Thermo Fisher Scientific SECURE-Spin Operating instructions

Type
Operating instructions
SECURE-Spin
for Thermo Scientific Multifuge X Pro / Sorvall X Pro Centrifuges
Instruction Manual
50167381-a • 06 / 2022
Contents
Activating SECURE-Spin � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 3
1� User Management � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
1� 1� Initial Startup � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 4
1� 2� User Settings � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 6
1. 2. 1. Login . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1. 2. 2. Search for Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1. 2. 3. Edit User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1. 2. 4. Add User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1. 2. 5. Password Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1. 2. 6. Login with expired password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1. 2. 7. Login with temporary password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1. 2. 8. Change a password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1. 2. 9. Deactivate & Reactivate User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1. 2. 10. Change password expiry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1. 2. 11. Change temporary password expiry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2� Centri-Log Plus � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 18
3� GMP � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 19
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This instruction manual refers to the SECURE-Spin features of the centrifuge.
SECURE-Spin (Cat. No. 75009990) adds advanced features to the centrifuge, including but not limited to:
Secure Mode involving user rights and data management.
connection to Centri-Log Plus¹ data management software (Cat. No. 75007742) via network.
GMP Mode² guiding user through a GMP workflow.
allowing use of Sample Tracking Kit¹,² (Cat. No. 75007740) or Sample Tracking Kit TT¹,² (Cat. No. 75007743).
¹ sold separately
² requires Centri-Log Plus
Activating SECURE-Spin
1. Go to the screen for “Access Control”/”Users”. Tap Activate Advanced Access Control.
2. The next screen shows the device code, required to generate the license key. Submit this device code together with the order for
the license key.
3. When the license key for this centrifuge is available, tap Activate to continue the activation process.
4. Enter the license key. The license key has 20 characters.
Tap Save or the Keyboard symbol .
5. Tap Activate.
6. The license key is validated by the software.
7. If the license key is valid the SECURE-Spin features will be activated.
A pop up screen shows as confirmation. Tap OK.
NOTICE If the license key is not valid the SECURE-Spin features will not be activated. A pop up screen shows this. Start the activation sequence
again and make sure the license key is entered correctly. If you have further issues, contact the customer service.
8. Restart the centrifuge to restart the software and finish the activation of the SECURE-Spin features.
After the restart the SECURE-Spin features are available.
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User Management
1. User Management
Make sure you have activated the Secure Mode on your device using the Activate Advanced Features button in the “Users” settings.
1. 1. Initial Startup
In the initial startup sequence you may choose to select Secure Mode for the centrifuge. If you do so, you will be asked to create an
administrator account (Figure 1). In this screen, fill in the required information by tapping on the First Name field, enter the first name,
and click Next on the keypad for the next field.
Figure 1: Administrator Account creation in initial setup
Figure 2: Missing field in account creation
Tap the Next button on the bottom of screen when you filled in all required fields. Any potentially invalid or missing fields will be highlighted
(Figure 2). If all the information was correct the initial startup sequence takes you to a list of security questions (Figure 3).
Figure 3: Security Questions in initial setup
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User Management
In this security questions screen you are required to select and answer three security questions to secure your administrator account. In
case you forgot your password, you may reset the password by answering your selected questions.
To set the security questions for your account, tap on any three questions you want to answer and set your answer by filling in the
appearing field (Figure 4).
Figure 4: Selected security question in Initial Setup
Tap the Next button when you answered three questions. The Initial Setup process will continue.
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User Management
1. 2. User Settings
Tapping the Users button on the “Settings” screen takes you to the “Users" screen (Figure 6). To access this screen, a valid administrator
account is required. If you are not logged in with an admin account, a popup is displayed where you can change to an admin account.
Refer to "1. 2. 1. Login" for details.
After logging in, the device takes you to the "Users" screen. This screen allows you to switch between "Open Mode" and "Secure Mode".
Figure 5: Open Mode in Users screen
Figure 6: Secure Mode in Users screen
While the “Users” screen in “Open Mode” allows you to change the Admin Passcode (Figure 5), the "Secure Mode" shows a list of all
users on your centrifuge including the user's Name, Username and Role (Figure 6).
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User Management
1. 2. 1. Login
For certain features, an account is required. You might either be asked to login when you try to access screens such as the “Users”
screen, or you may login using the Login button in the upper right corner of the main screen. In both cases, a login popup will be
displayed in where you are asked to enter your username and password (Figure 7). You may tap the eye button to hide or show the
password you entered. Tap the Login button to submit your username and password. If your values are correct, the popup will close.
