BN™ II System Software Version 2.7 Job Aid

SIEMENS Healthineers ---- ............... BN™II System Software Version 2.7 Job Aid Template Effective Date: 27 May 2019 | HOOD05162003010284 Job Aid Effective Date 23 Jul 2021 | HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Table of Contents Overview 3 O Sample results from archive Routine Operations 5 OK Results for Serum-3 from 2012-12-13 to 2012-12-13 Login 5 Sample: Serum-3 Assay: lgM Measuring time: 2012-12-13 11:16:03 Result: 1.44 g/l, Dilution: 1:20, Reference range: 0.40 - 2.30, Flags: Change User Passwords 7 Reagents: lgM (153286) Serial number of analyzer: Calibration: 2012-11-21 15:51:27 Logout 8 Standard: Prot. Standard SL (083690) Reagents: lgM (153286) Mean deviation: 1.84% Sample Details and Results 9 Released: 2021-05-31 19:16:54, by Lxxxxxxn Remark Find a Sample by its Sample ID in Lab Journal 9 last edited by: Lxxxxxxn at: 2021-05-31 19:16:19 Example text, Added text Framing controls View Sample Result Details & Menu Items in the Lab Journal 10 Start control: Prot. Kontrolle SL/M (084739) Measuring time: 2012-12-13 11:09:40 Result: 0.90 g/l Deviation: 23.1% Add a Remark to a Test Result in the Lab Journal 14 End control: Prot. Kontrolle SL/M (084739) Measuring time: 2012-12-13 11:43:27 Print/Export Sample Result Details in the Lab Journal Result: 0.89 g/l 17 Save to file ... Find a Sample by its Sample ID in the Archive 18 View Archived Sample Results 19 Print/Export Sample Results from the Archive 21 Enter Comments in the Audit Log 22 2 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Overview The BN™ II System software package version 2.7* includes new features designed to meet customer expectations for compliance with GDPR and FDA standards. The new software features include but are not limited to: • User management-separate login accounts for all users, managed by the Security Administrator. Accounts are linked with configurable privileges. Activity and results can be traced back to individual users. Electronic Signatures from individual users can now be documented • Data privacy-in compliance with data privacy regulations, (for example GDPR), patient and user data related to the system is protected. User viewing privileges of personal and patient data are adjusted based on institutional policy • Audit trail-user activity is tracked and logged in the system and comments can be added. User activity logs can be generated and viewed by the Security Administrator • Traceability-sample result traceability of all available data that contributes to a released result can be viewed in the user interface. Traceability reporting is archived to view this inactive data in the system • Sample search function-to quickly locate samples still stored in the system, search by the sample ID in the user interface. You can also search for samples in the archive using the sample ID *BN II software version 2.7 will only be provided with new BN II analyzers and as an optional update for existing systems. (Continued on the next page) 3 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Overview How does software version 2.7 protect personal data? How do I prevent loss of privacy protection? Data Encryption Ask “Is it mandatory to enter personal data?” • Protects against unauthorized persons reading patient data directly from files Limit entering personal data to what is necessary for the • System owner designates a trusted person (Security intended purpose Administrator) to issue, store and protect an encryption key (password). Siemens Healthineers service will not have Only enter personal data in fields provided knowledge of the password explicitly for the type of input • Provide the encryption key to Siemens Healthineers service if Do not enter personal data in fields that are not meant for files need to be transferred to another computer that data or that allow free input. Personal data entered in the correct fields is protected according to GDPR User traceability via separate login accounts avoids conformity unauthorized logins to view patient data • Security