Villa Sistemi Medicali ENDOS AC, ENDOS ACP User Manual
Release 30 August 2013 (Rev. 7)
ENDOS AC / ACP
0051
User's Manual
User's ManualUser's Manual
User's Manual
USER'S MANUAL
Revision history
(Rev. 7) ENDOS AC/ACP - CE
Revision history
Revision historyRevision history
Revision history Manual code 6961901103
Manual code 6961901103 Manual code 6961901103
Manual code 6961901103
Rev. Date Page/s Modification description
0 07.02.03 - Document approval.
1 11.04.03 All Introduction of KAILONG (China) X-ray tube.
Introduction of remote X-ray button with light
signaling of "Ready" or "Exposure in progress".
(Ref. RDM 5599)
2 25.09.03 All Remote timer version release
3 26.03.04 8 Notify body change for CE mark.
(Ref. RDM 5781)
4 15.03.05 8, 20, 39 Editorial correction on Enabling/Disabling the
"Ready" key.
Modified the DP arm label.
(Ref. RDM 5938, RDM 6052)
5 10.01.06 30 Dose linearity reference measurement time updated.
(Ref. RDM 6164)
6 13.07.07 All Directive 2002/96/EC information notice added.
7 30.08.13 6, 9 Identification labels update.
(Ref. RDM 7274)
USER'S MANUAL
Revision history
ENDOS AC/ACP - CE (Rev. 7)
THIS PAGE IS INTENTIONALLY LEFT BLANK
USER'S MANUAL
Contents
(Rev. 7) ENDOS AC/ACP - CE
i
Contents
1. INTRODUCTION 1
1.1 Icons in the manual................................................................................ 1
2. SAFETY ASPECTS 2
2.1 Warnings ................................................................................................ 3
2.2 Protection from X-rays............................................................................ 4
2.3 Environmental risks and disposal .......................................................... 5
2.4 Symbols in use ....................................................................................... 6
3. CLEANING AND DISINFECTION 7
4. DESCRIPTION 8
4.1 Identification labels ................................................................................ 8
4.2 Functions, Models and Versions ........................................................... 10
4.2.1 Extension arm and scissors arm.......................................................... 10
4.2.2 Tubehead............................................................................................ 10
4.2.3 Timer.................................................................................................. 11
4.3 Configurations...................................................................................... 12
4.3.1 Standard configuration ....................................................................... 12
4.3.2 Remote timer configuration ................................................................. 13
4.3.3 Dental chair configuration................................................................... 14
4.3.4 Ceiling configuration ........................................................................... 15
4.3.5 Mobile stand configuration .................................................................. 16
4.3.6 Remote X-ray button configuration ...................................................... 17
5. TECHNICAL DATA 18
5.1 Method for correcting exposure times................................................... 21
5.2 Method for measuring technical factors................................................ 23
5.3 Correct use of dosimeters to measure exposure times .......................... 24
5.4 Curves tube features ............................................................................ 26
5.5 Reference standard............................................................................... 30
5.6 Overall dimensions ............................................................................... 32
6. GENERAL USE INSTRUCTIONS 34
6.1 "ENDOS ACP" timer.............................................................................. 34
6.2 "ENDOS AC" timer................................................................................ 38
6.3 Visual signals ....................................................................................... 40
USER'S MANUAL
Contents
ENDOS AC/ACP - CE (Rev. 7)
ii
7. EQUIPMENT USE 41
7.1 Equipment preparation......................................................................... 42
7.1.1 Preparation of the timer for X-ray use with automatic selection
of exposure times (only for ENDOS ACP version) .................................. 42
7.1.2 Preparation of the timer for radiographic use with manual selection
of exposure times................................................................................ 43
7.1.3 Preparation of the timer for Digital Radiography (Videoradiography)
use with automatic selection of exposure times (only ENDOS ACP
version) .............................................................................................. 44
7.2 Preparation of the tubehead ................................................................. 45
7.3 Exposure techniques ............................................................................ 49
7.3.1 Bisecting technique............................................................................. 49
7.3.2 Parallel technique ............................................................................... 51
7.4 Exposure .............................................................................................. 52
7.5 Special functions .................................................................................. 54
7.5.1 Counting the number of exposures made............................................. 54
7.5.2 Selection of multiplication factor for different types of film ................... 55
7.5.3 Selection of multiplication factor for Video-X-Ray-Digital ..................... 57
8. MESSAGES ON DISPLAY 58
8.1 Functional messages ............................................................................ 58
8.2 Error signalling..................................................................................... 61
8.2.1 Non re-settable errors ......................................................................... 62
8.2.2 Non fatal errors in start-up phase ....................................................... 63
8.2.3 Errors in exposure phase .................................................................... 64
9. CHECK AND CORRECTION OF POSSIBLE ERRORS IN
DENTAL X-RAYS 65
9.1 Typical faults in intraoral X-rays .......................................................... 65
9.2 Typical faults caused by wrong positioning........................................... 67
10. MAINTENANCE 68
This publication can only be reproduced, transmitted, transcribed or translated
into any human or computer language with the written consent of the
Manufacturer.
