KaVo FOCUS User manual

FOCUS™
Intraoral X-ray
User Manual
ENGLISH
214760 rev. 3
0.805.4936

Copyright Code: 214760 rev. 3
Copyright © 2020 by Instrumentarium Dental, PaloDEx
Group Oy. All rights reserved.
KaVo™ is either registered trademark or trademark of
Kaltenbach & Voigt GmbH in the United States and/or
other countries.
FOCUS™ is either a registered trademark or trademark of
Instrumentarium Dental, PaloDEx Group Oy 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 Instrumentarium Dental,
PaloDEx Group Oy.
The original language of this manual is English.
Instrumentarium Dental, 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 Instrumentarium
Dental, PaloDEx Group Oy representative for the most
current information.
Manufacturer Instrumentarium Dental, PaloDEx Group Oy
Nahkelantie 160
FI-04300 Tuusula
FINLAND
Tel. [phone]
www.kavokerrgroup.com
For service, contact your local distributor.

i
1 Introduction..................................................................................................................1
1.1 FOCUS™ Intraoral X-ray ...................................................................................... 1
1.2 Intended use ......................................................................................................... 1
1.3 User profile............................................................................................................ 2
1.4 Symbols that may appear on the unit.................................................................... 3
1.5 Type and version................................................................................................... 5
1.6 Labels on the unit.................................................................................................. 6
1.7 Configurations ....................................................................................................... 7
1.8 Radiation protection guidelines ............................................................................. 9
1.9 Manufacturer's liability......................................................................................... 10
1.10 Disposal .............................................................................................................. 11
2 Unit description ......................................................................................................... 12
2.1 Main parts ........................................................................................................... 12
2.2 Cones.................................................................................................................. 13
2.3 Symbols on remote control ................................................................................. 15
3 Using the unit............................................................................................................. 17
3.1 Precautionary actions for safe use...................................................................... 17
3.2 Switching the power on/off .................................................................................. 17
3.3 Selecting the cone............................................................................................... 18
3.4 Selecting the exposure parameters .................................................................... 18
3.5 Positioning the patient......................................................................................... 20
3.6 Taking an exposure............................................................................................. 22
3.7 Monitoring of dose levels .................................................................................... 22
4 Default settings.......................................................................................................... 23
4.1 Program mode .................................................................................................... 23
4.2 Programmable anatomical time settings ............................................................. 24
5 Error messages.......................................................................................................... 25
6 Maintenance............................................................................................................... 27
6.1 Cleaning .............................................................................................................. 27
6.2 Disinfecting.......................................................................................................... 27
6.3 Periodic maintenance.......................................................................................... 28
6.4 Radiation dose measurement ............................................................................. 29
6.5 Changing the fuses ............................................................................................. 30
7 Technical data............................................................................................................ 31
7.1 Technical specifications ...................................................................................... 31
7.2 EMC declaration.................................................................................................. 35
8 User's statement........................................................................................................ 43
9 Recommended exposure times................................................................................ 49

ii

1 Introduction
FOCUS 1
1 Introduction
1.1 FOCUS™ Intraoral X-ray
FOCUS (hereafter called “the unit”) is a microprocessor
controlled intraoral x-ray unit with a HF DC generator. The
unit produces high quality dental images with film, imaging
plates or digital sensors.
The well-balanced support arm is easy to move and very
stable, keeping the unit motionless during the exposure.
The unit’s proprietary design has the VHF DC generator
built into the horizontal part of the units support arm
enabling greater reliability and ease of installation and
service.
The VHF DC generator keeps the patient dose to the
minimum. The user friendly remote control features pre-
programmed anatomical time settings making the
exposure selection quick and effortless. These settings can
be reprogrammed if needed.
Other user settings include selecting 60 or 70 kV, setting
exposure times between 0.02 and 3.2 seconds, and
pediatric or adult modes. Exposures can be made directly
from the remote control panel or with the optional remote
exposure button. With a choice of arm lengths and ability to
mechanically mount the unit in different configurations, the
unit is a fully customizable x-ray system.
As the manufacturer we strongly recommend that you read
this manual before placing the unit into service.
NOTICE! The unit must be installed according to the
Installation manual by a qualified technician. Only trained
personnel should be allowed to operate the unit.
1.2 Intended use
The unit is intended to be used for producing diagnostic x-
ray radiographs of dentition, jaws and other oral structures.
CAUTION! USA only: Federal law restricts this device to
sale by or on the order of a dentist or other qualified
professional.