Administrator-limited to sample ID, sample results and audit log, configures user access, keeps encryption key Lock the operating terminal of the system (password) when unattended • Lab Supervisor and Routine User-allowed full access to patient Prevent unauthorized persons from accessing data but no access to user ID personal data or other sensitive data or information • Siemens Healthineers service-limited to sample ID, sample result, sex, age and user display name for troubleshooting purposes 4 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Routine Operations Log in BNII File Edit Routine Results QC Calibration Definition System Thu 15:49 QE Ensure the analyzer and computer are switched on and the user has logged into the computer’s operating system. Request Login/Logout Number 1. Double click the icon BN II Alias on the desktop Full version: V2.7a3 released not released Release version: V2 in process The BN II software starts, the Siemens logo is waiting Current user: Lxxxxxxn • remeasureme displayed, followed by the dialog Info, the menu bar of User Validatio Password: the BN II software and the dialog Login/Logout Reference ci OK Cancel Change password OK not ok in process • This dialog can also be opened by selecting System > missing Logout Assays with Login / Logout in the menu invalid contr. Connection send behind Note: The software is supplied with an active Users & Access function. The user must log in via the dialog @ last sample measured: V2.783 Login/Logout, otherwise the analyzer will not be started (Continued on the next page) 5 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Routine Operations Log in (continued) Request Login/Logout Number Full version: V2.7a3 O 2. released O Enter your individual User ID and password not released Release version: V2 0 3. Select the OK button in process Current user: Lxxxxxxn 0 waiting 0 • If a message stating that the password has expired remeasureme O appears, change the password following the steps O detailed in the Operator’s Guide User: 0 2 Validatio Password: • If a message stating that the user’s login data is not valid appears, try logging in again or contact the Reference c 0 OK Security Administrator to re-enable the account. The Cancel Change password OK 3 not ok account is automatically disabled after 5 invalid logon in process attempts. The Security Administrator can also disable missing Logout Assays with user accounts invalid contr. 0 Connection Send behind Note: If the Security Administrator logs on after the BN II software starts, the analyzer will not initialize because the Security Administrator is not authorized to perform routine tasks 6 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Routine Operations Change User Passwords Req Login/Logout Number 0 released 0 not relea If your password has expired, the message “Your password in proce Your password has expired. Please change your password. waiting has expired. Please change your password.” is displayed remeasu 1 OK 0 0 Valic Password: You can also change your password by navigating to ........ Referen System > Login/Logout and select Change password OK 2 Change password OK not ok in proce: missing Logout 1. To confirm, select OK Assays invalid contr. 0 Connection Send behind The Login/Logout dialog is displayed • 2. Select Change password Change password 3. In the relevant fields, enter the User ID, old password and Req To change the password you must first enter the old the new password twice Number password and then enter the new password twice. 0 released 0 4. Select OK not relea User ID: O in proce O • The password has been changed and the dialog closes waiting Old password: 3 O remeasu O 5. Enter the new password in the Login/Logout dialog to New password: O o log in Valic Confirm password: Referen uc OK Display password not ok in proce: Cancel 4 OK missing Assays invalid contr. 