x-mind dc , xgenus dc and Leadex70 dc Installation and Maintenance Manual Rev F Oct 2018

MANUFACTURER de GötzenS.r.l. - a company of ACTEON Group Via Roma, 45 21057 OLGIATE OLONA (VA) – ITALY Tel. +39 0331 376760 Fax +39 0331 376763 www.acteongroup.com For information and technical assistance, contact the manufacturer [email protected]

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THE RADIOGRAPHIC SYSTEM DESCRIBED IN THIS MANUAL REFERS TO A WALL INSTALLATION. de Götzen S.r.l. – ACTEON Group RESERVES ITSELF THE RIGHT TO MODIFY THE PRODUCTION AND THE MANUAL WITHOUT NOTICE. IT IS PROHIBITED TO MODIFY, COPY, REPRODUCE, DISPLAY, SHARE, DISCLOSE AND PUBLISH THIS MANUAL AND ALL OTHER DOCUMENTS REFERRING TO “SYSTEM” IN ANY FORM WITHOUT PRIOR WRITTEN CONSENT BY de GÖTZEN® S.r.l. – ACTEON Group. THE MANUAL MUST ALWAYS BE KEPT NEAR THE MEDICAL DEVICE FOR FUTURE REFERENCE. de Götzen S.r.l. – ACTEON Group SHALL NOT BE LIABLE FOR AN INCORRECT USE OF THE INFORMATION CONTAINED IN THIS MANUAL.

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CONTENTS Summary CONTROL PANEL ... 6 PRELIMINARY INFORMATION ... 7 1.1. PRELIMINARY INFORMATION ... 7 1.2. INFORMATION FOR THE INSTALLER... 7 1.3 WARRANTY CONDITIONS ... 7 1.4. TRANSPORT CONDITIONS ... 8 1.5. SAFETY WARNINGS... 8 RADIOGRAPHIC SYSTEM ...12 2.1. RADIOGRAPHIC SYSTEM ...12 2.2. SYSTEM COMPONENTS...13 2.3 OPTIONAL ACCESSORIES ...14 2.4. OVERALL DIMENSIONS ...14 2.5. SYMBOLS ...16 INSTALLATION SPECIFICATIONS ...18 3.1. INSTALLATION SPECIFICATIONS ...18 INSTALLATION ...20 4.1. INSTALLATION ...20 4.2. UNPACKING ...20 4.3. ASSEMBLING THE WALL PLATE ...21 4.4. ASSEMBLING THE BRACKET ...22 4.5. ASSEMBLING THE PANTOGRAPH ARM ...23 4.6. ASSEMBLING THE TIMER ...24 4.7. ASSEMBLING THE TUBEHEAD ...25 4.8. BALANCING THE PANTOGRAPH ARM ...27 ELECTRIC CONNECTION ...30 5.1. ELECTRIC CONNECTION ...30 CONFIGURATION...33 6.1. CONFIGURATION ...33 6.2. CHANGING THE CONFIGURATION ...34 START UP ...36 7.1. START UP ...36 INSTALLATION CHECK LIST ...37 INSTALLATION & MAINTENANCE MANUAL • X-MIND DC • (06) • 10/2018 • NXDCEN020F

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8.1. INSTALLATION CHECKS ...37 DIAGNOSTIC ...38 9.1. DIAGNOSTIC ...38 CALIBRATION OF THE TUBEHEAD ...40 ERROR MESSAGES ...41 11.1. ERROR MESSAGES ...41 SUGGESTED MAINTENANCE ...43 12.1. SUGGESTED MAINTENANCE ...43 12.2. CLEANING THE OUTER SURFACE ...43 REPLACEMENT OF FUSES ...45 13.1

FUSES REPLACEMENT...45

REPAIR ...47 14.1. REPAIR ...47 14.2. DISPOSAL ...47 ANNEX 1 ...48 A1. TECHNICAL SPECIFICATIONS ...48 ANNEX 2 ...49 A2. DRAWINGS AND DIMENSIONS ...49 ANNEX 3 ...51 A3. INSTALLATION ELECTRICAL DIAGRAM ...51

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CONTROL PANEL

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PRELIMINARY INFORMATION 1.1. PRELIMINARY INFORMATION Before beginning to use the radiographic system, it is mandatory to carefully read and follow the instructions contained herein, so as to obtain the best possible performance and to assure the safety of the patient, operator, device and environment. Always pay close attention to the CAUTION WARNING PLEASE NOTE messages when operating the system. LEGEND CAUTION The word CAUTION identifies those occurrences which might compromise the operator’s personal safety or cause injuries to people. WARNING The word WARNING identifies those occurrences which might compromise the radiographic system’s performance. PLEASE NOTE PLEASE NOTE serve to give special indications so as to facilitate maintenance or make important information clearer.

