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Bayer HealthCare Certegra Operating instructions

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®
Operation Manual
REPLACE IMAGE AS NEEDED
Certegra® Applications and Workstation Accessories
Operation Manual i
Certegra® Applications and
Workstation Accessories
Operation Manual
Report any serious incident that has occurred in relation to this device to Bayer (radiology.bayer.com/contact) and
to your local European competent authority (or, where applicable, to the appropriate regulatory authority of the
country in which the incident has occurred).
A glossary of symbols can be found in Section 2 of this manual.
ii Certegra® Applications and Workstation Accessories
Operation Manual iii
1 Introduction ............................................................................................... 1
1.1 Certegra® Workstation............................................................................................................................................................. 1
1.1.1 Workstation Cybersecurity.......................................................................................................................................... 1
1.2 PACS, Speech Recognition (SR) Systems, and RIS.............................................................................................................. 1
2 Symbols ...................................................................................................... 3
2.1 Manufacturing Symbols.......................................................................................................................................................... 3
2.2 Shipper Symbols ........................................................................................................................................................................ 3
2.3 Regulatory Classifications...................................................................................................................................................... 4
3 Informatics Panel....................................................................................... 5
3.1 Data Flow .................................................................................................................................................................................... 5
3.2 Managing Patient Information ............................................................................................................................................. 5
3.2.1 Add or Edit Patient Information for Next Injection.............................................................................................. 5
3.2.2 Clear All Patient Information for Next Injection................................................................................................... 7
3.2.3 Cancel Edits to Patient Information for Next Injection....................................................................................... 8
3.3 Managing Procedure Information........................................................................................................................................ 8
3.3.1 Add or Edit Procedure Information for Next Injection......................................................................................... 8
3.3.2 Clear All Procedure Information for Next Injection............................................................................................11
3.3.3 Cancel Edits to Procedure Information for Next Injection ...............................................................................11
3.3.4 Load Defaults into Procedure Information for Next Injection.........................................................................11
3.4 Managing Fluid Information ...............................................................................................................................................11
3.4.1 Add or Edit Fluid Information for Next Injection (Fluid A or Fluid B) ............................................................11
3.4.2 Retrieve Previous Contrast Data (Fluid A Button)...............................................................................................14
3.4.3 Clear All Fluid Information for Next Injection (Fluid A or Fluid B).................................................................15
3.4.4 Cancel Edits to Fluid Information for Next Injection.........................................................................................16
3.4.5 Load Defaults into Fluid Information for Next Injection..................................................................................16
3.5 Managing Notes Information..............................................................................................................................................16
3.5.1 Add or Edit Notes Information for Next Injection...............................................................................................16
3.5.2 Clear All Notes Information for Next Injection ...................................................................................................17
3.6 Managing Events Information ............................................................................................................................................18
3.6.1 View Events Information...........................................................................................................................................18
3.6.2 Edit Notes from the Events Panel...........................................................................................................................19
3.7 Screen Navigation and Layout ............................................................................................................................................20
3.7.1 Informatics Panel........................................................................................................................................................20
3.7.2 Patient Tab....................................................................................................................................................................21
3.7.3 Procedure Tab ..............................................................................................................................................................22
3.7.4 Fluid A and Fluid B Tabs............................................................................................................................................23
3.7.5 Notes Tab .....................................................................................................................................................................24
3.7.6 Events Tab ....................................................................................................................................................................25
iv Certegra® Applications and Workstation Accessories
4 Modality Worklist .................................................................................... 27
4.1 Select a Patient........................................................................................................................................................................27
4.1.1 Setup the Patient and Study Information for a Contrast Injection................................................................27
4.1.2 Anonymous Patient Entry for a Contrast Injection............................................................................................28
4.2 Update the Patient Worklist from the Modality Worklist Server................................................................................29
4.3 Find a Patient in the Patient Worklist ...............................................................................................................................30
4.3.1 Sort the Patient Worklist (Applicable to All of the Patient Worklist Column Headers) ............................30