0 Connection Send behind 7 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Routine Operations Log Out Request Login/Logout Number Full version: V2.7a3 O You can log out of the system at any time during a routine run released O not released Release version: V2 0 with the following results: in process Current user: Lxxxxxxn O The analyzer will continue processing already waiting O • remeasureme O requested tests O The dialog Login/Logout remains open in the User: O • foreground Validatio Password: No dialogs can be accessed, meaning manually Reference c 0 • OK identifying samples and entering a manual predilution Cancel Change password OK not ok is not possible in process Lot data and nominal values cannot be read by the missing 2 Logout • Assays with handheld barcode reader invalid contr. 0 Connection Send behind 1. In the menu select System > Login/Logout The Login/Logout dialog is displayed • 2. Select Logout Note: To exit the software after a shift change, you do not have to log out since this happens automatically when you quit the BN II software 8 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Find a Sample by its Sample ID in the Lab Lab journal OK Action View ? Journal All Samples All Samples Own selection 0/79 4 ASLn Assay selection ... Serum-2 Search for samples that are still present in the Lab Journal (or Requested by ... lgG Patient Journal) using the sample ID. The Lab Journal includes IgA 2 Search sample ... IgM all of the results for the shift, however all results are stored C3c STAT samples only permanently in the Archive as soon as they are released* C4 HPT Finished samples AAG Samples loaded Samples with insufficient volumes 1. Select Lab journal from the menu bar lamb 2. Select View > Search sample in the toolbar BNII File Edit Routine Results QC Calibration Definition System • The dialog Search sample is displayed 3. Enter all or the first digits of the sample ID in the Search for sample starting with field OO Search sample 4. Select Search Search for sample ID starting 3 urna • The samples whose IDs start with the entered sequence of characters or numbers are displayed Cancel Search 4 BNII File Edit Routine Results QC Calibration Definition System Serum-2 lgG 11.50 g/ 1 9 * Archive search functionality will be explained later in this document Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results View Sample Result Details and Menu Items in BNII File Edit Routine Results QC Calibration Definition System the Lab Journal Lab journal OK Action View The Sample result details dialog allows you to view, comment Own selection 1/53 @ 1 44 200200650313 and print all result-relevant data for each sample currently in FLC_K 408.00 mg/l I FLC_L the Lab or Patient Journal. Exactly one sample is displayed 1 200200652513 FLO_N 25.00 mg/ Reagents with all its results. Open requests are not displayed D FLC_L 18.00 mg/l Reagents FLC- 1.43 ... missing DAD O 200200653813 FLC_K not sufficient 12.40 mg/l O FLC_L 31.20 mg/l H not required O O 1. Select the sample whose details you wish to view in the FLC- STDS/CTRLS 0.40 ··· 200200654513 missing O FLC_K 11.30 mg H not sufficient C Lab journal dialog FLC_L 13.00 mg not required 0 4 FLC- Information Logbook O Measurement (Continued on the next page) finished System status Send behind last sample measured V2.7b1 10 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results View Sample Result Details and Menu Items in BNII File Edit Routine Result QC Calibration Definition System the Lab Journal (continued) Lab journal Action View O? Own epeat 1/53| 2. Select Action > Show sample result details… Send to host again DAA 20020€ Request from host again FLO Accept measurement result H FL( Dationt i Show sample result details ... (Continued on the next page) 2 FL( 4 Change sample to control ... FL( Show controls to either side ... FLO Show last control ... DAA 20020€ FLC_K 12.40 mg/ FLC_L 31.20 mg/ H FLC- 200200654513 FLC_K H A 41.30 mg/l FLC_L 13.00 mg/l FLC-r 3.18 *** last sample measured : 11 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results View Sample Result Details and Menu Items in Sample result details the Lab Journal (continued) A OK Action ? 