Page 58 Ulthera, Inc
NOTE: For quality and safety reasons, the Ulthera® System collects data regarding
patient treatment and stores it on the device. If a device operator enters a patient
name or static patient identifier into the user interface screen on the device, an
identified patient record is created and stored. This is called the Exam Record and it
can be viewed by anyone who powers on the device. Data that may be entered
into the Exam Record include patient name, sex, clinician, facility name and details
about the treatment delivered. To protect patient privacy, Ulthera recommends
that you always delete the Exam Records from your device before sending it in for
service.
To delete this data from your device prior to sending it in for service, follow the steps
identified below:
Deleting data:
1. Save the records to be deleted from the database on an accessory
device.
(This step is not required, but it is highly recommended)
2. Tap the Delete button to remove an individual item or tap the Select All
button and then the Delete button to remove all items from the database.
Note: If you delete one or more patients by mistake, tap the Undelete
button to restore the items.
3. Tap the Close button to return to the Setup screen.
To recover deleted items from the database:
1. To recover one or more of the 50 previously deleted items, tap the
Undelete button. (A maximum of 50 previously deleted items may be
recovered.)
2. Select the images or records you would like to recover and tap the
Undelete button again.
The selected items are restored to the current database.
Also, for quality and safety purposes, the device creates and stores a “Support Log”
which contains all device parameters captured during single treatment
sessions. The Support Log is stored on the device compact flash drive. Patient data
contained in the Support Log is encrypted and can only be decrypted and read by
specifically authorized safety personal from Ulthera, Inc. Ulthera only decrypts and
views identified patient data in the Support Log when investigating potential
adverse events reported to Ulthera regarding the use of the device.
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