sefia S-2000 instrument ..................21 Touch screen user interface ........................27 Using the Sefia instrument in regulated environments ..............29 System log ................................ 31 Data privacy and security ...........................
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Eurasian Economic Union Евразийский экономический союз ....................175 9.4.5 Regulations for North America ....................... 177 9.4.6 Regulatory statements ..........................178 9.4.7 Declaration of Hazardous Substances (DoHS) ................179 Health and Safety Declaration Form ...................... 184 Sefia S-2000 Operating Instructions 29315810 AE...
This chapter contains important user information that you must read before operating the Sefia™ S-2000 cell processing instrument, and information about the user docu- mentation. In this chapter Section See page Important user information About this manual Associated documentation Sefia S-2000 Operating Instructions 29315810 AE...
• The user must read and understand the Safety instructions chapter in this manual. • The Sefia instrument must be installed and verified by a Service Engineer or Field Application Specialist from the manufacturer. Sefia S-2000 Operating Instructions 29315810 AE...
The manual covers BPAS version 2.0 and higher. See the separate Operator Manual supplied with the application for instructions on how to install a cell processing kit and perform cell separation with the Sefia S-2000 cell processing instrument.
Sefia instrument with BPAS 2.0 . Application Operator Manual for each Information needed to run the applica- application available for use with the tion on the Sefia instrument. Sefia S-2000 cell processing instrument Sefia S-2000 Operating Instructions 29315810 AE...
2 Safety instructions Safety instructions About this chapter This chapter describes safety precautions, labels and symbols that are attached to the equipment. In this chapter Section See page Safety precautions Symbols and abbreviations Emergency procedures Sefia S-2000 Operating Instructions 29315810 AE...
Follow the general precautions below. • Read all instructions before use. • Contact a Cytiva representative if you are unsure about any aspect of using the Sefia S-2000 instrument. • Only trained users should operate the system to ensure safe and effective use.
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• Direct sunlight or strong light sources. • Liquids or corrosive substances. • Physical shocks or vibrations. • Heavy weights. • Equipment that contains magnets or generates magnetic or electromagnetic fields. This includes devices such as mobile phones. Sefia S-2000 Operating Instructions 29315810 AE...
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Follow the precautions below when handling single-use kits. • Only use Sefia cell processing kits supplied by the manufacturer, in combination with the Sefia S-2000 instrument. The processing kits are supplied sterile and for single-use only. • Treat the used Processing Kit as biohazardous waste and follow local regulations for disposal of the kit.
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WARNING Follow the precautions below when using a USB flash drive. • Do not use the supplied USB flash drives for any use other than with the Sefia S-2000 instrument. • When transferring files from a computer to the USB flash drive, scan it with anti- virus software prior to inserting it into the instrument.
Alternating current (AC). Supply frequency Supply frequency (Hz). Power input Maximum power consumption (VA). Fuse rating Fuse rating: number of fuses, speed (T, slow acting), trip current (A), breaking capacity (H high), maximum voltage Sefia S-2000 Operating Instructions 29315810 AE...
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Pinch hazard. Located on the peristaltic pump. Power on. Power off. Symbols on the kit The following symbols may be present on the kit: Label Meaning Number of units included in each box of single-use consumables. Product number. Sefia S-2000 Operating Instructions 29315810 AE...
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Kit ID in barcode format that forms a unique traceability number. Sterilized using Ethylene oxide. STERILE EO Non-pyrogenic. Do not re-use. Minimum and maximum ambient temperature during operation. Use-by-date (YYYY-MM-DD). Do not use in case the package is damaged. Follow the Instructions for Use. Sefia S-2000 Operating Instructions 29315810 AE...
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2 Safety instructions 2.2 Symbols and abbreviations Label Meaning Name and address of the manufacturer. Sefia S-2000 Operating Instructions 29315810 AE...
Close all clamps on the processing kit to prevent any leakage if the stop- cocks are not automatically closed. Note: Stopcocks are closed when the blue arms of the stopcock are not aligned with any tubing line, as shown in the following illustration: Sefia S-2000 Operating Instructions 29315810 AE...
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On the control panel: Press the STOP button (or tap STOP on the touch screen) to abort the procedure. Result: All stopcocks are closed, and a confirmation dialog is shown. Close all clamps on the processing kit. Tap OK to confirm aborting the procedure. Sefia S-2000 Operating Instructions 29315810 AE...
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Restart the Sefia instrument and the application software. Recover cells from the process, using SmartResume if applicable, the Purge application, or manual purge with the pneumatic kit. Refer to the Operator Manual for the application for specific guidance about recovering cells. Sefia S-2000 Operating Instructions 29315810 AE...
This chapter gives an overview of the Sefia cell processing system, the control soft- ware, and accessories . In this chapter Section See page Description of the Sefia S-2000 instrument Touch screen user interface Using the Sefia instrument in regulated environments System log Data privacy and security...
3.1 Description of the Sefia S-2000 instrument Description of the Sefia S-2000 instrument Introduction This section provides a description of the main components in the Sefia S-2000 instru- ment, and illustrations of the different parts of the instrument. Main components The Sefia S-2000 instrument consists of the following main components: •...
