X MIND DC Operators Manual Rev 5.0 July 2014

Control panel MAIN SWITCH

CONTROL BUTTON DISPLAY

X-RAY BUTTON

RADIOGRAPHIC DISTANCE INDICATOR

KEY TO DECREASE EXPOSURE TIME

KEY TO INCREASE EXPOSURE TIME

TUBEHEAD TYPE INDICATOR

TUBEHEAD SELECTION

RADIOGRAPHIC VOLTAGE INDICATOR

SELECTION OF PATIENT TYPE

SAVE IN MEMORY

RADIOGRAPHIC CURRENT INDICATOR

MAXILLARY LOWER TEETH

MANDIBULARY LOWER TEETH

OCCLUSAL EXAM

BITE-WING EXAM X-RAY OUTPUT SIGNAL

DIGITAL X-RAY

PAUSE INDICATOR

MALFUNCTION INDICATOR

ON/OFF KEY

CONVENTIONAL X-RAY

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THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS TO A WALL INSTALLATION. “de Götzen® S.r.l.” RESERVES THE RIGHT TO MODIFY THE DESIGN OF THIS PRODUCT AND THE MANUAL WITHOUT PRIOR NOTICE. COPIES, EVEN PARTIAL, OF THIS MANUAL ARE ALLOWED ONLY FOR IN-HOUSE USE. “de Götzen® S.r.l.” SHALL NOT BE HELD LIABLE FOR ANY INCORRECT USE OF THE INFORMATION CONTAINED IN THIS MANUAL.

ORIGINAL LANGUAGE:

ITALIAN

MANUAL REVISION

6.0

EDITION

02/2010

DRAWN UP BY

APPROVED BY

C. Giani

M. de Götzen

PREVIOUS REVISIONS

DATES

0.0

01/2001

1.0

01/2002

1.1

02/2002

2.0

01/2003

3.0

11/2005

3.1

06/2007

4.0

12/2007

5.0

06/2009

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Summary Control panel ... 3 CHAPTER 1 ... 4 PRELIMINARY INFORMATION ... 4 INFORMATION FOR THE USER ... 4 WARRANTY CONDITIONS ... 5 TRANSPORT CONDITIONS ... 5 SAFETY WARNINGS ... 6

CHAPTER 2 ... 8 RADIOGRAPHIC SYSTEM ... 8 SYSTEM COMPONENTS ... 10 IDENTIFICATION TAGS ... 12

CHAPTER 3 ... 13 CONFIGURATION ... 13

CHAPTER 4 ... 15 INSTRUCTIONS FOR USE ... 15

CHAPTER 5 ... 23 CHART OF DEFAULT EXPOSURE VALUES ... 23

CHAPTER 6 ... 28 PROGRAMMING DEFAULT EXPOSURE VALUES ... 28 RESTORING ORIGINAL VALUES ... 30

CHAPTER 7 ... 31 DIAGNOSIS ... 31

CHAPTER 8 ... 32 ERROR MESSAGES ... 32

CHAPTER 9 ... 34 SYSTEM TECHNICAL DATA ... 34

CHAPTER 10 ... 38 RECOMMENDED MAINTENANCE ... 38 CLEANING THE OUTER SURFACE ... 38

CHAPTER 11 ... 39 REPAIRS ... 39 DISPOSAL ... 39

CHAPTER 12 ... 40 ATTACHMENTS ... 40

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CHAPTER 1 PRELIMINARY INFORMATION CHAPTER 1

PRELIMINARY INFORMATION Before you start to use the “xmind®dc” radiographic system, it is recommended to carefully read and follow the instructions contained herein, in order to obtain the best possible performance. Always pay close attention to the CAUTION WARNING PLEASE NOTE messages when operating the system.

KEY CAUTION The word CAUTION identifies those occurrences which might jeopardize the operator’s personal safety or cause physical injuries.

WARNING The word WARNING identifies those occurrences which might compromise the radiographic system’s performance.

PLEASE NOTE PLEASE NOTE gives special indications to facilitate maintenance or to make important information clearer.

INFORMATION FOR THE USER Dear Customer, Thanks for having chosen the “xmind®dc” radiographic system. It is designed and manufactured by “de Götzen  S.r.l.” and is the result of many years of experience in the field of radiology and in the application of advanced electronics. This high performance system represents a further development of technological research at the service of dental radiography. PLEASE NOTE This manual does not contain all the recommendations and the obligations relative to the possession of a source of ionising radiations - since they can vary from state to state - but only the most common ones. The user must consult his/her country’s legislation so as to fulfil all local obligations.