4.3.2 Scroll through the Patient Worklist........................................................................................................................30
4.3.3 Create a Filter on the Worklist.................................................................................................................................30
4.3.4 Remove a Filter on the Worklist..............................................................................................................................33
4.4 Screen Navigation and Layout ............................................................................................................................................34
4.4.1 Main Patient Worklist ................................................................................................................................................34
4.4.2 Detailed Worklist Entry Screen ................................................................................................................................36
4.4.3 Filter Creation Screen .................................................................................................................................................37
5 Informatics Panel and Modality Worklist Setup Options....................... 39
5.1 Setup Overview ........................................................................................................................................................................39
5.2 Configuring Informatics Panel Defaults...........................................................................................................................41
5.2.1 Enable or Disable the Display of the Informatics Panel...................................................................................41
5.2.2 Create a Default Setting for Categories with Specific Values ..........................................................................42
5.2.3 Create a Default Setting for Categories with User-Created Lists....................................................................42
5.3 Configuring User-Created Lists in Categories..................................................................................................................42
5.3.1 Rearrange Values in a User-Created List...............................................................................................................42
5.3.2 Add a Value to a User-Created List.........................................................................................................................43
5.3.3 Delete a Value in a User-Created List ....................................................................................................................43
5.3.4 Hide or Show a Value in a User-Created List .......................................................................................................43
6 Data Confirmation ................................................................................... 45
6.1 Enabling Data Confirmation................................................................................................................................................45
6.2 Data Confirmation Screen ....................................................................................................................................................45
6.3 Updating Exam Information Using Data Confirmation...............................................................................................47
6.3.1 Update Patient Data...................................................................................................................................................47
6.3.2 Retrieve Contrast Data (Fluid A Button)................................................................................................................49
6.3.3 Update Patient Worklist Selection..........................................................................................................................49
6.3.3.1 Update Patient Worklist Selection Using Anonymous Patient............................................................50
7 Certegra Manager .................................................................................... 53
7.1 Certegra Manager Login........................................................................................................................................................53
7.2 Compatibility Specifications ................................................................................................................................................54
7.3 Roles and Access .....................................................................................................................................................................54
7.4 Certegra Manager Navigation.............................................................................................................................................55
Operation Manual v
7.4.1 Help Page ......................................................................................................................................................................56
8 Mandatory Fields ..................................................................................... 59
8.1 Configuration and Setup.......................................................................................................................................................59
8.1.1 Login...............................................................................................................................................................................59
8.1.2 Enable Mandatory Fields ..........................................................................................................................................59
8.1.3 Configure Settings for Mandatory Fields ..............................................................................................................60
8.2 Use of Mandatory Fields ......................................................................................................................................................60
8.2.1 Mandatory Fields Pre-Injection (Informatics Panel) ..........................................................................................60
8.2.2 Mandatory Fields Post-Injection (Data Confirmation)......................................................................................61
9 Multiple Accession Number ..................................................................... 65
9.1 Licensing....................................................................................................................................................................................65
9.2 Enable ........................................................................................................................................................................................65
9.3 Select Accession Numbers ....................................................................................................................................................65
9.3.1 Select Accession Numbers Using Patient Worklist.............................................................................................65
9.3.2 Select Accession Numbers Using Barcode Reader Accessory...........................................................................66
9.4 Edit or Remove Selected Accession Numbers ..................................................................................................................66
9.5 Apply Selected Accession Numbers To Next Injection for Same Patient ..................................................................66
10 Data Manager......................................................................................... 67
10.1 Licensing .................................................................................................................................................................................67