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3 System description 3.1 Description of the Sefia S-2000 instrument Illustration of the instrument The following illustration shows the main parts of the Sefia S-2000 instrument. Part Description 1, 14 Handle: Use the handles for moving and lifting the instrument. At least two people are required to lift the instrument.
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3 System description 3.1 Description of the Sefia S-2000 instrument Part Description Optical line sensors: Uses the different light absorbency of the separated components to manage the automated separation procedure. Stopcock module: Rotary pins and stopcock cassette fixation system. Drip chamber support Control panel: Emergency STOP button and operating LEDs.
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3 System description 3.1 Description of the Sefia S-2000 instrument Part Description Rotary pin: Four rotary pins position the stopcocks of the kit to direct the flow of the separated components into the appropriate bag. Two fixation levers for the stopcock cassette...
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3 System description 3.1 Description of the Sefia S-2000 instrument The Sefia instrument provides both an electrical centrifugal drive and a pneumatic axial drive to the separation chamber in order to separate the processed product and transfer each component to the appropriate bag.
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3 System description 3.1 Description of the Sefia S-2000 instrument Rear panel components The following illustration shows the components on the rear panel of the Sefia instru- ment: Part Description USB1 to USB4: USB connectors for data storage, software installation, traceability, and Wi-Fi connectivity.
Footer with version and status information Menu system For each of the main menu items, further options are presented in the interaction window. The following illustration shows an example from the Settings menu, for editing default application parameters. Sefia S-2000 Operating Instructions 29315810 AE...
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Options to make the parameter visible and/or editable by the user (Administrators only) Select to go to the next level of parameter options (here: select the default value) Select to enable the parameter in the application. Sefia S-2000 Operating Instructions 29315810 AE...
Application parameter groups can be imported to the Sefia instrument, and different data are exported to Chronicle automation software, as described in the table below: Data direction Type of data Import from Chronicle automation soft- • Application parameter groups ware Sefia S-2000 Operating Instructions 29315810 AE...
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3.3 Using the Sefia instrument in regulated environments Data direction Type of data Export to Chronicle automation soft- • Real time monitoring of sensors ware • Alarms and errors (real time moni- toring) • Application parameters • System log Sefia S-2000 Operating Instructions 29315810 AE...
If there are any loopholes or compliance issues in the end user's enterprise network, Cytiva will not be liable for any data loss and/or data privacy and cybersecurity threats.
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Information collected for system diagnostics and support is not used by Cytiva for any other purpose. However, the user is responsible for ensuring the privacy of sensitive data, such as donor IDs in logs. The user is advised to collaborate with Cytiva in order to prevent any disclosure of sensitive information.
Parameter In operation Storage and transport Temperature +7°C to +27°C +4°C to 40°C Relative humidity 30% to 75%, non- 20% to 75%, non- condensing condensing Maximum altitude 2000 m, 80 kPa Sefia S-2000 Operating Instructions 29315810 AE...
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3 System description 3.6 Applications and processing kits Parameter In operation Storage and transport Pollution degree of the Pollution degree 2 intended environment Sefia S-2000 Operating Instructions 29315810 AE...
This section describes optional accessories for handling processing kits and isolating cells, and peripherals that are available for installing application software, storing data, reading barcodes and printing results. In this section Section See page 3.7.1 Accessories for processing kits 3.7.2 Peripherals Sefia S-2000 Operating Instructions 29315810 AE...
Accessories for processing kits Pneumatic kit for manual recovery A dedicated pneumatic kit, available from Cytiva, can be used to manually extract the contents of the separation chamber. The pneumatic kit applies pressure under the piston so that remaining content in the separation chamber can be recovered. This procedure can replace the automatic recovery procedure in case of power loss or failure of the Sefia instrument.
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3.7 Accessories 3.7.1 Accessories for processing kits Use the universal bag handler as shown in the illustration below: NOTICE The universal bag handler can hold up to 10 kg, do not exceed this weight. Sefia S-2000 Operating Instructions 29315810 AE...
Sefia barcode reader Datalogic™ 2270 USB flash drive Swissbit™ 14063 USB WiFi adapter Zyxel™ 29300935 Power cable C13 (IEC 60320-1) Japan – 2.0 m Schurter™ 6041 Power cable C13 (IEC 60320-1) Europe – 2.5 m Schurter Sefia S-2000 Operating Instructions 29315810 AE...
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Power cable C13 (IEC 60320-1) North America Schurter – 3.0 m 6081 Power cable C13 (IEC 60320-1) U.K. – 2.0 m Schurter 6082 Power cable C13 (IEC 60320-1) China – 2.0 m Schurter 6104 Ethernet cable - 3.0 m Distrelec Sefia S-2000 Operating Instructions 29315810 AE...
Chronicle automation software. About the delivery and installation The Sefia S-2000 instrument is shipped as two separate elements inside a cardboard box. A Service Engineer or Field Application Specialist from Cytiva will install and verify the system the first time.
Due to the weight, two people are required to lift and move the instrument in a safe way. WARNING Keep upright during transport. WARNING If moving the instrument to another location, it is the laboratory manager's responsibility to make sure it is installed correctly. Sefia S-2000 Operating Instructions 29315810 AE...
Pollution degree of the Pollution degree 2 intended environment Instrument ventilation NOTICE Do not block the air vents on the rear of the instrument. Heat output Component Heat output Sefia S-2000 instrument Maximum 1000 W Sefia S-2000 Operating Instructions 29315810 AE...