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CHAPTER 1 WARRANTY CONDITIONS

WARRANTY CONDITIONS Inappropriate use or any arbitrary tampering will nullify the liability of “de Götzen® S.r.l.”, as manufacturer of the “xmind®dc” radiographic system, for the provision of any service or other responsibility under the terms of the warranty. The warranty is valid only if the following precautions are taken:  Any repairs, modifications, adjustments, re-calibrations must be performed only by “de Götzen ® S.r.l.”  The installation must be made by professionally qualified technicians according to the regulations in force  The system must be installed and used in compliance with the instructions given in this Manual and for the purposes and applications for which it was designed  The power supply must be adequate to supply the required power indicated in the radiographic system’s nameplate data  In order to safeguard one’s warranty rights, please fill in the enclosed Warranty Document, immediately after the installation is completed, with the technician’s help.

TRANSPORT CONDITIONS The “xmind®dc” radiographic system travels at the receiver’s own risk. All claims for damage or loss regarding the shipment must be identified in the presence of the shipping agent. In the case of loss, or actual or suspected damage, the receiver should indicate the proper reserves on the way-bill or on the consignment note.

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CHAPTER 1 SAFETY WARNINGS

SAFETY WARNINGS The safety recommendations listed here below should be followed when using the “xmind®dc” radiographic system. CAUTION PROTECTION AGAINST RADIATIONS “The general principles regarding safety and protection of workers and people” must always be applied when using the unit: 1. Justification of the examination 2. Protection Optimisation (ALARA) 3. Reduction of the limits of individual dose and risks. The radiographic system must only be used by authorized and qualified personnel. All personnel present during the radiographic examination must comply with safety measures foreseen with regard to protection from radiation. For the operator’s own safety, a distance of more than 2 meters from the radiographic unit must always been respected. To protect the patient from unnecessary exposure to radiation, additional anti-radiation protections may be used whenever necessary (aprons, collars, etc.).

ATTENSION X-RAYS

CAUTION MECHANICAL RISK Before removing the tubehead from the positioning arm, RELEASE THE SPRING because the joint might burst open and hit the operator.

CAUTION ELECTRIC SAFETY The radiographic system contains high voltage. When inspecting internal parts, always turn off the power before touching any electric part. The unit must be used only in environments that are in full compliance with all electric safety standards for medical environments. The unit is NOT equipped with protections against the penetration of liquids; it will therefore be necessary to make sure that no water or other liquids penetrate inside so as to avoid short circuits or corrosion. Always disconnect the radiographic system from the power supply before cleaning and disinfecting operations.

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CHAPTER 1 SAFETY WARNINGS

CAUTION PROTECTION AGAINST EXPLOSIONS The radiographic system MUST NOT be used in the presence of disinfectants, flammable or potentially explosive gases or vapours that might catch fire and cause damage. In the case that these disinfectants have to be used let the vapour completely evaporate before turning on the radiographic system.

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CHAPTER 2 RADIOGRAPHIC SYSTEM CHAPTER 2

RADIOGRAPHIC SYSTEM The “xmind®dc” radiographic system guarantees maximum safety both for the operator and the patient. It is built in compliance with the following European Directives:  93/42/EEC MEDICAL DEVICES  73/23/EEC LOW VOLTAGE  89/336/EEC ELECTROMAGNETIC COMPATIBILITY  EURATOM 96/29 IONISING RADIATIONS 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:  Protection against the risk of electric injuries, ensured by a grounded protection conductor  Protection against leakage radiation, made negligible by the shielded casing  Protection against excessive radiations, thanks to the immediate activation of the safety device  Protection against continuous service, since the system is designed, according to standards, so as not to allow use in radioscopy  Protection for the patient against dangerous radiations, obtained by means of the high frequency technology capable of producing a constant and hard radiation  Protection against exposure mistakes obtained with the high frequency technology which is unaffected by voltage fluctuation and consequently capable to guarantee extremely accurate exposure parameters  Protection for the operator against irradiation ensured by the extensible cable of the hand control which allows for a safety distance of more than 2 meters  Protection against involuntarily selection of radiographic technique (FILM or DIGIT) obtained, according to standards, by means of the confirming of the key of selection.

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CHAPTER 2 RADIOGRAPHIC SYSTEM

“ELECTRO-MEDICAL” CLASSIFICATION According to paragraph 5 of the general safety regulations EC.EN.60 601-1/1998 on safety of medical equipment, the system is classified as: Class I - Type B. “MEDICAL DEVICES” CLASSIFICATION According to the classification rules indicated in attachment IX of the EEC Directive 93/42 on medical devices the system is classified as: Class IIb. “E.M.C.” CLASSIFICATION According to paragraph 4 of the EEC EN 55011, the system is classified as: Group 1 - Class B.

