X MIND DC Users Manual

TABLE OF CONTENTS

SUMMARY INTRODUCTION PRELIMINARY INFORMATION USER INFORMATION WARRANTY CONDITIONS TRANSPORT CONDITIONS SAFETY WARNINGS 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18.

“X-Mind DC” X-RAY SYSTEM SYSTEM COMPONENTS IDENTIFICATION TAGS CONTROL PANEL SYSTEM CONFIGURATION OPERATING INSTRUCTIONS CHART OF DEFAULT EXPOSURE VALUES FOR THE 12” CONE CHART OF DEFAULT EXPOSURE VALUES FOR THE 8” CONE PROGRAMMING DEFAULT EXPOSURE VALUES RESTORING ORIGINAL VALUES DIAGNOSTICS ERROR MESSAGES SYSTEM TECHNICAL DATA SUGGESTED MAINTENANCE CLEANING THE OUTER SURFACE IF A REPAIR BECOMES NECESSARY DISPOSAL ACCESSORIES

page page page page page page page

2 3 4 5 6 7 8

page page page page page page page page page page page page page page page page page page

9 10 12 13 14 15 22 23 26 28 29 30 32 36 37 37 37 38

INTRODUCTION

The radiographic system described in this manual is a “wall installation”. SATELEC® S.A.S. reserves the right to modify its products and manual without notice. SATELEC® S.A.S. shall not be liable for any incorrect use of the information contained in this manual. Any copies, even partial, of this manual are permitted solely for in-house use.

PRELIMINARY INFORMATION

Before beginning to use the “X-Mind DC” X-ray system, it is advisable to carefully read and follow the instructions contained herein should be carefully read and followed, in order to obtain the best possible performance. Always pay close attention to the CAUTION, WARNING and PLEASE NOTE messages when operating the system.

LEGEND

CAUTION The word CAUTION identifies those situations which might compromise the operator’s personal safety or cause personal injuries.

WARNING The word WARNING identifies those situations which might compromise the X-ray system’s performance. PLEASE NOTE The words PLEASE NOTE are used to give special indications to facilitate maintenance or make important information clearer.

USER INFORMATION

Dear Customer, Thank you for having chosen the “X-Mind DC” X-ray system. It was designed and manufactured by “de Götzen S.r.l.” in collaboration with “Satelec® S.A.S.” and is the result of many years of experience in the fields of radiology and advanced electronics applications. This high performance system represents ongoing development of technological research serving dental radiography. It is delivered with all the necessary technical documentation, which must always be kept close at hand for reference. PLEASE NOTE This manual does not contain all the recommendations and the obligations with respect to the possession of a source of ionizing radiation – as they vary from country to country – but only the most common ones. The user must consult his country’s legislation in order to comply with all local ordinances.

WARRANTY CONDITIONS

Inappropriate use or any arbitrary tampering with the equipment shall release “de Götzen® S.r.l.” or “Satelec® S.A.S.”, the manufacturer of the “X-Mind DC” system, from any warranty service or liability. The warranty is valid only if the following precautions are taken: 9

any repairs, modifications, adjustments, re-calibrations must be performed only by “de Götzen® S.r.l.” for “Satelec® S.A.S.”

9

installation must be done by professionally qualified technicians. pursuant to existing regulations

9

the system must be installed and used in compliance with the instructions set forth in this Manual and for the purposes and applications for which it was designed

9

the power supply must be adequate to supply the required power indicated in the X-ray system’s nameplate data

9

in order to safeguard the warranty rights, please fill in the enclosed Warranty Document, immediately completion of the installation , with the help of the technician

TRANSPORT CONDITIONS The “X-Mind DC” X-ray system shall be shipped at the receiver’s sole risk. All claims for damages or shipping loss with respect to the shipment must be noted presence of the shipping agent.

in the

In case of shipping losses, or actual or suspected damage, the receiver shall note the appropriate reserves on the way-bill or the consignment note.

SAFETY WARNINGS A few safety recommendations are listed below which should be followed when using the “X-Mind DC” radiographic system. PROTECTION AGAINST RADIATION “The general principles regarding safety and protection of workers and people” must always be applied when using the unit: 1. Justification of the practice 2. Protection Optimization (ALARA) 3. Reduction of individual dose limits and risks The X-ray system may only be used by authorized and qualified personnel. All personnel present during the radiological examination must comply with safety measures established with respect to radiation protection. For his or her own safety, the operator must always remain at least 2 meters from the tube head. To protect the patient from unnecessary exposure to radiations, additional anti-radiation protection may be used whenever necessary (i.e. aprons, collars, etc…)

This symbol calls ATTENTION to the danger of X-rays

ELECTRICAL SAFETY The X-ray system contains high voltage. When inspecting internal parts, always turn off the power before handling any electrical part. The unit must be used only in environments which comply with all electric safety standards for medical environments. The unit is NOT equipped with protection against penetration by liquids; it is therefore necessary to ensure that no water or other liquids penetrate the device, in order to avoid short circuits or corrosion. Always disconnect the X-ray system from the power supply before cleaning and disinfecting operations.

