KaVo ProXam iS User manual

KaVo ProXam iS
Instructions for use
EN

The manufacturer, assembler and importer are responsible for the safety, reliability and
performance of the unit only if:
- installation, calibration, modification and repairs are carried out by qualified
authorised personnel
- electrical installations are carried out according to the appropriate requirements such
as IEC 60364
- equipment is used according to the operating instructions.
Planmeca pursues a policy of continual product development. Although every effort
is made to produce up-to-date product documentation this publication should not be
regarded as an infallible guide to current specifications. We reserve the right to make
changes without prior notice.
COPYRIGHT PLANMECA
Publication number 1.015.1195 Revision 1
Released 1 March 2023

Table of contents
1 Introduction.................................................................................................................................................1
1.1 Usage environment........................................................................................................................ 1
2 Associated documentation..........................................................................................................................1
3 Symbols......................................................................................................................................................2
4 Safety precautions......................................................................................................................................3
4.1 Reporting serious incidents............................................................................................................ 4
5 Control box indicator light........................................................................................................................... 5
6 Before exposure......................................................................................................................................... 6
6.1 Positioning patient.......................................................................................................................... 6
6.2 Preparing and positioning sensor...................................................................................................6
6.3 Selecting exposure values..............................................................................................................8
7 Capturing intraoral images........................................................................................................................10
7.1 Capturing single intraoral images.................................................................................................10
7.2 Capturing images into study template.......................................................................................... 11
8 Image quality control.................................................................................................................................14
8.1 Quality check using SMPTE test pattern......................................................................................14
9 Sensor holders..........................................................................................................................................14
10 Cleaning and disinfection..........................................................................................................................15
10.1 Sensors and cables......................................................................................................................15
10.2 Sensor holders............................................................................................................................. 15
10.3 Control box................................................................................................................................... 16
11 Service......................................................................................................................................................17
12 Terms and conditions of warranty.............................................................................................................18
13 Disposal....................................................................................................................................................19
14 Technical specification..............................................................................................................................20
14.1 Sensor.......................................................................................................................................... 20
14.2 Ethernet ControlBox..................................................................................................................... 20
14.3 USB ControlBox........................................................................................................................... 21
14.4 Supported operating systems.......................................................................................................21
14.5 Operating environment.................................................................................................................21
14.6 Transportation and storage environment......................................................................................21
14.7 Distributor and manufacturer........................................................................................................21
Appendix A: Exposure value tables for KaVo ProXam iX...................................................................................23
A.1 Default exposure values...............................................................................................................23
A.2 Preprogrammed settings values...................................................................................................23
Instructions for use KaVo ProXam iS

Table of contents
KaVo ProXam iS Instructions for use

1 Introduction
This Instructions for use describes how to use and install the KaVo ProXam
iS sensor that is intended to be used for capturing digital intraoral X-ray
images from patient’s jaw, teeth, gums, roots and root canals by trained
dental care professionals.
The KaVo ProXam iS is a trade name of Planmeca ProSensor HD,
manufactured for and distributed by KaVo.
Please read this Instructions for use carefully before using the system.
KaVo ProXam iS automatically triggers and captures images to the start
and end of the X-ray radiation so that any intraoral X-ray unit supporting
exposure times and cones listed in section "Exposure value tables for KaVo
ProXam iX" on page 23 can be used.
The Romexis imaging software or third party software stating compatibility
with KaVo ProXam iS or software stating compatibility through TWAIN can
be used for image capturing.
KaVo ProXam iS is connected to a computer using Ethernet or USB
interface and it supports Windows and MAC operating systems, see details
in section "Technical specification" on page 20.
This Instructions for use is valid for Imaging software package 20 or later.
The Planmeca ProSensor HD sensor fulfils the requirements of Directives
93/42/EEC and RoHS, REACH and WEEE.
1.1 Usage environment
This X-ray unit is intended to be used in a professional healthcare
environment such as dental offices, clinics and similar environments.
2 Associated documentation
This Instructions for use should be used in conjunction with following
instructions:
• KaVo ProXam iX Instructions for use
• Romexis 6 User’s manual
• KaVo ProXam iS Assembly istructions
1 Introduction
Instructions for use KaVo ProXam iS 1

3 Symbols
Type BF equipment (Standard IEC 60601-1).
Medical Device
Consult electronic instructions for use (Standard ISO 7000-1641).
Attention, consult accompanying documents (Standard IEC 60601-1).
The use of accessory equipment not complying with the equivalent
requirements of this equipment may lead to a reduced level of safety of
the resulting system. Consideration relating to the choice shall include:
• use of the accessory in the Patient Vicinity
• evidence that the safety certification of the accessory has been
performed in accordance to appropriate IEC60601 and/or IEC60601-1-1
harmonized national standard.
Planmeca ProSensor is ETL classified and conforms to ANSI/AAMI
ES60601-1 and is certified to CAN/CSA C22.2 No. 60601.1.
Separate collection for electrical and electronic equipment according to
Directive 2002/96/EC (WEEE)
3143029
ETL CLASSIFIED
3 Symbols
2 KaVo ProXam iS Instructions for use

