Owandy Radiology Ow-RX User Manual Download

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USER MANUAL

Technical data

(Rev. 6)

Ow-RX

6.3.1

Reference standards related to wireless switch (applicable
only to configurations with wireless X-ray button)

The wireless switch for Ow-RX complies with the following standards:

ETSI EN 300 220-2 v.3.1.1

ETSI EN 301 489-3 v.1.6.1 and Final Draft ETSI EN 301 489-3

v.2.1.1

Electromagnetic Compatibility and Radio Spectrum matters (ERM).

Guarantees wireless switch for Ow-RX compliance with RED

Directive 2014/53/EU

CFR title 47 part 15

Subpart C-Intentional Radiators 15.231

Changes or modifications not expressly approved by the manufacturer

could void the user’s authority to operate the equipment.

This device complies with part 15 of the FCC Rules. Operation is subject

to the following two conditions: (1) This device may not cause harmful

interference, and (2) this device must accept any interference received,

including interference that may cause undesired operation.

Summary of Contents for Ow-RX

Page 1: ...Version July 2019 Rev 7 Ow RX User Manual 0051...

Page 2: ......

Page 3: ...ease 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...

Page 4: ...USER MANUAL Revision history Ow RX Rev 6 THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 5: ...ances 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...

Page 6: ...aring 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 opt...

Page 7: ...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 w...

Page 8: ...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 auton...

Page 9: ...ANUAL 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...

Page 10: ...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...

Page 11: ...to the above table for the dose values and apply a multiplication factor equal to Beam limiting device type Area 5 8 cm standard beam limiting device 26 41 cm2 4 5x3 5 cm rectangular beam limiting de...

Page 12: ...e 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 dif...

Page 13: ...e 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 electros...

Page 14: ...vironment 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 buil...

Page 15: ...pical 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 m...

Page 16: ...ated 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...

Page 17: ...nce 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 1...

Page 18: ...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 th...

Page 19: ...ith 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 equip...

Page 20: ...ction 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 indica...

Page 21: ...using the power switch Make sure water or other liquids do not penetrate inside the unit in order to prevent short circuits or corrosion Never use corrosive or abrasive substances alcohol petrol tric...

Page 22: ...USER MANUAL Description Ow RX Rev 6 16 5 DESCRIPTION 5 1 Identification plates 5 1 2 6 4 3...

Page 23: ...Ow RX plate 1b Ow RX plate for configuration with Wireless X ray button 2 MET certification plate 3 Tube head plate 4 DP arm plate 5 Extension arm plate 6 WARNING plate 7 Collimator 30 cm optional pla...

Page 24: ...hor sensor the digital sensor or a customised user mode Custom mode The Ow RX X ray unit has an LCD display with dimensions of 84mm x 45mm 240x128 pixel which makes it easier for the operator to perfo...

Page 25: ...mission of soft rays guaranteeing the constancy of the emission parameters kVp and mA The microprocessor based control ensures constant and repeatable exposure times by simply pressing a button it is...

Page 26: ...different pre set anatomical structures incisor canine premolar lower molar upper molar front bite wing and rear bite wing There are 36 fixed times available for manual selection which vary from a min...

Page 27: ...USER MANUAL Description Rev 6 Ow RX 21 5 3 Configurations 5 3 1 Standard configuration Figure 1 1 Tube head 2 Scissors arm 3 Extension arm 4 Timer 5 X ray button 1 2 3 4 5...

Page 28: ...d 2 Scissors arm 3 Extension arm 4 Wall support 5 Remote timer 6 X ray button NOTE Verify that in the radiological room direct audio and visual communication between operator and patient is always pos...

Page 29: ...on Rev 6 Ow RX 23 5 3 3 Mobile stand configuration Figure 3 1 Tube head 2 Scissors arm 3 Stand 4 Timer 5 X ray button WARNING The mobile version must be positioned so that the plug disconnection is no...

Page 30: ...remote X ray button 1 Figure 4 1 Remote X ray button optional NOTE Verify that in the radiological room direct audio and visual communication between operator and patient is always possible Otherwise...