172). This section gives instructions for moving the Sefia instrument within the laboratory. If you need to transport the system to another site, please contact Cytiva for support. Lifting the Sefia instrument Two people are required to lift the Sefia instrument. Follow the steps below:...
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Section 4.2 Site environmental requirements, on page At the new location: connect accessories to the USB ports, and connect electrical power. Verify that the instrument starts normally and displays the login screen. Sefia S-2000 Operating Instructions 29315810 AE...
The power cord with plug must always be easy to disconnect. Connect USB accessories If a barcode reader is used, it is recommended to connect it to the USB5 port on the right side of the instrument: Sefia S-2000 Operating Instructions 29315810 AE...
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4.4 Electrical connections Connect other USB accessories to the USB1-USB4 ports on the rear panel of the Sefia instrument. Connect to the network (optional) Connect a network cable to the ETH1 port on the rear panel. Sefia S-2000 Operating Instructions 29315810 AE...
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Connect power Connect the supplied power cable from the Sefia instrument to a grounded wall outlet with supply voltage corresponding to the marking on the instrument. Connect any accessories to separate grounded wall outlets. Sefia S-2000 Operating Instructions 29315810 AE...
Insert an application installation USB flash drive into an unused USB port on the Sefia instrument. Tap Application Installation on the Settings menu. Result: The Application Installation screen is displayed, listing the applications that will be installed from the USB flash drive. Sefia S-2000 Operating Instructions 29315810 AE...
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The application parameters are reset in case of installation of a new version of an application. Result: The End-User License Agreement is shown. Tap Next if you accept the license agreement. Result: The activation screen is shown. Sefia S-2000 Operating Instructions 29315810 AE...
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Application Uninstallation. Tap Remove to confirm removal of the old version and proceed with the installation. Tap Keep if you want to keep the current version and abort the installation. Wait for the installation to complete. Sefia S-2000 Operating Instructions 29315810 AE...
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Tap Cancel if you do not want to install more applications. Result: A confirmation screen is displayed, saying Application installation routine finished. Tap Next to return to the main screen. It may take a few seconds until the main screen shown. Sefia S-2000 Operating Instructions 29315810 AE...
See page Managing users, for Administrators Reset passwords after BPAS upgrade Editing user details, for Operators Connecting the Sefia instrument to Chronicle automation software Connecting to Active Directory Installing a processing kit, important instructions Sefia S-2000 Operating Instructions 29315810 AE...
Sefia instrument. The instructions in this section are intended for users with Administrator role. In this section Section See page 5.1.1 User roles 5.1.2 User authentication 5.1.3 Create and edit users Sefia S-2000 Operating Instructions 29315810 AE...
• Supervisor (Advanced laboratory users with extended permissions) • Administrator (Laboratory administrator) • Service user (Cytiva personnel or a third party authorized by Cytiva) Administrator users and Service users can assign the user access rights for Oper- ator and Supervisor users. Service users have further access to all functionalities.
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• Operator • Supervisor • Administrator • Service Activity All users Operation Shutdown Logout Select, run, and stop application View, select, and use assigned parameters and traceability groups in application Run application Save summary files Sefia S-2000 Operating Instructions 29315810 AE...
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Save, view, and print report files Run Smart Resume Manage users Reset user’s own password locally (if local user management is used) Settings View partial system information View system “about” info page Set sound volume Sefia S-2000 Operating Instructions 29315810 AE...
Initial start-up and login The first time the Sefia instrument is started, an Administrator must log in and create accounts for other users. Sefia S-2000 Operating Instructions 29315810 AE...
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On the login screen, enter the default User ID and Password. Tap Login. Result: A message is displayed saying that this is your first connection, and you need to set a new password. Tap Continue. Result: A password reset screen is shown. Sefia S-2000 Operating Instructions 29315810 AE...
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Result: A message is displayed saying that your password has been successfully changed. Tap Continue to complete the login. Result: The device test starts. When the test is completed, the Applications screen is shown. Sefia S-2000 Operating Instructions 29315810 AE...
Tap Users to set up or edit user accounts. Add a new user The Users menu enables an Administrator to setup local user accounts on the Sefia instrument. Follow the steps below to add a new user: Sefia S-2000 Operating Instructions 29315810 AE...
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Tap User ID and enter the user ID using the displayed keyboard. Tap Save. Tap Role and select the role for the new user (see Section 5.1.1 User roles, on 56). Tap Save. page Result: A Save button is added to the New user menu. Sefia S-2000 Operating Instructions 29315810 AE...
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Write down the password and tap Continue. Tap Save to return to the Users menu. Result: The new user name is listed, and the role is shown in the green area below the user ID. Sefia S-2000 Operating Instructions 29315810 AE...
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The menu for the selected user is shown. Tap Edit User. Result: The user details screen is shown: Edit the user's Role, First Name, Middle Name, Last Name, or Identity. The User name cannot be changed. Sefia S-2000 Operating Instructions 29315810 AE...
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Write down the password and tap Continue. Tap Users to return to the list of users. Delete user To delete a user: Step Action Tap the user name on the Users menu. Tap Delete User on the selected user's menu. Sefia S-2000 Operating Instructions 29315810 AE...
