Villa Sistemi Medicali ENDOS AC 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 696 90 03
Manual code 696 90 03 Manual code 696 90 03
Manual code 696 90 03
Rev. Date Page/s Modification description
0 07.02.03 - Document approval.
1 11.04.03 All Introduct on of KAILONG (Ch na) X-ray tube.
Introduct on of remote X-ray button w th l ght
s gnal ng of "Ready" or "Exposure n progress".
(Ref. RDM 5599)
2 25.09.03 All Remote t mer vers on release
3 26.03.04 8 Not fy body change for CE mark.
(Ref. RDM 5781)
4 15.03.05 8, 20, 39 Ed tor al correct on on Enabl ng/D sabl ng the
"Ready" key.
Mod f ed the DP arm label.
(Ref. RDM 5938, RDM 6052)
5 10.01.06 30 Dose l near ty reference measurement t me updated.
(Ref. RDM 6164)
6 13.07.07 All D rect ve 2002/96/EC nformat on not ce added.
7 30.08.13 6, 9 Ident f cat on 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
. INTRODUCTION
1.1 Icons n the manual................................................................................ 1
2. SAFETY ASPECTS 2
2.1 Warn ngs ................................................................................................ 3
2.2 Protect on from X-rays............................................................................ 4
2.3 Env ronmental r sks and d sposal .......................................................... 5
2.4 Symbols n use ....................................................................................... 6
3. CLEANING AND DISINFECTION 7
4. DESCRIPTION 8
4.1 Ident f cat on labels ................................................................................ 8
4.2 Funct ons, Models and Vers ons........................................................... 10
4.2.1 Extens on arm and sc ssors arm.......................................................... 10
4.2.2 Tubehead............................................................................................ 10
4.2.3 T mer.................................................................................................. 11
4.3 Conf gurat ons...................................................................................... 12
4.3.1 Standard conf gurat on ....................................................................... 12
4.3.2 Remote t mer conf gurat on ................................................................. 13
4.3.3 Dental cha r conf gurat on................................................................... 14
4.3.4 Ce l ng conf gurat on ........................................................................... 15
4.3.5 Mob le stand conf gurat on .................................................................. 16
4.3.6 Remote X-ray button conf gurat on...................................................... 17
5. TECHNICAL DATA 8
5.1 Method for correct ng exposure t mes................................................... 21
5.2 Method for measur ng techn cal factors................................................ 23
5.3 Correct use of dos meters to measure exposure t mes .......................... 24
5.4 Curves tube features ............................................................................ 26
5.5 Reference standard............................................................................... 30
5.6 Overall d mens ons ............................................................................... 32
6. GENERAL USE INSTRUCTIONS 34
6.1 "ENDOS ACP" t mer.............................................................................. 34
6.2 "ENDOS AC" t mer................................................................................ 38
6.3 V sual s gnals ....................................................................................... 40

USER'S MANUAL
Contents
ENDOS AC/ACP - CE (Rev. 7)
ii
7. EQUIPMENT USE 4
7.1 Equ pment preparat on......................................................................... 42
7.1.1 Preparat on of the t mer for X-ray use w th automat c select on
of exposure t mes (only for ENDOS ACP vers on) .................................. 42
7.1.2 Preparat on of the t mer for rad ograph c use w th manual select on
of exposure t mes................................................................................ 43
7.1.3 Preparat on of the t mer for D g tal Rad ography (V deorad ography)
use w th automat c select on of exposure t mes (only ENDOS ACP
vers on) .............................................................................................. 44
7.2 Preparat on of the tubehead ................................................................. 45
7.3 Exposure techn ques ............................................................................ 49
7.3.1 B sect ng techn que............................................................................. 49
7.3.2 Parallel techn que ............................................................................... 51
7.4 Exposure .............................................................................................. 52
7.5 Spec al funct ons .................................................................................. 54
7.5.1 Count ng the number of exposures made............................................. 54
7.5.2 Select on of mult pl cat on factor for d fferent types of f lm ................... 55
7.5.3 Select on of mult pl cat on factor for V deo-X-Ray-D g tal ..................... 57
8. MESSAGES ON DISPLAY 58
8.1 Funct onal messages ............................................................................ 58
8.2 Error s gnall ng..................................................................................... 61
8.2.1 Non re-settable errors ......................................................................... 62
8.2.2 Non fatal errors n start-up phase ....................................................... 63
8.2.3 Errors n exposure phase .................................................................... 64
9. CHECK AND CORRECTION OF POSSIBLE ERRORS IN
DENTAL X-RAYS 65
9.1 Typ cal faults n ntraoral X-rays .......................................................... 65
9.2 Typ cal faults caused by wrong pos t on ng........................................... 67
0. MAINTENANCE 68
Th s publ cat on can only be reproduced, transm tted, transcr bed or translated
nto any human or computer language w th the wr tten consent of the
Manufacturer.
Th s Manual s the Engl sh translat on of the Ital an or g nal vers on.

USER'S MANUAL
Introduction
(Rev. 7) ENDOS AC/ACP - CE
.
..
. INTRODUCTION
INTRODUCTIONINTRODUCTION
INTRODUCTION
NOTE:
Th s manual s updated to the product status t s sold w th, to
guarantee the user an adequate reference for equ pment use and any
aspect connected w th use safety. The manual may not reflect any
product var at on w thout mpact on operat ng procedures and use
safety.
The ntraoral rad ograph c ENDOS AC/ACP, produces h gh qual ty
ntraoral X-rays, thanks to reduced exposure t mes and the small
d mens ons of the focal spot.
ENDOS AC/ACP is exclusively intended for the execution of
intraoral X-rays.
The equ pment has the follow ng features:
•Very good qual ty X-rays p ctures
•user fr endly
•ergonom c des gn.
The equ pment s controlled by a m croprocessor that makes t poss ble
to reproduce exposure t mes and s composed of the follow ng parts:
•T mer: ENDOS AC or ENDOS ACP equ pped w th wall plate
•Extens on arm (30 cm, 60 cm or 80 cm for wall vers on)
•Sc ssors arm (DP)
•Tubehead 70 kV 8 mA – X-ray tube w th gr d.
The purpose of th s manual s to prov de the user w th nstruct ons that
w ll allow h m to run the equ pment safely and eff c ently.
The equ pment must be used accord ng to the procedures n the manual
and never for d fferent purposes from the ones for wh ch t has been
des gned.
.
..
. Icons in the manual
Icons in the manualIcons in the manual
Icons in the manual
Indicates a “NOTE”; we recommend part cular attent on n read ng the
subjects dent f ed w th th s con.
Indicates a “WARNING”; subjects dent f ed w th th s con concern
safety aspects regard ng the pat ent and/or the operator.
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USER'S MANUAL
Safety aspects
ENDOS AC/ACP - CE (Rev. 7)
2
2.
2.2.
2. SAFETY ASPECTS
SAFETY ASPECTSSAFETY ASPECTS
SAFETY ASPECTS
WARNING:
Read th s chapter very carefully.
V lla S stem Med cal des gns and makes the r equ pment accord ng to
safety requ rements; moreover, they supply all necessary nformat on for
appropr ate use and warn ngs relat ng to dangers connected w th X-ray
generators.
The manufacturer does not accept any responsibility for:
•Use of ENDOS AC/ACP equ pment for purposes other than those for
wh ch t has been des gned,
•damages to the equ pment, the operator, the pat ent caused both by
wrong nstallat ons and ma ntenance that do not follow the
procedures conta ned n the user manuals and the nstallat on
prov ded w th the equ pment, and by wrong operat ng techn ques,
•mechan cal and / or electr cal changes , made dur ng and after
nstallat on, that d ffer from the ones n the Serv ce 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
3
2.
2.2.
2. Warnings
WarningsWarnings
Warnings
The equ pment must be used accord ng to the procedures n th s manual
and never for d fferent purposes from the ones for wh ch t has been
des gned.
Before carry ng out any ma ntenance d sconnect the equ pment from the
power l ne us ng the c rcu t breaker prov ded.
ENDOS AC/ACP s an electro-med cal dev ce and for th s reason can be
used only under the superv s on of h ghly qual f ed med cal staff n
possess on of all the necessary knowledge about X-ray protect on.
The user s respons ble for fulf ll ng all the legal requ rements connected
w th the possess on, nstallat on and use of the equ pment tself.
ENDOS AC/ACP s bu lt for cont nuous runn ng w th nterm ttent load;
for th s reason the planned duty cycle must be observed.
Appropr ate accessor es, such as lead aprons, must be used to protect
the pat ent from rad at on.
Although the equ pment s des gned to prov de a reasonable degree of
protect on from electromagnet c nterference, accord ng to IEC
Internat onal regulat ons, t must be nstalled at an adequate d stance
from electr c ty transformer rooms, stat c cont nu ty un ts, from two-way
amateur rad os and cellular phones. The latter can be used only at a
m n mum d stance of 1.5m from any part of the equ pment.
Any nstrumentat on or equ pment for profess onal use located near
ENDOS AC/ACP must conform to Electromagnet c Compat b l ty
regulat ons. Non conform ng equ pment, w th known poor mmun ty to
electromagnet c f elds, must be nstalled at a d stance of at least 3m from
ENDOS AC/ACP and suppl ed by a ded cated electr c l ne.
ENDOS AC/ACP must be turned off when us ng electro-cautery or
s m lar equ pment n the v c n ty of the equ pment tself.
The equ pment s not des gned to be used n the presence of anaesthet c
m xtures nflammable w th a r, oxygen or n trous ox de.
Equ pment parts wh ch may come nto contact w th the pat ent must be
cleaned regularly accord ng to the nstruct ons g ven later n th s
document.
WARNING:
For safety reasons, t s forb dden to overload the extens on arm or the
sc ssors arm n an anomalous way, for nstance by lean ng on t.