4 Safety precautions
NOTE
The system should be operated by qualified personnel only.
NOTE
EMC requirements have to be considered, and the equipment must be
installed and put into service according to the specific EMC information
provided in the accompanying documents.
CAUTION
Handle the digital sensor according to the instructions given in this
Instructions for use. Do not pinch the sensor or the cable. Do not to drop
the sensor or pull strongly the sensor cable. Never cut, nick or sharply bend
the sensor cable. Always advise the patient not to bite the sensor or the
cable. The KaVo limited warranty does not cover damage which is due to
misuse, e.g. dropping the sensor, neglect, or any cause other than ordinary
application.
CAUTION
Do not let the sensor cable run along the floor. Protect the cable from rolling
over it with a chair or walking over it.
CAUTION
Do not store or use the digital sensor near (3m or 10 ft) an electrosurgical
knife.
CAUTION
Do not unnecessarily touch the connector pins to keep them clean.
CAUTION
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the X-ray unit, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment
could result.
WARNING
No modification of this dental unit is allowed.
NOTE
Portable mobile devices and other high frequency electromagnetic energy
emitting devices used close to the X-ray system may affect the system’s
performance. Diagnostic information of the X-ray image may be lost and
unnecessary X-ray dose to the patient may result.
NOTE
Portable devices should be stored securely when not in use so that they
cannot be stolen or damaged.
4 Safety precautions
Instructions for use KaVo ProXam iS 3

4.1 Reporting serious incidents
Serious incidents that have occurred in relation to the device must be
reported to the manufacturer and the local competent authority.
4 Safety precautions
4 KaVo ProXam iS Instructions for use

5 Control box indicator light
Control box indicator light explanation
CONTROL BOX INDICATOR LIGHT DIGITAL SENSOR STATUS
Off Digital sensor system power off
Dim blue Digital sensor system is off (not in intraoral
exposure-mode and the cable is connected to
the control box)
Bright blue Digital sensor system is on (Imaging program
communicates with the digital sensor system)
Slowly flashing blue Waiting for Ready
Steady green Waiting for Exposure
Rapidly flashing green The exposure is taken and image is transferred
from the sensor to the control box
Steady red Error mode
Slowly flashing yellow Service mode
Uploading control box software
Slowly flashing blue, turns to slowly flashing dim
blue, then to quickly flashing dim blue
Reading calibration files from the sensor
Flashing violet Control box startup with back-up software
Flashing white Sensor is being calibrated
Purple light at beginning when powering up the
control box
Control box is running a factory software
NOTE
The exposure can only be taken when the control box indicator light is green
and steady, not when the indicator light is flashing.
5 Control box indicator light
Instructions for use KaVo ProXam iS 5

6 Before exposure
NOTE
Detailed instructions for using KaVo ProXam iX X-ray unit and Romexis
software are given in their Instructions for use, which should be used in
conjunction with this Instructions for use.
NOTE
It is recommended to use a sensor holder. Select the correct sensor holder
according to the type of exposure, refer to the sensor holder Instructions for
use supplied with the sensor holder package.
NOTE
In case the environment temperature reaches 40°C the sensor surface
warms up to its maximum temperature of 46°C and may feel warm. The
surface temperature of the sensor cools off when in patient contact.
6.1 Positioning patient
Ask the patient to sit down. Place a protective lead apron over the patient’s
chest.
6.2 Preparing and positioning sensor
Before each use on a patient make sure the sensor has been appropriately
disinfected. For detailed cleaning instructions see section "Sensors and
cables" on page 15.
To avoid cross-contamination between patients during use, disposable
hygienic sheaths must be used.
NOTE
Always use a new disposable hygienic sheath for every sensor usage.
When using the sensor for the first time the message Loading calibration
files will appear on the Romexis window.
NOTE
When connecting the same sensor to another workstation the calibration
files will be reloaded.
Select the appropriate sensor and connect it to the control box.
6 Before exposure
6 KaVo ProXam iS Instructions for use

Paralleling technique (recommended)
Place the sensor (2) to a sensor holder and align the holder parallel to the
long axis of the tooth (1).
Use a long cone for the paralleling technique.
6 Before exposure
Instructions for use KaVo ProXam iS 7