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5.1.3 Create and edit users Step Action Result: A confirmation screen is shown. Tap Continue to confirm that you want to delete the user. Tap Cancel if you decide not to delete the user. Sefia S-2000 Operating Instructions 29315810 AE...
Instructions for unlocking a user account after BPAS upgrade Follow the steps below to reset the password and unlock a user account: Step Action Tap Access Management on the Settings menu. Sefia S-2000 Operating Instructions 29315810 AE...
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The Users screen is shown, listing available users. Select the user you want to unlock. Result: The menu for the selected user is shown. Tap Edit User. Result: The user details screen is shown. Sefia S-2000 Operating Instructions 29315810 AE...
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Write down the temporary password and tap Continue. The user must change the password at the first login. Tap the Access Enabled toggle switch to unlock the user account. Result: The toggle switch changes to green to indicate that the user account is enabled. Sefia S-2000 Operating Instructions 29315810 AE...
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5 Preparation 5.2 Reset passwords after BPAS upgrade Step Action Tap Users to return to the list of users. Sefia S-2000 Operating Instructions 29315810 AE...
Operators can edit a few details in their accounts. Follow the steps below to edit your details: Step Action On the Settings menu, tap Access Management. Tap Users on the Access Management menu. On the Users menu, tap your user name. Sefia S-2000 Operating Instructions 29315810 AE...
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Optionally edit Identity that will be shown in reports. Tap Save to save the changes and return to your user menu. Change password (operator) Follow the steps below if you need to change your password: Sefia S-2000 Operating Instructions 29315810 AE...
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5 Preparation 5.3 Editing user details, for Operators Step Action Tap Users on the Access Management menu. On the Users menu, tap your user name. On you user menu, tap Change Password. Sefia S-2000 Operating Instructions 29315810 AE...
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Enter your current password in the Old Password field. Enter your new password in the New Password and Confirmation fields. Tap Reset Result: A message is displayed saying that your password has been successfully changed. Sefia S-2000 Operating Instructions 29315810 AE...
Sefia instrument. The instrument is registered in Chronicle at the first connec- tion. Chronicle settings To connect the Sefia instrument to Chronicle automation software, enter the Connec- tivity menu: Step Action On the Settings menu, tap Connectivity. On the Connectivity menu, tap Chronicle. Sefia S-2000 Operating Instructions 29315810 AE...
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Connected. Chronicle is displayed next to a green oval at the lower left of all screens to show the connected state. Once the connection is established, Current status changes to Connected, and Chronicle is displayed next to a green oval at the lower left of the screen. Sefia S-2000 Operating Instructions 29315810 AE...
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5 Preparation 5.4 Connecting the Sefia instrument to Chronicle automation software Step Action Note: If the Chronicle server is not available, the oval is displayed in orange: Sefia S-2000 Operating Instructions 29315810 AE...
5. If the LDAP user name is new or changed, this user name or any changed informa- tion is stored in the local database. LDAP settings To connect the Sefia instrument via LDAP to an Active Directory server: Sefia S-2000 Operating Instructions 29315810 AE...
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5 Preparation 5.5 Connecting to Active Directory Step Action On the Settings menu, tap Connectivity. On the Connectivity menu, tap LDAP. Sefia S-2000 Operating Instructions 29315810 AE...
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The user roles of the Sefia instrument are displayed: Tap a user role and enter the corresponding LDAP user group. Result: The mapped LDAP user group is shown below the user role of the Sefia instrument : Sefia S-2000 Operating Instructions 29315810 AE...
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LDAP variable. Tap the LDAP to return to the LDAP settings menu. Tap the Activated toggle switch to activate the LDAP connection. Result: The toggle switch changes to green. Users will be authenticated via LDAP and must use their LDAP user names and passwords. Sefia S-2000 Operating Instructions 29315810 AE...
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(2) of an LDAP user. Testing the LDAP connection To test the LDAP connection to the Active Directory server: Step Action On the LDAP Settings menu, swipe up and tap Test connectivity. Sefia S-2000 Operating Instructions 29315810 AE...
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If there is an error, make sure that the LDAP settings are correct, and that the LDAP connection is activated. If VPN is used to access the LDAP direc- tory, this must also be activated. Sefia S-2000 Operating Instructions 29315810 AE...
Do not rotate the elbow connector on top of the separation chamber after closing the covers. Follow the steps below to install the separation chamber. Step Action Open the two separation chamber pit covers. Sefia S-2000 Operating Instructions 29315810 AE...
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Insert the separation chamber into the pit and firmly push it down. Close the chamber pit covers and tighten the cover lock (rotary seal) by pressing and rotating clockwise. CAUTION Clear the thermal mixer area before starting the proce- dure. Sefia S-2000 Operating Instructions 29315810 AE...
6 Operation Operation About this chapter This chapter provides instructions on how to operate the Sefia S-2000 instrument in a safe way. For application specific Operator Manuals, contact us, see Contact information for support, on page 172. In this chapter...
Follow the steps below to start the Sefia instrument and log in. Note: Start-up may take up to one minute depending on the attached peripherals and network connections. Step Action Switch the ON/OFF switch to the ON position (l). Result: The login keyboard is shown. Sefia S-2000 Operating Instructions 29315810 AE...
