Gendex Oralix AC User Manual

฀-ray System

Oralix

User Manual

฀฀

Manuale d'uso

M฀฀

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

Oralix

User Manual

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

GENDEX

Oralix AC

English

Oralix AC

INDEX

1 Introduction 3

1.1 Explanation of symbols 4

2 Operation 6

2.1 General principles of operation 6

2.2 Preparation and positioning for a intraoral radiograph 7

3 SECONDENT Timer 9

3.1 Anomalies & Alarms Chart 11

4 DENS-O-MAT Timer 12

4.1 Operation 13

4.2 Customization 14

4.3 Anomalies & Alarms Chart 16

5 Maintenance, Cleaning and Disinfecting 17

6 Safety 18

7 Technical Data 20

7.1 Storage and transportation conditions 21

7.2 Compliance with applicable standards 21

7.3 System labels 26

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

No part of this publication may be reproduced, transmitted, transcribed, or translated into any human or computer language in any form by any means without the written consent of the copyright holder.

Oralix

, DENS-O-MAT®, SECONDENT®, Visualix®are Registered TradeMarks of Gendex

Corporation.

This manual in English is the original version.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

1 Introduction

Intended Use

The Gendex Oralix AC is a high frequency X-ray system designed to produce gray scale intraoral images to film or digital receptors.

Oralix ® AC is a system for radiography of teeth in conjunction with an intraoral detector (intraoral film or electronic x-ray image sensor). It can provide radiographs useful for observing the formation and condition of deciduous and permanent teeth and of the surrounding bone structure, for the diagnosis of tender areas of teeth and gums, for locating impacted and supernumerary teeth, for root canal therapy, and in other conservation work. Oralix AC can also be used for certain radiographic procedures with extra-oral detector used in dento-maxillo-facial radiography, such as transcranial projection of the TMJ and submento-vertex or lateral projection of the mandible with extra-oral film-screen cassette.

i The Oralix AC system consists of: i The Oralix AC dental X-ray tubehead, i.e. a radiographic generator comprising a X-ray

tube and a high-voltage transformer assembled in the same enclosure that also includes various provisions for X-ray shielding and filtering, high voltage insulation, heat convection and sinking, and safety devices;

i A Beam Limiting Device (BLD) and Position Indicating Device (PID), also commonly

known as a dental "cone";

i An articulated suspension arm; i A rigid extension arm; i A wall support (except in the case of dental unit mount and of mobile assemblies); i A microprocessor-controlled timer, either DENS-O-MAT or SECONDENT, that provides

all necessary controls for the operation and the emission of x-rays. Note that one DENSO-MAT timer could control the operation of two tubeheads (if the relevant option has been installed).

Oralix AC provides high quality X-ray irradiation by means of state-of-the-art technology. The diagnostic value and quality of the radiographic images obtained ultimately depends as well upon good positioning, on the detector used (film or electronic sensor) and on the subsequent image processing (either chemical or electronic), on compliance with the appropriate radiographic procedure, and, last but not least, on proper viewing technique.

This manual is intended to assist the user in the safe and efficient operation of the equipment described.

The equipment must be used in accordance with the procedures contained in the manual and must not be used for purposes other than those which are described herein.

The equipment should only be used by persons having recognized qualification and, if relevant, having adequate training on the particular equipment, especially regarding protective measures such as radiation protection. It is the responsibility of the user to ensure that the applicable regulations regarding installation and operation of the equipment are observed. Incorrect operation, or failure of the user to maintain the equipment in accordance with the scheduled maintenance, relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, injury, defects and/or other malfunction.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

1.1 Explanation of symbols

The CE symbol ensures that the product here in specified, and manufactured from 1998 onwards, meets the provisions of European Council Directive 93/42 EEC concerning medical devices.

Consult Written Instructions (this Operator's Manual)

Device emitting x-rays.

Type B equipment (IEC 60601-1 : 1988)

Ŷ Focal spot

Filtration, Al equivalent

X-ray tube

Stand-by

X-rays on, for SECONDENT timer

X-rays ready, for DENS-O-MAT timer

Warning (in this Operator Manual)

Note (in this Operator's Manual)

Model Number

Serial Number

Manufacture Date

Manufacturer / Location

Source to Skin Distance

Beam Diameter

X-Ray Field

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Oralix AC

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Fuse

See page 13 for System Operation Symbols.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

2 Operation

2.1 General principles of operation

The tubehead-based dental X-ray system is a simple type of x-ray generator. Essentially, it consists of a high-voltage transformer that elevates the voltage taken from the mains supply up to an

extremely high value (e.g. 65 kVp = 65000 V peak), and applies it across a x-ray tube. The x-ray tube acts as a voltage rectifier and lets current pulses (the mA) flow through in correspondence with every half mains phase.