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CHAPTER 2 SYSTEM COMPONENTS

SYSTEM COMPONENTS 2

1

3 4

Figure 1 “xmind®dc” radiographic system (Figure 1) consists of: 1. xmind® TIMER The timer is the control panel used to manage the times and to safely use the tubehead. To take the exposure the control button is equipped with a safety button. The timer can be connected to two tubeheads. The timer is a “multi-technological” type and it is able to control tubeheads of different technologies: alternating current “xmind®ac” and direct current “xmind®dc”. In the case of alternating current tubeheads the timer technology is “self-compensating”. Depending on the line voltage fluctuation the microprocessor automatically modifies the predetermined exposure time guaranteeing a constant dose to the patient. This technological feature avoids the repetition of exposures due to over/under exposure errors. 2. PANTOGRAPH Thanks to the new shape and new mechanisms of the positioning arm, it can be adjusted in height and depth so as to precisely explore any spot in its reach. It is made of light alloy with an ABS coating.

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CHAPTER 2 SYSTEM COMPONENTS

3. xmind® TUBEHEAD The “xmind®dc” intra-oral tubehead is a monoblock type and 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 expansion chamber guarantees an adequate compensation to oil expansion for the entire temperature range. The x-ray tube is located in the back part of the container, allowing a source-skin distance 50% higher than traditional structures. In the second compartment are placed the main electronic board and the control electronic board. 4. CONE Made of the transparent polycarbonate, it allows for: 

Correct focal spot to skin distance



Dimension, direction and centering of x-ray beam



Realization of different radiographic technique (bisecting and parallel technique).

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CHAPTER 2 IDENTIFICATION TAGS

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

TUBEHEAD Made by de Götzen

®

S.r.l. - Via Roma 45 - 1057 OLGIATE OLONA (VA) - ITALIA ®

model xmind dc

70kVp 8Ma 0.415kVA Rated Line Voltage: V  50-60Hz Nominal line current: A S/N: Tube TOSHIBA DG-073B-AC S/N

Total Filtration: 2mm Al a 70kV Class I Type B

IP20

Manufacture date: 0.7

Complies with DHHS 21 CFR Subchapter J

TIMER Made by de Götzen

®

S.r.l. - Via Roma 45 - 1057 OLGIATE OLONA (VA) - ITALIA ®

model xmind dc

Line Voltage: Momentary current: S/N:

V  50-60Hz A

Class I Type B

IP20

Current: Manufacture date:

A

Complies with DHHS 21 CFR Subchapter J

CONE

GRADUATED SCALE

PICTOGRAMS USED THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 RELEVANT TO MEDICAL DEVICES THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS IS B TYPE REFER TO THE INSTRUCTIONS MANUAL

SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS

SIZE OF THE FOCAL SPOT WEEE (Waste Electrical and Electronic Equipment) symbol, in conformity with 2002/96/CE Directive and EN 50419 standard.

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CHAPTER 3 CONFIGURATION CHAPTER 3

CONFIGURATION The “xmind®dc” radiographic system is factory configured in “standard mode”. On the control panel the LED relevant to the following exposure parameters will light up: No. of the selected tubehead LED 1 Supplied cone LED 8” = SHORT CONE LED 12” = LONG CONE Tubehead type LED AC = ALTERNATING CURRENT LED DC = DIRECT CURRENT Radiographic voltage LED 70 kV Radiographic current LED 8 mA Type of patient LED ADULT Radiographic technique CONVENTIONAL LED D

The following exposure times (sec) have been stored: 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 PLEASE NOTE These times are in compliance with current CEI EN 60601-2-7 (1999) norms and with the ISO 497 series R’10 recommendations. MAY NOT BE MODIFIED

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CHAPTER 3 CONFIGURATION

Certain exposure values have been predefined which depend on the selection of the operating parameters:  Cone (8”/12”)  Type of patient (ADULT/CHILD)  Radiographic technique  Intra-oral test. PLEASE NOTE If one so desires, it is possible to change this values. (refer to Chapters 5 and 6)

POSSIBLE MODIFICATIONS OF THE EXPOSURE VALUES  Radiographic voltage (60 kV/70 kV)  Radiographic current (4 mA/8 mA)  Type of patient (ADULT/CHILD)  Radiographic technique.  (refer to Chapter 4)

POSSIBLE MODIFICATIONS OF THE EXPOSURE VALUES  Cone (8”/12”)  Type tubehead  Control button no.  inside the timer, by changing the dip-switch position. THIS OPERATION MUST BE CARRIED OUT BY THE INSTALLER ONLY.