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Logging in for the first time The first time you log in to the Sefia instrument, you must use the temporary password provided by your system Administrator. Sefia S-2000 Operating Instructions 29315810 AE...
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End User License Agreement. Tap Login to continue. Result: A message is displayed saying This is your first connection, you need to create a new password. Tap Continue. Result: The password reset screen is shown. Sefia S-2000 Operating Instructions 29315810 AE...
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Enter the new password in the New Password and Confirmation, and tap Reset. Result: A message is displayed saying that your password has been successfully changed. Tap Continue to complete the login. Logging out from the Sefia instrument To log out from the Sefia instrument: Sefia S-2000 Operating Instructions 29315810 AE...
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A message is shown: Are you sure you would like to shut down Sefia?. There is also a message reminding the user to switch off the power to the instrument when the screen turns black. Sefia S-2000 Operating Instructions 29315810 AE...
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Tap Continue to confirm the shutdown. Tap Cancel if you don't want to shut down the instrument right now. Shutdown takes around one minute, until the screen turns black. Once shutdown has completed, press the ON/OFF switch to the OFF posi- tion (O). Sefia S-2000 Operating Instructions 29315810 AE...
To save any summary and report files in local mode: Step Action Select Data from the main menu. Insert the supplied USB flash drive into a free USB port on the Sefia instru- ment, and tap Continue. Sefia S-2000 Operating Instructions 29315810 AE...
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Remove the USB flash drive from the Sefia instrument, and connect it to a computer. It will appear as an external hard drive. If you encountered a problem during the run, send the files and a description to Cytiva. Section 9.1 Get Help, on page 166.
Swipe up and down to see every Action performed on the system. Filter the actions by tapping Date, User or Category. Tap Apply to apply the selected filter. To remove all filters, tap Clear. Sefia S-2000 Operating Instructions 29315810 AE...
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When the message Saving done is shown, remove the USB flash drive and tap Continue. To view the exported System Log Report, insert the USB flash drive into a computer and open the PDF of the latest System Log Report from the User folder. Sefia S-2000 Operating Instructions 29315810 AE...
The settings are only accessible for users with Administrator role. Open the Settings menu To change local settings: Step Action Tap Settings. The following screen is shown: Swipe up to see more settings: Sefia S-2000 Operating Instructions 29315810 AE...
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Chronicle automation software and other systems connected to Chronicle. If daylight time saving is used, tap the toggle switch Set daylight time saving automatically. Adjusting the sound level Tap the volume button and select the desired level: Sefia S-2000 Operating Instructions 29315810 AE...
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6 Operation 6.4 Changing general settings Changing the language Step Action On the Settings menu, tap Language. Select language: Changing regional settings Step Action On the Settings menu, tap Regional Settings. Sefia S-2000 Operating Instructions 29315810 AE...
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Step Action On the Settings menu, tap Traceability. Result: The Traceability screen is shown: Tap the toggle switch Auto Print to enable or disable automatic printing of reports at the end of procedures. Sefia S-2000 Operating Instructions 29315810 AE...
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Sefia instrument: software version, serial number of the instrument, and other technical information. The following image shows the system information that is presented for an Operator user: About Copyright and trademarks information. Sefia S-2000 Operating Instructions 29315810 AE...
Set up a parameter group Follow the steps below to set up a parameter group: Step Action Tap Applications Parameters on the Access Management menu. Select the application for which you want to create a parameter group. Sefia S-2000 Operating Instructions 29315810 AE...
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The Select Group menu appears, showing existing parameter groups, as well as functions to Add a new Group and Duplicate a Group. To create a new parameter group, tap Add a new Group. Result: The New Group screen is displayed. Sefia S-2000 Operating Instructions 29315810 AE...
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Enter the name of the new group on the displayed keyboard. Result: A Save button appears, and the name of the new group is shown. Tap Save to return to the Select Group screen. Result: The new parameter group is added to the list. Sefia S-2000 Operating Instructions 29315810 AE...
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6.5 Setting up application parameters Step Action Duplicate a parameter group Follow the steps below to duplicate a parameter group: Step Action On the Select Group menu, tap Duplicate a Group. Result: The Duplicate Group screen is displayed. Sefia S-2000 Operating Instructions 29315810 AE...
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Result: A Save button appears, and the name of the new group is shown. Tap Save to return to the Select Group screen. Result: The new parameter group is added to the list. Sefia S-2000 Operating Instructions 29315810 AE...
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6 Operation 6.5 Setting up application parameters Step Action Set up application parameters Follow the steps below to set up application parameters: Step Action Select a parameter group from the Select Group menu. Sefia S-2000 Operating Instructions 29315810 AE...
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Clear the check box for users who should not have access. Tap the All Operators toggle switch to select all users with Operator role. Tap the back arrow to return to the Select Parameter Category menu for the selected parameter group. Sefia S-2000 Operating Instructions 29315810 AE...
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For editable parameters, tap the arrow (3) to adjust the default value. Tap the toggle switch (4) to enable or disable parameters application. Tap the back arrow to return to the Select Parameter Category menu. Sefia S-2000 Operating Instructions 29315810 AE...
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6 Operation 6.5 Setting up application parameters Step Action To delete the parameter group, tap Delete Group. Tap Continue to confirm the deletion of the group. Sefia S-2000 Operating Instructions 29315810 AE...