Inside the x-ray tube, the highly energetic electrons during the current pulses hit the tungsten surface of the anode and cause it to emit x-rays photons of various energies, the highest ones corresponding (in the keV unit of measurement) to the peak electron-accelerating voltage across the x-ray tube. Note that the higher the average energy of the x-ray photons, the more penetrating the x-ray beam is.

X-rays are only present during the very moment of the irradiation. They travel along a straight direction and cannot be deflected or reflected. When they pass through solid matter, or strike against a surface, they momentarily bring about a certain amount of secondary and less energetic x-rays, respectively called scattered and back scattered radiation.

The high-voltage transformer and the x-ray tube are soaked in dielectric oil both for electrical insulation and for convection of the intense heat generated in the x-ray tube. All around the x-ray tube there is lead shielding that effectively blocks x-rays in all directions, except through a small output window. This window also incorporates an Aluminum filter to remove the useless, less penetrating photons from the x-ray beam.

In front of this window and rigidly attached to the tubehead, there is an open-end Beam Limiting Device and Position Indicating Device (BLD/PID), that is a device including a lead diaphragm that collimates the x-ray beam field to the required shape and size, and means to apply such field to the required position. This device is also known as a "cone" (short for "coning device").

There are two types of cone that can equip your Oralix tubehead, depending on the option chosen, both providing a Source Skin Distance (SSD) of 20 cm:

A round BLD, consisting of a near-focus collimator and an open-end cylindrical spacer, with a circular irradiated field of 6 cm diameter. The tip of the cone includes a lead shielding for protection against back-scattered radiation.

A rectangular BLD, made out of metal, providing an irradiated field of 3.5 x 4.5 cm. It can be rotated so to align the x-ray field with the film.

The cone can be removed and interchanged by turning it anti clockwise. The rectangular BLD requires a more accurate operation than the round one (and re-takes may occasionally be

required). However, the integral imparted dose using rectangular BLD is less than half than with round BLD (due to the smaller irradiated area). Also, the image quality thus obtained benefits from the less scattered radiation.

Radiation Safety

X-ray equipment may cause injury if used improperly. The instructions contained in this manual must be read and followed when installing, servicing, or operating the Gendex Oralix AC. The Oralix AC provides a high degree of protection from unnecessary X-radiation. However, no practical design can provide complete protection, nor prevent operators from exposing themselves or others to unnecessary radiation. It is important that you become fully acquainted with applicable government radiation protection regulations.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

2.2 Preparation and positioning for a intraoral radiograph

Detailed operation may slightly vary among different types of image detector (film or electronic sensor). Instructions for using and positioning the detector in the mouth are normally provided with the detector itself. In the following instructions it is assumed that a conventional x-ray film is being used, unless otherwise specified.

Seat the patient on a dental chair, or any other accommodation providing appropriate support for the head, and tilt his or her head to the proper inclination. Always position the patient with the sagittal plane vertical. For upper jaw exposure, place the upper occlusal plane horizontal. For lower jaw exposures, place the lower occlusal plane horizontal.

Set the required exposure time on the timer. Refer to the next chapters for operation of the dental timer and selection of the proper exposure time.

1. Trunnion

2. Handgrip

3. Indication for the position of focal spot

4. Scale for the angle

5. lnterchangeable cone

6. Label with technical data

7. Reference Axis Indicators (alignment lines)

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Oralix AC

Rotate the tubehead in its trunnion, by holding the cone and the handgrip, to proper angle depending on the radiograph to be made. The tubehead angle can be read on the graduated scale on the side of the tubehead.

Please note that the tubehead can be rotated continuously around the horizontal axis (the vertical pivoting shaft), and for 270° vertically (around the horizontal axis of the trunnion). Make sure that you are using the proper (that is middle) part of the 270° range.

Position the film into the patient's mouth in the proper position, either by using a holder or a by free hand (in the latter case the film must be hold in position by the patient's index finger, not

the operator's!).

Paralleling Technique

Paralleling technique produces the most accurate image of the teeth as it follows the principles of accurate shadow casting (more closely than the bisecting technique does). An accurate shadow casting is obtained when the long axis of the tooth is placed parallel to the film. The undesirable enlargement of the object can be avoided by using a "parallel" x-ray beam. With the Oralix AC an SSD of 20 cm is used. At this distance, conditions are suitable for applying the paralleling technique. In order to escape the restrictions of the oral anatomy, the film must be positioned further away from the tooth. The radiographic enlargement will be approx. 15%. In order to place the film parallel to the tooth axis, film holders can be used.