1.2. INFORMATION FOR THE INSTALLER CAUTION The installer is responsible for the installation, with regards to the system safety and operation. For safe and reliable installation of the radiographic system it is advisable to: check that the voltage mentioned in the rating plate matches the line voltage; , install the radiographic system according to the procedures described in this manual; , provide the user with any information regarding the use of the radiographic system according to what stated in the manual; , certify the work done by filling-in the “Installation Check-list” to be returned to de Götzen S.r.l. – ACTEON Group.

1.3 WARRANTY CONDITIONS Inappropriate use or any arbitrary tampering with the equipment exempt de Götzen S.r.l. – ACTEON Group, as manufacturer of the radiographic system, from any service under warranty. The warranty is valid only if the following precautions are taken: , any repairs, modifications, adjustments, recalibrations must be performed only by de Götzen S.r.l. – ACTEON Group; , 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; INSTALLATION & MAINTENANCE MANUAL • X-MIND DC • (06) • 10/2018 • NXDCEN020F

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, , ,

the power supply must be adequate to supply the required power indicated in the radiographic system’s nameplate data; the system must be checked completely at least each 12 months by professionally qualified technicians according to the regulation in force; use the manuals provided with the device for reference; in case of repair, please use only spare parts from the manufacturer; otherwise basic safety and essential performances of the device will not be guaranteed.

1.4. TRANSPORT CONDITIONS The radiographic system travels at the receiver’s own risk. All claims for damage or miscarriage regarding the shipment must be pointed out in the presence of the shipping agent. In case of miscarriages, or actual or suspected damage, the receiver shall indicate the proper reserves on the transport documentation or on the consignment note.

1.5. SAFETY WARNINGS A few safety recommendations which should be followed when using the radiographic system are listed here below. CAUTION GENERAL REQUIREMENTS RESPONSIBLE ORGANIZATION is the authority that has the responsibility for the USE and MAINTENANCE of the radiographic system. The training and preparation of personnel is the responsibility of THE RESPONSIBLE ORGANIZATION. the radiographic system is an X-ray generator and must be used and handled only by specialized surgeons, dentists and authorized personnel, who meet the requirements provided by the national laws in force in the country of installation. It is mandatory for the RESPONSIBLE ORGANIZATION to provide a routine and special maintenance schedule for medical equipment; this schedule must be documented for every device and transmitted to the various operating levels (*). The preventive maintenance (that must be performed at least every 12 months), which includes functional, performance and safety tests of the device, must be carried out by qualified, authorized professional technicians. It is mandatory to ensure patients’ health and safety and proper radiographic system operation (IEC 60601-1 etc.). These operations must be carried out according to the methods and frequency indicated in this manual and in the installation and maintenance manual. The RESPONSIBLE ORGANIZATION must also provide for the safe and proper use of the equipment. (*) For Italy refer to Presidential Decree 14/01/1997, Legislative Decree No. 81/2008 (as subsequently amended and modified). Operators must know the environmental and operating specifications of the device, as well as the procedures to follow in the event of hazards or emergency stops. The radiographic system has been designed to acquire radiographic images for dental intraoral X-ray imaging. The medical device must not be used for X-ray imaging of other body parts. Carefully follow the instructions in this manual to install, operate and maintain the radiographic system. In the event that local laws and standards are more restrictive than the manufacturer’s indications, the former supersede the latter. The RESPONSIBLE ORGANIZATION must comply with the standards and regulations in force concerning the installation of the medical device in consideration of the place of installation. The operator is responsible to monitor the patient and the parameters of the radiographic system throughout the entire duration of the X-ray examination. It is prohibited to modify any part of the medical device. de Götzen S.r.l. – ACTEON Group and its authorized technicians are not required to verify compliance of the installation site with local standards concerning electrical safety and X-ray protection and with any other directive concerning safety in force in the Country of installation. The RESPONSIBLE ORGANIZATIONS of the facility must ensure compliance of the installation site with the local laws in force. Before each examination, it is mandatory to apply to the collimator cone (Beam Limiting Device) a disposable protection sheath designed to cover the end part of the X-ray unit, which is more susceptible of being directly contaminated during the X-ray exposure (class I Medical Device Directive 93/42/EEC and subsequent amendments). It can come in contact with the patient’s skin: verify biocompatibility according to the principles given in the ISO 10993 series of standards, refer for details to the disposable use protection’s instructions for use. Before operating the radiographic system, you must assure that the device has no visible signs of damage.