If the password or username is incorrect, the respective field will be highlighted (Figure 8).
Figure 7: Login Popup
Figure 8: Incorrect password in Login popup
It is possible that your account’s role does not satisfy the required rights for the operation you wanted to access initially. In this case, a
popup is displayed to inform you about the required role, and you will be taken back to the “Login” popup.
Under certain circumstances, additional action is required upon login. The following cases are possible:
Expired password: In case your password has expired since your last login, a popup appears to inform you about the password
expiration. Refer to "1. 2. 8. Change a password" for details on how the change the expired password. You will not be able to
login without changing your password.
Temporary password: In case you logged in using a temporary password, you will be prompted to set a new password. You may
close this popup without changing your password, but you will be asked to change the temporary password every time you are
logging in with this account.
Security Questions: In case you logged in with an Admin account and have not answered the security questions, you will be
prompted to provide the answers to the security questions.
NOTICE You may skip the security questions for any admin user except for the initial admin account. Please note that it is highly recommended to
answer the three security questions in case you need to reset the admin password. If you didn’t answer the questions, only another admin user can
reset the password of an admin account.
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User Management
1. 2. 2. Search for Users
You may use the magnifier button to search for users. Tap on the button and enter the name you are looking for in the popup (Figure 9).
Then tap the hook button to apply your search criteria. The user list will show users according to your search. Tap the magnifier button
again to close the search popup and return to the complete user list.
Figure 9: Search popup in Users screen
1. 2. 3. Edit User
To edit a User, tap the arrow button in the "Users" screen. Please note that only Admins have access to all user profiles. Basic users and
Advanced users can edit their own user account only.
In the following "Edit User" screen, you can find the details on the selected user and, depending on the role of the user who has logged
in, several actions on the buttons at the bottom of the screen.
The Save button is available for all user roles and can be used when you want to change any of the user's information (Figure 10).
Figure 10: Editing a user in Users settings
To do so, first change the details in the respective fields. The following information can be changed:
First Name
Last Name
Email
Password (Only for the user who has logged in to the software)
Role (Only if an Admin has logged in)
Tap the Save button to confirm your changes. Any invalid values will be highlighted (Figure 11).
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User Management
Figure 11: Wrong password in user edit
1. 2. 4. Add User
You may add Users from the "Users" screen if you are logged in with a valid Admin account.
Proceed as follows to create and store a new user:
1. Tap the Add User button on the "Users" Screen.
2. The “Add New User” screen appears (Figure 12).
Figure 12: Add New User screen
3. Tap the First Name field.
4. A keypad appears on top of the "Add New User" screen.
5. Enter a first name of maximum 30 characters length.
6. Tap Next on the keypad.
7. Enter a last name of maximum 30 characters length.
8. Tap Next on the keypad.
9. Enter a valid Email-address.
10. Tap Next on the keypad.
11. Enter a username that doesn't exist yet.
12. If you want to let the system create a temporary password, check the respective checkbox. If not, proceed to enter the password
by tapping on Next on the keypad.
13. If you didn't choose to create a temporary password, enter a valid password in the field. Note that a valid password must be between
6 and 12 characters long and contain at least one uppercase character, one lowercase character, one number and one symbol.
You may tap the eye button to show or hide the text you entered in this field.
14. Tap Next on the keypad.
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User Management
15. If you didn't choose to create a temporary password, confirm your password by entering it a second time. Again, you may tap the
eye button to show or hide the text you entered in this field.
16. Select the role for the user you want to create. Refer to Table 1 for details about the available user roles.
17. Click the Save button to save your data. If any fields are missing or are invalid, they are highlighted for you to correct them.
18. When the user was created successfully, a "New User Created" popup appears (Figure 13). Tap the OK button to confirm your user
creation.
Figure 13: User Created popup
If you selected the temporary password, as new popup will appear that shows the new temporary password (Figure 14). Make sure
to remember or note the temporary password since you can’t look it up later.
Figure 14: Temporary password popup
Tap the OK button to confirm the temporary password.
You will be returned to the "Users" screen.
Role Add, de-
activate,
activate
user
Create,
edit, delete
programs
Load
programs
Change set
values
Start/Stop
run
Export logs General
Settings
Acknowledge
alarms/alerts
Admin X X X X X X X X
Advanced user X X X X X X
Basic user X X X
Table 1: User roles
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User Management
1. 2. 5. Password Reset
As an administrator you may reset the password of any other user.