Set up a traceability group Follow the steps below to set up a traceability group: Step Action Select Applications Parameters from the Access Management menu. Select the application for which you want to create a traceability group. Sefia S-2000 Operating Instructions 29315810 AE...
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The Select Group menu appears, showing existing traceability groups, as well as functions to Add a new Group and Duplicate a Group. To create a new traceability group, tap Add a new Group. Result: The New Group screen is displayed. Sefia S-2000 Operating Instructions 29315810 AE...
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Enter the name of the new group on the displayed keyboard. Result: A Save button appears, and the name of the new group is shown. Tap Save to return to the Select Group screen. Result: The new traceability group is added to the list. Sefia S-2000 Operating Instructions 29315810 AE...
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6 Operation 6.6 Setting up traceability Step Action Duplicate a traceability group To duplicate a traceability group: Step Action On the Select Group menu, tap Duplicate a Group. Result: The Duplicate Group screen is displayed. Sefia S-2000 Operating Instructions 29315810 AE...
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Result: A Save button appears, and the name of the new group is shown. Tap Save to return to the Select Group screen. Result: The new traceability group is added to the list. Sefia S-2000 Operating Instructions 29315810 AE...
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Follow the steps below to define the users who should have access to traceability parameter groups, and to select the traceability parameters that should be visible. Step Action Select a traceability group from the Select Group menu. Sefia S-2000 Operating Instructions 29315810 AE...
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Clear the check box for users who should not have access. Tap the All Operators toggle switch to select all users with Operator role. Tap the back arrow to return to the Select Parameter Category menu for the selected traceability group. Sefia S-2000 Operating Instructions 29315810 AE...
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Tap the back arrow to return to the Select Parameter Category menu. To delete the traceability group, tap Delete Group. Tap Continue to confirm the deletion of the group. Sefia S-2000 Operating Instructions 29315810 AE...
In this section Section See page 6.7.1 Importing and duplicating parameters from Chronicle 6.7.2 Synchronizing application parameters with Chronicle automation software 6.7.3 Monitoring applications from Chronicle automation soft- ware 6.7.4 Exporting historical data to Chronicle Sefia S-2000 Operating Instructions 29315810 AE...
Import parameter groups from Chronicle Follow the steps below to import parameter groups that have been set up in Chronicle: Step Action In the Settings menu, tap Access Management. On the Access Management menu, tap Applications Parameters. Sefia S-2000 Operating Instructions 29315810 AE...
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Select the application for which you want to import parameters: On the Select Group Category menu, tap Parameter Groups Result: The Select Group menu appears, showing existing parameter groups, as well as functions to Add a new Group and Duplicate a Group. Sefia S-2000 Operating Instructions 29315810 AE...
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6.7 Working with Chronicle automation software 6.7.1 Importing and duplicating parameters from Chronicle Step Action Select a parameter group that is marked with the Chronicle icon: On the Select Parameter Category menu, tap Users Access. Sefia S-2000 Operating Instructions 29315810 AE...
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The parameters for the selected group are imported from Chronicle. If previ- ously imported, the parameters are synchronized to use the latest param- eter values. The parameters are read-only and cannot be edited from the Sefia instrument. Sefia S-2000 Operating Instructions 29315810 AE...
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Enter the name of the new local parameter group on the displayed keyboard. Result: A Save button appears, and the name of the new group is shown. Tap Save to return to the Select Group screen. Sefia S-2000 Operating Instructions 29315810 AE...
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6 Operation 6.7 Working with Chronicle automation software 6.7.1 Importing and duplicating parameters from Chronicle Step Action Result: The new parameter group is added to the list. Sefia S-2000 Operating Instructions 29315810 AE...
2. During synchronization, the message Chronicle syncing is displayed on a green background. View parameter groups from Chronicle To view parameter groups that have been imported from Chronicle: Step Action Wait for syncing to finish (Chronicle syncing has disappeared). Sefia S-2000 Operating Instructions 29315810 AE...
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On the Applications screen, select an application. Result: A list of parameter groups for the application is shown. Swipe until you see a Chronicle parameter group, identified by the icon: Tap View all to see all parameters in the group. Sefia S-2000 Operating Instructions 29315810 AE...
Chronicle automation software. For details of the selected application, see the Operator Manual for the application. Step Action On the Applications screen, select the application you want to run. Sefia S-2000 Operating Instructions 29315810 AE...
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Continue to follow the guidance in the application. Monitor the run via the graphs displayed in Chronicle: Temperature, Volume, Weight and Centrifuge. After the run, see the report from the run, in Chronicle, under Data logs. Sefia S-2000 Operating Instructions 29315810 AE...
For each log that is successfully exported, a status message is displayed in the Connectivity settings for Chronicle: In Chronicle, the imported logs will be visible under Data logs for the selected Sefia instrument. Sefia S-2000 Operating Instructions 29315810 AE...
The Mix Mode application is shown together with other installed applications on the Applications screen. The Mix Mode application regulates the temperature of the thermal mixer and sets the thermal mixer in motion. Sefia S-2000 Operating Instructions 29315810 AE...
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The thermal mixer starts to move and the temperature regulation begins. To return to the Applications screen without starting Mix Mode, tap Exit. Mix Mode settings The following settings are available in the Mix Mode application: Sefia S-2000 Operating Instructions 29315810 AE...
