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. [phone]
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

3 Unit description
3.4 Sensor holders
The sensor holder system includes the following parts:
Anterior holder Posterior holder
Horizontal bitewing holder Vertical bitewing holder
Universal bar Bitewing bar
Universal positioning ring Alignment bar cable clip
FS Ergo Sensor 11

3 Unit description
3.5 Accessories
Sensor cable clip Sensor garage
•USB extension cable
•Sensor sheaths 100 sample pack
12 FS Ergo Sensor

4 Installation
4 Installation
4.1 System overview
The system includes the sensor, a full set of sensor holders, and other consumables.
Package contents:
Software and documentation:
• FS Ergo Sensor User Manual
• Workstation Software (optional).
Sensor and sensor items and their usage:
• FS Ergo Sensor - direct USB intra-oral digital X-ray sensor
• Sensor garage - to store and protect sensor when it is not in use
• Sensor cable clip - used to attach sensor cable to clothing
• USB extension cable, 3 feet (1 m) - for easy access to the workstation´s USB port
• Sensor sheaths - sheaths for the sensor (sample bag of 100 pcs).
Accessories:
Sensor holder set:
• Anterior holders (2 pcs)
• Posterior holders (2 pcs)
• Horizontal bitewing holders (2 pcs)
• Vertical bitewing holders (2 pcs)
• Universal positioning ring (2 pcs)
• Universal bar (2 pcs)
• Bitewing bar (2 pcs)
• Alignment bar cable clip (5 pcs)
NOTICE! The FS Ergo Sensor and holders are designed for a custom fit. For best
comfort, use only the FS Ergo sensor holders.
NOTICE! If you want to order more consumables or accessories, refer to the list
in Accessories.
4.2 Hardware requirements
NOTICE! Connecting the unit to an IT-network that includes other equipment or
changing the IT-network, can cause unidentified risks to patients or operators.
It is the responsibility of the organization controlling the IT-network to identify,
analyze, evaluate and control these possible risks.
NOTICE! All IT components that are used in connection with the sensor need to
be in compliance with the applicable safety standards.
All X-ray equipment for Dental Intraoral Radiography for FS Ergo must conform to IEC
60601-2-65:2012.
WARNING! All IT components electrically connected to the FS Ergo sensor must
conform to IEC 60950-1.
FS Ergo Sensor 13

4 Installation
WARNING! The IT components are placed OUTSIDE the patient environment. IT
components placed INSIDE the patient environment (at least 1.5 m from the unit),
due to customer site requirements, must also conform to IEC 60601-1.
IEC 60601-1 defines the “Patient environment” as “any volume in which intentional or
unintentional contact can occur between a patient and parts of the ME Equipment or ME
System or between a Patient and other persons touching parts of the ME Equipment or
ME System.”
For workstation hardware requirements, refer to the used imaging software
specifications. See Support and help. When technology changes, the requirements are
updated to reflect the changes. Consult the current sensor systems requirements before
you purchase any hardware.
NOTICE! Systems that meet only the minimum requirements may fail to deliver
a satisfactory experience. Systems with faster processors, more memory, and
bigger, faster hard drives will significantly enhance performance.
4.3 Workstation upgrades
NOTICE! Always make back-ups of your data and store it off-site. Before
assuming that your back-up efforts have been successful, make sure that you
understand the backup process and try the restore process at least once on a test
system. Verify that both the operating system and data have been preserved.
To protect patient records and other critical data, consider the following solutions:
• Purchase a new computer and run a parallel system on it.
• If you must upgrade your existing system, purchase an additional hard drive and copy
the existing hard drive to it.
4.4 Installing the sensor
The installation of the sensor consists of:
• Installing the imaging software. Refer to your software manual for instructions.
• Connecting the sensor to your computer. See instructions in Connecting the sensor.
The sensor does not require any calibration or calibration file installation from a disc.
4.4.1 Connecting the sensor
1. Make sure the workstation to which you are connecting the sensor has a compatible
version of the software installed.
NOTICE! The sensor is a USB compliant device and shall be used with USB
compliant cables suitable for high speed/USB 2.0 cables. Such cables are
either marked “USB 2.0” or “USB high speed.” USB certified hubs can be used
to extend the distance to the USB host/computer. The length of the cable
connection to the hub or between hubs shall not exceed 5 m.
14 FS Ergo Sensor