3 0 Sample ID: Serum-2 The Sample result details dialog provides result information B Doe, John * 6/2/20 (0) [male] for overall result traceability A. Toolbar lgM 0.76 g/ 1:20 (0.40 - 2.30) Use the Toolbar options to close the dialog, print the Calibration: 11/21/12 15:51:27 Standard: Prot. Standard SL (083690) sample result details, and access submenus via the Reagents: IGM (153286) Action menu item Released: 5/31/21 17:20:08 by: 200345 Control: Prot. Kontrolle SL/M (084739) B. Patient Area Remark last edited: 5/31/21 17:13:21 by: 200345 The Patient Area includes the Sample ID, dilution C Example text factor (if applicable), patient data and patient C3c 1.930 g/l 1:20 (0.90 - 1.80) H Calibration: 11/23/12 11:07:40 remarks. Only available data is displayed Standard: Prot. Standard SL (083690) C. Results Area Reagents: 03 (153388) Released: 5/31/21 17:20:08 by: 200345 The Results Area consists of 1 entry for each test Control: Prot. Kontrolle SL/M (084739) result for the sample. It includes relevant data for the C4 0.346 g/l 1:20 (0.10 - 0.40) assay and documented remarks Calibration: 11/20/12 14:40:22 Standard: Prot. Standard SL (083690) (Continued on the next page) 12 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results View Sample Result Details and Menu Items in Sample result details the Lab Journal (continued) OK Action A Sample ID: Show raw data - kinetics Show calibration ... The menu item Action contains the following submenus: B Doe, John * 6/2 Show framing controls ... Enter remark ... A. Show raw data-kinetics… C View the kinetics graph available for the selected result. If D IgM 0.76 g/l 1:20 (0.40 - 2.30) no kinetics data is available, the message No kinetics Calibration: 11/21/12 15:51:27 available is displayed Standard: Prot. Standard SL (083690) Reagents: IGM (153286) B. Show calibration… Released: 5/31/21 17:20:08 by: 200345 Control: Prot. Kontrolle SL/M (084739) View the calibration curve that was used for the evaluation Remark last edited: 5/31/21 17:13:21 by: 200345 of the result. If no calibration curve is available, the Example text message No calibration curve available is displayed C3c 1.930 g/l 1:20 (0.90 - 1.80) H C. Show framing controls… Calibration: 11/23/12 11:07:40 Standard: Prot. Standard SL (083690) View the results of the framing controls and all sample Reagents: 03 (153388) Released: 5/31/21 17:20:08 by: 200345 measurements in between Control: Prot. Kontrolle SL/M (084739) D. Enter remark… C4 0.346 g/l 1:20 (0.10 - 0.40) Enter a remark for the selected result. This comment is then Calibration: 11/20/12 14:40:22 displayed in the list and saved in the data storage in the Standard: Prot. Standard SL (083690) system. Once a remark has been entered and saved, it can be reopened and edited via the Sample result details dialog 13 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Add a Remark to a Test Result in the Lab BNII File Edit Routine Results QC Calibration Definition System Tue 14:28 QE Journal Lab journal ... Sample result details OK Action View OK Action ? 3 1 All Samples Sample ID: Serum-2 Serum-1 PatientT 1. Select a test result in the Results area of the Sample lgG 12.50 g/l joe, John * 6/2/20 (0) [male] lgA 1.88 g/l IgM 0.89 g/l C3c 1.280 g/l result details dialog C4 0.172 g/l IgM 0.76 g/l 1:20 (0.40 - 2.30) HPT 0.40 g/l Calibration 11/21/12 15:51:27 AAG 0.65 g/l Prot. Standard SL (083690) Reagents: IGM (153286) lamb 1.77 g/ Released: 5/31/21 17:20:08 by: 200345 AI 1.37 g/l Control: Prot. Kontrolle SL/M (084739) lgG1 7.95 g/l Remark last edited: 5/31/21 17:13:21 by: 200345 (Continued on the next page) lgG2 4.71 g/l Example text b2M 2.90 mg/l H C3c 1.930 g/l 1:20 (0.90 - 1.80) H MYO 31.6 pg/l Calibration: 11/23/12 11:07:40 CysC 0.59 mg/l Standard: Prot. Standard SL (083690) 1 CAP1 <3.19 mg/ Reagents: C3 (153388) Released: 5/31/21 17:20:08 by: 200345 SAA 6.8 mg/l H Control: Prot. Kontrolle SL/M (084739) lgE2 40.9 IU/ml RFn < 10.0 IU/ml Calibration: 11/20/12 14:40:22 ASLn < 53.8 IU/ml Standard: Prot. Standard SL (083690) Serum-2 Doe, John . 