Gendex Oralix AC User Manual

USER MANUAL

MANUALE D'USO

M

Oralix ® AC

-ray System

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

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

USER MANUAL

Oralix ® AC

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

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

		GENDEX
			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

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GENDEX

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.

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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:

iThe 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;

iA 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);

iA 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 DENS- O-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.

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1.1Explanation 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)

ŶFocal 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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Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Fuse

See page 13 for System Operation Symbols.

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2 Operation

2.1General 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.

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2.2Preparation 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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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.

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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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GENDEX

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

Select 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)	Exp. time (s)	Exp. Time (s)
	D-type film	E-type film	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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3.1Anomalies & 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	Time selected lamp on 0.03 s		Exposure time is forced to 0.03 s
	voltage fluctuations) is less than	lamp flashing		(the lower limit).
	the minimum (< 0.03 s).
	The actually-required exposure
	time (corrected because of mains	Time selected lamp on 2.5 s lamp		Exposure time is forced to 2.5 s
	voltage fluctuations) is more than	flashing		(the upper limit).
	the maximum (> 2.5 s).
	The mains voltage fluctuates	lamp flashing		Exposure is inhibited until the
				mains returns within voltage
	beyond the allowed range (±10%).
		lamp flashing		range.
	An exposure was attempted during			Lamp flashing is reset at the end
	the cooling time (to prevent
		lamp flashing		of cooling time, or by selecting a
	tubehead overheating, exposure is
				shorter exposure time.
	disabled during cooling down).
	The exposure was prematurely			Exposure is inhibited. Reset by
	stopped by operator ("dead man"	lamp flashing
				actuation of the rotating knob.
	function)
	No power supply	No lamp lights up		Refer to Service Manual (note:
				fuse # 3 could be blown).
		lamp flashing,	turned off,	Exposure is inhibited. Turn off the
	Technical Alarms
		or		timer, wait a few seconds and turn
	(See Service Manual)			on again. If problem persists,
				contact your Gendex dealer.
		lamp flashing ,	turned on

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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.

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GENDEX

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.

4.1Operation

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:

Key for children and toothless jaw.

Key for young adults of normal size.

Key for heavy or calcified jaw.

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

Key upper molar (maxilla).

Key upper premolar (maxilla).

Key upper canine (maxilla).

Key upper incisor (maxilla).

Key lower incisor (mandible).

Key lower canine (mandible).

Key lower premolar (mandible).

Key lower molar (mandible).

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).

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4.2Customization

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	0.8	1	1.26	1.6	2
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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Default values (medium patient size, film speed coefficient =1):

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

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.

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4.3Anomalies & 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	0.03 s flashing	Exposure time is forced to 0.03 s (the lower
because of mains voltage fluctuations) is less than		limit).
the minimum (< 0.03 s).
The actually-required exposure time (corrected	2.5 s flashing	Exposure time is forced to 2.5 s (the upper
because of mains voltage fluctuations) is more		limit).
than the maximum (> 2.5 s).
Mains voltage fluctuates beyond the allowed range		Exposure is inhibited until mains fall within
(+/- 10%)	"oU" flashing	voltage range.
oU : above +10%	"uU" flashing
uU : under -10%
An exposure was attempted during the cooling	"-II-" flashing	Alarm status reset at the end of wait time or by
time (to prevent tubehead overheating, exposure is		pressing any key.
disabled during cooling down).
Exposure stops by dead man function.	Real exposure time	Exposure is inhibited. Reset alarm by pressing
	displayed flashing.	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	"BUT" flashing	Exposure is inhibited. Turn off the timer, wait a
(See Service Manual)	"trc" flashing	few seconds and turn on again. If problem
	"rSt" flashing	persists, contact your Gendex dealer.
	"Int" flashing
	"EEP" flashing

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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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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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7 Technical Data

Mains power supply:

Maximum mains voltage deviation:

Maximum frequency deviation:

Maximum current absorption:

Stand-by current absorption:

Mains resistance:

X-ray tube:

Secondary voltage, nominal: Secondary current, nominal: Maximum duty cycle ratio:

Permissible mean current: Focus (focal spot): Target material

lnherent filtration, minimum:

Output dose rate (approximate, indicative):

HVL - Half Value Layer (approximate, indicative): SSD - Source (focus) to skin distance: Manufacturer

Type:

230 V - 50/60 Hz.

±10%

±2 Hz

5 A

0.1 A

0.8 :

65 kVp

8.25 mA mean 1:30

360 mAs/hour

0.7 (IEC 336 - 1982) Tungsten

2 mm Al equivalent (IEC 522 1976)

0.2 mGy/s @ 20 cm from source (at cone tip)

2 mm Al

20 cm Gendex 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:	less than 0.044 mGy/h @ 1 m from
(taking into account the 1:30 maximum duty factor)	source
Reach:	1410 cm / 1860 cm

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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

7.1Storage 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

7.2Compliance with applicable standards

Oralix AC models are X-ray Equipment with radiation protection in accordance with IEC 60601- 1-3:1994.

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

Oralix AC models and associated equipment complies with:

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

General requirements for basic safety and essential performance

IEC 60601-1-1 : 2000

Safety requirements for medical electrical systems

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

Electromagnetic compatibility – Requirements and tests

IEC 60601-1-3 : 1994

Radiation protection in diagnostic X-ray equipment

IEC 60601-2-7 : 1998

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

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IEC 60601-2-28 : 1993

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

IEC 60601-2-32 : 1994

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

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

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		The Gendex Oralix AC uses RF energy only for its
		Group 1	internal function. Therefore, its RF emissions are very
	CISPR 11		low and are not likely to cause any interference in
			nearby electronic equipment.
	RF emissions	Class B
	CISPR 11
			The Gendex Oralix AC is suitable for use in all
	Harmonic emissions	Class B
			establishments, including domestic establishments
	IEC 61000-3-2
			and those directly connected to the public low-voltage
			power supply network that supplies buildings used for
	Voltage fluctuations/
			domestic purposes.
	flicker emissions	Complies
	IEC 61000-3-3

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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	Compliance level	Electromagnetic environment –
		test level		guidance
	Electrostatic		+/-2, 4 & 6 kV contact	Floors should be wood, concrete
		+/-6 kV contact		or
	discharge (ESD)
				ceramic tile. If floors are covered
			+/-2, 4 & 8 kV air
		+/-8 kV air		with synthetic material, the relative
	IEC 61000-4-2
				humidity should be at least 30 %.
		+/-2 kV for power	+/-1 kV for power
	Electrical fast		supply lines
		supply lines		Mains power quality should be that
	transient/burst
				of a typical commercial or hospital
			+/-1 kV for
		+/-1 kV for input/output		environment.
	IEC 61000-4-4		input/output
		lines
			lines
		+/-1 kV differential	+/-0.5 & 1 kV
	Surge		differential mode	Mains power quality should be that
		mode
				of a typical commercial or hospital
	IEC 61000-4-5	+/-2 kV common mode	+/-0.5, 1 & 2 kV	environment.
			common mode
		<5 % UT	<5 % UT
		(>95 % dip in UT)	(>95 % dip in UT)
		for 0,5 cycle	for 0,5 cycle	Mains power quality should be that
	Voltage dips, short	40 % UT	40 % UT	of a typical commercial or hospital
				environment. If the user of the
	interruptions and	(60 % dip in UT )	(60 % dip in UT )
				Gendex Oralix AC requires
	voltage variations	for 5 cycles	for 5 cycles
				continued operation during power
	on power supply
				mains interruptions, it is
	input lines	70 % UT	70 % UT
				recommended that the Gendex
		(30 % dip in UT)	(30 % dip in UT)
				Oralix AC be powered from an
	IEC 61000-4-11	for 25 cycles	for 25 cycles
				uninterruptible power supply or a
		<5 % UT	<5 % UT	battery.
		(>95 % dip in UT)	(>95 % dip in UT)
		for 5 sec	for 5 sec
	Power frequency			Power frequency magnetic fields
	(50/60 Hz)			should be at levels characteristic
	magnetic field	3A/m	3A/m	of a typical location in a typical
				commercial or hospital
	IEC 61000-4-8			environment.
	NOTE UT is the a.c. mains voltage prior to application of the test level.

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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	Compliance	Electromagnetic environment - guidance
		level	level
				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
	Conducted RF	3 Vrms	3 Vrms
				D	1,2	P
	IEC 61000-4-6	150 kHz to 80
		MHz
				D	1,2	P 80 MHz to 800 MHz
	Radiated RF	3 V/m	3 V/m
				D	2,3	P 800 MHz to 2,5 GHz
	IEC 61000-4-3	80 MHz to 2,5		where P is the maximum output power rating of the
		GHz
				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 deter-
				mined by an electromagnetic site survey,a should
				be less than the compliance level in each
				frequency range. b
				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.

a	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.

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

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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.

		Separation distance according to frequency of transmitter
	Rated maximum output				m
	power	150 kHz to 80 MHz			80 MHz to 800 MHz			800 MHz to 2,5 GHz
	of transmitter
		D 1,2 P			D 1,2 P			D 2,3 P
	W
	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.

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7.3System labels

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