This Manual is the English translation of the Italian original version.
USER'S MANUAL
Introduction
(Rev. 7) ENDOS AC/ACP - CE
1
1.
1.1.
1. INTRODUCTION
INTRODUCTIONINTRODUCTION
INTRODUCTION
NOTE:
This manual is updated to the product status it is sold with, to
guarantee the user an adequate reference for equipment use and any
aspect connected with use safety. The manual may not reflect any
product variation without impact on operating procedures and use
safety.
The intraoral radiographic ENDOS AC/ACP, produces high quality
intraoral X-rays, thanks to reduced exposure times and the small
dimensions of the focal spot.
ENDOS AC/ACP is exclusively intended for the execution of
intraoral X-rays.
The equipment has the following features:
• Very good quality X-rays pictures
• user friendly
• ergonomic design.
The equipment is controlled by a microprocessor that makes it possible
to reproduce exposure times and is composed of the following parts:
• Timer: ENDOS AC or ENDOS ACP equipped with wall plate
• Extension arm (30 cm, 60 cm or 80 cm for wall version)
• Scissors arm (DP)
• Tubehead 70 kV 8 mA – X-ray tube with grid.
The purpose of this manual is to provide the user with instructions that
will allow him to run the equipment safely and efficiently.
The equipment must be used according to the procedures in the manual
and never for different purposes from the ones for which it has been
designed.
1.1
1.11.1
1.1 Icons in the manual
Icons in the manualIcons in the manual
Icons in the manual
Indicates a “NOTE”; we recommend particular attention in reading the
subjects identified with this icon.
Indicates a “WARNING”; subjects identified with this icon concern
safety aspects regarding the patient and/or the operator.
USER'S MANUAL
Safety aspects
ENDOS AC/ACP - CE (Rev. 7)
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2.
2.2.
2. SAFETY ASPECTS
SAFETY ASPECTSSAFETY ASPECTS
SAFETY ASPECTS
WARNING:
Read this chapter very carefully.
Villa Sistemi Medicali designs and makes their equipment according to
safety requirements; moreover, they supply all necessary information for
appropriate use and warnings relating to dangers connected with X-ray
generators.
The manufacturer does not accept any responsibility for:
• Use of ENDOS AC/ACP equipment for purposes other than those for
which it has been designed,
• damages to the equipment, the operator, the patient caused both by
wrong installations and maintenance that do not follow the
procedures contained in the user manuals and the installation
provided with the equipment, and by wrong operating techniques,
• mechanical and / or electrical changes , made during and after
installation, that differ from the ones in the Service Manual.
Only personnel authorised by the Manufacturer may carry out
technical work on the equipment.
Only authorised personnel can remove the tubehead from its
support and/or gain access to live parts.
USER'S MANUAL
Safety aspects
(Rev. 7) ENDOS AC/ACP - CE
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2.1
2.12.1
2.1 Warnings
WarningsWarnings
Warnings
The equipment must be used according to the procedures in this manual
and never for different purposes from the ones for which it has been
designed.
Before carrying out any maintenance disconnect the equipment from the
power line using the circuit breaker provided.
ENDOS AC/ACP is an electro-medical device and for this reason can be
used only under the supervision of highly qualified medical staff in
possession of all the necessary knowledge about X-ray protection.
The user is responsible for fulfilling all the legal requirements connected
with the possession, installation and use of the equipment itself.
