KaVo FS Ergo Operating manual
FS Ergo Sensor
User and Installation Manual
ENGLISH
217161 rev. 7
0.805.5292
Contents
1 Disclaimer................................................................... 5
2 Introduction................................................................ 6
2.1 FS Ergo Sensor...................................................................................... 6
2.2 Indications for use (for North America)..................................................... 6
2.3 Intended use......................................................................................... 6
2.4 Intended user profile.............................................................................. 6
2.5 Terms and abbreviations......................................................................... 7
2.6 Signal words..........................................................................................7
2.7 Warnings and precautions....................................................................... 7
2.7.1 General warnings.........................................................................7
2.7.2 Disposal..................................................................................... 8
3 Unit description.......................................................... 9
3.1 Product description................................................................................. 9
3.2 Main parts............................................................................................. 9
3.3 Sensor statuses....................................................................................10
3.4 Sensor holders..................................................................................... 11
3.5 Accessories.......................................................................................... 12
4 Installation................................................................13
4.1 System overview.................................................................................. 13
4.2 Hardware requirements......................................................................... 13
4.3 Workstation upgrades............................................................................14
4.4 Installing the sensor............................................................................. 14
4.4.1 Connecting the sensor................................................................14
4.4.2 Mounting the sensor garage........................................................15
4.4.3 Adjusting the X-ray source......................................................... 15
5 Using the sensor....................................................... 17
5.1 Assembling the sensor holders............................................................... 17
5.2 Preparing the sensor for imaging............................................................20
5.3 Cable protection................................................................................... 20
5.4 Handling the sensor.............................................................................. 23
5.5 Correct sensor positioning using the parallering technique..........................23
5.6 Occlusal X-rays.....................................................................................25
5.7 After exposure..................................................................................... 26
5.8 After using the sensor...........................................................................26
6 Maintenance..............................................................27
6.1 Proper care of the sensor...................................................................... 27
6.2 Prosessing of the sensor holders............................................................ 27
6.3 Image quality assurance........................................................................28
7 Technical data...........................................................30
7.1 Technical specifications.......................................................................... 30
FS Ergo Sensor 3
7.2 EMC information................................................................................... 32
7.3 Symbols that may appear on the device or its parts..................................38
8 Support and help...................................................... 40
4FS Ergo Sensor
1 Disclaimer
1 Disclaimer
FS ERGO SENSOR User and Installation Manual, 217161 r7.
Copyright © 8-2018 by PaloDEx Group Oy. All rights reserved.
KaVo™ is a registered trademark of Kaltenbach & Voigt GmbH in the United States and/or
other countries.
All other trademarks are property of their respective owners.
Documentation, trademark and the software are copyrighted with all rights reserved.
Under the copyright laws the documentation may not be copied, photocopied,
reproduced, translated, or reduced to any electronic medium or machine readable form
in whole or part, without the prior written permission of PaloDEx Group Oy.
The original language of this manual is English.
PaloDEx Group Oy reserves the right to make changes in specification and features
shown herein, or discontinue the product described at any time without notice or
obligation. Contact your PaloDEx Group Oy representative for the most current
information.
The manufacturer has no liability for consequential damage, personal injury, loss,
damage or expense directly or indirectly caused by the use of the product. No agent,
distributor or other party is authorized to give warranty or other liability on behalf of the
manufacturer with respect to its products.
Manufacturer:
PaloDEx Group Oy
Nahkelantie 160
FI-04300 Tuusula
FINLAND
Tel. +358 10 270 2000
www.kavokerrgroup.com
For service, contact your local distributor.
FS Ergo Sensor 5
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.
6FS Ergo Sensor
2 Introduction
2.5 Terms and abbreviations
Workstation PC or other computer that is used in office work.
USB Universal Serial Bus
2.6 Signal words
The following signal words and labels are used in this document:
WARNING! Indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
CAUTION! Indicates a hazardous situation which, if not avoided, could result in
minor or moderate injury.
NOTICE! Highlights suggestions which will result in enhanced installation,
reliability, or operation. Not used for safety related hazards.
2.7 Warnings and precautions
2.7.1 General warnings
Sensor holders and hygienic sheaths are considered as applied parts, and they are safe
for normal or accidental patient contact during use.
Modifications
WARNING! No modification of the equipment is allowed.
WARNING! Any service attempts by unauthorized persons are strictly prohibited.
The sensor has no serviceable parts. Do not open the sensor to service it. All aspects
of the sensor that are meant to be attended to by you are accessible without opening
the internal components of the sensor. If there is a problem, contact a qualified dealer
service representative or Technical Support.
Placement
The workstation shall be placed in the same room and outside patient environment (at
least 1.5 m from the patient and patient support) to ensure patient safety.
Mains isolation
Disconnection from the supply mains occurs at the input to the computer. The sensor can
also be disconnected from the computer.
X-ray protection
The rules of dental radiography still apply to digital X-ray systems. Continue to use
protection for your patients. As a clinician, clear the immediate area when exposing the
sensor.
FS Ergo Sensor 7
2 Introduction
WARNING! Take the necessary steps to protect yourself from radiation. For
proper operator positioning, refer to the User Manual of FOCUS™ or other intraoral
X-ray equipment.
Prevention of cross-contamination
To help prevent cross-contamination between patients, place a new hygienic sheath on
the sensor for each new patient. The hygienic sheath must cover the sensor and at least
3 -4 inches (7-10 cm) of the cable.
For information about cleaning the sensor, refer to Proper care of the sensor.
Sensor inspection
Always inspect the sensor, cable, and positioning devices for physical damage prior to
every use. See chapter Proper care of the sensor.
WARNING! Remove sensor from use if damage to the cable or housing is
observed, otherwise exposure to elevated surface temperature or electrical energy
may result.
2.7.2 Disposal
CAUTION! Dispose of sheaths and other consumable products following the
normal dental office procedure for biomedical waste. Improper disposal of
biomedical waste can lead to the spread of illness or disease.
Properly dispose of the sensor when it has reached its end of life. For information, refer
to the explanation of this symbol in chapter Symbols that may appear on the device or
its parts.
8FS Ergo Sensor
3 Unit description
3 Unit description
3.1 Product description
An X-ray image sensor is positioned in the patient’s mouth similarly as an intraoral
film. There is no electrical or physical connection between the sensor and the X-ray
generator. Images are automatically acquired when X-rays are present in a dose which is
perceptible to the sensor.
Digital X-ray images are quickly displayed on the screen. Images can be optimized for
viewing via imaging software, stored as image files, and printed out on a suitable printer
if desired.
The sensor must be connected to a workstation through a standard USB port.
3.2 Main parts
1. Sensor head
2. Sensor cable
3. USB pod
4. Indicator light
5. USB connector
Type label
NOTICE! The label shown above is
for reference only. The texts may be
different in the actual label.
FS Ergo Sensor 9
3 Unit description
3.3 Sensor statuses
The LED on the sensor indicates the status of the sensor.
Indicator light Default state Function
No color Power off -
Orange Standby USB cable is connected but there
is no SW connection or Image
capture is not activated.
Green Ready Sensor is ready for capture
Blue Integration During x-ray exposure (~1s)
Orange blinking Readout Data transfer
10 FS Ergo Sensor
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