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CHAPTER 4 INSTRUCTIONS FOR USE CHAPTER 4

INSTRUCTIONS FOR USE TURN ON - 1° Put the main switch located on the upper part of the timer to the “I” position (ON).

Turn the key switch to the “I” position (ON).

1. The green light turns on indicating that the system is powered. 2. The LEDs of the set parameters automatically light up. 3. The exposure time is shown on the display. CAUTION If an error is detected when the system is turned on, the anomaly is indicated as follows:  An intermittent beep sounds  The

LED MALFUNCTION INDICATOR flashes

 The error code (E ….) appears on the display (refer to Chapter 8)  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 the “After Sales Service”.

PLEASE NOTE The exposure time and parameters which appear on the display are the last that were set before the timer was turned off. 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 the operative mode.

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CHAPTER 4 INSTRUCTIONS FOR USE

CHECK THE SELECTED PARAMETERS - 2° Before making the exposure check that the parameters selected on the control panel (from STEP 1 to STEP 8) are suitable for the radiographic examination.

STEP 1 CHECK THE SELECTED TUBEHEAD The LED of the chosen tubehead should be turned on. LED Rx 1 ON indicates that the tubehead connected to the timer XRAY1 terminal block is selected. LED Rx 2 ON indicates that the tubehead connected to the timer XRAY2 terminal block is selected. To change the selection press the button again.

STEP 2 CHECK THE SELECTED RADIOGRAPHIC DISTANCE CONE The LED of the cone length (source-skin distance = SSD) in use should be turned on. LED 8” ON indicates that the selected tubehead is equipped with 8” = 20 cm (SSD) cone. LED 12” ON indicates that the selected tubehead is equipped with 12” = 31 cm (SSD) cone. To change the selection call the “After Sales Service”. PLEASE NOTE After modification, default exposure values will be changed automatically.

STEP 3 CHECK THE SELECTED TYPE TUBEHEAD The LED of the type of selected tubehead should be turned on. LED AC ON indicates that the selected tubehead works in alternating current technology. LED DC ON indicates that the selected tubehead works in direct current technology. To change the selection call the “After Sales Service”. PLEASE NOTE After modification, default exposure values will be changed automatically.

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CHAPTER 4 INSTRUCTIONS FOR USE

STEP 4 CHECK THE SELECTED RADIOGRAPHIC VOLTAGE The LED of the desired radiographic voltage should be turned on. LED 60 kV ON indicates that the radiographic system is set with the high contrast radiodiagnostic technology. LED 70 kV ON indicates that the radiographic system is set with the low contrast radiodiagnostic technology. To change the selection press the button again. PLEASE NOTE 60 kV mode can be selected with the “xmind®dc” radiographic system only. PLEASE NOTE After the modification, default exposure values will be changed automatically.

STEP 5 CHECK THE SELECTED RADIOGRAPHIC CURRENT The LED of the desired radiographic current should be turned on. LED 4 mA ON indicates that the radiographic system is set with reduced dose. It is advisable when using the digital radiographic technique. LED 8 mA ON indicates that the radiographic system is set with nominal dose. It is advisable when using the conventional radiographic technique. To change the selection press the button again. PLEASE NOTE The 4 mA mode can be selected with the “xmind®dc” radiographic system only. PLEASE NOTE After modification, default exposure values will be changed automatically.

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CHAPTER 4 INSTRUCTIONS FOR USE

STEP 6 CHECK THE SELECTED TYPE OF PATIENT The LED of the desired patient type should be turned on. LED CHILD ON indicates that the radiographic system is set for a patient with a small physique. LED ADULT ON indicates that the radiographic system is set for a patient with a large physique. To change the selection press the button again. PLEASE NOTE After modification, default exposure values will be changed automatically.

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CHAPTER 4 INSTRUCTIONS FOR USE

STEP 7 CHECK THE SELECTED RADIOGRAPHIC TECHNIQUE CONVENTIONAL TECHNIQUE (FILM) The LED of the chosen film speed should be turned on. LED D ON: the radiographic system is set for use with D speed film. LED E ON: the radiographic system is set for use with E speed film. LED F ON: the radiographic system is set for use with F speed film. To change the selection press the button again for 3 sec until the signal beeps. PLEASE NOTE With films it is advisable to use a radiographic current of 8 mA (refer to STEP 5). PLEASE NOTE After modification, default exposure values will be changed automatically.

DIGITAL TECHNIQUE (SENSOR) The LED should be turned on. To change the selection press the button again for 3 sec until the signal beeps.

PLEASE NOTE With films it is advisable to use a radiographic current of 4 mA (refer to STEP 5). PLEASE NOTE After modification, default exposure values will be changed automatically.

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