ENDOS AC/ACP is built for continuous running with intermittent load;
for this reason the planned duty cycle must be observed.
Appropriate accessories, such as lead aprons, must be used to protect
the patient from radiation.
Although the equipment is designed to provide a reasonable degree of
protection from electromagnetic interference, according to IEC
International regulations, it must be installed at an adequate distance
from electricity transformer rooms, static continuity units, from two-way
amateur radios and cellular phones. The latter can be used only at a
minimum distance of 1.5m from any part of the equipment.
Any instrumentation or equipment for professional use located near
ENDOS AC/ACP must conform to Electromagnetic Compatibility
regulations. Non conforming equipment, with known poor immunity to
electromagnetic fields, must be installed at a distance of at least 3m from
ENDOS AC/ACP and supplied by a dedicated electric line.
ENDOS AC/ACP must be turned off when using electro-cautery or
similar equipment in the vicinity of the equipment itself.
The equipment is not designed to be used in the presence of anaesthetic
mixtures inflammable with air, oxygen or nitrous oxide.
Equipment parts which may come into contact with the patient must be
cleaned regularly according to the instructions given later in this
document.
WARNING:
For safety reasons, it is forbidden to overload the extension arm or the
scissors arm in an anomalous way, for instance by leaning on it.
USER'S MANUAL
Safety aspects
ENDOS AC/ACP - CE (Rev. 7)
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2.2
2.22.2
2.2 Protection from X
Protection from XProtection from X
Protection from X----rays
raysrays
rays
Although dosage given by modern X-ray equipment is low on average,
during the execution of the exposure, the operator must take all
precautions to protect the patient and himself in compliance with the
regulations in force.
WARNING:
Protection from X-ray radiation is regulated by law. The equipment must
be used by specialised personnel only.
a) The film (or the digital sensor) must be put into the patient’s mouth
manually or using the appropriate supports. If possible it must be
held by the patient himself.
b) During X-ray exposure, the operator must not come into contact
with the tubehead or the collimator cone.
c) During exposure, the operator must be at a certain distance from the
X-ray source (at least 2 metres), in the opposite direction to X-ray
beam.
d) During exposure, the operator and the patient are the only people
allowed in the room.
e) The lead aprons should be used to reduce the undesirable effect of
secondary radiation on the patient.
USER'S MANUAL
Safety aspects
(Rev. 7) ENDOS AC/ACP - CE
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2.3
2.32.3
2.3 Environmental risks and disposal
Environmental risks and disposalEnvironmental risks and disposal
Environmental risks and disposal
Some parts of the equipment contain material and fluids which must be
disposed of in special areas designated by the local health authorities at
the end of the equipment’s life cycle.
In particular the equipment contains the following materials and / or
components:
• Tubehead:
hard plastic materials, metal materials, glass, dielectric
oil, lead, tungsten
• Other parts of the equipment: hard plastic materials, metal
materials, printed circuits, iron-plastic materials.
NOTICE FOR THE USERS IN THE E.C.
According to the Directive 2002/96/EC on Waste from Electrical
and Electronic Equipment.
The crossed out wheeled bin symbol placed on the equipment or its
package means that the equipment must be collected separately from
the other waste.
The separate collection of this equipment at the end of its life cycle is
managed by the manufacturer/distributor. The user that want to discard
this equipment should contact the local distributor and follow the
system he adopted for the separate collection.
The correct separate collection for the subsequent recycling, treatment
and environmentally compatible disposal contributes to avoid negative
effects on the environment and on the health and promotes the reuse
and/or recycling of the materials that the equipment is made of.
The illegal disposal of the equipment made by the user will cause the
application of sanctions according to the local regulations.