The Oralix AC is thus positioned in relation to the film holder. As a consequence of the technique applied, a smaller tubehead angle is used than with the bisecting technique.

Bisecting Technique

With the bisecting technique, the radiographic enlargement is selected so that of the tooth axis equals the length on the radiograph. This is obtained by placing the central ray perpendicular to the bisector of tooth axis and film. The radiographic enlargement due to the different film-object distance along the length of the tooth is acceptable.

Grab the tubehead from behind, and move it close to the patient's head. Direct the tubehead and gently bring it to the patient's head until the cone tip touches the patient skin at the area to be examined. Finally check the angle again.

Please note that, in order to ensure the required mechanical stability, the folding arm needs to be open at least 10°. Smaller angles may cause the arm to drift to zero, i.e. completely folded, thus impairing stability and position of the x-ray source.

Make an exposure by keeping the exposure handswitch firmly pressed.

During an exposure all personnel must stay away from path of the primary x-ray beam, preferably behind the tubehead and at least 2.5 m from the patient's head, in order to ensure that the potential exposure to direct and scattered radiation be less than the limit indicated in the applicable international standards.

The value of a radiograph depends not only on the amount of details it reveals but also on the accuracy with which the film and object have been positioned, in relation to the x-ray beam. Therefore, the use of positioning devices is encouraged, in order to properly position and align the detector in relation with the radiographic object (e.g. the tooth to be radio graphed) and the cone.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

3 SECONDENT Timer

SECONDENT ® is a fully microprocessor-controlled dental timer, featuring sophisticated internal design in order to achieve very simple operation.

As the actual value of the mains voltage keeps fluctuating during the day, so does the kV applied to the x-ray tube and the resulting imparted x-ray dose rate (i.e. the flow of x-ray photons emitted). In a given system, the dose rate depends on the kV to a very large degree, and a difference of a few percent in the mains supply may well imply a twofold change in dose rate.

SECONDENT continuously adjusts the actual exposure time in order to ensure that the dose imparted in a given exposure is independent from such mains voltage fluctuations. For any selected nominal exposure time, the actual exposure time is automatically shortened or lengthened in such a way that the overall imparted dose is the same that would occur if the mains supply voltage was at nominal value (i.e. 230V).

Therefore, the actual exposure time corresponds to the nominal selected exposure time only when the line mains voltage is exactly at its nominal value of 230V.

To disable the time vs. voltage compensation (e.g. for test purpose) refer to the Technical Service Manual.

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Power on the system by the mains switch. Green mains lamp must light up, the timer is in stand-by mode.

Sel

ect the required exposure time with the 24-steps time selector rotary knob. The nominal selected exposure time will light up on the front panel. Use the table here under as a reference to select the exposure time as a function of the tooth. The exposure times given apply for an average patient and paralleling technique. It may be necessary to use different exposure times depending on the specific tooth and jaw thickness or density, the age of the patient, the efficiency of the film processor, the personal preferences of the observer of the radiograph, in case of bisecting technique, and if a film of different speed is used.

An exposure is made by means of the handswitch. The coiled cable of the handswitch can be stretched up to 2.5 m, to ensure the required distance between

operator and x-ray source (the tubehead). During the exposure the yellow lamp lights up and a warning tone is buzzed, indicating that x-rays are being emitted.

Press the handswitch push-button to start the exposure and keep it pressed until the lamp goes out and the warning tone stops. If the handswitch is released during exposure, the same will be interrupted (this is called "dead-man" operation).

EXPOSURE CHART

Object

Exp. time (s)

D-type film

Exp. time (s)

E-type film

Exp. Time (s)

Digital sensor

molars, upper jaw

0.8

0.4

0.20

premolars, upper jaw

0.64

0.32

0.16

canines, upper jaw

0.5

0.26

0.12

incisors, upper jaw

0.4

0.2

0.1

molars, lower jaw

0.5

0.26

0.12

premolars, lower jaw

0.4

0.2

0.1

canines, lower jaw

0.4

0.2

0.1

incisors, lower jaw

0.32

0.16

0.08

Occlusal. , post., upper jaw

1.6

0.8

0.4

Occlusal. , ant., upper jaw.

1.25

0.64

0.32

Occlusal. , post., lower jaw

1.0

0.5

0.26

Occlusal. , ant., lower jaw.

1.0

0.5

0.26

Interproximal, posterior

0.64

0.32

0.16

Interproximal, anterior

0.5

0.25

0.12

Children: reduce times by two settings i.e. approx. 40%

Edentulous mouth: reduce times by one setting i.e. approx. 25%.