Bisecting angle technique (optional)
The patient holds the sensor (1) in place with his finger. The X-ray beam
is directed perpendicularly towards an imaginary line (2) which bisects the
angle between the film plane and the long axis (3) of the tooth.
NOTE
Be very careful not to put excessive pressure on the sensor. Do not place a
clamp on the sensor. Do not take occlusal exposures with the sensor, and
advise the user not to bite the sensor.
NOTE
Never clamp the sensor package or cable with a hemostat or an unmodified
“Snap-a-ray” holder.
Make sure the digital sensor system is ready for the exposure and
communicates with Romexis (refer to section "Control box indicator light"
on page 5.
On how to place the sensor into the patient’s mouth refer to the sensor
holder manual supplied with the digital sensor.
6.3 Selecting exposure values
The following tables show the recommended exposure values for KaVo
ProXam iS.
Short cone 20 cm (8”) exposure values
Jaw mA TIME
0.010s 0.012s 0.016s 0.020s 0.025s 0.032s 0.040s 0.050s 0.063s 0.080s 0.100s 0.125s 0.160s 0.200s 0.250s 0.320s 0.400s 0.500s 0.630s 0.800s
MAXI 8 mA 70 kV/
child
I P M
MAND I P M
6 Before exposure
8 KaVo ProXam iS Instructions for use

Short cone 20 cm (8”) exposure values
Jaw mA TIME
0.010s 0.012s 0.016s 0.020s 0.025s 0.032s 0.040s 0.050s 0.063s 0.080s 0.100s 0.125s 0.160s 0.200s 0.250s 0.320s 0.400s 0.500s 0.630s 0.800s
MAXI 8 mA 66 kV/
child
I P M
MAND I P M
MAXI 8 mA 63 kV/
child
I P M
MAND I P M
MAXI 8 mA 60 kV/
child
I P M
MAND I P M
MAXI 8 mA 70 kV/
adult
I P M
MAND I P M
MAXI 8 mA 66 kV/
adult
I P M
MAND I P M
MAXI 8 mA 63 kV/
adult
I P M
MAND I P M
MAXI 8 mA 60 kV/
adult
I P M
MAND I P M
I = INCISORS, M = MOLARS, P = PREMOLARS AND CANINES
Long cone 30 cm (12”) exposure values
Jaw mA TIME
0.010s 0.012s 0.016s 0.020s 0.025s 0.032s 0.040s 0.050s 0.063s 0.080s 0.100s 0.125s 0.160s 0.200s 0.250s 0.320s 0.400s 0.500s 0.640s 0.800s
MAXI 8 mA 70 kV/
child
I P M
MAND I P M
MAXI 8 mA 66 kV/
child
I P M
MAND I P M
MAXI 8 mA 63 kV/
child
I P M
MAND I P M
MAXI 8 mA 60 kV/
child
I P M
MAND I P M
MAXI 8 mA 70 kV/
adult
I P M
MAND I P M
MAXI 8 mA 66 kV/
adult
I P M
MAND I P M
MAXI 8 mA 63 kV/
adult
I P M
MAND I P M
MAXI 8 mA 60 kV/
adult
I P M
MAND I P M
I = INCISORS, M = MOLARS, P = PREMOLARS AND CANINES
6 Before exposure
Instructions for use KaVo ProXam iS 9

7 Capturing intraoral images
When connecting the sensor for the first time the message Loading
calibration files appears on the Romexis window. Also, if you connect the
same sensor to another workstation the files will be loaded again.
7.1 Capturing single intraoral images
Steps
1. Click the intraoral exposure button on the main page of the 2D module or
on the top toolbar to initiate the intraoral image capture mode
The Intraoral Exposure window appears.
When the X-ray unit is getting ready for exposure, the message Waiting
for Ready appears on top of the window.
2. Prepare the patient for exposure, select exposure parameters and
position the intraoral X-ray unit as required, for more information refer
to the unit's user’s manual/Instructions for use.
NOTE
Inform the patient that the sensor may feel warm in the mouth.
When the intraoral sensor system is ready for exposure the message
Waiting for Exposure appears on top of the window.
3. Take an exposure as usual.
After the exposure the message Saving the image appears on the
display and the image is automatically stored into the database.
4. Define the tooth numbers and sensor orientation.
The sensor orientation is indicated in the image by a grey triangle.
7 Capturing intraoral images
10 KaVo ProXam iS Instructions for use

The triangle corresponds to the upper right corner of the sensor when
positioned as illustrated with the cable running on the backside of the
sensor.
5. Take the next exposure, or click Done to return to the Imaging module
when all exposures have been captured.
NOTE
Remove the sensor from patient’s mouth when all exposures have been
taken.
7.2 Capturing images into study template
About this task
The images are captured into study templates containing a predefined set of
multiple images.
Steps
1. Click the intraoral exposure with study button on the main page of the 2D
module or on the top toolbar.
2. Select the desired study template from the list.
At the beginning of the list there are empty templates and at the bottom
of the list there are studies with dates that already include images
captured earlier for the selected patient.
7 Capturing intraoral images
Instructions for use KaVo ProXam iS 11

