General Safety Notifications for Synapse
Introduction
Failure to follow the notifications in this section may cause misuse of system, operation confusion, system corruption, or other serious system failures that may result in patient or user safety problems, loss of data, misinterpretation of diagnostic results, delay of information delivery, or other safety problems.
You will find the latest safety notifications at the top of the list. The title may be followed by New (or another designation, such as Revised) so that you can quickly find the most recent notifications.
33 Study Mismatch When Using URL Calls
When launching Synapse via Web Query initiated by a third-party Worklist using the browser, Synapse can intermittently be out of sync with the third-party Worklist.
The FUJIFILM Synapse Extension used for window management must be installed to allow Synapse to close browser windows that display Synapse.
For more information, see the Updating Synapse Content topic in the Installation and Configuration guide and the Browser Considerations Overviewtopic in this users guide.
32 Platform Support
Running this device on unsupported platforms might cause issues. Using unsupported platforms is at the user's risk and might affect patient diagnosis. See Synapse PACS Product Release Specification for supported platforms.
Fujifilm validates platform-related updates on a monthly and quarterly basis. Fujifilm provides updates as articles on the Fujifilm extranet. See your System Administrator for more information.
If any of the platform updates cause issues, stop using the device and contact Fujifilm support or your System Administrator.
31 Dictation System Interface
Before starting the dictation, confirm in the dictation system window that the session on the dictation system is for the same study and patient displayed in Synapse.
- Study and Patient information displayed in the Dictation System and Synapse can be used to accomplish this task.
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In rare cases, ignoring this safety notification might lead to misdiagnosis, such as dictating a study for the wrong patient.
30 Browser Zoom
For best image quality, it is important to keep the browser and operating system zoom levels at 100% at all times. Even if you do not change the browser zoom level, another application might change it without your knowledge. On Windows 10, on workstations with multiple monitors with different resolutions, the zoom factor on the high resolution monitors might not default to 100%. The browser might automatically change the zoom factor each time a window moves between monitors. The following information will help the user be aware of what the browser zoom factor is.
See Ensuring the Browser and OS Zoom Factors are 100 Percent
29 Dynamic Gray Palette on High Resolution Monitors is Not Supported
Synapse does not support monitors configured for 8-bit and 16-bit color modes.
28 Using the Cine Feature
The cine toolbar lets you set the playback speed and save the cine as a video (.avi file format) for playback. Because compression for lossy video may affect image quality, .avi files are not intended for diagnostic purposes.
27 Operating System and Browser Updates
Synapse software relies on the integrity of the operating system and the web browser used. It becomes the customer's responsibility to remedy defects caused by the operating system and or browser.
26 Mammography Image Viewing on Synapse
- Synapse is capable of receiving and displaying Mammography images. Synapse provides spatial frequency enhancement, dynamic range control, or multi-objective frequency image processing for Fuji DICOM MG For Processing Mammography images. Synapse does not provide spatial frequency enhancement, dynamic range control, or multi-objective frequency image processing for DICOM MG For Presentation Mammography images.
- Mammography image interpretation should only be performed on a DICOM-compatible display that has been cleared for primary Mammography image interpretation by the FDA.
25 Prescription Device Statement
Caution! Federal Law restricts this device to use by or on the order of a health care practitioner. Use of Synapse must be in compliance with local regulations.
24 Security and Privacy
Customers shall use security features and measures in accordance with their procedures to prevent unauthorized access to Synapse and patient information.
23 Monitor Calibration and Monitor Defects
If a monitor is not calibrated, image quality may vary. Monitors must be calibrated by the monitor vendor's calibration method.
Image quality is subject to the quality of the monitor. An image displayed on a color monitor looks different from the same image displayed on a grayscale monitor.
A monitor may contain small defects on the surface, such as dust or scratches on the surface of the CRT, defects of LCD cell, etc. A customer should understand this problem and not confuse the defects with a software problem.
23.1 True Size Monitor Calibration
True Size Display is limited to Display devices where the physical Horizontal Pixel width is equal to the physical Vertical Pixel height. For True Size Display to be accurate, the display pixels at the used display resolution must be physically square.
After performing True Size Monitor Calibration, the user must be aware that if any characteristics of the display system (as specified in Calibrating Monitors for True Size Image Display) are changed, then failure to follow that page's instructions completely, to re-enter the new correct calibration setting value may result in incorrect true size measurements or improper matching of same physical scale across monitors.
If a monitor display size changes or drifts (as can happen in CRT monitors), then recalibration must occur for that monitor.
22 Hardware Qualification
- For workstation and server specifications, see the Product Release Specification.
- The hardware for the third-party software used with Synapse must be within the specification of the third-party software.
- The party responsible for the Synapse software implementation must also be responsible for the qualification of hardware.
21 UPS for Server
Synapse servers shall use UPS to prevent Synapse from problems due to unexpected power failure. The Synapse server must be shut down using the Windows operating system shutdown process while UPS battery power or alternate power is available. If a power generator is used, the UPS battery should supply power while the power source is changing to the generator.
20 Unknown Software
Synapse servers shall not have any software other than the software specified by Fujifilm.
Fujifilm performs best design efforts to maintain compatibility with other software used with the Synapse workstation software. However, during the product release testing, no other software is explicitly tested with Synapse. Although the risk that Synapse does not work with other software is low, it is the customer's responsibility to verify the compatibility of the software with Synapse workstation software.
19 Networking
Synapse is not accessible without a network, including LAN and WAN. The availability of a network is the customer's responsibility. This includes accessibility to other devices on the network such as printer, storage locations, etc.
18 Backup and Redundancy
Synapse software relies on hardware redundancies and backups for system availability and the protection of data. The backup/recovery and hardware redundancy plan is the responsibility of the customer. If Synapse is used in a filmless environment, at least one level of redundancy, such as RAID, shall exist in the hardware that holds database and images and both data must be properly backed up. Multiple levels of redundancy and backups are highly recommended.
Synapse supports the Synapse database backup feature. This feature must not be turned off. The backed up copy of database by Synapse backup feature must be backed up using standard IT backup methods, such as tape backup.
If an archive local is used, copying archive media is strongly recommended. Archived directory and configuration files must be also backed up.
Image data must be backed up in order to prevent the loss of data.
Using redundant hardware, such as redundant CPU, redundant power supply, cluster technology, etc., is highly recommended to achieve high availability.
Installing multiple workstations for redundancy is also recommended to prevent a local down caused by a workstation hardware failure.
17 Administrative Privilege
Synapse software and server administrative privileges and user authentication shall be managed by the customer for privacy and security.
16 Installation and Administration
The Synapse installation, upgrade, local maintenance, local administration, and Synapse administration shall only be performed by trained personnel except for the workstation code download.
Individuals performing installation, upgrade, local maintenance, local administration, and Synapse administration shall verify that Synapse is working as expected after the above tasks are completed.
Training materials must be created or updated using the correct version of service manual, user manual, implementation manual, or other formal documents released as a part of the Synapse product.
Trainers in the user's organization must be trained by an authorized Synapse implementation group from their respective country.
Fujifilm shall notify customers about installation and administration tasks that must be performed. Customers shall plan the proposed tasks in accordance with their internal procedures.
15 Server Location
Synapse servers shall be installed in a secure location protected from unauthorized access.
14 Information Refresh
- If the study information is updated while you are viewing images, Synapse might not automatically update some information. A manual refresh might be required to update the information.
- Supported browsers are designed to support the refresh feature (Refresh on the View menu, F5 key, CTRL-F5, or Refresh icon on the toolbar) for only the currently active browser window and does not normally refresh other open windows or sub-windows. If a sub-window of a study, such as PowerJacket, is opened and the F5 key is applied to refresh this window, only PowerJacket will be refreshed and the main study display window will not be refreshed. Alternatively the user can close and re-open the study.
- Users shall verify the information has been refreshed to include the latest changes before making final patient decisions.
13 Version and Study Deletion
Image versions can be deleted from Synapse by configuring Synapse Web Administration Tool (SWAT). The deletion mechanism relates to the SWAT configuration as well as the structure of the file storage location. If the local is not properly configured, unexpected files will be deleted. Maximum caution should be taken when version deletion is used.
If study deletion is activated in SWAT, studies will be deleted when all versions are deleted. Customers and administrators must be absolutely sure before turning on study deletion.
12 Creation or Modification of Study and/or Patient Matching Criteria
If additional matching criteria are created or existing criteria are modified, it may cause a misidentification of a patient or a study. If this occurs, there is risk that a study may be allocated to the wrong patient without causing an anomaly alert. Customers must authorize changes to the matching algorithm criteria before use.
11 Study and Patient Matching Under Non-Unique Identifier Environment
Synapse supports a non-unique identifier environment for patient medical record numbers (MRN), accession numbers (Study ID), and visit numbers. It also supports additional matching algorithms configured using non-unique matching criteria for unique or non-unique identifier environments.
If Synapse uses non-unique identifiers for matching, depending on the matching algorithm, there is risk that a study might be allocated to the wrong patient without causing an anomaly alert. The group responsible for the Synapse implementation must obtain the customer's agreement on the matching algorithm before it is used.
10 Study and Patient Matching
Synapse uses Patient ID and Study ID as its matching key and locates studies or patients if this key matches. But the key information might be incorrect when it is sent to Synapse. In order to detect this inconsistency, Synapse has a mismatch detection feature. If Synapse detects a mismatch, an anomaly entry will be created in the Anomalies folder. You must check the Anomalies folder routinely.
An anomaly alert will be displayed when you open a study with an anomaly. It is highly recommended to always have this warning enabled. With or without this warning, it is the user's responsibility to verify that the viewed study belongs to the correct patient.
The Synapse mismatch feature might not be able to detect all erroneous entries caused by information coming from the RIS, EMR, or modalities. It is the user's responsibility to send the correct information to Synapse from the RIS locals or modalities.
Switching to a new study or patient will update open windows. For example: If the Image viewer and PowerJacket are already open, they will update with new content and images from the selected patient/study. In rare occasions, content might not be accessible or available, or exceptions within the software will prevent loading the requested content. This can lead to windows or frames being out of sync with each other.
Prior to rendering a clinical diagnosis, decision, or administrating treatment, the user must confirm that the data, including reports and images that are displayed in different frames and windows, are for the same patient or study:
- Study and Patient information displayed in different windows can be used to accomplish this task.
- Not following this safety notification in rare cases could lead to misdiagnosis, such as dictating a study for the wrong patient.
9 Patient Demographics and Records
Special care should be taken when patient decisions are made based on patient demographics and other patient-related information. Patient demographics and other information could be incorrect due to incorrectly entered information or internal system errors resulting in misrepresentation and mismatches.
8 Measurement Results
Image Processing
Depending on the modality, Modality LUT in the DICOM header may be applied on the value of original pixels for measurement, or the larger measured value corresponds to either a darker area or a brighter area.
Data value measurements, such as the pixel value measurement or area measurement, are performed on the images after Fujifilm image processing is applied for FUJIFILM for processing images. This may be performed before or after the Modality LUT in the DICOM header due to an inconsistency in the DICOM standard. Users must calibrate the pixel value with the modality if the absolute value is used or when comparing the value across different modalities.
Measurements
Measurement calculations were enhanced in Synapse 7 and are more accurate. If you compare, for example, saved measurements in the report or a printed image from a previous Synapse version, including CV, to the same image in Synapse 7, the results might differ. 7 is the most accurate version.
With MDS configured to a Synapse system earlier than Synapse 7, differences may be encountered depending on which version performs the calculation.
7 Image Processing
For Fuji CR, CT, Fuji MG, and Fuji DX, a general image processing is also supported that can be applied to all modality types.
Image processing may create artifacts or overly enhance the image. Users must understand the effects of image processing before use. In the event of a perceived over-enhancement, users can select the Revert preset to go back to the last saved state, or select the Display as Acquired preset to go back to the acquired image state.
6 Position Marker Accuracy on an Image
Synapse displays orientation marker overlays on an image if they are available in the DICOM header. The accuracy of the orientation markers depends on the information sent from the modality. Users should follow standard clinical marking procedures and verify the accuracy of markers.
5 DICOM Header Mapping Feature
Synapse includes a DICOM Header mapping feature. The following fields must not be mapped using this feature:
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Patient and study demographic information, such as patient name, patient ID, study ID, study name, etc., must not be mapped. If incorrect information is mapped to patient or study-related fields, it may cause serious mislabeling problems.
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Pixel spacing information must not be mapped. If incorrect information is mapped to pixel spacing, and this information is used as a basis of measurement calculation, it will result in a measurement error.
4 Measurement and Scale Accuracy
The measurement and the scale implemented in the Synapse workstation uses the pixel size information sent from the modality. The accuracy of measurements, such as length or area, depends on the accuracy of the pixel size information sent from the modality through the DICOM interface. But DICOM header information may be incorrect. Users must confirm the scale accuracy.
Synapse will use the following order in the event there is more than one source of pixel size information:
- Synapse information has the highest priority and will be used if the image was calibrated using Synapse calibration functionality.
- If no Synapse calibration exists, the image header pixel size information will be used.
- If a magnification factor or manual calibration is applied, an asterisk (*) displays with the measurement results and the scale.
- Some X-ray equipment sends a magnification factor. The DICOM definition is the Estimated Radiographic Magnification Factor group and element (0018,1114). Although this is an optional value in DICOM, Synapse automatically uses this value in the measurement calculation if it exists. Users must pay attention as to whether or not the scale was automatically calibrated using the (0018, 1114) element.
Accuracy of measurements:
- Length: 99.7%
- Angle: 99.5%
- Circle: 99.7%
- 2D Area: 99.8%
- 2D Length: 99.9%
- 2D Volume MOD: 99.9%
- 2D Area: 99.4%
- 2D Length: 99.7%
- Doppler Slope: 99.9%
- Velocity: 99.6%
- P1/2 Time: 99.3%
- Peak Velocity: 99.9%
- Peak Gradient: 99.7%
- Time (Doppler): 99.9%
- VTI: 99.6%
- Peak Velocity: 99.9%
- Peak Gradient: 99.8%
- Mean Velocity: 98.1%
- Mean Gradient: 97.1%
- MM Time: 99.9%
- MM Length: 99.8%
- MM Slope: 99.9%
It is the user's responsibility to ensure measurement accuracy based on need. The above values do not account for human errors.
SUV evaluation can only be performed on a PET image that has the necessary parameters in the DICOM information. Depending on the modality, the software version, or the settings, it might not always be possible to perform SUV calculation or the results of calculation might be inaccurate.
3 Hardware Installation Environment (Temperature, Humidity, Pressure, Power, etc.)
All hardware shall be installed and used in the environment in accordance with the supplier's hardware specifications. Commercially available computer locals specified in this document to be used with Synapse software are not designed for use in explosive environments (anesthesia), where oxygen is in use, or in sterile environments such as operating rooms.
2 Hardware Selection for Patient Environment
Commercially available computer locals specified in this document for Synapse software are NOT designed to be used as medical instruments, for any form of patient contact, for direct patient care, or for use in close proximity to any patient.
If hardware is installed in a patient environment (within 2.5m around a patient), it is the customer's responsibility to provide additional methods to increase the safety characteristics specified in IEC60601-1 (IEC6060-1-1 and IEC60601-1-2).
1 General Hardware Selection
Synapse is a Medical Device product. Hardware, which is used with Synapse software, shall be regulated by IEC60601-1. The IEC60601-1 standard allows the use of general safety standards if hardware with Synapse software is installed in a non-patient environment.
Hardware must comply with the following safety and electromagnetic standards. Hardware must be installed within the environment specified in each standard. The following standards are for the U.S.A. It is the responsibility of each regional Synapse implementation organization to select hardware that complies with local regulations.
- General safety standards for all hardware: IEC60950, UL1950, or equivalent.
- Electromagnetic interference/susceptibility standards for all hardware: FCC Class A or B, or equivalent.
- X-ray radiation safety standard for CRT monitors: DHHS Title-21 CFR Sub Chapter-J.