Page 31: ...reless X ray button 1 Figure 5 1 Wireless X ray button optional NOTE Verify that in the radiological room direct audio and visual communication between operator and patient is always possible Otherwis...

Page 32: ...A rms impulsive 99 V Technical factors for maximum line current 70kV 6mA Absorbed power 582 VA 110 V 570 VA 240 V Maximum apparent line resistance 0 4 99 180 V 0 8 181 264 V Line voltage regulation 3...

Page 33: ...0 times the X ray time 1 30 Minimum focus to skin distance 20 cm optional 30 cm cone Focus position See Figure 6 Target angle See Figure 7 X ray diameter 20cm focus 6 cm 35x45 mm 25x35 mm 20x30 mm opt...

Page 34: ...humidity RH range 30 75 Operating atmospheric pressure range 700 1060 hPa Temperature range for transport and storing 20 C 70 C Humidity range for transport and storing 95 non condensing Minimum atmo...

Page 35: ...the exposure time to 1 second Anodic current value The anodic current value is defined as the average value of stationary current which settles on load after pre heating time The anodic current value...

Page 36: ...USER MANUAL Technical data Ow RX Rev 6 30 6 2 Tube characteristic curves D 045 Emission Filament characteristics Load...

Page 37: ...USER MANUAL Technical data Rev 6 Ow RX 31 Anode cooling curve Curva raffreddamento monoblocco 0 10 20 30 40 50 60 70 80 90 0 100 200 300 400 Time min E kJ Tube head cooling curve...

Page 38: ...agnostic X Ray Equipment IEC 60601 2 65 2012 Particular requirements for the basic safety and essential performance of dental intra oral X ray equipment IEC 62304 2006 Ac 2008 Medical device software...

Page 39: ...dio Spectrum matters ERM Guarantees wireless switch for Ow RX compliance with RED Directive 2014 53 EU CFR title 47 part 15 Subpart C Intentional Radiators 15 231 Changes or modifications not expressl...

Page 40: ...Type 7659303200 to which this declaration relates is in conformity with essential requirements and other relevant requirements of the RED Directive 2014 53 EU Art 3 1 a Health Art 3 1 a Safety Art 3 1...

Page 41: ...USER MANUAL Technical data Rev 6 Ow RX 35 6 4 Dimensions 30 0 30 FRONT VIEW Figure 8 Dimensions of the wall version 30 30 0 0 30 30 30 30 0 Figure 9 Dimensions of the mobile stand version...

Page 42: ...ay to view the operative messages and error signals The following figure shows a general view of the control panel while details on each functional area are provided in the following pages Figure 10 O...

Page 43: ...ng figure shows the LCD display details of every function area are shown on the following pages Figure 11 LCD display Tooth anatomic structure indication Dose indication Patient size indication Exposu...

Page 44: ...from among the exposure times pre set for the various teeth It is possible to select from among seven different anatomic structures and the selection is shown on the display Lower Upper Rear Front 7 1...

Page 45: ...Size key Press the Select size key to select in rotation from among the the different patient sizes small medium and large Also in this case the exposure times will change An acoustic signal is emitte...

Page 46: ...keys to select the type of receptor from among Film Phosphor Digital 3 Confirm the selection by pressing the Function key the icon indicating the presence of the long cone will start to flash SID 30 c...

Page 47: ...Confirm the selection by pressing the Function key NOTE As the setting menu is cyclic it will return to point 1 receptor type selection 9 To exit the setting menu hold down the Function key for appro...

Page 48: ...dy for X rays condition is signalled by the switching on of the relative green LED The ready for X rays condition remains for a set period of time variable during the installation phase default 2 minu...

Page 49: ...at is with values set by the manufacturer based on the size and type of tooth or perform an examination in manual mode where it is possible to change the set times With the programmed anatomic selecti...

Page 50: ...key Each time this key is pressed the selection of the type of tooth changes in rotation This is signalled acoustically and shown on the display Based on the type of film that is selected the pre set...

Page 51: ...0 10 0 14 Premolar 0 08 0 11 0 14 Lower molar 0 09 0 14 0 17 Upper molar 0 09 0 16 0 20 Front bite wing 0 07 0 10 0 14 Rear bite wing 0 09 0 16 0 20 Table 3 NOTE The times indicated in the tables are...