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Oralix AC

3.1 Anomalies & Alarms Chart

Even during normal operation, irregular conditions or any other anomalies might occur. In this case an alarm signal is generated and a lamp lights up.

Anomaly Signal Consequence

The actually-required exposure

time (corrected because of mains voltage fluctuations) is less than the minimum (< 0.03 s).

Time selected lamp on 0.03 s

lamp flashing

Exposure time is forced to 0.03 s

(the lower limit).

The actually-required exposure

time (corrected because of mains voltage fluctuations) is more than the maximum (> 2.5 s).

Time selected lamp on 2.5 s lamp

flashing

Exposure time is forced to 2.5 s

(the upper limit).

The mains voltage fluctuates beyond the allowed range (±10%).

lamp flashing

Exposure is inhibited until the

mains returns within voltage

range.

An exposure was attempted during the cooling time (to prevent tubehead overheating, exposure is disabled during cooling down).

lamp flashing

Lamp flashing is reset at the end

of cooling time, or by selecting a

shorter exposure time.

The exposure was prematurely

stopped by operator ("dead man" function)

lamp flashing

Exposure is inhibited. Reset by

actuation of the rotating knob.

No power supply No lamp lights up

Refer to Service Manual (note:

fuse # 3 could be blown).

Technical Alarms

(See Service Manual)

lamp flashing, turned off,

lamp flashing , turned on

Exposure is inhibited. Turn off the

timer, wait a few seconds and turn

on again. If problem persists,

contact your Gendex dealer.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

4 DENS-O-MAT Timer

Dens-O-Mat ® is a microprocessor-controlled dental timer, featuring object-oriented operation.

If the relevant option has been installed, two tubeheads can be connected to Dens-O-Mat. Selection of the tubehead to be controlled and operated is done via keys

1 and 2, and the

relevant lamp lights on. At power on, tubehead 1 is selected by default.

Tubehead selection is only possible if DENS-O-MAT automatically detects the relevant connection.

All DENS-O-MAT functions are independent and separate for either tubehead, e.g. the programmable modalities described further on (film speed adjustment, time scale customisation, digital sensor mode), or the tubehead overheating control.

In object-oriented operation, the exposure time is automatically set in accordance with the selected technique, that is the choice of object (tooth) and patient size done at the keyboard panel, and depending upon the pre-set film speed and other eventual customisations. This is called "Pre-Programmed Mode".

The operator can manually alter (increase or decrease) the set exposure time, by means of keys s+ and s-, thus entering a so-called "Manual Mode". In Pre-Programmed Mode, the exposure time is automatically corrected in order to compensate for mains voltage fluctuations, and to impart an exposure dose consistent for the selected technique. The actual exposure time is shown on the display.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

In Manual Mode, time compensation vs. mains voltage fluctuation is disabled.

In Pre-Programmed Mode, it is possible to read the value of the uncompensated exposure time, that is the exposure time with the selected technique, that would be set if the mains voltage was at exactly the nominal value (230 V). To do so, keep pressed for at least 2 s the key corresponding to the selected object (whose lamp is already lighted on).

In Manual Mode, setting an internal jumper can enable exposure time compensation for mains voltage fluctuations, please refer to the instructions in the Technical Service Manual.

4.1 Operation

Power on the system by means of the mains switch. Green lamp 1 will light up; the timer is in stand-by mode.

Set patient size:

x Key

for children and toothless jaw.

x Key

for young adults of normal size.

x Key

for heavy or calcified jaw.

Select the key corresponding to the tooth to be radio graphed:

x Key

upper molar (maxilla).

x Key

upper premolar (maxilla).

x Key

upper canine (maxilla).

x Key

upper incisor (maxilla).

x Key

lower incisor (mandible).

x Key

lower canine (mandible).

x Key

lower premolar (mandible).

x Key

lower molar (mandible).

x Key

bitewing.

When using DENS-O-MAT in connection with a digital intraoral sensor (e.g. Gendex Visualix

®), set key

. This will decrease all exposure times by a number of steps (or a factor) which

is selectable and is 4 steps by default (see Digital Mode Customization).

An exposure is made by means of the handswitch. The coiled cable of the handswitch can be stretched up to 2.5 m, to ensure the required distance between operator and x-ray source (the tubehead). During the exposure the yellow lamp lights up and a warning tone is buzzed, indicating that x-rays are being emitted.

Press the handswitch push-button to start the exposure and keep it pressed until the yellow lamp goes out and the warning tone stops. If the handswitch is released during exposure, the same will be interrupted (this is called "dead-man" operation).