4 Installation
2. Connect the sensor´s USB connector the workstation. Ensure that the plug is
properly oriented with the port of the workstation.
Max. distance 3 m Powered active USB HUB
NOTICE! The sensor cable is 3 m long. If a longer cable is required, use the
USB extension cable supplied with the sensor.
3. Sensor USB drivers are installed automatically when the sensor is connected to the
workstation.
4.4.2 Mounting the sensor garage
Install the sensor garage in a place that is convenient and secure.
NOTICE! The sensor garage should also be positioned so that the cable from the
sensor does not create a tripping hazard.
1. Clean the mounting surface.
2. Remove the backing from the double-sided tape.
3. Press the sensor garage firmly against the mounting surface.
4.4.3 Adjusting the X-ray source
The sensor is generally compatible with any dental X-ray unit and intraoral X-ray device
that can supply the required range of exposure times and doses.
Refer to your X-ray device´s User manual for the recommended exposure times for
digital sensors.
NOTICE! X-ray devices, even the same brands and types purchased at the same
time, differ widely in their performance. In addition, on a newer X-ray device, the
“digital” setting on your dial or keypad may not be the ideal setting.
4.4.3.1 X-ray generator settings
The radiation of X-ray tubes is controlled by the settings of:
• Exposure time (ms) or pulses
• Voltage (kV or kVp)
• Current (mA).
Some controls allow the modification of all the settings listed above, but some have fixed
settings for current and voltage. Follow the instructions of the X-ray generator to set the
desired dose range.
4.4.3.2 Distance of X-ray source to sensor
There is a correlation between the distance of the cone to the sensor and the dose
received by the sensor. The radiation that reaches the sensor decreases with the
FS Ergo Sensor 15

4 Installation
square of the distance. If you double this distance, the sensor receives only 25% of the
radiation.
16 FS Ergo Sensor

5 Using the sensor
5 Using the sensor
Before using the sensor, familiarize yourself with the sensor and the proper handling
guidelines in section Proper care of the sensor.
5.1 Assembling the sensor holders
Assemble the ring, bars and sensor holders so that the entire sensor is visible through
the ring. This applies both to bitewing and periapical assemblies.
FS Ergo Sensor 17

5 Using the sensor
HORIZONTAL BITEWING IMAGING VERTICAL BITEWING IMAGING
Required equipment:
• Horizontal bitewing holder
• Bitewing bar
• BW hole on the positioning ring
Required equipment:
• Vertical bitewing holder
• Bitewing bar
• BW hole on the positioning ring
Horizontal bitewing aim:
NOTICE! Check that the sensor is
in the middle of of the posititioning
ring.
Vertical bitewing aim:
NOTICE! Check that the sensor is
in the middle of of the posititioning
ring.
18 FS Ergo Sensor

5 Using the sensor
ANTERIOR IMAGING POSTERIOR IMAGING
Required equipment:
• Anterior holder
• Universal bar
• A/P hole on the positioning ring
• 2 x cable clips
Required equipment:
• Posterior holder
• Universal bar
• A/P hole on the positioning ring
• 2 x cable clips
Anterior aim:
NOTICE! Check that the sensor is
in the middle of of the posititioning
ring.
Posterior aim:
NOTICE! Check that the sensor is
in the middle of of the posititioning
ring.
FS Ergo Sensor 19

5 Using the sensor
5.2 Preparing the sensor for imaging
1. Connect the sensor´s USB connector to the workstation and open the imaging
software.
2. Place the hygienic sheath over the sensor.
3. Attach the sensor to the sensor holder. The sensor will only fit into the holder one
way.
4. Place the cable into the groove on the holder if it is possible. This protects the cable
when patient closes their mouth. See section Cable protection and the Positioning
Tutorial for complete information about cable protection.
WARNING! To help prevent cross-contamination between patients, place a
new sheath on the sensor for each new patient.
CAUTION! Due to intraoral imaging geometry and positioning, accurate
distance and angle measurements cannot be taken from intraoral images.
5.3 Cable protection
NOTICE! Check the condition of the cable before use. Do not use the sensor if
the cable is broken.
The sensor holders have a groove for housing the sensor cable during imaging and
patient positioning. Route the sensor cable into this groove. For added protection, when
using the universal bar, route the cable also through alignment bar cable clips.
NOTICE! If the sensor holder is assembled so that the cable cannot be routed
through the groove, use only the alignment bar cable clips to house the cable.
20 FS Ergo Sensor