Owandy Radiology Ow-RX User manual

Version July, 2019 (Rev. 7)
Ow-RX: User Manual
0051

USER MANUAL
Revision history
(Rev. 6) Ow-RX
Revision history Manual code 6959902203
Rev. Date Page Description of the changes
0 20.02.14 - Document approval
1 30.05.14 15, 25, 28, 29,
52, 53
Replaced CEI X-Ray tube with Toshiba D-045
model.
New FW for wireless X-ray button.
(Ref. RDM 7887, RDM 7904)
2 08.07.15 2, 3, from 5 to 7,
12, 14, 16, 17,
from 22 to 29,
from 32 to 34,
42, 61, 65
Adapted to the third edition of IEC 60601-1 and
its collateral applicable rules.
FCC approved revision.
MET approved revision.
Release of FW version 2.02 on CPU board.
(Ref. RDM 7903, RDM 7988, RDM 8037)
3 19.02.16 13, 44, 45, 60 Release of FW version 2.03 on CPU board
(programmed exposure pre-set times optimization,
added Error 50).
(Ref. RDM 8196)
4 06.09.16 17, 26, 29, 45 Added X-ray beam dimension on tube-head plate.
Technical characteristics update.
Added anodic current value measuring method.
Added Warning on pre-set exposure times values
in programmed exposure.
(Ref. RDM 8363, Complaint D1639)
5 18.11.16 56 Release of FW version 1.4 for wireless X-ray
button.
(Ref. RDM 8416)
6 14.02.18 14, 17, 22, 33,
34, 55
Modified duty cycle value.
Wireless switch conformity update (RED
Directive).
(Ref. RDM 8668)
7 07/2019 33 Removed reference to FCC ID

USER MANUAL
Revision history
Ow-RX (Rev. 6)
THIS PAGE IS INTENTIONALLY LEFT BLANK

USER MANUAL
Contents
(Rev. 6) Ow-RX
i
Contents
1. INTRODUCTION 1
1.1 Icons appearing in the manual ............................................................... 1
2. SPECIFICATION OF THE INTENDED USE 2
2.1 Application and medical purpose ............................................................ 2
2.1.1 Intended patient population ................................................................2
2.1.2 Operator profile...................................................................................2
2.1.3 Application environments ....................................................................2
2.2 Applied parts .......................................................................................... 3
2.3 Typical doses delivered to the patient during intraoral examinations ...... 4
3. SAFETY INFORMATION 6
3.1 Warnings ................................................................................................ 7
3.1.1 Electromagnetic emissions ..................................................................8
3.1.2 Electromagnetic immunity................................................................... 9
3.1.3 Recommended separation distances to portable and
mobile radio equipment ..................................................................... 11
3.2 Protection against radiation .................................................................. 12
3.3 Environmental risks and displacement................................................. 13
3.4 Symbols used ....................................................................................... 14
4. CLEANING AND DISINFECTION 15
5. DESCRIPTION 16
5.1 Identification plates .............................................................................. 16
5.2 Functions, models and versions............................................................ 18
5.2.1 High Frequency (HF) Generator ......................................................... 19
5.2.2 Extension arm and scissors arm........................................................ 19
5.2.3 Tube-head......................................................................................... 20
5.2.4 Timer ................................................................................................ 20
5.3 Configurations ...................................................................................... 21
5.3.1 Standard configuration...................................................................... 21
5.3.2 Remote timer configuration ............................................................... 22
5.3.3 Mobile stand configuration ................................................................ 23
5.3.4 Configuration with remote X-ray button............................................. 24
5.3.5 Configuration with wireless X-ray button ........................................... 25
6. TECHNICAL DATA 26
6.1 Method for measuring the technical factors .......................................... 29
6.2 Tube characteristic curves .................................................................... 30