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

4.2 Customization

Film Speed Adjustment

The general dose requirements for your specific x-ray system may differ depending on the speed of the film used, and on other factors (e.g. different cone length, or added filtration), therefore you may need to change the pre-set exposure time scale by a coefficient. This is done through the Film Speed Adjustment procedure:

Keep key P pressed at power on. The relevant lamp flashes, "FSA" is displayed for 2 s, after that the display shows the speed film coefficient (1 by default). Lamp P is flashing.

Using the s+ and s- keys, you may change the speed coefficient of the time scale as follows (according to the R10 scale). The entire time scale is altered by shifting all nominal time values by the given number of steps.

Coefficient

0.32

0.4

0.5

0.64

0.811.26

1.6

Nr of steps

-5 -4 -3 -2 -1 - +1 +2 +3

Recommended film speed coefficient is 1 for D type films (Kodak Ultra Speed), 0.5 for E type films (Kodak Ektaspeed Plus, Agfa Dentus M2

Comfort

) and 0.32 for F type films (Kodak

Insight). Press key P to confirm the selected speed coefficient, and to exit the Film Speed Adjustment

modality and enter the Time Scale Customization modality.

Time Scale Customization

Using this function it is possible to customize exposure times for each tooth/technique, (independently and separately for tubehead 1 and 2).

After the Film Speed Adjustment modality, the Time Scale Customization mode is initiated. The message TSC is displayed for 2 s and the lamp P lights on.

Select the tubehead of interest by the relevant key

. If only one tubehead is connected then

customization of tubehead 2 is inhibited. Select the tooth, and then change the set time via the s+ and s- keys.

Customization anyway maintains the one step separation between small-medium-large patients. The "medium" size is forced during this operation, the relevant lamp lights on, and the time is always displayed (the time vs. mains voltage compensation is disabled).

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Oralix AC

Default values (medium patient size, film speed coefficient =1):

The lamp associated to a tooth, whose set time has been changed, lights on. Press key P to save and enter Digital Mode Customization.

Digital Mode Customization

The message diG is displayed for 2 s, after that the display shows the digital mode coefficient (0.4s by

default). Lamp

is off and lamp P is flashing.

It is possible to set the timer for digital mode per default at start-up by following the instructions below.

Press the

key, the control LED lights up; press the P-key until "End" shows up in the display. As of

now the digital mode is set per default when starting up the timer. This setting can be made for one or both tubeheads (

1 and 2) controlled by the timer, should these be connected. To restore the

original setting, press the

key, the control LED does not light up.

Using the s+ and s- keys, you may change the coefficient of the time scale as follows (according to the R10 scale). The entire time scale is altered by shifting all nominal time values by the given number of steps. By default, the exposure time scale is shifted by -4 steps for the Digital Mode (0.4s on display).

Coefficient

0.32 0.4 0.5 0.64 0.8 1

Nr of steps

-5 -4 -3 -2 -1 -

Press key P to save the selected coefficient, and to exit the Digital Mode Customization. The message End is displayed. Switch off the timer, wait few seconds and switch on again to use the timer with the customization.

This procedure must be completed as described above to became effective, and is concluded only when "End" appears in the display.

Tooth mandible

Exposure Time

: lower incisor

0.32 s

: lower canine

0.40 s

: lower premolar

0.40 s

lower molar

0.50 s

Bitewing

0.50 s

Tooth maxilla

Exposure Time

upper incisor

0.40 s

upper canine

0.50 s

upper premolar

0.64 s

upper molar

0.80 s

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

4.3 Anomalies & Alarms Chart

Even during normal operation, irregular conditions or any other anomalies might occur. An alarm signal is then generated and the display shows an error message.

Anomaly

Signal

Consequence

The actually-required exposure time (corrected because of mains voltage fluctuations) is less than the minimum (< 0.03 s).

0.03 s flashing Exposure time is forced to 0.03 s (the lower limit).

The actually-required exposure time (corrected

because of mains voltage fluctuations) is more

than the maximum (> 2.5 s).

2.5 s flashing

Exposure time is forced to 2.5 s (the upper

limit).

Mains voltage fluctuates beyond the allowed range

(+/- 10%) oU : above +10%

uU : under -10%

"oU" flashing "uU" flashing

Exposure is inhibited until mains fall within

voltage range.

An exposure was attempted during the cooling

time (to prevent tubehead overheating, exposure is disabled during cooling down).

"-II-" flashing

Alarm status reset at the end of wait time or by

pressing any key.