USER'S MANUAL
Safety aspects
ENDOS AC/ACP - CE (Rev. 7)
4
2.2
2.22.2
2.2 Protection from X
Protection from XProtection from X
Protection from X-
--
-rays
raysrays
rays
Although dosage g ven by modern X-ray equ pment s low on average,
dur ng the execut on of the exposure, the operator must take all
precaut ons to protect the pat ent and h mself n compl ance w th the
regulat ons n force.
WARNING:
Protect on from X-ray rad at on s regulated by law. The equ pment must
be used by spec al sed personnel only.
a) The f lm (or the d g tal sensor) must be put nto the pat ent’s mouth
manually or us ng the appropr ate supports. If poss ble t must be
held by the pat ent h mself.
b) Dur ng X-ray exposure, the operator must not come nto contact
w th the tubehead or the coll mator cone.
c) Dur ng exposure, the operator must be at a certa n d stance from the
X-ray source (at least 2 metres), n the oppos te d rect on to X-ray
beam.
d) Dur ng exposure, the operator and the pat ent are the only people
allowed n the room.
e) The lead aprons should be used to reduce the undes rable effect of
secondary rad at on on the pat ent.

USER'S MANUAL
Safety aspects
(Rev. 7) ENDOS AC/ACP - CE
5
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 equ pment conta n mater al and flu ds wh ch must be
d sposed of n spec al areas des gnated by the local health author t es at
the end of the equ pment’s l fe cycle.
In part cular the equ pment conta ns the follow ng mater als and / or
components:
•Tubehead: hard plast c mater als, metal mater als, glass, d electr c
o l, lead, tungsten
•Other parts of the equipment: hard plast c mater als, metal
mater als, pr nted c rcu ts, ron-plast c mater als.
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 b n symbol placed on the equ pment or ts
package means that the equ pment must be collected separately from
the other waste.
The separate collect on of th s equ pment at the end of ts l fe cycle s
managed by the manufacturer/d str butor. The user that want to d scard
th s equ pment should contact the local d str butor and follow the
system he adopted for the separate collect on.
The correct separate collect on for the subsequent recycl ng, treatment
and env ronmentally compat ble d sposal contr butes to avo d negat ve
effects on the env ronment and on the health and promotes the reuse
and/or recycl ng of the mater als that the equ pment s made of.
The llegal d sposal of the equ pment made by the user w ll cause the
appl cat on of sanct ons accord ng to the local regulat ons.
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USER'S MANUAL
Safety aspects
ENDOS AC/ACP - CE (Rev. 7)
6
2.4
2.42.4
2.4 Symbols in use
Symbols in useSymbols in use
Symbols in use
The follow ng symbols are used n th s manual and n ENDOS AC/ACP,
bes des the symbols on the keyboard (see chapter 6):
Symbol Description
Equ pment w th appl ed parts Type B
A number of mach ne parts conta n mater als and l qu ds that
upon complet on of the mach ne’s l fe cycle must be d sposed of at
recovery centers establ shed by the local health un ts
∼
∼∼
∼ Alternate current
N Connect ng po nt to neutral conductor
L Connect ng po nt to l ve conductor
Protect on ground
Funct onal ground
OFF ; equ pment not connected to electr c ty l ne


 ON ; equ pment connected to electr c ty l ne
Perm ss on key to exposure; the perm tted exposure status s
d splayed by sw tch ng on the correspond ng green symbol
Focal spot accord ng to IEC 336
Focal spot accord ng to IEC 336
Product dent f cat on code
Ser al number
Date of manufacture (year and month)
F ltrat on
D agnost c source assembly ( Tube-head )
X-ray tube
Warn ng: see the accompany ng documentat on
Conform ty to the EC 93/42 D rect ve and subsequent amendments and
add t ons

USER'S MANUAL
Cleaning and disinfection
(Rev. 7) ENDOS AC/ACP - CE
7
3.
3.3.
3. CLEANING AND DISINFE
CLEANING AND DISINFECLEANING AND DISINFE
CLEANING AND DISINFECTION
CTIONCTION
CTION
The follow ng procedures should be observed carefully n order to
guarantee accurate hyg ene and clean ng:
•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 flu ds enter the equ pment n
order not to cause a short c rcu t and corros ons.
•Never use solvents (alcohol, petrol, Tr chloroethylene), corros ve or
abras ve substances when clean ng.
External surfaces
External surfacesExternal surfaces
External surfaces
Use a soft cloth and, for a stronger act on, a neutral soap to prevent
damag ng pa nted surfaces.
Dur ng clean ng operat ons, prevent surplus detergent and/or flu ds
enter ng the equ pment or stay ng on pa nted 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 d s nfected at regular ntervals w th a 2%
Glutaralde de solut on to guarantee hyg ene.

USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
8
4.
4.4.
4. DESCRIPTION
DESCRIPTIONDESCRIPTION
DESCRIPTION
4.
4.4.
4. Identification labels
Identification labelsIdentification labels
Identification labels
4
2
3

USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
9
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
Extens on arm
label
5
Coll mator 30 cm (opt onal)
label

USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
0
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 ntraoral rad ograph c equ pment s composed of the
follow ng parts:
4.2.
4.2.4.2.
4.2. Extension arm and scissors arm
Extension arm and scissors armExtension arm and scissors arm
Extension arm and scissors arm
It s composed of a double art culated jo nt arm, enabl ng extens on
hor zontally and vert cally. The tubehead s balanced n all pos t ons.
NOTE:
The sc ssors arm s des gned to work correctly at a max. angle of 160°; so
ts use requ res a flare angle of less than 160°.
Moreover, a hor zontal extens on arm can be added, ava lable n var ous
s zes, to meet all requ rements.
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 w th
gr d reduce exposure t mes and the quant t es of X-rays absorbed
by the pat ent. The rad ogen c equ pment s prov ded w th a
coll mator w th 20 cm focus sk n d stance and a 6 cm X-ray
em ss on d ameter at the ex t of the cone. The tubehead s
connected to the arm by a gu de, wh ch allows 360° hor zontal
rotat on and 290° vert cal rotat on.
Two alternate X-ray tube can be used: both have the same
character st cs and prov de the same performance.
The tubehead, assembled w th d fferent X-ray tubes, are nterchangeable
so long as preheat ng t me s set to the proper value nd cated on the
tubehead label.
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USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
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 t mer n use:
•ENDOS ACP
ENDOS ACPENDOS ACP
ENDOS ACP
ENDOS ACP s a d g tal t mer w th m croprocessor where
exposure t mes can be selected both manually and
automat cally.
W th automat c select on there s a cho ce of 30 pre-set t mes
depend ng on the pat ent’s s ze (small, med um or large) and
the type of tooth and acqu s t on mode (f lm, d g tal).
There are 33 f xed manual select on t mes that vary from a
m n mum of 0.02 seconds to a max mum of 3.20 seconds.
The ma n feature of th s t mer s that t has an automat c
exposure t me compensat on for dr ft of nom nal voltage w th n
± 10%.
•ENDOS AC
ENDOS ACENDOS AC
ENDOS AC
ENDOS AC has the same features as the ENDOS ACP t mer,
exclud ng automat c and d g tal anatom c select on.
It has manual exposure t me select on only.
NOTE:
A remote X-ray button conf gurat on can be made, outs de the exam
room. Th s can be a pure doorbell X-ray button or a dev ce wh ch also
show status of the un t ("READY" and "EXPOSURE IN PROGRESS".
NOTE:
The equ pment suppl es two separate contacts for connect on w th
external s gnall ng dev ces. One contact shows the status of funct on ng
equ pment ready for use and the second one the X-ray em ss on.
Connect on procedures and the necessary requ s tes for s gnall ng
dev ces are g ven n the "Serv ce Manual".
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USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
2
4.3
4.34.3
4.3 Configurations
ConfigurationsConfigurations
Configurations
4.3.
4.3.4.3.
4.3. Standard configuration
Standard configurationStandard configuration
Standard configuration
Figure 1
Tubehead
2 Sc ssors arm
3 Extens on arm
4 T mer
5 X-ray button

USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
3
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
Tubehead
2 Sc ssors arm
3 Extens on arm
4 Wall support (k t code 8161301002)
5 Remote t mer
6 X-ray button

USER'S MANUAL
Description
ENDOS AC/ACP - CE (Rev. 7)
4
4.3.3
4.3.34.3.3
4.3.3 Dental chair configuration
Dental chair configurationDental chair configuration
Dental chair configuration
Figure 3
Tubehead
2 Sc ssors arm
3 Dental cha r extens on arm 30 cm
4 Dental cha r connect on
5 T mer
6 X-ray button

USER'S MANUAL
Description
(Rev. 7) ENDOS AC/ACP - CE
5
4.3.4
4.3.44.3.4
4.3.4 Ceiling configuration
Ceiling configurationCeiling configuration
Ceiling configuration
Figure 4
Tubehead
2 Sc ssors arm
3 Ce l ng extens on arm
4 Ce l ng suspens on plate
5 T mer
6 X-ray button