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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 practice 2. Protection Optimization 3. Reduction of the limits of individual dose and risks The system is a medical device that generates X-rays; therefore, both the patients and the operator are exposed to risks due to ionizing radiation. The physician must assess the actual need for X-ray exposure. All personnel present during an X-ray examination must comply with safety regulations concerning protection against radiation. For their own safety, the operator must always keep a distance of more than 2 meters (6 ft.) and out of the path of the X-ray beam, in order to avoid the exposition to the stray radiation and residual radiation. The medical device must be used in compliance with the local standards in force and with the international directives concerning radiation protection. The device must comply with the guidelines and indications provided by an accredited specialist in radiation protection, who will recommend, if necessary, the additional shields or precautions for every specific case. The device installation site must be shielded in compliance with the local standards in force to protect the operator, patient and other people against X-rays. The operator and other personnel must keep clear from the patient during the scan. The personnel involved in the radiographic examination must take all the safety measures concerning radiation protection. The system generates X-rays: before using this X-ray system please refer to the regulation in force in your area concerning pediatric patients, pregnant women and anyone with health issues that contraindicate the use of X-rays. Investigate and make sure of this condition before starting the exposure.

This symbol indicates X-ray hazard.

CAUTION MECHANICAL RISK Before removing the tubehead from the positioning arm, RELEASE THE SPRING. The sudden opening of the joint may cause damage to people and/or things. Check that the installation of the unit complies with the mechanical specifications of the support (walls, ceiling, etc..) where it is installed. Adjustments or any kind of attempt of repairing or disassembling must only be performed by qualified and authorized service personnel. The radiographic system must not be used in environments or close to environments subjected to mechanical vibrations or mechanical shocks.

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CAUTION ELECTRICAL SAFETY The radiographic system contains high voltage. It’s prohibited to inspect internal parts of the system. Never attempt to open the X-ray tubehead. The covers on the radiographic system must only be removed by qualified and authorized service personnel. The unit must be used only in environments that are in compliance with all electrical safety standards set forth for medical environments. To avoid the risk of electric shock, this device must only be connected to a supply mains with protective earth. The unit is NOT equipped with protections against penetration of liquids; it will therefore be necessary to make sure that no water or other liquids penetrate inside in order to avoid short circuits or corrosion. Always disconnect the radiographic system from the power supply and wait for 2 minutes before beginning to clean, disinfect and maintenance operations. Do not connect the X-ray system to a multiple portable socket outlet (MPSO) nor to any type of extension cord. External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In addition, all such combinations shall comply with the safety requirements stated in the general standard CEI EN 60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in CEI EN 60601-1 shall be kept outside the patient environment i.e. at least 1,5 m from the patient support. It is mandatory to use an isolation device (Separation Device) to isolate the equipment located outside the patient environment from the equipment located inside the patient environment. In particular, such a Separation Device is required when a network or data connection is made. The requirements on the Separation Device is defined in CEI EN 60601-1, edition 3, clause 16. For the wall version of radiographic system: based on the CEI EN 60601-1, the installation is a permanent type (fixed). IT IS NOT ALLOWED TO connect the equipment to the main supply using a plug. The cone (beam limiting device) is an APPLIED PART of the system and it is classified as type B.

CAUTION EMC COMPATIBILITY EMC requirements must be considered and the “x-mind dc” must be installed and used accordingly with the specific EMC information provided in the accompanying documents. The device complies with the EMC (Electromagnetic Compatibility) requirements, according to CEI EN 60601-1-2. Radio transmitting equipment, cellular phones etc. shall not be used in close proximity of the unit as they could influence the performance of the system. Carefully read the indications relevant to the EMC in the dedicated appendix EMC compatibility of user manual. Repairs and replacements of any component included cables, must be carried out only using genuine spare parts supplied by de Götzen S.r.l. Using other cables may negatively affect EMC performance.

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

CAUTION SYSTEM MODIFICATIONS OR UPGRADES Modifications or upgrades of the system can be carried out only if advised by de Götzen S.r.l. – ACTEON Group and performed by authorized and qualified personnel, using ONLY genuine original spare parts of de Götzen S.r.l. – ACTEON Group. de Götzen S.r.l. – ACTEON Group proscribes improper, unauthorized modifications or upgrades of the device, in order to avoid malfunctions resulting in breakdowns and/or accident for patient, operator and equipment. Do not remove or attempt to remove the plastic covers of the device. It is strictly forbidden to attempt to repair electronic or mechanical parts by yourself. Disregarding this warning can result in irreversibly compromising the overall safety of the system and can be dangerous for operators, patients and environment.