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During the Mix Mode procedure, the following screen is displayed. See the table below for descriptions of the measured parameters. Parameter Description Running time Running time in hours, minutes and seconds IR Temperature Temperature monitored in the bag placed in the thermal mixer Sefia S-2000 Operating Instructions 29315810 AE...
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If you update any of the settings during the mixing, tap Stop and then immediately tap Start to resume the operation with the new configuration. To stop the mixing, tap Stop. The thermal mixer returns to its original position and the temperature regulation is stopped. Sefia S-2000 Operating Instructions 29315810 AE...
7 Maintenance Maintenance About this chapter This chapter provides instructions for cleaning the Sefia S-2000 instrument. WARNING Do not attempt to clean any internal parts of the instrument. This should be done by an approved technician as fluid entering the instrument can adversely affect its performance.
Clean the Sefia instrument on a regular basis: • weekly, or • after any incidents such as leakage Service The Sefia instrument should be serviced every 1000 procedures, or once per year at a minimum. Sefia S-2000 Operating Instructions 29315810 AE...
WARNING Wear rubber gloves and a protective gown to prevent direct skin contact with any spilled product. Follow the steps below to clean the outer surfaces of the Sefia S-2000 instrument. Step Action Switch the ON/OFF switch to the OFF position (O) to prevent electric shock.
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. Sefia S-2000 Operating Instructions 29315810 AE...
In addition, methods for purging the contents of the separation chamber are described. In this chapter Section See page General troubleshooting Warning messages Error messages Purge mode Manual purge How to get help Sefia S-2000 Operating Instructions 29315810 AE...
Sefia instrument. Motor-driven rotary pins in the stopcock module move the stopcocks to appropriate positions during the process. The following illustration shows an example of a stopcock cassette. Note: The numbering of the stopcock ports can differ between processing kits. Sefia S-2000 Operating Instructions 29315810 AE...
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You need to resume the procedure using SmartRe- sume, or restart the application with a new kit after recovering the cellular product. The illustrations below show examples of a warning and an error message. Warning Error message Sefia S-2000 Operating Instructions 29315810 AE...
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8.1 General troubleshooting Warnings and errors, instructions When the Sefia instrument shows a warning or error message, it is important to collect the relevant information and provide feedback to Cytiva. Follow the steps below: Step Action Write down the message.
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If a kit with other line numbering is used, the stopcock configurations will differ. For detailed information, see the application Operator Manual. Bag selection Stopcock configuration Bag selection Stopcock configuration All open All closed Sefia S-2000 Operating Instructions 29315810 AE...
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8 Troubleshooting 8.1 General troubleshooting Bag selection Stopcock configuration Bag selection Stopcock configuration Line 1 Line 2 Line 3 Line 4 Line 5 Line 6 Line 7 Line 8 Sefia S-2000 Operating Instructions 29315810 AE...
Description: Continuous flow step of cell concentration phase does not progress. Corrective action: Verify tubing of the waste line - line 9: Step Action Clamps are open. Tubing is correctly inserted in the peristaltic pump. Sefia S-2000 Operating Instructions 29315810 AE...
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Restart the kit test. Verify drip chamber Description: Air is detected in the drip chamber during the final phase of priming. Corrective action: Verify and properly place the drip chamber in its holder. Validate to continue. Sefia S-2000 Operating Instructions 29315810 AE...
Turn off the Sefia instrument, wait for 5 minutes, then restart. Re-launch the procedure. If the error persists, contact us. HCM high temperature Error ID: 10016, 10021, 10026, 10041 Description: HCM module high temperature. Corrective action: Sefia S-2000 Operating Instructions 29315810 AE...
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Description: Too high temperature related to the piston / piston microcontroller sensor. Corrective action: Step Action Turn off the Sefia instrument, wait for 5 minutes, then restart. Re-launch the procedure. If the error persists, contact us. Cover high temperature Error ID: 11820 Sefia S-2000 Operating Instructions 29315810 AE...
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If debris is found and removed, resume the procedure. If no debris is found and the error persists, recover the product using another instrument or a validated procedure, then contact us. Centrifuge overspeed Error ID: 11101 Description: Overspeed detected on the centrifuge block. Sefia S-2000 Operating Instructions 29315810 AE...
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Should the error persist, contact us. Weight sensor error Error ID: 12200, 12201, 12202, 12203, 12204, 12210, 12220 Description: Error related to the weight sensors Corrective action: Step Action Follow the screen prompts. Remove all bags from the hooks. Sefia S-2000 Operating Instructions 29315810 AE...
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Line-out pressure error Error ID: 12110, 12111 Description: The pressure in the chamber output line is too low or too high. Corrective action: Step Action Verify that clamps are open and stopcocks are correctly aligned. Sefia S-2000 Operating Instructions 29315810 AE...
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Switch off and restart the Sefia instrument. If the error persists, contact us. Piston unstable Error ID: 11800 Description: Position of the piston is detected as unstable. Corrective action: Step Action Follow the screen prompts. Resume the procedure. Sefia S-2000 Operating Instructions 29315810 AE...
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Error ID: 10133 Description: The emergency STOP button was pressed. Corrective action: Step Action Acknowledge the error message and follow the screen prompts. Continue operating the Sefia instrument as usual. If the error persists, contact us. Sefia S-2000 Operating Instructions 29315810 AE...
