GE Voluson E Series, Service Manual, Page: 166 / 356

5.1.4.21 Disk Encryption
Disk Encryption enables an encryption to secure all Patient Data, Patient Images and corresponding
measurements. A password, an USB storage device with unlock key, or the recovery key is required to
unlock the device during the boot-up process.
Note Any data stored on internal HDDs D:\ partition is encrypted by using BitLocker configured with AES 256-bits
key length.
Caution
Without the Encryption Password or Recovery Key it will not be possible to access the Ultrasound device
including emergency mode, scanning, patient information, images, or local archive. GE has no access to this
information or the ability to undo encryption in the event that the Encryption Password and Recovery Key are
lost. The security and safety of the Encryption Password and Recovery Key is solely the user's responsibility.
Note The "Disk Encryption” option is only available for Voluson E-Series systems with software version EC320
(BT17, requires Ext.4 or higher). At Voluson E-Series systems with software version EC330 (BT18), Disk
Encryption is part of the Advanced Security Features option.
Note A Voluson E-Series systems without the option but with encrypted disk is unlockable.
5.1.4.22 Advanced Security Features
The "Advanced Security Features" option consists of two vulnerability protection features:
•
"Disk Encryption" on page 5-20
•
"Whitelisting" on page 5-20
5.1.4.22.1 Whitelisting
Whitelisting prevents the Voluson E-Series system from installing unwanted software. It monitors all
applications/services if they are known and accepted (white-listed). Any application/service that is not known
on the system creates an error message on the screen.
"Whitelisting” is only available for Voluson E-Series systems with software version EC330 (BT18). It is part of
the
Advanced Security Features
option.
5.1.4.23 IOTA (International Ovarian Tumor Analysis)
Caution
The IOTA model (LR2 or Simple Rules) should not be used without an independent clinical evaluation and is
not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect
use of the IOTA model carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
If more than one IOTA option (i.e., IOTA LR2, IOTA Simple Rules) is available, it is possible to configure the
measure setup which worksheet is displayed.
IOTA LR2
The IOTA (International Ovarian Tumor Analysis) LR2 Worksheet contains an ovary measurement tool for
women with adnexal tumors that have been selected to undergo surgery. The LR2 model is based on
published literature and has been tested only on the stated population. The literature states that the LR2
model can help to estimate the probability of an adnexal mass of being malignant. The IOTA group has
evaluated other ways including an LR1 model in additional to the LR2 model.
Note
IOTA states that use outside of the intended population can overestimate risk. Users are expected to study
the literature and reach their own professional conclusions regarding the clinical utility of the tool. The model
cannot replace experience in ultrasonography and cannot compensate for poor quality ultrasound
equipment.
The IOTA mathematical logistic regression model, LR2 is stated in literature as described in the Advanced
Reference Manual (H48701UU).
General Electric is passing on this IOTA LR2 worksheet for your convenience based on published literature
of one group, but makes no representation of its effectiveness in your practice. This calculation is not to be
used as the primary driver in diagnostic decision making on the probability of malignancy. It is secondary
information for a physician to use based on recent literature.
Components and Functions (Theory)
5-20
Voluson E-Series Service Manual
5539550APB Revision 6