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RADIOGRAPHIC SYSTEM 2.1. RADIOGRAPHIC SYSTEM The radiographic system guarantees the maximum safety both for the operator and the patient. It is built in compliance with the following European Directives: ⋅ 93/42/EEC and subsequent amendments MEDICAL DEVICES ⋅ EURATOM 96/29 IONISING RADIATIONS and in compliance with the following American Standard: 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, not to allow the 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 self-compensating technology which, by revealing voltage fluctuation, is able to modulate the irradiation time ensuring the proper level of dose; - 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 (6 ft.); - protection against involuntarily selection of radiographic technique (FILM or DIGIT) obtained, according to standards, by means of the confirming on the selection key. “ELECTRO-MEDICAL” CLASSIFICATION According to paragraph §6 of the general safety regulations CEI EN 60601-1: 2007 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 and subsequent amendments the system is classified as: Class IIb “E.M.C.” CLASSIFICATION According to paragraph §4 of the CEI EN 55011, the system is classified as: Group 1 – Class B

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2.2. SYSTEM COMPONENTS

radiographic system (Fig. 1) consists of: 1. TIMER The timer is the control panel used to manage the exposure times and to safely use the tubehead. To make the exposure, the control button with safety key is available. The timer can be connected to n° 2 ac tubeheads. In case of alternate current tubeheads the technology of the timer is “self - compensating”: depending on the line voltage fluctuation, the microprocessor automatically modifies the predetermined exposure time ensuring a constant dose to the patient. This technological expedient avoids the repetition of the exposure because of over/under exposure errors. 2. WALL PLATE 3. BRACKET The horizontal bracket is available in 3 different lengths (110 cm, 80 cm, 40 cm) and represents the support for the pantograph arm. Its shaft is fixed in a dedicated section of the timer (top or bottom) and allows for 180° movement. 4. PANTOGRAPH ARM Thanks to the new shape and new mechanisms of the positioning arm, it can be adjusted in height and depth in order to precisely explore any spot in its reach. It is made of light alloy with an ABS coating. 5. TUBEHEAD The system The intra-oral tubehead “The system” is a monoblock type and its light alloy housing contains an airtight compartment. 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.

6. CONE The collimator cone or Beam Limiting Device represents the applied part of the device. Made of the polycarbonate, it allows: , the correct distance between focal spot and skin , dimension, direction and centering of X-ray beam , the realization of different radiographic technique (bisecting and parallel technique). During X-ray exposition, the collimator cone comes in contact with the skin of the patient. INSTALLATION & MAINTENANCE MANUAL • X-MIND DC • (06) • 10/2018 • NXDCEN020F

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Before each exam, it is necessary to apply to the cone a disposable protective cover designed to cover the end part of the X-ray generator. Such protection has two functions: avoid cross contamination (from patient to patient) and prevent the possibility of inflammations or other types of reactions of the skin caused by contact with the material that constitutes the cone.

2.3 OPTIONAL ACCESSORIES |The system LIGHT (X-ray signaling lamp for external use) |The system ECB (remote control button)

2.4. OVERALL DIMENSIONS Fig. 2A, 2B, 2C give the overall dimensions of the possible supply conditions: BRACKET 400: L = 41 cm – 16” 9/64 BRACKET 800: L = 82,5 cm – 32” 31/64 BRACKET 1100: L = 110 cm – 43” 5/16 BRACKET 400

BRACKET 800

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BRACKET 1100

Fig. 3 and 4 show the typical dimensions of the radiographic system:

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2.5. SYMBOLS PICTOGRAMS USED INSTALLATION & MAINTENANCE MANUAL • X-MIND DC • (06) • 10/2018 • NXDCEN020F

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SYMBOL INDICATING THE MANUFACTURER

THIS SYMBOL GUARANTEES THAT THE RADIOGRAPHIC SYSTEM COMPLIES WITH THE REGULATIONS CONTAINED IN THE EUROPEAN DIRECTIVE EEC 93/42 REGARDING MEDICAL DEVICES SIZE OF THE FOCAL SPOT

THE DEGREE OF PROTECTION AGAINST DIRECT AND INDIRECT ELECTRIC CONTACTS IS B TYPE

SYMBOL INDICATING THE SERIAL NUMBER

SYMBOL INDICATING DANGER DUE TO IONISING RADIATIONS

X-ray EMISSION (IEC 60417)

PAUSE (IEC 60417)

ATTENTION REFER TO THE ATTACHED DOCUMENTS

INSTRUCTIONS IN ELECTRONIC FORMAT

REFER TO MANUAL’S INSTRUCTIONS

WEEE (Waste Electrical and Electronic Equipment) SYMBOL, IN CONFORMITY WITH 2012/19/ CE DIRECTIVE AND EN 50419 STANDARD.

