DEXIS FOCUS Bedienungsanleitung
FOCUS™ Intraoral X-ray
User manual
224451-PTU rev. 1
ENGLISH
Contents
1 Disclaimer.............................................................................................................................. 5
2 Introduction........................................................................................................................... 6
2.1FOCUS™ Intraoral X-ray............................................................................................................ 6
2.2 Intended use............................................................................................................................. 6
2.3 User profile................................................................................................................................6
2.4 Signal words..............................................................................................................................6
2.5Symbols that may appear on the device or its parts..................................................................7
2.6 Type and version.......................................................................................................................9
2.7Labels on the device.................................................................................................................9
2.8 Configurations........................................................................................................................... 9
2.9Radiation protection guidelines................................................................................................10
2.10Manufacturer's liability........................................................................................................... 11
2.11Disposal and recycling.......................................................................................................... 11
3 Overview..............................................................................................................................12
3.1 Main parts............................................................................................................................... 12
3.2 Cones......................................................................................................................................13
3.3 Control panel...........................................................................................................................14
4Using the device............................................................................................................... 16
4.1Precautionary actions for safe use.......................................................................................... 16
4.2Powering on/off the device...................................................................................................... 16
4.3Changing the cone..................................................................................................................16
4.4Setting up the exposure program............................................................................................17
4.5Patient positioning................................................................................................................... 19
4.6 Taking an image......................................................................................................................19
4.7Monitoring X-ray dose levels................................................................................................... 20
5Device settings.................................................................................................................. 21
5.1Exposure program settings......................................................................................................21
5.2Changing the default exposure time settings...........................................................................22
5.3Default exposure time settings................................................................................................ 23
6Error messages................................................................................................................. 24
7Maintenance....................................................................................................................... 25
7.1 Cleaning.................................................................................................................................. 25
7.2 Disinfecting..............................................................................................................................25
7.3Periodic maintenance.............................................................................................................. 25
7.4Radiation dose measurement.................................................................................................. 26
7.5Changing the fuses................................................................................................................. 26
8Technical data....................................................................................................................27
8.1Technical specifications...........................................................................................................27
8.2 EMC declaration......................................................................................................................32
FOCUS™iii
1Disclaimer
1Disclaimer
FOCUS™ Intraoral X-ray User manual, 224451-PTU r1.
Copyright © 05-2022 by PaloDEx Group Oy. All rights reserved.
FOCUS™ is either a registered trademark or trademark of PaloDEx Group Oy.
DEXIS™ is a registered trademark or a common law trademark of Dental Imaging Technologies Corporation.
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. +358 10 270 2000
www.dexis.com
Download this manual in digital format or order one in printed format for no additional cost from:
http://www.dexis.com
Make sure that you get the manual that applies to your device.
For service, contact your local distributor.
FOCUS™5
2Introduction
2Introduction
2.1FOCUS™ Intraoral X-ray
FOCUS (hereafter called “device”) is a microprocessor controlled intraoral X-ray device with a HF DC
generator. The device 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 device motionless during the
exposure. The proprietary design of the device has the VHF DC generator built into the horizontal part of the
support arm. This makes the device more reliabile and easier to install and service.
The VHF DC generator keeps the patient dose to the minimum. The user friendly remote control has
preprogrammed 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 an
optional remote exposure button. With a choice of arm lengths and ability to mechanically mount the device
in different configurations, FOCUS is a fully customizable X-ray system.
As the manufacturer we strongly recommend that you read this manual before taking the device in use.
NOTICE! The device must be installed according to the Installation manual by a qualified technician.
Only trained personnel should be allowed to operate the device.
NOTICE! Report any incident, related to use of this device, having a serious effect on the health of a
patient, user or other person to the manufacturer and to the local competent authority.
2.2Intended use
The device 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.
2.3User profile
FOCUS 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 devices.
2.4Signal 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.
6FOCUS™
2Introduction
2.5Symbols that may appear on the device or its parts
Manufacturer
Date of manufacture
Medical device
Serial number
Catalog or model number
Lot number
Caution
Radiation warning
Radiation generating unit
X-ray source assembly: emitting
Type B Applied part
Dangerous voltage
On or enabled
Off or disabled
Ethernet
Connector for remote control
Protective earth (ground)
Focal spot
Total X-ray filtration
Do not reuse
Recyclable
FOCUS™7
2Introduction
Operating instructions
Refer to operating instructions for more information. The operating
instructions can be supplied electronically or in paper format.
Caution: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
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.
CE (0537) symbol
UKCA (UK Conformity Assessed) marking
NRTL Mark
Conforms to AAMI ES60601-1:2006. Certified to CSA.
Swiss authorised representative
Importer
n
Maximum number of boxes that can be stacked on the bottom box
(Packaging)
8FOCUS™
2Introduction
2.6Type and version
The type, serial number and version of the device is written in the device type label and on the tubehead.
The device is Class I, Type B and with IP 20 protection.
The focal length is specified in the cone label in addition to type and version.
The software version is momentarily shown on remote control display after powering on the device.
2.7Labels on the device
Labels on the picture are for reference purposes only. Actual texts and images may not be accurate.
2.8Configurations
WARNING! USE LIMITATION: The device 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-magnetic interference affecting or caused by the device,
call service. Portable and mobile RF communications equipment can interfere with operation of the
medical electrical equipment.
NOTICE! To maintain safe and correct operation of the device, only the approved accessories
should be used. All the standard and optional items and approved accessories are suitable for use
within the patient environment.
FOCUS™9
2Introduction
All accessories, items and configurations listed in this chapter can be ordered separately. Contact your local
authorized representative for more assistance.
Each device is equipped with a remote control with 10 m (32.8 ft) 8 wire cable with RJ-45 plugs.
MOUNTING CONFIGURATIONS:
• Wall mounting with narrow wall mount plate
• Wall mounting with wide wall mount plate
• Integration for other mounting structure with OpenMount™ configuration
ARM LENGTH CONFIGURATIONS:
The device is available in 3 different arm lengths.
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:
The device is available with 7 different cones to be used on the X-ray tube. See chapter Cones on page
13 for cone illustrations:
• 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)
OTHER ACCESSORIES:
• Additional remote control panel (one device can have up to 2 panels)
• Remote exposure switch (one device can have up to 2 switches)
2.9Radiation protection guidelines
The device emits X-ray radiation for medical purposes. The device may cause an injury if used improperly.
The instructions contained in this manual must be read and followed when operating the device. All
government and local regulations pertaining to radiation safety must be observed.
NOTICE! 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 Reports available from NCRP Publications
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 device must not be used in rooms where explosive hazards exist.
Use the device 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 2 m (7 ft) from the focal spot and
10 FOCUS™
Dieses Handbuch passt für folgende Modelle
7
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