6/2/20 System status lgG 11.50 g/ lgA 2.91 g/l IgM 0.76 g/l Send behind C3c 1.930 g/l H C4 0.346 g/l HPT 1.17 g/l AAG 0.85 g/l lamb 1.64 g/l AI 1.37 g/l lgG1 6.97 g/l lgG2 5.03 g/l 62M 2.83 mg/l MYO 35.0 pg/l Cysc 0.58 mg/ F I <<<<<<<<<<<<<< CAD1 0 8 0 last sample measured: V2.783 14 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Add a Remark to a Test Result in the Lab Sample result details OK Journal (continued) Action sample ID: Show raw data - kinetics ... Show calibration ... 2. Select Action > Enter remark… 2 Show framing controls ... Doe, John * 6/24 Enter remark ... lgM 0.76 g/ 1:20 (0.40 - 2.30) Calibration: 11/21/12 15:51:27 Standard: Prot. Standard SL (083690) Reagents: IGM (153286) Released: 5/31/21 17:20:08 by: 200345 Control: Prot. Kontrolle SL/M (084739) Remark last edited: 5/31/21 17:13:21 by: 200345 Example text C3c 1.930 g/l 1:20 (0.90 - 1.80) H Calibration: 11/23/12 11:07:40 Standard: Prot. Standard SL (083690) Reagents: 03 (153388) Released: 5/31/21 17:20:08 by: 200345 Control: Prot. Kontrolle SL/M (084739) C4 0.346 g/l 1:20 (0.10 - 0.40) Calibration: 11/20/12 14:40:22 Standard: Prot. Standard SL (083690) 15 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Add a Remark to a Test Result in the Lab Lab journal Sample result details Action View 5 OK Action Journal (continued) All Samples Sample ID: Serum-2 V Serum-1 Patienti lgG 12.50 g/l Doe, John * 6/2/20 (0) [male] IgA 1.88 g/l IgM 0.89 g/l 3. Enter the remark in the Remark field C3c 1.280 g/l C4 0.172 g/l lgM 0.76 g/l 1:20 (0.40 - 2.30) Text length cannot exceed 250 characters including HPT 0.40 g/l Calibration: 11/21/12 15:51:27 AAG 0.65 g/l Standard: Prot. Standard SL (083690) Reagents: IGM (153286) blanks. A remark can be edited several times lamb 1.77 g/l Released: 5/31/21 17:20:08 by: 200345 AI 1.37 g/l Control: Prot. Kontrolle SL/M (084739) 4. Select Save lgG1 7.95 g/l Remark last edited: 5/31/21 17:13:21 by: 200345 lgG2 4.71 g/l Example text The entry is saved and displayed in the dialog Sample b2M 2.90 mg/l H C3c 1.930 g/l 1:20 (0.90 - 1.80) I MYO 31.6 ug/1 Calibration: 11/23/12 11:07:40 result details CysC 0.59 mg/l Standard: Prot. Standard SL (083690) Reagents: C3 (153388) AAAAA CRP1 <3.19 mg/ Released: 5. Select the OK 5/31/21 17:20:08 by: 200345 in the toolbar to close the dialog SAA 6.8 mg/l H Control: Prot. Kontrolle SL/M (084739) lgE2 40.9 1U/ml C4 0.346 g/l 1:20 (0.10 - 0.40) RFn < 10.0 IU/ml Calibration: 11/20/12 14:40:22 ASLn < 53.8 IU/ml Standard: Prot. Standard SL (083690) Serum-2 Doe, John * 6/2/20 Enter remark lgG 11.50 g/l IgA 2.91 g/ Sample ID: Serum-2 lgM 0.76 g/l H Assay: C3c C3c 1.930 g/l C4 0.346 g/ Remark: HPT 1.17 g/l Example text AAG 0.85 g/ lamb 1.64 g/l A_I 1.37 g/ 3 lgG1 6.97 g/l lgG2 5.03 g/l b2M 2.83 mg/l H MYO 35.0 mg/l CysC 0.58 mg/l L Cancel Save 4 mal 16 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Print and/or Export Sample Result Details in Print the Lab Journal Printer: HP Laserjet 100 colorMFP M175nw (62612B) Presets: Default Settings 1. Open the Sample result details dialog for the sample Copies: Black & White whose details you wish to print Pages: AI 2. Select File > Print Sample result details 2001 3. To create a printout, configure the print settings in the Seturn-2 dialog and select Print ----- 4. To save as a PDF, select from the drop down to export (T20- 3.80) the data --- ------- 10.10-6-401 BNIL Results QC Calibration Definition System E --- File Edit Routine Close bre VE. 71. 12345 2 Page setup ... 1 of 4 Print one 36 P Print selection 4 PDF Show Details Cancel Print 3 Print ... 17 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Find a Sample by its Sample ID in the Archive BNII File Edit Routine Results C Calibration Definition System Lab journal Control journal Released results are deleted from the Lab Journal at the end Patient journal Loading Rack staty Raw data Journal Reference curves of each shift but are permanently stored in the Archive upon 1 Show sample from archive release. Use the search function to locate results in the Archive 1. Select Results > Show sample from archive Search sample ID in archive 2. Enter the complete sample ID in the Search for sample Enter the sample