10.2 Security and Compliance Safeguards..............................................................................................................................67
10.3 Roles and Access...................................................................................................................................................................67
10.4 Log In .......................................................................................................................................................................................68
10.5 Edit Injector Details..............................................................................................................................................................68
10.6 Manage Injections................................................................................................................................................................69
10.6.1 Match...........................................................................................................................................................................69
10.6.1.1 Match Additional Studies............................................................................................................................71
10.6.2 Unmatch .....................................................................................................................................................................71
10.6.3 Edit Injection..............................................................................................................................................................73
10.6.4 Transfer .......................................................................................................................................................................74
10.6.5 Hide/Unhide ...............................................................................................................................................................76
10.7 Export.......................................................................................................................................................................................77
10.7.1 Export Injection Summary......................................................................................................................................78
10.7.2 Export Injection Details...........................................................................................................................................79
10.7.3 Export Syringe Usage...............................................................................................................................................82
10.8 Site Management .................................................................................................................................................................83
10.8.1 Backup.........................................................................................................................................................................83
10.8.2 Restore.........................................................................................................................................................................84
10.9 User Management................................................................................................................................................................86
vi Certegra® Applications and Workstation Accessories
10.9.1 Add User......................................................................................................................................................................86
10.9.2 My Account.................................................................................................................................................................87
10.10 Anonymous Patient...........................................................................................................................................................87
10.10.1 Enable and Configure Anonymous Patient .....................................................................................................87
10.11 Data Manager Troubleshooting.....................................................................................................................................88
11 Barcode Reader Accessory and Setup.................................................... 89
11.1 Introduction...........................................................................................................................................................................89
11.1.1 Disclaimers.................................................................................................................................................................89
11.2 Assemble Barcode Reader Accessory ...............................................................................................................................89
11.2.1 Install USB Cable ......................................................................................................................................................89
11.2.2 Assemble Stand.........................................................................................................................................................90
11.2.2.1 Mount Stand (Optional) ..............................................................................................................................91
11.3 Scan Initialization Barcode for System Use ...................................................................................................................91
11.4 Verify Setup and Configuration for Use..........................................................................................................................91
12 Barcode Configuration........................................................................... 93
12.1 Login to Certegra Manager ................................................................................................................................................93
12.2 Enable Barcoding .................................................................................................................................................................93
12.3 Bayer 2D Contrast Barcode ................................................................................................................................................93
12.4 Configure Barcodes & Barcode Patterns for System Use ...........................................................................................94
12.4.1 Configure Contrast Barcode...................................................................................................................................94
12.4.1.1 Non-Bayer 2D Contrast Barcode...............................................................................................................95
12.4.1.2 Add Contrast Barcode ..................................................................................................................................95
12.4.1.3 Edit Contrast Barcode..................................................................................................................................96
12.4.1.4 Delete Contrast Barcode .............................................................................................................................97
12.4.1.5 Pre-Configured Contrast .............................................................................................................................97
12.4.2 Configure Barcode Pattern (Expiration Date, Lot/Batch, and Patient/Study)............................................97
12.4.2.1 Add Barcode Pattern ....................................................................................................................................98
12.4.2.2 Configure Barcode Pattern to Hide Characters (Prefix/Suffix)...........................................................99
12.4.2.3 Edit Barcode Pattern ................................................................................................................................. 100
12.4.2.4 Delete Barcode Pattern............................................................................................................................. 100
12.4.3 Configure Technologist Barcode........................................................................................................................ 100
12.4.3.1 Add Technologist Barcode ....................................................................................................................... 101
12.4.3.2 Edit Technologist Barcode....................................................................................................................... 101
12.4.3.3 Delete Technologist Barcode .................................................................................................................. 101
12.4.3.4 Import Technologist Barcode.................................................................................................................. 102
12.4.3.5 Search for Technologist............................................................................................................................ 102
12.4.3.6 Edit Tech ID Displayed on the Certegra Workstation ....................................................................... 102
12.4.4 Export Barcode Configurations.......................................................................................................................... 102
12.4.5 Import Barcode Configurations ......................................................................................................................... 103
Operation Manual vii
12.5 Configuration Troubleshooting and Notes................................................................................................................. 103
13 General Barcode Information .............................................................. 105
13.1 How to Use the Barcode Reader Accessory................................................................................................................. 105
13.1.1 Hand-Held Scan ..................................................................................................................................................... 105
13.1.2 Hands-Free Scan .................................................................................................................................................... 105
13.1.3 Beeps and LED Indications.................................................................................................................................. 106
13.2 Scan Barcodes for the Certegra Workstation.............................................................................................................. 107
13.2.1 Scan Barcodes Pre-Injection................................................................................................................................ 107
13.2.2 Scan Barcodes Post-Injection.............................................................................................................................. 108
13.3 Troubleshooting Barcode Reader Accessory............................................................................................................... 109
13.3.1 Reset Default Parameters (Optional)................................................................................................................ 110
13.3.2 Removing the USB Cable If Necessary ............................................................................................................. 110
13.4 Maintenance and Cleaning............................................................................................................................................. 111
13.4.1 General ..................................................................................................................................................................... 111
13.4.2 Daily .......................................................................................................................................................................... 111
13.4.3 Monthly.................................................................................................................................................................... 112
13.5 Required Training .............................................................................................................................................................. 112
13.6 Contraindications.............................................................................................................................................................. 112
13.7 Environmental Specifications......................................................................................................................................... 112
13.8 Options................................................................................................................................................................................. 112
viii Certegra® Applications and Workstation Accessories
Operation Manual 1 - 1
1 Introduction
NOTE: The display screens that appear in this document and the data values within them are for
representational purposes only and may vary slightly from what appears on each display.
The Certegra® Applications and Workstation Accessories operation manual provides instructional information on
optional applications and accessories available for the Certegra® Workstation. Except where specifically identified,
the functionality of each application and accessory applies to all supported injector systems.
NOTE: Each application and accessory may be sold separately or optionally turned on. Not all
applications and accessories are available in all markets. Contact a local product representative
for Bayer for more information or check country-specific operating instructions.
NOTE: Screen images in this manual are for illustration purposes only. Actual screens may vary.
1.1 Certegra® Workstation
The Certegra Workstation provides a platform that enables the management of contrast-enhanced injection
information from devices from Bayer as well as the exchange of this information to other devices within the
imaging suite. The system is designed as a scalable platform that hosts multiple licensed applications.
NOTE: Operating specifications, options, accessories, and feature availability may vary by country. Check
with a local product representative for Bayer and country-specific operating instructions.
1.1.1 Workstation Cybersecurity
When Informatics is enabled, the Certegra Workstation hard drive can contain Protected Health Information (PHI).
The security and privacy of this information must be safeguarded by all individuals interacting with the device. Prior
to disposing of the workstation, this information must be removed from the hard drive inside the system. Contact
Bayer or a local authorized dealer for further information. Refer to the back cover of this manual for contact
information.
1.2 PACS, Speech Recognition (SR) Systems, and RIS
PACS, Speech Recognition (SR) Systems, RIS, and other licensable features send information from the injector to
hospital information systems and can update other hospital systems with documentation about the injection when
licensed and enabled. This information includes, but is not limited to: patient, study, injection amount, contrast
name, contrast concentration, and more. The data available for interface is flexible and determined in discussion
with the customer.
These features are enabled via a technical setup performed by Service or an authorized designate. These features do
not have any user interaction or interface on the injector.
Contact a service representative to receive applicable technical documentation (DICOM [84304905] and HL7
[84304891] Conformance Statements) for further information.
1 - 2 Certegra® Applications and Workstation Accessories
Operation Manual 2 - 3
2 Symbols
2.1 Manufacturing Symbols
2.2 Shipper Symbols
Authorized Representative in the European Community (ISO 15223-1, 5.1.2)
Date of Manufacture (ISO 15223-1, 5.1.3)
Temperature range (ISO 15223-1, 5.3.7)
Humidity range (ISO 15223-1, 5.3.8)
Atmospheric pressure range (ISO 15223-1, 5.3.9)
Serial Number (ISO 15223-1, 5.1.7)
Catalog Number (ISO 15223-1, 5.1.6)
This side up (ISO 7000, 0623)
Keep dry (ISO 15223-1, 5.3.4)
Fragile, handle with care (ISO 15223-1, 5.3.1)
Consult instructions for use (ISO 15223-1, 5.4.3)
2 - 4 Certegra® Applications and Workstation Accessories
2.3 Regulatory Classifications
Indicates that this device conforms to the requirements of the European Medical
Device Directive 93/42/EEC.
Tested to comply with FCC standards.
Indicates that this product contains certain toxic or hazardous substances or
elements and can be used safely during its environmental protection use period,
indicated by the number in the center of the logo. This product should be recycled
immediately after its environmental protection use period has expired.
Taiwan BSMI (Bureau of Standards, Metrology, and Inspection) Registration of
Product Certification (RPC)
Australian Communications and Media Authority (ACMA) Regulatory Compliance
Marketing (RCM)
KC (Korea Certification) Mark
Indicates separate collection for Electrical and Electronic Equipment per Directive
2002/96/EC. Refer to the following website for additional information:
www.weee.bayer.com
10
20
R38706
Operation Manual 3 - 5
3 Informatics Panel
The Informatics Panel is the left-hand section of the Certegra Workstation user interface and enables the
interaction with the licensed applications and management of informatics. The Informatics Panel manages
information important to injection procedure. Key groups of information managed through the Informatics Panel
include patient information, procedure information, fluid information, procedure notes, and events information.
3.1 Data Flow
The following steps describe the data flow of a typical injection procedure when the Informatics Panel is used in
conjunction with the Certegra Workstation:
1. Prepare the imaging procedure on the modality and prepare the injector.
2. Enter information in the Patient and Procedure tabs.
3. Enter information in the Fluid A and Fluid B tabs.
4. Enter information in the Notes tab.
5. Initiate the injection and the scan.
6. Certegra Workstation captures injector system data as the injection occurs.
7. When the injection completes, the injection information is automatically matched to the patient,
procedure, fluid, and notes information and stored in the Certegra database.
3.2 Managing Patient Information
3.2.1 Add or Edit Patient Information for Next Injection
Prior to the injection, add the patient information to the injection record by using the Patient tab of the Informatics
Panel.
1. Select the Patient area of the Informatics Panel (Figure 3 - 1: Informatics Panel - Patient Information).
Figure 3 - 1: Informatics Panel - Patient Information
3 - 6 Certegra® Applications and Workstation Accessories
2. The Patient tab displays. Enter information into all relevant fields:
a. Patient’s ID, Last Name, First Name
i. Select ID, Last Name, or First Name field (Figure 3 - 2: Patient Tab - Patient ID, Last Name, First
Name Entry).
Figure 3 - 2: Patient Tab - Patient ID, Last Name, First Name Entry
ii. Enter data with the alphanumeric keyboard.
iii. Press Enter to accept changes made to a patient’s ID, last name, or first name, or press Cancel to
ignore changes made.
b. Patient’s Date of Birth
i. Select the DOB field (Figure 3 - 3: Patient Tab - Date Selection).
Figure 3 - 3: Patient Tab - Date Selection
ii. Above the numeric keyboard, select the Month, Day, or Year fields.
iii. Enter the month, day, or year data with the numeric keyboard.
iv. Press Enter to accept changes made to a patient’s date of birth, or press Cancel to ignore changes
made.
c. Patient’s Weight and Height
i. Select the Weight or Height field (Figure 3 - 4: Patient Tab - Weight Selection).
Operation Manual 3 - 7
Figure 3 - 4: Patient Tab - Weight Selection
ii. Enter the appropriate data with the numeric keypad.
iii. Press Enter to accept changes made to a patient’s weight or height, or press Cancel to ignore
changes made.
d. Patient’s Gender
i. Select the Gender field (Figure 3 - 5: Patient Tab - Gender Selection).
Figure 3 - 5: Patient Tab - Gender Selection
ii. Select the value from the Gender list. When the value is selected, the Gender field is updated, and
the list disappears.
iii. To clear the current gender, press Clear. To ignore changes made to a patient’s gender, press Can-
cel.
3. Press OK to accept all changes made to patient information, or press Cancel to ignore all changes made to
patient information.
3.2.2 Clear All Patient Information for Next Injection
Prior to the injection, clear patient information from the injection record by using the Patient Tab of the Informatics
Panel.
3 - 8 Certegra® Applications and Workstation Accessories
1. Select the Patient Information area from the Informatics Panel.
2. Press Clear All.
3. A message displays. Press Yes to confirm, or press No to return to the Patient tab.
4. Press OK to save changes made.
3.2.3 Cancel Edits to Patient Information for Next Injection
On the Patient Information tab, cancel any edits to the patient information for the next injection by selecting
Cancel. The changes being made are canceled, and the system returns to the Home screen.
3.3 Managing Procedure Information
3.3.1 Add or Edit Procedure Information for Next Injection
Prior to the injection, add procedure information to the injection record by using the Procedure tab of the
Informatics Panel.
1. Select the Procedure area from the Informatics Panel (Figure 3 - 6: Informatics Panel - Procedure).
Figure 3 - 6: Informatics Panel - Procedure
2. The Procedure tab displays. Enter information into all relevant fields:
a. Technologist ID
i. Select Technologist ID field (Figure 3 - 7: Procedure Tab - Technologist ID Entry).
Operation Manual 3 - 9
Figure 3 - 7: Procedure Tab - Technologist ID Entry
ii. Enter technologist ID with the alphanumeric keyboard.
iii. Press Enter to save changes made, or press Cancel to ignore changes made.
b. Injection Site
i. Select Injection Site field (Figure 3 - 8: Procedure Tab - Injection Site Selection).
Figure 3 - 8: Procedure Tab - Injection Site Selection
ii. Select the value from the Injection Site list. When the value is selected, the Injection Site field
updates, and the list disappears.
NOTE: If the correct injection site does not show, but arrows appear, press the Up or Down arrow to show
additional entries. If the Injection Site is not in the entire list, refer to 5.3.4 - Hide or Show a Value
in a User-Created List to show additional entries in the Injection Site list.
iii. Press Clear to clear the existing value, or press Cancel to ignore changes made.
c. Accession Number and Study Description
i. Select Accession Number or Study Description field (Figure 3 - 9: Procedure Tab - Accession Num-
ber/Study Description Entry).
3 - 10 Certegra® Applications and Workstation Accessories
Figure 3 - 9: Procedure Tab - Accession Number/Study Description Entry
ii. Enter data with the alphanumeric keyboard.
iii. Press Enter to save changes made to the accession number or the study description, or press Can-
cel to ignore changes made.
d. Catheter Gauge
i. Select Catheter Gauge field (Figure 3 - 10: Procedure Tab - Catheter Gauge Selection).
Figure 3 - 10: Procedure Tab - Catheter Gauge Selection
ii. Select the value from the Catheter Gauge list. When the value is selected, the Catheter Gauge field
updates, and the list disappears.
NOTE: If the correct catheter gauge does not appear on the Catheter Gauge list, but arrows appear, press
the Up or Down arrow to show additional entries. If the Catheter Gauge is not in the entire list,
refer to 5.3.4 - Hide or Show a Value in a User-Created List to show additional entries in the
Catheter Gauge list.
iii. Press Clear to clear the existing value, or press Cancel to ignore changes made.
3. Press OK to save all changes made to procedure information, or press Cancel to ignore all changes made.
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