MECHANICAL RISK Before removing the tube head from the positioning arm, RELEASE THE SPRING, as the joint might burst open and hit the operator.

PROTECTION AGAINST EXPLOSIONS The X-ray system MUST NOT be used in the presence of disinfectants, flammable or potentially explosive gases or vapors which might catch fire and cause damage. In the event that disinfectants must be used, allow the vapor to disperse completely before turning on the X-ray system.

1. “X-Mind DC” X-RAY SYSTEM The “X-Mind DC” X-ray system guarantees maximum safety patient.

for both the operator and the

It has been manufactured in compliance with the following European Directives:  directive 93/42/EEC on MEDICAL DEVICES and its amendments  directive 73/23/EEC on LOW VOLTAGE and its integration  directive 89/336/EEC on ELECTROMAGNETIC COMPATIBILITY  directive EURATOM 96/29 on ionizing radiation and the following American Standard:

 American Radiation Performance Standard 21 CFR, Subchapter J The following protective measures were adopted in the design and construction of the unit: 9 Protection against the risk of electrical injuries, ensured by a grounded cable 9 Protection against radiation leakage , rendered negligible by the shielded casing 9 Protection against excessive radiation, thanks to immediate activation of the safety device 9 Protection against continuous service, since the system is designed, according to standards, so as not to allow radiological overuse 9 Protection against exposure errors, by means of network compensation software, ensuring constant blackening 9 Patient protection against dangerous radiations, through the improvement of the quality of the radiation through the addition of an aluminum filter, in compliance with standards 9 Operator protection against irradiation ensured by the extendable hand control cable ,l which provides a buffer zone of over 2 meters 9 Protection against the involuntary selection of “film” or “digit”, obtained, in compliance with standards, by means of the confirmation of the selected touch key “ELECTRO-MEDICAL” CLASSIFICATION Pursuant to paragraph 5 of the general safety regulations EC EN 60 601-1/1998 on medical equipment safety, the system is classified as: Class I - Type B “MEDICAL DEVICES” CLASSIFICATION Pursuant to the classification rules set forth in attachment IX of the EEC Directive 93/42 on medical devices, the system is classified as: Class IIb “E.M.C.” CLASSIFICATION Pursuant to paragraph 4 of the EEC EN 55011, the system is classified as: Group 1 – Class B

2. SYSTEM COMPONENTS

f

e Fig. 1

c d

3. IDENTIFICATION TAGS

The “X-Mind DC” x-ray system (Fig. 1) consists of: c Tubehead

The tubehead is of the “monoblock” type with following characteristics:  high frequency generator at “constant potential”  double anode voltage 60kVp – 70kVp  double anode current 4mA – 8mA The light alloy housing is divided into two compartments. The high voltage transformer, the X-ray tube and the expansion chamber are submerged in highly dielectric insulating oil inside a light alloy container. The second compartment contains the electronic main board and the electronic control board. The X-ray tube is located in the back part of the housing thus allowing a focal spot to skin distance (SSD) which is 50% higher than the traditional structure. d Spacer Cone Made of transparent polycarbonate, it allows for:  correct focal spot to skin distance  dimension, direction and centering of the X-ray beam  use of different x-ray techniques (bisecting and parallel techniques) e Pantograph type arm Thanks to the new shape and new mechanisms of the positioning arm, the height and depth can be adjusted so as to precisely explore any spot in its reach. It is made of light alloy with an “ABS” coating. f Timer The timer is the control panel used to manage the times and to safely use the tubehead. It is “multi-technology” type and it is able to control both AC and DC x-ray systems. The “CONTROL BUTTON” with safety button is used for the exposure. The timer can be connected to n° 2 tubeheads: n° 2 ALTERNATE CURRENT “AC” X-RAY UNITS: “X-Mind AC” or n ° 2 DIRECT CURRENT “DC” X-RAY UNITS: “X-Mind DC” or n ° 1 ALTERNATE CURRENT “AC” + n° 1 DIRECT CURRENT “DC” X-RAY UNITS: “ X-Mind AC ®” + “X-Mind DC” OPTIONAL − short 8” (20 cm) cone – NOT AVAILABLE IN U.K. − long cone 12” (31 cm) with a rectangular section - dimensions: 44x35 mm − second “CONTROL BUTTON” with extension cable − RX signaling lamp for external use: X-Mind LIGHT − remote control button: X-Mind ECB

The identification tags on the tubehead, on the timer and on the cone indicate the model name, the serial number, the manufacturing date and the symbols of the main technical characteristics.

