foc.us 214760 User manual

FOCUS™
Intraoral X-ray
User Manual
ENGLISH
214760 rev. 1
0.805.4936

Copyright Code: 214760 rev 1 Date: 2016-10-27
Copyright 2016 by PaloDEx Group Oy.
All rights reserved.
Manufactured by Instrumentarium Dental, PaloDEx Group Oy,
Nahkelantie 160
FI-04300 Tuusula
FINLAND
Tel. [phone]
www.kavokerrgroup.com
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
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 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.
For service, contact your local distributor.

214760 rev 1 KaVo Dental GmbH i
1 Introduction..................................................................................................................1
1.1 FOCUS™ Intraoral X-ray ...................................................................................... 1
1.2 Intended use ......................................................................................................... 1
1.3 User profile............................................................................................................ 1
1.4 Symbols that may appear on the unit.................................................................... 2
1.5 Type and version................................................................................................... 4
1.6 Labels on the unit.................................................................................................. 5
1.7 Configurations ....................................................................................................... 6
1.8 Radiation protection guidelines ............................................................................. 8
1.9 Manufacturer's liability........................................................................................... 9
1.10 Disposal .............................................................................................................. 10
2 Unit description ...........................................................................................................1
2.1 Main parts ............................................................................................................. 1
2.2 Cones.................................................................................................................... 2
2.3 Symbols on remote control ................................................................................... 4
3 Using the unit...............................................................................................................7
3.1 Precautionary actions for safe use........................................................................ 7
3.2 Switching the power on/off .................................................................................... 7
3.3 Selecting the cone................................................................................................. 8
3.4 Selecting the exposure parameters ...................................................................... 8
3.5 Positioning the patient......................................................................................... 10
3.6 Taking an exposure............................................................................................. 12
3.7 Monitoring of dose levels .................................................................................... 12
4 Default settings..........................................................................................................13
4.1 Program mode .................................................................................................... 13
4.2 Programmable anatomical time settings ............................................................. 14
5 Error messages..........................................................................................................15
6 Maintenance...............................................................................................................17
6.1 Cleaning .............................................................................................................. 17
6.2 Disinfecting.......................................................................................................... 17
6.3 Periodic maintenance.......................................................................................... 18
6.4 Radiation dose measurement ............................................................................. 19
6.5 Changing the fuses ............................................................................................. 20
7 Technical data............................................................................................................21
7.1 Technical specifications ...................................................................................... 21
7.2 EMC declaration.................................................................................................. 25
8 User's statement........................................................................................................29
9 Recommended exposure times................................................................................35

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1 Introduction
214760 rev 1 KaVo Dental GmbH 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.
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.

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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

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214760 rev 1 KaVo Dental GmbH 3
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

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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.

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

1 Introduction
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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
EQUIPMENT and/or SYSTEM.
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 six different cones, see chapter
2.2 for cone illustrations:
CONFIGURATION HORIZONTAL ARM LENGTH REACH
Short arm 50 cm 176 cm
Long arm 65 cm 191 cm
Extra long arm 90 cm 216 cm
CONES
Short cone round
Short cone rectangular / Short cone rectangular for Germany
Long cone round
Long cone rectangular
Short full metal rectangular cone
Long full metal rectangular cone

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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
Wall mount plate for single stud
Wall mount plate for 16” center studs
ACCESSORIES
Short cone round
Short cone rectangular
Long cone round
Long cone rectangular
Long full metal rectangular cone
Short full metal rectangular cone
Short cone rectangular for Germany
Short horizontal arm 500 mm / 19.7 in
Long horizontal arm 650 mm / 25.6 in
Extra long horizontal arm 900 mm / 35.4 in
Additional remote control (one unit can be installed with two)
Remote exposure button (one unit can be installed with two)
Wall mount plate for single stud.
Wall mount plate for 16" center studs.

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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.

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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.

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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
214760 rev 1 KaVo Dental GmbH 1
2 Unit description
2.1 Main parts
1. Mounting plate
- Narrow wall mount (standard)
- Wide wall mount
- Adapter for Gendex Expert DC footprint
- Adapter for KaVo treatment units
2. Connection box
- Mains wiring
- Universal power 115V/230V
3. Horizontal arm
- Options: short, medium, extra long
- Includes an electronics module and internal cables
4. Scissors arm
-Includes: main cable, tube head arm
5. Tube head
6. Cone

2 Unit description
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Options:
- Short cone round
- Short cone rectangular
- Long cone round
- Long cone rectangular
- Short full metal rectangular cone
- Long full metal rectangular cone
7. Remote control with cable
2.2 Cones
Short cone round
Short cone rectangular
Long cone round
Long cone rectangular

2 Unit description
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Short full metal rectangular
cone
Long full metal rectangular
cone

2 Unit description
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2.3 Symbols on remote control
Maxillary molar
Maxillary cuspid
Maxillary incisors
Bitewing
Mandibular molar
Mandibular cuspid
Mandibular incisors
Occlusal
Exposure button
X-ray source assembly: emitting
Ready for exposure
Patient Size Selection
Digital mode selection
Voltage selection, 60 or 70 kV
Radiation warning
Exposure time & DAP display