Exposure stops by dead man function.

Real exposure time

displayed flashing.

Exposure is inhibited. Reset alarm by pressing any key.

Handswitch pressed at power on.

"PrP" flashing

Exposure is inhibited. Turn off the timer, wait a

few seconds and turn on again.

No power supply

No lamp lights up

Please refer to Service Manual (note: fuse # 3 could be blown).

Technical Alarms

(See Service Manual)

"BUT" flashing

"trc" flashing

"rSt" flashing

"Int" flashing

"EEP" flashing

Exposure is inhibited. Turn off the timer, wait a

few seconds and turn on again. If problem persists, contact your Gendex dealer.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

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Oralix AC

5 Maintenance, Cleaning and Disinfecting

Maintenance

No maintenance is normally required by user. Please refer to the Technical Service Manual for preventive and corrective maintenance, to be carried out by a trained technician.

In order to prevent interference during normal operation, the system should not be used in presence of strong electromagnetic fields.

Oralix contains non-environmental-friendly substances, in particular approx. 1 kg of dielectric oil in the tubehead. Therefore disposal of discarded parts must be done via a company specialized in industrial wastes.

Cleaning

Always disconnect the equipment from the mains supply before cleaning.

Do not allow water or other liquids to enter the equipment, as they may cause circuits and corrosion.

Enameled parts must only be cleaned by wiping with a damp cloth and mild detergent, followed by rubbing down with a dry woolen cloth. Do not use abrasive polishes.

Disinfecting

Always disconnect the equipment from the mains supply before disinfecting. Do not allow water or other liquids to enter the equipment, as they may cause short circuits or corrosion.

The powered equipment, accessories and connecting cables can be disinfected by wiping with a cloth dampened with a disinfectant solution.

Do not use solvent or corrosive disinfectants.

The equipment must not be exposed to gaseous disinfectants. Spray disinfectants are not recommended, as the disinfectant may enter the equipment causing short circuits or corrosion.

If sprays are unavoidable the following precautions shall be taken:

If the room in which the equipment is installed is to be disinfected by means of an atomizer, the equipment should be carefully covered with plastic sheet.

The equipment should be switched off and allowed to cool down well in advance in order to prevent convection currents drawing the disinfectant mist into the equipment.

After dispersal of disinfectant mist the plastic sheeting can be removed, and the equipment

can be disinfected by wiping.

The equipment may not be used in the presence of disinfectants which vaporize to form explosive mixtures, and the vapor must be allowed to disperse before the equipment is returned to use.

The method of disinfecting used should comply with current regulations and recommendations, including those concerning the prevention of explosion hazards.

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6 Safety

In the interest of the safety of patient and user, the following points should be observed:

Electrical Safety

Only qualified service representatives should be authorized to remove the covers, or otherwise obtain access to the powered circuits.

The equipment should preferably be used in rooms with provisions in compliance with the relevant national and/or international legislation and recommendations concerning electrical safety in rooms used for medical purposes, concerning provisions of an additional protective earth (ground) terminal for equipotent connection.

Always disconnect or switch the equipment off before cleaning or disinfecting

Mechanical Safety

Where complete safeguarding of the equipment is not possible due care must be taken to ensure that no part of the user's or patient's body or clothing can be trapped or injured by any part of the equipment.

In particular, make sure that fingers are not caught pinched in the articulated arm, when closing it.

Explosion Safety

The equipment is not suitable for use in the presence of flammable gasses or vapors.

Remember that some disinfectants vaporize to form explosive mixtures, and that if such disinfectants are used the vapor must be allowed to disperse before the equipment is returned to use.

Radiation Safety

Only qualified and authorized personnel may operate this equipment observing all laws and regulations upon Radiation Protection.

Operators are strongly urged to acquaint themselves with current recommendations of the International Commission on Radiological Protection.

Full use must be made of all radiation protection features on the equipment and of all radiation protection devices, accessories and procedure available to protect Patient and Operator from x-ray radiation.

The tubehead contains dielectric mineral oil, which is potentially injurious in case of ingestion or contact with skin or mucous membrane.

In case of damage, the oil can flow out of the tubehead. In that case, avoid contact with the oil or breathing any potential vapor. In case of a limited lost of oil, the oil can be wiped out, wearing impermeable gloves.

Mandatory reporting according to the European Directive 93/42 for medical devices

In order to fulfill the obligations foreseen for the CE marking, the user must report to the Health Authorities in charge any accident involving the medical device and any eventual alteration in its features or performances, including insufficient user's instructions, which could cause death, injuries or a health hazard to patient and/or operator. Such reporting must also be promptly notified to the manufacturer or his agent, in order to permit the fulfillment of the obligations foreseen in the a.m. European Directive for the manufacturer.