While capturing images using a template, Romexis navigates through
the template in a predefined order, denoting the current image to be
captured by a blue border around the slot.
3. Follow the tooth numbering and sensor orientation as shown on the
image and predefined in the template.
4. Prepare the patient for exposure, select exposure parameters and
position the intraoral X-ray unit as required, for more information refer
to the unit's user's manual / Instructions for use.
NOTE
Inform the patient that the sensor may feel warm in the mouth.
When the sensor system is ready for exposure the message Waiting for
Exposure appears on top of the window. You can now take exposures as
usual.
After the exposure the message Saving the image appears on the
display and the image is automatically stored into the database.
7 Capturing intraoral images
12 KaVo ProXam iS Instructions for use

5. Define the tooth numbers and sensor orientation.
The sensor orientation is indicated in the image by a grey triangle.
The triangle corresponds to the upper right corner of the sensor when
positioned as illustrated with the cable running on the backside of the
sensor.
To cancel the process click Cancel. The captured images are saved and
the incomplete study is preserved for later use.
6. Once all images have been captured click Done.
7 Capturing intraoral images
Instructions for use KaVo ProXam iS 13

8 Image quality control
Verify the image quality after installing the software and before patient
exposure. Perform quality control check according to the requirements of
local authorities, using for example Quart phantom or similar.
It is recommended to regularly monitor the image quality using the same
phantom according to the requirements of local authorities. See also KaVo
ProXam X-ray unit intraoral systems Constancy test Instructions for use.
Before performing phantom exposures verify that the brightness and contrast
settings of the monitor are accurate by using a SMPTE test pattern or
similar.
8.1 Quality check using SMPTE test pattern
The test image is specified by the Society of Motion Picture and Television
Engineers (www.smpte.org), and follows the SMPTE Recommended
Practise RP 133-1991 Specifications for Medical Diagnostic Imaging Test
Pattern for Television Monitors and Hard-Copy Recording Cameras. This
image should be used for monitor setting and quality checks performed:
• Before every working day: The 5% gray field inside the 0% field and the
95% gray field inside the 100% field should be visible. If not, adjust the
brightness and contrast of the monitor.
• Every month: The line raster in the corners and in the centre must be
visible, the vertical and horizontal lines must form undistorted squares
and the homogeneous grey background must not be coloured.
9 Sensor holders
The sensor holders provide an easy way to position the sensor for different
anatomical and diagnostic needs. For instructions how to use the sensor
holders, please refer to the manual supplied with the sensor holder package.
8 Image quality control
14 KaVo ProXam iS Instructions for use

10 Cleaning and disinfection
NOTE
Before cleaning the system, always check that the X-ray unit and the digital
sensor system are off (the control box indicator light is off).
Recommended disinfectants
For disinfection manufacturer recommends the following disinfectants for
wiping:
• CaviWipes (Metrex Research, USA)
• Dürr FD 322 (Dürr Dental AG, Orochemie GmbH)
• Dürr FD 333 (Dürr Dental AG, Orochemie GmbH
• Cidex Opa (Johnson & Johnson)
All recommended disinfecting agents have been tested and found to be
harmless to the surfaces.
10.1 Sensors and cables
The sensors allow enhanced infection control in surgery.
NOTE
Always use appropriate instruments for cleaning the sensors.
NOTE
It is mandatory to carefully follow the cleaning and disinfection
recommendations for not to damage the sensors.
CAUTION
The sensors cannot be sterilized in autoclave or UV oven.
Wipe the sensor surface with a soft cloth damped into a disinfectant solution.
The recommended disinfectant solutions are Dürr System Hygiene FD 322
or FD 333 or similar product.
If more effective disinfection or cold sterilization is preferred for cleaning, we
recommend the Johnson & Johnson Cidex Opa high level disinfectant.
NOTE
Follow carefully the manufacturer’s recommendations on disinfectant liquids.
Use a new disposable hygienic sheath for every sensor usage.
NOTE
The sensor connector can be cleaned using a soft cloth.
10.2 Sensor holders
For cleaning the sensor holders refer to the manual supplied with the sensor
holder package.
10 Cleaning and disinfection
Instructions for use KaVo ProXam iS 15

10.3 Control box
The control box can be cleaned with a soft cloth damped in a mild cleaning
solution.
CAUTION
Switch off the unit before cleaning.
NOTE
Do not disinfect the unit.
CAUTION
Never detach the control box ethernet cable without releasing the latch on
the cable connector. Forcefully detaching the cable will damage the control
box.
10 Cleaning and disinfection
16 KaVo ProXam iS Instructions for use