Page 52: ...n of the time is signalled by an acoustic message it is also possible to quickly change the exposure time 4 units per second by holding down one of the Increase or Decrease keys for more than 2 second...

Page 53: ...rease and Decrease keys to select the required value 2 Hold down the Function key until an acoustic signal is emitted a screen with the request to confirm or cancel the change will appear 3 Press the...

Page 54: ...d see paragraph 8 5 3 Move the tube head cone towards the patient and direct it exactly towards the tooth to be X rayed referring to the following figures NOTE If you want to use the rectangular colli...

Page 55: ...USER MANUAL System use Rev 6 Ow RX 49 MANDIBLE 15 15 CANINI canines canines 10 PREMOLARI premolars pr molaires MOLARI molars molaires 5 INCISIVI incisors incisives Figure 12...

Page 56: ...USER MANUAL System use Ow RX Rev 6 50 MAXILLA 40 40 CANINI canines canines 30 20 MOLARI molars molaires PREMOLARI premolars pr molaires INCISIVI incisors incisives Figure 13...

Page 57: ...v 6 Ow RX 51 OCCLUSAL 6 5 0 M A N D IB O L A lo w e rja w m a n d ib u le M A S C E L L A u p p e rja w m a c h o ir e Figure 14 BITE WING rc film 0 rc R A G G IO C E N T R A L E m a in b e a m ra y o...

Page 58: ...perpendicular to the bisector of the angle formed by the longitudinal axis of the tooth and by the film After positioning the X ray beam and the patient s head based on these criteria an average vert...

Page 59: ...ay beam must be adjusted horizontally in particular in the orthoradial direction relative to the interproximal spaces see Figure 17 to prevent an overlapping of structures see Figure 18 R C Figure 17...

Page 60: ...ion of molars When the film is introduced into the patient s mouth it is fixed on a support to prevent distortion The patient holds the support with his teeth Various types of supports are available o...

Page 61: ...xposure the emission is automatically stopped this situation is shown on the display by the message E13 if the button was released during pre heating and E12 if the button was released during the emis...

Page 62: ...ure the green LED on wireless button flashes quickly two times In the following table are described the different wireless X ray button green LED status Description Flashing frequence Duration Action...

Page 63: ...ated on the back of the button open the two half shells keeping the green button facing upwards and paying attention to the electronics located inside replace the batteries respecting the indicated po...

Page 64: ...of the number of exposures made With the ready for X ray status the user is able to view the number of exposures made by pressing the Increase and Tooth automatic selection keys at the same time The...

Page 65: ...d and their possible effect on the safety of the operators and or the system 9 1 Fatal errors upon power up and in the ready idle and cooling statuses These signals do NOT permit an examination to be...

Page 66: ...rors cannot always be removed without turning off the device and in most cases indicate situations of system faults or deterioration that require the intervention of technical assistance Displayed mes...

Page 67: ...e E12 Release of X ray button during emission None E13 Release of button during the pre heating phase None WARNING If CH0 is displayed the EEPROM will be reinitialized to the default parameters In cas...

Page 68: ...development time Film processor temperature higher than the recommended value Incorrect dilution of the developing liquids X rays out of focus impossible to see the details Possible causes The patien...

Page 69: ...rs when the film is folded excessively X rays with traces of electrostatic electricity When the film is compressed excessively and the air is dry electrostatic electricity may be released which is dis...

Page 70: ...tioning X rays with elongated or shortened images The X ray beam is not perpendicular to the bisector of the angle formed by the longitudinal axis of the tooth and by the film X rays with the top of t...

Page 71: ...ual inspection Daily Check that the unit is not damaged externally as to compromise the safety of protection from radiation Visual inspection Daily Check that there are no traces of oil on the tube he...

Page 72: ...allation Date Technician Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maintenance Date Technician Cause Maint...

Page 73: ...USER MANUAL Maintenance Rev 6 Ow RX 67...

Page 74: ...Cod 6959902203_Rev 6 0051...

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