ID TAG OF THE “X-Mind DC” TUBEHEAD

ID TAG OF THE “X-Mind DC” TIMER

ID TAG OF THE LONG 12” CONE ID TAG OF THE SHORT 8” CONE ID TAG OF THE RECTANGULAR CONE

Pictograms used

GRADUATED SCALE TAG

This symbol guarantees that the x-ray system complies with the regulations contained in the European Directive EEC 93/42 regarding Medical Devices The degree of protection against direct and indirect electric contacts is B type

Refer to Manual's instructions

Symbol indicating danger due to “ionizing radiations”

Size of the focal spot

4. CONTROL PANEL

MAIN SWITCH CONTROL BUTTON X-RAY KEY

DISPLAY KEY TO DECREASE EXPOSURE TIME

KEY TO INCREASE EXPOSURE TIME

TUBEHEAD TYPE INDICATOR

X-RAY DISTANCE INDICATOR TUBEHEAD SELECTION

RADIOGRAPHIC VOLTAGE INDICATOR

SELECTION OF TYPE OF PATIENT’S PHYSIQUE

STORAGE

UPPER JAW TEETH X-RAY CURRENT INDICATOR

LOWER JAW TEETH X-RAY OUTPUT SIGNAL

OCCLUSAL EXAM BITE-WING EXAM

PAUSE INDICATOR MULTIFUNCTION INDICATOR

DIGITAL RADIOGRAPHIC TECHNIQUE CONVENTIONAL X_RAY TECHNIQUE

KEY SWITCH

5. SYSTEM CONFIGURATION A. The “X-Mind DC” x-ray system is factory configured for an operative “standard mode” which determines: on the control panel by pressing the RX button N° 2 “X-Mind DC” tubeheads

Ö

Led 1 lights up, by pressing the button again, Led 2 lights up ** IF THE LONG 12” (31cm) CONE IS USED **

an x-ray distance SSD = 31cm (source skin distance) Ö on the control panel Led 12” with long 12” cone ** IF THE SHORT 8” (20cm) CONE IS USED ** an x-ray distance SSD = 20cm (source skin distance) Ö on the control panel Led 8” with short 8” cone with type “D” film

is lit

Ö the control panel Led “D”

n° 1 CONTROL BUTTON to perform the exposure

is lit

Ö

is lights up

The timer houses a key with extension cable

The configuration may be changed if: POSSIBLE MODIFICATION HOW TO CARRY OUT THE MODIFICATIONS − use type “E” and “F” films − use a digital system − use a voltage equal to 60 kV

Ö

refer to USER’S MANUAL §6 “USE INSTRUCTIONS”

Ö

by changing the dip-switch position THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY

− use a current equal to 4 mA − use the short 8” (20cm) cone is − use the long 12” (31cm) cone is − use one single tubehead − use a tubehead with “ac” technology − use n° 2 CONTROL BUTTON

B. The following exposure times have been stored in the “xminddc” x-ray system: 0.020 – 0.025 – 0.032 – 0.040 – 0.050 – 0.063 – 0.080 – 0.100 –0.125 – 0.160 – 0.200 – 0.250 – 0.320 – 0.400 – 0.500 – 0.630 – 0.800 – 1.00 – 1.250 – 1.600 – 2.000 – 2.500 – 3.200 sec PLEASE NOTE These times comply with current CEI EN 60601-2-7 (1999) standards and with the ISO 497 series R’10 recommendations. This programmed exposure times MAY NOT be modified. C. In the “X-Mind DC” x-ray system to further simplify and speed up the operations to select times of exposure, certain exposure times have been predefined which depend on:  the x-ray distance: 12” or 8”  the x-ray technique: FILM or DIGIT  the patient’s body size: ADULT or CHILD  the type of intra-oral test: PERIAPICAL, OCCLUSAL, BITE-WING PLEASE NOTE If one so desires, it is possible to change the “PREDEFINED EXPOSURE TIME VALUES” (refer to §9 “PROGRAMMING DEFAULT EXPOSURE VALUES”)

6. USE INSTRUCTIONS Here below is the suggested operative sequence for a correct exposure:

1. TURN ON THE TIMER to power the radiographic system

a.

Press the "MAIN SWITCH" located on the upper part of the timer to the “I” position (ON)

b. Turn the “’KEY SWITCH” to the “I” position (ON)

  Â

the green light turns on indicating that the system is powered up the Leds of the set x-ray parameters automatically light up the exposure time is shown on the display

c. THE RADIOGRAPHIC SYSTEM IS NOW READY FOR USE

CAUTION If an error is detected when the system is turned on, the anomaly is indicated as follows: •

an intermittent beep sounds

•

the “MALFUNCTIONING INDICATOR”

Led intermittently turns on

The error code (E ….) appears on the display (refer to §12 “ERROR MESSAGES”) •

All “Control Panel” functions are inhibited

In this case, turn off the timer and then turn it back on. If the error should repeat itself, call Customer Support. PLEASE NOTE The exposure time and x-ray parameters which appear on the display are the last that were set before the timer was turned off. PLEASE NOTE If installed, outside the office, the RX signaling lamp, corresponding to the selected tubehead turns on. PLEASE NOTE If the timer remains inactive for a few minutes, it switches to stand-by mode. Press any key on the “Control Panel” to restore it to operating mode.

2. CHECK THE SELECTED EXPOSURE PARAMETERS Before making the exposure check that the “Control (from Step 1 to Step 6) are suitable for the x-ray exam.

STEP 1

Â

Panel”

selected

parameter

Check the selected tubehead The

Led of the desired tubehead should be turned on:

Led Rx1 ON indicates that the tubehead connected to the timer XRAY1 terminal block is selected Led Rx2 ON indicates that the tubehead connected to the timer XRAY2 terminal block is selected To change the selection press the button “RX”

STEP 2

Â

Check the selected tubehead type

The DC

Led should be lit

If the DC Led is not lit call Customer Support

STEP 3

Â

Check the selected x-ray distance

The

Led of the desired SSD should be lit

Led 12”

SSD = 31 cm

Led 8”

SSD = 20 cm

If Led is NOT lit call Customer Support

CAUTION The assembled cone must be the cone corresponding to the selected SSD.

STEP 4

Â

Check the selected x-ray technique IF YOU ARE WORKING WITH CONVENTIONAL FILMS

Check that the

Led for the desired speed film is lit

Led “D” ON indicates that the system is set for use with “D” speed film Led “E” ON indicates that the system is set for use with “E” speed film Led “F” ON indicates that the system is set for use with “F” speed film To change the speed film, press “FILMTYPE” and keep it pressed for 3 sec. until the beep sounds PLEASE NOTE After modification, default automatically changed.

exposure

values

will

be

PLEASE NOTE With conventional films it is advisable to use a x-ray of 8mA (see STEP 7)

IF YOU ARE WORKING WITH A DIGITAL ACQUISITION SYSTEM (CCD OR EQUIVALENT)

Check that the

Led is lit

To change the speed film, press “DIGIT” and keep it pressed for 3 sec. until the beep sounds PLEASE NOTE After modification, default automatically changed.

exposure

values

will

be

PLEASE NOTE With the sensor it is advisable to use a stet current of 4mA (see STEP 7)

STEP 5

Â

Check the selected patient type

The

desired patient led of the should be lit

Led Child ON indicates that the system is set for a patient with a small physique Led Adult ON indicates that the System is set for a patient with a large physique To change the selection press the button located between the two icons “CHILD/ADULT”. PLEASE NOTE After modification, default exposure values will be automatically changed.

STEP 6

Â

Check the selected x-ray voltage

The

Led of the desired voltage should be lit

Led 60 kV ON indicates that the system is set with the “HIGT CONTRAST” radiodiagnostic technology Led 70 kV ON indicates that the system is set with the “LOW CONTRAST” radiodiagnostic technology To change the selection press the “kV” button PLEASE NOTE After modification, default exposure values will be automatically changed.

STEP 7

Â

Check the selected x-ray current

The

desired current led of the should be lit

Led 8 mA ON indicates that the system is set for “NOMINAL DOSE”. The use of “CONVENTIONAL FILMS (FILM)” is advisable Led 4 mA ON indicates that the system is set for “REDUCED DOSE”. The use of “DIGITAL SYSTEMS (FILM)” is advisable

To change the selection press the “mA” button PLEASE NOTE After modification, default exposure values will be automatically changed.

STEP 8

Â

Check the intra-oral test selected The Led for the desired tooth must be on FOR A PERIPERICAL EXAM

To change the selection, press the key for the desired tooth

FOR AN OCCLUSAL EXAM Check that the

Led is lit

MANDIBULA Led ON indicates that the system is set for the OCCLUSAL exam of the LOWER JAW MAXILLA Led ON indicates that the system is set for the OCCLUSAL exam of the UPPER JAW To change the selection, press the “OCCLUSAL”

FOR A BITE-WING EXAM

Check that the

Led or the

Led is lit.

ANT Led ON indicates that the system is set for the exposure time needed for the FRONT BITE-WING EXAM POST Led ON indicates that the system is set for the exposure time needed for the BACK BITE-WING EXAM To change the selection, press the key of the desired “BITE-WING” exam