1 Introduction
2FOCUS
1.3 User profile
The unit is intended only for professionally qualified dental
or medicinal personnel.
The typical user is a dental nurse with specific training for
using dental X-ray units.

1 Introduction
FOCUS 3
1.4 Symbols that may appear on the unit
The following symbols are used in the unit:
Name and address of the manufacturer
Serial number
X-ray source assembly: emitting
Radiation warning
Radiation generating unit
Focal spot
Filtration
Connector for remote control
Protective ground
Type B applied part
Dangerous voltage

1 Introduction
4FOCUS
ON or enabled
OFF or disabled
Operating instructions
Refer to operating instructions for more
information. The operating instructions can
be supplied electronically or in paper format
General caution
Caution: Federal law restricts this device to
sale by or on the order of a licensed
healthcare practitioner.
Do not reuse
Recyclable
Stacking limit
Max. 4 transportation packages may be
vertically stacked
CE (0537) symbol
MDD 93/42/EEC
ETL Mark
Conforms to UL STD 60601-1
Certified to CSA
This symbol indicates that the waste of
electrical and electronic equipment must not
be disposed as unsorted municipal waste
and must be collected separately. Please
contact an authorized representative of the
manufacturer for information concerning the
decommissioning of your equipment.
3155129

1 Introduction
FOCUS 5
1.5 Type and version
The type and version of the unit is defined in the main label
of the unit located on the under side of the horizontal arm
and in the tube / HV generator housing assembly label on
the tube head. The unit is class I, type B and with IP-20
protection.
The focal length is defined in the cone label in addition to
type and version.
The software version is momentarily displayed on remote
control display after switching the unit on.

1 Introduction
6FOCUS
1.6 Labels on the unit
Labels on the picture are for reference purposes only.
Actual texts may not be accurate.

1 Introduction
FOCUS 7
1.7 Configurations
WARNING! USE LIMITATION: The unit or its parts must
not be changed or modified in any way without approval
and instructions from the manufacturer.
The use of accessories, transducers, and cables other
than those specified may result in degraded
ELECTROMAGNETIC COMPATIBILITY of the device.
WARNING! If you suspect any electro-magnetical
interference affecting or caused by the unit, call service.
Portable and mobile RF communications equipment can
interfere with operation of the medical electrical equipment.
The unit is available with three different arm length
configurations:
Each unit is equipped with remote control with 32.8 feet
(10m) 8 wire cable with RJ-45 plugs and Installation
manual.
The unit is available with seven different cones, see
chapter 2.2 Cones for cone illustrations:
CONFIGURATION HORIZONTAL ARM LENGTH REACH
Short reach 50 cm 176 cm / 69 in
Medium reach 65 cm 191 cm / 75 in
Extra long reach 90 cm 216 cm / 85 in
CONES
Short cone, round (SSD 229 mm/9”, Ø60 mm)
Short cone, rectangular, small (SSD 229 mm/9”, 28x36 mm)
Short cone, rectangular (SSD 229 mm/9”, 35x45 mm)
Long cone, round (SSD 305 mm/12”, Ø60 mm)
Long cone, rectangular (SSD 305 mm/12”, 35x45 mm)
Short cone, full metal, rectangular (SSD 229 mm/9”, 35x45 mm)
Long cone, full metal, rectangular (SSD 305 mm/12”, 35x45 mm)

1 Introduction
8FOCUS
The unit has two mounting options:
Following accessories are approved items, and they can
be ordered separately.
NOTICE! To maintain safe and correct operation of the
unit, only the approved accessories should be used. All the
standard and optional items and approved accessories are
suitable for use within the patient environment.
WALL MOUNT PLATES
Narrow wall mount plate
Wide wall mount plate
ACCESSORIES
Short cone, round (SSD 229 mm/9”, Ø60 mm)
Short cone, rectangular, small (SSD 229 mm/9”, 28x36 mm)
Short cone, rectangular (SSD 229 mm/9”, 35x45 mm)
Long cone, round (SSD 305 mm/12”, Ø60 mm)
Long cone, rectangular (SSD 305 mm/12”, 35x45 mm)
Short cone, full metal, rectangular (SSD 229 mm/9”, 35x45 mm)
Long cone, full metal, rectangular (SSD 305 mm/12”, 35x45 mm)
Short reach, 176 cm / 69 in
Medium reach, 191 cm / 75 in
Extra long reach, 216 cm / 85 in
Additional remote control panel (one unit can have up to two panels)
Remote exposure switch (one unit can have up to two switches)
Narrow wall mount plate
Wide wall mount plate