USER MANUAL
Contents
Ow-RX (Rev. 6)
6.3 Reference standards ............................................................................. 32
6.3.1 Reference standards related to wireless switch (applicable only
to configurations with wireless X-ray button) ..................................... 33
6.3.1.1 Declaration of conformity in according to the
RED Directive 2014/53/EU ............................................... 34
6.4 Dimensions........................................................................................... 35
7. GENERAL INSTRUCTIONS FOR USE 36
7.1 Control panel - Description and functions ............................................ 36
7.1.1 "Tooth anatomic selection" key .......................................................... 38
7.1.2 “Increase/Decrease” key.................................................................... 38
7.1.3 "Select Size" key ................................................................................ 39
7.1.4 “Function” key (selection of receptor, cone presence and kV value) ..... 40
8. SYSTEM USE 42
8.1 Switching ON and OFF the device ......................................................... 42
8.2 Programmed/Manual exposure............................................................. 43
8.2.1 Performing a programmed exposure .................................................. 44
8.2.2 Performing a manual exposure .......................................................... 46
8.3 Storing customised times...................................................................... 47
8.4 Preparing the tube-head ....................................................................... 48
8.5 Exposure techniques ............................................................................ 52
8.5.1 Bisector technique ............................................................................ 52
8.5.2 Parallel technique ............................................................................. 54
8.6 Exposure with the supplied X-ray button.............................................. 55
8.7 Exposure with the wireless X-ray button (optional) ............................... 56
8.7.1 Indication of the battery charge status and replacement. ................... 57
8.7.2 Matching procedure between the remote control and timer ................ 57
8.8 Display of the number of exposures made............................................. 58
9. ERROR MESSAGES ON THE DISPLAY 59
9.1 Fatal errors upon power-up and in the ready, idle and
cooling statuses .................................................................................... 59
9.2 Fatal errors during X-ray emission ....................................................... 60
9.3 NON fatal errors.................................................................................... 61
10. CONTROL AND CORRECTION OF ANY ERRORS IN THE
DENTAL X-RAYS 62
10.1 Typical defects of intra-oral X-rays........................................................ 62
10.2 Typical defects caused by incorrect positioning..................................... 64
11. MAINTENANCE 65
No part of this publication may be reproduced, transmitted, transcribed or
translated without the prior written consent of the manufacturer.
This manual in English is the original version.

USER MANUAL
Introduction
(Rev. 6) Ow-RX
1
1. INTRODUCTION
NOTE:
This manual is updated for the product it is sold with, in order to
guarantee an adequate reference to use the product properly and safely.
The manual may not reflect changes to the product that do not affect
operating modes or safety.
The Ow-RX intra-oral X-ray unit takes high quality intra-oral X-rays
thanks to reduced exposure times and the small dimensions of the focus
spot.
Ow-RX is intended exclusively for intra-oral X-rays.
System operation is managed by a microprocessor, which permits high
reproducibility of the exposure times.
The system consists of the following parts:
•timer: Ow-RX complete with the wall support
•extension arm (30cm, 60 cm or 80cm for the wall version)
•Scissors arm (DP)
•Tube-head (60-65-70) kV ; 6 mA
The aim of this manual is to instruct the user on the safe and effective
use of the device.
The device must be used in compliance with the procedures described,
and never be used for purposes different from those herewith indicated.
1.1 Icons appearing in the manual
This icon indicates a NOTE: please read the items marked by this icon
thoroughly.
This icon indicates a WARNING: the items marked by this icon refer to
the safety aspects of the patient and/or the operator.



USER MANUAL
Specification of the intended use
Ow-RX (Rev. 6)
2
2. SPECIFICATION OF THE INTENDED USE
2.1 Application and medical purpose
Ow-RX is an extraoral source X-ray unit for dental radiographic
examination and diagnosis of diseases of the teeth, jaw and oral
structures.
The device is to be operated and used by dentists, radiologists and other
legally qualified health care professionals. It can be used with both
pediatric and adult patients.
Caution:
Federal law restricts this device to sale by or on the order of a dentist, a
radiologist or another legally qualified health care professional.
2.1.1 Intended patient population
Ow-RX system can be used with the following typology of patient:
•Age: pediatric to geriatric
•Patient status:
−self-sufficient patient (patient can autonomously place himself as
requested by the physician)
−non self-sufficient patient (patient is properly helped to take the
exam by medical personnel).
•Nationality: multiple.
2.1.2 Operator profile
This system may only be operated by persons who have the necessary
expertise in radiation protection or knowledge of radiation protection and
who have been instructed in the operation of the X-ray equipment.
2.1.3 Application environments
The application environments of the Ow-RX are hospitals, private clinics
or consultants, other radiology facilities and also residential
environment.

USER MANUAL
Specification of the intended use
(Rev. 6) Ow-RX
3
2.2 Applied parts
During normal use, Ow-RX comes in contact with the patient through
the collimator front plastic ring, classified as Type B applied part.