Proceed as follows to reset a user password:
1. Tap on the arrow button on the “Users” screen next to the user whose password you want to reset.
2. In the "Edit User" screen tap on the Reset Password button on the bottom of screen (Figure 15). Please note: For your own user
account, this button will not be displayed. You may change your password in the Password field in this case.
3. A "Temporary Password" popup appears, indicating that a new temporary password was assigned to the user (Figure 14). The new
password is displayed in the popup. Since you can't look up the temporary password later, make sure to remember or note the
password now.
4. Click OK to confirm the password reset.
Figure 15: Edit User screen with Password Reset option
The next time the user tries to log in using this new password, the system will ask the user to change it to a new non-temporary password
("1. 2. 7. Login with temporary password"). Note that the temporary password will expire after a certain time. "1. 2. 10. Change password
expiry" shows how to change the password expiration. Once the temporary password expired, it cannot be used to log in anymore, and
an administrator needs to create a new temporary password for this user.
You will be returned to the "Users" screen.
1. 2. 6. Login with expired password
When you try to log in with an expired password, a popup will inform you about the expired password (Figure 16).
Figure 16: Expired password popup
Process as described in Chapter 1.2.8 to change the password. Please note that you are required to change the password in this case,
otherwise you will not be logged in.
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User Management
1. 2. 7. Login with temporary password
When you log in with a temporary password, the following popup will inform you about the temporary password.
Figure 17: Popup after Login with temporary Password
When you tap OK to proceed, a new popup will inform you about the password requirements (Figure 18).
Process as described in "1. 2. 8. Change a password" to change the password. Please note that you can cancel the password change
in this screen by closing the popup. However, since the temporary password expiration period is significantly shorter than the regular
expiration, the temporary password will expire shortly after generation. Once the temporary password has expired, an admin user needs
to generate a new temporary password.
1. 2. 8. Change a password
When you are asked to change the password, the following popup informs you about the password requirements.
Figure 18: Password requirements popup
Tap OK to confirm the requirements. The following popup asks you to enter a new password (Figure 19).
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User Management
Figure 19: Change password popup
Enter the new password in the New Password field and enter it again in the second field. Once you tap OK your information will be
evaluated. In case of one of the following results, the information would be displayed in a new popup:
The given passwords don’t match
The password has been used before
The password does not fit the requirements for passwords
In these cases, tap on OK to close the popup. This will take you back to the “Change Password” popup.
Once the password has been changed successfully, a new popup notifies you about the password change (Figure 20).
Figure 20: Popup after successful password change
Tap the OK button to confirm. You will be returned either to the screen from where you started the login or to the screen that triggered
the login process to gain access.
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User Management
1. 2. 9. Deactivate & Reactivate User
In the “Users” screen in “Secure Mode” you may deactivate users if you have an administrator role.
Proceed as follows to deactivate users:
1. Tap on the arrow button on the “Users” screen next to the user you want to deactivate.
2. Tap the De-Activate button on the bottom of the screen (Figure 21).
3. Confirm the deactivation in the appearing popup by tapping OK (Figure 22).
4. In the user list in “Users” screen, you can now see that the user is marked as Deactivated, as seen in Figure 1.2.9 3.
Figure 21: User edit of basic user
Figure 22: User deactivated popup
Figure 23: Deactivated user in user list
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User Management
To reactivate the user, proceed as follows:
1. Tap on the arrow button on the “Users” screen next to the user you want to reactivate.
2. Tap the Re-Activate button on the bottom of the screen (Figure 24).
3. A Popup appears to inform you about the successful reactivation (Figure 25). A new temporary password will be generated for that
user. Make sure to remember or note the temporary password since you can’t look it up later.
4. Tap the OK button to close the popup. This will take you back to the “Users” screen.
Figure 24: Reactivate User
Figure 25: User reactivated popup
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User Management
1. 2. 10. Change password expiry
The password expiration function assures that user passwords can't be used for longer than a certain time period. When a given
password has not been changed for that time period, the user will be asked to set a new password on the next login.
Proceed as follows to change the password expiration:
1. Tap the Settings icon on the navigation bar.
2. Tap the Controls button on the "Settings" screen.
3. If you’re not logged in with a valid admin account, you will be asked to log in. Refer to "1. 2. 1. Login" for details.
