Instrumentarium Dental Focus User Manual
ENGLISH
FOCUS™
User Manual
51774-IMG rev. 13
Copyright Code: 51774-IMG rev 13 Date: 2 November 2015
Copyright © 11/2015 by Instrumentarium Dental, PaloDEx
Group Oy.
All rights reserved.
FOCUS™ and CLINIVIEW™ are either a registered
trademark or trademark of Instrumentarium Dental 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.
The original language of this manual is English.
Instrumentarium Dental 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
representative for the most current information.
Manufactured by Instrumentarium Dental, PaloDEx Group Oy
Nahkelantie 160
FI-04300 Tuusula
FINLAND
Tel. +358 10 270 2000
www.instrumentariumdental.com
For service, contact your local distributor.
Table of Contents
1 Introduction.................................................................................................................. 1
1.1 FOCUS™ .............................................................................................................. 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................................................................................................... 3
1.6 Labels on FOCUS .................................................................................................4
1.7 Configurations ....................................................................................................... 5
1.8 Radiation protection guidelines ............................................................................. 7
1.9 Manufacturer's liability...........................................................................................8
1.10 Disposal ................................................................................................................ 9
2 Unit description .........................................................................................................11
2.1 Main parts ........................................................................................................... 11
2.2 Cones..................................................................................................................12
2.3 Symbols on remote control ................................................................................. 13
2.4 FOCUS with SmartBox option............................................................................. 14
2.5 Unit mount model FOCUS ..................................................................................15
3 Preparations for the exposure.................................................................................. 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 AEC Automatic Exposure Control ....................................................................... 21
3.7 FOCUS with SmartBox ....................................................................................... 21
3.8 Taking an exposure............................................................................................. 22
3.9 Monitoring of dose levels ....................................................................................22
4 Program mode ...........................................................................................................23
4.1 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........................................................................................................ 39
9 Recommended exposure times................................................................................45
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1 Introduction
1.1 FOCUS™
1 Introduction
FOCUS is a microprocessor controlled intraoral x-ray unit
with a HF DC generator. FOCUS produces high quality
dental images with film or digital sensors.
The well-balanced support arm is easy to move and very
stable, keeping the unit motionless during the exposure.
FOCUS' 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
absolute 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 selections include 60 or 70 kV, exposure times
between 0.02 and 3.2 seconds, pediatric or adult modes,
and film and digital 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 FOCUS is a fully customizable x-ray
system.
As the manufacturer we strongly recommend that you read
this manual before placing the unit into service.
NOTE! FOCUS must be installed according to the FOCUS
Installation manual by a qualified technician. Only trained
personnel should be allowed to operate FOCUS.
1.2 Intended use
FOCUS is intended to be used for producing diagnostic xray 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 Introduction
1.4 Symbols that may appear on the unit
The following symbols are used in FOCUS
Name and address of the manufacturer
Serial number
X-ray source assembly: emitting
Radiation warning
Focal spot
Filtration
Connector for remote control
Protective ground
Type B applied part
Dangerous voltage
ON or enabled
OFF or enabled
Operating instructions
Refer to operating instructions for more
information. The operating instructions can
be supplied electronically or in paper format
General caution
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1 Introduction
3155129
Caution: Federal law restricts this device to
sale by or on the order of a licensed
healthcare practitioner.
Do not reuse
Recyclable
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.
1.5 Type and version
The type and version of FOCUS 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 Introduction
Labels on the picture are for reference purposes only.
Actual texts may not be accurate.
1.6 Labels on FOCUS
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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.
FOCUS is delivered with one of the following configuration:
FOCUS BASIC SYSTEMS:
1 Introduction
FOCUS x-ray machine with short reach 176 cm/ 69.2", 115 V,
FOCUS x-ray machine with long reach 191 cm/ 75.1", 115 V
FOCUS x-ray machine with extra long reach 216 cm/ 84.9",
115 V
FOCUS x-ray machine with short reach 176 cm/ 69.2", 230 V
FOCUS x-ray machine with long reach 191 cm/ 75.1", 230 V
FOCUS x-ray machine with extra long reach 216 cm/ 84.9",
230 V
Each FOCUS basic system is equipped with remote
control with 32.8 feet (10m) 8 wire cable with RJ-45 plugs
and Installation manual.
One chosen item from each module below is delivered with
the basic unit:
TO BE CHOSEN FOR BASIC SYSTEM:
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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1 Introduction
Wall mount plates
Wall mount plate for single stud
Wall mount plate for 16” center studs
Manual language
English
Italian
German
French
Following accessories are approved items, and they can
be ordered separately.
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 FOCUS unit can be installed
with two)
Remote exposure button (one FOCUS unit can be installed
with two)
Wall mount plate for single stud.
Wall mount plate for 16" center studs.
NOTE! To maintain safe and correct operation of FOCUS,
only the approved accessories should be used. All the
standard and optional items and approved accessories are
suitable for use within the patient environment.
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1.8 Radiation protection guidelines
The device 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 FOCUS. All government and
local regulations pertaining to radiation safety must be
observed.
NOTE! 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.
1 Introduction
WARNING! FOCUS must not be used in rooms where
explosive hazards exist.
Use FOCUS 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.
51774-IMG rev 13 Instrumentarium Dental 7
1 Introduction
WARNING:
This x-ray unit may be
dangerous to patient and
operator unless safe
exposure factors and
operating instructions
are observed.
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
FOCUS installation was performed according to the
FOCUS Installation Manual supplied with the unit.
FOCUS is used according to the FOCUS User's
Manual
Maintenance and repairs are performed by a qualified
FOCUS 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.
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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. FOCUS has at least the
following parts that should be regarded as nonenvironmentally friendly waste products:
- X-ray source assembly
- All electronic circuits
1 Introduction
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1 Introduction
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