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INSTALLATION SPECIFICATIONS 3.1. INSTALLATION SPECIFICATIONS WARNING Prior to installing the radiographic system, the Responsible Organization must as certain that: the environment, the electric system and the power supply comply with the requirements needed, otherwise he must provide the required adjustment. ENVIRONMENT REQUIREMENTS , The installation environment must be wide enough: check that the size and overall dimension of the environment don’t present any obstacle while positioning the radiographic system. , The environment must not be exposed to explosion hazards and must not be pressurized. , While operating, the ambient temperature must range within +5°C and +40°C. , The storage temperature must range within -15°C and +50°C. , The relative humidity must range within 25% and 75%. REQUIREMENTS OF THE SUPPORTING WALL , The radiographic system supporting wall must be able to stand a 200 Kg tear at every fixing point. PLEASE NOTE It is mandatory to check the nature and consistency of the wall and, if required, ask the support of a brickwork expert. The walls of uncertain consistency must be provided with a buried counter plate or with a sandwich type system. REQUIREMENTS OF THE ELECTRIC SYSTEM , The electric system must comply with the regulations in force. , The electric system must be able to supply the power and voltage required in the manufacturer’s rating plate of the radiographic system (Chart A). Chart A

MANUFACTURER’S RATING PLATE ELECTRIC SYSTEM

230 V ± 10%

115 V ± 10%

NOMINAL VOLTAGE MINIMUM LINE VOLTAGE MAXIMUM LINE VOLTAGE FREQUENCY ABSORBED POWER

230 V 207 V 253 V 50 / 60 Hz 1,2 kVA

115 V 103,5 V 126,5 V 50 / 60 Hz 1,1 kVA

Chart B

MANUFACTURER’S RATING PLATE POWER SUPPLY VOLTAGE

230 V ± 10% 198 ≤ V ≤ 253

115 V ± 10% 103,5 ≤ V ≤ 126,5

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MINIMUM CONDUCTOR SECTION MAXIMUM LINE LENGHT MAXIMUM CONDUCTOR SECTION MAXIMUM LINE LEGHT

1,5 mm2 10 m 2,5 mm2 20 m

PLEASE NOTE For longer lines, the conductor section must be increased in proportion. , ,

The cables (S11, S12 – S21, S22) connecting the timer and the X-ray signaling lamp for external use must be two-pole type, of section 0,5mm2. The electric line characteristics must have the following characteristics (Chart C):

MANUFACTURER’S RATING PLATE ELECTRICAL LINE MAXIMUM VOLTAGE DROP APPARENT LINE RESISTANCE

Chart C 230 V ± 10%

115 V ± 10% 3%

0,5 Ω

0,2 Ω

ELECTRIC CONNECTIONS WARNING Prior to installing the radiographic system, it is advisable that all the electric connections are arranged. TIMER On the timer installation wall, according to the installation electric diagram, suitable runs for the following electric cables must be provided: ⋅ timer electric cables; ⋅ cables for the connection between timer and tubehead; ⋅ cables for the connection between the timer and the X-ray signaling lamp for external use the system LIGHT (OPTIONAL); ⋅ cables for the connection between the timer and the remote-control button the system ECB (OPTIONAL). CAUTION According to the relevant standard, the timer must be installed in a position that allows the operator to constantly control the radiographic exposure. TUBEHEAD On the wall plate installation wall, a suitable run for the cable connecting timer and tubehead must be provided.

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INSTALLATION 4.1. INSTALLATION CAUTION The radiographic system must be installed by professionally trained technicians, who must be able to certify their work by “Declaration of Conformity”. WARNING Prior to installing the radiographic system, it is advisable to verify that all needed requirements have been satisfied (refer to Chapter 3).

4.2. UNPACKING The components of the radiographic system are duly packed within a carton box, as shown in the Fig. 5:

1. TUBEHEAD PACKAGING 2. TIMER + OPTIONAL PACKAGING 3. PANTOGRAPH TYPE ARM PACKAGING 4. WALL PLATE and BRACKET PACKAGING D QUICK START GUIDE and WARRANTY CARD PLEASE NOTE Prior to installation, duly check all components. PLEASE NOTE The carton board and the polystyrene foam can be completely recycled and can be disposed by authorized recycling companies. PLEASE NOTE It is advisable to store the original packaging to return the goods for repairs.

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