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Oralix AC

Proper Disposal of Electronic Equipment

NOTE: The following information is valid in the European Union. If you wish to discard this

product, please contact your local authorities or dealer and ask for the correct method of disposal.

This symbol on the products and/or accompanying documents means that used electrical and electronic products should not be mixed with general household waste. For proper treatment, recovery, and recycling please take these products to designated collection points where they will be accepted on a free-of-charge basis. Alternatively, in some countries, you may be able to return your products to your local retailer upon the purchase of an equivalent new product. Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling. Please contact your local authority for further details of your nearest designated collection point. Penalties may be applicable for incorrect disposal of this waste in accordance with national legislation.

NOTE: For Business users in the European Union ҏ If you wish to discard electrical and electronic equipment, please contact your dealer or supplier for further information.

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Oralix AC

7 Technical Data

Mains power supply:

230 V - 50/60 Hz.

Maximum mains voltage deviation: ± 10%

Maximum frequency deviation:

± 2 Hz

Maximum current absorption:

Stand-by current absorption:

5 A

0.1 A

Mains resistance:

0.8 :

X-ray tube:

Secondary voltage, nominal:

65 kVp

Secondary current, nominal:

8.25 mA mean

Maximum duty cycle ratio:

1:30

Permissible mean current:

360 mAs/hour

Focus (focal spot): 0.7 (IEC 336 - 1982)

Target material

Tungsten

lnherent filtration, minimum:

2 mm Al equivalent (IEC 522 1976)

Output dose rate (approximate, indicative): 0.2 mGy/s @ 20 cm from source (at cone tip)

HVL - Half Value Layer (approximate, indicative):

2 mm Al

SSD - Source (focus) to skin distance: 20 cm

Manufacturer

Gendex

Type:

800-0003G3

The serial number of the Gendex X-ray tube (PN 800-0003G3) is stamped on the copper anode of the tube assembly.

X-ray field at tip of cone:

60 mm (round BLD)

35 x 45 mm (rectangular BLD)

Leakage radiation:

(taking into account the 1:30 maximum duty factor)

less than 0.044 mGy/h @ 1 m from

source

Reach: 1410 cm / 1860 cm

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Oralix AC

Weights:

tubehead (excluding cone): 6 kg

round cone

0.3 kg

rectangular cone

0.4 kg

articulated arm 7 kg

extension arm, 45 cm

2.3 kg

extension arm, 90 cm

3.8 kg

Timer (SECONDENT/ DENS-O-MAT)

2.4 kg

7.1 Storage and transportation conditions

Temperature [°C] Relative Humidity

[%]

Pressure [hPa]

Min Max Min Max Min Max

DENSOMAT -40 70 10 95 500 1060

SECONDENT -40 70 10 95 500 1060

7.2 Compliance with applicable standards

Oralix AC models are X-ray Equipment with radiation protection in accordance with IEC 606011-3:1994.

X-ray Source Assembly (Gendex Model 9869-00-00101), IEC 601-2-28 (1993)

Oralix AC models and associated equipment complies with:

x IEC 60601-1 : 1988 + A1 : 1991 + A2 : 1995

General requirements for basic safety and essential performance

x IEC 60601-1-1 : 2000

Safety requirements for medical electrical systems

x IEC 60601-1-2 : 2001 + A1 : 2004

Electromagnetic compatibility – Requirements and tests

x IEC 60601-1-3 : 1994

Radiation protection in diagnostic X-ray equipment

x IEC 60601-2-7 : 1998

Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators

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Oralix AC

x IEC 60601-2-28 : 1993

Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.

x IEC 60601-2-32 : 1994

Particular requirements for the safety of associated equipment of X-ray equipment

x Council Directive 93/42/CEE, European Medical Device Directive

x ISO 13485 : 2003/Cor 1 : 2009

Medical devices – Quality management systems – Requirements for regulatory purposes

Oralix AC is a Class I, Type B equipment (IEC 60601-1 : 1988).

The Gendex Oralix AC, classified as Medical Electrical Equipment, requires special precautions regarding EMC and must be installed and put into service according to the EMC information provided in the accompanying product documentation. Portable and mobile RF communications equipment can effect Medical Electrical Equipment. The Gendex Oralix AC complies with EMC requirements when used with the cables and accessories supplied with the product. The use of accessories and cables other than those sold by Gendex Imaging and specified as replacement parts for internal components, may result in increased emissions or decreased immunity of the Gendex Oralix AC. The Gendex Oralix AC should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Gendex Oralix AC should be observed to verify normal operation in the configuration in which it will be used.