USER'S MANUAL
Safety aspects
ENDOS AC/ACP - CE (Rev. 7)
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2.4
2.42.4
2.4 Symbols in use
Symbols in useSymbols in use
Symbols in use
The following symbols are used in this manual and in ENDOS AC/ACP,
besides the symbols on the keyboard (see chapter 6):
Symbol Description
Equipment with applied parts Type B
A number of machine parts contain materials and liquids that
upon completion of the machine’s life cycle must be disposed of at
recovery centers established by the local health units
∼∼∼∼
Alternate current
N Connecting point to neutral conductor
L Connecting point to live conductor
Protection ground
Functional ground
OFF ; equipment not connected to electricity line
ON ; equipment connected to electricity line
Permission key to exposure; the permitted exposure status is
displayed by switching on the corresponding green symbol
Focal spot according to IEC 336
Focal spot according to IEC 336
Product identification code
Serial number
Date of manufacture (year and month)
Filtration
Diagnostic source assembly (
Tube-head
)
X-ray tube
Warning: see the accompanying documentation
Conformity to the EC 93/42 Directive and subsequent amendments and
additions
USER'S MANUAL
Cleaning and disinfection
(Rev. 7) ENDOS AC/ACP - CE
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3.
3.3.
3. CLEANING AND DISINFE
CLEANING AND DISINFECLEANING AND DISINFE
CLEANING AND DISINFECTION
CTIONCTION
CTION
The following procedures should be observed carefully in order to
guarantee accurate hygiene and cleaning:
• Before cleaning the equipment disconnect it from the line using
the cut-out switch which must be provided when setting up. This
operation is necessary as some internal parts remain live even
after it has been switched off from the on board switch.
• Be careful not to let water or other fluids enter the equipment in
order not to cause a short circuit and corrosions.
• Never use solvents (alcohol, petrol, Trichloroethylene), corrosive or
abrasive substances when cleaning.
External surfaces
External surfacesExternal surfaces
External surfaces
Use a soft cloth and, for a stronger action, a neutral soap to prevent
damaging painted surfaces.
During cleaning operations, prevent surplus detergent and/or fluids
entering the equipment or staying on painted surfaces.
Parts that come into contact with the patient’s skin
Parts that come into contact with the patient’s skinParts that come into contact with the patient’s skin
Parts that come into contact with the patient’s skin
These parts should be disinfected at regular intervals with a 2%
Glutaraldeide solution to guarantee hygiene.
USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
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4.
4.4.
4. DESCRIPTION
DESCRIPTIONDESCRIPTION
DESCRIPTION
4.1
4.14.1
4.1 Identification labels
Identification labelsIdentification labels
Identification labels
4
2
3
1
USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
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1
ENDOS AC/ACP
label
2a
Tubehead label
(X-ray tube type CEI)
2b
Tubehead label
(X-ray tube type KAILONG)
3
DP arm
label
4
Extension arm
label
5
Collimator 30 cm (optional)
label
USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
10
4.2
4.24.2
4.2 Functions, Models and Versions
Functions, Models and VersionsFunctions, Models and Versions
Functions, Models and Versions
ENDOS AC/ACP intraoral radiographic equipment is composed of the
following parts:
4.2.1
4.2.14.2.1
4.2.1 Extension arm and scissors arm
Extension arm and scissors armExtension arm and scissors arm
Extension arm and scissors arm
It is composed of a double articulated joint arm, enabling extension
horizontally and vertically. The tubehead is balanced in all positions.
NOTE:
The scissors arm is designed to work correctly at a max. angle of 160°; so
its use requires a flare angle of less than 160°.
Moreover, a horizontal extension arm can be added, available in various
sizes, to meet all requirements.
4.2.2
4.2.24.2.2
4.2.2 Tubehead
TubeheadTubehead
Tubehead
The 70 kVp voltage, the 8 mA current and the use of a tube with
grid reduce exposure times and the quantities of X-rays absorbed
by the patient. The radiogenic equipment is provided with a
collimator with 20 cm focus skin distance and a 6 cm X-ray
emission diameter at the exit of the cone. The tubehead is
connected to the arm by a guide, which allows 360° horizontal
rotation and 290° vertical rotation.
Two alternate X-ray tube can be used: both have the same
characteristics and provide the same performance.
The tubehead, assembled with different X-ray tubes, are interchangeable
so long as preheating time is set to the proper value indicated on the
tubehead label.
USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
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4.2.3
4.2.34.2.3
4.2.3 Timer
TimerTimer
Timer
The name of ENDOS AC/ACP depends on the type of timer in use:
• ENDOS ACP
ENDOS ACPENDOS ACP
ENDOS ACP
ENDOS ACP is a digital timer with microprocessor where
exposure times can be selected both manually and
automatically.
With automatic selection there is a choice of 30 pre-set times
depending on the patient’s size (small, medium or large) and
the type of tooth and acquisition mode (film, digital).
