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