ID and the time frame when the sample was measured. field 3. Enter the date of measurement in the Start date field Search for sample using the date format example in the field 2 Serum-2 • If the exact date of measurement is known, enter it in the Start date field. The End date field can be left 3 12/13/12 Start date (e.g. 5/31/21) End date (optional) blank Maximum time frame is 30 days. • If the exact date of measurement is not known, enter a time frame of 30 days maximum in the Start date Display raw data - kinetics field. Enter a date in the End date field 4 Display supporting points of calibration curve 4. Select the check boxes Display raw data-kinetics and Display supporting points of calibration curve as needed Cancel 5 Search (these boxes are not checked in this example) 5. Select Search 18 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results View Archived Sample Results Sample results from archive A OK Released results are stored in the Archive upon release and usually are deleted from the Lab Journal at the end of each B Results for Serum-3 from 2012-12-13 to 2012-12-13 Sample: Serum-3 shift. Use the search function to locate the archived results Assay: IgM Measuring time: 2012-12-13 11:16:03 C Result: 1.44 g/l, Dilution: 1:20, Reference range: 0.40 - 2.30, Flags: Reagents: IgM (153286) A. Toolbar Serial number of analyzer: B. Header containing the date of the requested timeframe Calibration: 2012-11-21 15:51:27 Area Sample Standard: Prot. Standard SL (083690) C. D Reagents: IgM (153286) D. Area Calibration Mean deviation: 1.84% E. Area Released E Released: 2021-05-31 19:16:54, by Lxxxxxxn F. Area Remark Remark last edited by: Lxxxxxxn at: 2021-05-31 19:16:19 G. Area Framing Controls (incomplete) F Example text, Added text Framing controls Note: This is an example of information that can be Start control: Prot. Kontrolle SL/M (084739) Measuring time: 2012-12-13 11:09:40 included in the Sample results from archive dialog. This Result: 0.90 g/ Deviation: 23.1% example shows basic results information without details on G reaction kinetics (measuring curve) and calibrations. Refer End control: Prot. Kontrolle SL/M (084739) Measuring time: 2012-12-13 11:43:27 to the BN II System Instruction Manual for an overview of Result: 0.89 g/ the information that can be seen in the dialog Save to file ... (Continued on the next page) 19 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results View Archived Sample Results (continued) O Sample results from archive OK This example shows the detail information for the kinetics Results for Serum-2 from 2012-12-13 to 2012-12-13 (measuring curve) and calibrations Calibration: 2012-11-21 15:51:27 Standard: Prot. Standard SL (083690) Reagents: IgM (153286) H. Calibration information Mean deviation: 1.84% I. Reaction kinetics (measuring curve) Supporting points Dilution: 1:80.0; Concentration: 0.0085; Value: 79; Deviation: -1.36% H Prereaction: 42; Start value: 204 Dilution: 1:40.0; Concentration: 0.0169; Value: 268; Deviation: 2.89% Prereaction: 86; Start value: 185 Dilution: 1:20.0; Concentration: 0.0339; Value: 616; Deviation: -1.51% Prereaction: 18; Start value: 257 Dilution: 1:10.0; Concentration: 0.0678; Value: 1316; Deviation: -1.13% Prereaction: 91; Start value: 313 Dilution: 1:5.0; Concentration: 0.1356; Value: 2496; Deviation: 2.62% Prereaction: 182; Start value: 456 Dilution: 1:2.5; Concentration: 0.2712; Value: 3769; Deviation: -1.52% Prereaction: 378; Start value: 877 Measuring curve Prevalue: 28 Start value: 223 Difference value: 716 I [4.70, 200], [6.72, 196), 24.58, 196], [26.55, 197], [41.83, 199]. [43.79, 201], [59.54, 204], [61.50, 205], [81.49, 211], [83.46, 212), [100.40, 217], [102.36, 219], [117.11, 224], [119.13, 227], [134.93, 248], [136.95, 256], [150.15, 306], [152.17, 315], [166.33, 367], [168.34, 374], [184.96, 433], [186.93, 441], [203.27, 499], [205.29, 503], [223.30, 566], Save to file ... 