4. In the "Controls" screen, scroll down to find the settings for "Password Expiration"
5. Tap on the drop-down list next to "Password Expiration" and select the new value for the password expiration.
6. Tap on the Save button to save your new password expiration.
7. A "Settings Saved" popup appears. Click OK to confirm the changes. Any regular user password will now expire after your selected
period. Users with expired passwords will be asked to create a new password on the next login.
You will be returned to the "Settings" screen.
Figure 26: Changing password expiry
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User Management
1. 2. 11. Change temporary password expiry
The temporary password expiration function assures that temporary passwords can't be used for longer than a certain time period. When
a given temporary password has not been changed for that time period, the user will not be able to login. An administrator will have to
create a new temporary password for that user.
Proceed as follows to change the temporary password expiration:
1. Tap the Settings icon on the navigation bar.
2. Tap the Controls button on the "Settings" screen.
3. If you’re not logged in with a valid admin account, you will be asked to log in. Refer to "1. 2. 1. Login" for details.
4. In the "Controls" screen, scroll down to find the settings for "Temporary Password Expiration"
5. Tap on the drop-down list next to "Temporary Password Expiration" and select the new value for the temporary password expiration.
6. Tap on the Save button to save your new temporary password expiration.
7. A "Settings Saved" popup appears. Click OK to confirm the changes. Any temporary user password will now expire after your
selected period. Users with expired temporary passwords will not be able to login. An administrator can reset the expired temporary
password ("1. 2. 5. Password Reset").
You will be returned to the "Settings" screen.
Figure 27: Changing temporary password expiry
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User Management
2. Centri-Log Plus
Centri-Log Plus enables you to manage users, programs and settings on your centrifuge via the Centri-Log Plus data management
software.
If you want to manage your centrifuge via using Centri-Log Plus, the management software activates the synchronization mode on the
centrifuge from time to time to download data. The following popup will be displayed on the device, indicating that the centrifuge is
currently being synchronized. You will not be able to use the centrifuge while the process is running.
Figure 28: Centri-Log Plus synchronization in progress
With Centri-Log Plus the centrifuge can be locked. In this case the following popup is displayed. Once a device is locked, you can only
unlock it in Centri-Log Plus.
Figure 29: Locked centrifuge popup using Centri-Log Plus
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User Management
3. GMP
Main Screen: In GMP mode with an active GMP sequence, any button except for Open Door, Start and Stop is disabled. Outside
an active GMP sequence, all buttons are disabled except for the case that an admin is logged in.
Programs: Create New and Edit buttons in Programs screen are disabled in Centri-Log Plus mode.
Access Mode: GMP mode always uses Secure Mode of the centrifuge. The access mode cannot be changed during GMP mode.
Access mode always returns to Open Mode when GMP mode is disabled.
Users: Any non-Admin user is logged out when navigating to Main screen when GMP mode is enabled. Logout is not possible
during a GMP sequence. Auto logout is disabled as well in this case.
Admin login in first step: Using the normal login in the first step ends the GMP sequence. The login workflow ends on main
screen, regardless of whether the login was successful or not.
Centri-Log Plus: GMP operation is not possible without management of the centrifuge using Centri-Log Plus. Editing or creating of
other users is not possible while Centri-Log Plus is enabled.
The Product Result Scan Finished popup does not close automatically after a certain time period.
User rights (level) of transmitted users via Centri-Log Plus are mapped to user roles. The lowest user role is a BASIC user who is
allowed to load programs.
Some features are disabled in GMP mode, e.g. unlocking a locked user after a certain amount of time or the auto open lid
feature.
To use the barcode laser-scanner, connect it to an USB port of the centrifuge. To scan a barcode aim at the barcode with the
barcode laser-scanner and keep the button pressed for scanning. Follow the dialogue on the user interface of the centrifuge for
when to scan a barcode. If a scanner holder is installed on the side of the centrifuge, use it to store the barcode laser-scanner.
The following section describes the general workflow including screens and popups of the GMP process:
In the beginning of the GMP sequence, you are asked to scan your user barcode.
Figure 30: GMP user identification
If the scanned user was invalid, the following popup informs you about the error. You may tap the Login button to leave the GMP
sequence and use the centrifuge in normal mode using your admin account.
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User Management
Figure 31: GMP invalid user identification
If the identified user was valid, you can scan a program code to load the saved program.
Figure 32: GMP process identification
If the scanned program was invalid, the following popup informs you about the error again.
Figure 33: GMP invalid process identification
Now you can add product codes to track the processed samples. You can scan multiple product codes in this step for multiple samples.
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Thermo Fisher Scientific SECURE-Spin Operating instructions

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Operating instructions

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