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Follow the screen prompts. Turn off and restart the Sefia instrument. If the error persists, contact us. Incorrect shutdown was detected Error ID: 13340 Description: The instrument was started after a previous incorrect shutdown. Corrective action: Sefia S-2000 Operating Instructions 29315810 AE...
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8 Troubleshooting 8.3 Error messages 8.3.1 Error messages from the Sefia instrument Step Action Follow the screen prompts. Tap OK and continue as normal. To prevent this message, follow the shutdown procedure. Sefia S-2000 Operating Instructions 29315810 AE...
If you have already installed the kit on the Sefia instrument, go directly to Open clamp, on page 159. Install the processing kit Step Action Select the Purge application from the Applications menu. Sefia S-2000 Operating Instructions 29315810 AE...
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Open clamp Step Action Follow the onscreen prompts and open the clamp between the separation chamber and your desired destination bag. Make sure that all other clamps remain closed. Confirm the message on the screen. Sefia S-2000 Operating Instructions 29315810 AE...
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Tap Stop if you need to stop the extraction. Complete post-procedure actions A message is shown when the separation chamber purge is completed. Follow the instructions on the screen: Step Action Close all the clamps. Tap Next to close the application. Sefia S-2000 Operating Instructions 29315810 AE...
(otherwise the content of the separation chamber will flow towards those air filters). If you really need to remove them, make sure that clamp scissors (not provided by Cytiva) are placed as close as possible to the air filters. Remove the processing kit from the instrument.
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Thanks to a valve inside the pneumatic kit, the syringe does not need to be removed before pulling out the piston. No air comes into contact with the product when pushing and pulling the piston of the syringe. Sefia S-2000 Operating Instructions 29315810 AE...
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8 Troubleshooting 8.5 Manual purge Step Action Once the separation chamber piston has reached the top of the chamber, close all the clamps and return the stopcocks to the initial positions as shown below: Sefia S-2000 Operating Instructions 29315810 AE...
Section 8.1 General troubleshooting, on page 141 for more information. If you cannot find the troubleshooting information you need, please contact our tech- nical support via the Cytiva web portal, see Section 9.1 Get Help, on page 166. Sefia S-2000 Operating Instructions 29315810 AE...
9 Reference information Reference information In this chapter Section See page Get Help Technical specifications Recycling information Regulatory information Health and Safety Declaration Form Sefia S-2000 Operating Instructions 29315810 AE...
Get Help Introduction You can submit your case online by creating an account on the Cytiva Web Portal at cytiva.com. You will then have the option to click on My Account and select Support Cases to directly report on the event.
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9 Reference information 9.1 Get Help • Any other relevant files to support the case (results of specific tests performed, proof of delivery, etc.) Sefia S-2000 Operating Instructions 29315810 AE...
1700 to 8000 rpm Overspeed protection 8800 rpm Accuracy: ± 1.5% Noise level 70 dB (A) or lower. Processing capacity Note: The processing capacity depends on the specific Sefia software application and cell processing kit combination. Sefia S-2000 Operating Instructions 29315810 AE...
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9 Reference information 9.2 Technical specifications Parameter Value Initial volume 50 mL to 10 L Final volume > 8 mL Sefia S-2000 Operating Instructions 29315810 AE...
Waste electrical and electronic equipment must not be disposed of as unsorted munic- ipal waste and must be collected separately. Please contact an authorized representa- tive of the manufacturer for information concerning the decommissioning of the equipment. Sefia S-2000 Operating Instructions 29315810 AE...
9.4.1 Contact information 9.4.2 European Union and European Economic Area 9.4.3 Great Britain 9.4.4 Eurasian Economic Union Евразийский экономический союз 9.4.5 Regulations for North America 9.4.6 Regulatory statements 9.4.7 Declaration of Hazardous Substances (DoHS) Sefia S-2000 Operating Instructions 29315810 AE...
The table below summarizes the required manufacturing information. Requirement Information Name and address of the legal manu- Biosafe S.A. facturer Route du Petit-Eysins 1 1262 Eysins Switzerland Telephone number of the legal manu- + 41 22 365 27 27 facturer Sefia S-2000 Operating Instructions 29315810 AE...
• 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. Sefia S-2000 Operating Instructions 29315810 AE...
• 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. Sefia S-2000 Operating Instructions 29315810 AE...
Telephone: +7 499 609 15 50 E-mail: rucis@cytiva.com Информация о производителе и импортере В следующей таблице приводится сводная информация о производителе и импортере, согласно требованиям Технических регламентов Таможенного союза и (или) Евразийского экономического союза. Sefia S-2000 Operating Instructions 29315810 AE...
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Member States of the Customs Union of the Eurasian Economic Union Данный знак о Евразийском соответствии указывает, что изделие одобрено для использования на рынках государств-членов Таможенного союза Евразийского экономического союза Sefia S-2000 Operating Instructions 29315810 AE...
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.
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. Sefia S-2000 Operating Instructions 29315810 AE...
Periodic replacement of those consumables or parts to maintain the declared 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. Sefia S-2000 Operating Instructions 29315810 AE...
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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. Sefia S-2000 Operating Instructions 29315810 AE...
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.
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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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