Table 201 - Guidance and manufacturer's declaration - electromagnetic emissions

Guidance and manufacturer’s declaration –electromagnetic emissions

The Gendex Oralix AC is intended for use in the electromagnetic environment specified below. The customer or the user of the Gendex Oralix AC should assure that it is used in such an environment.

Emissions test Compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The Gendex Oralix AC uses RF energy only for its

internal function. Therefore, its RF emissions are very

low and are not likely to cause any interference in

nearby electronic equipment.

RF emissions

CISPR 11

Class B

The Gendex Oralix AC is suitable for use in all

establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for

domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class B

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Complies

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Oralix AC

Table 202 - Guidance and manufacturer's declaration - electromagnetic immunity

Guidance and manufacturer's declaration - electromagnetic immunity

The Gendex Oralix AC is intended for use in the electromagnetic environment specified below. The

customer or the user of the Gendex Oralix AC should assure that it is used in such an environment.

Immunity test

IEC 60601

test level

Compliance level

Electromagnetic environment –

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

+/-6 kV contact

+/-8 kV air

+/-2, 4 & 6 kV contact

+/-2, 4 & 8 kV air

Floors should be wood, concrete

ceramic tile. If floors are covered

with synthetic material, the relative

humidity should be at least 30 %.

Electrical fast

transient/burst

IEC 61000-4-4

+/-2 kV for power

supply lines

+/-1 kV for input/output

lines

+/-1 kV for power

supply lines

+/-1 kV for

input/output

lines

Mains power quality should be that

of a typical commercial or hospital

environment.

Surge

IEC 61000-4-5

+/-1 kV differential

mode

+/-2 kV common mode

+/-0.5 & 1 kV

differential mode

+/-0.5, 1 & 2 kV

common mode

Mains power quality should be that

of a typical commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines

IEC 61000-4-11

<5 % U

(>95 % dip in UT)

for 0,5 cycle

40 % U

(60 % dip in U

)

for 5 cycles

70 % U

(30 % dip in U

)

for 25 cycles

<5 % U

(>95 % dip in U

)

for 5 sec

<5 % U

(>95 % dip in UT)

for 0,5 cycle

40 % U

(60 % dip in U

)

for 5 cycles

70 % U

(30 % dip in U

)

for 25 cycles

<5 % U

(>95 % dip in U

)

for 5 sec

Mains power quality should be that

of a typical commercial or hospital

environment. If the user of the

Gendex Oralix AC requires

continued operation during power

mains interruptions, it is

recommended that the Gendex

Oralix AC be powered from an

uninterruptible power supply or a

battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3A/m 3A/m

Power frequency magnetic fields should be at levels characteristic

of a typical location in a typical

commercial or hospital

environment.

NOTE UTis the a.c. mains voltage prior to application of the test level.

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Oralix AC

Table 204 - Guidance and manufacturer's declaration - electromagnetic immunity

Guidance and manufacturer’s declaration –electromagnetic immunity

The Gendex Oralix AC is intended for use in the electromagnetic environment specified below. The customer or the user of the Gendex Oralix AC should assure that it is used in such an environment.

Immunity test

IEC 60601 test

level

Compliance

level

Electromagnetic environment - guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80

MHz

3 V/m

80 MHz to 2,5

GHz

3 Vrms

3 V/m

Portable and mobile RF communications

equipment should be used no closer to any part of the Gendex Oralix AC, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Pd 2,1

80 MHz to 800 MHz

Pd 3,2

800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,ashould be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Gendex Oralix AC is used exceeds the applicable RF compliance level above, the Gendex Oralix AC should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Gendex Oralix AC.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

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Oralix AC

Table 206 - Recommended separation distances between portable and mobile RF communications

equipment and the Gendex Oralix AC

Recommended separation distances between

portable and mobile RF communications equipment and the Gendex Oralix AC

The Gendex Oralix AC is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the Gendex Oralix AC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Gendex Oralix AC as recommended below, according to

the maximum output power of the communications equipment.

Rated maximum output

power

of transmitter

Separation distance according to frequency of transmitter

150 kHz to 80 MHz

Pd 2,1

80 MHz to 800 MHz

Pd 2,1

800 MHz to 2,5 GHz

Pd 3,2

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,78

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d

in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

GENDEX

Oralix AC

7.3 System labels

Printed on: 22 Mär 2012, 09:22:12 am; Printed by: TOBIAS BAUER

+ 89 hidden pages

Gendex Oralix AC User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual