Introduction; Fs Ergo Sensor; Indications For Use (For North America); Intended Use - KaVo FS Ergo User And Installation Manual

2 Introduction

2 Introduction

2.1 FS Ergo Sensor

The FS Ergo sensor is a USB-driven digital sensor that has been designed specifically for
healthcare professionals already acquainted with the standard procedures for acquiring
dental intraoral radiographs.
The sensor design uses advanced ergonomic principles. Four beveled corners, a rounded
casing and soft material provide enhanced comfort for the patients. The sensor is
positioned in the patient's mouth similarly as an intra-oral film is positioned.
There is no electrical or physical connection between the sensor and the X-ray generator.
The sensor creates a digital image from X-ray beams perceptible by the sensor. The
created digital image is immediately visible on the screen of the workstation connected
to the sensor through a USB port.
To function, the device requires an additional workstation with MDD approved dental
imaging software. All softwares used with the device must conform to the MDD and the
relevant legal requirements in the USA. The workstation must conform to all the device
and dental imaging software requirements.
The imaging software, necessary for a complete dental diagnostic system, is not part of
the device. Dental imaging software can be purchased separately. The acquired images
can be optimized for specific diagnostic tasks, archived as image files, and printed out on
a suitable printer, if desired, with imaging software. The imaging software is one example
of a dedicated software that provides a number of utilities for optimizing viewing and
printing of images.

2.2 Indications for use (for North America)

The FS Ergo sensor is a digital sensor which is intended to acquire dental intraoral
radiography images. The sensor shall be operated by healthcare professionals, who are
educated and competent to perform the acquisition of dental intraoral radiographs.

2.3 Intended use

The FS Ergo sensor is a USB-driven digital sensor which is intended to acquire dental
intraoral radiography images. The sensor shall be operated by healthcare professionals,
who are educated and competent to perform the acquisition of dental intraoral
radiographs. The sensor can be used either in combination with special positioning
devices to facilitate positioning and alignment with the X-ray beam or it may also be
positioned by hand with the assistance of the patient.

2.4 Intended user profile

CAUTION! US Federal law restricts this device to sale by or on the order of a
dentist or other licensed practitioner.
Only for professionally qualified dental/medical personnel.
Typical user is a dental assistant with specific training for using dental X-ray devices.
6 FS Ergo Sensor