1 Introduction
FOCUS 9
1.8 Radiation protection guidelines
The unit emits X-ray radiation for medical purposes. The
unit may cause an injury if used improperly. The
instructions contained in this manual must be read and
followed when operating the unit. All government and local
regulations pertaining to radiation safety must be
observed.
NOTICE for USA!
Many provisions of these regulations are based on
recommendations of the National Council on Radiation
Protection and Measurements. Recommendations for
dental x-ray protection are published in NCRP Report #35
available from NCRP Publications, 7910 Woodmont
Avenue, Suite 1016, Bethesda, MD 20814.
Personal radiation monitoring and protective devices are
available and recommended for staff members. It is also
recommended to provide the patient with a protective
apron. Consult the physician before taking images of
pregnant patients.
WARNING! The unit must not be used in rooms where
explosive hazards exist.
Use the unit with radiation protection in accordance with
IEC 60601-1-3 (and/or local requirements).
PROTECTION BY DISTANCE
In all examinations the user of the x-ray equipment should
wear protective clothing. The operator does not need to be
close to the patient during normal use. The protection
against scatter radiation can be achieved by using the
remote control or the remote exposure button not less than
7 feet (2 meters) from the focal spot and the x-ray beam.
The cable length of the optional remote exposure button is
approximately 32 feet (10 meters). The operator should
maintain visible contact with the patient and technique
factors. This allows immediate termination of radiation by
the release of the exposure button in the event of a
malfunction or disturbance.

1 Introduction
10 FOCUS
Caution information on remote control
1.9 Manufacturer's liability
As a manufacturer we can only assume liability of safe and
reliable operation of this unit when:
The unit installation was performed according to the
Installation Manual supplied with the unit.
The unit is used according to this User's Manual.
Maintenance and repairs are performed by a qualified
FOCUS™ intraoral x-ray dental dealer.
Original or authorized spare parts are used.
If service on the unit is performed, a work order describing
the type and extent of repair must be provided by the
service technician. This must contain information of
changes of nominal data or work range performed. The
work order must furthermore indicate the date of repair, the
name of the company concerned and a valid signature.
User should keep this work order for future references.
WARNING:
This x-ray unit may be
dangerous to patient and
operator unless safe
exposure factors and
operating instructions
are observed.

1 Introduction
FOCUS 11
1.10 Disposal
When the unit does no longer meet the manufacturer's
intended operational specifications, despite proper
maintenance and repair, then the unit is no longer
serviceable and should be replaced. Follow all regulations
on disposal of waste parts. The unit has at least the
following parts that should be regarded as non-
environmentally friendly waste products:
- X-ray source assembly
- All electronic circuits

2 Unit description
12 FOCUS
2 Unit description
2.1 Main parts
1. Mounting system
Options:
• Narrow wall mount (default)
• Wide wall mount
• Adapter for KaVo treatment units
2. Connection box
• Mains wiring
3. Horizontal arm
Options:
• Short reach
• Medium reach
• Extra long reach
Includes an electronics module and internal cables

2 Unit description
FOCUS 13
4. Scissors arm
Includes main cable and tube head arm
5. Tube head
6. Cone
Options:
• Short cone, round
• Short cone, rectangular
• Long cone, round
• Long cone, rectangular
• Short cone, full metal, rectangular
• Long cone, full metal, rectangular
7. Remote control panel
Includes a 10m cable and exposure button on the
control panel
2.2 Cones
Short cone, round
SSD 229 mm/9”, Ø60 mm
Short cone, rectangular
SSD 229 mm/9”, 35x45 mm
Long cone, round
SSD 305 mm/12”, Ø60 mm

2 Unit description
14 FOCUS
Long cone, rectangular
SSD 305 mm/12”, 35x45 mm
Short cone, full metal, rectangular
SSD 229 mm/9”, 35x45 mm
Long cone, full metal, rectangular
SSD 305 mm/12”, 35x45 mm