USER MANUAL
Specification of the intended use
Ow-RX (Rev. 6)
4
2.3 Typical doses delivered to the patient during
intraoral examinations
The dose ranges delivered by Ow-RX to the patient during intraoral
examinations are given in the table below.
The actual value depends on the type of receptor selected (film, digital
sensor, phosphor plate) and on the focus-to-skin distance (20 cm without
optional collimator cone, 30 cm using optional collimator cone).
The range are given for the 3 patient sizes and for the 3 high voltage
values selectable.
Tooth HV
[kV]
Patient size
Small Medium Large
Dose [mGy]
Dose [mGy]
Dose [mGy]
Incisive
60
0,29 to 0,65 0,29 to 0,78 0,46 to 1,04
Canine
0,29 to 0,65 0,29 to 0,78 0,46 to 1,04
Premolar 0,34 to 0,78 0,34 to 0,98 0,52 to 1,31
Lower molar
0,46 to 1,04 0,46 to 1,17 0,69 to 1,57
Upper molar 0,57 to 1,31 0,57 to 1,44 0,86 to 1,96
Anterior bitewing
0,29 to 0,65 0,29 to 0,78 0,46 to 1,04
Posterior bitewing 0,57 to 1,31 0,57 to 1,44 0,86 to 1,96
Incisive
65
0,25 to 0,56 0,25 to 0,67 0,39 to 0,89
Canine 0,25 to 0,56 0,25 to 0,67 0,39 to 0,89
Premolar
0,30 to 0,67 0,30 to 0,84 0,44 to 1,12
Lower molar 0,39 to 0,89 0,39 to 1,01 0,59 to 1,34
Upper molar 0,49 to 1,12 0,49 to 1,23 0,74 to 1,68
Anterior bitewing 0,25 to 0,56 0,25 to 0,67 0,39 to 0,89
Posterior bitewing 0,49 to 1,12 0,49 to 1,23 0,74 to 1,68
Incisive
70
0,21 to 0,47 0,21 to 0,56 0,33 to 0,75
Canine
0,21 to 0,47 0,21 to 0,56 0,33 to 0,75
Premolar 0,25 to 0,56 0,25 to 0,71 0,37 to 0,94
Lower molar
0,33 to 0,75 0,33 to 0,85 0,50 to 1,13
Upper molar 0,41 to 0,94 0,41 to 1,03 0,62 to 1,41
Anterior bitewing
0,21 to 0,47 0,21 to 0,56 0,33 to 0,75
Posterior bitewing 0,41 to 0,94 0,41 to 1,03 0,62 to 1,41

USER MANUAL
Specification of the intended use
(Rev. 6) Ow-RX
5
For the calculation of the DAP (Dose Area Product) value, refer to the
above table for the dose values and apply a multiplication factor equal to:
Beam limiting device type Area
Ø 5,8 cm standard beam limiting device 26,41 cm2
4,5x3,5 cm rectangular beam limiting
device
15,75 cm2
2,5x3,5 cm rectangular beam limiting
device
8,75 cm2
2,0x3,0 cm rectangular beam limiting
device
6,0 cm2

USER MANUAL
Safety information
Ow-RX (Rev. 6)
6
3. SAFETY INFORMATION
WARNING:
Please read this chapter thoroughly.
NOTE:
The information for a proper installation and maintenance of the
equipment are present in the Service Manual.
The manufacturer designs and builds the devices in compliance with the
safety requirements; furthermore it supplies all information necessary for
correct use, and the warnings related to danger associated with X-ray
generating units.
The manufacturer cannot be held responsible for:
•use of Ow-RX equipment different from the purpose for which it was
originally designed,
•damage to the unit, the operator or the patient, caused both by
incorrect installation and maintenance procedures different from
those described in this user and service manuals supplied with the
unit, and by wrong operations,
•mechanical and/or electrical modifications performed during and
after the installation, different from those described in the service
manual.
WARNING:
No modification of this equipment is allowed.
Only personnel authorised by the manufacturer may carry out
technical operations on the unit.
Only authorised personnel can remove the tube-head from its
support and/or access the components under tension.


USER MANUAL
Safety information
(Rev. 6) Ow-RX
7
3.1 Warnings
The device must be used in compliance with the procedures described
and never be used for purposes different from those herewith indicated.
Before performing any maintenance operation, disconnect the unit from
the power supply using the provided circuit breaker.
Ow-RX is an electro-medical device and therefore it can be used only
under the supervision of suitably qualified medical personnel, with the
necessary knowledge on X-ray protection.
The user is responsible for the fulfilment of the legal requirements
regulating the ownership, installation and use of the equipment itself.
Ow-RX has been built to support continuous operation at intermittent
load; therefore please follow the described use cycles.
Wherever necessary, use the appropriate accessories, such as the leaded
aprons, to protect the patient from radiation.
Ow-RX must be turned off when using electrosurgical devices or similar
equipment near the unit.
This device has not been designed to be used in environments where
anaesthetic mixtures flammable with air, oxygen or nitrous oxide can be
detected.
In order to prevent risks of short-circuit and corrosion, avoid the entry of
water or other liquids in the equipment.
The parts of the unit that can come into contact with the patient must be
cleaned regularly according to the instructions provided below in this
document.
WARNING:
For safety reasons, it is prohibited to abnormally overload the extension
arm or the scissors arm, for example by leaning on it.
WARNING:
To avoid risk of electric shock, this equipment must only be connected to
a supply mains with protective earth.