20 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Print and Export Sample Results from the Archive BNIL File Edit Routine Results QC Calibration Definition System Close 2a Page setup ... Print one There are two ways to print the sample results details in the Print ... lab journal. Sample results from archive 2b OK Results for Serum-3 from 2012-12-13 to 2012-12-13 1. Open the Sample results from archive dialog for the Sample: Serum-3 1/81 Assay: lgM Measuring time: 2012-12-13 11:16:03 Result: 1.44 g/l, Dilution: 1:20, Reference range: 0.40 - 2.30, Flags: Doe, John * 6/2/20 sample whose details you wish to print Reagents: lgM (153286) Serial number of analyzer: 2a. Select File > Print in the menu and edit the settings as Calibration: 2012-11-21 15:51:27 2a Standard: Prot. Standard SL (083690) Reagents: lgM (153286) H Mean deviation: 1.84% needed, or Released: 2021-05-31 19:16:54, by Lxxxxxxn 2b. Select the print icon in the toolbar Remark last edited by: Lxxxxxxn at: 2021-05-31 19:16:19 Example text, Added text 3. Select the Save to file… button to export the data to a Framing controls Start control: Prot. Kontrolle SL/M (084739) Measuring time: 2012-12-13 11:09:40 text file Result: 0.90 g/l H Deviation: 23.1% End control: Prot. Kontrolle SL/M (084739) L Measuring time: 2012-12-13 11:43:27 Result: 0.89 g/ H 3 Save to file ... H ASLn 122.0 IU/ml Serum-3 Doe, John . 6/2/20 lgG 13.90 g/l D IgA 3.92 g/l IgM 1.44 g/l 1:20 1.44 g/l C3C 1.340 g/l C4 0.182 g/ HPT AAG 0.70 9/1 lamb 1.84 g/l AI 1.53 g/l lgG1 7.22 g/l lgG2 5.31 g/l b2M 2.36 mg/l MYO <26.2 ug/l last sample measured V2.783 21 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Enter Comments in the Audit Log BNII File Edit Routine Results QC Calibration Definiti In System $ 7 Mon 19:27 QE Loading Rack status ab Journal Patient Journa User service Control Journal Precision test Configuration Data exchange Any user can enter and save comments in the Audit Log 1 Shift change Change to night mode however only the Security Administrator can see the Show journal legend ... Audit log Audit log comment comments. Reset passwor Login/Logout Requests Samples Reagents • It is not possible to comment directly on events logged in Number 1422 Number Reagents released finished missing not released 1365 loaded not sufficient the Audit Log in process not sufficient not required waiting 0 missing STDS/CTRLS remeasurements without req. missing • To refer to a specific Audit Log event, include the date, not sufficient not required time, sample ID, or assay name in the Audit Log comment Validation Analyzer Information Reference curves 207 Diln. wells Logbook OK 201 available Measurement The date and time of the comment as well as the user not ok 6 missing finished • in process System liquids System status missing Cuvettes adding the comment are automatically added to the Assays with OK invalid contr. 2 Connection Send behind comment 1. Select System > Audit log comment in the menu 0 0 last sample measured: - Note: To conform with data privacy regulations, it is recommended not to enter any personal data as an Audit Log comment (Continued on the next page) 22 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 BN™ II System Software Version 2.7 – SIEMENS Healthineers Sample Details & Results Enter Comments in the Audit Log (continued) Audit log comment 2. Enter the comment in the Audit log comment field The IGA calibration from 2021-03-24 was deleted because it was initiated accidentally. Prior IGA A maximum of 150 characters (including blanks) can be 2 calibration from 2021-03-11 was set to active again. entered in this field 3. Select Save & Close Comment for the audit log (do not enter personal data] The dialog closes and the comment is added to the Audit Log. The date, time and display name of the user entering Cancel 3 Save & Close the comment automatically appear with the comment in the Audit Log 23 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022 SIEMENS Healthineers Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. © Siemens Healthcare GmbH 2022 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens-healthineers.com 24 Effective Date: 23 Jul 2021|HOOD05162003208513 Unrestricted © Siemens Healthineers, 2022