There are 33 fixed manual selection times that vary from a
minimum of 0.02 seconds to a maximum of 3.20 seconds.
The main feature of this timer is that it has an automatic
exposure time compensation for drift of nominal voltage within
± 10%.
• ENDOS AC
ENDOS ACENDOS AC
ENDOS AC
ENDOS AC has the same features as the ENDOS ACP timer,
excluding automatic and digital anatomic selection.
It has manual exposure time selection only.
NOTE:
A remote X-ray button configuration can be made, outside the exam
room. This can be a pure doorbell X-ray button or a device which also
show status of the unit ("READY" and "EXPOSURE IN PROGRESS".
NOTE:
The equipment supplies two separate contacts for connection with
external signalling devices. One contact shows the status of functioning
equipment ready for use and the second one the X-ray emission.
Connection procedures and the necessary requisites for signalling
devices are given in the "Service Manual".
USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
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4.3
4.34.3
4.3 Configurations
ConfigurationsConfigurations
Configurations
4.3.1
4.3.14.3.1
4.3.1 Standard configuration
Standard configurationStandard configuration
Standard configuration
Figure 1
1 Tubehead
2 Scissors arm
3 Extension arm
4 Timer
5 X-ray button
USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
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4.3.2
4.3.24.3.2
4.3.2 Remote timer configuration
Remote timer configurationRemote timer configuration
Remote timer configuration
5
6
1
2
3
4
Figure 2
1 Tubehead
2 Scissors arm
3 Extension arm
4 Wall support (kit code 8161301002)
5 Remote timer
6 X-ray button
USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
14
4.3.3
4.3.34.3.3
4.3.3 Dental chair configuration
Dental chair configurationDental chair configuration
Dental chair configuration
Figure 3
1 Tubehead
2 Scissors arm
3 Dental chair extension arm 30 cm
4 Dental chair connection
5 Timer
6 X-ray button
USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
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4.3.4
4.3.44.3.4
4.3.4 Ceiling configuration
Ceiling configurationCeiling configuration
Ceiling configuration
Figure 4
1 Tubehead
2 Scissors arm
3 Ceiling extension arm
4 Ceiling suspension plate
5 Timer
6 X-ray button
USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
16
4.3.5
4.3.54.3.5
4.3.5 Mobile stand configuration
Mobile stand configurationMobile stand configuration
Mobile stand configuration
Figure 5
1 Tubehead
2 Scissors arm
3 Mobile stand
4 Timer
5 X-ray button
USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
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4.3.6
4.3.64.3.6
4.3.6 Remote X
Remote XRemote X
Remote X----ray button configuration
ray button configurationray button configuration
ray button configuration
1
2
Figure 6
Alternative 1:
1 X-ray button (not supplied)
Alternative 2:
2 X-ray button + light signalling of "Ready"
or "Exposure in progress" (supplied as kit
P/N 6661309500)
USER'S MANUAL
Technical data
ENDOS AC/ACP - CE (Rev. 7)
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5.
5.5.
5. TECHNICAL DATA
TECHNICAL DATATECHNICAL DATA
TECHNICAL DATA
Technical features
Equipment ENDOS AC/ACP
Manufacturer VILLA SISTEMI MEDICALI
Buccinasco (MI)
Class
Class I° with type B applied parts
(EN 60601-1 classification)
Protection level Standard Apparatus IP20
Line voltage
230 V∼ ± 10%
Line frequency 50 Hz
Absorbed current
4 A rms impulsive @ 230 V ∼
Power consumption
920 VA impulsive @ 230 V ∼
Max. apparent line resistance
0.8 Ω max.
Main fuse 6 AF
Pre-set exposure times from 0.02 to 3.2 s in 33 steps
Automatic selection
(only for ENDOS ACP)
30 pre-set times
Exposure time accuracy
± 10% or ± 20 ms
(whichever is greater - see note
paragraph 5.5)
Circuit type Single phase self-rectifying with grid
control
kV selection (high voltage value) 70 kVp
Tubehead current 8 mA
KV accuracy
± 6 % @ nominal voltage
Tubehead (anode) current accuracy
± 13 % @ nominal voltage
Max. exposure time 3.2 s
Timer dimension
345×195×100 mm
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