USER MANUAL
Safety information
Ow-RX (Rev. 6)
8
3.1.1 Electromagnetic emissions
In accordance with the IEC 60601-1-2 standard, Ow-RX is suitable for
use in the electromagnetic environment specified below.
The customer or user of the system must ensure that it is used in the
said environment.
Emissions test Conformity EMC environment of use
RF emissions
CISPR 11
Class B
Ow-RX is suitable for use in all domestic
environments and in environments
directly connected to the mains power
supply at low voltage that supplies
buildings for domestic use.
Group I Ow-RX uses RF power only for its
internal functioning. As a result, its RF
emissions are very low and most likely
will not cause any interference in
electronic devices located nearby.
Harmonic emissions
IEC 61000-3-2
Class A
Flicker/voltage
fluctuation emissions
IEC 61000-3-3
In
compliance

USER MANUAL
Safety information
(Rev. 6) Ow-RX
9
3.1.2 Electromagnetic immunity
In accordance with the IEC 60601-1-2 standard, Ow-RX is suitable for
use in the electromagnetic environment described below.
The customer or user of the system must ensure that it is used in the
said environment.
Immunity test Test level
IEC 60601-1-2 Compliance level EMC environment of use
Electrostatic
discharges (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV in air
±6 kV contact
±8 kV in air
The flooring must be
must be wood, concrete
or ceramic tile. If the
flooring is covered with
synthetic material, the
relative humidity must
be at least 30%.
Transients/sequence
of rapid electric
impulses
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for
input/output lines
±2 kV for power
supply lines
±1 kV for
input/output lines
The quality of the mains
voltage must be the
same as a typical
commercial or hospital
environment.
Overvoltages
IEC 61000-4-5
±1 kV between
phases
±2 kV between
phase and earth
±1 kV between
phases
±2 kV between
phase and earth
The quality of the mains
voltage must be the
same as a typical
commercial or hospital
environment.
Voltage dips, short
breaks and voltage
variations of the
power supply feed
line IEC 61000-4-11
0 % U
t
for 0.5 cycles
40 % Utfor 5 cycles
70 % Utfor 25 cycles
0 % Utfor 5 s
0 % U
t
for 0.5 cycles
40 % Utfor 5 cycles
70 % Utfor 25 cycles
0 % Utfor 5 s
The quality of the mains
voltage must be the
same as a typical
commercial or hospital
environment. If the
Ow-RX user requires
continuous operation
during interruptions in
the mains voltage, it is
recommended to power
the Ow-RX with an
uninterrupted power
supply or batteries.
Magnetic field at the
main frequency
(50/60 Hz)
IEC 61000-4-8
3 A/m 3 A/m The levels of the
magnetic fields at mains
frequency must be the
same as a typical
commercial or hospital
environment.
Note: Utis the a.c. mains voltage prior to the application of the test level.

USER MANUAL
Safety information
Ow-RX (Rev. 6)
10
Immunity test Test level
IEC 60601-1-2
Compliance
level EMC environment of use
The RF portable and mobile
communications units should not be
used closer to any part of the Ow-RX,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Radiated RF
IEC 61000-4-3
3 V/m
from 80 MHz to
2.5 GHz
3 V/m
d = 1.2 x √ P from 80 MHz to
800 MHz
d = 2.3 x
√ P from 800 MHz to
2.5 GHz
Conducted RF
IEC 61000-4-6
3 V
from 150 kHz to
80 MHz
3 V d = 1.2 x
√ P
where "P" is the maximum rated
output of the transmitter in watts (W)
according to the transmitter
manufacturer and "d" is the
recommended separation distance in
meters (m).
The field strength of the fixed RF
transmitters, determined by an on-site
electromagnetic survey, should be
lower than the compliance level in
each frequency range.
Interference may be verified near
devices marked with the following
symbol:

USER MANUAL
Safety information
(Rev. 6) Ow-RX
11
3.1.3 Recommended separation distances to portable and mobile
radio equipment
Ow-RX is designed to operate in an electromagnetic environment in
which radiated RF disturbances are controlled.
The customer or user of the system can help prevent electromagnetic
interference by ensuring a minimum distance between mobile and
portable RF communication devices (transmitters) and Ow-RX as
recommended in the following table in relation to the maximum output
power of the radio devices.
Maximum rated
output power of
the transmitter
(W)
Separation distance according to the frequency of the
transmitter (m)
from 150kHz to
80MHz
d = 1.2 x √ P
from 80MHz to
800MHz
d = 1.2 x √ P
from 800MHz to
2.5GHz
d = 2.3 x √ P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters maximum rated output not shown in the table, the recommended
separation distance "d" in meters (m), can be calculated using the equation applicable to
the frequency of the transmitter, where "P" is the highest rated output of the transmitter in
watts (W) according to the manufacturer of the transmitter.
Note 1: at 80 MHz and 800 MHz, apply the separation distance for the higher frequency
interval.
Note 2: these guidelines may not apply to all situations. Electromagnetic propagation
depends on the absorption and reflection of structures, objects and people.

USER MANUAL
Safety information
Ow-RX (Rev. 6)
12
3.2 Protection against radiation
Although the dose supplied by modern X-ray units is quite low, the
operator must adopt the precautions and/or suitable protection for the
patient and himself according to current regulations, during the
execution of radiography.
WARNING:
Protection against radiation is regulated according to law. The equipment
may only be used by specialised personnel.
a) The film (or the digital sensor) must be placed in the patient's mouth
either manually or using the specific supports, and must be held in
position by the patient if necessary.
b) During exposure to the rays, the operator must not be in contact
with the tube-head or the collimator cone.
c) During exposure, the operator must maintain a certain distance from
the source of the rays (at least 2 metres) in the opposite direction of
the emission.
d) During exposure, only the operator and the patient may be present in
the room.
e) Use the specific leaded aprons to reduce the undesired effect of
secondary radiations for the patient.
NOTE:
In reference to the image receptor used, the operator must consider the
presence of residual radiation.


USER MANUAL
Safety information
(Rev. 6) Ow-RX
13
3.3 Environmental risks and displacement
Some of the device's components contain material and liquids that, at the
end of the equipment life-cycle, must be disposed of at the recycling
centres appointed by the local health units.
In particular, the device contains the following materials and/or
components:
•Tube-head: non biodegradable plastic materials, glass, dielectric oil,
lead, tungsten, aluminium, copper.
•Other parts of the device: non biodegradable plastic materials,
metal materials, printed circuits, iron-plastic materials.
INFORMATION FOR USERS OF THE EUROPEAN UNION according to
2012/19/EU Directive on waste electrical and electronic equipment
(WEEE)
The symbol with the waste bin crossed on the equipment or its
packaging, indicates that the product must be separately collected from
other waste at the end of its life.
The separate collection of the present equipment that has reached the
end of its life is organised and managed by the manufacturer. The user
who wishes to dispose of this equipment must contact the manufacturer
and follow their system to enable the separate collection of the equipment
at the end of its life.
Suitable separate waste collection for the subsequent start of the
equipment discarded for recycling, for treatment and for environmentally
friendly disposal, contributes in preventing possible adverse effects on
the environment and health and promotes the reuse and/or recycling of
materials of which the equipment is comprised.
Illegal disposal of the product by the holder implies the application of
administrative sanctions provided by law


USER MANUAL
Safety information
Ow-RX (Rev. 6)
14
3.4 Symbols used
In this manual and on the Ow-RX itself, apart from the symbols indicated
on the keypad, also the following icons are used (see Chapter 7):
Symbol Description
Device with type B applied parts
In some of its parts, the device contains materials and liquids that, at
the end of the lifespan of the unit, must be disposed of at the
appropriate disposal centres
∼
Alternating Current
N Connection point to the neutral conductor
L Connection point to the line conductor
Earth protection
Operation earthing
OFF; device not connected to the mains

ON; device connected to the mains
Exposure enabling key; the exposure enabled status is indicated by the
switching on of the corresponding green symbol
Ray Emission
Focus spot according to IEC 336
Warning: see the accompanying documentation
Product identification code
Serial number
Date of manufacture (year and month)
Manufacturer's name and address
Filtration
Tube-head
X-ray tube
0051
Conformity to the EC 93/42 Directive and subsequent amendments and
additions (subsequent amendments and additions)
Guarantees wireless switch for Ow-RX compliance with RED Directive
2014/53/EU